Page Range | 16053-17057 | |
FR Document |
Page and Subject | |
---|---|
81 FR 16053 - Building National Capabilities for Long-Term Drought Resilience | |
81 FR 16264 - Notice of Unsafe Condition Involving Commercial Motor Vehicles Affected by Volvo Trucks North America's Safety Recall and Out-of-Service Declaration | |
81 FR 16102 - Disestablishment of Danger Zone for Meteorological Rocket Launching Facility, Shemya Island Area, AK | |
81 FR 16093 - Disestablishment of Danger Zone for Meteorological Rocket Launching Facility, Shemya Island Area, AK | |
81 FR 16174 - Proposed Information Collection Request; Comment Request; The National Oil and Hazardous Substance Pollution Contingency Plan Regulation | |
81 FR 16173 - FY2016 Supplemental Funding for Brownfields Revolving Loan Fund (RLF) Grantees | |
81 FR 16139 - United States Manufacturing Council: Meeting of the United States Manufacturing Council | |
81 FR 16099 - Identifying and Reducing Regulatory Burdens | |
81 FR 16142 - Patent Quality Metrics for Fiscal Year 2017 and Request for Comments on Improving Patent Quality Measurement | |
81 FR 16196 - 30-Day Notice of Proposed Information Collection: Information Resource Center Customer Satisfaction Survey | |
81 FR 16194 - 60-Day Notice of Proposed Information Collection: Surveys of Community Development Marketplace Project Inventory and Recipients and Providers of HUD Technical Assistance and Training | |
81 FR 16211 - National Historic Landmarks Committee of the National Park System Advisory Board Meeting | |
81 FR 16138 - Notice of Final Results of Antidumping Duty Changed Circumstances Review: Drawn Stainless Steel Sinks From the People's Republic of China | |
81 FR 16213 - Notice of April 20-21, 2016, Meeting of the Preservation Technology and Training Board | |
81 FR 16212 - Notice of 2016 Meeting Schedule for Gettysburg National Military Park Advisory Commission | |
81 FR 16213 - Request for Nominations for the Gettysburg National Military Park Advisory Commission | |
81 FR 16203 - Contract Support Costs | |
81 FR 16204 - Yavapai-Apache Nation of the Camp Verde Indian Reservation Liquor Code | |
81 FR 16154 - Application for New Awards; Native American and Alaska Native Children in School Program | |
81 FR 16162 - National Committee on Foreign Medical Education and Accreditation | |
81 FR 16074 - Operations in Rural Areas Under the Truth in Lending Act (Regulation Z); Interim Final Rule | |
81 FR 16097 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pollock in the Bering Sea and Aleutian Islands | |
81 FR 16096 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod in the Aleutian Islands Subarea of the Bering Sea and Aleutian Islands Management Area | |
81 FR 16184 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 16184 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 16145 - Procurement List; Deletions | |
81 FR 16145 - Procurement List Proposed Additions and Deletions | |
81 FR 16146 - Procurement List; Deletions | |
81 FR 16282 - Submission for OMB Review; Comment Request | |
81 FR 16154 - Agency Information Collection Activities; Comment Request; Study of the Title III Native American and Alaska Native Children in School (NAM) Program | |
81 FR 16191 - Towing Safety Advisory Committee | |
81 FR 16127 - Submission for OMB Review; Comment Request | |
81 FR 16137 - In the Matter of: Nutveena Sirirojnananont, 399 Maplewood Avenue, Portmouth, NH 03801; Order Denying Export Privileges | |
81 FR 16254 - Surface Transportation Project Delivery Program; TxDOT Audit Report | |
81 FR 16175 - Environmental Impact Statements; Notice of Availability | |
81 FR 16214 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
81 FR 16176 - Privacy Act System of Records | |
81 FR 16207 - Privacy Act of 1974, as Amended; Notice To Amend an Existing System of Records | |
81 FR 16190 - Proposed Collection; 60-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research (OD) | |
81 FR 16224 - Notice of Submission for Approval: Information Collection 3206-0258; Questionnaire for Public Trust Positions (SF 85P) and Supplemental Questionnaire for Selected Positions (SF 85P-S) | |
81 FR 16187 - Meeting of the President's Council on Fitness, Sports, and Nutrition | |
81 FR 16188 - Meeting of the Advisory Committee on Minority Health | |
81 FR 16215 - Certain Height Adjustable Desk Platforms and Components Thereof Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation on the Basis of Settlement; Termination of Investigation | |
81 FR 16278 - Proposed Collection of Information: FHA New Account Request, Transition Request, and Transfer Request | |
81 FR 16168 - Combined Notice of Filings | |
81 FR 16166 - Combined Notice of Filings | |
81 FR 16279 - Office of Foreign Assets Control | |
81 FR 16141 - Submission for OMB Review; Comment Request | |
81 FR 16183 - Notice of the General Services Administration's Labor-Management Relations Council Meeting | |
81 FR 16224 - Final Adoption of Updated Federal Elements of the Comprehensive Plan for the National Capital | |
81 FR 16210 - Notice of Public Meeting for the Coastal Oregon Resource Advisory Council | |
81 FR 16280 - Financial Research Advisory Committee | |
81 FR 16188 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort | |
81 FR 16281 - 2016 Report on the Terrorism Risk Insurance Program | |
81 FR 16265 - Qualification of Drivers; Exemption Applications; Vision | |
81 FR 16200 - Draft Environmental Impact Statement; Eastern Collier Multi-Species Habitat Conservation Plan; Collier County, Florida | |
81 FR 16215 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Application for Registration Under Domestic Chemical Diversion Control Act of 1993, Renewal Application for Registration Under Domestic Chemical Diversion Control Act of 1993; DEA Forms 510, 510A | |
81 FR 16216 - Notice Lodging of Proposed Consent Decree Under the Oil Pollution Act | |
81 FR 16252 - San Jacinto Transportation Company, Inc.-Operation Exemption-SJRE-Railroad Series | |
81 FR 16202 - Endangered Species; Marine Mammals; Issuance of Permits | |
81 FR 16197 - Endangered Species; Receipt of Applications for Permit | |
81 FR 16229 - Premise Capital, LLC, et al.; Notice of Application | |
81 FR 16251 - North Carolina & Atlantic Railroad Co., Inc.-Lease and Operation Exemption-North Carolina Department of Transportation | |
81 FR 16252 - BNSF Railway Company-Trackage Rights Exemption-State of Washington, Department of Transportation | |
81 FR 16251 - Gulf & Ohio Railways, Inc., H. Peter Claussen and Linda C. Claussen-Continuance in Control Exemption-North Carolina & Atlantic Railroad Co., Inc. | |
81 FR 16199 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Annual Certification of Hunting and Sport Fishing Licenses Issued | |
81 FR 16223 - Advisory Committee on Construction Safety and Health (ACCSH) | |
81 FR 16172 - Combined Notice of Filings #1 | |
81 FR 16163 - Combined Notice of Filings # 1 | |
81 FR 16168 - Commission Information Collection Activities (FERC-714 and FERC-730); Comment Request | |
81 FR 16170 - Commission Information Collection Activities; (FERC-556, FERC-606, and FERC-607); Comment Request | |
81 FR 16164 - NextEra Energy Power Marketing, LLC Northeast Energy Associates, a Limited Partnership v. ISO New England Inc.; Notice of Complaint | |
81 FR 16168 - Notice of Commission Staff Attendance | |
81 FR 16165 - Pike County Light & Power Company; Notice of Application | |
81 FR 16167 - Dominion Carolina Gas Transmission, LLC; Notice of Application | |
81 FR 16164 - Combined Notice of Filings #2 | |
81 FR 16059 - Assessments | |
81 FR 16136 - Notice of Request for Extension of a Currently Approved Information Collection | |
81 FR 16186 - General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products; Draft Guidance for Industry; Availability | |
81 FR 16127 - Inviting Applications for Rural Cooperative Development Grants | |
81 FR 16217 - Workforce Innovation and Opportunity Act (WIOA) 2014; Lower Living Standard Income Level (LLSIL) | |
81 FR 16189 - National Institute on Aging; Notice of Meeting | |
81 FR 16190 - National Institute on Aging; Notice of Closed Meeting | |
81 FR 16189 - National Institute on Aging; Notice of Closed Meetings | |
81 FR 16270 - NHTSA Enforcement Guidance Bulletin 2016-01; Guidance on Submission and Treatment of Manufacturer Communications to Dealers, Owners, or Purchasers About a Defect or Noncompliance | |
81 FR 16277 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Minimum Security Devices and Procedures, Reports of Suspicious Activities, and Bank Secrecy Act Compliance Program | |
81 FR 16253 - Aviation Rulemaking Advisory Committee Meeting on Transport Airplane and Engine Issues | |
81 FR 16253 - Petition for Exemption; Summary of Petition Received; Wittman Regional Airport | |
81 FR 16141 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Pre-Assessment Webinar for South Atlantic Red Snapper and Gray Triggerfish | |
81 FR 16229 - Product Change-Priority Mail Express Negotiated Service Agreement | |
81 FR 16229 - Product Change-Priority Mail Express and Priority Mail Negotiated Service Agreement | |
81 FR 16228 - Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement | |
81 FR 16228 - Product Change-Parcel Select Negotiated Service Agreement | |
81 FR 16229 - Product Change-Priority Mail Negotiated Service Agreement | |
81 FR 16192 - Chemical Transportation Advisory Committee; Vacancies | |
81 FR 16247 - Northern Lights Fund Trust and Princeton Fund Advisors, LLC; Notice of Application | |
81 FR 16245 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change To Revise the ICC Operational Risk Management Framework | |
81 FR 16238 - Self-Regulatory Organizations; ISE Mercury, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
81 FR 16248 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Eliminate the Strict Concentration Limits on Primary Market Makers | |
81 FR 16240 - Self-Regulatory Organizations; ISE Mercury, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
81 FR 16227 - Product Change-Priority Mail Negotiated Service Agreement | |
81 FR 16228 - Product Change-Priority Mail Negotiated Service Agreement | |
81 FR 16228 - Product Change-First-Class Package Service Negotiated Service Agreement | |
81 FR 16226 - New Postal Product | |
81 FR 16095 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2016 Commercial Accountability Measure and Closure for South Atlantic Vermilion Snapper | |
81 FR 16190 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 16282 - Proposed Information Collection (Alternate Signer Certification (VA Form 21-0972)); Activity: Comment Request | |
81 FR 16283 - Proposed Information Collection (Marital Status Questionnaire, VA Form 21P-0537); Activity: Comment Request | |
81 FR 16227 - New Postal Product | |
81 FR 16269 - Continental Tire the Americas, LLC, Receipt of Petition for Decision of Inconsequential Noncompliance | |
81 FR 16268 - Cooper Tire & Rubber Company, Receipt of Petition for Decision of Inconsequential Noncompliance | |
81 FR 17057 - Acquisition of Items for Which Federal Prison Industries Has a Significant Market Share | |
81 FR 17055 - Defense Federal Acquisition Regulation Supplement: Costs Related to Counterfeit Electronic Parts (DFARS Case 2016-D010) | |
81 FR 17053 - Defense Federal Acquisition Regulation Supplement: Treatment of Interagency and State and Local Purchases (DFARS Case 2016-D009) | |
81 FR 17051 - Defense Federal Acquisition Regulation Supplement: Instructions for the Wide Area WorkFlow Reparable Receiving Report (DFARS Case 2016-D004) | |
81 FR 17050 - Defense Federal Acquisition Regulation Supplement: Prohibition on Use of Any Cost-Plus System of Contracting for Military Construction and Military Family Housing Projects (DFARS Case 2015-D040) | |
81 FR 17048 - Defense Federal Acquisition Regulation Supplement: Prohibition on Requiring the Use of Fire-resistant Rayon Fiber (DFARS Case 2016-D012) | |
81 FR 17047 - Defense Federal Acquisition Regulation Supplement: Buy American and Balance of Payments Program-Clause Prescription (DFARS Case 2015-D037) | |
81 FR 17045 - Defense Federal Acquisition Regulation Supplement: Clauses With Alternates-Small Business Programs (DFARS Case 2015-D017) | |
81 FR 17044 - Defense Federal Acquisition Regulation Supplement: Extension and Modification of Contract Authority for Advanced Component Development and Prototype Units (DFARS Case 2015-D008) | |
81 FR 17042 - Defense Federal Acquisition Regulation Supplement: Warranty Tracking of Serialized Items (DFARS Case 2014-D026) | |
81 FR 16146 - Proposed Collection; Comment Request | |
81 FR 16147 - Proposed Collection; Comment Request | |
81 FR 16094 - Approval of Air Quality State Implementation Plans (SIP); State of Iowa; Infrastructure SIP Requirements for the 2008 Lead National Ambient Air Quality Standard (NAAQS); Correction | |
81 FR 16102 - Approval of Air Quality Implementation Plans; New Jersey, Carbon Monoxide Maintenance Plan | |
81 FR 16147 - One-Time Deauthorization of Water Resources Projects | |
81 FR 16250 - Public Notice; 30-Day Notice of Proposed Information Collection: Smart Traveler Enrollment Program | |
81 FR 16107 - Odometer Disclosure Requirements | |
81 FR 16198 - Deer Flat National Wildlife Refuge, Canyon, Payette, Owyhee, and Washington Counties, ID, and Malheur County, OR; Comprehensive Conservation Plan and Record of Decision for Final Environmental Impact Statement | |
81 FR 16217 - Advisory Board; Notice of Meeting | |
81 FR 16892 - Exempt Chemical Preparations Under the Controlled Substances Act | |
81 FR 16140 - Small Business Innovation Research (SBIR) Request for Public Comments | |
81 FR 16140 - Science Advisory Board (SAB) | |
81 FR 16100 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters | |
81 FR 16193 - Federal Property Suitable as Facilities To Assist the Homeless | |
81 FR 16085 - Updating OSHA Standards Based on National Consensus Standards; Eye and Face Protection | |
81 FR 16275 - Hazardous Materials: Notice of Applications for Special Permits | |
81 FR 16276 - Hazardous Materials: Notice of Applications for Special Permits | |
81 FR 16286 - Occupational Exposure to Respirable Crystalline Silica |
Food and Nutrition Service
Rural Business-Cooperative Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Defense Acquisition Regulations System
Engineers Corps
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Drug Enforcement Administration
National Institute of Corrections
Employment and Training Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Bureau of the Fiscal Service
Comptroller of the Currency
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Deposit Insurance Corporation (FDIC).
Final rule.
Pursuant to the requirements of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) and the FDIC's authority under section 7 of the Federal Deposit Insurance Act (FDI Act), the FDIC is imposing a surcharge on the quarterly assessments of insured depository institutions with total consolidated assets of $10 billion or more. The surcharge will equal an annual rate of 4.5 basis points applied to the institution's assessment base (with certain adjustments). If the Deposit Insurance Fund (DIF or fund) reserve ratio reaches 1.15 percent before July 1, 2016, surcharges will begin July 1, 2016. If the reserve ratio has not reached 1.15 percent by that date, surcharges will begin the first day of the calendar quarter after the reserve ratio reaches 1.15 percent. (Lower regular quarterly deposit insurance assessment (regular assessment) rates will take effect the quarter after the reserve ratio reaches 1.15 percent.) Surcharges will continue through the quarter that the reserve ratio first reaches or exceeds 1.35 percent, but not later than December 31, 2018. The FDIC expects that surcharges will commence in the second half of 2016 and that they should be sufficient to raise the DIF reserve ratio to 1.35 percent in approximately eight quarters,
This rule will become effective on July 1, 2016.
Munsell W. St. Clair, Chief, Banking and Regulatory Policy Section, Division of Insurance and Research, (202) 898-8967; Nefretete Smith, Senior Attorney, Legal Division, (202) 898-6851; and James Watts, Senior Attorney, Legal Division (202) 898-6678.
On October 22, 2015, the FDIC's Board of Directors (Board) authorized publication of a notice of proposed rulemaking (NPR) to impose a surcharge on the quarterly assessments of insured depository institutions with total consolidated assets of $10 billion or more.
The NPR was published in the
The FDIC maintains a fund in order to assure the agency's capacity to meet its obligations as insurer of deposits and receiver of failed banks.
The Dodd-Frank Act, enacted on July 21, 2010, contained several provisions to strengthen the DIF.
Both the Dodd-Frank Act and the FDI Act grant the FDIC broad authority to implement the requirement to achieve the 1.35 percent minimum reserve ratio. In particular, under the Dodd-Frank Act, the FDIC is authorized to take such steps as may be necessary for the reserve ratio to reach 1.35 percent by September 30, 2020.
In the FDIC's view, the Dodd-Frank Act requirement to raise the reserve ratio to the minimum of 1.35 percent by September 30, 2020 reflects the importance of building the DIF in a timely manner to withstand future economic shocks. Increasing the reserve ratio faster reduces the likelihood of procyclical assessments, a key policy
The purpose of the final rule is to meet the Dodd-Frank Act requirements in a manner that appropriately balances several considerations, including the goal of reaching the minimum reserve ratio reasonably promptly in order to strengthen the fund and reduce the risk of pro-cyclical assessments, the goal of maintaining stable and predictable assessments for banks over time, and the projected effects on bank capital and earnings. The primary mechanism described below for meeting the statutory requirements—surcharges on regular assessments—will ensure that the reserve ratio reaches 1.35 percent without inordinate delay (likely in 2018) and will ensure that assessments are allocated equitably among banks responsible for the cost of reaching the minimum reserve ratio.
The Dodd-Frank Act gave the FDIC greater discretion to manage the DIF than it had previously, including greater discretion in setting the target reserve ratio, or designated reserve ratio (DRR), which the FDIC must set annually.
By statute, the FDIC also operates under a Restoration Plan while the reserve ratio remains below 1.35 percent.
In February 2011, the FDIC adopted a final rule that, among other things, contained a schedule of deposit insurance assessment rates that apply to regular assessments that banks pay. The FDIC noted when it adopted these rates that, because of the requirement making banks with $10 billion or more in assets responsible for increasing the reserve ratio from 1.15 percent to 1.35 percent, “assessment rates applicable to all insured depository institutions need only be set high enough to reach 1.15 percent” before the statutory deadline of September 30, 2020.
In the February 2011 final rule, the FDIC also adopted a schedule of lower regular assessment rates that will go into effect once the reserve ratio of the DIF reaches 1.15 percent.
The FDIC expects that, under the current assessment rate schedule, the DIF reserve ratio will reach 1.15 percent in the first half of 2016.
As proposed in the NPR, to implement the requirements of the Dodd-Frank Act, and pursuant to the FDIC's authority in section 7 of the FDI Act,
As proposed in the NPR, the annual surcharge rate will be 4.5 basis points, which the FDIC expects will be sufficient to raise the reserve ratio from 1.15 percent to 1.35 percent in 8 quarters, before the end of 2018.
The FDIC received several comments on the surcharge rate and estimated surcharge period. In a joint comment letter, three trade groups stated that a “strong” majority of large banks that they surveyed favored an alternative discussed in the NPR of charging lower surcharges over a longer period and imposing a shortfall assessment only if the reserve ratio has not reached 1.35 percent by a date nearer the statutory deadline. Specifically, the trade groups proposed an annual surcharge of no more than 2.25 basis points to reach 1.35 percent in 14 quarters, and a shortfall, if needed, to be assessed in the first quarter of 2020.
One commenter supported an alternative discussed in the NPR of foregoing surcharges entirely and, if the reserve ratio does not reach 1.35 percent by a deadline sometime near the statutory deadline, imposing a delayed
On the other hand, the joint comment letter submitted by the three trade groups did note that a few large banks surveyed supported the proposed surcharge rate and timeline in the NPR, while a few others favored a one-time assessment once the reserve ratio first reaches 1.15 percent (an alternative also discussed in the NPR). One bank in its comment letter also preferred a one-time assessment just after the reserve ratio first reaches or exceeds 1.15 percent in order to raise the reserve ratio closer to 1.35 percent (but not all the way to 1.35 percent) sooner than would occur under the proposal. Another trade group preferred charging surcharges over a shorter timeframe—four quarters—but found that the proposal in the NPR and a one-time assessment just after the reserve ratio first reaches or exceeds 1.15 percent were also reasonable options.
In the FDIC's view, the final rule strikes an appropriate balance among these options after considering: (1) The statutory deadline for reaching the minimum reserve ratio; (2) the importance of strengthening the fund's ability to withstand a spike in losses; (3) the goal of reducing the risk of larger assessments for the entire industry in a future period of stress; and (4) the effects on the capital and earnings of surcharged banks.
The FDIC expects that surcharges will result in the reserve ratio reaching 1.35 percent in 2018. Reaching the statutory target reasonably promptly and in advance of the statutory deadline has benefits. First, it strengthens the fund so that it can better withstand an unanticipated spike in losses from bank failures or the failure of one or more large banks.
Second, it reduces the risk of the banking industry facing unexpected, large assessment rate increases in a future period of stress. Once the reserve ratio reaches 1.35 percent, the September 30, 2020 deadline in the Dodd-Frank Act will have been met and will no longer apply. If the reserve ratio later falls below 1.35 percent, even if that occurs before September 30, 2020, the FDIC will have a minimum of eight years to return the reserve ratio to 1.35 percent, reducing the likelihood of a large increase in assessment rates.
In addition, large banks will account for future surcharges in the quarterly report of condition and income (Call Report) and other banking regulatory reports based on generally accepted accounting principles (GAAP) as quarterly expenses, as they do for regular assessments, effectively spreading the cost of the requirement over approximately eight quarters in a simple, predictable manner.
In contrast, a longer surcharge period or a delayed one-time assessment without surcharges would reduce the fund's ability to withstand a spike in losses and increase the risk of larger assessments for the entire industry in a future period of stress.
Five comment letters also stated that, rather than imposing a separate surcharge at a uniform rate, the FDIC should implement surcharges in a risk-based manner.
The final rule uses a flat-rate surcharge. As one commenter acknowledged, while the FDI Act requires that regular assessments be risk-based, no such requirement exists for special assessments.
Banks subject to the surcharge will continue to pay risk-based regular deposit insurance assessments. As a result, they will still have the incentives they now have to prudently manage risk and to issue long-term unsecured debt.
Moreover, because banks' risk profiles change over time, aggregate assessments using a risk-based surcharge would be more prone to vary than will a flat-rate surcharge. This variance would reduce the predictability of surcharge revenue and create additional uncertainty regarding the needed rates and the time required for the reserve ratio to reach 1.35 percent. Banks themselves would have less predictable surcharge assessments.
As proposed in the NPR, the banks subject to the surcharge (large banks) will be determined each quarter based on whether the bank was a “large institution” or “highly complex institution” for purposes of that quarter's regular assessments.
The FDIC received two comments from trade groups on which banks should be subject to the surcharge. One commenter suggested that the surcharge should not apply to mid-size banks and should only apply to highly complex banks, while another commenter proposed that the surcharge be restricted to only the largest banks, those considered “too big to fail,” or those controlling a large share of industry assets. As an alternative to their suggestions, both commenters proposed that the FDIC increase the $10 billion deduction from large banks' assessment bases for the surcharge (discussed below), for example, to $25 billion or $50 billion, which would effectively exempt banks with total assets under these threshold amounts from surcharges.
The FDIC has identified no compelling basis to distinguish between large banks based on any particular asset size or other profile. Further, the final rule is consistent with the statutory language. The Dodd-Frank Act requires the FDIC to “offset the effect of [the increase in the minimum reserve ratio] on insured depository institutions with total consolidated assets of less than $10,000,000,000,” and unlike other parts of the Act, there is no indication that section 334(e) should apply only to banks of a certain size or that engage in certain activities. The apparent purpose of the Act's requirement was to insulate banks with less than $10 billion in total assets from the cost of the increase in the minimum reserve ratio. The final rule appropriately meets this requirement.
The FDIC is cognizant of the concerns of large banks near the $10 billion threshold. As a practical matter, the $10 billion deduction from large banks' assessment bases for the surcharge has the effect of shifting the burden of the surcharges towards larger banks. While, as discussed later, the purpose of the $10 billion deduction is to avoid a “cliff effect” for banks near the $10 billion asset threshold, it has the concomitant effect of benefitting large banks closer in size to the $10 billion asset threshold relatively more than larger banks, since the relative effect of the $10 billion deduction decreases as asset size increases. As reflected in Table 1, based on data as of December 31, 2015, the simple average effective surcharge rate (the surcharge rate if applied to a bank's regular quarterly deposit insurance assessment base) for banks with assets between $10 billion and $50 billion will be approximately half the simple average effective rate for banks with assets greater than $100 billion. In fact, with lower regular assessment rates scheduled to take effect when the reserve ratio reaches 1.15 percent, more than half (36 out of 67) of large banks with total assets between $10 billion and $50 billion and roughly one-third of all large banks are expected to pay an effective assessment rate, even with the surcharge, that is lower than their current assessment rate.
Pursuant to the broad authorities under the Dodd-Frank Act and the FDI Act, including the authority to determine the assessment amount, which includes defining an appropriate assessment base for the surcharge (the surcharge base), each large bank's surcharge base for any given quarter will equal its regular quarterly deposit insurance assessment base (regular assessment base) for that quarter with certain adjustments.
The first adjustment under the final rule differs from the NPR, but is similar to an alternative method of determining the surcharge base on which the NPR requested comment. The NPR would have added the entire regular assessment bases of affiliated small banks to the surcharge bases of large bank affiliates, but sought comment on an alternative that would add only the amount of any increase in the regular assessment bases of affiliated small banks. In response to a joint comment letter from three trade groups and after balancing all the considerations expressed in the NPR, the FDIC has decided to add to a large bank's surcharge base each quarter only the cumulative net increase in the aggregate regular assessment bases of affiliated small banks above the aggregate regular assessment bases as of December 31, 2015 of affiliated small banks as of that date that is in excess of an effective annual rate of 10 percent.
The term “small bank” is synonymous with the term “small institution” as it is defined in 12 CFR 327.8(e) and used in existing portions of 12 CFR part 327 for purposes of regular assessments, except that it excludes: (1) An insured branch of a foreign bank whose assets as reported in its most recent most recent quarterly Call Report equal or exceed $10 billion; and (2) a small institution that, while surcharges are in effect, is the surviving or resulting institution in a merger or consolidation with a large bank or that acquired of all or substantially all of the assets or assumed all or substantially all of the deposits of a large bank.
The cumulative net increase in excess of an effective annual rate of 10 percent in the aggregate regular assessment bases of affiliated small banks will be calculated by compounding a quarterly rate of approximately 2.41 percent from December 31, 2015. Thus, for example, at the end of September 2016 (3 quarters after December 31, 2015), assuming that surcharges are in effect, the final rule will add to a large bank's surcharge base for that quarter any cumulative net increase in the aggregate regular assessment bases of affiliated small banks in excess of approximately 7.41 percent (approximately 2.41 percent per quarter compounded for 3 quarters). Similarly, at the end of March 2017 (5 quarters after December 31, 2015), assuming that surcharges are in effect, the final rule will add to a large bank's surcharge base for that quarter any cumulative net increase in the aggregate regular assessment bases of affiliated small banks in excess of approximately
A net increase in affiliated small banks' assessment bases includes any increase resulting from a merger or consolidation with an unaffiliated insured depository institution. A net decrease in the aggregate regular assessment bases of affiliated small banks below their aggregate regular assessment bases as of December 31, 2015 will not reduce the surcharge bases of affiliated large banks.
To prevent assessment avoidance, if a banking organization with at least one large bank but no small banks acquires or establishes a small bank after December 31, 2015, the entire assessment base of the small bank will be apportioned among the surcharge bases of large banks in the holding company in the manner discussed below. Also, if a large bank in a banking organization with multiple large bank affiliates becomes a small bank during the surcharge period, its entire assessment base will be apportioned among the surcharge bases of its large bank affiliates in the manner discussed below.
As of December 31, 2015, 19 banking organizations had both large and small banks.
Adding cumulative growth in excess of an effective annual rate of 10 percent in the regular assessment bases of affiliated small banks to the assessment bases of their large bank affiliates limits the ability of large banks to reduce their surcharges (and potentially shift costs to other large banks) either by transferring assets and liabilities to existing or new affiliated small banks or by growing the businesses of affiliated small banks instead of the large bank without unduly constraining the normal growth of the affiliated small banks.
Including only the amount of any cumulative net increase that is in excess of an effective annual rate of 10 percent in the aggregate regular assessment bases of affiliated small banks, rather than their entire assessment bases as proposed in the NPR, will have only a very small effect on total surcharge revenue and is unlikely to increase the number of quarters that surcharges are in effect.
The second adjustment is as proposed in the NPR. It deducts $10 billion from a large bank's regular assessment base (as increased by the first adjustment) to produce the surcharge base. Deducting $10 billion from each large bank's assessment base for the surcharge avoids a “cliff effect” for banks near the $10 billion asset threshold, thereby ensuring equitable treatment. Otherwise, a bank with just over $10 billion in assets would pay significant surcharges, while a bank with $9.9 billion in assets would pay none. The $10 billion reduction reduces incentives for banks to limit their growth to stay below $10 billion in assets, or to reduce their size to below $10 billion in assets, solely to avoid surcharges.
In a banking organization that includes more than one large bank, both (1) the $10 billion deduction, and (2) the cumulative net increase in affiliated small banks' regular assessment bases exceeding a 10 percent effective annual rate will be apportioned among all large banks in the banking organization in proportion to each large bank's regular assessment base for that quarter.
The FDIC received one joint comment letter from three trade groups related to the first adjustment. As proposed in the NPR, the first adjustment would have added the entire regular assessment bases of affiliated small banks to the surcharge bases of large bank affiliates. The joint comment letter opposed adding any portion of the assessment bases of small bank affiliates to large banks, but argued that, if any addition were to occur, it should be limited to no more than any increase in the assessment bases of small bank affiliates above “normal growth” after surcharges begin.
The joint comment letter also argued that Sec. 334 of the Dodd-Frank Act does not authorize the FDIC to augment large banks' assessment bases with those of their small bank affiliates. In fact, however, the Dodd-Frank Act and the FDI Act give the FDIC broad authority to determine the amount of any special assessments, including the surcharges, and thus an appropriate assessment base for the surcharge. See Public Law 111-203, 334(e), 124 Stat. 1376, 1539 (12 U.S.C. 1817(note)); 12 U.S.C. 1817(b)(5). The FDI Act contains no provisions mandating any particular assessment base for a special assessment.
The FDIC received three comments related to the second adjustment, the deduction of $10 billion from a large bank's assessment base and apportioning the deduction among all large banks in the banking organization. Two commenters proposed a larger deduction (discussed above). A joint comment letter submitted by three trade groups proposed that bank holding companies with multiple large banks be allowed to deduct $10 billion for each large bank, arguing that limiting large banks in a bank holding company to a single $10 billion deduction “discriminates against banking organizations with multiple affiliated large banks.”
The provisions in the final rule regarding the second deduction are unchanged from those proposed in the NPR. Allocation of the $10 billion deduction among affiliated large banks ensures that banking organizations of a similar size (in terms of large bank assessment bases) pay a similar surcharge. Thus, a banking organization with multiple large banks will not have an advantage over other similarly sized banking organizations that have only one large bank because, instead of deducting $10 billion from each large bank in the organization, the deduction will be apportioned among the multiple affiliated large banks.
Moreover, allowing each large bank in a banking organization to take a $10 billion deduction could, in effect, penalize the large majority of banking organizations that do not have more than one large bank by increasing the risk that surcharges would last longer than envisioned under the proposal.
The FDIC expects that surcharges combined with regular assessments will raise the reserve ratio to 1.35 percent before December 31, 2018. It is possible, however, that unforeseen events could result in higher DIF losses or faster insured deposit growth than expected, or that banks may take steps to reduce or avoid quarterly surcharges. While not expected, these events or actions could prevent the reserve ratio from reaching 1.35 percent by the end of 2018. In this case, provided the reserve ratio is at least 1.15 percent, the FDIC will impose a shortfall assessment on large banks.
If the reserve ratio remains or is projected to remain below 1.15 percent for a prolonged period after 2018 (and never reaches 1.35 percent), the FDIC Board may have to consider increases to regular assessment rates on all banks (in addition to the shortfall assessment on banks with $10 billion or more in assets) in order to achieve the minimum reserve ratio of 1.35 percent by the September 30, 2020 statutory deadline.
The provisions in the final rule regarding the shortfall assessment are as proposed in the NPR. If the reserve ratio has not reached 1.35 percent by the end of 2018, the FDIC will impose a shortfall assessment on large banks on March 31, 2019 and collect it on June 30, 2019.
If a shortfall assessment is needed, it will be imposed on any bank that was a large bank in any quarter during the period that surcharges are in effect (the surcharge period). Each large bank's share of any shortfall assessment will be proportional to the average of its surcharge bases (the average surcharge base) during the surcharge period. If a bank was not a large bank during a quarter of the surcharge period, its surcharge base will be deemed to equal zero for that quarter.
If a bank of any size acquires—through merger or consolidation—a large bank that had paid surcharges for one or more quarters, the acquiring bank will be subject to a shortfall assessment and its average surcharge base will be increased by the average surcharge base of the acquired bank.
A large bank's share of the total shortfall assessment will equal its average surcharge base divided by the sum of the average surcharge bases of all large banks subject to the shortfall assessment. Using an average of surcharge bases ensures that anomalous growth or shrinkage in a large bank's assessment base will not subject it to a disproportionately large or small share of any shortfall assessment.
In addition to the comments discussed above regarding the duration of the surcharge and timing of any required corresponding shortfall assessment, the FDIC received two other comments on the shortfall assessment. One commenter suggested that the shortfall assessment, in addition to the surcharges, should only be applied to “highly complex” banks. Another commenter stated that the shortfall assessment and surcharges should be risk-based.
For the reasons discussed previously in connection with the surcharge assessment, the shortfall assessment in the final rule is as proposed in the NPR. If a shortfall assessment is necessary, the expected revenue based on the calculation method adopted will be much more predictable than the expected revenue from a risk-based method. In previous special assessments, the FDIC used a uniform rate, rather than a risk-based rate, and large banks will continue to pay risk-based regular assessments. Moreover, as also noted above, neither the statute nor its legislative history suggest that only highly complex banks should be responsible for raising the reserve ratio from 1.15 percent to 1.35 percent. The statute requires that the FDIC offset the effect of the increase in the minimum reserve ratio on banks with less than $10 billion in consolidated assets.
Each large bank is required to take any actions necessary to allow the FDIC to debit its share of the surcharge from the bank's designated deposit account used for payment of its regular assessment. Similarly, each large bank subject to any shortfall assessment is required to take any actions necessary to allow the FDIC to debit its share of the shortfall assessment from the bank's designated deposit account used for payment of its regular assessment. Before the dates that payments are due, each bank must ensure that sufficient funds to pay its obligations are available in the designated account for direct debit by the FDIC. Failure to take any such action or to fund the account will constitute nonpayment of the assessment. Penalties for nonpayment will be as provided for nonpayment of a bank's regular assessment.
The FDIC received no comments on this part of the proposal. The final rule adopts this part of the proposal without change.
Under existing regulations, a bank that is not the resulting or surviving bank in a merger or consolidation must file a Call Report for every assessment period prior to the assessment period in which the merger or consolidation occurs. The surviving or resulting bank is responsible for ensuring that these Call Reports are filed. The surviving or resulting bank is also responsible and liable for any unpaid assessments on behalf of the bank that is not the resulting or surviving bank.
Thus, for example, a large bank's first quarter 2017 surcharge (assuming that the surcharge is in effect then), which will be collected on June 30, 2017, will include the large bank's own first quarter 2017 surcharge plus any unpaid first quarter 2017 or earlier surcharges owed by any large bank it acquired between April 1, 2017 and June 30, 2017 by merger or through the acquisition of all or substantially all of the acquired bank's assets. The acquired bank will be required to file Call Reports through the first quarter of 2017 and the acquiring bank will be responsible for ensuring that these Call Reports were filed.
Existing regulations also provide that, for an assessment period in which a merger or consolidation occurs, total consolidated assets for the surviving or resulting bank include the total consolidated assets of all banks that are parties to the merger or consolidation as if the merger or consolidation occurred on the first day of the assessment period. Tier 1 capital (which is deducted from total consolidated assets to determine a bank's regular assessment base) is to be reported in the
Existing regulations also provide that, when the insured status of a bank is terminated and the deposit liabilities of the bank are not assumed by another bank, the bank whose insured status is terminating must, among other things, continue to pay assessments for the assessment periods that its deposits are insured, but not thereafter.
Finally, in the case of one or more transactions in which one bank voluntarily terminates its deposit insurance under the FDI Act and sells certain assets and liabilities to one or more other banks, each bank must report the increase or decrease in assets and liabilities on the Call Report that is due after the transaction date and the banks will be assessed accordingly under existing FDIC assessment regulations. The bank whose insured status is terminating must, among other things, continue to pay assessments for the assessment periods that its deposits are insured. The same process will also apply to surcharges and shares of any shortfall assessment under the final rule.
The FDIC received no comments on this part of the proposal. The final rule adopts this part of the proposal without change.
While the reserve ratio remains between 1.15 percent and 1.35 percent, some portion of the deposit insurance assessments paid by small banks will contribute to increasing the reserve ratio. To meet the Dodd-Frank Act requirement to offset the effect on small banks of raising the reserve ratio from 1.15 percent to 1.35 percent, the FDIC will provide assessment credits to these banks for the portion of their assessments that contribute to the increase from 1.15 percent to 1.35 percent.
As proposed in the NPR, to determine the aggregate amount of credits awarded small banks, the FDIC will first calculate 0.2 percent of estimated insured deposits (the difference between 1.35 percent and 1.15 percent) on the date that the reserve ratio first reaches or exceeds 1.35 percent.
This method of determining the aggregate small bank credit implicitly assumes that all non-assessment revenue (for example, investment income) during the credit calculation period will be used to maintain the fund at a 1.15 percent reserve ratio and that regular assessment revenue will be used to maintain the fund at that reserve ratio only to the extent that other revenue is insufficient. Essentially, the method attributes reserve ratio growth to assessment revenue as much as possible and, with one exception, maximizes the amount of the aggregate small bank assessment credit. The exception is the assumption that all surcharge payments contribute to growth of the reserve ratio (to the extent of that growth), which is consistent with the purpose of the surcharge payments.
The FDIC projects that the aggregate amount of credits will total approximately $1 billion, but the actual amount of credits may differ.
The FDIC received only one comment on the proposed method of determining the aggregate amount of small bank credits. That comment, from a trade group, supported the proposal.
As proposed in the NPR, credits will be awarded to any bank, including a small bank affiliate of a large bank, that was a small bank at some time during the credit calculation period. An individual small bank's share of the aggregate credit (a small bank's credit share) will be proportional to its credit base, defined as the average of its regular assessment bases during the credit calculation period.
By making a small bank's credit share proportional to its credit base rather than, for example, its actual assessments paid, the final rule reduces the chances that a riskier bank assessed at higher than average rates will receive credits for these higher rates. The final rule thus reduces the incentive for banks to take on higher risk.
The FDIC received no comments on this part of the proposal.
If any bank acquires a bank with credits through merger or consolidation after the DIF reserve ratio reaches 1.35 percent, the acquiring bank will acquire the credits of the acquired small bank. Other than through merger or consolidation, credits are not transferable.
After the reserve ratio reaches 1.38 percent (and provided that it remains at or above 1.38 percent), the FDIC will automatically apply a small bank's credits to reduce its regular deposit insurance assessment up to the full amount of the bank's credits or assessment, whichever is less.
Second, the final rule provides that credits available to an institution may be used to offset the institution's entire quarterly insurance assessment, rather than limiting credit use to an annual rate of 2 basis points as proposed in the NPR.
As soon as practicable after the DIF reserve ratio reaches 1.35 percent, the FDIC will notify each small bank of the FDIC's preliminary estimate of the small bank's credit and the manner in which the credit was calculated (the notice). The estimate will be based on information derived from the FDIC's official system of records. The FDIC will provide the notice through FDICconnect or other means in accordance with existing practices for assessment invoices.
After the initial notice, periodic updated notices will be provided to reflect adjustments that may be made as the result of credit use, requests for review of credit amounts, or any subsequent merger or consolidation.
The final rule includes provisions that allow a small bank that disagrees with the FDIC's computation of, or basis for, its credits to request review or appeal. These provisions are unchanged from those proposed in the NPR.
The FDIC received no comments on this part of the proposal.
The FDIC estimates that it will collect approximately $10 billion in surcharges and award approximately $1 billion in credits to small banks, although actual amounts may vary from these estimates. The FDIC projects that a shortfall assessment will be unnecessary.
As discussed above, the benefits of the final rule will be to quickly strengthen the fund's ability to withstand an unanticipated spike in losses and reduce the risk of larger assessments for the entire industry. Under the final rule, the cost of raising the minimum reserve ratio will be spread over approximately eight quarters and calculated in a simple, predictable manner.
Based on FDIC analysis, banks subject to the surcharge will not account for future surcharges or a possible shortfall assessment as a present liability or a recognized loss contingency in the Call Report and other banking regulatory reports based on GAAP because the surcharges do not relate to a current condition or event giving rise to a liability under Financial Accounting Standards Board Accounting Standards Codification Topic 450,
Consistent with section 7(b)(2)(B) of the FDI Act, the analysis that follows estimates the effects of a 4.5 basis point surcharge on the equity capital and earnings of large banks.
The FDIC has estimated the effect of a 4.5 basis-point surcharge on large banks' earnings in two ways. First, as a percentage of
The analysis is based on large banks as of December 31, 2015. As of that date, there were 108 large banks. Banks are merger-adjusted, except for failed bank acquisitions, for purposes of determining income.
Although the surcharge is expected to continue for 8 quarters, the analysis examines the effect of the surcharge over one year. Each large bank's surcharge base is calculated as of December 31, 2015. Data from January 1, 2015 through December 31, 2015 are used to calculate each large bank's current earnings and adjusted earnings. Capital for each large bank is the amount reported as of December 31, 2015. The analysis assumes that current earnings equal pre-tax income before extraordinary and other items from January 1, 2015 through December 31, 2015. Using this measure eliminates the potentially transitory effects of extraordinary items and taxes on profitability. In calculating the effect on capital and banks' ability to maintain a leverage ratio of at least 4 percent (the minimum capital requirement
For all or almost all large banks, the effective surcharge annual rate measured against large banks' regular assessment base will be less than the nominal surcharge rate of 4.5 basis points because of the $10 billion deduction. The FDIC projects that the net effect of lower assessment rates that go into effect when the reserve ratio reaches 1.15 percent and the imposition of the surcharge will result in lower assessments for approximately one-third of all large banks. Specifically, the analysis estimates that 37 of the 108 large banks will pay lower assessments in the future than they pay currently.
The analysis reveals no significant capital effects from the surcharge. All large institutions continue to maintain a 4 percent leverage ratio, at a minimum, both before and after the imposition of the surcharge.
The annual surcharge also represents only a small percentage of bank earnings for most large banks. In the aggregate, the annual surcharge absorbs 2.33 percent of total large bank adjusted earnings and 2.36 percent of total large bank current earnings.
Table 2.A shows that as of December 31, 2015, for 83 percent of all large banks (86 large banks) the surcharge represents 3 percent or less of adjusted annual earnings. For 92 percent (96 large banks), the surcharge represents 5 percent or less of adjusted annual earnings. Only 8 large banks' adjusted annual earnings are affected by more than 5 percent, with the maximum effect on any single bank being 9.6 percent.
When evaluating the effect of the surcharge on current earnings (that is, excluding the gains projected from lower future regular assessments), the effect of surcharges is slightly greater, as expected, but the results are not materially different. Table 2.B shows that, for 82 percent of large banks as of December 31, 2015, (85 large banks), the surcharge represents 3 percent or less of current earnings. For 91 percent (95 large banks), the surcharge represents 5 percent or less of current earnings. Only 9 large banks' current earnings are affected by more than 5 percent, with the maximum effect on any single bank being 10.11 percent.
Finally, credits will result in a small increase in the income of small banks. Small bank annual earnings are estimated to increase between 2.5 and 2.7 percent due to these credits.
The FDIC received five comments noting the effects of the surcharge on banks' capital and earnings, including the effects of banks' ability to pay dividends or to grow. As discussed above, however, FDIC analysis reveals no significant capital effects on large banks from the surcharge. On average, the annual surcharge would absorb about 2.4 percent of large bank annual income.
In the NPR, the FDIC solicited comments on several alternatives.
Under the first alternative presented, the FDIC would forego surcharges and instead impose a one-time assessment, similar to a shortfall assessment, at the end of the quarter after the DIF reserve ratio first reaches or exceeds 1.15 percent. As previously discussed, the FDIC received two comments supporting this alternative. These comments are discussed earlier.
The second alternative would also forego surcharges and, if the reserve ratio does not reach 1.35 percent by a date sometime near the statutory deadline, impose a shortfall assessment at the end of the following quarter, to be collected at the end of the next quarter. The FDIC received one comment supporting this alternative, and a few banks surveyed by three trade groups submitting a joint comment letter also supported this alternative. These comments are also previously discussed.
The FDIC solicited comment on additional alternatives that are essentially variations of certain aspects of the surcharge proposal, including the method of determining the surcharge base, the method of allocating credits, and the length of the surcharge period. Comments in response to these alternatives are discussed in the relevant sections.
This rule will become effective on July 1, 2016. If the reserve ratio reaches 1.15 percent before that date, surcharges will begin July 1, 2016. If the reserve ratio has not reached 1.15 percent by that date, surcharges will begin the first day of the calendar quarter after the reserve ratio reaches 1.15 percent.
The Regulatory Flexibility Act (RFA) requires that an agency, in connection with a notice of final rulemaking, prepare a final regulatory flexibility analysis describing the impact of the rule on small entities or certify that the final rule will not have a significant economic impact on a substantial number of small entities.
As of December 31, 2015, of 6,191 FDIC-insured institutions,
The final rule affects small entities to the extent that they are eligible for credits in exchange for their contributions toward raising the DIF reserve ratio from 1.15 percent to 1.35 percent. The FDIC will apply these credits to future regular assessments, resulting in estimated average savings of 2.4 to 2.6 percent of annual earnings for small insured depository institutions.
The final rule does not directly impose any “reporting” or “recordkeeping” requirements, and the compliance requirements for the final rule would not exceed (and, in fact, would be the same as) existing compliance requirements for the current risk-based deposit insurance assessment system for small banks.
The final rule has been determined to be a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Title II, Pub. L. 104-121) by the Office of Management and Budget.
The Riegle Community Development and Regulatory Improvement Act requires that the FDIC, in determining the effective date and administrative compliance requirements of new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations.
In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number.
This final rule does not revise FDIC's Assessments Information Collection 3064-0057, Quarterly Certified Statement Invoice for Deposit Insurance Assessment. The FDIC will continue to obtain the information necessary to calculate the surcharge assessment and assessment credits from the Call Report. Therefore, no submission to OMB need be made.
The FDIC has determined that the final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681).
Section 722 of the Gramm-Leach-Bliley Act, Public Law 106-102, 113 Stat. 1338, 1471 (Nov. 12, 1999), requires the Federal banking agencies to use plain language in all proposed and final rulemakings published in the
Bank deposit insurance, Banks, Banking, Savings associations.
For the reasons set forth above, the FDIC amends part 327 as follows:
12 U.S.C. 1441, 1813, 1815, 1817-19, 1821.
(a)
(i) Large institutions, as defined in § 327.8(f);
(ii) Highly complex institutions, as defined in § 327.8(g); and
(iii) Insured branches of foreign banks whose assets are equal to or exceed $10 billion, as reported in Schedule RAL of the branch's most recent quarterly Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks.
(2)
(3)
(4)
(5)
(i)
(A) The institution's deposit insurance assessment base for the assessment period, determined according to § 327.5; plus
(B) The greater of the increase amount determined according to paragraph (a)(5)(iii) of this section or zero; minus
(C) $10 billion; provided, however, that an institution's surcharge base for an assessment period cannot be negative.
(ii)
(A) The institution's deposit insurance assessment base for the assessment period, determined according to § 327.5; plus
(B) The greater of the institution's portion, determined according to paragraph (a)(5)(v) of this section, of the increase amount determined according to paragraph (a)(5)(iii) of this section or zero; minus
(C) The institution's portion, determined according to paragraph (a)(5)(v) of this section, of $10 billion; provided, however, that an institution's surcharge base for an assessment period cannot be negative.
(iii)
(A) The amount of the aggregate deposit insurance assessment bases for the assessment period, determined according to § 327.5, of all of the institution's affiliated insured depository institutions that are not subject to the surcharge, minus
(B) The product of the increase multiplier set out in paragraph (a)(5)(iv) of this section and the aggregate deposit insurance assessment bases, determined according to § 327.5, as of December 31, 2015, of all of the small institutions, as defined in § 327.8(e), that were the institution's affiliated insured depository institutions for the assessment period ending December 31, 2015.
(iv)
(A) For the assessment period ending September 30, 2016, the increase multiplier shall be 1.0740995.
(B) For the assessment period ending December 31, 2016, the increase multiplier shall be 1.1000000.
(C) For the assessment period ending March 31, 2017, the increase multiplier shall be 1.1265251.
(D) For the assessment period ending June 30, 2017, the increase multiplier shall be 1.1536897.
(E) For the assessment period ending September 30, 2017, the increase multiplier shall be 1.1815094.
(F) For the assessment period ending December 31, 2017, the increase multiplier shall be 1.2100000.
(G) For the assessment period ending March 31, 2018, the increase multiplier shall be 1.2391776.
(H) For the assessment period ending June 30, 2018, the increase multiplier shall be 1.2690587.
(I) For the assessment period ending September 30, 2018, the increase multiplier shall be 1.2996604.
(J) For the assessment period ending December 31, 2018, the increase multiplier shall be 1.33100000.
(v)
(vi) For the purposes of this section, an affiliated insured depository institution is an insured depository institution that meets the definition of “affiliate” in section 3 of the FDI Act, 12 U.S.C. 1813(w)(6).
(6)
(ii) If an insured depository institution not subject to the surcharge is the surviving or resulting institution in a merger or consolidation with an insured depository institution that is subject to the surcharge or acquires all or substantially all of the assets, or assumes all or substantially all of the deposit liabilities, of an insured depository institution subject to the surcharge, then the surviving or resulting insured deposit institution or the insured depository institution that acquires such assets or assumes such deposit liabilities is subject to the surcharge.
(b)
(2)
(3)
(4)
(ii) If the reserve ratio of the DIF is less than 1.15 percent and has not reached or exceeded 1.35 percent by December 31, 2018, the shortfall assessment shall be imposed at the end of the assessment period immediately following the assessment period that occurs after December 31, 2018, during which the reserve ratio first reaches or exceeds 1.15 percent and shall equal 0.2 percent of estimated insured deposits as of the end of the calendar quarter in which the reserve ratio first reaches or exceeds 1.15 percent.
(5)
(i)
(ii)
(6)
(ii) For the purposes of the shortfall assessment, a merger or consolidation means any transaction in which an insured depository institution merges or consolidates with any other insured depository institution, and includes transactions in which an insured depository institution either directly or indirectly acquires all or substantially all of the assets, or assumes all or substantially all of the deposit liabilities of any other insured depository institution where there is not a legal merger or consolidation of the two insured depository institutions.
(c)
(ii)
(A) A large institution, as defined in § 327.8(f);
(B) A highly complex institution, as defined in § 327.8(g); or
(C) An insured branch of a foreign bank whose assets are equal to or exceed $10 billion, as reported in Schedule RAL of the branch's most recent quarterly Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks.
(2)
(3)
(i)
(ii)
(iii)
(4)
(i)
(ii)
(iii)
(5)
(6)
(7)
(ii)
(8)
(9)
(10)
(11)
(ii) The FDIC shall apply assessment credits to reduce an institution's quarterly deposit insurance assessments by each institution's remaining credits. The assessment credit applied to each institution's deposit insurance assessment for any assessment period shall not exceed the institution's total deposit insurance assessment for that assessment period.
(iii) The amount of credits applied each quarter will not be recalculated as a result of amendments to the quarterly Reports of Condition and Income or the quarterly Reports of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks pertaining to any quarter in which credits have been applied.
(12)
(d)
(2)
(A) The initial notice provided by the FDIC to the insured depository institution under paragraph (c)(7) of this section stating the FDIC's preliminary estimate of an eligible institution's assessment credit and the manner in which the assessment credit was calculated; or
(B) Any updated notice provided by the FDIC to the insured depository institution under paragraph (c)(7) of this section.
(ii) Any requests submitted after the deadline in paragraph (d)(2)(i) of this section will be considered untimely filed and the institution will be subsequently barred from submitting a request for review of its assessment credit.
(3)
(ii) The FDIC may request, as part of its review, additional information from the insured depository institution involved in the request and any such information must be submitted to the FDIC within 21 days of the FDIC's request;
(iii) The FDIC's Director of the Division of Finance, or his or her designee, will notify the requesting institution of his or her determination of whether a change is warranted within 60 days of receipt by the FDIC of the request for review, or if additional information had been requested from the FDIC, within 60 days of receipt of any such additional information.
(4)
(5)
(a) Subject to the limitations in paragraph (b) of this section, the amount of an eligible insured depository institution's one-time credit shall be applied to the maximum extent allowable by law against that institution's quarterly assessment payment under subpart A of this part, after applying assessment credits awarded under § 327.11(c), until the institution's credit is exhausted.
The following appendix will not appear in the Code of Federal Regulations.
Table 1.1 gives an example of the calculation of the surcharge base for a banking organization that comprises three large banks but no affiliated small banks.
The next tables give an example of the calculation of the surcharge base for a banking organization that comprises three large banks and two affiliated small banks. Table 1.2 shows the applicable amounts by which affiliated small banks' December 31, 2015 regular assessment bases will be multiplied to determine growth at a 10 percent effective annual rate. (The amounts in the table are calculated by compounding a quarterly rate of approximately 2.41 percent from December 31, 2015, to achieve a 10 percent effective annual rate.) Table 1.3 shows the calculation of the gross amount of the first adjustment (the net increase in affiliated small banks' assessment bases after December 31, 2015). Table 1.4 shows the apportionment of the first adjustment and the second adjustment (the $10 billion deduction) among the large banks in the banking organization.
The first adjustment calculates the cumulative net increase from December 31, 2015, in affiliated small banks' aggregate assessment bases in excess of an effective annual rate of 10 percent. In the example shown in Table 1.3, affiliated small bank X had an assessment base of $2.00 billion as of December 31, 2015, and affiliated small bank Y had an assessment base of $6.00 billion, or $8.00 billion in aggregate. On March 31, 2017, affiliated small bank X has increased its assessment base to $6.01 billion, and affiliated small bank Y has decreased its assessment base to $5.00 billion, so the affiliated small banks' aggregate assessment base is $11.01 billion. The amount of growth in excess of an effective annual rate of 10 percent is calculated by first multiplying the amount corresponding with March 31, 2017 in Table 1.2 (1.1265251) by the affiliated small banks aggregate assessment base of $8.00 billion as of December 31, 2015, and then subtracting the product from the affiliated small banks' aggregate assessment base of $11.01 billion as of March 31, 2017. The resulting amount, $2.00 billion, is the gross amount of the first adjustment.
The second adjustment deducts $10 billion from large banks' assessment bases. Both adjustments are apportioned among all large bank affiliates in a holding company in proportion to each large bank's regular assessment base. As shown in Table 1.4, each affiliated large bank's share of the banking organization's assessment base (the large bank share) is calculated by dividing the affiliated large bank's assessment base by the sum of all affiliated large bank assessment bases. Next, each large bank's share is multiplied by the gross amount ($2.0 billion) of the first adjustment, as calculated in Table 1.3, and the product is added to each large bank's surcharge base. Finally, each large bank's share is multiplied by the $10 billion deduction, and the product is subtracted from each large bank's surcharge base as increased by the first adjustment. The remaining amount constitutes each large bank's surcharge base for the quarter.
By order of the Board of Directors.
Bureau of Consumer Financial Protection.
Interim final rule with request for public comment.
This interim final rule amends certain provisions of Regulation Z in light of title LXXXIX of the Fixing America's Surface Transportation Act, entitled the Helping Expand Lending Practices in Rural Communities Act, Public Law 114-94. The amendments to Regulation Z concern two matters: The eligibility of certain small creditors that operate in rural or underserved areas for special provisions that permit the origination of balloon-payment qualified mortgages and balloon-payment high cost mortgages and for an exemption from the requirement to establish an escrow account for higher-priced mortgage loans and the determination of whether an area is rural for the purposes of Regulation Z.
This final rule is effective on March 31, 2016. Comments may be submitted on or before April 25, 2016.
You may submit comments, identified by Docket No. CFPB-2016-0013 or RIN 3170-AA59, by any of the following methods:
•
•
•
•
All comments, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Sensitive
Carl Owens, Terry J. Randall, or James Wylie, Counsels, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552, at (202) 435-7700.
The Bureau is issuing this interim final rule to amend Regulation Z to address the Helping Expand Lending Practices in Rural Communities Act of 2015 (HELP Rural Communities Act or the Act), which was enacted on December 4, 2015.
This interim final rule is implementing Congress's intention to expand the cohort of small creditors that are eligible for a special provision of Regulation Z that permits origination of balloon-payment qualified mortgages under § 1026.43(f) and for an exemption from the requirement to establish an escrow account for higher-priced mortgages (escrow exemption) under § 1026.35(b)(2)(iii). The Act's amendments to TILA authorize the Bureau to extend the special provision and exemption to certain small creditors that operate in rural or underserved areas, and remove TILA's prior limitation that eligible creditors must operate predominantly in such areas.
To expand eligibility for the special provisions and exemption, the interim final rule revises § 1026.35(b)(2)(iii)(A), which specifies the level of operations in rural or underserved areas at which a creditor is eligible for the special provisions and exemption. Under the interim final rule, a creditor satisfies the rural-or-underserved component of the eligibility criteria if the creditor originated a covered transaction secured by a property located in a rural or underserved area in the preceding calendar year or, if the application for the transaction was received before April 1 of the current calendar year, during either of the two preceding calendar years. The interim final rule also amends the current eligibility criteria for the escrow exemption to ensure that creditors that established escrow accounts solely to comply with the current rule will be eligible for the exemption if they otherwise meet its criteria under this interim final rule.
In addition to addressing the Act's amendments to TILA, this rule also amends § 1026.35(b)(2)(iv)(A), which sets forth the rule for determining whether an area is rural for the purposes of Regulation Z, by inserting a reference to any areas designated as rural through the application process mandated by the Act. This amendment also establishes that, consistent with the current definition of rural area in Regulation Z, only counties or census blocks are eligible areas for the purpose of the application process established by the Bureau pursuant to the Act. The Bureau is soliciting comments on the interim final rule's amendments to Regulation Z.
In response to an unprecedented cycle of expansion and contraction in the mortgage market that sparked the most severe U.S. recession since the Great Depression, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), signed into law on July 21, 2010.
As part of these changes, Congress vested the Bureau with specific authority to modify certain requirements with respect to small creditors operating predominantly in rural or underserved areas. TILA sections 129C(b)(2)(E)(iv)(I) and 129D(c)(1) granted the Bureau the discretion to create a special provision allowing origination of balloon-payment qualified mortgages, even though balloon-payment mortgages are otherwise precluded from being considered qualified mortgages, and an exemption from the requirement to establish an escrow account for higher-priced mortgage loans.
The Bureau issued several rules in early 2013 to implement these new statutory requirements.
The Bureau adopted a single test to determine whether a small creditor operated predominantly in rural or underserved areas for the purposes of eligibility for the special provisions and exemption.
In the spring of 2013, the Bureau adopted provisions establishing a two-year transition period during which small creditors that did not operate predominantly in rural or underserved areas could originate balloon-payment qualified mortgages. The Bureau explained that the transition period provided time for small creditors to make changes to their business practices, and noted the particular challenges posed by existing balloon-payment loans that would be due for renewal in the near term. The Bureau also stated that the transition period would give it time to study whether the definitions of rural or underserved should be adjusted.
In the fall of 2015, the Bureau adopted revisions that affected the special provisions and the escrow exemption.
Just over two months after the Bureau adopted these revisions, on December 4, 2015, the HELP Rural Communities Act was enacted into law.
On March 3, 2016, the Bureau published a procedural rule in the
The Bureau is issuing this final rule pursuant to its authority under TILA and the Dodd-Frank Act. TILA, as amended by the Dodd-Frank Act and the HELP Rural Communities Act, provides specific statutory bases for the Bureau's interim final rule. TILA section 129D(c) authorizes the Bureau to exempt, by regulation, a creditor from the requirement (in section 129D(a)) that escrow accounts be established for higher-priced mortgage loans if the creditor operates in rural or underserved areas, retains its mortgage loans in portfolio, does not exceed (together with all affiliates) a total annual mortgage loan origination limit set by the Bureau, and meets any asset-size threshold, and any other criteria, the Bureau may establish. TILA section 129C(b)(2)(E) authorizes the Bureau to provide, by regulation, that certain balloon-payment mortgages originated by small creditors receive qualified mortgage status, even though qualified mortgages are otherwise prohibited from having balloon-payment features.
With respect to the high cost mortgage provisions of TILA section 129, TILA section 129(p), as amended by the Dodd-Frank Act, grants the Bureau the
In addition, as amended by the Dodd-Frank Act, TILA section 105(a) authorizes the Bureau to prescribe regulations to carry out the purposes of TILA. Under section 105(a), such regulations may contain such additional requirements, classifications, differentiations, or other provisions, and may provide for such adjustments and exceptions for all or any class of transactions, as in the judgment of the Bureau are necessary or proper to effectuate the purposes of TILA, to prevent circumvention or evasion thereof, or to facilitate compliance therewith. Dodd-Frank Act section 1100A clarified the Bureau's TILA section 105(a) authority by amending that section to provide express authority to prescribe regulations that contain “additional requirements” that the Bureau finds are necessary or proper to effectuate the purposes of TILA, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.
In addition, section 1061 of the Dodd-Frank Act transferred to the Bureau the “consumer financial protection functions” previously vested in certain other Federal agencies, including the Board of Governors of the Federal Reserve System (Board). The term “consumer financial protection function” is defined to include “all authority to prescribe rules or issue orders or guidelines pursuant to any Federal consumer financial law, including performing appropriate functions to promulgate and review such rules, orders, and guidelines.”
To the extent that notice and comment would otherwise be required, the Bureau finds that there is good cause due to the exigencies created by the HELP Rural Communities Act to publish this interim final rule without notice and comment and for the rule to be effective less than 30 days after publication.
This interim final rule revises certain provisions in Regulation Z to effectuate the HELP Rural Communities Act's amendments to TILA, which broadened the cohort of creditors that may be eligible under TILA for the special provision permitting origination of balloon-payment qualified mortgages and for the escrow exemption.
These amendments to TILA, which were effective upon enactment on December 4, 2015, create uncertainty and confusion for creditors that are not currently eligible for the special provisions and exemption. For example, these creditors may question how the Act changes their eligibility for the special provisions and exemption. This uncertainty may lead these creditors to change their business practices, potentially imposing burden and costs on creditors to update their policies and procedures, make changes to their technology, and train staff. This uncertainty also creates legal risks for these creditors. They may mistakenly believe that the amendments to TILA automatically broadened the regulatory exemption and may take steps that might lead them out of compliance with the requirements in Regulation Z.
With respect to the special provisions pertaining to balloon-payment features, the consequences of this confusion can be avoided if the interim final rule is effective before April 1, 2016. Currently, the rural-or-underserved aspect of the eligibility criteria for the special provisions has no practical effect because, under temporary provisions that expire on April 1, 2016, creditors that meet all of the other eligibility criteria for the special provisions may originate balloon-payment qualified mortgages and balloon-payment high cost mortgages even if they do not satisfy the rural-or-underserved component of the test.
The need to clarify the amendment to TILA's effect on the escrow exemption is also urgent because the requirement that creditors operate predominantly in rural or underserved areas to be eligible for the escrow exemption currently applies and will continue to apply as long as the current version of § 1026.35(b)(2)(iii)(A) is still in effect. In light of the Act, creditors now face uncertainty surrounding the status of their eligibility for the exemption. As noted above, some creditors that are not eligible for the current exemption may be under the mistaken impression that the amendments to TILA automatically broadened the regulatory exemption and that they are no longer required to establish escrow accounts for higher-priced mortgage loans. This confusion creates legal risks for these creditors. In addition, some creditors may be uncertain about whether establishing an escrow account to comply with current law will disqualify them from the escrow exemption in the future, because creditors generally are not eligible for the escrow exemption if they maintain escrow accounts for any extension of consumer credit secured by real property or a dwelling that it or its affiliate currently services that were established after January 1, 2016.
The amendment to the definition of rural area under § 1026.35(b)(2)(iv)(A) must take effect by March 31, 2016. New § 1026.35(b)(2)(iv)(A)(
Section 1026.35(b)(2)(iii) currently provides that an escrow account need not be established for a higher-priced mortgage loan by small creditors if four conditions identified in § 1026.35(b)(2)(iii)(A) through (D) are satisfied at the time of consummation. Under current § 1026.35(b)(2)(iii)(A), a creditor satisfies the rural-or-underserved component of the eligibility criteria if, during the preceding calendar year or, if the application for the transaction was received before April 1 of the current calendar year, during either of the two preceding calendar years, a creditor extended more than 50 percent of its total covered transactions secured by first liens on properties that are located in rural or underserved areas. This provision is consistent with the statutory provision as adopted by the Dodd-Frank Act requiring that, in order for the Bureau to have the authority to grant the exemption, the creditor must operate predominantly in rural or underserved areas. The Bureau is revising § 1026.35(b)(2)(iii)(A) to remove the “more than 50 percent” aspect of the test and condition eligibility on a creditor extending one covered transaction secured by a first lien on a property located in a rural or underserved area.
The Bureau is revising § 1026.35(b)(2)(iii)(A) to reflect Congress's intent to expand the cohort of small creditors eligible for the special provision and exemptions by amending TILA sections 129C(b)(2)(E)(iv)(I) and 129D(c)(1) by removing “predominantly” from the statute. These sections of TILA relate to special provisions and an exemption that applies to certain small creditors operating in rural or underserved areas. Previously, TILA section 129C(b)(2)(E)(iv)(I) permitted the Bureau, by regulation, to define qualified mortgage as including a balloon loan for certain small creditors that operate predominantly in rural or underserved areas. Similarly, TILA section 129D(c)(1) permitted the Bureau, by regulation, to exempt certain small creditors that operate predominantly in rural or underserved areas from the requirement to establish an escrow account under TILA section 129D(a) in certain circumstances. The Act amended both provisions of TILA by striking the word “predominantly” and thereby extending the class of eligible creditors under TILA for the special provisions that permit balloon-payment qualified mortgages and for the escrow exemption.
The Bureau previously issued regulations exercising its authority under TILA sections 129C(b)(2)(E)(iv)(I) and 129D(c)(1).
Regulation Z uses a single test to determine whether a small creditor
When the Bureau adopted the “more than 50 percent” aspect of the test, it stated that it was implementing the use of “predominantly” in the statute.
The Bureau believes that TILA sections 129C(b)(2)(E)(iv)(I) and 129D(c)(1), as revised by the Act, are ambiguous with respect to what it means to “operate in a rural area,” and are subject to various possible reasonable interpretations. The Bureau believes that the one-loan test adopted by revised § 1026.35(b)(2)(iii)(A) is a reasonable interpretation of these provisions of TILA and is appropriate at this time in light of the recent regulatory context, including Congress's decision to remove the term that the Bureau had relied on to establish the “more than 50 percent” aspect of the test from the statute and the limited data currently available upon which to base consideration of other potentially reasonable interpretations. Furthermore, as discussed above in part IV, the Bureau believes that the amendments must take effect before April 1, 2016, to provide timely guidance for creditors who may have uncertainty about the effect of the Act on § 1026.35(b)(2)(iii)(A) and need to make prompt decisions for the near term about their business operations in light of the Act's amendments, including whether to apply for an area to be designated as rural.
The nearer term practical effect of the revisions to § 1026.35(b)(2)(iii)(A) is that they will likely preserve, for the most part, the current status of many small creditors eligible for the special provisions. As discussed above, under temporary provisions that expire on April 1, 2016, creditors that meet all of the other eligibility criteria for the special provisions may originate balloon-payment qualified mortgages and balloon-payment high cost mortgages even if they do not satisfy the rural-or-underserved component of the test.
The Bureau intends to monitor the market closely and thoroughly for negative effects on consumers or unintended effects on the mortgage market as a result of these revisions to § 1026.35(b)(2)(iii)(A). The Bureau expects to have better information available for analyzing these effects and considering other potentially reasonable interpretations of “operates in rural or underserved areas” in the future, including more data available from the National Survey of Mortgage Borrowers (NSMB), as well as the National Mortgage Database (NMDB).
At least one year after the effective date of this rule, and further dependent on when the Bureau believes newly available information may support considering additional rulemaking related to § 1026.35(b)(2)(iii)(A), the Bureau intends to invite public comment on the effect of these revisions to § 1026.35(b)(2)(iii)(A). If better information available to the Bureau, including further information provided by the public, shows that the revisions to § 1026.35(b)(2)(iii)(A) have had unintended effects on the mortgage market or negative effects on consumers, the Bureau intends to publish a notice of proposed rulemaking to exercise its authority to implement a revised test under § 1026.35(b)(2)(iii)(A). The Bureau requests comment on the optimal scope of the exemption for these creditors that the Bureau should consider as new data becomes available, and in what timeframe the Bureau should consider undertaking additional rulemaking related to the exemption. The Bureau also requests comment, including relevant data, on whether the
Section 1026.35(b)(1) generally requires a creditor to establish an escrow account for a higher-priced mortgage loan secured by a first lien on a consumer's principal dwelling. Section 1026.35(b)(2)(iii) provides an exemption from that requirement for certain small creditors. Section 1026.35(b)(2)(iii)(D) makes creditors that maintain existing escrow accounts ineligible for that exemption, with certain exceptions. One such exception, § 1026.35(b)(2)(iii)(D)(
Section 1026.35(b)(2)(iv)(A) currently considers an area as rural during a calendar year if it is: A county that is neither in a metropolitan statistical area nor in a micropolitan statistical area that is adjacent to a metropolitan statistical area; or a census block that is not in an urban area, as defined by the U.S. Census Bureau using the latest decennial census of the United States. The Bureau is adding new § 1026.35(b)(2)(iv)(A)(
As discussed above, on March 3, 2016, the Bureau published a procedural rule in the
The Bureau interprets the term “rural area,” as that term is used in section 89002 of the Act, to be an area comprising counties or census blocks. For reasons set forth in the section-by-section analysis of the October 2015 amendments to § 1026.35(b)(2)(iv)(A), the Bureau adopted counties or census blocks as the appropriate units of analysis for its rural classification scheme and rejected alternative proposals.
The Bureau is also making conforming changes to comments 35(b)(2)(iv)-1.i and -2.i.
The Bureau is revising comment 43(f)(1)(vi)-1 to remove references to the “more than 50 percent” test and replace them with references to the test under revised § 1026.35(b)(2)(iii)(A) for the reasons discussed above in the section-by-section analysis of that section and to add references to new § 1026.35(b)(2)(iv)(A)(
The Bureau is revising comment 43(f)(2)(ii)-1 to remove references to the “more than 50 percent” test and replace them with references to the revised test under § 1026.35(b)(2)(iii)(A) for the reasons discussed above in the section-by-section analysis of that section.
This interim final rule is effective on March 31, 2016.
In developing the final rule, the Bureau has considered potential benefits, costs, and impacts.
The discussion below considers the benefits, costs, and impacts of expanding eligibility of certain small creditors that operate in rural or underserved areas for special provisions that permit originations of balloon-payment qualified mortgages and for the escrow exemption for higher-priced mortgage loans (HPMLs).
The Bureau has chosen to evaluate the benefits, costs, and impacts of this rule relative to the current regulatory structure, including the October 2015 Small Creditor Final Rule.
The Bureau has relied on a variety of data sources to consider the potential benefits, costs and impacts of this rule.
The primary source of data used in this analysis is 2013 data collected under the Home Mortgage Disclosure Act (HMDA). The empirical analysis also uses data from the 4th quarter 2013 bank and thrift Call Reports
This rule expands the number of institutions that, under special provisions, are eligible to originate certain types of qualified mortgages and to take advantage of an exemption from the requirement to establish an escrow account for HPMLs under the January 2013 ATR Final Rule, the May 2013 ATR Final Rule, the January 2013 Escrows Final Rule, and the 2015 October Small Creditor Final Rule.
These special provisions and exemption are only available to small creditors that operate in rural or underserved areas (rural small creditors). Rural small creditors can originate qualified mortgages with balloon-payment features, as long as these loans are kept in portfolio and other requirements are met. These qualified mortgages with balloon-payment features are deemed to comply with the ability-to-repay requirement as long as these loans have an APR of less than 3.5 percentage points over APOR for a comparable transaction.
The Bureau discussed the benefits and costs of expanding the number of creditors eligible for the special provisions and exemption in detail in its 2015 October Small Creditor Final Rule Section 1022(b)(2) discussion.
Based on the 2013 data, the Bureau estimated in its 2015 October Small Creditor Final Rule that about 4,100 out of the 10,400 small creditors would qualify as rural based on the revised definitions and “predominantly” test as it had been defined by the Bureau. Based on the same data, roughly an additional 6,000 small creditors will qualify as rural under the new provisions. Approximately 300 small creditors did not make any loans in rural or underserved areas in 2013, but may do so going forward.
The roughly 6,000 small creditors that will qualify as rural under this rule originated approximately 1.1 million loans, including 360,000 portfolio loans and 70,000 HPMLs in 2013. The Bureau is unaware of how many of these loans were balloon loans. However, estimates from the National Survey of Mortgage Borrowers indicate that about 4 percent of the loans in rural areas had a balloon feature and about 2 percent of the loans in non-rural areas had a balloon feature. The Bureau does not know and lacks a method for estimating how many creditors who are newly eligible for the escrow exemption will choose to stop providing escrow accounts when originating HPMLs.
All methods of compliance under current law remain available to covered persons when this rule becomes effective.
As the Bureau noted in its 2015 October Small Creditor Final Rule that similarly expanded the set of creditors eligible for the special provisions, consumer benefit from the final provisions of this rule is a potential expansion or avoidance of contraction in access to credit. The Bureau outlined its analysis of the available data on access to credit in its 2015 October Small Creditor Final Rule, and that analysis still applies. Prior to its 2015 October Small Creditor Final Rule, the
As noted in the 2015 October Small Creditor Final Rule, the potential cost to consumers is the reduction of certain consumer protections as compared to the baseline established by the January 2013 ATR Final Rule, the May 2013 ATR Final Rule, and the January 2013 Escrows Final Rule. This rule would further reduce consumer protections from the 2015 October Small Creditor Final Rule. These consumer protections include a consumer's private cause of action against a creditor for violating the general ability-to-repay requirements for balloon loans and the requirement that every higher-priced mortgage loan have an associated escrow account for the payment of property taxes and insurance for five years.
The number of consumers affected is the same as the number of loans discussed above.
The only covered persons affected by this rule are those with no more than $10 billion in assets. The effect on these covered persons is described above.
The Bureau does not believe that there will be an adverse impact on access to credit resulting from the final provisions. Moreover, it is possible that there will be an expansion of access to credit.
Despite the Bureau's estimate that balloon loans are about twice as frequent in rural areas, this rule is not likely to disproportionately impact non-rural areas. The approximately 4,100 small creditors that operate predominantly in rural areas are already eligible for the special provisions and for the exemption due to the 2015 October Small Creditor Final Rule, and are thus unaffected by this rule.
Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
Consistent with the discussion in Section 1022(b)(2), the Bureau has determined that this rule does not impose any new or revised information collection requirements (recordkeeping, reporting, or disclosure requirements) on covered entities or members of the public that would constitute collections of information requiring OMB approval under the PRA.
Advertising, Appraisal, Appraiser, Banking, Banks, Consumer protection, Credit, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth in lending.
For the reasons set forth in the preamble, the Bureau amends Regulation Z, 12 CFR part 1026, as set forth below:
12 U.S.C. 2601, 2603-2605, 2607, 2609, 2617, 3353, 5511, 5512, 5532, 5581; 15 U.S.C. 1601
(b) * * *
(2) * * *
(iii) * * *
(A) During the preceding calendar year, or, if the application for the transaction was received before April 1 of the current calendar year, during either of the two preceding calendar years, the creditor extended a covered transaction, as defined by § 1026.43(b)(1), secured by a first lien on a property that is located in an area that is either “rural” or “underserved,” as set forth in paragraph (b)(2)(iv) of this section;
(D) * * *
(
(iv) * * *
(A) An area is “rural” during a calendar year if it is:
(
(
(
The revisions read as follows:
1. * * *
i. During the preceding calendar year, or during either of the two preceding calendar years if the application for the loan was received before April 1 of the current calendar year, a creditor extended a first-lien covered transaction, as defined in § 1026.43(b)(1), secured by a property located in an area that is either “rural” or “underserved,” as set forth in § 1026.35(b)(2)(iv).
A. In general, whether the rural-or-underserved test is satisfied depends on the creditor's activity during the preceding calendar year. However, if the application for the loan in question was received before April 1 of the current calendar year, the creditor may instead meet the rural-or-underserved test based on its activity during the next-to-last calendar year. This provides creditors with a grace period if their activity meets the rural-or-underserved test (in § 1026.35(b)(2)(iii)(A)) in one calendar year but fails to meet it in the next calendar year.
B. A creditor meets the rural-or-underserved test for any higher-priced mortgage loan consummated during a calendar year if it extended a first-lien covered transaction in the preceding calendar year secured by a property located in a rural-or-underserved area. If the creditor does not meet the rural-or-underserved test in the preceding calendar year, the creditor meets this condition for a higher-priced mortgage loan consummated during the current calendar year only if the application for the loan was received before April 1 of the current calendar year and the creditor extended a first-lien covered transaction during the next-to-last calendar year that is secured by a property located in a rural or underserved area. The following examples are illustrative:
1.
1. * * *
i. Under § 1026.35(b)(2)(iv)(A), an area is rural during a calendar year if it is: A county that is neither in a metropolitan statistical area nor in a micropolitan statistical area that is adjacent to a metropolitan statistical area; a census block that is not in an urban area, as defined by the U.S. Census Bureau using the latest decennial census of the United States; or a county or a census block that has been designated as “rural” by the Bureau pursuant to the application process established in 2016.
2.
1. * * *
i. During the preceding calendar year or during either of the two preceding calendar years if the application for the transaction was received before April 1 of the current calendar year, the creditor extended a first-lien covered transaction, as defined in § 1026.43(b)(1), on a property that is located in an area that is designated either “rural” or “underserved,” as defined in § 1026.35(b)(2)(iv), to satisfy the requirement of § 1026.35(b)(2)(iii)(A) (the rural-or-underserved test). Pursuant to § 1026.35(b)(2)(iv), an area is considered to be rural if it is: A county that is neither in a metropolitan statistical area, nor a micropolitan statistical area adjacent to a metropolitan statistical area, as those terms are defined by the U.S. Office of Management and Budget; a census block that is not in an urban area, as defined by the U.S. Census Bureau using the latest decennial census of the United States; or a county or a census block that has been designated as “rural” by the Bureau pursuant to the application process established in 2016.
A. The Bureau determines annually which counties in the United States are rural or underserved as defined by § 1026.35(b)(2)(iv)(A)(
B. For example, if a creditor extended during 2017 a first-lien covered transaction that is secured by a property that is located in an area that meets the definition of rural or underserved under § 1026.35(b)(2)(iv), the creditor meets this element of the exception for any transaction consummated during 2018.
C. Alternatively, if the creditor did not extend in 2017 a transaction that meets the definition of rural or underserved test under § 1026.35(b)(2)(iv), the creditor satisfies this criterion for any transaction consummated during 2018 for which it received the application before April 1, 2018, if it extended during 2016 a first-lien covered transaction that is secured by a property that is located in an area that meets the definition of rural or underserved under § 1026.35(b)(2)(iv).
1.
Occupational Safety and Health Administration (OSHA), Department of Labor.
Final rule.
On March 13, 2015, OSHA published in the
This final rule becomes effective on April 25, 2016. The incorporation by reference of certain standards listed in the rule was approved by the Director of the Federal Register as of April 25, 2016.
In accordance with 28 U.S.C. 2112(a), OSHA designates Ann S. Rosenthal, Associate Solicitor of Labor for Occupational Safety and Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, to receive petitions for review of the final rule.
The address for OSHA's docket office is: Docket Office, Technical Data Center, Room N-2625, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-2350. (OSHA's TTY number is (877) 889-5627)). The hours of operation for the OSHA Docket Office are 8:15 a.m. to 4:45 p.m., e.t. In addition, addresses and phone numbers for OSHA's state and regional offices can be found at
This final rule updates eye and face protection requirements in OSHA's general industry, shipyard employment, marine terminals, longshoring, and construction standards. The changes involve incorporation by reference of the latest ANSI/ISEA Z87.1-2010 standard on Occupational and Educational Eye and Face Protection Devices and removal of the oldest ANSI (Z87.1-1989) version of the same standard. In addition, OSHA is modifying the language in its construction standard to make it more consistent with the general and maritime industry standards.
This new rule will allow employers to continue to follow the existing ANSI standards referenced or allow employers to follow the latest version of the same ANSI/ISEA standard. Employers are not required to update or replace protection devices solely as a result of this rule and may continue to follow their current and usual practices for their eye and face protection. Therefore, this rule has no compliance or economic burdens associated with it.
OSHA requires employers to ensure that their employees use eye and face protection where necessary to protect them against flying objects, splashes or droplets of hazardous chemicals, and other workplace hazards that could injure their eyes and face. OSHA's standards state that the protection employers provide must meet specified consensus standards. For operations covered by OSHA's general industry, shipyard employment, longshoring, and marine terminals standards, the protection must comply with one of the following standards: ANSI Z87.1-2003, ANSI Z87.1-1989 (R-1998), and ANSI Z87.1-1989. Alternatively, the employer may show that the devices used are at least as effective as one of these consensus standards (29 CFR 1910.133(b); 29 CFR 1915.153(b); 29 CFR 1917.91(a)(1); 29 CFR 1918.101(a)(1)). The construction standard requires that eye and face protection meet the requirements of ANSI Z87.1-1968 (29 CFR 1926.102(a)(2)).
As a part of its ongoing efforts to update its standards with the latest versions of national consensus standards, (see 69 FR 68283), OSHA last updated its eye and face protection standards in 2009 (74 FR 46350). That effort did not address the eye and face protection requirements in the construction standard, which had been revised in 1993, and during the 2009 rulemaking OSHA received several comments suggesting that the construction requirements be updated as well. After the new ANSI/ISEA 87.1-2010 standard was published, OSHA decided to again update its eye and face protection requirements.
Before publishing a proposal, OSHA consulted the Advisory Committee on Construction Safety and Health (ACCSH) on May 8, 2014, as required by 29 CFR 1911.10. OSHA presented two options to ACCSH. The first option replaced all eye and face protection provisions in the construction standard with those of the general industry and maritime standards, except those that
On March 13, 2015, OSHA published an NPRM in the
OSHA received no significant adverse comment to the proposal, and this notice finalizes the rule updates as proposed. This action will ensure consistency among the Agency's standards, and eliminate any confusion, clarify employer obligations, and provide up-to-date protection for workers exposed to eye and face hazards.
ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, provides requirements for the selection, testing, use, and maintenance of protectors intended to minimize or prevent eye and face injuries including impact, non-ionizing radiation and chemical exposures, in occupational and educational environments. ANSI Z87.1-2003 and ANSI Z87.1-1989 (R-1998) are prior versions of this standard which are also incorporated by reference as alternative means of compliance with OSHA's eye and face protection requirements.
OSHA believes that the ANSI/ISEA and ANSI standards are reasonably available to interested parties. The ANSI/ISEA 2010 and ANSI 2003 and 1989 (R-1998) versions of the Z87.1 standard can be purchased as a package from ANSI in pdf form for $57 (
OSHA adopted the previous revision of the general industry and maritime eye and face protection standards on September 9, 2009 (74 FR 46350). These revisions, which became effective on October 9, 2009, permit compliance with ANSI Z87.1-2003, ANSI Z87.1-1989 (R-1998), or ANSI Z87.1-1989. Since OSHA published the previous revision, ANSI/ISEA Z87.1-2010 became available. This final rule includes ANSI/ISEA Z87.1-2010 in 29 CFR 1910.133(b)(1), 29 CFR 1915.153(b)(1), 29 CFR 1917.91(a)(1)(i) and removes references to ANSI Z87.1-1989. It also updates the general incorporation by reference section for each of these standards (
OSHA believes that eye and face protection meeting the 2010 ANSI/ISEA standard is already on the market, and the 2010 standard is not less protective than the previous versions of the standard. Therefore it is amending its standard to allow the use of such protection in the workplace.
The final rule involves: (1) Changes to the ANSI standard references and (2) inclusion of language from the general industry eye and face protection standard. With respect to the consensus standards update, OSHA is amending 29 CFR 1926.6 and 1926.102, which currently incorporate by reference ANSI Z87.1-1968 to include the same three consensus standards incorporated into the general industry and maritime standards, ANSI/ISEA Z87.1-2010, ANSI Z87.1-2003, and ANSI Z87.1-1989 (R-1998). OSHA is modifying certain existing language to make it nearly identical to the language in the general industry standard's eye and face protection provisions. It is retaining provisions unique to the current construction standard that are not covered in the versions of the consensus standards incorporated by the proposal.
Specifically, OSHA is placing language from the general industry standard, sections 1910.133(a)(1) through (a)(4) and 1910.133(b), in sections 1926.102(a)(1) through (a)(3), and (a)(7). Additionally, the Agency is replacing: (1) The scope section in 1926.102(a)(1) with the scope section in 1910.133(a)(1); (2) the reference to the 1968 ANSI standard in 1926.102(a)(2) with the updated list of national consensus standards in 1910.133(b)(1); and (3) the requirements for corrective lenses in 1926.102(a)(3) with the corrective-lens requirements in 1910.133(a)(3). The final rule removes the requirements in section 1926.102(a)(4)—to keep protective equipment clean, in good repair, and free of structural and optical defects—which are addressed by requirements in each of the three versions of the Z87.1 standard. Likewise, it deletes Table E-1, Eye and Face Protector Selection Guide, which is specific to the 1968 version of ANSI Z87.1 and referenced in the current section 1926.102(a)(5), and renumbers Tables E-2 and E-3 under this paragraph as Tables E-1 and E-2, respectively.
The final rule substitutes the marking requirement specified by section 1926.102(a)(7) with the marking requirement in section 1910.133(a)(4). The final rule removes the requirement in 1926.102(a)(8) that employers must transmit information from manufacturers to users about equipment
OSHA believes these changes are warranted because it will make compliance easier for employers who perform work that is covered both by the construction standard and another of OSHA's standards. Further, OSHA believes that the consensus standard reference should be updated because the new ANSI standards are at least as protective as the 1968 standard, and the Agency does not believe that personal protective equipment (PPE) designed and tested to the 1968 ANSI standard is currently available for purchase.
OSHA received twelve comments in response to the NPRM on eye and face protection consensus standards updating. While commenters generally supported OSHA's efforts to update its standards, some raised issues to which OSHA responds below.
Mr. Bruce Donato, a private citizen, Mr. Douglas Greenhaus of the National Automobile Dealers Association (NADA), and Ms. Julie Trembly of 3M commented on OSHA's use of consensus standards. Mr. Donato asked why OSHA uses consensus standards rather than proposing its own standards (ID: OSHA-2014-0024-0006). Mr. Greenhaus advocated for use of a performance-oriented approach and removal of all consensus standard references, believing this approach would free OSHA from the obligation to continuously review and adopt new versions of third-party standards (ID: OSHA-2014-0024-0015). Ms. Trembly mentioned that OSHA may want to allow compliance only with the 2010 ANSI/ISEA standard. She reasoned that this would ease compliance because the 2010 version is the most recent and maintains a hazard-based approach (ID: OSHA-2014-0024-0013).
OSHA disagrees with these commenters. First, the Agency is legally required to consider national consensus standards. The Occupational Safety and Health Act of 1970 (OSH Act) requires OSHA to follow them in promulgating a rule, unless OSHA explains why another requirement will better effectuate the purposes of the act (29 U.S.C. 655(b)(b)). In addition, the National Technology Transfer and Advancement Act of 1995 also requires OSHA (and other Federal agencies) to use voluntary consensus standards unless contrary to applicable law or impractical. Pub. L 104-113 § 12(d), 15 U.S.C.A. 272 note; see also OMB Circular A-119,
OSHA disagrees with the suggestion to only incorporate the latest ANSI/ISEA standard, because it believes some employers may be using eye and face protection meeting the ANSI 87.1-2003 and ANSI 87.1-1989 (R-1998) standards. OSHA is unaware of evidence that disallowing the use of PPE meeting those standards would significantly increase safety.
Relatedly, Mr. Donato and Mr. Greenhaus of NADA also expressed concern that the cost of obtaining consensus standards could be prohibitive to small businesses (IDs: OSHA-2014-0024-0006 and 0015). As noted above, all referenced consensus standards are available purchase for a modest sum and may be viewed for free in OSHA's regional offices, among other places.
Ms. Julie Weide, a private citizen, commented that she wanted more mandatory eye protection at worksites, in accordance with equipment manufacturers' warnings (ID: OSHA-2014-0024-0007). Though her suggestion falls outside of the scope of the proposal, OSHA notes that its current eye and face protection standards already require employers to ensure that affected employees use appropriate eye or face protection when exposed to hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation.
Several commenters supported OSHA's decision to make eye and face protection requirements consistent across all industry standards, stating that consistency makes compliance easier for employers (IDs: OSHA-2014-0024-0009, 0011, and 0012). OSHA agrees with the commenters' assessment.
Mr. Joe Miles of the Northeastern Retail Lumber Association (NRLA) commented that the final rule should provide a transition period so that associations such as the NRLA would have time to notify members of the new standards. Members could then inform their customers of the new PPE requirements, and have sufficient time to order and integrate necessary PPE into the workplace (ID: OSHA-2014-0024-0011). Mr. Greenhaus of NADA agreed, opining that small business employers should be given greater flexibility with respect to compliance (ID: OSHA-2014-0024-0015).
Under the final rule, employers may follow any of the three latest versions of the Z87.1 standards. The new rule places no new obligations, costs, or time constraints on employers. Employers already in compliance with OSHA's eye and face requirements may continue their current usual and customary practice in providing eye and face protection to their employees. The final now allows employers to follow the newest ANSI/ISEA Z87.1-2010 standard—if they choose and at their convenience—or to continue to follow the older versions (ANSI Z87.1-2003 or Z87.1-1989 (R-1998)), which appeared in the previous version of the rule. As Mr. Daniel Shipp of the ISEA commented, the removal of the 1989 version will have no effect on the acceptability of any product because it is identical to the 1989 (R-1998) standard, which remains in the final rule (ID: OSHA-2014-0024-0012). Further, OSHA anticipates that compliance with the 2010 version of the ANSI/ISEA Z87.1 standard will not be burdensome, because as commenters noted, most manufacturers of eye and face protection devices already follow the latest ANSI/ISEA standard (IDs: OSHA-2014-0024-0012 and 0013).
While they supported the proposal, Mr. Faulkner and Ms. Fitch from the United Steelworkers (USW) and Mr. McCann, a private citizen, discussed their concerns about improperly-fitting PPE, especially for women and men of nonstandard body types. They further indicated that OSHA's standardized PPE requirement throughout various industries was insufficient. Instead, OSHA should require employers to: (1) Provide the best fitting PPE available on the market for their workers at no cost, (2) regularly evaluate which PPE is provided to employees, and (3) purchase customized PPE where special orders are needed. They also highlighted a need to protect workers who complain about inadequate PPE from retaliation (ID: OSHA-2014-0024-0016 and 0017).
OSHA thanks the commenters for raising these issues and the agency agrees that PPE must fit properly no matter who is wearing it. A correct, comfortable fit helps to ensure the worker will receive the intended protection for the duration of the exposure. Many of the commenters' concerns are addressed in the existing PPE standard. Specifically, the general industry standard requires employers to select PPE that properly fits each affected employee, at no cost to the employee.
A number of commenters noted a more general need for OSHA to revise its standards to incorporate by reference the most recent versions of consensus standards (
Mr. Shipp from ISEA noted that OSHA incorrectly referenced to the 2010 consensus standard in its NPRM. OSHA appreciates this comment and has corrected the final rule so all references to the 2010 standard reflect the official designation of the consensus standard: ANSI/ISEA Z87.1-2010 (ID: OSHA-2014-0024-0012).
The purpose of the OSH Act is to achieve to the extent possible safe and healthful working conditions for all employees. 29 U.S.C. 651(b). To achieve this goal, Congress authorized the Secretary of Labor to promulgate and enforce occupational safety and health standards. 29 U.S.C. 654(b), 655(b). A safety or health standard is one “which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes reasonably necessary or appropriate to provide safe or healthful employment and places of employment.” 29 U.S.C. 652(8). A standard is reasonably necessary or appropriate within the meaning of Section 652(8) of the OSH Act when a significant risk of material harm exists in the workplace and the standard would substantially reduce or eliminate that workplace risk.
Moreover, this final rule neither reduces employee protection nor alters an employer's obligations under the existing standards. With respect to employee protection, because the final rule will allow employers to continue to provide the same eye and face protection they currently provide, employees' protection will not change. In terms of employers' obligations, the final rule will allow employers additional options for meeting the design-criteria requirements for eye and face protection. Accordingly, this final rule does not require an additional significant risk finding (
In addition, a safety standard must be technologically feasible.
OSHA has determined that employers can comply with the final rule by following their current usual and customary practice in providing eye and face protection to their employees. This final rule expands the options available to employers without removing any existing option and thus has no costs. Therefore, OSHA finds that the final rule is not economically significant within the context of Executive Order 12866, or a major rule under the Unfunded Mandates Reform Act or Section 801 of the Small Business Regulatory Enforcement Fairness Act. In addition, this final rule complies with Executive Order 13563 because employers are allowed increased flexibility in choosing eye and face protection for their employees and are not required to update or replace that protection solely as a result of this final rule if the employer's current practice meets the new standards. Because the final rule imposes no costs, OSHA certifies that it will not have a significant economic impact on a substantial number of private or public sector entities. Likewise, it does not meet any of the criteria for an economically significant or major rule specified by the Executive Order or relevant statutes.
As was the case for the NPRM, the Department has determined this rule does not establish new or revise any existing collection of information requirements subject to OMB approval
OSHA reviewed this final rule in accordance with the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999), which requires that agencies, to the extent possible, refrain from limiting state policy options, consult with states prior to taking any actions that would restrict state policy options, and take such actions only when clear constitutional authority exists and the problem is national in scope. Executive Order 13132 provides for preemption of state law only with the expressed consent of Congress. Agencies must limit any such preemption to the extent possible.
Under Section 18 of the OSH Act, 29 U.S.C. 651
While OSHA developed the final rule to protect employees in every state, Section 18(c)(2) of the OSH Act permits State Plan states and U.S. Territories to develop and enforce their own standards for eye and face protection provided these requirements are at least as effective in providing safe and healthful employment and places of employment as the requirements specified in this final rule.
In summary, this final rule complies with Executive Order 13132. In states without OSHA-approved state plans, this rule limits state policy options in the same manner as other OSHA standards. In State Plan states, this rule does not significantly limit state policy options because, as explained in the following section, State Plan states do not have to adopt this final rule.
When Federal OSHA promulgates a new standard or amends an existing standard to be more stringent than it was previously, the 28 states or U.S. Territories with their own OSHA-approved occupational safety and health plans must revise their standards to reflect the new standard or amendment, or show OSHA why such action is unnecessary,
With regard to this final rule, it will not impose any additional or more stringent requirements on employers compared to existing OSHA standards. Through this rulemaking, OSHA is updating the references in its regulations to recognize recent editions of the applicable national consensus standards, and deleting a number of outdated editions of the national consensus standards referenced in its existing PPE standards. The final rule does not require employers to update or replace their PPE solely as a result of this rulemaking if the PPE currently in use meets the existing standards. Therefore, the final rule does not require action under 29 CFR 1953.5(a), and States and U.S. Territories with approved State Plans do not need to adopt this rule or show OSHA why such action is unnecessary. However, to the extent these States and Territories have the same standards as the OSHA standards affected by this final rule, OSHA encourages them to adopt the amendments.
OSHA reviewed this final rule according to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501-1571, and Executive Order 12875, 58 FR 58093 (October 26, 1993). As discussed above in Section IV.B (“Final Economic Analysis and Regulatory Flexibility Act Certification”) of this preamble, OSHA determined that the final rule imposes no additional costs on any private-sector or public-sector entity. Accordingly, this final rule requires no additional expenditures by either public or private employers.
As noted above under Section IV.E (“State Plan States”) of this preamble, OSHA standards do not apply to state or local governments except in states that elected voluntarily to adopt an OSHA-approved state plan. Consequently, this final rule does not meet the definition of a “Federal intergovernmental mandate.”
OSHA reviewed this final rule in accordance with Executive Order 13175, 65 FR 67249 (November 6, 2000), and determined that it does not have “tribal implications” as defined in that order. The final rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
Incorporation by reference, Occupational Safety and Health, Personal Protective Equipment.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Ave. NW., Washington, DC 20210, authorized the preparation of this notice. OSHA is issuing this final rule pursuant to 29 U.S.C. 653, 655, and 657; 40 U.S.C. 3701
For the reasons stated above in the preamble, the Occupational Safety and Health Administration is amending 29 CFR parts 1910, 1915, 1917, 1918, and 1926 as follows:
29 U.S.C. 653, 655, 657; Secretary of Labor's Order Numbers 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable.
Sections 1910.6, 1910.7, 1910.8 and 1910.9 also issued under 29 CFR 1911. Section 1910.7(f) also issued under 31 U.S.C. 9701, 29 U.S.C. 9a, 5 U.S.C. 553; Public Law 106-113 (113 Stat. 1501A-222); Pub. L. 11-8 and 111-317; and OMB Circular A-25 (dated July 8, 1993) (58 FR 38142, July 15, 1993).
(e) * * *
(69) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 13, 2010; IBR approved for § 1910.133(b). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(70) ANSI Z87.1-2003, Occupational and Educational Eye and Face Personal Protection Devices Approved June 19, 2003; IBR approved for §§ 1910.133(b). Copies available for purchase from the:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(71) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, Reaffirmation approved January 4, 1999; IBR approved for § 1910.133(b). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable, and 29 CFR part 1911; Sections 1910.132, 1910.134, and 1910.138 of 29 CFR also issued under 29 CFR 1911; Sections 1910.133, 1910.135, and 1910.136 of 29 CFR also issued under 29 CFR 1911 and 5 U.S.C. 553.
(b)
(i) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1910.6;
(ii) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1910.6; or
(iii) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, incorporated by reference in § 1910.6;
Section 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); Sections. 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; 29 CFR part 1911.
Section 1915.100 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
Sections 1915.120 and 1915.152 of 29 CFR also issued under 29 CFR part 1911.
(d)(1) * * *
(vi) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 13, 2010; IBR approved for § 1915.153(b). Copies are available for purchase from:
(A) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(B) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(C) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(vii) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, approved June 19, 2003; IBR approved for § 1910.153(b). Copies available for purchase from the:
(A) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(B) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(C) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(viii) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection,
(A) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(B) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(C) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(b)
(i) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1915.5;
(ii) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1915.5; or
(iii) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, incorporated by reference in § 1915.5;
33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912),as applicable; and 29 CFR 1911.
Section 1917.28 also issued under 5 U.S.C. 553.
Section 1917.29 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
(b) * * *
(6) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 13, 2010; IBR approved for § 1917.91(a). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(7) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 13, 2010; IBR approved for § 1917.91(a). Copies available for purchase from the:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(8) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, Reaffirmation approved January 4, 1999; IBR approved for § 1917.91(a). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(a)(1)(i) The employer shall ensure that each affected employee uses protective eye and face protection devices that comply with any of the following consensus standards:
(A) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1917.3;
(B) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1917.3;
or
(C) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, incorporated by reference in § 1917.3;
33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR 1911.
Section 1918.90 also issued under 5 U.S.C. 553.
Section 1918.100 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
(b) * * *
(6) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 13, 2010; IBR approved for § 1918.101(a). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(7) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, Approved June 19, 2003; IBR approved for § 1918.101(a). Copies available for purchase from the:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(8) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, Reaffirmation approved January 4, 1999; IBR approved for § 1918.101(a). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(a) * * *
(1)(i) Employers must ensure that each employee uses appropriate eye and/or face protection when the employee is exposed to an eye or face hazards, and that protective eye and face devices comply with any of the following consensus standards:
(A) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1918.3;
(B) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1918.3; or
(C) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, incorporated by reference in § 1918.3
40 U.S.C. 3701
The revisions and additions read as follows:
(h) * * *
(31) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, Approved April 3, 2010; IBR approved for § 1926.102(b). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(32) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, Approved June 19, 2003; IBR approved for § 1926.102(b). Copies available for purchase from the:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
(33) ANSI Z87.1-1989 (R-1998), Practice for Occupational and Educational Eye and Face Protection, Reaffirmation approved January 4, 1999; IBR approved for § 1926.102(b). Copies are available for purchase from:
(i) American National Standards Institute's e-Standards Store, 25 W 43rd Street, 4th Floor, New York, NY 10036; telephone: (212) 642-4980; Web site:
(ii) IHS Standards Store, 15 Inverness Way East, Englewood, CO 80112; telephone: (877) 413-5184; Web site:
(iii) TechStreet Store, 3916 Ranchero Dr., Ann Arbor, MI 48108; telephone: (877) 699-9277; Web site:
40 U.S.C. 3701
The additions and revisions read as follows:
(a)
(2) The employer shall ensure that each affected employee uses eye protection that provides side protection when there is a hazard from flying objects. Detachable side protectors (
(3) The employer shall ensure that each affected employee who wears prescription lenses while engaged in operations that involve eye hazards wears eye protection that incorporates the prescription in its design, or wears eye protection that can be worn over the prescription lenses without disturbing the proper position of the prescription lenses or the protective lenses.
(4) Eye and face PPE shall be distinctly marked to facilitate identification of the manufacturer.
(b)
(i) ANSI/ISEA Z87.1-2010, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1926.6;
(ii) ANSI Z87.1-2003, Occupational and Educational Personal Eye and Face Protection Devices, incorporated by reference in § 1926.6; or
(iii) ANSI Z87.1-1989 (R-1998), Practice for Occupational and
(2) Protective eye and face protection devices that the employer demonstrates are at least as effective as protective eye and face protection devices that are constructed in accordance with one of the above consensus standards will be deemed to be in compliance with the requirements of this section.
(c)
(2)
(ii) All protective goggles shall bear a label identifying the following data:
(A) The laser wavelengths for which use is intended;
(B) The optical density of those wavelengths;
(C) The visible light transmission.
U.S. Army Corps of Engineers, DoD.
Direct final rule.
The U.S. Air Force has requested that the U.S. Army Corps of Engineers (Corps) disestablish the existing danger zone located in the Bering Sea near Shemya Island, Alaska. The danger zone was established on September 28, 1971. The purpose of the danger zone was to protect persons and property from dangers encountered in the area associated with the launching of weather rockets. The facility has not been used for this activity since the mid-1980s. As a result of the discontinued use of this area, the Air Force has requested the danger zone be disestablished.
This rule is effective May 24, 2016 without further notice, unless the Corps receives adverse comment by April 25, 2016. If we receive such adverse comment, we will publish a timely withdrawal in the
You may submit comments, identified by docket number COE-2016-0003, by any of the following methods:
Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922 or Ms. Linda Speerstra, U.S. Army Corps of Engineers, Alaska District, Regulatory Division, at 907-747-0658.
By letter dated December 18, 2015, the Chief, Pacific Air Forces Weather Operations Branch, Joint Base Pearl Harbor-Hickam, Hawaii requested the disestablishment of the danger zone at Meteorological Rocket Launching Facility on Shemya Island, Alaska. This request was made because the facility has not been used since the mid-1980s. In response to this request by the Pacific Air Forces Weather Operations Branch, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3), the Corps is amending the regulation at 33 CFR part 334 by disestablishing the danger zone in the waters of the Bering Sea, Meteorological Rocket Launching Facility on Shemya Island Area, Alaska.
The Corps is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comment. The Corps regulations governing restricted areas state that notice of proposed rulemaking and public procedures are not needed before publishing a final rule revoking a danger zone area (see 33 CFR 334.5(b)).
In the “Proposed Rules” section of today's
a.
b.
c.
d.
Danger zones, Navigation (water), Restricted areas, Waterways.
For the reasons set out in the preamble, the Corps amends 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
Environmental Protection Agency (EPA).
Direct final rule; technical amendment.
The Environmental Protection Agency (EPA) inadvertently approved and codified incorrect entry numbers in the part 52 instructions for the final rule action published on November 2, 2015. This technical amendment amends the part 52 codification instructions.
This action is effective March 25, 2016.
Jan Simpson at (913) 551-7089, or by email at
On November 2, 2015 (80 FR 67335), EPA published a final rule approving a SIP revision for Iowa that approved Iowa's November 4, 2011, submission addressing the requirements of the CAA sections 110(a)(1) and (2) as applicable to the 2008 Lead NAAQS. Specifically, EPA approved the following infrastructure elements: 110(a)(2)(A),
This technical amendment revises the erroneous part 52 instructions published in the
Chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(e)* * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for the commercial sector for vermilion snapper in the exclusive economic zone (EEZ) of the South Atlantic. NMFS projects that commercial landings for vermilion snapper will reach the commercial annual catch limit (ACL) for the January through June, 2016, fishing period by March 29, 2016. Therefore, NMFS closes the commercial sector for vermilion snapper in the South Atlantic EEZ on March 29, 2016, and it will remain closed until July 1, 2016, the start of the July through December fishing period. This closure is necessary to protect the South Atlantic vermilion snapper resource.
This rule is effective from 12:01 a.m., local time, March 29, 2016, until 12:01 a.m., local time, July 1, 2016.
Britni LaVine, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes vermilion snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The commercial ACL (equivalent to the commercial quota) for vermilion snapper in the South Atlantic is divided into separate quotas for two 6-month time periods, January through June and July through December. For the January through June, 2016, fishing season, the commercial quota is 388,703 lb (176,313 kg), gutted weight (431,460 lb (195,707 kg), round weight), as specified in 50 CFR 622.190(a)(4)(i)(D).
On February 26, 2016 (81 FR 9786), NMFS published a temporary rule in the
In accordance with regulations at 50 CFR 622.193(f)(1), NMFS is required to close the commercial sector for vermilion snapper when the commercial quota for that portion of the fishing year has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial quota for South Atlantic vermilion snapper for the January through June fishing period will be reached by March 29, 2016. Accordingly, the commercial sector for South Atlantic vermilion snapper is closed effective 12:01 a.m., local time, March 29, 2016, until 12:01 a.m., local time, July 1, 2016. The commercial quota for vermilion snapper in the South Atlantic is 388,703 lb (176,313 kg), gutted weight (431,460 lb (195,707 kg), round weight), for the July 1 through December 31, 2016, fishing period, as specified in 50 CFR 622.190(a)(4)(ii)(D).
The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having vermilion snapper on board must have landed and bartered, traded, or sold such vermilion snapper prior to 12:01 a.m., local time, March 29, 2016. During the closure, the bag limit specified in 50 CFR 622.187(b)(5) and the possession limits specified in 50 CFR 622.187(c)(1), apply to all harvest or possession of vermilion snapper in or from the South Atlantic EEZ. During the closure, the sale or purchase of vermilion snapper taken from the EEZ is prohibited. As specified in 50 CFR 622.190(c)(1)(i), the prohibition on sale or purchase does not apply to the sale or purchase of vermilion snapper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, March 29, 2016, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limits and the sale and purchase provisions of the commercial closure for vermilion snapper would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic vermilion snapper and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.193(f)(1) and is exempt from review under Executive Order 12866.
This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this action to close the commercial sector for vermilion snapper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect vermilion snapper since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and could result in a harvest well in excess of the established commercial quota.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod, except for the Community Development Quota program (CDQ), in the Aleutian Islands subarea of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the non-CDQ allocation of the 2016 Pacific cod total allowable catch (TAC) in the Aleutian Islands subarea of the BSAI.
Effective 1200 hrs, Alaska local time (A.l.t.), March 22, 2016, through 2400 hrs, A.l.t., December 31, 2016.
Josh Keaton, 907-586-7269.
NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The non-CDQ allocation of the 2016 Pacific cod TAC in the Aleutian Islands subarea of the BSAI is 11,465 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS, has determined that the non-CDQ allocation of the 2016 Pacific cod TAC in the Aleutian Islands subarea of the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 9,000 mt, and is setting aside the remaining 2,465 mt as
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of non-CDQ Pacific cod in the Aleutian Islands subarea of the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 21, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule.
NMFS is reallocating the projected unused amounts of the Aleut Corporation's pollock directed fishing allowance and the Community Development Quota from the Aleutian Islands subarea to the Bering Sea subarea directed fisheries. These actions are necessary to provide opportunity for harvest of the 2016 total allowable catch of pollock, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Effective 1200 hrs, Alaska local time (A.l.t.), March 25, 2016, until 2400 hrs, A.l.t., December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
In the Aleutian Islands subarea, the portion of the 2016 pollock total allowable catch (TAC) allocated to the Aleut Corporation's directed fishing allowance (DFA) is 14,700 metric tons (mt) and the Community Development Quota (CDQ) is 1,900 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
As of March 18, 2016, the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that 5,000 mt of Aleut Corporation's DFA and 1,900 mt of pollock CDQ in the Aleutian Islands subarea will not be harvested. Therefore, in accordance with § 679.20(a)(5)(iii)(B)(
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of AI pollock. Since the pollock fishery is currently open, it is important to immediately inform the industry as to the final Bering Sea subarea pollock allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery; allow the industry to plan for the fishing season and avoid potential disruption to the fishing fleet as well as processors; and provide opportunity to harvest increased seasonal pollock allocations while value is optimum. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 15, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Office of Budget and Program Analysis, USDA.
Request for Information (RFI); extension of comment period.
On January 26, 2016, the Office of the Secretary, USDA, published a document in the
The notice published January 26, 2016, at 81 FR 4213, is extended. Comments and information are requested on or before April 27, 2016.
Interested persons are invited to submit comments regarding this notice. All submissions must refer to “Retrospective Review” to ensure proper delivery.
•
•
Michael Poe, Telephone Number: (202) 720-3257.
USDA remains committed to minimizing the burdens on individuals, businesses, and communities for participation in and compliance with USDA programs that promote economic growth, create jobs, and protect the health and safety of the American people.
USDA programs are diverse and far reaching, as are the regulations and legislation that implement their delivery. The regulations range from nutrition standards for the school lunch program, natural resources and environmental measures governing national forest usage and soil conservation, emergency producer assistance as a result of natural disasters, to protection of American agriculture from the ravages of plant or animal pestilence. USDA regulations extend from farm to supermarket to ensure the safety, quality, and availability of the Nation's food supply. Regulations also specify how USDA conducts its business, including access to and eligibility for USDA programs. Finally, regulations specify the responsibilities of businesses, individuals, and State and local governments that are necessary to comply with their provisions.
The overall intention of Executive Orders 13563 and 13610 is to create a continuing process of scrutiny of regulatory actions.
Executive Order 13563, “Improving Regulation and Regulatory Review,” was issued to ensure that Federal regulations use the best available tools to promote innovation that will reduce costs and burden while allowing public participation and an open exchange of ideas. These principles enhance and strengthen Federal regulations to allow them to achieve their regulatory objectives, most important among them protecting public health, welfare, safety, and the environment. In consideration of these principles, and as directed by the Executive Order, Federal agencies and departments need to periodically review existing regulations that may be outmoded, ineffective, insufficient, or excessively burdensome and to modify, streamline, expand, or repeal them in accordance with what has been learned.
In addition, Executive Order 13610, “Identifying and Reducing Regulatory Burdens,” directed Federal agencies to conduct retrospective analyses of existing rules to examine whether they remain justified and whether they should be modified or streamlined in light of changed circumstances, including the availability of new technologies. Executive Order 13610 directs Federal agencies to give priority, consistent with law, to those initiatives that will produce significant quantifiable monetary savings or significant quantifiable reductions in paperwork burdens while protecting public health, welfare, safety, and the environment. For the regulatory requirements imposed on small businesses, it directs Federal agencies to give special consideration to initiatives that would simplify or harmonize the regulatory requirements.
USDA is seeking public comment on our effort: To identify and reduce regulatory burdens; to remove unintended regulatory obstacles to participation in and compliance with USDA programs; and to improve current regulations to help USDA agencies advance the USDA mission. USDA is particularly interested in public comments that speak to areas in which we can reduce costs and reporting burdens on the public, through technological advances or other modernization efforts, and comments on regulatory flexibility.
USDA is also seeking public input on measures that can be taken to reduce burdens and increase flexibility and freedom of choice for the public. Regulatory flexibility includes a variety of regulatory techniques that can help avoid unnecessary costs on regulated entities and avoid negative impacts. Regulatory flexibility techniques could include:
• Pilot projects, which can be used to test regulatory approaches;
• Safe harbors, which are streamlined modes of regulatory compliance and can serve to reduce compliance costs;
• Sunset provisions, which terminate a rule after a certain date;
• Trigger provisions, which specify one or more threshold indicators that the rule is designed to address;
• Phase-ins, which allow the rule to be phased-in for different groups at different times;
• Streamlined requirements, which provide exemptions or other streamlined requirements if a particular entity (for example, a small business) may otherwise experience disproportionate burden from a rule;
• State flexibilities, which provide greater flexibility to States or other regulatory partners, for example, giving them freedom to implement alternative regulatory approaches; and
• Exceptions, which allow exceptions to part of the rule, or the entire rule in cases where there is a potential or suspected unintended consequence.
In addition to retrospective review actions and other regulatory reforms identified in USDA's 2015 Fall Regulatory Agenda, we welcome comments from the public on any of USDA's existing regulations and ways to improve them to help USDA agencies advance the mission of the Department consistent with the Executive Order. USDA notes that this RFI is issued solely for information and program-planning purposes. While responses to this RFI do not bind USDA to any further actions, all submissions will be reviewed by the appropriate program office, and made publicly available on
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model BO-105LS A-3 helicopters. This proposed AD would require inspecting the helicopter records to determine if there is a life limit for the tension-torsion (TT) straps installed in the helicopter lifting system, establishing a life limit if there is not one, and replacing each TT strap that has met or exceeded its life limit. This proposed AD is prompted by an error in the Airworthiness Limitations section of the Model BO-105LS A-3 maintenance manual. The proposed actions are intended to prevent failure of a TT strap and subsequent loss of control of a helicopter.
We must receive comments on this proposed AD by May 24, 2016.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, Texas 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
EASA, which is the Technical Agent for the Member States of the European Union, issued EASA AD No. 2015-0042, dated March 9, 2015, to correct an unsafe condition for Airbus Helicopters Model BO105 LS A-3 helicopters.
These helicopters have been approved by the aviation authority of Germany and are approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
Airbus Helicopters issued Alert Service Bulletin ASB BO105LS-10A-013, Revision 0, dated March 9, 2015 (ASB). The ASB specifies adding a life limit for the TT strap P/N 2604067 or 117-14110 of 25,000 flights or 10 years, whichever occurs first, in the list of life-limited parts and corresponding log cards. The ASB also states TT straps that have exceeded the retirement time must be replaced and that only TT straps that have not exceeded the retirement time may be installed.
This proposed AD would require, within 20 hours time-in-service:
• Inspecting the Airworthiness Limitations section of the applicable maintenance manual or Instructions for Continued Airworthiness (ICA) and the component history card or equivalent record for each TT strap and determining whether those records specify a life limit of 25,000 flights or 10 years since the date of manufacture, whichever occurs first.
○ If the records do not specify a life limit for each TT strap or if they specify a different life limit than required, revising the Airworthiness Limitations section of the applicable maintenance manual or ICA by establishing a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first.
○ Creating a component history card or equivalent record for each TT strap, if one does not exist, and recording a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first.
• Removing from service each TT strap that has reached or exceeded its life limit.
This proposed AD would require compliance within 20 hours TIS. The EASA AD allows 2 months to calculate the flight cycles or calendar time of each TT strap.
We estimate that this proposed AD would affect 8 helicopters of U.S. Registry. Labor costs are estimated at $85 per hour. We estimate that it would take 2 work hours to inspect and revise the Airworthiness Limitations section and to calculate and record a life limit for the TT strap for a total cost of $170 per helicopter and $1,360 for the fleet. If a TT strap is replaced, we estimate it would take 8 work hours and $16,617 for required parts for a total cost of $17,297 per helicopter per TT strap.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model BO-105LS A-3 helicopters with a tension torsion (TT) strap part number (P/N) 2604067 or P/N 117-14110 installed, certificated in any category.
This AD defines the unsafe condition as a TT strap remaining in service beyond its fatigue life. This condition could result in failure of a TT strap and loss of control of a helicopter.
We must receive comments by May 24, 2016.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Within 20 hours time-in-service:
(1) Inspect the Airworthiness Limitations section of the applicable maintenance manual or Instructions for Continued Airworthiness (ICA) and the component history card or equivalent record for TT strap P/N 2604067 and P/N 117-14110. Determine whether those records specify a life limit of 25,000 flights or 10 years since the date of manufacture, whichever occurs first.
(2) If the Airworthiness Limitations section of the applicable maintenance manual or ICA or the component history card or equivalent record do not specify a life limit for the TT strap, or if they specify a different life limit than in paragraph (e)(1), do the following:
(i) Revise the Airworthiness Limitations section of the applicable maintenance manual or ICA by establishing a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first, for each TT strap P/N 2604067 and P/N 117-14110 by making pen-and-ink changes or by inserting a copy of this AD into the Airworthiness Limitations section of the maintenance manual or the ICA. For purposes of this AD, a flight would be counted anytime the helicopter lifts off into the air and then lands again regardless of the duration of the landing and regardless of whether the engine is shut down.
(ii) Create a component history card or equivalent record for each TT strap P/N 2604067 and P/N 117-14110, if one does not exist, and record a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first.
(3) Remove from service each TT strap that has reached or exceeded its life limit.
Special flight permits are prohibited.
(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, Texas 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
(1) Airbus Helicopters Alert Service Bulletin ASB BO105LS-10A-013, Revision 0, dated March 9, 2015, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0042, dated March 9, 2015. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 6200 Main Rotor System.
U.S. Army Corps of Engineers, DoD.
Proposed rule.
The U.S. Air Force has requested that the U.S. Army Corps of Engineers (Corps) disestablish the existing danger zone located in the Bering Sea near Shemya Island, Alaska. The danger zone was established on September 28, 1971. The purpose of the danger zone was to protect persons and property from dangers encountered in the area associated with the launching of weather rockets. The facility has not been used for this activity since the mid-1980s. As a result of the discontinued use of this area, the Air Force has requested the danger zone be disestablished. In the “Rules and Regulations” section of
Written comments must be received by April 25, 2016.
This document concerns the “Disestablishment of Danger Zone for Meteorological Rocket Launching Facility, Shemya Island Area, AK.” For further information, including instructions on how to submit comments, please see the information provided in the direct final rule that is located in the “Rules and Regulations” section of this
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the New Jersey Department of Environmental Protection. This revision will establish an updated ten-year carbon monoxide (CO) maintenance plan for the New Jersey portion of the New York-Northern New Jersey-Long Island (NYNNJLI) CO area which includes the following areas: Hudson, Essex, Bergen, and Union Counties, and the municipalities of Clifton, Passaic and Paterson in Passaic County. EPA is also proposing to approve the 2007 Attainment/Base Year CO emissions inventory. In addition, EPA proposes to approve the shutdown of 5 CO maintenance monitors in New Jersey. The New Jersey portion of the NYNNJLI CO area was redesignated to attainment of the CO National Ambient Air Quality Standard (NAAQS) on August 23, 2002 and the maintenance plan was also approved at that time. By
Comments must be received on or before April 25, 2016.
Submit your comments, identified by Docket ID Number EPA-R02-OAR-2016-0059, at
Henry Feingersh
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
The EPA is proposing to approve an updated ten-year carbon monoxide (CO) maintenance plan for the New Jersey portion of the New York-Northern New Jersey-Long Island (NYNNJLI) CO area. On August 23, 2002, the EPA approved a request from New Jersey to redesignate the New Jersey portion of the NYNNJLI CO area to attainment of the CO National Ambient Air Quality Standard (NAAQS) (67 FR 54574). In addition, the EPA also approved at that time a ten-year CO maintenance plan for the area. The Clean Air Act (the Act) requires that an area redesignated to attainment of the CO NAAQS must submit a second ten-year CO maintenance plan to show how the area will continue to attain the CO standard for an additional ten years. On June 11, 2015, New Jersey submitted a second ten-year CO maintenance plan for the New Jersey portion of the NYNNJLI CO area and requested that EPA approve the plan. This plan also included a request and the justification for shutting down 4 CO maintenance monitors. On February 8, 2016, New Jersey submitted an addendum to the plan which provides additional information to justify the shutdown of one additional CO maintenance monitor. The following sections describe how the EPA made its determination proposing to approve the second ten-year maintenance plan. Additionally, the EPA is proposing to approve the 2007 Attainment/Base Year CO emissions inventory. Finally, the EPA proposes to approve the shutdown of 5 CO maintenance monitors in New Jersey. A more detailed discussion of the EPA's review and proposed action is found in the Technical Support Document (TSD) available in the Docket for this action, and by contacting the individuals in the For Further Information Section.
A maintenance plan is a SIP revision that must demonstrate continued attainment of the applicable NAAQS in the maintenance area for at least ten years. The Act requires that a second ten-year plan be submitted in order to assure that the area will continue to stay in compliance with the relevant NAAQS. For the NYNNJLI CO area, the New Jersey Department of Environmental Protection is proposing to utilize EPA's limited maintenance plan approach, as detailed in the EPA guidance memorandum, “Limited Maintenance Plan Option for Nonclassifiable CO Nonattainment Areas” from Joseph Paisie, Group Leader, Integrated Policy and Strategies Group, Office of Air Quality and Planning Standards, dated October 6, 1995. Pursuant to this approach, the EPA will consider the maintenance demonstration satisfied for areas if the monitoring data show the design value is at or below 7.65 parts per million (ppm), or 85 percent of the level of the 8-hour CO NAAQS. The design value must be based on eight consecutive quarters of data. For such areas, there is no requirement to project emissions of CO over the maintenance period. EPA believes if the area begins the maintenance period at, or below, 85 percent of the CO 8 hour NAAQS, the applicability of Prevention of Significant Deterioration (PSD) requirements, the control measures already in the SIP, and Federal measures, should provide adequate assurance of maintenance over the 10-year maintenance period.
Section 175A of the Act sets forth the elements of maintenance plans for areas seeking redesignation from nonattainment to attainment. The initial and subsequent ten-year plans must each demonstrate continued attainment of the applicable NAAQS for at least ten years after approval. EPA is proposing action on the second ten-year maintenance plan which covers the period from 2015 through 2024. The specific elements of a maintenance plan are:
EPA's October 6, 1995 Limited Maintenance Plan guidance states that for inventory purposes the state is only required to submit an attainment inventory to EPA that is based on monitoring data which shows attainment. There is no requirement to project emissions over the maintenance period. The calendar year inventory selected for the attainment inventory is 2007. This means if 2007 is a calendar year which has monitoring data which demonstrates attainment of the standard, the 2007 base year inventory can be used as the attainment year
New Jersey submitted a limited maintenance plan which included a 2007 base year emissions inventory. The 2007 inventory is also classified as the attainment year inventory for the limited maintenance plan. New Jersey has elected 2007 because it is the attainment base year that will be used for the limited maintenance plan and 2007 represents one of the years of violation free monitored data in the area. The inventory included peak winter season daily emissions from stationary point, stationary area, non-road mobile, and on-road mobile sources of CO. These emission estimates were prepared in accordance with EPA guidance.
The EPA is proposing to approve the CO inventory for Hudson, Essex, Bergen, and Union Counties, and the municipalities of Clifton, Passaic and Paterson in Passaic County. Details of the inventory review are located in section IV of this action. A more detailed discussion of how the emission inventory was reviewed and the results of EPA's review are presented in the TSD.
Table 1 presents a summary of the 2007 CO peak winter season daily emissions estimates in tons per day for the NYNNJLI CO area. Again, under the Limited Maintenance Plan guidance, there is no requirement to project emissions over the maintenance period.
New Jersey has met the Limited Maintenance Plan air quality criteria requirement by demonstrating that its highest monitored design value is less than 85 percent (7.65 parts per million) of the CO standard of 9.0 parts per million. The highest monitored design value in the NYNNJLI CO area for the 2013-2014 design year was 2.5 parts per million at two monitoring sites in New Jersey. In addition, New Jersey commits to continued implementation of all other Federal and State measures already implemented as part of its CO SIP. Thus, according to the Limited Maintenance Plan Guidance, emission projections are not required.
New Jersey continues to operate its CO monitoring network and will continue to work with the EPA through the air monitoring network review process as required by 40 CFR part 58 to determine the adequacy of its network.
On August 8, 2011, New Jersey submitted their “New Jersey Ambient Air Monitoring Network Plan 2011” to the EPA. This document described New Jersey's ambient air monitoring network and also detailed proposed changes and the rationale for them.
New Jersey will continue annual reviews of its data in order to verify continued attainment of the NAAQS. As mentioned earlier, all of New Jersey's 8-hour design values are well below the 9.0 ppm 8-hour NAAQS for CO with the highest monitors in the New Jersey portion of the NYNNJLI reading 2.5 ppm, as shown in Table 2.
In its SIP revision, New Jersey submitted design values from 2006-2007 through 2012-2013. The EPA reviewed more recent data in addition to the submitted data and found the maximum 2013-2014 design value for New Jersey to be 2.5 ppm, which continues to show attainment of the NAAQS.
New Jersey will verify that the New Jersey portion of the NYNNJLI CO area continues to attain the CO NAAQS through an annual review of its monitoring data. If any design value exceeds 7.65 ppm, New Jersey will coordinate with EPA Region 2 to verify and evaluate the data and then, if warranted, develop a full maintenance plan for the affected maintenance area.
Section 175A(d) of the Act requires that a maintenance plan include a contingency plan which includes contingency measures, as necessary, to promptly correct any violation of the NAAQS that occurs after redesignation of the area. Contingency measures do not have to be fully adopted at the time of redesignation. However, the contingency plan is considered to be an enforceable part of the SIP and should ensure that the contingency measures are adopted expeditiously once they are triggered by a specified event. In addition, the contingency plan includes a requirement that the State continue to implement all control measures used to bring the area into attainment.
The triggers specified in New Jersey's previous maintenance plan are included in this Limited Maintenance Plan. If design values in any maintenance area in New Jersey exceeds 7.65 parts per million (ppm), New Jersey will coordinate with the EPA to verify the validity of the data, evaluate the data, and analyze available air quality and meteorological data and related activities in the area. If design values show noncompliance with the 9 ppm standard, New Jersey will implement the appropriate contingency measures.
New Jersey has implemented a number of measures to control motor vehicle CO emissions. Emission reductions achieved through the implementation of these control measures are enforceable. These measures include the Federal Motor Vehicle Control Program, Federal reformulated gasoline, New Jersey's pre-1990 modifications to its inspection and maintenance (I/M) program, and local control measures relied on in the SIP.
The State of New Jersey has demonstrated that actual enforceable emission reductions are responsible for the air quality improvement and that the CO emissions in the base year are not artificially low due to local economic downturn. The EPA finds that the combination of existing EPA approved- SIP and Federal measures contribute to the permanence and enforceability of reductions in ambient CO levels that have allowed the New Jersey portion of the NYNNJLI CO area to attain the NAAQS since 1995.
New Jersey commits to continue implementation of all control measures used to bring the area into attainment.
The State plans to continue to use the contingency measure from the original maintenance plan. The plan included implementation of an enhanced I/M program. This program is fully operational and the State commits to meet the performance standard for an enhanced I/M program in an effort to maintain the CO NAAQS. Although the plan is currently in place, EPA guidance allows for it to act as a contingency measure. We approved this measure in the previous maintenance plan and are proposing to approve it in this action. If, in the future, it becomes necessary to reduce CO levels further, New Jersey will work with the local Transportation Planning Organizations or Metropolitan Planning Organizations to identify and implement transportation control measures such as Transportation Demand Management measures, signal improvement projects, bicycle projects, and various transit related projects as necessary.
Section 176(c) of the Act defines conformity as meeting the SIP's purpose of eliminating or reducing the severity and number of violations of the NAAQS and achieving expeditious attainment of such standards. The Act further defines conformity to mean that no Federal activity will: (1) Cause or contribute to any new violation of any standard in any area; (2) increase the frequency or severity of any existing violation of any standard in any area; or (3) delay timely attainment of any standard or any required interim emission reductions or other milestones in any area.
The Federal transportation conformity rule, 40 CFR part 93 subpart A, sets forth the criteria and procedures for demonstrating and assuring conformity of transportation plans, programs and projects which are developed, funded or approved by the U.S. Department of Transportation, and by metropolitan planning organizations or other recipients of federal funds under Title 23 U.S.C. or the Federal Transit Laws (49 U.S.C. chapter 53). The transportation conformity rule applies within all nonattainment and maintenance areas. As prescribed by the Rule, once an area has an applicable SIP with motor vehicle emissions budgets, the expected emissions from planned transportation activities must be consistent with (“conform to”) such established budgets for that area.
In the case of the NYNNJLI, CO limited maintenance plan area, however, the emissions budgets may be treated as essentially not constraining for the length of this second maintenance period as long as the area continues to meet the limited maintenance criteria, because there is no reason to expect that these areas will experience so much growth in that period that a violation of the CO NAAQS would result. In other words, emissions from on-road transportation sources need not be capped for the maintenance period because it is unreasonable to believe that emissions from such sources would increase to a level that would threaten the air quality in this area for the duration of this maintenance period. Therefore, for the limited maintenance plan CO maintenance area, all Federal actions that require conformity determinations under the transportation conformity rule are not required to satisfy the regional emissions analysis requirements in 40 CFR 93.118 or 93.119 of the rule (40 CFR 93.109(e)).
Since limited maintenance plan areas are still maintenance areas, however, transportation conformity determinations are still required for transportation plans, programs and projects. Specifically, for such determinations, transportation plans, transportation improvement programs, and projects must still demonstrate that they are fiscally constrained (40 CFR part 108) and must meet the criteria for consultation and Transportation Control Measure (TCM) implementation in the conformity rule (40 CFR 93.112 and 40 CFR 93.113, respectively). In addition, projects in limited maintenance areas will still be required to meet the criteria for CO hot spot analyses to satisfy “project-level” conformity determinations (40 CFR 93.116 and 40 CFR 93.123) which must incorporate the latest planning assumptions and models that are available. All aspects of transportation conformity (with the exception of satisfying the emission budget test) will still be required. Approval of the limited maintenance plan does not supersede the current 2014 motor vehicle emissions budget. However, conformity determinations conducted now and in the future would not need to conduct an emission budget test.
If the area should monitor CO concentrations at or above the limited maintenance eligibility criteria or 7.65 parts per million then that maintenance area would no longer qualify for a limited maintenance plan and would revert to a full maintenance plan. In this event, the limited maintenance plan would remain applicable for conformity purposes only until the full maintenance plan is submitted and the EPA has found its motor vehicle emissions budget adequate for conformity purposes or the EPA approves the full maintenance plan SIP revision. At that time regional emissions
On July 27, 2015, the EPA posted New Jersey's CO limited maintenance plan on its Adequacy Review Web site:
In addition to transportation conformity, approval of the CO limited maintenance plan would have implications for general conformity (40 CFR part 93 Subpart B). Federal actions subject to general conformity would be presumed to conform under a limited maintenance plan as actions in this area will automatically satisfy the budget test of 40 CFR 93.158(a)(5)(i)(A), as described in the October 1995 EPA memo “Limited Maintenance Plan Option for Nonclassifiable CO Nonattainment Areas” from Joseph Paisie, Group Leader, Integrated Policy and Strategies Group, Office of Air Quality and Planning Standards.
Section 182(a)(3) and 172(c)(3) of the Act requires the periodic submission of a base inventory for SIP planning processes to address the pollutants for the eight hour-ozone, PM
There are specific components of an acceptable emission inventory. The emission inventory must meet certain minimum requirements for reporting each source category. Specifically, the source requirements are detailed below.
The review process, which is described in the accompanying TSD, is used to determine that all components of the base year inventory are present. This review also evaluates the level of supporting documentation provided by the state, assesses whether the emissions were developed according to current EPA guidance, and evaluates the quality of the data.
The review process is outlined here and consists of 8 points that the inventory must include. For a base year emission inventory to be acceptable, it must pass all of the following acceptance criteria:
1. Evidence that the inventory was quality assured by the state and its implementation documented.
2. The point source inventory was complete.
3. Point source emissions were prepared or calculated according to the current EPA guidance.
4. The area source inventory was complete.
5. The area source emissions were prepared or calculated according to the current EPA guidance.
6. Non-road mobile emissions were prepared according to the current EPA guidance for all of the source categories.
7. The method (
8. On-road mobile emissions were prepared according to the current EPA guidance.
Based on the EPA's review, New Jersey satisfied all of the EPA's requirements for purposes of providing a comprehensive, accurate, and current inventory of actual emissions for CO areas. Where applicable, CO peak winter season daily emissions are provided for the CO nonattainment area. The inventory was developed in accordance with
A summary of the EPA's review is given below:
1. The Quality Assurance (QA) plan was implemented for all portions of the inventory. The QA plan included a QA/Quality control (QC) program for assessing data completeness and standard range checking. Critical data elements relative to the inventory sources were assessed for completeness. QA checks were performed relative to data collection and analysis, and double counting of emissions from point, area and mobile sources. QA/QC checks were conducted to ensure accuracy of units, unit conversions, transposition of figures, and calculations. The inventory is well documented. New Jersey provided documentation detailing the methods used to develop emissions estimates for each category. In addition, New Jersey identified the sources of data used in developing the inventory.
2. The point source emissions are complete and in accordance with the EPA guidance.
3. The point source emissions were prepared/calculated in accordance with the EPA guidance.
4. The area source emissions are complete and in accordance with the EPA guidance.
5. Area source emissions were prepared/calculated in accordance with the EPA guidance.
6. Emission estimates for the non-road mobile source categories are correctly based on the latest non-road mobile model or other appropriate guidance and prepared in accordance with the EPA guidance.
7. The method used to develop VMT estimates is in accordance with the EPA guidance and was adequately described and documented in the inventory report.
8. The latest MOVES model was used in accordance with the EPA's guidance.
The 2007 base year inventory has been developed in accordance with EPA guidance. Therefore, EPA is proposing to approve the 2007 base year CO emission inventory. A more detailed discussion of how the emission inventory was reviewed and the results of the review are presented in the TSD. Detailed emission inventory development procedures can be found in the following document:
In order to conserve resources, the State is seeking to discontinue monitoring in Burlington, Freehold, Morristown, Perth Amboy, and East Orange since current air quality levels do not warrant the additional expense of running CO monitors in those areas. The State has committed to continue CO monitoring in Camden and Elizabeth, and will reestablish CO monitoring in Burlington, Freehold, Morristown, Perth Amboy, and East Orange if air quality in Camden and Elizabeth degrade significantly. The Camden and Elizabeth sites have been judged to be representative of these 5 CO maintenance monitor sites and are thus acting as their surrogate sites. Starting in the early 1970's, EPA has set national standards that have considerably reduced emissions of CO and other pollutants from motor vehicles, including tailpipe emissions, new vehicle technologies, and clean fuels programs. Because of this, the EPA believes that it is unlikely that the maintenance area will exceed the CO NAAQS again. Thus, we believe that the revisions that New Jersey has made to its maintenance plan will continue to protect the citizens of New Jersey from high CO concentrations, and also conserve resources. Additional detail can be seen in the accompanying TSD to this notice.
The EPA has evaluated New Jersey's submittals for consistency with the Act and Agency regulations and policy. The EPA is proposing to approve New Jersey's CO limited maintenance plan because it meets the requirements set forth in section 175A of the Act and continues to demonstrate that the NAAQS for CO will continue to be met for the next ten years. The EPA is also proposing to approve the 2007 Attainment/Base Year CO emissions inventory. Finally, the EPA also proposes to approve the shutdown of 5 CO maintenance monitors in New Jersey, since CO monitoring will continue at other representative locations across the State.
The EPA views the SIP revisions proposed in today's proposal as separable actions. This means that if the EPA receives adverse comments on particular portions of this notice and not on other portions, the EPA may choose not to take final action at the same time in a single notice on all of these SIP revisions. Instead, the EPA may choose to take final action on these SIP revisions in separate notices.
Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA Region 2 Office by the method discussed in the
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and the EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of Proposed Rulemaking (NPRM).
This notice is being issued pursuant to the Moving Ahead for Progress in the 21st Century Act of 2012 requiring NHTSA to prescribe regulations permitting States to adopt schemes for electronic odometer disclosure statements. To permit States to allow electronic odometer disclosures, NHTSA is proposing to amend the existing requirements to clarify that most of those requirements apply regardless of the technology used for the disclosure. NHTSA is further
You should submit comments early enough to ensure that Docket Management receives them not later than May 24, 2016.
You may submit comments to the docket number identified in the heading of this document by any of the following methods:
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Regardless of how you submit your comments, you should mention the docket number of this document.
You may call the Docket at (202) 366-9324.
This document is being issued pursuant to the Moving Ahead for Progress in the 21st Century Act of 2012 (MAP-21, or Pub. L. 112-141), which amended Section 32705 of Title 49, United States Code, by adding the following subsection:
(g) ELECTRONIC DISCLOSURES.—Not later than 18 months after the date of enactment of the Motor Vehicle and Highway Safety Improvement Act of 2012, in carrying out this section, the Secretary shall prescribe regulations permitting any written disclosures or notices and related matters to be provided electronically.
To permit States to allow electronic odometer disclosures, NHTSA is proposing to amend the existing requirements to clarify that most of those requirements apply regardless of the technology used for the disclosure. NHTSA is further proposing to add a new section containing specific additional requirements that would apply only to electronic disclosures to ensure the secure creation and maintenance of the electronic records. Through this proposal NHTSA seeks to allow odometer disclosures in an electronic medium while maintaining and protecting the existing system(s) that ensure accurate odometer disclosures and aid law enforcement in prosecuting odometer fraud. The new issues addressed by the new requirements are electronic signatures, security of the hardware in an electronic odometer disclosure system, determination of official document, power of attorney and record retention. NHTSA is also proposing to modify an existing exemption for vehicles more than 10 years old to 25 years.
In 1972, Congress enacted the Motor Vehicle Information and Cost Savings Act (Cost Savings Act) to, among other things, protect purchasers of motor vehicles from odometer fraud. See Public Law 92-513, 86 Stat. 947, 961-63 (1972).
To assist purchasers in knowing the true mileage of a motor vehicle, Section 408 of the Cost Savings Act required the transferor of a motor vehicle to provide written disclosure to the transferee in connection with the transfer of ownership of the vehicle. See Public Law 92-513, 408, 86 Stat. 947 (1972). Section 408 required the Secretary to issue rules requiring the transferor to give a written disclosure to the transferee in connection with the transfer of the vehicle. 86 Stat. 962-63. The written disclosure was to include the cumulative mileage registered on the odometer, or disclose that the actual mileage is unknown, if the odometer reading is known to the transferor to be different from the number of miles the vehicle has actually traveled. The rules were to prescribe the manner in which information is disclosed under this section and in which such information is retained. Id. Section 408 further stated that it shall be a violation for any transferor to violate any rules under this section or to knowingly give a false statement to a transferee in making any disclosure required by such rules. Id. The Cost Savings Act also prohibited disconnecting, resetting, or altering motor vehicle odometers. Id. The statute
Despite these protections, there were shortcomings in the odometer provisions of the Cost Savings Act. Among others, in some States, the odometer disclosure statement was not on the title; instead, it was a separate document that could easily be altered or discarded and did not travel with the title. Consequently, the separate disclosure statement did not effectively provide information to purchasers about the vehicle's mileage. In some States, the title was not on tamper-proof paper. The problems were compounded by title washing through States with ineffective controls. In addition, there were considerable misstatements of mileage on vehicles that had formerly been leased vehicles, as well as on used vehicles sold at wholesale auctions.
In 1986, Congress enacted the Truth in Mileage Act (TIMA), which added provisions to the odometer provisions of the Cost Savings Act. See Public Law 99-579, 100 Stat. 3309 (1986). The TIMA amendments expanded and strengthened Section 408 of the Cost Savings Act.
Among other requirements, TIMA precluded the licensing of vehicles, the ownership of which was transferred, in any State unless several requirements were met by the transferee and transferor. The transferee, in submitting an application for a title, is required to provide the transferor's (seller's) title, and if that title contains a space for the transferor to disclose the vehicle's mileage, that information must be included and the statement must be signed and dated by the transferor.
TIMA also precluded the licensing of vehicles, the ownership of which was transferred, in any State unless several titling requirements were met. Titles must be printed by a secure printing process or other secure process. They must indicate the mileage and contain space for the transferee to disclose the mileage in a subsequent transfer. As to lease vehicles, the Secretary was required to publish rules requiring the lessor of vehicles to advise its lessee(s) that the lessee is required by law to disclose the vehicle's mileage to the lessor upon the lessor's transfer of ownership of the vehicle. In addition, TIMA required that auction companies establish and maintain records on vehicles sold at the auction, including the name of the most recent owner of the vehicle, the name of the buyer, the vehicle identification number and the odometer reading on the date the auction took possession of the vehicle.
As amended by TIMA, Section 408(f) (1) of the Cost Savings Act provided that its provisions on mileage statements for licensing of vehicles (and rules involving leased vehicles) apply in a State, unless the State has in effect alternate motor vehicle mileage disclosure requirements approved by the Secretary. Section 408(f)(2) stated that “[t]he Secretary shall approve alternate motor vehicle mileage disclosure requirements submitted by a State unless the Secretary determines that such requirements are not consistent with the purpose of the disclosure required by subsection (d) or (e), as the case may be.”
In 1988, Congress amended section 408(d) of the Cost Savings Act to permit the use of a secure power of attorney in circumstances where the title was held by a lienholder. The Secretary was required to publish a rule to implement the provision. See Public Law 100-561 § 40, 102 Stat. 2805, 2817 (1988), which added Section 408(d)(2)(C). In 1990, Congress amended section 408(d)(2)(C) of the Cost Savings Act. The amendment addressed retention of powers of attorneys by States and provided that the rule adopted by the Secretary not require that a vehicle be titled in the State in which the power of attorney was issued. See Public Law 101-641 § 7(a), 104 Stat. 4654, 4657 (1990).
In 1994, in the course of the 1994 recodification of various laws pertaining to the Department of Transportation, the Cost Savings Act, as amended by TIMA, was repealed. It was reenacted and recodified without substantive change. See Public Law 103-272, 108 Stat. 745, 1048-1056, 1379, 1387 (1994). The statute is now codified at 49 U.S.C. 32705
Section 24111 of the Fixing America's Surface Transportation Act of 2015 (FAST Act, or Public Law 114-94), signed into law on December 4, 2015, allows States to adopt electronic odometer disclosure systems without prior approval of the Secretary (“the Secretary”) of the Department of Transportation. Any such system must comply with applicable State and Federal laws regarding electronic signatures under 15 U.S.C. 7001
In providing States with the opportunity to implement electronic odometer disclosure systems until the effective date of the regulations now being proposed, the FAST Act amendments do not alter existing statutory odometer disclosure requirements or modify the intent of those requirements. Effective odometer disclosure systems are essential to protecting consumers from odometer fraud and must reduce or eliminate opportunities for such fraud to the greatest practicable extent. Federal and State governments have an interest in preventing such fraud.
The agency's proposed regulations, as contained in this notice, as well as our prior responses to State petitions for approval of alternative disclosure schemes (discussed below) contain guidance on the potential strengths and weaknesses of electronic odometer disclosure schemes and may serve as a resource for States implementing electronic odometer disclosure systems under the FAST Act. NHTSA respectfully requests that States adopting electronic odometer disclosure schemes under the authority granted by the FAST Act be mindful of the persistence and ingenuity of those who would commit odometer fraud as well as their propensity to find and exploit weaknesses in the disclosure requirements of particular jurisdictions. The agency therefore suggests that the issues considered in this notice and the accompanying regulatory proposals be carefully considered in the formulation of any electronic odometer disclosure system.
The implementing regulations for the odometer provisions of the Cost Savings Act, as amended, are found in Part 580 of Title 49 of the Code of Federal Regulations (CFR). These regulations establish the minimum requirements for odometer disclosure, the form of certain documents employed in disclosures, and the security of title documents and power of attorney forms. The regulations also set the rules for
Regulations governing disclosures are codified in 49 CFR 580.5, 580.7 and 580.13. Section 580.5(c) requires, in connection with the transfer of ownership of a motor vehicle, the odometer disclosure by the transferor to the transferee on the title. Following the initial execution on a title, reassignment documents may be used. As provided by the regulations, in the case of a transferor in whose name the vehicle is titled, the transferor shall disclose the mileage on the title, and not on a reassignment document. Section 580.5(c) requires a transferor to sign, and to print his/her name on an odometer disclosure statement with the following information: (1) The odometer reading at the time of transfer (not to include tenths of miles); (2) the date of transfer; (3) the transferor's name and current address; (4) the transferee's name and current address; and (5) the identity of the vehicle, including its make, model, year, body type, and VIN. The transferor must also, under § 580.5(e), certify whether the odometer reading reflects the vehicle's actual mileage, disclose whether the odometer reading reflects mileage in excess of the odometers mechanical limit or, if the odometer does not reflect the actual mileage, must state that the odometer reading should not be relied on. The transferee must sign the statement. Each title, at the time it is issued to the transferee, must contain the mileage disclosed by the transferor.
To ensure that vehicles subject to leases of 4 months or more have accurate odometer readings executed on titles at the time of transfer, § 580.7(a) requires lessors to provide written notice to the lessee of the lessee's obligation to disclose the mileage of the leased vehicle and the penalties for failure to disclose the information. In connection with the transfer of ownership of a leased vehicle, lessees are required by § 580.7(b) to provide disclosures comparable to those required by §§ 580.5(c) and (e), noted above, to the lessor along with the date the lessor notified the lessee of disclosure requirements. Additionally, the lessor must state the date the lessor received the lessee's completed disclosure statement and must also sign it. Under § 580.7(d) a lessor transferring ownership of a vehicle (without obtaining possession) may indicate the mileage disclosed by the lessee on the vehicle's title unless lessor has reason to believe the lessee's disclosure is inaccurate.
If allowed by State law, the transferor may give the transferee a power of attorney to execute the mileage disclosure on the title, as provided by § 580.13(a) when the title is physically held by a lienholder or has been lost and the transferee obtains a duplicate title on behalf of a transferor. Sections 580.13(b) and (d) provide that the transferor must disclose information identical to that required by §§ 580.5(c) and (e) on part A of the secure power of attorney form. The transferee is required to sign the power of attorney form part A and print his/her name. See § 580.13(e). In turn, § 580.13(f) requires the transferee, upon receipt of the transferor's title, to make on the title exactly the mileage disclosure as disclosed by the transferor on the power of attorney.
After part A of the power of attorney form has been used, part B may be executed when a vehicle addressed on part A is resold. Part B of the secure power of attorney form, if permitted by State law, allows a subsequent transferee to give a power of attorney to his transferor to review the title and any reassignment documents for mileage discrepancies, and if no discrepancies are found, to acknowledge disclosure on the title, while maintaining the integrity of the first seller's disclosure. The disclosure required to be made by the transferor to the transferee for this transaction on part B of the power of attorney form tracks information required to be made by the transferor to the transferee on the title when ownership of a vehicle is transferred on a title under 49 CFR 580.5. Among other things, the power of attorney must contain a space for the transferor to disclose the mileage to the transferee and sign and date the form, and a space for the transferee to sign and date the form.
To ensure that disclosures made through a power of attorney are accurate, § 580.15 requires the person exercising the power of attorney to certify, on part C of the form, that the disclosures made on a title or reassignment document on behalf of the original seller are identical to those found on part A of the power of attorney. This section also requires a certification, when part B is used, that the mileage disclosed and acknowledged under part B is greater than the mileage disclosed in part A.
Odometer disclosures may only be made on certain documents. These specified documents are a vehicle title (§ 580.5(a)), a reassignment document when used by transferors other than those in whose name the vehicle is titled (§§ 580.5(b) and (c)), a disclosure statement made by a lessee (§ 580.7(b)), and a power of attorney when the title is held by a lienholder or is lost (§ 580.13(a)). When the power of attorney authorized by § 580.13(a) is used, a further power of attorney authorized by § 580.14(a) may be employed to allow a subsequent transferee to approve the seller's disclosure, per § 580.16. Both of the aforementioned powers of attorney must be on the same form.
Section 580.4 requires titles, reassignment documents, and the power of attorney form described §§ 580.13 and 580.14 to be protected against counterfeiting and tampering by a secure printing process or other secure process. These titles, reassignment documents, and powers of attorney must contain a statement referring to Federal odometer law and a warning that failure to complete the form or providing false information may result in fines or imprisonment pursuant to §§ 580.5(d), 580.13(c), and 580.14(c). For a leased vehicle, the lessor is obligated to provide the lessee with written notice of the obligation to make a mileage disclosure and that notice must contain the same warnings (§ 580.7(a)). Except in the limited context of the proper use of the power of attorney forms, no person shall sign an odometer disclosure statement as both the transferor and transferee in the same transaction (§ 580.5(h)).
Part 580 establishes minimum requirements for record retention, which ensures that adequate records exist to create a “paper trail” sufficient to support detection and prosecution of odometer fraud. Section 580.8(a) requires motor vehicle dealers and distributors who are required to issue an odometer disclosure to retain copies of each odometer statement they issue and receive for five years. Lessors of leased vehicles must retain the odometer statement they receive from their lessee for five years from the date they transfer ownership of the leased vehicle (§ 580.8(b)). If a power of attorney authorized by §§ 580.13 and/or 580.14 has been used, dealers must retain copies of the document for five years (§ 580.8(c)). Section 580.9 requires auction companies to retain the name of the most recent owner on the date the auction took possession of the motor
In addition to the recordkeeping requirements, Part 580 also requires that subsequent buyers of a vehicle that was transferred to their seller through a disclosure made with a Part A power of attorney under § 580.13(a) have access to that power of attorney if they elect not to use Part B and return to the seller to acknowledge disclosure on the title itself (§ 580.16).
Other sections of Part 580 establish a petition process by which States may seek assistance in revising their odometer laws (§ 580.10), may seek approval of alternative odometer disclosure schemes (§ 580.11), and establish exemptions from the disclosure requirements of § 580.5 and § 580.7 (§ 580.17). The exemptions in 580.17 apply to transfers or leases for: (1) Vehicles with a Gross Vehicle Weight Rating (GVWR) over 16,000 pounds; (2) vehicles that are not self-propelled; (3) vehicles manufactured in a model year beginning ten years before January 1 of the calendar year in which the transfer occurs; (4) certain vehicles sold by the manufacturer to any agency of the United States; and (5) a new vehicle prior to its first transfer for purposes other than resale.
The Cost Savings Act, as amended by TIMA in 1986, contains a specific provision on approval of State alternative odometer disclosure programs. Subsection 408(f)(2) of the Cost Savings Act (now recodified at 49 U.S.C. 32705(d)) provides that NHTSA shall approve alternate motor vehicle mileage disclosure requirements submitted by a State unless NHTSA determines that such requirements are not consistent with the purpose of the disclosure required by subsection (d) or (e) as the case may be. (Subsections 408(d), (e) of the Costs Savings Act were recodified to 49 U.S.C. 32705(b) and (c).)
Six States—Virginia, Wisconsin, Florida, New York, Texas, and Arizona—have filed petitions with NHTSA seeking approval of electronic alternative odometer programs under 49 U.S.C. 32705(d)). NHTSA has approved, in whole or in part, five of these six petitions and has not yet taken final action on the sixth and most recent petition. A review of these petitions and the agency's responses is instructive regarding the various concerns raised by the implementation of electronic odometer disclosure systems.
In December 2006, the Commonwealth of Virginia petitioned NHTSA to approve the Commonwealth's proposed electronic odometer disclosure requirements for intrastate transactions involving vehicles not subject to a lien. Virginia's proposal contemplated a paperless system where users would enter data directly into a State electronic system. To authenticate the identity of the participants, Virginia's petition stated that a unique personal identification number (PIN) and a unique customer number that would both be physically mailed to the individual would be used in conjunction with the customer's date of birth (DOB) to allow creation of an electronic odometer disclosure statement and signature. For dealers, the Virginia proposal stated that each dealer would provide the State with a list of employees authorized to make disclosures for the dealership. These individuals would be provided customer number PINS by mail and would use these identifiers in the same fashion as a private individual to verify their identity so they could complete transactions. In addition, transactions involving dealerships would require that the dealership enter a dealer number to complete the transaction.
Virginia's proposed electronic odometer disclosure would be made in the same way a paper disclosure would be made. The transferor would fill out the electronic form that contained the same entries and warnings as those found on a paper title and then sign it electronically. The transferee would then examine the odometer disclosure executed by the transferor and either accept it or reject it. The disclosure statement would be linked to the electronic title and the transferor would be instructed to mail any existing paper title to the State for destruction. The proposal also stated that the transferee could obtain a paper copy of the title upon request.
After finding that the Virginia proposal would properly verify the identity of users, would provide an equivalent level of security to the paper system, and would create an adequate system of records, NHTSA granted Virginia's request on January 7, 2009 (74 FR 643).
Texas filed a petition seeking approval of alternative odometer disclosure requirements in June 2008. The State proposal would transfer vehicles' titles electronically for in-state transactions between residents where there are no security interests in the vehicle. The proposal did not encompass leased vehicles, the use of a power of attorney, or interstate transactions. Texas's system would eliminate paper titles (except as requested) by creating an electronic title and require transfers of vehicle title for in-state transactions to be made using the internet. The identities of the parties, who would have to be Texas residents holding a valid State identification credential, would be verified by matching four personal data elements and two forms of identification against a State database. Odometer mileage disclosures would be made by requiring the seller and buyer to separately log into a secure Web site and each enter the odometer mileage. Upon successful completion of the transaction, the seller would mail the paper title to the State for destruction. The title would remain as an electronic record and the transferee could receive a paper title on request.
NHTSA's initial determination, published on November 18, 2009, 74 FR 59503, preliminarily granted the Texas petition on the condition that Texas amend its program to enable transferees to obtain a paper copy of the title that met the requirements of TIMA, require dealers to retain a copy of all odometer disclosures that they issue and receive, and require disclosure of the brand (the brand states whether the odometer reflects the actual mileage, reflects the mileage in excess of the designated odometer limit or differs from the actual mileage and is not reliable.) Id. at 59506. Following submission of comments by Texas clarifying features of its proposal, NHTSA granted the Texas petition in a final determination issued on April 22, 2010. 75 FR 20925. The final determination noted that the Texas petition and comments indicated that the proposed system contained sufficient safeguards and record keeping requirements to meet the purposes of TIMA. Further, the agency noted that since Texas would require persons with an electronic title to submit any paper titles to the State for destruction, the proposal would prevent potential mischief caused by duplicate titles. Id. at 20929.
In September 2009, Wisconsin filed a petition seeking approval of an electronic odometer disclosure system limited to intrastate transactions involving motor vehicle dealers. Identity verification would be based on customers entering a minimum of three personal identifiers—name, address, date of birth, product number, Driver License/ID number, and a Federal Employer Identification Number or partial Social Security Number—in the State system. Once the user is verified under this scheme, the user could begin the title transaction. As with the earlier petitions, Wisconsin proposed that electronic odometer disclosures be linked to, and become part of, the title record in the State's database and a title transfer could not be completed unless an electronic odometer disclosure had been completed. Also, if a paper title is needed, the Wisconsin DMV would print the title on secure paper with the odometer disclosure statement in the proper location and format under existing rules.
In April 2010, NHTSA published an Initial Determination proposing to approve Wisconsin's program, subject to the resolution of certain concerns. 75 FR 20965 (Apr. 22, 2010). In particular, NHTSA raised questions about how the Wisconsin program would manage odometer disclosures for leased vehicles. In response to NHTSA's concerns, Wisconsin submitted comments stating that lessee odometer disclosures would be addressed in the future.
NHTSA published a Final determination approving a revised Wisconsin electronic odometer disclosure plan on January 10, 2011. 76 FR 1367. The Agency found the Wisconsin proposal to be consistent with the odometer disclosure requirements. The verification scheme and form of the electronic disclosure provided adequate assurances that the persons executing the disclosure were the actual transferor and transferee. Thereafter the odometer disclosure statement would reside as an electronic record in the Wisconsin database and would be linked to the vehicle's title. NHTSA also noted that the electronic title would, under Wisconsin law, be the official title and that paper titles would be issued only if needed for an interstate transaction or a transfer that could not be completed electronically.
In December 2009, Florida proposed a hybrid electronic disclosure system in which the electronic transactions would be performed through authorized tag agents. Because the electronic data entries would only be made through terminals located at tag agent locations, Florida proposed that the required odometer disclosures for certain transactions would be made on physical documents that would then be delivered to tag agents who would then enter disclosure information into the State system. Under Florida's proposal a seller with a vehicle having an electronic title wishing to sell the car would visit a tag office with the buyer. After providing adequate identification to the tag agent, the buyer and seller would sign, in the presence of the tag agent, a secure reassignment form transferring ownership and disclosing the odometer reading. A title would then be issued in the buyer's name and stored electronically, or the buyer could choose to have the title printed as a physical document.
For transactions involving dealers, Florida proposed that a seller with e-title would bring the vehicle to a dealership. The seller and dealer would complete a secure reassignment form with odometer disclosure. When the dealer sold the vehicle to another buyer, the dealer and buyer would complete another secure reassignment form with odometer disclosure. The dealer would take both of the secure reassignment forms to a tag agency. The vehicle title would then be transferred to the buyer and the buyer would have the option to obtain a paper title or have Florida's Department of Transportation hold the title electronically.
Under Florida's proposal, the lessor of a leased vehicle would hold an e-title. When the lease ends, the lessee would bring the vehicle to a dealership. The lessee would sign an odometer disclosure statement on a secure physical document. The lessor would then sign a secure physical power of attorney to the dealer authorizing the dealer to execute the odometer disclosure. The dealer would then sign a physical secure reassignment form agreeing with the odometer disclosure. When the dealer sold the vehicle to another buyer, the dealer would take the various physical documents (bill of sale, reassignment document, and power of attorney) to the tag agency, where the title would be transferred to the buyer. The buyer would then have the option of obtaining a new paper title or having the Florida Department of Transportation hold the vehicle title electronically.
NHTSA's final determination granted the Florida petition in part and denied it in part. 77 FR 36935 (June 20, 2012). Florida's request was granted for electronic transactions involving transfers between private parties but was denied for transactions involving dealers and leased vehicles. Among other things, NHTSA's final determination observed that transactions involving dealers relied on a number of odometer disclosures being made on documents other than the title itself. This, in the Agency's view, was inconsistent with TIMA's command that disclosures be made on the title and not on a separate document. Further, the Florida scheme for dealer transactions would result in new registrations being issued after submission of a disclosure statement made on a physical reassignment document rather than on the title itself, thereby violating the requirement that a vehicle may only be registered if the new owner submits a title containing the odometer disclosure statement. NHTSA denied Florida's proposed requirements for leased vehicles on similar grounds. Because of the proposed system's reliance on tag agents as the only point of data entry, completion of a transaction and execution of the required disclosure statements required that the disclosures be made on a number of documents, none of which were the actual title. These documents also did not meet other content and security requirements. Moreover, the use of a power of attorney in an instance where the lessor would have access to the title, was viewed by the Agency as inconsistent with the narrow set of circumstances under which such a power of attorney could be used under TIMA.
The State of New York filed a petition with NHTSA in November 2010, seeking approval of alternative odometer disclosure requirements. The New York petition sought to convert the State's existing paper process for dealer transactions to an electronic process in which an authorized dealership user would sign on to the State's planned system and enter the vehicle's identifying information. The vehicle's odometer reading, disclosed on the title in the case of a consumer trading in or selling a vehicle to the dealer, would be recorded in the system by the dealer. Access to the system itself would occur only at dealerships by specific dealer employees whose identity would be verified by State issued credentials.
If that dealer sold a vehicle to another licensed New York dealer, the selling dealer would sign on to the proposed electronic system and enter current vehicle information, including the current odometer reading, as well as seller and purchaser information. The
Under the New York proposal, when a vehicle owned by a New York dealer is sold to a retail purchaser, salvage dealer, out-of-state buyer or other non-New York dealer purchaser, the selling dealer would access the vehicle information on the system. The selling dealer would enter current vehicle information, including the current odometer reading, and would enter seller and purchaser information. A two-part sales receipt/odometer statement would be created on the system. The purchaser would then review the information, including the odometer statement, on the draft receipt displayed on the computer screen. If the purchaser agrees with the odometer statement and other information, the authorized dealer representative would save the data in the system and then print a two-part sales receipt. Both parties would then sign the odometer disclosure statement printed on each of the two parts of the receipt. The dealer would retain the dealer part of the receipt for its files, while the purchaser would be given the purchaser's copy of the receipt along with the original title acquired by the dealer when it purchased the vehicle.
NHTSA's initial determination denied the New York petition because it used a non-secure receipt for odometer disclosure in transfers between New York dealers and out-of-state buyers and was therefore inconsistent with Federal odometer law. 76 FR 65487, 65491 (Oct. 21, 2011). New York subsequently amended its proposal by replacing the non-secure document with a secure State issued paper, New York State MV-50 (Retail Certificate of Sale) form. The result of this change was that a consumer purchasing a vehicle from a dealer would then receive the original title and odometer statement executed by the owner who sold the vehicle to the dealer and the secure MV-50 form with an odometer disclosure. In addition, the mileage disclosed at the time of the sale to the dealer and the mileage disclosed at the time the dealer sold the vehicle to the subsequent retail purchaser would be recorded in New York's system and available for viewing through a web portal.
The Agency's final determination, 77 FR 50381 (Aug. 12, 2012), granted the New York petition as amended. NHTSA found that the employment of the secure State issued and numbered MV-50 form, in conjunction with the odometer disclosure on the original seller's title and the recording of these disclosures in New York's electronic system, met the purposes of TIMA.
In December 2011, Arizona filed a petition with NHTSA seeking approval of alternative odometer disclosure requirements. The Arizona proposal was limited to transactions involving licensed Arizona dealers and did not encompass interstate transactions. Under this proposal, dealers would electronically scan and upload documents to the State. Dealers would scan documents using a specified format and resolution, encrypt the scanned images and transmit the images to a secure system using account codes, user/group profiles, and passwords. The State would retain electronic files in a document management system, and dealers would be required to retain hard copies of the documents. The disclosures would not be made on a title but on a form described as a Secure Odometer Disclosure. This form would be completed and signed by hand and submitted to Arizona along with other documents after being scanned. The petition appears to propose that the title would not be among the documents submitted to Arizona, and it may be that this procedure would be followed if the seller's title is an electronic title. If the dealer sells the vehicle, that dealer would again scan and electronically submit a Secure Odometer Disclosure, but not the title, to Arizona after selling the vehicle. The dealer would retain the original Secure Odometer Disclosure forms for the retention periods specified by Federal and Arizona law.
In instances where a dealer sought to sell a vehicle that had been purchased from an owner with a paper title, Arizona also proposed that the vehicle would be resold by a dealer using the paper title from the transferor. It appears, based on this description and the requirements of Arizona law that a dealer's name shall be recorded on a title certificate as transferee or purchaser and that a title include space for dealer reassignment information, that the dealer would make an odometer disclosure on the paper title at the time it resells the vehicle. However, the petition also specifies that if the dealer applies for a new title in the name of the vehicle purchaser, the dealer and purchaser would complete a Secure Odometer Disclosure form. The dealer would then scan and electronically submit a title application, the paper title, the Secure Odometer Disclosure form, and supporting documents to Arizona. The dealer would retain the original documents (including the original paper title) for the retention periods specified by Federal and Arizona law. According to the petition, a new title would be sent to the buyer if there is no lien on the vehicle. If there is a lien, both the lien and the title would be maintained as electronic records by the Arizona Department of Transportation.
NHTSA issued an initial determination denying the Arizona petition on August 20, 2012. 77 FR 50071. In this initial determination, the Agency stated that the Arizona petition did not meet 49 CFR 580.11(b), which establishes the requirements for alternative disclosure requirement petitions. The petition did not, in NHTSA's view, set forth the motor vehicle disclosure requirements in effect in the State or adequately demonstrate that the proposal was consistent with the purposes of the Motor Vehicle Information and Cost Savings Act. In regard to the latter, the agency found that making disclosures on documents other than the title, the proposed use of non-secure forms, the failure to address record keeping requirements, and the potential for alterations posed by the use of scanned documents were all inconsistent with the purposes of TIMA.
NHTSA's experience in processing State petitions for alternative electronic odometer disclosure schemes illustrates a number of concerns that remain relevant for the purposes of this rulemaking. First and foremost, any electronic odometer disclosure system must be conceived with a full appreciation of the importance of following the command found in TIMA that odometer disclosures must be made on the title itself, or the electronic equivalent of that title, and not, except for a very limited number of exceptions, on any other document. In particular, an electronic odometer disclosure system should minimize or eliminate odometer disclosures made on physical documents instead of promoting the use of such documents as some proposals
In addition, as addressed below, any electronic odometer disclosure system must provide adequate means for verifying the identity of transferors and transferees. In the absence of such verification, unauthorized and inaccurate disclosures could easily be entered into State systems by imposters, defeating the purposes of the Cost Savings Act and enhancements established in TIMA and the subsequent amendments. Electronic title and odometer disclosure systems must also foreclose the possibility that a seemingly valid physical paper title and an electronic title may co-exist. The presence of two such “valid” titles invites fraud and creates opportunities for confusion and deception. While States are under no obligation to implement electronic odometer disclosure systems that accommodate transactions involving leased vehicles, any system that proposes to do so must employ measures that meet the existing regulatory requirements without employing physical forms such as a power of attorney that are not authorized under agency regulations. Finally, all electronic odometer disclosure systems must be designed not to impede interstate vehicle sales while providing consumers with protection against odometer fraud. Unless and until electronic odometer disclosure is implemented in all States, Territories, and the District of Columbia, secure paper titles or their equivalent will be needed for the purposes of making odometer disclosures in interstate transactions.
In developing this proposal, NHTSA reviewed the experience of the Environmental Protection Agency (EPA) during the development of its requirements for electronic manifests for hazardous waste. See 79 FR 7517 (Feb. 7, 2014). While the authority EPA was operating under is different from NHTSA's current authority, and the existing system differed from the current odometer disclosure system, NHTSA believes there are lessons to be learned from EPA's experience transitioning from a paper to electronic environment.
The EPA proposal envisioned the agency setting minimum standards for an e-manifest system and various private entities stepping forward to develop and make available such systems. The “EPA proposed standards in 3 distinct areas: (1) Standard electronic data exchange formats for the manifest; (2) electronic signature methods that could be used to execute manifest signatures electronically; and (3) standard system security controls and work flow procedures to ensure the reliable and consistent processing of manifest data by electronic manifest systems, as well as to ensure the availability and integrity of manifest data submitted through the electronic systems.”
The EPA's ultimate solution was to develop a centralized system controlled by the EPA and funded by user fees. This option is not available to NHTSA for odometer disclosures. Nevertheless, we are mindful of the comments EPA received. Vehicle transactions cross State boundaries and the need for various State systems to interact must be considered. Further, both traditional paper-based and electronic systems are likely to exist in neighboring States for some time and must facilitate interstate transactions while providing protection against odometer fraud. The MAP-21 mandate to permit electronic odometer disclosures could be frustrated by requirements that set an unnecessarily higher bar than currently exists for paper documents. However, NHTSA believes that achieving the objectives of the statute—to ensure that consumers receive valid representations of the actual vehicle mileage at the time of transfer and to detect, prevent, and aid in prosecuting odometer fraud—some aspects of the specific disclosure requirements may need to differ for traditional and electronic systems. It is also neither helpful to the public nor wise to create rules that NHTSA must regularly amend to adapt to technological changes. Accordingly, NHTSA has been, and remains, aware of these lessons in developing this proposal.
The overall purpose of the odometer disclosure provisions of the Cost Savings Act, as amended, is to protect consumers by assuring that they receive valid representations of a vehicle's actual mileage at the time of transfer. An additional purpose is to create a system of records and a “paper trail” to facilitate detection and prosecution of odometer fraud. The statutory scheme and the current regulations adopted by NHTSA aim to achieve these overall purposes.
In developing the current proposal for electronic odometer disclosures pursuant to MAP-21, NHTSA desires a regulation that continues to achieve these purposes without imposing overly burdensome requirements that are not necessary to achieve these purposes in an electronic environment. That is, electronic disclosures must be made accurately by the actual parties to the transaction to protect consumers and provide assurances that a transferee receives a valid representation of a vehicle's actual mileage at the time of transfer. In addition, electronic disclosure schemes must have retention requirements to create a secure and reliable electronic trail to facilitate detection and prosecution of odometer fraud. Unique issues the agency considered were the ability of different State electronic systems to share data, and the security of that information sharing, as well as the ability to issue secure paper documents for use in States which do not choose to adopt electronic disclosure requirements.
An additional issue considered by the agency was the possibility that, if NHTSA were to adopt only minimum requirements necessary to achieve the above stated purposes, States that voluntarily chose to permit electronic odometer disclosures could do so in ways which could eventually create enough variation to hinder on-going efforts among the States to develop a national system for electronic titling of motor vehicles. However, NHTSA determined that its authority under MAP-21 was intended only to facilitate the change to electronic odometer disclosures, not to impose additional requirements for odometer disclosures. NHTSA requests comments, however, on whether it should go further than proposed in this notice in order to prevent, or limit, variation among the various State systems.
As noted earlier, NHTSA believes that meeting the objectives of the statute will require some variation in the requirements for traditional and electronic systems. To achieve this, NHTSA is proposing to restructure the requirements to accommodate both “physical” and “electronic” documents. Therefore we are proposing to amend 580.1 to add the option of electronic disclosures; 580.3 to add new definitions and amend existing definitions to accommodate physical and electronic filings; 580.4 to clarify separate requirements for the security of physical disclosures and electronic disclosures; 580.5 to clarify methods of disclosure for physical and electronic systems; 580.7 to add provisions allowing for the option of electronic disclosures for leased motor vehicles; 580.8 to include electronic copies among the forms of disclosures that must be retained and general requirements for that retention; 580.10 to update the address for NHTSA; 580.11 to add the newly created 580.6 to the sections a State may seek exemption from via petition for alternative disclosure requirements and update the address for NHTSA; 580.13 and 580.14 to revise the provisions relating to the use of a power of attorney to address the potential that transferors from an electronic title State wishing to convey a vehicle to a transferee in a physical title State may not have an opportunity to obtain a State issued secure physical title before transferring ownership of the vehicle and to correct a typographical error that would bring the disclosure requirements into conformity with the disclosure requirements under 580.5 and 580.7; 580.15 to add language clarifying that power of attorney certification is limited to physical document disclosures; and 580.17 to extend the disclosure exemption from ten years to twenty-five years and provide an updated example. NHTSA is proposing to strike the regulatory text in section 580.12 as the provision is obsolete and to reserve the section. Finally, NHTSA is proposing to create a new section 580.6 (previously reserved) which would contain unique requirements for electronic odometer disclosures.
The most basic proposed change NHTSA is making is to add new definitions for the terms “Electronic Document,” “Physical Document,” and “Sign or Signature,” which are necessary to provide clarity in the requirements for each, taking into account the different security concerns and practical challenges that arise under the different disclosure systems. NHTSA requests comments on whether the following new definitions are appropriate and properly identify the items and actions intended.
One issue NHTSA considered was the electronic equivalent of the existing requirements for physical signatures on odometer disclosures and how to securely authenticate an electronic signature. This is particularly important because in an electronic environment documents may be “signed” remotely. To address this issue, NHTSA reviewed the guidance in the National Institute of Standards and Technology (NIST) Special Publication 800-63-2,
NHTSA is aware that the American Association of Motor Vehicle Administrators (AAMVA) published a report from its Electronic Odometer Task Force in December 2014 (E-Odometer Task Force Report).
Attachment A to the OMB memorandum sets out six potential
• Inconvenience, distress or damage to standing or reputation.
• Financial loss or agency liability.
• Harm to agency programs or public interests.
• Unauthorized release of sensitive information.
• Personal Safety.
• Civil or criminal violations.
In reviewing these impact categories, NHTSA notes a definite potential for financial loss. The purpose of odometer fraud is to induce consumers to pay more for a used vehicle than they would if they knew the accurate mileage. For an individual consumer, it is important that the value of the vehicle reasonably match the price agreed to, and paid, based upon the information available to the consumer and provided by the seller. In addition, odometer fraud is often committed by the same individual(s) or entities multiple times, resulting in high dollar amounts of damages. State electronic title and odometer disclosure systems will also contain sensitive personal information that could be subject to unauthorized release if the system were not sufficiently secure. Last, odometer fraud is a criminal offense that victimizes innocent consumers. NHTSA and other enforcement agencies use odometer disclosure documents to prove these criminal violations.
Therefore, after reviewing this document, NHTSA has made a preliminary decision that a high level of assurance in the accuracy of the identity of the person making an odometer disclosure is necessary, and therefore the appropriate level of security for odometer disclosures is Level 3 according to the NIST guidelines. NHTSA is therefore proposing that any State which allows electronic odometer disclosures require security protocols at this level or higher. Under the NIST guidelines (
NHTSA is therefore proposing that the requirement for Level 3 authentication be incorporated in the definition of “signature” for electronic disclosures. However, this also will require the use of computers by all parties for all transfers in electronic title States. NHTSA requests comments on the appropriate NIST level and if specific identification verification(s) should be required, and further requests comments on how such a system should be implemented, including whether dealers should be required to provide secure computing services to transferors and transferees and what security measures should be mandatory for such services.
Next, NHTSA is proposing to require that each “signature” in an electronic environment apply only to a single individual, not to an organization. For example, if a dealership wished to allow multiple employees to execute odometer disclosures on behalf of the dealership, each employee would be required to have and maintain a distinct access identity or code to the electronic odometer system so that the actual individual making the disclosure, not just the dealership, is identified by the “signature.” The dealer or entity on whose behalf the individual is making the disclosure must also be identified in the transaction and the dealer(s) and entity on whose behalf the individual works must be recorded as part of the individual's distinct access identity or code.
NHTSA also considered the existing requirements that various parties provide copies of documents as part of the odometer disclosure process, and what would qualify as an equivalent in an electronic environment. For example, section 580.5(f) requires the transferee to return a copy of the odometer disclosure document to the transferor after it is signed. Under the current system, the transferee may apply for a new title for the vehicle, and generally, a State will not title a vehicle without an odometer disclosure statement that contains the signatures of both the transferor and the transferee. However, the State does not usually verify that a copy of the document was returned to the transferor or that the transferor retained it. For this reason, NHTSA is concerned about imposing any requirement in the electronic environment that would be more restrictive than these current requirements. NHTSA therefore proposes to specify only that the requirement to provide a document is satisfied by electronically transmitting the document, provided that the State allows the parties to the transaction access to the completed disclosure statements.
As discussed previously, one purpose of the signature requirement is to aid in the prosecution of odometer fraud. For this reason, NHTSA proposes requiring an electronic “signature” to identify an individual, not a business, for example. NHTSA requests comment on whether any other requirements are necessary to ensure that investigators can back trace an electronic “signature” to identify the individual and/or computer used in the electronic equivalent of a “paper trail.” Conversely, if an odometer disclosure is altered, do the proposed system requirements develop an adequate “paper trail” to lead investigators to the IP address or computer used to alter the disclosure, and if not, what additional system requirements are necessary?
Currently, § 580.4 requires that titles, which are necessarily all physical documents except in the five jurisdictions with approved petitions for electronic systems pursuant to 49 U.S.C. 32705(d), be printed using a secure printing or other secure process. Further, currently any power of attorney forms and all documents used to reassign title must be issued by the State and be created using a secure process. It is central to the integrity and efficacy of the motor vehicle titling systems and
The proposed changes and additions to § 580.4 seek to clarify that the existing requirements apply to physical documents, moving the language to a new paragraph (a), and set forth requirements for electronic documents, in a new paragraph (b), to ensure comparable levels of security and authenticity in electronic documents as exist currently for paper documents. Such requirements are necessary to protect both the financial interests of motor vehicle owner's and potential buyers, as well as to aid law enforcement in preventing, detecting, and prosecuting odometer fraud. NHTSA seeks comments as to whether the proposed changes and additions to § 580.4 appropriately match the security and authenticity requirement for electronic documents to the existing requirements, which apply to paper documents.
As discussed previously, § 580.4 requires the title, power of attorney or reassignment documents used for odometer disclosures to have certain security safety features to inhibit altering the disclosure and to aid in the detection of alterations.
NHTSA contemplated proposing specific minimum requirements for system security, but has preliminarily determined that it would be counter-productive, and thus inappropriate, to do so. NHTSA based this decision on the knowledge that the rulemaking process is typically slow, while developments in technology are fast and frequent. While proactive changes to enhance cyber security are constantly evolving and improving, cyber-attacks and efforts to undermine the security of electronic data systems are also changing rapidly and frequently. The rulemaking process would not be able to keep pace with these technological changes and it is foreseeable that, if NHTSA imposed specific system requirements, the specific requirements could become obsolete, yet remain the requirements while a new rulemaking is undertaken. Alternatively, to the extent that rulemaking by NHTSA would be able to keep up with the dynamic technological landscape, such constant revisions to the regulations would result in an ever-changing set of specific requirements for States to adhere to.
Further, the potential risks to property interests and commerce presented by insecure vehicle titling and odometer disclosure systems are obvious, since it is critical that the owners, buyers, and sellers of motor vehicles have certainty in their ownership status and avoid being defrauded in the fundamental details about the vehicle they own or are buying.
By NHTSA's adoption of more general minimum requirements, any State that choses to adopt an electronic disclosure system will be able to select the specific system requirements it believes are most appropriate, while ensuring information security for motor vehicle owners, buyers, and law enforcement.
While NHTSA's expectation is that any State implementing an electronic disclosure system would take these various risks into account and establish appropriate safeguards, NHTSA nonetheless requests comments on whether it should establish minimum specific security requirements in this rulemaking and, if so, what requirements would be appropriate. NHTSA requests comment on whether requirements should be included for the hardware used in an electronic odometer system to protect the system from threats which could disrupt the electronic records, either from natural or manmade sources and, if so, what requirements should be included in a final rule. For example, the Federal Information Security Management Act (FISMA) defines a framework to protect Federal government information systems from such threats. Should NHTSA, for example, require any computer or server attached to an electronic odometer system comply with FISMA?
NHTSA considered the issue of what odometer information disclosures and procedures should be required for paper and electronic disclosures, and what appropriate modifications can and should be made for electronic disclosures. In an effort to track the electronic disclosure requirements to the existing requirements, NHTSA makes the following proposals regarding the odometer disclosures and procedures.
In § 580.5 paragraph (a), NHTSA proposes to add the phrase “whether a physical or electronic document” to make clear that the disclosure requirements specified in § 580.5 apply to all titles issued. The requirements currently apply to all title transfers and, as a practical matter, this results in no change in the disclosure requirements whether made on a physical document or electronically.
Paragraph § 580.5(c) sets forth certain specific disclosures that must be made as part of a transaction transferring title of a vehicle, including that the odometer disclosure must be made on the title, or on a document being used to reassign the title. As currently written, this requirement necessarily implies the ability to affix information onto a document. To clarify this requirement, NHTSA proposes to add language specifying “physical document” in instances of paper title transfers and “electronic form incorporated into the electronic title” for instances of electronic title transfers. The requirement for making electronic disclosures on an electronic form incorporated into the electronic title means that paper disclosures would become the rare exception when electronic disclosure and titling is available. Further, the electronic systems would need to be designed to contain or otherwise embed the electronic odometer disclosure in the electronic title. Finally, for electronic transfers where the transferor is the individual in whose name the vehicle is titled, reassignment documents would not be necessary. NHTSA seeks comments on the proposal that disclosures be made on an electronic form incorporated into the electronic title.
NHTSA also considered the issue of how to provide the warnings currently contained in § 580.5(d) to parties conducting electronic transfers. NHTSA proposes to extend these existing requirements to electronic transfers by amending § 580.5(d), specifying that in instances of electronic transfer, the required information must be displayed on the screen, and acknowledged as understood by that party, before any signature can be applied to the transaction. This proposed requirement is intended to ensure that the information is provided in a size and location that is clearly viewable and readable to individuals making electronic transfers, and that transferors do not unintentionally bypass this information without having an opportunity to review it. NHTSA envisions that the acknowledgement would typically be a box for the party
NHTSA considered the existing requirements of § 580.5(f), that a transferee print his or her name on the disclosure and return a copy to the transferor and believes that the requirement on a transferee to “print” their name is inappropriate for electronic transfers, but that any electronic system should be able to provide some record of the disclosure for the transferor and transferee. NHTSA proposes to not extend the printed name requirement to electronic disclosures because the purpose of the printed name is to provide hand writing exemplars for use in fraud investigations and prosecutions. However, at present, NHTSA is not aware of electronic systems that capture handwriting with the level of clarity and precision that exists when applying hand-writing to paper. As a result, unlike physical handwriting exemplars, NHTSA does not currently believe that electronic handwriting exemplars would provide the intended investigatory and prosecution tools to law enforcement. The requirement that the transferee print his or her name on the disclosure therefore need not be extended to electronic disclosures. In contrast, it remains important for both parties to the transaction to have access to a record showing the disclosure that was made, and it is appropriate to extend the current requirement that the transferee provide a copy of the disclosure to the transferor to electronic transfers.
In an electronic disclosure jurisdiction, the parties would not have physical control of the disclosure documents and the responsibility to provide copies of the disclosure must fall to the operator(s) of the disclosure system. Thus, NHTSA proposes to amend § 580.5(f) to require that jurisdictions with electronic disclosure systems provide a way for the transferor and transferee to obtain copies, in the form of some detailed record, of the disclosure. These records not only provide assurance to the parties of what information was relied upon in the transaction, but could also aid law enforcement in investigations and prosecutions. NHTSA requests comments on the proposal to not extend the printed name requirement to electronic disclosures, including technologies that provide comparable electronic hand-writing exemplars as paper document exemplars, and on the proposal to require that any electronic system be capable of providing the transferor and transferee with a copy or record of the disclosure made.
NHTSA has considered how to handle odometer disclosure for a vehicle that has not been titled or for which the title does not contain a space for the information required. Under the existing paper disclosure systems, in such instances the parties execute the odometer disclosure as a separate paper document. This system would not make sense in an electronic disclosure system since the first time a title was obtained for any given vehicle the odometer disclosure would be incorporated into that electronic title at the time of creation and no electronic title system would be created that did not provide space for the required information. The option relating to insufficient space on the title is a holdover from when odometer disclosures were first required on the title and jurisdictions needed time to bring titles into conformity with the new regulation. That concern is not applicable here since electronic disclosure systems will be designed and implemented using the requirements established in this rule. Similarly, no special provision is needed for providing the information in the first instance of titling in an electronic disclosure jurisdiction, since any electronic system will include the execution of an electronic disclosure that is incorporated into the electronic title upon creation. NHTSA thus proposes to amend § 580.5(g) to add language clarifying that the existing regulation allowing for disclosure on a separate document for first title and instances where the title does not contain space for the disclosure is limited to transactions conducted using physical documents while disclosures for first title issuance in an electronic disclosure system must be made in the electronic system. NHTSA requests comments on the proposal to limit the current separate document disclosures for first title issuance and when the title does not contain sufficient space for the disclosure requirements to paper title jurisdictions, and requiring disclosures for first title issuance to be conducted within the electronic title system in electronic disclosure jurisdictions.
NHTSA has considered the differences between disclosures made on physical documents and those made on electronic documents and preliminarily determined that additional requirements are necessary to ensure the accuracy and authenticity of electronic disclosures. NHTSA has also considered the complications that could arise, including competing claims of vehicle ownership, if both paper and electronic titles co-exist as an official form of title issued within a jurisdiction. To address these issues, NHTSA is proposing to add a new § 580.6 (previously reserved), to provide requirements that apply only to electronic transactions.
First, NHTSA proposes to add § 580.6(a)(1), requiring that any electronic record be retained in a format that cannot be altered and, further, that indicates any attempts to alter it. This proposed requirement adds as an explicit condition for electronic disclosures an implicit reality of disclosures on physical documents. Disclosures on physical documents provide some method for detection of alterations or attempts to alter the document. While techniques for altering the physical documents evolve over time, they nonetheless leave an indicator, however hard to detect, of that alteration or attempt. Electronic documents thus present a different challenge since many documents are easily altered, and some of the techniques used can be difficult to trace. A system that prevents alteration is critical for consumer confidence in the disclosure system and information relating to the alteration of disclosure documents is critical to the enforcement of the odometer disclosure laws and in preventing odometer fraud. NHTSA requests comments on this proposed additional requirement for electronic disclosures and what, if any, more specific requirements would be appropriate to ensure that electronic records are not altered and indicate any attempts to alter them.
Currently, each person signs their own name to a physical document when completing an odometer disclosure and is uniquely identified as an individual. Or at least that is presumed for non-fraudulent transactions. Similarly, in an electronic disclosure system, each individual person will need to be uniquely identified by their own unique electronic signature. This is necessary to protect the financial interests of vehicle owners and purchasers, providing certainty that the vehicle title remains with the lawful owner and that odometer disclosures are made by the appropriate individuals, who can be located, if needed.
As a practical matter, this is particularly necessary for transactions involving individuals who complete portions of disclosures on behalf of others, like an employer. For example, when a vehicle owner seeks to trade in a car at a car dealership in an electronic disclosure jurisdiction the parties would no longer need to provide power of attorney and reassignment documents for the dealer to use in selling the vehicle at a later date, but instead would simply transfer title from the vehicle owner to the car dealer and make the odometer disclosure on the electronic form which is incorporated into the title. This will require an individual at a car dealership to enter information into the electronic disclosure system on behalf of the business or entity on whose behalf that individual is operating.
NHTSA has considered the importance of maintaining confidence that the parties are who they claim to be for ownership and law enforcement purposes. NHTSA has also considered challenges created in fraud investigation and prosecution if both the individual and business, or entity, are not identified by the code or signature associated with an individual acting in this capacity to input data into the system. Accordingly, NHTSA is proposing to add § 580.6(a)(2) requiring that any electronic signature identify an individual and, further, that if the individual is acting in a business capacity or otherwise on behalf of any other individual or entity, that the business or entity also be identified as part of that unique electronic signature. NHTSA requests comments on this proposal.
The physical document disclosure system currently established in § 580 generally requires in various places that individuals be provided with specific documentation. However, in an electronic system, in many cases there will not be any document to provide, and instead, information can be made available to the parties via the electronic system. Moreover, part of the rationale for using an electronic disclosure and titling system is to reduce the amount of paper being used. It would defeat one of the purposes of electronic disclosure to require the printing and delivery of documentation at various stages. It could also add unnecessary complications to the electronic delivery of documentation if specific electronic delivery mechanisms were required. Having considered this factors, NHTSA proposes to add § 580.6(a)(3), providing that any requirement in the regulations to disclose, issue, execute, return, notify, or otherwise provide information to another person is satisfied when a copy of the electronic disclosure or statement is electronically transmitted or otherwise electronically accessible to the party required to receive the disclosure. NHTSA requests comments on the usefulness of this proposal.
The continued use of physical documents to accomplish transfer of title or odometer disclosure in an electronic disclosure jurisdiction is strongly discouraged, as each different document presents a new opportunity for fraudulent activity to occur. However, to the extent that the continued use of physical documents is necessary in an electronic system, any physical documents used must comply with all requirements of this part. NHTSA thus proposes the new § 580.6(a)(7) to require that any physical documents used to make electronic disclosures comply with the existing applicable requirements.
NHTSA considered the issue of which title and/or odometer disclosure is, and should be, the official document in certain situations. In a written environment it is possible to determine which document has an original signature and, therefore, to distinguish original (or official) documents from copies. This method of determining the original/official document is not available when the original document was created electronically. In addition, when a print copy is made of an electronic odometer disclosure, what should be done to specify whether the print document is now the official document or the electronic document remains the official document? This issue could arise when a vehicle titled with an electronic odometer disclosure is moved to a State which either does not participate in electronic odometer disclosures or which has an electronic odometer system that cannot communicate directly with the system in the State in which the vehicle is currently titled. It could also occur if a vehicle owner in an electronic disclosure State would like a paper copy of a title and/or odometer disclosure for record-keeping purposes.
First, NHTSA is proposing that once an odometer disclosure is incorporated in the electronic title, the electronic title containing the disclosure is the official record of ownership and mileage. The electronic disclosure does not continue as a record separate from the electronic title as that would be contrary to TIMA and would provide additional opportunity for fraud. If an electronic title (containing an odometer disclosure) must be converted to a paper document as the official document, NHTSA is proposing additional requirements. First, only a State or State-authorized entity can create the new official document. Second, the paper document must be set forth by means of a secure printing method as a physical, paper document. As a practical matter, this may present certain logistical challenges, particularly for individuals in an electronic title State who seek to buy a new car, and trade-in their old car, in another State. This issue is discussed at greater length below regarding Power of Attorney, and NHTSA requests comments on how this logistical challenge can be avoided or mitigated. Third, the electronic record must be altered to clearly indicate that an official paper document has been issued, to whom, and the date of issuance.
Second, NHTSA is proposing to allow States to authorize the issuance of some type of record of ownership document that would contain the information on a title and/or odometer disclosure but would not replace the official document. This document could be used for persons who would like a paper copy but would not like the official document to be converted to a paper document. In the proposed § 580.6(a)(5) jurisdictions with electronic title and odometer disclosure systems would be allowed to provide vehicle owners with a paper record of ownership including the odometer disclosure information so long as the document clearly indicates that it is not an official title or odometer disclosure for that vehicle. NHTSA requests comments on the benefits and drawbacks of such a record and whether the option of obtaining such a document should be required under the regulations.
Finally, in reverse situations where a vehicle titled in a State that does not participate in an electronic odometer system is moved to a State with an electronic odometer system, NHTSA is proposing a new § 580.6(a)(4) to require that the prior title and odometer disclosure be copied electronically for retention by the electronic system State and that the paper document(s) be destroyed at the time they are converted to electronic documents. NHTSA further proposes that the electronic copy of the physical document be retained for a minimum of five years, in an order that
NHTSA requests comments on what standards should be used for scanning and maintaining the documents including whether the scan must be in color, be made at a minimum resolution (and if so, what required minimum resolution should be), or preserve the security features of the original to ensure that fraud or alteration could be detected, should it occur.
Section 580.7 deals with the disclosure obligations and requirements for leased vehicles. NHTSA is not aware of any reason why electronic disclosures could not be made for leased vehicles, though lessors wishing to utilize such a system for communications between themselves and lessees would need to develop an electronic system complying with the technological requirements established in § 580.4(b) of this part unless the jurisdiction where the leased vehicle is titled provides such a system. These requirements are necessary as security and authenticity of disclosure information is fundamental to all types of disclosures within the odometer disclosure system. Otherwise, disclosures regarding leased vehicles would continue on physical documents. As with all other electronic disclosures, it is appropriate and necessary that individuals making the disclosure be provided with the notice of Federal law and possible penalties for providing false information. The substantive disclosures would not change for electronic disclosure except that, as with all other electronic disclosures, the person making the disclosure need not provide their “printed name” for the reasons previously discussed.
Having considered the issues involved in lessor-lessee communications regarding odometer disclosure statements, NHTSA proposes to add language to § 580.7(a) specifying that legal notices given on paper odometer disclosure documents must be provided to, and acknowledged by, an individual making an electronic disclosure; add language to § 580.7(b) clarifying that a printed name need not be provided for electronic disclosures; and add a new § 580.7(e) requiring any electronic system maintained by a lessor for the purpose of complying with this section meet the requirements set forth in proposed § 580.4(b) or this part. NHTSA requests comments as to whether electronic disclosures of leased vehicles should be a required part of the electronic system established by a jurisdiction or are best left to individual companies/lessors to establish and whether the current proposal would sufficiently aid law enforcement in detecting altered documents.
Sections 580.8 and 580.9 include requirements for odometer disclosure record retention by motor vehicle dealers and distributors and by auction companies, respectively. Section 580.8(a) specifies that dealers and distributors must retain a “Photostat, carbon copy or other facsimile copy of each odometer mileage statement which they issue and receive.” An electronic odometer disclosure system that does not allow for dealers and distributors to maintain records in electronic format would undermine the purpose for moving to such a system. NHTSA is therefore proposing to amend this requirement to include electronic copies or electronic documents as an acceptable form of record.
Under both sections, records must be stored for five years in a manner and method so they are accessible to NHTSA investigators and other law enforcement personnel. The records must also be stored so they are difficult or impossible to modify. As previously discussed, unlike paper documents, alterations to electronic documents are much more difficult to detect from a visual inspection. Therefore, NHTSA is proposing to add a specific requirement in a new § 580.8(d) and in § 580.9 that electronic records kept by motor vehicle dealers and distributors and by auction companies must be stored in a format that cannot be altered and which indicates any attempts to alter the document, consistent with the standards set forth in proposed § 580.4(b). NHTSA requests comment on whether this requirement would be sufficient to allow law enforcement to detect altered documents.
NHTSA is proposing to modify the power of attorney provisions. A power of attorney generally should not be needed for transfers and disclosures within jurisdictions using electronic systems since there will not be a “lost” title, as the State system will hold the title record with the odometer disclosure, and any lienholder will not physically hold the title since the title will be on file in the State's electronic system. However, NHTSA proposes to amend § 580.13(a) and (b), to allow an individual with a vehicle titled in an electronic title State to use a power of attorney to sell a vehicle in a paper title State. In this way, the electronic title with the required odometer disclosure is equivalent to a lost title or a title held by a lienholder. Without this additional permitted use of power of attorney, the seller from an electronic title State cannot trade-in his old car and buy a new car in a paper title State unless the seller first remembers, and plans ahead, to obtain a printed title from the electronic title State before going car shopping. For example, assume Mr. Smith lives in an e-title State but goes to a paper title State to trade-in his old car and buy a new car. He must either get his paper title first or there must be some means for him to make his odometer disclosure without a title. Electronic title States will not likely be in a position to provide secure paper titles on demand. This means Mr. Smith cannot buy a new car unless he gets his electronic title printed as a physical title first. The agency believes this is unlikely to happen in many, if not most, instances.
While the use of power of attorney provides an additional step in the transfer process, and thus another opportunity for fraud to occur, the agency believes as a practical matter that there must be some other way for a vehicle owner from an electronic title State to sell the vehicle in a paper title State without first obtaining a converted official paper title from the electronic title State. However, power of attorney laws vary from State to State, so even with this modification there may still be States that retain paper title systems where vehicles registered in electronic title States could not be sold without the converted official paper title. NHTSA requests comments on the benefits and drawbacks of this proposal as well as other ideas to address this challenge while maintaining adequate safeguards of accurate disclosures and a paper-trail.
NHTSA also proposes to add the word “physical” in multiple places in § 580.13(f), § 580.14(a), (e), and (f), and in § 580.15(a). In § 580.13(f) this is necessary to make clear that the title being referenced at the two specified points is a physical title and not an electronic title, unlike the other references to “title” within paragraph
NHTSA requests comments on whether power of attorney would be necessary in an electronic odometer system for intra-state transfers. Second, NHTSA notes that the requirements in section 580.13 permitting disclosures by power of attorney assume that the power of attorney document itself is a physical document. Therefore, NHTSA requests comments on whether odometer disclosure by power of attorney would be made on other than a paper document,
NHTSA proposes to correct a typographical error that appears in both § 580.13(b)(5) and § 580.14(b)(5) by adding a comma between “model year,” which would bring the disclosure requirements for power of attorney forms into conformity with standard transfer disclosures and leased vehicle disclosures. This typographical error in the regulation creates inconsistency within the reporting scheme. Accordingly, NTHSA proposes to change “model year” to “model, year” in these two reporting provisions.
Section 580.17(3) currently exempts any vehicle which is more than 10 years old from the odometer disclosure requirements. The average age of the United States vehicle fleet has been trending upward and recently reached 11.5 years.
The agency is no longer located at the address currently provided in § 580.10. Accordingly, NHTSA is proposing to amend § 580.10(b)(2) to provide the correct address for applications for assistance to, which is the Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W41-326, Washington, DC 20590.
Section 580.11 provides States with procedures by which to petition NHTSA for approval of disclosure requirements differing from those required by 49 CFR part 580, specifically § 580.5, § 580.7, and § 580.13(f). NHTSA is proposing to amend § 580.11(a) to add the new § 580.6 to the sections for which a State may petition the agency to utilize different disclosure requirements and to add § 580.6 to the explanation of the effect of a grant or denial of a petition contained in § 580.11(c). NTHSA requests comments on whether a State should be permitted to use alternative disclosure requirements to those proposed in § 580.6.
Section 580.11 also provides the prior address for the agency, and NHTSA is proposing to amend § 580.11(b)(2) to provide the current address, which is the Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W41-326, Washington, DC 20590.
The petition provided for in § 580.12, allowing a State to seek an extension of time beyond the April 29, 1989 deadline to bring its laws into conformity with the requirements of Part 580, was due to the agency by February 28, 1989. These dates having long ago passed and States having brought applicable laws into compliance, the provisions within § 580.12 are now obsolete. Accordingly, NHTSA proposes to strike the regulatory text of § 580.12 and replace it with “[Remove and Reserve]” to reserve the section.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.
Your comments must not be more than 15 pages long. (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary supporting documents to your comments. There is no limit on the length of the attachments.
Comments may be submitted to the docket electronically by logging onto the Docket Management System Web site at
You may also submit two copies of your comments, including the attachments, to Docket Management at the address given above under
Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at:
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
Please note that, even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies require this agency to make determinations as to whether a regulatory action is “significant” and therefore subject to OMB review and the requirements of the aforementioned Executive Orders. Executive Order 12866 defines a “significant regulatory action” as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
We have considered the potential impact of this proposal under Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures, and have determined that it is not significant. This proposal amends existing requirements to allow States a new alternative means of complying with those requirements. It does not impose any new regulatory burdens. Therefore, this document was not reviewed by the Office of Management and Budget under E.O. 12866 and E.O. 13563.
We have reviewed this rule for the purposes of the National Environmental Policy Act and determined that it would not have a significant impact on the quality of the human environment.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601
In compliance with the Regulatory Flexibility Act, NHTSA has evaluated the effects of this proposed rule on small entities. The head of the agency has certified that the proposed rule would not have a significant economic impact on a substantial number of small entities. This proposal is only allowing States the option of an alternative means of complying with an existing requirement and therefore would not impose any new impact on any small entities.
NHTSA has examined today's NPRM pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999). Executive Order 13132 requires agencies to determine the federalism implications of a proposed rule. The agency has determined that the proposed rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The proposed rule merely adds another option to the way States are allowed to process and issue existing odometer disclosure requirements, and does not alter the effect on the States of existing statutory or regulatory requirements.
When promulgating a regulation, Executive Order 12988 specifically requires that the agency must make every reasonable effort to ensure that the regulation, as appropriate: (1) Specifies in clear language the preemptive effect; (2) specifies in clear language the effect on existing Federal law or regulation, including all provisions repealed, circumscribed, displaced, impaired, or modified; (3) provides a clear legal standard for affected conduct rather than a general standard, while promoting simplification and burden reduction; (4) specifies in clear language the retroactive effect; (5) specifies whether administrative proceedings are to be required before parties may file suit in court; (6) explicitly or implicitly defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship of regulations.
Pursuant to this Order, NHTSA notes as follows. The preemptive effect of this proposal is discussed above in connection with Executive Order 13132. NHTSA has also considered whether this rulemaking would have any retroactive effect. This proposed rule does not have any retroactive effect. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.
The policy statement in section 1 of Executive Order 13609 provides, in part:
The regulatory approaches taken by foreign governments may differ from those taken by U.S. regulatory agencies to address similar issues. In some cases,
NHTSA requests public comment on whether (a) “regulatory approaches taken by foreign governments” concerning the subject matter of this rulemaking, and (b) the above policy statement, have any implications for this rulemaking.
Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments, except when use of such a voluntary consensus standard would be inconsistent with the law or otherwise impractical. Voluntary consensus standards are technical standards (
The Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). In 2011 dollars, this threshold is $139 million.
This proposed rule would not result in the expenditure by State, local, or tribal governments, in the aggregate, or more than $139 million annually, and would not result in the expenditure of that magnitude by the private sector.
Under the procedures established by the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. Today's NPRM does not propose any new information collection requirements, it merely allows States to provide an alternative means of collecting information they already collect.
Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that isn't clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
If you have any responses to these questions, please include them in your comments on this proposal.
The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an organization, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the
Consumer protection, Motor vehicles, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, NHTSA proposes to amend 49 CFR part 580 as follows:
49 U.S.C. 32705; Pub. L. 112-141; delegation of authority at 49 CFR 1.95.
This part prescribes rules requiring transferors and lessees of motor vehicles to make electronic or written disclosure to transferees and lessors respectively, concerning the odometer mileage and its accuracy as directed by sections 408 (a) and (e) of the Motor Vehicle Information and Cost Savings Act as amended, 15 U.S.C. 1988 (a) and (e). In addition, this part prescribes the rules requiring the retention of odometer disclosure statements by motor vehicle dealers, distributors and lessors and the retention of certain other information by auction companies as directed by sections 408(g) and 414 of the Motor Vehicle Information and Cost Savings Act as amended, 15 U.S.C. 1990(d) and 1988(g).
(a) For a paper odometer disclosure, a person's name, or a mark representing it, as hand written personally.
(b) For an electronic odometer disclosure, an electronic sound, symbol, or process using an authentication system equivalent to or greater than Level 3 as described in National Institute of Standards and Technology (NIST) Special Publication 800-63-2,
(a) Each physical title shall be set forth by means of a secure printing process or other secure process. In addition, physical power of attorney forms issued pursuant to §§ 580.13 and 580.14 and physical documents which are used to reassign the title shall be issued by the State and shall be set forth by a secure process.
(b) Each electronic title shall be maintained in a secure environment so it is protected from unauthorized modification, alteration or disclosure. In addition, electronic power of attorney forms maintained and made available pursuant to §§ 580.13 and 580.14 and electronic documents which are used to reassign the title shall maintained by the State in a secure environment so that it is protected from unauthorized modification, alteration and disclosure. Any system employed to create, store and maintain the aforementioned electronic documents shall record the dates and times when the electronic document is created, the odometer disclosures contained within are signed and when the documents are accessed, including the date and time any attempt is made to alter or modify the electronic document and any alterations or modifications made.
(a) Each title, whether a physical or electronic document, at the time it is issued or made available to the transferee, must contain the mileage disclosed by the transferor when ownership of the vehicle was transferred and contain a space for the information required to be disclosed under paragraphs (c), (d), (e) and (f) of this section at the time of future transfer.
(c) In connection with the transfer of ownership of a motor vehicle using a physical document, each transferor shall disclose the mileage to the transferee on the physical title or, except as noted below, on the physical document being used to reassign the title. In connection with the transfer of ownership of a motor vehicle using an electronic document, each transferor shall disclose the mileage to the transferee on an electronic form incorporated into the electronic title. In the case of a transferor in whose name the vehicle is titled, the transferor shall disclose the mileage on an electronic form incorporated into the electronic title or on the physical title, and not on a reassignment documents. This disclosure must be signed by the transferor and if made on a physical title, must contain the transferor's printed name. In connection with the transfer of ownership of a motor vehicle in which more than one person is a transferor, only one transferor need sign the disclosure. In addition to the signature of the transferor, the disclosure must contain the following information:
(d) In addition to the information provided under paragraph (c) of this section, the statement shall refer to the Federal law and shall state that failure to complete or providing false information may result in fines and/or imprisonment. Reference may also be made to applicable State law. If the transaction at issue is electronic, the information specified in this paragraph shall be displayed, and acknowledged as understood by the party, prior to the execution of any electronic signatures.
(f) The transferee shall sign the disclosure statement, and in the case of a disclosure made on a physical title, shall print his name, and return a copy to his transferor. If the disclosure is incorporated into an electronic title, the electronic system shall provide a means for making copies of the disclosure statement available to the transferee and transferor.
(g) In jurisdictions employing paper title and odometer disclosure schemes, if the vehicle has not been titled or if the physical title does not contain a space for the information required, the written disclosure shall be executed as a separate physical document. In jurisdictions maintaining electronic title and odometer disclosure systems, the system shall provide a means for making the disclosure electronically and incorporating this disclosure into the electronic title when the title is created.
(a) Additional Requirements for Electronic Odometer Disclosures
(1) Any electronic record shall be retained in a format which cannot be altered, and which indicates any attempts to alter it.
(2) Any signature shall identify an individual, and not solely the organization the person represents or is employed by. If the individual executing the electronic signature is acting in a business capacity or otherwise on behalf of another individual or entity, the business or other individual or entity shall also be identified when the signature is made.
(3) Any requirement in these regulations to disclose, issue, execute, return, notify or otherwise provide information to another person is satisfied when a copy of the electronic disclosure or statement is electronically transmitted or otherwise electronically accessible to the party required to receive the disclosure.
(4) Upon creation of an electronic title to replace an existing physical title, an electronic copy of the physical title shall be created and retained, for not less than five years, by the State issuing the electronic title and the physical title shall be destroyed immediately following the successful creation of the electronic record. The electronic copy of the paper record shall be retained
(i) in a format which cannot be altered, and which indicates any attempts to alter it; and
(ii) in an order that permits systematic retrieval.
(5) A State allowing electronic odometer disclosures may provide for a paper record of ownership which includes the odometer disclosure information, provided the document clearly indicates it is not an official title, nor official odometer disclosure, for the vehicle.
(6) States maintaining an electronic title and odometer disclosure system shall retain the capacity to issue physical titles meeting all the requirements of this part. Once a physical title is created by a State with an electronic title and odometer disclosure statement system, the electronic record must indicate that a physical title has been issued and the electronic title and disclosure statement have been superseded by the physical title as the official title. The State electronic title and odometer disclosure
(7) Any physical documents employed by transferors and transferees to make electronic odometer disclosures shall comply with all requirements of this part.
(8) Any conversion of physical documents to electronic documents employed to comply with any of the requirements of this part must maintain and preserve the security features incorporated in the physical document so that any alterations or modifications to the physical document can be detected in the physical document's electronic counterpart. Scanning of physical documents must be made in color at a resolution of not less than 600 dots per inch (dpi).
(a) Before executing any transfer of ownership document, each lessor of a leased motor vehicle shall notify the lessee in writing on a physical document or within an electronic document stating that the lessee is required to provide a written disclosure to the lessor regarding the mileage. This notice shall contain a reference to the Federal law and shall state that failure to complete or providing false information may result in fines and/or imprisonment. Reference may also be made to applicable State law. If the transaction at issue is electronic, the information specified in this paragraph shall be displayed, and acknowledged as understood by the party, prior to the execution of any electronic signatures.
(b) In connection with the transfer of ownership of the leased motor vehicle, the lessee shall furnish to the lessor a written statement regarding the mileage of the vehicle. This statement must be signed by the lessee. If executed using a physical document, this statement, in addition to the information required by paragraph (a) of this section, shall contain the information in paragraphs 1 through 9 as set forth below. If executed using an electronic document, this statement, in addition to the information required by paragraph (a) of this section, shall contain the name of the person making the disclosure and the information contained in paragraphs 2 through 9 as set forth below.
(1) The printed name of the person making the disclosure;
(2) The current odometer reading (not to include tenths of miles);
(3) The date of the statement;
(4) The lessee's name and current address;
(5) The lessor's name and current address;
(6) The identity of the vehicle, including its make, model, year, and body type, and its vehicle identification number;
(7) The date that the lessor notified the lessee of disclosure requirements;
(8) The date that the completed disclosure statement was received by the lessor; and
(9) The signature of the lessor if executed using a physical document or the electronic signature of the lessor if statement is made electronically.
(e) Any electronic system maintained by a lessor for the purpose of complying with the requirements of this section shall meet the requirements of § 580.4(b) of this part.
(a) Dealers and distributors of motor vehicles who are required by this part to execute an odometer disclosure statement shall retain for five years a photostat, carbon, other facsimile copy or electronic copy or document of each odometer mileage statement which they issue and receive. They shall retain all odometer disclosure statements at their primary place of business in an order that is appropriate to business requirements and that permits systematic retrieval.
(d) Any electronic record shall be retained in a format which cannot be altered, and which indicates any attempts to alter it.
Each auction company shall establish and retain in physical document form, or electronic document form that complies with the requirement of § 580.4(b), at its primary place of business in an order that is appropriate to business requirements and that permits systematic retrieval, for five years following the date of sale of each motor vehicle, the following records:
(b) * * *
(2) Be submitted to the Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W41-326, Washington, DC 20590;
(a) A State may petition NHTSA for approval of disclosure requirements which differ from the disclosure requirements of § 580.5, § 580.6, § 580.7, or § 580.13(f) of this part.
(b) * * *
(2) Be submitted to the Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W41-326, Washington, DC 20590;
(c) Notice of the petition and an initial determination pending a 30-day comment period will be published in the
(a) If the transferor's title is physically held by a lienholder, if the transferor's title exists in electronic form and the transferee is located in a State that does not create or maintain electronic titles, or if the transferor to whom the title was issued by the State has lost his title and the transferee obtains a duplicate title on behalf of the transferor, and if otherwise permitted by State law, the transferor may give a power of attorney to his transferee for the purpose of
(b) In connection with the transfer of ownership of a motor vehicle, each transferor to whom a title was issued by the State whose title is physically held by a lienholder, whose title exists in electronic form and the transferee is located in a State that does not create or maintain electronic titles or whose title has been lost, and who elects to give his transferee a power of attorney for the purpose of mileage disclosure, must appoint the transferee his attorney-in-fact for the purpose of mileage disclosure and disclose the mileage on the power of attorney form issued by the State. This written disclosure must be signed by the transferor, including the printed name, and contain the following information:
(1) The odometer reading at the time of transfer (not to include tenths of miles);
(2) The date of transfer;
(3) The transferor's name and current address;
(4) The transferee's name and current address; and
(5) The identity of the vehicle, including its make, model, year, body type and vehicle identification number.
(f) Upon receipt of the transferor's title, the transferee shall complete the space for mileage disclosure on the title exactly as the mileage was disclosed by the transferor on the power of attorney form. The transferee shall submit the original power of attorney form to the State that issued it, with a copy of the transferor's physical title or with the actual physical title when the transferee submits a new title application at the same time. The State shall retain the power of attorney form and title for three years or a period equal to the State titling record retention period, whichever is shorter. If the mileage disclosed on the power of attorney form is lower than the mileage appearing on the title, the power of attorney is void and the dealer shall not complete the mileage disclosure on the title.
(a) In circumstances where part A of a secure power of attorney form has been used pursuant to § 580.13 of this part, and if otherwise permitted by State law, a transferee may give a power of attorney to his transferor to review the physical title and any physical reassignment documents for mileage discrepancies, and if no discrepancies are found, to acknowledge disclosure on the physical title. The power of attorney shall be on part B of the form referred to in § 580.13(a), which shall contain a space for the information required to be disclosed under paragraphs (b), (c), (d), and (e) of this section and, in part C, a space for the certification required to be made under § 580.15.
(b) The power of attorney must include a mileage disclosure from the transferor to the transferee and must be signed by the transferor, including the printed name, and contain the following information:
(1) The odometer reading at the time of transfer (not to include tenths of miles);
(2) The date of transfer;
(3) The transferor's name and current address;
(4) The transferee's name and current address; and
(5) The identity of the vehicle, including its make, model, year, body type and vehicle identification number.
(e) The transferee shall sign the physical power of attorney form, and print his name.
(f) The transferor shall give a copy of the physical power of attorney form to his transferee.
(a) A person who exercises a power of attorney under both §§ 580.13 and 580.14 must complete a certification that he has disclosed on the physical title document the mileage as it was provided to him on the physical power of attorney form, and that upon examination of the physical title and any physical reassignment documents, the mileage disclosure he has made on the physical title pursuant to the power of attorney is greater than that previously stated on the physical title and reassignment documents. This certification shall be under part C of the same form as the powers of attorney executed under §§ 580.13 and 580.14 and shall include:
(a) * * *
(3) A vehicle that was manufactured in a model year beginning at least twenty five years before January 1 of the calendar year in which the transfer occurs; or
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by April 25, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The data reported on the Program Activity Statement (FNS 366B) enables FNS to identify areas that may need improvement and to provide more effective technical assistance to State agencies. An increase in reporting frequency will allow for greater access to timely program data. It will help States, FNS, and other stakeholders identify trends, inconsistencies and inefficiencies earlier in each fiscal year. FNS uses the data to monitor State agency activity levels and performance and to target technical assistance to State agencies in need of performance improvements.
Rural Business-Cooperative Service, USDA.
Notice.
This Notice announces that the Rural Business-Cooperative Service (Agency) is accepting fiscal year (FY) 2016 applications for the Rural Cooperative Development Grant (RCDG) program as authorized by the Consolidated Appropriations Act, 2016 (Pub. L. 114-113). Approximately $5.8 million is available to be competitively awarded. The purpose of this program is to provide financial assistance to improve the economic condition of rural areas through cooperative development. Eligible applicants include a non-profit corporation or an institution of higher education. The Agency is encouraging applications that direct grants to projects based in or serving census tracts with poverty rates greater than or equal to 20 percent. This emphasis will support Rural Development's (RD) mission of improving the quality of life for Rural Americans and its commitment to directing resources to those who most need them.
Completed applications must be submitted on paper or electronically according to the following deadlines:
Paper applications must be postmarked and mailed, shipped, or sent overnight no later than June 23, 2016. You may also hand carry your application to one of our field offices, but it must be received by close of business on the deadline date. Late applications are not eligible for funding under this Notice and will not be evaluated.
Electronic applications must be received by June 20, 2016 to be eligible for grant funding. Please review the Grants.gov Web site at
You should contact a USDA Rural Development State Office (State Office) if you have questions. You are encouraged to contact your State Office well in advance of the application deadline to discuss your project and ask any questions about the application process. Contact information for State Offices can be found at
Program guidance as well as application and matching funds templates may be obtained at
Grants Division, Cooperative Programs, Rural Business-Cooperative Service, United States Department of Agriculture, 1400 Independence Avenue SW., Mail Stop 3253, Room 4208—South, Washington, DC 20250-3253, (202) 690-1374.
In accordance with the Paperwork Reduction Act, the paperwork burden associated with this Notice has been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0006.
The RCDG program is authorized under section 310B(e) of the Consolidated Farm and Rural Development Act (CONACT) (7 U.S.C. 1932 (e)) as amended by the Agricultural Act of 2014 (Pub. L. 113-79). You are required to comply with the regulations for this program published at 7 CFR part 4284, subparts A and F, which are incorporated by reference in this Notice. Therefore, you should become familiar with these regulations. The primary objective of the RCDG program is to improve the economic condition of rural areas through cooperative development. Grants are awarded on a competitive basis. The maximum award amount per grant is $200,000. Grants are available for non-profit corporations or higher education institutions only. Grant funds may be used to pay for up to 75 percent of the cost of establishing and operating centers for rural cooperative development. Grant funds may be used to pay for 95 percent of the cost of establishing and operating centers for rural cooperative development, when the applicant is a 1994 Institution as defined by 7 U.S.C. 301. The 1994 Institutions are commonly known as Tribal Land Grant Institutions. Centers may have the expertise on staff or they can contract out for the expertise, to assist individuals or entities in the startup, expansion or operational improvement of rural businesses, especially cooperative or mutually-owned businesses.
The terms you need to understand are defined and published at 7 CFR 4284.3 and 7 CFR 4284.504. In addition, the terms “rural” and “rural area,” defined at section 343(a)(13) of the CONACT (7 U.S.C. 1991(a)), are incorporated by reference, and will be used for this program instead of those terms currently published at 7 CFR 4284.3. The term “you” referenced throughout this Notice should be understood to mean “you” the applicant. Finally, there has been some confusion on the Agency's meaning of the terms “conflict of interest” and “mutually-owned business,” because they are not defined in the CONACT or in the regulations used for the program. Therefore, the terms are clarified and should be understood as follows.
Applicants must meet all of the following eligibility requirements. Applications which fail to meet any of these requirements by the application deadline will be deemed ineligible and will not be evaluated further.
You must be a nonprofit corporation or an institution of higher education to apply for this program. Public bodies and individuals cannot apply for this program. See 7 CFR 4284.507. You must also meet the following requirements:
a. An applicant is ineligible if they have been debarred or suspended or otherwise excluded from or ineligible for participation in Federal assistance programs under Executive Order 12549, “Debarment and Suspension.” The Agency will check the System for Award Management (SAM) to determine if the applicant has been debarred or suspended. In addition, an applicant
b. Any corporation that has been convicted of a felony criminal violation under any Federal law within the past 24 months or that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance provided with funds appropriated by the Consolidated Appropriations Act, 2016 (Pub. L. 114-113), unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government. Applicants will be required to complete Form AD-3030, “Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants,” if you are a corporation.
c. Applications will be deemed ineligible if the application includes any funding restrictions identified under section D.6. a and b. Inclusion of funding restrictions outlined in section D.6.a. and b. precludes the agency from making a federal award.
d. Applications will be deemed ineligible if the application is not complete in accordance with the requirements stated in section C.3.e., and will not be reviewed.
Your matching funds requirement is 25 percent of the total project cost (5 percent for 1994 Institutions). See 7 CFR 4284.508. When you calculate your matching funds requirement, please round up or down to whole dollars as appropriate. An example of how to calculate your matching funds is as follows:
a. Take the amount of grant funds you are requesting and divide it by .75. This will give you your total project cost.
$200,000 (grant amount)/.75 (percentage for use of grant funds) = $266,667 (total project cost)
b. Subtract the amount of grant funds you are requesting from your total project cost. This will give you your matching funds requirement.
$266,667 (total project cost)—$200,000 (grant amount) = $66,667 (matching funds requirement)
c. A quick way to double check that you have the correct amount of matching funds is to take your total project cost and multiply it by .25.
$266,667 (total project cost) × .25 (maximum percentage of matching funds requirement) = $66,667 (matching funds requirement)
You must verify that all matching funds are available during the grant period and provide this documentation with your application in accordance with requirements identified in section D.2.e.8. If you are awarded a grant, additional verification documentation may be required to confirm the availability of matching funds.
Other rules for matching funds that you must follow are listed below.
• They must be spent on eligible expenses during the grant period.
• They must be from eligible sources.
• They must be spent in advance or as a pro-rata portion of grant funds being spent.
• They must be provided by either the applicant or a third party in the form of cash or an in-kind contribution.
• They cannot include board/advisory council members' time.
• They cannot include other Federal grants unless provided by authorizing legislation.
• They cannot include cash or in-kind contributions donated outside the grant period.
• They cannot include over-valued, in-kind contributions.
• They cannot include any project costs that are ineligible under the RCDG program.
• They cannot include any project costs that are unallowable under the applicable grant “Cost Principles,” including 2 CFR part 200, subpart E, and the Federal Acquisition Regulation (for-profits) or successor regulation.
• They can include loan funds from a Federal source.
• They can include travel and incidentals for board/advisory council members if you have established written policies explaining how these costs are normally reimbursed, including rates. You must include an explanation of this policy in your application or the contributions will not be considered as eligible matching funds.
• You must be able to document and verify the number of hours worked and the value associated with any in-kind contribution being used to meet a matching funds requirement.
• In-kind contributions provided by individuals, businesses, or cooperatives which are being assisted by you cannot be provided for the direct benefit of their own projects as USDA Rural Development considers this to be a conflict of interest or the appearance of a conflict of interest.
Your application must propose the establishment or continuation of a cooperative development center concept. You must use project funds, including grant and matching funds for eligible purposes only (see 7 CFR 4284.508). In addition, project funds may be used for programs providing for the coordination of services and sharing of information among the centers (see 7 U.S.C 1932(e) (4) (C) (vi)).
All project activities must be for the benefit of a rural area.
Only one application can be submitted per applicant. If two applications are submitted (regardless of the applicant name) that include the same Executive Director and/or advisory boards or committees of an existing center, both applications will be determined not eligible for funding.
Your application must include a one-year grant period or it will not be considered for funding. The grant period should begin no earlier than October 1, 2016, and no later than January 1, 2017. Prior approval is needed from the Agency if you are awarded a grant and desire the grant period to begin earlier or later than previously discussed. Projects must be completed within a one-year timeframe. The Agency may approve requests to extend the grant period for up to an additional 12 months at its discretion. Further guidance on grant period extensions will be provided in the award document.
Your application will not be considered for funding if it fails to meet an eligibility criterion by time of application deadline and does not provide sufficient information to determine eligibility and scoring. In particular, you must include all of the forms and proposal elements as discussed in the regulation and as clarified further in this Notice.
If you have an existing RCDG award, you must discuss the status of your existing RCDG award at application time under the Eligibility Discussion. You must be performing satisfactorily to be considered eligible for a new award. Satisfactory performance includes being up-to-date on all financial and performance reports and being current on all tasks as approved in the work plan. The Agency will use its discretion to make this determination. In addition, if you have an existing award from the Socially-Disadvantaged Groups Grant (SDGG) program, formerly known as the Small Socially-Disadvantaged Producer Grants (SSDPG) program, you must discuss the status of your existing SSDPG award at application time under Eligibility Discussion and be performing satisfactorily to be considered for a new RCDG award.
Your negotiated indirect cost rate approval does not need to be included in your application, but you will be required to provide it if a grant is awarded. Approval for indirect costs that are requested in an application without an approved indirect cost rate agreement is at the discretion of the Agency.
For further information, you should contact your State Office at
You may submit your application in paper form or electronically through Grants.gov. If you submit in paper form, any forms requiring signatures must include an original signature.
To submit an application electronically, you must use the Grants.gov Web site at
You can locate the Grants.gov downloadable application package for this program by using a keyword, the program name, or the Catalog of Federal Domestic Assistance Number for this program.
When you enter the Grants.gov Web site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
To use Grants.gov, you must already have a DUNS number and you must also be registered and maintain registration in SAM. We strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov.
You must submit all of your application documents electronically through Grants.gov. Applications must include electronic signatures. Original signatures may be required if funds are awarded.
After electronically submitting an application through Grants.gov, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.
If you want to submit a paper application, send it to the State Office located in the State where your project will primarily take place. You can find State Office Contact information at:
Your application must contain all of the required forms and proposal elements described in 7 CFR 4284.510 and as otherwise clarified in this Notice. Specifically, your application must include: (1) The required forms as described in 7 CFR 4284.510(b) and (2) the required proposal elements as described in 7 CFR 4284.510(c). If your application is incomplete, it is ineligible to compete for funds. Applications lacking sufficient information to determine eligibility and scoring will be considered ineligible. Information submitted after the application deadline will not be accepted. You are encouraged, but not required to utilize the application template found at
• Standard Form (SF) 424—Your DUNS number should be identified in the “Organizational DUNS” field on SF 424, “Application for Federal Assistance.” Since there are no specific fields for a Commercial and Government Entity (CAGE) code and expiration date, you may identify them anywhere you want to on Form SF 424. In addition, you should provide the DUNS number and the CAGE code and expiration date under the applicant eligibility discussion in your proposal narrative. If you do not include the CAGE code and expiration date and the DUNS number in your application, it will not be considered for funding.
• Form AD-3030, “Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants,” if you are a corporation. A corporation is any entity that has filed articles of incorporation in one of the 50 States, the District of Columbia, the Federated States of Micronesia, the Republic of Palau, and the Republic of the Marshall Islands, or the various territories of the United States including American Samoa, Guam, Midway Islands, the Commonwealth of the Northern Mariana Islands, Puerto Rico, or the U.S. Virgin Islands. Corporations include both for profit and non-profit entities.
• You can voluntarily fill out and submit the “Survey on Ensuring Equal Opportunity for Applicants,” as part of your application if you are a nonprofit organization.
1. You must include the title of the project as well as any other relevant identifying information on the Title Page.
2. You must include a Table of Contents with page numbers for each component of the application to facilitate review.
3. Your Executive Summary must include the items in 7 CFR 4284.510 (c)(3), and also discuss the percentage of work that will be performed among organizational staff, consultants, or other contractors. It should not exceed two pages.
4. Your Eligibility Discussion must not exceed two pages and cover how you meet the eligibility requirements for applicant, matching funds, other eligibility requirements and grant period. If you have an existing RCDG or the Socially-Disadvantaged Groups Grant (SDGG) program, formerly known as the Small Socially-Disadvantaged Producer Grants (SSDPG) program award or both, you must discuss the current status of those award(s) under grant period eligibility.
5. Your Proposal Narrative must not exceed 40 pages and should describe the essential aspects of the project.
i. You are only required to have one title page for the proposal.
ii. If you list the evaluation criteria on the Table of Contents and specifically and individually address each criterion in narrative form, then it is not necessary for you to include an Information Sheet. Otherwise, the Information Sheet is required under 7 CFR 4284.510(c)(ii).
iii. You should include the following under Goals of the Project:
A. A statement that substantiates that the Center will effectively serve rural areas in the United States;
B. A statement that the primary objective of the Center will be to improve the economic condition of rural areas through cooperative development;
C. A description of the contributions that the proposed activities are likely to make to the improvement of the economic conditions of the rural areas for which the Center will provide services. Expected economic impacts should be tied to tasks included in the work plan and budget; and
D. A statement that the Center, in carrying out its activities, will seek, where appropriate, the advice, participation, expertise, and assistance of representatives of business, industry, educational institutions, the Federal government, and State and local governments.
iv. The Agency has established annual performance evaluation measures to evaluate the RCDG program. You must provide estimates on the following performance evaluation measures.
• Number of groups who are not legal entities assisted.
• Number of businesses that are not cooperatives assisted.
• Number of cooperatives assisted.
• Number of businesses incorporated that are not cooperatives.
• Number of cooperatives incorporated.
• Total number of jobs created as a result of assistance.
• Total number of jobs saved as a result of assistance.
• Number of jobs created for the Center as a result of RCDG funding.
• Number of jobs saved for the Center as a result of RCDG funding.
It is permissible to have a zero in a performance element. When you calculate jobs created, estimates should be based upon actual jobs to be created by your organization as a result of the RCDG funding or actual jobs to be created by cooperative businesses or other businesses as a result of assistance from your organization. When you calculate jobs saved, estimates should be based only on actual jobs that have been lost if your organization did not receive RCDG funding or actual jobs that would have been lost without assistance from your organization.
v. You can also suggest additional performance elements for example where job creation or jobs saved may not be a relevant indicator (
vi. You must describe in the application how you will undertake to do each of the following. We would prefer if you described these undertakings within proposal evaluation criteria to reduce duplication in your application. The specific proposal evaluation criterion where you should address each undertaking is noted below.
A. Take all practicable steps to develop continuing sources of financial support for the Center, particularly from sources in the private sector (should be presented under proposal evaluation criterion j., utilizing the specific requirements of section E.1.j.);
B. Make arrangements for the Center's activities to be monitored and evaluated (should be addressed under proposal evaluation criterion number h. utilizing the specific requirements of section E.1.h.); and
C. Provide an accounting for the money received by the grantee in accordance with 7 CFR part 4284, subpart F. This should be addressed under proposal evaluation criterion number a., utilizing the specific requirements of section E.1.a.
vii. You should present the Work Plan and Budget proposal element under proposal evaluation criterion number h., utilizing the specific requirements of section E.1.h. of this Notice to reduce duplication in your application.
viii. You should present the Delivery of Cooperative development assistance proposal element under proposal evaluation criterion number b., utilizing the specific requirements of section E.1.b. of this Notice.
ix. You should present the Qualifications of Personnel proposal element under proposal evaluation criterion number i., utilizing the specific requirements of section E.1.i. of this Notice.
x. You should present the Local Support and Future Support proposal elements under proposal evaluation criterion number j., utilizing the requirements of section E.1.j. of this Notice.
xi. Your application will not be considered for funding if you do not address all of the proposal evaluation criteria. See section E.1. of this Notice for a description of the proposal evaluation criteria.
xii. Only appendices A-C will be considered when evaluating your application. You must not include resumes of staff or consultants in the application.
6. You must certify that there are no current outstanding Federal judgments against your property and that you will not use grant funds to pay for any judgment obtained by the United States. To satisfy the Certification requirement, you should include this statement in your application: “[INSERT NAME OF APPLICANT] certifies that the United States has not obtained an unsatisfied judgment against its property and will not use grant funds to pay any judgments obtained by the United States.” A separate signature is not required.
7. You must certify that matching funds will be available at the same time grant funds are anticipated to be spent and that expenditures of matching funds are pro-rated or spent in advance of grant funding, such that for every dollar of the total project cost, not less than the required amount of matching funds will be expended. Please note that this Certification is a separate requirement from the Verification of Matching Funds requirement. To satisfy the Certification requirement, you should include this statement in your application: “[INSERT NAME OF APPLICANT] certifies that matching funds will be available at the same time grant funds are anticipated to be spent and that expenditures of matching funds shall be pro-rated or spent in advance of grant funding, such that for every dollar of the total project cost, at least 25 cents (5 cents for 1994 Institutions) of matching funds will be expended.” A separate signature is not required.
8. You must provide documentation in your application to verify all of your proposed matching funds. The documentation must be included in Appendix A of your application and will not count towards the 40-page limitation. Template letters are available for each type of matching funds contribution at
a. If matching funds are to be provided in cash, you must meet the following requirements.
• You: The application must include a statement verifying (1) the amount of the cash and (2) the source of the cash. You may also provide a bank statement
• Third-party: The application must include a signed letter from the third party verifying (1) how much cash will be donated and (2) that it will be available corresponding to the proposed grant period or donated on a specific date within the grant period.
b. If matching funds are to be provided by an in-kind donation, you must meet the following requirements.
• You: The application must include a signed letter from you or your authorized representative verifying (1) the nature of the goods and/or services to be donated and how they will be used, (2) when the goods and/or services will be donated (
• Third-Party: The application must include a signed letter from the third party verifying (1) the nature of the goods and/or services to be donated and how they will be used, (2) when the goods and/or services will be donated (
To ensure that you are identifying and verifying your matching funds appropriately, please note the following:
• If you are paying for goods and/or services as part of the matching funds requirement, the expenditure is considered a cash match, and you must verify it as such. Universities must verify the goods and services they are providing to the project as a cash match and the verification must be approved by the appropriate approval official (
• If you have already received cash from a third-party (
• Board resolutions for a cash match must be approved at the time of application.
• You can only consider goods or services for which no expenditure is made as an in-kind contribution.
• If a non-profit or another organization contributes the services of affiliated volunteers, they must follow the third-party, in-kind donation verification requirement for each individual volunteer.
• Expected program income may not be used to fulfill your matching funds requirement at the time you submit your application. However, if you have a contract to provide services in place at the time you submit your application, you can verify the amount of the contract as a cash match.
• The valuation process you use for in-kind contributions does not need to be included in your application, but you must be able to demonstrate how the valuation was derived if you are awarded a grant. The grant award may be withdrawn or the amount of the grant reduced if you cannot demonstrate how the valuation was derived.
Successful applicants must comply with requirements identified in Section F, Federal Award Administration.
In order to be eligible (unless you are excepted under 2 CFR 25.110(b), (c) or (d), you are required to:
(a) Provide a valid DUNS number in your application, which can be obtained at no cost via a toll-free request line at (866) 705-5711;
(b) Register in SAM before submitting your application. You may register in SAM at no cost at
(c) Continue to maintain an active SAM registration with current information at all times during which you have an active Federal award or an application or plan under consideration by a Federal awarding agency.
The Agency may not make a Federal award to you until you have complied with all applicable DUNS and SAM requirements. If you have not fully complied with requirements, the Agency may determine that the applicant is not qualified to receive a Federal award and the Agency may use this determination as a basis for making an award to another applicant.
Paper applications must be postmarked and mailed, shipped, or sent overnight no later than June 23, 2016, to be eligible for grant funding. The Agency will determine whether your application is late based on the date shown on the postmark or shipping invoice. You may also hand carry your application to one of our field offices, but it must be received by close of business on the deadline date. If the due date falls on a Saturday, Sunday, or Federal holiday, the reporting package is due the next business day. Late applications will automatically be deemed ineligible.
Electronic applications must be received by
Executive Order (E.O.) 12372, “Intergovernmental Review of Federal Programs,” applies to this program. This E.O. requires that Federal agencies provide opportunities for consultation on proposed assistance with State and local governments. Many States have established a Single Point of Contact (SPOC) to facilitate this consultation. For a list of States that maintain a SPOC, please see the White House Web site:
a. Project funds, including grant and matching funds, cannot be used for ineligible grant purposes (see 7 CFR 4284.10). Also, you shall not use project funds for the following:
• To purchase, rent, or install laboratory equipment or processing machinery;
• To pay for the operating costs of any entity receiving assistance from the Center;
• To pay costs of the project where a conflict of interest exists;
• To fund any activities prohibited by 2 CFR part 200; or
• To fund any activities considered unallowable by 2 CFR part 200, subpart E, “Cost Principles,” and the Federal Acquisition Regulation (for-profits) or successor regulations.
b. In addition, your application will not be considered for funding if it does any of the following:
• Focuses assistance on only one cooperative or mutually-owned business;
• Requests more than the maximum grant amount; or
• Proposes ineligible costs that equal more than 10 percent of total project costs. The ineligible costs will NOT be removed at this stage to proceed with application processing. For purposes of this determination, the grant amount requested plus the matching funds amount constitutes the total project costs.
We will consider your application for funding if it includes ineligible costs of 10 percent or less of total project costs, as long as the remaining costs are determined eligible otherwise. However, if your application is successful, those ineligible costs must be removed and replaced with eligible costs before the Agency will make the grant award, or the amount of the grant award will be reduced accordingly. If we cannot determine the percentage of ineligible costs, your application will not be considered for funding.
a. You should not submit your application in more than one format. You must choose whether to submit your application in hard copy or electronically. Applications submitted in hard copy should be mailed or hand-delivered to the State Office located in the State where you are headquartered. You can find State Office contact information at:
b. National Environmental Policy Act
All recipients under this Notice are subject to the requirements of 7 CFR part 1940, subpart G and any successor regulations. However, technical assistance awards under this Notice are classified as a Categorical Exclusion according to 7 CFR 1940.310(e), and do not require any additional documentation.
c. Civil Rights Compliance Requirements
All grants made under this Notice are subject to title VI of the Civil Rights Act of 1964 as required by the USDA (7 CFR part 15, subpart A) and section 504 of the Rehabilitation Act of 1973.
The State Offices will review applications to determine if they are eligible for assistance based on requirements in 7 CFR part 4284, subparts A and F, this Notice, and other applicable Federal regulations. If determined eligible, your application will be scored by a panel of USDA employees in accordance with the point allocation specified in this Notice. A recommendation will be submitted to the Administrator to fund applications in highest ranking order. Applications that cannot be fully funded may be offered partial funding at the Agency's discretion.
Scoring criteria will follow criteria published at 7 CFR 4284.513 as supplemented below including any amendments made by the section 6013 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234), which is incorporated by reference in this Notice. The regulatory and statutory criteria are clarified and supplemented below. You should also include information as described in section D.2.e.5.vi. if you choose to address these items under the scoring criteria. Evaluators will base scores only on the information provided or cross-referenced by page number in each individual evaluation criterion. The maximum amount of points available is 100. Newly established or proposed Centers that do not yet have a track record on which to evaluate the following criteria should refer to the expertise and track records of staff or consultants expected to perform tasks related to the respective criteria. Proposed or newly established Centers must be organized well-enough at time of application to address its capabilities for meeting these criteria.
a. Administrative capabilities (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated track record in carrying out activities in support of development assistance to cooperatively and mutually owned businesses. At a minimum, you must discuss the following administrative capabilities:
1. Financial systems and audit controls;
2. Personnel and program administration performance measures;
3. Clear written rules of governance; and
4. Experience administering Federal grant funding no later than the last 5 years, including but not limited to past RCDGs. Please list the name of the Federal grant program(s) and the amount(s) of funding received.
You will score higher on this criterion if you can demonstrate that the Center has independent governance. For applicants that are universities or parent organizations, you should demonstrate that there is a separate board of directors for the Center.
b. Technical assistance and other services (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated expertise no later than the last 5 years in providing technical assistance and accomplishing effective outcomes in rural areas to promote and assist the development of cooperatively and mutually owned businesses. You must discuss at least:
1. Your potential for delivering effective technical assistance;
2. The types of assistance provided;
3. The expected effects of that assistance;
4. The sustainability of organizations receiving the assistance; and
5. The transferability of your cooperative development strategies and focus to other areas of the U.S.
A chart or table showing the outcomes of your demonstrated expertise based upon the performance elements listed in section D.2.e.5.iv. or as identified in your award document on previous RCDG awards. At a minimum, please provide information for FY 2012-FY 2014 awards. We prefer that you provide one chart or table separating out award years. The intention here is for you to provide actual performance numbers based upon award years even though your grant period for the award was for the next calendar or fiscal year. Please provide a narrative explanation if you have not received a RCDG award.
You will score higher on this criterion if you provide more than 3 years of outcomes and can demonstrate that the organizations you assisted within the last 5 years are sustainable. Additional outcome information should be provided on RCDG grants awarded before FY 2012. Please describe specific project(s) when addressing a-e of this paragraph.
c. Economic development (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated ability to facilitate:
1. Establishment of cooperatives or mutually owned businesses;
2. New cooperative approaches (
3. Retention of businesses, generation of employment opportunities or other factors, as applicable, that will otherwise improve the economic conditions of rural areas.
You will score higher on this criterion if you provide economic statistics showing the impacts of your past development projects no later than 5 years old and identify your role in the economic development outcomes.
d. Past performance in establishing legal business entities (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated past performance in establishing legal cooperative business entities and other legal business entities during January 1, 2013-December 31, 2015. Provide the name of the organization(s) established, the date of formation and your role in assisting with the incorporation(s) under this criterion. In addition, documentation verifying the establishment of legal business entities must be included in Appendix C of your application and will not count against the 40-page limit for the narrative. The documentation must include proof that organizational documents were filed with the Secretary of State's Office (
e. Networking and regional focus (maximum score of 10 points). A panel of USDA employees will evaluate your demonstrated commitment to:
1. Networking with other cooperative development centers, and other organizations involved in rural economic development efforts, and
2. Developing multi-organization and multi-state approaches to addressing the economic development and cooperative needs of rural areas.
You will score higher on this criterion if you can demonstrate the outcomes of your multi-organizational and multi-state approaches. Please describe the project(s), partners and the outcome(s) that resulted from the approach.
f. Commitment (maximum score of 10 points). A panel of USDA employees will evaluate your commitment to providing technical assistance and other services to under-served and economically distressed areas in rural areas of the United States. You will score higher on this criterion if you define and describe the underserved and economically distressed areas within your service area, provide statistics, and identify projects within or affecting these areas, as appropriate.
g. Matching Funds (maximum score of 10 points). A panel of USDA employees will evaluate your commitment for the 25 percent (5 percent for 1994 Institutions) matching funds requirement. A chart or table should be provided to describe all matching funds being committed to the project. However, formal documentation to verify all of the matching funds must be included in Appendix A of your application. You will be scored on how you identify your matching funds.
1. If you met the 25 percent (5 percent for 1994 Institutions) matching requirement, points will be assigned as follows:
• In-kind only—1 point,
• Mix of in-kind and cash—3-4 points (maximum points will be awarded if the ratio of cash to in-kind is 30 percent and above of matching funds), or
• Cash only—5 points.
2. If you exceeded the 25 percent (5 percent for 1994 Institutions) matching requirement, points will be assigned as follows:
• In-kind only—2 points,
• Mix of in-kind and cash—6-7 points (maximum points will be awarded if the ratio of cash to in-kind is 30 percent and above of matching funds), or
• Cash only—10 points.
h. Work Plan/Budget (maximum score of 10 points). A panel of USDA employees will evaluate your work plan for detailed actions and an accompanying timetable for implementing the proposal. The budget must present a breakdown of the estimated costs associated with cooperative and business development activities as well as the operation of the Center and allocate these costs to each of the tasks to be undertaken. Matching funds as well as grant funds must be accounted for in the budget.
You must discuss at a minimum:
1. Specific tasks (whether it be by type of service or specific project) to be completed using grant and matching funds;
2. How customers will be identified;
3. Key personnel; and
4. The evaluation methods to be used to determine the success of specific tasks and overall objectives of Center operations. Please provide qualitative methods of evaluation. For example, evaluation methods should go beyond quantitative measurements of completing surveys or number of evaluations.
You will score higher on this criterion if you present a clear, logical, realistic, and efficient work plan and budget.
i. Qualifications of those Performing the Tasks (maximum score of 10 points). A panel of USDA employees will evaluate your application to determine if the personnel expected to perform key tasks have a track record of:
1. Positive solutions for complex cooperative development and/or marketing problems; or
2. A successful record of conducting accurate feasibility studies, business plans, marketing analysis, or other activities relevant to your success as determined by the tasks identified in the your work plan; and
3. Whether the personnel expected to perform the tasks are full/part-time employees of your organization or are contract personnel.
You will score higher on this criterion if you demonstrate commitment and availability of qualified personnel expected to perform the tasks.
j. Local and Future Support (maximum score of 10 points). A panel of USDA employees will evaluate your application for local and future support. Support should be discussed directly within the response to this criterion.
1. Discussion on local support should include previous and/or expected local support and plans for coordinating with other developmental organizations in the proposed service area or with state and local government institutions. You will score higher if you demonstrate strong support from potential beneficiaries and formal evidence of intent to coordinate with other developmental organizations. You may also submit a maximum of 10 letters of support or intent to coordinate with the application to verify your discussion. These letters should be included in Appendix B of your application and will not count against the 40-page limit for the narrative.
2. Discussion on future support will include your vision for funding operations in future years. You should document:
(i) New and existing funding sources that support your goals;
(ii) Alternative funding sources that reduce reliance on Federal, State, and local grants; and
(iii) The use of in-house personnel for providing services versus contracting out for that expertise. Please discuss your strategy for building in-house technical assistance capacity.
You will score higher if you can demonstrate that your future support will result in long-term sustainability of the Center.
The State Offices will review applications to determine if they are eligible for assistance based on requirements in 7 CFR part 4284, subparts A and F, this Notice, and other applicable Federal regulations. If determined eligible, your application will be scored by a panel of USDA employees in accordance with the point allocation specified in this Notice. A recommendation will be submitted to the Administrator to fund applications in highest ranking order. Applications that cannot be fully funded may be offered partial funding at the Agency's discretion. If your application is evaluated, but not funded, it will not be carried forward into the next competition.
If you are selected for funding, you will receive a signed notice of Federal award by postal mail from the State Office where your application was submitted, containing instructions on requirements necessary to proceed with execution and performance of the award.
If you are not selected for funding, you will be notified in writing via postal mail and informed of any review and appeal rights. You must comply with all applicable statutes, regulations, and notice requirements before the grant award will be approved. There will be no available funds for successful appellants once all FY 15 funds are awarded and obligated. See 7 CFR part 11 for USDA National Appeals Division procedures.
Additional requirements that apply to grantees selected for this program can be found in 7 CFR part 4284, subpart F; the Grants and Agreements regulations of the Department of Agriculture codified in 2 CFR parts 180, 400, 415, 417, 418, 421; 2 CFR parts 25 and 170; and 48 CFR 31.2, and successor regulations to these parts.
In addition, all recipients of Federal financial assistance are required to report information about first-tier subawards and executive compensation (see 2 CFR part 170). You will be required to have the necessary processes and systems in place to comply with the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109-282) reporting requirements (see 2 CFR 170.200(b), unless you are exempt under 2 CFR 170.110(b)).
The following additional requirements apply to grantees selected for this program:
• Agency-approved Grant Agreement.
• Letter of Conditions.
• Form RD 1940-1, “Request for Obligation of Funds.”
• Form RD 1942-46, “Letter of Intent to Meet Conditions.”
• Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters-Primary Covered Transactions.”
• Form AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion-Lower Tier Covered Transactions.”
• Form AD-1049, “Certification Regarding Drug-Free Workplace Requirements (Grants).”
• Form RD 400-4, “Assurance Agreement.”
• SF LLL, “Disclosure of Lobbying Activities,” if applicable.
• Form AD-3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Must be signed by corporate applicants who receive an award under this Notice.
After grant approval and through grant completion, you will be required to provide the following:
A SF-425, “Federal Financial Report,” and a project performance report will be required on a semiannual basis (due 30 working days after end of the semiannual period). The project performance reports shall include the following: A comparison of actual accomplishments to the objectives established for that period;
a. Reasons why established objectives were not met, if applicable;
b. Reasons for any problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular objectives during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation; and
c. Objectives and timetable established for the next reporting period.
d. Provide a final project and financial status report within 90 days after the expiration or termination of the grant.
e. Provide outcome project performance reports and final deliverables.
If you have questions about this Notice, please contact the appropriate State Office at
The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.)
If you wish to file an employment complaint, you must contact your agency's EEO Counselor within 45 days of the date of the alleged discriminatory act, event, or in the case of a personnel action. Additional information can be found online at
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at
Individuals who are deaf, hard of hearing or have speech disabilities and you wish to file either an EEO or program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities, who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (
Rural Business-Cooperative Service, USDA.
Proposed collection; Comments requested.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Business-Cooperative Service's (RBS) intention to request an extension of a currently approved information collection in support of the program 7 CFR part 4279-B, ” Guaranteed Loanmaking—Business and Industry Loans.”
Comments on this notice must be received by May 24, 2016 to be assured of consideration.
Ginger Allen, Business and Industry Loan Processing Branch, Rural Business-Cooperative Service, U.S. Department of Agriculture, STOP 3224, 1400 Independence Ave. SW., Washington, DC 20250-3224. Telephone: (202) 690-0309. The TDD number is (800) 877-8339 or (202) 708-9300.
Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division at (202) 692-0040.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of RBS, including whether the information will have practical utility; (b) the accuracy of RBS's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Ave. SW., Washington, DC 20250.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Business-Cooperative Service, USDA.
Proposed collection; Comments requested.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Business-Cooperative Service's (RBS) intention to request an extension of a currently approved information collection in support of the program for 7 CFR part 4279-A, “Guaranteed Loanmaking—General.
Comments on this notice must be received by May 24, 2016 to be assured of consideration.
Ginger Allen, Business and Industry Loan Processing Branch, Rural Business-Cooperative Service, U.S. Department of Agriculture, STOP 3224, 1400 Independence Avenue SW., Washington, DC 20250-3224. Telephone: (202) 690-0309. The TDD number is (800) 877-8339 or (202) 708-9300.
Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division at (202) 692-0040.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
On August 26, 2014, in the U.S. District Court for the District of New Hamsphire, Nutveena Sirirojnananont (“Sirirojnananont”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Sirirojnananont knowingly and willfully caused to be exported from the United States to Thailand firearms which were designated as defense articles on the United States Munitions List, without having obtained from the United States Department of State a license or written approval for the export of these defense articles. Sirirojnananont was sentenced to 10 months of imprisonment, one year of supervised release, and fined a $600 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Sirirojnananont's conviction for violating the AECA, and has provided notice and an opportunity for Sirirojnananont to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Sirirojnananont.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Sirirojnananont's export privileges under the Regulations for a period of 10 years from the date of Sirirojnananont's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Sirirojnananont had an interest at the time of her conviction.
Accordingly, it is hereby ORDERED:
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Enforcement and Compliance, International Trade Administration, Department of Commerce
On February 12, 2016, the Department of Commerce (the Department) published its notice of initiation and preliminary results of a changed circumstances review of the antidumping duty order on drawn stainless steel sinks (drawn sinks) from the People's Republic of China (PRC).
Effective March 25, 2016.
Ross Belliveau or Brian Smith, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4952 or (202) 482-1766, respectively.
On April 11, 2013, the Department published in the
On February 12, 2016, the Department published its notice of initiation and preliminary results of this changed circumstances review, determining that Ningbo is the successor-in-interest to Yuyao.
The products covered by the scope of this order are drawn stainless steel sinks with single or multiple drawn bowls, with or without drain boards, whether finished or unfinished, regardless of type of finish, gauge, or grade of stainless steel. Mounting clips, fasteners, seals, and sound-deadening pads are also covered by the scope of this order if they are included within the sales price of the drawn stainless steel sinks. For purposes of this scope definition, the term “drawn” refers to a manufacturing process using metal forming technology to produce a smooth basin with seamless, smooth, and rounded corners. Drawn stainless steel sinks are available in various shapes and configurations and may be described in a number of ways including flush mount, top mount, or undermount (to include the attachment relative to the countertop). Stainless
Excluded from the scope of the order are stainless steel sinks with fabricated bowls. Fabricated bowls do not have seamless corners, but rather are made by notching and bending the stainless steel, and then welding and finishing the vertical corners to form the bowls. Stainless steel sinks with fabricated bowls may sometimes be referred to as “zero radius” or “near zero radius” sinks.
The products covered by this order are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under statistical reporting number 7324.10.0000 and 7324.10.0010. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive.
For the reasons stated in the
We are issuing this determination and publishing these final results and notice in accordance with sections 751(b)(1) and 777(i)(1) and (2) of the Act and 19 CFR 351.216 and 351.221(c)(3).
International Trade Administration, U.S. Department of Commerce.
Notice of an open meeting.
The United States Manufacturing Council (Council) will hold an open meeting on Tuesday, April 12, 2016. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate on recommendations developed by the Workforce Development subcommittee looking at high school educational approach enhancements for consideration by the Manufacturing Council. The agenda may change to accommodate Council business. The final agenda will be posted on the Department of Commerce Web site for the Council at
Tuesday, April 12, 2016, 9:00 a.m.-12:00 p.m. The deadline for members of the public to register, including requests to make comments during the meetings and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5:00 p.m. EDT on April 4, 2016.
The meeting will be held at 1211 Euclid Avenue, Cleveland, Ohio. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Manufacturing Council, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230,
Archana Sahgal, the United States Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email:
National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Request for public comments and ideas on NOAA SBIR subtopics which would satisfy unmet industry needs.
Notice is hereby given that the U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), Small Business Innovation Research (SBIR) Program Office is requesting public comments to better understand the scientific community and small business concerns associated with the environmental industry, as well as improve our SBIR solicitation process.
Of NOAA's four major topics, which was derived from NOAA's Research and Development (R&D) goals, what problem statements or subtopic ideas can you suggest where the project outcome enables commercial products/services which would satisfy current or near term unmet industry needs. Please remember all submissions must be directly relevant to NOAA's mission. NOAA's four major mission topics are as follows:
a. Climate Adaptation and Mitigation
b. Weather-Ready Nation
c. Healthy Oceans
d. Resilient Coastal Communities and Economies
Please categorize submissions based on the four topics above and include as many problem statements or subtopic ideas as you see fit per topic. Also, please provide a brief description of the potential commercialized products/services for each idea submitted.
Comments and ideas must be received on or before April 29, 2016.
Send all comments via email to
Vince Garcia, NOAA SBIR Program Manager, at:
The NOAA Small Business Innovation Research (SBIR) Program Office is exploring options in streamlining and improving existing agency SBIR Phase I subtopic selection processes. The SBIR Program Office seeks to better understand unmet industry needs, which directly relate to NOAA's mission. Historically, subtopics are suggested by NOAA federally-employed scientists and engineers and are selected for publication in the annual SBIR Phase I solicitation by NOAA Line Office leadership.
Respondents shall not be obligated to provide the services described herein, if applicable, and it is understood by the United States Government that any cost estimates provided as a result of this request are “best” estimates only. All information submitted in response to this request for public comments is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government.
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open meeting.
The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.
Dr. Elizabeth Turner, Acting Executive Director, Science Advisory Board, NOAA, Room 146 Gregg Hall, 35 Colovos Road, Durham, NH 03824. Email:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 41 Post-Review Workshop Webinar.
The SEDAR 41 assessments of the South Atlantic stocks of
The SEDAR 41 Post-Review Workshop Webinar will be held on Friday, April 8, 2016, from 1 p.m. to 3 p.m.
The Webinar is open to members of the public. Those interested in participating should contact Julia Byrd at SEDAR (see
Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion for the Post-Review Workshop Webinar are as follows:
1. Participants will discuss any remaining assessment issues and recommendations from the Review Workshop in order to finalize the Review Workshop summary reports.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The Southeast Permits Office proposes to collect additional information on five applications for economic analysis and for purposes of notifying respondents. These data include race, sex, and business type and ownership information, as well as email addresses and the option to provide cellular contact information for digital notifications. The revision will also include a small business certification section, so NMFS can determine if the respondent is a small or large business according to standards established by the Small Business Administration. These proposed revisions will not change the current cost burden but will increase the annual time burden for respondents.
Currently, NMFS requires fishermen (respondents) to display one adhesive decal on their vessel indicating that they have a Federal fishing permit in at least one of two Gulf fisheries; the applicable permits are the Charter Vessel/Headboat Permit for Gulf Reef Fish, the Charter Vessel/Headboat Permit for Gulf Coastal Migratory Pelagic fish, and their respective Historical Captain endorsements. NMFS proposes to revise OMB Control Number 0648-0205 to split the single decal covering both fisheries into two decals, with one decal administered with each specific fishery permit or endorsement. In addition, this revision also addresses a new fee of $10 per decal to cover administrative costs, as required by NOAA Finance Handbook, Exhibit 9-1. The Federal Permit Application for Vessels Fishing in the Exclusive Economic Zone would also be revised to reflect the new fee. The decal is currently issued at no cost to permit applicants. These decals allow individuals and law enforcement officials to easily identify vessels that have Federal permits.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
United States Patent and Trademark Office, Commerce.
Request for comments.
The United States Patent and Trademark Office (USPTO) is revising its patent quality metrics to better identify quality-related issues and more clearly communicate its quality measurements to the public. The new patent quality metrics are part of the USPTO's Enhanced Patent Quality Initiative (EPQI), which was launched in 2015 to engage patent stakeholders in enhancing patent quality. As part of the Enhanced Patent Quality Initiative, the prior patent quality metrics have been reassessed, and new patent quality metrics are now being designed for adoption for fiscal year 2017. The new patent quality metrics for use in fiscal year 2017 are planned to focus on the correctness and clarity of Office actions and will be applied through a newly unified review process using a standardized review form that will permit data from a significantly larger number of finished product quality reviews conducted at the agency to be aggregated and mined for information. The USPTO will also mine data on transactions during patent prosecution (
Comments should be sent by electronic mail message over the Internet addressed to:
Although comments may be submitted by postal mail, the Office prefers to receive comments by electronic mail message over the Internet because sharing comments with the public is more easily accomplished. Electronic comments are preferred to be submitted in plain text, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that facilitates convenient digital scanning into ADOBE® portable document format.
Timely filed comments will be available for public inspection at the Office of the Commissioner for Patents, currently located in Madison East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia 22314. Comments also will be available for viewing via the Office's Internet Web site (
Michael T. Cygan, Senior Legal Advisor, at (571) 272-7700. Inquiries regarding this notice may be directed to the Office of Patent Legal Administration, by telephone at (571) 272-7701, or by electronic mail at
Prior to fiscal year 2005, the USPTO quality metric was solely directed to the correctness of the final output of the examination process that would result in a patent: An allowed application. During fiscal years 2005 through 2009, the USPTO expanded its review efforts, employing two official metrics of examination quality: (1) The correctness of the examiner's determination of allowance of an application; and (2) the quality of the actions taken during the
In 2011, based on stakeholder input, the USPTO adopted a new “Composite Quality Metric” for fiscal years 2011-2015 to track performance of those aspects that affect quality and provide a single comprehensive metric representing the overall state of patent examination quality. The Composite Quality Metric was composed of seven total factors: (1) The final disposition review, (2) the in-process review, (3) the first action on the merits (FAOM) search review, (4) the complete FAOM review, (5) the external quality survey, (6) the internal quality survey, and (7) an aggregation of five factors from the USPTO's Quality Index Report (QIR). The first four factors continued the USPTO's focus on the statutory compliance of work product;
On February 5, 2015, the USPTO launched the Enhanced Patent Quality Initiative to improve the quality of patents issued by the USPTO. This initiative began with a request for public comments on a set of six proposals outlined in a
The Enhanced Patent Quality Initiative targets three pillars of patent quality: (1) Excellence in work products; (2) excellence in measuring patent quality; and (3) excellence in customer service. In furtherance of the second pillar of patent quality, the USPTO is focusing on improving the internal metrics used to evaluate patent examination quality and on improving the communication of its patent examination quality measurements to the public. Through this initiative, the USPTO has received numerous comments on establishing appropriate quality metrics. The USPTO has considered all of the comments received through the Summit, the
First, the clarity of the examiner's determinations and the rationale underlying the decisions made in Office actions is an important part of overall patent examination quality and should be emphasized in reviews of USPTO work product. Second, individual metrics that clearly reflect individual aspects of USPTO work product would better communicate patent quality than a single quality composite number that combines scores from unrelated sources such as surveys, procedural efficiency statistics, and substantive patentability compliance reviews. Third, improving the granularity of work product quality measurement to monitor compliance with each statutory provision and enable meaningful data at the work group and art unit level is highly desirable for providing targeted training resulting in greater consistency. Fourth, monitoring the process of examination,
As the next step in advancing the second pillar of the Enhanced Patent Quality Initiative, the proposed fiscal year 2017 patent quality metrics refocus the USPTO's measurement of the quality of the work products produced from first Office action through final disposition. The proposed metrics continue to assess the correctness of an examiner's determinations in a given Office action with increased attention on assessing whether the examiner clearly set forth his or her reasoning in a given Office action. In addition, the Office will continue to review the transactions taken during patent prosecution through the QIR, but this information will be used to identify the need for further investigation rather than being measured against a goal. Additionally, the USPTO is changing its reporting of the quality metrics to provide simpler and clearer communication of results to the public.
The patent quality metrics of work product proposed here for fiscal year 2017 provide a tighter focus on measuring two foundational characteristics of patent examination: Statutory compliance and clarity of decision making in Office actions. These proposed patent quality metrics continue to measure correctness of actions in terms of their compliance
Furthermore, the new metrics greatly enhance the review of the clarity of the components of Office actions by including new clarity review items specifically designed for each of the substantive patentability determinations made in Office actions. For example, when reviewing an Office action containing an obviousness rejection under 35 U.S.C. 103, the review items consider not only whether the obviousness rejection was proper, but also whether the statement of the rejection mapped the elements identified in the prior art to the claim limitations, and whether the statement of the rejection explained the reasons for the rejection in a clear manner. The new clarity review items will also include, for example, items directed to the sufficiency of the recordation of any interview and the propriety of any reasons for allowance of an application.
For fiscal year 2017, the USPTO is proposing to capture the correctness and clarity review items with a single standardized review form as a repository for all of the review items, replacing the review-specific forms used in the 2011-2015 Composite Quality Metric. The review questions on such a standardized form, colloquially referred to as the “Master Review Form,” is planned to be used by all USPTO reviewers for finished product quality reviews of actions at every stage of prosecution. This Master Review Form will contain the above-described criteria for recording correctness for each of the substantive patentability requirements and for recording the clarity of each of those decisions and the supporting rationales set forth in the Office action under review. The full list of correctness and clarity items in the draft proposed version of the Master Review Form is available for viewing at
This draft proposed “Master Review Form” was developed as part of the Clarity and Correctness Data Capture program, which is part of the USPTO's Enhanced Patent Quality Initiative. The Clarity and Correctness Data Capture Program has been instituted to better capture the data produced through the different types of reviews within the Patents Organization. Historically, reviews have been performed not only by the quality assurance team, but also by other Technology Center personnel, with each reviewing area setting its own reviewing criteria. Moreover, the only work product reviews recorded for identification of trends were those undertaken by the Office of Patent Quality Assurance. The Master Review Form is designed to provide standardized reviewing criteria for quality reviews of finished work product. Through application of standardized reviewing criteria, the USPTO can better leverage the results from the many levels of review conducted at the agency. The improvements to the data capture process will enable meaningful data analysis at a more granular level than previously possible, permitting valid inferences to be drawn at the workgroup and art unit levels. Through this process, the USPTO and the stakeholders in the patent system will be able to gain a greater understanding of the state of patent prosecution and to work better together towards its improvement.
A further aspect of the new patent quality metrics will be the leveraging of the data representing the thousands of transactions made by the USPTO during prosecution to reveal information on the quality of the patent prosecution process itself. Transactions during prosecution, such as restrictions, first Office actions, and allowances, are monitored through the USPTO's PALM system. The USPTO monitors many of these transactions through its QIR. Since 2011, the USPTO has included some of these transactions, such as the number of occurrences of consecutive non-final rejections, as part of its reported quality data. For the proposed 2017 quality metrics, transactional data from the QIR will be used to identify information that can be used to prevent reopening of prosecution, reduce rework, and improve the consistency of decision making throughout the USPTO. Key indicators of the efficiency of prosecution will be instances of reopening of prosecution and repeated non-final Office actions, as well as other instances of rework (
In presenting the results of the quality data, the USPTO will seek to further improve the usefulness and transparency of our quality reporting and to communicate the results in a clear and simple manner. The 2011-2015 Composite Quality Metric, which combined seven different quality variables into a single composite number, will be discontinued. The Quality Index Report will be used to identify potential areas of concern, rather than as providing a single, reportable number. While internal and external surveys will still be performed, the results will not be part of the quality metric, but instead will serve as independent checks on the quality metrics.
Fiscal year 2016 will represent a transitional period for the quality metrics, emphasizing the fine-tuning of the fiscal year 2017 patent quality metrics. The USPTO will test and refine its proposed Master Review Form. This Master Review Form will contain new items, such as additional clarity review items, that will require a period of data collection to create numerical baselines for these items. The Master Review Form will initially be used in targeted reviews to determine the effectiveness of each individual clarity and correctness review item. The transactional data from the QIR will also be reviewed during 2016 to optimize the data analysis therein. Stakeholder comments on the Master Review Form in response to this notice will also form an important part of the process of optimizing the components of the patent quality metrics. During this transitional period, the information gleaned during fiscal year 2016 will be used to produce a finalized set of quality metrics for fiscal year 2017 that will represent the next phase of quality measurement, analysis, tracking, and reporting at the USPTO.
The USPTO seeks input and comments from the public through this notice and through public outreach on the following:
(1) Is the USPTO moving in the right direction by choosing to focus on two
(2) How can patent metrics best provide objective, rather than subjective, measurements of quality-related features in clarity and correctness reviews?
In addition to the three questions posed above, the USPTO welcomes comments on any and all areas of quality measurement. Suggestions for rephrased or additional quality metrics review items, especially clarity indicators, are welcomed. The USPTO will consider all submitted comments as it develops the next iteration of quality metrics.
For the most current information on this and other patent quality initiatives, please visit the Enhanced Patent Quality Initiative micro site at
Committee for Purchase From People Who Are Blind or Severely Disabled.
Deletions from the Procurement List.
This action deletes products from the Procurement List that were previously furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 2/19/2016 (81 FR 8486), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.
Accordingly, the following products are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to and Deletions from the Procurement List.
The Committee is proposing to add products to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities and, deletes services previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.
The following products are proposed for addition to the Procurement List for production by the nonprofit agency listed:
The following services are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Deletions from the Procurement List.
This action deletes products from the Procurement List that were previously furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Effective April 24, 2016.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 2/19/2016 (81 FR 8486), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.
Accordingly, the following products are deleted from the Procurement List:
Defense Finance and Accounting Service (DFAS), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by May 24, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this
If no SBP election is made at retirement time this form is mailed to the retiree. Automatic spouse coverage is established and the completion of this form provides Retired Pay with information about the spouse. In some instances, the retiree is unmarried and the coverage will be changed to reflect that.
Defense Finance and Accounting Service (DFAS), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by May 24, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Defense Finance and Accounting Service; Office of Financial Operations; Retired and Annuitant Pay Quality Product Assurance Division ATTN: Chuck Moss, Cleveland, OH 44199-2001, or call at (216) 204-4426.
The form is completed whenever a retiree determines that it is necessary for them to begin or change state tax withholding from their retired pay account.
Army Corps of Engineers, DoD.
Notice of Final Deauthorization Report.
The U.S. Army Corps of Engineers is publishing a Final Deauthorization Report of water resources development projects and separable elements that have been identified for deauthorization in accordance with section 6001(d) of the Water Resources Reform and Development Act of 2014, Public Law 113-121, 128 STAT. 1346-1347 (WRRDA 2014). The Assistant Secretary of the Army for Civil Works transmitted the Final Deauthorization Report to Congress on February 26, 2016. An electronic copy of the complete report is available at:
Mr. Joseph W. Aldridge, Headquarters, U.S. Army Corps of Engineers, Attention: CECW-IP, Washington, DC 20314-1000. Tel. (202) 761-4130 or
Final Deauthorization Report required by § 6001(d).
Section 6001(d) provides that the Secretary shall develop a Final Deauthorization Report. This report includes a list of each water resources
The Interim Deauthorization List was developed in accordance with Section 6001(c) of WRRDA 2014 and was published for public comment in the
Section 6001(d)(2)(A) of WRRDA 2014 requires that the Secretary shall include on the Final Deauthorization Report, projects and separable elements of projects that have, in the aggregate, an estimated Federal cost to complete that is at least $18 billion. The ASA(CW) has strived to meet the requirements of Section 6001, but was not able to identify projects that totaled $18 billion based upon the criteria provided in Section 6001. The projects and elements on the Final Deauthorization Report will be deauthorized automatically after 180 days following the date that the ASA(CW) submits the Final Deauthorization List to the Committees, unless the Congress passes a joint resolution disapproving the Final Deauthorization Report or the non-Federal interest for the project or separable element of a project provides sufficient funds to complete the construction of the project or separable element. The amount shown as the Federal Balance to complete is a working estimate generally based on the authorization and as such any non-Federal interests considering providing sufficient funds to complete a project or separable element should contact the appropriate District Commander to discuss the process necessary to develop a final cost to complete a project or separable element.
The Final Deauthorization Report identifies water resources development projects, or separable elements of a project, that meet the following criteria. Projects and separable elements eligible for deauthorization are those uncompleted construction projects and separable elements meeting all of the following criteria: (1) They were authorized for construction before November 8, 2007, or their most recent modification of the construction authorization predates November 8, 2007; (2) their construction has not been initiated, or, if construction has been initiated, there have been no obligations of Federal or non-Federal funds for construction in the current fiscal year or any of the past 6 fiscal years; and, (3) there has been no funding for a post-authorization study in the current fiscal year or any of the past 6 fiscal years. As specifically provided in section 6001(f)(1)(B) of WRRDA 2014, water resources development projects include environmental infrastructure assistance projects and programs of the U.S. Army Corps of Engineers. In accordance with section 103(f) of the Water Resources Development Act of 1986, separable elements is defined as “a portion of a project—
(1) which is physically separable from other portions of the project; and
(2) which—
(A) achieves hydrologic effects, or
(B) produces physical or economic benefits, which are separately identifiable from those produced by other portions of the project.”
The following elements of an authorized water resources development project also qualify as separable elements: an element for which there is an executed design agreement or project partnership agreement specific to that element; an element that has received funding specified for that element; an element that was authorized separately from or as an amendment to the authorization for the remainder of the water resources development project, that was separately identified in the authorization for the water resources development project, or for which a statute specifies an authorized cost, estimated cost, or amount authorized to be appropriated; an element that has been placed in service or for which the Government or the non-Federal partner has assumed operation and maintenance; an element that has been deauthorized; or the remaining portion of the water resources development project apart from other separable elements.
This notice is required by § 6001(d) of the Water Resources Reform and Development Act of 2014, Public Law 113-121, 128 STAT 1346-1347.
Office of Planning, Evaluation and Policy Development (OPEPD), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before May 24, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Joanne Bogart, 202-205-7855.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of English Language Acquisition, Department of Education.
Notice.
Native American and Alaska Native Children in School Program Notice inviting applications for new awards for fiscal year (FY) 2016.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.365C.
Applications Available: March 25, 2016.
Deadline for Notice of Intent to Apply: April 14, 2016.
Deadline for Transmittal of Applications: May 24, 2016.
Deadline for Intergovernmental Review: July 25, 2016.
The purpose of the Native American and Alaska Native Children in School (NAM) program is to award grants to eligible entities to develop and enhance capacity to provide effective instruction and support to Native American students, including Native Hawaiian and Native American Pacific Islander, who are identified as English learners (ELs). The goal of this program is to support the teaching, learning, and studying of Native American languages while also increasing the English language proficiency of students served to meet challenging State academic content and achievement standards.
Through previous competitions, the NAM program has funded a range of grantees that are currently implementing 25 projects across the country. As the educational needs of Native Americans and Alaska Natives continue to grow, there is also a need to increase knowledge of what practices work to effectively improve learning outcomes for Native American and Alaska Native ELs.
Congress, in the Native American Languages Act of 1990, recognized the fundamental importance of preserving Native American languages. Congress states that it is the policy of the United States to:
Preserve, protect, and promote the rights and freedom of Native Americans to use, practice, and develop Native American languages.
In addition, it is the policy of the United States to encourage and support the use of Native American languages as a medium of instruction in order to encourage and support—
(A) Native American language survival,
(B) educational opportunity,
(C) increased student success and performance,
(D) increased student awareness and knowledge of their culture and history, and
(E) increased student and community pride.
This Federal policy is supported by growing recognition of the importance
Not only is native language instruction critical for student engagement and fostering a rich sense of self, but research has shown that students who are bilingual have certain cognitive and social benefits that their monolingual peers may lack.
Therefore, to facilitate high-quality language instruction and academic success for Native American students who are classified as ELs, this competition includes an absolute priority for projects that will support the preservation and revitalization of Native American languages while also increasing the English language proficiency of the children served under the project.
For this competition, the Department also seeks to support projects designed to improve early learning and development outcomes for Native American and Alaskan Native students across one or more of the essential domains of school readiness for children from birth through third grade and throughout the early elementary school years. Accordingly, this notice includes a competitive preference priority related to improving early learning and development outcomes.
In addition, the Department is interested in projects designed to improve parental, family, and community engagement. Literature suggests that educators who involve families in their students' education can strengthen their instructional effectiveness with ELs.
Finally, to grow the evidence available on effective ways to support Native American and Alaska Native ELs, we include a selection criterion under which applications will be evaluated on the extent to which their proposed project designs are supported by strong theory, as defined in this notice. In addition, we include a selection criterion that encourages applicants to design evaluations of their projects that would provide them with continuous, formative feedback on their progress toward their project goals.
This priority is:
Projects that support the teaching, learning, and studying of Native American languages while also increasing the English language proficiency of the children served.
This priority is:
Projects that are designed to improve early learning and development outcomes across one or more of the essential domains of school readiness for children from birth through third grade (or for any age group within this range) through a focus on one or both of the following:
(a) Increasing access to high-quality early learning and development programs and comprehensive services, particularly for children with high needs.
(b) Improving the coordination and alignment among early learning and development systems and between such systems and elementary education systems, including coordination and alignment in engaging and supporting families and improving transitions for children along the birth-through-third-grade continuum, in accordance with applicable privacy laws.
This priority is:
Projects that will support meaningful parent, family, and community engagement (as defined in this notice) to improve student achievement.
Applicants are encouraged to design a comprehensive approach to leveraging sustained partnerships (as defined in this notice) with community-based organizations, institutions of higher education (IHEs), and other entities.
(A) Who is aged 3 through 21;
(B) Who is enrolled or preparing to enroll in an elementary school or secondary school;
(C)(i) Who was not born in the United States or whose native language is a language other than English;
(ii)(I) Who is a Native American or Alaska Native, or a Native resident of the outlying areas; and
(II) Who comes from an environment where a language other than English has had a significant impact on the individual's level of English language proficiency; or
(iii) Who is migratory, whose native language is a language other than English, and who comes from an environment where a language other than English is dominant; and
(D) Whose difficulties in speaking, reading, writing, or understanding the English language may be sufficient to deny the individual—
(i) The ability to meet the State's challenging State academic standards;
(ii) The ability to successfully achieve in classrooms where the language of instruction is English; or
(iii) The opportunity to participate fully in society. (Section 8101 of the ESEA, as amended by ESSA)
(A) In which an English learner is placed for the purpose of developing and attaining English proficiency, while meeting challenging State academic achievement standards; and
(B) That may make instructional use of both English and a child's native language to enable the child to develop and attain English proficiency, and may include the participation of English proficient children if such course is designed to enable all participating children to become proficient in English and a second language. (Section 3201 of the ESEA, as amended by ESSA)
Applicants may use resources such as the Pacific Education Laboratory's Education Logic Model Application (
(A) A majority of its governing board and employees consisting of fluent speakers of the traditional Native American languages used in the organization's educational programs; and
(B) Not less than five years successful experience in providing educational services in traditional Native American languages. (Section 3201 of the ESEA, as amended by ESSA)
For grades and subjects in which assessments are required under section 1111(b)(3) of the ESEA, as amended by NCLB: (1) A student's score on such assessments; and, as appropriate (2) other measures of student learning, such as those described in the subsequent paragraph, provided that they are rigorous and comparable across schools within an LEA.
For grades and subjects in which assessments are not required under section 1111(b)(3) of the ESEA, as amended by NCLB: (1) Alternative measures of student learning and performance, such as student results on pre-tests, end-of-course tests, and objective performance-based assessments; (2) student learning objectives; (3) student performance on English language proficiency assessments; and (4) other measures of student achievement that are rigorous and comparable across schools within an LEA. (Supplemental Priorities)
20 U.S.C. 6822.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to IHEs only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 or later years from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
1.
(a) Indian tribes.
(b) Tribally sanctioned educational authorities.
(c) Native Hawaiian or Native American Pacific Islander native language educational organizations.
(d) Elementary schools or secondary schools that are operated or funded by the Department of the Interior's Bureau of Indian Affairs, or a consortium of these schools.
(e) Elementary schools or secondary schools operated under a contract with or grant from the Bureau of Indian Affairs in consortium with another such school or a tribal or community organization.
(f) Elementary schools or secondary schools operated by the Bureau of Indian Affairs and an IHE, in consortium with an elementary school or secondary school operated under a contract with or a grant from the Bureau of Indian Affairs or a tribal or community organization.
Eligible applicants applying as a consortium should read and follow the regulations in 34 CFR 75.127 through 75.129.
Under section 3112(c) of the ESEA, as amended by NCLB, EL students served under NAM grants must not be included in the child count submitted by a school district under section 3114(a) for purposes of receiving funding under the English Language Acquisition State Grants program.
2.
3.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA 84.365C.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2. a.
We will be able to develop a more efficient process for reviewing grant applications if we know the approximate number of applicants that intend to apply for funding under this competition. Therefore, we strongly encourage each potential applicant to notify us of the applicant's intent to submit an application by emailing
Applicants must use the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles,
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The page limit for the application does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, certification of eligibility, or letters of support of project partners if applied as a consortium. However, the page limit does apply to all of the application narrative section of the application.
We will reject your application if you exceed the page limit.
b.
Given the types of projects that may be proposed in applications for the NAM program, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552, as amended).
Consistent with the process followed in the prior NAM competitions, we may post the project narrative section of funded NAM applications on the Department's Web site so you may wish to request confidentiality of business information. Identifying proprietary information in the submitted application will help facilitate this public disclosure process.
Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).
3.
Deadline for Notice of Intent to Apply: April 14, 2016. Informational Meetings: We intend to hold Webinars to provide technical assistance to interested applicants. Detailed information regarding these meetings will be provided on the NAM Web site at
Deadline for Transmittal of Applications: May 24, 2016.
Applications for grants under this competition must be submitted electronically using the Grants.gov application site. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
Deadline for Intergovernmental Review: July 25, 2016.
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants for the NAM program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
Applications for grants under the NAM program, CFDA number 84.365C, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the NAM program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.
Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to:
Patrice Swann, U.S. Department of Education, 400 Maryland Avenue SW., Room 5C144, Washington, DC 20202-6510. FAX: (202) 260-5496.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address:
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
(a)
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.
(2) The extent to which the design for implementing and evaluating the proposed project will result in information to guide possible replications of project activities or strategies including information about the effectiveness of the approach or strategies employed by the project.
(3) The extent to which the proposed project is supported by strong theory (as defined in this notice).
(b)
The Secretary considers the quality of the personnel who will carry out the proposed project. In determining the quality of project personnel, the Secretary considers the following factors:
(1) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(2) The qualifications, including relevant training and experience, of key project personnel.
(c)
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.
(2) The extent to which the time commitments of the project director and the principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.
(d)
The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors:
(1) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.
(2) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.
2.
Applicants should note, however, that we may screen for eligibility at multiple points during the competition process, including before and after peer review; applicants that are determined to be ineligible will not receive a grant award regardless of peer reviewer scores or comments. If we determine that a NAM grant application does not meet a NAM requirement, the application will not be considered for funding.
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) The Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
4.
(a)
Measure 1: The number and percentage of ELs served by the program who score proficient or above on the State reading assessment.
Measure 2: The number and percentage of ELs served by the program who are making progress in learning English as measured by the State-approved English language proficiency assessment.
Measure 3: The number and percentage of ELs served by the program who are attaining proficiency in English as measured by the State-approved English language proficiency assessment.
Data from local assessments are acceptable for evaluation under a performance measure only in cases in which a grantee is in a State that is undergoing an assessment transition.
Measure 4: The number and percentage of students served by the program who are enrolled in Native American language instruction programs.
Measure 5: The number and percentage of students making progress in learning a Native American language, as determined by each grantee, including through measures such as performance tasks, portfolios, and pre- and post-tests.
Measure 6: The number and percentage of students who are attaining proficiency in a Native American language as determined by each grantee, including through measures such as performance tasks, portfolios, and pre- and post-tests.
Measure 7: For programs that received competitive preference points, the number and percentage of preschool children ages three and four enrolled in the program.
Measure 8: For programs that received competitive preference points, the number and percentage of preschool children ages three and four who are screened for developmental or cognitive delays.
Measure 9: For programs that received competitive preference points, the number and percentage of coordination contacts between elementary schools and early learning programs to improve coordination and transition of children from preschool to kindergarten.
(b)
(c)
(1) Why each proposed performance target (as defined in this notice) is ambitious (as defined in this notice) yet achievable compared to the baseline for the performance measure.
(2) The data collection and reporting methods the applicant would use and why those methods are likely to yield reliable, valid, and meaningful performance data.
(3) The applicant's capacity to collect and report reliable, valid, and meaningful performance data, as evidenced by high-quality data collection, analysis, and reporting in other projects or research.
If the applicant does not have experience with collection and reporting of performance data through other projects or research, the applicant should provide other evidence of capacity to successfully carry out data collection and reporting for its proposed project.
(d)
(e)
5.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
Francisco Javier Lopez, U.S. Department of Education, 400 Maryland Avenue SW., Room 5E112, Washington, DC 20202. Telephone: (202) 401-4300. FAX: (202) 205-1229 or by email at
If you use a TDD or a TTY, call the Federal Relay Service, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Postsecondary Education, National Committee on Foreign Medical Education and Accreditation, U.S. Department of Education.
Announcement of a Committee meeting.
The purpose of this notice is to announce the upcoming meeting of the National Committee on Foreign Medical Education and Accreditation (NCFMEA). Parts of this meeting will be open to the public, and the public is invited to attend those portions.
Jennifer Hong, Executive Director for the NCFMEA, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W250, Washington, DC 20202; telephone: 202-453-7805, or email:
• Evaluate the standards of accreditation applied to foreign medical schools and,
• Determine the comparability of those standards to standards for accreditation applied to United States medical schools. A determination of comparability of accreditation standards by the NCFMEA is an eligibility requirement for foreign medical schools to participate in the William D. Ford Federal Direct Student Loan Program, 20 U.S.C. 1087a
The countries which are scheduled to be discussed are: Australia, Grenada, Pakistan, St. Kitts and Nevis, and the Dominican Republic. The meeting agenda, as well as the staff analyses pertaining to the meeting, will be posted on the Department of Education's Web site prior to the meeting at
§ 102 of the Higher Education Act of 1965, as amended.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on March 18, 2016, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e (2012), and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2015), NextEra Energy Power Marketing, LLC and Northeast Energy Associates, a Limited Partnership (collectively, Complainants) filed a complaint against ISO New England Inc. (Respondent) alleging that Respondent violated its
Complainants certify that copies of the complaint were serve on contacts for Respondent as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on March 10, 2016, Pike County Light & Power Company (PCL&P), 402 Broad Street, Milford, Pennsylvania 18337, filed an application pursuant to section 7(f) of the Natural Gas Act (NGA) for a service area determination. PCL&P also requests: (1) A finding that PCL&P continues to qualify as a local distribution company (LDC) for purposes of section 311 of the Natural Gas Policy Act of 1978 (NGPA); and (2) a waiver of the Commission's accounting and reporting requirements and other regulatory requirements ordinarily applicable to natural gas companies under the NGA and NGPA, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may also be viewed on the web at
Specifically, PCL&P requests a service area determination to allow it to continue to own and operate a 6-inch-diameter gas distribution pipeline at the Pennsylvania/New York border to receive natural gas in New York from the facilities of Orange and Rockland Utilities, Inc. (O&R), an LDC providing utility service in New York, and re-deliver the gas to PCL&P customers in Pennsylvania. PCL&P's application is related to O&R's application for a limited jurisdiction blanket certificate of public convenience and necessity filed in Docket No. CP16-101-000 on March 10, 2016.
Any questions regarding this application should be directed to John L. Carley, Assistant General Counsel, Orange and Rockland Utilities, Inc., Room 1815-S, 4 Irving Place, New York, New York 10003, (212) 460-2097 (telephone), or by email at
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 7 copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “filing” link at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on March 9, 2016, Dominion Carolina Gas Transmission, LLC (Dominion Carolina), filed an application pursuant to section 7(c) of the Natural Gas Act and Part 157 of the Commission's Regulations for a certificate of public convenience and necessity to construct, install, own, operate, and maintain certain facilities located in Aiken, Charleston, Dillon, Dorchester, Greenwood, Laurens, Newberry, and Spartanburg Counties, South Carolina (Transco to Charleston Project). Dominion Carolina will provide firm transportation service of 80,000 dekatherms per day (Dth/day) to meet increasing demand for natural gas for local commercial, industrial, and power generation customers. The filing may also be viewed on the web at
Any questions regarding this application should be directed to Richard D. Jessee, Gas Transmission Certificates Program Manager, Dominion Carolina Gas Transmission, LLC, 220 Operations Way, Cayce, SC 29033. Telephone (803) 726-3738 and email:
Dominion Carolina proposes to construct approximately 55 miles of 12-inch diameter natural gas transmission pipeline in Spartanburg, Laurens, New Berry, and Greenwood Counties, SC (Moore to Chappells Pipeline) and approximately 5 miles of 4-inch diameter natural gas transmission pipeline in Dillion County, SC (Dillion Pipeline). Dominion Carolina also proposes to install: Two 1,400-horsepower (hp) compressor units at existing Moore Compressor Station located in Spartanburg County, SC; three 1,200 hp compressor units at new Dorchester Compressor Station located Dorchester County, SC; and appurtenances. In addition, Dominion Carolina proposes to convert one existing 1,200 hp compressor unit from standby to use the unit for service, at existing Southern Compressor Station located in Aiken County, SC. Dominion Carolina has executed binding precedent agreements with its customers for the project's capacity of 80,000 Dth/day. Dominion Carolina proposes to charge a negotiated incremental rate for firm transportation service using the proposed project. The cost of the project is $119.3 million. Dominion Carolina proposes an in-service date of November 1, 2017.
On September 2, 2015, the Commission staff granted Dominion Carolina's request to use the National Environmental Policy Act (NEPA) Pre-Filing Process and assigned Docket No. PF15-29-000 to staff activities involving the proposed facilities. Now, as of the filing of this application on March 9, 2016, the NEPA Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP16-98-000, as noted in the caption of this Notice.
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
Motions to intervene, protests and comments may be filed electronically via the internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the Southeastern Regional Transmission Planning (SERTP) Process.
The above-referenced meeting will be via web conference.
The above-referenced meeting is open to stakeholders.
Further information may be found at:
The discussions at the meeting described above may address matters at issue in the following proceedings:
For more information, contact Valerie Martin, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-6139 or
Federal Energy Regulatory Commission, DOE.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collections FERC-714 (Annual Electric Balancing Authority Area and Planning Area Report) and FERC-730 (Report of Transmission Investment Activity) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the
Comments on the collections of information are due by April 25, 2016.
Comments filed with OMB, identified by the OMB Control No. 1902-0140 (FERC-714) and 1902-0239 (FERC-730) should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC16-5-000, by either of the following methods:
•
•
Ellen Brown may be reached by email at
The Commission uses the collected data from planning areas to monitor forecasted demands by electric utilities with fundamental demand responsibilities and to develop hourly demand characteristics.
• Management (Code 11-0000), $78.04/hr.
• Computer and mathematical (Code 15-0000), $58.25/hr.
• Electrical Engineers (Code 17-2071), $66.45/hr.
• Economist (Code 19-3011), $73.04/hr.
• Computer and Information Systems Managers (Code 11-3021), $94.55/hr.
• Accountants and Auditors (Code 13-2011), $51.11/hr.
• Transportation, Storage, and Distribution Managers (Code 11-3071), $73.65/hr.
• Power Distributors and Dispatchers (Code 51-8012), $54.16/hr.
• Actual transmission investment for the most recent calendar year, and projected, incremental investments for the next five calendar years (in dollar terms); and
• a project by project listing that specifies for each project the most up to date, expected completion date, percentage completion as of the date of filing, and reasons for delays for all current and projected investments over the next five calendar years. Projects with projected costs less than $20 million are excluded from this listing.
To ensure that Commission rules are successfully meeting the objectives of Section 219, the Commission collects
Federal Energy Regulatory Commission, DOE.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collections FERC-556 (Certification of Qualifying Facility Status for a Small Power Production or Cogeneration Facility), FERC-606 (Notification of Request for Federal Authorization and Requests for Further Information), and FERC-607 (Report on Decision or Action on Request for Federal Authorization) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the
Comments on the collections of information are due by April 25, 2016.
Comments filed with OMB, identified by the OMB Control Nos. 1902-0075 (FERC-556) and 1902-0241 (FERC-606 and FERC-607) should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC16-3-000, by either of the following methods:
•
•
Ellen Brown may be reached by email at
A primary statutory objective is efficient use of energy resources and facilities by electric utilities. One means of achieving this goal is to encourage production of electric power by cogeneration facilities which make use of reject heat associated with commercial or industrial processes, and by small power production facilities which use other wastes and renewable resources. PURPA encourages the development of small power production facilities and cogeneration facilities that meet certain technical and corporate
FERC's regulations in 18 CFR part 292, as relevant here, specify: (a) The certification procedures which must be followed by owners or operators of small power production and cogeneration facilities; (b) the criteria which must be met; (c) the information which must be submitted to FERC in order to obtain qualifying status; and (d) the PURPA benefits which are available to QFs to encourage small power production and cogeneration.
18 CFR part 292 also exempts QFs from certain corporate, accounting, reporting, and rate regulation requirements of the Federal Power Act,
FERC-607 requires agencies or officials to submit to the Commission a copy of a decision or action on a request for federal authorization and an accompanying index to the documents and materials relied on in reaching a conclusion.
The information collections can neither be discontinued nor collected less frequently because of statutory requirements. The consequences of not collecting this information are that the Commission would be unable to fulfill its statutory mandate under the Energy Policy Act of 2005 to:
• Establish a schedule for agencies to review requests for federal authorizations required for a project, and
• Compile a record of each agency's decision, together with the record of the Commission's decision, to serve as a consolidated record for the purpose of appeal or review, including judicial review.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice of the Availability of Funds.
The Environmental Protection Agency (EPA) plans to make available approximately $8 million to provide supplemental funds to Revolving Loan Fund (RLF) capitalization grants previously awarded competitively under section 104(k)(3) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). Brownfields Cleanup Revolving Loan Fund pilots awarded under section 104(d)(1) of CERCLA that have not transitioned to section 104(k)(3) grants are not eligible to apply for these funds. EPA will consider awarding supplemental funding only to RLF grantees who have demonstrated an ability to deliver programmatic results by making at least one loan or subgrant. The award of these funds is based on the criteria described at CERCLA 104(k)(4)(A)(ii).
The Agency is now accepting requests for supplemental funding from RLF grantees. Requests for funding must be submitted to the appropriate EPA Regional Brownfields Coordinator (listed below) by April 25, 2016. Funding requests for hazardous substances and/or petroleum funding will be accepted. Specific information on submitting a request for RLF supplemental funding is described below and additional information may be obtained by contacting the EPA Regional Brownfields Coordinator.
This action is effective March 25, 2016.
A request for supplemental funding must be in the form of a letter addressed to the appropriate Regional Brownfields Coordinator (see listing below) with a copy to Debi Morey,
Debi Morey, U.S. EPA, (202) 566-2735 or the appropriate Brownfields Regional Coordinator.
The Small Business Liability Relief and Brownfields Revitalization Act added section 104(k) to CERCLA to authorize federal financial assistance for brownfields revitalization, including grants for assessment, cleanup and job training. Section 104(k) includes a provision for EPA to, among other things, award grants to eligible entities to capitalize Revolving Loan Funds and to provide loans and subgrants for brownfields cleanup. Section 104(k)(4)(A)(ii) authorizes EPA to make additional grant funds available to RLF grantees for any year after the year for which the initial grant is made (noncompetitive RLF supplemental funding) taking into consideration:
(I) The number of sites and number of communities that are addressed by the revolving loan fund;
(II) the demand for funding by eligible entities that have not previously received a grant under this subsection;
(III) the demonstrated ability of the eligible entity to use the revolving loan fund to enhance remediation and provide funds on a continuing basis; and
(IV) such other similar factors as the [Agency] considers appropriate to carry out this subsection.
In order to be considered for supplemental funding, grantees must demonstrate that they have expended existing funds and that they have a clear plan for quickly expending requested additional funds. Grantees must demonstrate that they have made at least one loan or subgrant prior to applying for this supplemental funding and have significantly depleted existing available funds. For FY2016, EPA defines “significantly depleted funds” as any grant where $400,000 or less remains uncommitted. Additionally, the RLF recipient must have demonstrated a need for supplemental funding based on, among other factors, the number of sites that will be addressed; demonstrated the ability to make loans and subgrants for cleanups that can be started and completed expeditiously (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “The National Oil and Hazardous Substance Pollution Contingency Plan Regulation, Subpart J (40 CFR 300.900)” (EPA ICR No. 1664.11, OMB Control No. 2050-0141) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before May 24, 2016.
Submit your comments, referencing Docket ID No. EPA-HQ-OPA-2007-0042 online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Leigh DeHaven, Office of Emergency Management, Regulations Implementation Division (5104A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-1974; fax number: email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the
The use of bioremediation agents, dispersants, surface washing agents, surface collecting agents and miscellaneous oil spill control agents in response to oil spills in U.S. waters or adjoining shorelines is governed by Subpart J of the NCP regulation (40 CFR 300.900). Subpart J requirements include criteria for listing oil spill mitigating agents on the NCP Product Schedule, hereafter referred to as the Schedule. EPA's regulation, which is codified at 40 CFR 300.00, requires that EPA prepare a schedule of “dispersants, other chemicals, and other spill mitigating devices and substances, if any, that may be used in carrying out the NCP.” The Schedule is required by section 311(d)(2)(G) of the Clean Water Act (CWA), as amended by the Oil Pollution Act of 1990. The Schedule is used by Federal On-Scene Coordinators (FOSCs), Regional Response Teams (RRTs), and Area Planners to identify spill mitigating agents in preparation for and response to oil spills.
Under Subpart J, respondents who want to add a product to the Schedule must submit technical product data to the U.S. Environmental Protection Agency (EPA or Agency) as stipulated in 40 CFR 300.915. Specifically, Subpart J requires the manufacturer to conduct specific toxicity and effectiveness tests and submit the corresponding technical product data along with other detailed information to the EPA Office of Emergency Management, Office of Land and Emergency Management. For example, a dispersant must exceed the 50-percent (±5 percent) efficacy threshold in order to be listed on the Schedule. EPA places oil spill mitigating agents on the Schedule if all the required data are submitted and the product satisfies all requirements and meets or exceeds testing thresholds. The Product Schedule is available to FOSCs, RRTs, and Area Committees for determining the most appropriate products to use in various spill scenarios.
Products currently listed on the Schedule are divided into five basic categories: Dispersants, surface washing agents, surface collecting agents, bioremediation agents, and miscellaneous oil spill control agents. As of March 2016, 118 products are listed on the Schedule. It is estimated that 11 products per year will be submitted to EPA for listing on the Schedule. Over the three-year period covered by this ICR, an estimated 33 products may be listed. Additionally, EPA estimates that approximately 10 manufacturers will submit information to obtain sorbent certifications. The annual public reporting burden will be 315 hours. The total annual cost (including labor and non-labor) to manufacturers under Subpart J is estimated to be $89,590.
At 40 CFR 300.920(c), respondents are allowed to assert that certain information in the technical product data submissions is confidential business information. EPA will handle such claims pursuant to the provisions in 40 CFR part 2, subpart B. Such information must be submitted separately from non-confidential information, clearly identified, and clearly marked “Confidential Business Information.” If the applicant fails to make such a claim at the time of submittal, EPA may make the information available to the public without further notice.
• Manufacturers of industrial inorganic chemicals (SIC 281/NAICS 325188),
• Manufacturers of industrial organic chemicals (SIC 286/NAICS 325199), and
• Manufacturers of miscellaneous chemical products (SIC 289/NAICS 325988).
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Federal Communications Commission (FCC, Commission, or the Agency).
Notice; one altered Privacy Act system of records; eight new routine uses.
Pursuant to subsection (e)(4) of the
In accordance with subsections (e)(4) and (e)(11) of the Privacy Act, any interested person may submit written comments concerning the alteration of this system of records on or before April 25, 2016. The Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB), which has oversight responsibility under the Privacy Act to review the system of records, and Congress may submit comments on or before May 4, 2016. The proposed new system of records will become effective on May 4, 2016 unless the FCC receives comments that require a contrary determination. The Commission will publish a document in the
Address comments to Leslie F. Smith, Privacy Manager, Information Technology (IT), Room 1-C216, Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554, (202) 418-0217, or via the Internet at
Contact Leslie F. Smith, Privacy Manager, Information Technology (IT), 1-C216, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554, (202) 418-0217 or via the Internet at
As required by the
The FCC will achieve these purposes by altering this system of records with these changes:
Revision of language regarding the Security Classification, for clarity and to note that the FCC has in place a process to provide an appropriate security classification for this system, such that: The FCC's CIO team will provide a security classification to this system based on NIST FIPS-199 standards.
Revision of the language regarding the System Location, to note the changes to the system's address: Administrative Services Center (ASC), Office of the Managing Director (OMD), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554. Information related to those employees who participate in the Smartrip portion of the benefits program is also stored in a database administered by the Washington Metropolitan Area Transit Authority (WMATA), headquartered at 600 Fifth Street NW., Washington, DC 20001.
Revision of the language regarding the Categories of Individuals Covered by the System, for clarity and to note the expansion of the categories of individuals covered by this system to include FCC employees and their spouses, paid interns/co-op students, FCC contractors, and non-FCC Federal employees, such that: The categories of individuals in this system include those individuals who voluntarily apply for and/or participate in one of the FCC Transit Benefit and Parking Permit Programs, which include, but are not limited to:
1. FCC employees who have applied for and received monthly transit fare subsidies;
2. FCC employees and contractors who hold monthly FCC garage parking permits;
3. FCC employees, employee spouses, paid interns and co-op students, contractors, and non-FCC Federal agency employees who are members of carpools and vanpools that park in the FCC parking garage;
4. FCC employees who have applied for and received handicap status for FCC garage parking assignments as a “reasonable accommodation”; and
5. FCC employees who participate in ridesharing, including the Capital Bikeshare Program.
Revision of the language in the Categories of Records in the System, for clarity and to note the expansion in and various changes made to the categories of records covered by this system, including the list of FCC forms and the information requested in each form, as follows:
The FCC uses the records in this system to administer the Transit Benefit and Parking Permit Programs. These records include, but are not limited to, the information that is required to be submitted on the following forms and any related documentation that pertains to transit benefit subsidies, parking permits, ride-sharing, bike-sharing, and other, related transit and commuting programs available to FCC employees, contractors, and other individuals, which are sponsored and/or hosted by the FCC:
1. Form A-27, “FCC Pre-Tax Parking Benefit Form,” including, but not limited to: Employee Information: FCC employee's name; effective date; pay period; parking location; and monthly/daily fee; Benefit: Carpool/vanpool), metro parking, commercial lot, privately-owned lot, parking garage, or parking meter; and requested amount; whether the application is new, a cancellation, or a change; and effective date; and Certification: Employee signature; date; and attachments;
2. Form A-30, “FCC Parking Application,” including, but not limited to: Applicant's name, FCC bureau/office/division; address (required for carpool); FCC badge number; FCC telephone number; FCC employee/contractor/paid intern/co-op student; vehicle year, make, model, state, and license plate; handicap perm (yes/no); FCC title (executives only); transit benefit participant (yes/no); van pool/car pool riders (FCC and Non-FCC employees): Name, address, bureau/office or agency, telephone number, FCC ID number, and signature; applicant's signature and date; and attachments,
3. Form A-75, “FCC Headquarters Employee Transit Benefit Application,” including, but not limited to:
A. Applicant Information: Applicant's name, home address, bureau/office, office room number, telephone number, FCC badge number, and WMATA Smartrip Card serial number;
B. Employment Status: Full time, part time, paid intern/co-op student; and bargaining/non-bargaining unit status;
C. Mode(s) of Transportation (costs): Metro (rail only) and station name; metro (rail and bus) and station name; Metro (bus only); one-way transit user; commuter bus; commuter rail; and/or vanpool;
D. Telework: Approved telework agreement (yes/no); and telework days (Monday-Friday);
E. Employee certification: Employee signature and date; and
F. Transit benefit office action: Approved (yes and amount/no), disapproved (reason), signature and data; and attachments;
4. Form A-75-A, “FCC Employee Transit Benefit Change Request Form,” including, but not limited to:
A. Applicant Information: Applicant's name, home address, bureau/office, office room number, office telephone number, and FCC badge number;
B. Employment Status: Full time, part time, paid intern, or co-op student;
C. Change(s) Requested:
1. Mode(s) of transportation: Metro rail, metro bus, commuter rail, commuter bus, one-way transit user, vanpool, other, and transit provider name;
2. Monthly commuting cost: Old and new;
3. Badge number: Old and new;
4. Address change: Home address;
5. Name change: From/to; and
6. Smartrip Card serial number: Old and new; and
D. Employee Certification: Signature; date; and attachments.
Revision to the Authority for Maintenance of the System, to add several rule sections and delete several rule sections so that the statutory authorities more closely align with the system's current requirements, such that the authorities now include, as follows:
5 U.S.C. 301; 5 U.S.C. 5701-5733; 5 U.S.C. 7905; 26 U.S.C. 132(f); 40 U.S.C. 101 and 121; 44 U.S.C. 2104; 41 CFR 101-20.104-2, 102-74.205-210 (Ridesharing), and 102-74.265-310 (Parking Facilities); Executive Order 9397, as amended by Executive Order 13478; Executive Order 13150; Pub. L. 103-172; and the
Revision of the language regarding the Purposes for which the information in this system is maintained, for clarity, and to expand the system's purposes, to include cross-checking information and matching activity to eliminate fraud and a security check on participants to safeguard against possible criminal or terrorist activity, as follows:
The FCC will use information in this system, including the PII, to administer the Transit Benefit and Parking Permit Programs. This information enables the FCC to facilitate the timely processing of requests for parking permits, transit benefit subsidies, ride-sharing and bike-sharing programs and similar commuting arrangements, and other, related program, policies, and activities, which include, but are not limited to:
1. Managing the FCC's transit benefits program that provides transportation subsidies for public transit, including but not limited to WMATA Metro train and bus fares; Commuter rail services—Maryland Area Rail Commuters (MARC) and Virginia Railway Express (VRE) fares; Commuter bus services—DASH fares, etc.; One-way transit users; Vanpool fares; and other parking and
2. Managing the FCC's employee parking, executive parking, handicapped parking, and ridesharing programs (vanpools/carpools) for FCC employees, contractors, and non-FCC agency employees;
3. Conducting audits, reviews, oversight, and/or investigations of the transit benefits, parking, ridesharing programs (vanpools and carpools) to ensure their accuracy and integrity of the Transit Benefits and Parking Program, which includes but is not limited to cross-checking the Commission's data on parking assignees and transit benefit recipients to ensure that they are not participating in both programs, unless authorized; and, when appropriate, matching this information with the lists of other Federal agencies to ensure that the Commission's participants are not registered for a drive-alone, carpool, or other parking assignments with any other Federal agency, and to identify and locate former employees;
4. Administering, qualifying, and/or certifying the beneficiaries of the Transit Benefits and Parking Program, which includes but is not limited to ensure the eligibility of transit subsidy participants and to prevent misuse of the funds involved;
5. Preparing and administering listings and reports for use by the FCC and the other Federal, state, and local agencies charged with management and oversight of and/or contribution to the Transit Benefits and Parking Program subsidies, etc.; and
6. Ensuring that those non-FCC individuals who are participating in the ride-sharing and bike-sharing programs do not pose a security threat to FCC Headquarter garage facilities.
Revision of the language in Routine Use (1) “Financial Obligations as required by the National Finance Center
When the National Finance Center (the FCC's designated payroll office), the Department of the Treasury Debt Management Services, and/or a current employer to effect a salary, IRS tax refund, pre-tax benefit(s), or administrative offset to satisfy an indebtedness; and to Federal agencies to identify and locate former employees for the purposes of collecting such indebtedness, including through administrative, salary, or tax refund offsets. Identifying and locating former employees, and the subsequent referral to such agencies for offset purposes, may be accomplished through authorized computer matching programs. Disclosures will be made only when all procedural steps established by the Debt Collection Act of 1982 and the Debt Collection Improvement Act of 1996 or the Computer Matching and Privacy Protection Act of 1988, as appropriate, have been taken;
Revision of the language in Routine Use (2) “Program Partner” to expand the categories of transit information to include other applicable public transportations (in addition to WMATA), to note that these benefits are for FCC employees, and that the benefits relate to public transportation fare (
To WMATA and other applicable public transportations in connection with FCC employees participating in this public transportation fare,
Routine Use (3) “Adjudication and Litigation” is unchanged.
Revision of the language in Routine Use (4) “Law Enforcement and Investigation” to expand the categories to include government agencies and officials, the purposes that include but are not limited to sharing records in this system, and the reasons for disclosure, and to note that records may be referred for investigation, enforcement, or prosecution by the Commission (or another agency), regarding why a record from this system that may be disclosed:
Where there is a real or suspected indication of a violation or potential violation of a statute, regulation, rule, or order, records from this system may be shared with appropriate Federal, State, and/or local agencies, authorities, and officials for purposes that include but are not limited to obtaining additional information relevant to a FCC decision, referring the record for investigation, enforcement, or prosecution by the Commission or another agency;
Revision of the language in Routine Use (5) “Congressional Investigations and Inquiries” to change the title of the routine use and expand the categories of information to include investigations and inquiries, regarding a record from this system that may be disclosed:
To Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, for the purposes of an official Congressional investigation, including but not limited to, a request by a Congressional office in response to an inquiry made by an individual to the Congressional office for the individual's own records;
Revision of the language in Routine Use (6) “Government-wide Program Management and Oversight” to expand the number of Federal agencies and categories of information concerning a record from this system that may be disclosed, as follows:
To the General Services Administration (GSA), the National Archives and Records Administration (NARA), the Office of Personnel Management (OPM), and/or the Government Accountability Office (GAO) for the purpose of records management studies conducted under authority of 44 U.S.C. 2904 and 2906; to the Department of Justice (DOJ) in order to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or to the Office of Management and Budget (OMB) in order to obtain that office's advice regarding obligations under the Privacy Act. Such a disclosure shall not be used to make a determination about individuals;
Routine Use (7) “Labor Relations” is unchanged.
Addition of Routine Use (8) “Breach Notification,” as follows:
A record from this system may be disclosed to appropriate agencies, entities, and persons when: (1) The Commission suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Commission has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Commission or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm;
Addition of Routine Use (9) “Vanpool, Carpool, and Ridesharing,” as follows:
Vanpool, Carpool, and Ridesharing—Vanpool, carpool, and rideshare information,
Addition of Routine Use (10) “Statistical Reports on Commuting,” as follows:
Statistical Reports on Commuting—To Federal, state, local, and related organizations, Metropolitan Washington Council of Governments, that are studying local traffic commuting patterns (
Addition of Routine Use (11) “Department of Justice (DOJ),” as follows:
To DOJ or in a proceeding before a court or adjudicative body when:
(a) The United States, the Commission, a component of the Commission, or, when represented by the government, an employee of the Commission is a party to litigation or anticipated litigation or has an interest in such litigation, and
(b) The Commission determines that the disclosure is relevant or necessary to the litigation;
Addition of Routine Use (12) “Medical Certification,” as follows:
To a physician who is making a determination on a person's eligibility for a handicapped parking permit.
Addition of Routine Use (13) “Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by the Agency,” as follows:
To a Federal, State, local, foreign, tribal, or other public agency or authority maintaining civil, criminal, or other relevant enforcement records, or other pertinent records, or to another public authority or professional organization, if necessary to obtain information relevant to an investigation concerning the retention of an employee or other personnel action, the retention of a security clearance, the letting of a contract, or the issuance or retention of a grant or other benefit;
Addition of Routine Use (11) “Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by Other than the Agency,” as follows:
To a Federal, State, local, foreign, tribal, or other public agency or authority of the fact that this system of records contains information relevant to the retention of an employee, the retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit. The other agency or licensing organization may then make a request supported by the written consent of the individual for the entire records if it so chooses. No disclosure will be made unless the information has been determined to be sufficiently reliable to support a referral to another office within the agency or to another Federal agency for criminal, civil, administrative, personnel, or regulatory action; and
Addition of Routine Use (15) “Parking Garage Contractors,” as follows:
To the owners, managers, and staff who manage the garage parking for their use in assigning or checking the parking permits, checking credentials, assigning spaces, assisting with accidents, or other parking issues to ensure that the parking program functions properly and that parking privileges are not abused.
In each of these cases, the FCC will determine whether disclosure of the records is compatible with the purpose(s) for which the records were collected.
Revision of the language in the policies and practices regarding Storage of the information in this system, for clarity, to specify that the information in this system includes both paper and electronic records, to describe the Administrative Services Center's (ASC) current storage procedures, and to note that:
Paper records, files, and documents, which pertain to the information concerning the transit benefits and parking program that are maintained at the FCC, are stored in file folders in the ASC office suite.
The electronic records, files, and data are housed in the FCC's computer network databases, which are reserved for the transit benefit and parking permit program, and in the WMATA database that is associated with the Smartrip program.
Revision of the language in the policies and practices regarding the Retrievability of the information in this system, for clarity, and to specify that both paper and electronic records are retrievable, as follows:
Both the paper documents and electronic records and data are retrieved by the employer's name, or by the FCC Badge identification number, tag, and/or parking permit number.
Revision of the language in the policies and practices regarding the Safeguards for protecting the information in this system, for clarity, and to comply with the FCC's current safety and security protocols and procedures, including information noting that these FCC standards adhere to the requirements of the National Institutes of Standards and Technology (NIST) and the Federal Information Security Management Act (FISMA), as follows:
The safeguards for the information pertaining to the transit benefit and parking permit programs, which is maintained by the FCC, are as follows:
1. The paper documents, files, and records are kept in a locked cash box contained in a (cylinder lock) drawer. At the close of the business day, the cash box is secured in a government issued safe with a combination lock. Only authorized ASC supervisors, staff, and contractors may have access to these file cabinets. The ASC office suite is protected by a card-coded main door to limit access to the suite.
2. The electronic records, files, and data that are stored in the FCC computer network databases are secured by limited access card readers. Access to the electronic files is restricted to authorized ASC supervisors, staff, and contractors, and to the Information Technology (IT) staff and contractors, who maintain the FCC's computer network. Other FCC employees and contractors may be granted access only on a “need-to-know” basis. The FCC's computer network databases are protected by the FCC's security protocols, which include controlled access, passwords, and other IT security features and requirements as required under the IT guidelines issued by the National Institutes of Standards and Technology (NIST) and the Federal Information Security Management Act (FISMA) regulations. A
3. Safeguards in place adhere to Federal standards, including the NIST, FISMA, and FCC standards.
Revision of the language in the policies and practices regarding the Retention and Disposal of the information in this system, for clarity, and to specify that they comply with the current NARA requirements for both paper and electronic records, as follows:
Records under the control of the FCC are retained for three years in accordance with the General Records Schedule 6 (GRS 6) established by NARA at
Revision of the language regarding the System Manager(s) and Address, for clarity, and to note the current address of the system managers where they may be contacted, as follows:
Administrative Services Center (ASC), Office of the Managing Director (OMD), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554.
Revision of the language regarding the Notification, Record Access, and Contesting Procedures concerning information in this system, for clarity, and to comply with the Commission's current policies and practices for notifying individuals under the requirements of the Privacy Act, 5 U.S.C. 552a(d), as follows:
Notification Procedures: Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554; (202) 418-0217 or
Record Access Procedures: Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554; (202) 418-0217 or
Contesting Records Procedures: Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554; (202) 418-0217 or
Revision of the language in the Record Source Categories, for clarity, and to expand the sources of and details concerning the information in this system, as follows:
Information in the system is obtained from:
1. One or more FCC Forms, including, but not limited to FCC Forms A-27, A-30, A-75, and/or A-75-A, which are submitted by individuals who apply to participate in the FCC Transit Benefit and Parking Permit Programs, including but not limited to metrorail, bus, commuter rail, vanpools, carpools, and/or ridesharing arrangements.
2. WMATA and other agencies concerning individuals (including both FCC and non-FCC individuals) who have applied for and/or participate in the FCC's transit benefits program and/or the carpool/vanpool programs; and
3. Ride-Share Bike Program information.
This notice meets the requirement documenting the changes to the system of records that the FCC maintains, and provides the public, OMB, and Congress an opportunity to comment.
FCC Transit Benefit and Parking Permit Programs.
The FCC's CIO team will provide a security classification to this system based on NIST FIPS-199 standards.
Administrative Services Center (ASC), Office of the Managing Director (OMD), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554.
Information related to those employees who participate in the Smartrip portion of the benefits program is also stored in a database administered by the Washington Metropolitan Area Transit Authority WMATA, headquartered at 600 Fifth Street NW., Washington, DC 20001.
The categories of individuals in this system include those individuals who voluntarily apply for and/or participate in one of the FCC Transit Benefit and Parking Permit Programs, which include, but are not limited to:
1. FCC employees who have applied for and received monthly transit fare subsidies;
2. FCC employees and contractors who hold monthly FCC garage parking permits;
3. FCC employees, employee spouses, paid interns and co-op students, contractors, and non-FCC Federal agency employees who are members of carpools and vanpools that park in the FCC parking garage;
4. FCC employees who have applied for and received handicap status for FCC garage parking assignments as a “reasonable accommodation”;
5. FCC employees who participate in ridesharing, including the Capital Bikeshare Program.
The FCC uses the records in this system to administer the Transit Benefit and Parking Permit Programs. These records include, but are not limited to, the information that is required to be submitted on the following forms and any related documentation that pertains to transit benefit subsidies, parking permits, ride-sharing, bike-sharing, and other, related transit and commuting programs available to FCC employees, contractors, and other individuals, which are sponsored and/or hosted by the FCC:
1. Form A-27, “FCC Pre-Tax Parking Benefit Form,” including, but not limited to:
Employee Information: FCC employee's name; effective date; pay period; parking location; and monthly/daily fee; Benefit: carpool/vanpool), metro parking, commercial lot, privately-owned lot, parking garage, or parking meter; and requested amount; whether the application is new, a cancellation, or a change; and effective date; and Certification: employee signature; date; and attachments;
2. Form A-30, “FCC Parking Application,” including, but not limited to: Applicant's name, FCC bureau/office/division; address (required for carpool); FCC badge number; FCC telephone number; FCC employee/contractor/paid intern; vehicle year, make, model, state, and license plate; handicap perm (yes/no); FCC title (executives only); transit benefit participant (yes/no); van pool/car pool riders (FCC and Non-FCC employees): name, address, bureau/office or agency, telephone number, FCC ID number, and signature; applicant's signature and date; and attachments,
3. Form A-75, “FCC Headquarters Employee Transit Benefit Application,” including, but not limited to:
A. Applicant Information: applicant's name, home address, bureau/office, office room number, telephone number, FCC badge number, and WMATA Smartrip Card serial number;
B. Employment Status: full time, part time, paid intern/co-op student; and bargaining/non-bargaining unit status;
C. Mode(s) of Transportation (costs): metro (rail only) and station name; metro (rail and bus) and station name; metro (bus only); one-way transit user; commuter bus; commuter rail; and/or vanpool;
D. Telework: approved telework agreement (yes/no); and telework days (Monday-Friday);
E. Employee certification: employee signature and date; and
F. Transit benefit office action: approved (yes and amount/no), disapproved (reason), signature and data; and attachments;
4. Form A-75-A, “FCC Employee Transit Benefit Change Request Form,” including, but not limited to:
A. Applicant Information: applicant's name, home address, bureau/office, office room number, office telephone number, and FCC badge number;
B. Employment Status: full time, part time, paid intern, or co-op student;
C. Change(s) Requested:
1. Mode(s) of transportation: metro rail, metro bus, commuter rail,
2. Monthly commuting cost: old and new;
3. Badge number: old and new;
4. Address change: home address;
5. Name change: from/to; and
6. Smartrip Card serial number: old and new; and
D. Employee Certification: signature; date; and attachments.
5 U.S.C. 301; 5 U.S.C. 5701-5733; 5 U.S.C. 7905; 26 U.S.C. 132(f); 40 U.S.C. 101 and 121; 44 U.S.C. 2104 41 CFR 101-20.104-2, 102-74.205-210 (Ridesharing), and 102-74.265-310 (Parking Facilities); Executive Order 9397, as amended by Executive Order 13478; Executive Order 13150; Pub. L. 103-172; and the
The FCC will use information in this system, including the PII, to administer the Transit Benefit and Parking Permit Programs. This information enables the FCC to facilitate the timely processing of requests for parking permits, transit benefit subsidies, ride-sharing and bike-sharing programs and similar commuting arrangements, and other, related program, policies, and activities, which include, but are not limited to:
1. Managing the FCC's transit benefits program that provides transportation subsidies for public transit, including but not limited to, WMATA Metro train and bus fares; Commuter rail services—Maryland Area Rail Commuters MARC and Virginia Railway Express VRE fares; Commuter bus services—DASH fares, etc.; One-way transit users; Vanpool fares; and other parking and transit subsidies to Federal employees as allowed under 5 U.S.C. 7905, 5 U.S.C. 301, and Executive Order 13150 employee's request to participate in the transit subsidy or FCC garage parking program;
2. Managing the FCC's employee parking, executive parking, handicapped parking, and ridesharing programs (vanpools/carpools) for FCC employees, contractors, and non-FCC agency employees;
3. Conducting audits, reviews, oversight, and/or investigations of the transit benefits, parking, ridesharing programs (vanpools and carpools) to ensure their accuracy and integrity of the Transit Benefits and Parking Program, which includes but is not limited to cross-checking the Commission's data on parking assignees and transit benefit recipients to ensure that they are not participating in both programs, unless authorized; and, when appropriate, matching this information with the lists of other Federal agencies to ensure that the Commission's participants are not registered for a drive-alone, carpool, or other parking assignments with any other Federal agency, and to identify and locate former employees;
4. Administering, qualifying, and/or certifying the beneficiaries of the Transit Benefits and Parking Program, which includes but is not limited to ensure the eligibility of transit subsidy participants and to prevent misuse of the funds involved;
5. Preparing and administering listings and reports for use by the FCC and the other Federal, state, and local agencies charged with management and oversight of and/or contribution to the Transit Benefits and Parking Program subsidies, etc.; and
6. Ensuring that those non-FCC individuals who are participating in the ride-sharing and bike-sharing programs do not pose a security threat to FCC Headquarter garage facilities
Information about individuals in this system of records may routinely be disclosed under the following conditions:
1. Financial Obligations as required by the National Finance Center
2. Program Partner—To WMATA and other applicable public transportations in connection with FCC employees participating in this public transportation fare,
3. Adjudication and Litigation—Where by careful review, the agency determines that the records are both relevant and necessary to litigation and the use of such records is deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records, these records may be used by a court or adjudicative body in a proceeding when: (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity; or (c) any employee of the agency in his or her individual capacity where the agency has agreed to represent the employee; or (d) the United States Government is a party to litigation or has an interest in such litigation;
4. Law Enforcement and Investigation—Where there is a real or suspected indication of a violation or potential violation of a statute, regulation, rule, or order, records from this system may be shared with appropriate Federal, State, and/or local agencies, authorities, and officials for purposes that include but are not limited to obtaining additional information relevant to a FCC decision, referring the record for investigation, enforcement, or prosecution by the Commission or another agency;
5. Congressional Investigations and Inquiries—To Congress, or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, for the purposes of an official Congressional investigation, including but not limited to, a request by a Congressional office in response to an inquiry made by an individual to the Congressional office for the individual's own records;
6. Government-wide Program Management and Oversight—To the General Services Administration (GSA), the National Archives and Records Administration (NARA), the Office of Personnel Management (OPM), and/or the Government Accountability Office (GAO) for the purpose of records management studies conducted under authority of 44 U.S.C. 2904 and 2906; to the Department of Justice (DOJ) in order to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or to the Office of Management and Budget (OMB) in order to obtain that office's advice regarding obligations under the Privacy Act. Such a disclosure shall not be used to make a determination about individuals;
7. Labor Relations—To officials of labor organizations recognized under 5 U.S.C. Chapter 71 upon receipt of a formal request and in accord with the
8. Breach Notification-To appropriate agencies, entities, and persons when: (1) The Commission suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Commission has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Commission or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm;
9. Vanpool, Carpool, and Ridesharing—Vanpool, carpool, and rideshare information,
10. Statistical Reports on Commuting—To Federal, state, local, and related organizations, Metropolitan Washington Council of Governments, that are studying local traffic commuting patterns (
11. Department of Justice (DOJ)—To DOJ or in a proceeding before a court or adjudicative body when:
(a) The United States, the Commission, a component of the Commission, or, when represented by the government, an employee of the Commission is a party to litigation or anticipated litigation or has an interest in such litigation, and
(b) The Commission determines that the disclosure is relevant or necessary to the litigation; and
12. Medical Certification—To a physician who is making a determination on a person's eligibility for a handicapped parking permit;
13. Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by the Agency—To a Federal, State, local, foreign, tribal, or other public agency or authority maintaining civil, criminal, or other relevant enforcement records, or other pertinent records, or to another public authority or professional organization, if necessary to obtain information relevant to an investigation concerning the retention of an employee or other personnel action, the retention of a security clearance, the letting of a contract, or the issuance or retention of a grant or other benefit;
14. Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by Other than the Agency—To a Federal, State, local, foreign, tribal, or other public agency or authority of the fact that this system of records contains information relevant to the retention of an employee, the retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit. The other agency or licensing organization may then make a request supported by the written consent of the individual for the entire records if it so chooses. No disclosure will be made unless the information has been determined to be sufficiently reliable to support a referral to another office within the agency or to another Federal agency for criminal, civil, administrative, personnel, or regulatory action; and
15. Parking Garage Contractors—To the owners, managers, and staff who manage the garage parking for their use in assigning or checking the parking permits, checking credentials, assigning spaces, assisting with accidents, or other parking issues to ensure that the parking program functions properly and that parking privileges are not abused.
In each of these cases, the FCC will determine whether disclosure of the records is compatible with the purpose(s) for which the records were collected.
None.
Paper records, files, and documents, which pertain to the information concerning the transit benefits and parking program that are maintained at the FCC, are stored in file folders in the ASC office suite.
The electronic records, files, and data are housed in the FCC's computer network databases, which are reserved for the transit benefit and parking permit program, and in the WMATA database that is associated with the Smartrip program.
Both the paper documents and the electronic records and data are retrieved by the employee's name, or by the FCC Badge identification number, tag, and/or permit number.
The safeguards for the information pertaining to the transit benefit and parking permit program, which is maintained by the FCC, are as follows:
1. The paper documents, files, and records are kept in a locked cash box contained in a (cylinder lock) drawer. At the close of the business day, the cash box is secured in a government issued safe with a combination lock. Only authorized ASC supervisors, staff, and contractors may have access to these file cabinets. The ASC office suite is protected by a card-coded main door to limit access to the suite.
2. The electronic records, files, and data that are stored in the FCC computer network databases are secured by limited access card readers. Access to the electronic files is restricted to authorized ASC supervisors, staff, and contractors, and to the Information Technology (IT) staff and contractors, who maintain the FCC's computer network. Other FCC employees and contractors may be granted access only on a “need-to-know” basis. The FCC's computer network databases are protected by the FCC's security protocols, which include controlled access, passwords, and other IT security features and requirements as required under the IT guidelines issued by the National Institutes of Standards and Technology (NIST) and the Federal Information Security Management Act (FISMA) regulations. A
3. Safeguards in place adhere to Federal standards, including the NIST, FISMA, and FCC standards.
Records under the control of the FCC are retained for three years in accordance with the General Records Schedule 6 (GRS 6) established by NARA at
Administrative Services Center (ASC), Office of the Managing Director (OMD), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554.
Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554.
Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554.
Privacy Manager, Federal Communications Commission (FCC), 445 12th Street SW., Room 1-A804, Washington, DC 20554.
Information in the system is obtained from:
1. One or more FCC Forms, including but not limited to FCC Forms A-27, A-30, A-75, and/or A-75-A, which are submitted by individuals who apply to participate in the FCC Transit Benefit and Parking Permit Programs, including but not limited to metrorail, bus, commuter rail, vanpools, carpools, and/or ridesharing arrangements.
2. WMATA and other agencies concerning individuals (including both FCC and non-FCC individuals) who have applied for and/or participate in the FCC's transit benefits program and/or the carpool/vanpool programs; and
3. Ride-Share Bike Program information.
None.
Office of Human Resources Management (OHRM), General Services Administration (GSA).
Notice of meeting.
The General Services Administration's Labor-Management Relations Council (GLMRC), a Federal Advisory Committee established in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C., App., and Executive Order 13522, plans to hold a one and one-half day meeting that is open to the public.
The meeting will be held on Tuesday, April 12, 2016 from 9:30 a.m. to 4:30 p.m. and reconvene Wednesday, April 13, 2016 from 9:30 a.m. to 12:00 noon, Eastern Standard Time.
The meeting will be held in Room 1459, in the Conference Center located on the first floor of the General Services Administration's Headquarters Building located at 1800 F Street NW., Washington, DC 20405.
Ms. Paula D. Lucak, GLMRC Designated Federal Officer (DFO), OHRM, General Services Administration, at telephone 202-739-1730, or email at
The GLMRC is a forum for managers and the exclusive national labor Union representatives of the U.S. General Services Administration (GSA) employees. In this forum, managers and the Unions discuss Government operations to promote satisfactory labor relations and improve the productivity and effectiveness of GSA. The GLMRC serves as a complement to the existing collective bargaining process and allows managers and the Unions to collaborate in continuing to deliver the highest quality services to the public. The Council discusses workplace challenges and problems and recommends solutions that foster a more productive and cost-effective service to the taxpayer, through improving job satisfaction and employees' working conditions.
The purpose of the meeting is for the GLMRC to build its collaborative labor-management relationship, discuss the Council's activities and direction ahead for the year, and to consider Agency initiatives. The topics to be discussed include Council metrics & GSA EVS results, employee engagement activities, and human resource initiative updates.
This site is accessible to individuals with disabilities. In order to gain entry into the Federal building where the meeting is being held, public attendees who are Federal employees should bring their Federal employee identification cards. Members of the general public should bring their driver's license or another form of government-issued identification.
Please see the GLRMC Web site:
The public is invited to submit written comments for the meeting until 5:00 p.m. Eastern Time on the Monday prior to the meeting on April 11, 2016, by either of the following methods:
Any comments submitted in connection with the GLMRC meeting will be made available to the public under the provisions of the Federal Advisory Committee Act.
Centers for Medicare & Medicaid Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are require; to publish notice in the
Comments must be received by
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806, or Email:
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
2.
This proposed information collection was previously published in the
3.
This proposed information collection was previously published in the
4.
Section 155.405(a) of the Exchange Final Rule (77 FR 18310) provides more detail about the application that must be used by the Exchange to determine eligibility and to collect information necessary for enrollment. The regulations in § 435.907 and § 457.330 establish the requirements for State Medicaid and CHIP agencies related to the use of the single streamlined application. CMS is designing the single streamlined application to be a dynamic electronic application that will tailor the amount of data required from an applicant based on the applicant's circumstances and responses to particular questions. The paper version of the application will not be able to be tailored in the same way but is being designed to collect only the data required to determine eligibility. Individuals will be able to submit an application electronically, through the mail, over the phone through a call center, or in person, per § 155.405(c)(2) of the Exchange Final Rule, as well as through other commonly available electronic means as noted in § 435.907(a) and § 457.330 of the Medicaid Final Rule. The application may be submitted to an Exchange, Medicaid or CHIP agency. The electronic application process will vary depending on each applicant's circumstances, their experience with health insurance applications and online capabilities. The goal is to solicit sufficient information so that in most cases no further inquiry will be needed.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This draft guidance recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 24, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Gail Schmerfeld, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291, email:
FDA is announcing the availability of a draft guidance for industry entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” Prescription opioid analgesics are an important component of modern pain management. However, abuse and misuse of these drug products have created a serious and growing public health problem. One important step toward the goal of creating safer opioid analgesics has been the development of opioid drug products that are formulated to deter abuse. FDA considers the development of these products a high public health priority. It is important that generic versions of opioids that reference listed drugs whose labeling describes abuse-deterrent properties are available to help ensure availability of analgesics for patients who need them.
For FDA to approve an abbreviated new drug application (ANDA), the Agency must find, among other things, that the generic drug product has the same active ingredient(s), dosage form, route of administration, strength, and, with limited exceptions, labeling as the reference listed drug (RLD); is bioequivalent to its RLD; that the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are adequate to assure and preserve its identity, strength, quality, and purity; and that the inactive ingredients and composition of the generic drug are not unsafe for use under the conditions prescribed, recommended, or suggested in the labeling (see,
Accordingly, if the RLD's labeling describes abuse-deterrent properties, the ANDA applicant should evaluate its product to show that it is no less abuse-deterrent than the RLD with respect to all potential routes of abuse. Marketing a generic opioid drug product that is less abuse-deterrent than the RLD could lead opioid abusers to preferentially seek out and abuse generics.
This draft guidance describes FDA's current thinking about the studies that should be conducted by a potential ANDA applicant and submitted to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse-deterrent than its RLD with respect to all potential routes of abuse.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the principles for evaluating the abuse-deterrence of generic solid oral opioid drug products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
FDA intends to hold a public meeting following the close of the comment period to discuss further the evaluation of the abuse deterrence of generic opioid drug products and related issues, as appropriate. Further details will follow in a notice of public meeting published in the
Persons with access to the Internet may obtain the document at either
President's Council on Fitness, Sports, and Nutrition, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice of meeting.
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold its annual meeting. The meeting will be open to the public.
The meeting will be held on May 16, 2016, from 9:00 a.m. to 12:00 p.m.
Hubert H. Humphrey Building, 200 Independence Avenue SW., Great Hall, Washington, DC 20201.
Ms. Shellie Pfohl, Executive Director, Office of the President's Council on Fitness, Sports, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567. Information about PCFSN, including details about the upcoming meeting, can be obtained at
The primary functions of the PCFSN include (1) advising the President, through the Secretary, concerning progress made in carrying out the provisions of Executive Order 13545 and recommending to the President, through the Secretary, actions to accelerate progress; (2) advising the Secretary on ways to promote regular physical activity, fitness, sports
The PCFSN will hold, at a minimum, one meeting per fiscal year. The meeting will be held to (1) assess ongoing Council activities; and, (2) discuss and plan future projects and programs. The agenda for the planned meeting is being developed and will be posted at
The meeting that is scheduled to be held on May 16, 2016, is open to the public. Every effort will be made to provide reasonable accommodations for persons with disabilities and/or special needs who wish to attend the meeting. Persons with disabilities and/or special needs should call (240) 276-9567 no later than close of business on May 2, 2016, to request accommodations. Members of the public who wish to attend the meeting are asked to pre-register by sending an email to
Office of Minority Health, Office of the Secretary, Department of Health and Human Services.
Notice of meeting.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email
Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH),
The conference call will be held on April 14, 2016, 11:00 a.m.-1:00 p.m. ET
Instructions regarding participating in the call will be given at the time of preregistration.
Dr. Minh Wendt, Designated Federal Officer, ACMH, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852. Phone: 240-453-8222; fax: 240-453-8223; email
In accordance with Public Law 105-392, the ACMH was established to provide advice to the Deputy Assistant Secretary for Minority Health on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of the OMH.
Topics to be discussed during this conference call include planning for upcoming in-person meetings and finalizing the charge and the formation of the data workgroup.
This call will be limited to 125 participants. The OMH will make every effort to accommodate persons with special needs. Individuals who have special needs for which special accommodations may be required should contact Professional and Scientific Associates at (703) 234-1700 and reference this meeting. Requests for special accommodations should be made at least ten (10) business days prior to the meeting.
Members of the public will have an opportunity to provide comments at the meeting. Public comments will be limited to two minutes per speaker during the time allotted. Individuals who would like to submit written statements should email, mail, or fax their comments to the designated contact at least seven (7) business days prior to the meeting.
Any members of the public who wish to have electronic or printed material distributed to ACMH members should email
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Battelle Laboratories-King Avenue in Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 877-222-7570. Information requests can also be submitted by email to
42 U.S.C. 7384q(b). 42 U.S.C. 7384
On February 18, 2016, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Atomic Weapons Employees who worked at the facility owned by the Battelle Laboratories at the King Avenue site in Columbus, Ohio, during the period from July 1, 1956, through December 31, 1970, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation became effective on March 19, 2016. Therefore, beginning on March 19, 2016, members of this class of employees, defined as reported in this notice, became members of the SEC.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Aging.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Closed: May 10, 2016, 3:00 p.m. to 5:00 p.m.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,550.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The National Survey on Drug Use and Health (NSDUH) is a survey of the U.S. civilian, non-institutionalized population aged 12 years old or older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, the Office of National Drug Control Policy (ONDCP), Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources.
While NSDUH must be updated periodically to reflect changing substance use and mental health issues and to continue producing current data, for the 2017 NSDUH only the following minor changes are planned: (1) Updated questions so respondents who report no use of alcohol are not asked about misuse of prescription drugs with alcohol; and (2) included other minor wording changes to improve the flow of the interview, increase respondent comprehension or to be consistent with text in other questions.
As with all NSDUH/NHSDA
Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 15E57B, 5600 Fishers Lane, Rockville, MD 20857
Written comments should be received by May 24, 2016.
Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The Towing Safety Advisory Committee and its subcommittees will meet to discuss matters relating to shallow-draft inland and coastal waterway navigation and towing safety. The meetings will be open to the public.
Subcommittees are scheduled to meet on April 13, 2016, from 8 a.m. to 5:30 p.m., and the full Committee is scheduled to meet on April 14, 2016, from 8 a.m. to 5:30 p.m. Please note that these meetings may adjourn early if the Committee has completed its business.
The meetings will be held at the OMNI Riverfront Hotel, 701 Convention Center Boulevard, New Orleans, LA 70130. The telephone number for the hotel is 504-524-8200 and the Web site is:
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Alternate Designated Federal Officer as soon as possible.
To facilitate public participation, we are inviting public comment on the issues to be considered by the Committee as listed in the “Agenda” section below. Written comments for distribution to Committee members must be submitted no later than April 2, 2016, if you want the Committee members to be able to review your comments before the meeting, and must be identified by Docket No. USCG-2016-0142. Written comments may be submitted using the Federal eRulemaking Portal at
Mr. William J. Abernathy, Alternate Designated Federal Officer of the Towing Safety Advisory Committee; Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Stop 7509, Washington, DC 20593-7509; telephone 202-372-1363, fax 202-372-8382; or email
Notice of this meeting is given under the
The subcommittees will meet on April 13, 2016, from 8 a.m. to 5:30 p.m., to work on their specific task assignments:
(1) Recommendations regarding Automation Equipment, Testing, Assessment, and Trial Periods on Towing Vessels.
(2) Recommendations for the Maintenance, Repair, and Utilization of Towing Equipment, Lines, and Couplings.
(3) Recommendations concerning the MODU KULLUK Report of Investigation.
(4) Recommendations regarding Articulated Tug/Barge Manning and Operations.
(5) Recommendations for Electronic Charting Systems.
On April 14, 2016, from 8 a.m. to 5:30 p.m., the Towing Safety Advisory Committee will meet and receive reports concerning the following:
(1) Recommendations regarding Automation Equipment, Testing, Assessment, and Trial Periods on Towing Vessels, progress report,
(2) Recommendations for the Maintenance, Repair and Utilization of Towing Equipment, Lines and Couplings, final report,
(3) Recommendations concerning the MODU KULLUK Report of Investigation, final report,
(4) Recommendations regarding Articulated Tug/Barge Manning and Operations, progress report, and,
(5) Recommendations for Electronic Charting Systems, progress report.
In addition, the Committee will hear a presentation from the U.S. Coast Guard, District 8.
There will be a comment period for Towing Safety Advisory Committee members and a comment period for the public after each report presentation, but before each is voted on by the Committee. The Committee will review the information presented on each issue, deliberate on any recommendations presented in the Subcommittees' reports, and formulate recommendations for the Secretary's consideration.
A copy of all meeting documentation will be available at:
An opportunity for oral comments by the public will be provided during the meeting on April 14, 2016. Speakers are requested to limit their comments to 3 minutes. Please note the public oral comment period may end before 5:30 p.m. if the Committee has finished its business earlier than scheduled. Please contact Mr. William J. Abernathy, listed above in the
Minutes from the meeting will be available for public review and copying within 90 days following the close of the meeting and can be accessed from the Coast Guard Homeport Web site
To receive automatic email notices of any future Towing Safety Advisory Committee meetings in 2016, go to the online docket, USCG-2016-0142 (
Coast Guard, DHS.
Request for applications.
The Coast Guard seeks applications for membership on the Chemical Transportation Advisory Committee. The Chemical Transportation Advisory Committee provides advice and makes recommendations reflecting its independent judgment to the Commandant of the United States Coast Guard on matters concerning the safe and secure marine transportation of hazardous materials, including industry outreach approaches.
Completed applications should reach the Coast Guard on or before May 24, 2016.
Applicants should send a cover letter expressing interest in an appointment to the Chemical Transportation Advisory Committee that identifies which membership category the applicant is applying under, along with a resume detailing the applicant's experience via one of the following methods:
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Mr. Patrick Keffler, Alternate Designated Federal Official of the Chemical Transportation Advisory Committee; telephone (202) 372-1424, email
The Chemical Transportation Advisory Committee is established under the authority of Section 871 of the Homeland Security Act of 2002, 6 U.S.C. 451. The Chemical Transportation Advisory Committee is an advisory committee established in accordance with and operating under the provisions of the Federal Advisory Committee Act (Title 5 U.S.C. Appendix).
The Committee provides advice and makes recommendations reflecting its independent judgment to the
The Chemical Transportation Advisory Committee meets at least twice per year, typically every six months. It may also meet for extraordinary purposes. Its subcommittees may meet to consider specific tasks as required.
The Coast Guard will consider applications for seven positions that will be vacant on September 17, 2016.
The membership categories are: Marine Handling and Transportation, Marine Environmental Protection, Safety and Security, Vessel Design and Construction, and Chemical Manufacturing.
To be eligible, applicants should have experience in chemical manufacturing, marine handling or transportation of chemicals, vessel design and construction, marine safety or security, or marine environmental protection. Each member serves for a term of three years. Committee members are limited to serving no more than two consecutive three-year terms. A member appointed to fill an unexpired term may serve the remainder of that term. All members serve at their own expense and receive no salary, reimbursement of travel expenses, or other compensation from the Federal Government.
Registered lobbyists are not eligible to serve on federal advisory committees in an individual capacity. See “Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards and Commissions” (79 FR 47482, August 13, 2014). Registered lobbyists are lobbyists required to comply with provisions contained in 2 U.S.C. 1605.
The Department of Homeland Security does not discriminate in selection of Committee members on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age, membership in an employee organization, or any other non-merit factor. The Department of Homeland Security strives to achieve a widely diverse candidate pool for all of its recruitment actions.
If you are interested in applying to become a member of the Committee, send your cover letter and resume to Mr. Patrick Keffler, Alternate Designated Federal Officer of the Chemical Transportation Advisory Committee, via one of the transmittal methods in the
All email submittals will receive email receipt confirmation.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Office of Community Planning and Development, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Evan Gross, Office of the Deputy Assistant Secretary for Economic Development, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Evan Gross at
Copies of available documents submitted to OMB may be obtained from Mr. Gross.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The Community Development Marketplace Project Inventory survey (“CDM Survey”) will serve as a vehicle to target cohort learning using remote tools and technical assistance products, as well as provide information in a useful, sortable way to foundations and investors who are seeking community development investment opportunities and researching trends. An example of how the CDM Survey information could
If HUD decides to proceed with the CDM survey after public comment, HUD may embed the survey in max.gov, or the HUD Exchange Web site, or another online platform. HUD may also continue to ask for user feedback through online suggestions and surveys on HUD Exchange or similar Web sites that HUD may use in the future.
HUD proposes to survey the recipients and providers of technical assistance, including city and state grantees of HUD funds, public housing authorities, tribes, owners and operators of multifamily housing, Continuums of Care and other non-profit recipients of HUD funding. Technical assistance is provided by third-party organizations awarded funding through cooperative agreements or contracts with HUD. The survey responses will allow HUD and its providers to improve the way it delivers technical assistance HUD proposes to survey one representative from the recipient TA organization and one representative from each TA provider organization for either all or the majority of the TA engagements in a year. The number of engagements varies based on demand for TA and available funding to provide it, but based on past years' trends, HUD expects to survey approximately 200 representatives each from recipient organizations and TA providers, for a total of 400 respondents annually.
The survey will ask respondents to rate quality of the TA they received, their progress toward intended goals, and provide other feedback about the TA engagement including any challenges faced. At least annually, HUD will analyze the survey data to identify program strengths and opportunities for program improvements. HUD may follow up on surveys to secure additional qualitative information through interviews and focus groups.
HUD proposes to survey training participants in order to assess satisfaction with the course content and delivery. Participants include city and state HUD grantees, public housing authorities, tribes, owners and operators of multifamily housing, Continuums of Care (CoCs), and other non-profit recipients of HUD funding. Training is provided by third-party organizations awarded funding through cooperative agreements or contracts with HUD. The survey responses will allow HUD and its providers to improve the content and delivery of its training. All training participants will be offered the opportunity to provide feedback via a brief survey following the training. HUD estimates, based on past years' data, that about 7,000 training participants will be offered the opportunity to complete a feedback survey annually. The survey will ask respondents to rate their satisfaction with the training, including the relevance of the content to their job responsibilities, perceived knowledge gained, and quality of training delivery, and will provide space for comments regarding the training and suggestions to improve future training. At least annually, HUD will analyze the survey data to identify program strengths and opportunities for program improvements.
HUD may follow up on all of the surveys listed above to secure additional qualitative information through interviews and focus groups. HUD may also survey users of online tools and products to assess the usefulness and quality of these offerings.
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
For potential users, including foundations, investors, researchers, other stakeholders:
(5) What kind of potential user are you? HUD has heard from foundations, investors, communities, researchers and national intermediaries and stakeholder networks, but there may be others who can use this data.
(6) Does the Project Intake Survey template capture information that would be useful to you? If yes, how is this information useful to you? If the information captured by the CDM Survey is not useful to you, how could
(7) Please review the list of policy codes, financing types, funding source types, asset classes, and types of project sponsors that respondents are asked to select to categorize their project details. Would these options assist you in filtering and searching for information you would like to have? Are there any codes or options that would help you that missing? Are there any codes or options that are redundant?
(8) Does the project intake survey capture the information useful to organizations working in your community? Please elaborate on what is useful or what could be done to make it more useful.
(9) What are the typical information gaps that interfere with your organization's ability to target suitable funding opportunities? How can the project intake survey be enhanced to yield relevant information for your purposes?
(10) With regard to geography filters, projects in the draft database would be searchable by city, state, zip code, and census tract (where known by the respondent). Do these filters allow for geographic searches that would be useful to you?
(11) How can HUD better engage foundation, philanthropic, and impact investor community?
(12) Please review the questions in the proposed Project Intake Survey at [link]. If you are managing a local community development project or intervention, would you be willing and able to respond to the survey questions and to make your responses public for purposes of potentially connecting you to federal and private partners and/or peers that could facilitate your work? If not, why not?
(13) Do you perceive the benefits of responding to the CDM Survey as adequate and sufficiently motivating for you to respond? If not, what additional benefits would motivate you to respond?
(14) With regard to your and your partners' community revitalization efforts, please explain what particular types of information, peer exchange, introductions or other non-competitive assistance would be helpful to you as you move your work forward?
(15) With regard to geography filters, projects in the draft database would be searchable by city, state, zip code, and census tract (where known by the respondent). Do these filters allow for geographic searches that would be useful to you?
The goal of HUD's technical assistance and training is to help customers navigate challenges associated with HUD funding and programs and points them in the right direction to best serve their communities. HUD provides TA and training across its portfolio of programs, including public housing, Native American housing, community development, rental housing, and fair housing. HUD does not currently have a mechanism to systematically solicit TA or training recipient feedback.
The goal of the proposed survey(s) are to systematically collect information across TA and training engagements to learn how effectively they achieved the desired outcomes identified at the start of the engagement. From the information collected, HUD will be able to understand which types of TA and training are preferred by recipients and which seem to be most effective in achieving specific outcomes, and hold TA providers accountable for the quality of TA and training provided. It will provide information that will help HUD continuously improve the way it provides TA and training.
HUD is particularly interested in comments that address the following questions:
(16) Is an online survey sent after the TA engagement a practical way to capture feedback about the TA?
(17) Is a rating system (
(18) What type(s) of survey question(s) would best measure customer satisfaction with the quality of TA provided?
(19) What other methods besides a survey could be employed to assess the quality of TA provided?
(20) How can HUD most accurately measure customer satisfaction and outcomes of training?
(21) Should the survey of online or virtual training participants be different from the survey for in-person training participants?
(22) Are there any other questions that the survey should ask of HUD training recipients to measure the effectiveness of HUD training?
HUD encourages interested parties to submit comment in response to these questions. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before April 25, 2016.
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When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to re-export biological samples from wild mountain gorilla (
The applicant requests a permit to re-export biological samples from wild Amur tigers (
The applicant requests a permit to import biological samples from Bengal tigers (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: Ring-tailed lemur (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: Radiated tortoise (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: Radiated tortoise (
The applicant requests a permit to import egg samples from wild leatherback sea turtle (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Fish and Wildlife Service, Interior.
Notice of availability.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the Deer Flat National Wildlife Refuge (Refuge) comprehensive conservation plan (CCP) and record of decision (ROD) for the final environmental impact statement (EIS). The CCP describes the Refuge's management direction for the next 15 years, and includes the ROD, which explains our selection of Alternative 2 as the Refuge's management direction.
The Regional Director, Pacific Region, U.S. Fish and Wildlife Service, signed the ROD on April 3, 2015.
The libraries providing public viewing of the CCP/ROD are listed under
Refuge Manager, 208-467-9278 (phone).
With this notice, we finalize the CCP process for Deer Flat Refuge. We started this process by publishing a notice of intent in the
We completed a thorough analysis of impacts on the human environment and responded to public comments in the final CCP/EIS released to the public through a
We announce our decision and the availability of the CCP and ROD in accordance with National Environmental Policy Act (NEPA) (40 CFR 1506.6(b)) requirements. Alternative 2, as we described it in the final CCP/EIS, was selected for implementation at the Refuge. The CCP will guide Refuge management for 15 years.
The National Wildlife Refuge System Administration Act of 1966, 16 U.S.C. 668dd-668ee (Refuge Administration Act), as amended by the National Wildlife Refuge System Improvement Act of 1997, requires us to complete a CCP for each national wildlife refuge. The purpose for developing a CCP is to provide refuge managers with a 15-year plan for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and our policies. In addition to outlining broad management direction on conserving wildlife and their habitats, CCPs identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation and photography, and environmental education and interpretation. We will review and update the CCP at least every 15 years in accordance with the Refuge Administration Act.
Based on our comprehensive review and analysis of Deer Flat Refuge's resources and issues, the Service selected Alternative 2, our preferred alternative, for implementation, as it is described in the final CCP/EIS, with two modifications described below. In reaching our decision to implement Alternative 2, we identified and analyzed its impacts to the Refuge environment in the Draft and Final CCPs/EISs. Issues, comments, concerns, and opportunities identified by all stakeholders throughout the planning process were considered and addressed. A summary of public comments and our responses is available in the CCP, in Appendix H.
The following changes were made to wildlife-dependent public uses in the Lake Lowell Unit in Alternative 2 after the final CCP/EIS was released:
Noncompetitive jogging, bicycling, and horseback riding groups of 10 or fewer people are allowed without a special use permit (SUP). An SUP is still required for groups larger than 10, and competitive events are still prohibited.
Boats using wake-generating devices (wake-boats) are compatible with stipulations, including requiring wake-boats to use ballast filtering systems to prevent invasive species introductions. Wakes that impact grebe nests are a concern; however, the new no-wake zones will provide some additional protection, and we will continue to evaluate effects on wildlife to ensure the use remains compatible.
We will protect Lake Lowell's shoreline feeding and nesting sites for wintering and migratory birds by closing the lake October 1-April 14, establishing a 200-yard no-wake zone on the south side and in the Narrows, and expanding the southeast no-wake zone to Gotts Point.
Fishing and wildlife interpretation will be emphasized, and with increased law enforcement, Gotts Point will open to vehicles. We will increase wildlife inventory and monitoring, invasive species control, and restoration on the Snake River Islands Unit, and we will adjust closures to protect nesting and wading birds. Wildlife observation and hunting for deer, upland species, and waterfowl will be allowed on the unit, and most islands will be open for shoreline fishing and free-roam activities June 15-January 31; and heron- and gull-nesting islands will be open July 1-January 31. For additional details, the CCP/ROD is available on the Refuge's Web site:
Review the CCP/ROD at the following libraries and sources under
Caldwell Public Library, 1010 Dearborn St., Caldwell, ID 83605.
Homedale Public Library, 125 W Owyhee Ave., Homedale, ID 83628.
Lizard Butte District Library, 111 3rd Ave. W, Marsing, ID 83639.
Nampa Public Library, 101 11th Ave. S, Nampa, ID 83651.
Payette Public Library, 24 S 10th St., Payette, ID 83661.
Ada County District Library, 10664 W Victory Rd., Boise, ID 83709.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on March 31, 2016.
You must submit comments on or before April 25, 2016.
Send your comments and suggestions on this information collection to the Desk Officer for the Department of the Interior at OMB-OIRA at (202) 395-5806 (fax) or
To request additional information about this ICR, contact Hope Grey at
We again invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask OMB and us in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
Fish and Wildlife Service, Interior.
Notice of intent; announcement of public meeting.
Under the National Environmental Policy Act (NEPA), we, the Fish and Wildlife Service (Service), advise the public that we intend to gather information necessary to prepare a draft environmental impact statement (dEIS) related to an anticipated permit application from nine Collier County, Florida, landowners (prospective applicants) for the incidental take of federally listed species. The permit application would include an Eastern Collier Multiple Species Habitat Conservation Plan (ECMSHCP) prepared
Kenneth McDonald, (
Under NEPA (42 U.S.C. 4321
Section 9 of the Act and the Service's implementing regulations in the Code of Federal Regulations (CFR) at 50 CFR Part 17 prohibit the “take” of federally listed “endangered” and “threatened” species (16 U.S.C. 1538). The Act defines the term “take” as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed species or to attempt to engage in such conduct (16 U.S.C. 1532). “Harm” includes an act that actually kills or injures a listed species and may include significant habitat modification or degradation that actually kills or injures a species by significantly impairing essential behavioral patterns, including breeding, feeding, and sheltering (50 CFR 17.3). Under section 10(a)(1)(B) (16 U.S.C. 1539) of the Act, the Service may issue permits authorizing “incidental take” of listed species. “Incidental take” is defined as take otherwise prohibited but incidental to, and not the purpose of, carrying out an otherwise lawful activity (50 CFR 17.3). Regulations governing incidental take permits for endangered species and threatened species, respectively, are found in 50 CFR 17.22 and 50 CFR 17.32.
The prospective applicants intend to seek an incidental take permit (ITP) that would authorize take resulting from the residential and commercial development and earth mining activities described in the ECMSHCP on certain lands (“covered lands”). The ECMSHCP would include measures to avoid, minimize, and mitigate for incidental take with an emphasis on preserving some of the lands to maintain the viability and continued existence of populations of federally- listed threatened and endangered species.
The ECMSHCP also would include a funding mechanism for the avoidance, minimization, and mitigation measures, such as land acquisition, habitat mitigation, establishment of wildlife crossings, ecological restoration, land management, and actions to assist in the conservation of species through research. The proposed term of the ITP would be 50 years.
The prospective applicants are expected to seek incidental take authorization for the following federally listed species: The Florida scrub-jay (
The covered lands of the ECMSHCP encompass approximately 152,124 acres in northeastern Collier County, Florida, that surround the town of Immokalee. The covered lands are bordered to the south by the Florida Panther National Wildlife Refuge and Big Cypress National Preserve, to the north and east by the Okaloacoochee Slough State Forest, and to the northwest by the Audubon Corkscrew Swamp Sanctuary. The prospective applicants are expected to propose a conservation strategy in the ECMSHCP that would preserve a large portion of the covered lands as habitat for the covered species while conducting activities on smaller, clustered portions of the covered lands.
Biologically, the ECMSHCP would focus on maintaining areas of high-value habitat for the covered species while engaging in residential and commercial development and earth mining on 45,000 acres of the lands. The prospective applicants also would maintain suitable habitat within the impacted areas to ensure the availability of corridors for dispersal of the covered species.
The dEIS will consider a range of alternatives, including the proposed action (
Outside of the public scoping meeting, we will accept comments in written form only. To assist us in identifying the full range of issues related to the prospective permit
Comments may be submitted by any one of the following methods:
Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, there is no guarantee that we will be able to do so.
Persons needing reasonable accommodations in order to attend and participate in the public meeting should contact Vickie Scott at 813/675-6546 by no later than one week before the public meeting. Information regarding this proposed action is available in alternative formats upon request.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of issuance of permits.
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).
Brenda Tapia, U.S. Fish and Wildlife Service, Division of Management Authority, Branch of Permits, MS: IA, 5275 Leesburg Pike, Falls Church, VA 22041; fax (703) 358-2281.
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
On the dates below, as authorized by the provisions of the ESA (16 U.S.C. 1531
Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents to: U.S. Fish and Wildlife Service, Division of Management Authority, Branch of Permits, MS: IA, 5275 Leesburg Pike, Falls Church, VA 22041; fax (703) 358-2281.
Bureau of Indian Affairs, Interior.
Notice of tribal consultation.
This notice announces that the Office of the Assistant Secretary—Indian Affairs (AS-IA) will be hosting tribal consultation sessions on a streamlined draft policy that will address contract support costs (CSC) incurred by Tribes under Indian Self-Determination and Education Assistance Act (ISDEAA) self-determination contracts and Self-Governance funding agreements.
Written comments on the draft policy must be received the Department of the Interior (Department) by July 29, 2016. Please see the
A copy of the draft policy is available for review at:
Ms. Hankie Ortiz, Deputy Bureau Director—Indian Services, Bureau of Indian Affairs, at (202) 513-7640 or via email:
Indian Affairs has conducted several tribal consultations and listening sessions over the past two years regarding funding to tribes for CSC and is now presenting a draft policy to provide full funding for CSC incurred by tribes under ISDEAA self-determination contracts and Self-Governance funding agreements. The draft policy provides a streamlined approach to calculating CSC that reflects the Department's commitment to paying all Tribes full CSC.
We will be hosting the following consultation sessions to discuss this draft CSC policy and invites Tribes' participation:
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the liquor code of the Yavapai-Apache Nation of the Camp Verde Indian Reservation. The liquor code allows the Nation to govern, control and regulate liquor possession, distribution, sales, and service within the Nation's reservation to serve the best interests of the Nation.
This code shall become effective March 25, 2016.
Ms. Sharlot Johnson, Tribal Government Services Officer, Western Regional Office, Bureau of Indian Affairs, 2600 North Central Avenue, Phoenix, Arizona 85004, Telephone: (602) 379-6786, Fax: (602) 379-4100; or Laurel Iron Cloud, Chief, Division of Tribal Government Services, Office of Indian Services, Bureau of Indian Affairs, 1849 C Street NW., MS-4513-MIB, Washington, DC 20240, Telephone: (202) 513-7641.
Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary-Indian Affairs. I certify that the Yavapai-Apache Nation of the Camp Verde Indian Reservation Tribal Council duly adopted the Yavapai-Apache Nation Liquor Cody by Resolution No. 147-15 on August 27, 2015.
This Liquor Code is adopted by the Yavapai-Apache Nation (“YAN” or “Nation”) and shall be known as the Yavapai-Apache Nation Liquor Code (referred to herein as “Liquor Code” or “Code”).
The Tribal Council finds as follows:
A. The introduction, possession, and sale of liquor in Indian Country is a matter of particular concern to Indian tribes and the United States. Consistent with the laws of the United States, the control of liquor on the Yavapai-Apache Nation Reservation remains subject to the legislative enactments of the Nation in the exercise of its governmental powers over the Reservation.
B. Federal law prohibits the introduction of liquor into Indian Country (18 U.S.C. § 1154), and authorizes tribal governments to decide when and to what extent liquor possession, sales, and service shall be permitted within their reservations (18 U.S.C. § 1161) in a manner deemed consistent with state liquor laws.
C. The Tribal Council, as the governing body of the Nation under Article IV, Section 1 of the Constitution of the Yavapai-Apache Nation (hereinafter “Tribal Council”), has approved the issuance of liquor licenses in accordance with the liquor control laws of the state of Arizona. The limitation and regulation of liquor sales as provided in this Code will increase the Nation's ability to control possession and distribution of liquor within the Nation's Reservation.
A. This Code is enacted under authority of the Act of August 15, 1953, 67 Stat. 586, (18 U.S.C. Section 1161) and under authority of the Constitution of the Yavapai-Apache Nation (“YAN Constitution”), which authorizes the Tribal Council to exercise the following powers relevant to the adoption of this Liquor Code:
1. YAN Constitution, Article V(a), “To represent the Tribe and act in all matters that concern the health and welfare of the Tribe, and to make decisions not inconsistent with or contrary to this constitution.”
2. YAN Constitution, Article V (o), to enact codes and ordinances governing law enforcement on lands within the jurisdiction of the Tribe.”
3. YAN Constitution, Article V (u), “To exercise civil jurisdiction over all tribal members and any non-member of the Tribe to the extent permitted by federal law.”
4. YAN Constitution, Article V (v), “To enact laws, ordinances and resolutions necessary or incidental to the exercise of its legislative powers.”
B. This Liquor Code is adopted for the purpose of governing, controlling and regulating liquor possession, distribution, sales and service within the Nation's reservation.
A. Unless otherwise required by the context in which it is used, the following words and phrases shall have the following meanings.
1. “Alcohol” means the substance known as ethyl alcohol, hydrated oxide of ethyl, ethanol, or spirits of wine, from whatever source or by whatever process produced, and includes “spirituous Liquor” as defined below under Section 104(A)(7).
2. “Alcoholic Beverage” is synonymous with the term “liquor” as defined in this Section 104. (4) below.
3. “Beer” means any beverage obtained by the alcoholic fermentation, infusion, or decoction of barley malt, hops, or other ingredients not drinkable, or any combination thereof.
4. “Liquor” or “Liquor Products” includes the four varieties of liquor herein defined (alcohol, spirituous liquor, wine, and beer) and means all fermented, spirituous, vinous, or malt liquor, or a combination thereof, and mixed liquor, a part of which is fermented, spirituous, vinous, or malt liquor or otherwise intoxicating in every liquid or solid or semi-solid or other substance patented or not containing alcohol, spirits, wine, or beer, and all
5. “Liquor License” means the Liquor License approved by the Tribal Council and issued by the state of Arizona upon application by the Nation to such Subordinate Economic Organization or Enterprise of the Nation as the Council may authorize by resolution to hold such license and exercise the rights and privileges thereunder.
6. “Sale” and “Sell” means any transaction that includes any exchange, barter, sale and traffic; and also includes the selling, supplying or distributing, by any means whatsoever, of liquor by any person to any other person.
7. “Spirituous Liquor”, “Spirits”, or “Distilled Spirits” includes alcohol, brandy, whiskey, rum, tequila, mescal, gin, wine, porter, ale, beer, any malt liquor or malt beverage, absinthe, a compound or mixture of any of them or of any of them with any vegetable or other substance, alcohol bitters, bitters containing alcohol, any liquid mixture or preparation, whether patented or otherwise, which, when consumed in sufficient quantities, produces intoxication to any degree, fruits preserved in ardent spirits, and beverages containing more than one-half of one percent of alcohol by volume, and including wines exceeding twenty-four percent (24%) of alcohol by volume.
8. “Wine” means the product obtained by the fermentation of grapes or other agricultural products containing natural or added sugar or any such alcoholic beverage fortified with grape brandy and containing not more than twenty-four percent (24%) of alcohol by volume, including sweet wines fortified with wine spirits, such as port, sherry, muscatel, and angelica, not exceeding twenty-four percent (24%) of alcohol by volume.
In accordance with the law of the United States as set out at 18 U.S.C. 1161, the Nation asserts its jurisdiction to control and regulate liquor sales and service within the boundaries of the Yavapai-Apache Nation Reservation. For purposes of this Liquor Code “Reservation” or “Jurisdiction” means those lands within the exterior boundaries of the Yavapai-Apache Nation, any lands that are held in trust by the United States of America for the benefit of the Yavapai-Apache Nation or any of its members, both now and in the future, any other Yavapai-Apache Nation land constituting “Indian Country” within the meaning of 18 U.S.C. 1151 or any successor provision, and all lands falling within the Nation's Jurisdiction as provided under Article I of the Constitution of the Yavapai-Apache Nation as approved by the United states Secretary of Interior on April 13, 1992.
A. Authorized liquor sales and service within the Nation's Reservation and Jurisdiction shall comply with the State of Arizona's liquor laws to the extent required by 18 U.S.C. 1161 and other applicable law of the United States.
B. The Nation's Attorney General shall ensure that all liquor license requirements under this Code and under the laws of the State of Arizona are satisfied, that the license(s) authorized by the Tribal Council under this Code are renewed on an annual basis, and that all sales and service of liquor as authorized under this Code are carried out in a manner consistent with this Code and applicable laws of the Nation, and under Arizona law to the extent required by applicable law of the United States.
All prior codes, ordinances and resolutions of the Yavapai-Apache Nation regulating, authorizing, prohibiting, or in any way dealing with the sale or service of liquor, including, but not limited to the “Ordinance Legalizing the Introduction, Sale or Possession of Intoxicants”, as adopted under Tribal Council Resolution 91-85 on October 19, 1985, are hereby repealed and are declared to be of no further force or effect.
A. Liquor License Required. Liquor may be offered for sale and served on the Yavapai-Apache Nation Reservation only under a Liquor License as expressly authorized by the Tribal Council in accordance with this Code and applicable federal law.
B. The Council, through the adoption of Council resolutions consistent with this Code, may authorize liquor sales at such additional locations as the Council deems appropriate.
C. Sales for Personal Consumption Only. All liquor sales shall be for the personal use and consumption of the purchaser and not for the purchaser's resale. Any resale of any alcoholic beverage within the Jurisdiction of the Nation is prohibited. Any person or entity that is not licensed under this Code who purchases or possesses an alcoholic beverage within the Nation's Jurisdiction and sells it, whether in the original container or not, shall be guilty of a violation of this Code and shall be subject to such penalties as are prescribed by this Code.
D. License Not Transferable. Except as may be permitted under this Code, Liquor Licenses may not be transferred and said License may only be utilized by the entity holding the License under Section 108 A. above.
E. Inspections. All businesses and their premises holding a Liquor License under this Code shall be open for inspection by the Nation, acting through its officials, agents, employees or other designated representatives, at all reasonable times for the purpose of determining whether said business is complying with this Code.
A. In enforcing this Code, the Tribal Council, acting on behalf of the Nation, may take the following actions:
1. Publish and enforce such rules and regulations as deemed necessary by the Council to govern the manufacture, distribution, sale, and possession of liquor within the Nation's Jurisdiction.
2. Revoke any Liquor License approved by the Council under this Code, following a determination by the Council that the holder of said License has violated any provision of this Code or that the License is no longer in the best interest of the Nation. The holder of the License shall be provided notice and an opportunity to be heard in any such revocation action.
3. Bring suit in the Nation's Tribal Court, or any other court of competent jurisdiction, to enforce this Code.
4. Hold such hearings as the Council deems necessary to administer and enforce this Code.
5. Delegate to the Nation's Tribal Court such authority as may be necessary to enforce the civil penalties arising under this Code. Except as may otherwise be provided by applicable federal law, the Nation's Tribal Court shall have exclusive jurisdiction to enforce this Code.
6. Take all such actions as are within the Council's authority under the laws and Constitution of the Yavapai-Apache Nation in the enforcement of this Code.
A. General Prohibition. Except as authorized under a Liquor License issued under Section 107 of this Code, the introduction or possession of Liquor for sales, distribution or service is
B. Any person who shall sell or offer for sale or distribute or transport in any manner, liquor in violation of this Code, or who shall have liquor for sale in his possession without a Liquor License, shall be in violation of this Code.
C. Any person who, within the Nation's Jurisdiction, buys liquor from any person other than a properly licensed business under Section 108.A. of this Code shall be in violation of this Code.
D. Any person who knowingly keeps or possesses liquor upon his person or in any place or upon any premises conducted or maintained by his employer or principal or agent with the intent to sell or distribute the same contrary to the requirements of this Code, shall be in violation of this Code.
E. No person shall be authorized to sell or serve liquor within the Reservation unless they are at least 21 years of age, except as may be authorized under Arizona liquor control laws. No person may be sold or served liquor unless they are 21 years of age. Any person acting contrary to this prohibition shall be in violation of this Code.
F. No person under the age of 21 years shall consume, acquire or have in his/her possession any liquor. No person shall knowingly permit any other person under the age of 21 years to consume liquor on his/her premises or any premises under his/her control. Any person acting contrary to these prohibitions shall be in violation of this Code, with a separate violation accruing for every drink so consumed by the person under the age of 21 years.
G. Any person who shall sell or provide any liquor to any person under the age of 21 years shall be in violation of this Code for each such drink so provided.
H. Any person who lends, gives or in any way transfers in any manner an identification card or other representation of age to a person under the age of 21 years for the purpose of permitting such person to purchase or otherwise obtain liquor shall be in violation of this Code; provided that corroborative evidence from a source other than the underage person shall be a requirement for finding such violation.
I. Any person who purchases or attempts to purchase liquor through the use of false or altered identification, which falsely purports to show the person to be over the age of 21 years shall be in violation of this Code.
J. When requested by any business or entity holding a liquor license under this Code, any person shall be required to present, and shall present official documentation of the person's age, signature and photograph. This requirement may be satisfied by presentation of one of the following:
i. An unexpired driver license issued by any state, the District of Columbia, any territory of the United States or Canada if the license includes a picture of the licensee and the person's date of birth. A driver license issued to a person who is under twenty-one years of age is no longer an acceptable type of identification under this paragraph thirty days after the person turns twenty-one years of age.
ii. An unexpired non-operating identification license issued by any state, the District of Columbia, any territory of the United States or Canada if the license includes a picture of the person and the person's date of birth. An unexpired non-operating license issued to a person who is under twenty-one years of age is no longer an acceptable type of identification under this paragraph thirty days after the person turns twenty-one years of age.
iii. An unexpired armed forces identification card that includes the person's picture and date of birth.
iv. A valid unexpired passport or a valid unexpired resident alien card that contains a photograph of the person and the person's date of birth.
K. Off Premises Consumption of Liquor—Cliff Castle Casino. All liquor sales and service authorized by this Code at the Cliff Castle Casino and Hotel shall be fully consumed within the premises of the Cliff Castle Casino and Hotel. At the Cliff Castle Casino and Hotel, no open containers of liquor, or unopened containers of liquor in bottles, cans, cups or other containers, or otherwise shall be permitted outside of the above-described premises, except as provided in accordance with the liquor license(s) maintained by the Nation for the Cliff Castle Casino and Hotel, or under such special event license or permit as may be obtained consistent with said license(s). Any person acting contrary to these prohibitions shall be in violation of this Code.
L. No Credit Liquor Sales. The sales and service of liquor authorized by this Code shall be made upon a cash basis only. For purposes of this Code, payment for liquor on a cash basis shall include payment by cash, credit card, or check, including but not limited to any such cash sale of liquor for consumption on a retail licensed premises where the sale is included on bills provided to registered guest in hotels and motels. Any person making liquor sales contrary to this prohibition shall be in violation of this Code.
M. All Liquor which is possessed, including for any distribution, consumption or sale, in violation of the requirements of this Code is hereby declared to be contraband. Any officer of the Yavapai-Apache Nation Police Department shall seize all such contraband and preserve it in accordance with such provisions as apply to the preservation of evidence and impounded property. Upon being found to be in violation of this Code, the person from whom the contraband was seized shall forfeit all right, title and interest in the contraband seized and the same shall become the property of the Nation to be disposed of as it chooses.
A. The Nation's Tribal Court is hereby vested with exclusive jurisdiction to hear and determine all violations arising under Section 110 of this Code, including the determination of any violation by any person of the provisions of this Code and the imposition of any penalties arising from said violations.
B. Any person or entity found by the Tribal Court to have violated any provision of this Code shall be liable to pay to the Nation a civil penalty in an amount not less than $250.00 or greater than $500.00 for each such violation. The Tribal Court shall issue such further orders as are within its powers to ensure collection of said penalties by the
C. DECLARATORY AND INJUNCTIVE RELIEF
In addition to all other remedies, whether at law or in equity, available to the Nation's Tribal Court under the Constitution and Laws of the Yavapai-Apache Nation in the enforcement of this Code, the Tribal Court may employ such declaratory and/or injunctive relief as may be necessary to determine the rights and liabilities arising under this Code and to otherwise provide for enforcement of this Code to the fullest extent possible under the Nation's laws.
A. Nothing in this Liquor Code is intended or shall be construed as a waiver of the sovereign immunity of the Yavapai-Apache Nation. No official or employee of the Nation or any of the Subordinate Economic Organizations and Enterprises of the Nation shall be authorized, nor shall they attempt, to waive the sovereign immunity of the Nation in any manner under this Code.
A. If any provision or provisions in this Code are held invalid by a court of competent jurisdiction, this Code shall continue in effect as if the invalid provision(s) were not a part hereof.
A. This Code shall be effective immediately upon its approval by the Yavapai-Apache Nation Tribal Council, subject only to the certification of the United States Secretary of the Interior, or his/her designee, and its publication in the
Office of the Secretary, Interior.
Notice of an amendment to an existing system of records.
Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Interior is issuing a public notice of its intent to amend the Privacy Act system of records, “Mineral Lease and Royalty Accounting Files—Interior, MMS-1”, to update the system name, system location, categories of individuals covered by the system, categories of records in the system, authority for maintenance of the system, routine uses, storage, safeguards, retention and disposal, system manager and address, notification procedures, records access and contesting procedures, and records source categories. The system name will be updated to “Minerals Revenue Management Support System (MRMSS), OS-30” to reflect new organizational management. The purpose of the system is to facilitate billing, accounts receivable, general ledger, compliance management, and collection of revenues.
Comments must be received by April 25, 2016. The amendments to the system will be effective April 25, 2016.
Any person interested in commenting on this notice may do so by: Submitting comments in writing to Teri Barnett, Departmental Privacy Officer, U.S. Department of the Interior, 1849 C Street NW., Mail Stop 5547 MIB, Washington, DC 20240; hand-delivering comments to Teri Barnett, Departmental Privacy Officer, U.S. Department of the Interior, 1849 C Street NW., Mail Stop 5547 MIB, Washington, DC 20240; or emailing comments to
Minerals Revenue Management Support System Program Manager, Information Management Center (IMC), Office of Natural Resources Revenue, U.S. Department of the Interior, P.O. Box 25165, Lakewood, CO 80225, or by telephone at 303-231-3177.
The Department of the Interior (DOI) Office of Natural Resources Revenue (ONRR), within the Office of the Secretary, is responsible for the management of revenue associated with both Federal offshore and onshore mineral leases, and revenue management services for mineral leases on Indian lands in partnership with the Bureau of Indian Affairs. ONRR maintains the “Mineral Lease and Royalty Accounting Files—Interior, MMS-1,” system of records to manage these responsibilities in support of ONRR's mission to collect, disburse, and verify Federal and Indian energy and other natural resource revenues on behalf of Americans. Due to the restructuring of the Minerals Management Service and ONRR within the Office of the Secretary, DOI is proposing to revise the system name to “Minerals Revenue Management Support System (MRMSS), OS-30” to reflect the new organizational management. Other proposed amendments to the system include updating the system location, categories of individuals covered by the system, categories of records in the system, authority for maintenance of the system, routine uses, storage, safeguards, retention and disposal, system manager and address, notification procedures, record access and contesting record procedures, and records source categories. The Mineral Lease and Royalty Accounting Files—Interior, MMS-1 system notice was last published in the
The MRMSS system facilitates mineral lease revenue management including billing, accounts receivable, rents, royalty payments, general ledger activity, compliance management, reporting, and the collection of revenues. The system also supports ONRR Outreach program activities for Indian mineral owners, to foster communication and enhance ONNR's trust responsibilities, and resolve royalty-related problems in partnership with the Bureau of Indian Affairs, Bureau of Land Management, and Office of the Special Trustee for American Indians. The MRMSS system helps ONRR meet its fiduciary responsibilities to manage revenues from energy and mineral leases for the use of public natural resources. The records in the MRMSS are related to both business entities and individuals, though records concerning corporations and other business entities are not subject to the Privacy Act.
The amendments to the system notice will be effective as proposed at the end of the comment period (the comment period will end 30 days after the publication of this notice in the
The Privacy Act of 1974, as amended (5 U.S.C. 552a), embodies fair information practice principles in a statutory framework governing the means by which Federal agencies collect, maintain, use, and disseminate individuals' personal information. The Privacy Act applies to records about individuals that are maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency for which information about an individual is retrieved by the name or by some identifying number, symbol, or other identifier assigned to the individual. The Privacy Act defines an individual as a U.S. citizen or lawful permanent resident. As a matter of policy, DOI extends administrative Privacy Act protections to all individuals. Individuals may request access to their own records that are maintained in a system of records in the possession or under the control of DOI by complying with DOI Privacy Act regulations at 43 CFR part 2, subpart K.
The Privacy Act requires each agency to publish in the
In accordance with 5 U.S.C. 552a(r), DOI has provided a report of this system of records to the Office of Management and Budget and to Congress.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Minerals Revenue Management Support System (MRMSS), OS-30.
Unclassified.
Records in this system are located at the Office of Natural Resources Revenue Center, Denver Federal Center, P.O. Box 25165, MS6055A, Denver, Colorado 80225, and at Office of Natural Resources Revenue contractor facilities that process electronic Minerals Revenue Management Support System records.
Individuals covered by the system include lease and permit holders, current and former landowners and lessees, royalty payors and production operators, individuals who have reported rents, royalties, and bonuses from oil or other minerals or gas from producing or nonproducing Federal or Indian leases, current and former Federal employees and contractors, state and local government employees, and Tribal government officials. The system also contains records concerning corporations and other business entities that are not subject to the Privacy Act. However, records pertaining to individuals acting on behalf of corporations and other business entities may reflect personal information.
This system contains records relating to the general administration of the MRMSS, and records relating to minerals revenue asset management, compliance management, and financial management. These records are related to business entities and individuals and includes leases, permits, correspondence, forms, disbursements, reports, and other documents which may contain first and last names, addresses, telephone numbers, fax numbers, email addresses, other contact information, lease numbers, revenues collected, outreach information of individual Indian owners, dates due, customer identification number, owner identification number, location of land, type of lease, lessee and/or payor information, allottee production volume, commodity, reported revenues, sales value, royalty amounts, tax identification number, rate billed, amount charged, interest and penalty, collection actions, bank account number, check number, amount paid, contract number, agreement number, allotment number, well number, and other information that may be generated or maintained during the processing and administration of minerals revenue management responsibilities. The records concerning corporations and other business entities are compliance activities and are not subject to the Privacy Act. However, records pertaining to individuals acting on behalf of corporations and other business entities may reflect personal information.
ONRR Outreach program activities include phone calls, email, and correspondence, as well as meetings with individual Indian owners that have ownership in revenues that come from mineral leases. These records may include first and last name, email address, phone number, individual owner identification, allocated ownership percentage, estimated revenues from leases, and other information that may be contained in correspondence with or requests from individuals generated through outreach activities to support and provide a response to customer inquiries.
The Federal Oil and Gas Royalty Management Act of 1982, 30 U.S.C. 1701-1759; Chapter 12 of Title 25 of the U.S. Code, addressing the lease, sale, or surrender of allotted or unallotted lands, found at 25 U.S.C. 391-416j; Chapter 3A of Title 30 of the U.S. Code, addressing leases and prospecting permits, found at 30 U.S.C. 181-196; and the Outer Continental Shelf Lands Act, 43 U.S.C. 1331-1356b.
The purposes of the system are to collect royalties and rents; control revenues; distribute funds collected; maintain records of royalty accounts and associated sales and production information; provide data to facilitate comparative auditing of mineral production, royalties due, revenues collected, and funds distributed; gather statistics for managing the mineral leasing program; provide informational access to external users including states, Indian tribes or agencies, and Federal agencies; and provide outreach services to the Indian community.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be
(1) (a) To any of the following entities or individuals, when the circumstances set forth in paragraph (b) are met:
(i) The U.S. Department of Justice (DOJ);
(ii) A court or an adjudicative or other administrative body;
(iii) A party in litigation before a court or an adjudicative or other administrative body; or
(iv) Any DOI employee acting in his or her individual capacity if DOI or DOJ has agreed to represent that employee or pay for private representation of the employee;
(b) When:
(i) One of the following is a party to the proceeding or has an interest in the proceeding:
(A) DOI or any component of DOI;
(B) Any other Federal agency appearing before the U.S. Department of the Interior's Office of Hearings and Appeals;
(C) Any DOI employee acting in his or her official capacity;
(D) Any DOI employee acting in his or her individual capacity if DOI or DOJ has agreed to represent that employee or pay for private representation of the employee;
(E) The United States, when DOJ determines that DOI is likely to be affected by the proceeding; and
(ii) DOI deems the disclosure to be:
(A) Relevant and necessary to the proceeding; and
(B) Compatible with the purpose for which the records were compiled.
(2) To a congressional office in response to a written inquiry that an individual covered by the system, or the heir of such individual if the covered individual is deceased, has made to the office.
(3) To any criminal, civil, or regulatory law enforcement authority (whether Federal, state, local, tribal or foreign) when a record, either alone or in conjunction with other information, indicates a violation or potential violation of law—criminal, civil, or regulatory in nature, and the disclosure is compatible with the purpose for which the records were compiled.
(4) To an official of another Federal agency to provide information needed in the performance of official duties related to reconciling or reconstructing data files or to enable that agency to respond to an inquiry by the individual to whom the record pertains.
(5) To Federal, state, local, tribal, or foreign agencies that have requested information relevant or necessary to the hiring, firing or retention of an employee or contractor, or the issuance of a security clearance, license, contract, grant or other benefit, when the disclosure is compatible with the purpose for which the records were compiled.
(6) To representatives of the National Archives and Records Administration (NARA) to conduct records management inspections under the authority of 44 U.S.C. 2904 and 2906.
(7) To state, territorial and local governments and tribal organizations to provide information needed in response to court order and/or discovery purposes related to litigation, when the disclosure is compatible with the purpose for which the records were compiled.
(8) To an expert, consultant, or contractor (including employees of the contractor) of DOI that performs services requiring access to these records on DOI's behalf to carry out the purposes of the system.
(9) To appropriate agencies, entities, and persons when:
(a) It is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; and
(b) DOI has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interest, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by DOI or another agency or entity) that rely upon the compromised information; and
(c) The disclosure is made to such agencies, entities and persons who are reasonably necessary to assist in connection with DOI's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(10) To the Office of Management and Budget (OMB) during the coordination and clearance process in connection with legislative affairs as mandated by OMB Circular A-19.
(11) To the Department of the Treasury to recover debts owed to the United States.
(12) To the news media and the public, with the approval of the Public Affairs Officer in consultation with counsel and the Senior Agency Official for Privacy, where there exists a legitimate public interest in the disclosure of the information, except to the extent it is determined that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
(13) To other Federal agencies for the purpose of submitting reports, data and information related to the production of minerals such as oil, gas and solids associated with the management of revenues.
Pursuant to 5 U.S.C. 552a(b)(12), disclosures may be made to a consumer reporting agency as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal Claims Collection Act of 1996 (31 U.S.C. 3701(a)(3)).
Records are maintained in paper form in file folders stored in file cabinets, and electronic media such as computers, magnetic disk, diskette, compact discs and computer tapes. The electronic records are maintained in removable drives, computer servers, email and electronic databases.
Customer records are retrieved by name or customer identification number, owner name, or owner identification number; land information is retrieved by location and whether or not the lease is an Indian lease or a Federal onshore or offshore lease. Records are indexed by lease or contract number; lessee and/or payor; permittee; production reporter; and/or commodity.
The records contained in this system are safeguarded in accordance with 43 CFR 2.226 and other applicable security and privacy rules and policies. During normal hours of operation, paper records are maintained in locked filed cabinets under the control of authorized personnel. Computerized records systems follow the National Institute of Standards and Technology standards as developed to comply with the Privacy Act of 1974, 5 U.S.C. 552a; Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521; Federal Information Security Modernization Act of 2014, 44 U.S.C. 3551-3558; and the Federal Information Processing Standards 199: Standards for Security Categorization of Federal Information and Information Systems. Computer servers in which electronic records are stored are located in secured contractor facilities with physical, technical and administrative levels of security to prevent unauthorized access to the DOI network and information assets. Security controls include
Electronic data is protected through user identification, passwords, database permissions and software controls. Access to records in the system is limited to authorized personnel who have a need to access the records in the performance of their official duties, and each user's access is restricted to only the functions and data necessary to perform that person's job responsibilities. System administrators and authorized users are trained and required to follow established internal security protocols and must complete all security, privacy, and records management training and sign the DOI Rules of Behavior. A privacy impact assessment was conducted to ensure appropriate controls and safeguards are in place to protect the information within the system.
Records in this system are maintained under the Minerals Management Service (MMS) Comprehensive Schedule approved by NARA (NC1-057-84-07), which include both permanent and temporary dispositions. These records are subject to litigation holds and permanent retention. Administrative records and general correspondence files have temporary dispositions and are maintained in accordance their respective records schedules dependent on the specific subject matter or function and retention requirements. Temporary mission files related to mineral resource, lease and royalty management activities are cut off at the close of the fiscal year then transferred to a Federal records center, one year after cutoff, and destroyed 7 years after cutoff. Approved disposition methods include shredding or pulping paper records, and degaussing or erasing electronic records in accordance with 384 Department Manual 1 and NARA guidelines.
MRMSS Program Manager, Information Management Center (IMC), Office of Natural Resources Revenue, U.S. Department of the Interior, P.O. Box 25165, Lakewood, Colorado 80225.
An individual requesting notification of the existence of records on himself or herself should send a signed, written inquiry to the System Manager identified above. The request envelope and letter should both be clearly marked “PRIVACY ACT INQUIRY.” A request for notification must meet the requirements of 43 CFR 2.235.
An individual requesting records on himself or herself should send a signed, written inquiry to the System Manager identified above. The signed request should describe the records sought as specifically as possible. The request envelope and letter should both be clearly marked “PRIVACY ACT REQUEST FOR ACCESS.” A request for access must meet the content requirements of 43 CFR 2.238.
An individual requesting corrections or the removal of material from his or her records should send a signed, written request to the System Manager identified above. A request for corrections or removal must meet the requirements of 43 CFR 2.246.
Information in the system is obtained directly from lease and permit holders, current and former landowners and lessees, royalty payors and production operators, individuals who have reported rents, royalties, and bonuses from oil or other minerals or gas from producing or nonproducing Federal or Indian leases, current and former Federal employees and contractors, state and local government employees, and Tribal government officials. Information may also be obtained from DOI bureau and office records supporting revenue management and outreach activities including the Bureau of Ocean Energy Management, Bureau of Safety and Environmental Enforcement, Bureau of Land Management, Bureau of Indian Affairs, Office of the Special Trustee for American Indians, other offices or programs providing support or data for this system, and other Federal, state, tribal or local agencies.
None.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the Coastal Oregon Resource Advisory Council (RAC) will meet as indicated below:
The Coastal Oregon RAC will hold a public meeting Thursday, April 7th, 2016, from 12:30 p.m. to 5:00 p.m. and Friday, April 8th, 2016, from 8:00 a.m. to 2:30 p.m.
The Coastal Oregon RAC will meet at the Coos Bay District Office, 1300 Airport Lane, North Bend, Oregon 97459.
Megan Harper, Public Affairs Specialist, BLM Coos Bay District Office, 1300 Airport Lane, North Bend, Oregon 97459, (541) 751-4353, or email
The Coastal Oregon RAC consists of 15 members chartered and appointed by the Secretary of the Interior. Their diverse perspectives are represented in commodity, conservation, and general interests. They provide advice to BLM resource managers regarding management plans and proposed resource actions on public land in coastal Oregon. Tentative agenda items for the April 7th and 8th, 2016, meeting include review and recommendation of projects to fund under Title II of the Secure Rural Schools and Community Self Determination Act, as reauthorized. Any other matters that may reasonably come before the Coastal Oregon RAC may also be addressed. This meeting is open to the public in its entirety.
A public comment period will be available on April 7th, 2016 at 3:45 p.m. Unless otherwise approved by the Coastal Oregon RAC Chair, the public comment period will last no longer than 30 minutes, and each speaker may address the Coastal Oregon RAC for a maximum of 5 minutes. Meeting times and the duration scheduled for public comment periods may be extended or altered when the authorized representative considers it necessary to accommodate necessary business and all who seek to be heard regarding matters before the Coastal Oregon RAC.
Before including your address, phone number, email address, or other personal identifying information in your
National Park Service, Interior.
Notice of meeting.
Notice is hereby given in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), and Part 65 of title 36 of the Code of Federal Regulations, that a meeting of the National Historic Landmarks Committee of the National Park System Advisory Board will be held beginning at 10:00 a.m. on May 9, 2016, at the Charles Sumner School Museum and Archives. The meeting will continue beginning at 9:30 a.m. on May 10, 2016.
The meeting will be held on Monday, May 9, 2016, from 10:00 a.m. to 4:30 p.m.; and Tuesday, May 10 from 9:30 a.m. to 4:30 p.m. (EASTERN).
The committee may also consider the following historic trail:
Patricia Henry, Historian, National Historic Landmarks Program, National Park Service, 1849 C Street NW., Washington, DC 20240, email: (202) 354-2216 or email:
The purpose of the meeting of the National Historic Landmarks Committee of the National Park System Advisory Board is to evaluate nominations of historic properties in order to advise the National Park System Advisory Board of the qualifications of each property being proposed for National Historic Landmark designation, and to make recommendations regarding the possible designation of those properties as National Historic Landmarks to the National Park System Advisory Board at a subsequent meeting at a place and time to be determined. The Committee also makes recommendations to the National Park System Advisory Board regarding amendments to existing designations and proposals for withdrawal of designation. The members of the National Historic Landmarks Committee are:
The meeting will be open to the public. Pursuant to 36 CFR part 65, any member of the public may file, for consideration by the National Historic Landmarks Committee of the National Park System Advisory Board, written comments concerning the National Historic Landmarks nominations, amendments to existing designations, or proposals for withdrawal of designation.
Comments should be submitted to J. Paul Loether, Chief, National Historic Landmarks Program and National Register of Historic Places, National Park Service, 1849 C Street NW., Washington, DC 20240, email:
Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice of meetings.
This notice announces a schedule of upcoming meetings for the Gettysburg National Military Park Advisory Commission.
The Gettysburg National Military Park Advisory Commission will host two meetings on Thursday, April 28, 2016, and Thursday, September 15, 2016. Both scheduled meetings will begin at 7:00 p.m. and end at 9:00 p.m. (EASTERN). Efforts have been made locally to ensure that the interested public is aware of the meeting dates.
Ed Clark, Superintendent and Designated Federal Official, Gettysburg National Military Park, 1195 Baltimore Pike, Suite 100, Gettysburg, Pennsylvania 17325, or telephone (717) 334-1124 or email
The Gettysburg National Military Park Advisory Commission was established by Public Law 101-377. The scheduled meetings will be open to the public. Each scheduled meeting will include presentations on the Gettysburg National Military Park Operational Update, and subcommittee reports. The April 28, 2016, meeting will also have the nomination of new officers. Any member of the public may file with the committee a written statement with
Before including your address, telephone number, email address, or other personal identifying information in your comments—you should be aware that your entire comment—including your personal identifying information may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public view, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Meeting notice.
Notice is hereby given in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 1-16), that the Preservation Technology and Training Board (PTT Board) of the National Center for Preservation Technology and Training (NCPTT), National Park Service, will meet on April 20, 2016, and April 21, 2016, at Ball State University in Muncie, Indiana.
The PTT Board's meeting agenda will include: Review and comment on the NCPTT FY 2015 accomplishments, and operational priorities for FY 2016; FY 2015 and FY 2016 NCPTT budget and initiatives; recent research; and training programs.
Wednesday, April 20, 2016, 9:00 a.m. to 5:00 p.m. (CDT) and Thursday, April 21, 2016, 9:00 a.m. to 12:00 p.m. (CDT) in Muncie, Indiana.
The meeting location on Wednesday, April 20, 2016: Ball State University, L.A. Pittenger Student Center, Forum Room, 2nd Floor, Muncie, Indiana 47306. The meeting location on Thursday, April 21, 2016: Ball State University, Bracken Library, Room 215, 2nd Floor, Muncie, Indiana 47306.
Persons wishing more information concerning this meeting, or who wish to submit written statements, may contact: Kirk A. Cordell, Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457, telephone (318) 356-7444 or via email
The PTT Board was established by Congress to provide leadership, policy advice, and professional oversight to the NCPTT in compliance with Section 404 of the National Historic Preservation Act of 1966, as amended, (54 U.S.C. 305303).
The PTT Board meeting is open to the public. Facilities and space for accommodating members of the public are limited; however, visitors will be accommodated on a first-come, first-served basis. Any member of the public may file a written statement concerning any of the matters to be discussed by the PTT Board.
Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Minutes of the meeting will be available for public inspection no later than 90 days after the meeting at the office of the Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457, telephone (318) 356-7444.
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior, proposed to appoint new member to the Gettysburg National Military Park Advisory Commission (Commission). The NPS is requesting nominations for qualified persons to serve as members of the Commission.
Written nominations must be received by April 25, 2016.
Nominations or requests for further information should be sent to Catherine Lawhon, Management Assistant, Gettysburg National Military Park/Eisenhower National Historic Site, 1195 Baltimore Pike, Suite 100, Gettysburg, Pennsylvania, 17325, telephone at (717) 338-4402.
Catherine Lawhon, Management Assistant, Gettysburg National Military Park/Eisenhower National Historic Site, 1195 Baltimore Pike, Suite 100, Gettysburg, Pennsylvania, 17325, telephone at (717) 338-4402, email
The Commission was established by Public Law 101-377 (16 U.S.C. 430g-8), to advise the Secretary of the Interior on the coordination of the management of the Gettysburg National Military Park and Gettysburg Battlefield Historic District with local governmental jurisdictions.
The Commission is composed of 11 members, 10 of whom are appointed by the Secretary of the Interior, as follows: (a) One member representing each of the four townships surrounding the park (Cumberland, Mount Joy, Mount Pleasant, Straban Townships) and the Borough of Gettysburg; (b) one member representing the Adams County, Pennsylvania government; (c) one member representing the Pennsylvania State Historic Preservation Office; (d) two members who are residents of Adams County and are knowledgeable about the park and its resources, one of whom owns land or interests in land within the park boundary; and (e) one member with expertise in local historic preservation. The Director of the National Park Service or a designee, is an ex officio, non-voting member.
Each member shall be appointed for a term of three years. A member may serve after the expiration of that member's term until a successor has taken office. The Chairperson of the Commission shall be elected by the members.
We are currently seeking members representing Mount Joy Township, Straban Township, and the State Historic Preservation Office of the Commonwealth of Pennsylvania.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Commission and permit the Department of the Interior to contact a potential member.
Members of the Commission serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Commission as approved by the Designated Federal Officer, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under Section 5703 of Title 5 of the United States Code.
Individuals who are Federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Razor USA LLC, Inventist, Inc. and Shane Chen on March 22, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain motorized self-balancing vehicles. The complaint names as respondents Alibaba Group Holding Ltd. of Hong Kong; Alibaba Group Holding Ltd. (U.S.) of San Mateo, CA; Alibaba.com Ltd. of China; Alibaba Global Shipping Inc. a.k.a Alibaba Logistics, Inc. of Oakland, CA; Hangzhou Chic Intelligent Technology Co., Ltd. of China; Contixo of Ontario, CA; ZTO Store a.k.a. ZTO Trading, Inc. of Monterey Park, CA; CyBoard LLC a.k.a. Shark Empire Inc. of Glendale, CA; Genius Technologies a.k.a. Prime Capital of Hastings, MN; GyroGlyder.com of Stockton, CA; HoverTech of Hebron, KY; InMotion Entertainment Group LLC of Jacksonville, FL; Soibatian Corporation dba IO Hawk and dba Smart Wheels of Glendale, CA; Jetson Electric Bikes LLC of New York, NY; Joy Hoverboard, a.k.a. Huizhou Aoge Enterprize Co. Ltd. of China; Shenzhen Kebe Technology Co., Ltd. of China; Leray Group of China; Modell's Sporting Goods, Inc. of New York, NY; Newegg.com Inc. of City of Industry, CA; PhunkeeDuck, Inc. of Floral Park, NY; Powerboard a.k.a. Optimum Trading Co. of Hebron, KY; Shareconn International, Inc. of China; Shenzhen Chenduoxing Electronic Technology Ltd. of China; Shenzhen Jomo Technology Co., Ltd. of China ; Shenzhen R.M.T. Technology Co., Ltd. of China; Shenzhen Supersun Technology Co. Ltd., a.k.a. Aottom of China; Skque Products of Irwindale, CA; Spaceboard USA of Norcross, GA; Swagway LLC of Southbend, IN; Twizzle Hoverboard of La Puente, CA; and Uwheels of Santa Ana, CA. The complainant requests that the Commission issue a general exclusion order, or in the alternative, a limited exclusion order, and a cease and desist order.
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3129”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 14) granting the joint motion of complainant Varidesk LLC of Coppell, Texas (“Varidesk”) and respondent Brunswick Corp. of Lake Forest, Illinois (“Brunswick”) to terminate the above-referenced investigation on the basis of a patent license, and settlement and release agreement. The investigation is terminated.
Megan M. Valentine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2301. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on November 6, 2015, based on a Complaint filed by Varidesk, as supplemented and amended. 80
On February 17, 2016, Varidesk and Brunswick filed a joint motion to terminate this investigation based on a patent license, and settlement and release agreement. On February 25, 2016, OUII filed a response supporting the motion.
On February 25, 2016, the ALJ issued the subject ID, granting the joint motion for termination of the investigation. The ALJ found that the joint motion complied with the requirements of Commission Rule 210.21(b)(1) and that granting the motion would not be contrary to the public interest.
No petitions for review of the subject ID were filed.
The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information
Comments are encouraged and will be accepted for an additional 30 days until April 25, 2016.
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
If additional information is required please contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
On March 21, 2016, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Puerto Rico in the lawsuit entitled
The Consent Decree resolves the United States' and the Commonwealth of Puerto Rico's claims set forth in the complaint against Defendants GMR Progress LLC and General Maritime Management (Portugal) Lda for natural resource damages caused by an oil spill from the vessel Genmar Progress on August 29, 2007. Under the Consent Decree, the Defendants will pay a total of $2,750,000, including $83,090 in assessment costs and $2,666,910 to restore the injury to natural resources resulting from the Spill.
The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division and should refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $13.75 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $5.25.
This notice announces a forthcoming meeting of the National Institute of Corrections (NIC) Advisory Board. The meeting will be open to the public.
Employment and Training Administration (ETA), Labor.
Notice.
Title I of WIOA (Pub. L.113-128) requires the U.S. Secretary of Labor (Secretary) to update and publish the LLSIL tables annually, for uses described in the law (including determining eligibility for youth). WIOA defines the term “low income individual” as one who qualifies under various criteria, including an individual in a family with total family income for a six-month period that does not exceed the higher level of the poverty line or 70 percent of the LLSIL. This issuance provides the Secretary's annual LLSIL for 2016 and references the current 2016 Health and Human Services “Poverty Guidelines.”
This notice is effective March 25, 2016.
Please contact Samuel Wright, Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW., Room C-4526, Washington, DC 20210; Telephone: 202-693-2870; Fax: 202-693-3015 (these are not toll-free numbers); Email address:
Please contact Jennifer Kemp, Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW., Room N-4464, Washington, DC 20210; Telephone: 202-693-3377; Fax: 202-693-3113 (these are not toll-free numbers); Email:
The purpose of WIOA is to provide workforce investment activities through statewide and local workforce investment systems that increase the employment, retention, and earnings of participants. WIOA programs are intended to increase the occupational skill attainment by participants and the quality of the workforce, thereby reducing welfare dependency and enhancing the productivity and competitiveness of the Nation.
LLSIL is used for several purposes under the WIOA. Specifically, WIOA SEC.3(36) (A)(B)defines the term “low income individual” for eligibility purposes, and SEC.127(b)(2)(c), SEC.132(b)(1)(B)(IV),(V)(bb) define the terms “disadvantaged youth” and “disadvantaged adult” in terms of the poverty line or LLSIL for State formula allotments. The governor and state/local
WIOA Section 3(36)(B) defines LLSIL as “that income level (adjusted for regional, metropolitan, urban and rural differences and family size) determined annually by the Secretary [of Labor] based on the most recent lower living family budget issued by the Secretary.” The most recent lower living family budget was issued by the Secretary in fall 1981. The four-person urban family budget estimates, previously published by the U.S. Bureau of Labor Statistics (BLS), provided the basis for the Secretary to determine the LLSIL. BLS terminated the four-person family budget series in 1982, after publication of the fall 1981 estimates. Currently, BLS provides data to ETA, which ETA then uses to develop the LLSIL tables, as provided in the Appendices to this
ETA published the 2015 updates to the LLSIL in the
The updated figures for a four-person family are listed in Appendix A, Table 1, by region for both metropolitan and non-metropolitan areas. Numbers in all of the Appendix tables are rounded up to the nearest dollar. Since program eligibility for low-income individuals, “disadvantaged adults” and “disadvantaged youth” may be determined by family income at 70 percent of the LLSIL, pursuant to WIOA Section 3 (36)(A)(ii) and Section 3(36)(B), respectively, those figures are listed as well.
Jurisdictions included in the various regions, based generally on the Census Regions of the U.S. Department of Commerce, are as follows:
For Alaska, Hawaii, and Guam, the year 2016 figures were updated from the 2015 “State Index” based on the ratio of the urban change in the state (using Anchorage for Alaska and Honolulu for Hawaii and Guam) compared to the West regional metropolitan change, and then applying that index to the West regional metropolitan change.
Data on 23 selected Metropolitan Statistical Areas (MSAs) are also available. These are based on annual and semiannual CPI-U changes for a 12-month period ending in December 2015. The updated LLSIL figures for these MSAs and 70 percent of LLSIL are reported in Appendix C, Table 3.
Appendix D, Table 4 lists each of the various figures at 70 percent of the updated 2015 LLSIL for family sizes of one to six persons. Because Tables 1-3 only list the LLSIL for a family of four, Table 4 can be used to separately determine the LLSIL for families of between one and six persons. For families larger than six persons, an amount equal to the difference between the six-person and the five-person family income levels should be added to the six-person family income level for each additional person in the family. Where the poverty level for a particular family size is greater than the corresponding 70 percent of the LLSIL figure, the figure is shaded. A modified Microsoft Excel version of Appendix D, Table 4, with the area names, will be available on the ETA LLSIL Web site at
Governors should designate the appropriate LLSILs for use within the State from Appendices A, B, and C, containing Tables 1 through 3. Appendices D and E, which contain Tables 4 and 5, which adjust a family of four figure for larger and smaller families, may be used with any LLSIL designated area. The governor's designation may be provided by disseminating information on MSAs and metropolitan and non-metropolitan areas within the state or it may involve further calculations. For example, the State of New Jersey may have four or more LLSIL figures for Northeast metropolitan, Northeast non-metropolitan, portions of the state in the New York City MSA, and those in the Philadelphia MSA. If a workforce investment area includes areas that would be covered by more than one LLSIL figure, the governor may determine which is to be used.
A state's policies and measures for the workforce investment system shall be accepted by the Secretary to the extent that they are consistent with WIOA and WIOA regulations.
It should be noted that publication of these figures is only for the purpose of meeting the requirements specified by WIOA as defined in the law and regulations. BLS has not revised the lower living family budget since 1981, and has no plans to do so. The four-person urban family budget estimates series has been terminated. The CPI-U adjustments used to update LLSIL for this publication are not precisely comparable, most notably because certain tax items were included in the 1981 LLSIL, but are not in the CPI-U. Thus, these figures should not be used for any statistical purposes, and are valid only for those purposes under WIOA as defined in the law and regulations.
To use the 70 percent LLSIL value, where it is stipulated for the WIOA programs, begin by locating the region or metropolitan area where the program applicant resides. These are listed in Tables 1, 2 and 3. After locating the appropriate region or metropolitan statistical area, find the 70 percent LLSIL amount for that location. The 70 percent LLSIL figures are listed in the last column to the right on each of the three tables. These figures apply to a family of four. Larger and smaller family eligibility is based on a percentage of the family of four. To determine eligibility for other size families consult Table 4 and the instructions below.
To use Table 4, locate the 70 percent LLSIL value that applies to the individual's region or metropolitan area from Tables 1, 2 or 3. Find the same number in the “family of four” column of Table 4. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the maximum household income the individual is permitted in order to qualify as economically disadvantaged under the WIOA.
Where the HHS poverty level for a particular family size is greater than the corresponding LLSIL figure, the LLSIL figure appears in a shaded block. Individuals from these size families may consult the 2016 HHS poverty guidelines found on the Health and Human Services Web site at
To use the LLSIL to determine the minimum level for establishing self-sufficiency criteria at the State or local level, begin by locating the metropolitan area or region from Table 1, 2 or 3. Then locate the appropriate region or metropolitan statistical area and then find the 2015 adjusted LLSIL amount for that location. These figures apply to a family of four. Locate the corresponding number in the family of four in the column below. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the minimum figure that States must set for determining whether employment leads to self-sufficiency under WIOA programs.
Occupational Safety and Health Administration (OSHA), Labor.
Announcement of special meeting of the ACCSH.
ACCSH will hold a special meeting April 25-26, 2016, in Washington, DC, to draft a construction version of OSHA's planned Safety and Health Program Management Guidelines.
Submit (postmark, send, transmit) comments, requests to address the ACCSH meeting, speaker presentations (written or electronic), and requests for special accommodations for the ACCSH meeting, by April 15, 2016.
OSHA will post comments, requests to speak, and speaker presentations, including any personal information provided, without change, at:
ACCSH advises the Secretary of Labor and the Assistant Secretary of Labor for Occupational Safety and Health (Assistant Secretary) in the formulation of standards affecting the construction industry, and on policy matters arising in the administration of the safety and health provisions under the Contract Work Hours and Safety Standards Act (Construction Safety Act (CSA)) (40 U.S.C. 3701
• Assistant Secretary's remarks;
• Drafting of the construction version of the OSHA Safety and Health Program Management Guidelines; and,
• Public Comment Period.
• The amount of time requested to speak;
• The interest you represent (
• A brief outline of your presentation.
PowerPoint presentations and other electronic materials must be compatible with PowerPoint 2010 and other Microsoft Office 2010 formats.
Alternately, at the ACCSH meeting, you may request to address ACCSH briefly by signing the public-comment request sheet and listing the topic(s) you will address. You also must provide 20 hard copies of any materials, written or electronic, you want to present to ACCSH.
The ACCSH Chair may grant requests to address ACCSH as time and circumstances permit.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by 29 U.S.C. 656; 40 U.S.C. 3704; 5 U.S.C. App. 2; 29 CFR parts 1911 and 1912; 41 CFR 102-3; and Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).
National Capital Planning Commission.
Notice of final adoption of updated
The National Capital Planning Commission (NCPC) adopted updates to the Federal Elements of the
NCPC is the central planning agency for the federal government in the National Capital Region and prepares and adopts a “comprehensive, consistent, and coordinated plan for the National Capital.” The Federal Elements guide planning and development, and address matters related to Federal properties and interests in the National Capital Region, which include the District of Columbia; Montgomery and Prince George's Counties in Maryland; Arlington, Fairfax, Loudoun, and Prince William Counties in Virginia; and all cities within the boundaries of these counties. The Federal Elements provide the policy framework for Commission actions on plans and proposals submitted for its review. The eight Federal Elements in the Comprehensive Plan include Urban Design, Federal Workplace, Foreign Missions & International Organizations, Transportation, Parks & Open Space, Federal Environment, Historic Preservation, and Visitors & Commemoration.
The updated Federal Elements of the
Angela Dupont at
The updated Federal Elements of the
40 U.S.C. 8721(a).
U.S. Office of Personnel Management.
60-Day notice and request for comments.
Federal Investigative Services (FIS), U.S. Office of Personnel Management (OPM) is notifying the general public and other federal agencies that OPM is seeking Office of Management and Budget (OMB) approval of a revised information collection control number 3206-0258, Questionnaire for Public Trust Positions, Standard Form 85P (SF 85P) and Supplemental Questionnaire for Selected Positions, Standard Form SF 85P-S (SF 85P-S). OPM is soliciting comments for this collection as required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106). The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who
Comments are encouraged and will be accepted until May 24, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Federal Investigative Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Donna McLeod or by electronic mail at
A copy of this information collection, with applicable supporting documentation, may be obtained by contacting the Federal Investigative Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Donna McLeod or by electronic mail at
Questionnaire for Public Trust Positions, SF 85P and Supplemental Questionnaire for Selected Positions, SF 85P-S, including accompanying releases, housed in a system named e-QIP (Electronic Questionnaires for Investigative Processing), are information collections completed by applicants for, or incumbents of, Federal Government civilian positions, or positions in private entities performing work for the Federal Government under contract (SF 85P only). The collections are used as the basis of information for background investigations to establish that such persons are:
• Suitable for employment or retention in Federal employment in a public trust position or fit for employment or retention in Federal employment in the excepted service when the duties to be performed are equivalent in degree of trust reposed in the incumbent to a public trust position;
• Fit to perform work on behalf of the Federal Government pursuant to the Government contract, when the duties to be performed are equivalent in degree of trust reposed in the individual to a public trust position;
• Eligible for physical and logical access to federally controlled facilities or information systems, when the duties to be performed by the individual are equivalent to the duties performed by an employee in a public trust position.
The SF 85P and SF 85P-S are completed by applicants for, or incumbents of, Federal Government civilian positions, or positions in private entities performing work for the Federal Government under contract. For applicants, the SF 85P and SF 85P-S are to be used only after a conditional offer of employment has been made. The SF 85P-S is supplemental to the SF 85P and is used only as approved by OPM, for certain positions such as those requiring carrying of a firearm. e-QIP (Electronic Questionnaires for Investigations Processing) is a web-based system application that houses the SF 85P and SF 85P-S. A variable in assessing burden hours is the nature of the electronic application. The electronic application includes branching questions and instructions which provide for a tailored collection from the respondent based on varying factors in the respondent's personal history. The burden on the respondent is reduced when the respondent's personal history is not relevant to particular question, since the question branches, or expands for additional details, only for those persons who have pertinent information to provide regarding that line of questioning. Accordingly, the burden on the respondent will vary depending on whether the information collection relates to the respondent's personal history.
OPM proposes new changes to the SF 85P. The proposed changes identified in this notice represent modifications to the last approved version of this collection which were published in a 60-day notice in the
OPM proposes changes to the SF 85P-S. Question 3, ‘Your Use of Illegal Drugs and Drug Activity” will also include clarifying instruction that drug use or activity illegal under Federal laws must be reported, even if that use or activity is legal under state or local law(s). It is possible that there will be additional changes to conform language on the SF 85P-S to language in similar forms.
This ICR also requests categorizing these forms as common forms. OPM will continue to estimate the burden based on all Federal agencies that submit the SF 85P and SF 85P-S to OPM for investigation. If and when approves the use of common forms, all Federal agencies using these forms not in connection with an OPM investigation may request the use of these common forms without additional 60 or 30 day notice and comment requirements. At that point, each such agency will account for its number of respondents and the burden associated with the agency's use.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 198 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 198 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-99 and CP2016-127 to consider the Request pertaining to the proposed Priority Mail Contract 198 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than March 28, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-99 and CP2016-127 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than March 28, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail & First-Class Package Service Contract 16 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail & First-Class Package
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-105 and CP2016-133 to consider the Request pertaining to the proposed Priority Mail & First-Class Package Service Contract 16 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than March 28, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-105 and CP2016-133 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than March 28, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 197 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30-.35, the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 197 to the competitive product list.
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-98 and CP2016-126 to consider the Request pertaining to the proposed Priority Mail Contract 197 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than March 28, 2016. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Jennaca D. Upperman to serve as Public Representative in these dockets.
The version of the contract provided to the Commission under seal appears to redact information in Section F. The Postal Service is requested to provide an explanation and, if necessary, file an errata. The Postal Service response is due no later than March 23, 2016.
1. The Commission establishes Docket Nos. MC2016-98 and CP2016-126 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Jennaca D. Upperman is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. The Postal Service's response to the request for supplemental information is due no later than March 23, 2016.
4. Comments are due no later than March 28, 2016.
5. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on March 18, 2016, it filed with the Postal Regulatory Commission a
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940, as amended (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act.
Applicants request an order that would permit (a) series of certain open-end management investment companies to issue shares (“Shares”) redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Shares to be effected at negotiated market prices rather than at net asset value (“NAV”); (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days after the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares beyond the limits of Section 12(d)(1)(A) and (B) the Act.
Premise Capital, LLC (the “Initial Adviser”), ETF Series Solutions (the “Trust”) and Quasar Distributors, LLC (“Quasar”).
The application was filed on September 30, 2015, and amended on January 22, 2016.
An order granting the requested relief will be issued unless the Commission
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Premise Capital, LLC, 300 E. 5th Ave. Suite 265, Naperville, IL, 60563; The Trust and Quasar, 615 East Michigan Street, 4th Floor, Milwaukee, Wisconsin 53202, c/o W. John McGuire, Esq., Morgan Lewis & Bockius LLP, 1111 Pennsylvania Avenue NW., Washington, DC 20004-2541 and Michael D. Barolsky, Esq., U.S. Bancorp Fund Services, LLC, 615 Michigan Street Milwaukee, WI 53202.
Rachel Loko, Senior Counsel, at (202) 551-6883, or Holly Hunter-Ceci, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Trust is a Delaware statutory trust and is registered under the Act as an open-end management investment company with multiple series. Each series will operate as an exchange traded fund (“ETF”).
2. The Initial Adviser will be the investment adviser to the new series of the Trust (“Initial Fund”). The Initial Adviser is, and any other Adviser (as defined below) will be, registered as an investment adviser under the Investment Advisers Act of 1940 (“Advisers Act”). The Adviser may enter into sub-advisory agreements with one or more investment advisers to act as sub-advisers to particular Funds (each, a “Sub-Adviser”). Any Sub-Adviser will either be registered under the Advisers Act or will not be required to register thereunder.
3. The Trust will enter into a distribution agreement with one or more distributors. Each distributor for a Fund will be a broker-dealer (“Broker”) registered under the Securities Exchange Act of 1934 (“Exchange Act”) and will act as distributor and principal underwriter (“Distributor”) for one or more of the Funds. No Distributor is or will be affiliated with any national securities exchange, as defined in Section 2(a)(26) of the Act (“Exchange”). The Distributor for each Fund will comply with the terms and conditions of the requested order. Quasar, a Delaware limited liability company and broker-dealer registered under the Exchange Act, will act as the initial Distributor of the Funds.
4. Applicants request that the order apply to the Initial Fund and any additional series of the Trust, and any other open-end management investment company or series thereof, that may be created in the future (“Future Funds” and together with the Initial Fund, “Funds”), each of which will operate as an ETF and will track a specified index comprised of domestic or foreign equity and/or fixed income securities (each, an “Underlying Index”). Any Future Fund will (a) be advised by the Initial Adviser or an entity controlling, controlled by, or under common control with the Initial Adviser (each, an “Adviser”) and (b) comply with the terms and conditions of the application.
5. Each Fund will hold certain securities, currencies, other assets, and other investment positions (“Portfolio Holdings”) selected to correspond closely to the performance of its Underlying Index. Certain Underlying Indexes will be comprised of equity and/or fixed income securities issued by one or more of the following categories of issuers: (i) Domestic issuers and (ii) non-domestic issuers meeting the requirements for trading in U.S. markets. Other Funds will be based on Underlying Indexes that will be comprised of foreign and domestic, or solely foreign, equity and/or fixed income securities (“Foreign Funds”).
6. Applicants represent that each Fund will invest at least 80% of its assets (excluding collateral held from securities lending) in the component securities of its respective Underlying Index (“Component Securities”) and TBA Transactions,
7. Each Trust may issue Funds that seek to track Underlying Indexes constructed using 130/30 investment strategies (“130/30 Funds”) or other long/short investment strategies (“Long/Short Funds”). Each Long/Short Fund will establish (i) exposures equal to approximately 100% of the long positions specified by the Long/Short Index
8. A Fund will utilize either a replication or representative sampling strategy to track its Underlying Index. A Fund using a replication strategy will invest in the Component Securities of its Underlying Index in the same approximate proportions as in such Underlying Index. A Fund using a representative sampling strategy will hold some, but not necessarily all of the Component Securities of its Underlying Index. Applicants state that a Fund using a representative sampling strategy will not be expected to track the performance of its Underlying Index with the same degree of accuracy as would an investment vehicle that invested in every Component Security of the Underlying Index with the same weighting as the Underlying Index. Applicants expect that the returns of each Fund will have an annual tracking error of less than 5% relative to its Underlying Index.
9. Each Fund will be entitled to use its Underlying Index pursuant to either a licensing agreement with the entity that compiles, creates, sponsors or maintains the Underlying Index (each, an “Index Provider”) or a sub-licensing arrangement with the Adviser, which will have a licensing agreement with such Index Provider.
10. Applicants recognize that Self-Indexing Funds could raise concerns regarding the ability of the Affiliated Index Provider to manipulate the Underlying Index to the benefit or detriment of the Self-Indexing Fund. Applicants further recognize the potential for conflicts that may arise with respect to the personal trading activity of personnel of the Affiliated Index Provider who have access to or knowledge of changes to an Underlying Index's composition methodology or the constituent securities in an Underlying Index prior to the time that information is publicly disseminated.
11. Applicants propose that each Self-Indexing Fund will post on its Web site, on each day the Fund is open, including any day when it satisfies redemption requests as required by Section 22(e) of the Act (a “Business Day”), before commencement of trading of Shares on the Listing Exchange, the identities and quantities of the Portfolio Holdings that will form the basis for the Fund's calculation of its NAV at the end of the Business Day. Applicants believe that requiring Self-Indexing Funds to maintain full portfolio transparency will also provide an effective additional mechanism for addressing any such potential conflicts of interest.
12. In addition, Applicants do not believe the potential for conflicts of interest raised by the Adviser's use of the Underlying Indexes in connection with the management of the Self Indexing Funds and the Affiliated Accounts will be substantially different from the potential conflicts presented by an adviser managing two or more registered funds. Both the Act and the Advisers Act contain various protections to address conflicts of interest where an adviser is managing two or more registered funds and these protections will also help address these conflicts with respect to the Self-Indexing Funds.
13. Each Adviser and any Sub-Adviser has adopted or will adopt, pursuant to Rule 206(4)-7 under the Advisers Act, written policies and procedures designed to prevent violations of the Advisers Act and the rules thereunder. These include policies and procedures designed to minimize potential conflicts of interest among the Self-Indexing Funds and the Affiliated Accounts, such as cross trading policies, as well as those designed to ensure the equitable allocation of portfolio transactions and brokerage commissions. In addition, the Initial Adviser will adopt policies and procedures as required under section 204A of the Advisers Act, which are reasonably designed in light of the nature of its business to prevent the misuse, in violation of the Advisers Act or the Exchange Act or the rules thereunder, of material non-public information by the Initial Adviser or an associated person (“Inside Information Policy”). Any other Adviser or Sub-Adviser will be required to adopt and maintain a similar Inside Information Policy. In accordance with the Code of Ethics
14. To the extent the Self-Indexing Funds transact with an Affiliated Person of the Adviser or Sub-Adviser, such transactions will comply with the Act, the rules thereunder and the terms and conditions of the requested order. In this regard, each Self-Indexing Fund's board of directors or trustees (“Board”) will periodically review the Self-Indexing Fund's use of an Affiliated Index Provider. Subject to the approval of the Self-Indexing Fund's Board, the Adviser, Affiliated Persons of the Adviser (“Adviser Affiliates”) and Affiliated Persons of any Sub-Adviser (“Sub-Adviser Affiliates”) may be authorized to provide custody, fund accounting and administration and transfer agency services to the Self-Indexing Funds. Any services provided by the Adviser, Adviser Affiliates, Sub-Adviser and Sub-Adviser Affiliates will be performed in accordance with the provisions of the Act, the rules under the Act and any relevant guidelines from the staff of the Commission. Applications for prior orders granted to Self-Indexing Funds have received relief to operate such funds on the basis discussed above.
15. The Shares of each Fund will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified below, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
16. Purchases and redemptions of Creation Units may be made in whole or in part on a cash basis, rather than in kind, solely under the following circumstances: (a) To the extent there is a Cash Amount; (b) if, on a given Business Day, the Fund announces before the open of trading that all purchases, all redemptions or all purchases and redemptions on that day will be made entirely in cash; (c) if, upon receiving a purchase or redemption order from an Authorized Participant, the Fund determines to require the purchase or redemption, as applicable, to be made entirely in cash;
17. Creation Units will consist of specified large aggregations of Shares (
18. Each Business Day, before the open of trading on the Exchange on which Shares are primarily listed (“Listing Exchange”), each Fund will cause to be published through the NSCC the names and quantities of the instruments comprising the Deposit Instruments and the Redemption Instruments, as well as the estimated Cash Amount (if any), for that day. The list of Deposit Instruments and Redemption Instruments will apply until a new list is announced on the following Business Day, and there will be no intra-day changes to the list except to correct errors in the published list. Each Listing Exchange will disseminate, every 15 seconds during regular Exchange trading hours, through the facilities of the Consolidated Tape Association, an amount for each Fund stated on a per individual Share basis representing the sum of (i) the estimated Cash Amount and (ii) the current value of the Deposit Instruments.
19. Transaction expenses, including operational processing and brokerage costs, will be incurred by a Fund when investors purchase or redeem Creation Units in-kind and such costs have the potential to dilute the interests of the Fund's existing shareholders. Each Fund will impose purchase or redemption transaction fees (“Transaction Fees”) in connection with effecting such purchases or redemptions of Creation Units. In all cases, such Transaction Fees will be limited in accordance with requirements of the Commission applicable to management investment companies offering redeemable securities. Since the Transaction Fees are intended to defray the transaction expenses as well as to prevent possible shareholder dilution resulting from the purchase or redemption of Creation Units, the Transaction Fees will be borne only by such purchasers or redeemers.
20. Shares of each Fund will be listed and traded individually on an Exchange. It is expected that one or more member firms of an Exchange will be designated to act as a market maker (each, a “Market Maker”) and maintain a market for Shares trading on the Exchange. Prices of Shares trading on an Exchange will be based on the current bid/offer market. Transactions involving the sale of Shares on an Exchange will be subject to customary brokerage commissions and charges.
21. Applicants expect that purchasers of Creation Units will include institutional investors and arbitrageurs. Market Makers, acting in their roles to provide a fair and orderly secondary market for the Shares, may from time to time find it appropriate to purchase or redeem Creation Units. Applicants expect that secondary market purchasers of Shares will include both institutional and retail investors.
22. Shares will not be individually redeemable, and owners of Shares may acquire those Shares from the Fund, or tender such Shares for redemption to the Fund, in Creation Units only. To redeem, an investor must accumulate enough Shares to constitute a Creation Unit. Redemption requests must be placed through an Authorized Participant. A redeeming investor may pay a Transaction Fee, calculated in the same manner as a Transaction Fee payable in connection with purchases of Creation Units.
23. Neither the Trust nor any Fund will be advertised or marketed or otherwise held out as a traditional open-end investment company or a “mutual fund.” Instead, each such Fund will be marketed as an “ETF.” All marketing materials that describe the features or method of obtaining, buying or selling Creation Units, or Shares traded on an Exchange, or refer to redeemability, will prominently disclose that Shares are not individually redeemable and will disclose that the owners of Shares may acquire those Shares from the Fund or tender such Shares for redemption to the Fund in Creation Units only. The Funds will provide copies of their annual and semi-annual shareholder reports to DTC Participants for distribution to beneficial owners of Shares.
1. Applicants request an order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act, and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provision of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provisions of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.
3. Section 5(a)(1) of the Act defines an “open-end company” as a management company that is offering for sale or has outstanding any redeemable security of which it is the issuer. Section 2(a)(32)
4. Section 22(d) of the Act, among other things, prohibits a dealer from selling a redeemable security that is currently being offered to the public by or through an underwriter, except at a current public offering price described in the prospectus. Rule 22c-1 under the Act generally requires that a dealer selling, redeeming or repurchasing a redeemable security do so only at a price based on its NAV. Applicants state that secondary market trading in Shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Thus, purchases and sales of Shares in the secondary market will not comply with section 22(d) of the Act and rule 22c-1 under the Act. Applicants request an exemption under section 6(c) from these provisions.
5. Applicants assert that the concerns sought to be addressed by section 22(d) of the Act and rule 22c-1 under the Act with respect to pricing are equally satisfied by the proposed method of pricing Shares. Applicants maintain that while there is little legislative history regarding section 22(d), its provisions, as well as those of rule 22c-1, appear to have been intended to (a) prevent dilution caused by certain riskless-trading schemes by principal underwriters and contract dealers, (b) prevent unjust discrimination or preferential treatment among buyers, and (c) ensure an orderly distribution of investment company shares by contract dealers by eliminating price competition from non-contract dealers offering shares at less than the published sales price and repurchasing shares at more than the published redemption price.
6. Applicants believe that none of these purposes will be thwarted by permitting Shares to trade in the secondary market at negotiated prices. Applicants state that (a) secondary market trading in Shares does not involve a Fund as a party and will not result in dilution of an investment in Shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in Shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants contend that the price at which Shares trade will be disciplined by arbitrage opportunities created by the option continually to purchase or redeem Shares in Creation Units, which should help prevent Shares from trading at a material discount or premium in relation to their NAV.
7. Section 22(e) of the Act generally prohibits a registered investment company from suspending the right of redemption or postponing the date of payment of redemption proceeds for more than seven days after the tender of a security for redemption. Applicants state that settlement of redemptions for Foreign Funds will be contingent not only on the settlement cycle of the United States market, but also on current delivery cycles in local markets for underlying foreign securities held by a Foreign Fund. Applicants state that the delivery cycles currently practicable for transferring Redemption Instruments to redeeming investors, coupled with local market holiday schedules, may require a delivery process of up to fourteen (14) calendar days. Accordingly, with respect to Foreign Funds only, applicants hereby request relief under section 6(c) from the requirement imposed by section 22(e) to allow Foreign Funds to pay redemption proceeds within fourteen calendar days following the tender of Creation Units for redemption.
8. Applicants believe that Congress adopted section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds. Applicants propose that allowing redemption payments for Creation Units of a Foreign Fund to be made within fourteen calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants suggest that a redemption payment occurring within fourteen calendar days following a redemption request would adequately afford investor protection.
9. Applicants are not seeking relief from section 22(e) with respect to Foreign Funds that do not effect creations and redemptions of Creation Units in-kind.
10. Section 12(d)(1)(A) of the Act prohibits a registered investment company from acquiring securities of an investment company if such securities represent more than 3% of the total outstanding voting stock of the acquired company, more than 5% of the total assets of the acquiring company, or, together with the securities of any other investment companies, more than 10% of the total assets of the acquiring company. Section 12(d)(1)(B) of the Act prohibits a registered open-end investment company, its principal underwriter and any other broker-dealer from knowingly selling the investment company's shares to another investment company if the sale will cause the acquiring company to own more than 3% of the acquired company's voting stock, or if the sale will cause more than 10% of the acquired company's voting stock to be owned by investment companies generally.
11. Applicants request an exemption to permit registered management investment companies and unit investment trusts (“UITs”) that are not advised or sponsored by the Adviser, and not part of the same “group of investment companies,” as defined in section 12(d)(1)(G)(ii) of the Act as the Funds (such management investment companies are referred to as “Investing Management Companies,” such UITs are referred to as “Investing Trusts,” and Investing Management Companies and Investing Trusts are collectively referred to as “Funds of Funds”), to acquire Shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any Broker registered under the Exchange Act, to sell Shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
12. Each Investing Management Company will be advised by an investment adviser within the meaning of section 2(a)(20)(A) of the Act (the “Fund of Funds Adviser”) and may be sub-advised by investment advisers within the meaning of section 2(a)(20)(B) of the Act (each, a “Fund of
13. Applicants submit that the proposed conditions to the requested relief adequately address the concerns underlying the limits in sections 12(d)(1)(A) and (B), which include concerns about undue influence by a fund of funds over underlying funds, excessive layering of fees and overly complex fund structures. Applicants believe that the requested exemption is consistent with the public interest and the protection of investors.
14. Applicants believe that neither a Fund of Funds nor a Fund of Funds Affiliate would be able to exert undue influence over a Fund.
15. Applicants propose other conditions to limit the potential for undue influence over the Funds, including that no Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Fund) will cause a Fund to purchase a security in an offering of securities during the existence of an underwriting or selling syndicate of which a principal underwriter is an Underwriting Affiliate (“Affiliated Underwriting”). An “Underwriting Affiliate” is a principal underwriter in any underwriting or selling syndicate that is an officer, director, member of an advisory board, Fund of Funds Adviser, Fund of Funds Sub-Adviser, employee or Sponsor of the Fund of Funds, or a person of which any such officer, director, member of an advisory board, Fund of Funds Adviser or Fund of Funds Sub-Adviser, employee or Sponsor is an affiliated person (except that any person whose relationship to the Fund is covered by section 10(f) of the Act is not an Underwriting Affiliate).
16. Applicants do not believe that the proposed arrangement will involve excessive layering of fees. The board of directors or trustees of any Investing Management Company, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“disinterested directors or trustees”), will find that the advisory fees charged under the contract are based on services provided that will be in addition to, rather than duplicative of, services provided under the advisory contract of any Fund in which the Investing Management Company may invest. In addition, under condition B.5., a Fund of Funds Adviser, or a Fund of Funds' trustee or Sponsor, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Fund under rule 12b-1 under the Act) received from a Fund by the Fund of Funds Adviser, trustee or Sponsor or an affiliated person of the Fund of Funds Adviser, trustee or Sponsor, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor or its affiliated person by a Fund, in connection with the investment by the Fund of Funds in the Fund. Applicants state that any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
17. Applicants submit that the proposed arrangement will not create an overly complex fund structure. Applicants note that no Fund will acquire securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Fund to purchase shares of other investment companies for short-term cash management purposes. To ensure a Fund of Funds is aware of the terms and conditions of the requested order, the Fund of Funds will enter into an agreement with the Fund (“FOF Participation Agreement”). The FOF Participation Agreement will include an acknowledgement from the Fund of Funds that it may rely on the order only to invest in the Funds and not in any other investment company.
18. Applicants also note that a Fund may choose to reject a direct purchase of Shares in Creation Units by a Fund of Funds. To the extent that a Fund of Funds purchases Shares in the secondary market, a Fund would still retain its ability to reject any initial investment by a Fund of Funds in excess of the limits of section 12(d)(1)(A) by declining to enter into a FOF Participation Agreement with the Fund of Funds.
19. Sections 17(a)(1) and (2) of the Act generally prohibit an affiliated person of a registered investment company, or an affiliated person of such a person, from selling any security to or purchasing any security from the company. Section 2(a)(3) of the Act defines “affiliated person” of another person to include (a) any person directly or indirectly owning, controlling or holding with power to vote 5% or more of the outstanding voting securities of the other person, (b) any person 5% or more of whose outstanding voting securities are directly or indirectly owned, controlled or held with the power to vote by the other person, and (c) any person directly or indirectly controlling, controlled by or under common control with the other person. Section 2(a)(9) of the Act defines “control” as the power to exercise a controlling influence over the management or policies of a company, and provides that a control relationship will be presumed where one person owns more than 25% of a company's voting securities. The Funds may be deemed to be controlled by the Adviser or an entity controlling, controlled by or under common control with the Adviser and hence affiliated persons of each other. In addition, the Funds may be deemed to be under common control with any other
20. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act pursuant to sections 6(c) and 17(b) of the Act to permit persons that are Affiliated Persons of the Funds, or Second-Tier Affiliates of the Funds, solely by virtue of one or more of the following: (a) Holding 5% or more, or in excess of 25%, of the outstanding Shares of one or more Funds; (b) an affiliation with a person with an ownership interest described in (a); or (c) holding 5% or more, or more than 25%, of the shares of one or more Affiliated Funds, to effectuate purchases and redemptions “in-kind.”
21. Applicants assert that no useful purpose would be served by prohibiting such affiliated persons from making “in-kind” purchases or “in-kind” redemptions of Shares of a Fund in Creation Units. Both the deposit procedures for “in-kind” purchases of Creation Units and the redemption procedures for “in-kind” redemptions of Creation Units will be effected in exactly the same manner for all purchases and redemptions, regardless of size or number. There will be no discrimination between purchasers or redeemers. Deposit Instruments and Redemption Instruments for each Fund will be valued in the identical manner as those Portfolio Holdings currently held by such Fund and the valuation of the Deposit Instruments and Redemption Instruments will be made in an identical manner regardless of the identity of the purchaser or redeemer. Applicants do not believe that “in-kind” purchases and redemptions will result in abusive self-dealing or overreaching, but rather assert that such procedures will be implemented consistently with each Fund's objectives and with the general purposes of the Act. Applicants believe that “in-kind” purchases and redemptions will be made on terms reasonable to Applicants and any affiliated persons because they will be valued pursuant to verifiable objective standards. The method of valuing Portfolio Holdings held by a Fund is identical to that used for calculating “in-kind” purchase or redemption values and therefore creates no opportunity for affiliated persons or Second-Tier Affiliates of applicants to effect a transaction detrimental to the other holders of Shares of that Fund. Similarly, applicants submit that, by using the same standards for valuing Portfolio Holdings held by a Fund as are used for calculating “in-kind” redemptions or purchases, the Fund will ensure that its NAV will not be adversely affected by such securities transactions. Applicants also note that the ability to take deposits and make redemptions “in-kind” will help each Fund to track closely its Underlying Index and therefore aid in achieving the Fund's objectives.
22. Applicants also seek relief under sections 6(c) and 17(b) from section 17(a) to permit a Fund that is an affiliated person, or an affiliated person of an affiliated person, of a Fund of Funds to sell its Shares to and redeem its Shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
Applicants agree that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The requested relief to permit ETF operations will expire on the effective date of any Commission rule under the Act that provides relief permitting the operation of index-based ETFs.
2. As long as a Fund operates in reliance on the requested order, the Shares of such Fund will be listed on an Exchange.
3. Neither the Trust nor any Fund will be advertised or marketed as an open-end investment company or a mutual fund. Any advertising material that describes the purchase or sale of Creation Units or refers to redeemability will prominently disclose that Shares are not individually redeemable and that owners of Shares may acquire those Shares from the Fund and tender those Shares for redemption to a Fund in Creation Units only.
4. The Web site, which is and will be publicly accessible at no charge, will contain, on a per Share basis for each Fund, the prior Business Day's NAV and the market closing price or the midpoint of the bid/ask spread at the time of the calculation of such NAV (“Bid/Ask Price”), and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV.
5. Each Self-Indexing Fund, Long/Short Fund and 130/30 Fund will post on the Web site on each Business Day, before commencement of trading of Shares on the Exchange, the Fund's Portfolio Holdings.
6. No Adviser or any Sub-Adviser to a Self-Indexing Fund, directly or indirectly, will cause any Authorized Participant (or any investor on whose behalf an Authorized Participant may transact with the Self-Indexing Fund) to acquire any Deposit Instrument for the Self-Indexing Fund through a transaction in which the Self-Indexing Fund could not engage directly.
1. The members of a Fund of Funds' Advisory Group will not control (individually or in the aggregate) a Fund within the meaning of section 2(a)(9) of
2. No Fund of Funds or Fund of Funds Affiliate will cause any existing or potential investment by the Fund of Funds in a Fund to influence the terms of any services or transactions between the Fund of Funds or Fund of Funds Affiliate and the Fund or a Fund Affiliate.
3. The board of directors or trustees of an Investing Management Company, including a majority of the disinterested directors or trustees, will adopt procedures reasonably designed to ensure that the Fund of Funds Adviser and Fund of Funds Sub-Adviser are conducting the investment program of the Investing Management Company without taking into account any consideration received by the Investing Management Company or a Fund of Funds Affiliate from a Fund or Fund Affiliate in connection with any services or transactions.
4. Once an investment by a Fund of Funds in the securities of a Fund exceeds the limits in section 12(d)(1)(A)(i) of the Act, the Board of the Fund, including a majority of the directors or trustees who are not “interested persons” within the meaning of Section 2(a)(19) of the Act (“non-interested Board members”), will determine that any consideration paid by the Fund to the Fund of Funds or a Fund of Funds Affiliate in connection with any services or transactions: (i) Is fair and reasonable in relation to the nature and quality of the services and benefits received by the Fund; (ii) is within the range of consideration that the Fund would be required to pay to another unaffiliated entity in connection with the same services or transactions; and (iii) does not involve overreaching on the part of any person concerned. This condition does not apply with respect to any services or transactions between a Fund and its investment adviser(s), or any person controlling, controlled by or under common control with such investment adviser(s).
5. The Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Fund under rule 12b-l under the Act) received from a Fund by the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, or an affiliated person of the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, other than any advisory fees paid to the Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, or its affiliated person by the Fund, in connection with the investment by the Fund of Funds in the Fund. Any Fund of Funds Sub-Adviser will waive fees otherwise payable to the Fund of Funds Sub-Adviser, directly or indirectly, by the Investing Management Company in an amount at least equal to any compensation received from a Fund by the Fund of Funds Sub-Adviser, or an affiliated person of the Fund of Funds Sub-Adviser, other than any advisory fees paid to the Fund of Funds Sub-Adviser or its affiliated person by the Fund, in connection with the investment by the Investing Management Company in the Fund made at the direction of the Fund of Funds Sub-Adviser. In the event that the Fund of Funds Sub-Adviser waives fees, the benefit of the waiver will be passed through to the Investing Management Company.
6. No Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Fund) will cause a Fund to purchase a security in any Affiliated Underwriting.
7. The Board of a Fund, including a majority of the non-interested Board members, will adopt procedures reasonably designed to monitor any purchases of securities by the Fund in an Affiliated Underwriting, once an investment by a Fund of Funds in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any purchases made directly from an Underwriting Affiliate. The Board will review these purchases periodically, but no less frequently than annually, to determine whether the purchases were influenced by the investment by the Fund of Funds in the Fund. The Board will consider, among other things: (i) Whether the purchases were consistent with the investment objectives and policies of the Fund; (ii) how the performance of securities purchased in an Affiliated Underwriting compares to the performance of comparable securities purchased during a comparable period of time in underwritings other than Affiliated Underwritings or to a benchmark such as a comparable market index; and (iii) whether the amount of securities purchased by the Fund in Affiliated Underwritings and the amount purchased directly from an Underwriting Affiliate have changed significantly from prior years. The Board will take any appropriate actions based on its review, including, if appropriate, the institution of procedures designed to ensure that purchases of securities in Affiliated Underwritings are in the best interest of shareholders of the Fund.
8. Each Fund will maintain and preserve permanently in an easily accessible place a written copy of the procedures described in the preceding condition, and any modifications to such procedures, and will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any purchase in an Affiliated Underwriting occurred, the first two years in an easily accessible place, a written record of each purchase of securities in Affiliated Underwritings once an investment by a Fund of Funds in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth from whom the securities were acquired, the identity of the underwriting syndicate's members, the terms of the purchase, and the information or materials upon which the Board's determinations were made.
9. Before investing in a Fund in excess of the limit in section 12(d)(1)(A), a Fund of Funds and the Trust will execute a FOF Participation Agreement stating, without limitation, that their respective boards of directors or trustees and their investment advisers, or trustee and Sponsor, as applicable, understand the terms and conditions of the order, and agree to fulfill their responsibilities under the order. At the time of its investment in Shares of a Fund in excess of the limit in section 12(d)(1)(A)(i), a Fund of Funds will notify the Fund of the investment. At such time, the Fund of Funds will also transmit to the Fund a list of the names of each Fund of Funds Affiliate and Underwriting Affiliate. The Fund of Funds will notify the Fund of any changes to the list of the names as soon as reasonably practicable after a change occurs. The Fund and the Fund of Funds will maintain and preserve a
10. Before approving any advisory contract under section 15 of the Act, the board of directors or trustees of each Investing Management Company including a majority of the disinterested directors or trustees, will find that the advisory fees charged under such contract are based on services provided that will be in addition to, rather than duplicative of, the services provided under the advisory contract(s) of any Fund in which the Investing Management Company may invest. These findings and their basis will be fully recorded in the minute books of the appropriate Investing Management Company.
11. Any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
12. No Fund will acquire securities of an investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent the Fund acquires securities of another investment company pursuant to exemptive relief from the Commission permitting the Fund to acquire securities of one or more investment companies for short-term cash management purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
ISE Mercury proposes to amend its Schedule of Fees to count 100% of eligible traded volume preferenced to a Market Maker towards that member's volume tiers. The text of the proposed rule change is available on the Exchange's Internet Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
On March 10, 2016, ISE Mercury filed a proposed rule change to introduce fee and rebate tiers for Market Maker
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
ISE Mercury proposes to amend its Schedule of Fees by adopting volume-based tiered rebates and fees. These tiers are determined by a member's average daily volume of Priority Customer orders traded on the Exchange. The text of the proposed rule change is available on the Exchange's Internet Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
ISE Mercury is proposing to amend its Schedule of Fees to establish volume-based tiered rebates and fees (the “Member Volume Program” or “MVP”). The MVP tiers are determined by a member's average daily volume (“ADV”) of Priority Customer
Currently, the fees and rebates assessed for Regular Orders in standard options that are in the Penny Pilot are: (1) $0.20 per contract for Market Maker orders,
The Exchange proposes to amend the above fees and rebates so that they will be based on a member's ADV of Priority Customer orders traded in a given month and the highest tier threshold attained applies retroactively in a given month to all eligible traded contracts and applies to all eligible market participants. This Priority Customer ADV includes all Priority Customer volume executed on the Exchange in all symbols and order types, including volume executed in the Price Improvement Mechanism (“PIM”) and the Facilitation and Qualified Contingent Cross mechanisms.
Further, the Exchange will aggregate the trading activity of separate members in calculating Priority Customer ADV provided there is at least 75% common ownership between the firms as reflected on each firm's Form BD, Schedule A. The Exchange believes that aggregating this volume across members that share at least 75% common ownership will allow members to continue to execute trades on the Exchange through separate broker-dealer entities for different types of
The Exchange now proposes fees and rebates based on five volume tier levels as described in the table below. These fees and rebates will be based on the highest tier that a member reaches in a given month, and these tiered rates will apply retroactively to all eligible traded contracts for all client categories.
Additionally, the Exchange proposes to amend the Schedule of Fees to include language related to excluding days from the ADV calculations used to determine applicable fee and rebate tiers. Specifically, the Exchange proposes to (1) exclude from its ADV calculations any trading day on which the Exchange is closed early for holiday observance; (2) exclude days where the Exchange declares a trading halt in all securities or honors a market-wide trading halt declared by another market; and (3) permit days to be excluded from its ADV calculations where the Exchange is technically open for the entire trading day, but has instructed members to route away due to a systems or other error that ultimately does not impact trading on the Exchange. The Exchange also notes, however, that if it has a systems issue in the morning before the market opens, it may instruct members to route away to other markets. If the systems issue continues into trading hours, the Exchange is permitted to exclude the day for all members that would have a lower ADV with the day included. If, however, the systems issue is resolved prior to the opening of trading, the Exchange is not permitted to exclude the day from its ADV calculations. This is the case regardless of the fact that many members would have already made arrangements to route away in accordance with the Exchange's instructions. To prevent this undesirable result, and preserve the Exchange's intent behind adopting volume-based pricing, the Exchange proposes to allow days to be excluded from its ADV calculation whenever all members are instructed, in writing, to route their orders to other markets.
Because the days the Exchange proposes to exclude from its ADV calculation generally have artificially lower trading volume, the Exchange believes that it is reasonable and equitable to not include such days in determining fee and rebate tiers. If the Exchange did not have the ability to exclude aberrant low volume days when calculating ADV for the month, as a result of the decreased trading volume, the numerator for the calculation (
The Exchange notes that the fees charged to Non-ISE Mercury Market Maker, Firm Proprietary/Broker Dealer and Professional Customer in Penny and Non-Penny Symbols are the same as the current fees charged, regardless of the tier level reached. However, the tiered fees and rebates for both Priority Customers and Market Makers have changed. The proposed fees and rebates for each tier and participant type are as follows:
The Exchange proposes Penny and Non-Penny Symbol fees for Crossing Orders. The Exchange currently charges a fee of $0.20 per contract for Crossing Orders
As an exception to the fees charged for Crossing Orders, the Exchange charges a fee of $0.05 per contract for PIM Orders of 500 or Fewer Contracts in all symbols traded on the Exchange for all market participants, except that Priority Customer orders on the originating side of a PIM auction receive a rebate of ($0.13) per contract. Priority Customer orders on the contra-side of a PIM auction pay no fee and receive no rebate. PIM orders greater than 500 contracts pay the Crossing Order fee, described above. The Exchange now proposes to offer tiered fees and rebates based on Priority Customer volume, as described above, for PIM Orders of 500 or Fewer Contracts. The Exchange notes that the fees for Non-Priority Customer orders have not changed from current levels, but the fees for Priority Customer orders have changed as described in the table, below.
The Exchange proposes Penny and Non-Penny Symbol fees for Responses to Crossing Orders. A Response to a Crossing Order is any contra-side interest (
With respect to the proposed MVP, described above, the Exchange notes that the fees and rebates currently being paid on ISE Mercury are in the range of fees and rebates in the new structure. During the initial rollout of symbols on ISE Mercury, the Exchange did not adopt the proposed tiered structure due to the difficulty of calculating appropriate ADV thresholds for each tier when symbols were being listed on the Exchange each week. The Exchange, therefore, opted to provide attractive introductory rates and Priority Customer order rebates in order to attract Priority Customer orders to the Exchange during the initial rollout phase. By adopting the proposed tiered structure now, the Exchange seeks to incentivize members to send additional order flow to the Exchange in order to qualify for lower fees and higher rebates.
The Exchange is also proposing a $0.05 per contract discount to Market Maker fees when the Market Maker trades against Non-Priority Customer orders. We believe this will incentivize Market Makers to provide competitive markets. This discount does not apply to Crossing Orders.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes the fees proposed for transactions on ISE Mercury are reasonable. ISE Mercury will operate within a highly competitive market in which market participants can readily send order flow to any of the thirteen other competing venues if they deem fees at a particular venue to be excessive. The proposed MVP is intended to attract order flow to ISE Mercury by offering certain market participants incentives to submit their orders to ISE Mercury.
The Exchange believes the proposed fees and rebates in the MVP are reasonable and equitably allocated because ISE Mercury has already established fees for members trading on the Exchange, and is merely proposing to adopt volume-based tiers designed to incentivize members to send additional Priority Customer order flow to the Exchange. Further, the language permitting aggregation of volume amongst corporate affiliates for purposes
The Exchange believes that it is equitable and reasonable to permit the Exchange to eliminate from the calculation days on which the market is not open the entire trading day, either due to a holiday or trading halt, because it preserves the Exchange's intent behind adopting volume-based pricing. The proposed change is non-discriminatory because it applies equally to all members and to all volume tiers. Additionally, the Exchange believes that it is reasonable and equitable to exclude a day from its ADV calculations when members are instructed to route their orders to other markets as this preserves the Exchange's intent behind adopting volume-based pricing, and avoids penalizing members that follow this instruction. Without this change, members that route away in accordance with the Exchange's instructions may be negatively impacted, resulting in an effective cost increase for those members. The Exchange further believes that the proposed rule change is not unfairly discriminatory because it applies equally to all members and ADV calculations. As is the Exchange's current practice, the Exchange will inform members of any day to be excluded from its ADV calculations by sending members a notice and posting such notice on the Exchange's Web site.
The Exchange further believes that its proposal to provide rebates for Priority Customer orders is reasonable and equitable because the proposed rebates are competitive with the rebates offered by other exchanges employing similar tiered rebate structures based on Priority Customer volume. For example, MIAX Options Exchange (“MIAX”) and NASDAQ OMX PHLX (“PHLX”) have Priority Customer, tiered rebate programs.
The Exchange believes that providing higher rebates for Priority Customer orders, and creating ADV thresholds specifically for members that send such orders to ISE Mercury, attracts that order flow to the Exchange and thereby creates liquidity to the benefit of all market participants who trade on the Exchange. Further, the Exchange believes that it is equitable and not unfairly discriminatory to provide higher rebates to Priority Customer orders than to Professional Customer orders. A Priority Customer is by definition not a broker or dealer in securities, and does not place more than 390 orders in listed options per day on average during a calendar month for its own beneficial account(s). This limitation does not apply to participants on the Exchange whose behavior is substantially similar to that of market professionals, including Professional Customers, who will generally submit a higher number of orders (many of which do not result in executions) than Priority Customers. Further, Professional Customers engage in trading activity similar to that conducted by Market Makers and proprietary traders.
The Exchange believes that its proposal to assess a per contract fee for Market Maker orders is reasonable and equitable because the proposed fees are within the range of fees assessed by other exchanges employing similar tiered rebate structures such as MIAX, which offers tiered fees for Market Makers. In Penny Symbols, MIAX generally charges Market Makers a per contract fee as high as $0.25 for its base tier and a per contract fee of $0.05 for its highest tier.
The Exchange believes the proposed rebates for PIM Orders of 500 or Fewer Contracts
The Exchange's proposal to assess Penny and Non-Penny Symbol fees for Responses to Crossing Orders is reasonable and equitably allocated because they are within the range of fees assessed by other exchanges. Specifically, the Exchange proposes to keep fees for Responses to Crossing Orders in Penny Symbols the same and to increase fees for Responses to Crossing Orders in Non-Penny Symbols so that these fees are competitive with similar fees charged on other exchanges. For example, ISE Gemini's Fees for Responses to Crossing Orders
With respect to the Responses to Crossing Orders' tiered fees for Market Maker orders, the Exchange believes that the proposed fees are fair, equitable, and not unfairly discriminatory because the proposed fees are consistent with the fees charged at other exchanges. For example, ISE Gemini charges Market Makers a Fee for Responses to Crossing Orders of $0.49 per contract in Penny Symbols and $0.89 per contract in Non-Penny Symbols. Similarly, ISE Mercury's proposal would charge per contract fees ranging from $0.50 (Tier 1 fee plus Marketing Fee) to $0.35 (Tier 5 fee plus Marketing Fee) in Penny Symbols and per contract fees ranging from $0.95 (Tier 1 fee plus Marketing Fee) to $0.80 (Tier 5 fee plus marketing fee) in Non-Penny Symbols. As discussed above, the Exchange believes that the price differentiation between Market Makers and the other market participants is appropriate and not unfairly discriminatory because they have requirements and obligations to the Exchange that the other market participants do not. Market Makers also incur Marketing Fees, which the other market participants do not. Thus, the Exchange believes that it is equitable and not unfairly discriminatory to assess a higher fee to certain market participants that do not have such requirements and obligations that Exchange Market Makers do.
The Exchange believes the proposed Market Maker discount is reasonable, equitable, and not unfairly discriminatory because Market Makers have different requirements and obligations to the Exchange that other market participants do not and they incur Marketing Fees. The Exchange notes that when trading against a Priority Customer the exchange pays a rebate for Priority Customer orders, but the Exchange charges a fee for executions of Non-Priority Customer orders. The Exchange believes that offering a discount on the fees charged to Market Makers will encourage Market Maker to make better markets and execute more trades. Furthermore, charging Market Makers lower fees for trading against a Non-Priority Customer order is not a new concept in the industry. For example, BOX Options Exchange, in Non-Penny Pilot Symbols, charges Market Makers a maker fee of $0.85 per contract for trading against a Priority Customer order and a maker fee of $0.00 for trading against a Professional Customer/Broker Dealer order.
The Exchange notes that the proposed rule filing is intended to further establish ISE Mercury as an attractive venue for market participants to direct their order flow as the proposed fees and rebates are competitive with those established by other exchanges. The Exchange operates in a highly competitive market in which market participants can readily direct order flow to another exchange if they deem rebates at a particular exchange to be too low. For the reasons noted above, the Exchange believes that the proposed rebates are fair, equitable and not unfairly discriminatory.
In accordance with Section 6(b)(8) of the Act,
In establishing the MVP, the Exchange is not imposing any burden on competition. The established volume tiers are transparent and offer members a simple way to reach different levels of fees and rebates on the exchange, similar to levels and differentials these same participants are familiar with on several other exchanges. Volume tiers are not new to the options industry and generally reward members for submitting additional volume to the Exchange, with ISE Mercury now seeking to introduce a similar structure. The Exchange also notes that other exchanges have substantially similar requirements for aggregating affiliated member ADV in determining applicable tiered rebates.
Finally, in establishing a Market Maker discount for Market Makers trading against Non-Priority Customer orders, the Exchange is not imposing any burden on competition not necessary or appropriate in furtherance of the purposes of the Act because other exchanges offer lower fees to Market Makers trading against Non-Priority Customers. Additionally, the Exchange notes that when trading against a Priority Customer the exchange pays a rebate for Priority Customer orders, but the Exchange charges a fee for executions of Non-Priority Customer orders. The Exchange believes that offering a discount on the fees charged to Market Makers will encourage Market Maker to make better markets and execute more trades.
The Exchange operates in a highly competitive market in which market participants can readily direct their order flow to competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed fee changes reflect this competitive environment.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The principal purpose of the proposed rule change is to update ICC's Operational Risk Management Framework. These revisions do not require any changes to the ICC Clearing Rules.
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
ICC proposes updates to the ICC Operational Risk Management Framework. ICC believes such revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. The proposed revisions are described in detail as follows.
The ICC Operational Risk Management Framework details ICC's dynamic and independent program of risk assessment and oversight, managed by the Operational Risk Manager (“ORM”), which aims to reduce operational incidents, encourage process and control improvement, bring transparency to operational performance standard monitoring, and fulfill regulatory obligations. ICC proposes organizational changes to its Operational Risk Management Framework related to its operational risk management processes.
ICC has revised the Operational Risk Management Framework to frame its existing operational risk program and processes around an operational risk lifecycle, designed to highlight certain aspects of the processes and present the processes in a more efficient manner. The operational risk lifecycle utilized by ICC has five components: Identify, assess, monitor, mitigate and report. Each of these lifecycle components are first defined generally in the document then applied to each of ICC's two operational risk processes: Risk assessment; and performance objectives setting and monitoring. Specifically, the content for each risk process has been reorganized to fall into each of the operational risk lifecycle components (
ICC has categorized those aspects of the operational risk management program which do not fall within this lifecycle as “Operational Risk Focus Areas.” These risk focus areas include: Business continuity planning and disaster recovery; vendor assessment; new products and initiatives; information security; and technology control functions. ICC has reorganized the order of these risk focus areas to better distinguish which functions may, with oversight by the ORM, be outsourced to Intercontinental Exchange, Inc. (“ICE, Inc.”) or performed by departments dedicated to that particular risk area.
ICC has made several clarifying and organizational enhancements to the various risk focus area descriptions. Further, specific details contained within other ICC policies and procedures were removed and described more generally within the Operational Risk Management Framework, in an effort to reduce redundancy amongst ICC policies and procedures. ICC continues to maintain business continuity planning and disaster recovery as two separate programs with separate and distinct components; however, ICC has grouped the description of these programs together for purposes of the Operational Risk Management Framework. ICC enhanced the “Vendor Assessment” risk focus area description to note that the ORM is responsible for conducting a service provider risk assessment for critical vendors, and to list the specific steps taken as part of such risk assessment. ICC also enhanced the “Information Security” risk focus area description to note that the ICE, Inc. Information Security Department conducts its own risk assessments related to information security and physical security/environmental controls, pursuant to internal policies which are maintained by an ICE, Inc. internal committee. Information regarding the Firm Wide Incident Management Program was included in the new ‘Technology Controls Section.’ ICC enhanced the ‘Technology Control Functions’ risk focus area description to note that the ICC Systems Operations team is responsible for executing daily clearing functions within established service expectations and performing incident management. ICC described this incident management process generally within the framework, and removed more detailed aspects of the program which are contained in specific program documentation.
General information regarding the development and enforcement of a firm-wide operational risk framework was removed, as the revised framework more clearly lays out in each particular section who is responsible for the development and enforcement of that component of the operational risk management framework. Information regarding the human resource reporting line of the ORM and specific references to titles of documents utilized as part of the risk assessment process were removed. As the Vendor Risk Management policy was retired and encompassed within the Operational Risk Management Framework, reference to the policy was removed from the document. ICC removed internal audit responsibilities from the Operational Risk Management Framework as such responsibilities are contained within internal audit documentation.
The overall governance of the Operational Risk Framework has been updated to reflect current practices. Specifically, material amendments are reviewed by the Risk Committee, and approved by the Board. The Board reviews the Operational Risk Management Framework at least annually.
Other non-material changes were made to the framework to enhance readability. Previously, ICC included regulatory requirements and industry guidance information within the framework; this information has been moved to a separate appendix to the framework. Further, information regarding Regulation Systems, Compliance, and Integrity has been added for completeness. Certain information regarding governance and governing committees has been resituated to the reporting section of the relevant operational risk lifecycle. Similarly, information regarding the roles and responsibilities of the ORM and senior management has been resituated to the appropriate section the operational risk lifecycle.
Section 17A(b)(3)(F) of the Act
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The ICC Operational Risk Management Framework applies uniformly across all market participants. Therefore, ICC does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2016-003 and should be submitted on or before April 15, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application under Section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from Section 15(a) of the Act and Rule 18f-2 under the Act, as well as from certain disclosure requirements in Rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-07(2)(a), (b), and (c) of Regulation S-X (“Disclosure Requirements”). The requested exemption would permit an investment adviser to hire and replace certain sub-advisers without shareholder approval and grant relief from the Disclosure Requirements as they relate to fees paid to the sub-advisers.
Northern Lights Fund Trust (the “Trust”), a Delaware statutory trust registered under the Act as an open-end management investment company with multiple series, and Princeton Fund Advisors LLC, a Delaware limited liability company registered as an investment adviser under the Investment Advisers Act of 1940 (“the “Adviser,” and, collectively with the Trust, the “Applicants”).
The application was filed March 6, 2014, and amended on August 21, 2014, November 10, 2014, November 25, 2015, February 19, 2016, February 22, 2016, and March 16, 2016.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on April 18, 2016, and should be accompanied by proof of service on the applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: Trust: James P. Ash, Esq., Gemini Fund Services LLC, 80 Arkay Drive, Suite 110, Hauppage, NY 11788 and Adviser: Princeton Fund Advisors, LLC, 1125 17th Street, Suite 1400, Denver, CO 80202.
Jean E. Minarick, Senior Counsel, at (202) 551-6811, or Daniele Marchesani, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Adviser will serve as the investment adviser to the Funds pursuant to an investment advisory agreement with the Trust (the “Advisory
2. Applicants request an exemption to permit the Adviser, subject to Board approval, to hire certain Sub-Advisers pursuant to Sub-Advisory Agreements and materially amend existing Sub-Advisory Agreements without obtaining the shareholder approval required under Section 15(a) of the Act and Rule 18f-2 under the Act.
3. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the Application. Such terms and conditions provide for, among other safeguards, appropriate disclosure to Fund shareholders and notification about sub-advisory changes and enhanced Board oversight to protect the interests of the Funds' shareholders.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction or any class or classes of persons, securities, or transactions from any provisions of the Act, or any rule thereunder, if such relief is necessary or appropriate in the public interest and consistent with the protection of investors and purposes fairly intended by the policy and provisions of the Act. Applicants believe that the requested relief meets this standard because, as further explained in the Application, the Advisory Agreements will remain subject to shareholder approval, while the role of the Sub-Advisers is substantially similar to that of individual portfolio managers, so that requiring shareholder approval of Sub-Advisory Agreements would impose unnecessary delays and expenses on the Funds. Applicants believe that the requested relief from the Disclosure Requirements meets this standard because it will improve the Adviser's ability to negotiate fees paid to the Sub-Advisers that are more advantageous for the Funds.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
ISE proposes to eliminate the 30% strict cap on the number of Primary Market Maker (“PMM”) memberships that the ISE's Board of Directors (the “Board”) can approve for an ISE member to operate. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposal is to eliminate the 30% strict cap on the number of PMM memberships that the Board can approve for an ISE member to operate.
Due to the continued concentration and specialization in the options market making community, and the decreasing number of market makers available to operate these memberships, the Exchange is proposing to eliminate the 30% cap on the number of PMM memberships that the Board can approve for a member to operate.
As the number of market makers decreases, the Exchange is concerned that there may not be a sufficient number of members qualified to be PMMs if the Exchange retains the current 30% cap (thus limiting a member to operating three PMM memberships). The options markets are highly competitive, and each exchange actively seeks to attract order flow by disseminating tight and liquid markets and by providing a high level of customer satisfaction. Ensuring that the Exchange has high quality PMMs is critical in this competitive battle.
The Exchange believes that the proposed approach is consistent with treatment on other markets that do not have strict market maker concentration limits, and will enable the Board to approve members to operate multiple PMM memberships after the Board determines that good cause has been shown and if doing so would be in the best interest of the Exchange.
The Commission has previously approved rule changes that eliminated mandatory caps on the number of issues that may be allocated to market makers on other markets, such as on Pacific Exchange, Inc. (“PCX”) (n/k/a “NYSE Arca”), where the Commission approved a rule change by PCX to eliminate its Lead Market Maker (“LMM”) concentration limit of 15% of the issues traded on the PCX options floor.
The Exchange recognizes that increasing the number of PMM memberships a member can operate could raise issues regarding concentration of market making expertise. In this regard, the proposed rule change is only an enabling rule. With the proposed change, the Board will still be required to show good cause to approve any member to operate more than one PMM membership, and could consider the number of memberships already by the member in determining whether or not there is good cause shown. Thus, the Board will need to weigh each potential application on its own merits, balancing the potential benefits of allowing a member to exercise more than one PMM membership against any potential concentration concerns. The Board would not be prohibited under the rules and under the LLC Agreement, however, from approving PMMs to operate more than a specified percentage of outstanding memberships.
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The options industry continues to experience a consolidation and decrease in the number of market makers and therefore, the Exchange is proposing a rule change that would eliminate the 30% PMM cap and would allow the Board the flexibility to approve or deny each potential PMM application based upon its determination of whether good cause had been shown and if doing so would be in the best interest of the Exchange. Also as noted above, the Commission has previously approved rule changes eliminating mandatory caps on the number of issues that may be allocated to market makers on other markets, and has granted registration to new exchanges that do not have similar concentration limits. The Exchange therefore believes that the proposed rule change is designed to remove impediments to and perfect the mechanisms of a free and open market and a national market system. Furthermore, this proposed rule change would not amend the current prohibitions in the LLC Agreement and in the Exchange's rules against a member owning or voting more than 20% of any class of membership. Thus, the only way a member could operate more than 30% of all outstanding PMM memberships would be to lease such membership, with the lease providing that the lessor retains all voting rights.
In accordance with Section 6(b)(8) of the Act,
The Exchange has neither solicited nor received written comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Therefore, the Commission hereby waives the operative delay and designates the proposed rule change operative upon filing.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to April 25, 2016.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Derek Rivers, Bureau of Consular Affairs, Overseas Citizens Services (CA/OCS/PMO), who may be reached on 202-485-6332 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The Smart Traveler Enrollment Program (STEP) makes it possible for U.S. nationals to register on-line from anywhere in the world. In the event of a family emergency, natural disaster or international crisis, U.S. embassies and consulates rely on this registration information to provide critical information and assistance to them. 22 U.S.C. 2715 is one of the main legal authorities that deem the usage of this form necessary.
99% of responses are received via electronic submission on the Internet. The service is available on the Department of State, Bureau of Consular Affairs Web site
Gulf & Ohio Railways, Inc. (G&O), and H. Peter Claussen and Linda C. Claussen (the Claussens) (collectively, Applicants) have jointly filed a verified notice of exemption pursuant to 49 CFR 1180.2(d)(2) to continue in control of North Carolina & Atlantic Railroad Co., Inc. (NCAR), upon NCAR's becoming a Class III rail carrier.
This transaction is related to a concurrently filed verified notice of exemption in
Applicants expect to consummate the proposed transaction on or after April 8, 2016, the effective date of the exemption (30 days after the verified notice of exemption was filed).
According to Applicants, the Claussens own a controlling share of voting stock of G&O. G&O, in turn, wholly owns four Class III rail carriers operating in three states: (a) Knoxville & Holston River Railroad Co., Inc., operating in Tennessee; (b) Lancaster & Chester Railroad, LLC, operating in South Carolina; (c) Laurinburg & Southern Railroad Co., Inc., operating in North Carolina; and (d) Piedmont & Atlantic Railroad Co., Inc., d/b/a Yadkin Valley Railroad, operating in North Carolina.
Applicants certify that: (1) The rail lines to be operated by NCAR do not connect with any other railroads operated by the carriers in the Applicants' corporate family; (2) the continuance in control is not part of a series of anticipated transactions that would connect the rail lines to be operated by NCAR with any other railroad in Applicants' corporate family; and (3) the transaction does not involve a Class I rail carrier. Therefore, the transaction is exempt from the prior approval requirements of 49 U.S.C. 11323.
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under 11324 and 11325 that involve only Class III rail carriers. Accordingly, the Board may not impose labor protective conditions here, because all of the carriers involved are Class III carriers.
If the notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Stay petitions must be filed no later than April 1, 2016 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36009, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Applicants' representative, Rose-Michele Nardi, Transport Counsel PC, 1701 Pennsylvania Ave. NW., Suite 300, Washington, DC 20006.
Board decisions and notices are available on our Web site at “
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
North Carolina & Atlantic Railroad Co., Inc. (NCAR), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to lease from the North
This transaction is related to a concurrently filed verified notice of exemption in
NCAR certifies that the projected annual revenues as a result of this transaction will not exceed those that would qualify it as a Class II rail carrier and states that its projected annual revenue is expected not to exceed $5 million. NCAR states that the agreement regarding the subject line does not involve an interchange commitment.
The transaction may be consummated on April 8, 2016, the effective date of the exemption (30 days after the verified notice of exemption was filed). If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed by April 1, 2016 (at least seven days prior to the date the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36008 must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on applicant's representative, Rose-Michele Nardi, Transport Counsel PC, 1701 Pennsylvania Ave. NW., Suite 300, Washington, DC 20006.
According to NCAR, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at “
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
The State of Washington, Department of Transportation (WDOT), pursuant to a trackage rights agreement being negotiated between WDOT and BNSF Railway Company (BNSF),
The transaction may be consummated on or after April 10, 2016, the effective date of the exemption (30 days after the verified notice of exemption was filed).
As a condition to this exemption, any employees affected by the trackage rights will be protected by the conditions imposed in
This notice is filed under 49 CFR 1180.2(d)(7). If the notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed by April 1, 2016 (at least 7 days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36001, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Karl Morell, Karl Morell & Associates, 655 15th Street NW., Suite 225, Washington, DC 20005.
Board decisions and notices are available on our Web site at
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
San Jacinto Transportation Company, Inc. (SJTC), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to operate approximately 6.0 miles of rail line owned by SJRE-Railroad Series (SJRE), pursuant to an operating agreement with SJRE,
The transaction may be consummated on or after April 9, 2016, the effective date of the exemption (30 days after the exemption was filed).
SJTC certifies that, as a result of this transaction, its projected revenues will not result in the creation of a Class II or Class I rail carrier and will not exceed $5 million.
SJTC states that the operating agreement does not involve a provision or agreement which may limit future interchange with a third party connecting carrier. SJTC further states that, once the exemption becomes effective, it anticipates that UP and BNSF will enter into an interchange or switching agreement for SJTC to serve customers on the Line.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be
An original and 10 copies of all pleadings, referring to Docket No. FD 35996, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy must be served on John K. Fiorilla, Capehart & Scatchard, P.A., 8000 Midlantic Drive, Suite 300S, Mount Laurel, NJ 08054.
Board decisions and notices are available on our Web site at
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), DOT.
Notice of public meeting.
This notice announces a public meeting of the FAA's Aviation Rulemaking Advisory Committee (ARAC) Transport Airplane and Engine (TAE) Subcommittee to discuss TAE issues.
The meeting is scheduled for Wednesday, June 22, 2016, starting at 9:00 a.m. Eastern Time. Arrange for oral presentations by June 1, 2016.
Aerospace Industries Association, 1000 Wilson Blvd., Suite 1700, Arlington, VA 22209.
Ralen Gao, Office of Rulemaking, ARM-209, FAA, 800 Independence Avenue SW., Washington, DC 20591, Telephone (202) 267-3168, Fax (202) 267-5075, or email at
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. app. III), notice is given of an ARAC meeting to be held on June 22, 2016.
The agenda for the meeting is as follows:
Participation is open to the public, but will be limited to the availability of teleconference lines.
To participate, please contact the person listed in
The public must make arrangements by June 1, 2016, to present oral or written statements at the meeting. Written statements may be presented to the Subcommittee by providing a copy to the person listed in the
If you need assistance or require a reasonable accommodation for the meeting or meeting documents, please contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 14, 2016.
Send comments identified by docket number FAA-2016-4042 using any of the following methods:
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Taiya Carter (202) 267-2979, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice, request for comment.
The Surface Transportation Project Delivery Program (23 U.S.C. 327) allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal-aid highway projects. When a State assumes these Federal responsibilities, the State becomes solely responsible and liable for carrying out the responsibilities it has assumed, in lieu of FHWA. Prior to the Fixing America's Surface Transportation (FAST) Act of 2015, the program required semiannual audits during each of the first 2 years of State participation to ensure compliance by each State participating in the program. This notice announces and solicits comments on the second audit report for the Texas Department of Transportation's (TxDOT) participation in accordance to these pre-FAST Act requirements.
Comments must be received on or before April 25, 2016.
Mail or hand deliver comments to Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590. You may also submit comments electronically at
Dr. Owen Lindauer, Office of Project Development and Environmental Review, (202) 366-2655,
An electronic copy of this notice may be downloaded from the specific docket page at
The Surface Transportation Project Delivery Program (or NEPA Assignment Program) allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal-aid highway projects. This provision has been codified at 23 U.S.C. 327. When a State assumes these Federal responsibilities, the State becomes solely responsible and liable for carrying out the responsibilities it has assumed, in lieu of FHWA. The TxDOT published its application for assumption under the National Environmental Policy Act (NEPA) Assignment Program on March 14, 2014, at Texas Register 39(11): 1992, and made it available for public comment for 30 days. After considering public comments, TxDOT submitted its application to FHWA on May 29, 2014. The application served as the basis for developing the Memorandum of Understanding (MOU) that identifies the responsibilities and obligations TxDOT would assume. The FHWA published a notice of the draft of the MOU in the
Prior to December 4, 2015, 23 U.S.C. 327(g) required the Secretary to conduct semiannual audits during each of the first 2 years of State participation, and annual audits during each subsequent year of State participation to ensure compliance by each State participating in the program. The results of each audit were required to be presented in the form of an audit report and be made available for public comment. On December 4, 2015, the President signed into law the FAST Act (Pub. L. 114-94, 129 Stat. 1312 (2015)). Section 1308 of the FAST Act amended the audit provisions by limiting the number of audits to one audit each year during the first 4 years of a State's participation. However, FHWA had already conducted the second audit for TxDOT's participation. This notice announces the availability of the report for second audit for TxDOT conducted prior to the FAST Act and solicits public comment on same.
Section 1313 of Public Law 112-141; Section 6005 of Public Law 109-59; 23 U.S.C. 327; 49 CFR 1.48.
This report summarizes the results of Audit #2 of the performance by the Texas Department of Transportation (TxDOT) regarding its assumption of responsibilities and obligations, as assigned by Federal Highway Administration (FHWA) under a memorandum of understanding (MOU) whose term began on December 16, 2014. From that date, TxDOT assumed FHWA National Environmental Policy Act (NEPA) responsibilities and liabilities for the environmental review and compliance for highway projects
The FHWA Audit #2 team (team) was formed in June 2015 and met regularly to prepare for the on-site portion of the audit. Prior to the on-site visit, the team: (1) Performed reviews of TxDOT project file NEPA documentation in TxDOT's Environmental Compliance Oversight System (ECOS), (2) examined the TxDOT pre-Audit #2 information request responses, and (3) developed interview questions. The on-site portion of this audit, comprised of TxDOT and other agency interviews, was conducted September 8-9, 2015, and September 20-25, 2015.
The TxDOT continues to make progress developing, revising, and implementing procedures and processes required to implement the NEPA Assignment Program. Overall, the team found evidence that TxDOT is committed to establishing a successful program. This report summarizes the team's assessment of the current status of several aspects of the NEPA Assignment Program, including successful practices and 17 total observations that represent opportunities for TxDOT to improve its program. The team identified three non-compliance observations that TxDOT will need to address as corrective actions in its next self-assessment and subsequent report.
While TxDOT has continued to make progress toward meeting all the responsibilities it has assumed in accordance with the MOU, the recurring non-compliance observations require TxDOT corrective action. By taking corrective action and considering changes based on the observations in this report, TxDOT will continue to move the program toward success.
The Surface Transportation Project Delivery Program allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal highway projects. This program is codified at 23 U.S.C. 327. When a State assumes these Federal responsibilities, the State becomes solely responsible and liable for carrying out the obligations it has assumed, in lieu of FHWA.
The State of Texas was assigned the responsibility for making project NEPA and other related environmental decisions for highway projects on December 16, 2014. In enacting Texas Transportation Code, § 201.6035, the State has waived its sovereign immunity under the 11th Amendment of the U.S. Constitution and consents to defend any actions brought by its citizens for NEPA decisions it has made in Federal court.
The FHWA responsibilities assigned to TxDOT are varied and tied to project level decisionmaking. These laws include, but are not limited to, the Endangered Species Act (ESA), Section 7 consultations with the U.S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration National Marine Fisheries Service, and Section 106 consultations regarding impacts to historic properties. Two Federal responsibilities were not assigned to TxDOT and remain with FHWA: (1) Making project-level conformity determinations under the Federal Clean Air Act and (2) conducting government-to-government consultation with federally recognized Indian tribes.
Prior to December 4, 2015, FHWA was required to conduct semiannual audits during each of the first 2 years of State participation in the program and audits annually for 2 subsequent years as part of FHWA's oversight responsibility for the NEPA Assignment Program. The reviews assess a State's compliance with the provisions of the MOU and all applicable Federal laws and policies. They also are used to evaluate a State's progress toward achieving its performance measures as specified in the MOU; to evaluate the success of the NEPA Assignment Program; and to inform the administration of the NEPA Assignment Program. On December 4, 2015, the President signed into law the Fixing America's Surface Transportation (FAST) Act of 2015, which amended the audit provisions of the program by changing the frequency to one audit per year during the first 4 years of the State's participation. However, this audit was conducted prior to the passage of the FAST Act, and this report is being prepared and made available under the audit provisions as they existed prior to the passage of the FAST Act. This report summarizes the results of the second audit, and updates the reader on the status or corrective actions for the results of the first audit.
The overall scope of this audit review is defined both in statute (23 U.S.C. 327) and the MOU (Part 11). An audit generally is defined as an official and careful examination and verification of accounts and records, especially of financial accounts, by an independent unbiased body. With regard to accounts or financial records, audits may follow a prescribed process or methodology, and be conducted by “auditors” who have special training in those processes or methods. The FHWA considers this review to meet the definition of an audit because it is an unbiased, independent, official, and careful examination and verification of records and information about TxDOT's assumption of environmental responsibilities. The team that conducted this audit has completed special training in audit processes and methods.
The diverse composition of the team, the process of developing the review report, and publishing it in the
Audits, as stated in the MOU (Parts 11.1.1 and 11.1.5), are the primary mechanism used by FHWA to oversee TxDOT's compliance with the MOU, ensure compliance with applicable Federal laws and policies, evaluate TxDOT's progress toward achieving the performance measures identified in the MOU (Part 10.2), and collect information needed for the Secretary's annual report to Congress. These audits also must be designed and conducted to evaluate TxDOT's technical competency and organizational capacity, adequacy of the financial resources committed by TxDOT to administer the responsibilities assumed, quality assurance/quality control (QA/QC) process, attainment of performance measures, compliance with the MOU requirements, and compliance with applicable laws and policies in administering the responsibilities assumed. The four performance measures identified in the MOU are: (1) Compliance with NEPA and other Federal environmental statutes and regulations, (2) quality control and QA for NEPA decisions, (3) relationships with agencies and the general public, and (4) increased efficiency, timeliness, and completion of the NEPA process.
The scope of this audit included reviewing the processes and procedures used by TxDOT to reach and document
The intent of the review was to check that TxDOT has the proper procedures in place to implement the MOU responsibilities assumed, ensure that the staff is aware of those procedures, and that staff implement the procedures appropriately to achieve NEPA compliance. The review is not intended to evaluate project-specific decisions, or to second guess those decisions, as these decisions are the sole responsibility of TxDOT.
The team defined the timeframe for highway project environmental approvals subject to this second audit to be between March 2015 and June 2015. The focus on the second review included the 3 to 4 months after FHWAs audit #1 highway project file review concluded. The second audit intended to: (1) Evaluate whether TxDOT's NEPA decisionmaking and other actions comply with all the responsibilities it assumed in the MOU, and (2) determine the current status of observations in the Audit #1 report and required corrective actions (see summary at end of this report). The team established a population of 598 projects subject to review based on lists of NEPA approvals (certified compliant by TxDOT as required in MOU Part 8.7.1) reported monthly by TxDOT. The NEPA approvals included categorical exclusion (CE) determinations, 47 other types of environmental approvals including approvals to circulate an environmental assessment (EA), findings of no significant impacts (FONSI), re-evaluations of EAs, Section 4(f) decisions, approvals of a draft environmental impact statement (EIS), and a record of decision (ROD). In order to attain a sample with a 95 percent confidence interval, the team randomly selected 83 CE projects. In addition, the team reviewed project files for all 47 approvals that were not CEs. The sample reviewed by the team was 130 approval actions.
The interviews conducted by the team focused on TxDOT's leadership and staff at Environmental Affairs Division (ENV) Headquarters in Austin and nine TxDOT Districts. To complete the interviews of District staff, the team divided into three groups of four to conduct face-to-face interviews at TxDOT Districts in Dallas, Paris, Tyler, Lubbock, Childress, Amarillo, Houston, Beaumont, and Bryan. With these interviews completed, FHWA has interviewed staff from 60 percent (15 of 25) of the TxDOT District offices. The FHWA anticipates interviewing staff from the remaining TxDOT District offices over the next year.
The team recognizes that TxDOT is still implementing changes to address and improve its NEPA Assignment Program and that its programs, policies, and procedures may need revision. The TxDOT's efforts are appropriately focused on establishing and refining policies and procedures (especially in regards to the non-compliance observations made by FHWA), training staff, assigning and clarifying changed roles and responsibilities, and monitoring its compliance with assumed responsibilities. The team has determined that TxDOT continues to make reasonable progress despite some noted delays (pending ECOS upgrades) as the program matures beyond the start-up phase of NEPA Assignment operations. In addition, the team believes TxDOT is committed to establishing a successful program. The team's analysis of project file documentation and interview information identified several non-compliance observations, and several other observations including evidence of good practice. One non-compliance observation is recurrent from Audit#1, relating to “conditional clearances,” that appears to reflect a misunderstanding on the part of TxDOT on when and whether information at hand is sufficient to support a NEPA decision that complies with the requirements of the MOU. This is a point of concern for FHWA and if necessary, this issue will be a focus of future audits.
The TxDOT staff and management have engaged FHWA and have received constructive feedback from the team to revise TxDOT's standard operating procedures. By considering and acting upon the observations contained in this report, TxDOT should continue to improve upon carrying out its assigned responsibilities and ensure the success of its NEPA Assignment Program.
Non-compliance observations are instances where the team found the State was out of compliance or deficient with regard to a Federal regulation, statute, guidance, policy, or the terms of the MOU (including State procedures for compliance with the NEPA process). Such observations may also include instances where the State has failed to maintain adequate personnel and/or financial resources to carry out the responsibilities assumed. Other observations that suggest a persistent failure to adequately consult, coordinate, or take into account the concerns of other Federal, State, tribal, or local agencies with oversight, consultation, or coordination responsibilities could be non-compliant. The FHWA expects TxDOT to develop and implement corrective actions to address all non-compliance observations as soon as possible. The TxDOT has already informed the team it is implementing some recommendations made by FHWA to address non-compliance and other observations. The FHWA will conduct follow up reviews of the non-compliance observations as part of Audit #3, and if necessary, future audits.
The MOU (Part 3.1.1) states “pursuant to 23 U.S.C. 327(a)(2)(A), on the Effective Date, FHWA assigns, and TxDOT assumes, subject to the terms and conditions set forth in 23 U.S.C. 327 and this MOU, all of the USDOT Secretary's responsibilities for compliance with the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321
Non-compliance Observation #1 is an instance (1 out of 130 actions reviewed) where TxDOT made a CE determination for a project before all regulatory criteria for CE determination were met. The TxDOT followed a State procedure relating to the NEPA approval subject to “conditional clearances” that allowed the project to proceed to construction. Audit #1 Non-compliance Observation #2 also was an instance where a CE determination was made by TxDOT staff before all environmental requirements had been satisfied (
The Non-compliance Observation was that an ECOS project record showed that a TxDOT decisionmaker made a CE determination decision before the consultation for the project was completed. The completion of the consultation would have confirmed that a required constraint for the CE was met. This instance involved the determination of whether a project qualified for CE (c)(26). The FHWA's regulation at 23 CFR 771.117(c)(26) restricts the use of the CE to projects that meet all the constraints in 23 CFR 771.117(e). The constraint in 23 CFR 771.117(e)(3) prohibits the use of the CE if it involves a finding of “adverse effect” to a historic property or the use of a resource protected under Section 4(f), except for actions resulting in de minimis impacts. The ECOS record shows that at the time of the CE determination, these impacts were presumed, but consultation was not yet initiated in writing nor documented as completed such that the application of that CE could be justified. Later in time, after the CE determination was used to allow the project to proceed to a point where TxDOT made a request to FHWA to proceed to construction with Federal funding, the project record contained Texas Historical Commission (THC) concurrence that the effect was not adverse, and that a de minimis impact determination was supported. The TxDOT should not have applied a CE to a project before confirming that all conditions and constraints for use of that CE were met. By proceeding in this manner, TxDOT has not complied with the requirements for use of that CE, as specified in regulation. Also, the actions taken by TxDOT that lead to the ”conditional clearance” do not comply with FHWA's Section 4(f) regulation, 23 CFR 774, where the CE determination was made when outcome of the Section 4(f) impact was not determined.
At the team's request for additional information on projects processed with “conditional clearances,” TxDOT provided a list of 18 projects that included the non-compliant project identified in Audit #1 and described above. Eight project files showed documentation that a CE determination was made before the period for tribal consultation was complete. The TxDOT, FHWA, and Indian Tribes with an interest in Texas have executed programmatic agreements that define for which projects TxDOT would consult and manner of consultation. Those agreements commit TxDOT to send information to a Tribe and allow for a 30-day period for the Tribe to respond. If the Tribe does not respond after the 30 days, TxDOT may proceed to the next step of the process. These agreements commit TxDOT and FHWA to a manner of consultation that was not followed for eight projects. The TxDOT's assumption of FHWA's NEPA responsibilities does not permit TxDOT to disregard commitments it has made (along with FHWA) to complete tribal consultation before moving to the next step (making a CE determination). These actions are a violation of MOU Part 5.1.1 where TxDOT is subject to the same procedural and substantive requirements in interagency agreements such as programmatic agreements. Additionally, TxDOT's completion of NEPA decisionmaking prior to completing tribal consultation violates MOU Part 7.2.1 where TxDOT has committed to ensure that it has processes and procedures in place that provide for proactive and timely consultation to carry out responsibilities assumed under the MOU.
The TxDOT has a Standard Operating Procedure (SOP) for issuing a Letter of Authority (LOA) dated April 1, 2015, that enables the project to proceed to the next step in project development after a decisionmaker has made a NEPA decision based on incomplete information. Issuance of a LOA allows a project to proceed to the bidding process. For the 18 projects in the list provided, TxDOT certified to FHWA that the project's NEPA requirements were satisfied. The TxDOT has noted in the project record that the project was “conditionally cleared” for letting. Upon review, the team identified 11 projects of the 18 reviewed that did violate MOU Part 8.7.1 because the NEPA certification included projects that either did not conform to required conditions to apply CEs or did not complete required consultation requirements. Also, TxDOT's SOP for issuing a LOA does not comply with MOU Part 5.2.1 in that TxDOT's procedures did not result in compliance with Federal regulations. The remaining seven projects on the list of 18 “conditional clearance” projects advanced by TxDOT did not indicate an instance of an unjustified NEPA approval, but rather were for actions that occured post-NEPA approval (
As a result, FHWA has asked that TxDOT immediately refrain from issuing LOAs based on “conditional clearances.” The TxDOT has begun the process of revising the subject SOP. The FHWA will review the SOP to ensure that it satisfactorily complies with FHWA policy and the MOU. In addition, FHWA has requested that TxDOT report any projects that use the revised SOP to FHWA in advance of FHWA project authorization until further notice.
Two projects reviewed by the team were in error regarding NEPA decision reporting. The MOU Part 8.2.6 requires the listing of any approvals and decisions made. One CE determination was reported to FHWA as an action that would utilize less than $5 million of Federal funds (CE (c)(23)) where the project file listed the CE determination for an action that would take place entirely within the existing operational ROW (CE (c)(22)). A second project was correctly reported on the monthly list, but a review of the project file lacked documentation for this determination. Even though these may result from data entry errors, TxDOT should make every effort to ensure the decisions it reports monthly are accurate and project files are complete.
Twelve project file records were missing information that appeared to be out of compliance with TxDOT's procedures or documentation policy. One project's CE Determination Form
This section summarizes the team's observations about issues or practices that TxDOT may want to consider as areas to improve and practices the team believes are successful that TxDOT may want to continue or expand in some manner. Further information on these observations and practices is contained in the following subsections that address the six topic areas identified in FHWA's team charter and work plan to perform this audit.
Throughout the following subsections, the team lists 14 remaining observations that FHWA urges TxDOT to act upon in order to make improvements. The FHWA's suggested methods of action include: corrective action, targeted training, revising procedures, continued self-assessment, or some other means. The team acknowledges that, by sharing this draft audit report with TxDOT, TxDOT has the opportunity to begin the process of implementing actions to address the observations to improve its program prior to the publication of this report. The FHWA will consider the status of these observations as part of the scope of Audit #3. The team will also include a summary discussion that describes progress since the last audit in the Audit #3 report.
The team recognized four successful program management practices. First, it was evident through interviews that TxDOT has employed many highly qualified staff for its program. Second, the team saw evidence of strong communication between TxDOT's ENV and District staff with regard to explaining roles and responsibilities associated with implementation of the MOU for NEPA Assignment. Third, based on the response to the pre-Audit #2 information request and interview questions, the team recognized TxDOT ENV's efforts to develop and update procedures, guidance, and tools as necessary or required to assist Districts in meeting requirements of the MOU. Finally, District staff understands and takes pride in and ownership of their CE determinations. The ENV likewise takes pride in the responsibility for EA and EIS decisionmaking and oversight for the NEPA Assignment Program.
In addition, the team found evidence of six successful program management practices through information provided by TxDOT and through interviews. The team recognizes the TxDOT project Core Team concept, which provides joint ENV and District peer reviews for EAs and EISs as a good example of TxDOT utilizing its existing staff to analyze NEPA documents and correct compliance issues on higher level of NEPA documentation and procedures before project approval. Many Districts appreciate the efforts of and results from the project Core Team and credit them for assuring their projects are compliant.
The “NEPA Chat” continues to be a notable example of TxDOT's effort to achieve a compliant NEPA Assignment Program with enhanced communication among TxDOT environmental staff statewide. The NEPA Chat, led by ENV, provides a platform for complex issues to be discussed openly, and for Districts to learn about statewide NEPA Assignment Program issues, and new policies and procedures. To date, the NEPA Chat has proven to be an effective vehicle to disseminate relevant NEPA information quickly and selectively to the TxDOT District Environmental Coordinators.
Also, based on interviews and the response to the pre-audit information request, almost all of the ENV and District staff feel there is sufficient staff to deliver a successful NEPA Assignment Program at the ENV and District level. This is further supported by ENV's willingness to shift responsibilities to better align with the needs of the NEPA Assignment Program. After interviewing the various Districts, they indicated that ENV is available to assist the Districts whenever they need help.
The ENV Self-Assessment Branch (SAB) fosters regular and productive communication with District staff after environmental decisions are made. The SAB staff prepares and transmits a summary of the results of their reviews of project documentation, both positive and negative, and follows up with the District Environmental Coordinator responsible for the project via telephone. They provided this feedback within 2 weeks of their review, which resulted in early awareness of issues and corrective action, where necessary, and positive feedback.
The refinement of the pilot “Risk Assessment” tool (a “smart pdf form”) for environmental documents is a successful, but optional, procedure that may become part of ECOS during the scheduled upgrades. Based on the team's interviews, when District staff use the form, they are better able to understand the resources to be considered, what resources should receive further analysis, and the resulting output serves as documentation for District decisions. Even though this tool is not yet currently integrated within ECOS, it can be uploaded when used.
The TxDOT noted that it had recently developed a QA/QC Procedures for Environmental Documents Handbook (March 2015), and it is used by the project Core Team to develop EA and EIS documents. Through TxDOT's response to pre-Audit #2 questions and through interviews with various staff, TxDOT has continued to demonstrate that it has provided a good base of tools, guidance, and procedures with associated and timely updates to assist in meeting the terms of the MOU and still takes pride in exercising its assumed responsibilities.
The team considers three observations sufficiently important to note below. The FHWA urges TxDOT to consider ongoing and/or additional improvements or corrective actions to project management in its NEPA Assignment Program to address these observations.
Based on interviews with the USACE and USCG, FHWA would like to draw TxDOT's attention to several items. The team found that USCG had multiple ENV and District points of contact and preferred to deal with only one ENV point of contact at TxDOT. A single point of contact was the practice prior to the NEPA Assignment Program when issues needed to be elevated. The TxDOT has indicated that it identified a point of contact for USCG in August of this year, but will follow up in writing. The USACE noted that with the final rule the USACE opinion may change with regard to how it conducts its own regulatory process. This may prove to be problematic for applicants
The team found in a legacy project (
One project file contained information about an 8-mile detour categorized as not a “major traffic disruption.” An interviewee at a different District identified what they considered a different standard (
The team relied on information in ECOS, TxDOT's official file of record, to evaluate project documentation and records management. The ECOS is a tool for information records, management, and disclosure within TxDOT District Offices, between Districts and ENV, and between TxDOT and the public. The strength of ECOS is its potential for adaptability and flexibility. The challenge for TxDOT is to maintain and update the ECOS operating protocols (for consistency of use and document/data location) and to educate its users on updates in a timely manner.
A number of best practices demonstrated by TxDOT were evident as a result of the documentation and records management review. The ECOS has demonstrated system-wide improvements in usage by Districts since Audit #1, most notably in the areas of download speed and interface. The ECOS has improved in areas of connectivity and speed, and technical support for ECOS is rated as being very high and responsive. The team recognizes the need for continuous update and maintenance for the ECOS system and ENV's upcoming plans for additional NEPA compliance and documentation related improvements in five phases. The team also recognized that TxDOT Districts are making good use of the Project Risk Assessment Forms to Develop Project Scope and help guide the environmental process.
Based on examination of the 130 sample files reviewed, the team identified five general observations that are mostly issues where record keeping and documentation could be improved or clarified. The team used a documentation checklist to verify the presence of information required by regulation and review the files of the 130 sampled projects.
One project shows a NEPA clearance date that occurs after the LOA clearance date. The TxDOT has indicated that this was a data entry error that was preserved “in order to understand the progression of project development.” The NEPA clearance must occur before a date of LOA clearance according to TxDOT process.
During the interviews, the team learned that ECOS files may be deleted by their author and leave no trace of that deletion in ECOS. In addition, the team learned through interviews that deleted files may not be recovered. The FHWA is concerned and urges TxDOT to consider that if decisional information can be deleted, especially if the deletion occurs after the NEPA decision document is signed, the project record would not support the decisions made.
The team reviewed files for one project where the NEPA decision may be an example of a potential inconsistency in NEPA document content for a single project. The scope in the EA document described both a road widening with bridge replacement and widening without bridge replacement. The FONSI document project scope was described as roadway widening, the file documentation was unclear as to the status of the intent to replace the bridge. The team urges TxDOT to carefully compare the project description in an EA and any resulting FONSI and to explain in the FONSI any project description changes from the EA.
The team found there were 15 out of 83 project files where criteria for a specific CE category remained either undocumented or unclear for certain CEs (c(26)-(28)). Examples included a project that may not conform to 23 CFR 771.117(e)(4) due to major traffic disruption, a c(22) operational ROW project stated both “rehab lanes” and “widen lanes,” and c(23) projects not to exceed $5 million in Federal funds.
The FHWA is generally interested in how TxDOT fulfills its environmental commitments, which TxDOT records through an Environmental Permits, Issues and Commitments (EPIC) sheet. Such sheets become part of both the project record and often, the project bid package. In reviewing project files, the ECOS commitment tab defaults to the following note “No EPICs exist for this project” while the same file contained uploaded EPIC sheets in the ECOS documentation tab. Since the EPIC sheet is the way TxDOT implements its environmental commitments, the team would like to draw TxDOT's attention to occasional contradictory information on EPICs in its project files. The team acknowledges that TxDOT has recognized this issue and created a joint District and ENV team to address this issue to address this problem.
The team found two examples of a single project that had multiple CE approvals. Each decision document had a different approval date, however the project was unchanged. The approval documents (with different dates) otherwise appeared to be identical, with the exception of minor editorial changes, such as adding a position title or utilizing an updated form. After interviews with SAB staff, the team learned that this practice was used to
One type of decision reviewed by the team was a sequence of re-evaluations on the same project change that occurred after a NEPA approval has been made. The team found one project that had three partial re-evaluations in succession for the same design change (a sidewalk relocation) for adjacent parcels and a construction easement in each separate re-evaluation consultation checklist. The TxDOT indicated in its comment on this observation that the project was proceeding under a design-build contract that led to a number of changes. The FHWA is concerned that this TxDOT activity could possibly lead to segmenting the review of new impacts if this practice were to continue.
In general the team views the continuing delay in implementing needed substantive ECOS upgrades (
The team considers the QA/QC program to be generally in compliance with the provisions of TxDOT's QA/QC Plan. The team was pleased to see that many of the positive items mentioned and observed in Audit #1 appear to be continuing to occur.
The team observed four areas of successful practices currently in place that align with TxDOT's QA/QC Control Procedures for Environmental Documents. First, during the team site visits to the TxDOT Districts it learned that one District (Houston) has one person dedicated to reviewing the NEPA documents in order to review documentation for quality and completeness (QC as it occurs before the decision is made), and heard in an interview from another District (Dallas) they are planning to do the same.
Second, the team learned that the Core Team concept (QC) appears to be working and is well received by the District offices visited during the audit. The opportunity of District Environmental Coordinators to work with an ENV person early in the process to identify potential issues should result in efficient document preparation, an expectation of a quality document, complete project file, and improved project delivery.
Third, the team received a lot of positive comments from the Districts visited regarding the SAB of TxDOT. The District staffs stated that the SAB feedback (QA that occurs after the decision is made) was quick and resulted in a great training tool to improve documentation on future projects. The team urges TxDOT to continue this practice and encourages TxDOT to consider more focused and timely input at the pre-decision stage of project development process during QC. It is possible that the non-compliance observations cited in this report could have been identified and corrected if an enhanced pre-decisional (QC) process related check were implemented.
Fourth, since the beginning of 2015, TxDOT has created over 31 tool kits, guidance, forms, handbooks, and procedures to improve consistency and compliance of its NEPA documents and decisions. Feedback during interviews indicated that the TxDOT staff appreciated the effort from ENV to create user friendly forms and procedures to ensure compliance and reduce errors in their documentation.
As a result of the team's file reviews and interviews, it considers three observations as sufficiently important to urge TxDOT to consider improvements or corrective actions in its approach to QA/QC.
During the audit file reviews, the team occasionally found difficulty locating information in project files and could not determine whether environmental requirements were addressed but not documented. Based on what the team found in ECOS records, TxDOT appears to lack a statewide standard or guidance on ECOS naming conventions or ECOS file management. The FHWA reviewers found file names that were not intuitive for conducting efficient or comprehensive reviews. During interviews with the Districts visited, TxDOT staff at times also had trouble locating information in ECOS and was uncertain of the details of projects when questioned. This lack of consistency statewide is an issue that TxDOT acknowledged in a closeout meeting with the team and stated that it was working toward resolving the issue internally. The team will continue to monitor this issue in Audit #3.
Based on the recurring non-compliance observations from Audits #1 and #2, the team urges TxDOT to focus effort on its QA/QC actions. In a few instances, the team found documentation in the project files that was the result of QC, especially when a form was in error and had to be redone. But generally, the team found no entries in project files that showed projects had been reviewed for QC. The team could not determine for the project files reviewed for this audit whether TxDOT's actions effectively implemented QA/QC actions that were agreed to in MOU Part 8.2.4. The FHWA will focus efforts in Audit #3 on how TxDOT applies QC and implementing QA strategies to individual projects.
From interviews the team learned there are two attorneys in TxDOT's Office of General Counsel (OGC) who provide legal services on environmental issues. The OGC has an ongoing process to fill the third environmental attorney position in OGC. In addition, OGC has had an outside contract attorney providing legal assistance on environmental issues for a number of years. The OGC recently completed its biannual procurement of outside legal services for environmental issues, and has now obtained legal services from a total of three law firms. Legal counsel (both OGC staff and outside counsel) are primarily dedicated to serve as a resource providing legal assistance in project development, review of environment documents, and legal sufficiency reviews.
Assistance from OGC (who assisted in developing the sections) is guided by ENVs Project Delivery Manual Sections 303.080 through 303.086. These sections provide guidance on requesting legal sufficiency, legal sufficiency review of FHWA projects, and review of publishing a Notice of Intent (NOI) to prepare an EIS and Notice of Availability in the
The OGC is available as a resource to ENV and the Districts to answer questions on NEPA issues and specific questions on projects. Requests for assistance are made through ENV and the vehicle for communication is primarily email. The guidance states that communications between OGC and ENV for the purpose of rendering legal services or advice are protected by the attorney-client privilege.
Based on a report provided by OGC, since January 1, 2015, it has reviewed or has been involved in providing legal review for 15 project actions. These included five 139(l) notices, an FEIS/ROD, three RODs, one NOI, an EA, a public hearing and response report, an FEIS, and an FEIS errata sheet. The OGC provided legal sufficiency reviews for all 139(l) reviews, the FEIS errata sheet, and the FEIS.
Currently, ENV project managers request the review of documents and/or materials by OGC. The lead attorney in OGC assigns the project to staff based on workload and issues. He works with the project managers to agree upon an acceptable review timeframe. Per OGC, reviews are only done after the technical reports have been reviewed and approved by ENV. Comments from the attorney are provided in the usual comment/response matrix to ENV, which incorporates them into the overall comment/response matrix that is sent to the project Core Team to address. Once any comments are adequately addressed, the attorney will issue a legal sufficiency statement. The OGC does not maintain a separate project file as it completes review of a project.
In reviewing the document for legal sufficiency the OGC attorneys rely on Federal regulations and guidance, TxDOT toolkits and manuals, and discussions with project delivery managers. The OGC relies on the subject matter experts to ensure the technical reports are adequate, and only does an in-depth review of a technical report if warranted. In general, the attorneys are looking for consistent, well written documents that are reader friendly and clearly document the NEPA decision. After reviewing the document, there is a consultation between the lead attorney and staff attorney concerning the review results before a legal sufficiency finding is issued. Copies of emails providing comments on Federal and State register notices, the legal sufficiency reviews of several Section 139(l) notices, and an FEIS were provided to the team.
The lead attorney for OGC has 11 years of transportation experience with TxDOT but until NEPA assignment process began, only limited NEPA experience. The other OGC attorney's NEPA experience also began with the NEPA Assignment process. The contract attorney has had approximately 12 years of experience working NEPA issues and lawsuits in Texas. The OGC may hire outside law firms to provide assistance on an as-needed basis. All such firms have extensive transportation and NEPA experience.
The OGC indicated that there has been some early involvement in project familiarization and information gathering so that it is aware of potential issues, impacts, and timeframes during project initiation and scoping. The OGC is making a concerted effort also to attend public hearings and other project meetings as the project development process progresses. The OGC wants to be considered a resource for the ENV and TxDOT Districts from early on in project development as opposed to only being contacted when there are major issues.
Based on the team interviews and review of documentation, the requirements for legal sufficiency under the MOU are being adequately fulfilled. In FHWA's experience, legal staff can expand their role by inserting themselves into the project development process and promoting their availability as a resource to TxDOT staff.
Neither in the project delivery manual nor elsewhere does OGC provide an expectation for the time frame necessary for a legal review. The team urges TxDOT to establish a review time frame for legal sufficiency, develop some education and outreach to the TxDOT Districts regarding the OGC role, especially as a resource, and suggested additions to the legal sufficiency documentation.
Part 10 of the MOU identifies performance measures to be reported by TxDOT that FHWA would consider in conducting audits. The FHWA did not independently verify the measures reported by TxDOT. The TxDOT's first Self-Assessment Summary Report (since implementing NEPA Assignment) discusses progress made toward meeting the four performance measures. These measures provide an overall indication of TxDOT's discharge of its MOU responsibilities. In addition, in collecting data related to the reporting on the performance measures, TxDOT monitors its overall progress in meeting the targets of those measures and includes this data in self-assessments provided under the MOU (Part 8.2.5). The four performance measures are: (1) Compliance with NEPA and other Federal environmental statutes and regulations, (2) QA/QC for NEPA decisions, (3) relationships with agencies and the general public, and (4) increased efficiency and timeliness in completion of the NEPA process.
The TxDOT reports three measures of compliance with NEPA and other Federal laws and regulations: (1) Percent of complete NEPA Assignment Program Compliance Review Reports submitted to FHWA on schedule, (2) percent of identified corrective actions that are implemented, and (3) percent of final environmental documents that contain evidence of compliance with requirements of Section 7, Section 106, and Section 4(f). The measured results range between 97 percent and 100 percent complete.
The TxDOT considered QA/QC for NEPA decisions with three measures: (1) Percent of FEISs and individual Section 4(f) determinations with legal sufficiency determinations that pre-date environment document approval, (2) percent of EAs and EISs with completed environmental review checklists in the file, and (3) percent of sampled environmental project files determined to be complete and adequate for each self-assessment period. These measured results range between 94.3 percent and 100 percent.
The TxDOT is still in the process of assessing its measure of relationships with agencies and the general public. Since the completion of Audit #1, TxDOT has prepared and distributed a survey to agencies it interacts with as part of NEPA. The survey asked agency staff to respond to TxDOT's capabilities, responsiveness, efficiency, communications, and quality. The TxDOT proposes to poll agencies each year and report comparisons in future self-assessments. The TxDOT's measure of its relationship with the public is to compare the number of complaints received year to year. The TxDOT reports no complaints from the public received since assuming NEPA Assignment. A second measure for public relationship is the percent of signed final EA or EIS projects where a public meeting or hearing was conducted and the associated documentation was in the file. The TX DOT reports a measure of 92.3 percent because one EA file had a missing signed public hearing certification page. A third measure of relationships
The TxDOT provided its initial measures of increased efficiency and timeliness in completion of the NEPA process in the Self-Assessment Summary Report. Its first of three measures is to compare the median time to complete CEs, EAs, and EISs before and after assignment. The TxDOT reports that it needs more time to compile post-NEPA assignment data. The TxDOT reports that the pre-NEPA assignment median time frame to complete an EA is 1060 days (35.33 months) and 3,351 days (111.7 months) to complete an EIS. The second measure is the median time frame from submittal of biological assessment to receipt of biological opinion. The TxDOT reports that the pre-NEPA Assignment median time frame for completing a biological opinion is 43 days, and 16 days to complete informal consultation. The TxDOT reported a time frame of 65 days for a single biological opinion since NEPA Assignment. The 10 informal consultations since assignment had a median time frame of 28 days (12 days longer).
In interviews, the team learned of several best practices from the TxDOT CE Self-Assessment Report. The TxDOT's QA/QC process generates measures of error rates that provide useful information to improve the overall program management and efficiency. The TxDOT has used performance measures to evaluate the effectiveness of the SAB Feedback Program, and has demonstrated reduced error rates over its limited review time frames. Also, some of the measures closely correlated with follow up training which demonstrated its utility. One individual stated in an interview that the initial rate was initially in the high single digit percentiles (c.f., if CE determinations were signed or not). The team then considered three periods of data corresponding to rough quarter yearly time frames. In the initial quarter, people who made mistakes and were then mentored through a phone call showed a drop in number of errors over time. The same people were, for the most part, no longer making the same errors after the third quarter.
Another practice the team learned about through interviews was that TxDOT had collected and considered many measures of its performance in addition to the ones in the Self-Assessment Report Summary. The team requested more information about these additional measures from TxDOT and has received some details (TxDOT's CE Self-Assessment Report). The team hopes to see more. The team encourages TxDOT to generate performance measures in addition to the ones reported and to share those measures with the team as part of FHWA's overall review of NEPA assignment.
The team continues to be concerned that the measure for the TxDOT relationship with the public may be too limited by focusing on the number of complaints, and urges TxDOT to continue thoughtful consideration of the development of this measure. The team learned through interviews that the CSTAR database is where complaints get recorded and distributed to different parts of TxDOT, but that it apparently was not consulted to compute a baseline measure to use for comparison. Also, public complaints, according to District staff, come into individual District offices which may not be tabulated in CSTAR. The team urges TxDOT to consider the measure of public relationship in more refined detail than agency-wide scale to distinguish concerns that are tied to a particular project and those tied to program management and decisionmaking. The FHWA acknowledges that public comments and complaints were and will continue to be an important consideration in project level decisionmaking. The performance measure for public relationship should address TxDOT's consideration of project specific concerns (not just the number of complaints) and concerns about the environmental program.
The team recognizes the following successful practices. The team learned of resource sharing within the Houston District of Subject Matter Resource (SMR) staff who serve as in-house sources of knowledge and expertise. The SMR staff also commit to attend formal training and perform self-study in their resource areas, which allows them to provide training and mentor other staff on subjects within or related to the resource area.
A second best practice described to the team was that TxDOT conducted a survey of its staff in the summer of 2015 to determine needs and issues related to training. The TxDOT provided the survey results, and the team found these data to be both detailed and informative. The TxDOT reported during the pre-Audit #2 that this information was used to identify training needed by ENV staff to professionally develop Division staff and maintain expertise in their respective subject areas. The survey results from District staff identified training needed for District environmental staff to perform job duties. The team looks forward to reviewing TxDOT's progressive training plan and the updated training plan based on the new data.
A third best practice the team learned through interviews is that the TxDOT tool kit (available to consultants, local government staff, and the public) provides training opportunities for documentation and record keeping. When a consultant raises a question or concern in response to a TxDOT document review comment, staff can refer to the tool kit in order to support the TxDOT position. Finally, the ENV Director said in his interview that the tool kits contribute to increased consistency throughout the process (
The FHWA recognizes that TxDOT's annual environmental conference is its primary outreach to LPAs and consultants to address a wide array of environmental topics that reinforce existing and new environmental policies and procedures. However, the 2015 conference was not well attended by LPA staff, a fact acknowledged by the Director of ENV in his interview. He also indicated that he was thinking of reaching out to large metropolitan planning organizations and the Association of Texas Metropolitan Planning Organizations in a meaningful way in coordination with TxDOT's training coordinator. The team also learned through interviews that some, especially rural District local government staff, were uninformed of the changes with TxDOT NEPA Assignment. The team encourages the Director of ENV and the training coordinator to implement ways to train local government staff.
Audit #1 identified two non-compliance observations. One was related to the application of a CE action that related to a program that TxDOT did not have. The TxDOT acknowledges this non-compliance observation and has taken corrective action to prevent future non-compliance. Accordingly, a
The TxDOT ran into further delays in implementing its ECOS upgrade contract. The TxDOT has a plan in place that outlines five phases of work to be performed to upgrade ECOS over many years. Substantive ECOS upgrades are still pending as of the development of this draft report. This is leading to continued observations by FHWA, and inconsistencies within ECOS by TxDOT users. A lack of mandatory filing and naming conventions by ENV contributes to this issue. Of concern to FHWA is the ability for TxDOT users to potentially delete files and approvals in ECOS without an archive of such actions. This could be problematic as it differs from the FHWA's previous understanding of ECOS security measures in place from Audit #1.
Since Audit #1, TxDOT has implemented conflict resolution training for its ENV and District staff. This training has been well received and should help prepare staff to recognize when conflicts may occur and to take steps to address issues before they develop into disputes. Interviews conducted for Audit #2 suggest that TxDOT and resource agency staff may need to focus on improving communication in order to foster and nurture relationships.
This observation continues as is. The Local Public Agencys (LPA) were invited to the TxDOT Environmental Coordinators Conference (ECC), but TxDOT ENV confirmed that few LPAs attended. It was further noted by TxDOT that perhaps the ECC may not be the best training venue for LPAs that need more than introductory information or refreshers on NEPA related topics. Furthermore, some rural Districts indicated that they remain Department Delegate on local projects when LPAs can or should be project sponsors, because LPAs in the rural areas are sometimes unaware of what to do to develop their projects. The situation seems to be different in metropolitan areas where LPAs are more sophisticated and can perform well as project sponsors.
The team continued to find issues with the EPIC sheet and commitments in Audit #2. A total of 21 instances were found where inconsistencies in EPIC reporting were noted. Primarily, there was the fundamental problem of EPICs being required (and sometimes uploaded under the documentation tab) for a project but a notice stating “No EPICs Exist for this project” under the EPIC tab in ECOS was frequently found. The TxDOT has formed an internal team to address this issue.
The TxDOT has begun to address the issue of inadequate project descriptions by providing training on expectations for what should be in a project description in its 2015 environmental conference. The training instructors included individuals from FHWA and TxDOT. The team continued to find project descriptions that were unclear or may not have supported the decisions made in project files. The team suggests that TxDOT apply QA/QC to this issue. The TxDOT acknowledges this is a continuing issue and has indicated that it will continue to address it in NEPA chats and training.
The team continued to find outdated terms in project files (
The TxDOT has not taken any actions on this item other than to make information available upon request or at public meetings/hearings for a project.
The team learned that SAB only performs post decision (QA) reviews and provides feedback to both the Districts directly and the Corrective Action Team at ENV to consider if any process or procedural changes are needed. The FHWA believes there is a function that SAB or others could serve before the decision is made that would add value to the upfront QC process for both document content and procedural compliance. The FHWA understands the expected benefits of Core Team reviews but believes something more is needed and would be helpful to Districts.
The team learned in Audit #2 that there is a risk-based sampling method applied to choosing projects types that are selected for more detailed reviews, and that the number of staff available for the reviews dictates the number of reviews that are completed. The review sample is based on a computer generated model that chooses some of the projects randomly. There is no established sampling methodology for self-assessing the effectiveness of TxDOT's standards or guidance. The FHWA would like to see more clarification from TxDOT on the effectiveness of its current practice and be provided data to verify TxDOT claims of compliance.
Most of the confusion within TxDOT regarding these terms has been cleared up. The FHWA believes that additional internal (QC) review (beyond the Core Team concept for project documentation) for NEPA process related checks by TxDOT before the decisions were made would add value to the process, help ensure NEPA compliance, and assist with FHWA's requirement to make informed and fully compliant project authorization decisions.
The team's Observation #11 was that the QA/QC measure for NEPA decisions focused only on EA and EIS projects. The team urges TxDOT to consider evaluating a broader range of NEPA related decisions (including, but not limited to CEs, re-evaluations, Section 4(f), and STIP/Transportation Improvement Program (TIP) consistency). Note that the recurring non-compliance observations occurred on CEs with either STIP/TIP or Section 4(f) items that were not ready for a decision to be made. In recent interviews with TxDOT staff, the team learned that TxDOT will examine other measures on an ongoing basis for internal use. The team believes that if the QA/QC refocuses attention not only on the documentation, but also on the required sequential NEPA process related items, that improved efficiencies related to TxDOT's NEPA decision and FHWA project authorization could result. The team believes that a more relevant focus on process could potentially help avoid non-compliance actions by TxDOT under the MOU and FHWA non-compliance observations in future audits.
Observation #12 was that the utility of several of the performance measures was difficult to determine. Also, the team was concerned that the measure for the TxDOT relationship with the public may be too limited by focusing on the number of complaints. Through recent interviews, the team learned that TxDOT staff agree with FHWA's concerns about utility. Quantifying changes in relationships with the public or agencies is possible, but the number is hard to interpret. Regarding the survey of agencies, TxDOT staff indicated that they did not know if agencies have higher expectations of TxDOT compared with other agencies. Considering the TxDOT relationship with the public, staff told the team that, during the preparation of their application, they considered various sorts of surveys and social media outreach. Given the cost of these approaches, TxDOT was not convinced of their utility and so decided not to use any of them. This leaves the performance measure difficult to address for TxDOT and may be a recurring FHWA observation until it is resolved.
The team's Observation #13 was that the Caltrans training plan, which served as a basis for the TxDOT training plan, may not adequately meet the needs of TxDOT. The team urged TxDOT to consider other State DOT approaches to training. The TxDOT staff said in a recent interview that they had reviewed training plans from Virginia, Ohio, Alaska, and Florida. They also indicated that prior to Audit #2, TxDOT had completed a survey of staff in District offices and at ENV to assess training needs. The team was told that the surveys would be used to update the training plan in the spring of 2016.
Observation #14 urged TxDOT to assess whether the proposed training approach for non-TxDOT staff (relying heavily upon the annual ECC) is adequate and responsive enough to address a need to quickly disseminate newly developed procedures and policy. Through interviews, the team learned that TxDOT does not prioritize training classes specifically for non-TxDOT staff. The Director of ENV acknowledged that the training session at the recent ENV conference for LPA staff was not well attended and was thinking of reaching out to large planning organizations. The TxDOT concluded that its priority for training is first for TxDOT staff internally (ENV and District staff), second for consultants that TxDOT hires for environmental work, and third for LPAs. In years three and beyond of the TxDOT NEPA Assignment, the training plan may start to focus on the second, and eventually third, priority groups of individuals.
Observation #15 resulted in a team suggestion that the progressive training plan clearly identify the training required for each job classification. The TxDOT training coordinator told the team that the progressive training plan will address training required to meet State law (16 hours of training) and job task certification. This plan will be developed at the end of 2015.
The team learned in a recent interview that in the fall of 2015 (as in the fall of 2014), TxDOT subject matter experts planned to reach out to resource agencies to ask what training they would like to see conducted for TxDOT staff. Previously, USACE staff said that TxDOT needed 404 training. The TxDOT scheduled and completed Section 404 training in two different locations during October 2015. The TxDOT will continue to schedule Section 404 training.
The FHWA provided this draft audit report to TxDOT for a 14-day review and comment period. The team has considered TxDOT comments in developing this draft audit report. As the next step, FHWA will publish a notice in the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice.
FMCSA has determined that commercial motor vehicles manufactured by Volvo Trucks North America (Volvo Trucks) and affected by the National Highway Traffic Safety Administration (NHTSA) Part 573 Safety Recall Report No. 16V-097000, that have not already received the interim or permanent recall remedy repair specified by Volvo in the recall, are likely to cause an accident or breakdown because of a defective steering shaft which may disconnect from the junction block without warning, causing the vehicle to be in an unsafe condition. FMCSA is notifying commercial motor vehicle operators that vehicles subject to the recall without the interim or permanent repair will be subject to an immediate out-of-service order under 49 CFR 396.9 or compatible state regulations.
This Notice is effective March 23, 2016.
Charles J. Fromm, Deputy Chief
On February 16, 2016, Volvo Trucks initiated a safety recall affecting nearly 16,000 Class 8 motor vehicles in the United States. According to Volvo, a condition exists which could lead to separation of the steering shaft from the junction block. Also, the bolt connecting the upper steering shaft to the lower steering shaft may not have been properly tightened. Volvo's report to NHTSA states that either condition can lead to separation of the steering shaft and immediate loss of steering ability and control, which could lead to a crash. Volvo Trucks issued a Safety Recall Alert on March 10, which directed all owners of the affected vehicles to take the vehicles out of operation as soon as possible and cautioned that the separation can occur without warning and amended its safety recall on March 15, alerting NHTSA of the more serious hazard. Volvo Trucks strongly recommends that these vehicles remain out of service until repairs are made. NHTSA is overseeing Volvo Truck's recall efforts to ensure prompt notification of the defect to vehicle owners and that vehicles are not operated in a defective condition. Volvo's Safety Recall Report is available on its Web site at:
Additionally, to assist with notification efforts, on March 18, 2016, FMCSA posted an Inspection Bulletin on its Web site.
The Secretary of Transportation has statutory authority to set minimum standards for commercial motor vehicle safety, including ensuring that commercial motor vehicles “are maintained, equipped, loaded, and operated safely” and to prescribe requirements for the “safety of operation and equipment of, a motor carrier.” (49 U.S.C. 31136(a)(1) and 49 U.S.C. 31502(b)). The Secretary also has broad power in carrying out motor carrier safety statutes and regulations to, among other things, “inspect the equipment of a carrier or lessor” and “perform other acts the Secretary considers appropriate.” (49 U.S.C. 504(c)(1) and 49 U.S.C. 31133(a)(10)). The Administrator of FMCSA has been delegated authority under 49 CFR 1.87(f), (i) and (j) to carry out the functions vested in the Secretary of Transportation by 49 U.S.C. chapter 311, subchapter III, 49 U.S.C. chapter 315, and 49 U.S.C. 504. This delegation of authority includes the authority to declare unsafe vehicles out-of-service under 49 CFR 396.9. Under 49 U.S.C. 31102, MCSAP State partners agree to conduct roadside inspections. In 49 CFR part 350, MCSAP state partners agree to adopt state safety laws and regulations that are compatible with 49 CFR parts 390-397.
FMCSA has determined that commercial motor vehicles subject to Volvo Trucks' Safety Recall (NHTSA Part 573 Safety Recall Report No. 16V-097000), that have not already received the interim or permanent recall remedy repair specified by Volvo in the above-referenced recall, are likely to cause an accident or breakdown and are therefore in an unsafe condition. The condition of the steering column is also a violation of 49 CFR 393.209(c) which requires the steering column to be securely fastened. Because of the potential consequences associated with continued operation of these vehicles, through this notice FMCSA is declaring unsafe the operation of any unrepaired vehicle affected by the Volvo Trucks recall under NHTSA Campaign No. 16V097000 and declaring such vehicles to be in an out-of-service condition. The affected vehicles should not be operated, and the operation of an unrepaired affected vehicle will therefore subject the operator to an out-of-service order under federal or compatible state regulations.
FMCSA is directing its investigators and state partners conducting roadside inspections to perform a Level IV inspection on any unrepaired affected vehicles and to place the vehicle out of service based on the violation of 49 CFR 393.209(c). Level IV inspections, which are typically performed on a one-time basis on a particular item as a special inspection, are not included in FMCSA's Safety Measurement System (SMS), and therefore the out-of-service declaration will not affect a motor carrier's SMS score.
Placing the vehicle out-of-service under this Notice is not intended to provide a basis for further enforcement action and seeks only the immediate cessation of the operation of vehicles that have been deemed to be in an unsafe condition. Operators of vehicles declared out-of-service, however, must comply with an out-of-service order. Motor carrier operators who violate an out-of-service order will be subject to civil penalties and other enforcement as provided in the Federal Motor Carrier Safety Regulations.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 40 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or
The exemptions were granted December 15, 2015. The exemptions expire on December 15, 2017.
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at
On November 12, 2015, FMCSA published a notice of receipt of exemption applications from certain individuals, and requested comments from the public (80 FR 70060). That notice listed 40 applicants' case histories. The 40 individuals applied for exemptions from the vision requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate commerce.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. Accordingly, FMCSA has evaluated the 40 applications on their merits and made a determination to grant exemptions to each of them.
The vision requirement in the FMCSRs provides:
A person is physically qualified to drive a commercial motor vehicle if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber (49 CFR 391.41(b)(10)).
FMCSA recognizes that some drivers do not meet the vision requirement but have adapted their driving to accommodate their vision limitation and demonstrated their ability to drive safely. The 40 exemption applicants listed in this notice are in this category. They are unable to meet the vision requirement in one eye for various reasons, including amblyopia, aphakia, chronic optic neuropathy, complete loss of vision, corneal scar, macular scar, macular toxoplasmosis, optic atrophy, optic nerve atrophy, phthisical cornea, prosthetic eye, refractive amblyopia, retinal detachment, and strabismic amblyopia. In most cases, their eye conditions were not recently developed. Thirty of the applicants were either born with their vision impairments or have had them since childhood.
The 10 individuals that sustained their vision conditions as adults have had it for a range of 6 to 41 years.
Although each applicant has one eye which does not meet the vision requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected vision in the other eye, and in a doctor's opinion, has sufficient vision to perform all the tasks necessary to operate a CMV. Doctors' opinions are supported by the applicants' possession of valid commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before issuing CDLs, States subject drivers to knowledge and skills tests designed to evaluate their qualifications to operate a CMV.
All of these applicants satisfied the testing requirements for their State of residence. By meeting State licensing requirements, the applicants demonstrated their ability to operate a CMV, with their limited vision, to the satisfaction of the State.
While possessing a valid CDL or non-CDL, these 40 drivers have been authorized to drive a CMV in intrastate commerce, even though their vision disqualified them from driving in interstate commerce. They have driven CMVs with their limited vision in careers ranging for 3 to 51 years. In the past three years, 1 driver was involved in a crash, and 1 driver was convicted of a moving violation in a CMV.
The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the November 12, 2015 notice (80 FR 70060).
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. Without the exemption, applicants will continue to be restricted to intrastate driving. With the exemption, applicants can drive in interstate commerce. Thus, our analysis focuses on whether an equal or greater level of safety is likely to be achieved by permitting each of these drivers to drive in interstate commerce as opposed to restricting him or her to driving in intrastate commerce.
To evaluate the effect of these exemptions on safety, FMCSA considered the medical reports about the applicants' vision as well as their driving records and experience with the vision deficiency.
To qualify for an exemption from the vision requirement, FMCSA requires a person to present verifiable evidence that he/she has driven a commercial vehicle safely with the vision deficiency for the past 3 years. Recent driving performance is especially important in evaluating future safety, according to several research studies designed to correlate past and future driving performance. Results of these studies support the principle that the best predictor of future performance by a driver is his/her past record of crashes and traffic violations. Copies of the studies may be found at Docket Number FMCSA-1998-3637.
FMCSA believes it can properly apply the principle to monocular drivers, because data from the Federal Highway Administration's (FHWA) former waiver study program clearly demonstrate the driving performance of experienced monocular drivers in the program is better than that of all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996). The fact that experienced monocular drivers
The first major research correlating past and future performance was done in England by Greenwood and Yule in 1920. Subsequent studies, building on that model, concluded that crash rates for the same individual exposed to certain risks for two different time periods vary only slightly (See Bates and Neyman, University of California Publications in Statistics, April 1952). Other studies demonstrated theories of predicting crash proneness from crash history coupled with other factors. These factors—such as age, sex, geographic location, mileage driven and conviction history—are used every day by insurance companies and motor vehicle bureaus to predict the probability of an individual experiencing future crashes (See Weber, Donald C., “Accident Rate Potential: An Application of Multiple Regression Analysis of a Poisson Process,” Journal of American Statistical Association, June 1971). A 1964 California Driver Record Study prepared by the California Department of Motor Vehicles concluded that the best overall crash predictor for both concurrent and nonconcurrent events is the number of single convictions. This study used 3 consecutive years of data, comparing the experiences of drivers in the first 2 years with their experiences in the final year.
Applying principles from these studies to the past 3-year record of the 40 applicants, 1 driver was involved in a crash, and 1 driver was convicted of a moving violation in a CMV. All the applicants achieved a record of safety while driving with their vision impairment, demonstrating the likelihood that they have adapted their driving skills to accommodate their condition. As the applicants' ample driving histories with their vision deficiencies are good predictors of future performance, FMCSA concludes their ability to drive safely can be projected into the future.
We believe that the applicants' intrastate driving experience and history provide an adequate basis for predicting their ability to drive safely in interstate commerce. Intrastate driving, like interstate operations, involves substantial driving on highways on the interstate system and on other roads built to interstate standards. Moreover, driving in congested urban areas exposes the driver to more pedestrian and vehicular traffic than exists on interstate highways. Faster reaction to traffic and traffic signals is generally required because distances between them are more compact. These conditions tax visual capacity and driver response just as intensely as interstate driving conditions. The veteran drivers in this proceeding have operated CMVs safely under those conditions for at least 3 years, most for much longer. Their experience and driving records lead us to believe that each applicant is capable of operating in interstate commerce as safely as he/she has been performing in intrastate commerce. Consequently, FMCSA finds that exempting these applicants from the vision requirement in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to that existing without the exemption. For this reason, the Agency is granting the exemptions for the 2-year period allowed by 49 U.S.C. 31136(e) and 31315 to the 40 applicants listed in the notice of November 12, 2015 (80 FR 70060).
We recognize that the vision of an applicant may change and affect his/her ability to operate a CMV as safely as in the past. As a condition of the exemption, therefore, FMCSA will impose requirements on the 40 individuals consistent with the grandfathering provisions applied to drivers who participated in the Agency's vision waiver program.
Those requirements are found at 49 CFR 391.64(b) and include the following: (1) That each individual be physically examined every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirement in 49 CFR 391.41(b)(10) and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must have a copy of the certification when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
FMCSA received no comments in this proceeding.
Based upon its evaluation of the 40 exemption applications, FMCSA exempts the following drivers from the vision requirement in 49 CFR 391.41(b)(10):
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for 2 years unless revoked earlier by FMCSA. The exemption will be revoked if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
If the exemption is still effective at the end of the 2-year period, the person may apply to FMCSA for a renewal under procedures in effect at that time.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Cooper Tire & Rubber Company (Cooper), has determined that certain Cooper tires do not fully comply with paragraph S5.5.1(b) of Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
The closing date for comments on the petition is April 25, 2016.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and be submitted by any of the following methods:
•
•
•
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All documents submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
DOT's complete Privacy Act Statement is available for review in the
This notice of receipt of Cooper's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
S5.5.1
. . .
(b)
In support of its petition, Cooper submitted the following information and analysis of the subject noncompliance:
1. Cooper cited paragraph S5.5.1(b) of FMVSS No. 139, which requires tires manufactured on or after September 1, 2009 to be labeled with the TIN required by 49 CFR part 574 on the intended outboard sidewall of the tire.
2. Cooper also noted that 49 CFR 574.5 states that “[e]ach tire manufacturer shall conspicuously label on one sidewall of each tire it manufactures . . . a tire identification number containing the information set forth in paragraphs (a) through (d) of this section.” The company further noted that 49 CFR 574.5(d) specifies that “[t]he fourth grouping, consisting of four numerical symbols, must identify the week and year of manufacture,” with the first two symbols identifying the week and the last two identifying the year.
3. Cooper stated that the subject tires, on the outboard side only, were molded with an upside down and backwards DOT serial week and year. The serial number stamping should read: “DOT UPH4 1A6 3915.” The outboard side, which includes the date code, was molded with the date code information oriented incorrectly upside down and backwards, which resulted in the characters being out of proper sequence.
4. Cooper explained that the existence of the stamping error was determined by visual examination of a subject tire on October 21, 2015 by warehouse personnel in Grand Prairie, TX. Upon further investigation, it was determined that only tires cured in one press
5. Cooper states that the 338 subject tires do meet and/or exceed all performance requirements and all other labeling and marking requirements of FMVSS No. 139.
Furthermore, Cooper is not aware of any crashes, injuries, customer complaints, or field reports associated with the subject tires.
Cooper has informed NHTSA that the subject tires located in its inventory count reconciliation have been returned to the company's Findlay, OH plant, where they will be corrected prior to being released for sale.
In summation, Cooper believes that the described noncompliance is inconsequential to motor vehicle safety, and that its petition, to exempt Cooper from providing recall notification of the noncompliance, as required by 49 U.S.C. 30118, and remedying the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that Cooper no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after Cooper notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Continental Tire the Americas, LLC (CTA), has determined that certain CTA tires do not fully comply with paragraph S5.5(f) of Federal Motor Vehicle Safety Standard (FMVSS) No. 139
The closing date for comments on the petition is April 25, 2016.
Interested persons are invited to submit written data, views, and arguments regarding this petition. Comments must refer to the docket and notice number cited in the title of this notice and be submitted by any of the following methods:
•
•
•
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All documents submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
DOT's complete Privacy Act Statement is available for review in the
This notice of receipt of CTA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
S5.5
(f) The actual number of plies in the sidewall, and the actual number of plies in the tread area, if different.
In support of its petition, CTA submitted the following information pertaining to the subject noncompliance:
(a) CTA stated that the tires covered by this petition are labeled with incorrect information regarding the number of tread plies. The company noted that while the number of polyester and steel plies indicated on the sidewall is accurate, the number of polyamide plies indicated is incorrect. The company contended, however, that this mislabeling has no impact on the operational performance of these tires or on the safety of vehicles on which these tires are mounted. The company asserted that the tires meet or exceed all of the performance requirements of FMVSS No. 139.
(b) CTA noted that NHTSA has concluded in response to numerous other petitions that this type of noncompliance is inconsequential to motor vehicle safety. CTA referenced notices that NHTSA has published in the
• Petition of Hankook Tire America Corp., 79 FR 30688 (May 28, 2014);
• Petition of Bridgestone Americas Tire Operations, LLC, 78 FR 47049 (August 2, 2013);
• Petition of Cooper Tire & Rubber Company, 78 FR 47050 (August 2, 2013).
(C) CTA states that all tires covered by its petition meet or exceed the performance requirements of FMVSS No. 139, as well as the other labeling requirements of the standard.
(d) CTA also states that it is not aware of any crashes, injuries, customer complaints, or field reports associated with the subject noncompliance.
CTA additionally informed NHTSA that it has quarantined all existing inventory of the tires that contain the noncompliant tire sidewall labeling and has corrected the molds at the manufacturing plant so that no additional tires will be manufactured with the noncompliance.
In summation, CTA believes that the described noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and to remedy the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that CTA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers from the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after CTA notified them that the subject noncompliance exists.
49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Notice.
The National Highway Traffic Safety Administration (NHTSA) is issuing this notice to make manufacturers aware of the statutory requirement to index their communications to dealers, owners, or purchasers about a defect or noncompliance, and to provide recommendations for complying with the index requirement. Additionally, a change in the law requires NHTSA to publicly post all such communications on its Web site and it is therefore providing notice of its intention to do so. NHTSA will also publicly post on its Web site the manufacturers' indexes to their communications as they are received.
For legal issues: Kerry Kolodziej, Office of the Chief Counsel, NCC-100, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone: 202-366-5263).
For submission of documents pursuant to 49 CFR 579.5:
For submission of documents pursuant to 49 CFR 573.6(c)(10): Recalls Portal Help Desk, 1-888-719-9220;
The National Highway Traffic Safety Administration (NHTSA or Agency) is issuing this notice of its intent to enforce and implement the requirements of 49 U.S.C. 30166(f), as amended by the Moving Ahead for Progress in the 21st Century Act (MAP-21).
The National Traffic and Motor Vehicle Safety Act (Safety Act), as amended, requires motor vehicle and
The requirement for manufacturers to submit copies of their communications to the Agency is broad and requires not only submission of manufacturers' communications to dealers,
Moreover, the Agency has long interpreted the requirement that manufacturers submit copies of their communications to dealers, owners, or purchasers as capturing all defect-related communications.
NHTSA implements the statutory requirement that manufacturers submit representative copies of their communications to dealers, owners, or purchasers through two regulations: One specifically addressing recall communications, 49 CFR 573.6(c)(10), and the other addressing manufacturer communications more broadly, 49 CFR 579.5.
Many communications about a defect or noncompliance are communications manufacturers make to their dealers, owners, or purchasers about recalls. Some examples of these communications are letters to dealers and vehicle owners informing them about a recall and service bulletins (also known as technical service bulletins or TSBs) that provide repair instructions for trained technicians performing the recall remedy. NHTSA requires manufacturers to submit a representative copy to NHTSA of recall communications “not later than 5 days after they are initially sent to manufacturers, distributors, dealers, or purchasers.” 49 CFR 573.6(c)(10). This applies to “all notices, bulletins, and other communications that relate directly to the defect or noncompliance [that is the subject of a recall] and are sent to more than one manufacturer, distributor, dealer or purchaser.”
The second regulation that implements the requirement for manufacturers to submit communications about a defect or noncompliance to the Agency is 49 CFR 579.5. That requires manufacturers to submit “a copy of all notices, bulletins, and other communications (including those transmitted by computer, telefax, or other electronic means and including warranty and policy extension communiqués and product improvement bulletins) other than those required to be submitted pursuant to § 573.6(c)(10) of this chapter, sent to more than one manufacturer, distributor, dealer, lessor, lessee, owner, or purchaser, in the United States, regarding any defect in its vehicles or items of equipment (including any failure or malfunction beyond normal deterioration in use, or any failure of performance, or any flaw or unintended deviation from design specifications), whether or not such defect is safety-related.” 49 CFR 579.5(a). It also requires that “[e]ach manufacturer shall furnish to NHTSA a copy of each communication relating to a customer satisfaction campaign, consumer advisory, recall, or other safety activity involving the repair or replacement of motor vehicles or equipment, that the manufacturer issued to, or made available to, more than one dealer, distributor, lessor, lessee, other manufacturer, owner, or purchaser, in the United States.” 49 CFR 579.5(b). Manufacturer communications required by 49 CFR 579.5 are due to the Agency “not later than five working days after the end of the month” in which they were issued. 49 CFR 579.5(d).
It is important that manufacturers fully comply with the requirement to submit copies of communications to their dealers, owners, or purchasers about a defect or noncompliance so that the Agency can effectively carry out its mission. Among other things, the Agency reviews these communications to evaluate whether a safety issue is involved, to engage in proactive communications with manufacturers where there may be a misunderstanding or misidentification of the risk of a particular issue that a manufacturer has decided to control and remedy via a field action that is less than a recall, and to ensure that recalls are carried out effectively.
NHTSA posts a great deal of information on its Web site,
Where manufacturer communications involve a recall (
MAP-21 amended the Safety Act to require manufacturers to submit additional information to the Agency along with copies of their communications and to require the Agency to make that additional information and the communications themselves available on the Agency's Web site.
MAP-21 required manufacturers to accompany their submissions of communications to the Agency with an index to each communication. MAP-21, Public Law 112-141, § 31303(a)(2), 126 Stat. 405, 764 (2012) (codified at 49 U.S.C. 30166(f)(2)). Specifically, communications manufacturers are required to submit to NHTSA under 49 U.S.C. 30166(f) “shall be accompanied by an index to each communication, that—(A) identifies the make, model, and model year of the affected vehicles; [and] (B) includes a concise summary of the subject matter of the communication.”
While NHTSA already proactively made a substantial number of manufacturer communications available to the public on its Web site, MAP-21 also changed the law to make it mandatory for the Agency to post all manufacturer communications to dealers, owners, or purchasers about a defect or noncompliance on its Web site.
To implement these changes in the law, NHTSA is providing guidance to manufacturers on the index requirement. This guidance is warranted because manufacturers have not been submitting compliant indexes to the Agency since the MAP-21 changes became effective on October 1, 2012.
NHTSA is also providing notice of its intention to publicly post all manufacturer communications submitted to the Agency pursuant to 49 U.S.C. 30166(f) on its Web site. MAP-21 requires NHTSA to post all manufacturer communications to dealers, owners, or purchasers about a defect or noncompliance. Prior to MAP-21, the Agency did not post certain manufacturer communications (specifically, certain service bulletins) on its Web site, which some manufacturers claimed to be copyrighted documents. Congress in MAP-21's explicit requirement that the Agency post “each communication to the manufacturer's dealers or to owners” about a defect or noncompliance, has now made clear that copyright law is not a restriction on NHTSA action.
The law now requires manufacturers to submit to NHTSA copies of their communications to dealers, owners, or purchasers about a defect or noncompliance and requires that such communications “shall be accompanied by an index to each communication.” 49 U.S.C. 30166(f). The index must identify the make, model, and model year of the affected vehicles and include a concise summary of the subject matter of the communication. 49 U.S.C. 30166(f)(2). This requirement has been in effect since October 1, 2012.
Most manufacturers comply with the long-standing requirement to submit copies to the Agency of their communications to dealers, owners, or purchasers about a defect or noncompliance.
We are providing this guidance to make manufacturers aware of their legal obligation to index their communications. The Agency expects all manufacturers to expeditiously come into full compliance with the law and will take additional action to enforce the index requirement as necessary. The index requirement is subject to daily civil penalties.
We are also providing this guidance to communicate to manufacturers the content requirements for the index. We are providing recommendations for preparing and submitting the index to help ensure consistency across manufacturers and to enable the Agency to readily make the indexes publicly available in a searchable format on its Web site.
Every manufacturer of motor vehicles or motor vehicle equipment is responsible both for submitting copies of communications to dealers, owners, or purchasers and to provide an
As discussed in this notice, NHTSA implemented the requirement to submit copies of communications to dealers, owners, or purchasers about a defect or noncompliance through regulations at 49 CFR 573.6(c)(10) and 49 CFR 579.5. Therefore, a manufacturer must accompany its future submissions of all communications pursuant to these provisions with an index that meets the statutory requirements.
The index requirement became effective as of October 1, 2012.
A compliant submission requires both a complete index and copies of the indexed communications.
While a manufacturer must accompany future submissions of communications pursuant to 49 CFR 573.6(c)(10) (
The Agency has long had a practice of posting recall communications on its Web site along with a great deal of information about the recall. As safety critical information, the Agency wants to avoid any disruption that could occur by making changes to the recall portion of its Web site. Moreover, changes are unnecessary. Recall communications are already indexed and available on the Agency's Web site. Recall communications are readily accessible through a searchable interface that is familiar to public users of the Agency's Web site.
The law requires that communications submitted to the Agency “shall be accompanied by an index.” 49 U.S.C. 30166(f)(2). Therefore, manufacturers should submit an index at the same time as they submit communications to the Agency. As discussed above, 49 CFR 573.6(c)(10) requires submission of recall communications “not later than 5 days after they are initially sent to manufacturers, distributors, dealers, or purchasers.” Manufacturer communications required by 49 CFR 579.5 are due to the Agency “not later than five working days after the end of the month” in which they were issued. 49 CFR 579.5(d).
The Agency expects manufacturers to make a good faith effort to expeditiously comply with the requirement to provide an index to accompany the communications they submit to the Agency. However, the Agency recognizes that manufacturers will need to educate staff and may need to change internal policies and procedures to begin complying with this requirement. While the Agency is not excusing noncompliance with the law, the Agency recognizes that the entire industry has been out of compliance with the index requirement and intends to exercise its enforcement discretion to allow manufacturers a reasonable period of time from the date of this notice to come into compliance with the index requirement on a going forward basis. However, manufacturers should not delay providing communications to the Agency.
The Agency will not excuse manufacturers from providing indexes for communications submitted to the Agency pursuant to 49 CFR 579.5 on or after October 1, 2012. For any communications previously submitted to the Agency pursuant to 49 CFR 579.5 that were not accompanied by a fully compliant index at the time of submission, manufacturers must submit indexed communications to the Agency. As discussed above, this requires an index along with resubmission of all communications listed in the index. This is necessary to allow the Agency to fulfill its statutory obligations.
The Agency intends to exercise enforcement discretion to allow manufacturers a reasonable period of time to resubmit indexed communications required by 49 CFR 579.5. The Agency recognizes that, in many cases, the volume of communications submitted to the Agency since October 1, 2012 is significant. The Agency will take the volume of communications into account in considering what constitutes a reasonable period of time for a given manufacturer. In general, we expect that a manufacturer will resubmit indexed communications on a rolling basis until it achieves full compliance.
In sum, the Agency is not specifying a deadline for compliance with the index requirement before it expects to take enforcement action. All manufacturers must begin immediately making a reasonable good faith effort to take steps to comply expeditiously for both retroactive and future submissions. The Agency will take any such actions into account in evaluating whether a given manufacturer came into compliance with the law within a reasonable period of time.
Indexes are required by 49 U.S.C. 30166(f), therefore, failure to provide indexes, or failure to provide timely or complete indexes, is subject to civil
At a minimum, an index must identify the make, model, and model year of the affected vehicles and must include a concise summary of the subject matter of the communication. These are statutory requirements. 49 U.S.C. 30166(f)(2). This is mandatory information when applicable.
However, the Agency recognizes that for communications submitted by motor vehicle equipment manufacturers, in many cases, there are no specific affected vehicles. This is also true for a limited number of generalized communications by motor vehicle manufacturers. In such cases, the manufacturer should include other identifying information for the affected motor vehicles or motor vehicle equipment in lieu of make, model, and model year information for specific affected vehicles.
To help ensure consistency across manufacturers, the Agency is also providing recommendations on the specific format and content of the indexes. In addition to the recommendations provided in this notice, the Agency may provide more detailed recommendations on a forthcoming Web page at
NHTSA strongly recommends that manufacturers submit their indexes as word searchable electronic files. While the Agency is not requiring use of any particular software, to ensure compatibility, the Agency requests that manufacturers submit indexes as searchable Microsoft Excel files.
The Agency recommends that a manufacturer list each communication on a separate row in its index and include separate columns for each item of discrete information included. For example, the index should include separate columns for make, of the affected vehicles, model of the affected vehicles, and model year of the affected vehicles. We recommend including a separate row for each make, model, or model year of vehicle affected by a single communication. In other words, a single communication may populate multiple rows on an index. We also recommend including a column for manufacturer communication identifier number, if one is used.
The Agency's Web site and template index available for download will provide more specific recommendations and information on the Agency's preferred format for manufacturer indexes.
At a minimum, NHTSA recommends that a concise summary of the subject matter of a manufacturer's communication should identify the defect or noncompliance, describe the effect of the defect or noncompliance, and describe the purpose or type of the communication. In many cases, simply repeating the subject line or title of a communication will be insufficient. Likewise, a generic description that does not actually summarize the communication or describes multiple communications with minimal changes, such as “service bulletin number 123” does not meet the statutory requirements. The Agency will post examples of concise summaries on its Web site.
NHTSA requests that manufacturers submit their indexed communications to the Agency electronically. Electronic submission will best enable the Agency to make the manufacturer communications and searchable index available to the public on the Internet as the law requires.
As discussed above, manufacturers must index recall communications that they submit to the Agency pursuant to 49 CFR 573.6(c)(10) and communications that they submit pursuant to 49 CFR 579.5. Manufacturers are required to submit recall communications through NHTSA's recalls portal and should also submit their recall communication indexes through the portal.
We note that some manufacturers have had a past practice of submitting multiple communications under 49 CFR 579.5 in a consolidated format, such as a single large .pdf file. We strongly recommend that manufacturers discontinue this practice, in order to ensure that each communication listed in the manufacturer's index is a readily identifiable separate document. The Agency would prefer to receive each communication as a separate .pdf file.
NHTSA has reevaluated the information that the law permits it to make publicly available on its Web site in light of the changes made by MAP-21. As a result, NHTSA is providing this notice of its intent to publicly post all manufacturer communications submitted to it pursuant to 49 U.S.C. 30166(f).
The law now affirmatively requires NHTSA to “make available on a publicly accessible Internet Web site” copies of communications to manufacturers' dealers, owners, or purchasers about a defect or noncompliance that manufacturers submit to the Agency.
Prior to enactment of MAP-21, the Agency did not publicly post copies of all service bulletins that it received.
Pursuant to the fair use limitation on copyright, to date NHTSA has posted on its Web site copies of service bulletins for recall repairs and service bulletins related to its defect investigations.
Congress necessarily made the decision in enacting MAP-21, that copyright law does not restrict NHTSA from publicly posting copies of all manufacturer communications received by the Agency pursuant to 49 U.S.C. 30166(f) on its Web site. Indeed, 49 U.S.C. 30166(f) expressly requires the Agency to do so.
MAP-21 trumps the limited waiver of sovereign immunity for copyright infringement claims.
Because the law directs the Agency to make manufacturer communications publicly available on its Web site, the Agency is acting to effectuate the law. The Agency will post on its Web site those manufacturer communications submitted to the Agency on or after the October 1, 2012 effective date of MAP-21 that are not already available on the Agency's Web site. Going forward, the Agency intends to post to its public Web site all manufacturer communications submitted pursuant to 49 U.S.C. 30166(f), including documents submitted pursuant to 49 CFR 573.6(c)(10) or 579.5. The Agency will also post manufacturer indexes for communications submitted to the Agency on or after October 1, 2012 on a rolling basis as compliant indexes are received. The Agency intends to make manufacturer indexes available in a searchable format.
49 U.S.C. 30101,
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before April 25, 2016.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC or at
This notice of receipt of applications for special permit is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of Applications for Special Permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before April 25, 2016.
Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC or at
This notice of receipt of applications for special permit is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(6); 49 CFR 1.53(b)).
Office of the Comptroller of the Currency (OCC), Department of the Treasury.
Notice and request for comments.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning renewal of its information collection titled, “Minimum Security Devices and Procedures, Reports of Suspicious Activities, and Bank Secrecy Act Compliance Program.”
Written comments should be received on or before May 24, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0180, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Office of the Comptroller of the Currency, Washington, DC 20219.
Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
Under §§ 21.2 and 21.4; and §§ 568.2 and 568.4, national banks and savings associations are required to designate a security officer who must develop and administer a written security program. The security officer shall report at least annually to the institution's board of directors on the effectiveness of the security program. The substance of the report shall be reflected in the board's minutes. These requirements ensure that the security officer is responsible for the security program and that institution management and the board of directors are aware of the content and effectiveness of the program. These requirements ensure prudent institution management and institution safety and soundness.
The Financial Crimes Enforcement Network (FinCEN) and Federal financial institution supervisory agencies
In 1992, the Department of the Treasury was granted broad authority to require suspicious transaction reporting under the Bank Secrecy Act (BSA).
Banks and savings associations are required to maintain a copy of any SAR filed and the original or business record equivalent of any supporting documentation for a period of five years. The documents are necessary for criminal investigations and prosecutions.
Under 12 CFR 21.21, national banks and savings associations are required to develop and provide for the continued administration of a program reasonably designed to assure and monitor their compliance with the BSA and applicable Treasury regulations. The compliance program shall be in writing, approved by the board of directors and noted in the minutes. These requirements are necessary to ensure institution compliance with the BSA and applicable Treasury regulations.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information shall have practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology, and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the collections of information required to comply with the terms and conditions of FHA New Account Request, Transition Request, and Transfer Request.
Written comments should be received on or before May 24, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street, A4-A, Parkersburg, WV 26106-1328, or
Requests for additional information or copies of the form(s) and instructions should be directed to Dwayne Boothe, Branch Manager, Special Investments Branch; 200 Third Street, Room 119, Parkersburg, WV 26106-1328, or
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing updated identifying information for one individual whose property and interests in property are blocked pursuant to Executive Order (E.O.) 13469, “Blocking Property of Additional Persons Undermining Democratic Processes or Institutions in Zimbabwe,” and one entity whose property and interests in property are blocked pursuant to E.O. 13224, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism,” both of which have previously been designated and added to OFAC's Specially Designated Nationals and Blocked Persons (SDN) List.
OFAC's actions described in this notice were effective on March 22, 2016, as further specified below.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202/622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490, or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's Web site (
On March 22, 2016, OFAC updated the identifying information for one previously designated individual whose property and interests in property are blocked pursuant to E.O. 13469 and one previously designated entity whose property and interests in property are blocked pursuant to E.O. 13224. The updated identifying information for the individual and entity is as follows:
Individual:
AL-SHANFARI, Thamer Bin Said Ahmed (a.k.a. AL SHANFARI, SHEIKH THAMER; a.k.a. AL SHANFARI, Thamer; a.k.a. AL SHANFARI, Thamer Said Ahmed; a.k.a. AL-SHANFARI, Thamer Bin Saeed; a.k.a. AL-SHANFARI, Thamer Said Ahmed; a.k.a. SHANFARI, Thamer), P.O. Box 18, Ruwi 112, Oman; DOB 03 Jan 1968; nationality Oman; citizen Oman; Passport 00000999 (Oman); alt. Passport 3253 (Oman); Chairman & Managing Director, Oryx Group and Oryx Natural Resources (individual) [ZIMBABWE].
-to-
AL-SHANFARI, Thamer Bin Said Ahmed (a.k.a. AL SHANFARI, SHEIKH THAMER; a.k.a. AL SHANFARI, Thamer; a.k.a. AL SHANFARI, Thamer Said Ahmed; a.k.a. AL-SHANFARI, Thamer Bin Saeed; a.k.a. AL-SHANFARI, Thamer Said Ahmed; a.k.a. SHANFARI, Thamer), P.O. Box 18, Ruwi 112, Oman; DOB 03 Jan 1968; alt. nationality Oman; alt. citizen Oman; Passport 00000999 (Oman); alt. Passport 3253 (Oman) (individual) [ZIMBABWE].
Entity:
REVIVAL OF ISLAMIC HERITAGE SOCIETY (a.k.a. AFGHAN SUPPORT COMMITTEE; a.k.a. AHIYAHU TURUS; a.k.a. AHYA UL TURAS; a.k.a. AHYA UTRAS; a.k.a. AL-FORQAN AL-KHAIRYA; a.k.a. AL-FURQAN AL-KHARIYA; a.k.a. AL-FURQAN CHARITABLE FOUNDATION; a.k.a. AL-FURQAN FOUNDATION WELFARE TRUST; a.k.a. AL-FURQAN KHARIA; a.k.a. AL-FURQAN UL KHAIRA; a.k.a. AL-FURQAN WELFARE FOUNDATION; a.k.a. AL-TURAZ ORGANIZATION; a.k.a. AL-TURAZ TRUST; a.k.a. FORKHAN RELIEF ORGANIZATION; a.k.a. HAYAT UR RAS AL-FURQAN; a.k.a. HAYATURAS; a.k.a. HAYATUTRAS; a.k.a. HIYAT ORAZ AL ISLAMIYA; a.k.a. JAMIA IHYA UL TURATH; a.k.a. JAMIAT AL-HAYA AL-SARAT; a.k.a. JAMIAT AYAT-UR-RHAS AL ISLAMIA; a.k.a. JAMIAT IHIA AL-TURATH AL-ISLAMIYA; a.k.a. JAMIAT IHYA UL TURATH AL ISLAMIA; a.k.a. JAMITO AHIA TORAS AL-ISLAMI; a.k.a. LAJNAT UL MASA EIDATUL AFGHANIA; a.k.a. LAJNATUL FURQAN; a.k.a. ORGANIZATION FOR PEACE AND DEVELOPMENT PAKISTAN; a.k.a. RAIES KHILQATUL QURANIA FOUNDATION OF PAKISTAN; a.k.a. REVIVAL OF ISLAMIC SOCIETY HERITAGE ON THE AFRICAN CONTINENT; a.k.a. “AL MOSUSTA FURQAN”; a.k.a. “AL-FORKAN”; a.k.a. “AL-FURKAN”; a.k.a. “AL-MOSASATUL FURQAN”; a.k.a. “ASC”; a.k.a. “HITRAS”; a.k.a. “JAMIAT AL-FURQAN”; a.k.a. “MOASSESA AL-FURQAN”; a.k.a. “MOSASA-TUL-FORQAN”; a.k.a. “RIHS”; a.k.a. “SOCIAL DEVELOPMENT FOUNDATION”), House Number 56, E. Canal Road, University Town, Peshawar, Pakistan; Afghanistan; Near old Badar Hospital in University Town, Peshawar, Pakistan; Chinar Road, University Town, Peshawar, Pakistan [SDGT].
-to-
REVIVAL OF ISLAMIC HERITAGE SOCIETY (a.k.a. AFGHAN SUPPORT COMMITTEE; a.k.a. AHIYAHU TURUS; a.k.a. AHYA UL TURAS; a.k.a. AHYA UTRAS; a.k.a. AL FORQAN CHARITY; a.k.a. AL-FORQAN AL-KHAIRYA; a.k.a. AL-FURQAN AL-KHARIYA; a.k.a. AL-FURQAN CHARITABLE FOUNDATION; a.k.a. AL-FURQAN FOUNDATION WELFARE TRUST; a.k.a. AL-FURQAN KHARIA; a.k.a. AL-FURQAN UL KHAIRA; a.k.a. AL-FURQAN WELFARE FOUNDATION; a.k.a. AL-TURAZ ORGANIZATION; a.k.a. AL-TURAZ TRUST; a.k.a. EAST AND WEST ENTERPRISES; a.k.a. FORKHAN RELIEF ORGANIZATION; a.k.a. HAYAT UR RAS AL-FURQAN;
Office of Financial Research, Treasury.
Financial Research Advisory Committee-Solicitation of Applications for Committee Membership.
The Office of Financial Research is soliciting applications for membership on its Financial Research Advisory Committee.
Susan Stiehm, Designated Federal Officer, Office of Financial Research, Department of the Treasury, (212) 376-9808.
Pursuant to the Federal Advisory Committee Act, (Pub. L. 92-463, 5 U.S.C. App. 2 § 1-16, as amended), the Treasury Department established a Financial Research Advisory Committee (Committee) to provide advice and recommendations to the Office of Financial Research (OFR) and to assist the OFR in carrying out its duties and authorities.
The OFR was established under Title I of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203, July 21, 2010). The purpose of the OFR is to support the Financial Stability Oversight Council (Council) in fulfilling the purposes and duties of the Council and to support the Council's member agencies by:
The Financial Research Advisory Committee was established to advise the OFR on issues related to the responsibilities of the office. It may provide its advice, recommendations, analysis, and information directly to the OFR and the OFR may share the Committee's advice and recommendations with the Secretary of the Treasury or other Treasury officials. The OFR will share information with the Committee as the Director determines will be helpful in allowing the Committee to carry out its role.
The Financial Research Advisory Committee is an advisory committee that was established on April 6, 2012 and renewed its charter on March 8, 2016. The OFR is currently soliciting applications for membership in order to provide for rotation of membership, as provided in its original and renewed charter, as well as to provide for a diverse and balanced body with a variety of interests, backgrounds, and viewpoints represented. Providing for such diversity enhances the views and advice offered by the Committee.
Treasury seeks applications from individuals representative of a constituency within the fields of economics, financial institutions and markets, statistical analysis, financial markets analysis, econometrics, applied sciences, risk management, data management, information standards, technology, or other areas related to OFR's duties and authorities. The terms of members chosen to serve may vary. Membership on the Committee is limited to the individuals appointed and is non-transferrable. Regular attendance is essential to the effective operation of the Committee. Some members of the Committee may be required to adhere to the conflict of interest rules applicable to Special Government Employees, as such employees are defined in 18 U.S.C. 202(a). These rules include relevant provisions in 18 U.S.C. related to criminal activity, Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), and Executive Order 12674 (as modified by Executive Order 12731).
To apply, an applicant must submit an appropriately-detailed resume and a cover letter describing their interest, reasons for application, and qualifications. In accordance with Department of Treasury Directive 21-03, a clearance process includes fingerprints, tax checks, and a Federal Bureau of Investigation criminal check. Applicants must state in their application that they agree to submit to these pre-appointment checks.
The application period for interested candidates will extend to April 22, 2016. Applications should be submitted in sufficient time to be received by the close of business on the closing date and should be sent to
Return to policy office for delivery.
Deliver through the OFR Front Office (include specific instructions below).
Other (see below).
Specific delivery instructions:
Departmental Offices, U.S. Department of the Treasury.
Notice and request for comment.
The Terrorism Risk Insurance Act of 2002, as amended (TRIA), requires participating insurers to make insurance available for losses resulting from acts of terrorism, and provides a federal government backstop for the insurers' resulting financial exposure. TRIA established, in the U.S. Department of the Treasury, the Terrorism Risk Insurance Program (TRIP), which is administered by the Secretary of the Treasury (Secretary), with the assistance of the Federal Insurance Office (FIO). The Terrorism Risk Insurance Program Reauthorization Act of 2015 (Reauthorization Act), which extended and amended certain provisions of TRIP, requires the Secretary to submit a report to Congress concerning, among other things, the overall effectiveness of TRIP. To assist the Secretary in formulating the report, FIO is seeking comment on the statutory factors that the report must analyze and other related matters.
Comments must be submitted not later than April 15, 2016.
Interested persons may submit comments electronically through the Federal eRulemaking Portal at
Electronic submissions are encouraged.
Comments may also be mailed to the Department of the Treasury, Federal Insurance Office, MT 1410, 1500 Pennsylvania Avenue NW., Washington, DC 20220.
Richard A. Ifft, Senior Insurance Regulatory Policy Analyst, Federal Insurance Office, (202) 622-2922 (this is not a toll-free number) or Kevin Meehan, Policy Advisor, Federal Insurance Office, (202) 622-7009 (not a toll free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877-8339.
Section 111 of the Reauthorization Act (Pub. L. 114-1) requires the Secretary to submit a report to the Committee on Financial Services of the House of Representatives and the Committee on Banking, Housing, and Urban Affairs of the Senate on, among other things, the impact and effectiveness of TRIP. The report must also include an evaluation of information that is being separately collected by Treasury, including certain data appropriate for analyzing the effectiveness of TRIP.
Collecting additional information and views on the matters that must be addressed in the report to Congress will assist the Secretary in the formulation of the report and enhance the report's accuracy and value. Treasury seeks comment from interested parties on all Section 111 elements that must be covered in the report, including comments on:
1. The overall effectiveness of the TRIP;
2. Observed changes or trends relating to matters that Treasury is collecting data about under Section 111 of the Reauthorization Act;
3. Whether any aspects of TRIP have the effect of discouraging or impeding insurers from providing commercial property casualty insurance coverage or coverage for acts of terrorism; and
4. The impact of TRIP on workers' compensation insurers.
In addition to comments on the above, Treasury also seeks comment from interested parties on:
5. The availability and affordability of terrorism risk insurance coverage, both nationally and in particular geographic areas; and
6. Other issues relating to TRIP or terrorism insurance or reinsurance more broadly that may be relevant to Treasury's assessment of the effectiveness of TRIP.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before April 25, 2016 to be assured of consideration.
Send comments regarding the burden estimates, or any other aspect of the information collections, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained by emailing
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
VA Form 21-0972 will be used to collect the alternate signer information necessary for VA to accept benefit application forms signed by individuals on behalf of Veterans and claimants. The information collected will be used to contact the alternate signer for verification purposes.
Written comments and recommendations on the proposed collection of information should be received on or before May 24, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before May 24, 2016.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
(b) The NDRP, as described in section 5 of this memorandum, shall facilitate, coordinate, and monitor the implementation of the actions conducted to achieve these goals.
(a)
(A) improve the integration of all relevant drought-related data and information, and facilitate the use of such data, in coordination with the National Integrated Drought Information System, by State, regional, tribal, and local officials in drought planning and decisionmaking; and
(B) identify and use data formats that will allow these datasets to be incorporated into existing geospatial data platforms.
(b)
(A) provide technical and scientific information to State, regional, tribal, and local officials concerning the integration of drought planning, hazard mitigation, and preparedness planning; and
(B) ensure that local and regional officials are aware of drought-related planning activities and similar initiatives occurring in their region, which will avoid duplication of effort and prompt peer-to-peer collaboration.
(c)
(A) support information gathering and analysis to assess the risk of drought to critical infrastructure; and
(B) use the assessment described in section 4(c)(ii) of this memorandum to inform agencies and to better communicate accurate, science-based information about drought, and the risks of drought to communities, critical
(d)
(A) coordinate and use Federal programs and investments to better support drought resilience through improved information sharing and collaboration, building on existing place-based and program coordination efforts; and
(B) develop tools, guidance, and other relevant resources to ensure drought-related support to State, regional, tribal, and local officials occurs in an effective and efficient manner.
(e)
(A) identify and share effective practices with State, regional, tribal, and local water users on the use of innovative financing opportunities to facilitate the construction, maintenance, rehabilitation, or restoration of drought-resilient infrastructure;
(B) test innovative financing opportunities, to the extent permitted by law, to attract private investment into underserved and drought-sensitive rural water infrastructure; and
(C) where appropriate, provide technical assistance to support State and local efforts to develop strategies for more flexible water management, including through market-based mechanisms.
(f)
(A) engage with foreign partners in order to establish mechanisms through which to implement relevant research, monitoring, and technical assistance to support transfer and adaptation of more water-efficient practices and technologies domestically;
(B) facilitate the development of new technologies and practices or the expansion of existing technologies and practices to mitigate the consequences of drought; and
(C) promote expanded use of technologies that allow the use of produced, reused, brackish, recycled, or other alternative water sources where possible and appropriate.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(b)
(b) “Critical infrastructure” has the meaning provided in section 1016(e) of the USA Patriot Act of 2001 (42 U.S.C. 5195c(e)), namely, systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters.
(c) “Drought” has the meaning provided in section 2(1) of the National Integrated Drought Information System Act of 2006 (15 U.S.C. 313d note), namely, a deficiency in precipitation that leads to a deficiency in surface or subsurface water supplies (including rivers, streams, wetlands, groundwater, soil moisture, reservoir supplies, lake levels, and snow pack); and that causes or may cause substantial economic or social impacts or substantial physical damage or injury to individuals, property, or the environment.
(d) “Drought resilience” means the ability to anticipate, prepare for, and adapt to the anticipated consequences of drought conditions, particularly long-term or extreme drought.
(e) “Resilience” means the ability to anticipate, prepare for, and adapt to changing conditions and withstand, respond to, and recover rapidly from disruptions.
(b) Nothing in this memorandum shall be construed to impair or otherwise affect:
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) The Secretary of Agriculture is hereby authorized and directed to publish this memorandum in the
Occupational Safety and Health Administration (OSHA), Department of Labor.
Final rule.
The Occupational Safety and Health Administration (OSHA) is amending its existing standards for occupational exposure to respirable crystalline silica. OSHA has determined that employees exposed to respirable crystalline silica at the previous permissible exposure limits face a significant risk of material impairment to their health. The evidence in the record for this rulemaking indicates that workers exposed to respirable crystalline silica are at increased risk of developing silicosis and other non-malignant respiratory diseases, lung cancer, and kidney disease. This final rule establishes a new permissible exposure limit of 50 micrograms of respirable crystalline silica per cubic meter of air (50 μg/m
OSHA is issuing two separate standards—one for general industry and maritime, and the other for construction—in order to tailor requirements to the circumstances found in these sectors.
The final rule is effective on June 23, 2016. Start-up dates for specific provisions are set in § 1910.1053(l) for general industry and maritime and in § 1926.1153(k) for construction.
There are a number of collections of information contained in this final rule (see Section VIII, Paperwork Reduction Act). Notwithstanding the general date of applicability that applies to all other requirements contained in the final rule, affected parties do not have to comply with the collections of information until the Department of Labor publishes a separate notice in the
In accordance with 28 U.S.C. 2112(a), the Agency designates Ann Rosenthal, Associate Solicitor of Labor for Occupational Safety and Health, Office of the Solicitor of Labor, Room S-4004, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, to receive petitions for review of the final rule.
For general information and press inquiries, contact Frank Meilinger, Director, Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1999; email
For technical inquiries, contact William Perry or David O'Connor, Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1950.
The preamble to the rule on occupational exposure to respirable crystalline silica follows this outline:
In the docket for the respirable crystalline silica rulemaking, found at
When citing exhibits in the docket, OSHA includes the term “Document ID” followed by the last four digits of the document ID number, the attachment number or other attachment identifier, if applicable, page numbers (designated “p.” or “Tr.” for pages from a hearing transcript), and in a limited number of cases a footnote number (designated “Fn”). In a citation that contains two or more document ID numbers, the document ID numbers are separated by semi-colons. For example, a citation referring to the NIOSH prehearing comments and NIOSH testimony obtained from the hearing transcript would be indicated as follows: (Document ID 2177, Attachment B, pp. 2-3; 3579, Tr. 132). In some sections, such as Section V, Health Effects, author names and year of study publication are included before the document ID number in a citation, for example: (Hughes
This final rule establishes a permissible exposure limit (PEL) for respirable crystalline silica of 50 μg/m
The final rule is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so.
OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. OSHA has also developed estimates of the risk of silica-related diseases, assuming exposure over a working lifetime, at the preceding PELs as well as at the revised PEL and action level. Comments received on OSHA's preliminary analysis, and the Agency's final findings, are discussed in Section V, Health Effects, and Section VI, Final Quantitative Risk Assessment and Significance of Risk. OSHA finds that employees exposed to respirable crystalline silica at the preceding PELs are at an increased risk of lung cancer mortality and silicosis mortality and morbidity. Occupational exposures to respirable crystalline silica also result in increased risk of death from other nonmalignant respiratory diseases including chronic obstructive pulmonary disease (COPD), and from kidney disease. OSHA further concludes that exposure to respirable crystalline silica constitutes a significant risk of material impairment to health and that the final rule will substantially lower that risk. The Agency considers the level of risk remaining at the new PEL to be significant. However, based on the evidence evaluated during the rulemaking process, OSHA has determined a PEL of 50 μg/m
OSHA's examination of the technological and economic feasibility of the rule is presented in the Final Economic Analysis and Final Regulatory Flexibility Analysis (FEA), and is summarized in Section VII of this preamble. OSHA concludes that the PEL of 50 μg/m
OSHA developed quantitative estimates of the compliance costs of the rule for each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the rule and an evaluation of the economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA finds that compliance with the requirements of the rule is economically feasible in every affected industry sector.
The final rule includes several major changes from the proposed rule as a result of OSHA's analysis of comments and evidence received during the comment periods and public hearings. The major changes are summarized below and are fully discussed in Section XV, Summary and Explanation of the Standards.
The rule requires the employer to obtain a written medical opinion from physicians or other licensed health care professionals (PLHCPs) for medical
OSHA has revised the proposed compliance dates in both standards. The final rule is effective 90 days after publication. For general industry and maritime, all obligations for compliance commence two years after the effective date, with two exceptions: The obligation for engineering controls commences five years after the effective date for hydraulic fracturing operations in the oil and gas industry; and the obligation for employers in general industry and maritime to offer medical surveillance commences two years after the effective date for employees exposed above the PEL, and four years after the effective date for employees exposed at or above the action level. For construction, all obligations for compliance commence one year after the effective date, with the exception that certain requirements for laboratory analysis commence two years after the effective date.
Under the OSH Act's legal standard directing OSHA to set health standards based on findings of significant risk of material impairment and technological and economic feasibility, OSHA does not use cost-benefit analysis to determine the PEL or other aspects of the rule. It does, however, determine and analyze costs and benefits for its own informational purposes and to meet certain Executive Order requirements, as discussed in Section VII. Summary of the Final Economic Analysis and Final Regulatory Flexibility Analysis and in the FEA. Table I-1—which is derived from material presented in Section VII of this preamble—provides a summary of OSHA's best estimate of the costs and benefits of the rule using a discount rate of 3 percent. As shown, the rule is estimated to prevent 642 fatalities and 918 moderate-to-severe silicosis cases annually once it is fully effective, and the estimated cost of the rule is $1,030 million annually. Also as shown in Table I-1, the discounted monetized benefits of the rule are estimated to be $8.7 billion annually, and the rule is estimated to generate net benefits of approximately $7.7 billion annually.
The purpose of the Occupational Safety and Health Act (29 U.S.C. 651 et seq.) (“the Act” or “the OSH Act”), is “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources” (29 U.S.C. 651(b)). To achieve this goal Congress authorized the Secretary of Labor (“the Secretary”) “to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce” (29 U.S.C. 651(b)(3);
The Act provides that in promulgating standards dealing with toxic materials or harmful physical agents, such as respirable crystalline silica, the Secretary shall set the standard which “most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health . . . even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life” (29 U.S.C. 655(b)(5)). Thus, “[w]hen Congress passed the Occupational Safety and Health Act in 1970, it chose to place pre-eminent value on assuring employees a safe and healthful working environment, limited only by the feasibility of achieving such an environment” (
OSHA proposed this new standard for respirable crystalline silica and conducted its rulemaking pursuant to
Subject to the limitations discussed below, when setting standards regulating exposure to toxic materials or harmful physical agents, the Secretary is required to set health standards that ensure that “no employee will suffer material impairment of health or functional capacity . . .” (29 U.S.C. 655(b)(5)). OSHA has, under this section, considered medical conditions such as irritation of the skin, eyes, and respiratory system, asthma, and cancer to be material impairments of health. What constitutes material impairment in any given case is a policy determination on which OSHA is given substantial leeway. “OSHA is not required to state with scientific certainty or precision the exact point at which each type of [harm] becomes a material impairment” (
Section 3(8) of the Act requires that workplace safety and health standards be “reasonably necessary or appropriate to provide safe or healthful employment” (29 U.S.C. 652(8)). The Supreme Court, in its decision on OSHA's benzene standard, interpreted section 3(8) to mean that “before promulgating any standard, the Secretary must make a finding that the workplaces in question are not safe” (
The Supreme Court in
The Supreme Court further recognized that what constitutes “significant risk” is “not a mathematical straitjacket” (
If . . . the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, the risk clearly could not be considered significant. On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are 2% benzene will be fatal, a reasonable person might well consider the risk significant . . . (
Following
The Agency's final risk assessment is derived from existing scientific and enforcement data and its final conclusions are made only after considering all evidence in the rulemaking record. Courts reviewing the validity of these standards have uniformly held the Secretary to the significant risk standard first articulated by the
Once OSHA makes its significant risk finding, the “more stringent regulation” (
The OSH Act requires OSHA to set the standard that most adequately protects employees against harmful workplace exposures for the period of their “working life” (29 U.S.C. 655(b)(5)). OSHA's longstanding policy is to define “working life” as constituting 45 years; thus, it assumes 45 years of exposure when evaluating the risk of material impairment to health caused by a toxic or hazardous substance. This policy is not based on empirical data that most employees are exposed to a particular hazard for 45 years. Instead, OSHA has adopted the practice to be consistent with the statutory directive that “no employee” suffer material impairment of health “even if” such employee is exposed to the hazard for the period of his or her working life (
Even if it is only the rare worker who stays with asbestos-related tasks for 45 years, that worker would face a 64/1000 excess risk of contracting cancer; Congress clearly authorized OSHA to protect such a worker (Asbestos II, 838 F.2d at 1264-1265).
Section 6(b)(5) of the Act requires OSHA to set standards “on the basis of the best available evidence” and to consider the “latest available scientific data in the field” (29 U.S.C. 655(b)(5)). As noted above, the Supreme Court, in its Benzene decision, explained that OSHA must look to “a body of reputable scientific thought” in making its material harm and significant risk determinations, while noting that a reviewing court must “give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge” (
. . . the ultimate facts here in dispute are `on the frontiers of scientific knowledge', and, though the factual finger points, it does not conclude. Under the command of OSHA, it remains the duty of the Secretary to act to protect the workingman, and to act even in circumstances where existing methodology or research is deficient (
When there is disputed scientific evidence, OSHA must review the evidence on both sides and “reasonably resolve” the dispute (
A recent decision by the Eleventh Circuit Court of Appeals upholding a coal dust standard promulgated by MSHA emphasized that courts should give “an extreme degree of deference to the agency when it is evaluating scientific data within its technical expertise” (
The OSH Act requires that, in setting a standard, OSHA must eliminate the risk of material health impairment “to the extent feasible” (29 U.S.C. 655(b)(5)). The statutory mandate to consider the feasibility of the standard encompasses both technological and economic feasibility; these analyses have been done primarily on an industry-by-industry basis (
Although OSHA must set the most protective PEL that the Agency finds to be technologically and economically feasible, it retains discretion to set a uniform PEL even when the evidence demonstrates that certain industries or operations could reasonably be expected to meet a lower PEL. OSHA health standards generally set a single PEL for all affected employers; OSHA exercised this discretion most recently in its final rule on occupational exposure to chromium (VI) (71 FR 10100, 10337-10338 (2/28/2006);
A standard is technologically feasible if the protective measures it requires already exist, can be brought into existence with available technology, or can be created with technology that can reasonably be expected to be developed (
OSHA's standards may be “technology forcing,”
In its
[W]ithin the limits of the best available evidence . . . OSHA must prove a reasonable possibility that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations . . . The effect of such proof is to establish a presumption that industry can meet the PEL without relying on respirators . . . Insufficient proof of technological feasibility for a few isolated operations within an industry, or even OSHA's concession that respirators will be necessary in a few such operations, will not undermine this general presumption in favor of feasibility. Rather, in such operations firms will remain responsible for installing engineering and work practice controls to the extent feasible, and for using them to reduce . . . exposure as far as these controls can do so (
Additionally, the D.C. Circuit explained that “[f]easibility of compliance turns on whether exposure levels at or below [the PEL] can be met in most operations most of the time . . .” (
Courts have given OSHA significant deference in reviewing its technological feasibility findings.
So long as we require OSHA to show that any required means of compliance, even if it carries no guarantee of meeting the PEL, will substantially lower . . . exposure, we can uphold OSHA's determination that every firm must exploit all possible means to meet the standard (
Even in the face of significant uncertainty about technological feasibility in a given industry, OSHA has been granted broad discretion in making its findings (
OSHA cannot let workers suffer while it awaits . . . scientific certainty. It can and must make reasonable [technological feasibility] predictions on the basis of `credible sources of information,' whether data from existing plants or expert testimony (
For example, in
OSHA is permitted to adopt a standard that some employers will not be able to meet some of the time, with employers limited to challenging feasibility at the enforcement stage (
In addition to technological feasibility, OSHA is required to demonstrate that its standards are economically feasible. A reviewing court will examine the cost of compliance with an OSHA standard “in relation to the financial health and
OSHA must construct a reasonable estimate of compliance costs and demonstrate a reasonable likelihood that these costs will not threaten the existence or competitive structure of an industry, even if it does portend disaster for some marginal firms (
A reasonable estimate entails assessing “the likely range of costs and the likely effects of those costs on the industry” (
Standards may be economically feasible even though, from the standpoint of employers, they are financially burdensome and affect profit margins adversely. Nor does the concept of economic feasibility necessarily guarantee the continued existence of individual employers. It would appear to be consistent with the purposes of the Act to envisage the economic demise of an employer who has lagged behind the rest of the industry in protecting the health and safety of employees and is consequently financially unable to comply with new standards as quickly as other employers. As the effect becomes more widespread within an industry, the problem of economic feasibility becomes more pressing (
OSHA standards therefore satisfy the economic feasibility criterion even if they impose significant costs on regulated industries so long as they do not cause massive economic dislocations within a particular industry or imperil the very existence of the industry (
Because section 6(b)(5) of the Act explicitly imposes the “to the extent feasible” limitation on the setting of health standards, OSHA is not permitted to use cost-benefit analysis to make its standards-setting decisions (29 U.S.C. 655(b)(5)).
Congress itself defined the basic relationship between costs and benefits, by placing the “benefit” of worker health above all other considerations save those making attainment of this “benefit” unachievable. Any standard based on a balancing of costs and benefits by the Secretary that strikes a different balance than that struck by Congress would be inconsistent with the command set forth in § 6(b)(5) (
Thus, while OSHA estimates the costs and benefits of its proposed and final rules, these calculations do not form the basis for the Agency's regulatory decisions; rather, they are performed in acknowledgement of requirements such as those in Executive Orders 12866 and 13563.
OSHA's health standards traditionally incorporate a comprehensive approach to reducing occupational disease. OSHA substance-specific health standards generally include the “hierarchy of controls,” which, as a matter of OSHA's preferred policy, mandates that employers install and implement all feasible engineering and work practice controls before respirators may be used. The Agency's adherence to the hierarchy of controls has been upheld by the courts (
OSHA must prove a reasonable possibility that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations. . . . The effect of such proof is to establish a presumption that industry can meet the PEL without relying on respirators (
The hierarchy of controls focuses on removing harmful materials at their source. OSHA allows employers to rely on respiratory protection to protect their employees only when engineering and work practice controls are insufficient or infeasible. In fact, in the control of “those occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors,” the employers' primary objective “shall be to prevent atmospheric contamination. This shall be accomplished as far as feasible by accepted engineering control measures (for example, enclosure or confinement of the operation, general and local ventilation, and substitution of less toxic materials). When effective engineering controls are not feasible, or while they are being instituted, appropriate respirators shall be used pursuant to this section” (29 CFR 1910.134).
The reasons supporting OSHA's continued reliance on the hierarchy of controls, as well as its reasons for limiting the use of respirators, are numerous and grounded in good industrial hygiene principles (see Section XV, Summary and Explanation of the Standards, Methods of Compliance). Courts have upheld OSHA's emphasis on engineering and work practice controls over personal protective equipment in challenges to previous health standards, such as chromium (VI): “Nothing in . . . any case reviewing an airborne toxin standard, can be read to support a technological feasibility rule that would effectively encourage the routine and widespread use of respirators to comply with a PEL” (
In health standards such as this one, the hierarchy of controls is augmented by ancillary provisions. These provisions work with the hierarchy of controls and personal protective equipment requirements to provide comprehensive protection to employees in affected workplaces. Such provisions typically include exposure assessment, medical surveillance, hazard communication, and recordkeeping. This approach is recognized as effective in dealing with air contaminants such as respirable crystalline silica; for example, the industry standards for respirable crystalline silica, ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, take a similar comprehensive approach (Document ID 1466; 1504).
The OSH Act compels OSHA to require all feasible measures for reducing significant health risks (29 U.S.C. 655(b)(5);
Finally, while OSHA is bound by evidence in the rulemaking record, and generally looks to its prior standards for guidance on how to structure and specify requirements in a new standard, it is not limited to past approaches to regulation. In promulgating health standards, “[w]henever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired” (29 U.S.C. 655(b)(5)). In cases of industries or tasks presenting unique challenges in terms of assessing and controlling exposures, it may be more practicable and provide greater certainty to require specific controls with a demonstrated track record of efficacy in reducing exposures and, therefore, risk (especially when supplemented by appropriate respirator usage). Such an approach could more effectively protect workers than the traditional exposure assessment-and-control approach when exposures may vary because of factors such as changing environmental conditions or materials, and an assessment may not reflect typical exposures associated with a task or operation. As discussed at length in Section XV, Summary and Explanation of the Standards, the specified exposure control measures option in the construction standard (
The Occupational Safety and Health Administration's (OSHA's) previous standards for workplace exposure to respirable crystalline silica were adopted in 1971, pursuant to section 6(a) of the Occupational Safety and Health Act (29 U.S.C. 651 et seq.) (“the Act” or “the OSH Act”) (36 FR 10466 (5/29/71)). Section 6(a) (29 U.S.C. 655(a)) authorized OSHA, in the first two years after the effective date of the Act, to promulgate “start-up” standards, on an expedited basis and without public hearing or comment, based on national consensus or established Federal standards that improved employee safety or health. Pursuant to that authority, OSHA in 1971 promulgated approximately 425 permissible exposure limits (PELs) for air contaminants, including crystalline silica, which were derived principally from Federal standards applicable to government contractors under the Walsh-Healey Public Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and Safety Standards Act (commonly known as the Construction Safety Act), 40 U.S.C. 333. The Walsh-Healey Act and Construction Safety Act standards had been adopted primarily from recommendations of the American Conference of Governmental Industrial Hygienists (ACGIH).
For general industry (
In 1974, the National Institute for Occupational Safety and Health (NIOSH), an agency within the Department of Health and Human Services created by the OSH Act and designed to carry out research and recommend standards for occupational safety and health hazards, evaluated crystalline silica as a workplace hazard and issued criteria for a recommended standard (29 U.S.C. 669, 671; Document ID 0388). NIOSH recommended that occupational exposure to crystalline silica be controlled so that no worker is exposed to a TWA of free (respirable crystalline) silica greater than 50 μg/m
In December 1974, OSHA published an Advance Notice of Proposed Rulemaking (ANPRM) based on the recommendations in the NIOSH criteria document (39 FR 44771 (12/27/74)). In the ANPRM, OSHA solicited “public participation on the issues of whether a new standard for crystalline silica should be issued on the basis of the [NIOSH] criteria or any other information, and, if so, what should be the contents of a proposed standard for crystalline silica” (39 FR at 44771). OSHA also set forth the particular issues of concern on which comments were requested. The Agency did not issue a proposed rule or pursue a final rule for crystalline silica at that time.
As information on the health effects of silica exposure developed during the 1980s and 1990s, national and international classification organizations came to recognize crystalline silica as a human carcinogen. In June 1986, the International Agency for Research on Cancer (IARC), which is the specialized cancer agency within the World Health Organization, evaluated the available evidence regarding crystalline silica carcinogenicity and concluded, in 1987, that crystalline silica is probably carcinogenic to
In 1991, in the Sixth Annual Report on Carcinogens, the U.S. National Toxicology Program (NTP), within the U.S. Department of Health and Human Services, concluded that respirable crystalline silica was “reasonably anticipated to be a human carcinogen” (as referenced in Document ID 1417, p. 1). NTP reevaluated the available evidence and concluded, in the Ninth Report on Carcinogens, that “respirable crystalline silica (RCS), primarily quartz dust occurring in industrial and occupational settings, is known to be a human carcinogen, based on sufficient evidence of carcinogenicity from studies in humans indicating a causal relationship between exposure to RCS and increased lung cancer rates in workers exposed to crystalline silica dust” (Document ID 1417, p. 1). ACGIH listed respirable crystalline silica (in the form of quartz) as a suspected human carcinogen in 2000, while lowering the TLV to 0.05 mg/m
In 1989, OSHA established 8-hour TWA PELs of 0.1 mg/m
In 1992, OSHA, as part of the Air Contaminants proposed rule for maritime, construction, and agriculture, proposed the same PELs as for general industry, to make the PELs consistent across all the OSHA-regulated sectors (57 FR 26002 (6/12/92)). However, the U.S. Court of Appeals for the Eleventh Circuit vacated the 1989 Air Contaminants final rule for general industry (
In 1994, OSHA initiated a process to determine which safety and health hazards in the U.S. needed the most attention. A priority planning committee included safety and health experts from OSHA, NIOSH, and the Mine Safety and Health Administration (MSHA). The committee reviewed available information on occupational deaths, injuries, and illnesses and communicated extensively with representatives of labor, industry, professional and academic organizations, the States, voluntary standards organizations, and the public. The OSHA National Advisory Committee on Occupational Safety and Health and the Advisory Committee on Construction Safety and Health (ACCSH) also made recommendations. Rulemaking for crystalline silica exposure was one of the priorities designated by this process. OSHA indicated that crystalline silica would be added to the Agency's regulatory agenda as other standards were completed and resources became available.
In 1996, OSHA instituted a Special Emphasis Program (SEP) to step up enforcement of the crystalline silica standards. The SEP was intended to reduce worker silica dust exposures that can cause silicosis and lung cancer. It included extensive outreach designed to educate and train employers and employees about the hazards of silica and how to control them, as well as inspections to enforce the standards. Among the outreach materials available were slides presenting information on hazard recognition and crystalline silica control technology, a video on crystalline silica and silicosis, and informational cards for workers explaining crystalline silica, health effects related to exposure, and methods of control. The SEP provided guidance for targeting inspections of worksites that had employees at risk of developing silicosis. The inspections resulted in the collection of exposure data from the various worksites visited by OSHA's compliance officers.
As a follow-up to the SEP, OSHA undertook numerous non-regulatory actions to address silica exposures. For example, in October of 1996, OSHA launched a joint silicosis prevention effort with MSHA, NIOSH, and the American Lung Association (
In 1997, OSHA announced in its Unified Agenda under Long-Term Actions that it planned to publish a proposed rule on crystalline silica
. . . because the agency has concluded that there will be no significant progress in the prevention of silica-related diseases without the adoption of a full and comprehensive silica standard, including provisions for product substitution, engineering controls, training and education, respiratory protection and medical screening and surveillance. A full standard will improve worker protection, ensure adequate prevention programs, and further reduce silica-related diseases (62 FR 57755, 57758 (10/29/97)).
In November 1998, OSHA moved “Occupational Exposure to Crystalline Silica” to the pre-rule stage in the Regulatory Plan (63 FR 61284, 61303-61304 (11/9/98)). OSHA held a series of stakeholder meetings in 1999 and 2000 to get input on the rulemaking. Stakeholder meetings for all industry sectors were held in Washington, Chicago, and San Francisco. A separate stakeholder meeting for the construction sector was held in Atlanta.
OSHA initiated Small Business Regulatory Enforcement Fairness Act (SBREFA) proceedings in 2003, seeking the advice of small business representatives on the proposed rule (68 FR 30583, 30584 (5/27/03)). The SBREFA panel, including representatives from OSHA, the Small Business Administration's Office of Advocacy, and the Office of Management and Budget (OMB), was
In 2003, OSHA examined enforcement data for the years 1997 to 2002 and identified high rates of noncompliance with the OSHA respirable crystalline silica PELs, particularly in construction. This period covers the first five years of the SEP. These enforcement data, presented in Table III-1, indicate that 24 percent of silica samples from the construction industry and 13 percent from general industry were at least three times the then-existing OSHA PELs. The data indicate that 66 percent of the silica samples obtained during inspections in general industry were in compliance with the PEL, while only 58 percent of the samples collected in construction were in compliance.
In an effort to expand the 1996 SEP, on January 24, 2008, OSHA implemented a National Emphasis Program (NEP) to identify and reduce or eliminate the health hazards associated with occupational exposure to crystalline silica (CPL-03-007 (1/24/08)). The NEP targeted worksites with elevated exposures to crystalline silica and included new program evaluation procedures designed to ensure that the goals of the NEP were measured as accurately as possible, detailed procedures for conducting inspections, updated information for selecting sites for inspection, development of outreach programs by each Regional and Area Office emphasizing the formation of voluntary partnerships to share information, and guidance on calculating PELs in construction and shipyards. In each OSHA Region, at least two percent of inspections every year are silica-related inspections. Additionally, the silica-related inspections are conducted at a range of facilities reasonably representing the distribution of general industry and construction work sites in that region.
A more recent analysis of OSHA enforcement data from January 2003 to December 2009 (covering the period of continued implementation of the SEP and the first two years of the NEP) shows that considerable noncompliance with the then-existing PELs continued to occur. These enforcement data, presented in Table III-2, indicate that 14 percent of silica samples from the construction industry and 19 percent for general industry were at least three times the OSHA PEL during this period. The data indicate that 70 percent of the silica samples obtained during inspections in general industry were in compliance with the PEL, and 75 percent of the samples collected in construction were in compliance.
Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to respirable crystalline silica. For example, ASTM International (originally known as the American Society for Testing and Materials) has published voluntary consensus standards for addressing the hazards of crystalline silica, and the Building and Construction Trades Department, AFL-CIO also has recommended a comprehensive program standard. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance. The National Industrial Sand Association has also developed an occupational exposure program for crystalline silica that addresses exposure assessment and medical surveillance.
Throughout the crystalline silica rulemaking process, OSHA has presented information to, and consulted with, ACCSH and the Maritime Advisory Committee on Occupational Safety and Health. In December of 2009, OSHA representatives met with ACCSH to discuss the rulemaking and receive their comments and recommendations. On December 11, 2009, ACCSH passed motions supporting the concept of Table 1 in the draft proposed construction rule, recognizing that the controls listed in Table 1 are effective. As discussed with regard to paragraph (f) of the proposed standard for construction (paragraph (c) of the final standard for construction), Table 1 presents specified control measures for selected construction tasks. ACCSH also recommended that OSHA maintain the protective clothing provision found in the SBREFA panel draft regulatory text and restore the “competent person” requirement and responsibilities to the proposed rule. Additionally, the group recommended that OSHA move forward expeditiously with the rulemaking process.
In January 2010, OSHA completed a peer review of the draft Health Effects Analysis and Preliminary Quantitative Risk Assessment following procedures set forth by OMB in the Final Information Quality Bulletin for Peer Review, published on the OMB Web site on December 16, 2004 (
On August 23, 2013, OSHA posted its NPRM for respirable crystalline silica on its Web site and requested comments on the proposed rule. On September 12, 2013, OSHA published the NPRM in the
As part of the instructions for submitting comments, OSHA requested (but did not require) that parties submitting technical or scientific studies or research results and those submitting comments or testimony on the Agency's analyses disclose the nature of financial relationships with (
The Agency received several comments related to this request. For example, an industrial hygiene engineer supported the disclosure of potential conflict of interest information (Document ID 2278, p. 5). Other commenters, such as congressional representatives and industry associations, opposed the request, asserting that it could lead to prejudgment or questioning of integrity, in addition to dissuading participation in the rulemaking; some also questioned the legality of such a request or OSHA's interpretation of Executive Order 13563 (
An informal public hearing on the proposed standards was held in Washington, DC from March 18 through April 4, 2014. Administrative Law Judges Daniel F. Solomon and Stephen L. Purcell presided over the hearing. The Agency heard testimony from over 200 stakeholders representing more than 70 organizations, such as public health groups, trade associations, and labor unions. Chief Administrative Law Judge Stephen L. Purcell closed the public hearing on April 4, 2014, allowing 45 days—until May 19, 2014—for participants who filed a notice of intention to appear at the hearings to submit additional evidence and data, and an additional 45 days—until July 3, 2014—to submit final briefs, arguments, and summations (Document ID 3589, Tr. 4415-4416). After the hearing concluded, OSHA extended the deadline to give those participants who filed a notice of intention to appear at the hearings until June 3, 2014 to submit additional information and data to the record, and until July 18, 2014 to submit final briefs and arguments (Document ID 3569). Based upon requests from stakeholders, the second deadline was extended, and parties who filed a notice of intention to appear at the hearing were given until August 18, 2014, to submit their final briefs and arguments (Document ID 4192).
OSHA provided the public with multiple opportunities to participate in the rulemaking process, including stakeholder meetings, the SBREFA panel, two comment periods (pre- and post-hearing), and a 14-day public hearing. Commenters were provided more than five months to comment on the rule before the hearing, and nearly as long to submit additional information, final briefs, and arguments after the hearing. OSHA received more than 2,000 comments on the silica NPRM during the entire pre-and post-hearing public participation period. In OSHA's view, therefore, the public was given sufficient opportunities and ample time to fully participate in this rulemaking.
The final rule on occupational exposure to respirable crystalline silica is based on consideration of the entire record of this rulemaking proceeding, including materials discussed or relied upon in the proposal, the record of the hearing, and all written comments and exhibits timely received. Thus, in promulgating this final rule, OSHA considered all comments in the record, including those that suggested that OSHA withdraw its proposal and merely enforce the existing silica standards, as well as those that argued the proposed rule was not protective enough. Based on this comprehensive record, OSHA concludes that employees exposed to respirable crystalline silica are at significant risk of developing silicosis and other non-malignant respiratory disease, lung cancer, kidney effects, and immune system effects. The Agency concludes that the PEL of 50 μg/m
Silica is a compound composed of the elements silicon and oxygen (chemical formula SiO
Silica is classified as part of the “silicate” class of minerals, which includes compounds that are composed of silicon and oxygen and which may also be bonded to metal ions or their oxides. The basic structural units of silicates are silicon tetrahedrons (SiO
In crystalline silica, the silicon and oxygen atoms are arranged in a three-dimensional repeating pattern. Silica is said to be polymorphic, as different forms are created when the silica tetrahedrons combine in different crystalline structures. The primary forms of crystalline silica are quartz, cristobalite, and tridymite. In an amorphous state, silicon and oxygen atoms are present in the same proportions but are not organized in a repeating pattern. Amorphous silica includes natural and manufactured glasses (vitreous and fused silica, quartz glass), biogenic silica, and opals, which are amorphous silica hydrates (Document ID 2258, Attachment 8, pp. 45-50).
Quartz is the most common form of crystalline silica and accounts for almost 12% by volume of the earth's crust. Alpha quartz, the quartz form that is stable below 573 °C, is the most prevalent form of crystalline silica found in the workplace. It accounts for the overwhelming majority of naturally found silica and is present in varying amounts in almost every type of mineral. Alpha quartz is found in igneous, sedimentary, and metamorphic rock, and all soils contain at least a trace amount of quartz (Document ID 1334, p.
Cristobalite is a form of crystalline silica that is formed at high temperatures (>1470 °C). Although naturally occurring cristobalite is relatively rare, volcanic eruptions, such as Mount St. Helens, can release cristobalite dust into the air. Cristobalite can also be created during some processes conducted in the workplace. For example, flux-calcined diatomaceous earth is a material used as a filtering aid and as a filler in other products (Document ID 2258, Attachment 8, p. 44). It is produced when diatomaceous earth (diatomite), a geological product of decayed unicellular organisms called diatoms, is heated with flux. The finished product can contain between 40 and 60 percent cristobalite. Also, high temperature furnaces are often lined with bricks that contain quartz. When subjected to prolonged high temperatures, this quartz can convert to cristobalite.
Tridymite is another material formed at high temperatures (>870 °C) that is associated with volcanic activity. The creation of tridymite requires the presence of a flux such as sodium oxide. Tridymite is rarely found in nature and rarely reported in the workplace (Document ID 1424 pp. 5, 14).
When heated or cooled sufficiently, crystalline silica can transition between the polymorphic forms, with specific transitions occurring at different temperatures. At higher temperatures the linkages between the silica tetrahedrons break and reform, resulting in new crystalline structures. Quartz converts to cristobalite at 1470 °C, and at 1723 °C cristobalite loses its crystalline structure and becomes amorphous fused silica. These high temperature transitions reverse themselves at extremely slow rates, with different forms co-existing for a long time after the crystal cools (Document ID 2258, Attachment 8, p. 47).
Other types of transitions occur at lower temperatures when the silica-oxygen bonds in the silica tetrahedron rotate or stretch, resulting in a new crystalline structure. These low-temperature, or alpha to beta, transitions are readily and rapidly reversed as the crystal cools. At temperatures encountered by workers, only the alpha form of crystalline silica exists (Document ID 2258, Attachment 8, pp. 46-48).
Crystalline silica minerals produce distinct X-ray diffraction patterns, specific to their crystalline structure. The patterns can be used to distinguish the crystalline polymorphs from each other and from amorphous silica (Document ID 2258, Attachment 8, p. 45).
The specific gravity and melting point of silica vary between polymorphs. Silica is insoluble in water at 20 °C and in most acids, but its solubility increases with higher temperatures and pH, and it dissolves readily in hydrofluoric acid. Solubility is also affected by the presence of trace metals and by particle size. Under humid conditions water vapor in the air reacts with the surface of silica particles to form an external layer of silinols (SiOH). When these silinols are present the crystalline silica becomes more hydrophilic. Heating or acid washing reduces the amount of silinols on the surface area of crystalline silica particles. There is an external amorphous layer found in aged quartz, called the Beilby layer, which is not found on freshly cut quartz. This amorphous layer is more water soluble than the underlying crystalline core. Etching with hydrofluoric acid removes the Beilby layer as well as the principal metal impurities on quartz (Document ID 2258, Attachment 8, pp. 44-49).
Crystalline silica has limited chemical reactivity. It reacts with alkaline aqueous solutions, but does not readily react with most acids, with the exception of hydrofluoric acid. In contrast, amorphous silica and most silicates react with most mineral acids and alkaline solutions. Analytical chemists relied on this difference in acid reactivity to develop the silica point count analytical method that was widely used prior to the current X-ray diffraction and infrared methods (Document ID 2258, Attachment 8, pp. 48-51; 1355, p. 994).
Crystalline silica is used in industry in a wide variety of applications. Sand and gravel are used in road building and concrete construction. Sand with greater than 98% silica is used in the manufacture of glass and ceramics. Silica sand is used to form molds for metal castings in foundries, and in abrasive blasting operations. Silica is also used as a filler in plastics, rubber, and paint, and as an abrasive in soaps and scouring cleansers. Silica sand is used to filter impurities from municipal water and sewage treatment plants, and in hydraulic fracturing for oil and gas recovery (Document ID 1334, p. 11). Silica is also used to manufacture artificial stone products used as bathroom and kitchen countertops, and the silica content in those products can exceed 85 percent (Document ID 1477, pp. 3 and 11; 2178, Attachment 5, p. 420).
There are over 30 major industries and operations where exposures to crystalline silica can occur. They include such diverse workplaces as foundries, dental laboratories, concrete products and paint and coating manufacture, as well as construction activities including masonry cutting, drilling, grinding and tuckpointing, and use of heavy equipment during demolition activities involving silica-containing materials. A more detailed discussion of the industries affected by the proposed standard is presented in Section VII, Summary of the Final Economic Analysis and Final Regulatory Flexibility Analysis. Crystalline silica exposures can also occur in mining (which is under the jurisdiction of the Mine Safety and Health Administration), and in agriculture during plowing and harvesting.
As discussed more thoroughly in Section II of this preamble, Pertinent Legal Authority, section 6(b)(5) of the Occupational Safety and Health Act (OSH Act or Act) requires the Secretary of Labor, in promulgating standards dealing with toxic materials or harmful physical agents, to “set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life” (29 U.S.C. 655). Thus, in order to set a new health standard, the Secretary must determine that there is a significant risk of material impairment of health at the existing PEL and that issuance of a new standard will significantly reduce or eliminate that risk.
The Secretary's significant risk and material impairment determinations must be made “on the basis of the best available evidence” (29 U.S.C. 655(b)(5)). Although the Supreme Court, in its decision on OSHA's Benzene standard, explained that OSHA must look to “a body of reputable scientific thought” in making its material harm and significant risk determinations, the Court added that a reviewing court must “give OSHA some leeway where its findings must be made on the frontiers
This section provides an overview of OSHA's material harm and significant risk determinations: (1) Summarizing OSHA's preliminary methods and findings from the proposal; (2) addressing public comments dealing with OSHA's evaluation of the scientific literature and methods used to estimate quantitative risk; and (3) presenting OSHA's final conclusions, with consideration of the rulemaking record, on the health effects and quantitative risk estimates associated with worker exposure to respirable crystalline silica. The quantitative risk estimates and significance of those risks are then discussed in detail in Section VI, Final Quantitative Risk Assessment and Significance of Risk.
As discussed in detail throughout this section and in Section VI, Final Quantitative Risk Assessment and Significance of Risk, OSHA finds, based upon the best available evidence in the published, peer-reviewed scientific literature, that exposure to respirable crystalline silica increases the risk of silicosis, lung cancer, other non-malignant respiratory disease (NMRD), and renal and autoimmune effects. In its Preliminary Quantitative Risk Assessment (QRA), OSHA used the best available exposure-response data from epidemiological studies to estimate quantitative risks. After carefully reviewing stakeholder comments on the Preliminary QRA and new information provided to the rulemaking record, OSHA finds there to be a clearly significant risk at the previous PELs for respirable crystalline silica (equivalent to approximately 100 μg/m
These findings and conclusions are consistent with those of the World Health Organization's International Agency for Research on Cancer (IARC), the U.S. Department of Health and Human Services' (HHS) National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), and many other organizations and individuals, as evidenced in the rulemaking record and further discussed below. Many other scientific organizations and governments have recognized the strong body of scientific evidence pointing to the health risks of respirable crystalline silica and have deemed it necessary to take action to reduce those risks. As far back as 1974, NIOSH recommended that the exposure limit for crystalline silica be reduced to 50 μg/m
To reach these conclusions, OSHA performed an extensive search and review of the peer-reviewed scientific literature on the health effects of inhalation exposure to crystalline silica, particularly silicosis, lung cancer, other NMRD, and renal and autoimmune effects (Document ID 1711, pp. 7-265). Based upon this review, OSHA preliminarily determined that there was substantial evidence that exposure to respirable crystalline silica increases the risk of silicosis, lung cancer, NMRD, and renal and autoimmune effects (Document ID 1711, pp. 164, 181-208, 229). OSHA also found there to be suitable exposure-response data from many well-conducted epidemiological studies that permitted the Agency to estimate quantitative risks for lung cancer mortality, silicosis and NMRD mortality, renal disease mortality, and silicosis morbidity (Document ID 1711, p. 266).
As part of the preliminary quantitative risk assessment, OSHA calculated estimates of the risk of silica-related diseases assuming exposure over a working life (45 years) to 25, 50, 100, 250, and 500 μg/m
OSHA then combined its review of the health effects literature and preliminary quantitative risk assessment into a draft document, entitled “Occupational Exposure to Respirable Crystalline Silica—Review of Health Effects Literature and Preliminary Quantitative Risk Assessment,” and submitted it to a panel of scientific experts
Overall, the peer reviewers found that OSHA was very thorough in its review of the literature and was reasonable in its interpretation of the studies with regards to the various endpoints examined, such that the Agency's conclusions on health effects were generally well founded (Document ID 1711, p. 381). The reviewers had various comments on OSHA's draft Preliminary QRA (Document ID 1716, pp. 107-218). OSHA provided a response to each comment in the Review of Health Effects Literature and Preliminary QRA and, where appropriate, made revisions (Document ID 1711, pp. 381-399). The Agency then placed the Review of Health Effects Literature and Preliminary QRA into the rulemaking docket as a background document (Document ID 1711). With the publication of the Notice of Proposed Rulemaking (78 FR 56723 on 9/12/13), all aspects of the Review of Health Effects Literature and Preliminary QRA were open for public comment.
Following the publication of the proposed rule (78 FR 56273 (9/12/13)) and accompanying revised Review of Health Effects Literature and Preliminary QRA (Document ID 1711), the peer reviewers were invited to review the revised analysis, examine the written comments in the docket, and attend the public hearing to listen to oral testimony as it applied to the health effects and quantitative risk assessment. Five peer reviewers were available and attended. In their final comments, provided to OSHA following the hearings, all five peer reviewers indicated that OSHA had adequately addressed their original comments (Document ID 3574). The peer reviewers also offered additional comments on concerns raised during the hearing. Many of the reviewers commented on the difficulty of evaluating exposure-response thresholds, and responded to public comments regarding causation and other specific issues (Document ID 3574). OSHA has incorporated many of the peer reviewers' additional comments into its risk assessment discussion in the preamble. Thus, OSHA believes that the external, independent peer-review process supports and lends legitimacy to its risk assessment methods and findings.
OSHA also received substantial public comment and testimony from a wide variety of stakeholders supporting its Review of Health Effects Literature and Preliminary QRA. In general, supportive comments and testimony were received from NIOSH (Document ID 2177; 3998; 4233), the public health and medical community, labor unions, affected workers, private citizens, and others.
Regarding health effects, NIOSH commented that the adverse health effects of exposure to respirable crystalline silica are “well-known, long lasting, and preventable” (Document ID 2177b, p. 2). Darius Sivin, Ph.D., of the UAW, commented, “[o]ccupational exposure to silica has been recognized for centuries as a serious workplace hazard” (Document ID 2282, Attachment 3, p. 4). Similarly, David Goldsmith, Ph.D., testified:
There have been literally thousands of research studies on exposure to crystalline silica in the past 30 years. Almost every study tells the occupational research community that workers need better protection to prevent severe chronic respiratory diseases, including lung cancer and other diseases in the future. What OSHA is proposing to do in revising the workplace standard for silica seems to be a rational response to the accumulation of published evidence (Document ID 3577, Tr. 865-866).
Franklin Mirer, Ph.D., CIH, Professor of Environmental and Occupational Health at CUNY School of Public Health, on behalf of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), reiterated that silica “is a clear and present danger to workers health at exposure levels prevailing now in a large number of industries. Workers are at significant risk for mortality and illnesses including lung cancer and non-malignant respiratory disease including COPD, and silicosis” (Document ID 2256, Attachment 3, p. 3). The AFL-CIO also noted that there is “overwhelming evidence in the record that exposure to respirable crystalline silica poses a significant health risk to workers” (Document ID 4204, p. 11). The Building and Construction Trades Department, AFL-CIO, further commented that the rulemaking record “clearly supports OSHA's risk determination” (Document ID 4223, p. 2). Likewise, the Sorptive Minerals Institute, a national trade association, commented, “It is beyond dispute that OSHA has correctly determined that industrial exposure to certain types of silica can cause extremely serious, sometimes even fatal disease. In the massive rulemaking docket being compiled by the Agency, credible claims to the contrary are sparse to non-existent” (Document ID 4230, p. 8). OSHA also received numerous comments supportive of the revised standard from affected workers and citizens (
Regarding OSHA's literature review for its quantitative risk assessment, the American Public Health Association (APHA) and the National Consumers League (NCL) commented, “OSHA has thoroughly reviewed and evaluated the peer-reviewed literature on the health effects associated with exposure to respirable crystalline silica. OSHA's quantitative risk assessment is sound. The agency has relied on the best available evidence and acted appropriately in giving greater weight to those studies with the most robust designs and statistical analyses” (Document ID 2178, Attachment 1, p. 1; 2373, p. 1).
Dr. Mirer, who has served on several National Academy of Sciences committees setting risk assessment guidelines, further commented that OSHA's risk analysis is “scientifically correct, and consistent with the latest thinking on risk assessment,” (Document ID 2256, Attachment 3, p. 3), citing the National Academies' National Research Council's
Based on OSHA's Preliminary QRA, many commenters recognized that reducing the permissible exposure limit is necessary to reduce significant risks presented by exposure to respirable crystalline silica (Document ID 4204, pp. 11-12; 2080, p. 1; 2339, p. 2). For example, the AFL-CIO stated that “OSHA based its proposal on more than adequate evidence, but more recent publications have described further the risk posed by silica exposure, and further justify the need for new silica standards” (Document ID 4204, pp. 11-12). Similarly, the American Society of Safety Engineers (ASSE) remarked that “[w]hile some may debate the science underlying the findings set forth in the proposed rule, overexposure to crystalline silica has been linked to occupational illness since the time of the ancient Greeks, and reduction of the current permissible exposure limit (PEL) to that recommended for years by the National Institute for Occupational Safety and Health (NIOSH) is long overdue” (Document ID 2339, p. 2).
Not every commenter agreed, however, as OSHA also received critical comments and testimony from various employers and their representatives, as well as some organizations representing affected industries. In general, these comments were critical of the underlying studies on which OSHA relied for its quantitative risk assessment, or with the methods used by OSHA to estimate quantitative risks. Some commenters also presented additional studies for OSHA to consider. OSHA thoroughly reviewed these and did not find them adequate to alter OSHA's overall conclusions of health risk, as discussed in great detail in the sections that follow.
After considering the evidence and testimony in the record, as discussed below, OSHA affirms its approach to quantify health risks related to exposure to respirable crystalline silica and the Agency's preliminary conclusions. In the final risk assessment that is now presented as part of this final rule in Section VI, Final Quantitative Risk Assessment and Significance of Risk, OSHA concludes that there is a clearly significant risk at the previous PELs for respirable crystalline silica, with excess lifetime risk estimates for lung cancer mortality, silicosis mortality, and NMRD mortality each being much greater than 1 death per 1,000 workers as a result of exposure for 45 working years (
The health effects associated with silica exposure are well-established and supported by the record. Based on the record evidence, OSHA concludes that exposure to respirable crystalline silica causes silicosis and is the only known cause of silicosis. This causal relationship has long been accepted in the scientific and medical communities. In fact, the Department of Labor produced a video in 1938 featuring then Secretary of Labor Frances Perkins discussing the occurrence of silicosis among workers exposed to silica (
For lung cancer, OSHA reviewed the published, peer-reviewed scientific literature, including 60 epidemiological studies covering more than 30 occupational groups in over a dozen industrial sectors (
Since IARC's 1997 determination that respirable crystalline silica is a Group 1 carcinogen, the scientific community has reaffirmed the soundness of this finding. In March of 2009, 27 scientists from eight countries participated in an additional IARC review of the scientific literature and reaffirmed that respirable crystalline silica dust is a Group 1 human carcinogen (Document ID 1473, p. 396). Additionally, in 2000, the NTP, which is a widely-respected interagency program under HHS that evaluates chemicals for possible toxic effects on public health, also concluded that respirable crystalline silica is a known human carcinogen (Document ID 1164, p. 1).
For NMRD other than silicosis, based on its review of several studies and all subsequent record evidence, OSHA concludes that exposure to respirable crystalline silica increases the risk of emphysema, chronic bronchitis, and pulmonary function impairment (
OSHA also finds there to be suitable exposure-response data from many well-conducted studies that permit the Agency to estimate quantitative risks for lung cancer mortality, silicosis and NMRD mortality, renal disease mortality, and silicosis morbidity (
For silicosis and NMRD mortality, OSHA relies upon two published, peer-reviewed studies: A pooled analysis of silicosis mortality data from six epidemiological studies (Mannetje
The NMRD analysis by Park
For renal disease mortality, Steenland
For silicosis morbidity, OSHA reviewed the principal studies available in the scientific literature that have characterized the risk to exposed workers of acquiring silicosis, as detected by the appearance of opacities on chest radiographs (
In conclusion, OSHA finds, based on the best available evidence and methods to estimate quantitative risks of disease resulting from exposure to respirable crystalline silica, that there are significant risks of material health impairment at the former PELs for respirable crystalline silica, which would be substantially reduced (but not entirely eliminated) at the new PEL of 50 μg/m
As noted above, a wide variety of stakeholders offered comments and testimony in this rulemaking on issues related to health and risk. Many of these comments were submitted in response to OSHA's preliminary risk and material impairment determinations, which were presented in two background documents, entitled “Occupational Exposure to Respirable Crystalline Silica—Review of Health Effects Literature and Preliminary Quantitative Risk Assessment” (Document ID 1711) and “Supplemental Literature Review of Epidemiological Studies on Lung Cancer Associated with Exposure to Respirable Crystalline Silica” (Document ID 1711, Attachment 1), and summarized in the proposal in Section V, Health Effects Summary, and Section VI, Summary of OSHA's Preliminary Quantitative Risk Assessment.
In this subsection, OSHA summarizes the major findings of the two background documents. The Agency intends for this subsection to provide the detailed background necessary to fully understand stakeholders' comments and OSHA's responses.
As noted above, OSHA's Review and Supplemental Review of Health Effects Literature and Preliminary Quantitative Risk Assessment (Document ID 1711; 1711, Attachment 1) were the result of the Agency's extensive search and review of the peer-reviewed scientific literature on the health effects of inhalation exposure to crystalline silica, particularly silicosis, lung cancer and cancer at other sites, non-malignant respiratory diseases (NMRD) other than silicosis, and renal and autoimmune effects. The purposes of this detailed search and scientific review were to determine the nature of the hazards presented by exposure to respirable crystalline silica, and to evaluate whether there was an adequate basis, with suitable data availability, for quantitative risk assessment.
Much of the scientific evidence that describes the health effects and risks associated with exposure to crystalline silica consisted of epidemiological studies of worker populations; OSHA also reviewed animal and in vitro studies. OSHA used a weight-of-evidence approach in evaluating this evidence. Under this approach, OSHA evaluated the relevant studies to determine their overall quality. Factors considered in assessing the quality of studies included: (1) The size of the cohort studied and the power of the study to detect a sufficiently low level of disease risk; (2) the duration of follow-up of the study population; (3) the potential for study bias (
Based upon this weight-of-evidence approach, OSHA preliminarily determined that there is substantial evidence in the peer-reviewed scientific literature that exposure to respirable crystalline silica increases the risk of silicosis, lung cancer, other NMRD, and renal and autoimmune effects. The Preliminary QRA indicated that, for silicosis and NMRD mortality, lung cancer mortality, and renal disease mortality, there is a significant risk at the previous PELs for respirable crystalline silica, with excess lifetime risk estimates substantially greater than 1 death per 1,000 workers as a result of exposure over a working life (45 years, from age 20 to age 65). At the revised PEL of 50 μg/m
In its Review of Health Effects Literature, OSHA identified the adverse health effects associated with the inhalation of respirable crystalline silica (Document ID 1711). OSHA covered the following topics: Silicosis (including relevant data from U.S. disease surveillance efforts), lung cancer and cancer at other sites, non-malignant respiratory diseases (NMRD) other than silicosis, renal and autoimmune effects, and physical factors affecting the toxicity of crystalline silica. Most of the evidence that described the health risks associated with exposure to silica
Silicosis is an irreversible, progressive disease induced by the inflammatory effects of respirable crystalline silica in the lung, leading to lung damage and scarring and, in some cases, progressing to complications resulting in disability and death. Exposure to respirable crystalline silica is the only known cause of silicosis. Three types of silicosis have been described: An acute form following intense exposure to respirable dust of high crystalline silica content for a relatively short period (
Chronic silicosis is the most frequently observed type of silicosis in the U.S. today. Affected workers may have a dry chronic cough, sputum production, shortness of breath, and reduced pulmonary function. These symptoms result from airway restriction and/or obstruction caused by the development of fibrotic scarring in the alveolar sacs and lower region of the lung. Prospective studies that follow the exposed cohort over a long period of time with periodic examinations can provide the best information on factors affecting the development and progression of silicosis, which has a latency period (the interval between beginning of exposure to silica and the onset of disease) from 10 to 30 years after first exposure (Weissman and Wagner, 2005; Document ID 0481).
The scarring caused by silicosis can be detected by chest x-ray or computerized tomography (CT) when the lesions become large enough to appear as visible opacities. The clinical diagnosis of silicosis has three requirements: Recognition by the physician that exposure to crystalline silica has occurred; the presence of chest radiographic abnormalities consistent with silicosis; the absence of other illnesses that could resemble silicosis on a chest radiograph (
To address the low sensitivity of chest x-rays for detecting silicosis, Hnizdo
The causal relationship between exposure to crystalline silica and silicosis has long been accepted in the scientific and medical communities. OSHA reviewed a large number of cross-sectional and retrospective studies conducted to estimate the quantitative relationship between exposure to crystalline silica and the development of silicosis (
OSHA's review of the silicosis literature also focused on specific issues associated with the factors that affect the progression of the disease and the relationship between the appearance of radiological abnormalities indicative of silicosis and pulmonary function decline. From its review of the health literature, OSHA made a number of preliminary findings. First, the size of opacities apparent on initial x-ray films is a determinant of future disease
With respect to the relationship between radiological silicosis and pulmonary function declines, literature findings are mixed. A number of studies have reported pulmonary function declines among workers exhibiting a degree of small-opacity profusion consistent with ILO categories 2 and 3 (
Unlike most occupational diseases, surveillance statistics are available on silicosis mortality and morbidity in the U.S. The most comprehensive and current source of surveillance data in the U.S. related to occupational lung diseases, including silicosis, is the National Institute for Occupational Safety and Health (NIOSH) Work-Related Lung Disease (WoRLD) Surveillance System (NIOSH, 2008c, Document ID 1308). Other sources are detailed in the Review of Health Effects Literature (Document ID 1711). Mortality data are compiled from death certificates reported to state vital statistics offices, which are collected by the National Center for Health Statistics (NCHS), an agency within the Centers for Disease Control and Prevention (
Silicosis-related mortality has declined in the U.S. over the time period for which these data have been collected. From 1968 to 2005, the annual number of silicosis deaths decreased from 1,157 to 161 (NIOSH, 2008c, Document ID 1308;
Despite this decline, silicosis deaths among workers of all ages result in significant premature mortality; between 1996 and 2005, a total of 1,746 deaths resulted in a total of 20,234 years of life lost from life expectancy, with an average of 11.6 years of life lost. For the same period, among 307 decedents who died before age 65 (the end of a working life), there were 3,045 years of life lost up to age 65, with an average of 9.9 years of life lost from a working life (NIOSH, 2008c, Document ID 1308).
Surveillance data on silicosis morbidity, primarily from hospital discharge records, are available only from the few states that have administered disease surveillance programs for silicosis. For the reporting period 1993-2002, these states recorded 879 cases of silicosis (NIOSH 2008c, Document ID 1308). Nationwide hospital discharge data compiled by NIOSH (2008c, Document ID 1308) and the Council of State and Territorial Epidemiologists (CSTE, 2005, Document ID 0996) indicate that, for the years 1970 to 2004, there were at least 1,000 hospitalizations that were coded for silicosis each year, except one.
Relying exclusively on such passive case-based disease surveillance systems that depend on the health care community to generate records is likely to understate the prevalence of diseases associated with respirable crystalline silica (Froines
i. International Agency for Research on Cancer (IARC) Classification
In 1997, the IARC determined that there was sufficient evidence to regard crystalline silica as a human carcinogen (IARC, 1997, Document ID 1062). This finding was based largely on nine studies of cohorts in four industry sectors that IARC considered to be the least influenced by confounding factors (sectors included quarries and granite works, gold mining, ceramic/pottery/refractory brick industries, and the diatomaceous earth industry). NIOSH also determined that crystalline silica is a human carcinogen after evaluating updated literature (2002, Document ID 1110).
ii. Review of Occupation-Based Epidemiological Studies
OSHA conducted an independent review of the epidemiological literature on exposure to respirable crystalline silica and lung cancer, covering more than 30 occupational groups in over a dozen industrial sectors. OSHA's review included approximately 60 primary epidemiological studies. Based on this review, OSHA preliminarily concluded that the human data provides ample evidence that exposure to respirable crystalline silica increases the risk of lung cancer among workers.
The strongest evidence for carcinogenicity came from studies in five industry sectors:
• Diatomaceous Earth Workers (Checkoway
• British Pottery Workers (Cherry
• Vermont Granite Workers (Attfield and Costello, 2004, Document ID 0285; Graham
• North American Industrial Sand Workers (Hughes
• British Coal Miners (Miller
OSHA considered these studies as providing the strongest evidence for several reasons. They were all retrospective cohort or case-control studies that demonstrated positive, statistically significant exposure-response relationships between exposure to crystalline silica and lung cancer mortality. Except for the British pottery studies, where exposure-response trends were noted for average exposure only, lung cancer risk was found to be related to cumulative exposure. In general, these studies were of sufficient size and had adequate years of follow up, and had sufficient quantitative exposure data to reliably estimate exposures of cohort members. As part of their analyses, the authors of these studies also found positive exposure-response relationships for silicosis, indicating that underlying estimates of worker exposures were not likely to be substantially misclassified. Furthermore, the authors of these studies addressed potential confounding due to other carcinogenic exposures through study design or data analysis.
In the diatomaceous earth industry, Checkoway
In the British pottery industry, excess lung cancer risk was found to be associated with crystalline silica exposure among workers in a proportionate mortality ratio (PMR) study
In the Vermont granite cohort, Costello and Graham (1988, Document ID 0991) and Graham
Looking at the same population, Attfield and Costello (2004, Document ID 0285) developed a quantitative estimate of cumulative exposure (8 exposure categories) adapted from a job exposure matrix developed by Davis
In the North American industrial sand industry, studies of two overlapping cohorts found a statistically significant increased risk of lung cancer mortality with increased cumulative exposure in both categorical and continuous analyses (Hughes
OSHA noted that Brown and Rushton (2005a, Document ID 0303; 2005b, 0304) found no association between risk of lung cancer mortality and exposure to respirable crystalline silica among British industrial sand workers. However, a large portion of the cohort had relatively short service times in the industry, with over one-half the cohort deaths and almost three-fourths of the lung cancer mortalities having had less than 10 years of service. Considering the apparent high turnover in this industry and the absence of prior occupational histories, exposures from work experience other than in the industrial sand industry could be a significant confounder (Document ID 1711, p. 131). Additionally, as Steenland noted in a letter review (2005a, Document ID 1313), the cumulative exposures of workers in the Brown and Ruston (2005b, Document ID 0304) study were over 10 times lower than the cumulative exposures experienced by the cohorts in the pooled analysis that Steenland
In British coal miners, excess lung cancer mortality was reported in a large cohort study, which examined the mortality experience of 17,800 miners through the end of 2005 (Miller
In addition to the studies in these cohorts, OSHA also reviewed studies of lung cancer mortality in metal ore mining populations. Many of these mining studies, which showed mixed results, were subject to confounding due to exposure to other potential carcinogens such as radon and arsenic. IARC noted that only a few ore mining studies accounted for confounding from other occupational carcinogens and that, when confounding was absent or accounted for, an association between silica exposure and lung cancer was absent (1997, Document ID 1062). Many of the studies conducted since IARC's review, however, more strongly implicate crystalline silica as a human carcinogen (1997, Document ID 1062). Pelucchi
OSHA also preliminarily determined that the results of the studies conducted in three industry sectors (foundry, silicon carbide, and construction sectors) were confounded by the presence of exposures to other carcinogens. Exposure data from these studies were not sufficient to distinguish between exposure to silica dust and exposure to other occupational carcinogens. IARC previously made a similar determination in reference to the foundry industry. However, with respect to the construction industry, Cassidy
In addition, an analysis of 4.8 million death certificates from 27 states within the U.S. for the years 1982 to 1995 showed statistically significant excesses in lung cancer mortality, silicosis mortality, tuberculosis, and NMRD among persons with occupations involving medium and high exposure to respirable crystalline silica (Calvert
One of the more compelling studies OSHA evaluated and used in the Preliminary QRA (Document ID 1711) was Steenland
Smoking is known to be a major risk factor for lung cancer. However, OSHA maintained in the Preliminary QRA that it is unlikely that smoking explained the observed exposure-response trends in the studies described above (Document ID 1711). Studies by Hnizdo
Given these findings of investigators who have accounted for the impact of smoking, OSHA preliminarily determined that the weight of the evidence reviewed identified respirable crystalline silica as an independent risk factor for lung cancer mortality. OSHA also determined that its finding was further supported by animal studies demonstrating that exposure to silica alone can cause lung cancer (
Animal and in vitro studies have demonstrated that the early steps in the proposed mechanistic pathways that lead to silicosis and lung cancer seem to share some common features (
In general, studies of workers with silicosis, as well as meta-analyses that include these studies, have shown that workers with radiologic evidence of silicosis have higher lung cancer risk than those without radiologic abnormalities or mixed cohorts. Three meta-analyses attempted to look at the association of increasing ILO radiographic categories of silicosis with increasing lung cancer mortality. Two of these analyses (Kurihara and Wada, 2004, Document ID 1084; Tsuda
In addition to causing silicosis, exposure to crystalline silica has been associated with increased risks of other non-malignant respiratory diseases (NMRD), primarily chronic obstructive pulmonary disease (COPD), chronic bronchitis, and emphysema. COPD is a disease state characterized by airflow limitation that is usually progressive and not fully reversible. In patients with COPD, either chronic bronchitis or emphysema may be present or both conditions may be present together.
As detailed in the Review of Health Effects Literature, OSHA reviewed several studies of NMRD morbidity and preliminarily concluded that exposure to respirable crystalline silica may increase the risk of emphysema, chronic bronchitis, and pulmonary function impairment, regardless of whether signs of silicosis are present (Document ID 1711). Smokers may be at an increased risk relative to nonsmokers.
OSHA also reviewed studies of NMRD mortality that focused on causes of death other than silicosis. Wyndham
Park
Data on smoking, collected since the 1960s in the company's radiographic screening programme, were available for 1171 of the subjects (50%). However, smoking habits were unknown for 45 of the 67 workers that died from LDOC (67%). Our Poisson regression analyses for LDOC, stratified on smoking, have partially rectified the confounding by smoking issue. Furthermore, analyses performed without control for smoking produced slightly smaller and less precise estimates of the effects of silica, suggesting that smoking is a negative confounder. In their analysis of this cohort, Checkoway
Consequently, OSHA used this study in its Preliminary QRA (Document ID 1711, pp. 295-298).
Based on this evidence, and the other studies discussed in the Review of Health Effects Literature, OSHA preliminarily concluded that respirable crystalline silica increases the risk for mortality from non-malignant respiratory disease (not including silicosis) in an exposure-related manner. The Agency also preliminarily concluded that the risk is strongly influenced by smoking, and opined that the effects of smoking and silica exposure may be synergistic.
In its Review of Health Effects Literature, OSHA described the available experimental and epidemiological data evaluating respirable crystalline silica exposure and renal and/or autoimmune effects (Document ID 1711). In addition to a number of case reports, epidemiological studies have found statistically significant associations between occupational exposure to silica dust and chronic renal disease (Calvert
In a pooled cohort analysis, Steenland
OSHA noted that other studies failed to find an excess renal disease risk among silica-exposed workers. Davis
OSHA expressed its belief that there is substantial evidence, particularly the 3-cohort pooled analysis conducted by Steenland
For autoimmune effects, OSHA reviewed epidemiological information suggesting an association between respirable silica exposure and autoimmune diseases, including scleroderma (Sluis-Cremer
OSHA also examined evidence on the comparative toxicity of the silica polymorphs (quartz, cristobalite, and tridymite). A number of animal studies appear to suggest that cristobalite and tridymite are more toxic to the lung than quartz and more tumorigenic (
OSHA also discussed other physical factors that may influence the toxicologic potency of crystalline silica. A number of animal studies compared the toxicity of freshly fractured silica to that of aged silica (Porter
Surface impurities, particularly metals, have been shown to alter silica toxicity. Iron, depending on its state and quantity, has been shown to either increase or decrease toxicity (
Although it is evident that a number of factors can act to mediate the toxicological potency of crystalline silica, it is not clear how such considerations should be taken into account to evaluate lung cancer and silicosis risks to exposed workers. After evaluating many in vitro studies that investigated the surface characteristics of crystalline silica particles and their influence on fibrogenic activity, NIOSH concluded that further research is needed to associate specific surface characteristics that can affect toxicity with specific occupational exposure situations and consequent health risks to workers (2002, Document ID 1110). Thus, OSHA preliminarily concluded that while there was considerable evidence that several environmental influences can modify surface activity to either enhance or diminish the toxicity of silica, the available information was insufficient to determine in any quantitative way how these influences may affect disease risk to workers in any particular workplace setting.
OSHA presented in the Preliminary QRA estimates of the risk of silica-related diseases assuming exposure over a working life (45 years, from age 20 to age 65) to the revised 8-hour time-weighted average (TWA) PEL of 50 µg/m
To estimate lifetime excess mortality risks at these exposure levels, OSHA implemented each of the risk models in a life table analysis that accounted for competing causes of death due to background causes and cumulated risk through age 85. For these analyses, OSHA used lung cancer, NMRD, or renal disease mortality and all-cause mortality rates to account for background risks and competing risks (U.S. 2006 data for lung cancer and NMRD mortality in all males, 1998 data for renal disease mortality, obtained from cause-specific death rate tables published by the National Center for Health Statistics (2009, Document ID 1104)). OSHA calculated these risk estimates assuming occupational exposure from age 20 to age 65. The mortality risk estimates were presented in terms of lifetime excess risk per 1,000 workers for exposure over an 8-hour working day, 250 days per year, and a 45-year working life.
For silicosis morbidity, OSHA based its risk estimates on cumulative risk models used by various investigators to develop quantitative exposure-response relationships. These models characterized the risk of developing silicosis (as detected by chest radiography) up to the time that cohort members (including both active and retired workers) were last examined. Thus, risk estimates derived from these studies represented less-than-lifetime risks of developing radiographic silicosis. OSHA did not attempt to estimate lifetime risk (
In the Preliminary QRA, OSHA relied upon two published quantitative risk studies of silicosis and NMRD mortality (Document ID 1711). The first, Mannetje
As previously discussed, the second, Park
As silicosis is only caused by exposure to respirable crystalline silica (
OSHA also calculated preliminary risk estimates for NMRD mortality. These estimates were derived from Park
OSHA noted that, for exposures up to 250 µg/m
Since the time of OSHA's analysis, NCHS has released updated all-cause mortality and NMRD mortality background rates from 2011 (
In 1997, when IARC determined that there was sufficient evidence to regard crystalline silica as a human carcinogen, it also noted that some epidemiological studies did not demonstrate an excess risk of lung cancer and that exposure-response trends were not always consistent among studies that were able to describe such trends (Document ID 1062). These findings led Steenland et al. (2001a, Document ID 0452) to conduct a comprehensive exposure-response analysis—the IARC multi-center study—of the risk of lung cancer associated with exposure to crystalline silica. This study relied on all available cohort data from previously-published epidemiological studies for which there were adequate quantitative data on worker silica exposures to derive pooled estimates of disease risk. In addition, as discussed previously, OSHA identified four more recent studies suitable for quantitative risk assessment: (1) An exposure-response analysis by Rice
The Steenland
Steenland
Rice
Attfield and Costello (2004, Document ID 0285) analyzed the U.S. granite cohort originally studied by Costello and Graham (1988, Document ID 0991) and Davis
As mentioned previously, however, the rate ratio for the highest exposure group in the Attfield and Costello analysis (cumulative exposures of 6.0 mg/m
McDonald
Miller
In the Preliminary QRA, OSHA presented estimates of excess lung cancer mortality risk from occupational exposure to crystalline silica, based on data from the five epidemiology studies discussed above (Document ID 1711). In its preliminary analysis, OSHA used background all-cause mortality and lung cancer mortality rates from 2006, as reported by the National Center for Health Statistics (NCHS) (Document ID 1104). These rates were used in life table analyses to estimate lifetime risks at the exposure levels of interest, ranging from 25 to 500 μg/m
OSHA's preliminary estimates of lifetime excess lung cancer risk associated with 45 years of exposure to crystalline silica at 100 μg/m
OSHA also estimated the lung cancer risk associated with 45 years of exposure to the previous construction/shipyard PEL (in the range of 250 μg/m
Since the time of that original analysis, NCHS has released updated all-cause mortality and lung cancer mortality background rates from 2011.
In the Preliminary QRA, OSHA recognized that risk estimates can be inherently uncertain and can be affected by confounding, selection bias, and measurement error (Document ID 1711). OSHA presented several reasons as to why it does not believe that confounding or selection bias had a substantial impact on the risk estimates for lung cancer or silicosis mortality (Document ID 1711, pp. 299-302). However, because it was more difficult to assess the importance of exposure measurement error, OSHA's contractor, ToxaChemica, Inc., commissioned Drs. Kyle Steenland and Scott Bartell to perform an uncertainty analysis to examine the effect of uncertainty due to measurement error in the pooled studies (Steenland
There are two main sources of error in the silica exposure measurements. The first arises from the assignment of individual workers' exposures based on either exposure measurements for a sample of workers in the same job or estimated exposure levels for specific jobs in the past when no measurements were available, via a job-exposure matrix (JEM) (Mannetje
To examine the effect of error in the assignment of individual exposure values in the cohorts studied by Steenland
When an entire set of cumulative exposure values was assembled for all workers based on these randomly sampled values, the set was used in a conditional logistic regression to fit a new exposure-response model. The extent to which altering the exposure values led to changes in the results indicated how sensitive the previously presented risk estimates may have been to error in the exposure estimates. Among the individual cohorts, most of the mean regression coefficients resulting from the simulation analysis were consistent with the coefficients from the exposure-response analyses reported in Steenland
To examine the effect of error in estimating gravimetric respirable crystalline silica exposures from historical dust concentration data (
A new conversion factor was then sampled for each job from the appropriate distribution, and the complete set of sampled conversion factors was then used to re-run the risk analysis used by Steenland
To explore the potential effects of both kinds of random uncertainty described above, ToxaChemica, Inc. (2004, Document ID 0469) used the distributions representing the error in job-specific exposure assignment and the error in converting exposure metrics to generate 50 new exposure simulations for each cohort. A study-specific coefficient and a pooled coefficient were fit for each new simulation, with the assumption that the two sources of uncertainty were independent. The results indicated that the only cohort for which the mean of the exposure coefficients derived from the 50 simulations differed substantially from the previously calculated exposure
Drs. Steenland and Bartell also examined the effects of systematic bias in conversion factors, considering the possibility that these may have been consistently under-estimated or over-estimated for any given cohort. They addressed possible biases in either direction, conducting simulations where the true silica content was assumed to be either half or double the estimated silica content of measured exposures. For the conditional logistic regression model using log cumulative exposure with a 15-year lag, doubling or halving the exposure for a specific study resulted in virtually no change in the exposure-response coefficient for that study or for the pooled analysis overall. This is due to the use of log-transformed exposure metrics, which ensured that any multiplicative bias in exposure would have virtually no effect on conditional logistic regression coefficients (Document ID 0469, p. 17). That is, for this model, a systematic error in exposure estimation for any study had little effect on the lung cancer response rate for either the specific study or the pooled analysis overall.
Following the procedures described above for the lung cancer analysis, Toxachemica, Inc. (2004, Document ID 0469) combined both sources of random measurement error in a Monte Carlo analysis of the silicosis mortality data from Mannetje
Steenland
As detailed in the Preliminary QRA, OSHA estimated that exposure to the previous (100 μg/m
OSHA summarized, in its Preliminary QRA, the principal cross-sectional and cohort studies that quantitatively characterized relationships between exposure to crystalline silica and the development of radiographic evidence of silicosis (Document ID 1711). Each of these studies relied on estimates of cumulative exposure to evaluate the relationship between exposure and silicosis prevalence. The health endpoint of interest in these studies was the appearance of opacities on chest radiographs indicative of pulmonary fibrosis. Most of the studies reviewed by OSHA considered a finding consistent with an ILO classification of 1/1 to be a positive diagnosis of silicosis, although some also considered an x-ray classification of 1/0 or 0/1 to be positive. OSHA noted its belief, in the Preliminary QRA, that the most reliable estimates of silicosis morbidity, as detected by chest radiographs, come from the studies that evaluated radiographs over time, included radiographic evaluation of workers after they left employment, and derived cumulative or lifetime estimates of silicosis disease risk. OSHA also pointed out that the low sensitivity of chest radiography in detecting silicosis suggests that risk estimates derived from radiographic evidence likely underestimate the true risk.
Hnizdo and Sluis-Cremer (1993, Document ID 1052) described the results of a retrospective cohort study of 2,235 white gold miners in South Africa. A total of 313 miners had developed silicosis (x-ray with ILO 1/1 or greater) and had been exposed for an average of 27 years at the time of diagnosis. The average latency for the cohort was 35 years (range of 18-50 years) from the start of exposure to diagnosis. The average respirable dust exposure for the cohort overall was 290 μg/m
Steenland and Brown (1995b, Document ID 0451) studied 3,330 South Dakota gold miners who had worked at least a year underground between 1940 and 1965. Chest x-rays were obtained in cross-sectional surveys in 1960 and 1976 and used along with death certificates to ascertain cases of silicosis; 128 cases were found via death certificate, 29 were found by x-ray (defined as ILO 1/1 or greater), and 13 were found by both. OSHA notes that the inclusion of death certificate diagnoses complicates interpretation of the risk estimate from this study since, as noted by Finkelstein (2000, Document ID 1015), it is not known how well such diagnoses correlate with ILO radiographic interpretations; as such, the risk estimates derived from this study may not be directly comparable to others that rely exclusively on radiographic findings to evaluate silicosis morbidity risk. The mean exposure concentration was 50 μg/m
OSHA used the same life table approach as described for estimating lung cancer and NMRD mortality risks to estimate lifetime silicosis risk based on the silicosis rates, adjusted for age and calendar time, calculated by Steenland and Brown (1995b, Table 2, Document ID 0451). Silicosis risk was estimated through age 85, assuming exposure from age 20 through 65, and assuming that the silicosis rate remains constant after age 65. All-cause mortality rates to all males for calendar year 2006 were used to account for background competing risk. From this analysis, OSHA estimated the risk from exposure to the previous general industry PEL of 100 μg/m
Miller
Buchanan
Chen
Chen
In a later study, Chen
OSHA's risk estimates for silicosis morbidity ranged between 60 and 773 per 1,000 workers for a 45-year exposure to the previous general industry PEL of 100 μg/m
In this section, OSHA focuses on comments pertaining to the literature used by the Agency to assess risk for silicosis and non-malignant respiratory disease (NMRD) mortality and morbidity. As discussed in the Review of Health Effects Literature and Preliminary QRA (Document ID 1711) and in Section V.C, Summary of the Review of Health Effects Literature and Preliminary QRA, of this preamble, OSHA used two studies (ToxaChemica, 2004, Document ID 0469; Park
OSHA received both supportive and critical comments and testimony regarding these studies. Comments largely focused on how the authors of these studies analyzed their data, and concerns expressed by commenters generally focused on exposure levels and measurement, potential biases, confounding, statistical significance of study results, and model forms. This section does not include extensive discussion on exposure measurement error, potential biases, thresholds, confounding factors, and the use of the cumulative exposure metric, which are discussed in depth in other sections of this preamble, including V.J Comments and Responses Concerning Biases in Key Studies and V.K Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis. OSHA addresses comments on general model form and various other issues here and concludes that these comments do not meaningfully affect OSHA's reliance on the studies discussed herein or the results of the Agency's final risk assessment.
There are two published studies that report quantitative risk assessments of silicosis and NMRD mortality (
The American Chemistry Council (ACC) submitted several comments pertaining to the Park
OSHA acknowledges that there is some uncertainty in using models heavily influenced by exposures above the previous PEL due to potential deviance at areas of the relationship with fewer data points. However, OSHA believes that the ACC's characterization of exposures in the Park
The ACC also criticized the Park study for its treatment of possible confounding by smoking and exposure to asbestos. The ACC commented in its pre-hearing brief that data on smoking was available for only half of the cohort (Document ID 2307, Attachment A, p. 108). The Panel also wrote that, “while Park
OSHA has reviewed the ACC's concerns, and maintains that Park
Asbestos exposure was estimated for all workers in Park
Rice
The ACC also expressed concern about model selection. Louis Anthony Cox, Jr., Ph.D., of Cox Associates, on behalf of the ACC, was concerned that the linear relative rate model was not appropriate because it is not designed to test for exposure-response thresholds and, similarly, the ACC has argued that threshold models are appropriate for crystalline silica-related diseases (Document ID 2307, Attachment 4, pp. 91). The ACC claimed that the Park
In its post-hearing comments, NIOSH explained that categorical analysis for NMRD indicated no threshold existed with cumulative exposure corresponding to 25 μg/m
The ACC then questioned the use of unlagged cumulative exposures as the metric in Park et al. (2002). Dr. Cox noted that “[u]nlagged models are not very biologically plausible for dust-related NMRD deaths (if any) caused by exposure concentrations in the range of interest. Unresolved chronic inflammation and degradation of lung defenses takes years to decades to manifest” (Document ID 2307, Attachment 4, p. 92). OSHA considers this criticism overstated. Park
The ACC was also concerned about the truncation of cumulative exposures in the Park
OSHA acknowledges this concern about the truncation of data in the study, and asked Mr. Park about it at the public hearing. Mr. Park testified that there were good reasons to truncate the part of the exposed workforce at the high end of cumulative exposure. He noted several plausible reasons for the drop-off in the number of cases at high exposures (attenuation), including random variance in susceptibility to disease among different people and the healthy worker survivor effect
Dr. Morfeld also noted that alternative techniques that do not require truncation are available to account for a healthy worker survivor effect (Document ID 2307, Attachment 2, pp. 27-28). OSHA believes such techniques, such as g-estimation, to be relatively new or not yet in standard use in occupational epidemiology. As discussed above, OSHA finds Mr. Park's approach in his study to be reasonable.
Finally, Dr. Cox stated in his comments that:
Confounding occurs in an epidemiological study when the contribution of a causal factor cannot be separated from the effect of another variable (
The inclusion of Park
The ACC also submitted several comments on the Mannetje
Mannetje
The ACC next questioned the odds ratios generated in the Mannetje
OSHA believes that the ACC overstated its contention about confidence interval overlap between groups in the Mannetje
Finally, as discussed above and in detail in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis, the ToxaChemica
OSHA relied on five studies for determining risk for silicosis morbidity: Buchanan
Buchanan
Dr. Cox commented that age needed to be included for modeling in Dr. Miller's 1998 paper, the data from which were used in the Buchanan
Dr. Cox also questioned the modeling methods in the Buchanan paper, which presented logistic regression in progressive stages to search for significance (Document ID 2307, Attachment 4, pp. 97-98; 0306, pp. 161-163). Dr. Cox claimed that this is an example of uncorrected multiple testing bias where the post hoc selection of data, variables, and models can make independent variables appear to be statistically significant in the prediction model. He suggested that corrections for bias are needed to determine if the reported significance is causal or statistical (Document ID 2307, Attachment 4, pp. 97-98). OSHA peer reviewer Brian Miller, Ph.D., stated that Dr. Cox's claim that the model was affected by multiple testing bias is unfounded (Document ID 3574, pp. 31-32). He noted that the model was based on a detailed knowledge of the history of exposures at that colliery, and represented the researchers' attempt to build “a reality-driven and `best-fitting' model,” (Document ID 3574, p. 31, quoting 2307, Attachment 4, p. 4). Furthermore, none of OSHA's peer reviewers raised any concerns about the approach taken by Buchanan
The ACC also commented on several other studies used by OSHA to estimate silicosis morbidity risks; these were the studies by Chen
In the Chen
The study on gold miners (Steenland and Brown, 1995b, Document ID 0451), which found that cumulative exposure was the best disease predictor, followed by duration of exposure and average exposure, was also criticized by the ACC, which alleged that the exposure assessment suffered from “enormous uncertainty” (Document ID 2307, Attachment A, pp. 146-147). The ACC noted that exposure measurements were not available for the years prior to 1937 or after 1975 and that this limitation of the exposure information may have resulted in an underestimation of exposures (Document ID 2307, Attachment A, pp. 124-126). OSHA agrees that these are potential sources of uncertainty in the exposure estimates, but recognizes exposure uncertainty to be a common occurrence in occupational epidemiology studies. OSHA believes that the authors used the best measurement data available to them in their study.
The ACC also took issue with Steenland and Brown's conversion factor for converting particle count to respirable silica mass (10 mppcf = 100 μg/m
With respect to the Hnizdo and Sluis-Cremer (1993, Document ID 1052)
Thirdly, the ACC challenged the authors' estimate of the quartz content of the dust as 30 percent when it should have been 54 percent (Document ID 1052, p. 450; 2307, Attachment A, p. 120). According to the ACC, the 30 percent estimate was based on an incorrect assumption that the samples had been acid-washed (resulting in a reduction in silica content) before the quartz content was measured (Document ID 2307, Attachment A, pp. 120-122). This assumption would greatly underestimate the exposures of the cohort and the exposures needed to cause adverse effects, thus overestimating actual risk (Document ID 2307, Attachment A, pp. 121-122). The ACC recommended that the quartz content in the Hnizdo and Sluis-Cremer study be increased from 30 to 54 percent, based on the Gibbs and Du Toit study (2002, Document ID 1025, p. 602).
OSHA considered this issue in the Preliminary QRA (Document ID 1711, p. 332). OSHA noted that the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment reviewed the source data for Hnizdo and Sluis-Cremer, located in the Page-Shipp and Harris (1972, Document ID 0583) study, and compared them to the quartz exposures calculated by Hnizdo and Sluis-Cremer (OEHHA, 2005, Document ID 1322, p. 29). OEHHA concluded after analyzing the data that the samples likely were not acid-washed and that the Hnizdo and Sluis-Cremer paper erred in describing that aspect of the samples. Additionally, OEHHA reported data that suggests that the 30 percent quartz concentration may actually overestimate the exposure. It noted that recent investigations found the quartz content of respirable dust in South African gold mines to be less than 30 percent (Document ID 1322). In summary, OSHA concludes that no meaningful evidence was submitted to the rulemaking record that changes OSHA's original decision to include the Hnizdo and Sluis-Cremer study in its risk assessment.
Despite the uncertainties inherent in estimating the exposures of occupational cohorts in silicosis morbidity studies, the resulting estimates of risk for the previous general industry PEL of 100 μg/m
After carefully considering all of the comments on the studies relied on by OSHA to estimate silicosis and NMRD mortality and silicosis morbidity risks, OSHA concludes that the scientific evidence used in its quantitative risk assessment substantially supports the Agency's finding of significant risk for silicosis and non-malignant respiratory disease. In its risk estimates in the Preliminary QRA, OSHA acknowledged the uncertainties raised by the ACC and other commenters, but the Agency nevertheless concluded that the assessment was sufficient for evaluating the significance of the risk. After evaluating the evidence in the record on this topic, OSHA continues to conclude that its risk assessment (
As discussed above in this preamble, OSHA has relied on epidemiological studies to assess the risk of silicosis, a debilitating and potentially fatal occupationally-related lung disease caused by exposure to respirable crystalline silica. In the proposed rule (78 FR 56273, 56298; also Document ID 1711, pp. 31-49), OSHA also discussed data from silicosis surveillance programs that provide some information about the number of silicosis-associated deaths or the extent of silicosis morbidity in the U.S. (78 FR at 56298). However, as OSHA explained, the surveillance data are not sufficient for estimating the risks of health effects associated with exposure to silica, nor are they sufficient for estimating the benefits of any potential regulatory action. This is because silicosis-related surveillance data are only available from a few states and do not provide exposure data that can be matched to surveillance data. Consequently, there is no way of knowing how much silica a person was exposed to before developing fatal silicosis (78 FR at 56298).
In addition, the available data likely understate the resulting death and disease rates in U.S. workers exposed to crystalline silica (78 FR 56298). This understatement is due in large part to: (1) The passive nature of these surveillance systems, which rely on healthcare providers' awareness of a reporting requirement and submission of the appropriate information on standardized forms to health departments; (2) the long latency period of silicosis; (3) incomplete occupational exposure histories, and (4) other factors that result in a lack of recognition of silicosis by healthcare providers, including the low sensitivity, or ability of chest x-rays to identify cases of silicosis (78 FR 56298). Specific to death certificate data, information on usual industry and occupation are available from only 26 states for the period 1985 to 1999, and those codes are not verifiable (Document ID 1711). Added to these limitations is the “lagging” nature of surveillance data; it often takes years for cases to be reported, confirmed, and recorded. Furthermore, in many cases, the available surveillance systems lack information about actual exposures or even information about the usual occupation or industry of the deceased individual, which could provide some information about occupational
Comments and testimony focusing on the silicosis surveillance data alleged that OSHA should have used the surveillance data in its risk estimates. Stakeholders argued that the declining numbers of reported silicosis deaths prove the lack of necessity for a new silica standard. Commenters also claimed that the surveillance data prove that OSHA overestimated both the risks at the former permissible exposure limits (PELs) and the benefits of the new rule.
After reviewing the rulemaking record, OSHA maintains its view that these silicosis surveillance data, although useful for providing context and an illustration of a significant general trend in the reduction of deaths associated with silicosis over the past 4-5 decades, are not sufficient for estimating the magnitude of the risk or the expected benefits. In the case of silicosis, surveillance data are useful for describing general trends nationally and a few states have the ability to use the data at the local or state level to identify “sentinel events” that would justify initiating an inspection of a workplace, for example. The overall data, however, are inadequate and inappropriate for estimating risks or benefits associated with various exposure levels, as is required of OSHA's regulatory process, in part because they significantly understate the extent of silicosis in workers in the United States and because they lack information about exposure levels, exposure sources (
The principal source of data on annual silicosis mortality in the U.S. is the National Institute for Occupational Safety and Health (NIOSH) Work-Related Lung Disease (WoRLD) Surveillance System (
From 1968 to 2002, silicosis was recorded as an underlying or contributing cause of death on 16,305 death certificates; of these, a total of 15,944 (98 percent) deaths occurred in males (CDC, 2005, Document ID 0319). Over time, silicosis-related mortality has declined in the U.S., but has not been eliminated. Based on the death certificate data, the number of recognized and coded deaths for which silicosis was an underlying or contributing cause decreased from 1,157 in 1968 to 161 in 2005, corresponding to an 86-percent decline (Document ID 1711, p. 33; 1308, p. 55) (
OSHA's Review of Health Effects Literature and Preliminary QRA included death certificate statistics for silicosis up to and including 2005 (Document ID 1711, p. 33). OSHA has since reviewed the more recent NORMS and NCHS data, up to and including 2013, which appear to show a general downward trend in mortality, as presented in Table V-1.
However, more detailed examination of the most recent data collected through NCHS (Table V-2) indicates that the decline in the number of deaths with silicosis as an underlying or contributing cause has leveled off in more recent years, suggesting that the number of silicosis deaths being recorded and captured by death certificates may be stabilizing after 30 or more years of decline.
Robert Cohen, M.D., representing the American Thoracic Society, noted this apparent plateau effect, testifying that “[t]he data from the NIOSH work-related lung disease surveillance report and others show a plateau in silicosis
Some commenters raised the question about whether decedents who died more recently were exposed to high levels of silica (pre-1970s) and therefore wouldn't necessarily reflect mortalities relevant to the current OSHA standard (Document ID 4194, p. 9; 4209, pp. 7-8). OSHA has no information on the age of these decedents, or the timing of their exposure to silica. If we assume that workers born in 1940-1950 would have started working around 1960, at the earliest, and into the 1970's, and life expectancy in general of 70 years, or 60-70 years to account for years of life lost due to silicosis, most of these workers' working life would have been spent after the 1971 PEL went into effect. It is likely that some of the more recent decedents were exposed to silica prior to 1971; however, it is less likely that all were exposed prior to 1971. At the end of the day, there is no actual exposure information on these decedents, and this generalization does not account for overexposures, which have persisted over time.
There is no nation-wide system for collecting silicosis morbidity case data. The data available are from three sources: (1) The National Hospital Discharge Survey (Document ID 1711, p. 40-43); (2) the Agency for Healthcare Research and Quality's (AHRQ) Nationwide Inpatient Survey (Document ID 3425, p. 2;
Both of the first two sources of data on silicosis morbidity cases are surveys that provide estimates of hospital discharges. The first is the National Hospital Discharge Survey (NHDS), which was conducted annually from 1965-2010. The NHDS was a national probability survey designed to meet the need for information on characteristics of inpatients discharged from non-Federal short-stay hospitals in the United States (
Morbidity data are also available from the states that administer silicosis and/or pneumoconiosis disease surveillance. These programs rely primarily on hospital discharge records and also may get some reports of cases from the medical community and workers' compensation programs. Currently, NIOSH funds the State-Based Occupational Safety and Health Surveillance cooperative agreements (Document ID 1711, p. 40-41;
State-based hospital discharge data are a useful population-based surveillance data source for quantifying pneumoconiosis (including silicosis), even though only a small number of individuals with pneumoconiosis are hospitalized for that condition (Document ID 0996), and the data refer to hospitalizations with a diagnosis of silicosis, and not specific people. In addition to mortality data, NIOSH has updated its WoRLD Surveillance System with some state-based morbidity case data (
NIOSH has published aggregated state case data in its WoRLD Reports (Document ID 1308; 1307) for two ten-year periods that overlap, 1989 to 1998 and 1993 to 2002. State morbidity case data are compiled and evaluated by variables such as ascertainment source, primary industry, and occupations. For the time period 1989 to 1998, Michigan reported 589 cases of silicosis, New Jersey 191 cases, and Ohio 400 cases (Document ID 1307, p. 69). In its last published report, for the later and partially overlapping time period 1993 to 2002, Michigan reported 465 cases, New Jersey 135, and Ohio 279 (Document ID 1308, p. 72). Data for the years 2003 to 2011, from the CDC/NIOSH electronic report, eWoRld, show a modest decline in the number of cases of silicosis in these three states; however, decreases are not nearly as substantial as are those seen in the mortality rates (see Table V-3). Annual averages for the two ten-year periods and the nine-year time period were calculated by OSHA solely for the purpose of comparing cases of silicosis reported over time.
Industry representatives, including ACC's Crystalline Silica Panel and Dr. Jonathan Borak, representing the Chamber of Commerce (Chamber), contended that the steep decline seen in the number and rate of silicosis deaths since 1968 proves that OSHA cannot meet its burden of demonstrating that a more protective standard is necessary (
The Chamber, along with others, declared that OSHA ignored steep declines in silicosis mortality, which in its view indicates that there is no further need to reduce the PEL (Document ID 4194, pp. 7-8). OSHA has not ignored the fact that the available surveillance data indicate a decline in silicosis mortality. As discussed above and in the proposal, the Agency has acknowledged that the available surveillance data do show a decline in the silicosis mortality since 1968. Furthermore, OSHA has no information on whether underreporting has increased or decreased over time, and does not believe that differing rates of reporting and underreporting of silicosis on death certificates explains the observed decline in silicosis mortality. OSHA believes that the reductions in deaths attributable to silicosis are real, and not a statistical artifact. However, OSHA disagrees with commenters' argument that this trend shows the lack of a need for this new rule. First, as explained above, there is strong evidence that the death certificate data do not capture the entirety of silicosis mortality that actually exists, due to underreporting of silicosis as a cause of death. Second, the stakeholders' argument assumes that mortality will continue to decline, even in the absence of a stronger silica standard, and that OSHA and workers should wait for this decline to hit bottom (
Third, the decline in silicosis deaths recorded over the past several decades cannot be solely explained by improved working conditions, but also reflects the decline in employment in industries that historically were associated with high workplace exposures to crystalline silica. One of OSHA's peer reviewers for the Review of Health Effects Literature and Preliminary QRA, Bruce Allen, commented that the observed decline in mortality “. . . in no way adjusts for the declining employment in jobs with silica exposure,” making “its interpretation problematic. To emphasize the contribution of historic declines in exposure as the underlying cause is spurious; no information is given to allow one to account for declining employment” (Document ID 3574, p. 7). The CDC/NIOSH also identified declining employment in heavy industries where silica exposure was prevalent as a “major factor” in the reduction over time in silicosis mortality (Document ID 0319, p. 2). As discussed below, however, some silica-generating operations or industries are new or becoming more prevalent.
In his written testimony, Dr. Rosenman pointed out that there are “two aspects to the frequency of occurrence of disease (1) . . . the risk of disease based on the level of exposure and (2) the number of individuals at risk” (Document ID 3425, pp. 3-4). Dr. Rosenman estimated the decline in the number of workers in Michigan foundries (75 percent) and the number of abrasive blasting companies in Michigan (71 percent), and then compared these percentages to the percentage decline in the number of recorded silicosis deaths (80 percent) over a similar time period. The similarities in these values led him to attribute “almost all” of the decrease in silicosis deaths to a decrease in the population at risk (Document ID 3425, pp. 3-4).
Finally, OSHA's reliance on epidemiological data for its risk assessment purposes does not suggest that the Agency ignored the available surveillance data. As discussed above, the data are inadequate and inappropriate for estimating risks or benefits associated with various exposure levels, as is required of OSHA's regulatory process. Even in the limited cases where surveillance data are available, OSHA generally relies on epidemiological data, to the extent they include sufficiently detailed information on exposures, exposure sources (
Some stakeholders provided comments to the rulemaking record consistent with OSHA's assessment. For example, Dr. Borak stated that the surveillance data “provide little or no basis” (Document ID 2376, p. 8) for OSHA to evaluate the protectiveness of the previous PELs. Similarly, NIOSH asserted that relying on the surveillance data to show that there is no need for a lower PEL or that there is no significant risk at 100 μg/m
In its testimony, the AFL-CIO pointed out that a recent U.S. Government Accountability Office (GAO) report on the Mine Safety and Health Administration's (MSHA) proposed coal dust standard references the National Academy of Sciences (NAS) conclusion that risk assessments based on epidemiological data, not surveillance data, were an appropriate means to assess risk for coal-dust exposures (Document ID 4204, p. 21; 4072, Attachment 48, pp. 7-8). The NAS
Commenters from companies and industry groups also argued that they had no knowledge of workers acquiring silicosis in their companies or industry (
Commenters also argued that, due to the long latency of the disease, silicosis cases diagnosed today are the result of exposures that occurred before the former PELs were adopted, and thus reflect exposures considerably higher than the previous PELs (
Dr. Rosenman's testimony provides support for this point. He testified that newer industries with high silica exposures may also be under-recognized because workers in those industries have not yet begun to be diagnosed with silicosis due to the latency period (Document ID 3577, p. 858). Dr. Rosenman submitted to the record a study by Valiante
Sample results for this study indicated a significant risk of overexposure to crystalline silica for workers who performed the five highway repair tasks involving concrete. Sample results in excess of the OSHA PEL were found for operating a jackhammer (88 percent of samples), sawing concrete and milling concrete tasks (100 percent of samples); cleaning up concrete tasks (67 percent of samples); and drilling dowels (100 percent of samples). No measured exposures in excess of the PEL were found for milling asphalt and cleaning up asphalt; however, of the eight samples collected for milling asphalt, six (55 percent) results approached the OSHA PEL, and one was at 92 percent of the PEL. No dust-control measures were in place during the sampling of these highway repair operations.
The authors pointed out that surveillance systems such as those implemented by these states are limited in their ability to detect diseases with long latencies in highway repair working populations because of the relatively short period of time that modern repair methods had been in use when the study was conducted. Nevertheless, a few cases were identified, although the authors explain that the work histories of these cases were incomplete, and the authors recommended ongoing research to evaluate the silicosis disease potential among this growing worker population (Document ID 3926, pp. 876-880). In construction, use of equipment such as blades used on handheld saws to dry-cut masonry materials have increased both efficiency and silica exposures for workers over the past few decades (Document ID 4223, p. 11-13). Exposure data collected by OSHA as part of its technological feasibility analysis demonstrates that exposures frequently exceed previous exposure limits for these operations when no dust controls are used (
Furthermore, the general declining trend seen in the death certificate data is considerably more modest in silicosis morbidity data. In his written testimony, Dr. Rosenman stated that the nationwide number of hospitalizations where silicosis was one of the discharge diagnoses has remained constant, with 2,028 hospitalizations reported in 1993
Based on the testimony and evidence described above, OSHA finds that the surveillance data describing trends in silicosis mortality and morbidity provide useful evidence of a continuing problem, but are not suitable for evaluating either the adequacy of the previous PELs or whether a more protective standard is needed. In fact, it would not be possible to derive estimates of risk at various exposure levels from the available surveillance data for silica. OSHA therefore appropriately continues to rely on epidemiological data and its quantitative risk assessment to support the need to reduce the previous PELs in its final rule.
Commenters also argued that OSHA has failed to prove that a new standard is necessary because silica-associated deaths are due to existing exposures in excess of the previous PELs; therefore, the Agency should focus on better enforcing the previous PELs, rather than enacting a new standard (
Second, not all commenters agreed that overexposures were “widespread.” A few other commenters (
The surveillance data are also not comparable to OSHA's estimate of deaths avoided by the final rule because, as is broadly acknowledged, silicosis is underreported as a cause of death on death certificates. Thus, the surveillance data capture only a portion of the actual silicosis mortality. This point was raised by several rulemaking participants, including Dr. Rosenman; Dr. James Cone, MD, MPH, Occupational Medicine Physician at the New York City Department of Health, the AFL-CIO; and the American Thoracic Society (ATS) (Document ID 3425, p. 2; 3577, Tr. 855, 867; 4204, p. 17; 2175, p. 3; 3577, Tr. 772).
The rulemaking record includes one study that evaluated underreporting of silicosis mortality. Goodwin
Any decedent found to have evidence of silicosis on chest x-ray with a profusion score of 1/0 was considered to be a missed diagnosis. Of the 177 individuals who met study criteria, radiographic evidence of silicosis was found in 15 (8.5 percent). The authors concluded that silicosis goes undetected even when the state administers a case-based surveillance system. Goodwin
The Goodwin
Dr. Rosenman, a physician, epidemiologist and B-reader, testified that in his research he found silicosis recorded on only 14 percent of the death certificates of individuals with confirmed silicosis (Document ID 3425, p. 2; 3577, Tr. 854;
As noted above, factors that contribute to underreporting by health care providers include lack of information about exposure histories and difficulty recognizing occupational illnesses that have long latency periods, like silicosis (
The ATS and the American College of Chest Physicians commented that physicians often fail to recognize or misdiagnose silicosis as another lung disease on the death certificate, leading to under-reporting on death certificates (3577, Tr. 821, 826-827) and under-recognize and underreport cases of silicosis (Document ID 2175, p. 3). As Dr. Weissman from NIOSH responded:
. . . it's well known that death certificates don't capture all of the people that have a condition when they pass away, and so there would be many that probably would not be captured if the silicosis didn't directly contribute to the death and depending on who filled out the death certificate, and the conditions of the death and all those kinds of things. So it's an under-representation of people who die with the condition . . . . (Document ID 3579, pp. 166-167).
Although there is little empirical evidence describing the extent to which silicosis is underreported as a cause of death, OSHA finds, based on this evidence as well as on testimony in the record, that the available silicosis surveillance data are likely to significantly understate the number of deaths that occur in the U.S. where silicosis is an underlying or contributing cause. This is in large part due to physicians and medical residents who record causes of death not being familiar or having access to the patient's work or medical history (
Some commenters stated that the decline in silicosis mortality demonstrates that there is a threshold for silicosis above the prior PEL of 100 μg/m
There is also evidence in the record that silicosis morbidity statistics reviewed earlier in this section are underreported. This can be due, in part, to the relative insensitivity of chest roentgenograms for detecting lung fibrosis. Hnizdo
The study used three readers and defined a profusion score of 1/1 as positive for silicosis. Sensitivity was defined as the probability of a positive radiological reading (ILO category >1/1) given that silicotic nodules were found in the lungs at autopsy. Specificity was defined as the probability of a negative radiological reading (ILO category <1/1) given that no, or only an insignificant number of silicotic nodules were found at autopsy. The average sensitivity values were low for each of the three readers (0.39, 0.37, and 0.24), whereas the average specificity values were high (0.99, 0.97, and 0.98). For all readers, the proportion of true positive readings (
In the only published study that quantified the extent of underreporting of silicosis mortality and morbidity, Rosenman
OSHA disagrees with the criticisms that Dr. Hessel, commenting on behalf of the Chamber, offered on the study by Rosenman
Dr. Rosenman addressed many of these criticisms in the study and at the rulemaking hearing. Regarding the fact that the number of silicosis-related deaths does not reflect the decline in deaths after 1996, Dr. Rosenman testified that, although the number of recorded silicosis deaths have declined since then, the ratio of cases to deaths has increased because the number of cases has not declined. “The living to dead ratio that we reported in our published study in 2003 was 6.44. This ratio has actually increased in recent years to 15.2. A similar ratio . . . [was] found in the New Jersey surveillance data, which went from 5.97 to 11.5 times” (Document ID 3577, Tr. 854). If one were to apply the more recent ratio from Michigan (more than double the ratio used by Rosenman
At the hearing, Dr. Rosenman testified that he was the sole B-reader of lung x-rays for the study, and that he received the x-ray films from other radiologists who suspected but did not confirm the presence of silicosis (Document ID 3577, Tr. 877-878). Dr. Rosenman, while acknowledging that there could be differences between readers in scoring x-ray films, argued that such differences in scoring—for example, whether a film is scored a 3/3, 3/2, or 2/3—did not affect this study since the study design only required that a case be identified and confirmed (diagnosis requires a chest radiograph interpretation showing rounded opacities of 1/0 or greater profusion) (Document ID 3577, Tr. 877-878; 0420, p. 142).
Dr. Rosenman also addressed the criticism that Michigan's worker population with silica exposure is significantly different from the rest of the country. In the study, Rosenman
Finally, regarding the capture-recapture analysis, OSHA notes that Dr. Hessel acknowledged that this technique has been used in epidemiology to estimate sizes of populations identified from multiple overlapping sources (Document ID 2332, p. 2), which is the purpose for which Rosenman
OSHA finds all of Dr. Rosenman's responses to Dr. Hessel's criticisms to be reasonable. And based on Dr. Rosenman's comments and testimony, OSHA continues to believe that the Rosenman
Accordingly, after careful consideration of the available surveillance data, stakeholders' comments and testimony, and the remainder of the record as a whole, OSHA has determined that the available silicosis surveillance data are useful for providing context and an illustration of a significant general trend in the reduction of deaths associated with silicosis over the past four to five decades. As discussed above, and in large part because the data themselves are limited and incomplete, OSHA believes reliance upon them for the purpose of estimating the magnitude of the risk would be inappropriate. The Agency has chosen instead to follow its well-established practice of relying on epidemiological data to meet its burden of demonstrating that workers exposed to respirable crystalline silica at the previous PELs face a significant risk of developing silicosis and that such risk will be reduced when the new limit is fully implemented.
OSHA received numerous comments regarding the carcinogenic potential of crystalline silica as well as the studies of lung cancer mortality that the Agency relied upon in the Preliminary Quantitative Risk Assessment (QRA). Many of these comments, particularly from the ACC, asserted that (1) OSHA should have relied upon additional epidemiological studies, and (2) the studies that the Agency did rely upon (Steenland
As discussed in the Review of Health Effects Literature and Preliminary QRA (Document ID 1711, pp. 76-77), in 1997, the World Health Organization's International Agency for Research on Cancer (IARC) conducted a thorough expert committee review of the peer-reviewed scientific literature and classified crystalline silica dust, in the form of quartz or cristobalite, as Group 1, “carcinogenic to humans” (Document ID 2258, Attachment 8, p. 211). IARC's overall finding for silica was based on studies of nine occupational cohorts that it considered to be the least influenced by confounding factors (Document ID 1711, p. 76). In March of 2009, 27 scientists from eight countries participated in an additional IARC review of the scientific literature and subsequently, in 2012, IARC reaffirmed that respirable crystalline silica dust is a Group 1 human carcinogen that causes lung cancer (Document ID 1473, p. 396). Additionally, in 2000, the National Toxicology Program (NTP) of HHS concluded that respirable crystalline silica is a known human carcinogen (Document ID 1164, p. 1).
The ACC, in its pre-hearing comments, questioned the carcinogenic potential of crystalline silica, asserting that IARC's 1996 recommendation that crystalline silica be classified as a Group 1 carcinogen was controversial (Document ID 2307, Attachment A, p. 29). The ACC cited Dr. Patrick Hessel's 2005 review of epidemiological studies, published after the initial IARC determination, in which he concluded that “the silica-lung cancer hypothesis remained questionable” (Document ID 2307, Attachment A, p. 31). The ACC reasserted this position in its post-hearing brief, contending that “epidemiological studies have been negative as often as they have been positive” (Document ID 4209, pp. 33-34).
After the publication of Dr. Hessel's 2005 review article, IARC reaffirmed in 2012 its earlier Group 1 classification for crystalline silica dust (Document ID 1473). As pointed out by Steenland and
It is important to recognize that evidence for silica's carcinogenicity has been reviewed three times by the International Agency for Research on Cancer, once in 1987, 1997, and 2012. It has been evaluated by California's Proposition 65 in 1988, by the National Toxicology Program in 2000 and reaffirmed in 2011, and by the National Institute for Occupational Safety and Health in 2002 (Document ID 3577, Tr. 861-862).
Multiple organizations with great expertise in this area, including the American Cancer Society, submitted comments supporting the thorough and authoritative nature of IARC's findings regarding silica's carcinogenicity (
In addition to debating the conclusions of IARC, Peter Morfeld, Dr. rer. medic, testifying on behalf of the ACC Crystalline Silica Panel, concluded that OSHA's risk estimates for lung cancer are “unreliable” because they “ignore threshold effects and the apparent mediating role of silicosis” (Document ID 2307, Attachment 2, p. 16). Dr. Morfeld argued that silicosis is a necessary prerequisite for silica-related lung cancer. Commenters' arguments about silicosis being a prerequisite for lung cancer and silicosis having a threshold are linked; if it were shown both that silicosis requires a certain threshold of exposure and that only persons with silicosis get lung cancer, then silica-related lung cancer would also have an exposure threshold. As discussed in Section V.I, Comments and Responses Concerning Thresholds for Silica-Related Diseases, commenters claimed that there is a threshold for silicosis above the previous PEL for general industry, which would make any threshold for lung cancer above that level as well. OSHA discusses these comments in detail in that section, and has determined that even if lung cancer does not occur in the absence of silicosis, the record strongly supports the conclusion that workers exposed to respirable crystalline silica would still be at risk of developing lung cancer as a result of their exposure because silicosis can develop among workers whose average and cumulative exposures are below the levels permitted by the previous PELs.
OSHA received comments from other stakeholders, including Robert Glenn, representing the Brick Industry Association, and the AFS on the possible mediating role of silicosis in the development of lung cancer (Document ID 2307, pp. 29-35; 2343, Attachment 1, pp. 42-45; 2379, Attachment 2, pp. 24-25). The ACC cited several review articles in support of its claim that “silica exposures have not been shown to increase the risk of lung cancer in the absence of silicosis” (Document ID 2307, Attachment A, pp. 29, 32, 35). These articles included: A 2004 review of studies by Kurihara and Wada that found that while silicosis is a risk factor for lung cancer, exposure to silica itself may not be a risk factor (Document ID 1084); a 2006 review by Pelucchi
Similarly, the ACC stated that none of the studies of lung cancer mortality that OSHA relied upon in the Preliminary QRA demonstrates that silica exposure causes lung cancer in the absence of silicosis (Document ID 2307, Attachment A, p. 66). During the rulemaking hearing, NIOSH scientists addressed the issue of whether silicosis is a necessary precursor to the development of lung cancer. They stated that it is a difficult issue to resolve because the two diseases may have a similar pathway, such that they can develop independently but still appear correlated. Mr. Robert Park also added that:
[S]ilicosis isn't detectable until there's splotches on the lung that are visible in x-rays. So prior to that point, somebody could have [been] developing lung disease and you just can't see it. So, of course, people that have silicosis are going to have higher lung cancer, and it's going to look like a threshold because you didn't see the silicosis in other people that have lower lung cancer risk. To really separate those two, you'd have to do a really big study. You'd have to have some measures, independent measures of lung physiological pathology, and see what's going on with silicosis as a necessary condition for development of lung cancer (Document ID 3579, Tr. 245-247).
Similarly, David Weissman, MD, concurred that “there's quite a bit of reason as Bob [Park] said to think that the two processes [development of silicosis and development of lung cancer] don't require each other, and it would be extraordinarily difficult to sort things out in human data” (Document ID 3579, Tr. 247). Indeed, Checkoway and Franzblau (2000) reviewed the epidemiological literature addressing this topic, and found that the “limitations of existing epidemiologic literature that bears on the question at hand suggest that prospects for a conclusive answer are bleak” (Document ID 0323, p. 257). The authors concluded that silicosis and lung cancer should be treated in risk assessments as “separate entities whose cause/effect relations are not necessarily linked” (Document ID 0323, p. 257). Brian Miller, Ph.D., a peer reviewer of OSHA's Review of Health Effects Literature and Preliminary QRA, likewise wrote in his post-hearing comments, “I consider this issue unanswerable, given that we cannot investigate for early fibrotic lesions in the living, but must rely on radiographs” (Document ID 3574, p. 31).
During the public rulemaking hearing, several stakeholders pointed to a recent study of Chinese pottery workers and miners by Liu
The ACC argued that it is “premature to draw that conclusion,” stating that the Liu study's conclusions are not supported by the data and raising questions about uncertainty in the exposure estimates, modeling and statistics, confounding, and the silicosis status of cohort members (Document ID 2307, Attachment A, p. 48; 4027, pp. 35-36; 4209, pp. 40-51). With regard to exposure estimates, the ACC had a number of concerns, including that conversion factors determined by side-by-side sampling in 1988-1989 were used to convert Chinese total dust concentrations to respirable crystalline silica exposures (Document ID 4209, pp. 40-41). Dr. Cox expressed concern that these conversion factors from 1988-1989 might not have been applicable to other time periods, as particle size distributions could change over time (Document ID 4027, p. 32). OSHA acknowledges this concern, but given the “insufficient historical particle size data . . . to analyze whether there were changes in particle size distributions from the 1950s to the 1990s,” believes that the authors were justified in making their exposure assumptions (Document ID 4027, p. 32). Dr. Cox's concerns involving modeling and statistics (
On the issue of confounding, the ACC noted that Liu
The ACC also noted that Chen
During the public hearing, counsel to the ACC asked Dr. Steenland, a co-author on the Liu
With respect to the PAH data for the potteries, Dr. Weihong Chen, the study's first author, reported that, in measurements in 1987-1988 in the four potteries that were excluded from the Liu
Based upon these subsequent data, the ACC concluded that PAHs were likely present in the potteries but not in the mines (Document ID 4209, p. 45). OSHA believes this conclusion, although plausible, to be speculative. What is known is that the potteries that were excluded had a higher average level of PAHs, and that a significant association between cumulative silica exposure and lung cancer mortality remained in the included potteries even after the analysis was separated by potteries and mines. However, the association was less clear in the metal mines.
The ACC also raised concerns about the silicosis status of lung cancer cases in the Liu cohort, asserting that some workers may not have had post-employment radiography given that social health insurance only recently began to pay for it. As such, the ACC asserted that some workers who developed lung cancer post-employment may have also had undiagnosed silicosis (Document ID 4209, pp. 49-50). OSHA acknowledges the limitations of the study, as with any retrospective study, but also notes that no evidence was put forth to indicate that workers with silicosis were misclassified in the study as workers without silicosis. Further, Dr. Goldsmith testified that the method used by Liu
Thus, OSHA concludes that the Liu
Overall, after giving lengthy consideration to all evidence in the record regarding whether silicosis is a necessary precursor to the development of lung cancer, including the Liu study, the NIOSH testimony, and the mechanistic evidence for the carcinogenicity of crystalline silica discussed in Section V.H, Mechanisms of Silica-Induced Adverse Health Effects, OSHA concludes that the mediating role of silicosis in the development of lung cancer is not “apparent,” as suggested by Dr. Morfeld and the ACC (Document ID 2307, Attachment 2, p. 16). As such, OSHA continues to believe that substantial evidence supports the Agency's decision to consider lung cancer as a separate, independent health endpoint in its risk analysis. The Agency also notes that even if lung cancer does not occur in the absence of silicosis, the record strongly supports the conclusion that workers exposed to respirable crystalline silica would still be at risk of developing lung cancer as a result of their exposure because silicosis can develop from average and cumulative exposures below the levels allowed at the previous PEL (
Stakeholders also suggested several additional studies that they believe OSHA should include in its QRA on lung cancer. The AFS commented that OSHA's Preliminary QRA overlooked a 2003 report by the Health and Safety Executive (HSE, Document ID 1057), asserting that over 40 percent of the references cited by HSE were omitted in OSHA's review (Document ID 4035, p. 2). OSHA disagrees with this assessment of overlooking the report, noting that the Agency reviewed and referenced the HSE report in its Review of Health Effects Literature and Preliminary QRA (Document ID 1711, p. 77). As discussed in Section V.C, Summary of the Review of Health Effects Literature and Preliminary QRA, OSHA used a weight-of-evidence approach to evaluate the scientific studies in the literature to determine their overall quality. In so doing, OSHA thoroughly reviewed approximately 60 published, peer-reviewed primary epidemiological studies covering more than 30 occupational cohorts in over a dozen industrial sectors, as well as the IARC pooled study and several meta-analyses (Document ID 1711, pp. 75-172).
The AFS also submitted a 2011 review of 30 foundry epidemiology studies by the Industrial Industries Advisory Council (IIAC) and noted that only 7 of those 30 studies were included in OSHA's Review of Health Effects Literature and Preliminary QRA (Document ID 2379, p. 24). AFS wrote:
The PQRA largely dismisses the foundry epidemiology studies, based on assertions of positive confounding. However, a study showing that there is no adverse effect despite a positive confounder is not only still relevant to the question, but should be more persuasive than a study without positive confounders because the data then show that even with an additive risk, there is no increase in effect at the reported exposure levels (Document ID 2379, p. 24).
In response to this comment, OSHA gathered the remaining 23 foundry studies cited in the submitted report and placed them in the rulemaking docket during the post-hearing comment period. OSHA notes, in the first instance, that most of these studies were not designed to study the effects of silica exposure on foundry workers, and did not even attempt to do so; rather, their purpose was to examine lung cancer mortality and/or morbidity in foundry work, which involves many toxic and otherwise harmful substances besides silica. Therefore, OSHA would likely be unable to suitably use these studies as a basis for a quantitative risk assessment regarding respirable crystalline silica by itself.
With respect to AFS's assertions of studies showing “no adverse effect,” OSHA notes that the summary section of the IIAC review report, submitted as evidence by AFS, stated that, “The cohort mortality studies and two morbidity studies suggest an increased risk of lung cancer in foundry workers when considered overall, but do not support a doubling of risk. . . . Findings in the case-control studies, the majority of which adjust for the effects of smoking . . . tend to support those of the cohort studies” (Document ID 3991, p. 5). As such, this review of 30 foundry epidemiology studies showed an increased excess risk of lung cancer from foundry work; the fact that the excess risk was not increased by a factor of two is irrelevant to the current proceedings. The factor of two appears to be used by the IIAC in determining whether monetary benefits should be paid to foundry workers in Great Britain and is completely unrelated to OSHA's statutory requirements for determining whether workers exposed to silica are at a significant risk of material impairment of health. Given that excess lung cancer was observed in many of these studies, OSHA rejects the AFS's assertion that, even with positive confounding, there was no increase in adverse effect (
OSHA also notes that the IIAC's finding of an elevated risk of lung cancer in foundries is not surprising. As Dr. Mirer stated during his testimony, IARC categorized foundry work as Group 1, carcinogenic to humans, in 1987 based on observed lung cancer (Document ID 2257, Attachment 3, p. 5). IARC reaffirmed its Group 1 classification for foundry work in 2012 (Document ID 4130). However, as noted by OSHA in its Review of Health Effects Literature, the foundry epidemiology studies were profoundly confounded by the presence of exposures to other carcinogens, including PAHs, aromatic amines, and metals (Document ID 1711, p. 264). Because of this confounding, as well as the fact that most of these studies did not specifically study the effects of silica exposure on foundry workers, OSHA has decided not to include them in its QRA.
The ACC likewise cited several individual studies that it believed found no relationship between silica exposure and lung cancer risk (Document ID 2307, Attachment A, pp. 33-35). These included studies by: (1) Yu
Briefly, Chen
OSHA discussed the Birk
Following the ACC's citation of the Yu
Regarding these studies, OSHA notes that the Westberg
OSHA acknowledges that not every study reaches the same results and conclusions. This is typically true in epidemiology, as there are different cohorts, measurements, study designs, and analytical methods, among other factors. As a result, scientists critically examine the studies, both individually and overall, in the body of literature to draw weight-of-evidence conclusions. IARC noted, with respect to its 1997 carcinogenicity determination:
[N]ot all studies reviewed demonstrated an excess of cancer of the lung and, given the wide range of populations and exposure circumstances studied, some non-uniformity of results had been expected. However, overall, the epidemiological findings at the time supported an association between cancer of the lung and inhaled crystalline silica (α-quartz and cristobalite) resulting from occupational exposure (Document ID 1473, p. 370).
Given IARC's re-affirmation of this finding in 2012, OSHA does not believe that the individual studies mentioned above fundamentally change the weight of evidence in the body of literature supporting the carcinogenicity of crystalline silica. The best available evidence in the rulemaking record continues to indicate that exposure to respirable crystalline silica causes lung cancer. OSHA acknowledges, however, that there is some uncertainty with respect to the exact magnitude of the
Further, the ACC focused extensively on and advocated for a study by Vacek
Perhaps of most interest and relevance for present purposes—because the cohort has been studied so extensively in the past and because the present PEL is based indirectly on experience in the Vermont granite industry—is the mortality study of Vermont granite workers published in 2011. While the Vermont granite workers cohort has been studied on a number of previous occasions, this is the most comprehensive mortality study of Vermont granite workers to date (Document ID 2307, Attachment A, p. 36).
The ACC criticized OSHA for rejecting the Vacek
The ACC also pointed out that Attfield and Costello's exposure estimate for sandblasters was 60 µg/m
Lastly, the ACC posited that Attfield and Costello inappropriately excluded the highest exposure group, stating:
Vacek
Based upon these assertions, the ACC concluded, “In sum, when judged without a result-oriented confirmation bias, the larger, more recent, more comprehensive, and more detailed study by Vacek
OSHA initially discussed some issues surrounding the Vacek
The ACC did not agree with OSHA's review of the Vacek
Although OSHA notes that this latter phenomenon, in which the odds ratio for the second lowest exposure stratum is lower than that for the lowest stratum, is commonly observed and often attributable to some form of selection confounding, the Agency recognizes that there may be alternative explanations for the patterns observed in the Vacek
The HWE, as defined by Stayner
OSHA disagrees with the ACC's statement that “the possibility of a potential HWE in this cohort could not have affected the E-R analyses” in Vacek
In contrast, Attfield and Costello's stated rationale for excluding the highest exposure group is related to the healthy worker survivor effect:
We do know that this group is distinctive in entering the cohort with substantial exposures—83% had worked for 20 years or more in the high dust levels prevalent prior to controls. They were, therefore, a highly selected healthy worker group. A further reason may be that in the days when tuberculosis and silicosis were the main health concerns in these workers, lung cancer may have been obscured in this group as a cause of death in some cases” (Document ID 0284, p. 136).
Support for Attfield and Costello's reasoning is provided by a study by Applebaum
Vacek
The ACC also commented on Vacek
Vacek
In addition, as previously noted by OSHA, the SMRs for cancers largely attributable to smoking, such as those of the buccal cavity and pharynx (SMR = 1.01), larynx (SMR = 0.99), and esophagus (SMR = 1.15) were not significant in the Vacek
OSHA is also concerned about some features of the study design and exposure assessment in Vacek
In addition, Vacek
With respect to the different job exposure matrices, OSHA has reason to believe that the exposure data reported in the Attfield and Costello study are more accurate than the data Vacek
If there is a true [linear] relationship between exposure to silica dust and lung cancer mortality, classifying highly exposed workers incorrectly as low-exposed shifts the elevated risks to the low exposure range. The impact is to spuriously elevate risks at low exposures and lower them at high exposures, resulting in the exposure-response trend being flattened or even obscured. Ultimately, the true relationship may not be evident, or if it is, may be attenuated (Document ID 4233, p. 22, n. 1).
Vacek
For the reasons discussed herein, OSHA has decided not to reject the Attfield and Costello (2004) study in favor of the Vacek
As stated above, OSHA disagrees with the ACC's contention that Vacek
According to the ACC, OSHA's risk estimates based on the Miller and MacCalman (2009, Document ID 1306) study are “more credible than the others—because [the study] involved a very large cohort and was of higher quality in terms of design, conduct, and detail of exposure measurements,” and also adjusted for smoking histories (Document ID 2307, Attachment A, p. 73). Although the risk estimates generated from the Miller and MacCalman data were the lowest of the lung cancer mortality estimates, the ACC next asserted that they were biased upwards for several reasons. First, the ACC stated that exposure information was lacking for cohort members after the mines closed in the mid-1980's, and quoted OSHA as stating, “Not accounting for this exposure, if there were any, would bias the risk estimates upwards” (Document ID 2307, Attachment A, p. 74 (quoting 1711, p. 289)). OSHA, however, does not believe there to have been additional substantial quartz exposures. As the study authors wrote, “Because of the steep decline of the British coal industry, the opportunities for further extensive coal mine exposure were vanishingly small” (Document ID 1306, p. 11). Thus OSHA believes it to be unlikely that the risk estimates are biased upwards to any meaningful degree based on lack of exposure information at the end of the study period.
The ACC also stated that the unrestricted smoking of cohort members after the closure of the mines would have resulted in risk estimates that were biased upwards (Document ID 2307, Attachment A, p. 74). OSHA has no reason to believe, nor did the ACC submit any evidence in support of its contention, that unrestricted smoking occurred, however, and notes that the authors stated that the period after the mines closed was one of “greater anti-
Finally, the ACC noted that Miller and MacCalman did not adjust significance levels for the multiple comparisons bias with respect to lag selection that Dr. Cox alleged affected their study (Document ID 2307, Attachment A, p. 74). Dr. Cox claimed that trying multiple comparisons of alternative approaches, such as different lag periods, and then selecting a final choice based on the results of these multiple comparisons, leads to a multiple comparisons bias that could result in false-positive associations (Document ID 2307, Attachment 4, p. 28; see Section V.J, Comments and Responses Concerning Biases in Key Studies). He argued that the authors should have reduced the significance level (typically p = 0.05) at which a result is considered to be significant. “Lag” refers to the exclusion of the more recent years of exposure (
In summary, OSHA notes that the ACC has not provided any non-speculative evidence to support its claims that the risk estimates derived from the Miller and MacCalman (2009) study are biased upwards. As stated in the Review of Health Effects Literature and Preliminary QRA, and acknowledged by the ACC (Document ID 2307, p. 73), OSHA believes these risk estimates to be very credible, as the study was based on well-defined union membership rolls with good reporting, had over 17,000 participants with nearly 30 years of follow-up, and had detailed exposure measurements of both dust and quartz, as well as smoking histories (Document ID 1711, pp. 288-289).
OSHA also received several comments on the ToxaChemica (2004, Document ID 0469) analysis, which was based on the Steenland
[I]t reduces the effect of the very highest exposures being able to drive an exposure-response curve because those exposures are often [skewed] way out—skewed to the right, because occupational exposure data is often log normal. With some very high exposures, they are sort of extreme, and that can drive your exposure-response curve. And you take the log, it pulls them in, and so therefore gives less influence to those high data points. And I think those high data points are often measured with more error (Document ID 3580, Tr. 1265-1266).
OSHA finds this testimony to be persuasive and, therefore, believes that Dr. Steenland's use of a log transformation to address the heterogeneity was appropriate. The log transformation also permits a better model fit when attenuation of the response is observed at high cumulative exposures.
Dr. Morfeld commented that Steenland et al. did not take into account smoking, which could explain the observed excess lung cancer of 20 percent (SMR = 1.2). Dr. Morfeld stated, “Thus, lung cancer excess risks were demonstrated only under rather high occupational exposures to RCS dust, and, even then, an upward bias due to smoking and a necessary intermediate role for silicosis could not be ruled out” (Document ID 2307, Attachment 2, p. 10). Dr. Steenland addressed the concern about a potential smoking bias during his testimony:
We concluded that this positive exposure response was not likely due to different smoking habits between high exposed and low exposed workers. And the reason we did that was twofold. First, workers tend to smoke similar amounts regardless of their exposure level in general. We often worry about comparing workers to the general population because workers tend to smoke more than the general population. But, in internal analyses, we don't have this problem very often. When we have smoking data, we see that it is not related to exposure, so a priori we don't think it is likely to be a strong confounder in internal analyses. Secondly, a number of the studies we used in our pool[ed] cohort had smoking data, either for the whole cohort or partially. And when they took that into account, their results did not change. In fact, they also found that smoking was not related to exposure in their studies, which means that it won't affect the exposure-disease relationship because if it is going to do that, it has to differ between the high exposed and the low exposed, and it generally did not (Document ID 3580, Tr. 1227-1228).
In addition, Brown and Rushton (2009), in their review article submitted to the rulemaking record by Dr. Morfeld, appeared to agree with Dr. Steenland, stating, “This [Steenland
The ACC also commented that exposure misclassification due to uncertain exposure estimates in Steenland's pooled cohort could have created the appearance of a monotonic relationship, in which the response
OSHA disagrees with Dr. Borak's interpretation of the Mannetje
The ACC concluded:
For all these reasons, the pooled analysis by Steenland
The ACC then discussed the ToxaChemica report (2004), which the ACC claimed shows that “under the spline model (which the authors prefer over the log cumulative model because of biological plausibility)” reducing the PEL from 100 µg/m
OSHA notes that these risk estimates cited by the ACC were the original estimates for the spline model provided to OSHA by ToxaChemica in its 2004 report (Document ID 0469). These are not the risk estimates used by OSHA. Instead, to estimate the risks published in this final rule, the Agency used the exposure-response coefficients from the study in an updated life table analysis using background all-cause mortality and lung cancer mortality rates from 2006 and 2011, respectively. The risk estimates using the 2011 background data are the most updated numbers with which to make the comparisons ACC has suggested. With the 2011 background data, the estimated excess risk is 20 deaths per 1,000 workers at 100 µg/m
In addition, the linear spline model employed by Steenland et al. (2001) was only one of three models used by OSHA to estimate quantitative risks from the pooled analysis. OSHA also used the log-linear model with log cumulative exposure as well as the linear model with log cumulative exposure (see Section VI, Final Quantitative Risk Assessment and Significance of Risk). OSHA notes that all three models indicated a reduction in risk when comparing an exposure level of 100 µg/m
In summary, OSHA disagrees with the ACC's assertion that the Steenland et al. pooled analysis does not yield credible risk estimates for lung cancer mortality. Dr. Morfeld's assertion that the risk estimates were biased upwards due to smoking is quite unlikely to be true, given that the study was an internal (worker to worker) analysis. The ACC's claim that exposure estimation error resulted in false exposure-response relationships was not supported by any actual data; as discussed in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis, exposure estimation error can also bias results towards the null (weaken or obscure the exposure-response relationship) (Document ID 3580, Tr. 1266-67; 3576, Tr. 358-359; 3574, p. 21). For these reasons, OSHA rejects the ACC's claims that the Steenland study of lung cancer mortality does not yield credible risk estimates. Rather, based upon its review, OSHA believes this pooled analysis to be of high quality. As Dr. Steenland testified during the informal public hearings, this pooled analysis, with its more than 60,000 workers and 1,000 lung cancer deaths, involved “a rich dataset with high statistical power to see anything, if there was anything to see” (Document ID 3580, Tr. 1227). In fact, OSHA believes the Steenland
The ACC also commented on the Rice
The ACC also noted that the mean crystalline silica exposure in the diatomaceous earth worker cohort was 290 μg/m
The ACC also stated that the results of the Rice study were confounded by smoking and possibly asbestos exposure (Document ID 2307, Attachment A, p. 83). OSHA previously addressed the possible confounding in this cohort in its Review of Health Effects Literature and Preliminary QRA (Document ID 1711, pp. 139-143). Rice
Checkoway
Based upon these analyses, OSHA rejects the ACC's unsupported assertion that the results of Rice
Lastly, Dr. Cox asserted that there were several biases in Rice
The ACC, through the comments of Dr. Cox, presented a similar critique of the study of North American industrial sand workers by Hughes
OSHA discussed the Hughes
The ACC also noted that there was no consistent correlation in Hughes
In summary, OSHA considers the Hughes
Overall, regarding all of the studies upon which OSHA relied in its Preliminary QRA, the ACC concluded, “In sum, none of the studies on which OSHA relies is inconsistent with a concentration threshold above 100 μg/m
OSHA is not persuaded that the evidence presented by the ACC supports these conclusions. On the contrary, as OSHA discussed in the Section V.I, Comments and Responses Concerning Thresholds for Silica-Related Diseases, demonstrating the absence of a threshold is not a feasible scientific pursuit, and some models produce threshold estimates well below the PELs. Similarly, the ACC has not put forward any study that has proven that silicosis must be a precursor for lung cancer and, as discussed in Section V.H, Mechanisms of Silica-Induced Adverse Health Effects, some studies have shown genotoxic mechanisms by which exposure to crystalline silica may lead to lung cancer. The strong epidemiological evidence for carcinogenicity, supported by evidence from experimental animal and mechanistic studies, allowed IARC to conclude on multiple occasions that respirable crystalline silica is a Group I carcinogen. OSHA places great weight on this conclusion given IARC's authority and standing in the international scientific community. In addition, all of the lung cancer studies relied upon by OSHA used models that allow for the estimation of lung cancer risks at crystalline silica exposure levels of 100 μg/m
OSHA estimated quantitative risks for renal disease mortality (Document ID 1711, pp. 314-316) using data from a pooled analysis of renal disease, conducted by Steenland
OSHA received several comments from the ACC regarding the Agency's quantitative risk estimates for renal disease mortality. Specifically, the ACC argued that: (1) The pooled study (Steenland
Some commenters expressed concern about the Steenland
OSHA finds this assertion of study selection bias by the ACC and Dr. Morfeld to be unpersuasive because Steenland
Concern was also expressed about the model selection in the pooled analysis. Dr. Morfeld noted that a statistically significant association between exposure to crystalline silica and renal disease mortality was only found in the underlying cause analysis in which the model was logged (p = 0.03) (Document ID 2308, Attachment 4, p. 25). Dr. Morfeld commented, “The authors stated that the log-model fit better, but evidence was not given (
OSHA disagrees with this criticism because a log transformation of the cumulative exposure metric is reasonable, given that exposure variables are often lognormally distributed in epidemiological studies, as discussed in Section V.J, Comments and Responses Concerning Biases in Key Studies. Also, while it is true that Steenland
The ACC also noted that the authors of this study, Drs. Kyle Steenland and Scott Bartell, acknowledged the limitations of the data in their 2004 ToxaChemica report to OSHA. Specifically, in reference to the 51 renal deaths (underlying cause) and 23 renal cases in the pooled study, Drs. Steenland and Bartell wrote, “This amount of data is insufficient to provide robust estimates of risk” (Document ID 2307, Attachment A, p. 139, citing 0469, p. 27). Given this acknowledgement, the ACC concluded that OSHA's inclusion of the renal disease mortality risk estimates in the significant risk determination and calculation of expected benefits was speculative (Document ID 2307, Attachment A, pp. 139-140). During the hearing, Dr. Steenland further explained, “I think there is pretty good evidence that silica causes renal disease. I just think that there is not as big a database as there is for lung cancer and silicosis. And so there is more uncertainty” (Document ID 3580, Tr. 1245). OSHA agrees with Dr. Steenland and acknowledges, as it did in its Review of Health Effects Literature and Preliminary QRA (Document ID 1711, p. 357), that its quantitative risk estimates for renal disease mortality have more uncertainty and are less robust than those for the other health effects examined (
The ACC also identified limitations in each of the three epidemiological studies included in the Steenland
OSHA finds the ACC's suggestion of a threshold to be unpersuasive, as the ACC provided no analysis to indicate a threshold in this study. OSHA addresses the Steenland and Brown (1995a, Document ID 0450) exposure assessment in Section V.D, Comments and Responses Concerning Silicosis and Non-Malignant Respiratory Disease Mortality and Morbidity. The ACC also
The ACC had a similar criticism of the Steenland
The ACC also noted that, based on underlying cause of death, the SMR for acute renal death in the Steenland
OSHA does not find this criticism persuasive. For regulatory purposes, multiple-cause mortality data is, if anything, more relevant because renal disease constitutes the type of material impairment of health that the Agency is authorized to protect against through regulation regardless of whether it is determined to be the underlying cause of a worker's death. Moreover, the discrepancy in the renal disease mortality findings is a moot point, as only the model in the pooled study with renal disease as an underlying cause was used to estimate risks in the Preliminary QRA (Document ID 1711, p. 316). In any event, OSHA notes an important difference between the Steenland
The ACC further argued that the Steenland
OSHA notes that Steenland
The ACC also submitted to the record several additional studies that did not show a statistically significant association between exposure to crystalline silica and renal disease mortality. These included the aforementioned studies by McDonald
In light of the analysis contained in the Review of Health Effects Literature and Preliminary QRA, and OSHA's confirmation of its preliminary findings through examination of the record, OSHA finds these claims to be lacking in merit (Document ID 1711, pp. 211-229). In the Review of Health Effects Literature and Preliminary QRA, OSHA presented a comprehensive analysis of several studies that showed an association between crystalline silica
From this review of the studies on renal disease, OSHA concluded that there were considerably less data, and thus the findings based on them were less robust, than the data available for silicosis and NMRD mortality, lung cancer mortality, or silicosis morbidity. Nevertheless, OSHA concluded that the Steenland
Thus, OSHA recognizes that the renal risk estimates are less robust and have more uncertainty than those for the other health endpoints for which there is a stronger case for causality (
In this section, OSHA describes the mechanisms by which silica exposure may cause silica-related health effects, and responds to comments criticizing the Agency's analysis on this topic. In the proposal as well as this final rule, OSHA relied principally on epidemiological studies to establish the adverse health effects of silica exposure. The Agency also, however, reviewed animal studies (in vivo and in vitro) as well as in vitro human studies that provide information about the mechanisms by which respirable crystalline silica causes such effects, particularly silicosis and lung cancer. OSHA's review of this material can be found in the Review of Health Effects Literature and Preliminary Quantitative Risk Assessment (QRA), which provided background and support for the proposed rule (Document ID 1711, pp. 229-261).
As described in the Review of Health Effects Literature, OSHA performed an extensive evaluation of the scientific literature pertaining to inhalation of respirable crystalline silica (Document ID 1711, pp. 7-265). Due to the lack of evidence of health hazards from dermal or oral exposure, the Agency focused solely on the studies addressing the inhalation hazards of respirable crystalline silica. OSHA determined, based on the best available scientific information, that several cellular events, such as cytotoxicity (
Below, OSHA reviews the record evidence and responds to comments it received on the mechanisms underlying respirable crystalline silica-induced lung cancer and silicosis. The Agency also addresses comments regarding the use of animal studies to characterize adverse health effects in humans caused by exposure to respirable crystalline silica.
In 2012, IARC reevaluated the available scientific information regarding respirable crystalline silica and lung cancer and reaffirmed that crystalline silica is carcinogenic to
Non-genotoxic mechanisms are also believed to contribute to the lung cancer caused by respirable crystalline silica. Phagocytic activation as well as silica-induced cytotoxicity trigger release of the aforementioned ROS, cytokines (
The same non-genotoxic processes that may cause lung cancer from respirable crystalline silica exposure are also believed to lead to chronic inflammation, lung scarring, fibrotic lesions, and eventually silicosis. This would occur when inflammatory cells move from the alveolar space through the interstitium of the lung as part of the clearance process. In the interstitium, respirable crystalline silica-laden cells—macrophages and neutrophils—release ROS and TNF-α, as well as other cytokines, stimulating the proliferation of fibroblasts (
Although it is clear that exposure to respirable crystalline silica increases the risk of lung cancer in exposed workers (
Animal data has been used for decades to evaluate hazards and make inferences regarding causal relationships between human health effects and exposure to toxic substances. The National Academies of Science has endorsed the use of well-conducted animal studies to support hazard evaluation in the risk assessment process (Document ID 4052, p. 81) and OSHA's policy has been to rely on such studies when regulating carcinogens. In the case of respirable crystalline silica, OSHA has used evidence from animal studies, along with human epidemiology and other relevant information, to establish that occupational exposure is associated with silicosis, lung cancer, and other non-malignant respiratory diseases, as well as renal and autoimmune effects (Document ID 1711, pp. 261-266). Exposure to various forms of respirable crystalline silica by inhalation and intratracheal instillation has consistently caused lung cancer in rats (IARC, 1997, Document ID 1062, pp. 150-163). These results led IARC and NTP to conclude that there is sufficient evidence in experimental animals to demonstrate the carcinogenicity of crystalline silica in the form of quartz dust. IARC also concluded that there is sufficient evidence in human studies for the carcinogenicity of crystalline silica in the form of quartz or cristobalite.
In its pre-hearing comments and post-hearing brief, the ACC noted that increased lung cancer risks from exposure to respirable crystalline silica have not been found in animal species other than rats, and questioned the relevance of the rat model for evaluating potential lung carcinogenicity in humans (Document ID 2307, Attachment A, p. 30; 4209, p. 32). Specifically, the ACC highlighted studies by Holland (1995) and Saffiotti
The ACC proposed that the increased lung cancer risk in respirable crystalline silica-exposed rats is due to a particle overload phenomenon, in which lung clearance of nonfibrous durable particles initiates a non-specific response that results in intrapulmonary lung tumors (Document ID 2307, Attachment A, p. 30, n. 51). Dr. Cox, on behalf of the ACC, citing Mauderly (1997, included in Document ID 3600), Oberdorster (1996, Document ID 3969), and Nikula
Thus, OSHA finds that the Mauderly (1997) and Oberdorster (1996) articles generally support the rat as an appropriate model for qualitatively assessing the hazards associated with particle inhalation. OSHA likewise notes that the rat model is a common and well-accepted toxicological model used to assess human health effects from toxicant inhalation (ILSI, 2000, Document ID 3906, pp. 2-9). OSHA evaluated the available studies in the record, both positive and non-positive, and believes that it is appropriate to regard positive findings in experimental studies using rats as supportive evidence for the carcinogenicity of crystalline silica. This determination is consistent with that of IARC (Document ID 1473, p. 388) and NTP (Document ID 1164, p. 1), which also regarded the significant increases in incidence of malignant lung tumors in rats from multiple studies by both inhalation and intratracheal instillation of crystalline silica to be sufficient evidence of carcinogenicity in experimental animals and, therefore, to contribute to the evidence for carcinogenicity in humans.
The ACC asserted in its comments that “if it exists at all, silica-related carcinogenicity most likely arises through a silicosis pathway or some other inflammation-mediated mechanism, rather than by means of a direct genotoxic effect” (Document ID 2307, Attachment A, p. 52; 4209, p. 51; 2343, Attachment 1, pp. 40-44). It explained that the “silicosis pathway” means that lung cancer stems from chronic inflammatory lung damage, which in turn, “implies that there is a threshold for any causal association between silica exposure and risk of lung cancer” (Document ID 2307, Attachment A, pp. 52-53). The ACC went on to state that a mechanism that involves ROS, growth factors, and inflammatory cytokines from alveolar macrophages is “most consistent” with development of advanced chronic inflammation (
The ACC statement regarding acceptance by OSHA and the scientific community is inaccurate. It implies scientific consensus, as well as OSHA's concurrence, that the chronic inflammation from silicosis is the only mechanism by which crystalline silica exposure results in lung cancer. The ACC has over-simplified and neglected the findings of the mechanistic studies that show activation of phagocytic and epithelial cells to be an early cellular response to crystalline silica prior to chronic inflammation (
In pre-hearing comments the ACC commented, as proof of silicosis being linked to lung cancer, that fibrosis was linked to adenocarcinomas (Document ID 2307, Attachment A, p. 61). This statement is misleading. As explained
OSHA also received some comments that questioned the existence of a direct genotoxic mechanism. Jonathan Borak, M.D., on behalf of the U.S. Chamber of Commerce, commented, “there is no direct evidence that silica causes cancer by means of a directly DNA-reactive mechanism” (Document ID 2376, p. 21). Dr. Peter Morfeld, on behalf of the ACC, as well as Peter Valberg, Ph.D., and Christopher M. Long, Sc.D., of Gradient Corporation, on behalf of the U.S. Chamber of Commerce, cited a scientific article by Borm
OSHA reviewed the Borm
The extreme variation in response along with reliance on an insensitive genotoxicity test system could overestimate the appropriate genotoxic dose in human lung cells in vivo. In addition, Borm
Dr. Morfeld, in his hearing testimony on behalf of the ACC, referred to the paper by Borm
Reactive oxygen species are generated not only at the particle surface of crystalline silica, but also by phagocytic and epithelial cells exposed to quartz particles. . . . Oxidants generated by silica particles and by the respiratory burst of silica-activated phagocytic cells may cause cellular and lung injury, including DNA damage (Document ID 1473, p. 391).
Given the IARC determination as well as the animal and in vitro studies reviewed herein, OSHA finds that there is no conclusive evidence that silica-related lung cancer only occurs as a secondary response to chronic inflammation, or that silicosis is a necessary prerequisite for lung cancer. Instead, OSHA finds support in the scientific literature for a conclusion that tumors may form through genotoxic as well as non-genotoxic mechanisms that result from respirable crystalline silica interaction with alveolar macrophages and other lung cells prior to onset of silicosis.
It is well established that silicosis arises from an advanced chronic inflammation of the lung. As noted above, a common hypothesis is that pathological conditions that depend on chronic inflammation may have a threshold. The exposure level at which silica-induced health effects might begin
Discounting or overlooking the evidence that respirable crystalline silica may be genotoxic in the absence of chronic inflammation, Drs. Valberg and Long commented that crystalline silica follows a threshold paradigm for poorly soluble particles (PSPs). PSPs are defined generally as nonfibrous particles of low acute toxicity, which are not directly genotoxic (ILSI, 2000, Document ID 3906, p. 1). Specifically, Drs. Valberg and Long stated:
Mechanisms whereby lung cells respond to retention of a wide variety of PSPs, including crystalline silica, follow a generally accepted threshold paradigm, where the initiation of a chronic inflammatory response is a necessary step in the disease process, and the inflammatory response does not become persistent until particle retention loads become sufficient to overwhelm lung defense mechanisms. This overall progression from increased but controlled pulmonary inflammation across a threshold exposure that leads to lung damage has been described by a number of investigators (Mauderly and McCunney, 1995; ILSI, 2000; Boobis
Similarly, Dr. Cox, in his post-hearing comments, discussed his 2011 article describing a quantifiable exposure-response threshold for lung diseases induced by inhalation of respirable crystalline silica (Document ID 4027, p. 29). Dr. Cox hypothesized the existence of an exposure threshold such that exposures to PSPs, which he described as including titanium dioxide, carbon black, and crystalline silica, must be intense enough and last long enough to disrupt normal homeostasis (
OSHA disagrees with these characterizations about exposure thresholds because, among other reasons, respirable crystalline silica is not generally considered to be in the class of substances defined as PSPs.
During the public hearing, OSHA questioned Dr. Morfeld about the relevance of the rat overload response and whether he considered crystalline silica to be like other PSPs such as carbon black. Dr. Morfeld replied that he was well aware of the literature and indicated that crystalline silica was not considered one of the PSPs (specifically not like carbon black) that these reports reviewed (Document ID 3582, Tr. 2072-2074). OSHA also notes a report of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), which was cited by the ACC (Document ID 4209, p. 32) and stated that “particles exhibiting significant surface related (cyto)toxicity like crystalline silica (quartz) and/or other specific toxic properties do not fall under this definition [of PSPs]” (Document ID 3897, p. 5).
Respirable crystalline silica differs from PSPs because it does not require particle overload to induce the same response typical of PSPs. “Overload” refers to the consequence of exposure that results in a retained lung burden of particles that is greater than the steady-state burden predicted from deposition rates and clearance kinetics (Document ID 4174, p. 20). This is a result of a volumetric over-exposure of dust in the lung, which overwhelms macrophage function. Respirable crystalline silica does not operate on this mechanism since macrophage function is inhibited by the cytotoxic nature of respirable crystalline silica rather than a volumetric overload (Oberdorster, 1996, Document ID 3969). Therefore, respirable crystalline silica does not require particle overload to induce the same response. Studies have found that the respirable crystalline silica exposure levels required to induce tumor formation in some animal studies are similar to those observed in human studies, whereas studies involving PSPs tend to show responses at much higher levels of exposure (Muhle
A study by Porter
OSHA thoroughly reviewed Dr. Cox's 2011 article (Document ID 1470), in which he proposed a threshold for crystalline silica, in its Supplemental Literature Review (Document ID 1711, Attachment 1, pp. 37-39). OSHA concluded that the evidence used to support Cox's assertion that the OSHA PEL was below a threshold for lung disease in humans was not supported by the evidence presented (Document ID 1470, p. 1543; 1711, Attachment 1). Specifically, Cox (2011) modelled a threshold level for respirable crystalline silica using animal studies of PSPs. This approach, according to the ILSI report (2000) and ECETOC report (2013), is clearly not appropriate since the cytotoxic nature of crystalline silica is not consistent with the low-toxicity PSPs (Document ID 3906, p. 1; 3897, p. 5). Dr. Cox (2011) categorized crystalline silica incorrectly as a PSP and ignored the evidence for cytotoxicity and genotoxicity associated with crystalline silica. He further failed to consider or include studies indicating a tumor response at exposure levels below that leading to an excessive chronic inflammatory response, such as Porter
OSHA concludes that a better estimate of a threshold effect for inflammation and carcinogenesis was done by Kuempel
In pre-hearing comments, ACC stated that some health organizations suggested a silicosis-dependent threshold exists for lung cancer (ACC, Document ID 2307, Attachment A, pp. 60-62). Specifically, ACC cited Environment and Health Canada as stating:
Although the mechanism of induction for the lung tumours has not been fully elucidated, there is sufficient supportive mode of action evidence from the data presented to demonstrate that a threshold approach to risk assessment is appropriate based on an understanding of the key events in the pathogenesis of crystalline silica induced lung tumours (pp. 49-51 as cited by ACC, Document ID 2307, p. 62).
In addition to the statement submitted by ACC, Environment and Health Canada also stated that:
While there is sufficient evidence to support key events in a threshold mode of action approach for lung tumours, the molecular mechanism is still not fully elucidated. Also, despite the fact that the effects seen in rats parallel the effects observed in human studies, additional mechanistic studies could further clarify why lung tumours are not seen in all experimental animals . . . Thus, the question of whether silica exposure, in the absence of silicotic response, results in lung tumours remains unanswered.” (pp. 51-52 as cited by ACC, Document ID 2307, pp. 59-61).
It should be noted that the Environment and Health Canada report was to determine general population risk of exposure to respirable crystalline silica as a fraction of PM
A report by Mossman and Glenn (2013) reviewed the findings from several international OEL setting panels (Document ID 4070). The report cites findings from the European Commission's Scientific Committee on Occupational Exposure Limits for respirable crystalline silica. The findings “acknowledged a No Observed Adverse Exposure Level (NOAEL) for respirable crystalline silica in the range below 0.020 mg/m
While mechanistic data is limited, other observed health effects from inhalation of respirable crystalline silica include kidney and autoimmune effects. Translocation of particles through the lymphatic system and filtration through the kidneys may induce effects in the immune and renal systems similar to the types of changes observed in the lung (Miller, 2000, Document ID 4174, pp. 40-45). A review of the available literature indicates that respirable crystalline silica most likely induces an oxidative stress response in the renal and immune cells similar to that described above (Donaldson
OSHA has reviewed and responded to the comments received on the mechanistic studies of respirable crystalline silica-induced lung cancer and silicosis, as well as comments that the mechanistic data imply the existence of an exposure threshold. OSHA concludes that: (1) Lung cancer likely results from both genotoxic and non-genotoxic mechanisms that arise during early cellular responses as well
In this section, OSHA discusses comments focused on the issue of exposure-response thresholds for silica exposure. In the comments received by OSHA on this topic, an exposure-response “threshold” for silica exposure typically refers to a level of exposure such that no individual whose exposure is below that level would be expected to develop an adverse health effect. Commenters referred to thresholds both in terms of concentration and cumulative exposure (
OSHA has reviewed the evidence in the record pertaining to thresholds, and has determined that the best available evidence supports the Agency's use of non-threshold exposure-response models in its risk assessments for silicosis and lung cancer. The voluminous scientific record accrued by OSHA in this rulemaking supports lowering the existing PEL to 50 μg/m
In the Preliminary Quantitative Risk Assessment (QRA) (Document ID 1711, pp. 275, 282-285), OSHA reviewed evidence on thresholds from a lung dosimetry model developed by Kuempel
Steenland and Deddens (2002, Document ID 1124) examined a pooled lung cancer study originally conducted by Steenland
In its prehearing comments, the ACC argued that OSHA's examination of the epidemiological evidence, along with animal studies and mechanistic considerations, “has not shown that reducing exposures below currently permitted exposure levels would create any additional health benefits for workers. OSHA's analysis and the studies on which it relies have not demonstrated the absence of an exposure threshold above 100 μg/m
Members of OSHA's peer review panel for the Review of Health Effects Literature and Preliminary Quantitative Risk Assessment (Document ID 1711) rejected the ACC's comments as unsupportable. Peer reviewer Mr. Bruce Allen stated: “it is essentially impossible to distinguish between dose-response patterns that represent a threshold and those that do not” in epidemiological data (Document ID 3574, p. 8). Peer reviewer Dr. Kenneth Crump similarly commented:
OSHA is on very solid ground in the [Preliminary QRA's] statement that “available information cannot firmly establish a threshold exposure for silica-
Dr. Cox, representing the ACC, agreed with Dr. Crump that “it's impossible to prove a negative, empirically . . . you could never rule out that possibility” of a threshold at a low level of exposure (Document ID 3576, Tr. 402). However, he contended that it is possible to rule out a threshold in the higher-level range of observed exposures based on observed illness: “I think that there are plenty of chemicals for which the hypothesis of a threshold exist[ing] at or above current standards could be ruled out because you see people getting sick at current levels” (Document ID 3576, Tr. 403). Other commenters stated their belief that workers recently diagnosed with silicosis must have had exposures above the previous general industry PEL and, based on this supposition, concluded that OSHA has not definitively proven risk to workers exposed below the previous general industry PEL (Document ID 4224, pp. 2-5; Tr. 3582, pp. 1951-1963).
OSHA agrees with Dr. Cox that observation of workers “getting sick at current levels” can rule out a threshold effect at those levels. As is discussed below, there is evidence that workers exposed to silica at cumulative or average exposure levels permitted under the previous PELs have become ill and died as a result of their exposure. OSHA thus strongly disagrees with any implication from commenters that the Agency should postpone reducing a PEL until it has extensive documentation of sick and dying workers to demonstrate that the current PEL is not sufficiently protective (
The ACC's and Chamber's comments on this issue essentially argue that the model OSHA used to assess risk was inadequate to assess whether a threshold of risk exists and, if one does exist, at what level (Document ID 2307, Attachment A, pp. 52-65; 2376, pp. 20-22; 2330, pp. 17-21). According to OSHA peer reviewer Dr. Crump, however, the analytical approach taken by OSHA in the Preliminary QRA was appropriate. Considering the inherent limitations of epidemiological data:
A further source of uncertainty in investigating thresholds was highlighted by Dr. Mirer, on behalf of the AFL-CIO (Document ID 3578, Tr. 988-989) and by peer reviewer Dr. Andrew Salmon, who stated:
Peer reviewer Dr. Gary Ginsberg suggested that, recognizing these inherent limitations, OSHA should characterize the body of evidence and argument surrounding thresholds by discussing the following factors related to whether a threshold for silica-related health effects exists at exposure levels above the previous general industry PEL:
Following Dr. Ginsberg's suggestion, OSHA has, in its final health and risk analysis, considered the epidemiological evidence relevant to possible threshold effects for silicosis and lung cancer. As discussed below, first in “Thresholds—Silicosis and NMRD” and then in “Thresholds—Lung Cancer,” OSHA has carefully considered comments about statistical methods, exposure measurement uncertainty, and variability as they pertain to threshold effects. The discussion addresses the epidemiological evidence with respect to both cumulative and concentration thresholds. For reference, a working lifetime (45 years) of exposure to silica at the previous general industry PEL (100 μg/m
OSHA has determined that the studies most relevant to the threshold issue in this rulemaking are those of workers who have cumulative exposures or average exposure concentrations below the levels associated with the previous general industry PEL (100 μg/m
Mannetje
As discussed in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis, OSHA commissioned Drs. Kyle Steenland and Scott Bartell to examine the potential effects of exposure measurement error on the mortality risk estimates derived from the pooled studies of lung cancer (Steenland
As discussed in the Supplemental Literature Review of Epidemiological Studies, Vacek
Six of the 5,338 cohort members hired in or after 1940, when Vermont's dust control program was in effect, were identified as having died of silicosis by the end of the follow-up period (Vacek
In terms of morbidity, Graham
In an exposure-response study of 4,027 workers in 18 U.S. industrial sand plants, Steenland and Sanderson (2001) reported that approximately three-quarters of the workers with complete work histories had cumulative exposures below 1.28 mg/m
Hughes
A series of papers by Birk
Follow-up time is a critical factor for detection of silicosis, which has a typical latency of 20-30 years (
The lead author of the study, Dr. Peter Morfeld, testified at the public hearings on behalf of the ACC Crystalline Silica Panel. In his post-hearing comments, Dr. Morfeld stated that “[m]echanistic considerations imply that we should not expect to see a threshold for cumulative exposure” in silicosis, but that the question of whether a threshold concentration level may exist remains (Document ID 4003, p. 3). The study by Morfeld
In the Final Peer Review Report, Dr. Crump stated that Morfeld
I'll be the first one to tell you there is a lot of imprecision and, therefore, say confidence intervals or uncertainty should be respected, and that the—I'm hesitant to just focus on a single point number like the .25 [250 μg/m
NIOSH submitted post-hearing comments on the analysis in Morfeld
OSHA's greater concern with Dr. Morfeld's estimate of 250 μg/m
In a post-hearing comment, Dr. Morfeld offered a different interpretation of his results, describing his threshold estimate as a “population average” which would not be expected to characterize risk for all individuals in a population. Rather, according to Dr. Morfeld “we expect to see differences in response thresholds among subjects” (Document ID 4003, p. 5). OSHA agrees with this interpretation, which was similarly expressed in several comments from OSHA's peer reviewers on the subject of thresholds (
Dr. Morfeld's discussion of his estimate as a “population average” among workers with different individual responses to silica exposure
Peer reviewer Mr. Bruce Allen agreed that “[i]t makes no sense to discuss a single threshold value . . . Given, then, that thresholds must be envisioned as a distribution in the population, then there is substantial population-level risk even at the mean threshold value, and unacceptably high risk levels at exposures far below the mean threshold.” He further stated:
It is NOT, therefore, inappropriate to model the population-level observations using a non-threshold model . . . In fact, I would claim that it is inappropriate to include ANY threshold models (
OSHA concludes that this German porcelain workers cohort shows evidence of silicosis among workers exposed at levels below the previous PELs, and that continued follow-up of this cohort would be likely to show greater silicosis risk among low-exposed workers due to the short follow-up time. Furthermore, the Chamber's characterization of Dr. Morfeld's result as “a threshold concentration of 250 μg/m
The ACC submitted comments on the Park
OSHA concludes that the body of epidemiological literature clearly demonstrates risk of silicosis and NMRD morbidity and mortality among workers who have been exposed to cumulative exposures or average exposure concentrations at or below the levels associated with the previous general industry PEL (100 μg/m
OSHA's Preliminary QRA and supplemental literature review included several studies that provide information on possible threshold effects for lung cancer. OSHA has determined that the epidemiological studies most relevant to the threshold issue are those with workers who have cumulative exposures or average exposure concentrations below the levels associated with the previous general industry PEL (100 μg/m
Steenland
A follow-up letter by Steenland and Deddens (2002, Document ID 1124) addressed the possibility of an exposure threshold effect in the pooled lung cancer analysis conducted by Steenland
In response to comments from ACC Panel members Dr. Valberg and Dr. Long that the analysis presented by Steenland
[I]f you look at the figure, you see that the curve of the spline [a flexible, nonlinear exposure-response model] starts to go up around four on the log scale of microgram per meter cubed days. And if you transform that from the log to the regular scale, that is quite consistent with the threshold we got when we did a formal analysis using the log transform model [discussed above] (Document ID 3580, Tr. 1255).
The ACC representatives' comments do appear to be based on a misunderstanding of the figure in question, due to an error in Dr. Steenland's 2001 publication in which the axis of the figure under discussion was incorrectly labeled. This error was later corrected in an erratum (Document ID 3580, Tr. 1257; Steenland
In addition, at OSHA's request, Drs. Steenland and Bartell (ToxaChemica, 2004, Document ID 0469) conducted a quantitative uncertainty analysis to examine the effects of possible exposure measurement error on the pooled lung cancer study results (
In the Preliminary QRA and supplemental literature review, OSHA reviewed several studies on lung cancer among silica-exposed workers in the Vermont granite industry, whose exposures were reduced to relatively low levels due to a program for dust control initiated in 1938-1940 by the Vermont Division of Industrial Hygiene (Document ID 1711, pp. 97-102; 1711, Attachment 1, pp. 2-5; 1487, p. 73). As discussed above, Verma
Attfield and Costello (2004) examined a cohort of 5,414 Vermont granite workers, including 201 workers who died of lung cancer (Document ID 0285, pp. 130, 134). In this study, cancer risk was elevated at cumulative exposure levels below 4.5 mg/m
Vacek
The strengths and weaknesses of both studies and the differences between them that could account for their conflicting conclusions were discussed in great detail in Section V.F, Comments and Responses Concerning Lung Cancer Mortality. For the purpose of evaluating the effects of low concentrations of silica exposure, as well as whether a threshold exposure exists, OSHA believes the Attfield and Costello study may merit greater weight than Vacek
In conclusion, OSHA does not find compelling evidence in these studies of Vermont granite workers of a cumulative exposure threshold for lung cancer in the exposure range below the previous general industry PEL. This conclusion is based on the statistically significant elevations in lung cancer reported in both cohorts described above, which were composed primarily of workers whose cumulative exposures were below the level associated with a working lifetime of exposure. However, OSHA acknowledges that a strong conclusion regarding a threshold is difficult to draw from these studies, due to the disagreement between Attfield and Costello and Vacek
OSHA's Preliminary QRA (Document ID 1711, pp. 285-287) evaluated a 2001 case-control analysis of industrial sand workers including 2,640 men employed before 1980 for at least three years in one of nine North American sand-producing plants. One of the sites was a large associated office complex where workers' exposures were lower than those typically experienced by production workers (Hughes
In the Final Peer Review Report, Dr. Ginsberg commented on the relevance of the industrial sand cohort studies, which included low-exposed workers with exceptionally well-characterized exposures, for threshold issues:
With respect to the body of silica epidemiology literature, perhaps the case with the least amount of measurement error is of US industrial sand workers wherein many measurements were made with filter samples and SRD determination of crystalline silica and in which there was very careful estimation of historical exposure for both silica and smoking (MacDonald
OSHA agrees with Dr. Ginsberg's assessment of these studies and has found them to be particularly high quality. Thus, the Agency was especially interested in the studies' findings, which showed that cancer risk was elevated at cumulative exposure levels below 4.5 mg/m
Comments submitted by the ACC briefly mentioned several epidemiological studies that, they claim, “suggest the existence of a threshold for any increased risk of silica-related lung cancer,” including studies by Sogl
OSHA reviewed Mundt
Quantitative exposure estimates for this cohort showed an average annual exposure of 110 μg/m
The lung cancer mortality hazard ratios (HRs) associated with average annual exposure were statistically significant in two of the four average annual exposure groups: 2.1 (95% CI 1.1-4.0) for average annual exposure group >50-100 μg/m
The authors suggested the possibility of a threshold for lung cancer mortality. However, no formal threshold analysis for lung cancer was conducted in this study or in the follow-up threshold analysis conducted on this population by Morfeld
In pre-hearing comments, Dr. Morfeld described a study of 58,677 German uranium miners by Sogl
Checkoway
OSHA reviewed Pukkala
As discussed in the Review of Health Effects Literature and Preliminary Quantitative Risk Assessment (Document ID 1711, pp. 152-153), Calvert
In conclusion, OSHA has determined that the best available evidence on the issue of a threshold for silica-related lung cancer does not support the ACC's contention that an exposure-response threshold, below which respirable crystalline silica exposure is not expected to cause cancer, exists at or above the previous general industry PEL of 100 μg/m
In his pre-hearing comments, Dr. Cox stated that the observation of a positive and monotonic exposure-response relationship in epidemiological studies “does not constitute valid evidence against the hypothesis of a threshold,” and that OSHA's findings of risk at exposures below the previous PEL for general industry “could be due simply to exposure misclassification” in studies of silica-related health effects in exposed workers (Document ID 2307, Attachment 4, pp. 41-42). His statements closely followed his analyses from a 2011 paper, in which Cox presented a series of simulation analyses designed to show that common concerns in epidemiological analyses, such as uncontrolled confounding, errors in exposure estimates, and model specification errors, can obscure evidence of an exposure-response threshold, if such a threshold exists (Document ID 3600, Attachment 7). Dr. Cox concluded that the currently available epidemiological studies “do not provide trustworthy information about the presence or absence of thresholds in exposure-response relations” with respect to an exposure concentration threshold for lung cancer (Document ID 3600, Attachment 7, p. 1548).
OSHA has reviewed Dr. Cox's comments and testimony, and concludes that uncertainty about risk due to exposure estimation and confounding cannot be resolved through the application of the statistical procedures recommended by Dr. Cox. (Similar comments from Dr. Cox about alleged biases in the studies relied upon are addressed in the next section, where OSHA reaches similar conclusions). A reviewer on the independent peer review panel, Dr. Ginsberg, commented that:
OSHA agrees with Dr. Ginsberg. As discussed in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis, a “gold standard” exposure sample is not available for the epidemiological studies in the silica literature, so it is not possible to determine the direction or magnitude of the effects of exposure misclassification on OSHA's risk estimates. The silica literature is not unique in this sense. As stated by Mr. Robert Park of NIOSH, “modeling exposure uncertainty as described by Dr. Cox . . . is infeasible in the vast majority of retrospective observational studies. Nevertheless, mainstream scientific thought holds that valid conclusions regarding disease causality can still be drawn from such studies” (Document ID 4233, p. 32).
For the reasons discussed throughout this analysis of the scientific literature, OSHA concludes that, even acknowledging a variety of uncertainties in the studies relied upon, these uncertainties are, for the most part, typical or inherent in these types of studies. OSHA therefore finds that the weight of evidence in these studies, representing the best available evidence on the health effects of silica exposure, strongly supports the findings of significant risk from silicosis, NMRD, lung cancer, and renal disease discussed in this section and in the quantitative risk assessment that follows in the next section (
In summary, OSHA acknowledges that common issues with epidemiological studies limit the Agency's ability to determine whether and where a threshold effect exists for silicosis and lung cancer. However, as shown in the foregoing discussion, there is evidence in the epidemiological literature that workers exposed to silica at concentrations and cumulative levels allowable under the previous general industry PEL not only develop silicosis, but face a risk of silicosis high enough to be significant ( >1 per 1,000 exposed workers). Although the evidence is less clear for lung cancer, studies nevertheless show excess cases of lung cancer among workers with cumulative exposures in the range of interest to OSHA. Furthermore, the statistical model-based approaches proposed in public comments do not demonstrate the existence or location of a “threshold” level of silica exposure below which silica exposure is harmless to workers. The above considerations lead the Agency to conclude that any possible exposure threshold is likely to be at a low level, such that some workers will continue to suffer the health effects of silica exposure even at the new PEL of 50 μg/m
There is a great deal of argument and analysis directed at the question of thresholds in silica exposure-response relationships, but nothing like a scientific consensus about the appropriate approach to the question has emerged. If OSHA were to accept the ACC's claim that exposure to 100 μg/m
OSHA received numerous comments and testimony, particularly from representatives of the ACC, regarding biases in the data that the Agency relied upon to conduct its Preliminary Quantitative Risk Assessment (Preliminary QRA). In this section, OSHA focuses on these comments regarding biases, particularly with respect to how such biases may have affected the data and findings from the
The data utilized by OSHA to conduct its Preliminary QRA came from published studies in the peer-reviewed scientific literature. When developing health standards, OSHA is not required or expected to conduct original research or wait for better data or new studies (
Since OSHA is not a research agency, it draws from the best available existing data in the scientific literature to conduct its quantitative risk assessments. In most cases, with the exception of certain risk and uncertainty analyses prepared for OSHA by its contractor ToxaChemica, OSHA had no involvement in the data generation or analyses reported in those studies. Thus, in calculating its risk estimates, OSHA used published regression coefficients or equations from key peer-reviewed, published studies, but had no control over the actual published data; nor did the Agency have access to the raw data from such studies.
As discussed throughout Section V of this preamble, the weight of scientific opinion indicates that respirable crystalline silica is a human carcinogen that causes serious, life-threatening disease at the previously-permitted exposure levels. Under its statutory mandate, the Agency can and does take into account the potential for statistical and other biases to skew study results in either direction. However, the potential biases of concern to the commenters are well known among epidemiologists. OSHA therefore believes that the scientists who conduct the studies and subject them to peer review before publication have taken the potential for biases into account in evaluating the quality of the data and analysis. As discussed further below, OSHA heard testimony from David Goldsmith, Ph.D., describing how scientists use “absolutely the best evidence they can lay their hands on” and place higher value on studies that are the least confounded by other factors that, if unaccounted for, could contribute to the effect (
In his pre-hearing comments, Dr. Cox, on behalf of the ACC, claimed that the Preliminary QRA did not address a number of sources of potential bias:
The Preliminary QRA and the published articles that it relies on do not correct for well-known biases in modeling statistical associations between exposures and response. (These include study, data, and model selection biases; model form specification and model over-fitting biases; biases due to residual confounding,
These biases, according to Dr. Cox, nearly always result in false positives, i.e., finding that an exposure-response relationship exists when there really is no such relationship (Document ID 3576, Tr. 380). Although his comments appear to be directed to all published, peer-reviewed studies relied upon by OSHA in estimating risks, Dr. Cox admitted at the hearing that his statements about false positives were based on his review of the Preliminary QRA with relation to lung cancer only, and that he “[didn't] really know” whether the same allegations of bias he directed at the lung cancer studies are relevant to the studies of silica's other health risks (Document ID 3576, Tr. 426). In his comments, Dr. Cox discussed each source of bias in detail; OSHA will address them in turn. The concerns expressed by commenters, including Dr. Cox, about exposure uncertainty—another potential source of bias—are addressed in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis.
Dr. Cox stated that model specification error occurs when the model form, such as the linear absolute risk model, does not correctly describe the data (Document ID 2307, Attachment 4, p. 21). Using a simple linear regression example from Wikipedia, Dr. Cox asserted that common indicators of goodness-of-fit, including sum of square residuals and correlation coefficients, can be weak in identifying “nonlinearities, outliers, influential single observations, and other violations of modeling assumptions” (Document ID 2307, Attachment 4, pp. 52-53). He advocated for the use of diagnostic tests to check that a model is a valid and robust choice, stating, “[u]nfortunately, OSHA's Preliminary QRA and the underlying papers and reports on which it relies are not meticulous in reporting the results of such model diagnostics, as good statistical and epidemiological practice requires” (Document ID 2307, Attachment 4, p. 21). In his post-hearing brief, Dr. Cox further described these diagnostic tests to include plots of residuals, quantification of the effects of removing outliers and influential observations, and comparisons of alternative model forms using model cross-validation (Document ID 4027, p. 2). He also suggested using Bayesian Model Averaging (BMA) or other model ensemble methods to quantify the effects of model uncertainty (Document ID 4027, p. 3).
OSHA believes that guidelines for which diagnostic procedures should be performed, and whether and how they are reported in published papers, are best determined by the scientific community through the pre-publication peer review process. Many studies in
Dr. Cox's other suggested approach to addressing model uncertainty, BMA, can be used to construct a risk estimate based on multiple exposure-response models. Unlike BMA, standard statistical practice in the epidemiological literature is to evaluate multiple possible models, identify the model that best represents the observations in the data set, and use this model to estimate risk. In some cases, analysts may report the results of two or more models, along with their respective fit statistics and other information to aid model selection for risk assessment and show the sensitivity of the results to modeling choices (
In contrast, BMA is a probabilistic approach designed to account for uncertainty inherent in the model selection process. The analyst begins with a set of possible models (M
However, Kyle Steenland, Ph.D., Professor, Department of Environmental Health, Rollins School of Public Health, Emory University, the principal author of a pooled study that OSHA heavily relied upon, noted that BMA is not a standard method for risk assessment. “[Bayesian] model averaging, to my knowledge, has not been used in risk assessment ever. And so, sure, you could try that. You could try a million things. But I think OSHA has correctly used standard methods to do their risk assessment and [BMA] is not one of those standard methods” (Document ID 3580, Tr. 1259).
Indeed, BMA is a relatively new method in risk analysis. Because of its novelty, best practices for important steps in BMA, such as defining the class of models to include in the analysis, and choosing prior probabilities, have not been developed. Until best practices for BMA are established, it would be difficult for OSHA to conduct and properly evaluate the quality of BMA analyses. Evaluation of the quality of available analyses is a key step in the Agency's identification of the best available evidence on which to base its significant risk determination and benefits analysis.
OSHA also emphasizes that, as noted by Dr. Steenland, scientifically accepted and standard practices were used to estimate risk from occupational exposure to crystalline silica (Document ID 3580, Tr. 1259). Thus OSHA has decided that it is not necessary to use BMA in its QRA, and that the standard statistical methods used in the studies it relies upon to estimate risk are appropriate as a basis for risk estimation. OSHA notes that it is possible to incorporate risk estimates based on more than one model in its risk assessment by presenting ranges of risk, a strategy often used by OSHA when the best available evidence includes more than one model, analytical approach, or data set. In its Preliminary QRA, OSHA presented ranges of risks for silica-related lung cancer and silicosis based on different data sets and models, thus further lessening the utility of using more complex techniques such as BMA. OSHA continued this practice in its final risk assessment, presented in Section VI, Final Quantitative Risk Assessment and Significance of Risk.
Another bias described by Dr. Cox is study selection bias, which he stated occurs when only studies that support a positive exposure-response relationship are included in the risk assessment, and when criteria for the inclusion and exclusion of studies are not clearly specified in advance (Document ID 2307, Attachment 4, pp. 22-23). Dr. Cox noted the criteria used by OSHA to select studies, as described in the Supplemental Literature Review of Epidemiological Studies on Lung Cancer Associated with Exposure to Respirable Crystalline Silica (Supplemental Literature Review) (Document ID 1711, Attachment 1, p. 29). Dr. Cox, however, claimed that OSHA did not apply these criteria consistently, in that there may still be exposure misclassification or confounding present in the studies OSHA relied upon to estimate the risk of the health effects evaluated by the Agency (Document ID 2307, Attachment 4, pp. 24-25). Similarly, the American Foundry Society (AFS), in its post-hearing brief, asserted that, “No formal process is described for search criteria or study selection” and that OSHA's approach of identifying studies based upon the IARC (1997) and NIOSH (2002) evaluations of the literature “is a haphazard approach that is not reproducible and is subject to bias. Moreover it appears to rely primarily on information that is more than 10 years old” (Document ID 4229, p. 4).
OSHA disagrees with the arguments presented by Dr. Cox and the AFS, as did some commenters. The American Public Health Association (APHA), in its post-hearing brief, expressed strong
In response to the criticisms by Dr. Cox and the AFS, OSHA notes that the silica literature was exhaustively reviewed by IARC in 1997 and NIOSH in 2002 (Document ID 1062; 1110). As a result, there was no need for OSHA to initiate a new review of the historical literature. Instead, OSHA used the IARC and NIOSH reviews as a starting point for its own review. As recognized by the APHA, OSHA evaluated and summarized many of the studies referenced in the IARC and NIOSH reviews, and then performed literature searches to identify new studies published since the time of the IARC and NIOSH reviews. OSHA clearly described this process in its Review of Health Effects Literature: “OSHA has included in its review all published studies that the Agency deems relevant to assessing the hazards associated with exposure to respirable crystalline silica. These studies were identified from numerous scientific reviews that have been published previously such as the IARC (1997) and NIOSH (2002) evaluations of the scientific literature as well as from literature searches and contact with experts and stakeholders” (Document ID 1711, p. 8). For its Preliminary QRA, OSHA relied heavily on the IARC pooled exposure-response analyses and risk assessment for lung cancer in 10 cohorts of silica-exposed workers (Steenland
In addition to relying on these two pooled IARC multi-center studies, OSHA also identified single cohort studies with sufficient quantitative information on exposures and disease incidence and mortality rates. As pointed out by Dr. Cox, OSHA described the criteria used for selection of the single cohort studies of lung cancer mortality:
OSHA gave studies greater weight and consideration if they (1) included a robust number of workers; (2) had adequate length of follow-up; (3) had sufficient power to detect modest increases in lung cancer incidence and mortality; (4) used quantitative exposure data of sufficient quality to avoid exposure misclassification; (5) evaluated exposure-response relationships between exposure to silica and lung cancer; and (6) considered confounding factors including smoking and exposure to other carcinogens (Document ID 1711, Attachment 1, p. 29).
Using these criteria, OSHA identified four single-cohort studies of lung cancer mortality that were suitable for quantitative risk assessment; two of these cohorts (Attfield and Costello, 2004, Document ID 0285; Rice
With respect to Dr. Cox's claim that OSHA did not apply its criteria consistently, on the basis that there may still be exposure misclassification or confounding present, OSHA notes that it selected studies that best addressed the criteria; OSHA did not state that it only selected studies that addressed all of the criteria. Given the fact that some of the epidemiological studies concern exposures of worker populations dating back to the 1930's, there is always some potential for exposure misclassification or the absence of information on smoking. When this was the case, OSHA discussed these limitations in its Review of Health Effects Literature and Preliminary QRA (Document ID 1711). For example, OSHA discussed the lack of smoking information for cases and controls in the Steenland
With respect to the AFS's claim that OSHA relied on studies that were more than 10 years old, OSHA again notes that it reviewed, in its Review of Health Effects Literature and its Supplemental Literature Review, the studies in the silica literature and selected the ones that best met the criteria described above (Document ID 1711; 1711, Attachment 1). It would be improper to only select the most recent studies, particularly if the older studies are of higher quality based on the criteria. Furthermore, the studies OSHA relied upon in its Preliminary QRA were published between 1993 and 2009; the claim that OSHA primarily relied on older studies is thus misleading, when the studies were of relatively recent vintage and determined to be of high quality based on the criteria described above. The AFS also suggested that OSHA examine several additional foundry studies of lung cancer (Document ID 2379, Attachment 2, p. 24); OSHA retrieved all of these suggested studies, added them to the rulemaking docket following the informal public hearings, and discusses them in Section V.F, Comments and Responses Concerning Lung Cancer Mortality.
A related bias presented by Dr. Cox is data selection bias, which he stated occurs when only a subset of the data is used in the analysis “to guarantee a finding of a positive” exposure-response relationship (Document ID 2307, Attachment 4, p. 26). He provided an example, the Attfield and Costello (2004, Document ID 0285) study of lung cancer mortality, which excluded data as a result of attenuation observed in the highest exposure group (Document ID 2307, Attachment 4, pp. 26-27). Attenuation of response means the exposure-response relationship leveled off or decreased in the highest exposure group. Referring to another study of the same cohort, Vacek
OSHA believes there are very valid reasons for the observance of attenuation of response in the highest exposure group that would justify the exclusion of data in Attfield and Costello (2004, Document ID 0285) and other studies. This issue was discussed by Gary Ginsberg, Ph.D., an OSHA peer reviewer from the Connecticut Department of Public Health, in his post-hearing comments. Dr. Ginsberg noted that several epidemiological studies have found an attenuation of response at higher doses, with possible explanations including: (1) Measurement error, which arises from the fact that the highest doses are associated with the oldest datasets, which are most prone to measurement error; (2) “intercurrent causes of mortality” from high dose exposures that result in death to the subject prior to the completion of the long latency period for cancer; and (3) the healthy worker survivor effect, which occurs when workers with ill health leave the workforce early (Document ID 3574, p. 24). As discussed in Section V.F, Comments and Responses Concerning Lung Cancer Mortality, OSHA disagrees strongly with Dr. Cox's assertion that data were excluded to ensure a positive exposure-response relationship (Document ID 2307, Attachment 4, p. 26). In addition, as detailed in Section VI, Final Quantitative Risk Assessment and Significance of Risk, OSHA calculated quantitative risk estimates for lung cancer mortality from several other studies that did not rely on a subset of the data (Rice
Another selection bias presented by Dr. Cox is model selection bias, which he said occurs when many different combinations of models, including alternative exposure metrics, different lags, alternative model forms, and different subsets of data, are tried with respect to their “ability to produce `significant'-looking regression coefficients” (Document ID 2307, Attachment 4, p. 27). This is another aspect of model specification error, as discussed above under model averaging. Dr. Cox wrote:
This type of multiple testing of hypotheses and multiple comparisons of alternative approaches, followed by selection of a final choice based [on] the outcomes of these multiple attempts, completely invalidates the claimed significance levels and confidence intervals reported for the final ER [exposure-response] associations. Trying in multiple ways to find a positive association, and then selecting a combination that succeeds in doing so and reporting it as `significant,' while leaving the nominal (reported) statistical significance level of the final selection unchanged (typically at p=0.05), is a well-known recipe for producing false-positive associations (Document ID 2307, Attachment 4, p. 28).
Dr. Cox further stated that unless methods of significance level reduction (
During the informal public hearings, counsel for the ACC asked Mr. Park of NIOSH's Risk Evaluation Branch about this issue,
Investigations like this look at a number of options. They come into the study not totally naïve. They, in fact, have some very strong preference even before looking at the data based on prior knowledge. So cumulative exposure, for example, is a generally very high confidence choice in a metric. Trying different lags is interesting. It helps validate the study because you know what it ought to look like sort of. And in many cases, the choice does not make a lot of difference. So it's kind of a robust test, and similarly, the choice of the final model is not just coming in naïve. A linear exposure response has a lot of biological support in many different contexts, but it could be not the best choice (Document ID 3579, Tr. 150-151).
ACC counsel further asked, “And does one at the end of this process, though, make any adjustment in what you consider to be the statistically significant relationship in light of the fact that you've looked at so many different models and arrangements?” (Document ID 3579, Tr. 151-152). Mr. Park replied, “No, I don't think that's a legitimate application of a multiple comparison question” (Document ID 3579, Tr. 152). OSHA agrees with Mr. Park that significance level reduction is not appropriate in the context of testing model forms for risk estimation, and notes that, in the Agency's experience, significance level reduction is not typically performed in the occupational epidemiology literature. In addition, OSHA notes that, in many of the key studies relied upon by the Agency to estimate quantitative risks, the authors presented the results of multiple models that showed statistically significant exposure-response relationships. For example, Rice
Furthermore, OSHA disagrees with Dr. Cox's assertion that modeling choices are used to “produce `significant'-looking regression coefficients” (Document ID 2307, Attachment 4, p. 27). OSHA believes that the investigators of the studies it relied upon in its Preliminary, and now final, QRA made knowledgeable modeling choices based upon the exposure distribution and health outcome being examined. For example, in long-term cohort studies, such as those of lung cancer mortality relied upon by OSHA, most authors relied upon cumulative exposure (mg/m
Related to model selection bias is Dr. Cox's assertion of model uncertainty bias, which he said occurs when many different models are examined and then one is selected on which to base risk calculations; this approach “treats the finally selected model as if it were known to be correct, for purposes of calculating confidence intervals and significance levels. But, in reality, there remains great uncertainty about what the true causal relation between exposure and response looks like (if there is one)” (Document ID 2307,
Next, Dr. Cox discussed model over-fitting bias, which he said occurs when the same data set is used both to fit a model and to assess the fit; this “leads to biased results: Estimated confidence intervals are too narrow (and hence lower confidence limits on estimated ER [exposure-response] slopes are too high); estimated significance levels are too small (
OSHA does not agree that using the same data set to fit and assess a model necessarily results in an over-fitting bias. The Agency understands over-fitting to occur when a model is excessively complex relative to the amount of data available such that there are a large number of predictors relative to the total number of observations available. For survival models, it is the number of events,
Dr. Cox also asserted a bias due to residual confounding by age. Bias due to confounding occurs in an epidemiological study, in very general terms, when the effect of an exposure is mixed together with the effect of another variable (
The Park
This is a non-issue. The five-year categorization was used only for deriving the expected numbers of cases as an offset in the Poisson analysis using national rates which typically are classified in five-year intervals (on age and chronological time). The cumulative exposures were calculated with a 10-day resolution over follow-up and then averaged across observation time within 50 cumulative exposure levels cross-classified with the five-year age-chronological time cells of the classification table. There would be virtually no confounding between age and exposure [using this approach] (Document ID 4233, p. 33).
OSHA agrees with this assessment, noting that it appears that age groups were adequately constructed to prevent residual confounding. OSHA thus rejects this assertion of residual confounding by age in the Park
In summary, OSHA received comments and heard testimony on potential biases in the studies upon which it relied for its QRA. The ACC's Dr. Cox, in particular, posited a long list of biases, including model form specification bias, study selection bias, data selection bias, model selection bias, model over-fitting bias, model uncertainty bias, residual confounding bias, and bias as a result of exposure measurement error. OSHA, in this section, has specifically addressed each of these types of bias (except for bias due to exposure estimation error, which is addressed in Section V.K, Comments and Responses Concerning Exposure Estimation Error and ToxaChemica's Uncertainty Analysis).
In addition, OSHA heard testimony that countered the claims of biases and their potential to cause false positive results. When asked about the biases alleged by Dr. Cox and Dr. Long, Dr. Goldsmith testified, “All of these other things, it seems to me, are smoke screens for an inability to want to try and see what the body of evidence really shows” (Document ID 3577, Tr. 895-896). Later in his testimony, when asked about exposure misclassification, Dr. Goldsmith similarly noted, “[a]nd for a lot of the arguments that are being put forward by industry, they are speculating that there is the potential for these biases, but they haven't gotten, [from] my perspective, the actual evidence that this is the case” (Document ID 3577, Tr. 901). Similarly, OSHA has reviewed the record evidence extensively and is not aware of any specific, non-speculative evidence of biases in the studies that it relied upon.
There also is a question of the extent to which Dr. Cox actually reviewed all of the studies that he asserted to be biased. Upon questioning from Anne Ryder, Attorney in the Office of the Solicitor, Department of Labor, Dr. Cox admitted that he had not examined the
MS. RYDER: . . . You talked a little bit earlier about the false positives that are . . . present with a lot of the studies on lung cancer. And, but I believe, in your comment you didn't say that there are any of those same false positives with studies dealing with silicosis and silica exposure. Is that correct?
DR. COX: I don't think I opined on that. So—and I really haven't looked carefully at the question. I do take it as given that silica at sufficiently high and prolonged exposures causes silicosis. I've not really examined that literature.
MS. RYDER: So you don't think that those studies have the same issues that some of the lung cancer studies have?
DR. COX: I don't really know (Document ID 3576, Tr. 426).
Dr. Cox further testified, regarding the likelihood that the conclusions of the Preliminary QRA for silicosis are correct, “I expect that the evidence is much stronger for silica and silicosis. But I haven't reviewed it, so I can't testify to it” (Document ID 3576, Tr. 427).
OSHA believes this testimony to be inconsistent with some of the broad conclusions in Dr. Cox's pre-hearing written submission to the rulemaking record, in which he claimed that all adverse outcomes in the Preliminary QRA may have been affected by false positives. Dr. Cox concluded in this submission that:
These multiple uncontrolled sources of false-positive bias can generate findings of statistically “significant” positive ER [exposure-response] associations even in random data, or in data for which there is no true causal relation between exposure and risk of adverse health responses. Because OSHA's Preliminary QRA and the studies on which it relies did not apply appropriate technical methods (which are readily available, as discussed in the references) to diagnose, avoid, or correct for these sources of false-positive conclusions, the reported findings of “significantly” positive ER [exposure-response] associations between crystalline silica exposures at and below the current PEL and adverse outcomes (lung cancer, non-malignant lung disease, renal disease) are not different from what might be expected in the absence of any true ER [exposure-response] relations. They therefore provide no evidence for (or against) the hypothesis that a true ER [exposure-response] relation exists. Thus, OSHA has not established that a non-random association exists between crystalline silica exposures at or below the current PEL and the adverse health effects on which it bases its determination of significant risk and calculates supposed health effect benefits (Document ID 2307, Attachment 4, pp. 29-30).
OSHA notes that “non-malignant lung disease” includes silicosis, studies of which Dr. Cox subsequently testified that he did not examine.
In conclusion, the studies relied upon by OSHA for its risk assessment were peer-reviewed and used methods for epidemiology and risk assessment that are commonly used. Dr. Cox provided no study-specific evidence (
Exposure estimation error, a typical feature of epidemiological studies, occurs when the authors of an exposure-response study construct estimates of the study subjects' exposures using uncertain or incomplete exposure data. Prior to the publication of its Preliminary Quantitative Risk Assessment (Preliminary QRA), the Agency commissioned an uncertainty analysis conducted by Drs. Kyle Steenland and Scott Bartell, through its contractor, ToxaChemica, Inc., to address exposure estimation error in OSHA's risk assessment, and incorporated the results into the Preliminary QRA. After reviewing comments submitted to the record on the topic of exposure estimation error, OSHA maintains that it has relied upon the best available evidence by: (1) Using high-quality exposure-response studies and modeling approaches; (2) performing an uncertainty analysis of the effect of exposure estimation error on the risk assessment results; and (3) further submitting that analysis to peer review. OSHA concludes from its uncertainty analysis that exposure estimation error did not substantially affect the results in the majority of studies examined (Document ID 1711, pp. 299-314).
Furthermore, having carefully considered the public comments criticizing ToxaChemica's uncertainty analysis, OSHA has concluded that it was not necessary to conduct additional analyses to modify the approach adopted by Drs. Steenland and Bartell in the uncertainty analysis. Nor was it necessary to incorporate additional sources of uncertainty in the analysis. Also, given the evidence in the rulemaking record that these estimation errors bias results towards underestimating rather than overestimating the risks from exposure in many circumstances, it is very unlikely that regression coefficients and risk estimates from all of the different studies relied on in the Preliminary QRA were biased upward. Accordingly, OSHA remains convinced that the conclusions of the Agency's risk assessment are correct and largely unaffected by potential error in exposure measurement.
OSHA received significant comments on the topic of exposure estimation error in the studies it relied on in its Review of Health Effects Literature and Preliminary QRA (Document ID 1711). A number of commenters discussed the importance of accounting for exposure estimation error. Dr. Cox, representing the ACC, described exposure estimation error as perhaps the “most quantitatively important” issue in the studies OSHA relied upon (Document ID 2307, Attachment 4, p. 40). Similarly, Christopher M. Long, Sc.D., Principal Scientist at Gradient, representing the U.S. Chamber of Commerce (Chamber), testified that exposure measurement error is a “common source of uncertainty in most occupational and environmental epidemiologic studies” (Document ID 3576, Tr. 298). According to Dr. Long, this type of error can lead to inaccurate risk estimates by creating error in the exposure-response curve derived from a data set and obscuring the presence of a threshold (Document ID 3576, Tr. 300;
OSHA agrees with the assessments of the ACC and the Chamber with respect to the importance of exposure
Several commenters representing the ACC challenged the methods used in ToxaChemica's uncertainty analysis on the grounds that the analysis failed to adequately address exposure estimation error. In spite of their criticisms, critics were unable to supply better studies than those OSHA used. Indeed, when asked during the hearing, Dr. Long was unable to identify any studies that the Agency could use that acceptably account for the impact of exposure measurement error on exposure-response associations for crystalline silica (Document ID 3576, Tr. 356-357), and none was supplied following the hearings.
Taking into account the record evidence discussed above, OSHA concludes that it is possible for exposure measurement error to lead to either over- or under-estimation of risk and that this issue of exposure measurement error is not specific to the silica literature. It further concludes that industry representatives could not identify, and failed to submit, any published epidemiological studies of occupational disease that corrected for such bias to their satisfaction (Document ID 3576, Tr. 356-357).
Nevertheless, because OSHA agreed that an analysis of exposure estimation error as a source of uncertainty is important, it commissioned the uncertainty analysis discussed above to explore the potential effects of exposure measurement error on the conclusions of OSHA's risk assessment (Document ID 0469). The analysis examined the potential effects of exposure measurement error on the mortality risk estimates derived from the pooled studies of lung cancer (Steenland
The uncertainty analysis OSHA commissioned from Drs. Steenland and Bartell (2004, Document ID 0469) addressed possible error in silica exposure estimates from: (1) Random error in individual workers' exposure estimates and (2) error in the conversion of dust measurements (typically particle count concentrations) to gravimetric respirable silica concentrations, which could have affected estimates of average exposure for job categories in the job-exposure matrices used to estimate workers' silica exposure. To address possible error in individual workers' exposure estimates, the analysts performed a Monte Carlo analysis, a type of simulation analysis which varies the values of an uncertain input to an analysis (in this case, exposure estimates) to explore the effects of different values on the outcome of the analysis. The Monte Carlo analysis sampled new values for workers' job-specific exposure levels from distributions they believed characterized the exposures of individual workers in each job. In each run of the Monte Carlo analysis, the sampled exposure values were used to calculate new estimates of each worker's cumulative exposures, and the resulting set was used to fit a new exposure-response model.
Similarly, the analysts performed a Monte Carlo analysis to address the issue of uncertainty in conversion from dust to respirable silica exposure, sampling new conversion factors from a normal distribution with means equal to the original conversion factor, calculating new estimates of workers' cumulative exposures, and re-fitting the exposure-response model for each Monte Carlo run. To examine the sensitivity of the model to the joint effects of both error types, the analysts ran 50 Monte Carlo simulations using the sampling procedure for both individual exposures and job-specific conversion factors. They also examined the effects of systematic bias in conversion factors, considering that these may have been consistently under-estimated or over-estimated for any given cohort. They addressed possible biases in either direction, conducting 20 simulations where the true silica content was assumed to be either half or double the estimated silica content of measured exposures.
The results of their analysis indicated that the conclusions of the pooled lung cancer study conducted previously by Steenland
Drs. Long and Valberg, representing the Chamber, commented that Drs. Steenland and Bartell's uncertainty analysis did not address all potential sources of error and variability in exposure measurement, such as possible instrument error; possible sampling error; random variability in exposure levels; variability in exposure levels resulting from changes in worker job functions during work shifts, production process changes, or control system changes; variability in sampler type used; variability in laboratory methods for determining sampling results and laboratory errors; variability in duration of exposure sampling; variability in sampling locations; variability in reasons for sample data collection (
OSHA has determined that its reliance on the best available evidence provided it with a solid, scientifically sound foundation from which to conclude that exposure to crystalline silica poses a significant risk of harm, notwithstanding the various uncertainties inherent in epidemiology generally or potentially affecting any given study and that no studies exist entirely free from the types of data limitations or error and variability Drs. Valberg and Long identified. During the public hearing Dr. Long acknowledged
OSHA additionally notes that Dr. Kenneth Crump, an OSHA peer reviewer, in his examination of ToxaChemica's (Document ID 0469) study of exposure uncertainty in the Steenland
Similarly, Dr. Morfeld, representing the ACC, criticized Drs. Steenland and Bartell for performing only 50 simulations of workplace exposures as part of the uncertainty analysis (Document ID 2307, Attachment 2, p. 10). Peer reviewer Mr. Bruce Allen also remarked that this type of uncertainty analysis typically requires more than 50 simulations (Document ID 3574, p. 114). However, as stated by OSHA in the response to peer review section of the Review of Health Effects Literature and Preliminary QRA (Document ID 1711, pp. 379-400), the results did not appear to change much with an increased number of simulations. Thus, OSHA has concluded that the sensitivity findings would not have changed substantially by running more simulations. Indeed, in the final peer review report conveying his evaluation of OSHA's response to his comments of 2009, Mr. Allen stated that OSHA adequately addressed his comments in the updated risk assessment (Document ID 3574, p. 5).
The overall salient conclusion that OSHA draws from this peer-reviewed analysis is that even in those cohorts where exposure error had some impact on exposure-response models for lung cancer or silicosis, the resulting risk estimates at the previous and new PELs remain clearly significant. Therefore, OSHA continues to rely on, and have confidence in, the risk analysis it had performed. In particular, OSHA concludes that Drs. Steenland and Bartell's modeling choices were based on the best available data from a variety of industrial sources and, through their uncertainty analysis, reached conclusions that survive the ACC and Chamber criticisms of the study methodology. OSHA further concludes that it is not necessary to conduct additional analysis to modify the approach adopted by Drs. Steenland and Bartell or to incorporate additional sources of exposure estimation uncertainty in the analysis.
OSHA also disagrees with other specific criticisms that Drs. Long and Valberg made concerning the uncertainty analysis. Dr. Long testified that “there are no formal analyses conducted to determine the error structures of the three sources of exposure measurement error included in the sensitivity analyses; for example, without any formal analysis, the OSHA assessment simply assumed a purely Berkson type error structure from the assignment of job-specific average exposure levels for individual exposures” (Document ID 3576, 304-305).
OSHA has not developed an appropriate error model specifically for the exposure estimates in the crystalline silica studies and has not validated (
OSHA disagrees with Dr. Long's and Dr. Cox's characterizations, which implies that Drs. Steenland and Bartell did not adequately investigate the patterns of error in the data available to them. As noted in their 2004 report and by Dr. Steenland during the public hearings, ToxaChemica did not have the internal validation data (true exposures for a subset of the data set) that would be required to conduct formal analyses or validation of the error structure within each cohort of the pooled analysis (Document ID 0469, p. 16; 3580, pp. 1229-1231). Such data are not often available to analysts. However, Drs. Steenland and Bartell researched and reviewed worker exposure and dust composition data from several worksites to inform the error structures used in their analyses. For example, their analysis of individual workers' exposure data from the pooled analyses' industrial sand cohort formed the basis of the equation used for the exposure error simulation, which Dr. Cox represented as an assumption lacking any rationale. Drs. Steenland and Bartell also reviewed a number of studies characterizing the distribution of conversion factors across and within jobs at different worksites. OSHA concludes that Drs. Steenland and Bartell made a strong effort to collect data to inform their modeling choices, and that their choices were based on the
Dr. Long stated that “another limitation of the [ToxaChemica uncertainty] assessment was its assumption of log-linear . . . types of models, including log linear models with log-transformed exposure variables, and it focused on cumulative measures of silica exposure that obscure both within-person and between-person variability in exposure rates” (Document ID 3576 pp. 305-306). Dr. Long's assertion regarding the choice of exposure models is incorrect, as the sensitivity analysis was not limited to log-linear models. It included models with flexibility to capture nonlinearities in exposure-response, including spline analyses and categorical analyses, and log-transformation of the exposure variable was used only in the lung cancer analysis where it was shown in the original pooled analysis to better fit the data and address issues of heterogeneity between cohorts (Document ID 0469). Drs. Steenland and Bartell found only slight differences between the adjusted exposure-response estimates for each type of model.
Drs. Long and Valberg also contended that the cumulative exposure metric used in the Steenland and Bartell pooled study did not sufficiently allow for examination of the effects of exposure measurement uncertainty on the results of OSHA's risk assessment, because other exposure metrics could be more relevant. OSHA disagrees. As discussed in Section V.M, Comments and Responses Concerning Working Life, Life Tables, and Dose Metric, cumulative exposure is widely acknowledged by health experts as a driver of chronic diseases such as silicosis and lung cancer, has been found to fit the exposure-response data well in many studies of silicosis and lung cancer in the silica literature, and best fit the exposure-response data in the underlying pooled data sets to which Drs. Steenland and Bartell applied their subsequent uncertainty analyses. Thus, OSHA believes it was appropriate for this investigation of exposure estimation error to focus on the cumulative exposure metric, for reasons including data fit and general scientific understanding of this disease.
Furthermore, Dr. Long's concern that the choice of cumulative silica exposure might “obscure within-person variability in exposure rates” is not well supported in the context of lung cancer and silicosis mortality. Because death from these diseases typically occurs many years after the exposure that caused it, and complete records of past exposures do not typically exist, it is very difficult, using any metric, to trace within-person exposure variability (that is, changes in a person's exposure over time); these factors, not the choice of cumulative exposure metric, make it difficult to address variability in individuals' exposures over time and their effects on risk. OSHA notes that some analysts have explored the use of other exposure metrics in threshold analyses, submitting studies to the record which the Agency has reviewed and discussed in Section V.I, Comments and Responses Concerning Thresholds for Silica-Related Diseases.
Dr. Long also testified that “[t]here's very little discussion in the OSHA report regarding the potential impacts of exposure measurement error on identification of thresholds . . . [ToxaChemica's 2004 report] noted that exposure-response threshold estimates are imprecise and appear to be highly sensitive to measurement errors” (Document ID 3576 p. 306). Dr. Cox further noted that exposure misclassification can “create the appearance of a smooth, monotonically increasing estimated ER [exposure-response] relation” and shift thresholds to the left (Document ID 2307, Attachment 4, pp. 41-42); that is, create the appearance that a threshold effect occurs at a lower exposure level than would be seen in a data set without exposure misclassification.
In their uncertainty analysis, Drs. Steenland and Bartell estimated an exposure-response threshold for the pooled cohorts in each of the 50 runs conducted for their lung cancer analysis. They defined the “threshold” as the highest cumulative exposure for which the estimated odds ratio was less than or equal to 1.0, reporting a mean value of 3.04 mg/m
As noted by Dr. Long, the threshold estimates were highly variable across the 50 iterations (SD of 1.64 on the log scale), in keeping with other comments received by OSHA that estimates of exposure-response thresholds based on epidemiological data tend to be highly sensitive to sources of measurement error and other issues common to epidemiological investigations (see Section V.I, Comments and Responses Concerning Thresholds for Silica-Related Diseases). However, the Agency notes that the results of the uncertainty analysis, suggesting a possible cumulative exposure threshold at approximately one-fifth the final 50 μg/m
An additional concern raised by Dr. Cox was based on his misunderstanding that the equation used to characterize the relationship between true and observed exposure in Drs. Steenland and Bartell's simulation, “Exposuretrue = Exposureobserved + E”, concerned cumulative exposure. Dr. Cox stated that the equation is “inappropriate for cumulative exposures [because] both the mean and the variance of actual cumulative exposure received typically increase in direct proportion to duration” (Document ID 2307, Attachment 4, p. 45). That is, the longer period of time over which a cumulative exposure is acquired, the higher variance is likely to be, because cumulative exposure is the sum of the randomly varying exposures received on different days. However, the exposures referred to in the equation are the mean job-specific concentrations recorded in the job-exposure matrix (Exposureobserved) and individuals' actual exposure concentrations from each job worked (Exposuretrue), not their cumulative exposures (Document ID 0469, p. 11). Therefore, Dr. Cox's criticism is unfounded.
Dr. Cox additionally criticized the simulation analysis on the basis that “[t]he usual starting point for inhalation exposures [is] with the random number of particles inhaled per breath modeled as a time-varying (non-homogenous) Poisson process . . . It is unclear why ToxaChemica decided to assume (and why OSHA accepted the assumption) of an underdispersed distribution . . . rather than assuming a Poisson distribution” (Document ID 2307, Attachment 4, pp. 45-46). OSHA believes this criticism also reflects a misunderstanding of Drs. Steenland and Bartell's analysis. While it could be pertinent to an analysis of workers' silica dose (the amount of silica that enters the body), the analysis addresses the concentration of silica in the air near a worker's breathing zone, not internal dose. The worker's airborne concentration is the regulated exposure endpoint and the exposure of interest for OSHA's risk assessment. Thus, the uncertainty analysis does not need to
More broadly, Dr. Cox asserted that the Monte Carlo analysis “is an inappropriate tool for analyzing the effects of exposure measurement error on estimated exposure-response data,” citing a paper by Gryparis
In conclusion, through use of high quality studies and modeling, performance of an uncertainty analysis, and submission of the results of that analysis to peer review, OSHA maintains that it has relied upon the best available evidence. In addition, OSHA has carefully considered the public comments criticizing ToxaChemica's uncertainty analysis and has concluded that exposure estimation error did not substantially affect the results in the majority of studies examined (Document ID 1711, pp. 299-314). As a result, it was not necessary to conduct additional analyses modifying the approach adopted by Drs. Steenland and Bartell. Accordingly, OSHA reaffirms its determination that the conclusions of the Agency's risk assessment are correct and largely unaffected by potential error in exposure measurement.
As discussed in Section V.C, Summary of the Review of Health Effects Literature and Preliminary QRA, OSHA finds, based upon the best available evidence in the published, peer-reviewed scientific literature, that exposure to respirable crystalline silica increases the risk of silicosis, lung cancer, other non-malignant respiratory disease (NMRD), and renal and autoimmune effects. Exposure to respirable crystalline silica causes silicosis and is the only known cause of silicosis. For other health endpoints like lung cancer that have both occupational and non-occupational sources of exposure, OSHA used a comprehensive weight-of-evidence approach to evaluate the published, peer-reviewed scientific studies in the literature to determine their overall quality and whether there is substantial evidence that exposure to respirable crystalline silica increases the risk of a particular health effect. For example, with respect to lung cancer, OSHA reviewed 60 epidemiological studies covering more than 30 occupational groups in over a dozen industrial sectors and concluded that exposure to respirable crystalline silica increases the risk of lung cancer (Document ID 1711, pp. 77-170). This conclusion is consistent with that of the World Health Organization's International Agency for Research on Cancer (IARC), HHS' National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), and many other organizations and individuals, as evidenced in the rulemaking record and discussed throughout this section.
In spite of this, and in addition to asserting that OSHA's Preliminary QRA was affected by many biases, Dr. Cox, on behalf of the ACC, argued that OSHA failed to conduct statistical analyses of causation, which led to inaccurate conclusions about causation. He specifically challenged OSHA's reliance upon the IARC determination of carcinogenicity, as discussed in Section V.F, Comments and Responses Concerning Lung Cancer Mortality, and its use of the criteria for evaluating causality developed by the noted epidemiologist Bradford Hill (Document ID 2307, Attachment 4, pp. 13-14; 4027, p. 28). The Hill criteria are nine aspects of an association that should be considered when examining causation: (1) The strength of the association; (2) the consistency of the association; (3) the specificity of the association; (4) the temporal relationship of the association; (5) the biological gradient (
Instead, Dr. Cox suggested that OSHA use the methods listed in Table 1 of his 2013 paper, “Improving causal inferences in risk analysis,” which he described as “the most useful study designs and methods for valid causal analysis and modeling of causal exposure-response (CER) relations” (Document ID 2307, Attachment 4, p. 11). Because OSHA did not use these methods, Dr. Cox maintained that the Agency's Preliminary QRA “asserts causal conclusions based on non-causal studies, data, and analyses” (Document ID 2307, Attachment 4, p. 3). He also contended that OSHA “ha[d] conflated
Dr. Cox asserted that OSHA erred in its reliance on the IARC determination of carcinogenicity for crystalline silica inhaled in the forms of quartz or cristobalite. He believed OSHA only relied on the IARC findings because they aligned with the Agency's opinion, noting that the “IARC analysis involved some of the same researchers, same methodological flaws, and same gaps in explicit, well-documented derivations of benefits and conclusions as OSHA's own preliminary QRA” (Document ID 2307, Attachment 4, pp. 13-14). OSHA, however, relied on IARC's determination to include lung cancer in its quantitative risk assessment because it constitutes the best available evidence. For this reason, Dr. Cox's position is without merit and OSHA's
As discussed in Section V.F, Comments and Responses Concerning Lung Cancer Mortality, the IARC classifications and accompanying monographs are well recognized in the scientific community, and have been described by scientists as “the most comprehensive and respected collection of systematically evaluated agents in the field of cancer epidemiology” (Demetriou
Further supporting OSHA's reliance on IARC's determination of carcinogenicity for its quantitative risk assessment is testimony offered by scientists during the informal public hearings. This testimony highlighted IARC's carcinogenicity determinations as very thorough examinations of the scientific literature that demonstrate that exposure to respirable crystalline silica causes lung cancer. For example, when asked about Dr. Cox's causation claims during the informal public hearings, David Goldsmith, Ph.D., noted that causation was very carefully examined by IARC. He believed that IARC, in its 1997 evaluation of evidence for cancer and silica, “. . . chose . . . the best six studies that were the least confounded for inability to control for smoking or other kinds of hazardous exposures like radiation and asbestos and arsenic . . .” (Document ID 3577, Tr. 894-896). He also believed it “. . . crucial . . . that we pay attention to those kinds of studies, that we pay attention to the kinds of studies that were looked at by the IARC cohort that Steenland did from 2001. That's where they had the best evidence” (Document ID 3577, Tr. 894-896).
Regarding IARC's evaluation of possible biases and confounders in epidemiological studies, as well as its overall determination, Frank Mirer, Ph.D., of CUNY School of Public Health, representing the AFL-CIO, testified:
IARC has active practicing scientists review—I've been on two IARC monographs, but not these monographs, monograph working groups. It's been dealt with. It's been dealt with over a week of intense discussion between the scientists who are on these committees, as to whether there's chance bias in confounding which might have led to these results, and by 1987 for foundries and 1997 for silica, and it's been decided and reaffirmed.
So people who don't believe it are deniers, pure and simple. This is the scientific consensus. I was on the NTP Board of Scientific Counselors when we reviewed the same data. Known to be a human carcinogen. Once you know it's a human carcinogen from studies in humans, you can calculate risk rates (Document ID 3578, Tr. 937).
That OSHA relied on the best available evidence to draw its conclusions was also affirmed by Dr. Cox's inability to provide additional studies that would have cast doubt on the Agency's causal analysis. Indeed, during the informal public hearings, Kenneth Crump, Ph.D., an OSHA peer reviewer from the Louisiana Tech University Foundation, asked Dr. Cox if he could identify “any causal studies of silica that they [OSHA] should have used but did not use?” Dr. Cox responded: “I think OSHA could look at a paper from around 2007 of Brown's, on some of the issues and causal analysis, but I think the crystalline silica area has been behind other particulate matter areas . . . in not using causal analysis methods. So no, I can't point to a good study that they should have included but didn't” (Document ID 3576, Tr. 401-402). In light of the above, OSHA maintains that in relying on IARC's determination of carcinogenicity, its conclusions on causation are rooted in the best available evidence.
Dr. Cox also challenged OSHA's use of Hill's criteria for causation. He claimed that the Bradford Hill considerations were neither necessary nor sufficient for establishing causation, which was his reason for failing to include them in the statistical methods listed in Table 1 of his written comments for objectively establishing evidence about causation (Document ID 4027, p. 28). As explained below, based on its review of the record, OSHA finds this position meritless, as it is unsupported by the best available evidence.
As a preliminary matter, Hill's criteria for causation (Document ID 3948) are generally accepted as a gold standard for causation in the scientific community. Indeed, OSHA heard testimony during the informal public hearings and received post-hearing comments indicating that Dr. Cox's assertion that statistical methods should be used to establish causality is not consistent with common scientific practice. For example, Andrew Salmon, Ph.D., an OSHA peer reviewer, wrote:
The identification of causality as opposed to statistical association is, as described by Bradford Hill in his well-known criteria, based mainly on non-statistical considerations such as consistence, temporality and mechanistic plausibility: the role of statistics is mostly limited to establishing that there is in fact a quantitatively credible association to which causality may (or may not) be ascribed. OSHA correctly cites the substantial body of evidence supporting the association and causality for silicosis and lung cancer following silica exposure, and also quotes previous expert reviews (such as IARC). The causal nature of these associations has already been established beyond any reasonable doubt, and OSHA's analysis sufficiently reflects this (Document ID 3574, p. 38).
Similarly, Kyle Steenland, Ph.D., Professor, Department of Environmental Health, Rollins School of Public Health, Emory University, in response to a question about Dr. Cox's testimony on causation from Darius Sivin, Ph.D., of the UAW Health and Safety Department, stated that the Bradford Hill criteria are met for lung cancer and silicosis:
[M]ost of the Bradford Hill criteria apply here. You know you can never prove causality. But when the evidence builds up to such an extent and you have 100 studies and they tend to be fairly consistent, that's when we draw a causal conclusion. And that was the case for cigarette smoke in lung cancer. That was the case for asbestos in lung cancer. And when the evidence builds up to a certain point, you say, yeah, it's a reasonable assumption that this thing causes, X causes Y (Document ID 3580, pp. 1243-1244).
As a follow-up, OSHA asked if Dr. Steenland felt that the Bradford Hill criteria were met for silica health endpoints. Dr. Steenland replied, “For silicosis or for lung cancer. I had said they're met for both” (Document ID 3580, p. 1262).
Gary Ginsberg, Ph.D., an OSHA peer reviewer, agreed with Dr. Steenland, remarking to Dr. Cox during questioning, “I'm a little dumbfounded about the concern over causality, given all the animal evidence” (Document ID 3576, Tr. 406). Mr. Park from NIOSH's Risk Evaluation Branch, in his question to Dr. Cox, echoed the sentiments of Dr. Ginsberg, stating:
It's ludicrous to hear someone question causality. There's 100 years of research in occupational medicine, in exposure assessment. People here even in industry would agree that silica they say causes silicosis, which causes lung cancer. There's some debate about whether the middle step is required. There's no question that there's excess lung cancer in silica-exposed populations. We look at literature, and we identify what we call good studies. Good studies are ones that look at confounding, asbestos, whatever. We make judgments. If there's data that allows one to control for confounding, that's part of the analysis. If there is confounding that we can't control for, we evaluate it. We ask how bad could it be? There's a lot of empirical judgment from people who know these populations, know these exposures, know these industries, who can make very good judgments about that. We aren't stupid. So I don't know where you're coming from (Document ID 3576, Tr. 410-411).
Indeed, Kenneth Mundt, Ph.D., testifying on behalf of the International Diatomite Producers Association (part of the ACC Crystalline Silica Panel, which included Dr. Cox), and whose research study was the basis for the Morfeld
OSHA notes that Dr. Cox, upon further questioning by Mr. Park, appeared to concede that exposure to respirable crystalline silica causes silicosis; Dr. Cox stated, “I do not question that at sufficiently high exposures, there are real effects” (Document ID 3576, Tr. 412). Later, when questioned by Anne Ryder, an attorney in the Solicitor of Labor's office, he made a similar statement: “I do take it as given that silica at sufficiently high and prolonged exposures causes silicosis” (Document ID 3576, Tr. 426). Based upon this testimony of Dr. Cox acknowledging that silica exposure causes silicosis, OSHA interprets his concern with respect to silicosis to be not one of causation, but rather a concern with whether there is a silicosis threshold (
Based on the testimony and written comments of numerous scientists representing both public health and industry—all of whom agree that causation is established by applying the Bradford Hill criteria and examining the totality of the evidence—OSHA strongly disagrees with Dr. Cox's claims that the Bradford Hill criteria are inadequate to evaluate causation in epidemiology and that additional statistical techniques are needed to establish causation. OSHA defends its reliance on the IARC determination of 1997 and re-determination of 2012 that crystalline silica is a causal agent for lung cancer. OSHA's own Review of Health Effects Literature further demonstrates the totality of the evidence supporting the causality determination (Document ID 1711). Indeed, other than Dr. Cox representing the ACC, no other individual or entity questioned causation with respect to silicosis. Even Dr. Cox's questioning of causation for silicosis appears to be more of a question about thresholds, which is discussed in Section V.I, Comments and Responses Concerning Thresholds for Silica-Related Diseases.
OSHA reviewed the statistical methods provided by Dr. Cox in Table 1 of his 2013 paper, “Improving causal inferences in risk analysis,” (Document ID 2307, Attachment 4, p. 11), and explains below why the Agency did not adopt them. For example, Intervention Time Series Analysis (ITSA), as proposed by Dr. Cox in his Table 1, is a method for assessing the impact of an intervention or shock on the trend of outcomes of interest (Gilmour
Another method listed in Dr. Cox's Table 1, marginal structural models (MSM), was introduced in the late 1990s (Robins, 1998, cited in Document ID 2307, Attachment 4, p. 11) to address issues that can arise in standard modeling approaches when time-varying exposure and/or time-dependent confounders are present.
In addition, in his post-hearing brief, Dr. Cox contended that “[a] well-done QRA should explicitly address the causal fraction (and explain the value used), rather than tacitly assuming that it is 1” (Document ID 4027, p. 4). However, this claim is without grounds. OSHA understands Dr. Cox's reference to the “causal fraction” to mean that,
Dr. Cox also asserted that the same biases and issues with causation in OSHA's Quantitative Risk Assessment (QRA) were likewise present in the silica literature. He wrote, “In general, the statistical methods and causal inferences described in this literature are no more credible or sound than those in OSHA's Preliminary QRA, and for the same reasons” (Document ID 2307, Attachment 4, p. 30).
The rulemaking record contains evidence that contradicts Dr. Cox's claims with respect to the scientific foundation of the QRA. Such evidence includes scientific testimony and the findings of many expert bodies, including IARC, the HHS National Toxicology Program, and NIOSH, concluding that exposure to respirable crystalline silica causes lung cancer. At the public hearing, Dr. Steenland, Professor at Emory University, testified that the body of evidence pertaining to silica was of equal quality to that of other occupational health hazards (Document ID 3580, pp. 1245-1246). Dr. Goldsmith similarly testified:
Silica dust . . . is like asbestos and cigarette smoking in that exposure clearly increases the risk of many diseases. There have been literally thousands of research studies on exposure to crystalline silica in the past 30 years. Almost every study tells the occupational research community that workers need better protection to prevent severe chronic respiratory diseases, including lung cancer and other diseases in the future. What OSHA is proposing to do in revising the workplace standard for silica seems to be a rational response to the accumulation of published evidence (Document ID 3577, Tr. 865-866).
OSHA agrees with these experts, whose positive view of the science supporting the need for better protection from silica exposures stands in contrast to Dr. Cox's claim regarding what he believes to be the problematic nature of the silica literature. Dr. Cox asserted in his written statement:
Scientists with subject matter expertise in areas such as crystalline silica health effects epidemiology are not necessarily or usually also experts in causal analysis and valid causal interpretation of data, and their causal conclusions are often mistaken, with a pronounced bias toward declaring and publishing findings of `significant' effects where none actually exists (false positives). This has led some commentators to worry that `science is failing us,' due largely to widely publicized but false beliefs about causation (Lehrer, 2012); and that, in recent times, `Most published research findings are wrong' (Ioannadis, 2005), with the most sensational and publicized claims being most likely to be wrong. (Document ID 2307, Attachment 4, pp. 15-16).
Moreover, during the public hearing, Dr. Cox stated that, with respect to lung cancer in the context of crystalline silica, the literature base may be false:
MR. PERRY [OSHA Director of the Directorate of Standards and Guidance]: So as I understand it, you basically think there's a good possibility that the entire literature base, with respect to lung cancer now, I'm talking about, is wrong?
DR. COX: You mean with respect to lung cancer in the context of crystalline silica?
MR. PERRY: Yes, sir.
DR. COX: I think that consistent with the findings of Lauer [Lehrer] and Ioannidis and others, I think that it's very possible and plausible that there is a consistent pattern of false positives in the literature base, yes. And that implies, yes, they are wrong. False positives are false (Document ID 3576, Tr. 423).
The Ioannidis paper (Document ID 3851) used mathematical constructs to purportedly demonstrate that most claimed research findings are false, and then provided suggestions for improvement (Document ID 3851, p. 0696). Two of his suggestions appear particularly relevant to the silica literature: “Better powered evidence,
OSHA likewise notes that there was disagreement on Ioannidis' methods and conclusions. Jonathan D. Wren of the University of Oklahoma, in a correspondence to the journal that published the paper, noted that Ioannidis, “after all, relies heavily on other studies to support his premise, so if most (
Christiana A. Demetriou, Imperial College London,
Given these responses to Ioannidis, OSHA fundamentally rejects the claim that most published research findings are false. The Agency concludes that, most likely, where, as here, there are multiple, statistically significant positive findings of an association between silica and lung cancer made by different researchers in independent studies looking at distinct cohorts, the chances that there is a consistent pattern of false positives are small; OSHA's mandate is met when the weight of the evidence in the body of science constituting the best available evidence supports such a conclusion.
As discussed in Section V.C, Summary of the Review of Health Effects Literature and Preliminary QRA, OSHA presented risk estimates associated with exposure over a working lifetime to 25, 50, 100, 250, and 500 μg/m
OSHA received critical comments from representatives of the ACC and the Chamber. These commenters expressed concern that (1) the working lifetime exposure of 45 years was not realistic for workers, (2) the use of life tables was improper and alternative methods should be used, and (3) the cumulative exposure metric does not consider the exposure intensity and possible resulting dose-rate effects. OSHA examines these comments in detail in this section, and shows why they do not alter its conclusion that the best available evidence in the rulemaking record fully supports the Agency's use of a 45-year working life in a life table analysis with cumulative exposure as the exposure metric of concern.
The Chamber commented that 45-year career silica exposures do not exist in today's working world, particularly in “short term work-site industries” such as construction and energy production (Document ID 4194, p. 11; 2288, p. 11). The Chamber stated that careers in these jobs are closer to 6 years, pointing out that OSHA's contractor, ERG, estimated a 64 percent annual turnover rate in the construction industry. Referring to Section 6(b)(5) of the Occupational Safety and Health (OSH) Act of 1970, the Chamber concluded, “OSHA improperly inflates risk estimates with its false 45-year policy, contradicting the Act, which requires standards based on actual, `working life' exposures—not dated hypotheticals” (Document ID 4194, pp. 11-12; 2288, pp. 11-12).
As stated previously, OSHA believes that the 45-year exposure estimate satisfies its statutory obligation to evaluate risks from exposure over a working life, and notes that the Agency has historically based its significance-of-risk determinations on a 45-year working life from age 20 to age 65 in each of its substance-specific rulemakings conducted since 1980. The Agency's use of a 45-year working life in risk assessment has also been upheld by the DC Circuit (
In addition, OSHA heard testimony and received several comments with accompanying data that support a 45-year working life in affected industries. For example, six worker representatives of the International Union of Bricklayers and Allied Craftworkers (BAC), which represents a portion of the unionized masonry construction industry (Document ID 4053, p. 2), raised their hands in the affirmative when asked if they had colleagues who worked for longer than 40 years in their trade (Document ID 3585, Tr. 3053). Following the hearings, BAC reviewed its International Pension Fund and counted 116 members who had worked in the industry for 40 years or longer. It noted that this figure was likely an understatement, as many workers had previous experience in the industry prior to being represented by BAC, and many BAC affiliates did not begin participation in the Fund until approximately a decade after its establishment in 1972 (Document ID 4053, p. 2).
OSHA heard similar testimony from representatives of other labor groups and unions. Appearing with the Laborers' Health and Safety Fund of North America (LHSFNA), Eddie Mallon, a long-time member of the New York City tunnel workers' local union, testified that he had worked in the tunnel business for 50 years, mainly on underground construction projects (Document ID 3589, Tr. 4209). Appearing with the United Steelworkers, Allen Harville, of the Newport News Shipbuilding Facility and Drydock, testified that there are workers at his shipyard with more than 50 years of experience. He also believed that 15 to 20 percent of workers had 20 to 40 years of experience (Document ID 3584, Tr. 2571).
In addition, several union representatives appearing with the Building and Construction Trades Department (BCTD) of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) also
In its post-hearing comment, the BCTD submitted evidence on behalf of the United Association of Plumbers, Fitters, Welders and HVAC Service Techs, which represents a portion of the workers in the construction industry. A review of membership records for this association revealed 35,649 active members with 45 years or more of service as a member of the union. Laurie Shadrick, Safety and Health National Coordinator for the United Association, indicated that this membership figure is considered an underestimate, as many members had previous work experience in the construction industry prior to joining the union, or were not tracked by the union after transitioning to other construction trades (Document ID 4073, Attachment 1b). The post-hearing comment of the BCTD also indicated a trend of an aging workforce in the construction industry, with workers 65 years of age and older predicted to increase from 5 percent in 2012 to 8.3 percent in 2022 (Document ID 4073, Attachment 1a, p. 1). This age increase is likely due to the fact that few construction workers have a defined benefit pension plan, and the age for collecting Social Security retirement benefits has been increasing; as a result, many construction workers are staying employed for longer in the industry (Document ID 4073, Attachment 1a, p. 1). Thus, the BCTD expressed its support for using a 45-year working life in the construction industry for risk assessment purposes (Document ID 4073, Attachment 1a, p. 1).
In addition to BAC and BCTD, OSHA received post-hearing comments on the 45-year working life from the International Union of Operating Engineers (IUOE) and the American Federation of State, County and Municipal Employees (AFSCME). The IUOE reviewed records of the Central Pension Fund, in which IUOE construction and stationary local unions participate, and determined that the average years of service amongst all retirees (75,877 participants) was 21.34 years, with a maximum of 49.93 years of active service. Of these retirees, 15,836 participants recorded over 30 years of service, and 1,957 participants recorded over 40 years of service (Document ID 4025, pp. 6-7). The IUOE also pointed to the testimony of Anthony Bodway, Special Projects Manager at Payne & Dolan, Inc. and appearing with the National Asphalt Pavement Association (NAPA), who indicated that some workers in his company's milling division had been with the company anywhere from 35 to 40 years (Document ID 3583, Tr. 2227, 2228). Similarly, the AFSCME reported that, according to its 2011 poll, 49 percent of its membership had over 10 years of experience, and 21 percent had over 20 years (Document ID 3760, p. 2).
The rulemaking record on this topic of the working life thus factually refutes the Chamber's assertion that “no such 45-year career silica exposures exist in today's working world, particularly in construction, energy production, and other short term work-site industries” (Document ID 4194, p. 11; 2288, p. 11). Instead, OSHA concludes that the rulemaking record demonstrates that the Agency's use of a 45-year working life as a basis for estimating risk is legally justified and factually appropriate.
Dr. Cox, on behalf of the ACC, commented that OSHA should use “modern methods,” such as Bayesian competing-risks analyses, expectation-maximization (EM) methods, and copula-based approaches that account for subdistributions and interdependencies among competing risks (Document ID 2307, Attachment 4, p. 61). Such methods, according to Dr. Cox, are needed “[t]o obtain risk estimates . . . that have some resemblance to reality, and that overcome known biases in the naïve life table method used by OSHA” (Document ID 2307, Attachment 4, p. 61). Dr. Cox then asserted that the life table method used in the following studies to estimate mortality risks is also incorrect: Steenland
OSHA does not agree that the life table method it used to estimate mortality risks is incorrect or inappropriate. Indeed, the Agency's life table approach is a standard method commonly used to estimate the quantitative risks of mortality. As pointed out by Rice et al. (2001), the life table method was developed by the National Research Council's BEIR IV Committee on the Biological Effects of Ionizing Radiations (BEIR), Board of Radiation Effects Research, in its 1988 publication on radon (Document ID 1118, p. 40). OSHA notes that the National Research Council is the operating arm of the National Academy of Sciences and the National Academy of Engineering, and is highly respected in the scientific community. As further described by Rice
Regarding the alternative methods proposed by Dr. Cox, OSHA believes that these methods are not widely used in the occupational epidemiology community. In addition, OSHA notes that Dr. Cox did not provide any alternate risk estimates to support the use of his proposed alternative methods, despite the fact that the Agency made its life table data available in the Review of Health Effects Literature and Preliminary QRA (Document ID 1711, pp. 360-378). Thus, for these reasons, OSHA disagrees with Dr. Cox's claim that the life table method used by the Agency to estimate quantitative risks was inappropriate.
In its risk assessment, OSHA uses cumulative exposure, i.e., average exposure concentration multiplied by duration of exposure, as the exposure metric to quantify exposure-response relationships. It uses this metric because each of the key epidemiological studies on which the Agency relied to estimate risks used cumulative exposure as the exposure metric to quantify exposure-response relationships, although some
Commenting on this exposure metric, the ACC argued that cumulative exposure undervalues the role of exposure intensity, as some studies of silicosis have indicated a dose-rate effect,
OSHA acknowledges these concerns regarding the exposure metric and finds them to have some merit. However, it notes that the best available studies use cumulative exposure as the exposure metric, as in common in occupational epidemiological studies. As discussed below, there is also substantial good evidence in the record supporting the use of cumulative exposure as the exposure metric for crystalline silica risk assessment.
Paul Schulte, Ph.D., of NIOSH testified that “cumulative exposure is a standard and appropriate metric for irreversible effects that occur soon after actual exposure is experienced. For lung cancer and nonmalignant respiratory disease, NMRD mortality, cumulative exposure lagged for cancer is fully justified . . . For silicosis risk assessment purposes, cumulative exposure is a reasonable and practical choice” (Document ID 3579, Tr. 127). NIOSH also conducted a simulated dose rate analysis for silicosis incidence with data from a Chinese tin miners cohort and, in comparing exposure metrics, concluded that the best fit to the data was cumulative exposure with no dose-rate effect (Document ID 4233, pp. 36-39). This finding is consistent with the testimony of Dr. Steenland, who stated, “Cumulative exposure, I might say, is often the best predictor of chronic disease in general, in epidemiology” (Document ID 3580, Tr. 1227). OSHA also notes that using a cumulative exposure metric (
With regard to a possible dose-rate effect, OSHA agrees with Dr. Crump that if one exists and is unaccounted for, the result could be an overestimation of risks at lower concentrations (Document ID 1716, pp. 165-167). OSHA is aware of two studies discussed in its Review of Health Effects Literature and Preliminary QRA that examined dose-rate effects on silicosis exposure-response (Document ID 1711, pp. 342-344). Neither study found a dose-rate effect relative to cumulative exposure at silica concentrations near the previous OSHA PEL (Document ID 1711, pp. 342-344). However, they did observe a dose-rate effect in instances where workers were exposed to crystalline silica concentrations far above the previous PEL (
In its post-hearing brief, NIOSH also added that a “detailed examination of dose rate would require extensive and real time exposure history which does not exist for silica (or almost any other agent)” (Document ID 4233, p. 36). Similarly, Dr. Crump wrote, “Having noted that there is evidence for a dose-rate effect for silicosis, it may be difficult to account for it quantitatively. The data are likely to be limited by uncertainty in exposures at earlier times, which were likely to be higher” (Document ID 1716, p. 167). OSHA agrees with Dr. Crump, and believes that it has used the best available evidence to estimate risks of silicosis morbidity and sufficiently accounted for any dose-rate effect at high silica average concentrations by using the Buchanan
For silicosis/NMRD mortality, the ACC noted that Vacek
In addition, OSHA notes that Vacek
To demonstrate evidence for a dose-rate effect that is not captured by cumulative exposure, it would be most convincing to show some effect of dose rate that is in addition to the effect of cumulative exposure. To demonstrate such an effect one would need to model both cumulative exposure and some effect of dose rate, and show that adding the effect of dose rate makes a statistically significant improvement to the model over that predicted by cumulative exposure alone (Document ID 1716, p. 166).
Indeed, both Buchanan
Regarding lung cancer mortality, the ACC pointed out that Steenland
For these reasons, OSHA does not believe there to be any persuasive data in the record that supports a dose-rate effect at exposure concentrations near the revised or previous PELs. OSHA concludes that cumulative exposure is a reasonable exposure metric on which to base estimates of risk to workers exposed to crystalline silica in the exposure range of interest (25 to 500 μg/m
As discussed in the Review of Health Effects Literature and Preliminary Quantitative Risk Assessment (Document ID 1711, pp. 344-350), the toxicological potency of crystalline silica is influenced by a number of physical and chemical factors that affect the biological activity of the silica particles inhaled in the lung. The toxicological potency of crystalline silica is largely influenced by the presence of oxygen free radicals on the surfaces of respirable particles; these chemically-reactive oxygen species interact with cellular components in the lung to promote and sustain the inflammatory reaction responsible for the lung damage associated with exposure to crystalline silica. The reactivity of particle surfaces is greatest when crystalline silica has been freshly fractured by high-energy work processes such as abrasive blasting, rock drilling, or sawing concrete materials. As particles age in the air, the surface reactivity decreases and exhibits lower toxicologic potency (Porter
In the preamble to the proposed standard, OSHA preliminarily concluded that although there is evidence that several environmental influences can modify surface activity to either enhance or diminish the toxicity of silica, the available information was insufficient to determine to what extent these influences may affect risk to workers in any particular workplace setting (Document 1711, p. 350). NIOSH affirmed OSHA's preliminary conclusion regarding the silica-related risks of exposure to clay-occluded quartz particles, which was based on what OSHA believed to be the best available evidence. NIOSH stated:
NIOSH concurs with this assessment by OSHA. Currently available information is not adequate to inform differential quantitative risk management approaches for crystalline silica that are based on surface property measurements. Thus, NIOSH recommends a single PEL for respirable crystalline silica without consideration of surface properties (Document ID 4233, p. 44).
Two rulemaking participants, the Brick Industry Association (BIA), which represents distributors and manufacturers of clay brick, and the Sorptive Minerals Institute (SMI), which represents many industries that process and mine sorptive clays for consumer products and commercial and industrial applications, provided comment and supporting evidence that the crystalline silica encountered in their workplace environments presents a substantially lower risk of silica-related disease than that reflected in the Agency's Preliminary QRA.
BIA argued that the quartz particles found in clays and shales used in clay brick are occluded in aluminum-rich clay coatings. BIA submitted to the record several studies indicating reduced toxicity and fibrogenicity from exposure to quartz in aluminum-rich clays (Document ID 2343, Attachment 2, p. 2). It purported that “OSHA lacks the statutory authority to impose the proposed rule upon the brick and structural clay manufacturing industry because employees in that industry do not face a significant risk of material impairment of health or functional capacity” (Document ID 2242, pp. 2-3). BIA concluded that its industry should be exempted from the rule, stating: “OSHA should exercise its discretion to exempt the brickmaking industry from compliance with the proposed rule unless and until it determines how best to take into account the industry's low incidence of adverse health effects from silica toxicity” (Document ID 2242, p. 11).
SMI argued that silica in sorptive clays exists as either amorphous silica or as geologically ancient, occluded quartz, “neither of which pose the health risk identified and studied in OSHA's risk assessment” (Document ID 4230, p. 2). SMI further contended that OSHA's discussion of aged silica “does not accurately reflect the risk of geologically ancient, (occluded) silica formed millions of years ago found in
Having considered the evidence SMI submitted to the record, OSHA finds that although quartz originating from bentonite deposits exhibits some biological activity, it is clear that it is considerably less toxic than unoccluded quartz. Moreover, evidence does not exist that would permit the Agency to evaluate the magnitude of the lifetime risk resulting from exposure to quartz in bentonite-containing materials and similar sorptive clays. This finding does not extend to the brick industry, where workers are exposed to silica through occluded quartz in aluminum rich clays. The Love et al. study (1999, Document ID 0369), which BIA claimed would be of useful quality for OSHA's risk assessment, shows sufficient cases of silicosis to demonstrate significant risk within the meaning used by OSHA for regulatory purposes. In addition, OSHA found a reduced, although still significant, risk of silicosis morbidity in the study of pottery workers (Chen
BIA did not support a reduction in the PEL because although brick industry employees are exposed to crystalline silica-bearing materials, BIA believes silicosis is virtually non-existent in that industry. It contended that silica exposure in the brick industry does not cause similar rates of disease as in other industries because brick industry workers are exposed to quartz occluded in aluminum-rich layers, reducing the silica's toxicity. BIA concluded that “no significant workplace risk for brick workers from crystalline silica exposure exists at the current exposure limit” (Document ID 3577, Tr. 654) and that reducing the PEL would have no benefit to workers in the brick industry (Document ID 2300, p. 2). These concerns were also echoed by individual companies in the brick industry, such as Acme Brick (Document ID 2085, Attachment 1), Belden Brick Company (Document ID 2378), and Riverside Brick & Supply Company, Inc. (Document ID 2346, Attachment 1). In addition, OSHA received over 50 letters as part of a letter campaign from brick industry representatives referring to BIA's comments on the lack of silicosis in the brick industry (
The Tile Council of North America, Inc., also noted that “[c]lay raw materials used in tile manufacturing are similar to those used in brick and sanitary ware manufacturing” and also suggested that aluminosilicates decrease toxicity (Document ID 3528, p. 1). OSHA agrees with the Tile Council of North America, Inc., that their concerns mirror those of the BIA and, therefore, the Agency's consideration and response to BIA also applies to the tile industry.
On behalf of BIA, Mr. Robert Glenn presented a series of published and unpublished studies (Document ID 3418), also summarized by BIA (Document ID 2300, Attachment 1) as evidence that “no significant workplace risk for brick workers from crystalline silica exposure exists at the current exposure limit” (Document ID 3577, Tr. 654). Most of these studies, including an unpublished report on West Virginia brick workers (West Virginia State Health Department, 1939), a study of North Carolina brick workers (Trice, 1941), a study of brick workers in England (Keatinge and Potter, 1949), a study of Canadian brick workers (Ontario Health Department, 1972), two studies of North Carolina brick workers (NIOSH, 1978 and NIOSH, 1980), a study of English and Scottish brick workers (Love
Based on its review of the record evidence, OSHA finds that there are many silica-containing materials (
Mr. Glenn acknowledged shortcomings in the studies he submitted for OSHA's consideration, agreeing with Dr. Weissman's points about quality assurance for X-ray interpretation and study design (
Mr. Glenn further argued that the Agency should assess risk to brick workers based on studies from that industry because the incidence of silicosis among brick workers appears to be lower than among workers in other industries (Document ID 3577, Tr. 670). For the reasons discussed above, OSHA does not believe the studies submitted by Mr. Glenn provide an adequate basis for risk assessment. In addition, studies presented did not: (1) Include retired workers; (2) report the duration of workers' exposure to silica; (3) employ, in most cases, quality-assurance practices for interpreting workers' medical exams; or (4) include estimates of workers' silica exposures. Furthermore, Mr. Glenn acknowledged in the informal public hearing that the Love
Based on review of the Love
Love
OSHA concludes that, despite the possibly lower toxicity of silica in the clay brick industry compared to other forms, and despite the Love
Mr. Glenn additionally argued that the risk of lung cancer from silica exposure among brick workers is likely to be lower than among workers exposed to silica in other work settings. Mr. Glenn acknowledged that “there are no published mortality studies of brick workers that look at cause of death or lung cancer death” (Document ID 3577, Tr. 674). However, he stated that “pottery clays are similar to the structural clays used in brickmaking in that the quartz is occluded in aluminum-rich layers of bentonite, kaolinite, and illite,” and that OSHA should consider studies of mortality among pottery workers as representative of the brick industry (Tr. 674). Mr. Glenn cited the Chen
OSHA acknowledges that occlusion may weaken the carcinogenicity of silica in the brick clay industry, but does not believe that the Chen
Thus, OSHA concludes that the BIA's position is not supported by the best available evidence. The studies cited by Mr. Glenn to support his contention that brick workers are not at significant risk of silica-related disease do not have the same standards as those studies used by OSHA in its quantitative risk assessment. Furthermore, in the highest-quality study brought forward by Mr. Glenn (Love
SMI asserted that the physico-chemical form of respirable crystalline silica in sorptive clays reduces the toxicologic potency of crystalline silica relative to the forms of silica common to most studies relied on in OSHA's Preliminary QRA. In other words, the risk associated with exposure to silica in sorptive clays is assertedly lower than the risk associated with exposure to silica in other materials. SMI based this view on what it deemed the “best available scientific literature,” epidemiological, in vitro, and animal evidence OSHA had not previously considered. It believed the evidence showed reduced risk from exposure to occluded quartz found in the sorptive clays and that occluded quartz does not create a risk similar to that posed by freshly fractured quartz (Document ID 2377, p. 7). Based on this, SMI contended that the results of OSHA's Preliminary QRA were not applicable to the sorptive minerals industry, and a more stringent standard for crystalline silica is “neither warranted nor legally permissible” (Document ID 4230, p. 1). As discussed below, OSHA reviewed the evidence submitted by SMI and finds that although the studies provide evidence of some biological activity in quartz originating from bentonite deposits, there is not quantitative evidence that would permit the Agency to evaluate the magnitude of the lifetime risk resulting from exposure to quartz in bentonite-containing materials and similar sorptive clays.
SMI submitted a number of studies to the rulemaking record. First, it summarized a retrospective study by Waxweiler
Based on its review of the rulemaking record, OSHA concludes that the Waxweiler
SMI also presented a World Health Organization (WHO) document (2005, Document ID 3929), which recognized that “studies of workers exposed to sorptive clays have not identified significant silicosis risk” (Document ID 2377, p. 10). However, although WHO did find that there were no reported cases of fibrotic reaction in humans exposed to montmorillonite minerals in the absence of crystalline silica (Document ID 3929, p. 130), the WHO report does discuss the long-term effects from exposure to crystalline silica, including silicosis and lung cancer. In fact, with respect to evaluating the hazards associated with exposure to bentonite clay, WHO regarded silica as a potential confounder (Document ID 3929, p. 136). Thus, WHO did not specifically make any findings with respect to the hazard potential of quartz in the bentonite clay mineral matrix but instead recognized the hazard presented by exposure to crystalline silica generally.
Additionally, the WHO (Document ID 3929, pp. 114, 118) cited two case/case series reports of bentonite-exposed workers, one demonstrating increasing prevalence of silicosis with increasing exposure to bentonite dust (Rombola and Guardascione, 1955, Document ID 3998, Attachment 18) and another describing cases of silicosis among workers exposed to bentonite dust (Phibbs
The lack of specific exposure information on bentonite workers found with silicosis, combined with the extraordinary exposures experienced by workers in the bentonite plants studied by Phibbs
SMI also presented evidence from animal and in vitro studies that it believes shows that respirable crystalline quartz present in sorptive clays exists in a distinct occluded form, which significantly mitigates adverse health effects due to the physico-chemical characteristics of the occluded quartz. As discussed below, based on careful review of the studies SMI cited, OSHA believes these studies indicate that silica in bentonite clay is of lower toxicologic potency than that found in other industry sectors.
SMI submitted two studies: an animal study (Creutzenberg
Creutzenberg
SMI also cited Miles
With respect to the two studies just discussed, animal evidence cited by SMI demonstrates that quartz in bentonite induces a modest inflammatory reaction in the lung that does not persist (Creutzenberg
In sum, human evidence on the toxicity of quartz in bentonite clay includes one study cited by SMI that did not find an excess risk of respiratory disease (Waxweiller
OSHA finds that the evidence for quartz originating from bentonite deposits indicates some biological activity, but also indicates lower toxicity than standard experimental quartz (which has similar characteristics to quartz encountered in most workplaces where exposures occur). For regulatory purposes, however, OSHA finds that the evidence does not exist that would permit the Agency to evaluate the magnitude of the lifetime risk resulting from exposure to quartz in sorptive clays at the 100 μg/m
To promulgate a standard that regulates workplace exposure to toxic materials or harmful physical agents, OSHA must first determine that the standard reduces a “significant risk” of “material impairment.” Section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b). The first part of this requirement, “significant risk,” refers to the likelihood of harm, whereas the second part, “material impairment,” refers to the severity of the consequences of exposure. Section II, Pertinent Legal Authority, of this preamble addresses the statutory bases for these requirements and how they have been construed by the Supreme Court and federal courts of appeals.
It is the Agency's practice to estimate risk to workers by using quantitative risk assessment and determining the significance of that risk based on the best available evidence. Using that evidence, OSHA identifies material health impairments associated with potentially hazardous occupational exposures, and, when possible, provides a quantitative assessment of exposed workers' risk of these impairments. The Agency then evaluates whether these risks are severe enough to warrant regulatory action and determines whether a new or revised rule will substantially reduce these risks. For single-substance standards governed by section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b)(5), OSHA sets a permissible exposure limit (PEL) based on that risk assessment as well as feasibility considerations. These health and risk determinations are made in the context of a rulemaking record in which the body of evidence used to establish material impairment, assess risks, and identify affected worker population, as well as the Agency's preliminary risk assessment, are placed in a public rulemaking record and subject to public comment. Final determinations regarding the standard, including final determinations of material impairment and risk, are thus based on consideration of the entire rulemaking record.
In this case, OSHA reviewed extensive toxicological, epidemiological, and experimental research pertaining to the adverse health effects of occupational exposure to respirable crystalline silica, including silicosis, other non-malignant respiratory disease (NMRD), lung cancer, and autoimmune and renal diseases. Using the information collected during this review, the Agency
Even though OSHA's risk assessment indicates that a significant risk also exists at the revised action level of 25 μg/m
As discussed below and in OSHA's Review of Health Effects Literature and Preliminary QRA (Document ID 1711, pp. 7-229), there is convincing evidence that inhalation exposure to respirable crystalline silica increases the risk of a variety of adverse health effects, including silicosis, NMRD (such as chronic bronchitis and emphysema), lung cancer, kidney disease, immunological effects, and infectious tuberculosis (TB). OSHA considers each of these conditions to be a material impairment of health. These diseases make it difficult or impossible to work and result in significant and permanent functional limitations, reduced quality of life, and sometimes death. When these diseases coexist, as is common, the effects are particularly debilitating (Rice and Stayner, 1995, Document ID 0418; Rosenman
OSHA considers silicosis, an irreversible and potentially fatal disease, to be a clear material impairment of health. The term “silicosis” refers to a spectrum of lung diseases attributable to the inhalation of respirable crystalline silica. As described more fully in the Review of Health Effects Literature (Document ID 1711, pp. 16-71), the three types of silicosis are acute, accelerated, and chronic. Acute silicosis can occur within a few weeks to months after inhalation exposure to extremely high levels of respirable crystalline silica. Death from acute silicosis can occur within months to a few years of disease onset, with the affected person drowning in his or her own lung fluid (NIOSH, 1996, Document ID 0840). Accelerated silicosis results from exposure to high levels of airborne respirable crystalline silica, and disease usually occurs within 5 to 10 years of initial exposure (NIOSH, 1996, Document ID 0840). Both acute and accelerated silicosis are associated with exposures that are substantially above the previous general industry PEL, although no precise information on the relationships between exposure and occurrence of disease exists.
Chronic silicosis is the most common form of silicosis seen today, and is a progressive and irreversible condition characterized as a diffuse nodular pulmonary fibrosis (NIOSH, 1996, Document ID 0840). Chronic silicosis generally occurs after 10 years or more of inhalation exposure to respirable crystalline silica at levels below those associated with acute and accelerated silicosis. Affected workers may have a dry chronic cough, sputum production, shortness of breath, and reduced pulmonary function. These symptoms result from airway restriction caused by the development of fibrotic scarring in the lower regions of the lungs. The scarring can be detected in chest x-ray films when the lesions become large enough to appear as visible opacities. The result is a restriction of lung volumes and decreased pulmonary compliance with concomitant reduced gas transfer. Chronic silicosis is characterized by small, rounded opacities that are symmetrically distributed in the upper lung zones on chest radiograph (Balaan and Banks, 1992, Document ID 0289, pp. 347, 350-351).
The diagnosis of silicosis is based on a history of exposure to respirable crystalline silica, chest radiograph findings, and the exclusion of other conditions that appear similar. Because workers affected by early stages of chronic silicosis are often asymptomatic, the finding of opacities in the lung is key to detecting silicosis and characterizing its severity. The International Labour Organization (ILO) International Classification of Radiographs of Pneumoconioses (ILO, 1980, Document ID 1063; 2002, 1064) is the currently accepted standard against which chest radiographs are evaluated for use in epidemiological studies, medical surveillance, and clinical evaluation. The ILO system standardizes the description of chest x-rays, and is based on a 12-step scale of severity and extent of silicosis as evidenced by the size, shape, and density of opacities seen on the x-ray film. Profusion (frequency) of small opacities is classified on a 4-point major category scale (0-3), with each major category divided into three, giving a 12-point scale between 0/− and 3/+. Large opacities are defined as any opacity greater than 1 cm that is present in a film (ILO, 1980, Document ID 1063; 2002, 1064, p. 6).
The small rounded opacities seen in early stage chronic silicosis (ILO major category 1 profusion) may progress (through ILO major categories 2 and/or 3) and develop into large fibrotic masses that destroy the lung architecture, resulting in progressive massive fibrosis (PMF). This stage of advanced silicosis is usually characterized by impaired pulmonary function, permanent disability, and premature death. In cases involving PMF, death is commonly attributable to progressive respiratory insufficiency (Balaan and Banks, 1992, Document ID 0289).
Patients with ILO category 2 or 3 background profusion of small opacities are at increased risk, compared to those with category 1 profusion, of developing the large opacities characteristic of PMF. In one study of silicosis patients in Hong Kong, Ng and Chan (1991, Document ID 1106, p. 231) found the risk of PMF increased by 42 and 64 percent among patients whose chest x-
Silicosis is the oldest known occupational lung disease and is still today the cause of significant premature mortality. As discussed further in Section V.E, Comments and Responses Concerning Surveillance Data on Silicosis Morbidity and Mortality, in 2013, there were 111 deaths in the U.S. where silicosis was recorded as an underlying or contributing cause of death on a death certificate (NCHS data). Between 1996 and 2005, deaths attributed to silicosis resulted in an average of 11.6 years of life lost by affected workers (NIOSH, 2007, Document ID 1362). In addition, exposure to respirable crystalline silica remains an important cause of morbidity and hospitalizations. National inpatient hospitalization data show that in the year 2011, 2,082 silicosis-related hospitalizations occurred, indicating that silicosis continues to be a significant health issue in the U.S. (Document ID 3577, Tr. 854-855). Although there is no national silicosis disease surveillance system in the U.S., a published analysis of state-based surveillance data from the time period 1987-1996 estimated that between 3,600-7,000 new cases of silicosis occurred in the U.S. each year (Rosenman
It has been widely reported that available statistics on silicosis-related mortality and morbidity are likely to be understated due to misclassification of causes of death (for example, as tuberculosis, chronic bronchitis, emphysema, or cor pulmonale), lack of occupational information on death certificates, or misdiagnosis of disease by health care providers (Goodwin
Although most workers with early-stage silicosis (ILO categories 0/1 or 1/0) typically do not experience respiratory symptoms, the primary risk to the affected worker is progression of disease with progressive decline of lung function. Several studies of workers exposed to crystalline silica have shown that, once silicosis is detected by x-ray, a substantial proportion of affected workers can progress beyond ILO category 1 silicosis, even after exposure has ceased (
The risk of silicosis carries with it an increased risk of reduced lung function as the disease irreversibly progresses. There is strong evidence in the literature for the finding that lung function deteriorates more rapidly in workers exposed to silica, especially those with silicosis, than what is expected from a normal aging process (Cowie, 1988, Document ID 0993; Hughes
Several studies have reported no decrease in pulmonary function with an ILO category 1 level of profusion of small opacities but found declines in pulmonary function with categories 2 and 3 (Ng
Moreover, exposure to respirable crystalline silica in and of itself, with or without silicosis, increases the risk that latent tuberculosis infection can convert to active disease. Early descriptions of dust diseases of the lung did not distinguish between TB and silicosis, and most fatal cases described in the first half of this century were a combination of silicosis and TB (Castranova
Based on the information presented above and in its review of the health literature, OSHA concludes that silicosis remains a significant cause of early death and of serious illness, despite the existence of an enforceable exposure limit over the past 40 years. Silicosis in its later stages of progression (
OSHA considers lung cancer, an irreversible and frequently fatal disease, to be a clear material impairment of health (
The Agency's primary evidence comes from evaluation of more than 50 studies of occupational cohorts from many different industry sectors in which exposure to respirable crystalline silica occurs, including: Granite and stone quarrying; the refractory brick industry; gold, tin, and tungsten mining; the diatomaceous earth industry; the industrial sand industry; and construction. In addition, the association between exposure to respirable crystalline silica and lung cancer risk was reported in a national mortality surveillance study (Calvert
Although many of the stakeholders in this rule have focused their attention on the evidence related to silicosis and lung cancer, the available evidence shows that exposure to respirable crystalline silica also increases the risk of developing NMRD, in particular chronic bronchitis and emphysema. OSHA has determined that NMRD, which results in loss of pulmonary function that restricts normal activity in individuals afflicted with these conditions (
Decrements in pulmonary function have often been found among workers exposed to respirable crystalline silica absent radiologic evidence of silicosis. Several cross-sectional studies have reported such findings among granite workers (Theriault
OSHA also evaluated several longitudinal studies where exposed workers were examined over a period of time to track changes in pulmonary function. Among both active and retired granite workers exposed to an average of 60 μg/m
Each of these studies reported their findings in terms of rates of decline in any of several pulmonary function measures, such as FVC, FEV
Finally, OSHA's review of the literature reflects substantial evidence that exposure to crystalline silica increases the risk of renal and autoimmune diseases, both of which OSHA considers to be material impairments of health (
In addition, there are a number of studies that show exposure to be related to increased risks of autoimmune disease, including scleroderma (
To evaluate the significance of the health risks that result from exposure to hazardous chemical agents, OSHA relies on epidemiological and experimental data, as well as statistical methods. The Agency uses these data and methods to characterize the risk of disease resulting from workers' exposure to a given hazard over a working lifetime at levels of exposure reflecting both compliance with previous standards and compliance with the new standard. In the case of respirable crystalline silica, the previous general industry, construction, and shipyard PELs were formulas that limit 8-hour TWA exposures to respirable dust; the limit on exposure decreased with increasing crystalline silica content of the dust. OSHA's previous general industry PEL for respirable quartz was expressed both in terms of a particle count and a gravimetric concentration, while the previous construction and shipyard employment PELs for respirable quartz were only expressed in terms of a particle count formula. For general industry, the gravimetric formula PEL for quartz approaches 100 µg/m
In this final rule, OSHA has established a uniform PEL for respirable crystalline silica by revising the PELs applicable to general industry, construction, and maritime to 50 μg/m
After reviewing the evidence and testimony in the record, OSHA has determined that it is appropriate to base its final risk estimates on the same studies and models as were used in the NPRM (
For silicosis morbidity risk estimates, OSHA relied on the cumulative risk models developed by investigators of five studies who conducted studies relating cumulative disease risk to cumulative exposure to respirable crystalline silica (
OSHA notes that the updated risk estimates are not substantially different from those presented in the Preliminary QRA; for example, for exposure at the previous general industry PEL approaching 100 μg/m
OSHA also presents in the table the excess lung cancer mortality risk associated with 45 years of exposure to the previous construction/shipyard PEL (in the range of 250 to 500 µg/m
OSHA's final risk estimates for renal disease reflect the 1998 background all-cause mortality and renal mortality rates for U.S. males, rather than the 2011 rates used for lung cancer and NMRD, as updated in the previous sections. Background rates were not adjusted for the renal disease risk estimates because the CDC significantly changed the classification of renal diseases after 1998; they are now inconsistent with those used by Steenland
OSHA notes that the key studies in its final risk assessment were composed of
For estimates of lung cancer risk from crystalline silica exposure, OSHA has relied upon studies of exposure-response relationships presented in a pooled analysis of 10 cohort studies (Steenland
The Steenland
Using ToxaChemica's study (2004, Document ID 0469) of this pooled data, the estimated excess lifetime lung cancer risk associated with 45 years of exposure to 100 μg/m
In addition to the pooled cohort study, OSHA's Final Quantitative Risk Assessment presents risk estimates in Table VI-1 derived from four individual studies where investigators presented either lung cancer risk estimates or exposure-response coefficients. Two of these studies, one on diatomaceous earth workers (Rice
Rice
Somewhat higher risk estimates are derived from the analysis presented by Attfield and Costello (2004, Document ID 0543) of Vermont granite workers. OSHA's use of this analysis yielded a risk estimate of 54 excess deaths per 1,000 workers for 45 years of exposure to the previous general industry PEL of 100 μg/m
Hughes
Miller and MacCalman (2010, Document ID 1306; also reported in Miller
OSHA based its quantitative assessment of silicosis mortality risks on a pooled analysis conducted by Mannetje
To study non-malignant respiratory diseases (NMRD), of which silicosis is one, Park
OSHA's analysis of the health effects literature included several studies that have demonstrated that exposure to respirable crystalline silica increases the risk of renal and autoimmune disease (
OSHA's Final Quantitative Risk Assessment is based on several cross-sectional studies designed to characterize relationships between exposure to respirable crystalline silica and development of silicosis as determined by chest radiography. Due to the long latency periods associated with silicosis, OSHA relied on those studies that were able to contact and evaluate many of the workers who had retired. OSHA believes that relying on studies that included retired workers comes closest to characterizing lifetime risk of silicosis morbidity. OSHA identified studies of six cohorts for which the inclusion of retirees was deemed sufficient to adequately characterize silicosis morbidity risks well past employment (Hnizdo and Sluis-Cremer, 1991, Document ID 1051; Steenland and Brown, 1995b, 0451; Miller
For miners exposed to freshly cut respirable crystalline silica, OSHA estimates the risk of developing lesions consistent with an ILO classification of category 1 or greater to range from 120 to 773 cases per 1,000 workers exposed at the previous general industry PEL of 100 μg/m
In this section, OSHA presents its final findings with respect to the significance of the risks summarized above and the potential of the proposed standard to reduce those risks. Findings related to mortality risk will be presented first, followed by silicosis morbidity risks.
OSHA's Final Quantitative Risk Assessment described above presents risk estimates for four causes of excess mortality: Lung cancer, silicosis, non-malignant respiratory disease (including silicosis), and renal disease. Table VI-1 above presents OSHA's estimated excess lifetime risks (
Assuming a 45-year working life, as OSHA has done in significant risk determinations for previous standards, the Agency finds that the excess risk of disease mortality related to exposure to respirable crystalline silica at levels permitted by the previous OSHA standards is clearly significant. The Agency's estimate of such risk falls well above the level of risk the Supreme Court indicated a reasonable person would consider unacceptable (
To further demonstrate significant risk, OSHA compares the risks at the former PELs and the revised PEL for respirable crystalline silica to risks found across a broad variety of occupations. OSHA also compares the lung cancer risk associated with the former PELs and revised PEL to the risks for other carcinogens OSHA regulates. The Agency has used similar occupational risk comparisons in the significant risk determinations for other substance-specific standards.
Fatal injury rates for most U.S. industries and occupations may be obtained from data collected by the Department of Labor's Bureau of Labor Statistics (BLS). Table VI-3 shows annual fatality rates per 1,000 employees for several industries for 2013, as well as projected fatalities per 1,000 employees assuming exposure to workplace hazards for 45 years based on these annual rates. While it is difficult to meaningfully compare aggregate industry fatality rates to the risks estimated in the quantitative risk assessment for respirable crystalline silica, which address one specific hazard (inhalation exposure to respirable crystalline silica) and several health outcomes (lung cancer, silicosis, NMRD, renal disease mortality), these rates provide a useful frame of reference for considering risk from inhalation exposure to crystalline silica. For example, OSHA's estimated range of 5-54 excess lung cancer deaths per 1,000 workers from regular occupational exposure to respirable crystalline silica in the range of 50-100 μg/m
Because there is little available information on the incidence of occupational cancer across all industries, risk from crystalline silica exposure cannot be compared with overall risk from other workplace carcinogens. However, OSHA's previous risk assessments provide estimates of risk from exposure to certain carcinogens. These risk assessments, as with the current assessment for respirable crystalline silica, were based on animal or human data of reasonable or high quality and used the best information then available. Table VI-4 shows the Agency's best estimates of cancer risk from 45 years of occupational exposure to several carcinogens, as published in the preambles to final rules promulgated since the
The estimated excess lung cancer mortality risks associated with respirable crystalline silica at the previous general industry PEL, 11-54 deaths per 1,000 workers, are comparable to, and in some cases higher than, the estimated excess cancer risks for many other workplace carcinogens for which OSHA made a determination of significant risk (
OSHA's risk assessment also shows that reduction of the PELs for respirable crystalline silica to the final level of 50 μg/m
For silicosis mortality, OSHA's assessment indicates that risk will be reduced by 36 percent and by 58-68 percent as a result of reducing the previous general industry and construction/shipyard PELs, respectively. NMRD mortality risks will be reduced by 48 percent and by 77-87 percent as a result of reducing the general industry and construction/shipyard PELs, respectively, to the new PEL. There is also a substantial reduction in renal disease mortality risks; an 18-percent reduction associated with reducing the previous general industry PEL and a 38-49 percent reduction associated with reducing the previous construction/shipyard PEL.
Thus, OSHA believes that the final PEL of 50 μg/m
OSHA's Final Quantitative Risk Assessment also characterizes the risk of developing silicosis, defined as developing lung fibrosis detected by chest x-ray. For 45 years of exposure at the previous general industry PEL of 100 μg/m
One study of coal miners also permitted the agency to evaluate the risk of developing lung fibrosis consistent with an ILO category 2+ degree of profusion of small opacities (Buchanan
Throughout the development of OSHA's risk assessment for silica-related health effects, sources of uncertainty and variability have been identified by the Agency, peer reviewers, interagency reviewers, stakeholders, scientific experts, and the general public. This subsection reviews and summarizes several general areas of uncertainty and variability in OSHA's risk assessment. As used in this section, “uncertainty” refers to lack of knowledge about factors affecting exposure or risk, and “variability” refers to heterogeneity, for example, across people, places, or time. For more detailed discussion and evaluation of sources of uncertainty in the risk assessment and a comprehensive review of comments received by OSHA on the risk assessment, (
As shown in Table VI-1, OSHA's risk estimates for lung cancer are a range derived from a pooled analysis of 10 cohort studies (Steenland
The risks presented in Table VI-1, however, do not reflect variability in the consistency, duration or frequency of workers' exposures. As discussed previously in this section, OSHA's final estimates of health risks represent risk associated with exposure to an 8-hour time weighted average of 25, 50, 100, 250 and 500 μg/m
The remainder of this discussion reviews several general areas of uncertainty and variability in OSHA's risk assessment that are not quantitatively reflected in the risk estimates shown in Table VI-1, but that provide important context for understanding these estimates, including differences in the degree of uncertainty among the estimates. These areas include exposure estimation error, dose-rate effects, model form uncertainty, variability in toxicological potency of crystalline silica, and additional sources of uncertainty specific to particular endpoints, (
As discussed in Section V, OSHA identified exposure estimation error as a key source of uncertainty in most of the studies and thus the Agency's risk assessment. OSHA's contractor, ToxaChemica, Inc., commissioned Drs. Kyle Steenland and Scott Bartell to perform an uncertainty analysis to examine the effect of uncertainty due to exposure estimation error in the pooled studies (Steenland
To explore the potential effects of both kinds of uncertainty described above, ToxaChemica, Inc. (2004, Document ID 0469) used the distributions representing the error in job-specific exposure assignment and the error in converting exposure metrics to generate 50 exposure simulations for each cohort. A study-specific coefficient and a pooled coefficient were fit for each new simulation. The results indicated that the only lung cancer cohort for which the mean of the exposure coefficients derived from the simulations differed substantially from the previously calculated exposure coefficient was the South African gold cohort (simulation mean of 0.181 vs. original coefficient of 0.582). This suggests that the results of exposure-response analyses conducted using the South African cohort are sensitive to error in exposure estimates; therefore, there is greater uncertainty due to potential exposure estimation error in an exposure-response model based on this cohort than is the case for the other nine cohorts in Steenland
For the pooled analysis, the mean coefficient estimate from the simulations was 0.057, just slightly lower than the previous estimate of 0.060. Based on these results, OSHA concluded that random error in the underlying exposure estimates in the Steenland
Following the same procedures described above for the lung cancer analysis, ToxaChemica, Inc. (2004, Document ID 0469) combined both sources of random measurement error in a Monte Carlo analysis of the silicosis mortality data from Mannetje
OSHA received comments citing uncertainty in its risk assessment related to possible dose-rate effects in the silica exposure-response relationships, particularly for silicosis. For example, the ACC commented that extrapolating risks from the high mean exposure levels in the Park
The rationale for OSHA's reliance on a cumulative exposure metric to assess the risks of respirable crystalline silica is discussed in Section V. With respect to this issue of uncertainty related to dose-response effects, OSHA finds limited evidence in the record to either support or refute the effects hypothesized by the ACC. As such, OSHA acknowledges some uncertainty. Furthermore, use of an alternative metric such as concentration would not provide assurance that uncertainties would be mitigated or reduced.
Two studies discussed in OSHA's Review of Health Effects Literature and Preliminary QRA examined dose-rate effects on silicosis exposure-response (Document ID 1711, pp. 342-344). Neither study found a dose-rate effect relative to cumulative exposure at silica concentrations near the previous OSHA PEL (Document ID 1711, pp. 342-344). However, they did observe a dose-rate effect in instances where workers were exposed to crystalline silica concentrations far above the previous PEL (
The Buchanan
Based on its review of these studies, OSHA concluded that there is little evidence that a dose-rate effect exists at concentrations in the range of the previous PEL (100 μg/m
Another source of uncertainty in OSHA's risk analysis is uncertainty with respect to the form of the statistical models used to characterize the relationship between exposure level and risk of adverse health outcomes. As discussed in Section V, some commenters expressed concern that studies relied on by OSHA may not have considered all potential exposure-response relationships and might be unable to discern differences between monotonic and non-monotonic characteristics (
OSHA acknowledges that the possibility of error in selection of exposure-response model forms is a source of uncertainty in the silica risk assessment. To address this uncertainty, the Agency included studies in the risk assessment that explored a variety of model forms. For example, as discussed in Section V, the ToxaChemica reanalyses of the Mannetje
As discussed in Section V, OSHA has reviewed the best available evidence on the relationship between silica exposure and lung cancer mortality, and has concluded that the weight of evidence supports the finding that exposure to silica at the preceding and new PELs increases the risk of lung cancer. However, OSHA acknowledges that not every study in the literature on silica-related lung cancer reached the same conclusions. This variability is to be expected in epidemiology, as there are different cohorts, measurements, study designs, and analytical methods, among other factors. OSHA further acknowledges that there is uncertainty with respect to the magnitude of the risk of lung cancer from silica exposure. In the case of silica, the exposure-response relationship with lung cancer may be easily obscured, as crystalline silica is a comparably weaker carcinogen (
A study by Vacek
As discussed in Section V, OSHA acknowledges that there are considerably less data for renal disease mortality than those for silicosis, lung cancer, and non-malignant respiratory disease (NMRD) mortality. Although the Agency believes the renal disease risk findings are based on credible data, the risk findings based on them are less robust than the findings for silicosis, lung cancer, and NMRD.
Based upon its overall analysis of the literature, including the negative studies, OSHA has concluded that there is substantial evidence suggesting an association between exposure to crystalline silica and increased risks of renal disease. This conclusion is supported by a number of case reports and epidemiological studies that found statistically significant associations between occupational exposure to silica dust and chronic renal disease (Calvert
As discussed in detail in Section V, OSHA concludes that the evidence supporting causality regarding renal risk outweighs the evidence casting doubt on that conclusion, but acknowledges this divergence in the renal disease literature as a source of uncertainty.
OSHA estimated quantitative risks for renal disease mortality (Document ID 1711, pp. 314-316) using data from a pooled analysis of renal disease, conducted by Steenland
OSHA's final quantitative risk assessment includes risk estimates for silicosis mortality and morbidity. Silicosis mortality is ascertained by analysis of death certificates for cause of death, and morbidity is ascertained by the presence of chest radiographic abnormalities consistent with silicosis among silica-exposed workers. Each of these kinds of studies are associated with uncertainties in case ascertainment and use of chest roentgenograms to detect lung scarring due to silicosis.
For silicosis mortality, OSHA's analysis includes a pooled analysis of six epidemiological studies first published by Mannetje
OSHA's estimates of silicosis morbidity risks are based on studies of active and retired workers for which exposure histories could be constructed and chest x-ray films could be evaluated for signs of silicosis. There is evidence in the record that chest x-ray films are relatively insensitive to detecting lung fibrosis. Hnizdo
As discussed in Section V, the toxicological potency of crystalline silica is influenced by a number of physical and chemical factors that affect the biological activity of inhaled silica particles. The toxicological potency of crystalline silica is largely influenced by the presence of oxygen free radicals on the surfaces of respirable particles. These chemically-reactive oxygen species interact with cellular components in the lung to promote and sustain the inflammatory reaction responsible for the lung damage associated with exposure to crystalline silica. The reactivity of particle surfaces is greatest when crystalline silica has been freshly fractured by high-energy
In the preamble to the proposed standard, OSHA preliminarily concluded that although there is evidence that several environmental influences can modify surface activity to either enhance or diminish the toxicity of silica, the available information was insufficient to determine to what extent these influences may affect risk to workers in any particular workplace setting (Document 1711, p. 350). OSHA acknowledges that health risks are probably in the low end of the range for workers in the brick manufacturing industry, although the evidence still indicates that there is a significant risk at the previous general industry PEL for those workers. OSHA also acknowledges that there was a lack of evidence for a significant risk in the sorbent minerals industry due to the nature of crystalline silica present in those operations; as a result, it decided to exclude sorptive clay processing from this rule. Furthermore, Dudley and Morriss (2015) raise concerns about the whether the exposures reflected in the historical cohorts used in the risk assessment are sufficiently reflective of rapidly changing working conditions over the last 45 years.
OSHA received several comments pertaining to the Agency's determination of a significant risk of material impairment of health posed to workers exposed for a working life to the previous PELs. Although many of these comments were supportive of OSHA's conclusions regarding the significance of risk, others were critical or suggested that OSHA has an obligation to further reduce the risk below that estimated to remain at the revised PEL.
Referring to the previous PELs for respirable crystalline silica, the AFL-CIO commented that “[w]orkers face a significant risk of harm from silica exposure at the current permissible exposure limits,” and that “[t]here is overwhelming evidence in the record that exposure to respirable crystalline silica poses a significant health risk to workers” (Document ID 4204, pp. 10-11). The AFL-CIO noted that OSHA's mortality risk estimates well exceeded the benchmark of 1/1,000 excess risk over a working lifetime of exposure to the previous PELs, and also highlighted the risks of silicosis morbidity (Document ID 4204, p. 13). The AFL-CIO further pointed out that there is no cure for silicosis, and quoted oral testimony from workers at the informal public hearings demonstrating that “[s]ilica-related diseases are still destroying workers' lives and livelihoods” (Document ID 4204, p. 19).
Both the UAW and the Building and Construction Trades Department (BCTD) concurred with the AFL-CIO that the previous PEL needs to be lowered to adequately protect workers. Referring to the previous PEL, the BCTD stated that “[t]he record supports OSHA's determination that exposures at the current PEL present a significant risk” (Document ID 4223, p. 6). Although supportive of OSHA's proposed standard, the UAW also suggested the adoption of a PEL of 25 µg/m
As discussed above, OSHA acknowledges that there remains a significant risk of material impairment of health at the revised PEL; a further reduction in the PEL, however, is not currently technologically feasible (see Section VII, Summary of the Final Economic Analysis and Final Regulatory Flexibility Analysis, in which OSHA summarizes its assessment of the technological feasibility of the revised PEL). Despite this, the final PEL will provide a very substantial reduction in the risk of material impairment of health to silica-exposed workers, as described in the
In contrast to the foregoing comments from labor groups contending that OSHA would be setting the PEL too high if it made a final determination to lower the preceding PELs to 50 µg/m
In summary, as discussed throughout Section V and this final rule, OSHA concludes, based on the best available evidence in the scientific literature, that workers' exposure to respirable crystalline silica at the previous PELs results in a clearly significant risk of material impairment of health. The serious, and potentially fatal, health effects suffered by exposed workers include silicosis, lung cancer, NMRD, renal disease, and autoimmune effects. OSHA finds that the risk is substantially decreased, though still significant, at the new PEL of 50 µg/m
OSHA's Final Economic Analysis and Final Regulatory Flexibility Analysis (FEA) addresses issues related to the costs, benefits, technological and economic feasibility, and the economic impacts (including impacts on small entities) of this final respirable crystalline silica rule and evaluates regulatory alternatives to the final rule. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The full FEA has been placed in OSHA rulemaking docket OSHA-2010-0034. This rule is an economically significant regulatory action under Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by executive order.
The purpose of the FEA is to:
• Identify the establishments and industries potentially affected by the final rule;
• Estimate current exposures and the technologically feasible methods of controlling these exposures;
• Estimate the benefits resulting from employers coming into compliance with the final rule in terms of reductions in cases of silicosis, lung cancer, other forms of chronic obstructive pulmonary disease, and renal failure;
• Evaluate the costs and economic impacts that establishments in the regulated community will incur to achieve compliance with the final rule;
• Assess the economic feasibility of the final rule for affected industries; and
• Assess the impact of the final rule on small entities through a Final Regulatory Flexibility Analysis (FRFA), to include an evaluation of significant regulatory alternatives to the final rule that OSHA has considered.
OSHA changed the FEA for several reasons:
• Changes to the rule, summarized in Section I of this preamble and discussed in detail in the Summary and Explanation;
• Comments on the Preliminary Economic Analysis (PEA);
• Updates of economic data; and
• Recognition of errors in the PEA.
OSHA revised its technological and economic analysis in response to these changes and to comments received on the NPRM. The FEA contains some costs that were not included in the PEA and updates data to use more recent data sources and, in some cases, revised methodologies. Detailed discussions of these changes are included in the relevant sections throughout the FEA.
The FEA contains the following chapters:
Table VII-1 provides a summary of OSHA's best estimate of the costs and estimated benefits of the final rule using a discount rate of 3 percent. As shown, the final rule is estimated to prevent 642 fatalities and 918 silica-related illnesses annually once it is fully effective, and the estimated cost of the rule is $1,030 million annually. Also as shown in Table VII-1, the discounted monetized benefits of the final rule are estimated to be $8.7 billion annually, and the final rule is estimated to generate net benefits of $7.7 billion annually. Table VII-1 also presents the estimated costs and estimated benefits of the final rule using a discount rate of 7 percent.
The remainder of this section (Section VII) of the preamble is organized as follows:
Employees in work environments addressed by the final silica rule are exposed to a variety of significant hazards that can and do cause serious injury and death. As described in Chapter II of the FEA in support of the final rule, OSHA concludes there is a failure of private markets to protect workers from exposure to unnecessarily high levels of respirable crystalline silica and that private markets, as well as information dissemination programs, workers' compensation systems, and
After carefully weighing the various potential advantages and disadvantages of using a regulatory approach to improve upon the current situation, OSHA concludes that, in the case of silica exposure, the final mandatory standards represent the best choice for reducing the risks to employees. In addition, rulemaking is necessary in this case in order to replace older existing standards with updated, clear, and consistent health standards.
Chapter III of the FEA presents profile data for industries potentially affected by the final silica rule. The discussion below summarizes the findings in that chapter. As a first step, OSHA identifies the North American Industrial Classification System (NAICS) industries, both in general industry and maritime and in the construction sector, with potential worker exposure to silica. Next, OSHA provides summary statistics for the affected industries, including the number of affected entities and establishments, the number of workers whose exposure to silica could result in disease or death (“at-risk workers”), and the average revenue for affected entities and establishments.
The methodological basis for the industry and at-risk worker data presented in this chapter comes from the PEA, the Eastern Research Group (ERG) analysis supporting the PEA (2007a, 2007b, 2008a, and 2008b),
In the NPRM and PEA, OSHA invited the public to submit additional information and data that might help improve the accuracy and usefulness of the preliminary industry profile; the profile presented here and in Chapter III of the FEA reflects public comment.
The technological feasibility analyses presented in Chapter IV of the FEA identify the general industry and maritime sectors and the construction activities potentially affected by the final silica standard.
Employees engaged in various activities in general industry and maritime routinely encounter crystalline silica as a molding material, as an inert mineral additive, as a component of fluids used to stimulate well production of oil or natural gas, as a refractory material, as a sandblasting abrasive, or as a natural component of the base materials with which they work. Some industries use various forms of silica for multiple purposes. As a result, employers are faced with the challenge of limiting worker exposure to silica in dozens of job categories throughout the general industry and maritime sectors.
Job categories in general industry and maritime were selected for analysis based on data from the technical industrial hygiene literature, evidence from OSHA Special Emphasis Program (SEP) results, and, in several cases, information from ERG site visit reports and public comment submitted into the record. These data sources provided evidence of silica exposures in numerous sectors. While the available data are not entirely comprehensive, OSHA believes that silica exposures in other sectors are quite limited.
The industry subsectors in the overall general industry and maritime application groups that OSHA identified as being potentially affected by the final silica standard are as follows:
In some cases, affected industries presented in the technological feasibility analysis have been disaggregated to facilitate the cost and economic impact analysis. In particular, flat glass, mineral wool, and other glass products are subsectors of the glass industry described in Chapter IV, Section IV-9, of the FEA, and captive foundries,
As described in ERG (2008b, Document ID 1365) and updated in OSHA (2016), OSHA identified the six-digit NAICS codes for these subsectors to develop a list of industries potentially affected by the final silica standard. Table VII-2 presents the sectors listed above with their corresponding six-digit NAICS industries. The NAICS codes and associated industry definitions in the FEA are consistent with the 2012 NAICS edition.
The construction sector is an integral part of the nation's economy, accounting for approximately 4.5 percent of total private sector employment. Establishments in this industry are involved in a wide variety of activities, including land development and subdivision, homebuilding, construction of nonresidential buildings and other structures, heavy construction work (including roadways and bridges), and a myriad of special trades such as plumbing, roofing, electrical, excavation, and demolition work.
Construction activities were selected for analysis based on historical data of recorded samples of construction worker exposures from the OSHA Integrated Management Information System (IMIS) and the National Institute for Occupational Safety and Health (NIOSH). In addition, OSHA reviewed the industrial hygiene literature across the full range of construction activities and focused on dusty operations where silica sand was most likely to be fractured or abraded by work operations. These physical processes have been found to cause the silica exposures that pose the greatest risk of silicosis for workers.
The construction activities, by equipment or task, that OSHA identified as being potentially affected by the final silica standard are as follows:
As shown in OSHA (2016) and in Chapter IV of the FEA, these construction activities occur in the following industries and governmental bodies, accompanied by their four-digit NAICS codes:
Table VII-3 provides an overview of the industries and estimated number of workers affected by the final rule. Included in Table VII-3 are summary statistics for each of the affected industries, subtotals for construction and for general industry and maritime, and grand totals for all affected industries combined.
The first five columns in Table VII-3 identify the NAICS code for each industry in which workers are routinely exposed to respirable crystalline silica and the name or title of the industry, followed by the total number of entities, establishments, and employees for that industry. Note that, while the industries are characterized by such exposure, not every entity, establishment, and employee in these affected industries engage in activities involving silica exposure.
The next three columns in Table VII-3 show, for each affected industry, the number of entities and establishments in which workers are actually exposed to silica and the total number of workers exposed to silica. The number of affected establishments was set equal to the total number of establishments in an industry (based on Census data) unless the number of affected establishments would exceed the number of affected employees in the industry. In that case, the number of affected establishments in the industry was set equal to the number of affected employees, and the number of affected entities in the industry was reduced so as to maintain the same ratio of entities to establishments in the industry.
As shown in Table VII-3, OSHA estimates that a total of 652,600 entities (586,800 in construction; 65,900 in general industry and maritime), 675,800 establishments (600,700 in construction; 75,100 in general industry and maritime), and 2.3 million workers (2.0 million in construction; 0.3 million in general industry and maritime) would be affected by the final silica rule. Note that only 67 percent of the entities and establishments, and about 21 percent of the workers in affected industries,
The ninth column in Table VII-3, with data only for construction, shows for each affected NAICS construction industry the number of full-time-equivalent (FTE) affected workers that corresponds to the total number of affected construction workers in the previous column.
The last three columns in Table VII-3 show combined total revenues for all entities (not just affected entities) in each affected industry, and the average revenue per entity and per establishment in each affected industry. Because OSHA did not have data to distinguish revenues for affected entities and establishments in any industry, average revenue per entity and average revenue per affected entity (as well as average revenue per establishment and average revenue per affected establishment) are estimated to be equal in value.
The technological feasibility analyses presented in Chapter IV of the FEA contain data and discussion of worker exposures to silica throughout industry. Exposure profiles, by job category, were developed from individual exposure measurements that were judged to be substantive and to contain sufficient accompanying description to allow interpretation of the circumstance of each measurement. The resulting exposure profiles show the job categories with current overexposures to silica and, thus, the workers for whom silica controls would be implemented under the final rule.
Chapter IV of the FEA includes a section with a detailed description of the methods used to develop the exposure profile and to assess the technological feasibility of the final standard. The final exposure profiles take the exposure data that were used for the same purpose in OSHA's PEA and build upon them, using new data in the rulemaking record. The sampling data that were used to identify the affected industries and to develop the exposure profiles presented in the PEA were obtained from a comprehensive review of the following sources of information: OSHA compliance inspections conducted before 2011, OSHA contractor (ERG) site visits performed for this rulemaking, NIOSH site visits, NIOSH Health Hazard Evaluation reports (HHEs), published literature, submissions by individual companies or associations and, in a few cases, data from analogous operations (Document ID 1720, pp. IV-2-IV-3). The exposure profiles presented in the PEA were updated for the FEA using exposure measurements from the OSHA Information System (OIS) that were taken during compliance inspections conducted between 2011 and 2014 (Document ID 3958). In addition, exposure data submitted to the record by rulemaking participants were used to update the exposure profiles. The criteria used for determining whether to include exposure data in the exposure profiles are described in Section IV-2—Methodology in Chapter IV of the FEA. As explained there, some of the original data are no longer used in the exposure profiles based on those selection or screening criteria. OSHA considers the exposure data relied upon for its analysis to be the best available evidence of baseline silica exposure conditions.
Table VII-4 summarizes, from the exposure profiles, the total number of workers at risk from silica exposure at any level, and the distribution of 8-hour TWA respirable crystalline silica exposures by job category for general industry and maritime sectors and for construction activities. Exposures are grouped into the following ranges: Less than 25 μg/m
Table VII-5 presents data by NAICS code—for each affected general, maritime, and construction industry—on the estimated number of workers currently at risk from silica exposure, as well as the estimated number of workers at risk of silica exposure at or above 25 μg/m
In Chapter IV of OSHA's FEA, OSHA assesses the technological feasibility of the standard in all affected industry sectors and application groups. The analysis presented in this chapter is organized by industry sectors in general industry and maritime and by application groups in the construction industry. Employee exposures were analyzed at the operation, job category or task/activity level to the extent that the necessary data were available.
The technological feasibility analysis informed OSHA's selection of the rule's permissible exposure limit (PEL) of 50 µg/m
OSHA must prove a reasonable possibility that the typical firm will be able to develop and install engineering and work practice controls that can meet the PEL in most of its operations. . . . The effect of such proof is to establish a presumption that industry can meet the PEL without relying on respirators. . . . Insufficient proof of technological feasibility for a few isolated operations within an industry, or even OSHA's concession that respirators will be necessary in a few such operations, will not undermine this general presumption in favor of feasibility. Rather, in such operations firms will remain responsible for installing engineering and work practice controls to the extent feasible, and for using them to reduce . . . exposure as far as these controls can do so
Additionally, the D.C. Circuit explained that “[f]easibility of compliance turns on whether exposure levels at or below [the PEL] can be met in most operations most of the time . . . ” (
Consistent with the legal standard described above, Chapter IV of the FEA, which can be found at
As noted above, OSHA's technological feasibility analysis for this rule largely involved describing engineering and work practice controls that OSHA concludes can be expected to control respirable crystalline silica exposures to the PEL or below. For this portion of the analysis, OSHA relied on information and exposure measurements from many different sources, including OSHA's inspection database (OSHA Information System (OIS)), OSHA inspection reports, National Institute of Occupational Safety and Health (NIOSH) reports, site visits by NIOSH and OSHA's contractor, Eastern Research Group, Inc. (ERG), and materials from other federal agencies, state agencies, labor organizations, industry associations, and other groups. In addition, OSHA reviewed studies from the published literature that evaluated the effectiveness of engineering controls and work practices in order to estimate the reductions from current, baseline exposures to silica that can be achieved through wider or improved implementation of such controls. Finally, OSHA considered the extensive testimony and numerous comments regarding the feasibility of implementing engineering and work practice controls, including circumstances that preclude the use of controls in certain situations. In total, OSHA's feasibility analysis is based on hundreds of sources of information in the record, constituting one of the largest databases of information OSHA has used to evaluate the feasibility of a health standard.
The technological feasibility chapter of the FEA describes the industry sectors and application groups affected by the rule, and identifies the sources of exposure to respirable crystalline silica for each affected job category or task. The technological feasibility analysis subdivides the general industry and maritime workplaces into 24 industry sectors.
For the construction industry, OSHA identified application groups based on construction activities, tasks, or equipment that are commonly recognized to create silica exposures; these tasks involve the use of power tools (
OSHA developed exposure profiles for each sector and application group in order to characterize the baseline exposures and conditions for each operation or task (
The exposure profiles characterize what OSHA considers to be the baseline, or current, exposures for each job category or application group. Where sufficient information on control measures was available, the exposure profiles were subdivided into sample results with and without controls and the controls were discussed in the baseline conditions section. OSHA also discusses the sampling results associated with specific controls in the baseline conditions section. In these cases, the exposure profiles include exposures associated with a range of controlled and uncontrolled exposure scenarios.
The
In general industry and maritime, the exposure profiles in the technological feasibility analysis consist mainly of full-shift samples, collected over periods of 360 minutes or more (
In the construction industry, approximately 43 percent of the sampling data used in the exposure profiles also consisted of samples collected over periods of 360 minutes or more. Most of the samples (approximately 70%, or an additional 27%) in the construction industry exposure profiles were collected over periods of 240 minutes or more (
The Construction Industry Safety Coalition (CISC), comprised of 25 trade associations, was critical of several aspects of OSHA's feasibility analysis. CISC objected to the assumption of zero exposure for the unsampled portion of the work shift when calculating 8-hour TWAs for the construction exposure profiles. It claimed that assuming zero exposure underestimated TWA exposure levels when compared with the alternative assumption used for general industry that the exposure level measured during the sampled time period remained at the same level during the unsampled period (Document ID 2319, pp. 21-25). While there would be some uncertainty whichever assumption OSHA used, OSHA concludes that the no-exposure assumption for unsampled portions of a shift produces a more accurate result than the assumption of continued exposure at the same level because of the widely-recognized differences in work patterns between general industry and construction operations. In general industry, most operations are at a fixed location and involve manufacturing processes that remain relatively constant over a work shift. Also, most of the sample durations in general industry were 360 minutes or longer, and therefore were more likely to be representative of 8-hour TWA exposures. In contrast, construction work is much more variable with respect to the location of the work site, the number of different tasks performed, and the duration of tasks performed. As stated above, tasks that generate exposure to respirable crystalline silica in construction are often performed on an intermittent basis (
OSHA's conclusion that the variability in sample durations for the samples taken by OSHA in the construction industry more accurately reflects the variability in exposure duration for these activities thus comports with empirical experience. An assumption that exposure levels during short-term tasks continued for the entire work shift would substantially overestimate the actual 8-hour TWA exposures. The Building and Construction Trades Department, AFL-CIO (BCTD) supported OSHA's assumptions on work patterns, stating “OSHA correctly treated the unsampled time as having `zero exposure' in its technological feasibility assessment” (Document ID 4223, pp. 16-17). Its conclusion was based on research performed by The Center to Protect Workers' Rights, which developed a task-based exposure assessment model for the construction industry that combines air sampling with task observations and task durations in order to assess construction workers' exposure to workplace hazards (Susi,
CISC also commented that OSHA did not account for the varying amounts of crystalline silica that could exist in materials being disturbed by employees, and that OSHA did not account for differences in exposure results “due solely to what part of the country the activity took place in” (Document ID 2319, pp. 26-27). OSHA has determined that the sampling data relied on to establish baseline silica exposures are representative of the range of silica content in materials worked on by construction workers. Information on the percent silica content of the respirable dust sampled was available for 588 of the 881 samples used in the exposure profiles for construction tasks. The silica content in these samples ranged from less than 1 percent (non-detect) to 50 percent, with an average silica content of 9.1 percent. Thus, the sample results in the exposure profiles reflect the range in the silica content of the respirable dust sampled by OSHA at construction work sites. Similarly, the exposure profiles contain exposure results from many different construction tasks taken in a variety of locations around the country under different weather conditions. Therefore, OSHA concludes that the exposure data used in the exposure profiles are the best available evidence of actual exposures in construction representing nationwide weather patterns, and that these data reflect the broad range of silica exposures experienced by employees in the construction industry.
Each section in the technical feasibility analysis presented in Chapter
In particular, OSHA evaluated information and testimony from the record on the effectiveness of engineering and work practice controls and either: (1) Identified controls that have been demonstrated to reduce exposures to 50 μg/m
For general industry and maritime, the additional engineering controls and work practices identified by OSHA consist of equipment and approaches that are widely available and are already used in many applications. In some cases, the same technology can be transferred or adapted to similar operations in other industry sectors covered under the scope of this rule. Such controls and work practices include implementing and maintaining local exhaust ventilation (LEV) systems with dust collection systems (such as integrated material transfer stations); enclosing a conveyor of silica-containing material or other containment systems; worker isolation; process modifications; dust suppression, systems such as water sprays; and housekeeping. In many cases, a combination of controls is necessary to control exposures to silica. In general industry, enclosed and ventilated equipment is often already in use. For example, most paint and coating production operations have switched from manual transfer of raw materials containing crystalline silica to integrated bag dumping stations equipped with well-ventilated enclosures and bag compactors (
For construction, the exposure controls contained in Table 1 of the rule consist primarily of water-based dust suppression systems, and LEV systems that are integrated into hand tools and heavier equipment. As shown in Chapter IV of the FEA, such systems are commercially available from several vendors. In addition, equipment such as filtered, ventilated booths or cabs and water-based systems for suppressing fugitive dust generated by crushers and heavy equipment are available to control exposures of construction workers to respirable crystalline silica.
OSHA received numerous comments that disputed OSHA's preliminary conclusion in the Notice of Proposed Rulemaking (NPRM) that a PEL of 50 μg/m
As explained in Pertinent Legal Authority (Section II of this preamble to the final rule), a finding that a standard is technologically feasible requires that “provisions such as exposure measurement requirements must also be technologically feasible” (
Since the late 1960s, exposures to respirable crystalline silica (hereinafter referred to as “silica”) have typically been measured using personal respirable dust samplers coupled with laboratory analysis of the crystalline silica content of the collected airborne dust. The laboratory analysis is usually performed using X-ray diffraction (XRD) or infrared spectroscopy (IR). A colorimetric method of analysis that was used by a few laboratories has now been phased out (Harper
The ability of current sampling and analytical methods to accurately measure worker exposures to respirable crystalline silica was a subject of much comment in the rulemaking record. In particular, the Chamber of Commerce (Chamber) and American Chemistry Council (ACC) submitted comments and testimony maintaining that existing methods do not measure respirable crystalline silica exposures with sufficient accuracy to support OSHA's proposal in the Notice of Proposed Rulemaking to reduce the PEL to 50 μg/m
OSHA is basing its conclusions on the following findings, which are described in detail in this section. First, although there is variation in the performance of respirable dust samplers, studies have demonstrated that, for the majority of work settings, samplers will perform with an acceptable level of bias (as defined by international standards) as measured against internationally recognized particle-size selection criteria that define respirable dust samplers. This means that the respirable dust mass collected by the sampler will be reasonably close to the mass that would be collected by an ideal sampler that exactly matches the particle-size selection criteria. In addition, OSHA finds that the measure of precision of the analytical methods for samples collected at crystalline silica concentrations equal to the revised PEL and action level is only somewhat higher (
Several rulemaking participants commented that OSHA's analysis of the feasibility of sampling and analytical methods for crystalline silica was well supported and sound (Document ID 2080, pp. 3-4; 2244, p. 3; 2371, Attachment 1, p. 5; 3578, Tr. 941; 3586, Tr. 3284; 3577, Tr. 851-852; 4214, pp. 12-13; 4223, pp. 30-33). Gregory Siwinski, CIH, and Dr. Michael Lax, Medical Director of Upstate Medical University, an occupational health clinical center, commented that current laboratory methods can measure respirable crystalline silica at the 50 μg/m
The ACC, Chamber, and others base their argument that sampling and analytical methods for respirable crystalline silica are insufficiently precise on strict adherence to NIOSH's accuracy criterion of ±25 percent at a 95-percent confidence level for chemical sampling and analysis methods (
In the remainder of this section, OSHA first describes available respirable dust sampling methods and
Respirable dust comprises particles small enough that, when inhaled, they are capable of reaching the pulmonary region of the lung where gas exchange takes place. Measurement of respirable dusts requires the separation of particles by size to assess exposures to the respirable fraction of airborne dusts. A variety of different industrial hygiene sampling devices, such as cyclones and elutriators, have been developed to separate the respirable fraction of airborne dust from the non-respirable fraction. Cyclones are the most commonly used size-selective sampling devices, or “samplers,” for assessing personal exposures to respirable dusts such as crystalline silica. The current OSHA (ID-142, revised December 1996, Document ID 0946) and NIOSH (Method 7500, Document ID 0901; Method 7602, 0903; Method 7603,
Although respirable dust commonly refers to dust particles having an aerodynamic diameter of 10 μm (micrometer) or less, it is more precisely defined by the collection efficiency of the respiratory system as described by a particle collection efficiency model. These models are often depicted by particle collection efficiency curves that describe, for each particle size range, the mass fraction of particles deposited in various parts of the respiratory system. These curves serve as the “yardsticks” against which the performance of cyclone samplers should be compared (Vincent, 2007, Document ID 1456). Figure VII-1 below shows particle collection efficiency curves for two particle size selection criteria: The criteria specified in the 1968 American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) for respirable dust, which was the basis for the prior OSHA general industry silica PEL, and an international specification by the International Organization for Standardization (ISO) and the Comité Européen de Normalisation (CEN) known as the ISO/CEN convention, which was adopted by ACGIH in 1994 and is the basis for the definition of respirable crystalline silica in the final rule. In addition to the curves, which cover the full range of particle sizes that comprise respirable dust, particle size collection criteria are also often described by their 50-percent respirable “cut size” or “cut point.” This is the aerodynamic diameter at which 50 percent of the particle mass is collected,
For most workplace conditions, the change in the criteria for respirable dust in the final rule would theoretically increase the mass of respirable dust collected over that measured under the previous criteria by an amount that depends on the size distribution of airborne particles in the workplace. Soderholm (1991, Document ID 1661) examined these differences based on 31 aerosol size distributions measured in various industrial workplaces (
Incorporating the ISO/CEN convention in the definition of respirable crystalline silica will permit employers to use any sampling device that conforms to the ISO/CEN convention. There are a variety of these cyclone samplers on the market, such as the Dorr-Oliver, Higgins-Dewell (HD), GK2.69, SIMPEDS, and SKC aluminum. In the PEA, OSHA reviewed several studies demonstrating that these samplers collect respirable particles with efficiencies that closely match the ISO/CEN convention (Document ID 1720, pp. IV-21—IV-24). In addition to cyclone samplers, there are also personal impactors available for use at flow rates from 2 to 8 L/min that have been shown to conform closely with the ISO/CEN convention (Document ID 1834, Attachment 1). Cyclones and impactors both separate particles by size based on inertia. When an airstream containing particles changes direction, smaller particles remain suspended in the airstream and larger ones impact a surface and are removed from the airstream. Cyclones employ a vortex to separate particles centrifugally, while impactors use a laminar airflow around a flat surface such that particles in the desired size range impact onto the surface.
The current OSHA sampling method for crystalline silica, ID-142, is the method used by OSHA to enforce the silica PELs and is used by some employers as well. It specifies that a respirable sample be collected by drawing air at 1.7 ± 0.2 liters/minute (L/min) through a Dorr-Oliver 10 millimeter (mm) nylon cyclone attached to a cassette containing a 5-μm pore-size, 37-mm diameter polyvinyl chloride (PVC) filter (Document ID 0946). NIOSH sampling and analysis methods for crystalline silica (Method 7500, Method 7602, Method 7603) have also adopted the ISO/CEN convention with flow rate specifications of 1.7 L/min for the Dorr-Oliver 10-mm nylon cyclone and 2.2 L/min for the HD cyclone (Document ID 0901; 0903). Method 7500 also allows for the use of an aluminum cyclone at 2.5 L/min. NIOSH is revising its respirable dust method to include any sampler designed to meet the ISO/CEN criteria (Document ID 3579, Tr. 218).
The devices discussed above, when used at the appropriate flow rates, are capable of collecting a quantity of respirable crystalline silica that exceeds the quantitative detection limit for quartz (the principle form of crystalline silica) of 10 μg for OSHA's XRD method (Document ID 0946). For several scenarios based on using various devices and sampling times (8-hour, 4-hour, and 1-hour samples), OSHA calculated the amount of respirable quartz that would be collected at quartz concentrations equal to the existing general industry PEL, the proposed (and now final) rule's PEL, and the proposed (and now final) rule's action level. As seen in Table IV.3-A, computations show that the 10-mm nylon Dorr-Oliver operated at an optimized flow rate of 1.7 L/min, the aluminum cyclone operated at 2.5 L/min, the HD cyclone operated at 2.2 L/min, and the GK2.69 operated at 4.2 L/min will all collect enough quartz during an 8-hour or 4-hour sampling period to meet or exceed the 10 µg quartz limit of quantification for OSHA Method ID-142. Therefore, each of the commercially available cyclones is capable of collecting a sufficient quantity of quartz to exceed the limit of quantification when airborne concentrations are at or below the action level, provided that at least 4-hour air samples are taken. Table VII-7 also shows that the samplers can collect enough silica to meet the limit of quantification when the airborne respirable silica concentration is below the action level of 25 μg/m
A comment from the National Rural Electric Cooperative Association (NRECA) stated that the current OSHA and NIOSH analytical methods require sampling to collect a minimum of 400 liters of air, and that at the flow rates specified for current samplers, sampling would have to be performed for approximately 2.5 to 4 hours; however, this is considerably longer than most construction tasks performed in electrical transmission and distribution work, which tend to last 2 hours or less (Document ID 2365, pp. 2, 6-7). OSHA does not view this discrepancy to be a problem. The minimum sampling times indicated in the OSHA and NIOSH methods contemplate that exposure occurs over most of the work shift. Construction operations frequently involve shorter-term tasks after which there is no further exposure to respirable crystalline silica. In those situations, OSHA often does not itself continue sampling during inspections and does not expect employers to continue sampling when there is no exposure to silica, and considers the sampling result that is obtained from shorter-term task sampling to be sufficient to represent a worker's 8-hour time-weighted-average (TWA) exposure, which can be calculated assuming no exposure for the period of the shift that is not sampled. If the airborne concentration of silica for the task is low, the sampling result would likely be below the limit of quantification. In that case, it would be safe for the employer to assume that the exposure is below the action level.
In the final rule, OSHA is adopting the ISO/CEN particle size-selective criteria for respirable dust samplers used to measure exposures to respirable crystalline silica. Under the ISO/CEN convention, samplers should collect 50 percent of the mass of particles that are 4 μm in diameter (referred to as the cut point), with smaller particles being collected at higher efficiency and larger particles being collected at lower efficiency. Particles greater than 10 μm in diameter, which are not considered to be respirable, are to be excluded from the sample based on the ISO/CEN convention (Document ID 1446, pp. 112-113).
Several rulemaking participants supported OSHA's proposed adoption of the ISO/CEN criteria for respirable dust samplers (Document ID 1730; 1969; 3576, Tr. 290; 3579, Tr. 218-219; 4233, p. 4). For example, a representative of SKC, Inc., which manufactures samplers used to collect respirable crystalline silica, stated that:
Adoption of the ISO/CEN performance standard for respirable dust samplers by OSHA will bring the U.S. regulatory standards in line with standards/guidelines established by other occupational health and safety agencies, regulatory bodies, and scientific consensus organizations around the world. It will also align OSHA performance criteria for respirable dust samplers to that of NIOSH (Document ID 1730, pp. 1-2).
As discussed above, OSHA's previous (and currently enforceable) general industry PEL for crystalline silica was based on a 1968 ACGIH definition, which specified a model with a cut point of 3.5 μm. Based on available studies conducted over 40 years ago, the Dorr-Oliver 10-mm cyclone was thought to perform closely to this specification. As such, it is the sampling device specified in OSHA's respirable dust sampling and analytical methods, including Method ID-142 for respirable crystalline silica (Document ID 0946). For most sizes of respirable particles, the ISO/CEN convention specifies a greater efficiency in particle collection than does the 1968 ACGIH model; consequently, samplers designed to meet the ISO/CEN convention will capture somewhat greater mass of airborne particle than would a sampler designed to the 1968 ACGIH model, with the magnitude of the increased mass dependent on the distribution of particle sizes in the air. For most particle size distributions encountered in workplaces, the increase in dust mass theoretically collected under the ISO/CEN convention compared to the ACGIH model would be 25 percent or less (Soderholm, 1991, Document ID 1661).
Several rulemaking participants commented that moving from the 1968 ACGIH model to the ISO/CEN convention effectively decreased the PEL and action level below the levels intended, since more dust would be collected by samplers that conform to
Other rulemaking participants argued that moving to the ISO/CEN convention effectively invalidates OSHA's risk and feasibility analyses since the exposure data that underlie these analyses were obtained using devices conforming to the 1968 ACGIH specification. For example, Thomas Hall, testifying for the Chamber, stated that moving to the ISO/CEN convention “would produce a difference in [current] exposure results from . . . historical measurements that have been used in the risk assessments” (Document ID 3576, Tr. 435). Similarly, in its pre-hearing comments, the ACC argued that:
When OSHA conducted technological feasibility studies for attaining the proposed 50 μg/m
OSHA rejects these arguments for the following reasons. First, with respect to the risk information relied on by the Agency, exposure data used in the various studies were collected from employer records reflecting use of several different methods. Some studies estimated worker exposures to silica from particle counts, for which the sampling method using impingers does not strictly conform to either the ACGIH or ISO/CEN conventions (
Second, with respect to the feasibility analysis, OSHA relied on exposure data and constructed exposure profiles based principally on measurements made by compliance officers using the Dorr-Oliver cyclone operated at 1.7 L/min, as the Agency has done since Method ID-142 was developed in 1981, well before the 1990 cut-off date for data used to construct the exposure profiles. As explained earlier in the section, recent research shows that the Dorr-Oliver cyclone operated at this flow rate performs in a manner consistent with the ISO/CEN specification. Other data relied on by OSHA comes from investigations and studies conducted by NIOSH and others who used various cyclones that conform to the ISO/CEN specification. Thus, OSHA finds that the exposure profiles being relied on to evaluate feasibility and costs of compliance do not reflect sample results obtained using the 1968 ACGIH model. Instead, the vast majority of sample results relied upon were collected in a manner consistent with the requirements of the final rule. NIOSH supported this assessment, stating that, given the Dorr-Oliver sampler operated at a flow rate of 1.7 L/min conforms closely to the ISO/CEN convention, “there is continuation with historic exposure data” (Document ID 4233, p. 4). For these reasons, OSHA finds that it is appropriate to rely on the feasibility and cost analyses and underlying exposure data without adjustment to account for the final rule's adoption of the ISO/CEN specification for respirable dust samplers.
Several commenters raised issues concerning the accuracy of respirable dust samplers in relation to the ISO/CEN criteria, asserting that sampling respirable dust is uncertain and inaccurate, and that there are numerous sources of error. Chief among these were Dr. Thomas Hall of Industrial Hygiene Specialty Resources, LLC, testifying for the Chamber, and Paul K. Scott of ChemRisk, testifying for the ACC.
The Chamber's witnesses and others referenced studies showing that all samplers were biased against the ISO/CEN particle-size selection convention. This means that the sampler would collect more or less mass of respirable particulate than would an ideal sampler
Dr. Hall commented that “sampling results differ depending on the choice of sampler used” and that published evaluations have shown that they “have different collection efficiencies, specifically with respect to particle collection in aerosol clouds with large [MMADs greater than] 10 μm” (Document ID 2285, p. 16). He cited the work of Gorner
The ACC's witness, Mr. Scott, noted several potential sources of sampling error in addition to the conventional 5-percent pump flow rate error that is included in OSHA's estimate of sampling and analytical error (SAE, discussed further in Section IV-3.2.4—Precision of Measurement). These included variation in performance of the same cyclone tested multiple times (estimated at 6 percent) and variation between different cyclones tested in the same environment (estimated at 5 percent) (Document ID 2308, Attachment 6, pp. 7-8). Based on published estimates of the magnitude of these kinds of errors, Mr. Scott estimated a total sampling error of 9.3 percent after factoring in pump flow rate error, inter-sampler error, and intra-sampler error; this would increase the SAE by 4 percent, for example, from 15 to 19 percent at 50 μg/m
As described above, many different respirable dust samplers have been evaluated against the ISO/CEN convention for different particle size distributions and, in general, these biases are small for the vast majority of particle size distributions encountered in the workplace. OSHA concludes that Mr. Scott's estimate likely overstates the true total sampling error somewhat because the measurements of sampler bias against the ISO/CEN criteria involve accurately measuring and maintaining consistent pump flow rates during the testing of the samplers; therefore, adding pump flow rate error to estimates of inter- and intra-sampler measurement error is redundant. Furthermore, if an employer relies on a single type of cyclone sampler, as is OSHA's practice, there would be no inter-sampler variability between different field samples. If an employer is concerned about this magnitude of uncertainty, he or she can choose simply to use the same sampling device as OSHA (
The American Foundry Society (AFS) commented that the ASTM Standard D4532 for respirable dust sampling includes errors for sampling, weighing, and bias, none of which is included in OSHA's pump flow rate error (Document ID 2379, p. 29). This ASTM standard describes procedures for sampling respirable dust using a 10-mm cyclone, HD cyclone, or aluminum cyclone in a manner identical to that prescribed in the OSHA and NIOSH methods for sampling and analysis of silica. Thus, the kinds of errors identified by AFS are the same as those reflected in Mr. Scott's testimony described above, which, as OSHA has
OSHA further observes that the kinds of sampling errors described by rulemaking participants are independent of where the PEL is established and are not unique to silica; these biases have existed since OSHA began using the Dorr-Oliver cyclone to enforce the previous PELs for crystalline silica, as well as many other respirable dust standards, over 40 years ago. OSHA also believes that sampling error within the range quantified by Mr. Scott would be unlikely to change how an employer makes risk management decisions based on monitoring results. One Chamber witness, Gerhard Knutson, President of Knutson Ventilation, testified that the type of cyclone used to obtain exposure measurements for crystalline silica was not typically a consideration in designing industrial ventilation systems (Document ID 3576, Tr. 521-522). Dr. Hall, another Chamber witness, also testified that he has used all three sampling devices listed in the NIOSH Method 7500 and has not historically made a distinction between them, though he might make different decisions today based on the aerosol size distribution encountered in a particular workplace (Document ID 3576, Tr. 522-523). In his pre-hearing submission, Dr. Hall cited the Gorner
OSHA's PEA also described high-flow samplers, in particular the GK2.69 from BGI, Inc., which is run at a flow rate of 4.2 L/min in contrast to 1.7 L/min for the Dorr-Oliver and 2.5 L/min for the aluminum cyclone. High-flow devices such as this permit a greater amount of dust to be collected in low-dust environments, thus improving sensitivity and making it more likely that the amount of silica collected will fall within the range validated by current analytical methods. For example, a Dorr-Oliver run at 1.7 L/min where the silica concentration is 50 μg/m
The performance of high-flow samplers has been extensively studied, particularly by Lee
The Lee
Lee
Lee
Stacey
Mr. Scott testified that the high-flow samplers (including the GK2.69) studied by Lee
Dr. Hall expressed a similar concern as Mr. Scott. He cited Lee
OSHA notes that both Dr. Hall and Mr. Scott focus their comments regarding the performance of high-flow samplers on environments where the particle size distribution is characterized by larger particles and small variance (GSD). The findings by Lee
Mr. Scott, testifying for the ACC, was of the opinion that, although high-flow samplers have been evaluated by Gorner
OSHA does not agree with the implication that, until high-flow samplers have been evaluated according to the NIOSH (1995) protocol, the findings from the studies described above are not sufficient to permit an assessment of sampler performance. The NIOSH Guidelines cited by Mr. Scott state that “[a]n experimental design for the evaluation of sampling and analytical methods has been suggested. If these experiments are not applicable to the method under study, then a revised experimental design should be prepared which is appropriate to fully evaluate the method” (
URS Corporation, on behalf of the ACC, commented that precision will not be improved by the use of high-flow samplers because filter loadings of interferences will increase along with the amount of crystalline silica; this would, in URS's opinion, necessitate additional sample handling procedures, such as acid washing, that erode precision. URS also argued that such samples may require analysis of multiple peaks and that overall X-ray intensity may be diminished due to increased filter load (Document ID 2307, Attachment 12, p. 3). In its post-hearing brief, the ACC stated that the use of high-volume samplers “in addition to traditional Dorr-Oliver sampler” would reduce inter-laboratory precision (
OSHA finds that these arguments are unsupported. Although the high-flow sampler will collect more dust than lower-flow samplers in the same environment, the relative proportion of any interfering materials collected to the amount of crystalline silica collected would remain unchanged. Thus, there should be no increased effect from the interfering materials relative to the silica. OSHA recognizes that, to prevent undue interference or diminished X-ray intensity, it is important to keep the dust load on the filter within reasonable limits. Both OSHA and NIOSH methods stipulate a maximum sample weight to be collected (3 mg for OSHA and 2 mg for NIOSH) (Document ID 0946, p. 5; 0901, p. 3), and in the event that excess sample is collected, the sample can be split into portions and each portion analyzed separately (Document ID 0946, p. 5). In environments where using a high-flow sampler is likely to collect more than the maximum sample size, use of a lower-flow sampler is advised. In response to the concern that permitting use of high-flow samplers will affect inter-laboratory variability, OSHA observes that employers are already using a variety of commercially available samplers, such as those listed in the NIOSH Method 7500, to obtain exposure samples; not everyone uses the Dorr-Oliver sampler. Thus, for the final rule, OSHA is permitting employers to use any sampling device that has been designed and calibrated to conform to the ISO/CEN convention, including higher-flow samplers such as the GK2.69. In effect, this is a continuation of well-studied current practice, not an untested departure from it.
Crystalline silica is analyzed in the laboratory using either X-ray diffraction (XRD) or infrared spectroscopy (IR). A third method, colorimetric spectrophotometry, is no longer used (Document ID 3579, Tr. 211; Harper
For XRD, a dust sample that has been collected by a sampler is deposited on a silver-membrane filter and scanned by the X-ray beam, where X-rays diffract at specific angles. A sensor detects these diffracted X-ray beams and records each diffracted beam as a diffraction peak. Unique X-ray diffraction patterns are created when the diffraction peaks are plotted against the angles at which they occur. The intensity of the diffracted X-ray beams depends on the amount of crystalline silica present in the sample, which can be quantified by comparing the areas of the diffraction peaks obtained with those obtained from scanning a series of calibration standards prepared with known quantities of an appropriate reference material. Comparing multiple diffraction peaks obtained from the sample with those obtained from the calibration standards permits both quantitative and qualitative confirmation of the amount and type of crystalline silica present in the sample (
The OSHA Technical Manual lists the following substances as potential interferences for the analysis of crystalline silica using XRD: Aluminum phosphate, feldspars (microcline, orthoclase, plagioclase), graphite, iron carbide, lead sulfate, micas (biotite, muscovite), montmorillonite, potash, sillimanite, silver chloride, talc, and zircon (
The nationally recognized analytical methods using XRD include OSHA ID-142, NIOSH 7500, and MSHA P-2 (Document ID 0946; 0901; 1458). All are based on the XRD of a redeposited thin-layered sample with comparison to standards of known concentrations (Document ID 0946, p. 1; 0901, p. 1; 1458, p. 1). These methods, however, differ on diffraction peak confirmation strategies. The OSHA and MSHA methods require at least three diffraction peaks to be scanned (Document ID 0946, p. 5; 1458, p. 13). The NIOSH method only requires that multiple peaks be qualitatively scanned on representative bulk samples to determine the presence of crystalline silica and possible interferences, and quantitative analysis of air samples is based on a single diffraction peak for each crystalline silica polymorph analyzed (Document ID 0901, pp. 3, 5).
Infrared spectroscopy is based on the principle that molecules of a material will absorb specific wavelengths of infrared electromagnetic energy that match the resonance frequencies of the vibrations and rotations of the electron bonds between the atoms making up the material. The absorption of IR radiation by the sample is compared with the IR absorption of calibration standards of known concentration to determine the amount of crystalline silica in the sample. Using IR can be efficient for routine analysis of samples that are well
Interferences from silicates and other minerals can affect the accuracy of IR results. The electromagnetic radiation absorbed by silica in the infrared wavelengths consists of broad bands. In theory, no two compounds have the same absorption bands; however, in actuality, the IR spectra of silicate minerals contain silica tetrahedra and have absorption bands that will overlap. If interferences enhance the baseline measurement and are not taken into account, they can have a negative effect that might underestimate the amount of silica in the sample. Compared with XRD, the ability to compensate for these interferences is limited (Document ID 1720, pp. IV-29—IV-30).
The sensitivity of an analytical method or instrument refers to the smallest quantity of a substance that can be measured with a specified level of accuracy, and is expressed as either the LOD or the “Limit of Quantification” (LOQ). These two terms have different meanings. The LOD is the smallest amount of an analyte that can be detected with acceptable confidence that the instrument response is due to the presence of the analyte. The LOQ is the lowest amount of analyte that can be reliably quantified in a sample and is higher than the LOD. These values can vary from laboratory to laboratory as well as within a given laboratory between batches of samples because of variation in instrumentation, sample preparation techniques, and the sample matrix, and must be confirmed periodically by laboratories.
At a concentration of 50 µg/m
The rule's 50 µg/m
That XRD analysis of quartz from samples prepared from reference materials can achieve LODs and LOQs between 5 and 10 µg was not disputed in the record. Of greater concern to several rulemaking participants was the effect of interfering materials potentially present in a field sample on detection limits and on the accuracy of analytical methods at low filter loads when interferences are present. Although the Chamber's witness, Robert Lieckfield of Bureau Veritas Laboratories, did not dispute that laboratories could achieve this level of sensitivity (Document ID 3576, Tr. 485-486), the ACC took issue with this characterization of method sensitivity stating that “the LOQ for real world samples containing interferences is likely to be higher than the stated LOQ's for analytical methods, which are determined using pure NIST samples with no interferences” (Document ID 4209, p. 132). Both Mr. Lieckfield and Mr. Scott testified that the presence of interferences in samples can increase the LOQ and potential error of measurement at the LOQ (Document ID 2259, p. 7; 3460, p. 5).
Mr. Scott (Document ID 2308, Attachment 6, p. 5) cited a laboratory performance study by Eller
The presence of interferences can adversely affect the sensitivity and precision of the analysis, but typically only when the interference is so severe that quantification of crystalline silica must be made from secondary and tertiary diffraction peaks (Document ID 0946, p. 6). However, OSHA finds no evidence that interferences usually present serious quantification problems. First, there are standard protocols in the OSHA, NIOSH, and MSHA methods that deal with interferences. According to OSHA Method ID-142,
Software developed by instrument manufacturers and techniques such as acid washing of the sample when interferences are suspected to be present are also useful in resolving interferences. The Chamber's expert witness, Mr. Lieckfield, acknowledged that it was also their practice at his lab to chemically treat samples from the start to remove interfering materials and to analyze multiple diffraction peaks to resolve interferences (Document ID 3576, Tr. 533, 542). According to OSHA's representative from the SLTC, it is “nearly always possible” to eliminate interferences and is it no more difficult to obtain precise measurements when
ACC also cites the results of a round-robin performance study that it commissioned, in which five laboratories were provided with crystalline silica samples with and without interfering materials (Document ID 4209, p. 132). These laboratories reported non-detectable levels of silica for 34 percent of the filters having silica loadings of 20 μg or more. However, as discussed below in the section on inter-laboratory variability (Section IV-3.2.5—Measurement Error Between Laboratories), OSHA has determined that this study is seriously flawed and, in particular, that there was systematic bias in the results, possibly due to sample loss. This could explain the high prevalence of reported non-detectable samples by the laboratories, rather than the presence of interferences
Furthermore, OSHA's review of the several hundred inspection reports relied on to evaluate the technological feasibility of the final rule's PEL in many industry sectors does not show that investigators have particular difficulty in measuring respirable crystalline silica concentrations below the PEL. Sections IV-4 and IV-5 of this chapter contain hundreds of exposure measurement results in a wide variety of workplace settings that were detected and reported by a laboratory as being above detectable limits but below the PEL or action level. If, as ACC suggests, interferences have a profound effect on the ability to measure concentrations in this range, many of these samples might have been reported as “less than the LOD,” with the reported LOD in the range of 25 μg to 50 μg. Examination of the exposure data described in Sections IV-4 and IV-5 of this chapter shows clearly that this is not the case (
Therefore, OSHA finds that the presence of interfering substances on field samples will not, most of the time, preclude being able to detect concentrations of respirable crystalline silica in the range of the PEL and action level, and that such instances where this might occur are rare. Accordingly, even when the presence of interfering substances is taken into account, worker exposure is capable of being measured with a reasonable degree of sensitivity and precision.
All analytical methods have some random measurement error. The statistics that describe analytical error refer to the amount of random variation in measurements of replicate sets of samples containing the same quantity of silica. This variation is expressed as a standard deviation about the mean of the measurements. The relative standard deviation (RSD), a key statistic used to describe analytical error, is calculated by dividing the standard deviation by the mean for a data set. The RSD is also known as the coefficient of variation (CV).
When random errors are normally distributed, a 95-percent confidence interval can be calculated as X
OSHA also uses a statistic called the Sampling and Analytical Error (SAE) to assist compliance safety and health officers (CSHOs) in determining compliance with an exposure limit. The estimate of the SAE is unique for each analyte and analytical method, and must be determined by each laboratory based on its own quality control practices. At OSHA's Salt Lake Technical Center (SLTC), where analytical methods are developed and air samples taken for enforcement purposes are analyzed, the SAE is based on statistical analysis of results of internally prepared quality control samples. Sampling and analytical components are assessed separately, where CV
The current SLTC SAE for crystalline silica is approximately 0.17, according to testimony from a representative of SLTC (Document ID 3579, Tr. 95). OSHA uses the SAE in its enforcement of PELs, where the PEL times the SAE is added to the PEL for a substance and compared to a sample result (
OSHA's quality control samples, which were prepared and analyzed at SLTC, demonstrate that the XRD method has acceptable precision, even at the low range of filter loads (50 μg). For the period April 2012 through April 2014, SLTC's analysis of 348 quality control samples, with a range of filter loads of about 50 to 250 μg crystalline silica, showed average recovery (
The ACC raised several questions regarding OSHA's Method ID-142 and
While OSHA's published Method ID-142 reports an Overall Analytical Error of 26 percent, OSHA no longer uses this statistic (it is in the process of revising Method ID-142); the Agency provides measures of precision and SAE instead. The Overall Analytical Error, which is described in Method ID-142, published in 1996, included a bias term that is now corrected for in the data used to determine method precision, so there is no longer a need to include a bias term in the estimation of analytical error. As described above, the precision of Method ID-142 is about 21 percent based on recent quality control samples.
In comments submitted on behalf of the Chamber, Mr. Lieckfield cited the NIOSH Manual of Analytical Methods, Chapter R, as stating that “current analysis methods do not have sufficient accuracy to monitor below current exposure standards” (Document ID 2259, p. 1). However, this is contradicted by NIOSH's own post-hearing submission, which stated that, although method variability was assessed based on the exposure limits at that time (
At the time of the proposal, there was little data characterizing the precision of analytical methods for crystalline silica at filter loads in the range of the PEL and action level (
The ACC believed that OSHA's reliance on the 2013 study was “misplaced” because the results were not representative of “real world” samples that contain interfering minerals that could increase analytical error, and because the studies did not account for inter-laboratory variability (Document ID 4209, pp. 135-137; 2308, Attachment 6, p. 10). The ACC also believed that variability would have been depressed in this study because the samples were analyzed in close temporal proximity by the same analyst and using the same instrument calibration, and the study involved only 10 samples at each filter load (Document ID 4209, pp. 137-138; 2308,
Despite the criticism that OSHA's investigation involved a small number of samples analyzed at the same time, the results obtained were comparable to OSHA's analysis of quality control samples at somewhat higher filter loads (between 50 and 51.6 μg) analyzed over a two-year period (Document ID 3764, Attachment 1). These results, described above, showed a precision of 20.7 percent, compared to 17 and 19 percent for quartz filter loads of 40 and 20 μg, respectively (Document ID 1847, Attachment 1; Document ID 3764). From these results, OSHA concludes that any effect on analytical error from performing a single study using the same analyst and instrument calibration is modest.
OSHA also concludes that Mr. Scott's argument that particle size effects were not taken into account is without merit. The samples prepared and analyzed in OSHA's study, like any laboratory's quality control samples, use standard materials that have a narrow range in particle size. Although large (non-respirable) size particles can result in an overestimate of crystalline silica content, in practice this is not typically a serious problem with air samples and is more of a concern with analyzing bulk samples. First, as discussed above, respirable dust samplers calibrated to conform to the ISO/CEN convention are collecting respirable particulate and excluding larger particles (Document ID 3579, Tr. 219). In analyzing field samples, OSHA uses microscopy to identify whether larger particles are present and, if they are, the results are reported as a bulk sample result so as not to be interpreted as an airborne exposure (Document ID 3579, Tr. 213). Additionally, OSHA's Method ID-142 calls for grinding and sieving bulk samples to minimize particle size effects in the analysis (Document ID 0946, p. 13). OSHA also notes that the Chamber's witness, Mr. Lieckfield, testified that his laboratory does not check for oversized particles (Document ID 3576, p. 483).
With regard to interferences, as discussed above, there are procedures that have been in place for many years to reduce the effect of interfering materials in the analysis. The presence of interferences does not typically prevent an analyst from quantifying crystalline silica in a sample with reasonable precision. As to the claim regarding XRD versus IR, a recent study of proficiency test data, in which multiple laboratories are provided comparable silica samples, both with and without interfering materials added, did not find a meaningful difference in precision between laboratories using XRD and those using IR (Harper
With respect to the ACC's and Mr. Scott's reference to inter-laboratory variation in silica sample results, OSHA discusses data and studies that have evaluated inter-laboratory variance in analytical results in the next section.
The sources of random and systematic error described above reflect the variation in sample measurement experienced by a single laboratory; this is termed intra-laboratory variability. Another source of error that affects the reliability of results obtained from sampling and analytical methods is inter-laboratory variability, which describes the extent to which different laboratories may obtain disparate results from analyzing the same sample. Inter-laboratory variability can be characterized by using data from proficiency testing, where laboratories analyze similarly-prepared samples and their results are compared. In practice, however, it is difficult to separate intra- and inter-laboratory variability because each laboratory participating in a proficiency test provides analytical results that reflect their own degree of intra-laboratory variability. Thus, use of proficiency test data to compare performance of laboratories in implementing an analytical method is really a measure of total laboratory variability.
The best available source of data for characterizing total variability (which includes an inter-laboratory variability component) of crystalline silica analytical methods is the AIHA Industrial Hygiene Proficiency Analytical Testing (PAT) Program. The AIHA PAT Program is a comprehensive testing program that provides an opportunity for laboratories to demonstrate competence in their ability to accurately analyze air samples through comparisons with other labs. The PAT program is designed to help consumers identify laboratories that are deemed proficient in crystalline silica analysis.
Crystalline silica (using quartz only) is one of the analytes included in the proficiency testing program. The AIHA PAT program evaluates the total variability among participating laboratories based on proficiency testing of specially prepared silica samples. The AIHA contracts the preparation of its crystalline silica PAT samples to an independent laboratory that prepares four PAT samples in the range of about 50 to 225 μg (Document ID 3586, Tr. 3279-3280) and one blank sample for each participating laboratory per round. Each set of PAT samples with the same sample number is prepared with as close to the same mass of crystalline silica deposited on the filter as possible. However, some variability occurs within each numbered PAT sample set because of small amounts of random error during sample preparation. Before the contract laboratory distributes the round, it analyzes a representative lot of each numbered set of samples to ensure that prepared samples are within ±10 percent (Document ID 3586, Tr. 3276). The samples are distributed to the participating laboratories on a quarterly basis (Document ID 1720, p. IV-36). The PAT program does not specify the particular analytical method to be used. However, the laboratory is expected to analyze the PAT samples using the methods and procedures it would use for normal operations.
The results of the PAT sample analysis are reported to the AIHA by the participating laboratories. For each PAT round, AIHA compiles the results and establishes upper and lower performance limits for each of the four sample results based on the mean and RSD of the sample results. For each of the four samples, a reference value is defined as the mean value from a selected set of reference laboratories. The RSD for each of the four samples is determined from the results reported by the reference labs after correcting for outliers (generally clear mistakes in analysis or reporting, particularly those that are order-of-magnitude errors) (Document ID 4188, p. 2). A participating laboratory receives a passing score if at least three out of the four sample results reported are within 20 percent of the reference mean for the sample (Document ID 3586, Tr. 3291).
In the PEA, OSHA presented PAT results from its SLTC for the period June 2005 through February 2010 (PAT Rounds 160-180) (Document ID 1720, pp. IV-40-41). The mean recovery was 99 percent, with a range of 55 to 165 percent. Eighty-one percent of the samples analyzed over this period were within ±25 percent of the reference mean and the RSD for this set of samples was 19 percent, showing reasonable agreement with the reference mean. OSHA also evaluated PAT data from all participating laboratories for the period April 2004 through June 2006 (PAT Rounds 156-165) (Document ID 1720, pp. IV-37—IV-40). Overall, the mean lab RSD was 19.5 percent for the sample range of 49 to 165 μg. Beginning with Round 161, PAT samples were prepared by liquid deposition rather than by sampling a generated silica aerosol, in order to improve consistency and reduce errors in sample preparation. The improvement was reflected in the results, with the mean lab RSD declining from 21.5 percent to 17.2 percent after the change to liquid deposition, demonstrating the improved consistency between PAT samples.
In the time since OSHA analyzed the PAT data, Harper
Despite the improvement seen with the change in deposition method, it is important to understand that the observed variation in PAT results between labs still reflects some sample preparation error (limited to ±10 percent as explained above), a source of error not reflected in the analysis of field samples. Other factors identified by the investigators that account for the improved performance include the phasing out of the colorimetric method among participating labs, use of more appropriate calibration materials (
OSHA finds that this study provides substantial evidence that employers will obtain reliable results from analysis of respirable crystalline silica most of the time for the purpose of evaluating compliance with the PEL. From Round 162 through 194 (after the deposition method was changed), and over the full range of PAT data, only about 7 out of the 128 (5 percent) lab RSD values reported were above 25 percent (Document ID 3404, Figure 2). For filter loads of 75 μg or less, only 3 lab RSD values out of about 30 reported, were above 25 percent. As stated above, the mean RSD at a filter load of 50 μg was less than 25 percent and agreement between labs improved substantially compared to earlier PAT data.
Summary data for PAT samples having a target load of less than 62.5 μg were provided by AIHA in a post-hearing comment (Document ID 4188) and compared with the findings reported by Harper
In its post hearing comments, the National Stone, Sand & Gravel Association (NSSGA) contended that analytical laboratories cannot provide adequately precise and accurate results of silica samples (Document ID 4232). NSSGA provided a detailed analysis of low-load samples from the same 15 PAT rounds as examined by AIHA (Document ID 4188) and concluded that “employers and employees cannot rely on today's silica sampling and analytical industry for consistently accurate sample results necessary to achieve or surpass compliance requirements” (Document ID 4232, p. 26). The NSSGA compared individual labs' sample results to the reference mean for each sample and found, from the AIHA PAT data, that 76-84 percent of the results were within 25 percent of the reference mean, and the range of results reported by laboratories included clear outliers, ranging from zero to several-fold above the target filter load (Document ID 4232, p. 8, Table 1, rows 1-6). NSSGA concluded from this that “[i]t is of little value to employers that a given lab's results meet the NIOSH Accuracy Criterion while other labs' results cannot, particularly since employers almost certainly won't know which labs fall into which category” (Document ID 4232, p. 10). NSSGA's point appears to be that the outliers in the PAT data erode an employer's ability to determine if they are receiving accurate analytical results, without which they have little ability to determine their compliance status with respect to the PEL or action level. Further, NSSGA suggests that OSHA's analysis of the PAT data, discussed above, is not adequate to demonstrate the performance of an individual
In response to NSSGA's criticism, OSHA points out that its analysis of the PAT data was part of its analysis of technological feasibility in which the Agency's legal burden is to show that employers can achieve compliance in most operations most of the time. It may be an unavoidable fact that lab results may be inaccurate some of the time, but that does not render the standard infeasible or unenforceable. OSHA contends that its analysis has satisfied that burden and nothing in the NSSGA's comments suggests otherwise.
NSSGA further suggests that employers have no means of determining, based on a laboratory's PAT proficiency rating alone, whether that individual laboratory is likely to produce erroneously high or low results. OSHA concurs that selecting a laboratory based on accreditation, price, and turnaround time, as NSSGA suggests (Document ID 4232, p. 5), is common but may be inadequate to determine whether an individual laboratory is capable of producing results of consistently high quality. Employers and their industrial hygiene consultants can, and should, ask additional questions and request additional assurances of quality from the laboratories they consider using. For example, employers can ask to review the laboratory's individual PAT results over time, focusing on and questioning any significant outliers in the laboratory's results. While NSSGA suggests that the PAT results are treated as confidential by the AIHA-PAT program (Document ID 4232, p. 6), there is nothing stopping a laboratory from sharing its PAT data or any other information related to its accreditation with their clients or prospective clients.
Further, laboratories routinely perform statistical analyses of their performance in the context of analyzing known samples they use for equipment calibration, and often perform statistical comparisons among the various technicians they employ. Review of these statistics can shed light on the laboratory's ability to provide consistent analysis. Finally, as employers conduct exposure monitoring over time, and come to understand what results are typically seen in their workplaces, clear outliers should become more identifiable; for example, if employee exposures are usually between the action level and PEL, and a sample result shows an exposure significantly above the PEL without any clear change in workplace conditions or operations, employers should question the result and ask for a reanalysis of the sample. Employers could also request gravimetric analysis for respirable dust against which to compare the silica result to confirm that the silica content of the dust is consistent with past experience. For example, if, over time, an employer's consistent results are that the silica content of respirable dust generated in its workplace is 20 percent silica, and subsequently receives a sample result that indicates a significantly higher or lower silica content, it would be appropriate for the employer to question the result and request reanalysis. Therefore, OSHA rejects the idea that employers are at the mercy of random chance and have to simply accept a high degree of uncertainty in exposure measurements; rather, there are positive steps they can take to reduce that uncertainty.
Results from the AIHA PAT program were discussed at considerable length during the rulemaking proceeding. After considering all of the analyses of PAT data presented by Eller
To support its contention that reliably measuring silica at the final rule's PEL and action level is not possible, the ACC cited Harper
Finally, the ACC sponsored a performance testing study to assess inter-laboratory variability at crystalline silica filter loads at 40 and 20 μg (
The samples were initially prepared on 5 μm PVC filters; however, due to sample loss during preparation, RJ Lee changed to 0.8 μm PVC filters. It should be noted that the 2-propanol used to suspend the Min-U Sil sample for deposition onto the 0.8 μm filter dissolved between 50 and 100 μg of filter material, such that the amount of minerals deposited on the filter could not be verified from the post-deposition filter weights. In addition, two of the labs had difficulty dissolving these filters in tetrahydrofuran, a standard method used to dissolve PVC filters in order to redeposit the sample onto silver membrane filters for XRD analysis. These labs were replaced by two laboratories that used muffle furnaces to ash the filters before redeposition, as
Results reported from the labs showed a high degree of both intra- and inter-laboratory variability as well as a systematic negative bias in measured vs. applied silica levels, with mean reported silica values more than 30 percent lower than the deposited amount. Across all laboratories, mean results reported for filter loads of 20, 40, and 80 μg were 13.36, 22.93, and 46.91 μg, respectively (Document ID 2307, Attachment 14, pp. 5-6). In addition, laboratories reported non-detectable results for about one-third of the silica samples (Document ID 2307, Attachment 14, p. 7) and two blank filters sent to the labs were reported to have silica present, in one case an amount of 52 μg (Document ID 2307, Attachment 14, pp. 9-10; 3582, Tr. 1995). Individual CVs for the labs ranged from 20 to 66 percent, up to more than 3 times higher than the CVs reported by OSHA or NIOSH for their respective methods. After examining variability in reported results, the investigators concluded that two-fold differences in filter load could not be reliably distinguished in the concentration range of 25 to 100 μg/m
OSHA identifies several deficiencies in this study; these deficiencies are sufficient to discredit the finding that high variability in silica results can be attributed to the inability of the analytical method to accurately measure crystalline silica at filter loads representative of concentrations at the action level and PEL set by this rule. Principally, the loss of filter material during deposition of the samples, combined with the lack of any verification of the actual amount of silica loaded onto the filters, makes it impossible to use the laboratory results to assess lab performance since the amount of silica on the filters analyzed by the labs cannot be known. The large negative bias in lab results compared to the target filter load implies that there was significant sample loss. In addition, the quality control employed by RJ Lee to ensure that filter loads were accurately known consisted only of an analysis of six separately prepared samples to evaluate the recovery from the 0.8 μm PVC filter and two sets of filters to evaluate recovery and test for shipping loss (Document ID 3461, Slides 8, 15, 16; 3582, Tr. 2090-2091). This is in stark contrast to the procedures used by the AIHA PAT program, which verifies its sample preparation by analyzing a statistically adequate number of samples prepared each quarter to ensure that sample variation does not exceed ±10 percent (Document ID 3586, Tr. 3276-3277). RJ Lee's use of the 0.8 μm PVC copolymer filter (Document ID 4001, Attachment 1) is also contrary to the NIOSH Method 7500 (Document ID 0901), which specifies use of the 5 μm PVC filter, and may have introduced bias. As stated at the hearing by Mary Ann Latko of the AIHA Proficiency Analytical Testing Programs, “[a]ny variance from the NIOSH method should not be considered valid unless there's a sufficient quality control data provided to demonstrate the reliability of the modified method” (Document ID 3586, Tr. 3278).
OSHA finds that the AIHA PAT data are a far more credible measure of inter-laboratory variation in crystalline silica measurement than the ACC-sponsored RJ Lee study. Strict procedures are used to prepare and validate sample preparation in accordance with ISO requirements for conformity assessment and competence of testing in calibration laboratories (Document ID 3586, Tr. 3275) and the database includes 200 rounds of silica testing since 2004, with 55 laboratories participating in each round (Document ID 3586, Tr. 3264-3265). By comparison, the RJ Lee study consisted of three rounds of testing among five laboratories.
One of the goals of the RJ Lee study was to conduct a double-blind test so that laboratories would not know they were analyzing prepared samples for proficiency testing; according to Mr. Bailey, a laboratory's knowledge that they are participating in a performance study, such as is the case with the AIHA PAT program, “can introduce bias into the evaluation from the very beginning” (Document ID 3582, Tr. 1989; Document ID 4209, p. 147). However, OSHA doubts that such knowledge has a profound effect on laboratory performance. Accredited laboratories participating in the PAT program undergo audits to ensure that analytical procedures are applied consistently whether samples are received from the field or from the PAT program. According to testimony from Mr. Walsh:
[S]ite assessors [for the AIHA accreditation program] are very sensitive to how PAT samples are processed in the lab. It's a specific area that's examined, and if the samples are processed in any way other than a normal sample, the laboratory is cited as a deficiency (Document ID 3586, Tr. 3299-3300).
Therefore, after considering the evidence and testimony on the RJ Lee study and AIHA PAT Program data, OSHA concludes that the AIHA PAT data are the best available data on which to evaluate inter-laboratory variability in measuring respirable crystalline silica. The data evaluated by Harper
Although laboratory performance has not been broadly evaluated at filter loads below 40 μg, particularly when interferences are present, OSHA's investigations show that the XRD method is capable of measuring crystalline silica at filter loads of 40 μg or less without appreciable loss of precision. The analysis of recent PAT data by Harper
Based on the record evidence reviewed in this section, OSHA finds that current methods to sample respirable dust and analyze samples for respirable crystalline silica by XRD and IR methods are capable of reliably measuring silica concentrations in the range of the final rule's PEL and action level. This finding is based on the following considerations: (1) Several sampling devices are available that conform to the ISO/CEN specification for particle-size selective samplers with a level of bias and accuracy deemed acceptable by international convention, and moving to the ISO/CEN convention will maintain continuity with past practice, (2) both the XRD and IR methods can measure respirable crystalline silica with acceptable precision at amounts that would be collected by samplers when airborne concentrations are at or around the PEL and action level, and (3) laboratory proficiency data demonstrate that there is reasonable agreement between laboratories analyzing comparable samples most of the time.
There are several sampling devices that can collect respirable crystalline silica in sufficient quantity to be measured by laboratory analysis; some of these include the Dorr-Oliver nylon cyclone operated at 1.7 L/min air flow rate, the Higgins-Dewell cyclones (2.2 L/min), the SKC aluminum cyclone (2.5 L/min), and the GK2.69, which is a high-flow sampler (4.2 L/min). Each of these cyclones can collect the minimum amount of silica necessary, at the PEL and action level, for laboratories to measure when operated at their respective flow rates for at least four hours. In addition, each of these devices (as well as a number of others) has been shown to conform to the ISO/CEN convention with an acceptable bias and accuracy for a wide range of particle-size distributions encountered in the workplace. OSHA used the Dorr-Oliver at a flow rate of 1.7 L/min to enforce the previous PELs for respirable crystalline silica, so specifying the use of sampling devices conforming to the ISO/CEN convention does not reflect a change in enforcement practice. The modest error that is associated with using respirable dust samplers is independent of where the PEL is set, and these samplers have been used for decades both by OSHA, to enforce the preceding silica PEL (and other respirable dust PELs), and by employers in managing silica-related risks. Therefore, OSHA finds that these samplers are capable of and remain suitable for collecting respirable dust samples for crystalline silica analysis.
Both XRD and IR analytical methods are capable of quantifying crystalline silica with acceptable precision when air samples are taken in environments where silica concentrations are around the PEL and action level. OSHA's quality control samples analyzed by XRD over the past few years show the precision to be about 20 percent over the range of filter loads tested (about one-half to twice the former PEL). OSHA conducted studies to characterize the precision of its Method ID-142 at low filter loads representing the amounts that would be captured using the Dorr-Oliver cyclone at the action level and PEL (
Evaluation of data from AIHA's Proficiency Analytical Testing Program shows that results from participating laboratories are in agreement (
Inter-laboratory variability has not been well characterized at filter loads below 50 μg, which is slightly more than would be collected by a Dorr-Oliver cyclone sampling a silica concentration at the PEL over a full shift. However, OSHA concludes that the studies conducted by SLTC show that acceptable precision can be achieved by the XRD method for filter loads obtained by collecting samples with the Dorr-Oliver and similar devices at the action level and PEL. If employers are concerned about the accuracy that their laboratory would achieve at filter loads this low, samplers with higher flow rates could be used to collect an amount of silica that falls within the working range of the OSHA method and within the range of filter loads currently used by the PAT program (
Based on the information and evidence presented in this section, OSHA is confident that current sampling and analytical methods for respirable crystalline silica provide reasonable estimates of measured exposures. Employers should be able to rely on sampling results from laboratories meeting the specifications in Appendix A of the final standards to analyze their compliance with the PEL and action level under the new silica rule; employers can obtain assurances from laboratories or their industrial hygiene service providers that such requirements are met. Similarly, employees should be confident that those exposure results provide them with reasonable estimates of their exposures to respirable crystalline silica. Thus, OSHA finds that the sampling and analysis requirements under the final rule are technologically feasible.
In order to demonstrate the technological feasibility of the final PEL, OSHA must show that engineering and work practices are capable of reducing exposures to the PEL or below for most operations most of the time. Substantial information was submitted to the record on control measures that can reduce employee exposures to respirable crystalline silica, including but not limited to LEV systems, which could include an upgrade of the existing LEV or installation of additional LEV; process enclosures that isolate the employee from the exposure; dust suppression such as wet methods; improved housekeeping; and improved work practices. Substantial information was also submitted to the record on the use of respiratory protection; while OSHA does not, as a rule, consider the use of respirators when deciding whether an operation is technologically
OSHA finds that many engineering control options are currently commercially available to control respirable dust (
Table VII-8 lists the general industry sectors included in the technological feasibility analysis and indicates the numbers of job categories in each sector for which OSHA has concluded that the final PEL of 50 μg/m
OSHA has determined that some engineering controls are already commercially available for the hydraulic fracturing industry, and other controls that have demonstrated promise are currently being developed. OSHA recognizes, however, that engineering controls have not been widely implemented at hydraulic fracturing sites, and no individual PBZ results associated with controls have been submitted to the record.
The available information indicates that controls for dust emissions occurring from the sand mover, conveyor, and blender hopper have been effective in reducing exposures. KSW Environmental reported that a commercially-available control technology reduced exposures in one test with all 12 samples below the NIOSH recommended exposure limit (REL) of 50 μg/m
These findings indicate that, with good control of the major dust emission sources at the sand mover and along the conveyor to the blender hopper, exposures can be reduced to at least 100 μg/m
Therefore, OSHA finds that the PEL of 50 μg/m
The American Petroleum Institute (API), the Marcellus Shale Coalition (MSC), and Halliburton questioned whether the analysis of engineering controls presented in the PEA was sufficient to demonstrate the technological feasibility of reducing exposures to silica at hydraulic fracturing sites to levels at or below 50 μg/m
OSHA sought additional information on current exposures and dust control practices. Throughout the NPRM and hearings, OSHA, as well as other stakeholders, requested additional information on exposures and engineering controls (Document ID 3589, Tr. 4068-4070, 4074-4078, 4123-4124; 3576, Tr. 500, 534). Submissions to the record indicate that significant efforts are currently being made to develop more effective dust controls specifically designed for hydraulic fracturing (Document ID 1530; 1532; 1537; 1538; 1570; 4072, Attachments 34, 35, 36; 4204, p. 35, Fn. 21). However, industry representatives provided no additional sampling data to evaluate the effectiveness of current efforts to control exposures. Thus, NIOSH and OSHA provided the only detailed air sampling information for this industry, and summary data were provided by a few rulemaking participants (Document ID 4204, Attachment 1, p. 35, Fn. 21; 4020, Attachment 1, p. 4).
When evaluating technological feasibility, OSHA can consider engineering controls that are under development. Under section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b), OSHA is not bound to the technological status quo and can impose a standard where only the most technologically advanced companies can achieve the PEL even if it is only some of the operations some of the time.
OSHA concluded that these technologies will enable the industry to comply within five years. OSHA has described technologies that have been developed and tested, and that have demonstrated that the PEL is obtainable. These technologies have been developed to reduce exposures to the preceding PEL, but some of them appear also to have the capability to reduce some exposures to the PEL of 50 µg/m
Evidence in the record shows widespread recognition of silica exposure hazards on hydraulic fracturing sites and industry's efforts to address them primarily through the efforts of the National Service, Transmission, Exploration & Production Safety (STEPS) network's Respirable Silica Focus Group. The STEPS network initiated action to address exposure to silica at hydraulic fracturing sites in 2010, when NIOSH first conducted air sampling and then publicized the severity of hazardous silica exposures as part of its Field Effort to Assess Chemical Exposures in Gas and Oil Workers (Document ID 1541). Recognition of silica exposures in the industry well above the preceding PEL of 100 µg/m
In June 2012, the STEPS network, in which AESC and many other industry, educational and regulatory entities participate, launched a respirable silica focus group to spread awareness, better characterize on-site silica exposures, and facilitate and evaluate the development of engineering controls (Document ID 3589, Tr. 4059; 1537). This enabled several manufacturers of engineering controls, such as KSW Environmental (formerly Frac Sand Dust Control and Dupre) who had developed a working model in 2009 (Document ID 1520), to collaborate and share information on various engineering controls. As a consequence, the silica control field has grown significantly during this period, including the development, testing and, in some cases, deployment of new technologies, including those from KSW Environmental, J&J Truck Bodies, SandBox Logistics, and NIOSH's baghouse. For example, John Oren, the co-inventor of the SandBox Logistics technology, said it had taken his company only three years to develop the product and make it commercially available (Document ID 3589, Tr. 4148). OSHA concludes that an additional five years will be more than enough time for these and other firms to complete development and increase manufacturing and sales capacity, and, simultaneously, for hydraulic fracturing employers to test, adopt and adapt these emerging technologies to their workplaces. Indeed, in light of the progress that has already been made, it may be more accurate to call the standard “market-accelerating” than “technology-forcing.”
During the rulemaking, API touted the efforts of this industry to develop technology to protect workers against the hazards of silica (Document ID 4222, Attachment 2, p. 9). OSHA agrees with API that these efforts have been noteworthy and that more time is warranted to allow for continued development, commercialization, and implementation of these innovative technologies. OSHA is confident that with the innovation displayed by this industry to date, the hydraulic fracturing industry can further reduce worker exposures to the PEL if sufficient time is provided. Therefore, OSHA is providing an extra three years from the effective date of the standard—for a total of five years—to implement engineering controls for the hydraulic fracturing industry. OSHA concludes that this is ample time for this highly technical and innovative industry to come into compliance with the final PEL. This is consistent with, but longer than, the time frame OSHA granted for implementation of engineering controls for hexavalent chromium, where OSHA provided four years to allow sufficient time for some industries to coordinate efforts with other regulatory compliance obligations as well as gain experience with new technology and learn more effective ways to control exposures (71 FR 10100, 10372, Feb. 28, 2006). Thus, with the extra time provided for this industry to come into compliance, OSHA finds that the final PEL of 50 µg/m
In the two years leading up to the effective date, the hydraulic fracturing industry will continue to be subject to the preceding PEL in 29 CFR 1910.1000 (Table Z). In order to meet the preceding PEL of 100 µg/m
OSHA has determined that a PEL of 50 µg/m
Even if captive foundries are excluded from consideration, OSHA considers the standard to be feasible for shipyards with the use of respirators by painters doing abrasive blasting. OSHA recognizes that, consistent with its hierarchy of controls policy for setting methods of compliance, respirator use is not ordinarily taken into account when determining industry-wide feasibility. Neither this policy nor the “most operations most of the time” formulation for technological feasibility is meant to place OSHA in a “mathematical straitjacket” (
Table VII-9 lists the construction application groups included in the technological feasibility analysis and indicates the numbers of tasks in each application group. As this table shows, OSHA has determined that the rule's PEL is feasible for the vast majority of tasks (19 out of 23) in the construction industry. For those construction tasks listed in Table 1 of paragraph (c) of the construction standard, OSHA has determined that the controls listed on Table 1 are either commercially available from tool and equipment manufacturers or, in the case of jackhammers, can be fabricated from readily available parts. Therefore, OSHA has determined that these control requirements are technologically feasible and will, with few exceptions, achieve exposures of 50 μg/m
Where available evidence indicates that exposures will remain above this level after implementation of dust controls (
OSHA has also evaluated the feasibility of three application groups that do not appear on Table 1: Underground construction, drywall finishing work, and abrasive blasting. For these operations, employers will be subject to the paragraph (d) requirements for alternative exposure control methods. Due in part to the complexity of excavating machines, dust controls, and the ventilation systems required to control dust for underground operations, OSHA decided not to include underground construction and tunneling operations in Table 1 of paragraph (c) of the construction standard. Nonetheless, OSHA has determined that the PEL is technologically feasible in underground construction because exposures can be reduced to 50 µg/m
The American Chemistry Council's (ACC's) Crystalline Silica Panel contended that OSHA did not demonstrate that the proposed standard would be technologically feasible in all affected industry sectors because OSHA had failed to account for day-to-day environmental variability in exposures (Document ID 4209, Attachment 1, p. 97). ACC noted that OSHA enforces PELs as never-to-be-exceeded values and that an employer can be cited based
OSHA recognizes the existence of exposure variability due to environmental factors that can affect employee exposures, especially in the construction industry where work sites and weather conditions can change on a daily basis. OSHA has acknowledged this in past rulemakings where the same issue was raised (
Exposures go up and down not by magic but by particular conditions, differences in work methods, differences in control efficiency, differences in adjacent operations (Document ID 3578, Tr. 971).
OSHA concludes from the evidence in the record that the consistent use of engineering controls will reduce exposure variability. By improving or adding effective controls and work practices to reduce employee exposures to the PEL or below, employers will reduce exposure variability, and this reduction will provide employers with greater confidence that they are in compliance with the revised PEL. OSHA does, however, acknowledge that exposure controls cannot entirely eliminate variability. Some day-to-day variability in silica exposure measurements may remain, despite an employer's conscientious application and maintenance of all feasible engineering and work practice controls. Nonetheless, the legal standard for finding that a PEL is technologically feasible for an industry sector is whether most employers can implement engineering and work practice controls that reduce exposures to the PEL or below most of the time. As explained in Section XV, Summary and Explanation, in situations where exposure measurements made by OSHA indicate that exposures are above the PEL, and that result is clearly inconsistent with an employer's own exposure assessment, OSHA will use its enforcement discretion to determine an appropriate response. Moreover, for the vast majority of construction employers (and some general industry or maritime employers doing tasks that are “indistinguishable” from Table 1 tasks and choose to comply with the construction standard), full compliance with Table 1 will eliminate the risk that an employer will be subject to citation for exposures above the PEL, even when the employer has instituted all feasible controls that normally or typically maintain exposures below the PEL.
OSHA also received a number of general comments on the feasibility of wet methods and LEV, as well as comments on challenges faced when employing these dust control strategies in specific work settings. In general industry, several commenters indicated for specific industries that there was no one control that could obtain the PEL of 50 μg/m
Other commenters addressed the use of water on construction sites; several commenters asserted that it is not always possible for employers to use water for dust suppression. For example, in its post-hearing submission, CISC discussed what it believed to be “significant obstacles” to using wet dust suppression technologies on construction sites. Such obstacles include freezing weather, which contraindicates water use, and a lack of running water onsite, which requires employers to deliver water, a practice which, according to CISC, is both “costly and time consuming” (Document ID 4217, pp. 18-19). However, many other participants commented that these barriers can be overcome. For example, Phillip Rice, of Fann Contracting, Inc., uses water trucks to haul water to sites and includes the cost of doing so in his bids. He added that “when someone says they can't get water on their project there is something wrong” (Document ID 2116, Attachment 1, p. 33). Representatives of the International Union of Bricklayers and Allied Craftworkers pointed out that water is essential for work in the masonry trades and without it, no mortar can be mixed to set materials (Document ID 3585, Tr. 3059-3060). They testified that, in their experience, it was rare to work on sites that did not have water or electricity available, but when they do, they bring in water trucks and gas-powered generators to run saws (Document ID 3585, Tr. 3061-3063). With respect to weather conditions, heated water or heated shelters can be used if construction work is being performed in sub-freezing temperatures (Document ID 3585, Tr. 3095-3096).
These comments and testimony indicate that the vast majority of the barriers to wet dust suppression raised by CISC have already been overcome in various construction settings. However, OSHA recognizes that there will be limited instances where the use of wet dust suppression is not feasible, particularly where its use can create a greater hazard. For example, water cannot be used for dust control in work settings where hot processes are present due to the potential for steam explosions (Document ID 2291, p. 13; 2298, p. 3), nor can it be used safely where it can increase fall hazards, such as on a roof (Document ID 2214, p. 2). Nevertheless, OSHA finds that many employers currently use wet dust suppression, that there are many commercially available products with integrated water systems for dust suppression, and that these products
Some commenters questioned whether OSHA had adequately considered the difficulties in complying with the PEL for maintenance activities. The National Association of Manufacturers, for example, quoted one of its members, who stated:
OSHA has addressed maintenance activities in each sector's technological feasibility analysis, but the standard itself acknowledges the difficulties of some maintenance activities. Paragraph (g)(1)(ii) of the standard for general industry and maritime (paragraph (e)(1)(ii)(B) in construction) requires respiratory protection “where exposures exceed the PEL during tasks, such as certain maintenance and repair tasks, for which engineering and work practice controls are not feasible” (
CISC submitted comments suggesting that the technological feasibility analysis was incomplete because it did not cover every construction-related task for which there is the potential for exposure to silica dust. It listed more than 20 operations, including cement mixing, cutting concrete pavers, demolishing drywall or plaster walls/ceilings, overhead drilling, demolition of concrete and masonry structures, and grouting floor and wall tiles, that it stated OSHA must examine in order to establish feasibility, in addition to the application groups already covered by OSHA's analysis (Document ID 2319, pp. 19-21). CISC asserted that, because of the many types of silica-containing materials used in the construction industry, as well as the presence of naturally occurring silica in soil, additional data collection and analysis by OSHA should be conducted before promulgating a final rule (Document ID 2319, pp. 25-26; 4217, p. 3).
As explained in the NPRM, OSHA's analysis for construction focuses on tasks for which the available evidence indicates that significant levels of respirable crystalline silica may be created, due primarily to the use of powered tools or large equipment that generates visible dust. OSHA notes that many of the examples of tasks for which CISC requested additional analysis are tasks involving the tools and equipment already covered in this feasibility analysis. For example, overhead drilling is addressed in section IV-5.4 Hole Drillers Using Handheld or Stand-Mounted Drills, and the demolition of concrete and masonry structures is addressed in section IV-5.3 Heavy Equipment Operators. In other cases, such as for concrete mixing, there are no sampling data in the record to indicate that the task is likely to result in 8-hour TWA exposures above the action level. Exposure can occur when cleaning dried cement, and the feasibility of control measures to reduce exposures when cleaning out the inside of cement mixers is discussed in section IV-4.17 Ready Mix Concrete. Other tasks listed by CISC involve working with wet or intact concrete, which is unlikely to result in 8-hour TWA exposures above the action level. Further, CISC did not submit to the record any air monitoring data to support its assertion that these activities result in significant exposures. Therefore, OSHA has not added these additional activities to the feasibility analysis.
In the NPRM, OSHA invited comment on whether it should consider a lower PEL because it determined there was still significant risk at the proposed PEL of 50 μg/m
The UAW submitted comments and data to the record, maintaining that a PEL of 25 μg/m
Although available exposure data indicate that exposures below 25 μg/m
For most of the industries and application groups included in this analysis, a review of the sampling data indicates that an alternative PEL of 25 μg/m
For instance, in the ferrous foundry industry, the baseline median exposure in the profiles exceeds 50 μg/m
For other general industry sectors, OSHA has insufficient data to demonstrate that engineering and work practice controls will reduce exposures to or below 25 μg/m
OSHA has also determined that application groups in construction that use large quantities of silica containing material or involve high energy operations will not be able to consistently achieve 25 μg/m
Therefore, OSHA concludes that 50 μg/m
This section assesses the costs to establishments in all affected industry sectors of reducing worker exposures to silica to an 8-hour time-weighted average (TWA) permissible exposure limit (PEL) of 50 μg/m
OSHA estimates that the standard will have a total cost of $1,029.8 million per year in 2012 dollars. Of that total, $370.8 million will be borne by the general industry and maritime sectors, and $659.0 million will be borne by the construction sector. Costs originally estimated for earlier years in the PEA were adjusted to 2012 dollars using the appropriate price indices. In general, all employee and supervisor wages (loaded) were from the 2012 BLS OES (Document ID 1560); medical costs were inflated to 2012 dollars using the medical services component of the Consumer Price Index; and, unless otherwise specified, all other costs were inflated using the GDP Implicit Price Deflator (Document ID 1666).
All costs were annualized using a discount rate of 3 percent, which—along with 7 percent
OSHA's exposure profile, presented in Chapter III of the FEA, represents the Agency's best estimate of current exposures (
For both construction and general industry/maritime, the estimated costs for the silica rule represent the additional costs necessary for employers to achieve full compliance with the new standard, assuming that all firms are compliant with the previous standard. Thus, the estimated costs do not include any costs necessary to achieve compliance with previous silica requirements, to the extent that some employers may not be fully complying with previously-applicable regulatory requirements. OSHA almost never assigns costs for reaching compliance with an already existing standard to a new standard addressing the same health issues. Nor are any costs associated with previously-achieved compliance with the new requirements included.
Because of the severe health hazards involved, as well as current OSHA regulation, the Agency expects that the estimated 11,640 abrasive blasters in the construction sector and the estimated 3,038 abrasive blasters in the maritime sector are currently wearing respirators as required by OSHA's abrasive blasting provisions (29 CFR 1915.154 (referencing 29 CFR 1910.134)). Furthermore, an estimated 264,761 workers, including abrasive blasters, will need to use respirators at least once during a year to achieve compliance with the new silica rule in construction, and, based on the NIOSH/BLS respirator use survey (NIOSH/BLS, 2003, Document ID 1492), an estimated 56 percent of construction employees whose exposures are high enough that they will need respirators under the new rule currently use such respirators. OSHA therefore estimates that 56 percent of affected construction employees already use respirators in compliance with the respirator requirements of the final silica rule.
Other than respiratory protection, OSHA did not assume baseline compliance with any other ancillary provision, even though some employers have reported that they currently monitor silica exposure, provide silica training, and conduct medical surveillance.
The remainder of this chapter is organized as follows. First, unit and total costs by provision are presented for general industry and maritime and for construction. Following that, the chapter concludes with a summary of the estimated costs of the rule for all affected industries.
The engineering control section in Chapter V of the FEA covers OSHA's estimates of engineering control costs for general industry and maritime sectors. Oil and natural gas fracturing operations are addressed separately because OSHA used a different methodology to estimate engineering control costs for this application group. This section will address OSHA's overall methodology, the methodology for each category of costs (such as ventilation, housekeeping, conveyors), issues specific to small entities, and issues specific to the hydraulic fracturing industry. Within each of these discussions, this section summarizes the methodology used in the PEA to estimate engineering control costs, summarizes and responds to the comments on the PEA, and summarizes the changes made to the methodology used in the PEA for the FEA. Finally, the chapter presents OSHA's final estimates of engineering control costs.
The PEA's technological feasibility analysis identified the types of engineering controls that affected industries or sectors would need in order to control worker exposures to at
Table V-4 of the PEA provided a list of possible controls on an industry-by-industry basis and included details on control specifications and costs. The basic information for the types of controls needed was taken from the PEA's technological feasibility analysis. The following discussion explains how OSHA developed and used these estimates to prepare the aggregate costs of engineering controls presented in the PEA.
In developing engineering control cost estimates for the PEA, OSHA made a variety of estimates about the size or scope of the engineering or work practice changes necessary to reduce silica exposures in accordance with the proposed rule. In some cases, OSHA estimated that employers would need to install all new engineering controls. In other cases, though, employers were expected to only need to add additional ventilation capacity or improve maintenance for existing equipment. In these cases, the costs were based on judgments of the amount of incremental change (either additional capacity or additional maintenance work) required per year. These estimates of the size or scope of the necessary engineering or work practice changes reflected representative conditions for the affected workers based on technical literature (including National Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluations), judgments of knowledgeable consultants and industry observers, and site visits. A detailed list of the specific costing assumptions and information sources for each control, grouped by job category or industry sector, was shown in PEA Appendix V-A, Table V-A-1.
In order to estimate costs in a consistent manner, OSHA, in the PEA, estimated all costs on an annualized basis. For capital costs, OSHA calculated the annualized capital cost, using a three percent discount rate over the expected lifetime of the capital item. The capital costs for long-lasting capital items (such as ventilation system improvements) were annualized over ten years. OSHA estimated that, in the general industry and maritime sectors, any capital expenditure would also entail maintenance costs equal to ten percent of the value of the capital investment annually.
OSHA, in the PEA, estimated control costs on a per-worker basis. Costs were related directly to the estimates of the number of workers needing controls (
In general, in the PEA, OSHA inferred the extent to which exposure controls were already in place from the distribution of overexposures among the affected workers. Thus, if most exposures in a facility were above the preceding PEL, OSHA broadly interpreted this as a sign of limited or no controls, and if most exposures were below the proposed (new) PEL of 50 μg/m
OSHA determined that multiple controls would be needed for almost all jobs in general industry in order reduce exposures from baseline conditions to meeting the proposed (new) PEL of 50 μg/m
URS, speaking for the American Chemistry Council (ACC), argued that OSHA's approach underestimated the costs of controls because it based costs on controls per worker instead of controls per facility (Document ID 2307, Attachment 8, p. 4). Since OSHA did not provide a distribution of exposures by facility or provide facility-specific information, URS used data in the record to create its own models to account for facility size. URS described its approach as follows:
URS created three statistical binomial distributions of overexposed workers, one for each of the three facility sizes, using OSHA's estimate of the percentage of over-exposed workers for that job. The result was a binomial distribution curve indicating the percentage of overexposed workers for each job category for each size-specific “model facility.”
For each binomial distribution, the peak of the distribution curve centers on the average number of overexposed workers per facility for that job description according to OSHA's estimate (Document ID 2307, Attachment 8, p. 7).
In taking this approach, URS erroneously assumed that the
OSHA disagrees with URS's implicit conclusion that overexposures are random across facilities. It is not reasonable to assume that controls have no relation to exposure level as this approach assumes. As will be discussed later in the context of OSHA's treatment of the preceding PEL, the data underlying the exposure profile show that establishments with low exposures are much more likely to have controls in place than those with very high exposures.
URS then assumed that if one worker in a job category is overexposed, then all controls listed by OSHA will be needed (Document ID 2307, Attachment 25, Engineering Costs). URS did not dispute that multiple controls would be needed for almost all jobs in general industry in order reduce exposures from baseline conditions to meeting the proposed (new) PEL of 50 μg/m
The best possible approach to what engineering controls are needed might differ based on whether: (1) There are no controls for a job category in place at all and most workers are overexposed by a large margin; or (2) only some workers in a job category are overexposed by a small margin (
In the first case, the most common approach would be to apply a relatively full set of controls, as explained in OSHA's technological feasibility analysis. This might start with enclosures and local exhaust ventilation (LEV), but, if exposures are high and the establishment is very dusty, it might also include initial cleaning or the introduction of ongoing routine housekeeping. In these situations, in which most employees are overexposed, OSHA estimated that the full set of controls listed in the technological feasibility analysis would be applied and, in these cases, there would be little difference in the results obtained using OSHA's approach and the results obtained using the approach suggested by URS.
However, the approach to controlling silica exposures that OSHA believes to be typical when establishments are faced with the second situation would be quite different, and therefore different from what URS expected. Commenters from both labor (Document ID 4204, p. 40) and industry (Document ID 1992, p. 6) pointed out that when there are controls in place or only some workers are overexposed, the first step is to examine work practices. The AFL-CIO noted that exposures can be controlled through work practices, repositioning ventilation systems, and controlling fugitive emissions (carryover from adjacent silica emitting processes) (Document ID 4204, p. 40). Implementing these types of changes can be inexpensive. The principal cost of improving work practices may only be training or retraining workers in appropriate work practices. OSHA's proportional cost approach in the PEA may therefore overestimate costs for situations in which overexposures can be corrected with work practice changes because the Agency will have included costs for engineering controls when, in fact, none will be needed. The URS approach will always include the costs of all controls for a job category in any facility where anyone in a job category is overexposed, and will thus yield even higher estimates.
As described in Chapter IV, Technological Feasibility, of the FEA, and summarized below, in situations in which there are LEV systems in place but the PEL is still not being met, employers would typically try many things short of removing the entire system and replacing it with a system with greater air flow velocities (and thus greater capacity and cost). The incremental solutions to controlling silica exposures include minor design modification of existing controls, better repair and maintenance of existing controls, adding additional LEV capacity to existing systems, improving housekeeping, modifying tools or machinery causing high levels of emissions, and reducing cross contamination.
Some worksites might require a slightly different and readily modified design. For example, an OSHA special emphasis program inspection of a facility in the Concrete Products industry discovered that installing a more powerful fan motor, installing a new filter bag for the bag-filling machine LEV, and moving hoods closer to the packing operator's position reduced respirable dust exposure by 92 percent, to 11 μg/m
In other cases, better equipment repair and maintenance procedures can be the key to meeting the PEL when there are already controls in place. For example, as described in Chapter IV of the FEA, in the Concrete Products industry, OSHA obtained a sample of 116 μg/m
In other cases, as pointed out by a foundry commenter, adding LEV capacity to existing systems for silica emissions not yet subject to any LEV control can be a good strategy for lowering exposures (Document ID 1992, p. 6). In one foundry, NIOSH investigators recommended installation of LEV over the coater and press areas, enclosure of the coating process, and/or repair and servicing of existing process enclosures and ventilation systems to eliminate leaks and poor hood capture (Document ID 0889, pp. 12-13; 0891, pp. 3 and 11; 0890, p. 14; 0893, p. 12).
Various combinations of improved housekeeping, initial cleaning, and switching to High-Efficiency Particulate Air (HEPA) vacuums can also help employers meet the PEL. In the Structural Clay industry, professional cleaning in a brick manufacturing facility removed “several inches” of dust from floors, structural surfaces and equipment (Document ID 1365, pp. 3-19-3-20; 0571). These changes alone led
Good housekeeping also increases the useful life of equipment. As discussed in Chapter IV of the FEA, dust clogs machines and reduces their useful life. As an example, regulating cotton dust was acknowledged to increase productivity by reducing down time. It also increased the useful life of looms (Document ID 2256, Attachment 4, p. 11). The Agency predicts that this is likely to be the case with silica controls as well. Dust being properly captured at the source can also result in cost savings in housekeeping activities because less dust needs to be cleaned up when it is captured at the source and not allowed to spread (Document ID 2256, Attachment 4, p. 11).
In specific situations, there are a variety of other controls that may be useful. As discussed in the Technological Feasibility chapter of the FEA, Simcox et al. (1999) (Document ID 1146) found that Fabricators in the Cut Stone industry had a mean exposure of 490 μg/m
Finally, in situations where there is cross contamination, employers may achieve the PEL for some workers without implementing any controls specific to that job category. As pointed out by the AFL-CIO, when this occurs, OSHA's costs may be overestimated (Document ID 4204, Attachment 1, p. 105).
These examples show that in many situations, where there are already controls in place, or where exposures are only slightly above the PEL, the PEL can be met by a variety of mechanisms short of installing an entirely new set of controls. Since the record shows that, frequently, exposures can be controlled without installing new engineering controls, OSHA's approach of estimating costs based on the proportion of the workers exposed above the PEL is much more likely to be accurate than estimates based on URS's suggestion that all controls are needed whenever one worker is exposed above the PEL.
The URS facility-based approach would require taking the costs of newly installing a full set of controls even if only one worker is exposed above the PEL. This approach assumes that (1) the existing exposure levels in a given facility have been achieved without the use of any controls; and (2) existing controls cannot be improved upon for less than the cost of installing an entirely new system of controls. These assumptions are unsupported by the URS comments and the nature of exposure control, as discussed above.
OSHA, therefore, rejects URS's approach and is maintaining its per-worker basis for calculating costs for the FEA. Based on the evidence presented in this section, the Agency concludes that OSHA's proportional approach of assigning control costs to each worker based on the cost per worker of a complete set of controls is a better approach to commonly encountered exposure situations than to assume that any reading above the PEL triggers the need for a complete set of controls.
The AFL-CIO argued that OSHA's proportional approach resulted in an over-estimation of costs because it involved adding costs for the exposed occupation wherever there was an overexposure, even when the overexposure was primarily or solely the result of cross contamination. The AFL-CIO recommended that OSHA “identify operations which are unlikely to [generate] silica emissions, or background and bystander exposure measurements, and subtract those measured exposure levels from those operations which do emit silica” (Document ID 4204, Attachment 1, pp. 31-32). OSHA has routinely included the elimination of cross contamination as a component of the controls needed for some job categories. As discussed in Chapter IV of the FEA, OSHA also believes that other controls will still be needed for many job categories in which cross contamination is common and as long as these additional controls are needed, overall costs will not decline as a result of controlling cross contamination. However, OSHA agrees that there may be situations in which correcting cross contamination alone would be sufficient. In this case, the commenter is right that OSHA may sometimes overestimate costs.
Many commenters argued that OSHA should have attributed the costs of reaching the preceding PEL of 100 μg/m
OSHA's preliminary initial regulatory flexibility analysis (PIRFA) for the 2003 Small Business Advocacy Review (SBAR) panel included benefits and costs associated with future compliance with existing silica requirements on the basis that the rule would help improve compliance with the existing silica rules (OSHA, 2003a and 2003b) (Document ID 1685 and 0938, respectively). Upon further consideration, OSHA determined that a more fair and accurate measure of the benefits and costs of the proposed rule was to begin the analysis with a baseline of full compliance with existing requirements; OSHA has retained this approach for the final rule. The Agency offers three reasons in support of this approach. First, the obligation to comply with the preceding silica PEL is independent of OSHA's actions in this rulemaking. The benefits and costs associated with achieving compliance with the preceding silica rules are a function of those rules and do not affect the choice of PEL. The question before the Agency was whether to adopt new rules, and its analysis focused on the benefits and costs of those new rules. Second, the Agency's longstanding policy is to assume 100 percent compliance for purposes of estimating the costs and benefits of new rules, and to assume less than full compliance with the existing OSHA rules would be inconsistent with that policy. Finally, assuming full compliance with the existing rules is in keeping with standard OSHA practice in
Some commenters also disagreed with the way OSHA attributed costs to employers whose workers were being exposed to silica at levels greater than the preceding PEL of 100 μg/m
In addition URS, among others, argued that “OSHA fails to account for the non-linear costs associated with each incremental reduction in silica concentrations,” meaning that URS believed that it is more costly to achieve additional reductions in exposure as exposures are lowered. For example, according to URS's contention, it would be more costly to reduce exposures from 75 μg/m
OSHA has several responses to these criticisms. In response to the criticism that OSHA overestimated the number of workers with exposure levels above 100 μg/m
The technological feasibility analysis (presented in Chapter IV of the FEA) describes the controls necessary for reducing exposures from the highest levels observed in an industry's exposure profile to the new PEL. In all application groups except two (asphalt paving products and dental laboratories), the highest observed exposures were above the preceding PEL. With the exception of hydraulic fracturing,
It was not necessary for OSHA to distinguish between controls necessary to achieve the preceding PEL and those necessary to achieve the new PEL in order to demonstrate the technological feasibility of achieving a PEL of 50 μg/m
For the purposes of costing engineering controls for general industry and maritime in the PEA, OSHA assigned all of the costs for meeting a PEL of 50 μg/m
OSHA has therefore decided to adopt an approach to the estimation of costs different from that adopted in the PEA. In the FEA, OSHA relied on data available in the rulemaking record to both correct the overestimate of costs for those below the preceding PEL and, as many industry commenters urged, estimate the costs necessary to meet the preceding PEL as well as the new PEL for those above the preceding PEL.
To be clear, these data still do not enable OSHA to distinguish between the exact controls needed to get from uncontrolled exposures to the preceding PEL and those needed to get from the preceding PEL to the new PEL on an industry-by-industry and occupation-by-occupation basis. However, the data do enable OSHA to show that the majority of the costs of controlling silica exposures are incurred in order to reduce exposures from uncontrolled levels to the preceding PEL. OSHA will then assume that 50 percent of the costs incurred will be to implement the controls necessary to get from the uncontrolled situation to the preceding PEL and 50 percent to implement the controls necessary to go from the preceding PEL to meeting the new PEL. If, in fact, a majority of the costs are incurred in order to reduce exposures to the preceding PEL, the assumption that attributes 50 percent of costs to going from the preceding PEL to the new PEL will overestimate the true costs for establishments with exposures at the preceding PEL or between the preceding PEL and the new PEL.
In order to assess whether the majority of the costs are necessary to meet the preceding PEL, OSHA first examined what kinds of exposures are associated with the uncontrolled situations that served as the starting point for the estimates of needed controls in the technological feasibility analysis. The average level of exposure across all of general industry for employees with exposure exceeding the preceding PEL is over 300 μg/m
In general, to reduce exposures from over 2.5 times the preceding PEL to the preceding PEL, employers would have to implement some measure or measures, and those measures would be the ones that provide the greatest reduction in silica exposures and therefore control most of the silica exposures in the facility. In most cases this will be a working LEV system or some form of worker isolation. Measures like improved housekeeping cannot reduce exposures from the levels observed in uncontrolled exposure situations to the preceding PEL. OSHA reviewed industry-by-industry and occupation-by-occupation cost estimates for engineering controls and found that, on average 63 percent of the costs were for LEV, 23 percent were for housekeeping, and 16 percent were for other controls, most commonly wet methods (based on OSHA, 2016). In many cases, where wet methods were applicable, wet methods represented the majority of the costs and there were not significant LEV costs. As a result, 79 percent of the costs of controls, on average, are attributable to either wet methods or LEV. The combination of LEV or wet methods with some improvement in housekeeping (though not the improvements necessary to meet the new PEL) will constitute the majority of costs for virtually all occupational categories. Some improvement in housekeeping will typically also be required to meet even the preceding PEL.
To confirm the findings of this cost-spreadsheet-based analysis of where the majority of the costs are incurred, OSHA reviewed industries where good data are available on controls in both uncontrolled situations and situations with exposures between the new and the preceding PEL. OSHA examined the exposures and controls in eight ferrous sand casting foundry facilities. In these eight facilities, four had relatively few workers exposed above 50 μg/m
Based on these findings, OSHA determined that the majority of costs are incurred in order to implement controls necessary to get from an uncontrolled situation to the preceding PEL. However, OSHA developed cost estimates for engineering controls based on the conservative assumption that 50 percent of the total costs of going from an uncontrolled situation to the new PEL is incurred in order to reach the preceding PEL and the remaining 50 percent are incurred to reach the new
As presented in more detail below, this approach results in a total annualized cost estimate for general industry and maritime engineering controls of $225 million. Fortunately, this cost estimate is not highly sensitive to the allocation percentage chosen. Each decrement of 5 percentage points changes the engineering control costs by approximately 5.5 percent. Thus, for example, if 65 percent of the costs are necessary to go from the preceding PEL to the new PEL, then the annualized cost estimate for engineering controls would rise to $261 million per year.
Some commenters suggested that OSHA failed to account for the downtime that installing engineering controls or performing an initial through cleaning would require (
Almost all firms need downtime occasionally in order to perform general maintenance, inventory, or other tasks. In the final rule, OSHA has extended the compliance date for general industry from one year to two years. This will allow almost all employers to schedule work that might require downtime to install, improve, or maintain controls that they determine are necessary to meet the new PEL or to perform the initial thorough cleaning at times when they would already need scheduled downtime for other purposes. Therefore, OSHA has determined that there will be no additional costs incurred for downtime in order for employers to install engineering controls or to perform the initial thorough cleaning.
One commenter, Dr. Ruth Ruttenberg, testifying for the AFL-CIO, argued that OSHA had overestimated costs by failing to consider technological change:
Technological improvements—both engineering and scientific—are constantly occurring, especially when the pressure of a pending or existing regulation provide a strong incentive to find a way to comply at a lower cost. . . . These improvements are well-documented following the promulgation of rules for vinyl chloride, coke ovens, lead, asbestos, lock-out/tag-out, ethylene oxide, and a host of others (Document ID 2256, Attachment 4, p. 2).
Dr. Ruttenberg recognized that OSHA, in the PEA, already predicted some “technological and cost-saving advances with silica,” such as expanding the use of automated processes and developing more effective bag seals, but criticized OSHA for not accounting for those cost savings in its analysis:
Technological improvements are as sure a reality—based on past experience and academic research—as overestimation of cost and underestimate of benefits are in an OSHA regulatory analysis. More than 40 years of OSHA history bear this out (Document ID 2256, Attachment 4, p. 3).
When promulgating health standards, OSHA generally takes an approach in which cost estimates and economic feasibility analyses are based on the technologies specified in the technological feasibility analysis. This is a conservative approach to satisfying OSHA's legal obligations to show economic and technological feasibility. As a result, the Agency does not account for some factors that may reduce costs, such as technological changes that reduce the costs of controls over time and improvements in production that reduce the number of employees exposed. As pointed out in the PEA, and from the examples described in the “Total Cost Summary” at the end of this chapter, some past experience suggests that these factors tend to result in OSHA's costs being overestimated.
The cost calculations in the PEA included estimates of the number of workers whose exposures are controlled by each engineering control. Because working arrangements vary within occupations and across facilities of different sizes, there are no definitive data on how many workers are likely to be covered by a given set of controls. In many small facilities, especially those that might operate only one shift per day, some controls will limit exposures for only a single worker. Also, small facilities might have only one worker in certain affected job categories. More commonly, however, and especially in the principal production operations, several workers are likely to derive exposure reductions from each engineering control.
The PEA relied on case-specific judgments of the number of workers whose exposures are controlled by each engineering control (see Table 3-3 in ERG, 2007b, Document ID 1608). The majority of controls were estimated to benefit four workers, based on the judgment that there is often multi-shift work and that many work stations are shared by at least two workers per shift. The costs of some types of equipment that protect multiple employees, such as HEPA vacuums, were spread over larger groups of employees (
Some commenters questioned OSHA's estimate of the number of workers whose exposures could be controlled per newly added or enhanced control. OSHA's PEA most commonly estimated that four workers would have their exposures reduced for each new or enhanced engineering control. Dr. Ronald Bird, testifying for the Chamber of Commerce, argued that OSHA's estimates were simply arbitrary assumptions (Document ID 2368, p. 14). Stuart Sessions, testifying for the ACC, argued that the use of a single standard crew size of four led OSHA to underestimate costs and economic impacts for smaller establishments, at which, he argued, “there are virtually never as many as four overexposed workers in any job category, and it is simply impossible that one application of a package of controls in this situation could protect as many as 4 overexposed workers on average” (Document ID 4231, Attachment 1, p. 6).
The approach OSHA used was intended to represent the average number of employees affected by a given set of controls. Larger establishments may have more than four workers whose exposures are reduced by a single control, and smaller establishments may have fewer than four. However, OSHA agrees that this approach may result in an underestimate of costs for the smallest establishments. Because it is particularly important to consider the costs to the smallest establishments, OSHA has reduced the number of employees whose exposures are reduced per control by half for establishments with fewer than twenty employees, so that in those small establishments a given control is assumed to reduce exposures for two workers instead of four as assumed in the PEA. Because larger establishments may have greater numbers of employees whose exposures are reduced per control, this change may result in an overall overestimation of costs. (In the PEA, the overestimation of costs for larger facilities was partially offset by the underestimation of costs for smaller establishments. This is no longer the case in the FEA.) OSHA nevertheless believes the revised approach used in the FEA is better than the approach used in the PEA for purposes of capturing economic impacts on smaller establishments, even though it may result in aggregate costs being overestimated.
Some commenters argued that both OSHA's technological feasibility and cost analyses were flawed because OSHA neglected to address the day-to-day variability of exposure measurements. By failing to address the issue of variability, these commenters argued, OSHA grossly underestimated the costs of engineering controls. These commenters reported that silica exposures would have to be controlled to levels considerably lower than the proposed (new) PEL in order to account for the variation in exposures across jobs and from day to day (
Both AFS and ARMA offered estimates of the magnitude of this variability by measuring the statistical variance of exposures. AFS stated that to assure 84 percent confidence in compliance with the preceding PEL, the mean exposures in some specific jobs in specific foundries would need to be below half that PEL, and that the “mean level necessary to achieve the 95 percent confidence of compliance could not be determined but is significantly below one half the PEL” (Document ID 2379, Appendix 1, p. 23).
ARMA examined the distribution of silica exposures in over 1,300 samples from 57 asphalt roofing facilities. These data showed that even though the median exposures for all jobs were below the new action level of 25 μg/m
One serious problem with the ARMA analysis is that the discussions of variability and the estimates of mathematical variance are based on results either from different facilities with potentially different levels of controls or from all job categories within one facility. The key issue for assessing the importance of variability is the variance within a given job category in a specific establishment with specific controls. The methodology employed is such that even if individual job categories or individual facilities had no variance, pooling data across facilities would create variance.
ARMA estimated that sufficiently controlling variation would require investment in capture vents, duct work, and dust collection systems costing up to $2.1 million each in initial costs per manufacturing line (Document ID 2291, p. 12). AFS did not provide a cost estimate solely for sufficiently controlling variation.
The AFL-CIO disagreed with industry's arguments and instead argued that the best way to reduce variability was not simply to add additional engineering controls because, as explained earlier in the discussion of URS's comments on the per-worker cost basis, overexposures are not random:
The worker-to-worker variation is explainable and controllable: Workers use different methods, they may take different positions relative to ventilation systems, they may use different work practices, and they may be subject to fugitive emissions (carryover from adjacent silica emitting processes). These differences in conditions can be observed by the industrial hygienist collecting the air sample, compared to exposure levels, and changed. Day-to-day variation for the same worker is caused by variation in materials, ventilation systems, production rate, and adjacent sources showing such variation. Sometimes these variations can be large, based on breakdowns of ventilation, process upsets and blowouts (Document ID 4204, p. 40).
OSHA's enforcement policies are discussed in Chapter IV of the FEA and in this preamble. Variability of exposures is potentially a cost issue when there are technologically feasible controls that have costs not otherwise accounted for that could further reduce environmental variability. If it is not technologically feasible to reduce variability then there will be no further costs. For example, if an employer has
As noted above, those (AFS, ARMA) who argued that OSHA had underestimated costs by failing to account for exposure variability, in general, assumed that the best approach to reducing variability would be to increase the levels of LEV to reduce the average exposure level to half of the PEL or less, without examining the origin of the variability.
OSHA agrees with the AFL-CIO that variability in exposure is likely controllable by examining the origins of the variability. One origin is poor work practices. To improve work practices, employers could observe work practices when monitoring takes place; determine which work practices are associated with high exposures; and modify those work practices found to lead to high exposures. Variability can also be the result of a failure of controls not functioning properly, either resulting from sudden failures or from gradual deterioration of performance over time. The latter can be prevented by good maintenance.
Both in its cost assessment for the proposal and in the modifications made for this final rule, OSHA has taken account of the costs necessary to reduce unusual and exceptionally high exposure levels and thus reduce some sources of variation. As discussed in the cost of ancillary provisions, OSHA has estimated costs for exposure monitoring that include the time for observation of the worker. OSHA has also estimated costs for training to assure good work practices, and has increased the estimated length of training in general industry to ensure that the time is sufficient for training on work practices. In this section, OSHA has costed LEV, LEV maintenance, and the need for replacement LEV to assure that the LEV will function properly. OSHA has therefore already accounted for a variety of costs associated with steps that can be taken to reduce variability in exposures.
For several industries, employers might lower silica exposures by substituting low- or non-silica inputs for existing inputs. While this option can be an extremely effective method for controlling silica exposures in many industries, OSHA did not cost this option in the PEA. OSHA determined that there were often complicating factors that restricted the potential for broad substitution of non-silica-containing inputs for silica-containing inputs throughout the affected industries. It is possible that the same product quality cannot be maintained without using silica. Some products made with substitute ingredients were judged to be inferior in quality and potentially not viable in the market. In addition, a substitute silica ingredient might introduce adverse health risks of its own. Further, in several instances, the availability of reasonably inexpensive alternative non-silica ingredients was well known but the alternative was not selected as a control option by most firms. In light of these concerns, OSHA decided not to include the option of non-silica substitutes in estimating the cost of the proposed rule.
Some commenters complained that OSHA's analysis did not account for the costs of substitution (Document ID 2264, Attachment 1, p. 27; 2379, Attachment 2, p. 6; 3485, p. 25; 3487, p. 17).
OSHA considered the comments on the issue but has decided to adhere to the approach taken in the PEA. OSHA did not take account of the costs of substituting other substances for silica, because, while such substitution might have substantial benefits and avoid the need for engineering controls, OSHA determined that, in most situations, substitution is not the least costly method of achieving the proposed or new PEL (Document ID 2379, Attachment 2, p. 6). As a result, OSHA's final cost analyses do not account for the possibility that firms would choose to substitute for substances other than silica. To the extent that substitutes are the least costly solution in some situations, OSHA has overestimated the costs.
The Agency received comments suggesting that foundries and other manufacturing plants would be required by the Environmental Protection Agency (EPA), or other federal or state environmental authorities, to incur an administrative cost to ensure their systems are compliant with relevant EPA regulations. Commenters expressed concern that the permitting process itself could be a major undertaking, made worse by difficult compliance deadlines. Given that the final rule provides extra time for planning and permitting, OSHA has examined the potential impacts of the new rule and finds that the commenters are overstating the potential for such costs. The argument for significant permitting costs was typically combined (
Upon investigation, while OSHA agrees that it would be appropriate to recognize an administrative burden with respect to the interfacing environmental regulations, the Agency believes that many of the commenters' concerns were overstated. First, many control methods needed to comply with the final rule will not require alterations to existing ventilation systems. As discussed earlier in Chapter V of the FEA, work practices, housekeeping and maintenance are important components in controlling exposures; in many cases existing ventilation, as designed and permitted with the environmental authority, is adequate, but needs to be maintained better. In addition, most establishments, particularly smaller ones, will continue to have particulate emissions levels that fall below the level of EPA permit requirements. In the case of large facilities that do not, the changes will be on a sufficiently small scale that they will not require elaborate repermitting, but will only require minor incremental costs for notifying the environmental authorities, or in some cases, submitting a “minor” permit (
The Agency recognizes, however, that there will be minor incremental costs for notifying environmental authorities. While many establishments in the United States may have no requirement to do so, the Agency has conservatively assumed that all establishments with twenty or more employees in most industries will need to dedicate a certain amount of time to preparing a one-time notification to environmental authorities to ensure that their air permits accurately reflect current operating conditions. OSHA has determined that small establishments
To allow for adequate administrative time for creating and submitting the notification, at those facilities that could potentially incur costs, OSHA allocated 20 hours to establishments with 20 to 499 employees and 40 hours to establishments with 500 or more employees. A manager's loaded hourly wage rate of $74.97 was applied to estimate the cost to employers (BLS, OES, 2012, Document ID 1560). The costs per establishment were estimated at approximately $1,500 per medium establishment and $3,000 per large establishment. Because both new permit applications and permit modifications are minor administrative chores, OSHA's cost estimates are sufficient to cover either case.
In the PEA, OSHA determined that at many workstations, employers needed to improve ventilation to reduce silica exposures. The cost of ventilation enhancements estimated in the PEA generally reflected the expense of ductwork and other equipment for the immediate workstation or individual location and, potentially, the cost of incremental capacity system-wide enhancements and increased operating costs for the heating, ventilation, and air conditioning (HVAC) system for the facility.
In considering the specific ventilation enhancements for given job categories the PEA estimated the type of LEV and the approximate quantity in cubic feet per minute (cfm) of air flow required to reduce worker exposures.
To develop generally applicable ventilation cost estimates for the PEA, a set of workstation-specific and facility-wide ventilation estimates were defined using suggested ventilation approaches described in the American Conference of Governmental Industrial Hygienists (ACGIH) Industrial Ventilation Manual, 24th edition (Document ID 1607). With the assistance of industrial hygienists and plant ventilation engineering specialists, workstation estimates of cfm were derived from the ACGIH Ventilation Manual, and where not covered in that source, from expert judgements for the purpose of costing LEV enhancements (Document ID 1608, p. 29).
Over a wide range of circumstances, ventilation enhancement costs, which included a cost factor for HEPA filters and baghouses, where needed, varied from roughly $9 per cfm to approximately $18 per cfm (Document ID 1608, p. 29). Because of a lack of detailed data to estimate the specific ventilation installation costs for a given facility, an estimate of the likely average capital cost per cfm was used and applied to all ventilation enhancements. Based on discussions with ventilation specialists, $12.83 per cfm was judged to be a reasonable overall estimate of the likely capital costs of ventilation enhancements (Document ID 3983, p. 1).
OSHA applied the per-cfm capital cost estimate to estimated cfm requirements for each workstation. By using the unit value of $12.83 per cfm, the cost estimates for each ventilation enhancement included both the cost of the LEV enhancement at the workstation and the contribution of the enhancement to the overall facility ventilation system requirements. That is, each ventilation enhancement at a workstation was expected to generate costs to the building's general ventilation system either by requiring increased capacity to make up for the air removed by the LEV system or to filter the air before returning it to the workplace.
For operating costs, engineering consultants analyzed the costs of heating and cooling system operation for 12 geographically (and therefore, climatologically) diverse U.S. cities. The analysis, presented in Table 3-2 in the ERG report (Document ID 1608, p. 30), showed the heating and cooling British Thermal Unit (BTU) requirements for 60-hours-a-week operation (12 hours a day, Monday through Friday) or for a continuous 24-hour-a-day, year-round operation, with and without recirculation of plant air. Facilities that recirculate air have much lower ventilation system operating costs because they do not need to heat or cool outside air to comfortable inside temperatures.
In the PEA, ventilation operating costs were based on a weighted average of the costs of four operating scenarios: (1) No recirculated air, continuous operation; (2) no recirculated air, operating 60 hours per week; (3) recirculated HEPA filtered air, continuous operation; and (4) recirculated HEPA filtered air, operating 60 hours per week. These scenarios were chosen to reflect the various types of operating system characteristics likely to be found among affected facilities. The weights (representing the share of total facilities falling into each category) and operating costs per cfm for each of these scenarios are shown below in Table VII-11-1:
The national average annual operating cost per cfm was estimated to be $2.22. This estimate was a weighted average of the operating costs for facilities that recirculate air and those that require make-up air. The operating costs for HEPA-filter recirculated air were estimated at $0.50 per cfm for facilities operating 60 hours per week and $1.40 per cfm for those continuously operating 24 hours per day. The operating costs for facilities that do not recirculate air were $5.78 per cfm for those operating 60 hours per week and $15.55 per cfm for those operating continuously. In generating these estimates, it was judged that 80 percent of facilities would recirculate airflow and 20 percent would not, and that 75 percent within each group operate for 12 hours per day on weekdays, with the remainder operating continuously, year-round, for 24 hours a day.
OSHA also added a maintenance factor to the operating cost estimates, which was 10 percent of the capital cost investments of $12.83 per cfm for ventilation systems. As a result, the total annual costs per cfm, excluding annualized capital costs, were estimated to be $3.50 (weighted average operating costs of $2.22 plus annual maintenance costs of 10 percent of $12.83).
Underlying the cost results was the assumption that, over the course of the proposed one-year compliance period for engineering controls, employers would schedule installation of ventilation to minimize disruption of production, just as they would with any modification to their plants.
Local exhaust ventilation represents one of the major costs associated with engineering controls in both the PEA and in the FEA. Commenters raised issues both about OSHA's PEA estimates of the unit costs of LEV and about the adequacy of OSHA's estimates of the volume of LEV that would be needed to adequately control silica exposures.
URS, testifying on behalf of ACC, argued that any firm that would be utilizing LEV to meet a PEL of 50 μg/m
MR. BURT: I want to be sure I understand what that's saying. Let's say you encountered a situation in which there were four workers. Two were exposed at 35, two at 60. You would scrap all of the controls and start over again. That's what it seems to be saying.
[. . .]
MR. WAGGENER: [Y]es, that they would need to be replaced with a more adequate system (Document ID 3582, Tr. 2109-2110).
OSHA's examination of the spreadsheets URS provided documenting its independently developed cost estimates shows that, in all cases where any employee in an establishment was exposed above 50 μg/m
John Burke from OSCO Industries took a different approach to the question that better illustrates the options that OSHA believed to be available when it developed the PEA estimates:
A single large dust collector is probably already handling the exhausting of the entire sand conditioning system. Most likely all the pick-up points referenced in the economic analysis already have suction being applied and yet there is still an overexposure. What do you do and how much is that going to cost? If the sand system operator is overexposed then you could first evaluate work practices controls. If work practice controls are unsuccessful and additional suction is needed, that suction is going to be very expensive! If your environmental operating permit allows it you may be able to tweak the performance of the dust collector. There may be some things you can
OSHA agrees with Mr. Burke. As discussed above, there are usually a wide variety of ways to improve existing controls before removing and reinstalling an LEV system. As a result, OSHA finds the URS approach unrealistic and likely to significantly overestimate costs.
One commenter, URS, questioned OSHA's estimates of the volume of additional LEV that would be needed to comply with the standard. URS, testifying for ACC, reported that OSHA's estimates in the PEA were too low as compared to the recommendations in Table 6-2 of the ACGIH Ventilation Manual (28th Edition). They criticized OSHA's estimates saying that OSHA routinely underestimated required capture velocities by at least a factor of two for particles with high (conveyor loading, crushing) or very high (grinding, abrasive blasting, tumbling) energies of dispersion (Document ID 2308, Attachment 8, pp. 12 and 14). URS said that “the capture velocities for LEV systems in OSHA's models were often based on the minimum recommended velocity,” that OSHA's estimated additional LEV was too low because “the ACGIH capture velocity values used by OSHA were first developed and published many years ago” and were not sufficient to control dust to the levels OSHA is now proposing, and that “the velocity values used in OSHA's cost model are most likely undersized by a factor of 2 or more” (Document ID 2308, pp. 11-12). Other than its own supposition, URS did not identify an alternative source for OSHA to use as the basis for estimates of ventilation capacity necessary to control silica exposures.
In response to these comments, and in order to determine whether ACGIH recommendations had changed between the 24th edition (which OSHA used to develop estimates in the PEA) and the more recent 28th edition, OSHA checked its estimated volumes against those in the more recent ACGIH Ventilation Manual (Chapter 13 in the 28th edition (Document ID 3883)). In the 24th edition of the Manual, ACGIH provided a single recommendation for ventilation capacity rather than a range. In the PEA, OSHA adopted this recommendation and did not choose a value from within a range of values. The 28th edition of the Manual provides more flexibility in system design and specification and incorporates a recommended range. However, OSHA determined that the ventilation capacity estimates did not change between the 24th edition of the Manual and the 28th edition. In most cases, OSHA's estimated volumes were identical to those recommended by ACGIH. The exceptions were situations in which ACGIH provided no recommendation (in which case OSHA relied on recommendations of industrial hygienists), and situations in which the technological feasibility analysis recommended additional volumes of LEV capacity above what employers were typically using. In the latter situations, OSHA estimated that an additional 25 percent of the ACGIH specification would be necessary to adequately control silica exposures (
URS argued that silica was different from other substances LEV might be applied to in ways that would call for higher volumes of ventilation (Document ID 2308, Attachment 8, p. 14). However, in all cases involving silica (such as shake-out stations), the ACGIH Manual recommended the volumes used by OSHA and criticized by URS.
OSHA's estimates of the ventilation capacity necessary to control silica exposures relied on a detailed set of recommendations provided by ACGIH while URS simply asserted that these values are “most likely undersized by a factor of 2 or more” without providing additional evidence to support this (Document ID 2308, Attachment 8, p. 12). Based on these findings, OSHA has determined that the ACGIH recommendations constitute the best available evidence and has maintained the estimates of ventilation capacity from the PEA for the FEA.
Other commenters provided much higher costs than OSHA's estimates but without providing any background to allow OSHA to put those costs in context. It is difficult for OSHA to evaluate a cost estimate without information on the size of the facility, the estimated volume of air, and the exposure levels before and after the LEV was installed.
The Interlocking Concrete Pavement Institute (ICPI) commented that OSHA underestimated compliance costs because “[o]ne ICP manufacturer reported that it could cost $150,000 to acquire and install highly efficient vacuum and water dust-control systems” and other manufacturers reported similarly high costs (Document ID 2246, p. 11). At the public hearings, OSHA sought clarification on the assumptions underlying the ICPI cost estimate, and the ICPI representative stated that $150,000 was a mid-range estimate. The representative also confirmed that this was the cost of an entirely new system:
MR. BLICKSILVER: [D]oes this actually represent the incremental cost associated with complying with OSHA's proposed rule? . . . Or is this an overall cost for dust control in these manufacturing plants?
MR. SMITH: The latter (Document ID 3589, Tr. 4407-4409).
In a follow-up verbal exchange, OSHA requested that ICPI analyze its survey data to produce median values for the range of cost estimates and submit their analysis as a post-hearing comment (Document ID 3589, Tr. 4409). However, no ICPI comments appeared in the record following the Institute's testimony at the hearings.
Similarly, OSHA asked Mr. Tom Slavin, testifying for AFS, for additional information from AFS on the many cost estimates for individual foundries that it had included in its comments:
MR. BURT: You provide many examples of cost to specific foundries of specific activities. I would like to suggest that those can be most useful if we have data on the size of the firm in question, the type of foundry if that's appropriate, and what they were trying to accomplish with this effort.
Were they at 400 and trying to get to 100, at 100 trying to get lower? Something that puts it in context would again make these many, many helpful quotes much more useful.
Size is just critical, just because of the fact that when we don't know whether we're talking about 20 or 200 people in a foundry really affects what you want to do with those cost estimates. And that one's relatively simple, size of firm, type of foundry if you have it, what they were trying to do with that effort (Document ID 3584, Tr. 2773-2774).
Later in the exchange, OSHA requested information on “the components of [AFS's estimated cost per cfm of additional ventilation] that would be capital cost, installation cost, and then any other operating costs you have” (Document ID 3584, Tr. 2784). OSHA received no response to this request.
Unfortunately, it is almost impossible for OSHA to make use of commenters' estimates of costs or volume of LEV systems without information on the size of the facility and on what the resulting system accomplished in terms of reducing exposure levels. OSHA consistently requested this kind of
Many commenters thought that OSHA's unit costs for ventilation were too low. With respect to the annualized value of the capital costs plus operating and maintenance costs of $5.33 that OSHA used in the PEA, AFS stated:
The PEA uses an annual cost factor of $5.33 for ventilation, including ducting and bag house operation [...] is far below foundry experience. A group of foundry ventilation managers and ventilation experts estimated the annual cost per CFM at $20 for exhaust alone and another $6-10 for makeup air critical to achieving the lower PEL. The cost to meet the new U.S. Environmental Protection Agency (EPA) dust loading criteria increases the exhaust annual cost to $25 per CFM. Any new installation would be expected to design to the new criteria even if not yet required to do so for that specific jurisdiction (Document ID 2379, Appendix 3, p. 9).
URS, commenting on behalf of ACC, estimated the annualized cost of LEV to be $27 per cfm, and increased OSHA's original estimate of capital costs from $12.83 to $22 per cfm for the purpose of URS's cost estimate (Document ID 2308, Attachment 8, pp. 13-14).
Many other commenters from industry suggested unit costs for additional LEV. For example, AFS provided independent estimates of annualized costs of $20 to $25 per cfm and URS estimated $22 to $27 capital costs per cfm (Document ID 2379, Appendix 1, p. 45; 2308, Attachment 8, p. 14; 2379, Appendix 2, p. 13; 2503, p. 2; 2119, Attachment 3, p. 4; 2248, p. 8; 3490, p. 3; 3584, Tr. 2779).
OSHA agrees that there can be a wide range of both capital and operating costs associated with LEV. Capital costs will vary according to such factors as the exact nature of the ventilation (including the design of the slot, hood, or bagging station), the volume of materials to be handled by the ventilation, and the length of the ductwork necessary. OSHA also would like to clarify that, as shown in OSHA's spreadsheets (OSHA, 2016), where there are major structural changes associated with a control, such as automation, a new bagging station, or conveyor closure, these costs are estimated over and above the basic capital costs of LEV. Annual operating costs vary according to climate, hours of operation, and the extent to which air is recirculated. To examine these possible costs, OSHA reviewed the thoroughly documented LEV costs presented in its Final Economic Analysis for the Occupational Exposure to Hexavalent Chromium Standard (Document ID 3641). In that FEA, OSHA's estimates of the capital costs for LEV (updated to 2012 dollars) averaged more than $20 per cfm when major work station changes, such as automated bag slitting stations, were included in the cost of LEV. Ordinary additional LEV without major workstation changes was estimated to have an average capital cost of $9 per cfm in 2012 dollars. Operating costs in that rulemaking were estimated to be somewhat higher than estimated here, but combined annualized costs (capital plus operating costs) were approximately the same (
OSHA agrees that the capital costs of some kinds of LEV that involve significant workstation modifications or even automation can exceed $20 per cfm, but finds an average of $13.34 (in 2012 dollars) per cfm in capital costs to be reasonable given that some kinds of LEV installation can cost as little as $3 to $5 per cfm. OSHA also finds the operating cost estimates used in the FEA to be a reasonable average across a very wide variety of circumstances.
For a number of occupations, the technological feasibility analysis in the PEA indicated that improved housekeeping practices were needed to reduce silica exposures. The degree of incremental housekeeping depended upon how dusty the operations were and the appropriate equipment for addressing the dust problem. The incremental costs for most such occupations reflected labor associated with additional housekeeping efforts. Because incremental housekeeping labor was required on virtually every work shift by most of the affected occupations, the costs of housekeeping in the PEA were significant. The PEA also estimated that employers would need to purchase HEPA vacuums and to incur the ongoing costs of HEPA vacuum filters. The time needed for such housekeeping varied from five to twenty minutes per affected worker per day. Appendix V-A in the PEA provided detailed specifications on the application of housekeeping and other dust-suppression controls in each occupational category and the sources of OSHA's unit cost data for such controls.
For some indoor dust suppression tasks, it was assumed that dust suppression mixes—often sawdust-based with oil or other material that adheres to dust and allows it to be swept up without becoming airborne—were spread over the areas to be swept. For these products, estimates were made of usage rates and the incremental times necessary to employ them in housekeeping tasks.
For outdoor dust suppression, the PEA determined that workers must often spray water over storage piles and raw material receiving areas. The methods by which water is provided for these tasks can vary widely, from water trucks to available hoses. It was judged that most facilities would make hoses available for spraying and that spraying requires a materials-handling worker to devote part of the workday to lightly spray the area for dust control.
The PEA did not include any costs for thorough cleaning designed to remove accumulated dust, either as a one-time cost or as an annual cost.
Commenters had a number of issues with respect to how OSHA treated the costs of housekeeping, including the time and equipment needed for vacuuming, the need for professional floor to ceiling cleaning, and the costs of the ban on dry sweeping.
With respect to the use of HEPA vacuums, AFS commented that due to the volume of sand involved, foundries often use vacuum systems that cost $45,000 instead of the $3,500 estimated by OSHA in the PEA (Document ID 4229, Attachment 1, p. 23). Several commenters reported that HEPA semi-mobile central vacuum systems cost more than $40,000 to purchase and cost approximately $4,000 per year to maintain, and that sweeping compound costs approximately $4,000 per year (Document ID 2384, p. 7; 2114, Attachment 1, p. 4). Several others noted that acquiring HEPA vacuums and employee time for vacuuming would be expensive (Document ID 2301, Attachment 1, p. 74; 3300, pp. 4-5; 2114, Attachment 1, p. 4).
OSHA's costs are for improved housekeeping, beyond the necessary tasks related to dealing with the large volumes of sand used in foundries. For this final rule, OSHA estimates the costs
With respect to the shipbuilding sector, OSHA found that it had not accounted for the costs of HEPA vacuums for abrasive blasting helpers. OSHA has added costs for the vacuums, but not for the time spent performing housekeeping as the vacuums replace dry sweeping.
As to the possible costs of the ban on dry sweeping, OSHA has modified this prohibition in ways that should avoid significant costs in situations where dry sweeping is the only effective method of housekeeping.
URS, testifying for ACC, questioned OSHA's omission of “professional cleaning” from its cost models for some industries, noting that professional cleaning was identified in the PEA as necessary for some industries to achieve the PEL (Document ID 2308, Attachment 8, p. 12). URS also provided estimates of the cost of professional cleaning:
Based on communications with several industries, URS estimates that a thorough annual professional cleaning will cost about $1.00 per square foot of the facility process operations area.
. . . A professional cleaning can take several days to accomplish [. . .] For square footage, URS assumed 20,000 square feet for very small facilities, 50,000 square feet for small facilities, and 200,000 square feet for large facilities (Document ID 2308, Attachment 8, p. 24).
Initial thorough facility cleaning and rigorous housekeeping are supplemental controls and work practices addressed in the technological feasibility analysis for the following application groups: Concrete Products, Pottery, Structural Clay, Mineral Processing, Iron Foundries, Nonferrous Sand Foundries, and Captive Foundries. OSHA failed to include the costs of a thorough initial cleaning in the PEA, but has developed estimates of these costs for the FEA in response to the URS comment. The final standard sets the performance objective of achieving the PEL using engineering controls, work practices, and where necessary, respiratory protection, and, with respect to facility cleaning and housekeeping, the rule does not mandate that firms hire outside specialists. To estimate the final costs for initial thorough facility cleaning, OSHA first developed an analysis of average production floor space in square feet for two plant sizes based on data on plant floor space and employment for individual facilities reported in various NIOSH control technology and exposure assessment field studies (OSHA examined Document ID 215; 216; 268; 1373; 1383; 3786; 3996; and 4114. The analysis is in Exhibit:
For the purpose of estimating cleaning costs, OSHA characterized establishments with fewer than twenty employees as very small establishments, and characterized establishments with twenty or more employees as larger establishments.
OSHA determined, based on a review of the data in the NIOSH field studies, that production floor space averages 725 square feet per employee (
For very small establishments with fewer than 20 employees, OSHA used an average of 7 employees per establishment. For larger establishments, OSHA used an average of 80 employees. (These estimates of the number of employees are based on OSHA (2016), which shows that the average number of employees for establishments with fewer than 20 employees is 7 employees and that the average number of employees for establishments with more than 20 employees is 80 employees.) Based on these parameters, OSHA's floor space model found that the typical floor space for very small establishments is 5,075 square feet and for larger establishments is 58,000 square feet.
ERG spoke with a representative of an upper-Midwestern firm specializing in the industrial cleaning of foundries and related facilities (Document ID 3817, p. 2). According to that representative, cleaning costs depend on numerous factors, such as the distance to the facility that needs to be cleaned, the size and number of machines and pieces of equipment present, the types of required cleaning activities, and the presence of confined spaces. The representative described one of his company's clients as a sand-casting foundry that produces 42,000 tons of gray and ductile iron castings per year in a 210,000 square foot facility. According to the representative, a crew of two technicians cleans the facility every 2 to 3 weeks at a cost of $2,200 to $3,500 per cleaning, which requires one day, or roughly $0.01 to $0.02 per square foot in 2014 dollars.
For the FEA, OSHA is estimating, based on data from the ERG field interviews, that it will take 4 to 5 days to perform a one-time initial cleaning (remove all visible silica dust) and that if the same facility is cleaned every 2 to 3 weeks it will take 1 day to clean it. At a cost of $0.02 per day per square foot, and using a cleaning duration of 5 days, OSHA calculated a cost of $0.15 per square foot in 2012 dollars for an initial thorough cleaning. This value is derived from inflating the 2003 estimate of $0.10 per square foot ($0.02 per day per square foot over 5 days) to 2012 dollars, which raised the cost to $0.12 per square foot. OSHA also allowed for an additional allotment of 25 percent of the estimated cost of $0.12 per square foot (in 2012 dollars) to ensure that the cleaning was sufficiently thorough to achieve compliance, increasing the total from $0.12 to $0.15. OSHA judges that this is a reasonable average for the range of facilities to be covered, especially given that some annual cleaning is probably already occurring at most facilities and therefore the full cost of cleaning would not be attributable to this rule. The costs here are applied to represent an incremental cleaning beyond that employed for normal business purposes.
As discussed earlier in this chapter, URS, an engineering consultant to ACC, estimated that a thorough annual professional cleaning will cost about $1.00 per square foot of a facility's process operations area. URS provided no specific reference for that unit estimate other than that it communicated with industry representatives (Document ID 2308, Attachment 8, p. 24). The data OSHA used to develop its cost estimates are based on interviews with a company that provides housekeeping services rather than companies that may or may not have purchased such services. OSHA's estimated costs for a thorough initial cleaning are over five times the costs of a thorough cleaning where there is just few weeks' worth of accumulated dust. Greater accumulations during an initial cleaning do not mean that the initial cleaning will cost 50 times the cost of a more basic/regular cleaning, as much of the cost of the initial cleaning will be due to the time spent going over the entire facility with the appropriate cleaning devices—a cost that is fixed by area and not by accumulation. OSHA therefore rejects the URS unit estimate of $1.00 per square foot as not representative of a typical cost for initial thorough facility cleaning, particularly for firms that choose to use in-house resources. Nonetheless, OSHA
For this final analysis of costs for initial thorough facility cleaning, OSHA estimated that an upfront, one-time, extensive servicing (using vacuum and wash equipment) to rid the production area of respirable crystalline silica during plant turnaround or other downtime would cost $0.15 per square foot (including the additional allowance to ensure a sufficiently thorough cleaning) or $0.02 when annualized at 3 percent for 10 years, and OSHA applied that unit cost along with the average production floor space discussed above in OSHA's cost model (725 square feet per employee) to derive final costs for facility cleaning by application group. For the seven affected application groups, OSHA estimates that annualized initial thorough facility cleaning costs will range from just under $45,000 for Nonferrous Sand Foundries to $488,000 for Concrete Products. Across all seven affected application groups, OSHA estimates that annualized costs for initial thorough facility cleaning will total $2.8 million.
The technological feasibility analysis in the PEA recommended reducing silica exposures by enclosing process equipment, such as conveyors, particularly where silica-containing materials were transferred (and notable quantities of dust can become airborne), or where dust is generated, such as in sawing or grinding operations. For the PEA, OSHA estimated the capital costs of conveyor covers as $20.73 (updated to 21012 dollars) per linear foot, based on Landola (2003, Document ID 0745) (as summarized in footnote a in Table V-3 of the PEA). OSHA estimated that each work crew of four affected workers would require 100 linear feet of conveyors. OSHA, based on ERG's estimates, calculated maintenance costs as 10 percent of capital costs. Based on the technological feasibility analysis, OSHA also included the cost of LEV on the vents of the conveyors for the structural clay, foundry, asphalt roofing, and mineral processing application groups, but not for the glass and mineral wool application groups.
URS commented that OSHA underestimated the length of conveyors by using 100 linear feet in its estimate, and suggested that the estimate of 200 feet that it used as the basis for its estimates was still an underestimation for some foundries (Document ID 2307, Attachment 26, Control Basis and Control Changes tabs). URS maintained OSHA's estimate of $20.73 per linear foot in its own calculations. However, it appears that URS did not understand that OSHA estimated 100 linear feet of conveyors for every 4 workers, not 100 linear feet of conveyors for an entire affected establishment. Further, the URS comment indicated that 100 linear feet was an underestimate for “medium and large foundries.” But because OSHA's estimate of 100 linear feet is for every four workers, OSHA actually estimated much longer conveyor lengths for larger facilities with more workers. OSHA has determined that its estimate of 100 linear feet for every four workers at a cost of $20.73 per linear foot is a reasonable approach for estimating the costs of conveyor covers.
Consistent with ERG's cost model, in the PEA OSHA chose not to estimate costs for some control options mentioned in the accompanying technological feasibility analysis in Chapter IV of the PEA. In these cases, OSHA judged that other control options for a specific at-risk occupation were sufficient to meet the PEL. AFS identified several control options for which OSHA did not estimate costs:
Just because a control is mentioned in the technological feasibility analysis does not mean that OSHA has determined that its use is required—only that it represents a technologically feasible method for controlling exposures. The Agency developed cost estimates based on the lowest cost combination of controls that allows employers to move from an uncontrolled situation to meeting the new PEL. OSHA did not include the costs for possible controls that were either more expensive or were not necessary to achieve the PEL. OSHA (2016) describes in detail which controls were considered necessary to achieve the PEL. OSHA continues in the FEA to exclude costs for these kinds of more expensive possible controls.
In its preliminary estimates, OSHA inadvertently applied the preceding general industry PEL of 100 μg/m
Both in the PEA and in the FEA, OSHA presented the methods of estimating the costs of controlling silica exposures during hydraulic fracturing separately from the engineering control costs for all other portions of general industry because there are some fundamental differences in the methodology OSHA used, and thus in the comments OSHA received on that methodology. In the PEA, OSHA began its analysis of hydraulic fracturing in the standard way of examining the set of engineering controls available to control employee exposures to silica. Unlike the way OSHA handled the rest of general industry, however, for hydraulic fracturing OSHA identified precisely which controls were necessary to go from current levels of exposure to the preceding general industry PEL of 100 μg/m
As discussed in the Industry Profile section of the FEA (Chapter III), the basic unit for analysis for this industry is the fleet rather than the establishment. Rather than allocating costs according to the proportion of workers above a given exposure level, as was done for the rest of general industry, for hydraulic fracturing the controls applied per fleet were judged to reduce the exposures of all workers associated with the fleet.
Though there were extensive comments on OSHA's estimates of engineering control costs for hydraulic fracturing, no commenter objected to the differences in methodology compared to OSHA's treatment of the other general industry sectors (as outlined above). Halliburton Energy Services, Inc. commented that OSHA's analysis “lacks data” (Document ID 4211, p. 5). As discussed in Chapter IV Technological Feasibility, OSHA agrees that there is limited experience with many possible controls. For this reason, OSHA has allowed this industry an extended compliance deadline of five years before they have to meet the new PEL with engineering controls. However, OSHA does not agree that this adds significant uncertainty to the costs analysis. The costs of the controls OSHA has examined, and especially those needed to go from the preceding general industry PEL to the new PEL can readily be ascertained. It is possible that the cost of some controls that have not yet been tested and that OSHA has not costed could be much lower than the costs OSHA estimated in the PEA and in the FEA.
In the joint comments submitted by the American Petroleum Institute and the Independent Petroleum Association of America (API/IPAA or “the Associations”), the Associations disagreed with OSHA's estimated current compliance rate for the use of engineering controls. In the PEA, OSHA estimated a compliance rate of ten percent for engineering controls in this industry. In their comments the Associations said that “ERG assumed that 10% of all hydraulic fracturing firms already utilize: (1) Baghouse controls; (2) caps on fill ports; (3) dust curtains; (4) wetting methods; and (5) conveyor skirting systems” (Document ID 2301, p. 40, fn. 148).
While OSHA used a compliance rate of ten percent for all of these controls, it is not meant to represent that all prescribed controls are used in ten percent of firms. OSHA's compliance rates take into account that some well sites, as documented in Chapter IV of the FEA, were observed to be using a variety of controls that reduce dust levels, and as a result, those firms will not need to implement as many additional controls in order to achieve the new PEL. Further, as noted in Chapter IV of the FEA, the industry is constantly installing additional controls to reduce silica exposures. Thus the Agency sees no reason to change its estimate of current compliance. In any case, removing the assumption would make only a ten percent difference to the cost estimates, which would not be a change of large enough magnitude to threaten OSHA's conclusion that compliance with the final rule is economically feasible for the hydraulic fracturing industry.
In the PEA, OSHA estimated that the life of most capital equipment would be ten years, and that maintenance and operating costs would range from ten to thirty percent of capital costs per year (ten percent being most common).
API/IPAA argued that the hostile, sandy environment of the well site shortens the useful life of equipment and increases maintenance costs. The Associations estimated that the useful life of equipment ranges from 5 years to 7.5 years and that annual operating and maintenance costs range from 10 percent to 25 percent of capital costs. While OSHA agrees that the oilfield environment is challenging and dusty, there is no evidence in the record that these environments are more challenging than other industrial settings where equipment lives of 10 years and operating and maintenance costs of 10 to 30 percent have been used as reasonable estimates.
In the PEA, OSHA estimated that there would need to be one dust booth for each sand moving machine, and that this would result in one dust booth for small fleets, three for medium fleets, and five for large fleets. In critiquing OSHA's cost analysis for hydraulic fracturing, API/IPAA disagreed with OSHA's estimates that only sand mover operators would need to utilize dust control booths in order to achieve the new PEL (Document ID 2301, p. 69). API/IPAA suggested that instead there would need to be one booth per affected worker and that only one worker could utilize a given booth. In the Associations' estimate this would mean that there would need to be 3, 8 and 12 booths for small, medium, and large fleets, respectively (Document ID 2301, Attachment 4, Dust Booths, row 9).
As discussed in the technological feasibility chapter of the FEA, OSHA agrees that workers other than sand mover operators will need to use dust booths. However, OSHA does not agree that a booth can only accommodate a single person. These booths are places of refuge and are not assigned to specific individuals. The technological feasibility chapter in the FEA determined that dust booths can accommodate more than one person per booth. Because OSHA agrees that more employees than sand mover operators will need booths, OSHA has raised its estimates of booths needed by size class from 1, 4, and 5 booths to 3, 6, and 8 booths. While this estimate of the number of booths is lower than that recommended by API/IPAA, OSHA finds that these booths can accommodate 2 persons per booth and thus can accommodate more workers than API/IPAA suggested.
In the PEA, OSHA estimated the transportation costs for booths as $37.25 per booth. API/IPAA disagreed. The Associations argued that a cost of $513 for a small fleet, which would only have one booth, would be more appropriate (Document ID 2301, p. 69). Most of the difference between API/IPAA's cost estimate for deploying dust control booths and OSHA's estimate is attributable to the fact that the Associations presented their cost per fleet and OSHA presented its cost per
In the PEA, OSHA estimated that water misting system would be needed to control residual emissions from some releases from sand moving systems. These water misting systems were estimated to cost $60,000 per fleet to purchase and an additional 20 percent of the purchase cost for installation. API/IPAA incorrectly assumed that these water misting systems were intended to control all dust emission from truck traffic and other sources (Document ID 2301, pp. 69-70). This was not the case—dust suppression for truck and other traffic was costed at a much higher rate separately from water misting.
OSHA's cost estimates for misting systems were based on conversations with a mining dust control specialist who indicated the price and efficacy of available water misting systems (Document ID 1571). While API/IPAA disagreed with OSHA's costs, they did not offer any data to show an alternative cost, instead simply carrying OSHA's estimate for water misting systems forward in their analysis to arrive at their cost estimate (Document ID 2301, Attachment 3, Water Misting, cells K:O6 and J8). OSHA has determined that the equipment that formed the basis for its cost estimates in the PEA may not be durable enough to stand up to the wear from frequent loading, unloading, and transportation. Therefore, the Agency, based on its own judgement, has increased the estimated cost of a water misting system by 33 percent in order to account for the need for a more durable system. Based on this, OSHA's final cost analysis for hydraulic fracturing includes costs of $79,800 per fleet to purchase the equipment plus installation costs of $15,960 for installation (20 percent of the purchase price) for water misting equipment to control residual dust emissions from sand moving systems.
In developing the costs for hydraulic fracturing firms to comply with this rule in the PEA, it was determined that the baghouse controls that are commercially available are integrated into sandmover units and therefore should not present any logistical difficulties for transportation purposes. However, in examining the costs to transport, assemble, and disassemble the control equipment, API/IPAA noted potential difficulties in adding baghouse controls to sandmovers, which are often nearly at weight limits for road movement (Document ID 2301, p. 71).
OSHA's determination about integrated units has not changed since the PEA. The existence of integrated units is further discussed in Chapter IV of the FEA, Technological Feasibility. OSHA notes that sandmover units are not the heaviest items transported by hydraulic fracturing firms, so the additional weight associated with baghouse controls would be insignificant in this context. These firms are highly experienced in moving the heavy, bulky equipment needed on well sites and including additional controls on this equipment is not expected to create a situation that exceeds the capabilities of these firms.
Commenting on OSHA's analysis of the cost of controls for hydraulic fracturing, API/IPAA expressed concern that OSHA was considering requiring the use of containerized systems. The Associations stated that these systems would be economically infeasible for small fleets and raised questions about whether these systems would be sufficient to allow fleets using them to achieve the PEL (Document ID 4222, p. 7). Neither in the PEA nor the FEA has OSHA's cost analysis reflected the use of containerized systems, nor does OSHA require their use. Instead, containerized systems represent a possible technological change that could potentially reduce the costs of silica control. OSHA has in no way quantitatively tried to estimate the effects of this possible reduction.
In the PEA, OSHA found that conveyor skirting systems with appropriate LEV would be needed to meet the new PEL, and included the cost of such controls in the incremental costs associated with the new PEL. As discussed in Chapter IV, Technological Feasibility, in the FEA, however, OSHA now finds that these conveyor skirting systems will be needed to meet the preceding PEL, but not to further lower exposures to the new PEL, so OSHA is not including costs for these controls as incremental costs associated with achieving the new PEL. As a result, the FEA does not include costs for conveyor skirting systems and LEV.
On the other hand, dust suppression to control silica emissions generated by truck traffic, estimated in the PEA as necessary only to meet the preceding PEL, has now been determined to be necessary to meet the new PEL (
OSHA made two additional changes to the costs of dust suppression from the PEA to the FEA. First, OSHA accepted the unit costs for dust suppression application provided by API/IPAA (Document ID 2301, Attachment 3, Dust Suppression). This unit cost is somewhat lower than the original estimate that OSHA adopted in the PEA (Document ID 1712). This seems reasonable to OSHA based on the costs of the most commonly used dust suppression materials. Second, OSHA has determined that these controls will be utilized to reduce exposures for ancillary support workers and remote/intermittent workers, 50 percent of whom work in situations that currently have exposures below the new PEL (as shown in the exposure profile in the section on hydraulic fracturing in Chapter IV, of the FEA, technological feasibility). As a result, instead of assigning dust suppression costs for all wells (as in the PEA), OSHA determined in the FEA that dust suppression costs would be incurred by 50 percent of wells. This aligns with a view that, in many cases, natural conditions (silica content of soils, dustiness, wetness and/or climate) are such that dust suppression is not needed.
Before publishing the NPRM, OSHA received comment on the accuracy of its unit costs through the Small Business Advocacy Review (SBAR) Panel process.
The Small Entity Representatives (SERs) who participated in the 2003 SBAR Panel process on OSHA's draft standards for silica provided many comments on the estimated compliance costs OSHA presented in the Preliminary Initial Regulatory Flexibility Analysis (PIRFA) for general industry and maritime (Document ID 0938).
In response to the SERs' comments, OSHA carefully reviewed its cost estimates and evaluated the alternative estimates and methodologies suggested by the SERs. OSHA updated all unit costs presented in the PIRFA to reflect the most recent cost data available and inflated all costs to 2009 dollars prior to publication of the proposed rule. However, the Agency generally determined that the control cost estimates in the PIRFA were based on sound methods and reliable data sources.
For the PEA, OSHA reviewed the SERs' cost estimates for small entities in the foundry and structural clay industries. Given that those SERs did not report their own sizes, the Agency could not compare their estimates to the estimates in the PEA. OSHA concluded that the compliance costs reported by the SERs in general industry that did provide size data were not incompatible with OSHA's own estimates of the costs of engineering controls to comply with the PEL. As discussed above, for the FEA, OSHA has halved the number of workers assumed to be covered by each control for most controls in establishments with fewer than twenty employees, which results in a doubling of the engineering control costs for these establishments.
Stuart Sessions, testifying on behalf of ACC, argued that OSHA had underestimated costs to small establishments for two reasons: (1) Small establishments may have higher exposures and therefore many need to spend more money installing controls to reduce those exposures; and (2) costs to small establishments may involve diseconomies of scale—whereby smaller facilities would have to pay more per unit to procure and install systems—that OSHA had not accounted for (Document ID 4231, Attachment 1, pp. 2-4).
With respect to the issue about small establishments having higher exposures—the commenter simply asserted that this is the case without providing any evidence to support the claim. Mr. Sessions speculated that smaller businesses have a “lesser ability to afford compliance expenditures and lesser ability to devote management attention to compliance responsibilities” (Document ID 4231, Attachment 1, p. 2). While it is possible that very small establishments may not have the same controls already in place as large establishments, as asserted by the commenter, this does not necessarily mean that very small establishments will have higher exposures. Small and very small establishments typically only have one shift per day, so fewer shifts are being worked where there is a potential for exposure. They also may spend more time on activities not involving silica exposures. For example, a small art foundry that produces one or two castings a week will simply spend proportionally less time on activities that lead to silica exposure than a large production foundry.
With respect to the issue of diseconomies of scale, OSHA has taken this phenomenon into account in its cost estimates in the FEA. First, in order to provide a conservative estimate of costs for the purposes of determining the impacts on very small employers, OSHA has revised what Mr. Sessions called “the most inappropriate of OSHA's assumptions” (Document ID 4231, Attachment 1, p. 6). In the PEA, OSHA estimated that a single control would reduce the exposures of four workers. For the FEA, OSHA has revised its estimates so that the number of workers whose exposures are reduced by a control are half that used in the PEA for establishments with fewer than 20 employees—reducing the number of workers covered by a control from four to two. OSHA made this adjustment even though there are ways in which small establishments may have lower costs per cfm than larger establishments. For capital costs, a major element of cost per cfm is the length of ductwork. Within the same industry, the length of ductwork will be much shorter in smaller establishments. For operating costs per cfm, length of operating time is a key element of costs.
OSHA has continued to estimate that the exposures of four employees whose exposures would be reduced per control for establishments with more than twenty employees (even though it is likely that more than four workers have their exposures reduced per control in the largest establishments). This effectively means that very large establishments with hundreds of employees have been modeled as if their costs were equivalent to that of several 20-40 person establishments combined. Far from neglecting diseconomies of scale, in an effort to be conservative and adequately account for the challenges faced by smaller establishments, OSHA has instead neglected to account for economies of scale in larger establishments.
Mr. Sessions calculated some higher overall costs for smaller establishments (Document ID 4231, Attachment 1, pp. 6-10). However, these costs are critically dependent on the assumptions already addressed and rejected by OSHA, such as that exposures are random and that any exposures require that all possible controls be installed to control those exposures.
For the FEA, OSHA used unit costs developed in the PEA for specific respirable crystalline silica control measures from product and technical literature, equipment vendors, industrial engineers, industrial hygienists, and other sources, as relevant to each item. Some PEA estimates were modified for the FEA based on comments in the record, and all costs were updated to 2012 dollars. Specific sources for each estimate are presented with the cost estimates. Wherever possible, objective cost estimates from recognized technical sources were used. Table V-4 in the FEA provides details on control specifications and data sources underlying OSHA's unit cost estimates.
Table V-5 in the FEA summarizes the estimated number of at-risk workers and the annualized silica control costs for each application group. Control costs in general industry and maritime for firms to achieve the PEL of 50 μg/m
Table V-6 in the FEA shows aggregate annual control costs in general industry and maritime by NAICS industry. These costs reflect the disaggregation of
In both the PEA and the FEA, OSHA determined that employers, in order to minimize exposure monitoring costs, would select appropriate controls from Table 1. The final estimate for control costs, however, includes Table 1 control costs for a larger number of employees than in the PEA. For the purpose of estimating control costs in the PEA, OSHA examined all of the employers with employees engaged in Table 1 tasks but judged that only a subset of those employers (those with workers exposed above the proposed silica PEL) would require additional engineering controls. For this final rule, OSHA has judged, for costing purposes, that
OSHA is also likely overestimating the cost of controls for another reason. If the employer is able to demonstrate by objective data, or other appropriate means, that worker exposures would be below the action level under any foreseeable conditions, the employer would be excluded from the scope of the final rule. These employers would not require additional controls. OSHA did not have sufficient data to identify this group of employers and did not try to reduce the costs to reflect this group, so OSHA's estimate of costs is therefore overestimated by an amount equal to the costs for those employers engaged in covered construction tasks but excluded from the scope of the rule.
A few tasks involving potentially hazardous levels of silica exposure are not covered in Table 1. Employers would have to engage in exposure monitoring for these tasks pursuant to paragraph (d) and use whatever feasible controls are necessary to meet the PEL specified in paragraph (d)(1). For example, tunnel boring and abrasive blasting are not covered by Table 1 and are therefore addressed separately in this cost analysis. Although several commenters identified various other activities that they believed were not covered by Table 1 that could result in crystalline silica exposure over the PEL (Document ID 2319, pp. 19-21; 2296, pp. 8-9), some of these activities were simply detailed particularized descriptions of included activities. For example, overhead drilling is addressed in the FEA, Chapter IV-5.4 Hole Drillers Using Handheld or Stand-Mounted Drills, and the demolition of concrete and masonry structures is addressed in the FEA, Chapter IV-5.3 Heavy Equipment Operators. For the remainder, the available exposure data did not indicate that these activities resulted in a serious risk of exposure to respirable crystalline silica (
The control costs for the construction standard are therefore based almost entirely on the tasks and controls specified in Table 1. Most of the remainder of this section is devoted to explaining the manner in which OSHA estimated the costs of applying appropriate engineering controls to construction activities as required by Table 1 of the final standard. These costs are generated by the application of known dust-reducing technology, such as the application of wet methods or ventilation systems, as detailed in the technological feasibility analysis in Chapter IV of the FEA. These costs are discussed first, and, following that, the control costs for tasks not specified in Table 1 are separately estimated.
OSHA revised Table 1 between the PEA and the FEA. The entries included in the table have been modified with some tasks being added and some being removed.
• New entries on Table 1—
○ Handheld power saws for cutting fiber-cement board (with blade diameter of 8 inches or less)
○ Rig-mounted core saws and drills
○ Dowel drilling rigs for concrete
○ Small drivable milling machines (less than half-lane)
○ Large drivable milling machines (half-lane and larger for cuts of any depth on asphalt only and for cuts of four inches in depth or less on any other substrate)
○ Heavy equipment and utility vehicles used to abrade or fracture silica-containing materials (
○ Heavy equipment and utility vehicles for tasks such as grading and excavating but not including: Demolishing, abrading, or fracturing silica-containing materials
• Removed entry for drywall finishing from Table 1
• Revised entries on Table 1—
○ Drivable saw entry revised to permit outdoor use only.
○ Portable walk-behind or drivable masonry saws divided into two entries—walk-behind saws and drivable saws.
○ Handheld drills entry revised to include stand-mounted drills and overhead drilling.
○ Combined entries for vehicle-mounted drilling rigs for rock and vehicle-mounted drilling rigs for concrete.
○ Milling divided into three tasks—walk-behind milling machines and floor grinders; small drivable milling machines (less than half-lane); and large drivable milling machines (half-lane and larger with cuts of any depth on asphalt only and for cuts of four inches in depth or less on any other substrate).
○ Heavy equipment used during earthmoving divided into two tasks—(1) heavy equipment and utility vehicles used to abrade or fracture silica-containing materials (
○ Revised crushing machines entry to require equipment designed to deliver water spray or mist for dust suppression and a ventilated booth or remote control station.
In addition to the new and revised tasks in Table 1, some of the controls and specifications required by Table 1 were revised for this final rule, including removal of “Notes/Additional Specifications” from individual Table 1 entries and addition of substantive paragraphs after the table. Those revisions include:
• Revised or newly required controls/specifications for Table 1 tasks—
○ Revised requirement to operate and maintain tools/machine/equipment in accordance with manufacturer's instructions to minimize dust emissions.
○ Revised specifications for dust collectors to require they provide at least 25 cubic feet per minute (cfm) of air flow per inch of blade/wheel diameter (for some, but not all entries that include a dust collection system as a control method).
○ Revised specification for dust collectors to require they provide the air flow recommended by the tool manufacturer, or greater, and have a filter with 99 percent or greater efficiency and a filter-cleaning mechanism (for some, but not all entries that include a dust collection system as a control method). The entries for handheld grinders for mortar removal (
○ Revised requirement for tasks indoors or in enclosed areas to provide a means of exhaust as needed to minimize the accumulation of visible airborne dust (paragraph (c)(2)(i)).
○ Added requirement for wet methods to apply water at flow rates sufficient to minimize release of visible dust (paragraph (c)(2)(ii)).
○ Revised specifications for enclosed cabs to require that cabs: (1) Are maintained as free as practicable from settled dust; (2) have door seals and closing mechanisms that work properly; (3) have gaskets and seals that are in good condition and working properly; (4) are under positive pressure maintained through continuous delivery of fresh air; (4) have intake air that is filtered through a filter that is 95% efficient in the 0.3-10.0 μm range (
○ Added requirement to operate handheld grinders outdoors only for uses other than mortar removal, unless certain additional controls are implemented.
○ Added wet methods option for use of heavy equipment and utility vehicles for tasks such as grading and excavating but not including: Demolishing, abrading, or fracturing silica-containing materials.
○ Added requirement to use wet methods when employees outside of the cab are engaged in tasks with heavy equipment used to abrade or fracture silica-containing materials (
• Removed controls/specifications for Table 1 tasks—
○ Removed requirements to change water frequently to avoid silt build-up in water.
○ Removed requirements to prevent wet slurry from accumulating and drying.
○ Removed requirements to operate equipment such that no visible dust is emitted from the process.
○ Removed local exhaust dust collection system option and requirement to ensure that saw blade is not excessively worn from the entry for handheld power saws.
○ Removed requirement to eliminate blowing or dry sweeping drilling debris from working surface from the entry for handheld and stand-mounted drills (including impact and rotary hammer drills).
○ Removed additional specifications for dust collection systems for vehicle-mounted drilling rigs for concrete (
○ Removed requirements to operate grinder for tuckpointing flush against the working surface and to perform the work against the natural rotation of the blade.
○ Removed dust collection system option and requirement to use an enclosed cab from crushing machines.
These and other changes to Table 1 are discussed in detail in Section XV: Summary and Explanation of this preamble. While Table 1 has changed with regard to the tasks included and the control methods required, OSHA's methodology used to estimate the costs of controls for the construction industry has remained basically the same as that explained in detail in the PEA, with steps added (and explained in the following discussion) to address cost issues raised during the comment period and the updates and revisions to Table 1. OSHA summarizes the methodology in the following discussion, but the PEA includes additional details about the methodology not repeated in the FEA.
OSHA adopted the control cost methodology developed by ERG (2007a, Document ID 1709) for the PEA and subsequently for the FEA. In order to provide some guidance on that cost methodology, OSHA itemizes below the three major steps, with sub-tasks, used to estimate control costs in construction, with two additional steps added for the FEA to estimate the number of affected workers by industry and equipment category
• Step 1: Baseline daily costs, relative costs of controls, and labor share of value
○ Use RSMeans (2008, Document ID 1331) estimates to estimate the baseline daily cost for every representative job associated with each silica equipment category (Table V-30) and unit labor and equipment costs (Table V-31).
○ Use vendors' equipment prices and RSMeans estimates to estimate the unit cost of silica controls (Table V-32), and estimate the productivity impact for every silica control and representative job, to be added to the cost of the control applied to a particular job (Table V-33).
○ Use the costs from Tables V-32 and V-33 to calculate the incremental productivity impact, labor cost, and equipment cost for each representative job when controls are in place (Table V-34).
○ Using Tables V-30 and V-34, calculate the percentage incremental cost of implementing silica controls for each representative job (Table V-35).
○ Calculate the weighted average incremental cost (in percentage terms) and labor share of total costs for each silica job category (outdoors and indoors estimated separately) using the assumed distribution of associated representative jobs (Tables V-36a and V-36b).
• Step 2: Total value of activities performed in all Table 1 silica equipment categories
○ Match BLS Occupational Employment Statistics OES
○ Based on the distribution of occupational employment by industry from OES, distribute the full-time-equivalent employment totals for each equipment category by NAICS construction industry (Table V-39).
• Step 3: Total affected employment by industry and equipment category
○ Disaggregate construction industries into four distinct subsectors based on commonality of construction work (Table V-40a) and then estimate the percentage of affected workers by occupation, equipment category, and construction subsector (Table V-40b).
○ Use the percentage of affected workers by occupation, equipment category, and construction subsector (Table V-40b) to obtain total affected employment by occupation (Table V-41) and total affected employment by industry and task (Table V-42).
• Step 4: Aggregate silica control costs (not including self-employed persons)
○ Using the FTE employment totals for each task by NAICS construction industry (Table V-39) and the mean hourly wage data from OES, adjusted for fringe benefits, calculate the annual labor value of each Table 1 silica activity by NAICS construction industry (Table V-43).
○ Using the labor share of value calculated for each activity performed in a silica-related equipment category (Table V-43), estimate the total value of each Table 1 equipment/task category by industry (Table V-44).
○ Estimate the distribution of silica work by equipment type, duration of activity, and location of activity (Table V-45).
○ Multiply the total value of Table 1 construction activities requiring controls (Table V-44) by the percentage incremental cost associated with the controls required for each activity that uses equipment in each equipment category (Tables V-36a and V-36b) and weighted by the percentage of tasks performed outdoors and indoors/within an enclosed space (Table V-45), to calculate the total control costs, adjusted for baseline compliance, by Table 1 equipment category and industry (Table V-46).
○ Calculate engineering control costs for silica-generating construction activities not covered in Table 1 (Tables V-47a and V-47b).
○ Combine the control costs for Table 1 construction activities (Table V-46) and the control costs for construction activities not covered in Table 1 (Tables V-47a and V-47b) to calculate the total control costs by equipment category and construction industry (Table V-48).
• Step 5: Adjust aggregate silica control costs to include self-employed persons
○ Use data from the BLS Current Population Survey to estimate the ratio of the number of self-employed persons to the number of employees by occupation (Table V-49) and then redo the estimation after restricting self-employed persons to just those occupations covered by OSHA that potentially involve exposure to hazardous levels of respirable crystalline silica (Table V-50).
○ Multiply the FTE rate for each occupation (from Tables V-38a and V-38b) by the number of self-employed workers and employees in that occupation (from Table V-50) to obtain the ratio of FTE self-employed persons to FTE employees and then reduce that ratio to reflect only self-employed persons working on a multi-employer worksite where the work of the self-employed person cannot be isolated in time or space (Table V-51).
○ Increase the earlier estimate of control costs by equipment category and industry (Table V-48) by the adjusted FTE ratio of self-employed workers (Table V-40) to calculate total control costs by equipment category and industry with self-employed persons included (Table V-52).
OSHA's cost estimates address the extent to which current construction practices incorporate silica dust control measures. Thus, OSHA's baseline reflects such safety measures as are currently employed. To the limited extent that silica dust control measures are already being employed, OSHA has reduced the estimates of the incremental costs of silica control measures to comply with the new PEL. As discussed in Chapter III of the FEA and summarized in Tables III-A-1 and III-A-2, OSHA estimates that 44 percent of workers with exposures currently below the new PEL are using the controls required in Table 1.
Unlike the situation with the general industry/maritime standard, OSHA does not have extensive data identifying the number of employees engaged in Table 1 tasks or the duration of their exposure to respirable crystalline silica during those tasks. Therefore, ERG developed a model based on “representative jobs” for the purposes of identifying the control costs necessary to comply with Table 1. Using RSMeans
Table V-30 of the FEA shows the specifications for each representative job and the associated daily labor, equipment, and material costs. Table V-31 of the FEA provides a summary of the labor rates and equipment charges used to estimate the daily cost of each representative construction job in Table V-30 of the FEA. Note that the data on hourly wages with overhead and profit in Table V-31 of the FEA, obtained from RSMeans (2008, Document ID 1331), are employed here to be consistent with other RSMeans cost parameters to estimate the baseline costs of representative jobs. The RSMeans estimates are published for the purpose of helping contractors formulate job bids, so ERG relied on that data as an indicator of the amount of labor and time that would be required for each of the representative jobs in the cost model developed for this analysis. These RSMeans estimates are later used only to determine two ratios: The labor share of the costs of representative construction jobs and the percentage increase in the cost of each representative job due to the addition of controls to comply with the final rule. Everywhere else in the cost chapter, when the actual wages were important to the calculations and are expressed as
Prior to the publication of the PEA, one SBREFA commenter criticized the methodology for estimating engineering control costs on the grounds that while RSMeans estimates were used to establish the marginal costs of new controls (as a percentage of baseline costs), average wage rates (including fringe benefits) from the BLS
First, the commenter's concern is misplaced because the choice of the RSMeans estimates source does not skew the results in the manner suggested by the commenter; nor does it even have a significant impact on the cost analysis. The RSMeans estimates were used only to develop the ratio of costs for the representative jobs to the total labor cost and then to determine the incremental compliance costs as a percentage of the total and the share (percentage) of estimate value with controls accounted for by labor. Because the RSMeans estimates are organized by project cost to assist contractors in bid planning, that data set is the logical choice for this purpose over BLS data, which provides wage data but does not provide comparable costs for projects. Dividing project labor value by the labor share of project value yields an estimate of total project value.
The absolute level of the RSMeans wage and equipment cost levels do not directly affect the resultant aggregate compliance costs. While lower wage rates would lower the baseline costs of the representative jobs, it does not follow that control costs as a percent of baseline costs would also be lower. In fact, if lower wage rates are combined with the same equipment costs, the equipment part of incremental control costs would be a higher percentage of total baseline costs. Only the labor share (percentage) of baseline costs, along with the incremental compliance costs as a percent of baseline costs, are taken from the analysis of representative costs and used in the subsequent estimation of aggregate costs. The absolute levels of the wage rates and equipment costs taken from RSMeans do not directly enter the aggregate cost analysis.
Second, OSHA notes that the BLS wage data, on which the aggregate compliance costs are based, are obtained from a statistically valid, national survey of employment and compensation levels and are the best available data characterizing national averages of wages by detailed occupation. For some of the reasons the commenter noted, OSHA believes that the BLS wage estimate provides a more accurate reflection of average wages.
Another set of SBREFA commenters criticized OSHA's cost estimation methodology, arguing that fundamental errors resulted in serious underestimates of the costs of engineering controls. The commenters asserted without any significant explanation that the task-by-task incremental cost estimates (shown in Table V-23 of the PIRFA, Document ID 1720, p. 749) should have been multiplied by two factors: (1) “The ratio of the RSMeans labor rate to the BLS wage and benefits rate,” and (2) the inverse of the “percentage in key occupations working on task” from Table V-26 (also in the PIRFA, Document ID 1720, p. 766). Under this approach, the commenters argued that “the cost of PEL controls for brickmasons, blockmasons, cement masons and concrete finishers performing grinding and tuckpointing would be approximately seventy-two (72.0) times the ERG estimate, and . . . the cost of PEL controls for drywall finishing (at the 50 μg/m
The rationalization for these calculations was not provided, and OSHA found these conclusions without merit. The incremental control costs shown in Table V-34 of the FEA were based on RSMeans estimates for labor and equipment costs. As shown in Table V-34, these cost estimates, after adjustments for productivity impacts, are used to calculate the percentage increase in baseline costs associated with each control. The RSMeans-based cost estimates shown in Table V-34 are also used to estimate the share of total baseline task/project costs accounted for by labor requirements. The averages of the percentage increase due to incremental control costs and the labor share (percentage) of total baseline costs are shown in Table V-37 of the FEA. These two percentages are used to extrapolate the aggregate control costs associated with each task. This extrapolation was based on (1) the full-time-equivalent employment in key and secondary occupations associated with each task, and (2) the value of the labor time as measured by the BLS occupational wage statistics, adjusted for fringe benefits.
OSHA provided similar responses in the PEA and requested comment on its responses to the SBREFA comments, but received none (
The same set of SBREFA commenters further argued that OSHA's analysis contained five more “fundamental errors” (Document ID 0004). First, the commenters asserted that OSHA's calculations understate the actual cost because they are based on old data (1999 or 2000 data from RSMeans rather than RSMeans 2003 data). OSHA used the most recent available data at the time the initial preliminary analysis was completed and subsequently updated those data for the PEA (and the FEA) using RSMeans estimates from 2008 (Document ID 1331). However, as noted previously, the RSMeans estimates do not directly determine the absolute level of aggregate compliance costs, but rather the labor share (percentage) of project costs and incremental compliance costs as a percentage of baseline costs. This aspect of the analysis received no further comment and has been retained for the FEA.
Second, the commenters asserted that there is no information to “suggest much less substantiate the premise that the exposure monitoring data in Tables 3-1 and 3-2 [in the ERG (2007a) report, Document ID 1709)] (even if they were properly collected and analyzed) are in any way representative of current workplace exposures across the country” (Document ID 0004). In response, OSHA points out that the profiles used to estimate the numbers of workers exposed in excess of each PEL option were, in fact, based on the extensively documented technological feasibility analysis with many of the data points in the exposure profiles being taken from the findings of OSHA inspections (and based on ERG, 2007a, Document ID 1709). OSHA is tasked with using the best available evidence to develop the analyses, and the data in the exposure profile represent the best available evidence on current workplace
Third, the commenters claimed that there is “is no information to suggest much less substantiate the premise that the exposure monitoring data in Tables 3-1 and 3-2 (even if they were representative of current workplace exposures) are in any way representative of the non-existent, theoretical jobs artificially created by the FTE [full-time equivalent] analysis so as to justify their use as the foundation for Table 4-12” (Document ID 0004). However, OSHA notes that the representative jobs on which the cost analysis is based were designed to correspond directly to the tasks assessed in the technological feasibility analysis. Furthermore, Table 4-12 in ERG (2007a, Document ID 1709) was derived directly from Table 3-2 and is independent of the “FTE analysis.”
Fourth, the commenters argued that a more logical and appropriate methodology would assume that all FTEs were exposed above the PEL in the absence of controls, and the commenter could find “no justification, and substantial support to the contrary, for an approach that artificially condenses actual exposures into far more highly concentrated exposures (by condensing all at-risk task hours into FTEs) and then [assumes] that, despite the impact of this change, the grab bag of exposure monitoring described in ERG Tables 3-1, 3-2 and 4-12 represents these FTEs” (Document ID 0004). The commenters asserted that the effect in ERG (2007a, Document ID 1709) of “first multiplying total project costs by the FTE percentage (from Table 4-8) and then by the `Percentage of Workers Requiring Controls' from Table 4-12 (and then by the average `Total Incremental Costs as % of Baseline Costs' by job category from Table 4-7) results in an unjustified double discounting of exposed workers in the incremental cost calculation” (Document ID 0004).
OSHA disagrees. The Agency notes that ERG (2007a, Document ID 1709) used the exposure profiles from the industry profile to estimate the number of full-time equivalent workers that are exposed above the PEL. In other words, this exposure profile is applicable if all exposed workers worked full time only at the specified silica-generating tasks. The
Finally, the SBREFA commenters argued that the “application of the FTE analysis to the additional equipment costs is based on the wholly unfounded assumption, contrary to actual experience, that this additional equipment could be used with perfect efficiency (
Having already incorporated comments from small business in the SBREFA panel process, the Agency produced revised estimates for the PEA in support of the proposed silica rule. In the PEA, OSHA requested comments from rulemaking participants on the Agency's preliminary estimate of control costs in construction. Below are comments representative of the prominent issues that raised concerns.
The most broad-based critique of the construction cost analysis came from the Construction Industry Safety Coalition (CISC), and its consultant Environomics (Document IDs 2319, 2320, and 4217). Several of their arguments regarding underestimation of costs related to an undercount of the affected construction population (for example, they believed OSHA should have accounted for the cost to control silica exposures for plumbers). OSHA agrees in part that there were some occupations—plumbers, plumber helpers, electricians, electrician helpers, roofers, roofer helpers, terrazzo workers and finishers, and sheet metal workers—that likely have exposure and should be included in this analysis, as they do perform some activities covered by Table 1. These are discussed in FEA Chapter III, Industry Profile.
OSHA also received comments regarding the availability of control equipment. In its post-hearing brief, CISC commented:
In the Agency's cost analysis, it has also made the entirely impractical assumption that controls (
While OSHA agrees that CISC's argument has merit, during hearing testimony CISC's representative acknowledged that its estimates did not initially take into account the economic life of a control. This is reflected in the following conversation between CISC's Stuart Sessions and OSHA's Robert Stone:
MR. STONE: So returning to the methodology for costing, you pretty much used our numbers and you used our, presumably, like you mentioned the dust shroud that has a one-year life and, therefore,
MR. SESSIONS: Yes. That's a good point, and I hadn't thought about that.
MR. STONE: Okay, thank you. A related point is actually the same issue. It would be operating in maintenance costs. You're—it's going to be one-sixth of our original estimate, but I don't think you've made that adjustment.
MR. SESSIONS: Correct. (Document ID 3580, Tr. 1501-1502).
After the hearing discussion, CISC revised its methodology, noting:
After additional thought and discussion about this issue with several construction tradespeople, we . . . concluded that useful life is a function of both how often the tool and controls are used, but also how long they sit in the construction worker's truck and get bounced around going from job site to job site (even when they are not used), and how often they are taken out of the truck and returned to the truck (even when they are only set up then taken down at the job site but not actually used). Thus useful life will increase if a tool sits idle for some percentage of the time when it is available, but useful life will not increase to the same proportional extent as the decrease in usage. We assumed in the example in workbook Tab # X2B that using the tool and equipment 1/4 as often will double its useful life (Document ID 4217, p 89).
OSHA agrees with this updated methodology and has adopted CISC's approach—essentially assuming one-half of the usage life over which to amortize the purchased control equipment—for jobs that typically involve intermittent short-term exposure. The jobs for which the Agency assumed a half-life of the control equipment were: (1) Hole drillers using hand-held or stand-mounted drills—for electricians, plumbers, carpenters, and their helpers, and for sheet metal workers; and (2) handheld power saws for carpenters and their helpers. Note that OSHA's adoption of this updated approach resolves CISC's criticism that OSHA had not accounted for productivity decreases from controls not being available when the worker needs to use them for short-term or intermittent silica jobs.
For all other construction jobs (
• In most cases, an employer's own/rent decision for control equipment will be determined by the own/rent decision for the construction equipment (including construction tools) to which the control equipment will be applied. If the employer rents/owns the construction equipment, the employer will rent/own the control equipment. The major exception would be if a particular piece of control equipment could be applied to many types of construction equipment. An example might be a dust collector. In that situation, the employer might find it economic to rent the construction equipment and own the control equipment. But, in that case, the purchased control equipment will not be sitting idle.
• Construction equipment is sufficiently expensive that employers, as a general matter, will not find it economically efficient to have it sitting idle. That is why employers so frequently rent construction equipment. Of course, employers that do only one type of construction job all year (or those that are sufficiently large that they work on that particular type of construction job all year) will find it economic to own the construction equipment—as well as the control equipment—but then the control equipment will not be sitting idle.
• In light of permit requirements and other job-planning requirements, in almost all cases, the employer will have advance knowledge of the details of the construction job (as opposed to, sometimes, repair work in general industry). This knowledge would include the construction equipment—and controls—required to perform the job. In fact, employers will often schedule construction jobs precisely to avoid having construction equipment sitting idle. In other words, the typical employer—and certainly the competent employer—won't come to the job site unprepared, needing to leave the job site to obtain rental equipment or controls.
• The construction sector is a significant component of the U.S. economy. There is a large, competitive construction equipment/control rental market in place to serve it. In most places, employers should be able to obtain needed construction equipment/controls in a timely manner under terms similar to those estimated here.
For the aforementioned reasons, OSHA believes that the ownership-versus-rental cost issue, except in the case of construction jobs that involve intermittent short-term exposure, is somewhat of a red herring. The difference in amortized cost should be negligible, given that employers will choose to own or rent based on whichever is the lower-cost alternative. In fact, because rental costs are typically somewhat higher than amortized ownership costs, OSHA may have overestimated compliance costs for those employers who purchase control equipment.
CISC, and its contractor Environomics, claimed in their comments that OSHA had omitted the costs of compliance by sole proprietors (typically self-employed persons) (Document ID 4217, p. 80). The inclusion of such costs and the circumstances under which they would arise are discussed in Chapter III of the FEA. In the FEA OSHA has accounted for costs associated with controlling employee exposures from sole proprietor activities. The actual self-employment data and the estimated effect on employer costs are presented at the end of this section on engineering control costs in construction.
Prior to the PEA, a participant in the SBREFA process noted that while OSHA established the total incremental cost for each silica control method (summarized for the final rule in Table V-35 of the FEA), the cost estimates were based on the application of a single control method. The commenter argued that there may be cases where two or more control methods would have to be applied concurrently to meet the exposure limits (Document ID 0968, p. 14). In response, OSHA noted in the PEA that for each task, specified control options correspond to the control methods described in the technological feasibility analysis in Chapter IV (of the PEA). These methods reflected the choices laid out in Table 1 of the proposed rule; they were also presented in Table V-25 in the PEA along with OSHA's calculation of the weighted average proportion of project costs attributable to labor and the incremental
Throughout the comment period, CISC reiterated its pre-PEA objections to OSHA's methodology of estimating incremental costs instead of the “full” compliance costs, which CISC defined as including the costs for employers to meet their existing duty to comply with OSHA's old PEL (CISC claims employers of “nearly 60,000 workers” were not in compliance with OSHA's preceding standard and would have OSHA attribute the costs of compliance with the preceding standard to the costs of this rule) (Document ID 4217, p. 33):
In our view, OSHA has made two errors in the approach it has taken:
• First, the “full” compliance costs for reducing worker exposures from their current levels to below the proposed new PEL are the conceptually correct costs to estimate when assessing economic feasibility, not the “incremental” costs for reducing exposures to below the proposed new PEL from a starting point assuming compliance with the current PEL. In practice, employers will face the full costs, not the lesser incremental costs, and the economic feasibility assessment should consider whether employers can afford these full costs, not the hypothetical and lower incremental costs.
• Second, OSHA has made a conceptual error in the Agency's methodology for estimating compliance costs * * * Insofar as OSHA omits all costs for [employees with exposures >250 µg/m
Both arguments are now largely moot because in the FEA almost all of the construction engineering control costs are based on compliance with Table 1 and encompass all employees engaged in the Table 1 tasks, regardless of their current level of exposure. OSHA has included the full incremental—and full total—costs for all employers in construction who have workers who are performing tasks listed on Table 1, even those workers with exposures currently above 250 µg/m
CISC's arguments for the construction sector are now only relevant to the very few tasks not covered by Table 1, such as tunnel boring. OSHA therefore addresses CISC's arguments in the context of those few tasks.
The first argument is that employers who are not in compliance with the preceding PEL of 250 µg/m
The second argument can be dismissed on similar grounds. CISC's argument appears to assume that employers will incur different costs for different controls necessary to reduce exposures from above 250 µg/m
James Hardie Building Products commissioned Peter Soyka of Soyka & Company LLC to perform an evaluation of the PEA. While Mr. Soyka's comments cover many aspects of the analysis and overlap with those of other commenters, some were relatively unique.
In one place, Mr. Soyka questions the entire method of analyzing jobs from the level of workers and their tasks. He expressed concern about both what he termed the failure to capture the cost to the establishment, as well as the need for workers to have controls available (Document ID 2322, Attachment G, p. 165). OSHA did not, however, ignore other costs for establishments. Elements of these costs are dealt with at the establishment level for some ancillary provisions of the standard, and are discussed later in this chapter. The second element, regarding the availability of controls for certain occupations, mirrors concerns raised by Environomics and CISC, and has been dealt with above.
Elsewhere in his comments, Mr. Soyka states that “OSHA should develop revised unit costs that consider the full array of elements that affect what a business charges its customers for a unit of time expended.” Such unit costs,” he submitted, “would include direct labor, fringe benefits, overhead, SG&A, and a reasonable allowance for profit (
Following publication of the NPRM, a representative of petrochemical employers, the American Fuel and Petrochemical Manufacturers, raised concerns about retrofitting and clean-up costs that it claimed were improperly omitted from OSHA's analysis of engineering controls in construction:
OSHA claims “[t]he estimated costs for the proposed silica standard rule include the additional costs necessary for employers to achieve full compliance.”[ ] Yet it fails to consider the additional costs of retrofitting existing equipment to comply with Table 1 in Section 1926.1053 (Table 1). In addition to acquiring new engineering controls not previously implemented, many employers will have to modify pre-existing equipment to come into compliance (
OSHA also fails to account for the clean-up costs associated with the natural by-products from Table 1's required engineering controls. For example, many of the engineering controls require the use of wet methods or water delivery systems. [ ] Employers will incur costs from removing (from the clean-up process itself and lost time) excess water to prevent ice or mold from developing. Yet these costs go unaccounted for in the PEA (Document ID 2350, pp. 6-7).
In the FEA, the Agency does not include any specific cost for retrofitting equipment. The record indicates that almost universally employers either already have equipment with the required controls available for use (
Regarding the question of clean-up costs, the commenter treats the issue as if there were no clean-up costs associated with generating silica currently. As discussed in the Environmental Impact Analysis (Section XIV of this preamble) and in the discussion of productivity impacts later in this section, there was substantial comment to the record indicating that in many, if not most, situations, the controls associated with reducing silica exposure will lead to a net decrease in the amount of time required for cleanup after a job. While OSHA is not attempting to quantify any potential cost savings, the record likewise does not support attributing additional costs to cleanup.
William Turley, executive director of the Construction & Demolition Recycling Association (CDRA), broadly described the impacts he anticipated for his industry.
Recyclers who crush materials for reentry into the economic mainstream as aggregate products would appear to have to do all of the following:
• Purchase and install climate-controlled enclosures or cabs for all crusher operators;
• Install crusher baghouses for particulate emission reduction;
• Enclose conveyor belts—a measure unprecedented in our industry;
• Install effectively designed and maintained water spraying equipment;
• Impose full-shift use of respirators for all quality control hand pickers working on processing lines;
• Establish and implement emission testing protocols and procedures to ensure compliance with the PEL;
• Implement medical surveillance programs for all employees engaged in material crushing activities; and
• Achieve a “no visible emissions” standard, which frankly is both unattainable and utterly unreasonable.
To the best of our knowledge, no recycler in the United States has a system even resembling the above. The cost of such systems will unquestionably threaten the economic viability of construction & demolition debris recyclers across the Country. It must also be pointed out that the industry has an exceptionally diverse composition of larger operators with higher economic margins and small operations with limited capabilities to capitalize the type of equipment called for in this rulemaking (Document ID 2220, pp. 2-3).
The final silica rule does not require all the above steps. OSHA expects that crushing machines will be used for construction/demolition activities, as discussed in detail in the Summary and Explanation of the standard. As such, OSHA anticipates that employers engaged in the recycling operation would follow Table 1 and would not need to conduct exposure monitoring.
For crushing machines, OSHA removed the “no visible emissions” requirement and the requirement for enclosed cabs, both of which had been in the proposed Table 1. Employers are now required to use a spray system and comply with manufacturer instructions. Also, there is no requirement to enclose conveyor belts or install crusher baghouses. Instead, employees must use a remote control station or ventilated booth that provides fresh, climate-controlled air to the operator. For the FEA, OSHA added the cost of a ventilated booth for the use of crushing machines in construction/demolition activities. Most crushing machines are already equipped with movable controls that will allow operation of the machine from inside the booth, so no additional equipment modifications will be required for most machines. Crushers available for purchase or rental are also typically equipped with a water spray system, so OSHA has not assessed any incremental cost for sprayers.
The National Roofing Contractors Association (NRCA) objected to OSHA's preliminary cost estimates for controls used to limit silica exposure in roofing operations, claiming that OSHA's preliminary estimate of an average of $550 per year for firms that employ 20 workers or fewer (covering the majority of roofing contractors) had significantly underestimated the cost of specialized saws that would be required for roofing equipment. In support of the argument that OSHA had underestimated costs, NRCA identified costs for retrofitting portable saws with integrated dust collection systems along with specialized vacuums equipped with HEPA filters (Document ID 2214 p. 4).
The task of cutting most roofing materials would fall under “Handheld power saws (any blade diameter)” in Table 1, and the final version of Table 1 does not allow for the dust collection methods described, so the majority of costs quoted by NAHB are not relevant. Instead, the final version of Table 1 requires that the employer use wet methods. Second, the estimate of $550 a year in costs to very small employers was an estimated average across all affected establishments with fewer than 20 employees, not just roofing operations in homebuilding. Questions of small business impact or economic
The comments submitted by consultant Peter Soyka on behalf of James Hardie Building Products (“Hardie”) presented a table of typical devices with engineering controls involved in fiber cement cutting and an un-sourced range of costs for the retail prices of those types of devices and their controls (Document ID 2322, p. 13).
Hardie's inclusion of a table of retail prices for the purchase of equipment with controls suggests there may have been a misunderstanding of the nature of OSHA's cost methodology—it is not based on purchasing entirely new pieces of equipment, but making sure the equipment has the controls necessary to comply with Table 1. To the extent commenters submitted estimates addressing the latter question, OSHA has taken them into consideration in its final estimates.
Fann Contracting, Inc. acknowledged that the availability of equipment with built-in controls is rising. However, the commenter suggested that OSHA's preliminary assessment of the design specifications and costs for the engineering controls identified in Table 1 of the proposed rule had under-counted the amount of milling machines and other paving-related equipment that the commenter believed would still require additional retrofits to enclosed cabs (sealing cracks, adding air conditioning, upgrading to HEPA filters, etc.) to satisfy the requirements in Table 1 (Document ID 2116, pp. 6-7).
Table 1 in the final rule does not require a cab for milling machines or any of the equipment identified by the commenter for paving purposes, so the commenter's concerns are not relevant. Table 1 only requires cabs for “(xvii) Heavy equipment and utility vehicles used to abrade or fracture silica-containing materials (
A SBREFA commenter raised questions about the availability of silica-free joint compound for drywall finishing (Document ID 0004). In the PEA, OSHA relied on NIOSH studies showing that silica-free joint compounds had become readily available in recent years (
Whether equipment, and the relevant controls, are rented or purchased, the effective annual cost of the equipment is based on the assumed number of days per year that it would be used. In the PEA, OSHA had estimated rental of the equipment for 150 days during each 365-day period. Based on comments received from industry representatives during the 2003 SBAR Panel process (Docket ID 0968), this estimate had been reduced from an average of 250 days in the Preliminary Initial Regulatory Flexibility Analysis (PIRFA). This reduced workday estimate presumably reflected winter weather slowdown in many parts of the country, as well as general weather conditions (such as rain) that can interfere with many construction processes, and resulted in
However, Environomics, in developing its own cost estimates, assumed that control equipment would be used for 250 days a year, without an articulated rationale for departing from the estimate provided during the SBAR Panel process (Document ID 4023, Attachment 2, X2B-Hole Drilling Unit Costs, Cell P:Q44). More importantly, Environomics selectively and inconsistently applied 250 days only to the frequency of usage but not to the daily rate (which OSHA had based on 150 days of usage). To see why it is a problem to apply a different number of days to the same daily rate, consider a piece of control equipment, with a one-year life, known to cost $1,500. Using a 150-day construction work-year, OSHA would estimate a daily rate for the control equipment of $10 ($1,500/150 days in the construction work-year). The annual cost for that control would be $1,500 ($10 multiplied by 150 days). Using the same example, Environomics would keep OSHA's daily rate of $10 (amortized over 150 days) but apply it to a 250-day calendar to arrive at an annual cost of $2,500—where the one-year cost of the equipment was known to be $1,500. In short, the selective 250-day methodology Environomics used results in an overestimation of costs by 67 percent.
Accordingly, OSHA has decided to retain the 150-day construction work year based on the best available evidence, and the Agency has consistently applied that work-year throughout the cost analysis developed in the FEA for construction. (General industry and maritime work is typically less affected by weather, so a separate work-year number of days is used for those calculations).
In developing the cost estimates in the FEA, OSHA defined silica dust control measures for each representative job (
The unit costs for most control equipment are based on price information collected from manufacturers and vendors. In some cases, control equipment costs were based on data from RSMeans (2008) on equipment rental charges (Document ID 1331). Table V-32 of the FEA shows the general unit control equipment costs and the assumptions that OSHA used to estimate the costs for specific types of jobs.
For each job identified as needing engineering controls, OSHA estimated
In addition to incremental equipment costs, OSHA estimated in the PEA the incremental labor costs generated by implementing silica dust controls. These labor costs were generated by: (1) The extra time needed for workers to set up the control equipment; (2) potential reductions in productivity stemming from use of the controls; (3) additional time to service vacuum dust control equipment; and (4) additional housekeeping time associated with or generated by the need to reduce exposures. All additional labor costs related to the use of controls were subsumed into a single additional labor productivity impact estimate for each of the representative job categories. Except where otherwise noted, the productivity impact described is negative, meaning that the addition of the control is expected to reduce productivity. To develop estimates of the labor productivity impacts of the dust control equipment that would be required as a result of the proposed standard, ERG interviewed equipment dealers, construction contractors, industry safety personnel, and researchers working on construction health topics.
In part, because most silica dust controls are not yet the norm in construction, knowledge about the impact of dust controls on productivity was uneven and quite limited. More precisely, few individuals that ERG interviewed were in any position to compare productivity with and without controls and the literature on this topic appears deficient in this regard. Overall, telephone contacts produced a variety of opinions on labor productivity effects, but very few quantitative estimates. Of all the sources contacted, equipment rental agencies and construction firms estimated the largest (negative) productivity impacts. Some equipment vendors suggested that there are positive productivity effects from control equipment due to improved worker comfort (from the reduction in dust levels). Others suggested that the use of dust collection equipment reduces or eliminates the need to clean up dust after job completion. Comments to the record, discussed below, closely mirrored this preliminary information.
The estimation of labor productivity effects is also complicated by the job- and site-specific factors that influence silica dust exposures and requirements for silica dust control. Potential exposures vary widely with hard-to-predict characteristics of some specific work tasks (
After considering the existing evidence OSHA concluded that labor productivity impacts are often likely to occur and accounted for them in the PEA analysis. In the PEA, depending on the general likelihood of productivity impacts for each activity, OSHA used a productivity impact ranging from zero to negative five percent of output. After considering the many comments advocating for both increasing and decreasing the productivity impact estimates, OSHA has concluded that the estimates in the PEA were approximately correct and has retained the PEA estimates for the FEA. The comments and factors influencing each selection are described in the following discussion.
In response to the SBREFA Panel, the Reform OSHA Coalition commented on the estimates of the impact of exposure control equipment on productivity during construction operations. This SBREFA commenter noted that the estimates of the productivity impact of using additional control measures were based on interviews with dealers, contractors, and researchers working on construction health topics and expressed its opinion that it was not clear how this “purely qualitative analysis [was translated] into productivity [impact] rates . . . . ” (Document ID 0968, p. 14). The commenter indicated that engineering control compliance costs would be sensitive to the ultimate choice of productivity impact measures (Id.).
OSHA responded to these comments in the PEA as part of the discussion of the basis for OSHA's productivity estimates. OSHA summarizes the responses to SBREFA comments here for the convenience of the reader. As described in the PEA, ERG's research revealed little substantive, quantitative evidence about the magnitude of the productivity impacts of the controls, and in some cases, the direction of the impacts (positive or negative) appeared to depend on the specific nature of the job. OSHA's estimates in the preliminary analysis reflected ERG's best professional judgment about the likely magnitude of these impacts. Some of the estimates may be conservative because under some scenarios for certain tasks the productivity impacts could be significantly smaller than those shown in Table V-23 of the PEA. In some scenarios the productivity impact may even be positive.
The same commenter also expressed a concern that even though “silica is not now considered a hazardous waste,” OSHA had not analyzed the impact of the proposed rule on disposal of “[silica-]contaminated” wastes such as “filters of dust control vacuums and contaminated water discharge” (Document ID 0968, p. 28). The commenter asserted that disposal issues are “acute on the construction site where a means to readily dispose of such material or water is not available” (Id.). The comment was somewhat puzzling because the comment was premised on the fact that there is not currently any “hazardous” classification for such waste that would trigger special disposal duties, and the commenter did not explain why any additional costs would be incurred beyond normal disposal practices. OSHA did not identify any new areas of cost in its Environmental Impacts analysis presented in the FEA, and finds no evidence that employers will be required to incur additional environmental costs as a result of this rule, other than some potential permit-modification notification costs addressed in the discussion of engineering control costs for general industry in the FEA. The incremental disposal costs resulting from dust collected in vacuums, discarded filters, and other sources in construction are therefore likely to be de minimis. An analysis of wet methods for dust controls suggests that in most cases the amount of slurry discharge is not
OSHA invited comment on the productivity impacts—positive and negative—resulting from the introduction of controls to limit exposure to silica. In the discussion below, OSHA reviews comments supporting both negative productivity impacts and positive productivity impacts. The comments supporting negative productivity impacts include assertions that OSHA underestimated the negative productivity impact of complying with the silica rule, failed to include a productivity impact on equipment, and failed to include a fixed productivity impact. OSHA considered those comments before concluding that it will generally retain the approach it used in the PEA, with the exception of selectively adding additional costs for productivity impacts on equipment in response to a point raised by CISC. OSHA will also explain separately why it is not calculating any productivity impact for two specific activities: (1) Use of cabs for earthmoving equipment, and (2) drywall installation.
The Interlocking Concrete Pavement Institute reported that “converting from in-place paver cutting to wet cutting and/or vacuum systems could induce a 50 percent productivity penalty,” but did not otherwise substantiate that claim beyond noting that it was a survey response from one of its members (Document ID 2246, Attachment 1, p. 3).
Mr. Soyka, in the comments prepared for Hardie, critiqued OSHA's estimates of the productivity impact on construction operations as “far too small” and urged OSHA to adjust productivity-loss estimates based on empirical data “if available” (Document ID 2322, Appendix G, pp. 14-15 and 21-22). However, the commenter did not clearly identify any such empirical data in the comments. The only labor-based engineering control cost alternative offered by the commenter that resembled “empirical data” is the addition of a seven-hour penalty per job that was “based on a JHI time-motion study” apparently conducted exclusively in a single industry (new home construction) and comprised of data from just the JHI study (Document ID 2322, Appendix G, Attachment A, p. A-8). OSHA could not determine whether it would actually supply new “empirical evidence” that would warrant a change from the preliminary estimate because the study was not submitted into the record. The commenter cites “James Hardie Building Products, Inc., undated, pg. 15,” which appears to align with an entry in the list of references to an undated “James Hardie Labor Efficiency Manual,” but that manual was not submitted into the record.
Mr. Soyka recommended that OSHA use time-motion studies to derive the estimated productivity impacts.
[. . . F]ew [of the productivity penalties estimated by OSHA] are supported by actual data (
In addition, Mr. Soyka developed an alternative cost model that included additional productivity impacts that OSHA did not include. In this model Mr. Soyka “assumed that wherever possible, company owners in the residential construction industry will outsource their compliance obligations to specific subcontractors . . . providing the products and services that might generate significant amounts of silica dust” (Document ID 2322, Appendix G, p. 26). In this scenario, Mr. Soyka determined that the employer would require “the subcontractor to relocate its work location outside the house(s) being constructed to a distance sufficient to ensure that silica dust concentrations remained minimal inside and around the house(s)” and that “relocating the materials and work giving rise to silica dust generation [. . .] would add substantially to the time required to complete the associated tasks” (Document ID 2322, Appendix G, p. 30). He accounted for this additional time by increasing the productivity impact on the specialty subcontractors to seven hours per job, “based upon time-motion studies conducted by James Hardie (James Hardie Building Products, Inc., undated, pg. 15)” (Document ID 2322, Appendix G, p. 31).
Mr. Soyka's model also included a productivity impact for “wearing respirators to account for fatigue and adverse impacts on employee-to-employee communication” (Document ID 2322, Appendix G, p. 32).
OSHA fundamentally disagrees with the Mr. Soyka's assumptions. Mr. Soyka's assumption that all silica-generating tasks need to be removed from the homebuilding site results from a misunderstanding of OSHA's statement that “[i]n response to the proposed rule, many employers are likely to assign work so that fewer construction workers perform tasks involving silica exposure; correspondingly, construction work involving silica exposure will tend to become a full-time job for some construction workers” (FR, 2013, at 56357) (Document ID 2322, Appendix G, p. 25). OSHA did not mean that silica-generating tasks will be subcontracted out and that subcontractors will be forced to perform these tasks off-site. Rather, the Agency was acknowledging that construction employers would likely consolidate the responsibilities for performing silica-generating tasks to as few workers as possible in order to limit exposures to peripheral workers.
As mentioned previously, the “time-motion studies” performed by James Hardie, compiled in an unpublished reference, were not provided for public inspection. Moreover, the description of how those data were used in developing the model suggests that Mr. Soyka's relevant assumptions are not based on time-motion studies of how long it actually takes to perform specific tasks with controls added. Rather, it appears that Mr. Soyka assumed inflated times to perform the tasks, based on a misunderstanding of what the proposed rule required; in any case, it is not descriptive of the requirements for the final rule. Mr. Soyka's suggested approach contrasts with the estimates provided by CISC/Environomics, which accepted the limitations of the analytical exercise and agreed with most of the estimates in the PEA regarding the “variable” productivity effect.
Moreover, it should be noted that aside from weighing the possible competing forces on productivity in the course of a shift (
CISC and its consultant Environomics, as well as some other commenters, questioned OSHA's productivity-loss estimates associated with the required controls. CISC/Environomics claimed that overall OSHA “underestimated productivity losses associated with performing tasks using the prescribed controls by an amount roughly equal to the average equipment intensity of about 42 percent” (Document ID 2320, p. 29). CISC/Environomics reported that this underestimation came largely from OSHA failing to account for what they termed “fixed productivity impacts” and for productivity impacts to equipment. Both of these concerns are discussed below.
In its post-hearing brief, CISC/Environomics presented the results from a questionnaire and interviews conducted with employers and knowledgeable tradespeople; the results included a finding that “the variable penalty percentages [. . .] were the same as or slightly larger than those that OSHA had estimated” (Document ID 4217, p. 92). CISC/Environomics did not submit the questionnaire or the answers received, nor the details of the interviews, to the record so OSHA could not fully evaluate the findings or compare them to its own findings. Based on the available summary information it appears that, while CISC and OSHA's estimates for variable productivity costs were nearly identical, it is not clear that CISC's estimates took current compliance into account. CISC stated that its members felt that “something greater than zero variable productivity penalty should be estimated for masons using portable saws controlled with wet methods [. . .] and for heavy equipment operations using enclosed cabs and HEPA filters” (Document ID 4217, pp. 92-93). OSHA acknowledges that there would be a productivity impact to comply with the requirements of the silica rule relative to using no controls for those activities. However, as shown in Chapter III of the FEA, Industry Profile, OSHA has found high levels of baseline compliance with the provisions of the rule for those activities. As is standard in OSHA's costing methodology, only costs above and beyond those incurred under current standards are attributable to the final rule.
In addition, CISC argued that OSHA should take higher productivity impacts because “in some fraction of these instances [(where controls would be required)], the controls are hellaciously difficult to use” (Document ID 3580, Tr. 1321). The testimony goes on to give examples of such difficulties such as when “building houses where the utilities are not yet in and the water is not yet in,” when working in places where power is not readily available such as in parking garages or on scaffolding, and when doing work that requires wet methods outdoors in extremely cold temperatures (Document ID 3580, Tr. 1321-1322). A different commenter, the National Utility Contractors Association, similarly criticized OSHA's estimates for excluding additional water-transportation costs: “there is not always a water supply available which would require trucking large volumes of water to the job site which adds additional costs.” (Document ID 3729, p.3)
Given the fact that the majority of the silica-generating equipment requiring controls under this standard—such as tuckpointing grinders and concrete drilling equipment—require electricity, OSHA does not find merit in applying any productivity impact simply because the controls for those tools may also need electricity. If the employer can find a way to power the equipment, it can also power the controls when necessary. Similarly, employers must commonly transport water to worksites without it for cleanup and sanitation purposes, and OSHA's technological feasibility analysis explains why the amount of water required to generate the spray mist is not typically very significant. Although it seems plausible that wet methods would occasionally be used outdoors by some employers in weather cold enough to freeze the water mist used to control the silica dust, this is far from a common construction occurrence. Moreover, it is not entirely clear from the record that freezing mist would decrease productivity. OSHA's estimates of productivity impacts is intended to represent an average across all situations, and the tiny fraction of time wet methods will need to be used outdoors in extremely cold weather should not skew the average productivity impact.
CISC/Environomics stated that there should also be a productivity impact on equipment rental or use as well as for the additional labor to operate that equipment longer. Environomics reported that a complete cost estimate of productivity loss would include not only the additional labor time required, but also the cost of having to rent equipment for a longer period of time.
. . . Simply put, a productivity penalty for labor will translate to a productivity penalty for equipment. For example, if due to a labor productivity loss, the labor time required to complete a job increases from eight hours to eight hours and 15 minutes, the equipment time required for job completion will also increase to eight hours and 15 minutes. Additional equipment rental costs will be incurred for the additional 15 minutes, or equipment owned by the employer will be delayed for use on another job by 15 minutes (Document ID 2320, p. 29).
This concern was reiterated both in its hearing testimony (Document ID 3580, Tr.1323) and in its post-hearing brief where Environomics stated that “OSHA's analysis should add an equipment component to the costs associated with whatever productivity penalty is incurred in performing a construction task using the Table 1 controls” (Document ID 4217, p. 91). OSHA agrees, in part, and recognizes that there can be a productivity impact for equipment (as well as for labor) for many tasks when there is a cost created by having to extend the rental time of the equipment.
In the PEA, OSHA had estimated the labor productivity impacts associated with engineering controls to reduce silica exposure. For the FEA, the Agency has added a parallel cost for the equipment portion of the cost for a number of equipment categories. These are itemized in Table V-34 of the FEA. For example, for Task 15 (Demolition of concrete slabs, mesh-reinforcing, up to 3″deep), there is estimated to be a 2 percent labor increase related to maintaining wet methods for dust suppression. In the original Means estimates, it was estimated that approximately 70 percent of the costs of the task were labor-related, divided between an operator and a laborer. This 2 percent additional cost is estimated to amount to $9.39 in added labor cost for an equipment operator and $7.84 for a laborer, or a total labor productivity cost per job of $17.23. For the FEA, OSHA is adding an additional cost item of $7.58 to reflect an opportunity cost, in the form of a prospective extended equipment rental cost, raising the total incremental estimated cost to $24.81 per task. As with the other construction engineering control costs, this additional cost item is task-specific.
While OSHA judged that equipment productivity can be impacted negatively by the new rule for many tasks, there are two general categories for which the Agency determined that there would be
The second category of tasks for which the Agency did not assess any equipment productivity impact is the group of tasks in which there is not a fixed ratio of labor to capital (capital in this case including rental costs). For example, as explained in the following unit cost discussion, Task 10 (as detailed in Table V-34 of the FEA) involves performing earthmoving as a heavy equipment operation task. In this case, while extra time by a laborer would be required to tend to the application of wet methods, such application would be done simultaneously with actually performing the earth-moving task. Thus, while wet methods for Task 10 would require an added labor cost (itemized as a “productivity” cost), it would not actually slow down the operation so as to require the longer period of use of the equipment that would impose an equipment impact.
CISC/Environomics also argued that part of the productivity effect was fixed and would therefore need to be accounted for separately. This fixed component, CISC/Environomics reported, would be “typically involving activities such as initial set-up and final take-down and clean-up of the control equipment, [which] often occur at the beginning and end of a job or work shift” (Document ID 4217, p. 90,
Other commenters did not agree that there would be costs related to set up. During the hearings, Deven Johnson, of the Operative Plasterers' and Cement Masons' International Association, testified that the concrete grinding “tools that are on the market today come integral with the capture device[. . .] The hose is attached to the grinder already. The electrical cord is attached to the motor already. [. . .] You simply plug it in and start using it [. . .] there's no setup time” and that for “a walk-behind concrete diamond-bladed saw for cutting slabs, the setup time is, make sure there's gas in it and . . . hook a water hose up to it and turn the water on” (Document ID 3581, Tr. p. 1699). During the hearing, Manafort Brothers described a wheel-based machine used to suppress dust during demolition operations, which was simply wheeled onto the worksite and hooked up to a water supply and electrical source (Document ID 3583, Tr. 2430), and the Building Trades Construction Department (BCTD) of the AFL-CIO submitted an extensive list of available tools that included the controls required by the rule that would require little or no set up (Document ID 4073, Attachment 4a).
Based on the evidence in the record, OSHA determined that any time needed to set up the engineering controls required by this rule is adequately accounted for in the productivity impacts the Agency has included, particularly in light of the fact that OSHA is not making any adjustment to account for productivity improvements that are likely to result from this rule (see the discussion of comments identifying productivity improvements later in this section). Environomics' inclusion of both a “fixed” productivity impact as well as a “variable” productivity impact, without recognizing offsetting productivity benefits identified by other commenters', results ins a significant overestimate of the productivity impact.
BCTD strongly disagreed with CISC's estimates about productivity decreases resulting from the rule, stating in their post-hearing brief:
So in the case of the carpenters with the dust extraction equipment on the drill and the HEPA vacuum, the carpenter takes a little bit longer to do his hole-drilling task because he's got to attach the equipment to the drill. He's got to attach the hose to the HEPA vacuum. He's got to walk over before he drills and he's got to turn on the HEPA vacuum. Then after he drills, he's got to turn off the HEPA vacuum. He's got to periodically empty the HEPA vacuum. He's got to worry about the vacuum hose from the drill to the vacuum getting kinked and all that sort of thing. So the job takes a little bit longer. Tr:1317-18.
CISC offered no evidence that its analytical approach is more accurate than OSHA's. Moreover, this description of how its hypothetical carpenter would deploy control technology assumes the employer would select the most cumbersome and inefficient technique available, rather than taking advantage of the range of more suitable and less costly tools that are readily available on the market. See, e.g., Ex. 4073, Att.7a (ROI: hand-held drill with integrated dust collection) (Document ID 4223, pp. 55-56).
BCTD also took exception to the fact that “CISC acknowledged that `there may be a productivity net gain in terms of cleanup from using a control,' Tr:1319 (Sessions), [but did] not appear to have taken potential gains into consideration when estimating its lost productivity cost” (Document ID 4223 pp. 55).
Dr. Ruth Ruttenberg highlighted the various areas where the PEA may have overestimated the negative productivity effect of engineering controls in construction. She stated that the assumption of a negative impact on productivity
. . . is yet another example of OSHA erring on the side of being conservative in cost estimates. Despite the fact that some who were interviewed suggested there could be a positive impact on productivity, OSHA's PEA assessed anywhere from 0 percent to a 5 percent penalty in productivity loss as a result of OSHA compliance with the proposed silica rule. (PEA, p. V-123-124) The impact of an assumption of lost productivity can be profound, and OSHA acknowledges this: “. . . the magnitude of the productivity impacts can substantially change the estimate of the overall cost increase associated with controls” (PEA, p. V-131).
Despite the fact that OSHA leaves likely productivity increases out of its calculations, it does point to opportunities to increase productivity with dust control. [. . .]
Limiting dust increases visibility for workers. (PEA, p. V-126) Vacuum systems speed up drilling because continuous removal of drill cuttings from the hole, reduce the need for workers to periodically stop and clean. (PEA, p. V-128) And the list goes on. OSHA's cost estimates are conservative, and high, when it comes to productivity impact (Document ID 2256-A4, p. 7).
In addition to comment that the productivity loss due to this rule would be minimal, OSHA also received considerable comment to the record that the controls would improve productivity in a number of ways the Agency had not factored in—for example by reducing clean-up time by capturing dust at the source, improving worker comfort and morale, and encouraging innovation.
Testimony at the public hearings by the International Union of Bricklayers and Allied Craftworkers on the experience by union members with engineering controls suggested that use of controls may boost productivity by reducing the amount of dust that needs to be cleaned up during a given shift. The following is a hearing dialogue between Chris Trahan of BCTD, and Sean Barrett of the International Union of Bricklayers and Allied Craftworkers:
MS. TRAHAN: [. . .] In your experience is there any productivity gains or benefits that you can describe?
MR. BARRETT: I can. These machines, when running correctly, when [. . .] the vacs are regulated, the filters are running good. You can run that machine until 3 o'clock in the afternoon, shut it off, and go home. [. . .] If [the machine is] not [running correctly], you constantly got to keep going back and cleaning up what you already did. You're losing productivity. And over the course of [. . .] a month you're talking 40 man-hours. You're talking a—paying a guy for a week. It's—that's not the case at all [if dust controls are functioning]. You would actually increase productivity by having the right equipment there and not have people have to keep coming back or jimmy-rig little things to try to get by. Just do it the way it was designed, and you'll get a lot farther. . . . (Document ID 3585, Tr. 3055-3057).
Deven Johnson of the Operative Plasterers' and Cement Masons' International Association elaborated on the potential time savings of some of the new engineering controls:
One of the other things that collecting the dust from these operations on the front end does, it saves time on cleanup. Some of the industry people have said that it's prohibitive to do that because it takes more time to collect the dust. That's also not true. If you're collecting the dust as it's generated and it's going into a HEPA-filtered container, it's not being blown all over the job site, you don't need anybody else to clean it up (Document ID 3581, Tr. 1594).
Walter Jones of the Laborer's Health and Safety Fund testified that, for some tasks, reducing or eliminating the need to clean up after a job can dramatically increase productivity, in this case by one-third:
We had the Bricklayers here a few days ago and they were talking about their ability to work till 3:00, because they did not have to clean up. Instead, when they use non-dust controlling or capturing devices, they would have to stop right after lunch in order to begin cleaning up. So we're looking at adding a few more hours to the workday. So to me, in my mind, they're way more productive (Document ID 3589, Tr. 4246).
Joel Guth, President of iQ Power Tools and a mason contractor, testified that he had been able to document the savings in clean-up time.
In certain industries we've been able to measure the time savings from cleaning up the silica dust [. . .] It saves them one to two to three hours a day in cleanup time because they don't have to wash down the house or wash the windows or wash the bushes where they're inherently dry cutting (Document ID 3585, Tr. 2981).
Scott Schneider, CIH, Director of Occupational Safety and Health. Laborer's Health and Safety Fund of North America, discussed how engineering controls contribute to a more productive workplace:
When you control the dust and you don't have—you're not breathing it into your lungs, but you're also not spraying it all over the construction site, all over the sidewalk, and you have to clean it up, there's a lot of other costs involved in not controlling. So I think we're going to realize those benefits by implementing the standard (Document ID 3589, Tr. 4277).
OSHA also heard a good deal of testimony suggesting that productivity will be improved through the use of engineering controls due to improving the working conditions for workers.
Mr. James Schultz of Wisconsin Coalition of Occupational Safety and Health described the physiological and practical benefits of introducing or enhancing engineering controls:
I think if you would work in the work environment that was less dust or hopefully dust free, it would definitely increase the amount of productivity just because so much of the time you're spending wiping the dust off your brow because it's falling into your eyes or something like that. Even if you have the respirator, it still interferes with your vision and things like that. So a cleaner environment would definitely be more productive just because [. . .], you spend less time trying to think about how you can protect yourself from this hazard, and I know myself, after working in the place for many years, I've started to have breathing problems and so if you can eliminate those breathing problems, if you can breathe freely, you're also going to be much more productive because you're not going to stop because you have [to] wheeze or go stand outside to get some fresh air for awhile or those types of things (Document ID 3586, Tr. 3253-3254).
Deven Johnson, mentioned previously, testified about the human effect of controlling silica as well:
Another thing is, an individual who is working in an environment where [. . .] he or she is constantly bombarded with concrete dust all day long, your productivity drops as you get more and more miserable as the day goes on. Commonsense would dictate, if you're not blasting me in the face with dust and sand and silica for eight hours a day, that I'm going to feel physically better and I'm not going to be as tired and exhausted and pissed off as I normally would be at the end of the day. Your productivity goes up[. . .]. (Document ID 3581, Tr. 1594-1595).
Mr. Javier Garcia Hernandez, from National Council for Occupational Safety and Health/Equality State Policy Center/Laborsafe, testified on the cognitive factors that affect productivity, and why engineering controls should aid productivity:
. . . as a construction worker, I highly believe that we're more productive when we are protected[. . . .]. We spend less energy focusing on how to protect ourselves. Just imagine you're working in a roomful of dust and you're just trying to either close your eyes or cover your mouth so the less you breathe. So you're constantly thinking about how to breathe less dust but if you have the respirator or the wet, the controlled area, whether it is water or respiratory protection, you're much more productive because our mind is less occupied in how to protect ourselves and we spend that time that we would have spent protecting ourselves working (Document ID 3586, Tr. 3248-49).
Todd Ward, a bricklayer, testified that workers have some awareness of the hazards of dry cutting blocks and that
. . . when [workers] on the job [are] dry cutting they know—it affects morale as well when they know [. . .] they have some safeguards and they're protecting their lungs. So there is an increased productivity when you have a good morale then on the job (Document ID 3585, Tr. 3057).
OSHA received comments on the fact that OSHA standards often lead to innovation.
The Laborers' Health and Safety Fund of North America pointed out that “[j]ust about every OSHA standard has had a look-back that has shown [that] industry has innovated to meet the new standard” and continued, saying that “[w]e believe a new OSHA standard with a lower PEL will spur innovation in the construction industry to meet the challenge” (Document ID 3589, pp. 4183-4184).
Charles Gordon observed that “reality is that the new technology will increase productivity faster, so that the actual costs will be much less than predicted” (Document ID 3855, Tr. 3815).
In summary, while some commenters have asserted that OSHA has underestimated the productivity penalties of using engineering controls in construction, other evidence in the record suggests that the aggregate net
There is one exception: OSHA has removed the productivity impact that it had included in the PEA for drywall installers. As explained in the unit cost discussion, the Agency has determined from the record that there is no economic reason why drywall installers would now use silica-based drywall installation—the U.S. market has shifted entirely to a silica-free compound (Document ID 2287, p. 38; 2296, Attachment 1, p. 30; 1335, pp. 3-4, 7, 10). Therefore, there is no longer a logical basis for a assigning a productivity loss to workers performing this task.
Table VII-12 summarizes the labor productivity estimates. As discussed previously, while empirical quantitative data are quite limited on productivity, it is possible to gauge the relative productivity impacts across the principal control options. For example, OSHA judged that there are no productivity impacts for certain controls, such as mobile crushing machines. On the other hand, OSHA found that the controls required for tuckpointers and grinders may result in additional time being spent setting up and maintaining controls over the course of a workday. In Table V-34 of the FEA, productivity impacts, or “lost production time,” are shown by task and are factors in OSHA's estimate of incremental cost per day.
As discussed, OSHA has retained most of its original estimates of the productivity effects from the PEA. In some cases, however, Table 1, which forms the basis for the equipment categories listed in Table VII-12, was changed from the PEA in response to comment. (see Methods of Compliance in this preamble for further discussion on the changes to Table 1). In other cases, OSHA received clarification on the manner of exposure and added elements to Table VII-12, but did not adjust the productivity impact. For example, OSHA received very specific comments on tasks involving portable masonry saws used to cut fiber cement materials (
This equipment category includes the following Table 1 tasks:
• Dowel drilling rigs for concrete; and
• Vehicle-mounted drilling rigs for rock and concrete
This equipment category covers a range of drilling activities using truck-mounted and similar drilling equipment, such as quarry drills and crawler-type drills. Dust control requires the use of either a dust collection system or wet drilling methods. Studies of the effectiveness of available dust collection systems have not addressed performance issues, but ERG judged that their use does not affect drilling productivity. While workers must service the dust control equipment during the workday, this activity generally does not affect the rate of drilling, except perhaps for short-duration jobs. The wet drilling methods are integrated into drilling equipment and also should not adversely affect the drilling rate. Thus, OSHA estimates that there will be no lost production time for these tasks.
This equipment category includes the following Table 1 tasks:
• Handheld grinders for mortar removal (
• Handheld grinders for uses other than mortar removal
According to ERG's search of the literature, grinding tools can be retrofitted with dust control shrouds that connect to a vacuum system (Buser, 2001 & 2002, Document ID 0577). Studies on the use of these controls indicate that extra time is required to install the shroud and periodically
For interior jobs and for exterior work that requires site cleanup of grinding debris, the additional work time required to use a vacuum system might be partially offset by savings in the time required to seal work areas (to prevent dust migration) and to clean the work area after task completion. Overall, clean-up times will vary depending on the size of the job site, the quantity of grinding debris, and the strength and capacity of the vacuum.
Grinding without a dust-control shroud can generate clouds of dust that might impair a worker's views of the grinding area. Whereas metal shrouds also block the view of the grinding area, plastic shrouds allow workers a view of the work area. Some contractors have noted, however, that use of shrouds does not allow for the precision required for certain tasks, such as grinding an inside corner (Lattery, 2001, Document ID 0777).
For exterior jobs where cleanup is not required and where the work area is not sealed, the use of vacuum equipment is likely to decrease productivity for the amount of time required for servicing the vacuum collectors. If, for example, five minutes were required to empty the vacuums every two hours, production time would decline about 4 percent, due simply to dumping the accumulated dust.
At some construction sites, vacuums have been used during the grinding process, but without shrouds. In these cases, one worker typically holds the vacuum nozzle near the grinding tool, which another worker operates. Switching to shrouds with a direct vacuum attachment would eliminate the need for this assistant and is a more productive operation.
Manufacturers and vendors cited other benefits from using the shroud-vacuum systems. Because dust does not build up on and clog the surface of the grinding wheel, the wheels last longer, resulting in an approximate 40 percent savings on the grinding discs (Eurovac, 2001, Document ID 0688). Another source contacted by ERG estimated that shrouds can increase the abrasive life of a grinding wheel by more than 500 percent (Buser, 2001 & 2002, Document ID 0577). In this regard, workers would spend slightly less time replacing wheels over the life of the equipment.
OSHA concluded that while the productivity impacts of vacuum systems can sometimes be partly offset by other factors, net productivity impacts are likely to remain negative. For exterior work, productivity is clearly lower when workers use a vacuum system. Overall, based on ERG's research, OSHA's final cost estimates include a 5 percent impact for lost production time associated with grinding operations in construction. This productivity impact is identical to the impact estimated for this activity in the PEA.
For a tuckpointing project, NIOSH researchers examined the use of vacuum system controls at a large college building complex (Gressel
Manufacturers and vendors contacted by ERG estimated that polyurethane shroud-vacuum systems with tuckpointing equipment, similar to those used with hand-held grinders, actually enhance productivity. Among the reasons provided for productivity improvements were: (1) Fewer workers were required; (2) cleanup times were reduced; (3) workers had improved visibility of the work surface; and (4) blades last longer (Buser, 2001 & 2002, Document ID 0577; Caperton, 2002, Document ID 0580; Eurovac, 2001, Document ID 0688; Nash and Williams, 2000, Document ID 0829). These observations on productivity applied to tuckpointers with 2- to 8-inch diameter wheels. In addition, positive effects on worker productivity have also been reported for shrouds that fit on 5-inch and 7- to 8-inch (18-lb) tuckpointers with integrated dust-collection systems since equipment without integrated dust-collection systems require that an additional worker be present to continually vacuum dust away from the work area (Document ID 0577). On the equipment that can be used with the tuckpointers with 5- to 8-inch wheels, an impeller inside the tool housing pushes dust down a hose into a reusable dust-collection bag (Document ID 0577). One vendor estimated that the operational productivity of these tools is no different from that of the same tool without dust control capability. Workers would still be required to periodically empty dust bags, although other clean-up time might be somewhat reduced (Document ID 0580). Because tuckpointing work is almost exclusively exterior work, however, clean-up is often not required.
Based on the considerations for hand-held grinding tools discussed above and the findings from the NIOSH tuckpointing study, OSHA judged in the PEA that use of a vacuum system during tuckpointing operations would impose, on average, a 5 percent negative productivity impact. Based on these findings and because manufacturer optimism about any positive productivity impacts has not been documented in controlled studies, OSHA included the same 5 percent negative productivity impact for tuckpointing tasks in the FEA.
This activity includes the following Table 1 tasks:
• Heavy equipment and utility vehicles used to abrade or fracture silica-containing materials (
• Heavy equipment and utility vehicles for tasks such as grading and excavating but not including: Demolishing or abrading or fracturing silica-containing materials
The control method proscribed in the proposed silica standard was to enclose and ventilate the operator's cab. The requirement for an enclosed cab is only retained in the final standard with respect to the use of heavy equipment used to abrade or fracture silica-containing materials or used during demolition. Final Table 1 allows employers to control dust from heavy equipment used for other purposes (
Using an enclosed cab on heavy construction equipment will not require maintenance beyond the general maintenance necessary to maintain the integrity of the cab enclosure. Therefore, OSHA estimated in the PEA that no productivity loss will be incurred for this control.
In the case of heavy equipment operations, CISC/Environomics estimated that there would be a one percent productivity penalty for
First, it is not clear that communication issues are being created by setting some minimal standards for enclosed cabs. Information supplied in the record indicates that there are alternate means of communication beyond shouting from the cab to the front-line workers outside the cab, including hand signals (Document ID 3583, Tr. 2441) and existing wireless communication systems (Document ID 0805, p. 4; 2262, p. 28). Many of these work environments are noisy, which seems to make alternate means of communication desirable, if not required.
Second, it appears that it may be more economical and desirable for workers to operate in a climate-controlled cab and that equipment with enclosed cabs has become standard in the construction industry. In fact, OSHA has determined that relevant heavy equipment currently comes with an enclosed cab as standard equipment (Document ID 3813, 3814, 3815, 3816), and in pricing construction jobs, RS Means included a cab as a standard equipment (meaning that it was already included in the equipment cost, not an added engineering control). In any case, the fact that cabs are standard suggests that potential buyers do not view the presence of a cab to be undesirable. While Environomics acknowledged this possibility at the hearings, their judgment remained that there would be a net productivity loss (without providing information on how these offsetting considerations were being incorporated) (Document ID 3580, Tr. 1434-1435). While OSHA is not persuaded that the evidence in the record supports Environomics conclusions, their argument is largely moot. Any productivity impact would result only from the addition of new controls, but enclosed cabs appear to have become standard on the relevant equipment, meaning that in most cases employers would not have the option of using open cabs even if OSHA's new rule was not in effect. Thus, there can be no productivity impact attributed to the requirement for a cab.
Although OSHA is not including any productivity impact to account for enclosed cabs, final Table 1 requires water, or other dust suppressants, during specified heavy equipment operations in order to protect workers outside the cab and as an alternative method of protecting operators for activities that do not involve silica abrading or fracturing. OSHA has therefore, as indicated in Table VII-12, added a 2 percent productivity impact for heavy equipment tasks involving grading and excavating, and 3 percent during demolishing, abrading or fracturing silica-containing materials. OSHA judged that the abrading, fracturing, and demolition-related tasks tend to be relatively dustier, and would therefore require relatively more labor to administer.
This equipment category includes the Table 1 task “handheld and stand-mounted drills (including impact and rotary hammer drills).”
This category includes workers in the construction industry who use handheld drills to create clearly defined holes for attachments (
Handheld and rig-mounted drills can be equipped with local exhaust ventilation to effectively capture dust generated when drilling small diameter holes. Larger core drills, also referred to as core saws, are more frequently used with water as a coolant to extend the service life of the drill bit, as well to suppress dust.
One rock-drill manufacturer asserts that use of vacuum systems speeds drilling by continuously removing the drill cuttings from the hole, making it unnecessary for workers to periodically stop drilling to accomplish this task (Atlas-Copco, 2001, Document ID 0542). On the other hand, the connection and servicing of the vacuum equipment requires incremental work that could reduce productivity. If the construction project at hand involves interior work, this impact might be offset by reductions in the time necessary for cleanup (
This equipment category includes the Table 1 task “Jackhammers and handheld powered chipping tools.”
Silica exposures generated during pavement breaking, concrete demolition, and other concrete work using jack hammers and other handheld powered chipping tools (including pavement breakers and other similar tools) are controlled through the use of wet or dry methods.
Regarding wet methods, because the work area generally cannot be presoaked effectively (
However, OSHA judged that the incremental productivity impact from the spraying activity is modest because various crew members could occasionally be enlisted to keep the water spray directed in the correct location. Further, because of the interactive nature of the various crew member activities, the time to move the water sprayer is unlikely to affect the overall crew output. In addition, incremental cleanup costs generally would not be significant since most drilling projects are performed outside. Nevertheless, to allow for some incremental work related to supplying water and positioning the spray when wet methods are used, as was the case in the PEA, for the FEA OSHA estimated a 3 percent productivity impact for this equipment category when wet methods are used.
A separate, higher, productivity impact was defined for use of dry methods for activities where jackhammers and other handheld powered chipping tools are used. Dry methods are somewhat less flexible and require a shroud for the close capture of dust as it is generated during operations. Workers also periodically have to empty
This equipment category includes the following Table 1 tasks:
• Handheld power saws (any blade diameter);
• Handheld power saws for cutting fiber-cement board (with blade diameter of 8 inches or less);
• Rig-mounted core saws or drills;
• Walk-behind saws; and
• Drivable saws
Drivable saws and walk-behind saws have an integrated water tank, and the sawing is almost always done wet (
As has been noted, most portable hand-held concrete saws are designed with wet-sawing capability (see Chapter IV, Technological Feasibility of the FEA). These saws have a water hookup for a hose attachment, but might also be used for dry cutting. (Dry-cut diamond blades for dry cutting are available; these are made especially so that the tips do not separate during dry cutting.)
A construction equipment distributor judged that there are no operational productivity advantages for dry cutting, as opposed to wet cutting (Healy, 2002, Document ID 0726). Wet cutting, however, requires access to water (water line or pressurized tank), and some time is needed to connect the equipment (although OSHA received a number of comments saying that this hook up is very simple and not time consuming—
For the final rule, the Agency has clarified in Table 1 that hand-held circular saws with a blade diameter of eight inches or less specially designed for cutting fiber cement board can be used outdoors without respiratory protection, when equipped with a local exhaust ventilation. The productivity impact for this group is also estimated at 2 percent because, although it does not have an impact on job performance, it involves some set-up time and incremental maintenance.
This equipment category includes the Table 1 task “Stationary masonry saws.” Stationary saws for masonry, brick, and tile cutting come equipped with water systems for wet cutting, which is the conventional, baseline control method for this type of work. Some modest incremental time is needed to provide for and connect the water supply and to maintain the water nozzles and spray system. This incremental time was the basis for OSHA to estimate a 2 percent cost in lost production, both in the PEA and in the FEA.
This equipment category includes the following Table 1 tasks:
• Walk-behind milling machines and floor grinders;
• Small drivable milling machine (less than half-lane);
• Large drivable milling machines (half-lane and larger with cuts of any depth on asphalt only and for cuts of four inches in depth or less on any other substrate)
The activities performed using equipment in this category range from cold planing and cleaning of asphalt to surface planing or grinding of concrete. In large-scale projects, such as street resurfacing, baseline practices are judged to control silica dust exposures. No additional controls would be needed, and therefore no negative productivity impacts are expected.
While some grinding machines designed for milling concrete surfaces have built-in dust collection or wet-method systems, others must be attached to external vacuum equipment. ERG reviewed the available literature and found no evidence that the grinding operation is slowed when such vacuum equipment is attached. Nevertheless, workers must devote some time to setting up equipment, changing vacuum bags or barrels, and cleaning filters. On the other hand, using an LEV system to capture dust as it is generated reduces the time required for cleaning up the settled dust from the surfaces following completion of the grinding task. OSHA estimated in the PEA that there would be a 2 percent productivity impact for milling using wet methods and a 5 percent productivity impact when using LEV systems.
This equipment category comprises the Table 1 task “Crushing machines.”
OSHA projected in the PEA that there would be no productivity impact for this equipment category. The Table 1 requirements for this machinery have changed in the final rule, but OSHA's conclusion that there will be no productivity impact remains the same. Final Table 1 requires employers to protect employees through a combination of sprayers and requiring the operator to operate the machinery from within a ventilated booth or at a remote control station. Once installed, the sprayer systems will be part of the crushing machine operation and will not impact production rates. For the purpose of the economic analysis of this rule, OSHA has accounted for additional costs for use of the ventilated booth. Because the booth can be located close to the machinery, there would not be productivity loss from the operator having to travel to a different location for operation. In most cases the booth can be set up quickly once at each location, so in most cases there will not be any significant productivity loss associated with the use of the booth.
Table V-34 in the FEA, and presented as Table VII-13 in this section, summarizes the control method and costs per day for each representative construction job. These costs include incremental equipment costs and indirect labor costs due to productivity impacts (decreases in productivity associated with the use of the control equipment).
Note that the only silica tasks in Table V-34 of the FEA considered to have short-term infrequent work where the employee would own the equipment are Task 11: Hole drilling using hand-held or stand-mounted drills and Task 18: Masonry cutting using portable saws—II. Note also that all the indoor tasks in Table V-34 of the FEA have an additional daily control equipment cost of $1.67 for a fan.
Table V-35 of the FEA summarizes the baseline costs and incremental control costs from Tables V-30 and V-34, of the FEA, respectively, for each representative silica-related job in OSHA's silica construction cost analysis. The control cost (defined as incremental control costs per day) are shown in Table V-35 of the FEA as a percentage of the baseline daily job costs. As the incremental control costs were obtained from Table V-34, they are just the sum of additional labor and equipment costs associated with the use of silica controls, including the labor and equipment productivity impacts of the use of the silica controls.
As is evident from Table V-35 of the FEA, these incremental control costs can range from 0.3 percent to 7.8 percent of the baseline job cost. The magnitude of the productivity impacts can substantially change the estimate of the overall cost increase associated with the silica dust controls.
Table V-36a of the FEA presents the weighted average of control costs by task category for outdoor tasks. OSHA defined “weights” for each job category (column “Relative Frequency Within Categories”) based on the projected relative applicability of the controls and/or tasks within each category (as determined in the technological feasibility analysis in Chapter IV of the FEA). These percentages did not change from the PEA except for the two tasks that have each been further partitioned into multiple tasks in the final rule: Heavy construction operators and masonry cutters using portable saws. Heavy equipment operators are subdivided into tasks that involve fracturing, abrading, or demolishing silica-containing materials such as masonry or concrete, that require use of wet methods whenever workers other than the equipment operator are present, and tasks that involve use of heavy equipment for earthmoving and excavation of soil, that require wet methods only as necessary to minimize fugitive dust. Masonry cutters using portable saws are subdivided into five categories: (1) Handheld power saws such as cutoff saws; (2) handheld power saws for cutting fiber-cement board with blade diameters of less than eight inches; (3) walk-behind saws; (4) drivable saws; and (5) rig-mounted core saws. Wet methods are specified as a control method for all use of portable saws except for handheld power saws for cutting fiber-cement board, for which LEV rather than use of water to suppress dust is required. The labor cost as a percentage of project costs—which, as subsequently shown, is a critical factor in calculating the total value of all silica-generating construction activities—is derived from Table V-30 of the FEA.
Table V-36b of the FEA presents the weighted average of control costs by task category for tasks indoors or in enclosed areas (“indoor tasks”). The procedures are identical to those used in Table V-36a of the FEA, and the only difference is that the total incremental costs as a percentage of baseline costs are higher due to the addition of the cost of a fan for indoor tasks.
Once the total value of all silica-generating construction activity is calculated for each task, as shown in Table V-44 of the FEA, the incremental costs associated with each task category as a percentage of baseline costs (from Tables V-36a and V-36b of the FEA) will determine the costs that the engineering control requirements in the final construction standard add to the costs of construction activity—that is, the incremental costs of the resulting reduction in silica exposure.
To estimate aggregate labor costs or value for each equipment category, OSHA first matched OES occupational classifications with the labor requirements for each equipment category (
“Key” occupations refer to the worker or workers on each crew who perform the principal silica-generating activity using the equipment in each equipment category. For each equipment category, ERG estimated the overall percentage of time that workers in key occupations devote to the activity.
Other “secondary” crew members (
For the key occupations, OSHA was able to obtain some data with which to estimate the proportion of time workers perform activities using silica-generating equipment. For the secondary occupations, such estimates were generally not possible. Thus, the participation of secondary occupations in silica-generating activities was defined based on their relationship to the key occupations. This participation is defined by their presence in the job crews, as shown in Table V-30 of the FEA. To illustrate the need for this approach, consider the difficulty in predicting how often construction foremen of all types are present during activities where silica-generating equipment is used. BLS data, for example, provide only a total number of foremen, but no information about how they might spend their time. It is reasonable to forecast, however, using the job-crew definitions, that foremen will be present in some proportion to the number of workers in key occupations using jackhammers and other powered handheld chipping tools, rock and concrete drillers, and other silica-generating equipment. OSHA presented these data in the PEA and requested comments, but did not receive any on this aspect of the analysis. Therefore, OSHA is retaining its estimates from the PEA, except as noted.
For some activities, the crew size and composition vary among the jobs defined in the equipment category. In those cases, OSHA used ERG determinations as to the most representative crew composition and used that crew model to define the ratio
The estimates of the number of FTE employees engaged in activities using silica-generating equipment are one of many factors that influence the final cost estimates. There are few data, however, on the breakdown of time spent by construction workers in various activities. The following discussion presents the basis for the time-on-task estimates for the key occupations as included in the PEA and the FEA (except where noted). OSHA presented most of these estimates for public comment in the PEA but did not receive any comments challenging them.
A review of NIOSH reports covering rock and concrete drillers showed that over 75 percent of driller time was spent on actual drilling (NIOSH 1992a, Document ID 0911, NIOSH 1992b, Document ID 0910, NIOSH 1995, Document ID 0907) and is supported by updated data in NIOSH, 1999b (Document ID 0220). Therefore, for the PEA and FEA, OSHA used 75 percent as the best indication of the time spent using dust-generating equipment for workers in this category.
Grinding and tuckpointing are only two of the numerous jobs performed by brickmasons, cement masons, and their helpers. Workers in those trades are much more frequently performing bricklaying, cement work, and masonry construction. Where tuckpointers and grinders are being used, a review of the OSHA Special Emphasis Program reports revealed that the time spent using tuckpointers and grinders varied widely (
For the final rule, heavy equipment operators and ground crew laborers were split into two categories in Table 1 based on how the heavy equipment and utility vehicles are being used, which reflects distinctions added in the final rule. This equipment is considered to either be used a) to abrade or fracture silica-containing materials (
ERG estimated that workers using heavy equipment to abrade or fracture silica-containing materials or for demolition devoted only 2.5 percent of their time, on an FTE-equivalent basis, to doing this work.
Key workers in the companion group using heavy equipment for grading and excavating often spend the bulk of their work shift on the equipment itself, engaged in construction work. OSHA Inspection Reports and other documentation consistently show that heavy equipment operators perform their tasks for more than 7 hours per shift (OSHA SEP Inspection Reports 122212079, 116179359; Greenspan,
While many workers might occasionally be assigned to drill holes in concrete, this equipment category represents a very small part of the activities of the occupational groups performing this work. ERG judged that carpenters, electricians, plumbers, sheet metal workers, and helpers (construction laborers) spend one percent of their time drilling holes in silica-containing materials in the affected industries. OSHA presented this estimate in the PEA and did not receive comment or alternate estimates and has therefore retained the estimate for the FEA.
OSHA estimated in the PEA that in the key occupation of construction laborers, relatively few use equipment in this category. In developing the estimate of time spent using equipment in this category for the PEA, ERG examined a snapshot of construction activities from the BLS publication,
The key occupations using portable saws to cut masonry and concrete, namely brickmasons, blockmasons, stonemasons, and their helpers, spend, on average, a small share of their time cutting these materials with portable saws. In Table 1, OSHA notes three types of portable saws: (1) Hand-held saws, (2) walk-behind saws, and (3) drivable saws. Each of those is encompassed in this analysis, although small-diameter handheld saws are addressed separately. According to OSHA and NIOSH reports, the workers in these occupations perform multiple masonry activities and might engage in cutting for only a small portion of their shift (OSHA SEP Inspection Report 300646510; NIOSH, 1999a) (Document ID 0084). Another glimpse of this activity can be gleaned from the BLS injury report for construction laborers, where 3 percent of workers were injured while breaking up or cutting concrete, asphalt, brick, rocks, etc. For each of the applicable occupations, OSHA estimated in the PEA that 10 percent of the workers' time would be spent using
The task of using handheld power saws for cutting fiber-cement board (with blade diameter of 8 inches or less) was separated out in Table 1 in the final rule to recognize portable saws used for cutting cement fiberboard or cement fibersiding as a potential source of silica-containing dust. OSHA judged that portable saws would be used by carpenters or their helpers to cut fiber-cement board and that, on average, they would spend 2.5 percent of their time using equipment in this category to cut the referenced materials.
As noted earlier, OSHA and NIOSH surveillance publications report that saw operators perform multiple masonry cutting activities and might engage in cutting silica-containing materials for only a small portion of their shift (OSHA SEP Inspection Report 300646510; NIOSH, 1999a). For the PEA, OSHA used ERG's estimate that workers in mason occupations spend 10 percent of their time cutting silica-containing materials with stationary saws. The Agency received no comment on this estimate and has therefore retained this estimate for the FEA.
In the PEA, ERG identified two key occupation groups where millers are using portable or mobile machines: (1) Cement masons and (2) paving, surfacing, and tamping equipment operators. In response to comments (
According to information collected from ERG communication and OSHA SEP inspection reports, rock crushing machine operators spend most, if not all, of their shifts at and around the rock crushing process (Polhemus, 2000, Document ID 0958; Haney, 2001, Document ID 0721; OSHA SEP Inspection Report 2116507, Document ID 0186; OSHA SEP Inspection Report 300441862, Document ID 0030). OSHA estimated in the PEA that this occupational group spends 75 percent of its time using rock crushing machines and did not receive any comment on the estimate. OSHA has retained this estimate for the FEA.
Underground workers perform both tunnel work and other types of construction work. The majority of these underground tasks still fall under Table 1 and have been accounted for elsewhere in the appropriate construction task analysis. However, a small amount of silica-generating underground construction work outside the scope of Table 1, primarily in tunnel boring, is expected to occur. The cost of engineering controls for this activity (to comply with the new PEL) is presented after the total engineering control costs to comply with Table 1 are presented.
As stated in the comments during the Silica SBREFA process, one SBREFA commenter was “unable to reconcile ERG's statement that ‘the amount of time . . . grinders and tuck-pointers perform grinding ranges widely, from about 1 hour per shift up to a full 8-hour shift (or longer)’ [
In response, OSHA reiterated in the PEA that Table V-26 of the PEA showed the estimates of the full-time-equivalent number of workers in key and secondary occupations using equipment to perform silica-generating tasks. These occupations are taken from the BLS
OSHA did not receive further comment on this explanation. Therefore, OSHA has not changed these estimates in the FEA. For each occupation the estimates in Table V-37 of the FEA are meant to reflect the typical or average amount of a worker's time (over a year) devoted to the listed tasks.
Tables V-38a and V-38b of the FEA provide estimates, by occupation, of the full-time-equivalent (FTE) number of key and secondary workers, respectively, for each task category, using the percentages and ratios from Table V-37 of the FEA. These tables are relatively direct compilations from previous tables with adjustments needed, in a few cases, to assure that the industry-specific FTE occupational totals did not exceed the total occupational employment for any industry.
Table V-39 of the FEA shows the corresponding estimates by NAICS code for the construction industry.
OSHA distributed FTE at-risk workers across NAICS codes according to the combination of task categories and occupational (key and secondary) categories (from BLS, 2012, Document ID 1560) derived and updated by ERG for each industry group (ERG, 2007a, Document ID 1709).
Overall, a full-time equivalent of 374,003 workers is estimated to use equipment to perform work on silica-containing materials in construction, ranging from 1,135 FTEs for rock crushing machine operators and tenders to 198,585 FTEs for heavy equipment operators and ground crew laborers (grading and excavating).
In the PEA, OSHA used a relatively crude approach to convert the estimated number of FTE affected construction workers to the number at-risk construction workers. There, OSHA used a multiplier of 2 or 5, depending on the industry, to convert the number of FTEs to the number of at-risk workers (in Table V-37 of the PEA).
OSHA received several comments regarding the analysis used in the PEA as being too simplistic. Joseph Liss challenged OSHA's methodology:
Even though OSHA estimates the number of workers needing training for silica exposure under the proposed rule by
Additionally, the Construction Industry Safety Coalition (CISC) submitted calculations to arrive at their own results of at-risk workers. They note:
These percentages represent our quick judgement across both the key occupations and the secondary occupations that OSHA identifies as participating in the crew when the at-risk task is performed. If we had more time, we would like to make this judgement more carefully (Document ID 4032, Tab 6).
For the FEA, in response to comments, OSHA refined its process, as described below, to allow for a more nuanced approach to estimating the number of affected workers. As a result of this revised approach, the ratio of the estimated number of at-risk construction workers to the estimated number of FTE-affected construction workers increased from approximately three to one in the PEA to over five to one in the FEA. OSHA first assigned each of the affected NAICS construction industries to one of four subsectors in order to account for likely differences among specific industries with respect to the frequency with which silica-generating equipment is used. These subsectors are shown in Table V-40a of the FEA. Note that non-construction industries doing construction work—state and local governments and electric utilities—are included in Subsector 3.
Second, because at-risk workers do not necessarily specialize in jobs that use equipment that generates silica-containing dust, ERG independently estimated the number of “affected” workers based on judgments of the share of workers in each occupation that would likely ever perform these tasks. These judgments were also made on a subsector-by-subsector basis. In most cases, costs for program requirements (but not for engineering controls) are based on the numbers of affected workers performing each task in a given industry. The estimated share of affected workers for the key occupations, taking into account the specific construction subsector and task, is shown in Table V-40b of the FEA.
Using the FTE rates, secondary ratios, and affected rate parameters displayed in Table V-37 of the FEA, OSHA calculated, in Table V-39 of the FEA, that there are an estimated 374,003 FTEs affected by the rule. Table V-41 of the FEA converts these FTEs to 2.02 million affected construction workers disaggregated by occupation based on 2012 County Business Pattern (CBP) total employment of 2.93 million in affected occupations in construction industries. Thus, as shown in Table V-41 of the FEA, about 68.9 percent of construction workers in affected occupations will be affected by the final rule. Table V-42 of the FEA shows the same estimated number of affected workers, but disaggregated by NAICS industries and equipment category. There are an estimated 13.45 million workers total in the affected industries, meaning that about 15 percent of the workers in these industries are affected by the final rule. That percentage is misleading, however, because almost 7.7 million of total employment in affected industries (almost 60 percent) are employed in state and local governments, of which only 2 percent are affected by the final rule. When these public workers are removed, approximately 32 percent of the construction workers in affected private industries are affected by the final rule.
All of the above statistics do not include the estimated 11,640 at-risk abrasive blasters working in construction industries. Also, because some occupations are associated with the use of more than one equipment category, the “affected” totals are constrained to be less than or equal to the industry total for each at-risk occupation.
To derive labor costs and project value for construction work done using the specified equipment where occupational exposure to silica is found, OSHA multiplied the mean hourly wage, as reported by OES (BLS, 2012, Document ID 1560), for each affected occupation within each affected industry, by 2,000 hours. Then, to derive the total value of annual wages expended for work done using specified equipment to perform silica exposure-generating activities, OSHA multiplied that product by the number of affected full-time-equivalent employees. These estimates were then inflated to adjust for fringe benefits. These loaded-wage costs, totaled by industry and equipment category, are summarized in Table V-43 of the FEA as the annual labor value (or labor cost) of silica-generating projects. Overall, OSHA estimated the labor value of all silica-generating construction work performed with the specified equipment to be $21.8 billion annually.
OSHA then converted the labor values for each industry and task category from Table V-43 of the FEA to the total project value by dividing by the labor share of project costs. This conversion is possible because the labor share for each task category equals the labor value divided by project value, so dividing the labor value by the labor share generates an estimate of project value. The corresponding estimates of total project value for each industry and equipment category are shown in Table V-44 of the FEA. Overall, OSHA estimated the value of silica-generating construction work performed with the specified equipment at $41.2 billion. The values for specific equipment categories ranged from $136.2 million for rock crushing machine operators and tenders to $28.0 billion for heavy construction equipment operations-II.
The value of work performed using the specified equipment was then summed by NAICS industry to derive the total value of at-risk projects, a base from which OSHA calculated control costs associated with compliance with Table 1 or the final PEL.
For the final rule, OSHA revised Table 1 to include separate engineering control and respirator requirements for tasks indoors or in enclosed areas (“indoor tasks”) to provide a means of exhaust as needed to minimize the accumulation of visible airborne dust. As a result, indoor tasks will have an additional cost to reflect use of control equipment (
To derive estimates in Table V-46 of the FEA of aggregate incremental compliance costs to meet final Table 1, the total value of construction work using the specified equipment and requiring controls (in Table V-44 of the FEA) was multiplied by the percentage of incremental cost associated with the controls required for each equipment category (in Tables V-36a and V-36b of the FEA), weighted by the percentage of work using each type of equipment performed outdoors and indoors (in Table V-45 of the FEA), and reduced by the percentage of baseline compliance.
As indicated in Table V-46 of the FEA, OSHA estimates that the incremental compliance costs for engineering controls (excluding tunnel boring and abrasive blasting) will total $386.4 million for construction work performed using the specified equipment affected by the final standard.
In the PEA, OSHA estimated that some abrasive blasting crews were not currently using all feasible engineering controls and added costs for wet methods for them to achieve the proposed PEL. OSHA did not receive comments on the PEA estimates of engineering control costs for abrasive blasting crews and has retained the same methodology to estimate costs for the FEA.
Consistent with what was done in the PEA, Table V-47a of the FEA presents the unit costs and analytical assumptions applied in OSHA's cost analysis of controlling silica exposures during abrasive blasting operations. As shown in the table, after accounting for the number of affected workers, crew size, daily output, blasting cost per square foot, number of blasting days per year, and the percentage of crews using sand, OSHA estimates that baseline annual costs for sand blasting total $126.7 million. As in the PEA, ERG estimated that the incremental cost for wet blasting is 30 percent of baseline costs and that 50 percent of crews currently use wet methods. Therefore, the annual costs to comply with the final standard by using wet methods during sand blasting are expected to total $19.0 million, or $2,366 per worker for the approximately 8,033 workers exposed to silica dust.
Distributing these annualized costs by industry, OSHA estimates that employers in NAICS 238200, Building Finishing Contractors, will incur compliance costs of $12.1 million annually, while firms in NAICS 238900, Other Specialty Trade Contractors, will incur compliance costs of $6.9 million annually.
Tunnel boring is not included on Table 1 of the final rule. An employer engaged in tunnel boring must comply with the PEL of 50 μg/m
In most cases, employers are able to reduce exposures to the preceding PEL by providing suction at the drill head, removing the dust as soon as it is generated. The technological feasibility chapter of the FEA demonstrates that employers can do so by extending the existing suction controls as the drill head progresses. There are limits on these extensions, however, and the amount of worker exposure can increase if the suction is not extended frequently enough to keep it at the drill head. This extension does not require additional machinery, but it is likely to require the employer to invest more labor time to extend the suction device more frequently to meet the new PEL than previously necessary to meet the preceding PEL. OSHA has estimated in Table V-47 of the FEA the control costs for tunnel boring using the same cost methodology applied in the PEA (see Tables V-21 and V-24 in the PEA) to calculate the incremental cost as a percentage of baseline control costs (0.013%). The rest of the calculations in Table V-47 reflect 2012 data on the number of affected FTE tunnel workers and 2012 hourly wage rates. The resulting estimate of annualized incremental control costs for tunnel boring is about 0.02 million.
Table V-48 of the FEA adds the abrasive blasting and the tunnel boring control costs in construction to the control costs for Table 1 tasks presented in Table V-46 of the FEA.
The OSH Act provides authority for OSHA to regulate employers for the protection of their employees. Because sole proprietors without employees, referred to as “self-employed workers” for the purposes of this discussion, are not “employers” under the Act, OSHA cannot require them to comply with the silica standard. On a multi-employer worksite, however, their silica activities could expose employees protected by the Act to respirable crystalline silica.
Employers must still protect their employees from exposure to silica in accordance with the standard, whether it is generated by work performed by their own employees or by the work performed by a sole proprietor not regulated by the Act (
As discussed in Chapter III of the FEA, CISC requested that the Agency account for the costs arising from self-employed workers separately based on the theory that self-employed workers will use the controls necessary to comply with Table 1 to reduce exposures to others when working on a multi-employer worksite where employees are present (Document ID 4217, p. 80). CISC identified several reasons why this might happen, including self-interested recognition of “Table 1 specifications as the safe way to perform their work”; demands by construction general contractors that anyone working on their site, whether self-employed or not, conform to regulatory requirements; and demands by nearby employers that their employees “not suffer increased silica
While these are not costs that OSHA typically includes in its analysis, OSHA recognizes that Table 1 is unique among OSHA standards, and that it is possible that controlling employers on a multi-employer construction worksite may assume some costs of engineering controls—either by providing the controls or by reimbursing the self-employed persons for the costs of the controls through increased fees—when they cannot resolve the issue through simple scheduling choices. Therefore, OSHA is estimating the additional cost of the engineering controls in that scenario.
In order to estimate the number of self-employed persons in construction, CISC's contractor, Environomics, Inc., took the following approach:
The U.S. Census Bureau, in Revised 2008 Nonemployer Statistics Reflecting 2009 Methodology Changes, provides information on the number of self-employed individuals (“nonemployers”) working in each of the 4-digit construction industries (total of 2.52 million self-employed construction workers), but no further information on the occupations of these self-employed workers. In order to estimate the number of self-employed workers in each of the various at-risk construction occupations that OSHA identified and that we added, we simply assumed that these 2.52 million “nonemployers” are distributed among occupations within each construction NAICS in the same proportion as employed workers are distributed among occupations within the NAICS (Document ID 4217, p. 80).
Note that the Census data that Environomics used provides detail on self-employed persons by 4-digit NAICS construction industries but not by occupation. Hence, in the absence of occupational data, Environomics simply assumed that the number of self-employed persons by occupation was proportional to the number of employees by occupation—which implies that the ratio of the number of self-employed persons to employees was the same for each occupation. Using this database and approach, Environomics estimated that the ratio of self-employed persons to employees for all occupations affected by the rule was 40.1 percent (1,811,009 self-employed relative to 4,519,889 employees). Based on the full-time-equivalent (FTE) number of workers—which, in OSHA's estimation methodology, determines the amount of engineering control equipment used—Environomics calculated that the ratio of FTE self-employed persons to FTE employees for all occupations affected by the rule was 35.7 percent.
Having reviewed the Environomics self-employment analysis, OSHA has concluded that the occupation of the self-employed persons is a much more relevant factor for estimating costs than the 4-digit construction industry in which self-employed persons work. Therefore, for its analysis, OSHA has chosen to rely on data from the 2013 BLS Current Population Survey, with the goal of estimating the ratio of the number of self-employed persons to the number of employees by occupation. Table V-49 of the FEA presents data from the 2013 BLS Current Population Survey with the focus on the ratio of the self-employed to the non-self-employed (
Table V-50 of the FEA presents the same data as shown in Table V-49 of the FEA, but restricted to just those occupations where OSHA estimated that workers are potentially exposed to hazardous levels of respirable crystalline silica. One thing that is immediately obvious in this table is the very wide variation from occupation to occupation in the ratio of the self-employed to the employed, with the ratio ranging from 0 percent to 47.53 percent. This wide variation is clearly incompatible with the assumption made by Environomics that the ratio of the number of self-employed to employees is the same for all occupations. Table V-50 of the FEA also shows that average ratio of self-employed to employees over all construction occupations involving silica exposure (when the ratio is allowed to vary by occupation) is 22.82 percent when weighted by the number of employees (as compared to 40.1 percent as estimated by Environomics).
As noted above, in OSHA's methodology, the amount of engineering control equipment used is based on the FTE number of workers. In Table V-51 of the FEA, OSHA multiplied the FTE rate for each occupation (from Tables V-38a and V-38b of the FEA) by the number of self-employed workers and employees in that occupation (from Table V-48 of the FEA). As shown in Table V-51 of the FEA, there are an estimated 69,461 FTE self-employed workers in at-risk occupations, relative to the total of 377,913 FTE employees in at-risk occupations. In other words, the number of at-risk FTE self-employed workers is 18.38 percent of the number of at-risk FTE employees (as compared to 35.7 percent as estimated by Environomics).
The analysis of the number of self-employed persons conducted by Environomics stopped at this point. However, as OSHA explained in Chapter III of the FEA, self-employed workers are not required to comply with the final rule and are only likely to do so in two situations: (1) Where self-employed workers are generating silica dust while working in a multi-employer construction worksite such that their activities could expose the employees of others, and (2) where the host employer (or competent person) is unable to schedule the self-employed worker's activities or location so as to prevent the exposure or overexposure of other, covered workers. OSHA does not have data on the likelihood of either of these two conditions. OSHA judges that self-employed workers work at multi-employer construction sites at the same times as others a minority of their worktime, and work even less frequently within the same area such that covered employees could be exposed. Nevertheless, OSHA is conservatively estimating here that they do so 50 percent of the time. OSHA also judges that the host contractor (with the assistance of the competent person) would be able to schedule the self-employed workers' activities or location so as to prevent the exposure or overexposure of other, covered workers a majority of the time. This makes sense because self-employed workers would often be used on multi-employer sites when they possess special skills not otherwise available onsite. Therefore, their work frequently could be performed at a different time or location from the other work. In any case, for costing purposes, OSHA is conservatively estimating that the work of self-employed persons cannot be isolated in time or space so as to prevent the exposure or overexposure of other, covered workers 50 percent of the time that those self-employed workers are on the multi-employer worksite.
Based on these estimates, OSHA calculates that only 25 percent of the at-risk work of self-employed workers would meet the conditions in which a host or controlling employer would incur engineering control costs to mitigate the exposures to employees on the site. At the bottom of Table V-51 of the FEA, OSHA has accordingly reduced the number of FTE self-
Finally, in Table VII-13, OSHA increased the estimates of the control costs for work performed using the specified equipment in construction presented in Table V-48 of the FEA by 4.60 percent to include the engineering control costs that would be incurred by host or controlling employers to control the exposures caused by self-employed workers. This increases the annualized cost of engineering controls needed in construction to comply with the final rule from $405.5 million to $423.4 million.
OSHA's cost estimates assume that implementation of the recommended silica controls prevents workers in general industry and maritime from being exposed over the PEL in most cases. Specifically, based on its technological feasibility analysis, OSHA expects that the engineering controls are adequate to keep silica exposures at or below the PEL for an alternative PEL of 100 μg/m
For the FEA, OSHA estimates that respirators will be required: (1) For all workers that the Agency's technological feasibility analysis has determined will require respirator use; and (2) for ten percent of the remaining workers currently exposed above 50 μg/m
This is a change in methodology from the PEA, where OSHA estimated the percentage of workers requiring respirators in an industry as either (1) or (2), whichever was larger. The Agency believes that the FEA formula, which results in higher estimates of respirator usage, is more accurate in that it reflects the combined effects of (1) and (2) whereas the earlier methodology did not. The number of workers that the FEA estimates will need respirators is presented in Table V-13 in the FEA.
In the PEA, OSHA concluded that all maritime workers engaged in abrasive blasting were already required to use respirators under existing OSHA standards and, therefore, maritime establishments would incur no additional costs for maritime workers to use respirators as a result of this final rule. However, for the FEA, OSHA has determined from its earlier technological feasibility analysis that only abrasive blasting operators, but not abrasive blasting helpers, are already required to use respirators under existing OSHA standards. The Agency, therefore, has added respirator costs for abrasive blaster helpers in maritime (half of all the abrasive blaster workers) as a result of this final rule.
For construction, employers whose workers are exposed to respirable silica above the proposed PEL were assumed to adopt the appropriate task-specific engineering controls and, where required, respirators prescribed in Table 1 and paragraph (g)(1) in the final standard. Respirator costs in the construction industry have been adjusted to take into account OSHA's estimate (consistent with the findings from the NIOSH Respiratory Survey, 2003, Document ID 1492) that 56 percent of establishments in the construction industry are already using respirators that would be in compliance with the final silica rule.
OSHA used respirator cost information from a 2003 OSHA respirator study to estimate the annual cost of $367 (general industry) or $286 (construction) for disposable filtering facepiece respirators, $520 (general industry) or $409 (construction) for a half-mask, non-powered, air-purifying respirator and $644 (general industry) or $533 (construction) per year (in 2012 dollars) for a full-face non-powered air-purifying respirator (ERG, 2003, Document ID 1612). These unit costs reflect the annualized cost of respirator use, including accessories (
The PEA estimated that (with the exception of workers who are entering regulated areas) all workers in general industry and construction who need respirators with an assigned protection factor (APF) of 10 would use non-disposable, half-face respirators. The FEA estimates that in general industry half of the workers who need respirators will use half-face elastomeric respirators and half will use disposable N95 respirators. This is because, as clarified in the final rule, both disposable and non-disposable respirators are available with an APF of 10, and, with each type of respirator offering certain advantages, OSHA accordingly estimates that about half of the employees in general industry and maritime will prefer the ease of use of disposable respirators while the other half will prefer the durability of non-disposable respirators. For the construction sector, the FEA estimates that 10 percent of workers needing respirators will use elastomeric half-face respirators and 90 percent will use disposable N95 respirators. This is because very few workers in construction engage in tasks requiring respirator use full-time. Under those circumstances, disposable respirators are both more convenient to use and much less expensive than reusable respirators.
In addition to bearing the costs associated with the provision of respirators, employers will incur a cost burden to establish respirator programs. OSHA projects that this expense will involve an initial 8 hours for establishments with 500 or more employees and 4 hours for all other firms. After the first year, OSHA estimates that 20 percent of establishments would revise their respirator program every year, with the largest establishments (500 or more employees) expending 4 hours for program revision, and all other employers expending 2 hours for program revision. Consistent with the findings from the NIOSH Respiratory Survey (2003) (Document ID 1492), OSHA estimates that 56 percent of establishments in the construction industry that would require respirators to achieve compliance with the final PEL already have a respirator program.
OSHA developed separate cost estimates for (1) initial monitoring or any exposure monitoring at hydraulic fracturing sites and (2) scheduled monitoring at fixed sites (which excludes hydraulic fracturing). Costs under (2) were estimated to be lower because the exposure monitoring is expected to be of shorter duration (possibly obviating an overnight stay) and could be conducted by a lower-cost Industrial Hygienist (IH) or IH technician rather than by a CIH. Based on the comments received in the record, OSHA decided to significantly increase its estimate from $500 (in the PEA) to $2,500 for an IH consultant to perform initial exposure monitoring or to perform at sites that have not previously been well characterized. In the construction sector, the $2,500 cost estimate for IH services applies to all exposure monitoring since the worksite is not fixed and has not been previously characterized. OSHA estimates that the IH periodic exposure monitoring costs would be approximately $1,250, or half of the $2,500 estimate. These IH monitoring costs would cover 2, 6, and 8 personal breathing zone (PBZ) samples per day for small, medium, and large establishments, respectively.
For initial monitoring or any exposure monitoring at hydraulic fracturing sites, the total unit cost of an exposure sample is estimated to range from $487 to $1,425 (depending on establishment size). For periodic monitoring in general industry and maritime, excluding hydraulic fracturing sites, the total unit cost of an exposure sample is estimated to range from $328 to $796 (depending on establishment size).
Tables V-14 and V-61 in the FEA shows the unit costs and associated assumptions used to estimate exposure assessment costs. Unit costs for exposure sampling include direct sampling costs, the costs of productivity losses, and recordkeeping costs, and, depending on establishment size, range from $328 to $1,421 per sample in general industry and maritime and from $488 to $1,425 per sample in construction.
For costing purposes, based on OSHA (2016), OSHA estimated that there are four workers per work area. OSHA interpreted the initial exposure assessment in general industry and maritime as requiring first-year testing of at least one worker in each distinct job classification and work area who is, or may reasonably be expected to be, exposed to airborne concentrations of respirable crystalline silica at or above the action level.
For periodic monitoring, the final standard provides employers an option of assessing employee exposures either under a performance option (paragraph (d)(2)) or a scheduled monitoring option (paragraph (d)(3)). For the performance option, the employer must assess the 8-hour TWA exposure for each employee on the basis of any combination of air monitoring data or objective data sufficient to accurately characterize employee exposures to respirable crystalline silica. For the scheduled monitoring option (termed the “periodic” monitoring option in the proposal), the employer must perform initial monitoring to assess the 8-hour TWA exposure for each employee on the basis of one or more (PBZ) air samples that reflect the exposures of employees on each shift, for each job classification, in each work area. Where several employees perform the same job tasks on the same shift and in the same work area, the employer may sample a representative fraction of these employees in order to meet this requirement. In representative sampling, the employer must sample the employee(s) who are expected to have the highest exposure to respirable crystalline silica. Under the scheduled monitoring option, requirements for periodic monitoring depend on the results of initial monitoring. If the initial monitoring indicates that employee exposures are below the action level, no further monitoring is required. If the most recent exposure monitoring reveals employee exposures to be at or above the action level but at or below the PEL, the employer must repeat monitoring within six months of the most recent monitoring. If the most recent exposure monitoring reveals employee exposures to be above the PEL, the employer must repeat monitoring within three months of the most recent monitoring. OSHA used the fixed schedule option under the frequency-of-monitoring requirements to estimate, for costing purposes, that exposure monitoring will be conducted (a) twice a year where initial or subsequent exposure monitoring reveals that employee exposures are at or above the action level but at or below the PEL, and (b) four times a year where initial or subsequent exposure monitoring reveals that employee exposures are above the PEL.
As required under paragraph (d)(4) of the final rule, employers must reassess exposures whenever a change in the production, process, control equipment, personnel, or work practices may reasonably be expected to result in new or additional exposures at or above the action level, or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred. In response to comments, OSHA increased its estimate from 15 percent to 25 percent of the share of workers whose initial exposure or subsequent monitoring was at or above the action level would undertake additional monitoring.
Changes from the proposed to the final rule have resulted in a significant reduction in OSHA's estimate of the annual number of samples taken by construction employers. For the final rule, employers following Table 1 are not required to engage in initial or subsequent exposure monitoring for those construction workers engaged in tasks on Table 1. Therefore, OSHA only estimated scheduled semi-annual exposure monitoring (for expected exposures at or above the action level but at or below the PEL) and scheduled quarterly exposure monitoring costs (for expected exposures above the PEL) for those operations are not listed on Table 1. In addition, OSHA estimated that some small fraction of employers—1 percent—will choose to conduct initial sampling to investigate the possibility that exposures are so low (below the action level) that Table 1 need not be followed.
A more detailed description of unit costs, other unit parameters, and methodological assumptions for exposure assessments is presented in Chapter V of the FEA.
Paragraph (i) of the final standard requires the employer to make medical surveillance available for each employee occupationally exposed to respirable crystalline silica at or above the action level of 25 μg/m
In accordance with paragraph (i)(2) of the final standard, the initial medical examination will consist of (1) a medical and work history, (2) a physical examination with special emphasis on the respiratory system, (3) a chest x-ray interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconiosis by a NIOSH-certified B Reader, (4) a pulmonary function test administered by a spirometry technician with a current certificate from a NIOSH-approved course, (5) testing for latent tuberculosis (TB) infection, and (6) any other tests deemed appropriate by the PLHCP. In accordance with paragraph (i)(3) of the final standard, the contents of the periodic medical examinations are the same as those for the initial examination, with the exception that testing for latent tuberculosis infection is not required.
As shown in Table V-16 in the FEA, the estimated unit cost of the initial health screening for current employees in general industry and maritime ranges from approximately $415 to $435 and includes direct medical costs, the opportunity cost of worker time (
The unit cost components of the initial health screening for new hires in general industry and maritime are identical to those for existing employees with the exception that the percentage of workers expected to travel offsite for the health screening would be somewhat larger (due to fewer workers being screened annually, in the case of new hires, and therefore yielding fewer economies of onsite screening). OSHA estimates that 10 percent of establishments with fewer than 20
The unit costs of medical surveillance in construction were derived using identical methods. As shown in Table V-63 of the FEA, the estimated unit costs of the initial health screening for current employees in construction range from approximately $429 to $467; the estimated unit costs of the initial health screening for new hires in construction range from $433 to $471.
In accordance with paragraph (h)(2) of the final standard, the initial medical examination will consist of (1) a medical and work history, (2) a physical examination with special emphasis on the respiratory system, (3) a chest x-ray interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader, (4) a pulmonary function test administered by a spirometry technician with a current certificate from a NIOSH approved course, (5) testing for latent tuberculosis (TB) infection, and (6) any other tests deemed appropriate by the physician or licensed health care professional (PLHCP). In accordance with paragraph (h)(3) of the final standard, the contents of the periodic medical examinations are the same as those for the initial examination, with the exception that testing for latent tuberculosis infection is not required.
The estimated unit cost of periodic health screening also includes direct medical costs, the opportunity cost of worker time, and recordkeeping costs. As shown in Table V-16 in the FEA, these triennial unit costs in general industry and maritime vary from $415 to $435. For construction, as shown in Table V-63 in the FEA, the triennial unit costs for periodic health screening vary from roughly $429 to $467. The variation in the unit cost (with or without the chest x-ray and pulmonary function test) is due entirely to differences in the percentage of workers expected to travel offsite for the periodic health screening. OSHA estimated that the share of workers traveling offsite, as a function of establishment size, would be the same for the periodic health screening as for the initial health screening for existing employees.
OSHA estimated a turnover rate of 75 percent in general industry and maritime and 40 percent in construction, based on estimates of the separations rate (layoffs, quits, and retirements) provided by the Bureau of Labor Statistics (BLS, 2012). However, not all new hires would require initial medical testing. As specified in paragraph (h)(2) of the final rule, employees who had received a medical examination that meets the requirements of this section within the previous three years would be exempt from undergoing a second “initial” medical examination. OSHA estimates that 25 percent of new hires in general industry and maritime and 60 percent of new hires in construction would be exempt from the initial medical examination.
Although OSHA believes that some affected establishments in construction currently provide some medical testing to their silica-exposed employees, there was significant testimony in the record that many employers would at least have to make changes to their existing practices in order to comply with the new standard. Therefore, for costing purposes, the Agency assumed no current compliance with the health screening requirements of the rule.
OSHA requested information from interested parties on the current levels and the comprehensiveness of health screening in general industry, maritime, and construction. Although testimony in the record indicated that current medical surveillance programs exist to a limited extent among affected employers (
Finally, OSHA estimated the unit cost of a medical examination by a pulmonary specialist for those employees found to have signs or symptoms of silica-related disease or are otherwise referred by the PLHCP. OSHA estimates that a medical examination by a pulmonary specialist costs approximately $335 for workers in general industry and maritime and $364 for workers in construction. This cost includes direct medical costs, the opportunity cost of worker time, and recordkeeping costs. In all cases, OSHA anticipates that the worker will travel offsite to receive the medical examination by a pulmonary specialist (
OSHA did not estimate any employer familiarization costs in the PEA in support of the proposed rule. OSHA's rationale for not including familiarization costs in the PEA was that there was already an existing silica standard in place and, therefore, the Agency expected that any familiarization costs for a revised silica standard would be negligible.
However, several commenters on the proposed rule argued that employers will need to spend time to become familiar with the requirements of the final rule; that the employer time spent is the direct result of the final rule itself; and, therefore, that OSHA should include employer familiarization costs as part of the costs of the final rule.
OSHA found the comments in support of including some familiarization costs persuasive and the Agency has now concluded that employers will need to spend some time to understand the ancillary provisions and the other new and revised components of the final rule and to determine what actions they must take in order to comply. OSHA estimated that 8 hours would be spent on familiarization in its 2012 update to the Hazard Communication Standard (
For the silica rule OSHA used the number of employees as a proxy for the level of familiarization that would be needed. Accordingly, OSHA has reduced the average of 8 hours of familiarization time for establishments with fewer employees and increased it significantly for establishments with a larger number of employees: 4 hours per covered employer with fewer than 20 employees; 8 hours per covered employer with 20 to 499 employees; and 40 hours per covered employer with 500 or more employees. These estimates represent average familiarization times; it is expected that some establishments will spend less time on familiarization than estimated here (
The final standard requires two forms of hazard communication to employees: Paragraph (j)(1) notes that employers
OSHA estimated separate costs for initial training of current employees and for training new hires. Given that new-hire training might need to be performed frequently during the year, OSHA estimated a smaller class size for new hires. OSHA anticipates that training, in accordance with the requirements of the final rule, will be conducted by in-house safety or supervisory staff with the use of training modules or videos and will last, on average, one hour. OSHA judged that establishments could purchase sufficient training materials at an average cost of $2.10 per worker, encompassing the cost of handouts, video presentations, and training manuals and exercises. Included in the cost estimates for training are the value of worker and trainer time as measured by 2012 hourly wage rates (to include fringe benefits). OSHA also developed estimates of average class sizes as a function of establishment size. For initial training, OSHA estimated an average class size of 5 workers for establishments with fewer than 20 employees, 10 workers for establishments with 20 to 499 employees, and 20 workers for establishments with 500 or more employees. For new hire training, OSHA estimated an average class size of 2 workers for establishments with fewer than 20 employees, 5 workers for establishments with 20 to 499 employees, and 10 workers for establishments with 500 or more employees.
The unit costs of training are presented in Tables V-22 (for general industry/maritime) and V-69 (for construction) in the FEA. Based on ERG's work, OSHA estimated the annualized cost (annualized over 10 years) of initial training per current employee at between $3.39 and $4.10 and the annual cost of new-hire training at between $30.90 and $47.05 per employee in general industry and maritime, depending on establishment size. For construction, OSHA estimated the annualized cost of initial training per employee at between $4.21 and $4.99 and the annual cost of new hire training at between $38.14 and $55.76 per employee, depending on establishment size.
OSHA recognizes that many affected establishments currently provide training on the hazards of respirable crystalline silica in the workplace. In the PEA OSHA estimated that 50 percent of affected establishments already provide such training. However, some of the training specified in the final rule requires that workers be familiar with the training and medical surveillance provisions in the rule.
The Agency reviewed its baseline training estimates in light of comments in the record decided to take a more conservative approach to estimating current compliance with the training provisions in the final rule. Therefore, for the FEA, OSHA assumed no baseline respirable crystalline silica training (other than that already required under the HCS) and that a full hour of training, on average, will be required for all covered workers. This removal of baseline respirable crystalline silica training in estimating training costs has the effect, by itself, of increasing the effective training costs in the FEA relative to the PEA by 33 percent (from an average training time, per employee, of 45 minutes to 60 minutes). OSHA recognizes that this change may lead to an overestimation of training costs for some employers.
Paragraph (e)(1) of the final standard requires employers in general industry and maritime to establish a regulated area wherever an employee's exposure to airborne concentrations of respirable crystalline silica is, or can reasonably be expected to be, in excess of the PEL. Paragraph (e)(2)(i) requires employers to demarcate regulated areas from the rest of the workplace in a manner that minimizes the number of employees exposed to respirable crystalline silica within the regulated area. Paragraph (e)(2)(ii) requires employers to post signs at all entrances to regulated areas bear the legend specified in paragraph (j)(2) of the standard. Under paragraph (e)(3), employers must limit access to regulated areas and under paragraph (e)(4), employers must provide each employee and designated employee representative entering a regulated area with an appropriate respirator (in accordance with paragraph (g) of the standard) and require each employee and designated employee representative to use the respirator while in a regulated area.
Based on OSHA (2016), OSHA derived unit cost estimates for establishing and maintaining regulated areas to comply with these requirements and estimated that one area would be necessary for every eight workers in general industry and maritime exposed above the PEL. Planning time for a regulated area is estimated to be an initial seven hours of supervisor time (initial cost of $282.67 in 2012 dollars), and one hour for changes annually (at a cost of $40.38 in 2012 dollars); material costs for signs and boundary markers (annualized at $66.93 in 2012 dollars); and costs of $526 annually for two disposable respirators per day to be used by authorized persons (other than those who regularly work in the regulated area) who might need to enter the area in the course of their job duties. Tables V-25 in the FEA shows the cost assumptions and unit costs applied in OSHA's cost model for regulated areas in general industry and maritime. Overall, OSHA estimates that each regulated area would, on average, cost employers $666 annually in general industry and maritime.
A written exposure control plan provision was not included in the silica proposal, and no costs for a written exposure control plan were estimated in the PEA. Paragraph (f)(2) in the final standard for general industry and paragraph (g) in the final standard for construction specify the following requirements for a written exposure control plan: (i) A description of the tasks in the workplace that involve exposure to respirable crystalline silica; (ii) a description of the engineering controls, work practices, and respiratory protection used to limit employee exposure to respirable crystalline silica for each task; (iii) a description of the housekeeping measures used to limit employee exposure to respirable crystalline silica; and (iv) for construction, a description of the procedures used to restrict access to work areas, when necessary, to minimize the number of employees exposed to respirable crystalline silica and their level of exposure, including exposures generated by other employers or sole proprietors.
In the FEA, Table V-27 shows the unit costs and assumptions for written exposure control plans in general
Unit costs for a written exposure control plan were calculated based on establishment size, and the Agency assumed, for costing purposes, that a supervisor will develop and update the written exposure control plan for each establishment, spending 1 hour for establishments with fewer than 20 employees, 4 hours for those establishments with between 20 and 499 employees, and 16 hours for those establishments with 500 or more employees. OSHA estimated that 1 hour would be sufficient for very small establishments because there is, on average, barely more than 1 worker covered by the standard per very small establishment in general industry and maritime.
OSHA further determined that the additional supervisory time needed to review and evaluate the effectiveness of the plan, and to update it as necessary, will also vary by establishment size. OSHA estimated 0.5 hours for establishments with fewer than 20 employees, 2 hours for those with between 20 and 499 employees, and 8 hours for those with 500 or more employees to perform the annual review and update. The Agency expects that no other labor or materials will be required to implement the plan, so the sole cost for this provision is the time it will take to develop, review, and update the plan.
In the context of general industry or maritime activities in permanent facilities, the implementation of the written exposure control plan will not typically involve significant time or effort above existing operations. In construction, however, employers may be faced with new costs to implement the written exposure plan as they move from site to site. OSHA has therefore included costs for implementation, in addition to the costs for development of the plan, for construction activities. The plan must be implemented by a “competent person,” and OSHA has addressed the additional costs for training the competent person after the discussion of the general implementation costs.
Paragraph (g)(4) requires the employer to designate a competent person to implement the exposure control plan, and restrict access to work areas, when necessary, to minimize the number of employees exposed to respirable crystalline silica and their level of exposure, including exposures generated by other employers or sole proprietors. The competent person has two broad options to restrict access to work areas when necessary: (1) Notifying or briefing employees, or (2) direct access control. The direct access control component is similar to the written access control plan included in the PEA, which OSHA has replaced with the written exposure control plan in the final rule. While the requirements for the written exposure control plan are more performance-oriented and thus should provide more flexibility for employers and reduce the cost of compliance, OSHA has estimated the costs of these options using, where appropriate, comparable components of the regulated area and written access control plan costs estimated in the PEA.
For the employee notification or briefing option, OSHA estimated that, on average, it will take the competent person 15 minutes (0.25 hours) per job to revise the briefing plan, that each job will last 10 work-days, and that there are 150 construction working days in a year (Document ID 1709, p. 4-6). OSHA further estimated that it will take the competent person 6 minutes (0.1 hours) to brief each at-risk crew member (where an at-risk crew member could be an employee, a contractor, a subcontractor, or other worker under the control of the competent person) and that each crew consists of 4 at-risk workers. As shown in Table V-74 in the FEA, the annual cost of the job briefing option is $105.25 per at-risk crew member.
For the direct access control option, OSHA estimated that, on average, it will take the competent person 15 minutes (0.25 hours) per job to revise the plan concerning direct access control and, again, that each job will last 10 work-days and that there are 150 construction working days in a year. Thus, OSHA estimates that, on average, each employer would implement a direct access control 15 times per year over a total of 3.75 hours per year.
OSHA also added the cost of signage and tape for constructing physical barriers: 100 feet of hazard tape (per job) and three warning signs. These costs are all displayed in Table V-74 in the FEA. As also shown there, the annualized cost of the direct access control option is $71.40 per at-risk crew member.
As discussed in the Summary and Explanation section of this preamble concerning the written exposure control plan, restricting access is necessary where respirator use is required under Table 1 or when an exposure assessment reveals that exposures are in excess of the PEL, or in other situations identified by the competent person. On the other hand, when exposure to respirable crystalline silica is being successfully contained by engineering controls and work practices specified in Table 1 and no respirator use is required by Table 1, implementation of access control procedures is not required.
OSHA assumed that, in restricting access, half the time employers would use the briefing option and the other half of the time they would use direct access control. Consequently, as shown in Table V-74, the annualized cost of restricting access to work areas is $88.33 per at-risk crew member.
As specified in paragraph (g)(4) of the final standard, a competent person must carry out the responsibilities of implementing the written exposure control plan. As defined in the standard, “competent person” means an individual who is capable of identifying existing and foreseeable respirable crystalline silica hazards in the workplace and who has authorization to take prompt corrective measures to eliminate or minimize them, as well as has the knowledge and ability necessary to fulfill the responsibilities set forth in paragraph (g) of the standard. OSHA has utilized the competent person provision in other construction standards, such as 1926.1127, Cadmium, and 1926.1101, Asbestos, so the Agency expects that there is widespread familiarity with both the concept and the responsibilities of competent person in the construction sector. As in other OSHA construction rules, a major purpose of the competent person provision in this final silica standard is to identify who has the responsibility for inspections of the job sites, materials, and equipment. Thus, OSHA expects that most employers will have training programs in place to produce competent persons, and the cost of training someone will only be a relatively small marginal increase in the overall training cost. For that reason, the Agency expects that many employees designated as competent persons will undergo some training for the position. OSHA is estimating that each competent person will, on average, undergo two hours of training—in addition to the one hour of silica training estimated for all construction employees. OSHA does not anticipate any additional costs beyond training costs to be associated with the requirement that a competent person implement the written exposure control plan.
While the competent person provision does not specify a training requirement, the competent person is required to possess the knowledge and skills to perform the functions required by the standard. For that reason, the Agency expects that many employees designated as competent persons will undergo some training for the position.
OSHA expects that competent persons will be trained by a supervisor, presumably one who went through the process to become familiar with the requirements of the respirable crystalline silica standard, or by a combination of supervisory and/or technical staff that are familiar with the operation of the engineering controls. While the competent persons are not required to be supervisors and some of the staff providing the training may not be supervisors, OSHA is using a supervisor's wage to estimate the costs for time spent by both the trainers and the trainees in order to provide the upper cost limit, realizing that the cost for establishments who do not designate supervisors as the competent person will be lower. OSHA estimated that the total cost per establishment to train a competent person in construction will range from $21 to $114 (
Table VII-14 shows that the estimated combined costs for employers in the general industry and maritime sectors to comply with the final silica rule are approximately $370.8 million annually. These costs include $238.1 million annually for engineering controls and $10.5 million annually for respirators to meet the final PEL of 50 μg/m
Table V-B-1 in Appendix V-B in the FEA presents estimated compliance costs by NAICS industry code and program element for small business entities (as defined by the Small Business Act and the Small Business Administration's implementing regulations;
Table VII-15 summarizes the engineering control costs, respirator costs, and program costs of the rule for the construction sector. Annualized compliance costs in construction are expected to total $659.0 million, of which $423.4 million are for engineering controls, $22.4 million are for respirators, and $213.2 million are to meet the ancillary provisions of the rule. These ancillary annual costs consist of $16.5 million for exposure monitoring; $66.7 million for medical surveillance; $89.9 million for familiarization and
Table V-B-1 in Appendix V-B in the FEA presents estimated compliance costs by NAICS industry code and program element for small entities (as defined by the Small Business Administration) in construction, while Table V-B-2 in the FEA presents estimated compliance costs, by NAICS code and program element, for very small entities (fewer than twenty employees) in construction.
As shown in Table VII-16, annualized compliance costs associated with the rule are expected to total $1,030 million. Table VII-16 also provides total annualized costs for general industry, maritime, and construction separately, by major provision or program element included in the rule. This table shows that engineering control costs represent 64 percent of the costs of the standard for all three affected industry sectors: general industry, maritime, and construction. Considering other leading cost categories, costs for exposure assessment and medical surveillance represent, respectively, 30 percent and 15 percent of the costs of the standard for general industry and maritime; costs for training and familiarization and medical surveillance represent, respectively, 14 percent and 10 percent of the costs of the standard for construction.
While the costs presented here represent the Agency's best estimate of the costs to industry of complying with the rule under static conditions (that is, using existing technology and the current deployment of workers), OSHA recognizes that actual costs could be somewhat higher or lower, depending on the Agency's possible overestimation or underestimation of various cost factors. In Chapter VII of the FEA, OSHA provides a sensitivity analysis of its cost estimates by modifying certain critical unit cost factors. Beyond this sensitivity analysis, OSHA notes that its cost estimates do not reflect the possibility that, in response to the rule, industry may find ways to reduce compliance costs.
This could be achieved in three ways. First, in construction, 36 percent of the estimated costs of the rule (all costs except engineering controls) vary directly with the number of workers exposed to silica. However, as shown in Table III-5 in the FEA, more than five times as many construction workers will be affected by the rule as will the number of full-time-equivalent construction workers necessary to do the work. This is because most construction workers currently doing work involving silica exposure perform such tasks for only a portion of their workday. In response to the rule, many employers are likely to assign work so that fewer construction workers perform tasks involving silica exposure; correspondingly, construction work involving silica exposure will tend to become a full-time job for some construction workers.
Second, industry could demonstrate that certain construction activities result in exposures below the action level under any foreseeable conditions—in which case, workers engaged only in those silica-generating activities would not be subject to the requirements of the final rule. For example, an employer could make this demonstration by using objective data developed for short-term, intermittent tasks involving limited generation of silica dust. In estimating the costs for this final rule, however, OSHA included all costs, including ancillary costs as appropriate, associated with short-term intermittent silica tasks.
Third, the costs presented here do not take into account the possible development and dissemination of cost-reducing compliance technology in response to the rule.
OSHA has decided not to include in its analysis any possible cost-reducing technological advances or worker specialization because the technological and economic feasibility of the rule can easily be demonstrated using existing technology and employment patterns. However, OSHA believes that actual costs, which will incorporate any future developments of this type, will likely be lower than those estimated here.
Appendix V-C in the FEA presents, for analytical purposes, costs for an alternative PEL of 100 μg/m
An appropriate discount rate
Following OMB (2003) guidelines (Document ID 1493), OSHA has estimated the annualized costs of the rule using separate discount rates of 3 percent and 7 percent. Consistent with the Agency's own practices in recent proposed and final rules,
In addition to using a 3 percent discount rate in its main cost analysis, OSHA estimated compliance costs, in Appendix V-D in the FEA, using alternative discount rates of 7 percent and zero percent. Table V-D-1 and V-D-2 in Appendix V-D present total costs at a 7 percent discount rate for both (1) all employers by major industry category and program element, and (2) affected employers by NAICS industry code and employment size class (all establishments, small entities, and very small entities). Tables V-D-3 and V-D-4 present the same breakdowns of total costs estimated at a zero percent discount rate.
As shown in Appendix V-D, the choice of discount rate has only a minor effect on total annualized compliance costs, with annualized costs increasing from 1,030 million using a three percent discount rate to $1,056 million using a seven percent discount rate, and decreasing to $1,012 million using a zero percent discount rate.
OSHA analyzed the stream of (unannualized) compliance costs, by industry sector, for the first ten years after the rule takes effect under the simplifying assumption that no provisions of the rule are phased in. As shown in Table VII-16, total compliance costs are expected to peak in Year 1 at more than $1.5 billion. After that, costs are estimated to decline and remain relatively flat after the initial set of capital and program start-up expenditures has been incurred. Costs are projected to rise somewhat in Year 4 as a result of the triennial medical examinations and in Year 6 because of a second cycle of control equipment purchases in construction for short-term, intermittent work. Thereafter there are fluctuations but no strong trend. OSHA notes that the differences between costs for Year 1 and costs for subsequent years are narrower than might otherwise be the case due to (1) the expectation that, in the construction sector, a large percentage of control equipment will be rented (leading to constant annual expenses for the rented control equipment) rather than purchased as capital in Year 1; and (2) the expectation that the only engineering controls needed in the maritime sector will be wet methods, which do not require capital expenditures. On the other hand, the ancillary provisions are expected to have a relatively large number of initial costs (mainly labor rather than capital) in Year 1.
Chapter VI of the FEA presents OSHA's analysis of the economic impacts of its final silica rule on affected employers in general industry, maritime, and construction. The discussion below summarizes the findings in that chapter.
As a first step, the Agency explains its approach for achieving the two major objectives of its economic impact analysis: (1) To establish whether the final rule is economically feasible for all affected industries, and (2) to determine if the Agency can certify that the final rule will not have a significant economic impact on a substantial number of small entities. Next, this approach is applied to industries with affected employers in general industry and maritime and then to industries with affected employers in construction. Finally, OSHA examines the employment effects of the silica rule. This includes a review of estimates of employment effects that commenters provided and a summary of a report prepared for the Agency by Inforum—a not-for-profit corporation (based at the University of Maryland) specializing in the design and application of macroeconomic models of the United
Many commenters questioned OSHA's preliminary conclusions concerning economic feasibility, but did so for reasons that OSHA has responded to in previous chapters.
A variety of commenters raised issues concerning industries with possible silica exposure that were not covered in the Preliminary Economic and Initial Regulatory Feasibility Analysis (PEA). A full discussion of these comments and of industries added is provided in the FEA.
Many commenters questioned why OSHA used no data after 2006 (see comments by the Brick Industry Association (BIA) (Document ID 2300, p. 5), the American Fuel & Petrochemical Manufacturers (AFPM) (Document ID 2350, p. 6), the Belden Brick Company (Document ID 3260, p. 3), Basalite Concrete Products, LLC (Document ID 2083, p. 1), SBG Consulting (Document ID 2222, p. 1), Acme Brick (Document ID 2182, p. 4), Erie Bronze & Aluminum (Document ID 1780, p. 1), Calstone (Document ID 3391, p. 2), the Chamber of Commerce (Document ID 1782, p. 1), the Mason Contractors Association of America (MCAA) (Document ID 1767, p. 2), Scango Consulting LLC d.b.a. Capitol Hardscapes (Document ID 2241, p. 3), the National Concrete Masonry Association (NCMA) (Document ID 3585, p. 2944), the American Road and Transportation Builders Association (ARTBA) (Document ID 2245, p. 4), and the Construction Industry Safety Coalition (CISC) (Document ID 4217, Attachment 1, pp. 4 and 49-52)). As discussed in Chapter III of the FEA, OSHA is using revenue data from 2012 and profit data averaged across the years 2000 through 2012. The revenue data from 2012 represent a reasonable choice because this year was neither a peak growth year nor a recession year and was the most up-to-date data available at the time this analysis was developed. The range of years for profits assures the use of profit rates from throughout the business cycle—including two recessions and two sustained growth periods.
One commenter questioned OSHA's sources and methodology for estimating revenues (Document ID 2308, Attachment 9, pp. 7-8 and 14-16). This commenter questioned the methodology used to update revenue estimates between Economic Census years. This is no longer an issue as OSHA is using 2012 Economic Census data and using 2012 as the base year for the analysis. Therefore, there is no need for a methodology to update Economic Census revenues.
OSHA also received criticism on the choice of the data source and the methodology for estimating profits of the construction industry. These include comments from the National Association of Home Builders (NAHB) and the CISC (Document ID 2296, Attachment 1, pp. 20-22; 2308, Attachment 9, pp. 7-12).
Stuart Sessions, submitting on behalf of the CISC, criticized OSHA for using the Internal Revenue Service's (IRS) Corporation Source Book (CSB) as the source for industry profits since those data are only presented at the four-digit NAICS level instead of the five- or six-digit NAICS level. Mr. Sessions recommended that OSHA use an alternative data source for profit data and recommended Bizminer or RMA (Document ID 4231, Attachment 1, pp.12-13). OSHA investigated these sources and determined that these data were private data sources and that their publishers would not allow the data to be made publicly available. These other sources of profit data also suffered from the disadvantage of not representing adequate and random samples of the affected industries. A further discussion on this issue appears in Chapter III of the FEA.
In the PEA, OSHA used IRS data to calculate profit rates as the ratio of net income to total receipts (with the numerator including only firms with positive net income and the denominator including firms with and without net income) by NAICS industry. In response to comments criticizing this ratio as an inappropriate method to calculate industry profitability (Document ID 2308, Attachment 9, pp. 11-12; 4209, pp. 115-116), OSHA has revised the way that estimated profits are calculated. In the FEA, OSHA calculates profit rates using the method recommended by Mr. Sessions, which is discussed more fully in Chapter III. This method includes unprofitable firms and divides the “net income” from all firms (profitable and unprofitable) by total receipts from all firms (profitable and unprofitable), resulting in somewhat lower profit rates.
Similarly, Mr. Sessions criticized OSHA for using data that he believed were at a level that was too aggregated to show economic impacts of the costs of the rule accurately (Document ID 2319, Attachment 1, p. 71). The Portland Cement Association likewise disagreed with OSHA's presentation of costs as averages across industries. It said that “a more focused explanation of individual plant and facility costs is relevant to those industries with significant compliance responsibilities” (Document ID 2284, p. 6). OSHA's data sources for profile data are presented in Chapter III of the FEA. In general, OSHA has disaggregated industries to the extent that the source data will allow.
The most common criticism of OSHA's preliminary conclusions on economic feasibility was that the conclusions were based on costs that were underestimated or inaccurate (
OSHA responded to comments on its preliminary cost estimates in Chapter V of the FEA. In the aggregate, OSHA increased its cost estimate by approximately 46 percent, in part, as a result of changes in cost estimates made in response to comments and, in part, as a result of changes in the rule.
Some commenters argued that OSHA had not adequately considered the possibility that smaller establishments might have higher costs or that the costs have a greater impact on small businesses (Document ID 4231, Attachment 1, p. 11; 2379, Attachment 2, p. 7; 3582, Tr. 2107-2109; 2203, p. 1; 2351, p. 8; 3433, p. 9; 3580, Tr. 1398). As discussed in Chapter V, OSHA has made a number of changes to the costs analysis to reflect higher costs for small establishments.
The Court of Appeals for the D.C. Circuit has long held that OSHA standards are economically feasible so long as their costs do not threaten the existence of, or cause massive economic dislocations within, a particular industry or alter the competitive structure of that industry.
In practice, the economic burden of an OSHA standard on an industry—and whether the standard is economically feasible for that industry—depends on the magnitude of compliance costs incurred by establishments in that industry and the extent to which they are able to pass those costs on to their customers. That, in turn, depends, to a significant degree, on the price elasticity of demand for the products sold by establishments in that industry.
The price elasticity of demand refers to the relationship between the price charged for a product and the demand for that product: The more elastic the relationship, the less an establishment's compliance costs can be passed through to customers in the form of a price increase and the more it has to absorb compliance costs in the form of reduced profits. When demand is inelastic, establishments can recover most of the variable costs of compliance (
The court's summary is in accord with microeconomic theory. In the long run, firms can remain in business only if their profits are adequate to provide a return on investment that ensures that investment in the industry will continue. As technology and costs change, however, the long-run demand for some products naturally increases and the long-run demand for other products naturally decreases. In the face of additional compliance costs (or other external costs), firms that otherwise have a profitable line of business may have to increase prices to stay viable. Increases in prices typically result in reduced quantity demanded, but rarely eliminate all demand for the product. Whether this decrease in the total production of goods and services results in smaller output for each establishment within the industry, or the closure of some plants within the industry; a reduced number of new establishments entering the industry; or a combination of the three, is dependent on the cost and profit structure of individual firms within the industry.
If demand is perfectly inelastic (
If the demand is perfectly elastic (
A commonly discussed intermediate case would be a price elasticity of demand of one.
A decline in output as a result of an increase in price may occur in a variety of ways: Individual establishments could each reduce their levels of production; some marginal plants could close; or, in the case of an industry with high turnover of establishments, new entry may be delayed until demand equals supply. In many cases a decrease in overall output for an industry will be a combination of all three kinds of reductions. Which possibility is most likely depends on the rate of turnover in the industry and on the form that the costs of the regulation take.
When turnover in an industry is high, or an industry is expanding rapidly, then the key issue is the long run costs as determined by the cost of entry into the industry. For example, if there is annual turnover in an industry of ten percent per year, and a price elasticity of one, then a single year without new entry would result in a price rise of ten percent. Such a rise would be more than enough to compensate existing employers for a cost increase of one percent of revenues. If the costs are variable costs (
This leaves two kinds of costs that are, in some sense, fixed costs—capital costs of engineering controls in general industry and certain initial costs that new entrants to the industry will not have to bear.
Fixed costs in the form of capital costs of engineering controls in general industry and maritime due to this standard are relatively small as compared to the total costs, representing less than 21 percent of total annualized costs and approximately $1,019 per year per affected establishment in general industry.
There are some initial fixed costs in the sense that they might only be borne by firms in the industry today. For example, costs for general training not currently required and initial costs of medical surveillance may not be borne by establishments new to the industry to the extent they can hire from a workforce that may have already had this training and/or initial medical surveillance. An initial thorough facility cleaning is not a cost a new establishment would need to bear. These costs will disappear after the initial year of the standard and thus would be difficult to pass on. These costs, however, represent less than two percent of total costs and less than $58 per affected establishment. These initial fixed costs that may be borne by firms in the affected industries today, together with capital costs, give a total fixed cost of approximately 22 percent of total annual costs.
Because the remaining three-fourths of the total annual costs are variable, OSHA expects it is somewhat more likely that reductions in industry output resulting from the increase in costs associated with this rule will be met by reductions in output at each affected facility rather than as a result of plant closures or reduced new entry. However, closures of some marginal plants or poorly performing facilities are always possible. To determine whether a rule is economically feasible, OSHA begins with two screening tests to consider minimum threshold effects of the rule under two extreme cases: (1) All costs are passed through to customers in the form of higher prices (consistent with a price elasticity of demand of zero), and (2) all costs are absorbed by the firm in the form of reduced profits (consistent with an infinite price elasticity of demand).
In the former case, the immediate impact of the rule would be observed in increased industry revenues. While there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of one percent of annual revenues. Retrospective studies of previous OSHA regulations have shown that potential impacts of such a small magnitude are unlikely to eliminate an industry or significantly alter its competitive structure,
In the latter case, the immediate impact of the rule would be observed in reduced industry profits. OSHA uses the ratio of annualized costs to annual profits as a second check on economic feasibility. Again, while there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of ten percent of annual profits. In the context of economic feasibility, the Agency believes this threshold level to be fairly modest, given that normal year-to-year variations in profit rates in an industry can exceed 40 percent or more.
In general, it is usually the case that firms would be able to pass on some or all of the costs of the rule to their customers in the form of higher prices. OSHA therefore will tend to give much more weight to the ratio of industry costs to industry revenues than to the ratio of industry costs to industry profits. However, if costs exceed either the threshold percentage of revenue or the threshold percentage of profits for an industry, or if there is other evidence of a threat to the viability of an industry because of the standard, OSHA will examine the effect of the rule on that industry more closely. Such an examination would include market factors specific to the industry, such as normal variations in prices and profits, international trade and foreign competition, and any special circumstances, such as close domestic substitutes of equal cost, which might make the industry particularly vulnerable to a regulatory cost increase.
The preceding discussion focused on the economic viability of the affected industries in their entirety. However, even if OSHA found that a final standard did not threaten the survival of affected industries, there is still the question of whether the industries' competitive structure would be significantly altered. For example, if the
Some commenters were concerned that reductions of profits of less than ten percent could still represent major losses to an employer. For example, one commenter said:
The proposed rule states that in no cases will the amount of revenue or profits exceed 8.8% noting that this number is easily passed to consumers in the form of increased product and service costs. For a rule as specific and slight as one affecting only silica dust inhalation, a reduction in profits by 8.8% should give the government pause (Document ID 2189, p. 1).
Another commenter expressed similar concerns about a reduction in profits of 4.8 percent (Document ID 1882, Attachment 1, p. 2). OSHA is not dismissive of losses in profits of less than ten percent. However, such losses need to be weighed against the OSH Act's objectives of occupational safety and health. For purposes of assessing economic feasibility, OSHA needs to be concerned with major dislocating effects on entire industries, which will not be the result of relatively small changes in profits. Further, as will be discussed below, these costs can likely be passed on to consumers.
API/IPAA, while disagreeing with OSHA's cost estimates, acknowledged that OSHA's use of the rules of thumb of ten percent of profits or one percent of revenues has been upheld in court (Document ID 2301, Attachment 1, pp. 62-63).
Some commenters were also concerned that OSHA's screening analysis methodology did not give adequate consideration to upfront costs (Document ID 2379, Attachment 3, p. 39; 2119, Attachment 3, p. 22). As will be discussed below, OSHA's choice of a threshold level of ten percent of annual profits is low enough that even if, in a hypothetical worst case, all compliance costs were upfront costs, then upfront costs would still equal 88.5 percent of profits and thus would be affordable from profits alone without needing to resort to credit markets. (If the cost exceeds 100 percent of profits then the company would have to borrow to pay the balance. Otherwise the firm will not have to borrow but could finance the cost internally.)
While not specifically addressed to the issue of the screening analysis, Mr. Sessions provided some estimates of how various percentage cost increases might interact with demand and supply elasticities to produce estimates of declines in total industry output. His estimates show that the decline in total revenues (and, in this situation, total production) associated with increased costs of one percent of revenues ranges from zero to 0.83 percent of total production (the range depending on the elasticities of supply and demand, with the highest impact on total revenues associated with a very unlikely price elasticity of ten) (Document ID 4231, Attachment 1, p. 31). Even the largest decline in revenues would result in only a 0.83 percent decline in revenues, which would not represent a major dislocation of any affected industry. While OSHA does not necessarily endorse this particular approach to calculating changes in total revenue for given percentage change in costs, the calculation confirms OSHA's general view that increases of less than one percent of costs do not render a standard economically infeasible.
After reviewing these comments, OSHA has decided to retain its screening test of ten percent of profits and one percent of revenues as levels below which significant dislocation of an industry is extremely unlikely.
The Regulatory Flexibility Act (RFA), Public Law 96-354, 94 Stat. 1164 (codified at 5 U.S.C. 601), requires Federal agencies to consider the economic impact that a final rulemaking will have on small entities. The RFA states that whenever an agency “promulgates a final rule under section 553 of this title, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a final regulatory flexibility analysis” (FRFA). 5 U.S.C. 604(a). Pursuant to section 605(b), in lieu of an FRFA, the head of an agency may certify that the final rule will not have a significant economic impact on a substantial number of small entities. A certification must be supported by a factual basis. If the head of an agency makes a certification, the agency shall publish such certification in the
OSHA makes its determination about whether it can issue the required certification by applying screening tests to consider minimum threshold effects of the rule on small entities. These screening tests are similar in concept to those OSHA described above to identify minimum threshold effects for the purposes of demonstrating economic feasibility and are discussed below.
There are, however, two differences. First, for each affected industry, the screening tests are applied, not to all establishments, but to small entities (defined as “small business concerns” by the Small Business Administration (SBA)) and also to very small entities (as defined by OSHA as small businesses with fewer than 20 employees). Second, although OSHA's regulatory flexibility screening test for revenues also uses a minimum threshold level of annualized costs equal to one percent of annual revenues, OSHA has established a minimum threshold level of annualized costs equal to five percent of annual profits for the average small entity or very small entity (rather than the ten percent threshold applicable for general economic feasibility screening). The Agency has chosen a lower minimum threshold level for the profitability screening analysis and has applied its screening tests to both small entities and very small entities in order to ensure that certification will be made, and an FRFA will not be prepared, only if OSHA can be highly confident that a final rule will not have a significant economic impact on a substantial number of small entities or very small entities in any affected industry.
OSHA has prepared separate regulatory flexibility screening tests for general industry, maritime, and construction.
In this section, OSHA will determine whether (1) the rule is economically feasible for all affected industries in general industry and maritime, and (2) the Agency can certify that the rule will not have a significant economic impact on a substantial number of small entities in general industry and maritime. OSHA concludes that the rule is economically feasible, but the Agency is unable to certify that it will not have a significant economic impact on a substantial number of small entities.
Earlier chapters of the FEA identified the general industry and maritime sectors potentially affected by the final rule; presented summary profile data for affected industries, including the number of affected entities and establishments, the number of at-risk workers, and the average revenue for affected entities and establishments; and developed estimates, by affected industry, of the costs of the rule. The economic impacts of the final rule on general industry and maritime are driven, in part, by the costs of additional dust control measures, respirators, and silica program activities needed to comply with the rule.
To determine whether the final rule's projected costs of compliance would threaten the economic viability of affected industries; OSHA first compared, for each affected industry, annualized compliance costs to annual revenues and profits per (average) affected establishment. The results for all affected establishments in all affected industries in general industry and maritime are presented in Table VII-18, using annualized costs per establishment for the PEL of 50 μg/m
The annualized costs per affected establishment for each affected industry were calculated by distributing the industry-level (incremental) annualized compliance costs among all affected establishments in the industry, where annualized compliance costs reflect a three percent discount rate. The annualized cost of the rule for the average establishment in all of general industry and maritime is estimated to be $4,939 in 2012 dollars. It is clear from Table VII-18 that the estimates of the annualized costs per affected establishment in general industry and maritime vary widely from industry to industry. These estimates range from $220,558 for NAICS 213112 (Support Activities for Oil and Gas Operations) and $57,403 for NAICS 331511 (Iron Foundries) to $304 for NAICS 621210 (Offices of Dentists) and $377 for NAICS 324121 (Asphalt Paving Mixture and Block Manufacturing).
Table VII-18 also shows that, within the general industry and maritime sectors, there are no industries in which the annualized costs of the final rule exceed 1 percent of annual revenues and there are eight industries in which the annualized costs of the rule exceed ten percent of annual profits and none where annualized costs exceed one percent of annual revenues. NAICS 213112 (Support Activities for Oil and Gas Operations), has the highest cost impact as a percentage of revenues, of 0.56 percent. NAICS 327120 (Clay Building Material and Refractories Manufacturing) has the highest cost impact as a percentage of profits, of 31.08 percent. For all affected establishments in general industry and maritime, the estimated annualized cost of the rule is, on average, equal to 0.06 percent of annual revenue and 2.43 percent of annual profits.
The industries with costs that exceed ten percent of profits are: NAICS 327110—Pottery, Ceramics, and Plumbing Fixture Manufacturing, 31 percent; NAICS 327120—Clay Building Material and Refractories Manufacturing, 31 percent; NAICS 327991—Cut Stone and Stone Product Manufacturing, 24 percent; NAICS 327390—Other Concrete Product Manufacturing, 17 percent; NAICS 327999—All Other Miscellaneous Nonmetallic Mineral Product Manufacturing, 16 percent; NAICS 327332—Concrete Pipe Manufacturing, 13 percent; NAICS 327331 Concrete Block and Brick Manufacturing, 13 percent; and NAICS 327320 Ready-Mix Concrete Manufacturing, 10 percent.
The United States has a dynamic and constantly changing economy in which an annual percentage changes in industry revenues or prices of one percent or more is common. Examples of year-to-year changes in an industry that could cause such variations in revenues or prices include increases in
To demonstrate the normal year-to-year variation in prices for all the manufacturers in general industry and maritime affected by the rule, OSHA developed in the FEA year-to-year producer price indices and year-to-year percentage changes in producer prices, by industry, for the years 2004 through 2014. As shown in Table VI-3 in the FEA, for the combined affected manufacturing industries in general industry and maritime over the 12-year period, the average change in producer prices was 2.7 percent a year. For the industries in general industry and maritime with the largest estimated potential annual cost impact as a percentage of revenue—NAICS 213112—Support Activities for Oil and Gas Operations, 0.56 percent; and NAICS 327991—Cut Stone and Stone Product Manufacturing, 0.42 percent—the average annual changes in producer prices in these industries over the 12-year period were, respectively, 3.8 percent, and 0.5 percent.
Based on these data, it is clear that the potential cost impacts of the final rule in general industry and maritime are all well within normal year-to-year variations in prices in those industries. The maximum cost impact of the rule as a percentage of revenue in any affected industry is 0.56 percent, while the average annual change in producer prices for affected industries was 2.7 percent for the period 2004 through 2014 (changed from 1998 to 2009 in the PEA). Furthermore, even a casual examination of Table VI-3 of the FEA reveals that annual changes in producer prices in excess of five or even ten percent are possible without threatening an industry's economic viability. Thus, OSHA concludes that the potential price impacts of the final rule would not threaten the economic viability of any industries in general industry and maritime.
Changes in profit rates are also subject to the dynamics of the U.S. economy. A recession, a downturn in a particular industry, foreign competition, or the increased competitiveness of producers of close domestic substitutes are all easily capable of causing a decline in profit rates in an industry of well in excess of ten percent in one year or for several years in succession.
To demonstrate the normal year-to-year variation in profit rates for all the manufacturers in general industry and maritime affected by the rule, OSHA in the FEA developed Table VI-4 and Table VI-5, which show, respectively, year-to-year profit rates and year-to-year percentage changes in profit rates, by industry, for the years 2000 through 2012. For the combined affected manufacturing industries in general industry and maritime over the thirteen-year period, OSHA calculated an average change in profit rates of 138.5 percent a year (average for all industries calculated from the per-NAICS averages shown in Table VI-5 in the FEA). For the industries in general industry and maritime with the largest estimated potential annual cost impacts as a percentage of profit—NAICS 327120—Clay Building Material and Refractories Manufacturing, 31 percent; NAICS 327110—Pottery, Ceramics, and Plumbing Fixture Manufacturing, 31 percent; and NAICS 327991—Cut Stone and Stone Product Manufacturing, 24 percent—the average annual percentage changes in profit rates in these industries over the 13-year period were, respectively, 951 percent, 951 percent, and 113 percent.
One complicating factor is that the annualized costs of the rule, if absorbed in lost profits, would involve not just a temporary loss of profits but a longer term negative effect on profits relative to the baseline. To address this issue, the Agency compared the effect of a longer term reduction in profits to much larger reductions in profits but over shorter periods. Assuming a three-percent discount rate, the Agency determined a ten percent decline in profit rates relative to the original baseline, which remains constant at that lower level over a ten-year period, would be equivalent to:
• An 88.5 percent decline in profit rates for one year;
• a 44.5 percent decline in profit rates that remains constant at the lower level for two years; or
• a 30 percent decline in profit rates that remains constant at the lower level for three years.
An examination of Table VI-5, for the thirteen year period from 2000 to 2012, clearly shows that short-run changes in average industry profit rates of the above magnitudes have occurred on numerous occasions in general industry and maritime, without threatening the economic viability of the affected industries. For this reason, OSHA is confident that potential profit rate impacts of ten percent or less as a result of the rule would not threaten the economic viability of the affected industries in general industry and maritime.
A longer-term loss of profits in excess of ten percent a year could be more problematic for some affected industries and might conceivably, under sufficiently adverse circumstances, threaten an industry's economic viability. In OSHA's view, however, affected industries would generally be able to pass on most or all of the costs of the final rule in the form of higher prices rather than bear the costs of the final rule in reduced profits. In other words, the demand for the goods and services produced by affected industries in general industry and maritime do not appear to be perfectly elastic or close to it. While there are substitutes for these products, there are no perfect substitutes that would lead the price elasticity to be extremely high. As a result, the demand for quantities of brick and structural clay, vitreous china, ceramic wall and floor tile, other structural clay products (such as clay sewer pipe), and the various other products manufactured by affected industries would not significantly contract in response to a 0.48 percent (or lower) price increase for these products. It is of course possible that such price changes will result in some reduction in output, and the reduction in output might be met through the closure of a small percentage of the plants in the industry. However, the only realistic circumstance under which an entire industry would be significantly affected by small price increases would be the availability in the market of a very close or perfect substitute product not subject to OSHA regulation. The classic example, in theory, would be foreign competition. In the following discussion OSHA examines the threat of foreign competition for affected U.S. establishments in general industry and maritime and concludes that it is unlikely to threaten the viability of any affected industry.
The American Chemistry Council (ACC) stated, with respect to a similar analysis in the PEA, that short-term volatility within an industry sector is of little value in projecting what will
OSHA first examines the issue of changes in prices over time. Such changes, on the whole, represent pass through of changes in costs, since profits are not continually rising. These changes in costs are not “fluctuations” with upward and downward shifts in prices. For almost all industries these changes in costs are continuing upward shifts that average each year much larger changes than the maximum price change any industry will need to incur in order to comply with the silica rule.
For variations in profits, these are indeed fluctuations and profits do indeed both rise and fall. However, if, as the commenters argue only long-term average profits matter, then we could reach the very counterintuitive result that there should be no excess plant closures during recessions. This is not the case because long-term profits are, in fact, nothing more than a prediction and the present value of long term profits will be different at the beginning than at the end of a recession. Recognizing these timing effects is why OSHA examined the annualized value of losses in profits associated with the recession beginning 2008 and compared it to the annualized value of the loss in profits as result of costs of this standard. While temporary and permanent losses are different, the use of discounting enables us to compare short- and long-term losses.
The magnitude and strength of foreign competition is an important factor in determining the ability of firms in the U.S. to pass on (part or all of) the costs of the rule in the form of higher prices for their products. If firms are unable to do so, they must absorb the costs of the rule out of profits, possibly resulting in the business failure of individual firms or even, if the cost impacts are sufficiently large and pervasive, causing significant dislocations within an affected industry.
As in the PEA, OSHA in the final economic analysis examined how likely such an outcome is. The analysis there included a review of trade theory and empirical evidence and the estimation of impacts. Throughout, the Agency drew on ERG (2007c) (Document ID 1710), which was prepared specifically to help analyze the international trade impacts of OSHA's final silica rule. A summary of the FEA results is presented below.
OSHA focused its analysis on eight of the industries likely to be most affected by the final silica rule and for which import and export data were available. OSHA combined econometric estimates of the elasticity of substitution between foreign and domestic products, Annual Survey of Manufactures data, and assumptions concerning the values for key parameters to estimate the effect of a range of hypothetical price increases on total domestic production. In particular, OSHA estimated the domestic production that would be replaced by imported products and the decrease in exported products that would result from a 1 percent increase in prices—under the assumption that firms would attempt to pass on all of a 1 percent increase in costs arising from the final rule. The sum of the increase in imports and decrease in exports represents the total loss to industry attributable to the rule. These projected losses are presented as a percentage of baseline domestic production to provide some context for evaluating the relative size of these impacts.
The effect of a 1 percent increase in the price of a domestic product is derived from the baseline level of U.S. domestic production and the baseline level of imports. The baseline ratio of import values to domestic production for the eight affected industries ranges from 0.04 for iron foundries to 0.547 for ceramic wall and floor tile manufacturing—that is, baseline import values range from 4 percent to more than 50 percent of domestic production in these eight industries. OSHA's estimates of the percentage reduction in U.S. production for the eight affected industries due to increased domestic imports (arising from a 1 percent increase in the price of domestic products) range from 0.013 percent for iron foundries to 0.237 percent for cut stone and stone product manufacturing.
OSHA also estimated the baseline ratio of U.S. exports to consumption in the rest of the world for the sample of eight affected industries. The ratios range from 0.001 for other concrete manufacturing to 0.035 percent for nonclay refractory manufacturing. The estimated percentage reductions in U.S. production due to reduced U.S. exports (arising from a 1 percent increase in the price of domestic products) range from 0.014 percent for ceramic wall and floor tile manufacturing to 0.201 percent for nonclay refractory manufacturing.
The total percentage change in U.S. production for the eight affected industries is the sum of the loss associated with increased imports and the loss resulting from reduced exports. The total percentage reduction in U.S. production arising from a 1 percent increase in the price of domestic products range from a low of 0.085 percent for other concrete product manufacturing to a high of 0.299 percent for porcelain electrical supply manufacturing.
These estimates suggest that the final rule would have only modest international trade effects. It was previously hypothesized that if price increases resulted in a substantial loss of revenue to foreign competition, then the increased costs of the final rule would have to come out of profits. That possibility has been contradicted by the results reported in this section. The maximum loss to foreign competition in any affected industry due to a 1 percent price increase was estimated at approximately 0.3 percent of industry revenue. Because, as reported earlier in this section, the maximum cost impact of the final rule for any affected industry would be 0.56 percent of revenue, this means that the maximum loss to foreign competition in any affected industry as a result of the final rule would be 0.2 percent of industry revenue —which would hardly qualify as a substantial loss to foreign competition. This analysis cannot tell us whether the resulting change in revenues will lead to a small decline in the number of establishments in the industry or slightly less revenue for each establishment. However it can reasonably be concluded that revenue changes of this magnitude will not lead to the elimination of industries or significantly alter their competitive structure.
Based on the Agency's preceding analysis of economic impacts on revenues, profits, and international trade, along with the discussion of industry concerns below, OSHA concluded that the annualized costs of the final rule are below the threshold level that could threaten the economic viability of any industry in general industry or maritime. OSHA further noted that while there would be additional costs (not attributable to the final rule) for some employers in general industry and maritime to come into compliance with the new silica standard, these costs would not affect the Agency's determination of the economic feasibility of the final rule.
The following comments discuss the loss of business to foreign competition in the foundry industry. The comments have been grouped together by issue and are followed by OSHA's response. The first group of commenters used impact numbers from an alternative cost model to discuss the loss of business to foreign competition.
The United States Chamber of Commerce (“the Chamber”) stated that additional costs of the rule's ancillary provisions along with engineering controls will result in reduced competitiveness relative to foreign foundries (Document ID 2288, pp. 27-28). The Chamber also critiqued OSHA's inability to determine feasibility because of a lack of data to analyze economic impacts across facilities by age, design, operations, condition and region (Document ID 2288, pp. 29-30).
In the comments above, the negative economic effect of losing business to foreign competition is based on an alternative cost model report prepared for the American Foundry Society (AFS) by Environomics. This report is addressed in the Engineering Control Costs section in Chapter V of the FEA, where OSHA concluded that the costs in that report were inflated. Because these inflated costs also underpin the Chamber's claim that the rule will reduce competitiveness with foreign foundries, OSHA does not accept that claim. In response to the Chamber's criticism of OSHA's data sources, the Agency notes that Chapter III, the section on Survey Data and OSHA Economic Analyses, discusses why it was infeasible to collect and compile a full-scale national survey of the kinds of baseline conditions and practices that the Chamber of Commerce urged OSHA to consider.
The following comments from foundry firms and associations address foreign competition in metalcasting from China and India along with the inability to pass the cost on to their customers.
AFS submitted comments that the metalcasting industry would lose business to foreign competition as follows:
Many foundries have closed in recent years with foreign competition assuming much of that business. Five of the eleven identifiable foundries used in the PEA to support OSHA's assertion of feasibility have closed. Because castings are the starting point of many manufacturing processes, loss of foundry jobs also means loss of other manufacturing jobs.
The U.S. metalcasting industry is made up of 1,978 facilities, down from 2,170 five years ago. This reduction can be attributed to the recession, technological advancements, foreign competition and tightening regulations (Document ID 2379, Attachment 3, p. 42; 4035, p. 5).
The Indiana Cast Metals Association concurred with these comments and also suggested that other industries would also be negatively impacted if U.S. foundries shut down (Document ID 2049, p. 1). The Ohio Cast Metals Association submitted two comments stating that the rule will increase costs and undermine the Ohio-based metalcasting industry's ability to compete in the global marketplace:
[The silica rule] will significantly increase costs, slow down or eliminate hiring, reduce the number of foundry jobs and undermine our industry's ability to compete in the global marketplace. For some foundries, the rulemaking could be the final straw that destroys their business.
. . . Over the past two decades Ohio foundries along with other manufacturers throughout the United States have faced tremendous international competition from China, Brazil, and India and many foundries have closed and thousands of employees have lost their jobs during this period. To suggest that Ohio foundries can just pass on the tremendous costs associated with compliance with the proposed silica rule with “minimal loss of business to foreign competition” indicates that the individuals performing this analysis were driven by other agendas or misinformed (Document ID 2119, Attachment 3, pp. 1-2).
Grede Holdings L.L.C. submitted a comment expressing its view that it would be difficult for foundries to pass the cost of compliance to the customer because of international competition, and that the number of foundries in the U.S. has dropped by more than half since 1980, going from 4,200 foundries to 2,050 foundries (Document ID 2298, p. 3).
Sawbrook Steel submitted two comments voicing concern that the implementation of the regulation will cause jobs to move overseas, resulting in a shrinking of the domestic casting manufacturing (Document ID 2227, p. 2; 1995, p. 1).
In the comments above, businesses and associations state that the costs of the rule will be too high and they will lose business to foreign competition. The chief advantage of foreign imports to downstream users, as reported to the U.S. International Trade Commission (ITC) during an investigation they conducted into the competitive conditions in the U.S. foundry market, is their low pricing. Respondents to the investigations said the cost of foreign produced products ranged from ten percent to forty percent less than the cost of U.S. products (Document ID 0753, table 5-60, p. 5-53 as referenced in Document ID 1710, pp. 5-4). U.S. producers have responded to competition with a broad array of initiatives, such as implementing lean manufacturing, improving customer service, and increasing automation (Document ID 0753, pp. 10-14 and 10-15). According to the ITC study:
The use of technology may also be influenced by the type of castings produced and relative wage rates. Low-value, low-quality castings, for example, generally require a lower level of technology and relatively more semi-skilled labor than foundries producing more complex castings. To lower labor costs, foundries in developed countries with higher wage rates may install more automation and technological improvements, whereas foundries in developing countries with relatively lower wage rates may substitute labor for relatively high-cost capital investments (Document ID 0753, p. 2-11).
Before addressing issues on international competition for metalcasters, it should be noted that all foundry industries affected by this rule are below the ten percent cost to profit threshold and one percent cost to revenue threshold. This means that even if the argument that costs cannot be passed on were to be correct, the loss in profits would be less than ten percent and unlikely to effect the feasibility of the industry. Further the costs to be passed on would require less than one percent price increases. In general, metalcasters in the U.S. have shortened lead times, improved productivity through computer design and logistics management, provided expanded design and development services to customers, and provided a higher quality product than foundries in China and other nations where labor costs are low (Document ID 0753, p. 3-12). All of these measures, particularly the higher quality of many U.S. metalcasting products and the ability of domestic foundries to fulfill orders quickly, are substantial advantages for U.S. metalcasters that may outweigh the very modest price increases projected in Tables VI-3 and VI-4 of the FEA (Document ID 1710, p. 5-4). According to the ITC study, quality was the number one purchasing decision factor for the majority of purchasers, with price and lead times ranking lower, and U.S. metalcasters are able to deliver that quality (Document ID 0753, p. 4-5). The ITC report noted:
Certain purchasers noted that when inventory management and complex manufacturing skills are required, U.S. foundries excel. U.S. foundries were also cited by responding U.S. purchasers as manufacturing with a low defect (rejection) rate. (Id.)
Purchaser responses to the ITC's survey stated that some U.S. foundries are also completely inoculated against foreign competition, even if the prices of U.S. foundry products rise:
As noted in questionnaire responses, certain purchasers are committed to buying solely U.S.-made castings. One U.S. foundry official noted that if downstream customers require castings to be made in the United States, then U.S. foundries are guaranteed that business. This situation often occurs when foundries supply castings for federally funded operations, such as construction projects (Document ID 0753, p. 4-5).
Foundries in China and India, while expanding their capacities, are also faced with rising domestic demand due to their own rapidly expanding domestic industrial economies, which affect their ability to fulfill export demand (Document ID 0753, p. 5-16). ERG's research noted a growth in U.S. foundry exports, which could help to offset some of the foreign imports entering the U.S. market. According to one report cited by ERG, U.S. foundry exports were roughly equivalent to 53 percent of the imports (Document ID 1710, p. 5-5).
ERG's research also provided some evidence that the combination of U.S. and foreign demand for metalcasting may outstrip the supply to such a degree that, even if the U.S. foundries operated at full capacity, their maximum output would fail to meet the demand from the U.S. and foreign markets (Document ID 1710, p. 5-5). The U.S. foundry industry is unlikely to face any significant economic impacts if there is ample demand and a limited supply because such a condition makes it easier to pass along any costs of the rule.
The following comments discuss the difficulties of competing with foreign tile producers followed by OSHA's response.
Tile Council of North America (TCNA) noted the import price sensitivity between domestic tile and imported tile as follows:
The low cost of imported tile places an enormous burden on U.S. tile manufacturers to maintain current pricing to remain competitive. According to the latest data collected by TCNA, the average price per square foot of U.S. tile shipments is $1.43. The average price per square foot of Chinese imports is $0.86. With Chinese imports 60% less expensive than U.S. tile in what is an extremely price-competitive market, OSHA's claim that “any price increases would result in minimum loss of business to foreign competition” strains credulity.
To illustrate the tremendous import/price sensitivity between domestic tile and imports, we note the increase in imports from Peru as a result of a bilateral free trade agreement between Peru and the United States eliminating duty on tile from Peru. Although only amounting to a price change of 4—5 cents per square foot, from 2008, the year before the bilateral agreement to the end of 2011, tile imports from Peru into the United States grew by 59%. This illustrates how even a small change in price due to modest increases in operating costs and raw material costs pose an existential threat to the tile manufacturing industry.
The import sensitivity of domestic tile manufacturing operations is well known by the United States International Trade Commission (USITC) and the office of the United States Trade Representative (USTR). The assertion made by OSHA that cost increases will not result in lost market share to foreign competition is in direct conflict with information known by USITC and the USTR and contrary to established public policy (as reflected in existing Free Trade Agreements) and industry testimony.
Contrary to the assertion made by OSHA, the marginal price increases anticipated by required conformance to the rule as proposed would make the domestic tile manufacturing industry highly uncompetitive threatening the very viability of this import-sensitive industry (Document ID 2363, p. 9).
The National Tile Contractors Association also questioned OSHA's preliminary determination that the tile industry could pass on most or all costs through higher prices, calling the claim “wildly erroneous”:
Implementation of the proposed rule's requirements would increase both production and installation costs, and would put pressure on consumer prices. At a time when U.S. consumption of ceramic tile is more than 25% below its peak level (2006), this is a serious concern. The U.S. market is already flooded with lower quality, lower priced imports from many countries that likely do not respect the health, safety, and rights of workers. The low cost of imported tile places an enormous burden on U.S. tile manufacturers to maintain current pricing to remain competitive (Document ID 2267, p. 8).
Dal-Tile echoed the TCNA comments regarding the inability to pass costs onto the customer (Document ID 2147, p. 3).
OSHA does not dispute the commenters' information indicating that Chinese and Peruvian tile are significantly cheaper than U.S. tile, but that point actually undercuts their claim that a small change in the price of U.S. tile would place an “enormous burden” on U.S. tile manufacturers. The commenters note that Chinese tile is already available in the U.S. at just over half the price of U.S. tile. If the market was actually as sensitive as the commenters suggest, and the Chinese tile was competing for the same market share as U.S. tile, under the commenter's logic the U.S. tile industry would have already gone out of business. But that has not happened, suggesting that U.S. tile manufacturers have been able to identify customers for whom the tile price is not the predominant factor. Likewise, the example of Peruvian tile demonstrates only that the lower-priced imported tile is sensitive to small price changes. The commenter provides no evidence that the Peruvian tile is competing for the same customers as the U.S. tile industry.
In summary, the TCNA's argument that cost increases will result in lost market share to foreign competition is unconvincing because it is not clear that there is a strong relationship between the price of the foreign tile and the price of the U.S. tile. One likely cause for this disconnect is that, as TCNA notes, the market is “already flooded with lower quality, lower priced” imports (Document ID 2363, p. 8), suggesting that tile from China, Peru, and the other lower-priced foreign importers are of a lower quality that may be targeted at a different customer base than the higher-quality U.S. tile. This perception that tile from China and other low-cost tile producing countries may be of lower quality produces an imperfect substitution scenario and adds to the inelasticity of demand for domestic tiles, enabling producers to pass some of the costs on to the consumer.
On the other end of the tile price range are the Italian tiles. Italy and China are the top countries of origin for tiles imported into the U.S., but tiles from these countries command very different prices. In terms of general tile products, one source indicates that the average prices of tiles imported by the U.S. in 2012 were $20.20 to $20.90 per square meter for Italian tiles and between $8.30 and $8.70 per square meter for Chinese tiles imported by the U.S., a significant price difference that could be explained by a difference in quality.
Using price as an indicator of quality, the tile market can be segmented into three categories: Low quality, mid-grade, and high quality. The U.S. tile industry has located a niche between the lowest quality/lowest priced tile and the highest quality/highest priced tile. While it is possible that a few tile firms that produce very low-quality or very high-quality tile may be negatively impacted by an increase in the price of their tile, OSHA concludes that the majority of firms would not experience a significant negative economic impact. This is along with the fact that the increase in price from this rule is expected to be minimal. TCNA commented that the average price per square foot of U.S. tile shipments is $1.43. The cost to revenue ratio for NAICS 327122 Ceramic Wall and Floor Tiles is 0.35 percent, meaning this final rule will increase the average cost of U.S. tile by five hundredths of a cent (or $0.0005 per square foot). It is therefore fair to say this extremely modest increase in the average price of U.S. tile would not have a significant economic impact on the U.S. tile industry as a whole.
During the public hearing Belden Tri-State Building Materials stated that the brick industry has foreign competition, mostly from Canada, and some from Mexico (particularly in Texas, Oklahoma or Arkansas), and Germany (Document ID 3586, Tr. 3457). They indicated that their competition includes not only imported brick but also “other cladding materials like vinyl siding and HardiePlank,” but the competition from imported brick is typically “more expensive brick” because of “innovations in Europe that we just haven't caught up to, different sizes, different colors, different processes” (Id.).
Acme Brick Company representatives indicated in testimony that oversees competition was virtually nonexistent because it is “hard to get that across the ocean economically” and noted that they generally locate their production facilities strategically to be near their markets because “[p]roduction costs really are about a third of the cost of the brick when we have them close . . . [The] farther away [the bricks come from]—there are some distinctions in the quality or the makeup of a brick” (Document ID 3577, Tr. 736).
This testimony indicates to OSHA that international competitors will not be able to take advantage of any potential price increases made by U.S. producers in the U.S. domestic brick market. The brick making industry will therefore be able to pass on most, if not all, of the costs of complying with the rule.
To determine the economic impacts for most industries, OSHA used the Census Bureau's Statistics of U.S. Businesses to estimate revenues on a six-digit NAICS basis but these revenue data were not sufficiently precise to isolate the hydraulic fracturing component from the larger industry (NAICS 213112). As a result, instead of using data from the Economic Census, revenues for hydraulic fracturing firms were based on estimated utilization rates and per stage revenues. As discussed in Chapter III of the FEA, Profile of Affected Industries, the data on this industry have been updated to reflect the comments in the record and the best data available in 2012. The cost to profit percentage for the hydraulic fracturing industry estimated in the FEA is 7.67 percent (below OSHA's ten percent threshold) for fleets of all sizes. The ratio of costs to revenues for hydraulic fracturing firms in the FEA is estimated to be 0.54 percent for all establishments in the industry, 0.17 percent for small entities and 0.24 percent for very small entities. Although the costs as a percent of revenue increased for all establishments, the impacts still remain well below the one percent threshold.
However, these estimates are based on the state of the industry in the base year of 2012 supplemented with data provided in comments to the proposed rule in 2013 and early 2014. When the PEA was published in 2006, the price of oil fluctuated between $70 and $80 a barrel. During the years following the publication of the PEA the price of oil has had some large fluctuations. Before the recession of 2008 the price of oil peaked at $146 per barrel but dropped to $44 dollars per barrel during the economic downturn in 2008.
Hydraulic fracturing nearly doubled U.S. oil production from 5.6 million barrels a day in 2010 to a rate of 9.3 million barrels a day in 2015. Up until the drop in oil prices during the fourth quarter of 2014, the expected annual increase in production was one million barrels. The economics of hydraulic fracturing wells is much different than conventional wells.
Hydraulic fracturing wells have a very short life compared to conventional wells. For example, a well in the Bakken region straddling Montana and North Dakota may start out producing 1,000 barrels a day then decline to 280 barrels at the beginning of year two. By year three, more than half of the reserves will be depleted. Therefore, to generate revenue, producers need to constantly drill new wells. In this sense, hydraulic fracturing wells are more like gold or silver mines than conventional oil production.
The Energy Information Administration (EIA) projects the Brent crude oil price will average $40 a barrel in 2016 and $50 a barrel in 2017. However, EIA expects crude oil prices
However, the possibility that oil prices are not going to increase in the near future has spurred a new wave of innovation in energy exploration. Now that prices have dropped to around $50 a barrel, companies are focusing on efficiency and getting the most petroleum for the least amount of money. With the effective date of this rule on the horizon, it is possible that some of this innovation will lead to technologies that not only increase efficiency but reduce worker exposures to silica at the same time.
Through the application of new technology OSHA believes that, even in a lower price environment, hydraulic fracturing entrepreneurs will be able to implement the controls required by this final rule without imposing significant costs, causing massive economic dislocations to the hydraulic fracturing industry, or imperiling the industry's existence. Big oil-field-services like Haliburton Co. and Schlumberger Ltd. report that they have witnessed customers concentrating on using technology such as lasers and other high-tech equipment and data analytics before they drill to make sure new wells deliver the most crude for the investment cost. The application of this new technology as well as fiber-optic tools that help monitor a well during hydraulic fracturing to make sure that it's working as well as possible and new techniques to stimulate microbes already present that attach themselves to bits of oil, essentially breaking it up and making it easier for the crude to flow through rock
Although the drop in the price of oil has caused an initial reduction in hydraulic fracturing operations, the application of recently developed technology to new wells has increased per well production. One expert was quoted in Fortune magazine as saying “[t]here tailing off in U.S. drilling activity, but I expect continued development drilling in major new areas, particularly the Bakken, even at $50 (a barrel).”
A sign of the ongoing effectiveness of upgrades in efficiency in the hydraulic fracturing business is evident in the projections for U.S. crude production. The EIA's Annual Energy Outlook for 2015 has projected that the U.S. is on track to hit reach a record for crude output at 10.6 million barrels a day in 2020.
While the economic conditions faced by the hydraulic fracturing industry have changed significantly since the publication of the proposed rule, this discussion shows that there is significant reason to believe that this rule will not have a significant impact on the hydraulic fracturing industry. Advancements in technology and the application of new efficient drilling methods continue to increase the per-rig production capacity of new-well oil drilling rigs while lowering the costs of operating these rigs. These technological changes increase the energy recovered through hydraulic fracturing, and thus the value of fracturing services, without increasing the costs per well associated with controlling silica exposures. Further, the demand for fracturing services will depend, in part, on energy prices. The costs associated with complying with the silica rule are a minor issue by comparison. Thus, OSHA's conclusion that this rule is economically feasible for the hydraulic fracturing industry has not changed.
In the PEA, OSHA did not include any estimates of costs as percentage of revenues or as a percentage of profits for railroads. This was due to the fact that the standard sources of economic statistics that were used for data on revenues and employment for all other affected industries do not include railroads. The Association of American Railroads (AAR) expressed concern about the impact of the rule on small railroads (although not on larger railroads), but did not provide any estimates or analysis, or suggest that OSHA use any specific sources to conduct such an analysis. For the FEA, OSHA did examine costs as percentage of revenues and profits for the railroad industry as a whole using supplemental information from sources typically relied on by the industry.
For the FEA, OSHA estimated that 16,895 workers in the rail transportation industry (NAICS 4821; “railroads”) will be covered by the final standard, including 7,239 workers employed as Ballast Dumpers and 9,656 workers employed as Machine Operators (for the purposes of this analysis, OSHA assumed that the machine operators would be conducting at least some work outside of the cab of the equipment). The Agency estimated that compliance costs for railroads will total $16.6 million, or $980 per affected worker.
Based on these estimates, OSHA judged that the final rule is feasible for railroads because combining
The AAR noted that small railroads had not been covered in the Initial Regulatory Flexibility Analysis (Document ID 2366, p. 4). The commenter is correct that OSHA did not examine small entities in this sector but has done so for the FEA using supplemental information on railroads.
In 2012, 574 U.S. freight rail establishments, employing 181,264 workers, operated on roughly 169,000 miles of track.
• Class I for freight railroads defined as railroads with annual operating revenues above $467.1 million ($2013)
• Class II, includes some regional railroads, defined as railroads each with operating revenues between $37.4 million and $467.1 million ($2013)
• Class III for all other freight rail operations (including smaller regional, short-line, switching, and terminal).
In 2013, in addition to the seven Class I freight railroad systems, there were 21 regional railroads (line-haul railroads operating at least 350 miles of road and/or earning revenue between roughly $40 million and the Class I threshold), and over 500 local railroads (line-haul or short-line railroads smaller than regional railroads).
In 2012, employment within 546 local railroad companies totaled 12,293 workers and employment within 21 regional railroads totaled 5,507 workers. Line Haul Railroads are classified in NAICS 482111 and entities within this industry with 1,500 or fewer workers are classified as small by SBA size standards. Local/Short Line Railroads are classified in NAICS 482112 and entities within this industry with 500 or fewer workers are classified as small by the SBA size standard. For 2012, OSHA estimated that all 567 Class II and Class III railroads (combined total of 17,800 workers) qualified as small entities according to the SBA definitions.
In a recent study prepared for Congress,
OSHA estimated that compliance costs for rail transportation will total $16,562,059. Therefore, if costs per affected worker ($980 per worker) are apportioned to the establishments operating Short-Line Railroads, OSHA estimates that costs for these local railroads will total $1.1 million, or roughly $35,100 per establishment. As noted above, annual revenues among Short-Line rail operations total approximately $2.6 billion, or $81.3 million per establishment. Applying the industry-wide profit rate of 6.23 percent for NAICS 4821, OSHA estimated that profits per establishment in NAICS 482112 are $5.1 million. Therefore, OSHA estimates that impacts measured as costs as a percent of revenues will not exceed 0.04 percent, and that impacts measured as costs as a percent of profits will not exceed 0.69 percent. Thus, OSHA concludes that the silica standard will not impose a significant impact on a substantial number of small entities in rail transportation and therefore will not threaten the competitive structure or viability of small entities in NAICS 482110.
The preceding discussion focused on the economic viability of the affected industries in their entirety. Even though OSHA found that the final standard did not threaten the survival of these industries, there is still the possibility that the competitive structure of these industries could be significantly altered.
To address this possibility, OSHA followed its normal rulemaking procedure for examining the annualized costs per affected small entity and per very small entity for each affected industry in general industry and maritime. Again, OSHA used its typical minimum threshold level of annualized costs equal to one percent of annual revenues—and, secondarily, annualized costs equal to ten percent of annual profits—below which the Agency has concluded that the costs are unlikely to threaten the survival of small entities or very small entities or, consequently, to alter the competitive structure of the affected industries.
Compliance costs for entities with fewer than 20 employees were estimated, in many cases, using a derived compliance cost per employee. Assuming costs to be equally distributed among all employees, OSHA estimated the compliance cost per employee by dividing total costs for each NAICS by the number of employees. OSHA then multiplied the compliance cost per employee with the ratio of the average number of employees per entity with fewer than 20 employees. Similarly, compliance costs per small entity were estimated from the product of compliance costs per employee and the
As shown in Table VII-19 and Table VII-20, the annualized cost of the final rule is estimated to be $2,967 for the average small entity in general industry and maritime and $1,532 for the average very small entity in general industry and maritime. These tables also show that the only industry in which the annualized costs of the final rule for small entities exceed one percent of annual revenues is NAICS 213112 (Support Activities for Oil and Gas Operations), which is estimated to be 1.29 percent. There are two industries for very small entities exceeding one percent of annual revenues—NAICS 213112 (Support Activities for Oil and Gas Operations), 2.09 percent and NAICS 327110 (Pottery, Ceramics, and Plumbing Fixture Manufacturing), 1.21 percent.
Small entities in nine industries in general industry and maritime are estimated to have annualized costs in excess of ten percent of annual profits; NAICS 327110: Pottery, Ceramics, and Plumbing Fixture Manufacturing (38.6 percent); NAICS 327120: Clay Building Material and Refractories Manufacturing (33.6 per cent); NAICS 327991: Cut Stone and Stone Product Manufacturing (24.7 percent); NAICS 327999: All Other Miscellaneous Nonmetallic Mineral Product Manufacturing (20.9 percent); NAICS 327390: Other Concrete Product Manufacturing (18.6 percent); NAICS 213112: Support Activities for Oil and Gas Operations (18.2 percent); NAICS 327332: Concrete Pipe Manufacturing (14.5 percent); NAICS 327331: Concrete Block and Brick Manufacturing (13.1 percent); and NAICS 327320: Ready-Mix Concrete Manufacturing (11.5 percent).
Very small entities in sixteen industries are estimated to have annualized costs in excess of ten percent of annual profit: NAICS 327110: Pottery, Ceramics, and Plumbing Fixture Manufacturing (90.6 percent); NAICS 327120 Clay Building Material and Refractories Manufacturing (58.5 percent); NAICS 327999: All Other Miscellaneous Nonmetallic Mineral Product Manufacturing (51.1 percent); NAICS 327991: Cut Stone and Stone Product Manufacturing (30.8 percent); NAICS 213112: Support Activities for Oil and Gas Operations (29.5 percent); NAICS 327390: Other Concrete Product Manufacturing (29.2 percent); NAICS 327212: Other Pressed and Blown Glass and Glassware Manufacturing (22.7 percent); NAICS 327332: Concrete Pipe Manufacturing (22.1 percent); NAICS 327211: Flat Glass Manufacturing (20.4 percent); NAICS 327331: Concrete Block and Brick Manufacturing (19.5 percent); NAICS 327993: Mineral Wool Manufacturing (17.4 percent); NAICS 327992: Ground or Treated Mineral and Earth Manufacturing (16.3 percent); NAICS 327320: Ready-mix Concrete Manufacturing (15.9 percent); NAICS 331513: Steel Foundries (except investment) (12.3 percent); NAICS 331524: Aluminum Foundries (except die-casting) (11.3 percent); and NAICS 331511: Iron Foundries (10.0 percent).
In general, cost impacts for affected small entities or very small entities will tend to be somewhat higher, on average, than the cost impacts for the average business in those affected industries. That is to be expected. After all, smaller businesses typically suffer from diseconomies of scale in many aspects of their business, leading to lower revenue per dollar of cost and higher unit costs. Small businesses are able to overcome these obstacles by providing specialized products and services, offering local service and better service, or otherwise creating a market niche for themselves. The higher cost impacts for smaller businesses estimated for this rule generally fall within the range observed in other OSHA regulations for which there is no record of major industry failures.
In allocating the share of costs to very small entities, OSHA did not have direct information about how many very small entities were engaged in silica-related activities. Instead, OSHA assumed that the affected employees would be distributed among entities of different size according to each entity size class's share of total employment. In other words, if 15 percent of employees in an industry worked in very small entities (those with fewer than 20 employees), then OSHA assumed that 15 percent of affected employees in the industry
In this section, OSHA reviews comments addressing economic impacts in general industry and maritime that were submitted during the SBREFA process prior to the PEA. OSHA addressed these comments in the PEA that was made available for public comment, but OSHA did not receive comments specifically addressing its responses to the SBREFA recommendations. OSHA is reprinting its responses here for the convenience of the reader.
SERs from foundries stated that there had been a long-run decline in the number of foundries in the United States, with the industry under continued pressure from foreign competitors and the need to meet new domestic regulations. The total expense of the draft standard and inability to meet lower PELs would pressure more U.S. foundries out of business, continuing an historical trend in this industry, SERs said. The variability in the foundry products and small open-area production plants would make meeting lower PELs difficult and costly. Many smaller foundries would be put out of business, the SERs said, and many jobs lost in the industry. “Twenty percent of profits is a great deal to spend on engineering controls with questionable results . . . . [t]he economics of the foundry industry today are not pretty,” one SER said. And another: “The cost of meeting the standard will be very difficult . . . . A PEL of 50 would put us out of business.” OSHA found in this FEA that costs as percentage of profits for even very small foundries would not rise to a level of 20 percent.
SERs from the brick industry stated that meeting the provisions of the draft proposed standard, particularly with a lower PEL, would be very tough for their competitive, low margin industry. Similarly, a SER from the pre-cast concrete industry said, “The problem is not putting the company out of business, but that the price of products will increase.” OSHA found that because bricks face limited foreign competition, a very small change in the price of bricks would not affect the viability of the industry.
Other SERs (industrial sand, molding powders, refractory concrete) noted that the impact of the standard on them, particularly if the PEL is lowered, would entail substantial costs, but indirect effects could be significant as well since their major customers (foundries) could be negatively impacted, too. “Refractory companies are going out of business with the foundries,” one SER said. OSHA has concluded that foundries will not, in general go out of business.
To determine if the Assistant Secretary of Labor for OSHA can certify that the final silica standard for general industry and maritime will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the final standard on small entities. The minimum threshold effects for this purpose are annualized costs equal to one percent of annual revenues and annualized costs equal to five percent of annual profits applied to each affected industry. (OSHA uses five percent as a threshold for significant impacts on small entities rather than the ten percent used for potentially serious impacts on industries in order to assure that small entity impacts will always receive special attention.) OSHA has applied these screening tests both to small entities and to very small entities. For purposes of certification, the threshold level cannot be exceeded for affected small entities or very small entities in any affected industry. Table VII-19 and Table VII-20 show that, in general industry and maritime, the annualized costs of the final rule exceed one percent of annual revenues for small entities and very small entities in one industry. These tables also show that the annualized costs of the final rule exceed five percent of annual profits for small entities in 15 industries and for very small entities in 25 industries. OSHA is therefore unable to certify that the final rule will not have a significant economic impact on a substantial number of small entities in general industry and maritime and must prepare a Final Regulatory Flexibility Analysis (FRFA). The FRFA is presented in Section VII.I of this preamble.
To determine whether the final rule's estimated costs of compliance would threaten the economic viability of affected construction industries, OSHA used the same data sources and methodological approach that were used earlier in this section for general industry and maritime. OSHA first compared, for each affected construction industry, annualized compliance costs to annual revenues and profits per (average) affected establishment. The results for all affected establishments in all affected construction industries are presented in Table VII-21, using annualized costs per establishment for the final PEL of 50 μg/m
The annualized cost of the rule for the average establishment in construction, encompassing all construction industries, is estimated at $1,097 in 2012 dollars. The estimates of the annualized costs per affected establishment range from $4,811 for NAICS 237300 (Highway, Street, and Bridge Construction) and $4,463 for NAICS 237100 (Utility System Construction) to $364 for NAICS 236100 (Residential Building Construction) and $360 for NAICS 221100 (Electric Utilities).
Table VII-21 shows that the annualized costs of the rule do not exceed one percent of annual revenues or 10 percent of annual profits for any affected construction industry. NAICS 238100 (Foundation, Structure, and Building Exterior Contractors) has both the highest cost impact as a percentage of revenues, of 0.12 percent, and the highest cost impact as a percentage of profits, of 3.66 percent. For all affected establishments in construction, the estimated annualized cost of the final rule is, on average, equal to 0.05 percent of annual revenue and 1.52 percent of annual profit. These are well below the minimum threshold levels of 1 percent and 10 percent, respectively.
Therefore, even though the annualized costs of the final rule incurred by the construction industry as a whole are roughly twice the combined annualized costs incurred by general industry and maritime, OSHA concludes, based on its screening analysis, that the annualized costs as a percentage of annual revenues and as a percentage of annual profits are below the threshold level that could threaten the economic viability of any of the construction industries. OSHA therefore finds that the final rule is economically feasible for each of the industries engaged in construction activities. OSHA further notes that while there would be additional costs (not attributable to the final rule) for some employers in construction industries to come into compliance with the preceding silica standard, these costs would not affect the Agency's
Below, OSHA provides additional information to further support the Agency's conclusion that the final rule would not threaten the economic viability of any construction industry.
As previously noted, the United States has a dynamic and constantly changing economy in which large year-to-year changes in industry profit rates are commonplace. A recession, a downturn in a particular industry, foreign competition, or the increased competitiveness of producers of close domestic substitutes are all easily capable of causing a decline in profit rates in an industry of well in excess of 10 percent in one year or for several years in succession.
To demonstrate the normal year-to-year variation in profit rates for all the establishments in construction affected by the final rule, OSHA presented data in the FEA on year-to-year profit rates and year-to-year percentage changes in profit rates, by industry, for the years 2000-2012. For the combined affected industries in construction over the 13-year period, the average change in profit rates was 63.09 percent a year. If the three worst years are excluded, there is still substantial variation in profits, far larger than the change in profits that would be necessary if the costs of this rule cannot be passed on.
These data indicate that even if the annualized costs of the final rule for the most significantly affected construction industries were completely absorbed in reduced annual profits, the magnitude of reduced annual profit rates is well within normal year-to-year variations in profit rates in those industries and does not threaten their economic viability. Of course, a permanent loss of profits would present a greater problem than a temporary loss, but it is unlikely that all costs of the final rule would be absorbed in lost profits. Given that, as discussed in Chapter VI of the FEA, the overall price elasticity of demand for the outputs of the construction industry is fairly low and that almost all of the costs estimated in Chapter V of the FEA are variable costs, the data and economic theory suggest that most firms will see small declines in output rather than that any but the most extremely marginal firms would face any real risk of closure. Many parts of the construction industry have already absorbed much more drastic changes in profit without evidence of industry collapse or major change.
At a conceptual level, the market-determined output of the construction industry depends on the intersection of demand and supply curves. Incremental compliance costs of the rule (which are almost entirely variable costs) shift the construction supply curve upward. The net effect is an increase in the price for construction activities and a reduction in the level of activity (with the magnitude of this effect depending on the price elasticity of demand). Lower levels of activity mean less construction work, a reduction in the number of construction establishments, and a concomitant reduction in construction employment. The greater the price elasticity of demand and the greater the increase in marginal costs, the larger will be the reduction in equilibrium output. In terms of prices, the greater the price elasticity of demand, the smaller the increase in prices will be for a given increment to marginal costs, and the larger the reduction in output.
Increasing the cost of construction project activities that generate silica exposures has two effects on the demand for these activities. First, increasing the cost of silica-related jobs relative to the costs of other construction inputs might result in substitution away from this type of work. Architects, building designers, and contractors might be more likely to choose building methods and materials that eliminate or reduce the need to perform silica-related jobs. For example, pre-cast concrete structures that require a relatively high level of concrete finishing work would become more expensive relative to other building technologies. Contractors and others could reduce the cost impact of the standard by switching to other building methods unaffected by the silica rule when the alternative would result in lower cost than would compliance with the rule. The magnitude of these impacts will depend on the feasibility, characteristics, and relative expense of alternative technologies.
Second, some of the increase in the cost of silica-generating activities will increase the marginal cost of construction output and cause the construction supply curve to shift upward, resulting in a higher price for each quantity produced. The magnitude of the impact of the cost increases due to the silica rule on the supply relationship will depend on the size of the cost increases and the importance of silica-generating activities in the overall cost of construction projects. If the silica-generating activities are a small portion of the overall cost of construction then the supply curve shift will be smaller when compared to a shift in the supply curve from silica-generating activity that is a large portion of the overall cost of construction. If, for example, there is a one percent increase in the costs of a silica generating activity and the silica generating activity constitutes only one percent of the costs of a building, then the total increase in the cost of the building will be an almost unobservable 0.01 percent. Magnitude of shifts in derived demand for a service used in making another product are determined by the price change for the final product, not the price change for the service itself.
In practice, if one considers the costs of the final rule relative to the size of construction activity in the United States, it is clear that the price and profit impacts of the final rule on construction industries must be quite limited. The annualized cost of the final rule would be equal to approximately 0.1 percent of the value of annual construction activity in the U.S. Moreover, construction activity in the U.S. is not subject to any disadvantage from foreign competition—any foreign firms performing construction activities in the United States would be subject to OSHA regulations.
The demand for construction services originates in three independent sub-sectors: residential building construction, nonresidential building construction, and nonbuilding construction.
Many of the silica-generating construction activities affected by the rule are not widely used in single-family construction or renovation. This assessment is consistent with the cost estimates that show relatively low impacts for residential building contractors. (
While a number of studies have examined the factors that determine the demand for publicly financed construction projects, these studies have focused on the ability to finance such projects (
Public utility construction comprises the remainder of nonbuilding construction. This type of construction is subject to the same derived-demand considerations discussed for nonresidential building construction, and for the same reasons, OSHA expects the price and profit impacts to be quite small.
In this section OSHA reviews comments addressing economic impacts in construction that were submitted during the SBREFA process prior to the PEA. OSHA addressed these comments in the PEA that was made available for public comment, but did not receive comments specifically addressing its responses to the SBREFA recommendations. OSHA is reprinting its responses here for the convenience of the reader.
One commenter believed that OSHA had ignored the range of profitability among businesses, and thus did not adequately recognize that the average percentage reduction in profits could mean bankruptcy for those firms struggling to stay afloat. The Agency's approach to economic feasibility is designed to address the overall health of industries in compliance with legal precedent, which permits OSHA to find a regulation economically feasible even though it may close some marginal firm. In most years, ten percent or more of construction firms exit the industry (See U.S. Census Bureau Business Dynamics Statistics, available at
The commenter also asserted that OSHA ignored the cost of credit and that this also varies across businesses. OSHA believes that the cost of credit is not an important issue in this case because OSHA's analysis demonstrates that, in most cases, upfront costs can usually be met from cash flow. Earlier in this chapter, OSHA noted that its choice of a threshold level of ten percent of annual profits for economic feasibility determinations is low enough that even if, in a hypothetical worst case, all compliance costs were upfront costs, then upfront costs would still equal 88.5 percent of profits and thus would be affordable from profits alone without needing to resort to credit markets. As shown in Table VI-12 of the FEA, all industries' costs are a very small percentage of profits, assuring that even upfront costs can be met from profits without resorting to credit markets. Further, a firm that is having trouble meeting upfront costs can rent the appropriate tools without incurring any upfront capital investment costs.
A SER asserted that the impact of the rule would be “catastrophic” for the concrete cutting industry. One SER maintained that the rule would be both economically and technologically infeasible for the specialty trade concrete cutting industry (Document ID 0937, p. 69). The Small Business Advocacy Review (SBAR) Panel recommended that OSHA thoroughly review the economic impacts, and develop a more detailed economic feasibility analysis for certain industries (Document ID 0937, p. 69). OSHA believes that the analyses in this chapter and in Chapter IX of the FEA address the SER's comments and the SBAR Panel recommendations.
Concrete cutting is undertaken for such purposes as grooving for projects such as highways, bridges, and sidewalks along with repairing these structures when they become operationally unsound. These contracts are bid on by firms who will all fall under the final silica rule, so there is no economic disadvantage between firms caused by the silica rule. Because the silica rule only applies in areas subject to OSHA jurisdiction, there is no foreign competition that would not also be subject to the silica standard. The cutting industry also works on runways and parking lots along with homebuilders for smaller projects. The demand for these products are relatively inelastic and not subject to foreign competition, enabling these companies to pass most of the costs of this final rule onto their consumers. Based on these analyses, OSHA disagrees that the rule would be “catastrophic” or economically infeasible for the concrete cutting industry.
The preceding discussion focused on the economic viability of the affected construction industries in their entirety. However, even though OSHA found that the silica standard did not threaten the
To address this possibility, OSHA examined the annualized costs per affected small and very small entity for each affected construction industry. Table VII-22 and Table VII-23 show that in no construction industries do the annualized costs of the final rule exceed one percent of annual revenues or 10 percent of annual profits either for small entities or for very small entities. Therefore, OSHA concludes, based on its screening analysis, that the annualized costs as a percentage of annual revenues and as a percentage of annual profits are below the threshold level that could threaten the competitive structure of any of the construction industries.
Below, OSHA provides some additional information about differential compliance costs for small and very small entities that might influence the magnitude of differential impacts for these smaller businesses.
The distribution of impacts by size of business is affected by the characteristics of the compliance measures. For silica controls in construction, the dust control measures consist primarily of equipment modifications and additions made to individual tools, rather than large, discrete investments, such as might be applied in a manufacturing setting. As a result, compliance advantages for large firms through economies of scale are limited. It is possible that some large construction firms might derive purchasing power by buying dust control measures in bulk. However, given the simplicity of many control measures, such as the use of wet methods on machines already manufactured to accommodate controls, such differential purchasing power appears to be of limited consequence.
The greater capital resources of large firms will give them some advantage in making the relatively large investments needed for some control measures. For example, cab enclosures on heavy construction equipment or foam-based dust control systems on rock crushers might be particularly expensive for some small entities with an unusual number of heavy equipment pieces. Nevertheless, where differential investment capabilities exist, small construction firms may also have the capability to achieve compliance with lower-cost measures, such as by modifying work practices. In the case of rock crushing, for example, simple water spray systems can be arranged without large-scale investments in the best commercially available systems.
In the program area, large firms might have a slight advantage in the delivery of training or in arranging for health screenings. This phenomenon has been accounted for in the analysis that OSHA provides.
To determine if the Assistant Secretary of Labor for OSHA can certify that the final silica standard for construction will not have a significant economic impact on a substantial number of small entities, OSHA applies the same screening analysis to construction as it does for general industry, as discussed earlier in that section for the same reasons: annualized costs equal to one percent of annual revenues and annualized costs equal to five percent of annual profits applied to each affected industry. OSHA has applied these screening tests both to small entities and to very small entities. For purposes of certification, the threshold levels cannot be exceeded for affected small or very small entities in any affected industry.
Table VII-22 and Table VII-23 show that in no construction industries do the annualized costs of the final rule exceed one percent of annual revenues or five percent of annual profits either for small entities or for very small entities. However, as previously noted in this section, OSHA is unable to certify that the final rule will not have a significant economic impact on a substantial number of small entities in general industry and maritime and must prepare a Final Regulatory Flexibility Analysis (FRFA). The FRFA is presented in Section VII.I of this preamble.
The discussion below on employment impacts of the silica rule on the U.S. economy is divided into three parts: (1) a brief summary of the employment impacts of the proposed silica rule (based on an analysis performed for OSHA by its subcontractor, Inforum, in 2011, Document ID 1701) that the Agency included in the PEA in support of the silica proposal; (2) a review of estimates provided by commenters on the employment effects of the silica proposal; and (3) a summary of a recent analysis of the employment effects of the final silica rule that Inforum performed for OSHA, followed by a critique of the commenters' analysis of employment effects relative to Inforum's analysis.
In October 2011, OSHA directed Inforum
Three commenters on the silica proposal—the National Federation of Independent Business (NFIB) with the NFIB Research Foundation; the American Chemistry Council (ACC) with Stuart Sessions of Environomics, Inc.; and the Construction Industry Safety Coalition (CISC) with Environomics, Inc.—provided or reported estimates of the employment effects of the proposed silica rule. These commenter estimates are summarized below.
. . . also represent new demand for private sector goods and services for firms who assist businesses affected by the new PEL in
The summary findings of the NFIB Research Foundation study included an overall loss of 27,000 jobs and lost output of over $72 billion in the long run, with at least half the loss expected to occur in the small business sector.
Mr. Sessions estimated economic impacts based on the URS Corporation estimates of $6.131 billion as the cost of the proposed silica rule on 19 general industry sectors (Document ID 4209-1, pp. 102-103). (Note that the analysis does not include the construction sector and is more than 50 times higher than OSHA's general industry cost estimate in the proposal). The economic impacts were estimated in two analytical steps: (1) estimate the impact of the proposed regulation's compliance costs on the value of output of the affected industries; and (2) estimate how the expected changes in output will reverberate throughout the economy, using IMPLAN—a well-known input-output model of the U.S. economy.
The first step was achieved by estimating the amount of cost pass-through of the compliance costs, using a supply elasticity of 1.0, and then estimating the demand response to this price increase assuming a demand elasticity of -1.5. This results in a decline in industry revenue equal to about 20 percent of annualized compliance costs, which—given URS's estimates of compliance costs—is equal to $1.23 billion per year. Again using the IMPLAN model, the corresponding estimated employment effect is 18,000 lost jobs annually (5,400 direct effect; 5,000 indirect effect; and 7,500 induced effect) and a loss in economic output/GDP of more than $1.6 billion per year.
Additionally, Mr. Sessions reviewed Inforum's analysis of the employment impacts of the proposed rule. He asserted that OSHA had supplied Inforum with year-by-year compliance costs that were only 53 percent of the annualized costs that OSHA had estimated in the PEA so that Inforum's projections of employment effects would be seriously underestimated:
OSHA estimates the cost of the Proposed Standard to be $658 million per year in 2009 dollars on an annualized basis, excluding the hydraulic fracturing industry. Assuming a 7%/year discount rate, this annual cost,
In reviewing the above procedures, OSHA concludes that Mr. Sessions has misinterpreted his own calculations. The annualized value of an infinite series of costs (
The employment effects estimated by Environomics (2015) reflect annual costs to construction industries of $4.9 billion, which includes almost $3.9 billion of direct compliance costs to construction employers and another $1.05 billion of costs passed through from general industry (as a result of the silica rule for general industry) to the construction industry (Document ID 4242). Environomics used the IMPLAN model to translate the estimated $4.9 billion annual cost of the silica rule into more than 52,700 lost jobs related to the construction industry. These job losses would consist of about 20,800 in construction; 12,180 additional jobs lost in industries that supply materials, products, and services to the construction industry; and nearly 20,000 further jobs lost when those who lose their jobs in construction and supplier industries no longer have earnings to spend (
In December 2015, OSHA directed Inforum to run its macroeconomic model to estimate the industry and aggregate employment impacts on the U.S. economy of the cost of OSHA's final silica rule.
Using industry-by-industry compliance cost estimates provided by OSHA,
The most significant Inforum result is that the final silica rule cumulatively generates an additional 9,500 job-years over the period 2017-2026, or an additional 950 job-years annually, on average, over the period (Inforum, 2016). It should be noted, however, that these results vary significantly from year to year. For example, in 2017, the first year in which the silica final rule would be in effect and when most capital costs for control equipment would be incurred, an additional 21,100 job-years would be generated as a result of the silica rule. Then, through 2026, the change in job-years relative to the baseline ranges from a high of 19,600 (in 2019) to a low of −17,300 (in 2020).
The employment impacts of the silica rule would also vary significantly from industry to industry and from sector to sector. For example, for the period 2017-2026, the construction industry would, on average, gain 4,260 job-years annually while the rest of the U.S. economy would, on average, lose 3,310 job-years annually. Again, relative to total employment in the construction sector of about 10 million workers and employment in the rest of the U.S. economy of about 150 million workers over the 10-year period, these employment impacts should be considered negligible. For a fuller discussion of OSHA's estimate of the employment and other macroeconomic impacts of the silica rule, see Inforum (2016).
One obvious question is why the employment impacts of the silica rule would be positive in construction and negative elsewhere. There seem to be two major reasons. One is that, as reflected in the Inforum model, there is little foreign competition in U.S. construction and the price elasticity of demand in construction is extremely low relative to demand for products in most other industries. Hence, output and employment would be expected to decline minimally in response to any price increase if employers in construction pass on the costs of the silica rule. Second, and probably more important, in OSHA's view, compliance with many of the provisions in the silica rule is relatively labor-intensive, often requiring the application of additional labor in the regulated firms themselves. Examples would include time spent for training, medical surveillance, and activities to meet the PEL (such as setting up and using control equipment and performing housekeeping tasks). The increased labor required to produce a unit of output in regulated firms would tend to increase employment in those industries (holding output constant). This is particularly true in construction, where compliance with the PEL would be much more labor-intensive—both because engineering controls in construction are typically mobile and require more worker activity and because housekeeping and other worker actions are expected to play a larger role in achieving compliance with the PEL. By comparison, engineering control equipment in general industry/maritime is usually in a fixed location (eliminating the need for workers to move the equipment) and worker actions would play a smaller role in achieving compliance with the PEL.
Finally, OSHA turns to a critique of the commenters' analysis of employment effects of the proposed silica rule relative to Inforum's analysis of employment effects of the final silica rule. This critique reflects comments provided in the Inforum report (Inforum, 2016).
Another important difference from Inforum's analysis is that the NFIB study did not attempt to quantify the additional jobs created in the affected industries. In Inforum's LIFT model, these were captured as changes in labor productivity. For several industries, especially construction, although the industry does experience increased costs, it must also hire more workers to comply with the silica rule. The additional jobs required in the affected industries are not discussed or apparently modeled in the NFIB study. In summary, it seems that the
What accounts for the difference between LIFT simulations and the CISC and ACC estimates? There are several factors at play:
Probably most importantly, CISC's estimate starts with annual compliance costs for the construction industry that are nearly 7 times larger than OSHA's estimates for the construction industry (only) ($4.1 billion vs. an average of over $600 million, both in 2012 dollars). Meanwhile, the ACC study estimates costs for general industry that are more than 16 times larger than OSHA's estimates for the final rule ($6.1 billion in 2009 dollars versus $359 million in 2012 dollars. Moreover, the CISC and ACC studies assumes that the same annualized cost estimates are imposed each year, whereas the OSHA cost estimates vary over the 10 year time period, with peak costs occurring in the first year.
Neither the CISC nor the ACC application of the IMPLAN model accounted for the increase in demand for capital equipment and intermediate goods and services needed to comply with the proposed silica rule. Thus, the employment and income boosting impacts of these expenditures are not captured in their analysis. In contrast, Inforum's methodology uses an explicit price function where annual compliance costs by industry change commodity prices in proportion to their share of total annual gross costs. In turn, price changes affect production and employment through a dynamic general equilibrium framework. Demand and supply price elasticities in the LIFT model are composites of several sets of empirically estimated functions for final demand, exports, imports, and price mark-ups. Furthermore, the parameters of these functions vary by type of product according to the econometric estimation.
At OSHA's request, Inforum made a separate run using the LIFT model in the absence of the final silica rule for the construction industry but with the final silica rule for general industry and maritime. The purpose of this run was to calculate the indirect effects (only) of the final silica rule for general industry and maritime on prices and employment in the construction industry (Inforum, 2016). This LIFT simulation estimated that the final silica rule for general industry and maritime indirectly increased prices in the construction industry by an average of .005 percent. The direction, if not the magnitude of this effect, is consistent with the CISC/Environomics results (Environomics, 2015, Document ID 4242). This led to a modest decline in construction output and construction jobs. As shown in Table 9 of the Inforum report (Inforum, 2016), the decline in jobs varied from +290 to −940 a year over the period 2017 to 2026, with a cumulative job impact of −4.8 thousand jobs over the 10-year period. Again, it should be emphasized that this separate run was made in the absence of the final silica rule for the construction industry.
The IMPLAN model is static and cannot compute employment and output impacts over time, and it cannot show how the economy evolves to cope with changes in costs. In order to extrapolate over ten years, the authors simply multiply the first year effects by 10. The results are implausible for a dynamic economy as the full static one-year impact is unlikely to be the average impact over the course of several years. At least theoretically, the economy contains powerful forces pushing it towards full employment equilibrium. Therefore, most changes to output and employment due to cost or demand shocks tend to be neutralized through time. That is, most impacts, negative or positive, will approach zero over the long term. Indeed, Inforum's LIFT model produces dynamic results that vary from year to year, which is consistent with fluctuations in the state of the economy and with short and long term expenditure effects. It shows how the employment is reallocated among industries and how the economy eventually will return to the baseline, or potential, level of employment.
While the IMPLAN study places the regulatory analysis within the context of the overall economy, it does not take full advantage of the framework. For instance, given data for gross output in the base year it is possible to compute the industry price effect so that the revenue shocks can be judged relative to a price elasticity of demand. Instead, the study employs an unrealistically large construct of a 5 to 1 compliance cost to revenue loss. Finally, the IMPLAN model's inability to model the long-term properties of the economy severely undermines the study's conclusion of long term cost to the economy.
In this section, OSHA discusses the benefits and net benefits of the final silica rule. To set out an approach to estimate the benefits, the Agency will, in the following sections, estimate the number of silica-related diseases prevented as a result of the rule, estimate the timing of the potentially avoided diseases, monetize their economic value, and discount them. Taking into account the estimated costs of the final rule, presented in Chapter V of the FEA, OSHA will then estimate the net benefits and incremental benefits of the rule. Finally, the Agency will assess the sensitivity of the estimates to changes in various cost and benefit parameters.
This section presents OSHA's quantitative estimates of what rule-induced benefits would be under certain assumptions. OSHA acknowledges that these estimates are heavily influenced by the underlying assumptions, and also that the long time frame of this analysis (60 years) is a source of uncertainty. The assumptions underlying these estimates of deaths and morbidity avoided will be discussed in detail as they appear in the remainder of this chapter, but the major ones are as follows:
• The exposure profile and other industrial profile data presented in Chapter III of the FEA reflect both current conditions and future conditions (extending over the next sixty years);
• To separate the effects of this new rule from the effects of compliance with existing standards, it is assumed that any workers currently exposed above the preceding PEL are exposed to levels of silica that exactly meet the preceding PEL;
• The rule will result in workers being exposed at the new PEL but will never reduce exposures below the new PEL;
• Workers have identical exposure tenures (45 years, except where otherwise noted);
• The effects of baseline respirator use on risk are ignored; and
• The assumptions inherent in developing the exposure-response functions discussed in Section VI, presented in Table VI-1 of this preamble, are reasonable throughout the exposure ranges relevant to this benefits
The first two assumptions are also the basis for the cost analysis in Chapter V of the FEA. The basis for the last assumption is discussed in greater detail in Section VI of this preamble and will be briefly reviewed in this section. It bears emphasis, however, that the sources of data for OSHA's benefits analysis are the same as those used in the Quantitative Risk Assessment (Section VI of this preamble) and the technological feasibility analysis in Chapter IV of the FEA.
While OSHA did not quantify the benefits of the ancillary provisions, consistent with the statute (29 U.S.C. 655(b)(7), section 6(b)(7)), the Agency finds that these provisions are beneficial and necessary in order for the standard to be fully and correctly implemented and for the full benefits of the rule to be realized. On the whole, OSHA intends the requirements for training on control measures, housekeeping, and other ancillary provisions of the rule to apply where those measures are used to limit exposures. Without effective training on use of engineering controls, for example, it is unreasonable to expect that such controls will be used properly and consistently. The ancillary provisions found in the rule are generally standard and common throughout OSHA regulations.
The provision requiring exposure assessment in general industry is integral to determining the engineering controls and work practices needed to control employee exposure to the new PEL, to evaluate the effectiveness of the required engineering and work practice controls, and to determine whether additional controls must be instituted. In addition, monitoring is necessary to determine which respirator, if any, must be used by the employee, and it is also necessary for compliance purposes.
The requirement for regulated areas in general industry and maritime serves several important purposes including alerting employees to the presence of respirable crystalline silica at levels above the PEL, restricting the number of people potentially exposed to respirable crystalline silica at levels above the PEL, and ensuring that those who must be exposed are properly protected. Similarly, the competent person requirement in the construction standard will protect bystanders by restricting access to work areas only when necessary, benefiting those bystanders through reduced exposures.
Written exposure control plans provide a systematic approach for ensuring proper function of engineering controls and effective work practices that can prevent overexposures from occurring. OSHA expects a written exposure control plan will be instrumental in ensuring that employers comprehensively and consistently protect their employees.
The medical surveillance provisions have the potential to protect workers through the early detection of silica-related illnesses and will enable employees to take actions in response to information about their health status gleaned from medical surveillance. Additionally, by requiring medical surveillance to general industry and maritime workers exposed at or above the action level, OSHA provides an incentive for employers to further reduce exposures, where possible, to avoid incurring the costs of medical surveillance.
For reasons described in detail in this preamble, OSHA has adopted a PEL of 50 μg/m
OSHA determined exposure levels at or below the preceding PELs by first developing an exposure profile of current exposures for industries with workers exposed to respirable crystalline silica, using OSHA inspection and site-visit data, and then applying this exposure profile to the total current worker population. The industry-by-industry exposure profile is presented in Chapter III of the FEA.
Because OSHA relied solely on measurement of airborne exposures, respirator use may result in lower baseline exposures inside the respirator than would be indicated by the airborne exposures measurements. The extent to which this affects OSHA's benefits calculations depends on the extent to which there was baseline respirator use in the risk assessment studies OSHA relied on and how these studies accounted for respirator use, if they did so at all. OSHA reviewed the risk assessment studies it is relying on as well as earlier studies that described the source of exposure data for each cohort and how exposures were estimated for cohort members to determine whether respirator use was accounted for. OSHA found that the overwhelming majority of studies did not mention either respirator use or how they accounted for respirator use, even though many took place in time periods and at exposures levels where some respirator use could have been expected. Some studies accounted for use of “dust controls” but did not state whether these “dust controls” included respirator use. Two studies (Rando
OSHA also is not able to quantify the effectiveness of respirator use. (OSHA regulations provide for assigned protection factors, but these are based on ideal conditions rather than real world conditions.) It is thus difficult to know how to correct for possible respirator use. As will be discussed below, OSHA estimates benefits relative to a baseline characterized by compliance with the preceding PEL. The preceding PEL in construction and maritime is approximately 250 μg/m
By applying the dose-response relationships from the literature to estimates of exposures at or below the preceding PELs across industries, it is possible to estimate the number of cases of the following diseases expected to occur in the worker population given exposures at or below the preceding PELs (the “baseline”):
• fatal cases of lung cancer,
• fatal cases of non-malignant respiratory disease (NMRD) (including silicosis),
• fatal cases of end-stage renal disease, and
• cases of silicosis morbidity.
Non-fatal cases of lung cancer, NMRD and end-stage renal disease were not estimated. In that respect, the estimates of the benefits are understated. However, OSHA's benefits calculations do not, for example, factor in any impact on the rule's implementation of the following aspect of the Agency's enforcement approach: As a general matter, where compliance with a standard's requirement clearly creates a new hazard, employers can raise a defense that compliance with the requirement is not feasible, and OSHA would work with the employer to implement an alternative means of protection that does not create a serious hazard.
In a comment suggesting that some reductions in exposures (and thus some benefits) were not included in OSHA's analysis, Dr. Ruth Ruttenberg noted that “OSHA/ERG did not consider stomach cancer, autoimmune disease, and other cancer and non-cancer health effects of silica exposure” (Document ID 2256, Attachment 4, p. 11). These potential benefits were not quantified, for the PEA or FEA, because the Agency does not, at this time, have sufficient exposure-response data to perform a quantitative risk assessment for these illnesses. The Health Effects and Significance of Risk section of this preamble contain a more detailed discussion of these potential silica-related health effects that were not quantified.
The core of OSHA's methodology for benefits analysis is to calculate the number of estimated premature deaths and illness cases avoided as a result of the new rule. To do this, OSHA estimates the expected number of mortality and morbidity cases expected to occur under the assumption that the preceding PEL is being met (
By focusing on exposures between the preceding PEL (even for workers exposed above the preceding PEL) and the new PEL exclusively, and ignoring the possibility that workers' exposures are reduced below the new PEL, OSHA's calculations will have a tendency toward underestimation. Some exposures may be reduced to below the new PEL of 50 μg/m
In order to estimate the number of deaths prevented, OSHA uses a lifetime risk model, which is a mathematical framework that explicitly follows workers from the beginning of their work lives until retirement. Workers are assumed to start work at age 20 and work continuously until age 65, resulting in a 45-year work life, and then assumed to live another 15 years post-retirement, or until age 80. This estimate is useful because the OSH Act requires OSHA to examine exposures for an entire working life. Shorter job tenures will be discussed further below.
Using this model, OSHA calculates the workers' cumulative workplace exposures to silica, and estimates the probability of their dying each year from silica-related diseases. The model also establishes the background probability of the workers' dying from non-silica-related causes. The increase in the workers' probability of dying due to cumulative silica exposure in the workplace is added to this background probability. As will be explained in more detail later, the difference in these probabilities is used to form the basis for estimating the number of illnesses and deaths due to silica exposures as they currently exist and the estimated number of illnesses and deaths that would be avoided when the standard is fully in effect, assuming full compliance.
The background, age-specific survival probabilities are based on the current (2011) U.S. (male) population, the latest year for which age-specific all-cause mortality statistics are available.
The results in Table III-9 in the FEA represent average daily exposures in the risk model for general industry and maritime. In construction, occupational exposure is commonly intermittent (
In order to calculate the number of expected and avoided cases for each health outcome, OSHA assumes that all workers whose exposures fall within a band are exposed the same and assigns the average of all individual exposure observations within the relevant band (
As an example, Table VII-23-1 presents the summary calculations for a risk model that produces one estimate of the number of lung cancer deaths avoided by the revised standard for workers in general industry if they were all exposed to silica for 45 years (this uses the ToxaChemica 2004 risk model of lung cancer deaths avoided).
In Table VII-23-1, the total General Industry population at risk for excess lung cancer is 291,019. There are 142,071 workers in the range of silica exposure of below 25 µg/m
Table VII-23-1 also presents the estimated excess risk of lung cancer per 1,000 workers for each exposure band and the number of lung cancer deaths that would occur among workers exposed within each exposure band for 45 years. For example, among workers exposed within the lowest exposure band, the lifetime risk model estimates an increased risk of lung cancer above the background mortality risk of 14.7 deaths per 1,000 workers at a constant exposure to 14 µg/m
The preceding example assumes a constant exposure level each year for 45 years. Elsewhere in this chapter, OSHA examines what would happen if the day-to-day exposure remains the same but job tenure is shorter. In order to have a valid comparison, OSHA compares each scenario to what is estimated to happen over 45 years. All job tasks, and hence cumulative exposure, do not change with decreased job tenure; they are just spread over more workers. Thus, if OSHA were to examine a job tenure of 25 years, almost twice as many workers would be exposed for almost half as long as for the 45-year assumption. With a strictly proportional (linear) risk function the benefits of having half the exposure for twice the number of workers would exactly offset each other and final benefits would be the same. Hence the net effect of such changes is directly related to non-linearities in the various lifetime risk models.
OSHA received a number of comments concerning the Agency's preliminary risk assessment and discussion of the health effects of silica in this preamble to the proposed rule. Those comments are discussed in detail in Sections V (Health Effects) and VI (Final Quantitative Risk Assessment and Significance of Risk) of this preamble to the final rule.
OSHA examined the various lung cancer risk models presented in its QRA to estimate the benefits of lowering the PEL. As can be inferred from Table VI-1 of the Final QRA, the ToxaChemica, Inc. (2004, Document ID 0469) log-linear model estimated the lowest estimate of lung cancer cases avoided from lowering the PEL to 50 or 100 μg/m
Table VII-24 shows the range of modeled estimates for the number of avoided fatal lung cancers for PELs of 50 μg/m
Following Park (2002, Document ID 0405), as discussed in the Agency's QRA, OSHA's estimation model suggests that the final PEL of 50 μg/m
Certain commenters argued that the recent CDC count of silicosis mortality from death certificates is evidence that OSHA's benefits were overestimated.
Some commenters, such as the American Chemistry Council and Faten Sabry, Ph.D., representing the Chamber of Commerce, argued—based on the numbers of silicosis-related deaths recorded in recent years reported in mortality surveillance data—that OSHA overestimated the estimated benefits of the standard (Document ID 2263, p. 57; 3729, p. 1; 2288, Appendix 6; 4209, pp. 3-4). Dr. Sabry stated that the 52 deaths reported by the CDC in 2010 where silicosis was identified as an underlying cause of death were considerably fewer than the number of silicosis-related deaths that OSHA claimed would be avoided once the proposed standard becomes fully implemented. Dr. Sabry concluded, “[s]o, by OSHA's calculation, reducing the PEL to 50 µg/m
OSHA disagrees that the silicosis mortality surveillance data alone provides evidence that OSHA has overstated the quantitative benefits of the rule. OSHA derived its benefits estimates from exposure data presented in the Industry Profile chapter of the FEA and from its quantitative risk assessment, which is based on epidemiological data that quantify relationships between exposure and disease risk. OSHA relied on these estimates to estimate the number of silicosis-related deaths and illnesses that would occur absent a revised standard and the number of deaths that would be avoided by promulgation of such a standard. From this analysis, OSHA estimated that 325 deaths from silicosis and other non-malignant lung disease and 918 silicosis morbidity cases are estimated to be avoided annually once the full effects of the standards are realized. The 52 deaths cited by Dr. Sabry appears to refer to only the number of deaths with silicosis coded as the “underlying” cause of death on death certificates, and does not include deaths coded with silicosis as a “contributing” cause. Combined with the deaths where silicosis is coded as a “contributing” cause, in this case 49, CDC/NIOSH reported a total of 101 deaths where silicosis was either an underlying cause of death or a contributing cause of death.
OSHA's model does not only count fatalities related to silicosis. OSHA's estimate of the impact of exposure to respirable crystalline silica includes deaths from other diseases (lung cancer, non-malignant respiratory disease such as chronic bronchitis and emphysema, and end-stage renal disease) that, according to scientific evidence, can be caused by exposure to respirable crystalline silica (Document ID 1711; 2175, p. 2). OSHA also estimated, based on the Park study discussed previously, that 325 cases of fatal non-malignant respiratory diseases associated with exposure to silica, including, but not limited to silicosis, that would be prevented annually due to the final standard. Thus, OSHA's estimates of the numbers of deaths prevented that are due to non-malignant respiratory disease are not comparable to surveillance statistics that only capture silicosis as a cause of death. Furthermore, Dr. Sabry's comments are primarily focused on the hydraulic fracturing industry, which only recently became a major source of silica exposure, where most of the effects of current exposures will likely not be seen for a number of years, underlining why this analysis of past trends is not instructive for epidemiological estimates.
In response to NUCA's comparison of OSHA's estimate of 679 deaths avoided to the estimate of fewer than 100 deaths from the surveillance data, the Agency again points out that the model accounts for causes of death other than those resulting from silicosis and therefore reported to CDC/NIOSH in the surveillance data. Therefore, NUCA's comparison is faulty because focusing exclusively on silicosis mortality fails to capture silicosis morbidity, as well as mortality and morbidity resulting from other diseases related to silica exposure, including lung cancer, other non-malignant respiratory disease such as chronic bronchitis and emphysema, and renal disease (
George Kennedy of the National Utilities Contractor's Association makes a similar “apples and oranges” error in his comment:
OSHA predicts that this rule will prevent approximately 600 silica-related deaths per year. But how is this possible if the CDC is reporting less than 100? (Document ID 3583, p. 2240)
Mr. Kennedy's comment is based on comparing CDC counts of documented silicosis fatality cases, but this count is not a report on
As also discussed in the Agency's QRA, OSHA finds that workers with higher cumulative exposures to silica are at elevated risk of lung cancer, end-stage renal disease, and non-malignant respiratory diseases. Based on the midpoint of the lower high-end estimate (Attfield and Costello, 2004, Document ID 0543) and a higher low-end estimate (ToxaChemica log-linear model, Document ID 0469), OSHA's estimation model estimates that the new PEL of 50 μg/m
Combining the three major fatal health endpoints—lung cancer, non-malignant respiratory diseases, and end-stage renal disease—OSHA's modeling approach yields estimates that the new PEL would prevent between 26,216 and 31,541 premature fatalities over the lifetime of the current worker population, with a midpoint estimate of 28,879 fatalities prevented. This is the equivalent of between 583 and 701 premature fatalities avoided annually, with a midpoint estimate of 642 premature fatalities avoided annually, given a 45-year working life of exposure.
In addition, the final silica rule is estimated to prevent a large number of cases of silicosis morbidity. Table VII-25 is designed to compare available estimates of actual silicosis cases to the estimates generated by OSHA exposure profile and models. The first set of rows compares present estimates of 2/1 and the second set of rows estimates of 1/0 cases of silicosis generated by various risk models using OSHA's exposure profile. Going across, the first columns are for a tenure length of 45 years, the second set for a tenure length of 13 years. Then below in the second panel, the final set of rows is based on Rosenman,
A number of commenters took issue with the general idea that silicosis is an occupational health problem for workers whose exposures to silica did not exceed the preceding PELs. These commenters typically pointed to the significant decline in the number of silicosis deaths reported by the CDC in the last few decades.
OSHA does not find these comments persuasive. As explained in depth in the Health Effects and Risk Assessment sections of this preamble, while the Agency welcomes any apparent decline in silicosis cases, the Agency has substantial evidence that significant risk remains at preceding PELs. The commenters do not account for the undercounting of silicosis deaths from death certificates, as demonstrated by Rosenman (Document ID 1166] and others; nor do they address other health endpoints beyond fatal silicosis. Although the decline in reported cases may indicate the Agency's success up to this point in reducing the incidence of silicosis, it cannot be taken as an absolute measure of how many silica-related disease cases currently exist in the population. Most silicosis cases are not fatal—given that the total cases of silicosis have apparently remained largely constant, fewer silicosis fatalities may mean that more individuals are living with silicosis for longer periods while ultimately dying of other causes.
While OSHA has estimated morbidity from silicosis, it has not attempted to estimate the number of morbidity cases
As summarized in Table VII-25, OSHA expects that, in the scenario in which workers are uniformly exposed to silica for 45 years, the silica rule will eliminate the majority of 1/0, 1/1, and 1/2 silicosis cases. However, the Agency has not included the elimination of these less severe silicosis cases in its estimates of the monetized benefits and net benefits of the final rule. Instead, as shown above in Table VII-24, OSHA focused its morbidity-only benefits and related net benefits analysis exclusively on the number of silicosis cases reaching the more severe levels of 2/1 and above (moderate-to-severe silicosis, using the ILO method for assessing severity). As discussed in the Agency's QRA, OSHA estimates that the new PEL of 50 μg/m
As previously discussed, OSHA based its estimates of reductions in the number of silica-related diseases using estimates that reflect a working life of constant exposure for workers who are employed in a respirable crystalline silica-exposed occupation for their entire working lives, from ages 20 to 65.
Table VII-26a presents cases for a worker exposed for 25 years. While each individual worker is estimated to have less cumulative exposure under the 25-years-of-exposure assumption, in fact 56 percent (25/45) as much, the effective exposed population over time is proportionately increased (due to the turnover of workforce for a constant number of jobs, and hence total exposure), over the same time period. A comparison of Table VII-26a to Table VII-24, reflecting exposures over 25 working years versus 45 working years, shows variations in the number of estimated prevented cases by health outcome. Estimated prevented cases of fatal end-stage renal disease are higher in the 25-year model, whereas cases of fatal non-malignant respiratory disease and silicosis morbidity are lower. In the case of lung cancer, the effect varies by model, with a decrease in the Attfield and Costello, 2004 higher estimate (Document ID 0543) and an increase in the ToxaChemica, 2004 lower estimate (Document ID 0469). Looking at overall totals, the midpoint estimate of the number of avoided fatalities under the new PEL of 50 μg/m
A commenter, Joseph Liss, objected to the Agency's approach of simultaneously increasing the estimated exposed population—not because it was technically incorrect, but because it makes it harder to see the difference in risk to a particular exposed population (Document ID 1950, pp. 16-19).
OSHA reported in the PEA that in the construction industry, which has an unusually high rate of job turnover compared to other industries, BLS data show that the mean job tenure with one's current employer is 6.6 years (BLS, 2010a, Document ID 1620), and the median age of construction workers
Dr. Ronald Bird, submitting a comment on behalf of the U.S. Chamber of Commerce—as well as an unaffiliated commenter, Joseph Liss—suggested that OSHA's estimates of disease cases prevented from 45 years of silica exposure is unrepresentative of the typical tenure of workers affected by the standard, particularly in construction (Document ID 2368, p. 18; Document ID 1950, pp. 15-19). Dr. Bird suggested that workers will routinely change occupations in the course of their lifetime. From a probabilistic standpoint, he calculated that workers would, on average, likely work in an occupation for less than six years. The comments directly from the Chamber of Commerce go further, to say that “[n]o such 45-year career silica exposures exist in today's working world . . .” (Document ID 2288, p. 11).
The article (Rytina, 1983, Document ID 2368) that Dr. Bird cited for his data on occupational turnover provides data that refute the assumptions of Dr. Bird's model. While Dr. Bird assumes that occupational turnover is constant without regard to age or length of occupational experience, the Rytina article states:
Not surprisingly, occupational mobility rates declined sharply with age . . . The rate for workers age 35-44 was less than one fourth as high as that for workers 18 and 19 years of age. * * * [O]ccupational change among older workers occurs less frequently because of attachments to a particular occupation or the risks of losing income, job security, and pension rights, which might accompany an occupational shift (Rytina, 1983, Document ID 2368, p. 5).
Furthermore, the Rytina article shows that among workers 45 to 54 years of age, 16.5 percent of workers have been in the same occupation for 25 years or more, and among workers 55 and older, 32.9 percent have been in the same occupation for 25 years or more. By comparison, Dr. Bird's model suggests that, regardless of age, no more than 13 percent of workers will remain in a given occupation for more than 20 years.
Two commenters also provided evidence of the average tenures of their workers that is contrary to Dr. Bird's estimates. The National Industrial Sand Association (NISA) noted, “many NISA member company employees work at their workplaces for all or much of their worklives. In 2004, a study calculated the mean tenure for NISA member company employees fitting the definition of the study's cohort to be 19.7 years” (Document ID 2195, p. 19). Southern Company, an electric utility, noted that it “has approximately 8000 employees in job titles performing activities with potential exposures to silica-containing materials. The average tenure for these employees is 17 years; 37% of these employees have over 20 years work experience” (Document ID 2185, p. 3).
Other commenters provided evidence to refute the Chamber of Commerce claim that that 45-year career silica exposures no longer exist in today's working world (Document ID 2288, p. 11). During the public hearing, participants on a panel comprised of members of the International Union of Bricklayers and Allied Craftworkers (BAC) were asked if they had colleagues who had worked longer than forty years in their trade. All six of the participants affirmed that they did (Document ID 3585, Tr. 3053). Further, several labor groups submitted evidence of lengthy worker tenure. The BAC noted that:
A review of our International Pension Fund records documented 116 individuals who have worked for 40 years or more. We consider this figure to understate the work lives of Fund participants because many of these individuals had previous work experience in the construction industry before being represented by BAC. In additional, we believe this figure understates the number of participants with work lives of 45 years, because the Fund was established in 1972 and it was not until roughly a decade later that even half of BAC affiliates had commenced participation in the Fund (Document ID 4053, Attachment 1, p. 2).
Similarly, The United Association of Plumbers, Fitters, Welders, and HVAC Service Techs, submitted that “a review of membership records documented 35,649 active members who have worked 45 years or more while they have been a member of the union.” They also concur with the BAC statement that the number may be understated given previous work experience (Document ID 4073, Attachment 3, p. 1). And the International Union of Operating Engineers' Central Pension Fund found the average operating engineer has over 20 years of service in the trade with a range up to 49.93 years (Document ID 4025, Attachment 1, pp. 6-7).
Dr. Bird also objected to OSHA's approach of using a single representative exposure to measure lifetime exposure. He states: “If exposures are variable over the course of a year, the lifetime exposure pattern is contrary to OSHA's assumption and the benefits from the proposed reduction in the PEL would be considerably less” (Document ID 2368, p. 19). Dr. Bird apparently faults the Agency for not considering the possibility that future exposures may be lower than those observed on a given day. However, it is equally plausible that a worker's future exposures may be higher than on the day they were observed by OSHA. The single-day exposure data is the best available data in the record for those workers, and the Agency does not find any persuasive evidence in this record to suggest an obvious bias to characterizing exposure from a single day rather over the course of consecutive days.
Paragraph (i)(2)(v) of the general industry and maritime standard and paragraph (h)(2)(v) of the construction standard also contain specific provisions for diagnosing latent tuberculosis (TB) in the silica-exposed population and thereby reducing the risk of TB being spread to the population at large. OSHA currently lacks good methods for quantifying these benefits. Nor has the Agency attempted to assess benefits directly stemming from enhanced medical surveillance in terms of reducing the severity of symptoms from the illnesses that do result from present or future exposure to silica. Dr. Ruth Ruttenberg, an economist representing the AFL-CIO, noted this as a source of the underestimation of the benefits in her comments (Document ID 2256, Attachment 4, pp. 9-12). However, no commenters suggested how to quantify these effects.
OSHA's risk estimates are based on application of exposure-response models derived from several individual epidemiological studies as well as the pooled cohort studies of Steenland
Section VI of this preamble provides a more complete discussion of the source of uncertainty in the risk assessment functions used in this benefits analysis. The sources of uncertainty include the degree to which OSHA's risk estimates reflect the risk of disease among workers with widely varying exposure patterns. Some workers are exposed to fairly high concentrations of crystalline silica only intermittently, while others experience more regular and constant exposure. Risk models employed in the quantitative assessment are based on a cumulative exposure metric, which is the product of average daily silica concentration and duration of worker exposure for a specific task. Consequently, these models assume the same risk for a given cumulative exposure regardless of the pattern of exposure, reflecting a worker's long-term average exposure without regard to intermittencies or other variances in exposure. That is, the use of the cumulative exposure metric in these models assumes that there are no significant dose-rate effects in the relationship between silica exposure and risk.
Possible dose-rate effects in the silica exposure-response relationships, particularly for silicosis. OSHA's reliance on a cumulative exposure metric to assess the risks of respirable crystalline silica is discussed in Section V of this preamble. Uncertainty with respect to the form of the statistical models used to characterize the relationship between exposure level and risk of adverse health outcomes is discussed in Section VI.
In its quantitative risk assessment, OSHA used the exposure-response models from the best available evidence (
OSHA attributes this apparent difference in the exposure-response relationships for silicosis mortality and morbidity to several factors. First, the silicosis mortality study (ToxaChemica, 2004, Document ID 0469) defined deaths using death certificate data, in which silicosis or unspecified pneumoconiosis was recorded as the underlying cause of death. In contrast, the silicosis morbidity study (Buchanan
In addition, as discussed in Section V.E, Comments and Responses Concerning Surveillance Data on Silicosis Morbidity and Mortality, silicosis is well-known to be underreported on death certificates in that deaths due to silicosis could have been reported as tuberculosis or chronic obstructive pulmonary disease (Document ID 1089, pp. 724-725; 1030; 3425, p. 2; 3577, Tr. 855, 867; 4204, p. 17; 2175, p. 3; 3577, Tr. 772). Also, silica-exposed workers are at risk for other silica-related diseases, including lung cancer and renal disease, as well as other non-exposure-related causes of death such that many workers who contract silicosis will not ultimately die from silicosis. Therefore the reported silicosis deaths at any level are the lowest possible number of such deaths. Workers with higher cumulative exposures are also likely to be older, and therefore may have a higher rate of other conditions that could have been listed on death certificates. Furthermore, as discussed in Section VI, OSHA's risk assessment required some degree of extrapolation at high doses (
Risk assessments in the occupational environment are generally designed to estimate the risk of an occupationally related illness over the course of an individual worker's lifetime. As previously discussed, the current occupational exposure profile for a particular substance for the current cohort of workers can be matched up against the expected profile after the final standard takes effect, creating a “steady state” estimate of benefits. However, in order to annualize the benefits for the period of time after the silica rule takes effect, it is necessary to create a timeline of benefits for an entire active workforce over that period.
There are various approaches for modeling the workforce. As explained below, OSHA uses a model that considers the effect of lowering exposures for the entire working population. At one extreme, however, one could assume that all of the relevant silica exposures will occur after the
The model OSHA uses, therefore, is one that considers the effect of lowering exposures for the entire working population. This population-based approach does not simply follow the pattern of the risk assessments, which are based in part on life tables, and observe that typically the risk of the illness grows gradually over the course of a working life and into retirement. While this would be a good working model for an individual exposed over a working life, it is not very descriptive of the exposed population as a whole. In the latter case, in order to estimate the benefits of the standard over time, OSHA considers that workers currently being exposed to silica are going to vary considerably in age. Since the health risks from crystalline silica exposure depend on a worker's cumulative exposure over a working lifetime, the overall benefits of the final standard will phase in over several decades, as the cumulative exposure gradually falls for all age groups, until those now entering the workforce reach retirement and the annual stream of silica-related illnesses reaches a new, significantly lowered “steady state.” However, the beneficial effects of the rule begin in the near term and increase over time until that “steady state” is reached; and, for a given level of cumulative exposure, the near-term impact of the final rule will be greater for workers who are now middle-aged or older, compared to younger workers with similar current levels of cumulative exposure. This conclusion follows from the structure of the relative risk models used in this analysis and the fact that the background mortality rates for diseases such as lung cancer, chronic obstructive pulmonary disease and renal disease increase with age.
In order to characterize the magnitude of benefits before the steady state is reached, OSHA created a linear phase-in model to reflect the potential timing of benefits. Specifically, OSHA estimated that, for all non-cancer cases, while the number of cases of silica-related disease would gradually decline as a result of the final rule, they would not reach the steady-state level until 45 years had passed. The reduction in cases in any given year in the future was estimated to be equal to the steady-state reduction (the number of cases in the baseline minus the number of cases in the new steady state) times the ratio of the number of years since the standard was implemented and a working life of 45 years; in other words, the number of non-malignant silica-relates cases of disease avoided is assumed to increase in direct proportion to the number of years the standard is in effect until year 45, at which point the numbers hold steady. This formulation also assumes that the number of workers is constant over the entire time frame. Expressed mathematically:
In the case of lung cancer, the function representing the decline in the number of cases as a result of the final rule is similar, but there would be a 15-year lag before any reduction in cancer cases would be achieved. Expressed mathematically, for lung cancer:
This model was extended to 60 years for all the health effects previously discussed in order to incorporate the 15-year lag, in the case of lung cancer, and a 45-year working life. OSHA also has estimated the benefits using other job tenures. For this purpose, OSHA examined scenarios for the same number of years—60 years—but with the work force restarting exposure whenever the first job tenure cycle was complete.
OSHA also has estimated the benefits using other job tenures. For this purpose, OSHA examined scenarios for the same number of years—60 years—but with the work force restarting exposure whenever the first job tenure cycle was complete.
In order to compare costs to benefits, OSHA assumes that economic conditions remain constant and that annualized costs will continue for the entire 60-year time horizon used for the benefits analysis (as discussed in Chapter V of the FEA). OSHA invited comments on this assumption in the PEA, for both the benefit and cost analysis. OSHA was particularly interested in what assumptions and time horizon should be used instead and why. The Agency did not receive any comments on this point.
OSHA also estimates the monetary value of health and longevity improvements of the type associated with the final silica rule. These estimates are for informational purposes only because OSHA cannot use benefit-cost analysis as a basis for determining the PEL for a health standard. The Agency's methodology for monetizing benefits is based on both the relevant academic literature and on the approaches OSHA and other regulatory agencies have taken in the past for similar regulatory actions.
In explaining OSHA's methodology for monetizing health and longevity improvements, OSHA relied on a 45 year occupational tenure. Later, OSHA discusses monetization under alternative occupational tenures of 25, 13 and 6.6 years.
To estimate the monetary value of the reductions in the number of silica-related fatalities, OSHA relied, as OMB recommends in its Circular A-4, on estimates developed from the willingness of affected individuals to pay to avoid a marginal increase in the risk of fatality. While a willingness-to-pay (WTP) approach clearly has theoretical merit, it should be noted that an individual's willingness to pay to reduce the risk of fatality would tend to underestimate the total willingness to pay, which would include the willingness of others—particularly the
For estimates using the willingness-to-pay concept, OSHA relies on existing studies of the imputed value of fatalities avoided based on the theory of compensating wage differentials in the labor market. These studies rely on certain critical assumptions for their estimates, particularly that workers understand the risks to which they are exposed and that workers have legitimate choices between high- and low-risk jobs. Actual labor markets only imperfectly reflect these assumptions. A number of academic studies, as summarized in Viscusi and Aldy (2003, Document ID 1220), have shown a correlation between higher job risk and higher wages, suggesting that employees demand monetary compensation in return for a greater risk of injury or fatality. The estimated trade-off between lower wages and marginal reductions in fatal occupational risk—that is, workers' willingness to pay for marginal reductions in such risk—yields an imputed value of an avoided fatality: the willingness-to-pay amount for a reduction in risk divided by the reduction in risk.
OSHA has used this approach in many recent proposed and final rules (see 69 FR 59305 (Oct. 4, 2004) and 71 FR 10099 (Feb. 28, 2006), the preambles for the proposed and final hexavalent chromium rule). Limitations to this approach (see Hintermann, Alberini and Markandya, (2010, Document ID 0739)), have been examined in a recent WTP analysis, by Kniesner et al. (2012, Document ID 3819), using panel data to examine the trade-off between fatal job risks and wages. This article addressed many of the earlier econometric criticisms by controlling for measurement error, endogeneity, and heterogeneity. Accordingly, OSHA views this analysis as buttressing the estimates in Viscusi and Aldy (2003, Document ID 1220), which the Agency is continuing to rely on for the FEA.
OSHA received several comments on the use of willingness-to-pay measures and estimates based on compensating wage differentials. For example, Peter Dorman, Professor of Economics, Evergreen State College, Eric Frumin of Change to Win, and Dr. Ruth Ruttenberg, representing the AFL-CIO, in addition to critiquing the academic studies used to develop the willingness-to-pay measure, cited the absence of effective labor markets for capturing a wage differential for hazardous work (Document ID 2260, Attachment 1; 2372, Attachment 1, pp. 4-15; 2256, Attachment 4, p. 9). OSHA acknowledges that there has been an absence of a wage premium for risk in certain labor markets, and cites this absence in Chapter II of the FEA as an example of market failure. Nonetheless, while the Agency agrees that the absence of a wage premium for risk demonstrates the need for regulatory intervention in the labor market, it does not, in itself, invalidate the use of the willingness-to-pay approach for the informational purposes for which OSHA calculates benefits, so long as there are some reasonably well-functioning parts of the labor market that can be used to estimate the willingness to pay for some subset of workers. OSHA finds that there are such sections of the labor market.
Several studies indicate that there are enough functional parts of the labor market to allow for some quantification of the risk, typically expressed as the value of a statistical life (VSL), a possible measure of willingness to pay. For example, Viscusi and Aldy (2003) conducted a meta-analysis of studies in the economics literature that use a willingness-to-pay methodology to estimate the imputed value of life-saving programs and found that each fatality avoided was valued at approximately $7 million in 2000 dollars. For the PEA, the Agency used the GDP Deflator (U.S. BEA, 2010) to convert this estimate to $8.7 million in 2009 dollars for each fatality avoided. For the FEA, the base year has been further updated to 2012 using the GDP Deflator (U.S. BEA, 2013), yielding an estimate of $9.0 million per fatality avoided.
There are a number of factors that could influence the value of a statistical life (VSL) calculation in different labor markets, but for the purpose of its analysis OSHA has identified methods for normalizing the risk between markets. For example, in Kniesner, Viscusi, and Ziliak (2010, Document ID 0767), the authors addressed the issue of the heterogeneity of the VSL approach among various labor markets by developing analytical tools (quantile regressions) for differentiating by income. For the purpose of quantifying the effects of income growth over time on the value of a statistical life, OSHA relies on their data, which generally show that VSL increases with increased worker income (as banded by quartile). Despite potential weaknesses in the VSL approach, Executive Order 12866 recommends monetization of regulatory benefits (including increases in longevity), and the Agency concludes this constitutes the best available method for this purpose.
In addition to the benefits that are based on the imputed value of fatalities avoided, workers also place a value on occupational injuries or illnesses avoided, which reflect their willingness to pay to avoid monetary costs (for medical expenses and lost wages) and quality-of-life losses as a result of occupational illness. Silicosis, lung cancer, and renal disease can be totally disabling and adversely affect individuals for years or even decades in non-fatal cases, or before ultimately proving fatal. Because monetary measures of the willingness to pay for avoiding these illnesses are rare and difficult to find OSHA has included a range based on a variety of estimation methods.
Consistent with Buchanan
There are several benchmarks for valuation of health impairment due to silica exposure, using a variety of techniques, which provide a number of mid-range estimates between OSHA's high and low estimates of $5.2 million and $64,000. For example, EPA (2008) recently estimated a cost of approximately $460,000, in 2008 dollars, per case of chronic bronchitis, which OSHA (2009) used as the basis for comparison with less severe lung impairments from diacetyl exposure. Another approach is to employ a cost-of-injury model. Combining estimates of productivity losses (
Miller (2005) also estimated the morbidity costs of several different pneumoconioses other than silicosis and found the other cases to be even more costly to society than silicosis. While the full costs of renal disease are less well known, the medical costs alone of dealing with end-stage renal disease run over $64,000 annually per patient (Winkelmayer, 2002). This suggests that a more comprehensive analysis of the direct costs of renal disease, as well as for the various lung impairments, would produce an estimate well above the $64,000 estimate of injuries in Viscusi and Aldy (2003). Moreover, several studies (
Thus, the various studies presented in Chapter VII of the FEA suggest that the imputed value of avoided morbidity associated with silica exposure, both for cases preceding death and for non-fatal cases, ranges between $64,000 and $5.2 million, depending in part on the model used to compute the value and in part on the severity and duration of the case. OSHA considers this wide range of estimates is descriptive of the value of preventing morbidity associated with moderate-to-severe silicosis, as well as the morbidity preceding mortality due to other causes enumerated here—lung cancer, lung diseases other than cancer, and renal disease. OSHA is therefore applying these values to monetize cases of avoided silica-related morbidity.
OSHA requested public input on the issue of valuing the cost to society of non-fatal cases of moderate-to-severe silicosis, as well as the morbidity associated with other related diseases of the lung, and with renal disease. A number of commenters did not directly provide quantitative estimates of the cost of silicosis or other silica-related health effects, but provided qualitative descriptions of the heavy burden to health, work, and family life incurred by having silicosis.
For example, Alan White, of the United Steelworkers Local Union 593, who developed silicosis after working in a foundry for 16 years as a general helper, described the practical implications of developing silicosis:
First of all, for me, there was the growing problem of being out of breath sooner than I used to. That's a difficult situation for a competitor, especially since I didn't know why. Then, I received a big surprise during the conversation with the first doctor when I found out that I have silicosis and that I will lose my job. He and the other doctors all agreed that the diagnosis is silicosis. Watching your wife and other loved ones cry as they figure out what silicosis is was a big hit and then, shortly afterward, there was the radical pay cut from a transfer out of the foundry to a department where I knew nothing because I chose my health over money . . . There are also difficulties outside of work and issues for me to look forward to in the future. Walking while talking on a cell phone is very exhaustive, as well as walking up the stairs from my basement to my second floor apartment. I have increasing difficulty on my current job. Certain irritants like air fresheners, potpourri and cleaners make home life increasingly difficult and I was told that it's downhill from here for both work and home life (Document ID 3477, p. 2).
Mr. White also described how the foundry went to considerable expense to hire people to do the job he previously had done, including the costs to the foundry for mistakes made by the trainees replacing him. Such personnel costs to the employer would not be
In addition to questioning the underlying willingness to pay approach, at least one commenter indicated various ways in which the approach employed by OSHA would tend to underestimate the economic benefits of the rulemaking. Dr. Ruttenberg argued that the WTP approach does not include costs to third parties of silica-related illnesses and injuries, starting with a number of government programs:
In its
Part of the cost of the injury or fatality may be borne in substantial part by the victim's family:
There is another group of costs that can easily double, or even triple, the direct and indirect totals. These are social and economic impacts that are also caused by an incident. They often involve third-party payments, or stress on the victim or his/her family members. The financial pressures on a family can include the need for a caregiver, need for additional income from children or spouse to fill the gap between previous earnings and workers compensation, or psychotherapy for family members to cope with harsh new realities. When children lose their chance at college and higher future earnings, the impact can be hundreds of thousands of dollars (Document ID 2256, Attachment 4).
Dr. Ruttenberg pointed to an existing Department of Transportation study, which suggested that only a fraction of the economic cost of motor vehicle accidents was actually borne by the victim, with the remainder of the costs split between governmental bodies, insurers, and other parties (Document ID 2256, Attachment 4, p. 11).
The Center for Progressive Reform argued that there is value to reducing economic inequities created by occupational illnesses related to silica exposure:
The proposal's implications for fair treatment of workers also deserve more attention. The proposed standards would benefit a population comprising mostly construction workers (more than 85% of the total affected population). This is an industry that is a bastion for middle class workers and those striving to attain middle class status. It is also an industry that employs a significant number of foreign-born and non-union workers, groups who typically have limited power to negotiate improved working conditions. Ensuring that these workers' health is better protected against the hazards of silica exposure is an important step toward reducing socioeconomic inequality, given the linkages between individual health and social mobility. Other federal agencies, including the National Highway Traffic Safety Administration (NHTSA) and Department of Justice (DOJ), have gone so far as to argue that equity and other non-monetizable benefits are sufficient to justify rules for which the monetized costs far outweigh the monetized benefits. (As with the OSH Act, the authorizing statutes under which NHTSA and DOJ were acting do not require cost-benefit analysis, much less require the agencies to produce rules with monetized benefits that outweigh monetized costs) (Document ID 2351, p. 7) (citations omitted).
The Agency recognizes that, as with third party effects, there are aspects of economic equity issues related to occupational injury, illness, and mortality that merit attention for policy making. As noted previously, however, the OSH Act requires that OSHA policy for toxic substances be ultimately determined by issues of risk and feasibility, as opposed to cost-benefit criteria.
The Agency requested public input on the issue of valuing the cost to society of non-fatal cases of moderate to severe silicosis, as well as the morbidity associated with other related diseases of the lung, and with renal disease. The final benefits analysis summarized below and discussed in greater detail in the FEA incorporates OSHA's response to public comment.
In the PEA, OSHA suggested, provided estimates, and requested comment on adjusting future values of illness and mortality prevention to account for changes in real income over time. Ronald White of the Center for Effective Government favored integrating this element into the monetized benefits analysis (Document ID 2341, p. 3).
OSHA's estimates of the monetized benefits of the final rule are based on the imputed value of each avoided fatality and each avoided silica-related disease. As previously discussed, these, in turn, are derived from a worker's willingness-to-pay to avoid a fatality (with an imputed value per fatality avoided of $9.0 million in 2012 dollars) and to avoid a silica-related disease (with an imputed value per disease avoided of between $64,000 and $5.3 million in 2012 dollars). Two related factors suggest that these values will tend to increase over time and help to better identify the amount that a worker would be willing to pay to avoid a fatality.
First, economic theory and empirical evidence from the relevant studies indicate that the value of reducing life-threatening and health-threatening risks—and correspondingly the willingness of individuals to pay to reduce these risks—will increase as real per capita income increases.
Second, real per capita income has broadly been increasing throughout U.S. history, including during recent
On the basis of the predicted increase in real per capita income in the United States over time and the expected resulting increase in the value of avoided fatalities and diseases, OSHA has adjusted its estimates of the benefits of the final rule to reflect the anticipated increase in their value over time. This type of adjustment has been supported by EPA's Science Advisory Board (EPA, 2000b, Document ID 0652)
What remains is to estimate a value for “k” with which to increase benefits annually in response to annual increases in real per capita income, where “k” is equal to (1 + g) * (η), “g” is the expected annual percentage increase in real per capita income, and “η” is the income elasticity of the value of a statistical life. Probably the most direct evidence of the value of “k” comes from the work of Costa and Kahn (2003, 2004). They estimate repeated labor market compensating wage differentials from cross-sectional hedonic regressions using census and fatality data from the Bureau of Labor Statistics for 1940, 1950, 1960, 1970, and 1980. In addition, with the imputed income elasticity of the value of life on per capita GNP of 1.7 derived from the 1940-1980 data, they then predict the value of an avoided fatality in 1900, 1920, and 2000. Given the change in the value of an avoided fatality over time, it is possible to estimate a value of “k” of 3.4 percent a year from 1900-2000; of 4.3 percent a year from 1940-1980; and of 2.5 percent a year from 1980-2000.
Other, more indirect evidence comes from estimates in the economics literature on the income elasticity of the value of a statistical life. Viscusi and Aldy (2003, Document ID 1220) performed a meta-analysis on 49 wage-risk studies and concluded that the confidence interval upper bound on the income elasticity did not exceed 1.0 and that the point estimates across a variety of model specifications ranged between 0.5 and 0.6.
More recently, Kniesner, Viscusi, and Ziliak (2010, Document ID 0767), using panel data quintile regressions, developed an estimate of the overall income elasticity of the value of a statistical life of 1.44. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of “k” of about 3.9 percent a year.
Based on the preceding discussion of these three approaches for estimating the annual increase in the value of the benefits of the final rule and the fact that the estimated increase in real per capita income in the United States has flattened in recent years and could remain so, OSHA has selected a conservative value for “k” of approximately 2 percent a year over the next 60 years.
Thus, based on the best current thinking and data on willingness to pay and its relationship to income elasticity as income increases, OSHA concludes that a 2 percent increase in benefits per year, as measured by a corresponding anticipated increase in VSL, is a reasonable, mid-range estimate. However, OSHA recognizes the uncertainties surrounding these estimates and has subjected them to sensitivity analysis, as discussed below.
Accordingly, OSHA concludes that the rising value, over time, of health benefits is a real phenomenon that should be taken into account in estimating the annualized benefits of the final rule. Table VII-4, in the following section, and the monetized benefits estimates that follow it, show estimates of the monetized benefits of the silica rule with this adjustment integrated into the valuation. OSHA provides a sensitivity analysis of the effects of this approach later in this chapter.
Table VII-27 presents the estimated annualized (over 60 years, using a 0 percent discount rate) benefits from each of these components of the valuation, and the range of estimates, based on risk model uncertainty (notably in the case of lung cancer), and the range of uncertainty regarding valuation of morbidity. As shown, the full range of monetized benefits, undiscounted, for the final PEL of 50 µg/m
This result comports with the very wide range of valuation for morbidity. At the low end of the valuation range, the total value of benefits is dominated by mortality ($7.7 billion out of $7.9 billion at the case frequency midpoint), whereas at the high end the majority of the benefits are related to morbidity ($11.2 billion out of $18.7 billion at the case frequency midpoint). Also, the analysis illustrates that most of the morbidity benefits are related to silicosis cases that are not ultimately fatal. At the valuation and case frequency midpoint of $13.3 billion, $7.7 billion in benefits are related to mortality, $2.0 billion are related to morbidity preceding mortality, and $3.5 billion are related to morbidity not preceding mortality.
As previously noted, the estimated stream of benefits arising from the final silica rule is not constant from year to year, both because of the 45-year delay after the rule takes effect until all active workers obtain reduced silica exposure over their entire working lives and because of, in the case of lung cancer, a 15-year latency period between reduced exposure and a reduction in the probability of disease. An appropriate discount rate
Following OMB (2003) guidelines (Document ID 1493], OSHA has estimated the annualized benefits of the final rule using separate discount rates of 3 percent and 7 percent. Consistent with the Agency's own practices in recent final and final rules, OSHA has also estimated, for benchmarking purposes, undiscounted benefits—that is, benefits using a zero percent discount rate.
The “appropriate” or “preferred” discount rate to use to monetize health benefits is a controversial topic, which has been the source of scholarly economic debate for several decades.
The social opportunity cost of capital approach reflects the fact that private funds spent to comply with government regulations have an opportunity cost in terms of foregone private investments that could otherwise have been made. The relevant discount rate in this case is the pre-tax rate of return on the foregone investments (Lind, 1982b, pp. 24-32) (Document ID 1622).
The rate of time preference approach is intended to measure the tradeoff between current consumption and future consumption, or in the context of the final rule, between current benefits and future benefits. The
A usual method for estimating the social rate of time preference is to calculate the post-tax real rate of return on long-term, risk-free assets, such as U.S. Treasury securities (OMB, 2003, Document ID 1493). A variety of studies have estimated these rates of return over time and reported them to be in the range of approximately 1-4 percent.
OMB Circular A-4 (2003) recommends using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach) to estimate benefits and net benefits (Document ID 1493). Ronald White of the Center for Effective Government endorsed the use of a 3 percent discount rate—since it “appropriately reflects a social rate of time preference approach consistent with recommendations for benefits evaluation by the U.S. Environmental Protection Agency” (Document ID 2341, pp. 3-4). Charles Gordon argued for a 0 percent discount rate:
The economic literature indicates that the social discount rate should be 2 percent or 3 percent. But I believe the social discount rate should be zero, because if you were asked the question, do you want yourself saved from crystalline silica exposure . . . or do you want your son to be saved from crystalline silica death 20 years from now, you could not answer that question. You could not give a preference (Document ID 3588, Tr. 3789-90).
In acknowledgement of OMB Circular A-4 (2003, Document ID 1493), OSHA presents benefits and net benefits estimates using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach). The weight of the evidence favors using a discount rate of 3 percent or less, and that 3 percent is one of the options permitted by OMB, the Agency is using a 3 percent discount rate to display its primary estimates of benefits under the social rate of time preference method.
Table VII-28a through Table VII-28d presents OSHA's estimates of the sum of the annualized benefits of the final rule, under various occupational tenure assumptions, using alternative discount rates of 0, 3, and 7 percent, with a breakout between construction and general industry/maritime, with each table presenting these results for a different tenure level. All of these benefits calculations reflect willingness-to-pay values that, as previously discussed, increase in real value at 2 percent a year.
Given that the stream of benefits extends out 60 years, the value of future benefits is highly sensitive to the choice of discount rate. As previously established in Table VII-27, the undiscounted benefits (
Comparing across tenure levels for representative benefits, Table VII-28a for 45 years tenure has total benefits at the midpoint estimate of $8.7 billion at a 3 percent discount rate and $4.8 billion at 7 percent discount rate. Table VII-28b for 25 years tenure has total benefits at the midpoint estimate of $10.0 billion at a 3 percent discount rate and $5.5 billion at 7 percent discount rate. Table VII-28c for 13 years tenure has total benefits at the midpoint estimate of $12.3 billion at a 3 percent discount rate and $6.8 billion at 7 percent discount rate. Finally, Table VII-28d for 6.6 years tenure has total benefits at the midpoint estimate of $16.1 billion at a 3 percent discount rate and $9.0 billion at 7 percent discount rate.
OSHA has estimated as shown in Table VII-29, the monetized and annualized net benefits of the final rule (with a PEL of 50 µg/m
Table VII-29 shows net benefits using alternative discount rates of 0, 3, and 7 percent for benefits and costs, including the previously discussed adjustment to monetized benefits to reflect increases in real per capita income over time.
As previously noted, the OSH Act requires the Agency to set standards based on eliminating significant risk to the extent feasible. An alternative criterion of maximizing net (monetized) benefits may result in very different regulatory outcomes. Thus, this analysis of estimated net benefits has not been used by OSHA as the basis for its decision concerning the choice of a PEL or of ancillary requirements for the final silica rule. Instead, it is provided pursuant to Executive Orders 12866 and 13563. OSHA has used the 45 year occupational tenure in its main analysis. OSHA has also examined other possible tenures and provided the results. The occupational tenure results are such the benefits are higher the shorter the occupational tenure. Examination of shorter tenure would actually increase the net benefits because more workers are exposed to silica, albeit for a shorter time each.
Table VII-29 also shows results of estimates of annualized net benefits for an alternative PEL of 100 µg/m
As previously noted in this summary, the choice of discount rate for annualizing benefits has a significant effect on annualized benefits. The same is true for net benefits. For example, the net benefits using a 7 percent discount rate for benefits are considerably smaller than the net benefits using a 0 percent discount rate, declining by more than half to two-thirds under all scenarios. (Conversely, as noted in Chapter V of the FEA, the choice of discount rate for annualizing costs has only a very minor effect on annualized costs.)
The estimates of net benefits in Table VII-29 show that:
• While the net benefits of the final rule vary considerably—depending on the choice of discount rate used to annualize benefits and on whether the calculated benefits are in the high, midpoint, or low range—benefits exceed costs for the 50 μg/m
• The Agency's best estimate of the net annualized benefits of the final rule—using a uniform discount rate for both benefits and costs of 3 percent—and cognizant of the uncertainties inherent in the analysis, is between $3.8 billion and $11.6 billion, with a midpoint value of $7.7 billion.
• The alternative of a 100 μg/m
One commenter, the Mercatus Institute, argued that the benefits for the proposed rule were overestimated due to OSHA's assumption of full compliance, and that this simultaneously underestimated costs, since the cost of complying with existing rules is assumed away. This commenter stated that the Agency should not assume that firms will necessarily comply with the Agency's rules and the benefits estimates should therefore be lower (Document ID 1819, p. 9). OSHA makes three points in response. First, the argument is logically inconsistent—if the Agency did not assume full compliance with the previous PELs and assumes compliance with the new PEL, as Mercatus advocates, it is true that the estimated costs would increase, but so would the estimated benefits. Second, the logic for the Mercatus Institute's argument seems to be undercut by the Mercatus Institute's own observation that the Agency has had success in reducing silicosis, which suggests that in the long run, at least, firms actually do comply with OSHA rules (Document ID 1819, pp. 4-5). Finally, as discussed in the engineering controls section of Chapter V of the FEA, the Agency has determined that the best way for it to calculate costs and benefits is to estimate the incremental costs and benefits of the standard by assuming full compliance. OSHA also emphasizes that the compliance assumption applies to both costs and benefits so that the comparison of one to the other is not necessarily unduly weighted in either direction (an exception would be the counterfactual scenario in which extremely high non-compliance by a few employers changed benefits estimates substantially but cost estimates only slightly).
Incremental costs and benefits are those that are associated with increasing the stringency of the standard. A comparison of incremental benefits and costs provides an indication of the relative efficiency of the final PEL and the alternative PEL. Again, OSHA has conducted these calculations for informational purposes only and has not used this information as the basis for selecting the PEL for the final rule.
Tables VII-30A and VII-30B show result of estimates of the costs and benefits of reducing exposure levels from the preceding PELs of approximately 250 µg/m
Table VII-30A breaks out costs by provision and benefits by type of disease and by morbidity/mortality, while Table VII-30B breaks out costs and benefits by major industry sector or construction task sector. As Table VII-30A shows, at a discount rate of 3 percent, a PEL of 50 µg/m
Table VII-30B continues this incremental analysis but with breakdowns between construction and general industry/maritime. As shown, both sectors show strong positive net benefits, which are greater for the final PEL of 50 µg/m
The estimates in Tables VII-30A and VII-30B indicate that, across all discount rates, there are net benefits to be achieved by lowering exposures from the preceding PEL (250 μg/m
However, the majority of the benefits and costs that OSHA estimates for the final rule (PEL of 50 μg/m
In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard. These alternatives are discussed in the following Chapter VIII of the FEA: Regulatory Alternatives.
In this section, OSHA presents the results of two different types of sensitivity analysis. In the first type of sensitivity analysis, OSHA made a series of isolated changes to individual cost and benefit input parameters in order to determine their effects on the Agency's estimates of annualized costs, annualized benefits, and annualized net benefits. In the second type of sensitivity analysis—a so-called “break-even” analysis—OSHA also investigated isolated changes to individual cost and benefit input parameters, but with the objective of determining how much they would have to change for annualized costs to equal annualized benefits.
Again, the Agency has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the final rule.
The methodology and calculations underlying the estimation of the costs and benefits associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to isolated variations a particular input parameter. For example, if the estimated time that employees need to travel to (and from) medical screenings is doubled, the corresponding labor costs double as well.
OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. OSHA first considered changes to input parameters that affected only costs and then changes to input parameters that affected only benefits. Each of the sensitivity tests on cost parameters had only a very minor effect on total costs or net costs. Much larger effects were observed when the benefits parameters were modified; however, in all cases, net benefits remained significantly positive. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the cost or benefit input parameters still show significant net benefits for the final rule. The results of the individual sensitivity tests are summarized in Table VII-31A and B and are described in more detail below.
OSHA has tailored the sensitivity analysis to examine issues raised by commenters, particularly with respect to costs. (For more detail,
In the second example, OSHA doubled the estimated familiarization time needed to understand the requirements of the new standard
In the third example, OSHA doubled the estimated daily amount of housekeeping per worker necessary to comply with the standard, from 10 minutes to 20 minutes. As shown in Table VII-31A, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of the final rule increased by $12.5 million annually, or by about 1.2 percent, while net benefits declined by the same amount annually, from approximately $7,657 million to $7,645 million annually.
In the fourth example, OSHA examined the effect of increasing its estimate of the frequency with which thorough cleaning of the workplace would be performed in general industry. The Agency examined the effect of increasing the frequency from only one initial thorough cleaning to the initial cleaning plus an annual thorough cleaning, or alternately, a thorough cleaning every 5 years. As shown in Table VII-31A, if thorough cleaning were an annual cost, the total estimated costs of the final rule increased by $17.2 million annually, or by about 1.7 percent, while net benefits declined by the same amount annually, from $7,657 million to $7,640 million annually. In the second variation of this test, for a thorough cleaning every 5 years, as shown in Table VII-31A, the increase in annual costs is only 0.2 percent.
In the fifth example, OSHA increased its estimate of respirator use. In Chapter V of the FEA, OSHA explained that it calculated the costs of respirators for general industry and maritime workers who will still be exposed above the PEL after all feasible controls are in place. In addition, to be conservative, OSHA added costs to provide respirators to 10 percent of the remaining population. For this sensitivity test, OSHA doubled its estimate of the amount of additional respirator use in general industry from 10 percent to 20 percent. As shown in Table VII-31A, the total estimated costs of the final rule increased by $20.0 million annually, or by about 1.9 percent, while net benefits decreased by the same amount annually, from approximately $7,657 million to $7,637 million annually.
In the sixth example, reflecting in part the range of comments the Agency received on the issue (discussed in detail in Chapter V), OSHA explored the effect of increasing, and alternately decreasing, by 50 percent the size of the productivity impact arising from the use of engineering controls in construction. As shown in Table VII-31A, if OSHA's estimates of other input parameters remained unchanged, under the first variation, the total estimated costs of the final rule increased by $99.6 million annually, or by about 9.7 percent, while net benefits declined by the same amount annually, from $7,657 million to $7,558 million annually. Under the second variation, the decrease in costs and increase in net benefits would be of the same magnitude, with final estimated net benefits rising to $7,757 million.
As shown in Table VII-31B, OSHA also performed sensitivity tests on several input parameters used to predict the benefits of the final rule. In the first two tests, in an extension of results previously presented in Table VII-27, the Agency examined the effect on annualized net benefits of employing the high-end estimate of the benefits, as well as the low-end estimate. As discussed previously, the Agency examined the sensitivity of the benefits to both the valuation of individual silica-related disease cases prevented, as well as the number of lung cancer deaths prevented. Table VII-31B presents the effect on annualized net benefits of using the extreme values of these ranges, the high count of cases prevented and the high valuation per case prevented, and the low count and the low valuation per case prevented. As indicated, using the high estimate of cases prevented and their valuation, the benefits rise by 45 percent to $12.6 billion, yielding net benefits of $11.5 billion. For the low estimate of both cases prevented and their valuation, the benefits decline by 45 percent, to $4.8 billion, yielding net benefits of $3.8 billion.
In the third sensitivity test of benefits, OSHA examined the effect of raising the discount rate for benefits to 7 percent. The fourth sensitivity test of benefits examined the effect of removing the adjustment to monetized benefits to reflect increases in real per capita income over time. The results of the first of these sensitivity tests for net benefits was previously shown in Table VII-29 and is repeated in Table VII-31B. Raising the interest rate to 7 percent lowers the estimated benefits by 45 percent, to $4.8 billion, yielding annualized net benefits of $3.8 billion. Removing the two-percent annual increase to monetized benefits to reflect increases in real per capita income over time decreases the benefits by 50 percent, to $4.3 billion, yielding net benefits of $3.3 billion.
OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the final rule. However, for these, the Agency performed a “break-even” analysis, asking how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits. The results are shown in Table VII-32.
OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the final rule. However, for these, the Agency performed a “break-even” analysis, examining how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits
In the first break-even test on cost estimates, OSHA examined how much costs would have to increase in order for costs to equal estimates benefits. As shown in Table VII-32, this point would be reached if costs increased by $7.7 billion.
In a second test, looking specifically at the estimated engineering control costs, the Agency found that these costs would also need to increase by $7.7 billion for costs to equal estimates benefits.
In a third sensitivity test, on benefits, OSHA examined how much its estimated monetary valuation of an avoided illness or an avoided fatality would need to be reduced in order for the costs to equal the benefits. Since the total valuation of prevented mortality and morbidity are each estimated to exceed at least $2.6 billion, while the estimated costs are $1.0 billion, an independent break-even point for each is impossible. In other words, for example, if no value is attached to an avoided illness associated with the rule, but the estimated value of an avoided fatality is held constant, the rule still has substantial net benefits. Only through a reduction in the estimated net value of both components is a break-even point possible.
OSHA, therefore, examined how large an across-the-board reduction in the monetized value of all avoided illnesses and fatalities would be necessary for the benefits to equal the costs. As shown in Table VII-32, for costs to equal estimated benefits, the estimated value per life saved would have to decline to $1.10 million per life saved, and an equivalent percentage reduction to about $0.3 million per illness prevented.
In a break-even sensitivity test, OSHA estimated how many silica-related fatalities and illnesses would be required for benefits to equal costs. As shown in Table VII-32, a reduction of 88 percent, relative to the morbidity and mortality estimates is required to reach the break-even point—566 fewer fatalities prevented annually, and 809 fewer silica-related illnesses prevented annually.
This section discusses several major regulatory alternatives to the final OSHA silica standard, pursuant to Executive Orders 13653 and 12866. The presentation of regulatory alternatives in this chapter serves two important functions. The first is to demonstrate that OSHA explored less costly ways (compared to the final rule) to provide workers an adequate level of protection from exposure to respirable crystalline silica. The second is tied to the Agency's statutory requirement, which underlies the final rule, to reduce significant risk to the extent feasible. If OSHA had been unable to support its findings of significant risk and feasibility based on evidence presented during notice and comment, the Agency would then have had to consider regulatory alternatives that do satisfy its statutory obligations.
Each regulatory alternative presented here is described and analyzed relative to the final rule. Where relevant, the Agency notes that some regulatory alternatives are not permissible based on the required legal findings OSHA has made regarding significant risk and feasibility. The regulatory alternatives have been organized into four categories similar to those used in the PEA: (1) Alternative PELs to the new PEL of 50 μg/m
OSHA selected a new PEL for respirable crystalline silica of 50 μg/m
OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. The Agency has also developed estimates of the risk of silica-related diseases assuming exposure over a working lifetime at the final PEL and action level, as well as at OSHA's preceding PELs. These analyses are presented in a background document entitled “Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment” and its final findings are described in this preamble in Section V, Health Effects, and Section VI, Final Quantitative Risk Assessment and Significance of Risk. The available evidence indicates that employees exposed to respirable crystalline silica well below the previous PELs are at increased risk of lung cancer mortality and silicosis mortality and morbidity. Occupational exposures to respirable crystalline silica also can result in the development of kidney and autoimmune diseases and in death from other nonmalignant respiratory diseases. As discussed in Section VI Significance of Risk, in this preamble, OSHA finds that worker exposure to respirable crystalline silica at the previous and new PELs constitutes a significant risk and that the final standard will substantially reduce this risk.
Section 6(b) of the OSH Act (29 U.S.C. 655(b)) requires OSHA to determine that its standards are technologically and economically feasible. OSHA's examination of the technological and economic feasibility of the final rule is presented in the FEA, and is summarized in this section (Section VII) of this preamble. For general industry and maritime, OSHA has concluded that the final PEL of 50 μg/m
For construction, determined that the engineering and work practice controls specified in Table 1 are feasible for all affected activities and in most cases will keep exposures at or below 50 μg/m
OSHA developed quantitative estimates of the compliance costs of the final rule for each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has concluded that compliance with the requirements of the final rule would be economically feasible in every affected industry sector.
OSHA has examined two regulatory alternatives (named Regulatory Alternatives #1 and #2) that would modify the PEL for the final rule. Under Regulatory Alternative #1, the final PEL would be changed from 50 µg/m
Tables VII-33 and VII-34 present, for informational purposes, the estimated costs, estimated benefits, and estimated net benefits of the final rule under the new PEL of 50 μg/m
As previously noted, Tables VII-33 and VII-34 also show the costs and estimated benefits of a PEL of 25 μg/m
As Tables VII-33 and VII-34 show, going from the final rule to Regulatory Alternative #2 (PEL of 25 μg/m
Section 6(b)(7) of the OSH Act, 29 U.S.C. 655(b)(7), requires standards to prescribe, where appropriate, the monitoring or measuring of employee exposure for the protections of employees. Section 6(b)(7) also requires the standards to prescribe, where appropriate, the type and frequency of medical exams to be provided by employers “in order to most effectively determine whether the health of [exposed] employees is adversely affected by such exposure.” The final rule contains several ancillary provisions (provisions other than the PEL), including requirements for exposure assessment, medical surveillance, familiarization and training, regulated areas (in general industry and maritime), and a written exposure control plan.
OSHA's reasons for including each of the ancillary provisions are detailed in Section XV of this preamble, Summary and Explanation of the Standards. In particular, OSHA has determined that requirements for exposure assessment (or alternately, using specified exposure control methods for selected construction operations) provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is particularly important because workers exposed at levels below the new PEL are still at significant risk of death and illness (OSHA's decision not to lower the PEL further was due to limitations on technological feasibility, rather than a determination that significant risk was eliminated at the new PEL). Medical surveillance will allow for identification of respirable crystalline silica-related adverse health effects at an early stage so that appropriate intervention measures can be taken. Regulated areas and a written exposure control plan are important in part because they help limit exposure to respirable crystalline silica to as few employees as possible. Finally, worker training is necessary to inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize potential health hazards. Worker training on silica-related work practices is particularly important in controlling silica exposures because engineering controls frequently require action on the part of workers to function effectively.
As shown in Table VII-33, these ancillary provisions represent approximately $340 million (or about 35 percent) of the total annualized costs of the final rule of $962 million (using a 3 percent discount rate). The three most expensive of the ancillary provisions are the requirements for medical surveillance, with annualized costs of $96 million; the requirements for training and familiarization, with annualized costs of $94 million; and exposure assessment, with annualized costs of $71 million.
The requirements for exposure assessment in general industry and maritime are triggered by the action level. The exposures of workers in construction for whom all Table 1 requirements have been met do not have to be assessed, but if Table 1 requirements are not met, the requirements for exposure assessment in construction would also be triggered by the action level. As described in this preamble, OSHA has defined the action level for the standard as an airborne concentration of respirable crystalline silica of 25 μg/m
As explained in Chapter IV of the FEA, OSHA finds that proper implementation of engineering and work practice controls, particularly those specified in Table 1, will eliminate much of the variability in silica exposure that characterizes baseline conditions in the general industry, maritime, and construction sectors. OSHA recognizes, however, that some variability is unavoidable and uncontrollable even with such controls. Because of this variability of employee exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level should provide reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the PEL on days when no exposure measurements are made. Even when all measurements on a given day fall between the PEL and the action level, there is some chance that on another day, when exposures are not measured, actual exposure may exceed the PEL. When exposure measurements are below the PEL but above the action level, the employer cannot be certain that employees have not been exposed to respirable crystalline silica concentrations in excess of the PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring.
As specified in the final rule, all workers in general industry and maritime exposed to respirable crystalline silica at or above the action level of 25 μg/m
OSHA's conclusion is that the requirements triggered by the action level will result in a very real and necessary, but non-quantifiable, reduction in risk beyond that provided by the PEL alone. OSHA has determined that these ancillary provisions (periodic exposure assessment, medical surveillance in general industry/maritime) will reduce significant risk in at least three ways: (1) Providing economic incentives to employers to
In response to comments on the proposed rule and PEA, among other changes discussed in Chapter V, OSHA added familiarization costs and increased estimated training costs in the FEA, and increased the cost of an industrial hygienist when conducting exposure monitoring. These changes, however, were the result of OSHA revisions to its cost estimates, not changes to the text of the regulation. Medical surveillance and exposure assessments were the ancillary provisions that were the focus of regulatory alternatives in the PEA. For these reasons, the Agency has examined four regulatory alternatives (Regulatory Alternatives #3, #4, #5, and #6) involving changes to one or the other of these two ancillary provisions. These four regulatory alternatives are defined below and the incremental cost impact of each is summarized in Table VII-35. In addition, OSHA has qualitatively considered a regulatory alternative (Regulatory Alternative #7) that would remove all ancillary provisions.
Under Regulatory Alternative #3, the action level would be raised from 25 µg/m
Under Regulatory Alternative #4, the action level in general industry and maritime would remain at 25 µg/m
Under Regulatory Alternative #5, the only change to the final rule would be to the medical surveillance frequency requirements. Instead of requiring qualifying workers to be offered a medical check-up every three years, an annual medical check-up would be required to be offered. Assuming all workers will accept this offer, as shown in Table VII-35, Regulatory Option #5 would increase the annualized cost of the final rule by about $110 million, using a discount rate of 3 percent (and by about $108 million, using a discount rate of 7 percent).
Under Regulatory Alternative #6, medical surveillance would be triggered by the PEL (in general industry and maritime), not the action level, and all workers (including in construction) subject to medical surveillance would be required to have a medical check-up annually rather than triennially. As shown in Table VII-35, Regulatory Alternative #6 would cause a net increase of the annualized cost of the final rule by about $42 million, using a discount rate of 3 percent (and by about $40 million, using a discount rate of 7 percent).
While the Agency expects there will be substantial benefits related to its ancillary provisions, it does not have the same quantitative basis for estimating benefits, and therefore does not have quantitative estimates for the benefits of the preceding four regulatory alternatives.
The final regulatory alternative affecting ancillary provisions, Regulatory Alternative #7, would eliminate all of the ancillary provisions of the final rule, including exposure assessment, medical surveillance, training, regulated areas, and the written exposure control plan. This alternative would be difficult to justify legally in light of 29 U.S.C. 655(b)(5) and (b)(7) along with case law requiring OSHA to use ancillary provisions to reduce significant risk remaining at the PEL when these provisions result in more than a de minimis benefit to workers (
OSHA finds that the benefits estimated under the final rule will not be fully achieved if employers do not implement the ancillary provisions of the final rule. For example, OSHA believes that the effectiveness of the final rule depends on regulated areas and the written exposure control plan to further limit exposures and on medical surveillance to identify disease cases when they do occur. For construction work, the written exposure control plan is an integral part of the overall scheme to protect workers engaged in activities covered by Table 1. Without this provision, workers would risk exposures from the activities of others and exposure monitoring would need to be significantly increased to ensure protection for those workers.
Both industry and worker groups have recognized that a comprehensive standard, as opposed to a PEL alone, is needed to protect workers exposed to respirable crystalline silica. For example, the industry consensus standards for crystalline silica, ASTM E 1132—06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626—09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, as well as the draft proposed silica standard for construction developed by the Building and Construction Trades Department, AFL-CIO, have each included comprehensive programs. These recommended standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance (Document ID 1466; 1504; 1509.
The final standard in general industry and maritime requires employers to implement engineering and work practice controls to reduce employees' exposures to or below the PEL. Where engineering and/or work practice controls are insufficient, employers are still required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. Under the final construction standard, employers are given two options for compliance. The first option specifies, in Table 1 of the final rule, the exposure control methods and respiratory protection required for compliance when performing the specified task or operating the specified machines. Employers choosing this option must fully and properly implement the control methods and respiratory protection on the table to be considered to be in compliance with Table 1. The second option largely follows the requirements in the general industry and maritime standard: employers must conduct exposure monitoring and provide sufficient controls to ensure that their workers are not exposed above the PEL.
One regulatory alternative (Regulatory Alternative #8) involving methods of compliance would be to eliminate Table 1 as a compliance option in the construction sector. This was suggested by one commenter (Document ID 1950), as a means of promoting innovation.
As discussed in the Summary and Explanation in detail, OSHA fashioned the final rule as a sensible compromise between providing clear direction for employers, in a manner that reduces compliance burdens, and allowing for flexibility and innovation when desired. Table 1 is an option in the final rule that promotes both goals. While OSHA assumes that most establishments will choose to follow Table 1, in part to avoid the cost of monitoring, it is not a requirement. Employers are free to follow the other option (paragraph (d) of the standard) and conduct the required monitoring and devise their own means of complying with the PEL if they choose. To eliminate Table 1, therefore, would actually provide less flexibility and impose additional costs upon employers. OSHA therefore did not quantify costs or benefits for eliminating Table 1. Nonetheless, the Agency
The final rule will become effective 90 days following publication of the final rule in the
There are many theoretical options that OSHA could explore with regard to compliance dates. These include: Requiring the fracking industry to follow the same compliance schedule as all other general industry and maritime employers; going back to the dates originally proposed (one year for engineering controls, two years for laboratories, six months for all other provisions); allowing more time for all employers to comply with the final rule; or allowing less time for all employers to come into compliance. These options are explored in detail in the Summary and Explanation for
The Regulatory Flexibility Act, as amended in 1996, requires an agency to prepare a Final Regulatory Flexibility Analysis (FRFA) whenever it promulgates a final rule that is required to conform to the notice-and-comment rulemaking requirements of section 553 of the Administrative Procedure Act (APA) (
1. A statement of the need for, and objectives of, the rule;
2. a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;
3. the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments;
4. a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;
5. a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and
6. a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected; and for a covered agency, as defined in section 609(d)(2), a description of the steps the agency has taken to minimize any additional cost of credit for small entities. 5 U.S.C. 604.
The Regulatory Flexibility Act further states that the required elements of the FRFA may be performed in conjunction with or as part of any other agenda or analysis required by any other law if such other analysis satisfies the provisions of the FRFA. 5 U.S.C. 605.
In addition to these elements, OSHA also includes, in this section, the recommendations from the Small Business Advocacy Review (SBAR) Panel and OSHA's responses to those recommendations.
While a full understanding of OSHA's analysis and conclusions with respect to costs and economic impacts on small entities requires a reading of the complete FEA and its supporting materials, this FRFA summarizes the key aspects of OSHA's analysis as they affect small entities.
Exposure to crystalline silica has been shown to increase the risk of several serious diseases. Crystalline silica is the only known cause of silicosis, which is a progressive respiratory disease in which respirable crystalline silica particles cause an inflammatory reaction in the lung, leading to lung damage and scarring, and, in some cases, to complications resulting in disability and death. In addition, many well-conducted investigations of exposed workers have shown that exposure increases the risk of mortality from lung cancer, chronic obstructive pulmonary disease (COPD), and renal disease. OSHA's detailed analyses of the scientific literature and silica-related health risks were presented in OSHA's Review of Health Effects Literature and Preliminary QRA in the NPRM (Document ID 1711, pp. 7-229), and are included in Section VI Significance of Risk in this preamble.
OSHA reviewed numerous studies and found that they all demonstrated positive, statistically significant exposure-response relationships between exposure to crystalline silica and lung cancer mortality (
OSHA has also quantitatively evaluated the mortality risk from non-malignant respiratory disease, including silicosis and COPD. Risk estimates for silicosis mortality are based on a study by Mannetje
OSHA also identified five studies that quantitatively described relationships between exposure to respirable crystalline silica and silicosis morbidity, as diagnosed from chest radiography. Based on the results of these studies, OSHA estimates a cumulative risk for silicosis morbidity of 60 to 773 cases per 1,000 workers for a 45-year exposure to the preceding general industry PEL of 100 µg/m
OSHA's estimates of crystalline silica-related renal disease mortality risk are derived from an analysis by Steenland
The objective of the final rule is to reduce the numbers of fatalities and illnesses occurring among employees exposed to respirable crystalline silica in general industry, maritime, and construction sectors. This objective will be achieved by requiring employers to install engineering controls where appropriate and to provide employees with the equipment, respirators, training, exposure monitoring, medical surveillance, and other protective measures necessary for them to perform their jobs safely. The legal basis for the rule is the responsibility given to the U.S. Department of Labor through the Occupational Safety and Health Act of 1970 (OSH Act). The OSH Act provides that, in promulgating health standards dealing with toxic materials or harmful physical agents, the Secretary “shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.” 29 U.S.C. 655(b)(5) (
Small business representatives commented on all aspects of this rule, and their comments and OSHA's responses are covered throughout this preamble and the FEA. This section of the FRFA focuses only on comments that directly concern this FRFA or the screening analysis that precedes it.
One commenter questioned the use of SBA definitions for small businesses, arguing that some definitions include firms with 500 employees or more, which, according to the commenter, are too large to constitute “small” businesses. The commenter commended OSHA for also including an analysis of very small entities with fewer than 20 employees (Document ID 2351, Attachment 1, p. 8). OSHA determined that both the analysis of the impacts on SBA-defined small entities and the analysis of the impacts on very small entities (those with fewer than twenty employees) are useful and important for examining small business impacts.
Two commenters were concerned that their industries had not been covered in the IRFA. The American Railroad Association noted that small railroads had not been covered (Document ID 2366, Attachment 1, p. 4). The commenter is correct that OSHA did not examine small entities in this sector in the IRFA. For the FEA, OSHA has added a discussion of small entities in the railroad industry to Chapter VI, Economic Impacts. The Sorptive Minerals Institute also stated that their industry was not covered in the IRFA (Document ID 4230, Attachment 1, p. 16). As discussed in Chapter IV, the sorptive mineral industry was covered as part of a larger industry. In any case, OSHA has excluded exposures that result from the processing of sorptive clays from the scope of the final rule.
Many commenters were concerned that OSHA had not used economic data that included the effects of the recent “great recession”. This issue was addressed in the Chapter VI Introduction, but some commenters specifically discussed this topic in reference to small entities (Document ID 1822, Attachment 1, p. 1; 2187, Attachment 1, p. 2; 2322, p. 13; 3433, p. 8; 4231, Attachment 1, pp. 15-17). Complete data of the kind that OSHA needs for a thorough analysis of economic impacts were not yet available at the time the PEA was developed. As discussed in Chapter II, Industrial profile, the FEA, including this FRFA, uses 2012, the most recent year with complete data, as a base year and used average profits from years including the recession and surrounding years.
Some commenters were concerned with OSHA's estimates of small business profits. One commenter pointed out that OSHA had relied entirely on C corporation data, even though many affected firms might be S corporations, partnerships or sole proprietorships (Document ID 2296, Attachment 1, p. 23). This is true, but there are no published data on S corporation, partnership, or sole proprietorship profits, and thus C corporation data is the best available data. As another commenter pointed out, reported profits of small business are generally lower than the total returns earned by owners who also act as executives for their firms. The same commenter explained that smaller firms have a great deal of flexibility in deciding what portions of entity gains are reported as profits, what portions are reported as management salaries, and what portions are reported as management bonuses (Document ID 2163, Attachment 1, p. 7). As a result, it is possible that OSHA has underestimated small firm profits and thus overestimated potential impacts on profits.
Stuart Sessions argued that OSHA should have analyzed whether smaller firms have higher or lower profits than larger firms (Document ID 4231, Attachment 1, pp. 11-12). The limited data supplied by Mr. Sessions, however, did not show that small firms either had larger or smaller profits than bigger firms on an across-industry basis (Document ID 4231, Attachment 1, p. 11). Mr. Sessions developed an economic model that used a combination of multiple data sources to determine profit rates of small firms (RMA and BizMiner). In Chapter III Industrial Profile, Revenue and Profit,
At least one commenter argued that OSHA might have inaccurately estimated small firm revenues as a result of OSHA's method of projecting revenues for years when Census data are not available (Document ID 4231, Attachment 1, pp. 15-17). This argument is now moot, as OSHA is using data from the 2012 Economic Census, and is not using projected revenues in this analysis.
Some commenters argued that OSHA had not adequately accounted for diseconomies of scale in small firms (Document ID 4231, Attachment 1, pp. 2-5; 2307, Attachment 10, p. 25; 2322, Attachment 1, pp. 15-16). During his testimony, Stuart Sessions testified that it was his “guess . . . that small businesses are substantially more likely to be noncompliant currently than large businesses,” and requested that OSHA conduct additional analysis to “handle the differential compliance rates between small and large business” (Document ID 3580, Tr. 1399). As discussed in Chapter V, OSHA has changed its approach to estimating costs of small firms to account for diseconomies of scale in small firms. However, there is no evidence, other than Mr. Sessions's “guess,” that small firms are less compliant than large firms.
Janet Kaboth, testifying on behalf of a small company in the brick manufacturing industry, stated that small businesses are more impacted by the rule because they have more difficulty accessing capital to upgrade engineering controls:
[Engineering controls] must be purchased and paid for in the first year of compliance. . . . It is extremely unlikely that a small entity such as Whitacre Greer would be able to obtain a bank loan . . . for something that does not reduce costs or increase revenue and additionally adds cost (Document ID 3589, Tr. 3397-3399).
As discussed in Chapter VI, Economic Impacts, small firms will typically be able to pay for the first year costs of engineering controls from a single year's profits. Thus, there is no need to account for possible difficulties in obtaining credit.
A different commenter requested that OSHA provide additional guidance in Table 1 of the construction standard as a way to mitigate the impact on small businesses (Document ID 2322, p. 6). OSHA has done so, and agrees that it will likely ease compliance for small construction businesses because it provides them with task-specific guidance that will allow them to avoid more complicated exposure monitoring processes.
Many companies, associations, and private individuals submitted comments requesting a new SBAR Panel based a number of changes that have occurred since the SBAR Panel for this rule was held in 2003. The first and most common concern was that the economic data and information gathered during the Panel have become outdated and do not represent the dramatic changes in economic conditions that have resulted from the boom and bust economic cycle that occurred in the years following 2003 (Document ID 2224, p. 2; 2004, p. 1; 3580, Tr. 1274-1276; 1779, p. 2; 1767, p. 2; 1783, p. 1; 2140, p. 1; 3495, p. 2; 1798, p. 6; 1811, pp. 1-2; 2023, p. 1; 2222, p. 1; 2224, p. 2; 2230, p. 1; 2248, Attachment 1, p. 5; 2294, p. 2; 2300, p. 2; 2305, p. 13; 2279, p. 11; 2289, p. 9; 2391, p. 2; 3275, pp. 2-3; 2075, p. 4; 2083, p. 1; 2114, Attachment 1, p. 2; 2150, p. 2; 2170, Attachment 1, p. 1; 2210, Attachment 1, pp. 1-2; 4194, p. 5; 4210, Attachment 1, p. 2; 4217, Attachment 1, p. 7). Some commenters claimed that their industries have not recovered from the recession of 2008 and feel that their economic circumstances as small entities have changed as a result (Document ID 1779, p. 2; 1767, p. 2; 1783, p. 1; 2140, p. 1; 3495, p. 2).
OSHA conducted the SBAR Panel early in the rulemaking process in order to address small business concerns during the development of the proposed rule. The Agency used information gathered during the SBAR Panel to make significant changes to the proposed rule itself, as well as to the cost, impact, and other analyses contained in the proposal. OSHA's proposal contained six pages of tables that described every recommendation from the SBAR Panel, along with the Agency's responses.
OSHA's extensive rulemaking process included small business feedback not only from the original SBREFA review in 2003, but also from the subsequent written comment period in 2013 and 2014, as well as from the public hearings held in 2014. The rulemaking record shows the major issues that arose with respect to technological feasibility, costs, economic feasibility, and possible alternatives to the proposed rule represented largely the same issues addressed by small entity representatives (SERs) in 2003. To the extent there may be new issues that have arisen since the SBAR Panel made its recommendations, OSHA is confident that commenters, including small entities and the Small Business Administration's Office of Advocacy, were able to raise those issues and express whatever concerns they had about them later in the rulemaking process. OSHA has addressed comments regarding recent and current economic conditions under which small businesses are operating by considering this information in developing the final rule and supporting analyses.
A second concern raised by commenters who were advocating for OSHA to hold a new SBAR Panel, related to the changes in technology and work practices that have taken place over the last ten years. For example, one commenter claimed that the comments of the SERs were not reflective of the greater use of tools with dust collection capability, and other devices currently being used that release water at the point of cutting, to control silica dust (Document ID 2210, Attachment 1, p. 1). However, the commenters who wanted OSHA to account for improved technology and work practices did not generally provide information to supplement or update the information OSHA received from the SERs, despite opportunities to do so.
While there has been progress in the development and adoption of technologies that reduce silica exposures, the record (including comments from the commenters calling for a new Panel) brought out few, if any, fundamentally new technologies for reducing silica exposure. In any event, the advancement of technologies that would improve silica control or reduce the cost impact of the final rule would not necessitate a new SBAR panel.
There were also a number of construction firms that expressed disappointment at not being able to
No SERs from the hydraulic fracturing industry were included in the 2003 SBAR panel. OSHA did not determine that this industry would be affected by this rule until the preparation of the NPRM and the PEA. As a result, OSHA has received comments from associations and businesses requesting a new SBAR Panel that would allow a more detailed analysis of the potential impacts on small entities in this industry. Commenters pointed out that the unique economic circumstances of the hydraulic fracturing industry were not presented for public comment or analysis on regulatory alternatives and small business impacts during the Agency's 2003 SBAR Panel (Document ID 2301, Attachment 1, p. 63; 3589, pp. 15-16; 2288, p. 5).
OSHA is not required to assure that every industry affected by a rule is represented on the Panel by a SER. The hydraulic fracturing industry had extensive opportunities to comment throughout this rulemaking process. In fact, a number of commenters, including several trade associations, submitted comments and testified at the hearing, providing analysis of the hydraulic fracturing industry for the record. OSHA sees no indication that the record would be better developed by convening a different SBAR panel with a SER from the hydraulic fracturing industry. OSHA has, however, extended the compliance deadline for these firms to install the required engineering controls required by this final rule to five years; three more years than for establishments in general industry and four more years than for construction firms.
The Chief Counsel for Advocacy of the Small Business Administration (“Advocacy”) provided OSHA with comments on this rule on February 11, 2014 (Document ID 2349). Advocacy provided comment on OSHA's risk assessment and benefits analysis; technological feasibility analysis; cost analysis; current economic conditions; preferred alternatives; and procedural issues.
With respect to the risk assessment, Advocacy was concerned that OSHA was attributing benefits to reducing the PEL to 50 μg/m
Advocacy also expressed concerns about the accuracy of older exposure data (Document ID 2349, p. 4). OSHA's exposure profile, used for examining feasibility and benefits, now shows only exposures measured after 1990 and includes data from OSHA's OIS system for 2011 to 2014.
Advocacy was also concerned that OSHA might not have adequately accounted for varying risk levels associated with different types of silica (Document ID 2349, p. 4). OSHA carefully considered this issue in the risk assessment section and found there were insufficient data to demonstrate significant risk for silica exposures that result from processing sorptive clays. As a result, OSHA excluded this processing activity from the scope of the final standard. OSHA found that, while the risk from other forms of silica may vary, there is evidence of significant risk for all of the other forms of respirable crystalline silica.
Advocacy also reported that small business representatives were concerned that “OSHA's assumption that silica exposure occurs over a working life of eight hours per day for 45 years does not reflect modern working conditions” (Document ID 2349, p. 4). OSHA is required by the OSH Act to consider the risk of a hazard over a worker's entire working life (see 29 U.S.C. 655(b)(5)). In Chapter VII of the FEA, OSHA also examined other possible average tenure assumptions.
Advocacy also reported that small business representatives “noted the uncertainty of assessing silica-related risk because of confounding factors, such as smoking or exposure to other chemicals, and the long latency period for silica-related illness to appear” (Document ID 2349, p. 4). OSHA notes in Section VI, Significance of Risk, in this preamble that study after study finds that incidence of the diseases caused by exposure to silica rises with increasing exposures to silica. In order to see this type of result, and for those results to be driven by smoking as a confounding factor, it would be necessary not just that the silica-using population smoke more than the comparable non-silica using population, but also that smoking rates rise as silica exposures increase. This seems very unlikely and there is no evidence in the record that this is the case.
Advocacy noted that small business representatives had raised many concerns about whether the controls OSHA indicated as appropriate to achieve the PEL were feasible in all circumstances and could, in fact, allow an employer to fully achieve the PEL (Document ID 2349, p. 4). OSHA has thoroughly examined all comments on this kind of issue across all affected industries in Chapter IV of the FEA, and OSHA notes that employers may raise infeasibility as a defense in enforcement actions. Advocacy also noted that small business representatives were concerned about whether available methods of measuring exposure were sufficiently accurate to correctly measure the action level and PEL (Document ID 2349, p. 4). OSHA has explained in Chapter IV of the FEA why existing equipment is sufficiently accurate to correctly measure airborne respirable silica at the levels established by the new PEL and action level.
Advocacy said that one small business representative “noted that increasing the volume of air needed for additional ventilation could result in a violation of a facility's air permit” (Document ID 2349, p. 5). While the Agency does not believe that most small employers exhaust large enough volumes of air that the additional
Advocacy also said that one small business representative “noted that creating regulated areas is not feasible in many open-design facilities” (Document ID 2349, p. 5). Regulated area requirements have been a part of OSHA health standards for many years and employers have consistently found ways to make them work. The Agency does not expect that establishing a regulated area for silica would be any more difficult than establishing such an area for any of the other substances for which OSHA has regulated area requirements. In addition, OSHA does not have a regulated area requirement in construction where workplaces (such as in road building or repair) are more mobile.
Advocacy stated that small business representatives generally felt that OSHA underestimated costs, and were particularly concerned about OSHA's “cost per exposed worker” approach and OSHA's estimates of the number of workers whose exposures are controlled per engineering control (Document ID 2349, p. 5). The specific methodological issues that Advocacy mentions are issues for OSHA's general industry and maritime cost estimates, but not for construction cost estimates because the cost estimation methodologies for the construction sector are quite different and do not use the “cost per exposed worker” approach. OSHA has provided detailed responses to comments on costs in Chapter V. In general industry and maritime, OSHA continues to use the cost per exposed worker approach and defends this approach in Chapter V. OSHA has lowered its estimate of the number of workers whose exposures are reduced per engineering control in response to comments from small business representatives and others.
Advocacy also noted that small business representatives objected to OSHA focusing on the incremental cost of moving from the preceding PELs to the new PEL. Advocacy reported that small business representatives believed OSHA should have included the costs of reaching the preceding PEL in its analysis (Document ID 2349, p. 5). Contrary to Advocacy's suggestion, OSHA did not conduct the analysis this way because it would require an assumption that employers are not complying with OSHA's existing requirements to meet the preceding PEL, but would now choose to comply with a more stringent requirement. OSHA's exposure profiles do indicate that many employers are failing to meet the preceding PELs, but the question that the Agency has to address with this analysis for this rulemaking is whether OSHA should require employers to meet a lower PEL than the preceding PEL. The costs of meeting the preceding PEL are not relevant to that decision.
Advocacy reported that “small business representatives stated that OSHA was using older economic data that does not reflect current economic conditions, and [thus] that OSHA's cost pass-through assumptions are unrealistic” (Document ID 2349, p. 5). For the FEA, OSHA is using 2012 as the base year for economic data and includes data from the recent recession in analyzing average industry profits and historical changes in profits and prices. OSHA has updated its findings on the ability of firms to pass costs on to buyers in light of the updated data, resolving Advocacy's concern on this issue.
Advocacy commended OSHA for following the advice of small business representatives and adopting the Table 1 approach for the construction sector, but urged OSHA to make the table clearer, more workable, and more specific, and to relieve employers of any remaining duty to conduct exposure monitoring when engaged in Table 1 tasks (Document ID 2349, p. 6). OSHA has revised Table 1, as Advocacy and small business representatives suggested, to provide employers with a clear alternative to exposure monitoring and to provide greater clarity and specificity in the descriptions of controls.
Advocacy also urged OSHA to consider the option of leaving the PEL unchanged and instead improving enforcement, noting that this was the option most favored by small business representatives (Document ID 2349, p. 3). However, the OSH Act commands OSHA to protect workers from harmful substances by setting
OSHA did consider the option of lowering the construction PEL to 100 μg/m
Finally, Advocacy urged OSHA to consider the option of abandoning the hierarchy of controls, which is OSHA's longstanding policy of preferring engineering controls and administrative controls over personal protective equipment such as respirators (Document ID 2349, pp. 4-5). This issue is addressed in the summary and explanation section discussion of the methods of compliance provision. It should also be noted that OSHA defines technological feasibility in terms of what can be accomplished with engineering controls, not in terms of what can be accomplished with respirators.
Advocacy also expressed concern that small businesses did not have adequate opportunity for participation in the rulemaking process and that the SBAR panel was held over ten years before the proposed rule was issued (Document ID 2349, p. 7). OSHA responded to these concerns in section two of this FRFA.
OSHA has analyzed the impacts associated with this final rule, including the type and number of small entities to which the standard will apply. In order to determine the number of small entities potentially affected by this rulemaking, OSHA used the definitions of small entities developed by the Small Business Administration (SBA) for each industry.
OSHA estimates that approximately 646,000 small business or government entities would be affected by the silica standard. Within these small entities, roughly 1.4 million workers are exposed to crystalline silica and would be protected by this final standard. A breakdown, by industry, of the number of affected small entities is provided in Table III-6 in Chapter III of the FEA.
OSHA estimates that approximately 579,000 very small entities would be affected by the silica standard. Within these very small entities, roughly 785,000 workers are exposed to crystalline silica and would be protected by the standard. A breakdown, by industry, of the number of affected very small entities is provided in Table III-7 in Chapter III of the FEA.
Tables VII-36 and VII-37 show the average costs of the silica standard and the costs of compliance as a percentage of profits and revenues by NAICS code for, respectively, small entities (classified as small by SBA) and very small entities (those with fewer than 20 employees). The costs for SBA defined small entities ranges from a low of $295 per entity for entities in NAICS 238200 Building Equipment Contractors, to a high of about $161,651 for NAICS 213112 Support Activities for Oil and Gas Operations.
The cost for very small entities ranges from a low of $223 for entities in NAICS 238200 Building Equipment Contractors, to a high of about $119,072 for entities in NAICS 213112 Support Activities for Oil and Gas Operations.
Tables VII-38a and VII-38b show the unit costs which form the basis for OSHA's cost estimates for the average small entity and very small entity.
OSHA has made a number of changes in the final silica rule that will serve to minimize significant impacts on small entities consistent with the objectives of the OSH Act.
First, OSHA has made two changes to the scope of the rule that will minimize impacts for small business. OSHA has eliminated from the scope of the rule exposures that result from the processing of sorptive clays. OSHA's analysis did not determine whether any or all of the processers of sorptive minerals are small businesses, but to the extent they are, this change will reduce impacts on such entities. OSHA has also rewritten the scope of the rule with respect to the coverage of employers whose employees are exposed to silica at levels below the action level. The final rule does not apply to employers in general industry and maritime where the employer has objective data demonstrating that employee exposure to respirable crystalline silica will remain below 25 μg/m
OSHA also revised Table 1 for the construction industry in ways that will minimize impacts on small businesses. OSHA requested comment on the approach for construction in the NPRM. After carefully reviewing the comments received on this issue, the Agency significantly revised the structure of the construction rule to focus on the tasks known to generate high exposures to respirable crystalline silica and to expand Table 1 to cover almost all of them (tunnel boring and abrasive blasting are the exceptions). Under this final rule, where employers fully and properly implement the specified engineering controls, work practices, and respiratory protection for each employee engaged in a task identified on Table 1, the employer is not also required to conduct exposure assessments to determine compliance with the PEL. Specifying the kinds of dust controls for construction tasks that are expected to reduce exposures to the 50 µg/m
After carefully reviewing the comments received on respiratory protection requirements for the construction standard and the exposure data in the record (described in Chapter IV of the FEA), OSHA identified those situations where respiratory protection is necessary and made significant revisions to the respiratory protection requirements specified on Table 1 based on those findings. The result is that respiratory protection is not required for most of the tasks covered by Table 1 (
For this final rule, the Agency has significantly revised the requirements for initial exposure assessment and periodic exposure assessment in order to provide employers with greater flexibility. The standard allows the employer to use either the performance option or the scheduled monitoring option for initial and periodic exposure assessments. OSHA also clarified that the performance option provides employers with flexibility in the methods used to assess employee exposures, and provided examples of how employers can accurately characterize employee exposures using the performance option (
At the suggestion of many commenters, OSHA has eliminated regulated area/access control plan requirements in construction. Employers in construction now have more flexibility in determining the best way to control exposures through a written exposure control plan.
In the final rule, OSHA has agreed with many commenters to eliminate the requirements for protective clothing, and thus has reduced costs to small businesses.
OSHA requested comment on the use of wet methods as a substitute for dry sweeping in the NPRM. After carefully reviewing the comments received on this issue, the Agency revised the provision to prohibit dry sweeping only where such activity could contribute to employee exposure to respirable crystalline silica. Moreover, the standard contains an exception to the prohibition on dry sweeping in such circumstances if wet sweeping, HEPA-filtered vacuuming, or other methods that minimize the likelihood of exposure are not feasible (
In the NPRM, OSHA requested comment on the prohibition of employee rotation to achieve compliance when exposure levels exceed the PEL. After carefully reviewing the comments received on this issue, OSHA removed the prohibition on employee rotation from the rule (
OSHA examined the issue of a 30-day exemption in the NPRM. After carefully reviewing the comments received on this issue, the Agency decided not to include a 30-day exemption from the requirement to implement engineering and work practice controls. However, OSHA clarified that where engineering controls are not feasible, such as for certain maintenance and repair activities, the use of respirators is permitted (
OSHA adopted these alternatives to reduce costs and regulatory burdens consistent with the requirements of the OSH Act and court interpretations of the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so (
OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to respirable crystalline silica. The Agency has also developed estimates of the risk of silica-related diseases
As discussed in Section VI, Significance of Risk, in this preamble, OSHA determined that worker exposure to respirable crystalline silica constitutes a significant risk and that the final standard will substantially reduce this risk. Further, there is significant risk well below the new PEL of 50 μg/m
Section 6(b) of the OSH Act requires OSHA to determine that its standards are technologically and economically feasible. OSHA's examination of the technological and economic feasibility of the final rule is presented in the FEA and FRFA. OSHA has concluded that the new PEL of 50 μg/m
For those few operations where the new PEL is not technologically feasible, even when workers use recommended engineering and work practice controls, employers can supplement controls with respirators to achieve exposure levels at or below the new PEL.
OSHA developed quantitative estimates of the compliance costs of the final rule for each of the affected industry sectors in Chapter V of the FEA. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts in Chapter VI of the FEA. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has concluded that compliance with the requirements of the final rule will be economically feasible in every affected industry sector.
OSHA has also provided analyses of the costs and benefits of alternative PELs, though it should be pointed out these are for informational purposes only. Benefit cost analysis cannot be used as a decision criteria for OSHA health standards under the OSH Act. OSHA has examined two regulatory alternatives (named Regulatory Alternatives #1 and #2) that would have modified the PEL for the final rule. Under Regulatory Alternative #1, the PEL would have been 100 μg/m
Table VII-39 presents, for informational purposes, the estimated costs, benefits, and net benefits of the final rule under Regulatory Alternatives #1 and #2, using alternative discount rates of 3 and 7 percent. The tables also present the incremental costs, the incremental benefits, and the incremental net benefits of going from a PEL of 100 μg/m
Because OSHA determined that a PEL of 25 μg/m
As shown in Table VII-39, going from the final rule to Regulatory Alternative #2 would prevent, annually, an additional 295 silica-related fatalities and an additional 122 cases of silicosis. These estimates support OSHA's finding that there is significant risk remaining at the new PEL of 50 μg/m
Table VII-40 lists all of the SBAR Panel recommendations and OSHA's responses to these recommendations.
The final general industry/maritime (“the general industry standard”) and construction standards (“the standards”) for respirable crystalline silica contain collections of information (also referred to as “paperwork” requirements) that are subject to review by the Office of Management and Budget (OMB). In accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3506(c)(2)), OSHA solicited public comments on the
The proposed rule invited the public to submit comments to OMB, in addition to OSHA, on the proposed collections of information with regard to the following:
• Whether the proposed collections of information are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and cost) of the collections of information, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the compliance burden on employers, for example, by using automated or other technological techniques for collecting and transmitting information (78 FR 56438).
The Department of Labor submitted the final ICR on the date of publication, containing a full analysis and description of the burden hours and costs associated with the collections of information of the final rule, to OMB for approval. A copy of the ICR is available to the public at
The major collections of information found in the standards are listed below.
The collections of information in the rule are needed to assist employers in identifying and controlling exposures to respirable crystalline silica in the workplace, and to address respirable crystalline silica-related adverse health effects. OSHA will also use records developed in response to these standards to determine compliance.
The final rule imposes new collections of information for purposes of the PRA. In response to comments on the proposed rule, OSHA has revised provisions of the final rule that affect the collections of information. These revisions include:
○ OSHA has also not established time limitations for air monitoring results used to characterize employee exposures under the performance option. Although the proposed rule limited employers using air monitoring data for initial exposure assessment purposes to data obtained no more than twelve months prior to the rule's effective date, there were no such time restrictions on monitoring data used to conduct periodic exposure assessments under the performance option. Nevertheless, many commenters found the 12-month limit on the use of monitoring results for initial exposure assessments using existing data to be too restrictive. OSHA has been persuaded by these commenters not to establish time limitations for monitoring results used to assess exposures under the performance option, as long as the employer can demonstrate the data accurately characterize current employee exposures to respirable crystalline silica.
○ Scheduled monitoring option. Paragraph (d)(3) of the general industry standard (paragraph (d)(2)(iii) for construction) describes the scheduled monitoring option, which provides employers with a clearly defined, structured approach to assessing employee exposures. OSHA made a number of minor changes to the requirements for periodic monitoring under the scheduled monitoring option (paragraphs (d)(3)(iii)-(d)(3)(v) of the general industry standard, paragraphs (d)(2)(iii)(C)-(d)(2)(iii)(E) in construction) to clarify that the “most recent” exposure monitoring sample determines how often an employer must monitor.
○ Revisions to requirements to reassess exposures. Paragraph (d)(4) of the general industry standard (paragraph (d)(2)(iv) in construction) requires employers assessing exposures using either the performance option or the scheduled monitoring option to reassess employee exposures whenever there has been a change in the production, process, control equipment, personnel, or work practices that may reasonably be expected to result in new or additional exposures to respirable crystalline silica at or above the action level, or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred. OSHA added the phrase “or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred” to the proposed language to make clear that
○ The contents of the written medical report for the employee are set forth in paragraphs (i)(5)(i)-(iv) of the general industry standard (paragraphs (h)(5)(i)-(iv) of the construction standard). They include: A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment of health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment; any recommended limitations on the employee's use of respirators; any recommended limitations on respirable crystalline silica exposure; and a statement that the employee should be examined by a specialist if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B reader, or if referral to a specialist is deemed appropriate by the PLHCP. The health-related contents of the PLHCP's report to the employee are fairly consistent with the proposed PLHCP's opinion to the employer, but two major exceptions are noted. Because only the employee will be receiving the written medical report, (1) the written medical report should include diagnoses and specific information on health conditions, including those not related to respirable crystalline silica and (2) medical conditions that require further evaluation or follow-up are not limited to those related to respirable crystalline silica exposure. Although the employer will not be responsible for further evaluation of conditions not related to respirable crystalline silica exposure, the PLHCP has an ethical obligation to inform the employee about those conditions. In addition, a minor difference from the proposed opinion is that the report specifies limitations of respirator use rather than personal protective equipment (PPE), because a respirator is the only type of PPE required under this rule.
○ The contents of the PLHCP's written medical opinion for the employer are presented in paragraphs (i)(6)(i)(A)-(C) and (i)(6)(ii)(A)-(B) of the general industry standard (paragraphs (h)(6)(i)(A)-(C) and (h)(6)(ii)(A)-(B) of the construction standard). The contents of the written opinion are to include only the following: The date of the examination, a statement that the examination has met the requirements of the standard, and any recommended
○ Under paragraph (i)(5) of the general industry standard (paragraph (h)(5) of the construction standard), the employer must ensure that the PLHCP explains the results of the examination to the employee and gives the employee a written report within 30 days of each medical examination performed. Under paragraphs (i)(6)(i) and (i)(6)(iii) of the general industry standard (paragraphs (h)(6)(i) and (h)(6)(iii) of the construction standard), employers must ensure that the PLHCP gives them and that the employee receives a copy of the employer's written medical opinion within 30 days of each medical examination. OSHA had proposed that the employer obtain the PLHCP's medical opinion within 30 days of the medical examination and then provide a copy to the employee within 2 weeks after receiving it.
○ The proposed opinion for the employer called for a statement that the PLHCP had explained to the employee the results of the medical examination, including findings of any medical conditions related to respirable crystalline silica exposure that require further evaluation or treatment, and any recommendations related to use of protective clothing or equipment. As noted above, OSHA has retained the requirement that the employer ensure that the PLHCP explains the results to the employee in paragraph (i)(5) of the standard (paragraph (h)(5) of the standard for construction), but no longer requires the PLCHP to include a statement of this fact in the opinion for the employer. OSHA is not mandating how the employer ensures that the employee gets the required information because there are various ways this could be done, such as in a contractual agreement between the employer and PLHCP. PLHCPs could still include the verification in the PLHCP's opinion for the employer if that is a convenient method for them to do so.
The Agency reviewed the respirable crystalline silica rule according to the most recent Executive Order on Federalism, Executive Order 13132, which requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States before taking actions that would restrict States' policy options, and take such actions only when clear constitutional authority exists and the problem is of national scope (64 FR 43255 (8/10/1999)). The Executive Order allows Federal agencies to preempt State law only with the express consent of Congress. In such cases, Federal agencies must limit preemption of State law to the extent possible.
Under Section 18 of the Occupational Safety and Health Act (29 U.S.C. 667), Congress expressly provided that States may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards. OSHA refers to States that obtain Federal approval for such plans as “State-Plan States.” Occupational safety and health standards developed by State-Plan States must be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. Subject to these requirements, State-Plan States are free to develop and enforce their own occupational safety and health standards.
This rule complies with Executive Order 13132. The problems addressed by this new respirable crystalline silica rule are national in scope. As explained in Chapter VI, Final Quantitative Risk Assessment and Significance of Risk, employees face a significant risk of material health impairments from exposure to crystalline silica in the workplace. These employees are exposed to respirable crystalline silica in general industry, construction, and shipyard workplaces across the country. Accordingly, the rule establishes requirements for employers in every State to protect their employees from the risks of exposure to respirable crystalline silica. In States without OSHA-approved State plans, Congress expressly provides for OSHA standards to preempt State occupational safety and health standards in areas addressed by the Federal standards. In these States, this rule limits State policy options in the same manner as every standard promulgated by the Agency. In States with OSHA-approved State plans, this rule does not significantly limit State policy options. Any special workplace problems or conditions in a State with an OSHA-approved State plan may be dealt with by its State standard, provided the standard is at least as effective as this rule.
When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, the 28 States and U.S. territories with their own OSHA-approved occupational safety and health plans (“State-Plan States”) must revise their standards to reflect the new standard or amendment. The State standard must be at least as effective as the Federal standard or amendment, and must be promulgated within six months of the publication date of the final Federal rule (29 U.S.C. 667(c)(2); 29 CFR 1953.5(a)).
A State-Plan State may demonstrate that a standard change is unnecessary because the State standard is already the same as or at least as effective as the new or amended Federal standard. In order to avoid delays in worker protection, the effective date of the State standard and any of its delayed provisions must be the date of State promulgation or the Federal effective date, whichever is later. The Assistant Secretary may permit a longer time period if the State timely demonstrates that good cause exists for extending the time limitation (29 CFR 1953.5(a)). Of the 28 States and territories with OSHA-approved State plans, 22 cover public and private-sector employees: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. Six States and territories cover only public-sector employees: Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin Islands.
This respirable crystalline silica rule applies to general industry, construction, and maritime, and imposes additional or more stringent requirements as compared to the existing permissible exposure limits for respirable crystalline silica. This rule requires that all State-Plan States revise their general industry and construction standards appropriately within six months of the date of this notice. In addition, State plans that cover private sector maritime employment or have public employees working in the maritime industry covered by this standard would be required to adopt comparable provisions to their maritime standards within six months of publication of the final rule.
OSHA reviewed this rule according to the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
OSHA concludes that the final rule would impose a Federal mandate on the private sector in excess of $100,000,000 in expenditures in any one year, as documented in the Final Economic Analysis (FEA) (
Executive Order 13045 requires that Federal agencies submitting covered regulatory actions to the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) for review pursuant to Executive Order 12866 must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency (62 FR 19885 (4/23/1997)). Executive Order 13045 defines “covered regulatory actions” as rules that may (1) be economically significant under Executive Order 12866 (
The respirable crystalline silica rule is economically significant under Executive Order 12866 (
A few commenters expressed concerns about exposure of children to respirable crystalline silica through their parents' contaminated work clothing (
Because OSHA does not believe that the health risks of respirable crystalline silica have a disproportionate impact on children, OSHA concludes the respirable crystalline silica rule does not constitute a covered regulatory action as defined by Executive Order 13045. To the extent children are exposed to respirable crystalline silica either as employees or at home as a result of family members' workplace exposures, the final rule offers greater protection than did the previous permissible exposure limits.
OSHA reviewed this final rule in accordance with Executive Order 13175 on Consultation and Coordination with Indian Tribal Governments (65 FR 67249 (11/9/2000)), and determined that it does not have “tribal implications” as defined in that Executive Order. The Occupational Safety and Health Act (29 U.S.C. 651
OSHA has reviewed the final rule according to the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
To reach this conclusion, OSHA examined comments received about the potential environmental impacts posed by the final rule. Comments addressed two main issues: (1) Potential water runoff from construction tasks; and (2) costs associated with federal, state, and local environmental permits employers could be required to obtain as a result of the final rule. There were no specific comments regarding soil quality, plant or animal life, or land use. This section first lays out OSHA's preliminary conclusions regarding environmental impacts and then shows why the best available evidence in the rulemaking record reaffirms those conclusions. SBREFA and Conclusions Contained in the PEA
Pursuant to the recommendations from the Small Business Advocacy Review Panel, the Agency investigated potential environmental impacts and articulated its findings in the PEA. As noted in the SBREFA report (Document ID 0937, p. 77), the Panel requested that OSHA clarify how its silica rulemaking was related to designating silica-containing materials as hazardous wastes. In the PEA, OSHA explained that it did not believe silica wastes are classified as hazardous wastes for purposes of the Environmental Protection Agency (EPA) (Document ID 1720, p. IX-68). And the contents of OSHA's final rule on silica have no direct bearing on whether silica waste is classified as hazardous for EPA purposes.
In addition, some Small Entity Representatives (SERs) raised the possibility that the use of wet methods to limit silica exposures in some areas could violate EPA rules with respect to suspended solids in runoff unless provisions are made for recycling or settling the suspended solids out of the water. The SBAR Panel recommended that OSHA investigate this issue, add appropriate costs if necessary, and solicit comment. In response, the Agency identified six construction tasks where wet methods were utilized and found negligible costs related to controlling excess water because the amount of water used to control silica dust was minimal and typically did not produce runoff. OSHA's estimate of the potential environmental impact of each of these six equipment types was summarized in the PEA as follows:
• Stationary masonry saws: Most stationary saws come equipped with a water basin that typically holds several gallons of water and a pump for recycling water for wet cutting. The water is recirculated and, thus, not continually discharged. When emptied, the amount of water is not sufficient to produce a runoff.
• Hand-held masonry saws: Large quantities of water typically are not required in order to control dust. With these saws, water is supplied from a small capacity water tank. Any slurry residue after cutting could be dealt with by sweeping or vacuuming.
• Walk-behind and other large concrete saws: Larger concrete saws are equipped with a tank to supply water to the blade while cutting. These saws leave a slurry residue, but do not require so much water as to create a runoff.
• Walk-behind concrete grinders and millers: Some tools are equipped with a water-feed system. In these, a water line from a tank, a garden hose, or other water supply leads to the grinding head and delivers water to spray or flood the cutting tool and/or the work surface. When an automatic water feed is not available, a helper can apply water directly to the cutting surface. While such wet methods might generate enough water to create a runoff, these grinding and milling activities are typically done during the finishing stages of structure construction (
• Asphalt millers for pavement resurfacing: A typical asphalt milling machine has a built-in reservoir from which water is applied to the cutting drum. The amount of water used, however, is insufficient to produce a runoff.
• Impact drillers/pavement breakers: Water for dust suppression can be applied manually or by using a semi-automated water-feed device. In the simplest method for suppressing dust, a dedicated helper directs a constant spray of mist at the impact point while another worker operates the jackhammer. The helper can use a hose with a garden-style spray nozzle to maintain a steady and carefully directed mist at the impact point where material is broken and crushed. Jackhammers retrofitted with a focused water mist aimed at the tip of the blade offer a dramatic decrease in silica exposure. Although water-fed jackhammers are not commercially available, it is neither expensive nor difficult to retrofit equipment. Studies suggest that a water flow rate of 1/8 to 1/4 gallon per minute is best for silica dust control. At this rate, about 7.5 to 15 gallons of water per hour would be applied to (
In the PEA, OSHA found that employers typically have pre-existing obligations to limit runoff of solid waste, such as from rainfall, into storm drains. The Agency preliminarily concluded that: (1) The use of wet methods for certain construction tasks would not cause significant environmental problems from water runoff; and (2) employers should be able to comply with non-OSHA environmental regulations because runoff from wet methods can be easily controlled. As explained below, in light of the best available evidence contained in the record, OSHA reaffirms its preliminary conclusions.
While the Agency did not receive any comments directly addressing the PEA's discussion of environmental impacts, it did receive several comments on the water runoff issue. Most of the concerns expressed related to construction work, although a few comments came from entities in general industry. The construction and general industry commenters that addressed the issue of water runoff from the use of wet methods to comply with the final PEL included James Hardie Building Products, Inc.; the Unified Abrasives Manufacturers' Association; American Road & Transportation Builders Association; the General Contractors Association of New York; the Masonry & Concrete Saw Manufacturers Institute; and the Fertilizer Institute. None of the commenters to raise this issue provided any evidence to establish that runoff created by wet methods would actually create a problem (Document ID 2322, Attachment G, p. 14; 2243, p. 2; 2245, p. 4; 2314, p. 2; 2316, Attachment 1, pp. 2-3; 2101, pp. 6-7, 11-12). For example, one commenter, the Construction Industry Safety Coalition, advanced a theoretical argument that wet methods would either: (a) Require “tremendous” amounts of water; or (b) fail to effectively control silica. It stated:
For employers using wet methods, even attempting to meet this “no visible dust” standard will require a tremendous amount of water—many studies discussed in the technological feasibility analysis certainly support this notion. Such large amounts of water run counter to OSHA's contractor's assessment that “minimal” water should be used to avoid environmental contamination issues. The Agency contends that construction employers can mitigate any environmental concerns by utilizing as little water as possible to prevent accumulations from occurring or potentially damaging residential or commercial buildings. Even if utilizing only a little water will effectively reduce exposures to below the proposed PEL, the CISC has significant concerns that it will prevent all visible dust from being emitted (Document ID 2320, Attachment 1, pp. 9-10).
In light of the discussion set forth in Chapter VI of the FEA, Technological Feasibility, and evidence in the record, OSHA's preliminary findings regarding water runoff are affirmed. The Agency concludes that the comments it received expressing concerns about the runoff issue are unsubstantiated and theoretical and do not provide a sufficient justification for OSHA to alter its preliminary conclusions. As discussed in the Technological Feasibility section, OSHA finds that appropriate wet methods will typically require only limited application of water, possibly as little as a mist. In such conditions, the water will evaporate before collecting into a body of water. Where a greater water flow is necessary to suppress airborne silica, the runoff, rather than forming a free-flowing stream, will typically consolidate into slurry. In addition, because employers want to keep nearby structures and materials dry, they will typically use as little water as necessary.
OSHA finds support for these findings in the hearing testimony compilation assembled by the Building and Construction Trades Department. That evidence demonstrates the practical reality that water runoff from construction tasks is insignificant (Document ID 4223, pp. 28-30). Indeed, Deven Johnson, of the Operative Plasterers' and Cement Masons' International Association, stated that in her years of experience in using wet methods to control relatively dusty situations involving demolition, she had never had a problem with runoff-related issues. She indicated that runoff tends to create a slurry, which is easily vacuumed up (Document ID 3581, pp. 1695-1696). Gary Fore, a consultant and former Vice President for the American National Asphalt Pavement Association, likewise said that runoff was never a problem. He confirmed the PEA's preliminary conclusion for asphalt milling operations. While there may be a substantial amount of water used in the course of a day, it is applied as an aerosol. Further, although the pavement surface may be temporarily moist, it does not produce runoff from the construction site (Document ID 3583, p. 2209). Finally, Donald Hulk, Safety Director for Manafort, a construction contractor, testified that contrary to hypothetical assertions about potential runoff issues, his company did not find managing potential runoff from wet methods to be a problem. His reasoning confirmed the PEA's finding that the amount of water required for typical silica-containing dust suppression will not create substantial runoff. Moreover, he testified that in the case of demolition related to roadway construction, excess water is typically absorbed into demolition debris or evaporates—which is aided by the fact that most construction activity occurs during the warmer parts of the year (Document ID 3583, Tr. 2384-2385).
Certain industries voiced water runoff concerns specific to their workplaces. For example, the fertilizer industry stated its apprehension about OSHA's “preference” for wet methods to control silica exposure and indicated that such methods would be potentially problematic from an environmental standpoint at its facilities (Document ID 2101, pp. 6-7, 11-12). OSHA finds the fertilizer industry's concern misplaced because the final standard does not require the use of wet methods in general industry. Additionally, as discussed in Chapter III, the Agency estimates that exposures to respirable crystalline silica in the fertilizer industry are sufficiently low that most fertilizer-related manufacturing industries will not be affected by the final standard; the mixing-only fertilizer industry, NAICS 325314, was the only one judged to be affected.
The coal-fired electric industry also raised the issue of water runoff in its industry. The Edison Electric Institute and Alabama Power Company indicated a potential for conflict between an EPA rulemaking regarding ash ponds at the site of coal-fired electric utilities and this rulemaking (Document ID 2357, pp. 28-29; 2185, Attachment 1, p. 11). OSHA considered this concern, but has concluded that this will not be a problem in practice. The commenters never explained how the wet methods that might be required in Table 1 for construction activities (
Regulations that will reduce the atmospheric concentration of respirable crystalline silica in the air within industrial and other facilities and workplaces have the potential to affect, either positively or negatively, the amount of respirable crystalline silica emitted by these sources into the ambient (external) environment. In most cases, the change will be small. As discussed in Chapter V of the FEA, Costs of Compliance, most ventilation is needed to reach the preceding PEL rather than the new PEL. The extent to which the reduction in the PEL—and, hence, occupational exposures—under the OSHA standard will impact air quality depends on how employers handle the increased volume of respirable crystalline silica captured by the relevant control technologies. Taking into account the measures employers are already using to comply with the existing silica PEL, and the fact that the baghouses employers are already using capture at least 99 percent of silica emissions (Document ID 3641, p. VII-19), OSHA concludes that the final rule will not have a significant impact on air quality
A number of commenters raised concerns that the final rule would create an onerous and cost-increasing administrative burden because it would necessitate obtaining EPA environmental permits, notably with regard to air quality regulations and related permits and process approvals at the state and local level. The concern was not an adverse environmental impact, per se, but rather the burden of complying with existing environmental rules in the context of the new OSHA standard (
A prime concern voiced by the commenters was having to comply with OSHA compliance deadlines while simultaneously meeting deadlines under applicable air quality permitting regulations.
For example, the Asphalt Roofing Manufacturers Association (ARMA) raised the issue of EPA permits related to changes in ventilation systems.
As the Agency explains in the Summary & Explanation section of the preamble dealing with paragraph (j), dates, the final rule's effective and enforcement dates have been tailored to allow a sufficient period of time for employers to meet requirements for approval by other regulatory agencies. (A discussion of various state permitting times can be found in “Examples of State Environmental Agency Permit Turnaround Times,” ERG, 2015.) The Agency believes providing longer compliance deadlines should address the primary concerns expressed by commenters regarding the time necessary to obtain any required environmental permit approvals. Ultimately, as discussed in the Summary and Explanation, cases that are unusually problematic can be addressed through OSHA's enforcement discretion if the employer can show that it has made good faith efforts to implement engineering controls, but has been unable to implement such controls due to the time needed for environmental permitting.
Some industries raised permit concerns unique to their operations. The Association of American Railroads and American Short Line and Regional Railroad Association stated that it foresaw a need for a permit under the Clean Water Act if a ballast was sprayed with a chemical, which, through run off or by another means, reached a body of water (Document ID 2366, p. 7).
OSHA considers the railroad industry's concern about the threat of significant water contamination from chemical dust suppressant speculative because of the limited amount of water potentially used. Consequently, the Agency does not foresee a significant environmental impact. Additionally, no current OSHA standard governs the use of chemical dust suppressants. While some state or local governments may require a permit, it is not clear this would pose a new issue for the railroads, as OSHA believes it is likely that they already have to deal with such issues in the context of runoff from deicing chemicals, as well as oil and metal particles from normal operations. OSHA notes, however, that the analysis in the railroad section of Chapter IV of the FEA, Technological Feasibility, discusses chemical suppressants merely as a possibility for reducing exposures, but it is not ultimately identified as necessary to enable employers in the industry to meet the PEL of 50 μg/m
The Shipbuilders Council of America (SCA) stated that if the final silica rule altered blasting technologies and/or facility equipment, the data currently used for shipyard permits in certain states (
Based on its review of the record, OSHA concludes that the final rule will potentially have a positive environmental impact. At least one industry commenter, in the context of the hydraulic fracturing industry, suggested that its technology, the adoption of which would presumably be hastened by the promulgation and enforcement of the final rule, would reduce potential environmental impacts (Document ID 3589, Tr. 4140). In a similar vein, as discussed in both Chapters IV and V of the FEA, the final standard actually helps construction employers' reduce fugitive and co-generated dust, aiding in their compliance with environmental standards related to the dust. (The issue of controlling fugitive dust overlaps with the issue of existing employer obligations to minimize the runoff of solid waste into public water, discussed previously in this chapter, as well as the general expectation that employers clean up their work sites after their work is completed, as discussed in Chapter V).
As a result of this review, OSHA has reaffirmed its conclusions in the PEA, that the silica final rule will have no significant impact on air, water, or soil quality; plant or animal life; the use of land; or aspects of the external environment. It finds that the final standard is in compliance with NEPA and will have no significant environmental impact.
OSHA proposed two standards for occupational exposure to respirable crystalline silica—one for general industry and maritime and a second for construction. Both proposed standards were structured according to OSHA's traditional approach, including separate provisions for a permissible exposure limit (PEL), exposure assessments, and methods of compliance, which includes a requirement to follow the hierarchy of controls. The methods of compliance provision in the proposed construction standard included Table 1, which specified engineering controls, work practices, and respiratory protection for common construction operations (now referred to as tasks). Construction employers who would have chosen to fully implement engineering controls, work practices, and respirators for a task in proposed Table 1 would have been exempted from conducting exposure assessments for employees conducting
The structure of the final standard for general industry and maritime remains generally consistent with other OSHA health standards. The most significant structural change from the proposed general industry and maritime standard is that “cleaning methods,” which was under the
Many stakeholders thought that construction employers who fully and properly implement the engineering controls, work practices, and respiratory protection specified in Table 1 should be considered to be in compliance with the PEL. As reflected in paragraph (c) of the standard for construction (which includes Table 1), and as discussed in more detail in the summary and explanation, OSHA agrees that construction employers who fully and properly implement the engineering controls, work practices, and respiratory protection for a task on Table 1 do not have to demonstrate compliance with the PEL for that task, because these controls provide a level of protection equivalent to that provided by the alternative approach that includes the 50 µg/m
OSHA also received many comments about the challenges of conducting exposure assessments in the construction industry. OSHA expects that because of these challenges most construction employers will follow Table 1. Therefore, OSHA made major structural changes to the standard for construction to emphasize Table 1 in paragraph (c) for employers who choose to follow that approach. Paragraph (d) of the standard for construction provides alternative exposure control methods for construction employers who choose not to follow Table 1 or who perform tasks that are not included in Table 1 (
Construction employers who choose to follow Table 1 of paragraph (c) are exempt from following paragraph (d) but must comply with provisions in all other paragraphs of the standard for construction. On the other hand, construction employers who follow the alternate exposure control methods in paragraph (d) are exempt from following the provisions in paragraph (c) but must comply with the provisions in all other paragraphs of the standard for construction.
Although the structure of the standard for general industry and maritime differs from the structure of the standard for construction, many of the requirements are the same or similar in both standards. Therefore the summary and explanation is organized according to the main requirements of the standards. It includes paragraph references to the standard for general industry and maritime, followed by paragraph references for the standard for construction. The summary and explanation uses the term “rule” when referring to both standards. Generally, when the summary and explanation refers to the term “rule,” it is referring to the final rule. To avoid confusion, the term “final rule” is sometimes used when making a comparison to or clarifying a change from the proposed rule.
Separate standards for general industry/maritime and construction. OSHA proposed two separate standards addressing occupational exposure to respirable crystalline silica: one for exposures in general industry and maritime, and another for exposures in the construction industry. The proposed standards were intended to provide equivalent protection for workers while accounting for the different work activities, anticipated exposures, and other conditions in these sectors.
Commenters representing construction employers, labor unions, and governmental entities noted the intrinsic differences between construction and other industries and were generally supportive of OSHA's decision to propose one standard for general industry and maritime and another for construction (
The Association of Occupational and Environmental Clinics opposed applying occupational health protection measures differently (Document ID 3399, p. 4). Edison Electric Institute (EEI) argued that differences in the standards may create confusion, administrative burden, and ambiguity, and could ultimately frustrate good-faith compliance efforts. EEI suggested that the easiest solution would be for OSHA to have “a single regulation applicable to the electric utility industry, rather than separate General Industry and Construction requirements” (Document ID 2357, p. 17).
Commenters representing utility providers, surface mineral mining, rock crushing, railroad operations, and truck distribution expressed concerns about separate standards creating uncertainty about which requirements would apply to various activities (Document ID 2101, p. 3; 2185, pp. 4-5; 2318, p. 13; 2357, p. 4; 2366, p. 3; 3492, p. 2). Southern Company cited the installation of new power delivery lines versus the repair or maintenance of existing power delivery lines as an example, indicating that once a concrete pole is in the ground the process of mounting hardware is exactly the same, but the applicable standard may be different (Document ID 2185, p. 4).
The International Brotherhood of Teamsters (IBT) also expressed concerns about work activities where it may not be clear whether the general industry or construction standard applies. IBT noted that ready-mix concrete truck drivers frequently travel to more than one work location and may work at many different construction sites on any given day. These workers are typically covered by the general industry standard; however, they may work at construction sites and perform certain tasks that could be considered construction work (Document ID 2318, p. 13).
Several commenters requested that OSHA develop a table listing specified exposure control methods for general industry, comparable to proposed Table 1 for construction, or that OSHA add general industry tasks to Table 1 (Document ID 2116, Attachment 1, p. 3; 2212, p. 2; 2244, p. 4; 2339, p. 8; 2357, p. 1). The American Society of Safety Engineers requested that Table 1 “be considered for the general industry/maritime standard for commonly performed tasks involving high levels of silica exposure” (Document ID 2339, p. 8).
After considering the concerns raised by commenters, OSHA is issuing one standard that addresses occupational exposure to respirable crystalline silica in general industry and maritime work and another for construction work. As reflected primarily in paragraph (c) and
In issuing separate standards for general industry/maritime and construction, OSHA's intent is to ensure that employees exposed to respirable crystalline silica in construction are, to the extent feasible, provided equivalent protection to that afforded employees in general industry and maritime. Specifically, OSHA intends that Table 1 in paragraph (c) of the construction standard, while providing employers with an alternative, flexible approach to addressing exposure to respirable crystalline silica in construction, will provide the same level of protection against exposures to silica for construction employees as is provided to general industry and maritime employees; the same is true for construction employees whose employers are following the traditional exposure assessment and hierarchy of controls approach under paragraph (d) of the construction standard.
OSHA recognizes that in some circumstances, general industry activities and conditions in workplaces where general industry tasks are performed may be indistinguishable from those found in construction work. In some cases, employers whose primary business is classified as general industry may have some employees who perform construction work, and employers whose primary business is classified as construction may have some employees who perform general industry work. Given the wide variety of tasks performed in the workplace, it is inevitable that questions will arise regarding the classification of certain activities, and these questions have been and will continue to be addressed in letters of interpretation and other guidance issued by OSHA. However, the distinction between sectors is generally well understood by both OSHA enforcement personnel and the regulated community, and OSHA concludes that any attempt to create exceptions or to provide different criteria in this final rule would not improve upon the current criteria but would, rather, cause confusion.
In certain circumstances, tasks performed in a general industry setting may be indistinguishable from the tasks listed on Table 1, and, under these circumstances, OSHA intends to treat full compliance with the construction standard as full compliance with the general industry/maritime standard. Accordingly, OSHA has revised the scope provision (
These indistinguishable tasks should not be merely parallel or complementary to or occurring at the same time and place as the construction tasks listed on Table 1, but rather should be of the same nature and type as those construction tasks. OSHA anticipates that the option in paragraph (a)(3) will apply primarily to maintenance and repair tasks performed in general industry or maritime settings. For example, an employee using a portable masonry saw to cut brick to patch a section of an existing brick wall, which is typically maintenance, would require tools and controls that are the same as those of an employee cutting brick while building a new brick wall, which is construction work. In performing this task, the employer could follow the construction standard, including paragraph (c)(1)(ii) of Table 1, rather than the general industry and maritime standard. Similarly, the installation of new power delivery lines is considered a construction activity, while the repair or maintenance of existing power delivery lines is considered a general industry task, even though a handheld drill may be used to drill a hole in concrete during both activities. In this situation, if the employer complies with the entry on Table 1 for handheld and stand-mounted drills (paragraph (c)(1)(vii) of the construction standard), in addition to all other applicable provisions of the construction standard (
Paragraph (a)(3)(ii) of the general industry and maritime standard provides that, in order for the employer to be able to avail itself of the option to follow the construction standard, the task must not be performed regularly in the same environment and conditions. For example, an employer that performs sanding or cutting of concrete blocks in a concrete block manufacturing plant may not follow the construction standard, because the task is performed regularly in the same environment and conditions. Likewise, an employer whose business includes chipping out concrete from inside the drums of ready-mixed concrete trucks using pneumatic chipping tools may not follow the construction standard, because that task will be regularly performed in a relatively stable and predictable environment that would not require the accommodation of Table 1, which is intended in part to accommodate situations where the tasks will be performed in different environments and conditions.
Regarding comments that exposure controls should be specified in the general industry and maritime standard in a manner similar to that of Table 1 for construction tasks, OSHA concludes that, for most general industry operations, it is not possible to develop a specification that would broadly apply to facilities that vary widely in size, process design, and complexity while being specific enough to provide reasonably objective criteria against which to judge compliance with the standard. Unlike for construction tasks, the rulemaking record does not provide sufficient information for OSHA to account for the wide variety of potential
Section 4(b)(1) of the OSH Act limits OSHA's authority; the Act does not apply to working conditions of employees with respect to which other Federal agencies exercise statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health. Many of the regulatory boundaries between FRA and OSHA are documented in an FRA policy statement that outlines the respective areas of jurisdiction between FRA and OSHA with regard to the railroad industry, but the FRA has also defined some boundaries through rulemaking (Document ID 0692 (43 FR 10583-10590 (3/14/78))). In 2003, FRA amended the Railroad Workplace Safety regulations, 49 CFR part 214, to require that new and employer-designated existing on-track roadway maintenance machines be equipped with, among other things, positive pressurized ventilation systems, and be capable of protecting employees in the cabs of the machines from exposure to air contaminants, including silica, in accordance with OSHA's air contaminants standard, 29 CFR 1910.1000 (49 CFR 214.505). In that rulemaking, the FRA articulated the overlap of its authority with OSHA's concerning protection from air contaminants: “when working inside the cab, workers receive protection from FRA; when working outside the cab, workers receive protection from OSHA” (68 FR 44388, 44393-44394 (7/28/03)). Consequently, this OSHA rule applies only to those railroad activities outside the cab (
As discussed in Section V of this preamble, Health Effects, OSHA has concluded, based on the available scientific evidence, that quartz,
Some commenters contended that OSHA should differentiate between crystalline silica and amorphous silica in the scope of the rule. The Society for Protective Coatings stated that this differentiation would avoid confusion and unnecessary burden, especially for small businesses (Document ID 2120, p. 1; 3544, p. 16). NAIMA stated that NIOSH, IARC (the International Agency for Research on Cancer), EPA (the Environmental Protection Agency), and the California Office of Environmental Health Hazard Assessment all recognize the distinction in potential hazards to workers between amorphous and crystalline silica (Document ID 3544, p. 16). However, OSHA never intended to, and did not, include amorphous silica in the proposed rule. Nor do the final standards apply to amorphous silica. In fact, each standard bears the title, “Respirable crystalline silica”; only the respirable fraction of crystalline silica, where it exists as quartz, cristobalite, and/or tridymite, is covered.
OSHA addresses the concerns of commenters regarding situations where they believe exposures are minimal and represent very little threat to the health of workers by including in the standards' scope and application sections an exception based on the level of exposure to respirable crystalline silica. Therefore, paragraph (a)(2) of the standard for general industry and maritime provides an exception for circumstances where the employer has objective data demonstrating that employee exposure to respirable crystalline silica will remain below 25 micrograms per cubic meter of air (25 μg/m
OSHA concludes this approach is sensible policy because providing an exception for situations where airborne exposures are less likely to present significant risk allows employers to focus resources on the exposures of greatest occupational health concern. The Agency has included a definition for “objective data” in the rule (discussed with regard to Definitions) to clarify what information and data can be used to satisfy the obligation to demonstrate that respirable crystalline silica exposures will be below 25 μg/m
When using the phrase “any foreseeable conditions” OSHA is referring to situations that can reasonably be anticipated. The Agency considers failure of engineering controls to be a situation that is generally foreseeable. Although engineering controls are usually a reliable means for controlling employee exposures, equipment does occasionally fail. Moreover, OSHA intends the requirements for training on control measures, housekeeping, and other ancillary provisions of the rule to apply where engineering controls are used to limit exposures. Without effective training on use of engineering controls, for example, it is unreasonable to expect that such controls will be used properly and consistently. Thus, the exception does not apply where exposures below 25 μg/m
OSHA considers the exclusion from the application of the rule for exposures below the 25 μg/m
NADA's submission provides an example of data that can be used to meet the requirements of the standard (Document ID 4197; 4198). NADA conducted air monitoring for employees performing a variety of tasks in automobile body shops. NADA selected body shops from a random sample of members, and worked to ensure that those selected were not the most technologically advanced or cleanest in order to ensure that the results of the study were representative of typical operations. The sampling was conducted in accordance with procedures described in OSHA's Technical Manual, and techniques for controlling dust generated during sanding operations were recorded and monitored. NADA retained a consultant to review testing methodology and final results and worked with Maine's OSHA Consultation Program to gather samples. In the body shops sampled, all but one of the samples taken for respirable crystalline silica indicated that exposures were below the limit of detection. For the one sample where the level of exposure was above the limit of detection, the result was below 25μg/m
The construction standard, paragraph (a), also provides an exception where employee exposure will remain below 25 μg/m
When performed without adequate controls, some tasks can generate such high exposures. However, for some construction tasks that may be performed occasionally, for brief periods of time, exposures would not generally be expected to exceed 25 μg/m
Rather than require construction employers to develop objective data to support an exception from the construction standard for employees who are exposed to minimal levels of respirable crystalline silica, or who are occasionally exposed to respirable crystalline silica for brief periods, OSHA is structuring the scope paragraph (
In the NPRM, OSHA asked stakeholders whether the Agency should limit the coverage of the rule to materials that contain a threshold concentration (
OSHA has not included a threshold concentration exception in these standards. The Agency has concluded that it would not be appropriate to establish a threshold crystalline silica concentration because the evidence in the rulemaking record is not sufficient to lead OSHA to determine that the suggested concentration thresholds would be protective of employee health. The Agency's exposure assessment findings show that exposures to respirable crystalline silica can exceed the action level of 25 mg/m
The Brick Industry Association (BIA) argued that its members should be exempt from compliance with the respirable crystalline silica rule, indicating that the low toxicity of crystalline silica in the brick and structural clay industry does not cause a material risk of health impairment. BIA noted that OSHA has established specific requirements for certain industries in the past, such as the pulp, paper and paperboard mill industry in 29 CFR 1910.216, and the textile industry in 29 CFR 1910.262. BIA requested that OSHA take a similar approach for the brick industry because, BIA argued, silicosis is essentially non-existent in the brick industry's workers (Document ID 2300, pp. 2-4). OSHA also received comments and testimony from stakeholders in the brick, tile, and fly ash industries who argued that in their industries, crystalline silica was most commonly shrouded or occluded within matrices of aluminosilicates, and therefore the silica was less bioavailable and exhibited reduced toxicity (
As discussed in Section V of this preamble,
OSHA also received multiple studies, along with testimony and comments from the Sorptive Minerals Institute (SMI) (Document ID 2377; 4230). SMI stated that sorptive clays are limited to a specific and discreet subset of deposits in the U.S., including specifically: The Monterey formation (California), the Porters Creek formation (Mississippi Valley), the Twiggs and Meigs fullers earth (southeastern U.S.), the Wyoming or Western-type sodium bentonite deposits, the calcium bentonite deposits (north-central Florida), and the fullers earth deposits of eastern Virginia (Document ID 4230, p. 3). As discussed in Section V, Health Effects, SMI contended that silica in sorptive clays exists as either amorphous silica or as geologically ancient, occluded quartz, and that neither form poses the health risk described in OSHA's risk assessment (Document ID 4230, p. 2). After evaluation of the evidence SMI submitted to the record, OSHA finds that quartz originating from bentonite and similar sorptive clays is considerably less toxic than unoccluded quartz, and evidence does not exist that would permit the Agency to evaluate the magnitude of the lifetime risk resulting from exposure to silica in sorptive clay deposits. OSHA is therefore excluding sorptive clays from the scope of the rule, as described in paragraph (a)(1) of the general industry and maritime standard. The PEL in 29 CFR 1910.1000 Table Z-3 (
The respirable crystalline silica rule has no effect upon OSHA's standard for coke oven emissions, the existing PEL for coal dust, or any other substance-specific standard. None of these requirements provide the full range of protections afforded by the respirable crystalline silica rule. The PEL for coal dust is only a PEL; it does not provide any additional protections, such as medical surveillance. Other requirements therefore do not provide protection equivalent to the respirable crystalline silica rule. Accordingly, the silica rule applies to these situations to the extent there is silica exposure and the conditions for excluding them from the rule's scope are not met.
Paragraph (b) of the standard for general industry and maritime (paragraph (b) of the standard for construction) provides definitions of terms used in the standards.
“Action level” means a concentration of airborne respirable crystalline silica of 25 micrograms of respirable crystalline silica per meter cubed of air (μg/m
Because of the variable nature of employee exposures to airborne concentrations of respirable crystalline silica, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the permissible exposure limit (PEL) on days when no exposure measurements are made. Even when all measurements on a given day fall below the PEL but are above the action level, there is a reasonable chance that on another day, when exposures are not measured, the employee's actual exposure may exceed the PEL (Document ID 1501). The importance of the action level is explained in greater detail in the summary and explanation of
The action level in this rule is set at one-half of the PEL. This is the same ratio of action level to PEL that has been used and been effective in other standards, including those for inorganic arsenic (29 CFR 1910.1018), ethylene oxide (29 CFR 1910.1047), benzene (29 CFR 1910.1028), methylene chloride (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1026).
Following the publication of the proposed rule, OSHA received a number of comments pertaining to the definition of the action level. Some commenters, such as National Council for Occupational Safety and Health (NCOSH), American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), International Brotherhood of Teamsters, United Steelworkers (USW), Center for Effective Government (CEG), American Public Health Association (APHA), American Thoracic Society (ATS), and Cara Evens, a private citizen, supported OSHA's proposal to include an action level of 25 μg/m
This action level will further reduce exposure to respirable crystalline silica by workers and will incentivize employers to implement best-practice controls keeping exposures at a minimum as well as reducing costs of monitoring and assessments. The USW believes measuring airborne concentrations of silica at 25ug/m
AFL-CIO noted that action levels have long been incorporated into OSHA standards in recognition of the variability of workplace exposures and argued that the inclusion of an action level is particularly important in this
As discussed in more detail in the summary and explanation of
The National Institute for Occupational Safety and Health (NIOSH) supported an action level that is lower than the PEL because it is consistent with longstanding industrial hygiene practice, and an action level is included in other OSHA standards. NIOSH did not recommend a value for the action level but cited a 1975 study by NIOSH (Leidel
Other commenters supported having an action level, but advocated a higher level (
Southern Company asserted that OSHA set the proposed action level too low, because it believed it is difficult to measure based on current laboratory detection limits (Document ID 2185, pp. 5-6). It recommended that OSHA consider setting the action level at an achievable analysis level (though a suggested level for OSHA to consider was not provided) or conduct further cost analyses of additional sampling and ancillary provisions this may trigger. As stated further below, OSHA's conclusion that silica exposures can be measured with reasonable accuracy at the action level is discussed in the Sampling and Analysis discussion of technological feasibility in Chapter IV of the Final Economic Analysis and Final Regulatory Flexibility Analysis (FEA).
Other commenters supported an action level but argued that the proposed action level was set too high. For example, the United Automobile, Aerospace and Agricultural Implement Workers of America (UAW) argued that the action level would need to be set at 12.5 μg/m
Finally, some commenters opposed having any action level (Document ID 2085, p. 3; 2296, p. 40; 2305, pp. 4, 10; 2312, p. 2; 2317, p. 2; 2327, Attachment 1, pp. 13, 15-17; 2305, pp. 4, 10; 2296, p. 40; 3577, Tr. 707-708). Mercatus Center of George Mason University (Mercatus Center) asserted that OSHA did not provide adequate justification for the proposed action level, arguing that because OSHA found a PEL of 25 μg/m
OSHA considered these comments and has decided to retain an action level of 25 µg/m
OSHA agrees, however, that maintaining exposures below an action level that is half the PEL provides reasonable assurance that employees will not be exposed to respirable crystalline silica at levels above the PEL on days when no exposure measurements are made. OSHA's early standards relied, in part, on a statistical basis for using an action level of one-half the PEL (
OSHA thus agrees with UAW and BGA that an action level lower than one-half of the PEL would provide a higher degree of confidence that exposures are not likely to exceed the PEL. However, OSHA's policy is to set the action level at a value that effectively encourages employers to reduce exposures below the action level while still providing reasonable assurance that employee exposures are typically below the PEL. The Agency's experience with previous standards also indicates that an action level of one-half the PEL effectively encourages employers, where feasible, to reduce exposures below the action level to avoid the added costs of required compliance with provisions triggered by the action level.
OSHA is convinced, therefore, that an action level is needed and decided to set the action level at one-half of the PEL, based on residual risk at the PEL of 50 μg/m
“Competent person” means an individual who is capable of identifying existing and foreseeable respirable crystalline silica hazards in the workplace and who has authorization to take prompt corrective measures to eliminate or minimize them. The competent person must also have the knowledge and ability necessary to fulfill the responsibilities set forth in paragraph (g) of the construction standard. OSHA has not included requirements related to a competent person in the general industry and maritime standard. This definition therefore is included only in the construction standard.
In the proposal, OSHA defined competent person as one who is capable of identifying existing and predictable respirable crystalline silica hazards in the surroundings or working conditions and who has authorization to take prompt corrective measures to eliminate them. OSHA received a number of comments related to this definition. Many of these commenters suggested that the definition should be expanded. For example, Building and Construction Trades Department, AFL-CIO (BCTD) recommended that OSHA revise the proposed definition to require that the competent person be capable of identifying the proper methods to control existing and predictable hazards in the surroundings or working conditions. BCTD also asked that the definition specify that the competent person be “designated by the employer to act on the employer's behalf.” It proposed specific language that incorporated these suggestions (Document ID 4223, p. 112). International Union of Operating Engineers (IUOE) endorsed the BCTD definition and International Union of Bricklayers and Allied Craftworkers (BAC) agreed with BCTD that OSHA's definition needed to be more fully developed (Document ID 2262, p. 40; 2329, p. 5).
The American Society of Safety Engineers (ASSE) advocated for the following definition, which it based on that of the asbestos standard:
Competent person means, in addition to the definition in 29 CFR 1926.32(f), one who is capable of identifying existing respirable crystalline silica hazards in the workplace and selecting the appropriate control strategy for such exposure and for developing and overseeing written access control plans, who has the authority to take prompt corrective measures to eliminate such hazards, as specified in 29 CFR 1926.32(f), and who is trained in a manner consistent with OSHA requirements for training (Document ID 4201, pp. 3-4).
Finally, NIOSH noted the American National Standards Institute (ANSI) AIO.38 definition of competent person:
One who, as a result of specific education, training, and/or experience, is capable of identifying existing and predictable hazards in the surroundings [or] working conditions that are unsanitary, hazardous or dangerous to employees, and who has the authorization and responsibility to take prompt corrective measures to eliminate them [emphasis omitted] (as cited in Document ID 2177, Attachment B, p. 9).
In determining if the proposed definition for competent person needed to be revised, OSHA considered these comments and the definition of competent person in the safety and health regulations for construction (29 CFR 1926.32(f)). Under 29 CFR 1926.32(f), competent person is defined as one capable of identifying existing and predictable hazards in the surroundings or working conditions that are unsanitary, hazardous, or dangerous to employees and who is authorized to take prompt corrective measures to eliminate them. OSHA concludes that its definition for competent person is consistent with 1926.32(f) but tailored to respirable crystalline silica by specifying “respirable crystalline silica hazards” instead of “unsanitary, hazardous, or dangerous” conditions. OSHA did make a few minor revisions to its proposed definition. The Agency replaced the word “one” with “individual,” which is merely an editorial change. The Agency removed the phrase “in the surroundings or working conditions” and changed it to “in the workplace” to make it specific to the workplace. The Agency removed the phrase “to eliminate them” and changed it to “to eliminate or minimize them” to denote there may be cases where complete elimination would not be feasible. OSHA also changed “predicted” to “foreseeable” to make the wording consistent with the scope of the standard (paragraph (a)).
OSHA agrees with ASSE and the ANSI definition highlighted by NIOSH that the definition for competent person must indicate that the competent person has appropriate training, education, or experience. Therefore, OSHA further
The requirement that the competent person have the knowledge and ability to fulfill the responsibilities set forth in paragraph (g) addresses BCTD's and ASSE's requests to amend the definition to specify that the competent person be capable of identifying or selecting the proper methods to control hazards in the surroundings or working conditions. It is clear from paragraph (g) that the competent person must be familiar with and also capable of implementing the controls and other protections specified in the written exposure control plan.
ASSE also requested that the definition indicate that the competent person be capable of developing and overseeing the written access control plan, which OSHA had proposed. However, the final rule does not specify a written access control plan, and instead requires a written exposure control plan. Regardless, OSHA does not agree with ASSE's suggestion that the definition should be revised to indicate capability to develop a written plan. OSHA assigns that responsibility to the employer because under paragraph (g)(4), the competent person is someone on the job site who makes frequent and regular inspections, and thus may not be involved in developing the written exposure control plan in an office environment. OSHA also disagrees with BCTD that the definition should specify that the competent person is designated by the employer to act on behalf of the employer. The employer's obligation to designate a competent person is clearly specified in paragraph (g)(4) and the definition clearly states that the competent person has authority to promptly apply corrective measures.
The competent person concept has been broadly used in OSHA construction standards (
“Employee exposure” means the exposure to airborne respirable crystalline silica that would occur if the employee were not using a respirator. This definition clarifies the requirement that employee exposure must be measured as if no respiratory protection is being worn. The definition, which is consistent with OSHA's previous use of the term in other standards, did not generate any comment and is unchanged from the proposal.
“High-efficiency particulate air (HEPA) filter” means a filter that is at least 99.97 percent efficient in removing mono-dispersed particles of 0.3 micrometers in diameter. The definition is unchanged from the proposal. HEPA filters are more efficient than membrane filters because they are designed to target much smaller particles. In the housekeeping requirements of paragraph (h)(1) of the standard for general industry and maritime (paragraph (f)(1) of the standard for construction), OSHA refers to HEPA-filtered vacuuming as an example of an appropriate cleaning method, and the Table 1 entry for handheld and stand-mounted drills requires use of a HEPA-filtered vacuum (if a commercially available hole-cleaning kit connected to a dust collector is not being used). OSHA had also proposed HEPA-filtered dust collectors as controls for some tasks listed on Table 1 of the proposed standard for construction.
The Agency received one comment related to HEPA filters from the Occupational and Environmental Health Consulting Services (OEHCS). First, OEHCS recommended that the definition be expanded to indicate that HEPA filters are effective at removing particles in the 0.3-micrometer size range, as measured by a laser particle counter. Second, it requested addition of the term “Portable High Efficiency Air Filtration (PHEAF)” device, defined as a portable device equipped with a certified HEPA filter that, when tested as a complete unit, is 99.97 percent effective in removing particles in the 0.3-micrometer size range, as measured by a laser particle counter (Document ID 1953, pp. 4-6). OEHCS advocated for a requirement that portable filtration devices (
OSHA encourages employers to ensure that HEPA filters function in the field according to the specifications of this definition. However, the Agency concludes that it is not appropriate to include requirements for PHEAF devices, as defined by OEHCS, or laser particle counting testing, in the rule due to the lack of documented effectiveness or consistency with the definition and because of the lack of support in the record. As a result, OSHA is retaining its proposed definition for HEPA filter and is not adding PHEAF to the definitions section.
“Objective data” means information, such as air monitoring data from industry-wide surveys or calculations based on the composition of a substance, demonstrating employee exposure to respirable crystalline silica associated with a particular product or material or a specific process, task, or activity. The data must reflect workplace conditions closely resembling or with a higher exposure potential than the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations.
The proposed definition of “objective data” also included “calculations based on the . . . chemical and physical properties of a substance” as an example of a type of objective data that might demonstrate employee exposure to respirable crystalline silica. BCTD objected to this example's inclusion in the definition (Document ID 2371, Attachment 1, pp. 11-12). Although BCTD agreed that the chemical and physical properties of a substance are among the factors that may be relevant in determining whether data from one set of circumstances can be used to characterize the exposures in other circumstances, BCTD stated that the proposed definition suggested that the chemical and physical properties of the material could be determinative in every instance. It also maintained that on construction sites the work processes themselves are more consistently a significant predictor of ambient silica exposures than percentage of silica in the material itself. Finally, BCTD argued that it is very important to focus not only on the overall operation, but also the specific silica dust-generating task.
In including this item in the definition, OSHA did not intend to imply that it would be relevant in all circumstances. Nonetheless, OSHA has removed the phrase “chemical and physical properties” from the final definition of “objective data” because it has concluded that a substance's
The proposed rule also stated that objective data is information demonstrating employee exposure to respirable crystalline silica associated with a particular product or material or a specific process, operation, or activity. Throughout this rule, OSHA has often replaced the word “operation” with the word “task” (
In addition, the proposal indicated that “objective data” needed to reflect workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations. Dow Chemical Company stated that this requirement is generally appropriate, but argued that when data pertain to a more challenging work environment with higher potential for exposure, those data should be considered objective data (Document ID 2270, p. 2). It explained:
If data from a more challenging environment demonstrate compliance with the Permissible Exposure Limit, then one may infer with confidence that workers in a less challenging environment (
OSHA agrees with Dow that data pertaining to an environment with higher exposure potential can be used as objective data for other environments with less potential for exposure. Therefore, OSHA added “or with a higher exposure potential” to the definition.
Edison Electric Institute (EEI) requested that OSHA harmonize the definition of “objective data” throughout its regulations (Document ID 2357, p. 22). OSHA recognizes that the term has evolved over time based on the Agency's experience implementing those standards. “Objective data”, as defined in this standard, is based on the record in this rulemaking and reflects an appropriate definition in the context of exposures to respirable crystalline silica. Additionally, OSHA has established a process, the Standards Improvement Project, to improve and streamline OSHA standards, including the revision of individual requirements within rules that are inconsistent. OSHA will consider reviewing the consistency of this definition in the next iteration of this ongoing effort.
Many commenters suggested that OSHA add specificity with regards to what is considered objective data and establish criteria for objective data in the definition (
Commenters also provided examples of alternative exposure measurement and characterization strategies that could generate objective data, such as: area sampling (Document ID 2195, pp. 36-37); area exposure profile mapping (Document ID 2379, Appendix 1, pp. 48-49); real-time monitoring (Document ID 2256, Attachment 3, p. 12; 2357, pp. 37-38; 2379, Appendix 1, pp. 48-49, 55-56; 3578, Tr. 941-942; 3579, Tr. 161-162; 3588, Tr. 3798-3800; 4204, p. 56); and geotechnical profiling with testing for crystalline silica content (Document ID 2262, p. 13). Trolex LTD pointed to emerging methods and technologies, such as new optical methods for particle counting and identification, which might provide enhanced measurements of real-time employee exposure to respirable crystalline silica in the future (Document ID 1969, p. 2).
In addition, commenters provided specific examples of types of information and information sources that they felt should be considered objective data. For example, the American Foundry Society (AFS) commented that objective data should include data that permits reliable estimation of exposure, such as: data from real-time monitors and area exposure mapping; data from less than full-shift samples where professional judgment can be used to determine exposure levels; and exposure data where the percent of silica is calculated using a historical average for the area or operation involved (Document ID 2379, Appendix 1, pp. 54-55). The National Association of Manufacturers suggested the following as reliable sources of objective data: published scientific reports in the open scientific literature; NIOSH Health Hazard Evaluations; insurance carriers' loss prevention reports; and information that the silica in a process cannot be released because it is bound in a matrix preventing formation of respirable particles (Document ID 2380, Attachment 2, p. 26). ASSE identified industry-wide data, safety data sheets from product manufacturers, prior historical sampling data under comparable conditions, and aggregated company-wide sampling information as reliable sources of objective data (Document ID 3578, Tr. 1036). Commenters also pointed to data collected by a trade association from its members (
The Agency, while including specific examples in the definition (
Objective data is further discussed in the summary and explanation of
“Physician or other licensed health care professional [PLHCP]” means an individual whose legally permitted scope of practice (
OSHA received two comments on the definition of PHLCP, both of which addressed the scope of the PHLCP's qualifications, from APHA and ATS (Document ID 2175, p. 5; 2178, Attachment 1, p. 5). ATS agreed with OSHA's determination of who is qualified to be a PLHCP (Document ID 2175, p. 5). APHA advocated that the PLHCP:
As discussed further in the summary and explanation of
OSHA has included the same definition for PLHCP in other standards and continues to find that it is appropriate to allow any individual to perform medical examinations and procedures that must be made available under the standard when he or she is appropriately licensed by state law to do so and is therefore operating under his or her legal scope of practice. PLHCP, as defined and used in this standard, is consistent with other recent OSHA standards, such as chromium (VI) (29 CFR 1910.1026), methylene chloride (29 CFR 1910.1052), and respiratory protection (29 CFR 1910.134). OSHA's experience with PLHCPs in these other standards supports the Agency's determination.
“Regulated Area” means an area, demarcated by the employer, where an employee's exposure to airborne concentrations of respirable crystalline silica exceeds, or can reasonably be expected to exceed, the PEL. The definition is unchanged from the proposed standard. This definition is consistent with the use of the term in other OSHA standards, including those for chromium (VI) (29 CFR 1910.1026), 1,3-butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052).
OSHA proposed the inclusion of regulated areas in the standards for both construction and general industry/maritime, but has not included this provision, or the associated definition, in the final standard for construction. Construction industry stakeholders should instead refer to paragraph (g)(1)(iv) for written exposure control plan requirements to describe procedures for restricting access.
Several stakeholders, including the Construction Industry Safety Coalition (CISC) and National Association of Home Builders, requested that OSHA clarify what “reasonably expected” means (
As noted above, the language in the regulated areas definition has been included in a number of previous OSHA standards. Based on OSHA's experience with these standards, OSHA expects that employers will have little difficulty understanding the meaning of the phrase “reasonably be expected to exceed.” One reason OSHA chooses to utilize language that has been used in previous standards, where possible, is to avoid the sort of confusion CISC describes. In addition, the basis for establishing regulated areas in general industry and maritime and the reason for omitting this requirement in the construction standard are discussed in further detail in the summary and explanation of
“Respirable crystalline silica” means quartz, cristobalite, and/or tridymite contained in airborne particles that are determined to be respirable by a sampling device designed to meet the characteristics for respirable-particle-size-selective samplers specified in the International Organization for Standardization (ISO) 7708:1995: Air Quality—Particle Size Fraction Definitions for Health-Related Sampling. The definition in the rule is very similar to the proposed definition with one modification. OSHA changed the wording from “means airborne particles that contain quartz, cristobalite, and/or tridymite and whose measurement is determined by a sampling device . . .” to “means quartz, cristobalite, and/or tridymite contained in airborne particles that are determined to be respirable by a sampling device . . .” to make it clear that only that portion of the particles that is composed of quartz, cristobalite, and/or tridymite is considered to be respirable crystalline silica.
The definition for respirable crystalline silica encompasses the forms of silica (
The U.S. Chamber of Commerce (the Chamber), Halliburton, and the National Rural Electric Cooperative Association (NRECA) asserted that OSHA's proposed definition of respirable crystalline silica would encompass non-respirable particles (Document ID 2288, p. 15; 2302, p. 7; 2365, p. 12). NRECA stated:
As indicated in the discussion of the feasibility of measuring respirable crystalline silica exposures in Chapter IV of the FEA, there is currently no sampling device that precisely matches the ISO criteria in capturing respirable dust. However, available research indicates that many existing devices can achieve good agreement with the ISO criteria. When operated correctly, the sampling devices do not collect total dusts; they collect only the respirable fraction.
The Chamber and NRECA also argued that OSHA's proposed definition of respirable crystalline silica would include substances other than crystalline silica (Document ID 2288, p. 15; 2365, p. 12; 3578, Tr. 1138). NRECA stated:
An additional concern with the definition is that it states “any particles that contain quartz, cristobalite, and/or tridymite . . .” It is possible to interpret this portion of the definition to mean that any other mineral/impurities that were able to be collected into the sampling media will be counted/weighed as opposed to just the silica portions . . . (Document ID 2365, p. 12).
OSHA recognizes that the proposed definition could have been misunderstood to encompass components of respirable dust particles other than quartz, cristobalite, and tridymite. This was not the Agency's intent, and, in response to these comments, OSHA has revised the definition to clarify that only the portion of the particles composed of quartz, cristobalite, or tridymite is considered to be included in the definition of respirable crystalline silica.
Ameren Corporation supported OSHA's inclusion of quartz and cristobalite and allowing the use of a sampling device designed to meet the characteristics for respirable particle size-selective samplers specified in ISO 7708:1995 in the definition, but indicated that the definition should be limited to a “percentage of 1% or greater” (Document ID 2315, p. 3). However, it did not provide a rationale for why OSHA should include this in the definition. Including such a limitation in the definition of respirable crystalline silica would have the effect of limiting coverage of the rule to situations where crystalline silica concentrations in a mixture exceed the 1 percent threshold. As discussed in the summary and explanation of
The Society for Protective Coatings (SSPC) and the National Automobile Dealers Association recommended that OSHA distinguish between amorphous silica and crystalline silica in the definition (Document ID 2120, p. 2; 2358, p. 5). SSPC also provided a link to a Web page (
The SEFA Group (formerly the Southeastern Fly Ash Company) suggested adding a definition for “free respirable crystalline silica” to describe crystalline silica as an independent structure with varying surface chemistry, as distinguished from crystalline silica that is incorporated into a larger matrix of the parent mineral (Document ID 2123, p. 2). OSHA has revised the definition to clarify that respirable crystalline silica includes only the crystalline silica contained in airborne particles,
“Specialist” means an American Board Certified Specialist in Pulmonary Disease or an American Board Certified Specialist in Occupational Medicine. The term is used in paragraph (i) of the standard for general industry and maritime, (paragraph (h) of the standard for construction), which sets forth requirements for medical surveillance. For example, paragraph (i)(7)(i) of the standard for general industry and maritime, (paragraph (h)(7)(i) of the standard for construction) requires that the employer make available a medical examination when specialist referral is indicated in the PLHCP's written medical opinion for the employer.
The proposed rule did not include this term in the Definitions paragraph because it only allowed referral to an American Board Certified Specialist in Pulmonary disease, which was clearly addressed in the
OSHA is retaining the requirement for board certification to ensure a high level of competency. However, OSHA is persuaded by comments and testimony that individuals who are either American Board Certified in Occupational Medicine or American Board Certified in Pulmonary Disease are recognized specialists qualified to examine patients referred for possible respirable crystalline silica-related diseases. OSHA concludes that both pulmonary disease and occupational medicine specialists are qualified to counsel employees regarding work practices and personal habits that could affect their respiratory health, consistent with recommendations in Section 4.7.2 in ASTM standards E 1132-06, Standard Practice for Health Requirements Relating to Occupational
“Assistant Secretary,” “Director,” and “This section” are also defined terms. The definitions are consistent with OSHA's previous use of these terms in other health standards and have not changed since the proposal, which elicited no comments.
Finally, stakeholders suggested that OSHA define a number of new terms, including: “affected employee” (American Iron and Steel Institute (AISI) (Document ID 2261, p. 4)), “aged silica” (the Sorptive Minerals Institute (Document ID 3587, Tr. 3698-3699)), “asphalt milling” (IUOE (Document ID 2262, pp. 23-24)), “chest radiograph” (NIOSH (Document ID 2177, Comment B, pp. 40-41)), “controlling employer” (BAC and BCTD (Document ID 2329, p. 7; 2371, pp. 38-40)), “each employee” or “each affected employee” (AISI (Document ID 3492, p. 3)), “earth moving” (IUOE (Document ID 2262, pp. 6-9, 15)), “earth moving equipment” (IUOE (Document ID 3583, Tr. 2356-2360; 2262, pp. 6-9, 15)), “estimating respirable dust, excessive” (Industrial Hygiene Specialty Resources (Document ID 2285, p. 7)), “gross contamination” or “grossly contaminated” (ORCHSE, AFS, and NAHB (Document ID 2277, p. 4; 3584, Tr. 2669-2671; 3487, pp. 21-22; 2296, p. 29; 2379, Attachment B, p. 32)), “grossly” (Tile Council of North America (Document ID 2363, p. 6)), “intermittent work” (EEI (Document ID 2357, p. 14)), “respirable dust” (AFS (Document ID 2379, Attachment B, pp. 16, 28)), “safety and health professional technician” (Dr. Bird of the Chamber (Document ID 3578, Tr. 1176-1177)), “short duration” (EEI (Document ID 2357, p. 14)), and “silica exposure” (AIHA (Document ID 2169, p. 5)).
OSHA has concluded that these terms do not need to be defined in the rule. Many of the terms were part of the proposal or were included in stakeholder's comments on the proposal, but do not appear in the rule. For example, the proposed rule contained a provision related to protective work clothing in regulated areas that would have been triggered where there is potential for employees' work clothing to become grossly contaminated with finely divided material containing crystalline silica. As discussed in summary and explanation of
OSHA concludes that many of the other terms that stakeholders asked the Agency to define are sufficiently explained in the preamble or their meanings are clear. For example, OSHA explains the term “affected employee” in the summary and explanation of
The concept for the specified exposure control methods approach was included in the proposed rule. OSHA also included a version of Table 1 in the proposed rule for construction employers, identifying specific engineering controls, work practices, and respiratory protection for common construction tasks that employers could use to meet the requirement to implement engineering and work practice controls. Employers fully implementing the engineering controls, work practices, and respiratory protection on Table 1 would not have been required to conduct exposure assessments for employees performing a listed task, but would have been required to comply with the 50 µg/m
Prior to the NPRM, OSHA included this alternative compliance approach in the Preliminary Initial Regulatory Flexibility Analysis (PIRFA) provided to small business representatives during the Small Business Regulatory Enforcement Fairness Act (SBREFA) process (Document ID 0938, pp. 16-17). Participants in the SBREFA process generally supported the approach and their comments further informed the Agency in developing the proposed rule (Document ID 0937, pp. 37-39). An alternative compliance approach similar to that developed by OSHA for the SBREFA process was also included in ASTM E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, a consensus standard issued in May
The approach of specifying a list of tasks with a corresponding list of controls to simplify compliance in the construction industry received wide support from representatives in government, including the National Institute for Occupational Safety and Health (NIOSH); professional organizations, including the American Industrial Hygiene Association (AIHA) and the American Society of Safety Engineers (ASSE); labor, including the International Union of Operating Engineers (IUOE), the Building and Construction Trades Department of the AFL-CIO (BCTD), the Laborers' Health and Safety Fund of North America (LHSFNA), and the International Union of Bricklayers and Allied Craftworkers (BAC); and industry groups, including the Associated General Contractors of New York State, the Edison Electric Institute (EEI), and the National Asphalt Pavement Association (NAPA) (
Industry trade associations, such as the Construction Industry Safety Coalition (CISC), Leading Builders of America (LBA), the Mechanical Contractors Association of America, and individual construction employers, including Atlantic Concrete Cutting, Inc. and Holes Incorporated, generally supported the overall approach while being critical of the specifics of Table 1 (
One commenter, Francisco Trujillo, safety director for Miller and Long, Inc., suggested that the specified exposure control methods approach to compliance in the construction industry is not a substitute for safety professionals and industrial hygienists conducting exposure assessments and selecting the appropriate engineering controls, work practices, and respiratory protection for each task based on the results. He commented that “[t]he implication that if Table 1 is followed everything will be fine is unrealistic . . .” and recommended that Table 1 be at most non-mandatory guidance (Document ID 2345, p. 4).
OSHA agrees that safety professionals and industrial hygienists play a key role in ensuring the safety of employees exposed to silica during certain activities, including those not listed on Table 1, and can also help ensure that the engineering controls, work practices, and respiratory protection specified on Table 1 are fully and properly implemented. However, as discussed below, the Agency is not persuaded that construction employees will always be better protected by the traditional performance approach of establishing a PEL and requiring periodic exposure assessments, particularly when the tasks and tools that cause high exposures to respirable crystalline silica, and the dust control technologies available to address such exposures, can be readily identified.
Although there was general agreement among commenters that an alternative approach was needed to simplify compliance for the construction industry, commenters provided various opinions on how such an alternative compliance approach should be structured to ensure that it was workable in practice. Several commenters, including BCTD, LHSFNA, EEI, LBA, Fann Contracting, Inc., CISC, ASSE, the National Association of Home Builders (NAHB), the Associated Builders and Contractors (ABC), and Holes Incorporated, urged OSHA to exempt employers complying with Table 1 from also complying with the PEL (
Similarly, commenters from both industry and labor, including the American Federation of State, County, and Municipal Employees, Mechanical Contractors Association of America, the American Federation of Labor and Congress of Industrial Organizations, BAC, BCTD, and LHSFNA, also argued that exposure assessments should not be required where employers implement control measures specified on Table 1 for construction tasks (
On the other hand, other commenters, including NIOSH, argued that fully implementing the controls described on Table 1 would not automatically provide a sufficient level of confidence that exposures are adequately controlled; employers would also need to ensure that the exposures of employees performing Table 1 tasks would not exceed the revised PEL (
Several commenters, including Fann Contracting, IUOE, LBA, CISC, Charles Gordon, a retired occupational safety and health attorney, Arch Masonry, Inc., and NUCA argued that as proposed, the alternative compliance option would not necessarily simplify compliance for some employers, as they would still need to do exposure assessments for a variety of reasons, such as monitoring employees working in the vicinity of Table 1 tasks, complying with the PEL, providing monitoring data to controlling employers on multi-employer worksites, and complying with the rule for tasks
Other commenters supported the inclusion of exposure assessment requirements for employees performing tasks on Table 1 even where employers implement the specified engineering controls, work practices, and respiratory protection to best protect employees in the construction industry. The Center for Progressive Reform commented that:
The International Safety Equipment Association (ISEA) opined that the most protective approach for employees is for employers to take air samples of respirable crystalline silica (Document ID 2212, p. 1). AIHA argued that there remained a need for exposure monitoring to verify that the controls in place for Table 1 tasks actually reduce exposures (Document ID 2169, p. 3). NIOSH recommended periodic exposure monitoring requirements for these tasks to provide a sufficient level of confidence that exposures are adequately controlled and that the employers' selection of equipment, maintenance practices, and employee training were effective (Document ID 2177, Attachment B, pp. 17, 26). Charles Gordon proposed that when performing a Table 1 task, employers should be required to semi-annually monitor each task and keep records of that monitoring to ensure that workers are not exposed to high levels of respirable crystalline silica (Document ID 3539; 3588, Tr. 3801).
After reviewing the comments on this issue, OSHA concludes that the best approach for protecting employees exposed to respirable crystalline silica in the construction industry is to provide a set of effective, easy to understand, and readily implemented controls for the common equipment and tasks that are the predominant sources of exposure to respirable crystalline silica. OSHA is persuaded by comments and data in the record that requiring specific engineering controls, work practices, and respiratory protection for construction tasks, in lieu of a performance-oriented approach involving a PEL and exposure assessment, is justified for several reasons so long as employers fully and properly implement the engineering controls, work practices, and respiratory protection specified on Table 1.
First, the controls listed on Table 1 represent the feasible controls identified in the record for each listed task, and there is substantial evidence that demonstrates that, for most of the Table 1 tasks, exposure to respirable crystalline silica can be consistently controlled below 50 µg/m
Second, this approach recognizes and avoids the challenges of characterizing employee exposures to crystalline silica accurately in many construction tasks while also ensuring that employees are protected. In manufacturing settings and other more stable environments subject to the general industry standard, exposure assessment can provide an accurate depiction of the silica exposure that could be typically expected for employees in normal operating conditions. In general, such assessments need not be repeated frequently, costs are therefore minimized, and the results will be timely even if there is a delay for lab processing. In contrast, the frequent changes in workplace conditions that are common in construction work (
Third, requiring employers to implement specified dust controls absent an additional PEL requirement simplifies compliance for employers who fully and properly implement the engineering controls, work practices, and respiratory protection listed on Table 1. Simplifying compliance will also encourage employers performing tasks listed on Table 1 to use this approach, rather than the alternative of performing exposure assessments and implementing dust controls, as required by paragraph (d) of the standard for construction, and thus, will also reduce regulatory burden on construction employers of all sizes. For this reason, OSHA expects that the vast majority of construction employers will choose to follow Table 1 for all Table 1 tasks.
Fourth, this approach will also create greater awareness of appropriate controls, which may in turn facilitate better implementation and compliance, by making it far easier for employees to understand what controls are effective for a given task and what controls the employer must provide. Employees can locate the task they are performing on Table 1 and immediately see what controls are required, along with any specifications for those controls. It will, further, be clear if an employer is not providing the correct controls or ensuring that they are being used appropriately.
Other commenters provided suggestions for what they believed should be considered “fully and properly implementing” the controls specified on Table 1. NIOSH recommended that OSHA provide checklists and require a daily evaluation
Although the specified exposure control methods approach affords compliance flexibility for the employer, OSHA sees value in reminding employers and employees that this option will only be protective if they take steps to ensure that the engineering controls, work practices, and respiratory protection are as effective as possible. Thus, the Agency is requiring employers to fully and properly implement the specified engineering controls, work practices, and respiratory protection for each employee performing a task described on Table 1 in order to be in compliance with paragraph (c)(1) of the standard for construction. To do otherwise would undermine the entire basis for this compliance approach.
Merely having the specified controls present is not sufficient to constitute “fully and properly” implementing those controls. Employees will not be protected from exposure to respirable crystalline silica if the specified engineering controls, work practices, and respiratory protection are not also implemented effectively. In order to be in compliance with paragraph (c)(1) of the standard for construction, employers are required to ensure that the controls are present and maintained and that employees understand the proper use of those controls and use them accordingly.
While OSHA has decided not to further define “fully and properly” by providing specific checklists for employers or requiring employers to conduct inspections at set intervals, there are several readily identifiable indicators that dust controls are or are not being fully and properly implemented, many of which are discussed with regard to specific equipment and tasks in Chapter IV of the FEA and in the discussions of specific controls that appear further below in the section. For example, for dust collection systems, the shroud or cowling must be intact and installed in accordance with the manufacturer's instructions; the hose connecting the tool to the vacuum must be intact and without kinks or tight bends that would prevent the vacuum from providing the air flow recommended by the tool manufacturer; the filter(s) on the vacuum must be cleaned or changed as frequently as necessary in order to ensure they remain effective (it may be necessary to activate a back-pulse filter cleaning mechanism several times during the course of a shift); and dust collection bags must be emptied as frequently as necessary to avoid overfilling, which would inhibit the vacuum system from operating effectively. For water-based dust suppression systems, an adequate supply of water for dust suppression must be available on site. For worksites without access to a water main, a portable water tank or water truck having enough water for the task must be provided. The spray nozzles must be working properly to produce a spray pattern that applies water at the point of dust generation and inspected at regular intervals to ensure they are not clogged or damaged. All hoses and connections must be inspected as necessary for leaks that could signal that an inadequate flow rate is being delivered.
Manufacturer's instructions can also provide information about how to fully and properly implement and maintain controls. For example, the operator's instruction manual for EDCO concrete/asphalt saws provides a pre-start checklist that includes information about the proper functioning of wet-cutting equipment (Document ID 1676, p. 5). In some cases, industry associations and employers, in collaboration with equipment manufacturers, have also developed best practices with regard to the full and proper implementation of engineering controls, work practices, and respiratory protection for their particular industry or operation. For example, NAPA and the Association of Equipment Manufacturers (AEM) provided operational guidance for water systems during milling operations that includes pre-operation inspection activities, preparations for safe operation, and other operation considerations (Document ID 2181, p. 52).
In addition, paragraph (g) of the standard for construction requires employers to establish and implement a written exposure control plan, which includes provisions for a competent person to make frequent and regular inspection of job sites, materials, and equipment in order to implement the plan (
OSHA expects that in most instances it will be straightforward for a designated competent person to identify whether the controls have been fully and properly implemented. For example, a significant amount of visible dust being frequently or continuously emitted from the material being worked on can serve as an indication that controls are not fully and properly implemented. A small amount of dust can be expected even with new equipment that is operating as intended by the manufacturer. The amount of visible dust associated with the new dust controls should be noted when equipment is put into service and checked periodically. A noticeable increase in dust emissions would indicate that the dust control system is not operating as intended.
It is not OSHA's intent, however, for all employees who are in the vicinity of a listed task to be considered “engaged in the task.” To protect the other employees in the vicinity of a listed task, the employer must account for the potential exposures of these employees to respirable crystalline silica as part of its written exposure control plan. As discussed in the summary and explanation of
Table 1 in the final standard differs from Table 1 in the proposed standard in a number of respects. As proposed, “Table 1—Exposure Control Methods for Selected Construction Operations,” listed 13 construction operations that expose employees to respirable crystalline silica, as well as control strategies and respiratory protection that reduce those exposures. In developing Table 1 for the proposed standard, OSHA reviewed the industrial hygiene literature across the full range of construction activities and focused on tasks where silica-containing materials were most likely to be fractured or abraded and where control measures existed to offer protection against a variety of working conditions. OSHA also included additional specifications on proposed Table 1 to ensure that the strategies listed were properly implemented and remained effective.
Table 1 was the subject of many comments in the rulemaking record. Commenters, such as BCTD, urged OSHA to reconsider its use of the proposed term “operation” to describe the activities listed on Table 1 (Document ID 2371, Attachment 1, p. 23). Kellie Vazquez, on behalf of Holes Incorporated and CISC, suggested that it would be helpful to include more specifically-defined tasks, rather than broader operations (Document ID 2320, pp. 8-9). In the same vein, BCTD suggested that OSHA “revise [Table 1] to make clear that its focus is on particular silica dust-generating
Other commenters requested that OSHA include additional activities on Table 1. The Sheet Metal Air Conditioning Contractors National Association (SMACNA) commented that using powder-actuated tools should be added (Document ID 2226, p. 2), and the Interlocking Concrete Pavement Institute (ICPI) suggested that OSHA include compacting pavers, sweeping sand into paver joints, and compacting the aggregate base (Document ID 2246, pp. 2, 11). NAHB noted that Table 1 failed to cover hand-mixing concrete (Document ID 2334, p. 4). OSHA did not receive data showing that employees engaged in many of these additional minor tasks (pulling concrete forms, mixing concrete for post holes, etc.) experience significant routine exposure to respirable crystalline silica above the action level that would require their employers to comply with provisions of this rule. Because OSHA does not currently have data indicating that additional controls for these tasks would be needed on a regular basis or would be effective, it has determined not to include them on Table 1.
OSHA recognizes the possibility that employers may later discover that there are tasks that are not covered by Table 1 where they may have difficulty meeting the PEL. If such cases arise, OSHA can address them in several ways, including: considering technological or economic infeasibility defenses, and applying its variance process—either temporary or permanent, pursuant to which an
Several commenters requested that OSHA add tasks or activities and equipment to Table 1 that are associated with general industry operations such as asphalt plant operations, shale gas fracturing, and artificial stone and granite countertop work (Document ID 2212, p. 2; 2116, Attachment 1, p. 28; 2244, p. 4). OSHA is not including these in the construction standard for the reasons discussed in the summary and explanation of Scope.
NUCA requested that OSHA add underground construction, specifically excavation, onto Table 1, stating:
The nature of excavation underground construction is continuously mobile. Exposure assessments take time to evaluate by a lab, and in that time, the jobsite conditions will change or crews will move to other sites. Test results simply could not be available in enough time to be relevant to a particular jobsite. This not only makes costly lab assessments irrelevant to particular sites, it also does nothing to protect the workers on those sites (Document ID 2171, p. 2).
OSHA's technological feasibility analysis for underground operations (Section 5.12 of Chapter IV of the FEA) indicates that employees performing activities not specific to tunneling, such as grinding, hole drilling, or chipping, receive similar exposures from their equipment as employees performing those same activities aboveground in enclosed environments (
Likewise, although abrasive blasting is a common source of silica exposure in construction, OSHA does not include an entry for abrasive blasting on Table 1 for reasons explained more fully below. As described in the Introduction to Chapter IV of the FEA, the tasks included on Table 1 of the final rule are those that have been widely recognized as high-exposure tasks in construction, and for which there has been considerable research performed on the effectiveness of dust control strategies. The record indicates that the tasks reflected in Table 1, with few exceptions such as underground construction and abrasive blasting, are the tasks that employers will most frequently need to address to ensure employee protection from crystalline silica hazards. For tasks not included on Table 1 that foreseeably generate silica exposures above the action level, construction employers will, in accordance with paragraph (d) of the standard for construction, need to conduct an exposure assessment and maintain exposures at or below the PEL through use of the traditional hierarchy of controls.
Commenters also weighed in on OSHA's general approach to selecting the engineering controls and work practices for each task. LBA argued that there was a disconnect between the feasibility evidence and the controls and work practices included on Table 1 (Document ID 2269, p. 17). NAHB urged OSHA to ensure that the protection methods included on Table 1 are based on verifiable studies that show effective solutions (Document ID 2296, p. 28). BCTD also opined that only “control measures supported by good quality evidence should be listed on Table 1” (Document ID 2371, Attachment 1, p. 24).
OSHA agrees that the engineering controls, work practices, and respiratory protection specified on Table 1 need to be consistent with the evidence presented in its technological feasibility analyses (
CISC commented that the requirement for an integrated water system limited options for employers and may reduce the use of the table, stating “. . . if a construction employer finds a way to effectively deliver water through another mechanism, in the CISC's view that should be encouraged” (Document ID 2319, p. 103; 2320, p. 16). OSHA expects that most employers will use integrated water systems, as provided by manufacturers, and will follow Table 1 but its intent is not to prohibit the use of other dust suppression methods during cutting. Employers may implement other controls or wet method configurations if they determine that the alternative control is more appropriate for their intended use. However, employers who choose to use controls not listed on Table 1 will be required to conduct exposure assessments and comply with the PEL in accordance with paragraph (d) of the standard for construction.
CISC also questioned the appropriateness of requiring an integrated water delivery system when most integrated systems are intended to keep the blade cool and are not designed for dust suppression (Document ID 2319, p. 103; 2320, p. 16). In written testimony, Rashod Johnson of the Mason Contractors Association of America stated that
However, product literature from five major saw manufacturers (Andreas Stihl, Husqvarna, Hilti, Makita USA, and Wacker Group) highlights the use of water application equipment to suppress dust in addition to blade cooling (Document ID 3998, Attachment 12a, pp. 9, 15-16; 3998, Attachment 12e, p. 3; 3998, Attachment 12f; 3998, Attachment 12g, p. 5; 3998, Attachment 12h, p. 8). For example, Stihl's manual for the model 410 and 420 cut-off machines (handheld masonry saws) specifically recommends a water flow rate for dust suppression (Document ID 3998, Attachment 12a, pp. 9, 15-16). Furthermore, Stihl is not the only cut-off saw manufacturer to state that water used with its product is intended to suppress dust emissions. Husqvarna's product literature for the K 3000 Wet describes the product as a power cutter for wet applications that is equipped with a dust extinguisher system (Document ID 3998, Attachment 12f, p. 1). Hilti also recognizes that water suppresses dust and recommends the use of wet cutting to reduce dust in its instruction manual for the Hilti DSH 700/DSH 900 model handheld masonry saws (Document ID 3998, Attachment 12e, p. 3).
CISC asked that OSHA clarify whether there needs to be a separate integrated water delivery system in addition to the system provided by the manufacturer to keep the blade cool (Document ID 2319, p. 104). Beamer
OSHA is requiring the use of a commercially available dust collection system (
CISC opposed OSHA's requirement for commercially available systems, stating “[t]his specification eliminates specialty manufactured products that may be equally effective” (Document ID 2320, p. 11). However, CISC did not provide examples or describe what is meant by “specialty manufactured products.” It is not OSHA's intent to prevent employers from using products that are custom made by aftermarket manufacturers (
In Table 1 of the proposed rule, OSHA would have required dust collection systems be equipped with High-Efficiency Particulate Air (HEPA) filters, which are 99.97 percent efficient in capturing particles having an aerodynamic diameter of 0.3 μm or larger. In the final standard, OSHA is not requiring the use of HEPA filters and instead is requiring the use of filters with a capture efficiency of 99 percent or greater for respirable particulate. Although OSHA received comments and testimony in support of using HEPA filters to capture silica dust (Document ID 1953, pp. 3-4; 1973, pp. 2-3), extensive comments were submitted to the record expressing concern regarding this requirement.
Occupational and Environmental Health Consulting Services, Inc. (OEHCS) noted the numerous deficiencies found with HEPA filtration from ineffective seals, deterioration of the filter, and inadequate testing prior to use, which often results in employee exposure to potentially-hazardous particles and possible recontamination of the work environment (Document ID 1953, Attachment 1). The Precast/Prestressed Concrete Institute (PCI), NUCA, and LBA noted that HEPA filters do not work well in the construction environment because filters will clog up quickly and must be changed often (Document ID 2276, p. 10; 3729, p. 3; 2269, p. 23). CISC noted that HEPA filters will typically not last an entire shift, stating that they clog up quickly and need to be monitored and changed frequently (Document ID 2320, p. 114). Consequently, CISC asserted, HEPA filters are not effective at filtering respirable dust or at reducing exposures to respirable silica (Document ID 2319, p. 95).
OSHA reached the same conclusion in its technological feasibility finding for mortar and concrete grinding as well (
OSHA is persuaded that it should not require that dust collection systems be equipped with HEPA filters because HEPA filters in some applications will result in loss of airflow and concomitant degradation of dust-capture efficiency. In examining manufacturers' specifications for many commercially-available dust collectors, OSHA finds that most offer, in addition to HEPA filters, other filters with a 99 percent efficiency or better in the respirable-particle-size range. Many examples of products equipped with filters that do not meet HEPA specifications but nevertheless meet the requirement for 99 percent efficiency in the respirable-particle-size range were submitted to the
OSHA also received many specific comments about particular changes to the notes and additional specifications, associated with the entries on Table 1, and on the specified engineering and work practice control methods identified for each entry, which are further discussed later in this section.
Some commenters stated that the notes were too detailed, while others argued that the notes were not detailed enough (Document ID 2319, p. 6; 2262, p. 29; 3581, Tr. 1631-1632; 3585, Tr. 2924-2925, 3052-3053; 4223, pp. 95-97). Several commenters expressed concern that certain notes were unrealistic or too confusing for an employer to comply with. CISC stated that the inclusion of the notes left Table 1 “unworkable” for most employers in the construction industry (Document 2319, p. 6). Others questioned whether these additional specifications were a mandatory component of Table 1 or simply suggested guidelines to help determine the efficacy of the control (Document ID 2296, p. 28; 3441, pp. 4-5). On the other hand, some commenters asserted that the additional specifications were needed on Table 1 to ensure that controls are properly operated and effective (Document ID 3589, Tr. 4286-4287; 3581, Tr. 1631-1632; 4223, pp. 95-97).
To balance the need to clarify how the specifications apply to make Table 1 workable with the need to provide more specific information about the controls in order to ensure that they are effective, OSHA has removed most of the notes and additional specifications from the individual entries on Table 1 and has instead included revised specifications for the controls in paragraph (c)(2) of the standard for construction. This approach has the added benefit of making Table 1 more readable because specifications that apply to multiple rows can now be addressed in a single subparagraph.
Paragraph (c)(2)(i) of the standard for construction requires employers to provide a means of exhaust as needed to minimize the accumulation of visible airborne dust for tasks performed indoors or in enclosed areas. When tasks are performed indoors or in enclosed areas, the dispersal of dust can be impeded such that concentrations can build up without the aid of forced ventilation. Flanagan et al. (2006) concluded that the degree to which a work area is enclosed is an important determinant of employee exposure based on data demonstrating increased exposures to respirable crystalline silica for enclosed environments (those with two to four walls, as well as those having walls, a roof, and windows), as compared to outdoor environments (Document ID 0677, pp. 148-149). Increased exposures to respirable crystalline silica were also demonstrated for tasks listed on Table 1 in enclosed areas, such as jackhammering inside a large pool area (Document ID 3958, Rows 1064, 1065, 1066) and handheld sawing in a large garage building open in front and closed on three sides (Document ID 3777, p. 65).
Sufficient air circulation in enclosed or indoor environments is important to ensure the effectiveness of the control strategies included on Table 1 and to prevent the accumulation of airborne dust. The “means of exhaust” necessary to minimize the accumulation of visible airborne dust could include dilution ventilation through the use of portable fans that increase air movement and assist in the removal and dispersion of airborne dust, which would otherwise remain in the enclosure and contribute to elevated exposures. To be effective, the ventilation must be implemented so that movements of employees, or the opening of doors and windows, will not adversely affect the airflow.
Paragraph (c)(2)(ii) of the standard for construction requires employers, for tasks performed using wet methods, to apply water at flow rates sufficient to minimize release of visible dust generated by the task. BCTD and LHSFNA encouraged OSHA to specify minimum flow rates for water where there are data or studies to support such a recommendation (Document ID 3581, Tr. 1632; 3589, Tr. 4286-4287). NIOSH recommended a flow rate of 0.5 L/min for handheld power saws based on experimental data and recommended that OSHA specify a minimum water flow rate of 300 mL/minute for jackhammers based on a field study of control equipment fabricated specifically for the study (Document ID 2177, Attachment B, pp. 19, 33; 0867, p. 6). Water has been proven an efficient engineering control method to reduce exposures to airborne crystalline silica-containing dust. Adequate dust capture is dependent on a variety of factors such as dust particle size, velocity, spray nozzle size and location, use of surfactants or other binders, and environmental factors (water hardness, humidity, weather, etc.) that must be considered when implementing wet methods. Water flow rates suggested by various studies, while perhaps instructive, may not be applicable to all of the different types of equipment that could be used or the conditions that may be encountered by employers following Table 1. Because the appropriate water flow rates for controlling silica dust emissions can vary, OSHA is not establishing a required flow rate for wet suppression systems or specifying a flow rate for individual Table 1 entries.
Paragraphs (c)(2)(iii)(A)-(F) of the standard for construction require employers implementing measures that include an enclosed cab or booth to ensure that the enclosed cab or booth is maintained as free as practicable from settled dust, has door seals and closing mechanisms that work properly, has gaskets and seals that are in good condition and work properly, is under positive pressure maintained through continuous delivery of fresh air, has intake air that is filtered through a pre-filter that is 95 percent efficient in the 0.3-10.0 µm range (
Dust can be unintentionally carried into enclosed cabs or booths through a number of routes, including on employees' boots, during the opening of doors when accessing or exiting the cab, through leaks in the system, or when employees roll down windows. IUOE, recommending that OSHA add specificity to the cab requirements (
Direct-reading instruments show that fine particle (0.3 micron (μm) in size) concentrations inside operator cabs can be reduced by an average of 93 percent when cabs are clean, sealed, and have a functionally adequate filtration and pressurization system (Document ID 1563, p. 1). Cecala
OSHA determined that the requirements specified in paragraphs (c)(2)(iii)(A)-(F) of the standard for construction reduce the likelihood of respirable crystalline silica exposure in enclosed cabs or booths when employees are present by lowering the potential for dust to be re-suspended inside the enclosure, promoting the ability of the enclosed cab or booth to keep dust from entering through cracks or openings (
IUOE also suggested that OSHA require employers to provide boot brushes or mudflingers to minimize the dust brought into the cab, to equip cabs with dust-resistant materials, and to affix warning labels to the interior of the cab (Document ID 2262, p. 30; 4025, p. 17). The Agency has not included these additional requirements since it expects that the specifications in paragraphs (c)(2)(iii)(A)-(F) of the standard for construction combined with frequent inspections by the competent person will be sufficient to protect employees against the potential respirable crystalline silica exposures within the enclosure.
OSHA has not included more specific requirements in paragraphs (c)(2)(i)-(c)(2)(iii) of the standard for construction (
OSHA did not include specifications on visible dust and wet slurry, included as notes in individual entries on proposed Table 1, in the standard. The Agency has determined that these issues are best addressed by other provisions of the standard, rather than as a note or additional specification included in each relevant Table 1 entry. Further discussion about these specifications is also included below.
Many commenters expressed concern with the note, contained in proposed Table 1 for all but two entries, requiring employers to operate equipment such that no visible dust is emitted from the process. Industry commenters, including the Power Tool Institute (PTI), Western Construction Group, SMACNA, the Independent Electrical Contractors, the Distribution Contractors Association, CISC, the Utility and Transportation Contractors Association of New Jersey, Atlantic Concrete Cutting, ABC, LBA, Holes Incorporated, and N.S. Giles Foundations objected to this note, stating that it was an unrealistic requirement which made Table 1 unworkable (
Some industry commenters asserted that it is impossible to perform tasks, such as sawing, grinding, and drilling, without generating any visible dust (Document ID 2357, pp. 27-28; 3441, p. 6; 4073, Attachment 9e, p. 1). Holes Incorporated noted that when grinding or using other hand-held pieces of equipment, the work cannot be performed with the tool flush against the impacted surface, and at times, there will be a gap and visible dust will be emitted even when local exhaust ventilation or wet methods are utilized (Document ID 3441, p. 6).
Other commenters expressed concern that there is no true dustless system, clarifying that even those tools marketed as “dustless” produce some level of airborne dust (Document ID 2345, p. 4; 3585, Tr. 2960; 4216, pp. 2-3). Francisco Trujillo, safety director for Miller and Long, stated that:
Every “dustless” system I have ever witnessed has produced some level of airborne dust. This fact alone should show that Table 1 sets criteria that are impossible to achieve . . . (Document ID 2345, p. 4).
On the other hand, commenters, including NAPA and BAC, noted that in their experience there is no visible dust generated when certain equipment, such as asphalt machines for milling or stationary masonry saws, is used with available dust controls (Document ID 3583, Tr. 2216; 3585, Tr. 3072). They did not, however, provide any indication that the same results could be achieved with all of the other equipment listed on Table 1.
Several commenters provided a different rationale for their objections to this note. AIHA opined that the requirement to operate equipment such that no visible dust is emitted from the process is a subjective determination and recommended it be removed from Table 1 entries (Document ID 3578, Tr. 1029-1030; 2169, p. 5). The Masonry and Concrete Saw Manufacturers Institute (SMI) noted that “[a]dding requirements for . . . avoiding
Not all industry commenters objected to the note on visible dust contained in the proposed Table 1. ICPI supported a version of Table 1 that included the no-visible-dust requirement for nearly all of the operations listed (Document ID 2352, pp. 4-8).
Commenters from both industry and labor suggested revisions to clarify the note and make it workable. LHSFNA believed the note was needed to ensure the effective use of controls and was not too vague, but acknowledged that the language could be clarified to say something like “visible dust should be minimized” (Document ID 4207, p. 2). BCTD also provided significantly revised language for the no-visible-dust requirement. For those operations that involve cutting and grinding on silica-containing substrate, BCTD suggested that, for wet systems, Table 1 of the standard should require that water flow be “sufficient to control the dust generated so that no visible dust . . . is emitted from the process once the blade has entered the substrate being cut” and that the relevant note on Table 1 be revised to read:
A small amount of visible dust may be present when the blade or tool initially enters the substrate and when it is being removed at the end of a task. However, if visible dust is present after the blade or tool has entered the work surface/substrate, this is a sign that the control is not working properly. The operation should be stopped and the equipment and/or workers' cutting technique checked and fixed (Document ID 4223, Appendix 1, p. 14).
PTI's suggested revisions to Table 1 include a note for many of the entries specifying that “during operation, if excessive visible dust is emitted from the process, immediately stop work and verify that the dust control system is functioning properly” (Document ID 1973, pp. 2-9).
While opinions varied widely on the utility of a no-visible-dust requirement, no commenters suggested that excessive visible dust generated from tasks abrading silica-containing materials (sawing, grinding, etc.) does not present a risk of significant employee exposure to silica. As noted above, BCTD confirmed that the presence of visible dust after the blade or tool has entered the work surface/substrate is a sign that the control method is not working properly (Document ID 4223, Appendix 1, p. 14). PTI recommended that, when excessive visible dust was present, work stop immediately until the employer could verify the proper functioning of the control (Document ID 1973, pp. 2-9).
OSHA agrees that excessive visible dust is an indication that a control's effectiveness may be compromised, but, after reviewing the entire record on this point, has decided not to include a no-visible-dust requirement for the Table 1 entries. Instead, it has concluded that the purpose of such a requirement is best achieved by bolstering other requirements in the rule, as it applies to construction. First, OSHA considers the written exposure control plan to be centrally important and expects employers to address signs that controls may not be working effectively (
OSHA finds that the difference between the small amount of dust generated when control measures are operated effectively and the large amount of dust generated during tasks when control measures are not used or not operated effectively can readily be observed. Several videos presented in the record support this conclusion (
Commenters also objected to the specification to prevent wet slurry from accumulating and drying when implementing wet methods, as proposed for several Table 1 entries. Both Holes Incorporated and NAHB objected to the ambiguity of the requirement and presented concerns about how employers on a construction site would comply with such a requirement (Document ID 3441, p. 9; 2296, p. 28).
Other commenters expressed concern regarding the disposal of silica slurry (Document ID 2246, pp. 9-10; 3585, Tr. 2886; 2319, p. 94). ICPI noted that employers have to expend extra effort to locate a place to dispose of dust-filled slurry, which is not possible in some conditions or locations (Document ID 2246, pp. 9-10). CISC described how slurry created using wet-cutting methods outside can flow into storm drains, potentially violating environmental regulations (Document ID 2319, p. 94). The Mason Contractors Association of America explained that in California, silica slurry produced from wet cutting is classified as a hazardous material, requiring contractors working in the state to follow hazmat procedures for its disposal (Document ID 3585, Tr. 2886).
However, NIOSH argued that since the vast majority of masonry saws provide water on the blade itself to cool and lubricate the blade and suppress dust, employers already have to deal with slurry when cutting masonry and concrete (Document ID 4233, Attachment 1, p. 6). OSHA agrees that the standard does not pose any new requirements regarding the disposal of slurry on employers who already use wet methods for sawing masonry products.
OSHA concludes that any measures necessary to manage slurry in order limit employee exposure to respirable crystalline silica (
In several Table 1 entries, OSHA has included a requirement to operate and maintain tools in accordance with
OSHA's proposed Table 1 for construction would seem to suggest that the Agency believes a construction employer can achieve the PEL with engineering and work practice controls. Yet the Agency then requires respiratory protection for 60 percent of the operations listed in Table 1. This failure is even more perplexing since OSHA failed to identify, obtain and/or cite sufficient data for its conclusions with respect to the 13 operations addressed in Table 1 (Document ID 2187, p. 3).
OSHA's reliance on respiratory protection is analytically inconsistent with its position that it is technologically feasible to reach the proposed PEL in most construction operations most of the time, and particularly when the control measures specified in Table 1 are used. Requiring such heavy use of respirators . . . will serve as a significant barrier to effective use of [Table 1] (Document ID 2319, p. 102).
Respirator requirements on Table 1 of the final rule are based on a review of all the evidence pertaining to exposure profiles and available controls in the rulemaking record, including an evaluation of the updated exposure profiles and evidence on available controls submitted to the rulemaking record, as described in Chapter IV of the FEA. A primary purpose of such evaluation was for OSHA to better identify those situations where exposures above the PEL are likely to persist despite full and proper implementation of the specified engineering and work practice controls and supplemental respiratory protection will therefore be necessary to ensure employees are protected from silica-related health risks. As documented in its analyses of technological feasibility for each Table 1 task, OSHA finds that most of the time employees are performing tasks on Table 1, respiratory protection will not be required. For most of the tasks or equipment on Table 1, OSHA expects that work will be performed for four hours or less and/or outdoors (
Consequently, required respiratory protection under Table 1 is limited to situations in which OSHA has determined that exposures over 50µg/m
OSHA has also used the terms “indoors or in an enclosed area” rather than “indoors or within a partially sheltered area” in order to clarify that any requirement to use respiratory protection when the task is performed under these conditions is limited to those areas where the dispersal of dust can be impeded such that concentrations can build up without the aid of forced ventilation. For example, a work area with only a roof that does not impede the dispersal of dust would not be considered “enclosed,” while it may have been considered by some to be a “partially sheltered area.”
As a result of these modifications, OSHA expects that many fewer employees will need to use respiratory protection than was the case for the proposed rule, and respiratory protection will not be necessary for the most commonly encountered work situations and environments specified on Table 1.
ISEA suggested that OSHA make the respirator requirements on Table 1 more user-friendly and performance-oriented by listing only an APF and recommending that users consult the APF table found in the respiratory protection standard, rather than listing generic respirator types (Document ID 2212, p. 2). In response to this comment, OSHA has maintained certain requirements for respiratory protection, but has eliminated specific requirements for the type of respirator that must be used (
The respirator requirements on Table 1 are divided by task duration: “less than or equal to four hours/shift” and “greater than four hours/shift.” AIHA recommended that OSHA clarify what time is included when determining less than or greater than four hours (Document ID 2169, p. 6). OSHA has determined that time starts when the operator begins using the tool, and continues to be counted until he or she completes the task. This time includes intermittent breaks in tool usage and clean-up. For example, an employee cuts and places bricks, one at a time, for three hours consecutively. The employee then spends 30 minutes cleaning up the saw and empting slurry or dust collectors. All three hours spent cutting and laying bricks along with the 30 minutes for clean-up count. Tasks that are performed multiple times per day, during distinct time periods, should be counted as separate tasks, and times should be combined. For example, an employee cuts multiple bricks for 15 minutes, lays bricks for two hours and returns to cut more bricks for another 30 minutes. The two hours spent laying bricks do not count towards the total time for compliance with Table 1.
The duration of a task that generates respirable crystalline silica influences the extent of employee exposure and, in some cases, requirements for use of respirators. Some commenters suggested that OSHA modify the time breakdown for activities and respirator usage, such as BCTD's suggestion to divide tasks on Table 1 into two hours, four hours, and eight hours. Other commenters such as CISC, Holes Incorporated, and the Mason Contractors Association of America, suggested that OSHA exclude short duration tasks (
After reviewing these comments, OSHA has decided to maintain this division in the standard. OSHA selected four hours as an appropriate division point for respirator usage because it finds that employers and employees can anticipate whether a task will take less than half of a shift or more than half of a shift (as opposed to smaller time intervals), and so can plan accordingly on the need for respirator use on a given job. In addition, OSHA selected only a single durational division for respirator tasks in all of the relevant Table 1 tasks to avoid the confusion that could result from triggering mandatory respirator use at different times for different tasks. OSHA also determined that excluding short duration tasks from Table 1, although included in the ASTM E 2625-09 consensus standard, was inappropriate, given that employees engaged in a task listed on Table 1 are best protected using the available engineering controls, work practices, and respiratory protection specified for the task and are only exempt from complying with the standard where employee exposure will remain below 25 µg/m
Table 1 of the proposed rule used the phrase “4 hours per day” to indicate when respirators were required, but Table 1 of the final standard uses “4 hours per shift.” OSHA's exposure data is largely drawn from samples of employee exposure averaged over an 8-hour period, which is a typical time for a shift. The proposed rule referred to a time period of four hours “per day” for the purpose of limiting employee's exposure during the normal 8-hour shift that most employees work during a single day. OSHA recognizes, however, that some common tasks such as jackhammering during nighttime highway construction may occur during an 8-hour period that spans two calendar days (
OSHA also recognizes that the form and length of a shift may vary such that an employee may have a break between work periods (
The requirement to provide respirators for Table 1 tasks is based on the anticipated duration of the task. Some commenters, such as EEI, expressed confusion about how this requirement would apply to non-continuous work (
The nature of non-continuous work can also make it hard to anticipate when a certain task may exceed four hours per day. Suppose, for example, a job task using a stationary masonry saw is not anticipated to last beyond four hours, so all controls listed in Table 1 are followed, and the employee does not wear a respirator. Then, due to unforeseen complications, the job lasts beyond four hours. Simply following the regulations as proposed, it is unclear whether the employee would be allowed to put on a half-mask after four hours, or if OSHA will not allow the employer to use the Table 1 option because the employee was not in a half-mask for the first four hours (Document ID 2357, p. 27).
Commenters, including BCTD, Fann Contracting, and IUOE, expressed confusion about whether an employee must wear a respirator for the entire duration of a task when that task is expected to last more than four hours, or rather wear the respirator for only the portion of the task that exceeds four hours (
The objective of the silica standard is to limit an employee's average exposure over a work shift. In each of OSHA's health standards, this is accomplished by establishing a PEL expressed as an 8-hour TWA. Because a PEL is a time-weighted average, the Agency has traditionally required employees to use respirators throughout a shift when employees work on a task or in an area where exposure to a hazardous substance contributes significantly to an employee's exposure in excess of the PEL at any point during that shift. This same reasoning applies to wearing a respirator from the beginning of a shift where respirators are required on Table 1. Thus, OSHA is continuing the same approach to respirator use for tasks listed on Table 1 of the standard for construction as it has for other OSHA health standards. Under Table 1 of the final standard for construction, when a respirator is required only when a task is performed for more than four hours per shift and when the employer estimates that the duration of the task will exceed four hours, the employer must provide and ensure that a respirator is used the entire time that task is performed over the shift, not just during the time beyond the first four hours that the task is performed. For example, if an employer anticipates that an employee will operate a jackhammer outdoors for more than four hours, the employer must provide respiratory protection with an APF of 10 and require that it be used for the entire duration of the task. For tasks that are typically intermittent, employers are required to estimate at the outset the total time during the shift that the task itself will be performed and provide respirators required by Table 1 based on that estimate. If an employer knows from experience that an employee will perform a single task listed on Table 1 for four hours or less during a single shift, then the employer must ensure that the employee uses whichever respirator is specified in the “≤ 4 hr/shift” column on Table 1 (or need not provide a respirator if no respirator is required on Table 1 for that duration). As another example, if a contractor needs to cut four concrete walls using a handheld power saw (outdoors), and cutting each wall typically takes 45 minutes to complete, for a total time of 3 hours, the employer would not be required by Table 1 to provide a respirator. But if cutting each wall typically takes in excess of 60 minutes, the employer should expect that the total duration of the task will exceed four hours and provide respirators as required under Table 1. The employer is required to provide respirators as soon as it becomes evident that the duration of the task will exceed four hours. Thus, in most situations an employee will be protected by a respirator for all or the majority of a task that exceeds four hours because the rate of progress on the task will become apparent to the employer early on. An employee cannot be allowed to work more than four hours without a respirator when one is required under Table 1 because the employer will have certainty at that point that the task is exceeding four hours.
The above examples assume that employees are engaged in only one task covered by Table 1 each shift. Paragraph (c)(3) of the standard for construction requires that, where employees perform more than one task on Table 1 during the course of a shift for a combined total of more than four hours, employers must provide, for the entire duration of each task performed, respiratory protection that is consistent with that specified in the “> 4 hr/shift” column of Table 1, even if the individual duration of each task is less than four hours. If no respirator is specified for a task in the “> 4 hr/shift” column of Table 1, then respirator use would not be required for that part of the employee's shift. For example, if an employer plans to have his employee use a handheld grinder outdoors on a concrete wall for three hours and then use a chipping hammer for two additional hours, the employer would not be required to ensure that his employee uses a respirator for the three hours the employee is using the grinder, since respiratory protection is not specified on Table 1 for the use of a grinder outdoors for more than four hours per shift; however, the employer would be required to ensure that his employee uses a respirator with an APF of 10 for the two hours the employee is using the chipping hammer. This is so even though use of the chipping hammer, if performed with no grinding beforehand, would not have required a respirator for the duration that the tool was used. If the employee will be engaged in two activities that both have “None” specified for respiratory protection in both the “≤ 4hr/shift” and the “> 4 hr/shift” columns, such as driving a half-lane milling machine and then operating a walk-behind milling machine equipped with an integrated water delivery system, then respirator use would not be required for any part of an employee's shift even if the employer knows that the cumulative total of that work will exceed four hours.
When an employee performs multiple tasks that do not exceed a combined total of more than four hours, employers must provide the respiratory protection specified in the “≤ 4 hr/shift” column of Table 1 for each task. For example, if an employer plans to have his employee use a handheld grinder for mortar removal for one hour and a stationary masonry saw for an
Thus, whatever permutations may arise, the employer must estimate the duration of the task(s) to determine whether Table 1 will trigger the requirement for respiratory protection. If unforeseen conditions arise that cause the estimated duration to be revised for any of the tasks, the employer is required to provide the required respiratory protection as soon as it becomes evident that the employee will be engaged in the task for more than four hours during the shift.
Commenters also provided specific recommendations for the frequency at which OSHA should update Table 1 and the process by which OSHA should do so. James Hardie Building Products, Inc. commented that additional controls demonstrated to maintain or increase employee protection should be incorporated by reference whenever they become available “without the need to undergo a formal rulemaking process” (Document ID 2322, pp. 21-22). The National Consumers League and the American Public Health Association suggested that OSHA consider updating Table 1 periodically (
Other commenters urged OSHA to consider mechanisms to update Table 1 without going through the rulemaking process. NIOSH suggested that the Agency develop a database of control technologies to supplement those on Table 1, rather than initiate rulemaking to update Table 1 (Document ID 2177, Attachment B, pp. 20-21). LHSFNA suggested that OSHA post enforcement decisions based on objective data online and permit employers performing similar tasks to use the controls specified in those decisions to meet their obligations under Table 1 (Document ID 4207, pp. 2-3). Holes Incorporated argued that Table 1 should be amendable by employers when testing proves that using such controls would ensure compliance with the PEL (Document ID 3441, p. 12; 3580, Tr. 1491).
IUOE, BCTD, and BAC argued that Table 1 should be an appendix to the rule so that it can be more easily updated (Document ID 2262, pp. 48-49; 2329, p. 6; 2371, Attachment 1, pp. 30-31). BCTD offered an approach for updating Table 1 that relied on the Agency establishing a mechanism for employers, equipment manufacturers, and others to submit data to the Agency for evaluation and subsequent inclusion in future versions of Table 1. BCTD proposed:
OSHA could publish the criteria in a non-mandatory appendix to the standard, so employers, manufacturers and researchers would have a clear understanding of what they will have to demonstrate to get their proposed controls onto the table.
Interested parties could then request that OSHA evaluate a control option, supporting their request with objective data, peer-reviewed studies, reports by NIOSH or other governmental agencies, or other reputable sources. If OSHA determined, based on the supporting data, that the technology meets its criteria for inclusion on Table 1, OSHA would issue an interpretative letter to that effect and/or issue a compliance directive advising its compliance officers that employers that fully and properly implement the particular control should be treated as if they were in compliance with the requirements of Table 1. This approach would enable OSHA to continually add to the options employers can utilize as new technologies come on-line, while at the same time ensuring that these additional controls meet the Agency's criteria (Document ID 4223, p. 100).
Charles Gordon also provided a detailed suggestion for the addition of regulatory text to address the issue of updating Table 1:
Updating controls. (i) Three years from the effective date of this standard and every 3 years thereafter, OSHA shall request comments on new or improved engineering controls which can achieve the PEL or Action Level without supplementary respirator use for operations specified in Table 1 or other operations not in Table 1 that have crystalline silica exposure over the Action Level.
(ii) If OSHA concludes that a new control will achieve the PEL without supplementary respirator use, it shall publish a notice permitting that control to be used for that Table 1 operation along with the other permitted controls or publish a direct final rule including that other operation in Table I and permitting the use of that control.
(iii) If a commenter submits to OSHA an engineering control for an operation in Table 1, which can achieve the action level without supplementary respirator use based on valid studies and cost data showing it is feasible, then no later than the date specified in paragraph (f)(6)(i), OSHA shall publish a proposal, proposing that that engineering control be the required engineering control for that operation (Document ID 4236, Appendix 1, p. 1).
Based on the comments and perspective reflected in the rulemaking record, OSHA sees the value in periodically updating Table 1 and is concerned that a static Table 1 may discourage innovation in the development of control technologies for reducing silica exposure. However, while OSHA may certainly consider future updates or adjustments to Table 1 if warranted, it will likely need to accomplish substantive changes through additional rulemaking. In any event, it has no intention to bind a future Administration to such rulemaking, whether to update Table 1 in particular or the entire rule in general, according to a schedule built into this rule. Meanwhile, the need to revise Table 1 in the future should be limited since the controls specified—primarily wetting the dust or ventilating and collecting the dust—are stated in general terms that will not be rendered obsolete by, for example, design improvements to water spraying or vacuuming equipment.
Even if the proposed mechanisms are consistent with the law governing rulemaking, OSHA is unwilling to specify a mechanism for updating Table 1 for several reasons. First, the procedures outlined by BCTD and Charles Gordon would commit the Agency to spend future resources to accept a large volume of information from interested parties, evaluate it in a timely manner, and prepare the needed economic and technological feasibility analysis and other rulemaking documents. OSHA may have higher rulemaking priorities and demands on its resources at that time, however. Second, Table 1 cannot both contain enforceable means of compliance and also be contained in a non-mandatory appendix. To ensure that employers who do not conduct exposure monitoring comply fully with the Table 1 provisions, OSHA must include the control specifications of Table 1 in the final standard for construction as requirements rather than as non-mandatory recommendations. Third, the
Thus, OSHA rejects the suggestions to establish a specific mechanism for updating Table 1 in the future. If significant technological advances occur that require OSHA to initiate rulemaking in order to incorporate emerging technology not already encompassed by this rule, it will do so in the context of its rulemaking priorities at that time. Of course, interested parties may petition the Agency at any time to modify the dust control specifications on Table 1 of the standard for construction, and OSHA will consider such petitions based on the likely benefit that will accrue to workers and the Agency's available resources at the time.
When using stationary masonry saws, paragraph (c)(1)(i) of the standard for construction requires that saws be equipped with an integrated water delivery system that continuously feeds water to the blade and that the tool be operated and maintained in accordance with manufacturer's instructions to minimize dust emissions. Saw designs vary between manufacturers and, as with other operating parameters, manufacturer's recommendations for optimizing wet methods are likely to vary somewhat with the saw size and
The language describing the required control for stationary masonry saws was revised from the proposed rule to clarify that water must be continuously applied to the blade, and language was added to require that manufacturer's instructions be followed. This reflects OSHA's intent that employers use a saw with integrated water delivery system supplied by the saw manufacturer. OSHA finds that systems that are developed in conjunction with the tool are more likely to control dust emission effectively by applying water at the appropriate dust emission points based on tool configuration, and not interfere with other tool components or safety devices. These include free-flowing water systems, with or without a pump and basin, that are designed for blade cooling, as well as manufacturer systems designed for dust suppression alone (Document ID 1555, p. 509; 3998, Attachment 12a, pp. 9, 15-16; 3998, Attachment 12e, p. 3).
The proposed entry for stationary masonry saws also included a note requiring that water be changed frequently to avoid silt build-up in water and that the blade not be excessively worn. CISC commented that terms such as these were too ambiguous and would thus prevent the table from being a realistic compliance option (Document 2319, p. 98). OSHA understands that these notes could be subject to interpretation and in response, has removed the notes from Table 1. However, these practices are often included in manufacturer's instructions, and OSHA considers these type of instructions to be part of fully and properly implementing engineering controls (
In the FEA, OSHA's exposure profile for stationary masonry saws shows that wet cutting is an effective dust control. The median 8-hour TWA exposure in the profile is 34 μg/m
In addition to these field results, the record includes experimental studies that examined the effectiveness of wet dust control systems. Meeker
CISC questioned the appropriateness of requiring an integrated water delivery system when most integrated systems are intended to keep the blade cool and are not designed for dust suppression (Document ID 2319, p. 109). However product literature submitted to the docket from five major saw manufacturers (Andreas Stihl, Husqvarna, Hilti, Makita USA, and Wacker Group) highlights the use of water application equipment to suppress dust in addition to blade cooling (Document ID 3620, pp. 6, 10, 24, 30; 3998, Attachment 12a, pp. 9, 15-16; 3998, Attachment 12e, p. 3; 3998, Attachment 12f; 3998, Attachment 12h; 4233, Attachment 1, p. 6). Beamer
Several commenters suggested that OSHA include an option for dry cutting on Table 1 (
OSHA addresses the issue of freezing temperatures and availability of water in the technological feasibility analysis (Chapter IV of the FEA) and has determined that these barriers can be overcome in most instances, for example by wrapping gutter heat tape around drums of water or adding environmentally-friendly antifreeze additives to water (
OSHA finds that the study by Carlo
OSHA understands that there may be limited situations where the use of wet systems is not feasible for a given application. For those situations, the employer may use other means of dust control such as LEV systems, but the employer must then follow paragraph (d) rather than paragraph (c) of the standard for construction,
Stationary masonry saws with integrated water systems are readily available from several manufacturers including EDCO, Andreas Stihl, Hilti, Makita USA, Husqvarna, Wacker Group, MK Diamond, and Bosch (for tile cutting) and are effective and the best control option available (Document ID 4073, Attachment 4a, Rows 59-63, 183-188, 292-297, 347-351, 417-419; 4073, Attachment 4b, pp. 10-12, 21; 3998, Attachment 12a; 3998, Attachment 12e; 3998, Attachment 12f; 3998, Attachment 12g; 3998, Attachment 12h). Therefore, OSHA has determined that an integrated water delivery system is the appropriate control for inclusion on Table 1.
In the proposed rule, OSHA required the use of a half-mask respirator for employees who operated stationary masonry saws for more than four hours. OSHA made this determination based on the highest exposure results included in its exposure profile. OSHA has since determined that when fully and properly implementing all of the provisions under paragraph (c), employees can operate stationary masonry saws without the use of respirators. This is supported by the exposure profile contained in Table 5.7-B in Section 5.7 of Chapter IV of the FEA, which shows a mean exposure of 41 μg/m
Handheld power saws are used in the construction industry for cutting a variety of materials (
When using handheld power saws with any blade diameter (except saws used to cut fiber-cement board), paragraph (c)(1)(ii) of the standard for construction requires that saws be equipped with an integrated water delivery system that continuously feeds water to the blade and that it be operated and maintained in accordance with manufacturer's instructions to minimize dust emissions. Like stationary saws, designs vary between manufacturers and, as with other operating parameters, recommendations for optimizing wet methods are likely to vary somewhat with the saw size and design. In light of these variables, OSHA is not specifying a minimum flow rate. In addition, OSHA is recognizing that the employer's best available information for reducing dust with a specific control comes from the manufacturer's operating instructions, which is why OSHA is requiring the saw be operated and maintained according to the manufacturer's instructions to minimize dust. Water-fed handheld saws are commercially available from a variety of sources (Document ID 0615; 0737; 3998, Attachment 12e; 3998, Attachment 12a; 3998, Attachment 12f; 3998, Attachment 12g; 3998, Attachment 12h).
The data in the record and the studies reviewed by OSHA demonstrate that water spray suppression systems reduce respirable crystalline silica exposures substantially where the system was well designed and properly implemented and maintained (Document ID 0868; 1181; 3497; 3610; 3777; 4073, Attachment 8a). Use of an integrated water delivery system on the cut-off, chop, quickie or masonry saws has been shown to reduce respirable dust exposures by 78-96 percent (Document ID 0868, p. v; 1181, p. 443; 3610, p. 157; 3777, p. 67). Data compiled by the CSDA from member jobsites as well as NIOSH documents showed that all outdoor hand sawing using a saw equipped with a water supply produced exposure levels below a TWA of 50μg/m
In a laboratory study, Thorpe
NIOSH also evaluated the performance of a commercially available water backpack and spray attachment, pre-set by the attachment manufacturer to provide 1.4 liters per minute water consumption (0.36 gallons per minute) for handheld saws during concrete block cutting (Document ID 0868, pp. 8, 11). The handheld electric abrasive cutter was used outdoors to make cuts through concrete blocks laid lengthwise on a plank 17 inches above the ground. During the 5- to 10-minute trials with water-fed saws, the water spray attachment reduced quartz exposures by an average of 90 percent from uncontrolled levels (Document ID 0868, p. 10). Middaugh
Based on the information in the record, OSHA concludes that most of the time, handheld power saw operators use the saw for two hours or less over the course of a workshift, typically using handheld saws for brief, intermittent periods repeated numerous times over the course of a shift (Document ID 1431, p. 3-63). The Mason Contractors Association of America stated that “90 minutes is actually a really long time to be cutting something. The vast majority of [cutting tasks] are under 15 minutes [total] in any given day” (Document ID 3585, Tr. 2911). The Bay Area Roofers Waterproofers Training Center agreed, clarifying that when cutting is performed as part of its work it is usually half an hour to 45 minutes a day (Document ID 3581, Tr. 1598). Information contained in research supports this as well. Thorpe
Estimated TWA exposures (
In the proposal, OSHA based its requirement to use respiratory protection for operating saws more than four hours per shift on the few higher exposure values in its exposure profile, which indicated that exposures would exceed 50 μg/m
The vast majority of samples reviewed by OSHA involve the use of handheld saws outdoors. However, employees may occasionally use handheld saws indoors. When an employee uses a water-based system indoors or within enclosed areas, elevated exposures can still occur (Document ID 0675; 0177; 0846; 3497; 3777). Data submitted by CSDA shows that almost all indoor hand sawing using wet methods produced exposure levels above 50μg/m
Representatives from the roofing industry expressed concern regarding the use of wet methods in their industry, citing primarily the potential increase in slips and falls from introducing water to elevated worksites (Document ID 2320, p. 116; 2192, p. 4; 3526, p. 7). The Tile Roofing Institute stated that in California and Arizona, rooftop operations with roofing tiles or pavers are given an exemption from the requirement to use a dust reduction system because there is no way to address both the silica and fall protection hazard (Document ID 3587, Tr. 3595). Conversely, testimony from the public hearings indicates that wet dust control systems can be used to reduce exposures to silica during cutting of roofing tiles and pavers. Dan Smith, director of training for the Bay Area Roofers and Waterproofers Training Center, testified that the roofing industry in California is starting to voluntarily cut roofing tiles and pavers wet (Document ID 3581, Tr. 1600-1601; 1638) and that use of controls may actually increase visibility, thereby reducing a potential fall hazard (Document ID 3581, Tr. 1603-1604). He also explained that dry cutting of roofing tiles is prohibited in the U.K., and that the contractors association (the National Federation of Roofing Contractors), “. . . provides guidance and training. They use wet saws on scaffolding at the roof level . . . they use a [water] mister on the tile saw. They use a system like the hytile . . . which is a tile breaking tool” (Document ID 3581, Tr. 1601).
OSHA understands the concerns expressed by representatives from the roofing industry regarding the use of wet methods and increased risk for falls; however, OSHA concludes that alternate project planning can enable employers to use wet methods by implementing some of the measures described above.
In the proposed rule, OSHA included an option under Table 1 for the use of LEV when using portable masonry saws. While including LEV as an alternative to wet methods in the table was supported by both labor and industry groups (Document ID 2296, p. 32; 4223, p. 140; 4233, Attachment 1, p. 1), OSHA has removed this option from Table 1 based on information contained in the record indicating that LEV cannot consistently maintain exposure at or below a TWA exposure level of 50 μg/m
When using handheld power saws with a blade diameter of 8 inches or less for cutting fiber-cement board outdoors, paragraph (c)(1)(iii) of the standard for construction requires saws to be equipped with a commercially available dust collection system that provides the air flow recommended by the manufacturer and a filter with a 99 percent or greater efficiency, operated in accordance with the manufacturer's instructions to minimize dust emissions. OSHA is not providing an entry for use of these saws indoors on Table 1 because fiber-cement board, used as siding and fascia applied to the exterior of buildings, is usually cut outdoors and the record lacks information on exposures to silica that would result from cutting fiber-cement board indoors. Therefore, employers who choose to operate saws to cut fiber-cement board indoors must conduct exposure assessments and comply with the PEL in accordance with paragraph (d) of the standard for construction.
This entry was added to Table 1 of the final standard for construction in response to comments NIOSH and the fiber-cement board industry submitted to the rulemaking record. These submissions provided substantial data on control technology (a specially configured saw) for controlling silica exposure when saw operators cut fiber-cement board (Document ID 2177, Attachment B, pp. 17-19; 2322, Attachment B-E and H).
The James Hardie Building company submitted 75 samples for workers using specially configured circular saws (with specialty blades of less than 8 inches) for cutting fiber-cement board with LEV (Document ID 2322, pp. 19-20). These saws were all fitted with cutting blades designed for the fiber-cement board product and some form of dust collector (but not always designed with vacuum suction). Workers using these saws had a mean 8-hour TWA exposure of 11 μg/m
Based on the evidence in the record, commercially available dust collection systems for handheld power saws with a blade diameter of 8 inches or less and a dust collection device providing the air flow recommended by the manufacturer have been demonstrated to be particularly effective in controlling silica during outdoor cutting of fiber-cement board. One type of saw evaluated was a handheld, dust collecting model equipped with dust collection device rated at 200 cfm over a 7.25-inch-diameter blade (27.5 cfm per inch); however, the measured flow rate was reported to be 69 to 106 cfm. Using this configuration, all 21 exposure
Based on the evidence in the record, OSHA is not requiring the use of respiratory protection when employees are using handheld power saws with a blade diameter of 8 inches or less, for cutting fiber-cement board outdoors in accordance with Table 1 for any task duration. OSHA has determined that in such circumstances, employee exposures will be reduced to 50 μg/m
Saw designs vary among manufacturers, and as with other operating parameters, recommendations for optimizing wet methods are likely to vary somewhat with the saw size and design. As with other saws, OSHA is not specifying a minimum flow rate, but rather anticipates that the water flow rates specified by the manufacturer will optimize dust reduction. OSHA recognizes that the employer's best available information for reducing dust with a specific control comes from the manufacturer's operating instructions, which is why OSHA is requiring the saw be operated and maintained according to the manufacturer's instructions to minimize dust. Water-fed walk-behind saws (manual and self-propelled) are widely available from many manufacturers and construction tool distributors, such as Grainger, EDCO, MK Diamond, and CS Unitec (Document ID 0715; 1676; 1185; 0643; 0615).
CSDA stated that “nearly 100% of CSDA contractors use water on each and every job and this has to do with extending the life of the expensive diamond tools. The use of water has an additional benefit of containing silica particles that could become airborne” (Document ID 3496, p. 3). This was supported by others during the public hearings (Document ID 3580, Tr. 1438; 3585, Tr. 2885) and in written comments (Document ID 2316, p. 3). Disagreeing, both SMI and the Mason Contractors Association of America commented that most water-fed systems are designed to keep the blade cool, and their ability to suppress dust has not been sufficiently researched (Document ID 2316, p. 3; 3585, Tr. 2885). CISC similarly asked whether an additional water feed is needed for these saws or whether the one currently integrated for the purpose of cooling the saw will suffice (Document ID 2319, p. 104).
OSHA finds that considerable evidence in the record shows that water application reduces dust emissions, and several saw manufacturers state that using wet cutting will suppress dust (
CISC questioned the feasibility of using wet methods in situations where there is no established water main on site (Document ID 2319, p. 112). OSHA finds that water tanks, which were used to provide water to the walk-behind saws in Linch (2002), are already commonly available on many construction sites and could provide water for a walk-behind saw (Document ID 0784, pp. 216-217).
Data contained in the record show that none of the respirable silica results associated with wet cutting outdoors using walk-behind saws exceeds 50μg/m
Since walk-behind saws are used to cut pavement, they are most commonly used outdoors, though they can also be used indoors (Document ID 1431, pp. 3-63). Although the data are limited, water-fed walk-behind saws used indoors or in enclosed areas may result in higher exposures than those measured outdoors. Studies by both NIOSH and Flanagan
In its Technological Feasibility analysis (see Section 5.6 of Chapter IV of the FEA), OSHA analyzes exposures for workers using drivable saws. The exposure profile includes three samples, two using wet methods as required by Table 1 and one operating under other conditions. The two samples taken on workers using wet saws showed TWA silica exposures of 12 μg/m
In the proposed rule, dust control requirements were specified for drivable and walk-behind saws together, and the proposed rule would have required respirator use when operating either saw in indoor or enclosed environments. In the final standard for construction, the requirements for these kinds of saws are separated on Table 1 because, unlike walk-behind saws, drivable saws are rarely, if ever, used in indoor environments. Because the requirements of Table 1 only apply to outdoor use of drivable saws, and the data available to OSHA demonstrate that the wet methods described above can consistently control exposures in that environment, Table 1 does not require the use of respiratory protection when these controls are implemented, regardless of task duration.
SMI and CISC commented that currently drivable saws use water to cool the cutting tool, and the effectiveness of cooling water for respirable crystalline silica dust mitigation has not been comprehensively researched (Document ID 2316, Attachment 1, p. 3; 2319, p. 112). SMI stated specifically that “parameters such as flow rate, volume, flow delivery characteristics, velocity, and delivery location have not been evaluated or compared” (Document ID 2316, p. 3). However, Atlantic Concrete Cutting agreed that all of its cutting services were performed with water (Document ID 2367, p. 2), and that the application of water minimized and most likely eliminated exposure to respirable crystalline silica. Atlantic Concrete Cutting also stated that the use of a “water-fed system that delivers water continuously at the cut point” would be an appropriate silica dust control for drivable saws and that respirators would not be needed to further protect employees (Document ID 2367, pp. 2-4). In light of this testimony, OSHA concludes that it is appropriate to permit employers to fully and properly implement water-based systems on drivable saws in compliance with Table 1, eliminating their need to conduct exposure assessments for employees engaged in a task using drivable saws. Moreover, as reflected in Table 1, OSHA concludes that full and proper implementation of this control will not require the use of respirators for this task even if performed for more than four hours in a shift and so has not included respiratory protection for this task.
For rig-mounted core drills, there is one specified control that consists of using a tool equipped with an integrated water delivery system that supplies water to the cutting surface, operated and maintained in accordance with manufacturer's instructions to minimize dust emissions. Based on evidence in the record, OSHA has determined that baseline conditions for core cutting involve using wet methods and that most core cutting machines are provided with and intended to be used with a water feed system (
Comments submitted by SMI expressed confusion as to whether or not core drilling was included on the table under the entry for drills and the appropriateness of using LEV as required under the proposed table during core cutting (Document ID 2316, p. 2). In the proposed rule, OSHA specifically excluded core cutters from hole drillers using handheld drills (
Kellie Vasquez of Holes Incorporated testified that the process of core drilling is much different than other types of drilling due to the different drill bits used, resulting in much less silica exposure (Document ID 3580, Tr. 1484). This is supported by OSHA's review of record data on core cutting/drilling, which shows that operators generally experience little or no silica exposure during this low-speed process, which is already performed using water-fed equipment as a standard practice (Document ID 0675, pp. 1097-1098; 0898, p. 15).
Additional exposure data compiled by CSDA from member jobsites (Document ID 3497) and other studies (Document ID 0675; 0679; 0898) show that using a
Paragraph (c)(1)(vii) of the standard for construction requires that handheld and stand-mounted drills be equipped with a commercially available shroud or cowling with dust collection system that provides at least the minimum air flow recommended by the manufacturer. The dust collection system must include a filter cleaning mechanism and be equipped with a filter with 99 percent or greater efficiency. The dust collection system must be operated in accordance with the manufacturer's instructions to minimize dust emissions. In addition, OSHA is requiring that a HEPA-filtered vacuum be used when cleaning debris from drill holes.
The proposed Table 1 labeled this category of tools “Using rotary hammers or drills (except overhead).” In response to several comments, OSHA has revised this description to make clear that drills mounted on stands are also included and also removed the exclusion for overhead drilling. For example, SMACNA recommended expanding the entry for rotary hammers and drills to include overhead drilling, contending that overhead drilling would be just a safe as other drilling if done as directed on the table (Document ID 2226, p. 2). The Mechanical Contractors Association of America commented that overhead drilling should be included in Table 1 since overhead drilling is a common operation in several trades (Document ID 2143, p. 2). OSHA received testimony that overhead drilling along with a drill stand with a vacuum attachment addresses both ergonomic and silica exposure hazards. After review of the evidence in the record, OSHA has determined that it is appropriate to remove the exclusion for overhead drilling in the Table 1 entry for handheld and stand-mounted drills.
As proposed, Table 1 had separate entries for “Rotary Hammers or Drills” and “Jackhammers and Other Impact Drillers.” OSHA received comments from PTI suggesting that impact drills be covered by the entry for “Rotary Hammers or Drills,” rather than by the “Jackhammers and Other Impact Tools” entry (Document ID 1973, Attachment 1, p. 4). NIOSH also commented on the potential for confusion, noting that a rotary hammer or drill is technically an impact driller (Document ID 2177, Attachment B, pp. 32-33). Therefore, the entry for handheld or stand-mounted drills in final Table 1 covers activities related to the use of impact and rotary hammer drills. Chipping and breaking activities, which are associated with more intense silica exposures, are covered by the entry for jackhammers and handheld power chipping tools.
CISC commented that OSHA did not state in the proposed rule that the dust collection system needs to be “commercially available” (Document ID 2320, p. 112). In the final standard for construction, OSHA has clarified that Table 1 requires that the handheld or stand-mounted drill be equipped with a commercially available shroud or cowling with dust collection system. Several drilling equipment manufacturers sell dust extractors or dust collectors to minimize dust escaping into the work area. These systems include a vacuum with a filter cleaning mechanism and a filter with 99 percent or greater efficiency. Some examples include Bosch, DeWalt, Hilti, and Metabo (Document ID 3998, Attachment 10; 4073, Attachment 4a, Rows 15-18, 64-70, 111-119, 189-195, 289-301, 352-357). OSHA has determined that it is feasible for employers to obtain controls for handheld and stand-mounted drills that meet the specifications in Table 1.
Based on evidence in the record, OSHA finds that, for most tools, a commercial dust control system using an appropriate vacuum will provide the most reliable dust capture. Average respirable quartz levels varied among the different cowling/vacuum combinations. In one study, all commercial cowl/vacuum combinations tested resulted in personal breathing zone exposures of 28 μg/m
The practice of dry sweeping or brushing debris from a hole, or using compressed air to clean holes, contributes to the exposure of employees using drills. Based on the evidence in the record, OSHA is requiring that holes be cleaned with a HEPA-filtered vacuum. Any method for cleaning holes can be used, including the use of compressed air, if a HEPA-filtered vacuum is used to capture the dust. If a HEPA-filtered vacuum is not used when cleaning holes, then the employer must assess and limit the exposure of that employee in accordance with paragraph (d) of the standard for construction.
While the paragraph on housekeeping (paragraph (f) of the standard for construction) also applies when employers are following paragraph (c) of the standard for construction, the employer must ensure that all of the engineering controls and work practices specified on Table 1 are implemented.
PCI noted that anchor holes must be blown clean to obtain adequate adhesion, and recommended that the use of compressed air and dry sweeping be allowed unless exposures will exceed 50 μg/m
Data suggest that decreasing employees' reliance on blowing or dry sweeping drilling debris can reduce exposures by approximately 50 percent (
NIOSH found that employees using compressed air to clean the filter after dowel drilling resulted in some of the highest measured exposure to respirable dust during the task, and could cause damage to the filter (Document ID 4154, p. 26). NIOSH also pointed out that the reverse pulse feature on the dust collector should preclude the need to remove filters for cleaning (Document ID 4154, p. 26). OSHA agrees and has included the specification for a filter cleaning mechanism for dowel drills in Table 1. Finally, Table 1 requires that a HEPA-filtered vacuum is used when cleaning holes. OSHA recognizes that it may be necessary at times for employers to use compressed air to clean holes, and thus, as with handheld and stand-mounted drills, Table 1 does not preclude its use when cleaning the debris from holes caused by dowel drilling, so long as a HEPA-filtered vacuum is employed at the same time to effectively capture the dust.
In the proposed rule, OSHA included dowel drills within the entry titled “Operating Vehicle-Mounted Drilling Rigs for Concrete.” However, OSHA has determined that the exposures that result from dowel drilling rigs equipped with LEV systems are substantially higher than is the case for vehicle-mounted concrete drilling rigs. Therefore, respirator requirements are different for the two kinds of equipment (
Exposure information on concrete dowel drilling in the record is limited but shows that, even with LEV, exposures are likely to exceed 50 μg/m
Comments on OSHA's proposed requirements for dowel drilling were limited. Holes Incorporated, Atlantic Concrete Cutting and CISC all stated that outdoor concrete dowel drilling should be included on Table 1 (Document ID 2338, p. 3; 2320, p. 14; 2367, p. 4). Atlantic Concrete Cutting further suggested that the appropriate control for dowel drilling is to limit this task to outdoors only and “provide sufficient ventilation” (Document ID 2367, p. 4). As suggested, OSHA has included a separate entry for concrete dowel drilling on Table 1, but with more detailed control requirements than suggested by Atlantic Concrete Cutting based on information contained in the record. OSHA agrees with Atlantic Concrete Cutting that the entry on Table 1 should be limited to outdoor operations since there is no information in the record as to the appropriate level of respiratory protection needed when operating dowel drills in enclosed areas, and has accordingly revised Table 1 of the final rule to so indicate.
PCI commented that anchor holes must be blown clean using compressed air to obtain adequate adhesion (Document ID 2276, p. 10). In its feasibility analysis, OSHA identified this task as a significant source of exposure to respirable crystalline silica. Therefore, for the reasons previously stated, Table 1 also includes a requirement to use a HEPA-filtered vacuum when cleaning holes, with or without the use of compressed air, in connection with this task.
The proposed rule had separate entries for vehicle-mounted drilling rigs for rock and vehicle-mounted drilling rigs for concrete, both of which specified a combination of LEV and water use. OSHA has determined that, since the rigs and the approach to dust control are similar for both, they can be combined in Table 1 of the final standard for construction. OSHA has also determined that it is appropriate to allow employers the option of having the drill operator work within an enclosed cab meeting the requirements of paragraph (c)(2)(iii) of the standard for construction and to apply water at the drill bit to ensure that the operator and other employees assisting are protected when working near the drill bit.
Workers using vehicle-mounted drilling rigs position and operate the drill rigs from control panels mounted on the rigs. These workers may also perform intermittent tasks near the drilling point such as fine-tuning the bit position, moving debris away from the drill hole, and working directly or indirectly with compressed air to blow debris from deep within the holes. Workers using drilling rigs can be exposed to dust generated by the action of the drill bit and from dust raised by air movement or a compressed air nozzle. Although rig-based drilling is often a one-person job, some of the associated activities, such as fine-tuning the drill position and clearing debris from in or around the holes, can be performed by a second worker (Document ID 0908, p. 1; 1563, p. 3).
In the proposed rule, OSHA specified requirements for the dust collections systems regarding smooth ducts, transport velocities, clean-out points, pressure gauges, and activation of the LEV. These requirements came from a NIOSH evaluation of control technology for dowel-pin drilling (Document ID 1628). The final rule does not require these specific control parameters for vehicle-mounted drilling rigs for rock and concrete. OSHA has determined that dust controls for dowel drilling rigs are substantially different than vehicle-mounted rock and concrete drilling rigs; they are addressed separately in the previous section. Dust collection systems that use a hood or shroud around the drill bit have been proven effective in reducing exposures to respirable crystalline silica. NIOSH found that, when used properly, modern shroud designs now help achieve dust control objectives more consistently for rock drilling rigs than in the past (Document ID 0967, pp. 5-9). Based on information contained in the record, OSHA finds that dust collectors and shrouds are commercially available (Document ID 0669; 0813).
Although the LEV system will control dust emissions at the drill bit, there are still dust emissions at the dust collector discharge area, which can contribute to either the operator's or other employees' exposures. Organiscak and Page (1995) found that enclosing the dust collector discharge area with a shroud can reduce respirable dust levels by 80 percent (Document ID 3613, p. 11). However, evidence in the record shows that the combination of LEV at the drill bit and water application will be more effective in that water can be used to control dust emission points where drilled material is discharged. Organiscak and Page (1995) illustrated the effectiveness of combined wet methods and dust collectors in their U.S. Bureau of Mines study, which compared rock drilling using LEV with and without the addition of water for dust suppression. The addition of wet methods to the LEV system showed a 92 percent reduction in respirable dust and eliminated nearly all of the visible dust. Quartz results decreased from 143 μg/m
OSHA received many comments related to the proposed requirements for rock and concrete drillers. CISC noted that it is more common to use wet methods when operating vehicle-mounted drilling rigs for rocks as opposed to using dust collection systems (Document ID 2319, pp. 108-109). A number of other commenters noted the prevalence of wet methods use in the industry (
Industry practice is to use the engineering control of soap injection where water is mixed with foam. The foam mixtures of water and foam products are effective in mitigating the hazard of dust when properly used as they can carry particles ranging from .03 mm to the size of a quarter. There are multiple manufacturers of the foam products and these products have been approved for use when drilling sanitary water wells. The foam agents are NSF approved and have also been approved for use in many states (Document ID 1983, pp. 1-2).
NGWA also explained that all rotary drilling machines have been equipped with some type of water injection system since the early 1970s (Document ID 1983, p. 2).
Historically, construction and mining investigators have reported dust control efficiencies of 96 to 98 percent through the routine use of wet dust suppression methods, depending on the methods used; however, the water flow necessary for dust control can create problems under certain working conditions (
OSHA's exposure profile contains five sample results for workers using wet methods with no other controls while drilling. These five samples have a mean of 24 μg/m
OSHA also finds that the use of an enclosed cab can effectively reduce exposures for vehicle-mounted drill operators. Enclosed cabs, however, only benefit the operator when the operator remains in the cab, and they do not control employee exposure during positioning or hole-tending activities. Therefore additional controls are necessary to protect employees from exposure to silica dust when performing activities outside of the cab. As described above, OSHA has determined that the use of water for dust suppression on the drill bit will effectively reduce exposures in situations where employees must also perform activities outside the cab.
Based on the information discussed above, Table 1 of this standard provides the option for employees to operate a vehicle-mounted rock or concrete drill from within an enclosed cab in conjunction with water applied at the drill bit for dust suppression; wherever cabs are specified in Table 1, however, the cabs must meet the requirements of paragraph (c)(2)(iii) of the standard for construction, as discussed above. OSHA has determined that the enclosed cab will adequately protect the operator while the addition of water at the drill bit will reduce exposures for employees in the area. The alternative control option included in Table 1, a dust collection system and water sprays at the discharge point (where the system ultimately dumps extracted dust), has also been proven to reduce exposures for both the operator at the drill controls and those employees in the vicinity. When the specified dust control methods are fully and properly implemented, TWA exposure levels are expected to remain below 50 μg/m
IUOE commented that Table 1 would be clearer if it specified that employers who use open cabs during concrete drilling are not exempt from exposure assessment when employers implement the other controls listed for vehicle-mounted drilling rigs for concrete (Document ID 2262, Attachment 1, p. 48). OSHA considers the rule to be clear as written: If an employer chooses to operate vehicle-mounted drilling rigs for rock and concrete from within an enclosed cab, it must follow the requirements in paragraph (c)(2)(iii) of the standard for construction and apply water for dust suppression at the drill bit. Otherwise, the employer must follow the alternative shrouded dust-collection-system compliance method in Table 1 or the requirements in paragraph (d) of the standard for construction, which allow for alternate exposure control methods provided that employee exposures are assessed and exposures are kept at or below the PEL. Additionally, IUOE suggested that OSHA explicitly state on Table 1 that the employer does not have the option of respirator use as a means to control exposures during rock crushing or rock and concrete drilling if the employer chooses not to use enclosed cabs as an engineering control (Document ID 2262, Attachment 1, p. 48). OSHA notes that Table 1 of this final standard does not require that drilling rig operators work from enclosed cabs exclusively. Because employers can choose between the two control methods listed on Table 1, employees that use open cabs during drilling activities would not be required to conduct exposure assessments if they are using a dust collection system with a close capture hood or shroud around the drill bit and are ensuring that the material at the dust collector discharge point is being wetted. If that method is followed, OSHA, having found based on the exposure profile and record evidence that exposures will consistently be at or below the PEL, has not included a respirator requirement on Table 1; where respirators are not required to satisfy compliance obligations (as is the case here if Table 1 is fully and properly implemented), OSHA does not expect employers to require the use of respirators anyway. However employers that do not follow either control strategy specified in Table 1 must comply with paragraph (d) of the standard for construction, which could require respirator use if exposures are measured at or above the PEL when using feasible engineering and work practice controls.
IME stated that the final rule should allow for the use of equivalent, alternative control methods (Document 2213, Attachment 1, p. 2). Table 1 is intended to represent the most reliable control methods available for reducing exposures, based on the evidence contained in the record. Employers who wish to implement an alternative control method can do so, but those employers must comply with paragraph (d) of the standard for construction.
IUOE, among others, urged OSHA to explore additional options for exposure controls to protect operators working outside the cab when drilling. Both IUOE and Fann Contracting asserted that Table 1 does not address protection of operators who perform construction activities outside the cab with or without remote controls (Document ID 2262, Attachment 1, p. 45; 2116, Attachment 1, p. 5). In response, Table 1 of the final standard now includes a requirement to use water for dust suppression at the drill bit when the drill is being operated from an enclosed cab to minimize the exposure to other employees outside the cab.
OSHA's proposed Table 1 entry for rock drilling would have required that employees use respirators when working under the shroud. OSHA proposed this requirement based on a determination that employees' exposures would be high given their proximity to the point of dust generation. IME suggested that respirators should not be required at all times because there are circumstances where the time spent working under the shroud is extremely brief or infrequent and potential exposures will be minimal or negligible (Document ID 2213, p. 2). NUCA commented that this requirement creates hazards for employees working under the shroud (Document ID 2171, p. 10). In response to these comments and after reviewing the record, OSHA has not retained this respirator requirement in the final standard. The Agency finds that the record contains substantial evidence that when the dust controls required by Table 1 are fully and properly implemented, TWA exposures to silica are unlikely to exceed 50 μg/m
NSSGA recommended that OSHA clarify the requirement for wearing respirators while working under the shroud by replacing the term “shroud” with “engineered fugitive dust control method,
In the proposed standard, this entry was titled “Using Jackhammers and Other Impact Drillers.” OSHA had a separate entry for “Rotary Hammers or Drills.” NIOSH commented on the potential for confusion with these titles, noting that a rotary hammer or drill is technically an impact driller (Document ID 2177, Attachment B, pp. 32-33). OSHA has revised the headings for the relevant Table 1 entries ((c)(1)(vii) and (x)). The revised heading for paragraph (c)(1)(x) removes the term “other impact drillers” and replaces it with “handheld powered chipping tools.” This change was made to clarify that this entry applies only to handheld tools that use an impact movement to chip or fracture the material being worked on. The heading for (c)(1)(vii) was revised from “Using Rotary Hammers of Drills” to “Handheld and Stand-Mounted Drills (Including Impact and Rotary Hammer Drills)” in order to clarify that all handheld drills, including impact drilling, are covered under that entry.
When using jackhammers and other handheld powered chipping tools at construction sites to fracture silica-containing material, paragraph (c)(1)(x) of the standard for construction requires the employer to operate the tools using either a water delivery system that supplies a continuous stream or spray of water at the point of impact, or a tool equipped with a commercially available shroud and dust collection system operated and maintained in accordance with manufacturer's instructions to minimize dust emissions. If the employer is operating a tool with the shroud and dust collection system, Table 1 requires that the dust collector (
OSHA revised the respirator use requirements from the proposed rule by distinguishing between indoor and outdoor environments. Table 1 of the final standard for construction does not require respiratory protection if tools are used outdoors for four hours or less per shift. OSHA based this revision on record evidence showing that exposures can be maintained at or below 50 μg/m
NUCA testified during the hearing that jackhammering is one of the construction activities most likely to expose employees to silica (Document ID 3583, Tr. 2255). OSHA's exposure profile for this task confirms this (Table IV.5.5-B in Section 5.5 of Chapter IV of the FEA); 73 of 98 TWA sample results (74 percent) were above 50 µg/m
The shroud and LEV control for jackhammers and handheld powered chipping tools was found to be less effective than water suppression but still reduced exposures up to 69 percent (Document ID 1267, pp. 493-494; 0865, p. iv; 0651, p. 1; 0667, pp. 1-3; 0862, pp.10-11, 14). Also, the respirable silica levels generated by these tools are dependent on whether they are being operated outdoors, indoors, or in an enclosed area. Several powered impact tool manufacturers currently offer LEV options (
OSHA received a number of comments on the jackhammer and handheld powered chipping tool entries on Table 1. CISC commented that OSHA did not indicate in the proposed Table 1 that the dust collection system needed to be commercially available and did not set parameters for the functioning of the dust collection system (Document ID 2319, p. 107). Based on comments and testimony in the record, OSHA has clarified the entry in Table 1 for jackhammers and handheld powered chipping tools to read “use tool equipped with commercially available shroud and dust collection system.” OSHA has added to Table 1 the following requirements: Operate and maintain the tool in accordance with the manufacturer's instructions to minimize dust emissions; provide at least the air flow recommended by the tool manufacturer; and use a filter with a 99 percent or greater efficiency and a filter cleaning mechanism.
CISC also expressed concern that using wet methods may raise quality issues, for example by introducing water to the base when pouring new concrete (Document ID 2319, p. 107). The water delivery system required by Table 1 must deliver a continuous stream or spray of water at the point of impact. The water delivery system evaluated by NIOSH delivered between 250 and 300 ml of water per minute and the authors observed that water applied at these flow rates did not add a substantial amount of water to the work surface nor did it result in substantial accumulation of water (Document ID 0867, pp. 8, 15). Given that a substantial amount of water is not needed, OSHA finds that proper implementation of the water delivery system is unlikely to lead to quality control issues. Furthermore, other than the hypothetical situation raised by CISC, there is no evidence in the record showing that using wet methods with jackhammers and powered chipping tools results in quality issues. Furthermore, Table 1 of the final standard provides two options for dust control of jackhammers and handheld powered chipping tools. The employer can use a tool that is equipped with a commercially available shroud and dust collection system as an alternative to using water.
Some commenters discussed that water may introduce slip hazards; however, comments and hearing testimony described current contractor practices that countered these concerns (Document ID 2171 p. 4; 3589, Tr. 4295-4296). OSHA understands the concerns about possible slip hazards from the use of water; however, NIOSH investigators noted that the relatively low water flow rates (300 ml/min) used to suppress dust during jackhammering did not result in a substantial accumulation of water on work surfaces. OSHA expects that proper implementation of the water delivery system will include taking measures to contain any runoff to prevent the accumulation of water on walking and working surfaces.
The water delivery systems described in OSHA's feasibility assessment chapter on jackhammers, chipping hammers, and other powered handheld impact tools (
Paragraph (c)(1)(xi) of the standard for construction requires that this task be performed using a grinder equipped with a commercially available shroud and dust collection system and operated in accordance with manufacturer's instructions. Additionally, the dust collection system must be capable of providing at least 25 cfm of air flow per inch of wheel diameter and be equipped with a filter that has a 99 percent or greater efficiency and either a cyclonic pre-separator or a filter cleaning mechanism. The proposed requirement was similar but specified the air flow to be at least 80 cfm, rather than 25 cfm per inch of blade diameter, and also included a number of work practices. OSHA revised the controls for this task based on comments received in the record, as described below.
BCTD commented that “Tuckpointing,” as the entry was titled in proposed Table 1, is an operation that consists of a series of tasks (chipping or cutting out old mortar, preparing replacement mortar, cleaning the joints, applying fresh mortar, and applying a sealer), while the listed control was clearly directed at the task of using a “hand-operated tuckpoint grinder” (Document ID 2371, p. 25). To clarify its intent to address the grinding of old mortar, OSHA has re-named the entry for paragraph (c)(1)(xi) of the standard for construction to be “Handheld grinders for mortar removal (
Recent dust control efforts for tuckpointing have focused on using a dust collection hood (also called a shroud) that encloses most of the grinding blade and a vacuum cleaner system that is used to suction (exhaust) air from these hoods to collect dust and debris. These shroud and vacuum combinations generally capture substantial amounts of debris. In hearing testimony, Tom Ward, representing BAC, showed a video of local exhaust engineering controls for tuckpointing and described them as “extremely effective” (Document ID 3585, Tr. 3069). However, OSHA's exposure profile for tuckpointing shows that, even with these controls, silica exposures often exceed 100 µg/m
CISC questioned why employers can only use commercially available shrouds for hand-operated grinders, eliminating the use of specialty manufactured products (Document ID 2319, p. 110). OSHA is unsure of what CISC means by “specialty manufactured products” and CISC's written comments and testimony did not provide further detail. However, it is not OSHA's intent to eliminate the use of products that are custom made by aftermarket manufacturers (
In proposed Table 1, OSHA specified that the dust collection system used must provide at least at 80 cfm airflow through the shroud. For the final standard, Table 1 requires that dust collectors have an air flow of at least 25 cfm per inch of wheel diameter. This change is due to OSHA's review of the evidence in the rulemaking record. Computational and laboratory studies by Heitbrink and Bennett (2006) and Collingwood and Heitbrink (2007) found that an air flow rate of 80 to 85 cfm (based on a 4- or 4.5-inch wheel) is the minimum needed to efficiently capture dust generated by angle grinders used for tuckpointing (Document ID 0728, p. 366; 0600, p. 877). ACGIH (2010) recommends 25 cfm to 60 cfm per inch of blade diameter (Document ID 3997, pp. VS-40-01—VS-40-03). For a typical 4-inch tuckpointing blade, 25 cfm/inch of diameter is equivalent to 100 cfm, higher than the 80 to 85 cfm used by Heitbrink and Bennett (2006) and Collingwood and Heitbrink (2007). Laboratory tests conducted by Heitbrink and Bennett indicate that a vacuum and shroud used by tuckpointers during grinding can reduce respirable dust emissions by a factor of more than 400 under ideal circumstances, but this reduction factor dropped to 10 when vacuum air flow was reduced to less than 80 cfm (Document ID 0728, p. 375). Furthermore, computational modeling showed that even a modest decrease in the air flow rate, from 85 cfm to 70 cfm, cuts the shroud's ability to capture dust by more than half. As a result, the estimated worker exposure level would be twice as high as it would have been if the air flow rate had remained constant at 85 cfm.
A NIOSH field trial on a vacuum that generated an air flow of 111 cfm for a grinder with a 4-inch blade showed that exposure levels for respirable dust were cut in half compared to using a 76 cfm flow rate (Document ID 0863, pp. 24-35). Based on the evidence contained in the record, OSHA has determined that the ACGIH (2010) recommendations are more protective given the variety of blade diameters, and is requiring a minimum 25 cfm of airflow per inch of grinding blade diameter instead of the 80 cfm minimum airflow (regardless of blade diameter) through the shroud.
To adequately capture debris during the grinding phase of tuckpointing, OSHA is requiring that vacuums be equipped with a cyclonic pre-separator to collect large debris before the air reaches the filters or be equipped with a filter cleaning mechanism. Cyclonic pre-separators minimize the accumulation of debris on filters in the vacuum, enhancing the ability of the vacuum to maintain the initial air flow rate. When testing a vacuum cleaner model equipped with a cyclonic pre-separator, Collingwood and Heitbrink found that the collected debris caused the average air flow rate to decrease only from 90 cfm to 77 cfm (Document ID 0600, p. 884). Heitbrink and Santalla-Elías evaluated two different brands of commercially available vacuum cleaners (Tiger-Vac and Dustcontrol) incorporating cyclonic pre-separation. Air flow rates for both of these vacuums were “largely unaffected” by debris accumulation up to 35 pounds. Debris accumulation also had very little effect on the flow rate measured before and after the filter was cleaned (Document ID 0731, pp. 377, 380). Similarly, during the Collingwood and Heitbrink field trials, the Dustcontrol vacuum with cyclonic pre-separator did not lose as much air flow as the vacuum designed with vacuum cleaner bags (bags are a more common pre-separation method but are subject to clogging) (Document ID 0600, pp. 883-884). OSHA concludes that cyclonic pre-separation is an effective technology for helping to maintain air flow and vacuum system effectiveness for the duration of tuckpointing tasks by preventing the static pressure increase caused by clogging that would otherwise lead to a dramatic decrease in air flow and loss of effective dust capture at the shroud.
The accumulation of material and debris on the filter (filter caking) during work causes pressure losses that eventually limit air flows in even the most powerful vacuums. As debris accumulates, the filter becomes caked with collected dust and air flow decreases. Unless the filter is properly cleaned following manufacturer's recommendations, the air flow declines rapidly. Cooper and Susi used a Dustcontrol 2900c vacuum with ICS Dust Director shroud and Bosch tuckpointing grinder to evaluate dust control in a field experiment. The authors reported that in four hours of continuous grinding up to 130 pounds of dust was collected, and that flow rates in the vacuum dropped from 90 cfm to 80 cfm in as little as 8 minutes. Thus, regular stops to conduct the proper reverse air pulse filter cleaning procedure were crucial to successful dust control (Document ID 4073, Attachment 9M, pp. 4-5, 7-9). Therefore OSHA is requiring the use of a filter-cleaning mechanism when a cyclonic pre-separator, which removes larger debris, is not in place. To assist employees in determining when it is time to run a filter cleaning cycle, vacuums equipped with a gauge indicating filter pressure or equivalent device (
PTI and OEHCS submitted comments emphasizing the importance of effective HEPA filtration in protecting employees from silica dust, and recommended that Table 1 require that dust collectors used with grinders be equipped with HEPA filters (Document ID 1953, pp. 3-4; 1973, p. 2-3). However, HEPA filters may rapidly clog during mortar grinding, leading to static pressure drop and loss of air flow needed to capture dust (
In proposed Table 1, OSHA included a specification that the grinder be operated flush against the work surface and that work be performed against the natural rotation of the blade (
Western Construction Group also commented that it is not always possible to operate the grinder against the natural rotation of the blade,
CISC commented that a significant portion of tuckpointing takes place at elevated locations on scaffolds and expressed concern about the control measures listed introducing significant trip and fall hazards at elevated locations (Document ID 2319, p. 110). Grinding related to tuckpointing does take place on scaffolds, as evidenced by one building project evaluated by Cooper
In the proposed standard, OSHA required personal air purifying respirators (PAPR) with an APF of 25 to be used while tuckpointing, regardless of task duration. The proposed requirement was based on high exposures results, including a TWA measurement of 6,196 μg/m
Paragraph (c)(1)(xii) of the standard for construction specifies two control options. The first control option, which applies only when grinders are used outdoors, is to use a grinder equipped with an integrated water delivery system that continuously feeds water to the grinding surface. When employers choose to use wet grinders indoors or in an enclosed area, they must comply with the requirements of paragraph (d) of the final rule. The second option is to use a dust collector equipped with a commercially available shroud and dust collection system. The dust collector must provide 25 cfm or greater of air flow per inch of wheel diameter and have a filter with a 99 percent or greater efficiency and a cyclonic pre-separator or filter-cleaning mechanism. OSHA is requiring that the control must be operated and maintained in accordance with manufacturer's instructions to minimize dust emissions. The second option is identical to the option required for handheld grinders used for mortar removal.
In the proposed standard, OSHA did not specify that the water delivery system be integrated with the grinder. However, OSHA has determined that systems that are designed and developed in conjunction with the tool are more likely to control dust emissions effectively by applying water at the appropriate rate and dust emission points based on tool configuration. Further, integrated systems will not interfere with other tool components or safety devices. These include free-flowing water systems designed for blade cooling as well as manufacturers' systems designed for dust suppression alone. OSHA is not specifying a minimum flow rate, but rather anticipates that the water flow rates specified by the manufacturer will optimize dust reduction. OSHA also recognizes that using makeshift water delivery systems can pose hazards. PTI commented that the use of a water feeding system not specified by the tool manufacturer could result in serious personal injury and electric shock for tools that are electrically operated (Document ID 1973, p. 1). Due to the potential hazards from using a water delivery system not specified by the manufacturer, and to ensure the effectiveness of the system in controlling dust, OSHA has modified Table 1 to require use of integrated water systems that are operated and maintained according to manufacturer's instructions to minimize dust emissions.
OSHA received a number of comments related to the use of wet methods as a control for handheld grinders. SMI and CISC commented on the difficulties of using an integrated water system while grinding, arguing that there is a lack of options with both safety guards and water supply, that grinders equipped with a water delivery system are designed to cool the blade rather than control the dust, and that the dust mitigation effects of the water are speculative (Document ID 2316, p. 2; 2320, p. 10). However, NIOSH reported that “several manufacturers of smaller grinders do offer electric grinders with
Francisco Trujillo of Miller and Long commented that wet methods often present significant slip and fall hazards and that attempting to apply wet methods to any non-horizontal surface has proven ineffective and often hazardous when using grinders (Document ID 2345, p. 2). Similarly, Stuart Sessions, an economist testifying on behalf of CISC, noted that it is difficult to use wet methods in winter in locations where the water may freeze (Document ID 3580, Tr. 1322). OSHA acknowledges that not every control option is practical in every situation, and in such situations, Table 1 of the final standard permits use of LEV systems to control dust. However, OSHA concludes that wet methods represent a feasible and effective option outdoors.
Those who do not implement the wet methods described above, or those grinding indoors, have the option to use a dust collector equipped with a commercially available shroud and dust collection system. Several rulemaking participants testified on the commercial availability of such equipment, including Gerry Scarano, Executive Vice President of BAC, Deven Johnson, director of training, health and safety for the Operative Plasterers and Cement Masons International Association, and Francisco Trujillo of Miller and Long (Document ID 3581, Tr. 1562, 1592-1593; 3585, Tr. 2962-2964). The record shows that Makita, DeWalt, Bosch, and Ostec all make grinding dust collection systems (
The LEV-based exposure controls for surface grinding function similarly to the LEV-based controls for mortar removal described in paragraph (c)(1)(xi) of the standard for construction, as mortar removal (tuckpointing) is simply a specialized form of grinding that uses the same grinding tools. The factors that influence vacuum flow rate for mortar removal (tuckpointing) are equally important to LEV dust controls for all types of surface grinding, and for other hand-operated power tools as well. Collingwood and Heitbrink note that “vacuum cleaners will probably continue to be an important control option for respirable dust exposures in construction for dust exposure sources such as mortar removal, concrete grinding, hole drilling, and brick cutting where water application is impractical” (Document ID 0600, p. 884). Older studies of LEV effectiveness have found exposure reductions of 86-99 percent (Document ID 0611, p. 463; 0247, pp. 6, 8). A more recent study by Akbar-Khanzadeh
OSHA received a number of comments about the proposed entry on Table 1 for handheld (or hand-operated) grinders using LEV. The proposed entry specified use of a grinder with a commercially available shroud and dust control system. Several commenters questioned why shrouds needed to be commercially available and whether appropriate shrouds are, in fact, commercially available (
In Section 5.11 of Chapter IV of the FEA, OSHA's exposure profile shows that 60 percent of ceiling grinders who perform overhead grinding using LEV, and 50 percent of outdoor grinders using LEV or water have achieved exposures below 50 µg/m
In addition, Gerry Scarano, representing BAC, stated that since 2009, “the availability and effectiveness of control options have improved, adding force to OSHA's conclusion that it is feasible to reduce the dust in most cases down to the proposed PEL” (Document ID 3581, Tr. 1562). Thus, the effectiveness of controls available today is likely higher than those that were used when the exposure samples included in the exposure profile were obtained.
SMI commented that there are no commercially available dust shrouds that currently meet American National Standards Institute (ANSI) B7.1 (and OSHA) guard design requirements (Document ID 2316, p. 2). SMI stated that available dust shrouds are plastic and are used in place of the original equipment's steel guards but do not meet the requirements of ANSI B7.1, which is a safety design specification standard for grinding wheels (Document ID 2316, p. 2). However, NIOSH reported that several major tool manufacturers sell grinders with integrated dust shrouds designed to meet applicable safety standards, and the tools are labeled accordingly. For example, the Underwriter's Laboratory
In the proposed standard, OSHA specified that the dust collection system must have an air flow of at least 25 cfm per inch of wheel diameter. OSHA has maintained this requirement in the final standard. CISC commented that for larger blades, it may be difficult to design and operate a system that pulls air flow at 25 cfm per inch of blade diameter (Document ID 2319, p. 105). NAHB also expressed concern that a dust collector with a HEPA vacuum would need to be at least 112.5 cfm for a small, 4.5-inch grinder (Document ID 2296, Attachment 1, p. 29). PTI recommended revising the Table 1 entry for grinders to require use of vacuums equipped with a HEPA filter that operates at 80 cubic feet per minute or greater, noting that commercial dust collection systems are typically rated at approximately 130 cfm (Document ID 1973, pp. 2-3). BCTD, on the other hand, recommended that OSHA specify airflow rates for grinder LEV based on blade diameter (Document ID 2371, p. 32). As explained above in the discussion of grinders used for mortar removal, OSHA has determined that 25 cfm per inch of blade diameter is more protective and consistent with established engineering principles as reflected in the ACGIH Industrial Ventilation Manual, 28th Edition, which generally expresses minimum cfm requirements for a variety of (stationary) grinders in relation to the wheel diameter (Document ID 3883, pp. 13-147—13-152).
To adequately capture debris during the grinding, OSHA is requiring that dust collection systems used with grinders have a filter with 99-percent or greater efficiency, along with either a cyclonic pre-separator to collect large debris before the air reaches the filters or a filter-cleaning mechanism. Because the same factors that cause air flow to decline during tuckpointing affect air flow during other tasks such as surface grinding, the measures discussed in the section on grinders used for mortar removal also need to be used when surface grinding to minimize filter clogging.
Echt and Sieber reported respirable quartz concentrations ranging from 44 µg/m
OSHA included three additional specifications in the proposed standard; two of these, preventing wet slurry from accumulating and drying, and ensuring that visible dust was not emitted from the process, were completely removed as described above. OSHA is retaining the third specification, which requires employers to minimize the accumulation of visible airborne dust when working indoors or in enclosed areas by providing sufficient ventilation when needed; this requirement is now located in paragraph (c)(2)(i) of the standard for construction.
In the proposed standard, OSHA required the use of a half-mask respirator with an APF of 10 during wet grinding for more than four hours. No respiratory protection was required when wet grinding for four hours or less. When using a grinder equipped with a commercially available dust collection system, OSHA required the use of a half-mask respirator with an APF of 10 regardless of task duration. In the final standard, OSHA has decided it is appropriate to distinguish between respiratory protection needed when grinding outdoors and grinding indoors or in enclosed areas. This division has allowed OSHA to more appropriately apply the use of respirators, limiting the number of tasks that requires their usage. Based on data in the record, OSHA concludes that most employees using hand-operated grinders without controls currently experience exposures above 50 µg/m
The available data presented in Table IV.5.11-B in Section 5.11 of Chapter IV of the FEA suggest that the mean indoor grinding exposure level with dust collection systems is about twice that for grinding outdoors, with 50 percent of exposures between 100 and 250µg/m
OSHA finds that there is inadequate evidence in the record to demonstrate that wet grinding indoors or in an enclosed area is as effective as using LEV. Accordingly, OSHA is permitting the use of water-based dust control for grinding tasks outdoors only and is not requiring the use of respiratory protection regardless of the duration of the task. OSHA notes from its exposure profile that the vast majority of exposure samples taken during indoor grinding where dust controls were used made use of LEV systems rather than water-based dust control systems (21 out of 23 samples) (
Paragraph (c)(1)(xiii) of the standard for construction covers wheeled machines, equipped with a cutting tool, that are guided by hand with the worker positioned more than an arm's length away from the grinding action of the tool (
Walk-behind milling machines and floor grinders are currently available with water systems (
In specifying the option for a machine equipped with an integrated water delivery system that continuously feeds water to the cutting surface, OSHA is not specifying a minimum flow rate for water used with the integrated delivery system, but rather anticipates that the water flow rates specified by the manufacturer will optimize dust reduction. Evidence in the record demonstrates the effectiveness of wet methods to control exposures when using walk-behind milling machines and floor grinders. ERG (2000) measured exposure levels below the LOD (12µg/m
Blute
Alternatively, employers following Table 1 may use a machine equipped with a dust collection system recommended by the manufacturer. The similarity between vehicular and walk-behind milling machines supports the use of vacuum dust collection (exhaust suction) methods for the smaller, walk-behind form of milling equipment. A study by TNO Bouw (2002) found that when exhaust suction methods were applied to the milling drum area of drivable milling machines, exposure levels for operators obtained over a five-day period ranged from less than4 µg/m
Based on the evidence in the record, OSHA has determined that employees' exposure when using walk-behind milling machines can be further reduced by cleaning up debris when work is performed indoors or in enclosed areas. During a study on exposures while operating a scabbler in a parking garage, researchers noted that the worker generated the most airborne dust when passing the machine over a previously milled area (Document ID 0633, pp. 812-813). OSHA's OIS data also contains a non-detectable silica exposure result for a helper who vacuumed behind the operator of a floor grinder and scarifier preparing an indoor concrete floor for painting where LEV was used as the dust control (Document ID 3958, Row 211). Under paragraph (c)(1)(xiii) of the standard for construction, when using a walk-behind milling machine or floor grinder indoors or in an enclosed area, milling debris in the form of loose dust must be removed with a HEPA-filtered vacuum prior to making a second pass over an area. This prevents the debris from interfering with the seal between machine and floor and minimizes the gap. Additionally, it prevents debris from being re-suspended and acting as another source of exposure. Accordingly, OSHA is requiring the use of a vacuum with a HEPA filter to clean up any loose dust prior to making additional passes over the area when work is conducted indoors or in enclosed spaces with LEV (Document ID 0633, pp. 812-813; 1391, pp. 28, 40).
In addition, the effectiveness of vacuum suction also depends on minimizing the gap between the bottom of the machine and the surface being milled, as discussed by Hallin (1983), who found that exposures to respirable dust increased when the housing around the base of the tool was removed (Document ID 1391, p. 25). To achieve acceptable dust control and ensure that the LEV system is fully and properly implemented, milling must proceed in a manner that limits the gap between the bottom of the walk-behind milling machine and the surface being milled.
Based on the data described above, OSHA concludes that most employees operating walk-behind milling machines will experience exposure levels of 50 µg/m
The proposed standard contained a single entry for “Milling” and treated all drivable milling machines alike, requiring them to use a water-fed system that continuously applied water at the cut point. In the final standard, OSHA has separated smaller milling machines (less than a half-lane wide) from larger ones based on comment and testimony in the record. In response to commenters, OSHA has decided it is more appropriate to divide drivable milling activities into separate entries for large milling machines (half-lane and larger) and small milling machines (less than half-lane) (Document ID, 3583, Tr. 2171, 2212-2213; 2181, pp. 4, 7, 9). IUOE and a road milling machine manufacturer categorized drivable milling machines as either small or large (half-lane or larger, with cutting drum about 79 inches or wider) (Document ID 3583, Tr. 2441; 1229). NAPA commented that large milling machines should be identified separately on Table 1 of the construction standard. Based on these comments and evidence showing that the dust control systems are different between the two classes of drivable milling machine (Document ID 3583, Tr. 2171, 2212-2213), Table 1 in the final standard treats them as two separate tasks.
Under paragraph (c)(1)(xiv) of the standard for construction, small drivable milling machines (less than a half-lane in width) must be used with supplemental water sprays designed to suppress dust. The water used must be combined with a surfactant. Manufacturers of smaller drivable milling machines currently make such systems (Document ID 1229; 4073, Attachment 4a). Unlike for larger milling machines, Table 1 does not specify as an option a water spray and exhaust ventilation combination system for small milling machines because it appears that such systems are not currently available.
Including a surfactant additive in the water is a practical way to reduce employee exposures to the lowest level achievable with this wet method (Document ID 1216, p. 3; 1217, Slides 4 and 8; 3583, Tr. 2187-2188). This is because it offers particle binding properties that are ideal for dust suppression (Document ID 1216, p. 3).
Small drivable milling machines generally produce less dust than large drivable machines, since small machines are used intermittently and have smaller cutting tools (Document ID 1229, pp. 1-3; 3583, Tr. 2213). As discussed in the technological feasibility section on millers using portable or mobile machines (
Water applied to the cutting drum helps reduce respirable silica exposures among milling machine operators and helpers. In a study conducted in the Netherlands, a water spray dust emission suppression system using additives reduced the PBZ respirable quartz exposures of asphalt milling machine drivers to a mean of 20 µg/m
Based on information presented here and in the technological feasibility analysis (
These controls are currently available (Document ID 2181, pp. 11, 21-29). All of the manufacturers of large milling machines currently provide dust-suppressing water spray systems on new equipment and as retrofit kits for older machines. In addition, as discussed in the Section 5.8.4 of Chapter IV of the FEA, new machines will be equipped with both dust-suppressing water spray systems and dust collection systems by 2017 at the latest, when industry members are committed under the Silica/Asphalt Milling Machine Partnership, which includes representatives from the road construction contractors industry and major road milling machine manufacturers, NAPA, AEM, IUOE, LHSFNA, and NIOSH, to equip new machines with both dust-suppressing water spray systems and LEV (Document ID 2181, pp. 11, 21-29).
The controls included on Table 1 for large drivable milling machines are based on research on dust control technologies conducted by the Silica/Asphalt Milling Machine Partnership, which has been studying dust controls for milling machines since 2003 (Document ID 2181, pp. 1-2; 3583, Tr. 2152, 2160; 4149) with the goal to develop innovative engineering controls “that all but eliminate dust and potential silica exposure,” and methods “to retrofit existing milling machines to ensure a safe workplace” (Document ID 3583, Tr. 2153). Much of the data contained in the record on the effectiveness of control strategies for large drivable milling machines come from the Partnerhip's efforts and are contained in NIOSH publications (
Based on the data in the record, exposures among large drivable milling machine operators can be reduced to 50 µg/m
NIOSH recommended LEV plus water-spray dust suppression controls be included on Table 1 for drivable milling machines (Document ID 2177, Attachment B, p. 20). As discussed in Section 5.8.4 of Chapter IV of the FEA, a dust suppression system with a foam additive kept exposures below 30 µg/m
Proposed Table 1 specified the use of a respirator (half-mask APF 10) for drivable milling machines with a water-fed system used more than four hours a day irrespective of the material milled. NAPA recommended removing the proposed requirements for use of respirators when milling asphalt (Document ID 2181, pp. 11-12, 16). Upon review of the evidence in the record, OSHA agrees that this is appropriate for all asphalt and concrete milling operations. As explained in Section 5.8 of Chapter IV of the FEA, the controls contained in Table 1 in the final standard will keep exposures below 50 µg/m
IUOE recommended separate treatment of operators and tenders of large milling machines since the exposures of operators are lower than the exposures of tenders. IUOE further stated that operators are located farther from the silica source than tenders, and appropriate protection varies depending upon the location of the worker from the silica source (Document ID 2262, p. 24). Evidence summarized above shows that most tenders and operators will not experience silica exposures in excess of 50 μg/m
Proposed Table 1 contained dust control specifications for all drivable milling machines, including when milling concrete. OSHA received comments from IUOE, BCTD, and NAPA recommending that Table 1 be modified to separate asphalt milling and concrete milling and require appropriate controls based on the respective exposure levels (Document ID 2262, pp. 3, 17; 2371, Attachment 1, p. 26; 2181, p. 9). Concrete milling is performed less frequently than asphalt milling (Document ID 1231; 3583, Tr. 2213-2214), but silica exposures could be higher than when milling asphalt. This difference is likely due to the potential for the silica content to be higher in some concrete compared with some asphalts (Document ID 1699), and also the softness and “stickiness” of asphalt milled warm, which likely helps reduce separation of the pavement components and perhaps limits dust release in hot weather (Document ID 1251, p. 14; 1231). In addition, cutting drums for concrete have smaller teeth, which can produce more fine dust than is the case with asphalt (Document ID 1699). Anthony Bodway, representing NAPA, also noted that silica exposures are higher for concrete milling than for asphalt milling (Document ID 2181, p. 15). In the FEA, OSHA concludes that water dust suppression and LEV systems should be equally effective for concrete and asphalt in terms of percent reduction in dust emissions when making cuts of four inches in depth or less on any substrate (
The Silica/Asphalt Milling Machine Partnership conducted field trials for large road milling machine LEV systems making cuts up to 11 inches deep (Document ID 4147; 4149). NIOSH evaluated exposures among workers at four road construction sites (Document ID 4147, pp. v, 5-7, 13, Table 1; 4149, pp. v, 5-7, 13, Table 1). All the samples obtained during the studies for operators and tenders combined showed that exposure levels never exceeded 25 μg/m
However, other evidence contained in the record indicates that cutting depths of more than four inches, in one pass, reduces the effectiveness of controls (Document ID 3798, pp. 2, 14; 0555, p. 1). Therefore OSHA has determined that if an employer is using a large drivable milling machine to mill concrete, or road surface material that contains both concrete and asphalt, deeper than four
IUOE also recommended excluding road demolition and asphalt reclamation from asphalt milling in Table 1. Road demolition involves removal of the road substructure in addition to the road surface material and asphalt reclamation involves deeper cuts than typical “mill and fill” cuts of four inches in depth or less. IUOE asserted that this change should eliminate the need for respirator use by operators during typical asphalt “mill and fill” operations when engineering controls are properly implemented (Document ID 2262, p. 23).
Paragraph (c)(1)(xv) of the standard for construction excludes road demolition and asphalt reclamation operations by limiting milling activities on materials other than asphalt to cuts of four inches in depth or less. The NIOSH studies of LEV for drivable milling machines were conducted using large asphalt road milling machines (half-lane or wider) and provide strong evidence that exposure levels below 50 μg/m
As previously stated, when milling only on asphalt, OSHA is allowing cuts of any depth to be made when machines are equipped with exhaust ventilation on the drum enclosure and supplemental water sprays designed to suppress dust. When milling all other material to a depth of more than four inches Table 1 does not apply and employers will be required to conduct exposure assessments and comply with the PEL in accordance with paragraph (d) of the standard for construction. Additionally, road demolition, such as cutting the roadway into manageable size pieces or squares that involves equipment other than milling machines, such as saws, dowel drills, and various kinds of heavy equipment, is not covered under this entry on Table 1 (
Wet spray methods can greatly reduce the exposure levels of operators and laborers who work near crushers tending the equipment, removing jammed material from hoppers, picking debris out of the material stream, and performing other tasks (Document ID 0203, pp. 3-6, 9; 1152; 1360; 1431, pp. 3-93-3-94; 3472, pp. 61-76; 4073, Attachment 9a; 4073, Attachment 15g, p. 1). These systems are currently available and all crushers and associated machinery (conveyors, sizing screens, discharge points) can be retrofitted with water spray or foam systems (Document ID 1360; 0769; 0770; 0830; 0831; 0832). Spray systems can be installed for remote control activation (Document ID 0203, pp. 11, 12, 14; 0830). The design and application of water spray systems will vary depending on application. For airborne dust suppression, spray nozzles should be located far enough from the target area to provide coverage but not so far so as to be carried away by wind. In addition, nozzles should be positioned to maximize the time that water droplets interact with airborne dust. Droplet size should be between 10 and 150 μm (Document ID 1540, pp. 62-63). Alternatively, to prevent airborne dust from being generated, nozzles should be located upstream of dust generation points and positioned to thoroughly wet the material, and the volume and size of droplets increased to ensure that the material is sufficiently wetted (Document ID 1540, pp. 62-63). Information from IUOE, BCTD, and the U.K. Health and Safety Executive shows that water application can be expected to reduce exposure levels from 78 to 90 percent (Document ID 1330, p. 94; 4025, Attachment 2; 4073, Attachment 9a, pp. 1-4; 4073, Attachment 15g, p. 2).
The record did not contain information on exposures of tenders or other employees working near a crusher operation without dust controls. However, OSHA concludes that employees assisting with crusher operations can be exposed to elevated levels of respirable crystalline silica if water sprays are not used to control dust emissions. This conclusion is based on evidence gathered by OSHA's contractor, ERG, which visited a concrete crusher site. At the site, ERG observed a crusher operator who spent time outside of a control booth shoveling dried material from under a conveyor. The operator was exposed to 54 μg/m
CISC argued that OSHA's preliminary finding that it was feasible to achieve exposures of 50 μg/m
Crushers are currently available with remote controls as standard equipment (Document ID 0770; 0769, p. 2). The remote operation permits the operator to stand back from the crusher or move upwind of dust emissions. IUOE provided exposure data from large highway reconstruction projects (Document ID 4025, Attachment 2, p. 9). Four samples were collected where the operator platform was next to the crushing operation and the operator was directly exposed to the crusher emissions, resulting in a mean respirable crystalline silica exposure of 410 μg/m
An isolated and ventilated operator control booth can significantly reduce the respirable silica exposures of employees associated with crushing. At a visit to a crusher facility, ERG found non-detectable levels of respirable crystalline silica inside the operator's control booth, compared to a concentration of 103 μg/m
Other studies of operator cabs also reported silica or dust exposure reductions ranging from 80 percent to greater than 90 percent (Document ID 0589, p. 3; 0590, p. 54; 1431, p. 3-95). In the PEA, OSHA recognized that control booths for crushers are commercially available, although they are not commonly used on construction sites (Document ID 1720, p. IV-494). However, Kyle Zimmer, director of health and safety for IUOE Local 478, stated during the hearing that “contractors report that they are using portable crusher control booths with air conditioning to operate the plant remotely” (Document ID 3583, Tr. 2341).
Evidence indicates that operators experience high exposure levels when they must operate the crusher from above the feed hopper where dust emissions are highest (Document ID 0030; 4073, Attachment 10a). In light of this evidence, OSHA concludes that removing or isolating the operator from this high-exposure location will be effective in lowering the exposure of the operator. It is not clear that a control booth alone will be sufficient to protect the operator from exposure to silica, since operators periodically leave the booth to perform work around the crusher, and the booth does not offer any protection for other employees outside the booth such as tenders. A study of crushers used in the South Australian extraction industry found operator exposures ranged from 20 to 400 μg/m
Because providing a filtered booth for the operator will not protect other employees assisting with the operation or working nearby, OSHA finds that a water-based dust suppression system is necessary to prevent excessive exposure to silica among tenders and other employees nearby. Therefore, OSHA has determined that the combination of water use and either a remote control station or a ventilated booth for the mobile crusher operator will be effective in minimizing exposure of the operators and tenders. Summary data submitted by IUOE show that, with water use, the addition of remote control stations further reduced operator exposures by a factor of 3 (Document ID 4025, Attachment 2, p. 9). At the crusher operation visited by ERG, the operator's TWA exposure was 54 μg/m
In the proposed standard, OSHA required the use of a half-mask respirator with an APF of 10 for all employees outside of the cab, regardless of task duration or whether water sprays or LEV were implemented. No respiratory protection was required for those employees who operated the crusher from within the cab. OSHA proposed to require respirator use because the data available at the time suggested that neither water spray nor LEV systems would consistently reduce exposures to 50 μg/m
Information from IUOE, BCTD and the U.K. Health and Safety Executive show that water application can be expected to reduce exposure levels by 78 to 90 percent (Document ID 1330; 4025, Attachment 2, pp. 7-23; 4073, Attachment 9a, pp. 1-4; 4073, Attachment 15g, p. 2). Using the mid-point of this exposure control range (84 percent) and applying it to the highest value in the exposure profile (300 μg/m
The use of LEV systems was discussed in the NPRM, but evidence in the record indicates that it has yet to be proven practicable for mobile construction crushing equipment and is not currently used extensively. William Turley of the Construction and Demolition Recycling Association stated, “While there are crushing operations that have used baghouses on the crusher, none use . . . ventilation equipment for conveyors” (Document ID 2220, p. 2). Phillip Rice of Fann Contracting contended that large crushing systems with multiple conveyor belts would make it very difficult to use LEV cost effectively (Document ID 2116, Attachment 1, p. 31). In contrast, Kyle Zimmer of IUOE testified that employers are using dust collectors with baghouses at some crushing operations (Document ID 3583, Tr. 2341). Nevertheless, the record does not contain substantial and convincing evidence that LEV alone can be applied when using mobile crushing machines to reduce exposure levels to the same extent as water-based dust suppression systems combined with the use of remote control stations or filtered control booths. Therefore, OSHA is not specifying the use of LEV systems for crushing operations on Table 1 of the final standard.
Paragraph (c)(1)(xvii) of the standard for construction requires the operator to be in an enclosed cab, regardless of whether other employees are in the area and the cab must meet the requirements of paragraph (c)(2)(iii) of the standard for construction. When other employees are engaged in the task, water, dust suppressants, or both combined must also be applied as necessary to minimize dust emissions. Paragraph (c)(2)(iii) of the standard for construction requires enclosed cabs to be kept as free as practicable from settled dust, to have door seals and closing mechanisms that work properly, to be under positive pressure maintained through continuous delivery of fresh air, to have gaskets and seals that are in good condition and work properly, to have intake air that is filtered through a filter that is 95 percent efficient in the 0.3-10.0 μm range, and to have heating and cooling capabilities.
In the proposed Table 1, OSHA included one entry for heavy equipment and required that an enclosed cab be used. Although OSHA analyzed all types of work with heavy equipment, including demolition, in its preliminary feasibility analysis for heavy equipment, the proposed Table 1 entry described the activity as “use of heavy equipment during earthmoving activities.”
Several commenters requested clarification on what uses of heavy equipment OSHA intended to cover in the entry on proposed Table 1. IUOE requested that OSHA include a definition of the range of “activities encompassed within earthmoving,” and specifically acknowledge whether or not demolition activities are intended to be encompassed within this definition of earthmoving on Table 1 (Document ID 2262, p. 7). IUOE further explained that while earthmoving activities are “dust-filled” and likely to result in some exposure to respirable silica, it was inappropriate to combine earthmoving and demolition into one entry for heavy equipment operators on Table 1 because earthmoving “does not fracture or abrade silica-containing materials, and thus, does not expose any heavy equipment operators to [a] high concentration of respirable silica.” IUOE opined that treating the two tasks separately in the final rule would allow for better control of the hazards (Document ID 2262, pp. 3, 6, 9, 14). LHSFNA supported the IUOE position on demolition versus earthmoving and how it should be addressed in Table 1 (Document ID 4207, p. 3). BCTD requested that Table 1 specify that the Table 1 controls only apply when the listed task is performed on or with silica-containing materials, noting that some operations, such as earthmoving equipment, do not generate silica dust unless the material contains silica (Document ID 2371, p. 24).
OSHA agrees with these recommendations and has separated heavy equipment into two entries on Table 1: Paragraph (c)(1)(xvii) of the standard for construction covers heavy equipment and utility vehicles used to abrade or fracture silica-containing materials or during demolition activities; paragraph (c)(1)(xviii) of the standard for construction covers heavy equipment and utility vehicles used for tasks such as grading and excavating (but not including demolishing, abrading, or fracturing silica-containing materials). As explained below, only heavy equipment and utility vehicles used to abrade or fracture silica-containing materials or during demolition activities require an enclosed cab at all times, whereas the employer has a choice between an enclosed cab or applying water and/or dust suppressant when these vehicles are used for tasks such as grading and excavating, provided there are no other employees engaged in the task beside the heavy equipment operator.
In the proposed standard, the only control option for heavy equipment was to operate from within enclosed cabs. Several commenters noted that enclosed cabs do not protect other employees, such as laborers, who perform tasks in the area but remain outside the cab (
NUCA expressed concern that operating from within a fully enclosed cab may reduce visibility of the work zone and impair verbal communication. and thereby pose potential safety risks (Document ID 2171, pp. 2, 4, 22). However, modern heavy equipment already come equipped with enclosed, filtered cabs that are designed with visibility in mind to allow the operator to perform the work required. Furthermore, radios or cell phones can be used for communication if necessary. Therefore, OSHA concludes that filtered, fully enclosed cabs have been and can continue to be used without compromising worker safety or the effectiveness of the cab.
The exposure profile in TableIV.5.3-B in Section 5.3 of Chapter IV of the FEA shows that approximately 8 percent (1 out of 13 samples) of heavy equipment operators performing demolition, abrading, or fracturing activities have exposures above 50μg/m
The information presented in OSHA's technological feasibility analysis for heavy equipment operators and ground crew laborers (Section 5.3 of Chapter IV of the FEA) and summarized above provides evidence that the use of enclosed cabs and water and/or dust suppressants will reduce exposures to 50 μg/m
Employees engaged in this task operate a variety of wheeled or tracked vehicles ranging in size from large heavy construction equipment, such as bulldozers, scrapers, loaders, and road graders, to smaller and medium sized utility vehicles, such as tractors, bobcats and backhoes, with attached tools that are used to excavate and move soil, rock, and other silica-containing materials (see Section 5.3 of Chapter IV of the FEA). Typically tasks conducted with this equipment include earthmoving, grading, excavating, and other activities such as moving, loading, and dumping soil and rock (
As discussed under the explanation of (c)(1)(xvii) of the standard for construction, OSHA included one entry for heavy equipment operators performing earthmoving activities in the proposed standard, but has divided this entry to distinguish between the controls needed when using heavy equipment for abrading, fracturing, or demolishing silica-containing material, on the one hand, and for grading and excavating silica-containing materials, on the other hand.
OSHA's exposure profile for earthmoving (
Under both entries, however, the specified controls to protect laborers are the same. Thus, as when engaged in abrading, fracturing, or demolition tasks near or alongside heavy equipment or utility vehicles, OSHA has included a requirement that water and/or dust suppressants be applied as necessary to minimize dust emissions so that employees, including such laborers, who are engaged in such tasks as grading and excavating silica-containing materials in conjunction with operators of heavy equipment or utility vehicles are protected from excessive exposure to respirable crystalline silica.
Enclosed cabs are not mandated for this task. They may be used if the equipment operator is the only
Other commenters were concerned about the availability of enclosed cabs on heavy equipment used for these types of earthmoving activities. NUCA, NAHB, and CISC expressed concern regarding the cab requirements; NUCA stated that the majority of earthmoving equipment is “equipped with open canopies or unpressurized cabs” (Document ID 2171, p. 3; 2296, p. 32; 2319, p. 114). OSHA understands that some equipment currently in use may not be equipped with enclosed, pressurized cabs as required by Table 1 when enclosed cabs are used. Where an employer chooses not to retrofit existing equipment for grading and excavating, it must apply water and/or dust suppressants as necessary to minimize dust emissions in order to comply with Table 1. Employers that neither choose to retrofit equipment nor suppress dust using water or other dust suppressants must comply with the requirements of paragraph (d) of the standard for construction.
Evidence in the record indicates that exposures of employees during common excavation and grading operations are likely to remain below 25 μg/m
NIOSH tested bulk samples of a commercially available joint compound and found up to 6 percent quartz, although silica was not listed on the safety data sheet for the product (Document ID 0213, p. 5). However, in a more recent study, NIOSH determined that three of six drywall compounds purchased at a retail store contained only trace amounts of silica (less than 0.5 percent) (Document ID 1335, p. iii). The researchers concluded that for the most part the results of each sample analysis agreed with the composition stated in the manufacturers' material safety data sheets (Document ID 1335, pp. 3-4, 7, 10). OSHA finds that joint compound is more accurately labeled than it was in the past, and that manufacturers' labeling and SDSs are the best source for determining whether employees may be exposed to silica that could become respirable.
Additionally, the exposure profile includes 15 full-shift, personal breathing zone samples of respirable crystalline silica. The median exposure is 12 μg/m
In the event that the use of silica-free joint compound is not possible, or during renovation work where silica-containing joint compound might be present, OSHA has determined that there are engineering controls, as discussed in Section 5.2 of Chapter IV of the FEA, that reduce exposure to respirable crystalline silica to 50 μg/m
The Society for Protective Coatings (SSPC) requested that abrasive blasting be included in Table 1 (Document ID 2120, p. 3). SSPC recommended the inclusion of an abrasive blasting entry which “simplifies compliance and eliminates the need for measuring workers' exposure to silica, while still ensuring adequate protection for workers” (Document ID 2120, p. 3). However, OSHA has determined that it is not appropriate to add abrasive blasting to Table 1.
There are a variety of options available to employers to control
OSHA has decided that employees will be best protected when employers, following the traditional approach set forth in paragraph (d) in the standard for construction, choose among these dust control strategies to select the controls that best fit the needs of each job. OSHA's conclusion is based on the following additional considerations: (1) Abrasive blasting operators must, separate from this rule, be provided with and wear the respiratory protection required by 29 CFR 1926.57(f), and (2) employees helping with the operation, or who otherwise must be in the vicinity of the operation, must also be adequately protected by a combination of engineering controls, work practices, and respirators. OSHA thus concluded that the Table 1 approach did not lend itself to specifying one or more controls that would be suitable for all such operations. Furthermore, based on its technological feasibility analysis for abrasive blasting (
Paragraph (d) of the standard for construction describes the requirements for the alternative exposure control methods approach, which applies for tasks not listed in Table 1 or where the employer chooses not to follow Table 1 or does not fully and properly implement the engineering controls, work practices, and respiratory protection described in Table 1. The alternative exposure control methods approach is similar to OSHA's traditional approach of demonstrating compliance with a permissible exposure limit (PEL) through required exposure assessments and controlling employee exposures through the use of feasible engineering controls and work practices (
Paragraph (d)(1) specifies that construction employers who must or choose to follow paragraph (d) shall limit employee exposures to respirable crystalline silica at or below the PEL of 50 μg/m
Paragraph (d)(2) specifies the requirements for exposure assessments, such as the types of assessments that are required under the standard (
Paragraph (d)(3) specifies the methods of compliance, which include a requirement to reduce exposure through feasible engineering and work practice controls before using respiratory protection, and cross-references standards for abrasive blasting. These requirements are fully discussed in the summary and explanation of
Paragraph (c) of the standard for general industry and maritime (paragraph (d)(1) in the construction standard) establishes an 8-hour time-weighted average (TWA) exposure limit of 50 micrograms of respirable crystalline silica per cubic meter of air (50 μg/m
OSHA proposed a PEL of 50 μg/m
The PEL was a focus of comment in the rulemaking process, revealing sharply divided opinion on the justification for and attainability of a PEL of 50 μg/m
Some commenters contended that OSHA's proposed PEL was too low, arguing that the proposed limit was infeasible or not justified by the health and risk evidence (
Other commenters, including the United Automobile, Aerospace, and Agricultural Implement Workers of America and the American Public Health Association, contended that the
After considering the evidence in the rulemaking record, OSHA is establishing a PEL of 50 μg/m
The Agency considers the level of risk remaining at the revised PEL to be significant. However, based on the evidence evaluated during the rulemaking process, OSHA has determined a PEL of 50 μg/m
OSHA has also determined that the proposed alternative PELs, 100 μg/m
Even though OSHA's risk assessment indicates that a significant risk also exists at the revised action level of 25 μg/m
Instead, OSHA has concluded that a PEL of 50 μg/m
The proposed definition of respirable crystalline silica also would have established a single PEL that would have encompassed the three forms of silica covered under the previous OSHA silica PELs. While commenters generally supported a single PEL for respirable crystalline silica, they did not all agree on whether a single PEL should include quartz, cristobalite, and tridymite (
Halliburton Energy Services said that, given that OSHA has acknowledged that the risk to workers exposed to a given level of respirable crystalline silica may not be equivalent in different work environments, OSHA's “one size fits all” silica PEL for different forms of crystalline silica with varied physicochemical properties was unwarranted (Document ID 2302, p. 5).
As discussed in Section V, Health Effects, OSHA has concluded, based on the available scientific evidence, that quartz, cristobalite, and tridymite have similar toxicity and carcinogenic potency. The Agency therefore concludes that a single PEL is appropriate for quartz, cristobalite, and tridymite.
A number of commenters supported the proposed switch from these formulas to a PEL expressed as a gravimetric measurement of respirable crystalline silica. For example, several stakeholders, including the American Foundry Society (AFS), the American Petroleum Institute, the Fertilizer Institute, and the North American Insulation Manufacturers Association, agreed that OSHA should revise the previous formulaic PELs into straightforward concentration/gravimetric-based thresholds (
After considering the record on this issue, OSHA has decided to adopt a PEL which is expressed as a gravimetric measurement of respirable crystalline silica. OSHA expects that the revised PEL will improve compliance because the PEL is simple and relatively easy to understand, and is consistent with modern sampling and analytical methods. In addition, OSHA finds that a uniform PEL will provide consistent levels of protection for workers in all sectors covered by the rule.
OSHA considers the level of risk remaining at the new PEL of 50 μg/m
Requiring OSHA to set multiple PELs—taking into account the feasibility considerations unique to each industry or operation or group of them—would impose an enormous evidentiary burden on OSHA to ascertain and establish the specific situations, if any, in which a lower PEL could be reached. Such an onerous obligation would inevitably delay, if not preclude, the adoption of important health standards. In addition, the demanding burden of setting multiple PELs would be complicated by the difficulties inherent in precisely defining and clearly distinguishing between affected industries and operations where the classification determines legal obligations. The definitional and line-drawing problem is far less significant when OSHA merely uses a unit of industries and operations for analytical purposes, and when it sets a PEL in the aggregate,
OSHA also finds that a uniform PEL will ultimately make the standard more effective by making it easier for affected employers to understand and comply with the standard's requirements. Moreover, a uniform PEL makes it
The approach OSHA believes appropriate and has chosen for this and other standards is the lowest level achievable through engineering controls and work practices in the majority of locations. This approach is intended to provide maximum protection without excessively heavy respirator use. Id.
OSHA has also rejected such an approach in rulemakings on benzene and chromium (VI).
In the case of cotton dust, where OSHA did set different PELs for certain discrete groups, the groups involved exposures to different kinds of cotton dust and different degrees of risk. Even so, OSHA did not adopt a unique PEL for every single affected sector (
As discussed in Section V, Health Effects, OSHA does not find these arguments persuasive. First, many of the commenters used OSHA's enforcement data to make this point. These data were obtained during inspections where non-compliance was suspected and thus were skewed in the direction of exceeding the preceding PELs. As the Building and Construction Trades Department, AFL-CIO (BCTD) explained, OSHA data showing noncompliance with the preceding PEL is not representative of typical exposure levels, since sampling for compliance purposes targets worst-case exposure scenarios (Document ID 3581, Tr. 1634-1636).
Moreover, not all commenters agreed that overexposures were “widespread.” A few other commenters (
OSHA recognizes that differences in exposure can occur due to workplace variables such as fluctuations in environmental conditions or air movement. However, many of the major sources of day-to-day variability can be moderated by the consistent use of engineering controls and appropriate work practices (Document ID 3578, Tr. 971; 3589, Tr. 4251-4252; 4234, Attachment 2, pp. 31-38).
OSHA has acknowledged and discussed exposure variability in past rulemakings where the same issue was raised (
Reviewing courts have held that OSHA's obligation to show that a PEL can be achieved in most operations most of the time has been met despite the presence of random exposure variability. These courts have noted, in particular, OSHA's flexible enforcement policies, which allow the Agency to take such exposure variability into account before issuing a citation (
Such an enforcement policy recognizes the possibility that OSHA may measure silica exposures on a day when exposures are above the PEL due to unforeseeable, random exposure variations. In such a case, when the employer has previously monitored the work area, OSHA inspectors would review the employer's long-term body of data demonstrating the exposure pattern for tasks/operations that are representative of those under OSHA's evaluation. After comparing the employer's exposure data with OSHA's sampling results, OSHA's determination whether to resample would be governed by the inspector's judgment of whether the OSHA sampling results are representative.
Where an employer can show, based on a series of measurements made pursuant to the sampling and analytical protocols set out in these standards or other relevant data, that the OSHA one-day measurement may be unrepresentatively high, OSHA may re-inspect the workplace and measure exposures again. If, after such a reinspection, OSHA has reason to believe that there are circumstances that account for the high exposure measurement, OSHA may decide not to issue a citation.
For OSHA to consider a reinspection rather than citation, an employer must demonstrate that the inspector's one-day sample is unrepresentative of normal exposure levels. In most cases, this demonstration would consist of a series of full shift measurements representative of the exposure of the employee under consideration. These measurements should consist of all valid measurements related to the employee under consideration taken within the last year and should show that only on rare occasions could random fluctuations result in TWA concentrations above the PEL.
The lack of current, direct measures of ambient quartz concentrations is a major limitation of the data available for use in estimating U.S. ambient silica concentrations (Document ID 3637, pp. 3-31).
The report also indicated that “. . . another limitation of the available data is the fact that neither current nor dated quartz measurements were taken using PM
In addition, OSHA notes that the sampling methodology used in the Davis study does not measure respirable crystalline silica, as defined in OSHA's silica rule. Rather, the Davis study presents data from dichotomous samplers that are equipped with particle size selection inlets. These samplers allow for measurement of two particle size fractions: A fine fraction with particle sizes having aerodynamic diameter less than 2.5 microns (PM
OSHA concludes that the sampling results presented in the Davis study are not comparable to respirable crystalline silica measurements, as defined in OSHA's rule. It is clear that the sampling methodology considered in the Davis study would overstate respirable crystalline silica levels measured using the ISO sampling methodology. Moreover, OSHA has demonstrated that compliance with the PEL is technologically feasible. OSHA's evaluation of the technological feasibility of the PEL involved evaluation of thousands of respirable crystalline silica samples collected in a variety of occupational settings that include contributions from environmental sources in different geographic areas. Because the exposure data considered by OSHA in its evaluation of the technological feasibility of the PEL includes contributions from environmental sources, these contributions are already taken into account in determining the feasibility of the PEL. Therefore, OSHA finds that environmental sources of respirable crystalline silica exposure, to the extent they contribute to workplace exposures, are already considered in the Agency's conclusion that the revised PEL is feasible.
OSHA clarifies that the respirable crystalline silica rule does not change the existing PEL for coal dust. However, as indicated previously, the Dorr-Oliver 10-mm cyclone used by OSHA for enforcement of respirable dust standards exhibits acceptable bias against the ISO/CEN specification when operated in accordance with OSHA's existing method. Employers can continue to use the Dorr-Oliver cyclone to evaluate compliance with the new respirable crystalline silica PEL, as well as with the PEL for coal dust; duplicate sampling is not necessary. Employers can also use other ISO/CEN-compliant samplers to evaluate compliance with either or both PELs.
The preceding PELs for respirable crystalline silica are retained in 29 CFR 1910.1000 Table Z-3, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A. Footnotes are added to make clear that these PELs apply to any sectors or operations where the new PEL of 50μg/m
While the preceding PELs for respirable crystalline silica in 29 CFR 1910.1000 Table Z-3 are being retained, the PELs for total crystalline silica dust are being deleted. OSHA proposed to delete the previous general industry PELs for exposure to total crystalline silica dust because development of crystalline silica-related disease is related to the respirable fraction of, rather than total, dust exposure (
Paragraph (d) of the standard for general industry and maritime (paragraph (d)(2) of the standard for construction) sets forth requirements for assessing employee exposures to respirable crystalline silica. The requirements are issued pursuant to section 6(b)(7) of the OSH Act, which mandates that any standard promulgated under section 6(b) shall, where appropriate, “provide for monitoring or measuring employee exposure at such locations and intervals, and in such manner as may be necessary for the protection of employees” (29 U.S.C. 655(b)(7)).
Assessing employee exposure to toxic substances is a well-recognized and accepted risk management tool. The purposes of requiring an assessment of employee exposures to respirable crystalline silica include: Determination of the extent and degree of exposure at the worksite; identification and prevention of employee overexposure; identification of the sources of exposure; collection of exposure data so that the employer can select the proper control methods to be used; and evaluation of the effectiveness of those selected methods. Assessment enables employers to meet their legal obligation to ensure that their employees are not exposed in excess of the permissible exposure limit (PEL) and to ensure employees have access to accurate information about their exposure levels, as required by section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)). In addition, exposure data enable the physicians or other licensed health care professionals (PLHCP) performing medical examinations to be informed of the extent of occupational exposures.
In the proposed standard for general industry and maritime, OSHA included a requirement for employers to assess the exposure of employees who are reasonably expected to be exposed to respirable crystalline silica at or above the action level of 25 µg/m
The proposed standard for construction included the same requirements for exposure assessment as the proposed standard for general industry and maritime; however, employers were not required to assess the exposure of employees performing tasks on Table 1 where the employer fully implemented the engineering controls, work practices, and respiratory protection specified in Table 1. This exception to the general requirement for exposure assessment was intended to relieve the construction employer of the burden of performing an exposure assessment in these situations, because appropriate control measures are already identified.
Commenters, such as the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the American Society of Safety Engineers (ASSE), the National Industrial Sand Association (NISA), and the International Diatomite Producers Association, supported the inclusion of an exposure assessment provision in the general industry standard (
Other commenters from both construction and general industry, including Ameren Corporation (Ameren), the Concrete Company, the Glass Association of North America, the Washington Aggregates and Concrete Association, the North American Insulation Manufacturers Association (NAIMA), EEI, the National Stone, Sand, and Gravel Association (NSSGA), the National Association of Manufacturers (NAM), Lafarge North America (Lafarge), the Asphalt Roofing Manufacturers Association (ARMA), and NAHB, argued that employers should not be required to conduct air monitoring for employees on each shift, for each job classification, and in each work area unless differences exist between shifts (
In response to these comments, OSHA restructured the exposure assessment requirements in order to provide employers with greater flexibility to meet their exposure assessment obligations using either the performance option or the scheduled monitoring option. This restructuring emphasizes the performance option in order to provide additional flexibility for employers who are able to characterize employee exposures through alternative methods. Commenters, including Arch Masonry, Inc., the Building and Construction Trades Department, AFL-CIO (BCTD), and the Precast/Prestressed Concrete Institute (PCI), strongly supported this approach (
While some small businesses and construction employers, like Holes Incorporated, noted the difficulties with utilizing this option, there were other similarly situated commenters, like Arch Masonry, that felt the performance option was necessary to fulfill their exposure assessment obligations (
In addition, the restructured standard for construction provides added flexibility to construction employers in another significant way. As described in the summary and explanation of
The rule also includes the scheduled monitoring option in order to provide employers with a clearly defined, structured approach to assessing employee exposures. Some commenters, such as CISC and ASSE, urged OSHA to reconsider the inclusion of the scheduled monitoring option, finding it to be impractical, infeasible, and burdensome (
OSHA received a number of comments on this general provision. For example, the Center for Progressive Reform (CPR) recommended that OSHA require employers to conduct exposure assessments for each employee who is or may “foreseeably” be exposed at or above the action level, rather than only for those employees “reasonably expected” to be exposed at or above the action level. They argued that “expected” exposures might be lower than “foreseeable” exposures, and cited equipment malfunctions and problems with respiratory protection programs as situations that are “foreseeable” but may not be “expected” (Document ID 4005, pp. 2-4). OSHA is not persuaded by this argument. The Agency has decided that employers should not be required to conduct assessments when employee exposures are only likely to exceed the action level during a foreseeable, but unexpected event. Therefore, an employer who reasonably expects the exposure of an employee to remain below the action level does not have to assess the exposure of that employee. However, if equipment malfunctions or other unexpected events that could affect employee exposures occur, then the employer may not be able to reasonably expect employee exposure to remain below the action level and would be required to conduct an assessment. As to CPR's comment that anticipated problems with respiratory protection programs might be foreseeable, but unexpected, OSHA reminds employers that this rule defines “employee exposure” to mean exposure that would occur without the use of a respirator, so inadequacies in an employer's respiratory protection program do not affect the requirement for exposure assessment.
OSHA also received a number of comments on whether triggering exposure monitoring at an action level of 25 µg/m
Other commenters, including NISA, the Industrial Minerals Association—North America, the Institute of Makers of Explosives (IME), and the American Petroleum Institute (API), agreed that assessing exposures at an action level was necessary, but believed the action level should be 50 µg/m
On the other hand, commenters including the Fertilizer Institute, NSSGA, and Acme Brick Company and others in the brick industry did not believe that an action level trigger for exposure assessment was necessary and that the PEL should be the trigger for exposure assessment (
OSHA concludes that an action level trigger for exposure assessment is appropriate and agrees with commenters that an action level trigger is needed in order to maintain exposures below the PEL. An action level trigger, typically set at half the PEL, is consistent with other OSHA health standards, such as the standards for 1,3-butadiene (29 CFR 1910.1051), methylene chloride (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1026). It provides employees and employers with some assurance that variations in exposure levels will be accurately tracked and exposures above the PEL will be identified and corrective actions will be taken to protect employees. Assessment at the action level is also necessary to determine eligibility for medical surveillance in the standard for general industry and maritime. Where it is possible for employers to reduce exposures below the action level, the trigger encourages employers to do so in order to minimize their exposure assessment obligations while maximizing the protection of
OSHA disagrees with AXPC's suggestion to consider the effect of respiratory protection when setting the exposure assessment trigger or when triggering other provisions in this rule. Although there may be some circumstances where a breathing zone sample does not reflect the actual exposure of an employee who is being protected by a respirator, this argument overlooks the fact that exposure monitoring is not a single purpose activity. It is necessary to know employee exposure levels without the use of respiratory protection to evaluate the effectiveness of the required engineering and work practice controls and to determine whether additional controls must be instituted. In addition, monitoring is necessary to determine which respirator, if any, must be used by the employee, and it is also necessary for compliance purposes.
In addition, as discussed in the summary and explanation of
EEI urged OSHA to consider exempting intermittent and short-duration work in the electric utility industry from the exposure assessment requirement where employees exposed at or above the action level wear appropriate personal protective equipment required under either 29 CFR part 1910, subpart I or 29 CFR part 1926, subpart E (Document ID 2357, pp. 13-14). While OSHA understands that conducting exposure monitoring in these situations may present challenges, it is important that employees who perform intermittent and short-duration work in the electric utility industry have their exposures assessed; the need for accurate information on exposures is no less for these employees than for other employees exposed to respirable crystalline silica at or above the action level. Where exposure assessments are required for intermittent and short-duration work, the performance option provides considerable flexibility for meeting these obligations. However, other provisions of the rule may relieve employers from conducting exposure assessments in some of these situations. For general industry and maritime, in situations where employers have objective data demonstrating that employee exposure will remain below 25 µg/m
As discussed above, paragraph (d)(1) of the standard for general industry and maritime (paragraph (d)(2)(i) of the standard for construction), unlike the general exposure assessment requirement in the proposal, provides two options for exposure assessment—a performance option and a scheduled monitoring option. The scheduled monitoring option provides a framework that is familiar to many employers, and has been successfully applied in the past. The performance option provides flexibility for employers who are able to characterize employee exposures through alternative methods. In either case, employers must assess the exposure of each employee who is or may reasonably be expected to be exposed to respirable crystalline silica at or above the action level.
Where the employer elects this option, the employer must conduct the exposure assessment prior to the time the work commences, and must demonstrate that employee exposures have been accurately characterized. To accurately characterize employee exposures under the performance option, the assessment must reflect the exposures of employees on each shift, for each job classification, in each work area. However, under this option, the employer has flexibility to determine how to achieve this. For example, under this option an employer could determine that there are no differences between the exposure of an employee in a certain job classification who performs a task in a particular work area on one shift and the exposure of another employee in the same job classification who performs the same task in the same work area on another shift. In that case, the employer could characterize the exposure of the second employee based on the characterization of the first employee's exposure.
Accurately characterizing employee exposures under the performance option is also an ongoing duty. In order for exposures to continue to be accurately characterized, the employer is required to reassess exposures whenever a change in production, process, control equipment, personnel, or work practices may reasonably be expected to result in new or additional exposures at or above the action level, or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred (
When using the performance option, the burden is on the employer to demonstrate that the data accurately characterize employee exposure. However, the employer can characterize employee exposure within a range, in order to account for variability in exposures. For example, a general industry or maritime employer could use the performance option and determine that an employee's exposure is between the action level and the PEL. Based on this exposure assessment, the employer would be required under paragraph (i)(1)(i) to provide medical surveillance if the employee is exposed for more than 30 days per year. Where an employer uses the performance option and finds exposures to be above the PEL after implementing all feasible controls, the employer would be required to provide the appropriate level of respiratory protection. For example, an employer who has implemented all feasible controls could use the performance option to determine that exposures exceed the PEL, but do not exceed 10 times the PEL. The employer would be required under paragraph (g) of the standard for general industry and maritime (paragraph (e) of the standard for construction) to provide respiratory protection with an assigned protection factor of at least 10, as well as medical surveillance for employees exposed for more than 30 days per year.
Several commenters requested that OSHA provide more guidance as to how employers should implement the performance option. Commenters, including AFL-CIO, the International Union of Bricklayers and Allied Craftworkers (BAC), the United Steelworkers, BCTD, and the International Union of Operating Engineers (IUOE), felt that clarification and guidance on the kind of data that may or may not be relied upon was needed in order to ensure that the data adequately reflected employee exposures (Document ID 2256, Attachment 2, p. 10; 2329, p. 4; 2336, p. 6; 2371, Attachment 1, pp. 11-13; 3581, Tr. 1693-1694; 3583, Tr. 2341; 4204, p. 54; 4223, p. 70). The American College of Occupational and Environmental Medicine recommended that OSHA more precisely specify the type and periodicity of collection of industrial hygiene data that would be required to assure representative exposure measurements (Document ID 2080, p. 4). The American Industrial Hygiene Association (AIHA) argued that a sufficient number of samples and a sampling strategy that is representative of the employees and tasks being sampled is needed to ensure that exposure assessments using the performance option accurately characterize employee exposure (Document ID 3578, Tr. 1049-1050). To do this, AIHA suggested that OSHA,
CISC also indicated that the construction industry needed additional guidance, such as how often and when monitoring should be conducted under the performance option in order to determine whether it would be effective and viable (Document ID 2319, p. 86). Charles Gordon, a retired occupational safety and health attorney, suggested the performance option was too flexible and needed to be omitted until real-time monitoring could be incorporated into it (Document ID 2163, Attachment 1, p. 17).
OSHA has not included specific criteria for implementing the performance option in the rule. Since the goal of the performance option is to give employers flexibility to accurately characterize employee exposures using whatever combination of air monitoring data or objective data is most appropriate for their circumstances, OSHA concludes it would be inconsistent to specify in the standard exactly how and when data should be collected. Where employers want a more structured approach for meeting their exposure assessment obligations, OSHA also provides the scheduled monitoring option.
OSHA does, however, offer two clarifying points. First, the Agency clarifies that when using the term “air monitoring data” in this paragraph, OSHA refers to any monitoring conducted by the employer to comply with the requirements of this standard, including the prescribed accuracy and confidence requirements. Second, the term does not include historic air monitoring data, which are “objective data.” Additional discussion of the types of data and exposure assessment strategies that may be used by employers as “objective data” to accurately characterize employee exposures to respirable crystalline silica can be found in the summary and explanation of
For example, trade associations and other organizations could develop objective data based on industry-wide surveys that members could use to characterize employee exposures to respirable crystalline silica. For example, the National Automobile Dealers Association (NADA) conducted air monitoring for employees performing a variety of tasks in automobile body shops (Document ID 4197; 4198). NADA worked to ensure that the results of the study were representative of typical operations. The sampling procedures and techniques for controlling dust were documented. These data may allow body shops that perform tasks in a manner consistent with that described in the NADA survey to rely on this objective data to characterize employee exposures to respirable crystalline silica.
Employers could also use portable, direct-reading instruments to accurately characterize employee exposures to respirable crystalline silica. These devices measure all respirable dusts, not only crystalline silica. But where the employer is aware of the proportion of crystalline silica in the dust, direct-reading instruments have the advantage of providing real-time monitoring results. For example, in a facility using pure crystalline silica, the employer could assume that the respirable crystalline silica concentration in the air is equivalent to the respirable dust measurement provided by the direct reading instrument. Where exposures involve dusts that are not pure crystalline silica, the employer could determine the concentration of crystalline silica by analysis of bulk samples (
Where employers rely on objective data generated by others as an alternative to developing their own air monitoring data, they will be responsible for ensuring that the data relied upon from other sources are accurate measures of their employees' exposures. Thus, the burden is on the
CPR suggested that OSHA require an independent audit of employers' objective data calculations to ensure that they provide the same degree of assurance of accurate exposure characterization as air monitoring data (Document ID 2351, pp. 12-13). As explained above, employers using the performance option must ensure that the exposure assessment is sufficient to accurately characterize employee exposure to respirable crystalline silica. Because employers already bear the burden of ensuring accurate characterization of employee exposures, OSHA does not find that an independent audit of employers' objective data is necessary to assure proper compliance.
The Laborers' Health and Safety Fund of North America urged OSHA to collect and post all objective data that meet the definition on its Web site, so that it could be used by anyone performing the same task under the same conditions (Document ID 2253, p. 4). Other commenters, including BAC, BCTD, and IUOE, agreed that developing a means for collecting and sharing objective data was important (Document ID 2329, p. 4; 2371, Attachment 1, p. 13; 3583, Tr. 2394-2395). OSHA recognizes that the collection and sharing of objective data can be a useful tool for employers characterizing exposures using the performance option. OSHA anticipates that there could be a substantial volume of objective data that would require significant resources to collect, organize, present, and maintain in a way that is accessible, understandable, and valuable to employers. The Agency does not have the resources to do this; however, employers, professional and trade associations, unions, and others that generate objective data are encouraged to aggregate and disseminate this type of information.
As with the standard for chromium (VI), 29 CFR 1910.1026, OSHA does not limit when objective data can be used to characterize exposure. OSHA permits employers to rely on objective data for meeting their exposure assessment obligations, even where exposures may exceed the action level or PEL. OSHA's intent is to allow employers flexibility to assess employee exposures to respirable crystalline silica, but to ensure that the data used are accurate in characterizing employee exposures. For example, where an employer has a substantial body of data (from previous monitoring, industry-wide surveys, or other sources) indicating that employee exposures in a given task exceed the PEL, the employer may choose to rely on those data to determine his or her compliance obligations (
OSHA has also not established time limitations for air monitoring results used to characterize employee exposures under the performance option. Although the proposed standard would have limited employers using air monitoring data for initial exposure assessment purposes to data collected no more than twelve months prior to the rule's effective date, there were no such time restrictions on monitoring data used to conduct periodic exposure assessments under the performance option. Nevertheless, many commenters, including Ameren, TCNA, NAM, NAIMA, Associated General Contractors of New York State, ARMA, EEI, the National Rural Electric Cooperative Association, the Glass Packaging Institute, Verallia North America, and Holes Incorporated, found the 12-month limit on the use of monitoring results for initial exposure assessments using existing data to be too restrictive (
We have been collecting data on silica for several years as well as sharing within our industry group. This provision seems to be arbitrary and provides only a short window of time for data collection while eliminating the value and importance of past [efforts] we have placed on this issue (Document ID 2185, p. 7).
OSHA has been persuaded by these commenters not to establish time limitations for monitoring results used to assess exposures under the performance option, as long as the employer can demonstrate the data accurately characterize current employee exposures to respirable crystalline silica. The general principle that the burden is on the employer to show that the data accurately characterize employee exposure to respirable crystalline silica applies to the age of the data as well as to the source of the data. For example, monitoring results obtained 18 months prior to the effective date of the standard could be used to determine employee exposures, but only if the employer could show that the data were obtained during work operations conducted under workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations. Regardless of when they were collected, the data must accurately reflect current conditions.
Any air monitoring data relied upon by employers must be maintained and made available in accordance with the recordkeeping requirements in paragraph (k)(1) of the standard for general industry and maritime (paragraph (j)(1) of the standard for construction). Any objective data relied upon must be maintained and made available in accordance with the recordkeeping requirements in paragraph (k)(2) of the standard for general industry and maritime (paragraph (j)(2) of the standard for construction).
NISA commented that a performance option needs to be consistently interpreted by compliance officers in order for such an approach to be truly useful to employers (Document ID 2195, p. 36). OSHA agrees. OSHA regularly establishes policies and directives to guide compliance officers in a uniform, consistent manner when enforcing standards. These policies ensure that all the provisions of OSHA standards, including performance options, are consistently applied in the field.
Under the scheduled monitoring option, just as under the performance option, employers must accurately characterize the exposure of each employee to respirable crystalline silica. In some cases, this will entail monitoring all exposed employees. In other cases, monitoring of “representative” employees is sufficient. Representative exposure sampling is permitted when several employees perform essentially the same job on the same shift and under the same conditions. For such situations, it may be sufficient to monitor a subset of these employees in order to obtain data that are “representative” of the remaining employees. Representative personal sampling for employees engaged in similar work, with respirable crystalline silica exposure of similar duration and magnitude, is achieved by monitoring the employee(s) reasonably expected to have the highest respirable crystalline silica exposures. For example, this could involve monitoring the respirable crystalline silica exposure of the employee closest to an exposure source. The exposure result may then be attributed to other employees in the group who perform the same tasks on the same shift and in the same work area.
Exposure monitoring should include, at a minimum, one full-shift sample taken for each job function in each job classification, in each work area, for each shift. These samples must consist of at least one sample characteristic of the entire shift or consecutive representative samples taken over the length of the shift. Where employees are not performing the same job under the same conditions, representative sampling will not adequately characterize actual exposures, and individual monitoring is necessary.
Stakeholders offered numerous comments and suggestions about the proposed provisions that would have required employers to assess employee exposure on the basis of personal breathing zone air samples that reflect the exposure of employees on each shift, for each job classification, and in each work area. Many of these comments and suggestions involved specific concerns with the practicality and necessity of assessing employee exposure on each shift, for each job classification, and in each work area (
NAIMA suggested that OSHA should make adjustments to exposure monitoring requirements for extended work shifts (
OSHA agrees that this is an appropriate way to conduct sampling for extended work shifts. This practice is already reflected in the OSHA Technical Manual, which describes the two approaches advanced by NAIMA, including sampling the worst (highest exposure) eight hours of a shift or collecting multiple samples over the entire work shift and using the highest samples to calculate an 8-hour TWA (OSHA Technical Manual, Section II, Chapter 1, 2014,
CISC argued that the ASTM Standard E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, takes what CISC considered to be a more reasonable approach to representative air monitoring in the construction industry. The ASTM standard states that measurements “need to be representative of the worker's customary activity and be representative of work shift exposure” (Document ID 1504). CISC argued that this approach is,
OSHA acknowledges that variability in exposures is a concern in the construction industry. The construction standard does not require exposure assessment for employees engaged in a task identified on Table 1 where the employer fully and properly implements the specified exposure control methods presented on Table 1 (
Under the scheduled monitoring option, requirements for periodic monitoring depend on the results of initial monitoring and, thereafter, any required subsequent monitoring. Paragraphs (d)(3)(ii)-(iv) of the standard for general industry and maritime (paragraphs (d)(2)(iii)(B)-(D) of the standard for construction) describe the employers' duties depending on the initial (and, after that, the most recent) monitoring results. If the initial monitoring indicates that employee exposures are below the action level, no further monitoring is required. If the most recent exposure monitoring reveals employee exposures to be at or above the action level but at or below the PEL, the employer must repeat monitoring within six months of the most recent monitoring. If the most recent exposure monitoring reveals employee exposures to be above the PEL, the employer must repeat monitoring within three months of the most recent monitoring.
Paragraph (d)(3)(v) of the standard for general industry and maritime (paragraph (d)(2)(iii)(E) of the standard for construction) provides that if the most recent (non-initial) exposure monitoring indicates that employee exposures are below the action level, and those results are confirmed within six months of the most recent monitoring by a second measurement taken consecutively at least seven days afterwards, the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring. As discussed below, reassessment is always required whenever a change in the workplace may be reasonably expected to result in new or additional exposures at or above the action level or the employer has any reason to believe that new or additional exposures at or above the action level have occurred, regardless of whether the employer has ceased monitoring because exposures are below the action level under
OSHA made a number of minor changes to the requirements for periodic monitoring under the scheduled monitoring option from the proposal based on stakeholder comments. For example, paragraph (d)(3)(i)(B) of the proposed regulatory text provided that “[w]here initial or subsequent exposure monitoring reveals that employee exposures are above the PEL, the employer shall repeat such monitoring at least every three months.” Subparagraph (C) then stated: “the employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least 7 days apart, are below the action level, at which time the employer may discontinue monitoring . . .”
ARMA argued that these provisions were confusing and “might be interpreted to require employers to continue monitoring quarterly, even if two consecutive measurements are at or above the action level but at or below the PEL”—a reading that ARMA believed conflicted with the language of paragraph (d)(3)(i)(A), which provided that “[w]here initial or subsequent exposure monitoring reveals that employee exposures are at or above the action level but at or below the PEL, the employer shall repeat such monitoring at least every six months” (Document ID 2291, p. 23). ARMA added that it anticipated that OSHA intended these provisions to impose the same periodic monitoring requirements that appear routinely in other OSHA health standards. It explained: “[u]nder that approach, even if periodic monitoring must be conducted quarterly because the initial (or subsequent) assessment shows exposures in excess of the PEL, the frequency can be reduced to quarterly once two consecutive measurements more than seven days apart fall below the PEL but above the action level” (Document ID 2291, p. 23).
OSHA agrees with ARMA's comment and has revised the periodic monitoring provisions under the scheduled monitoring option to better reflect OSHA's intent—as a general rule, the most recent exposure monitoring sample determines how often an employer must monitor. OSHA has also revised proposed paragraph (d)(3)(i)(C) to clarify the circumstances under which employers who choose the scheduled monitoring option may discontinue periodic monitoring.
Stakeholders also commented on how often employers should be required to conduct exposure monitoring. Several commenters, including the National Tile Contractors Association (NTCA), Dal-Tile, Grede Holdings, ORCHSE Strategies (ORCHSE), Benton Foundry, PCI, TCNA, and NISA, disagreed with the proposed frequency of monitoring and suggested other frequencies (every 6 months, 12 months, 18 months, or as determined by a competent person) (
Francisco Trujillo, representing Miller and Long, proposed that where exposures were between the action level and the PEL, exposure assessment be required at least every six months unless employers implement the same controls used to control exposures above the PEL (Document ID 2345, p. 3). OSHA recognizes that exposures in the workplace may fluctuate. Periodic monitoring, however, is intended to provide the employer with reasonable assurance the employees are not experiencing exposures that are higher than the PEL and require the use of additional control measures. If the employer installs or upgrades controls, periodic monitoring will demonstrate whether or not controls are working properly or if additional controls are needed. In addition, periodic monitoring reminds employees and employers of the continued need to protect against the hazards associated with exposure to respirable crystalline silica. Because of the fluctuation in exposures, OSHA finds that when initial monitoring results equal or exceed the action level, but are at or below the PEL, employers must continue to monitor employees to ensure that exposures remain at or below the PEL. Likewise, when initial monitoring results exceed the PEL, periodic monitoring allows the employer to maintain an accurate profile of employee exposures. Selection of appropriate respiratory protection also depends on adequate knowledge of employee exposures.
In general, the more frequently periodic monitoring is performed, the more accurate the employee exposure profile. Selecting an appropriate interval between measurements is a matter of judgment. OSHA concludes that the frequencies of six months for subsequent periodic monitoring for exposures in between the action level and the PEL, and three months for exposures above the PEL, provide intervals that are both practical for employers and protective for employees. This finding is supported by OSHA's experience with comparable monitoring intervals in other standards, including those for chromium (VI) (1910.1026), cadmium (29 CFR 1910.1027), methylenedianiline (29 CFR 1910.1050), methylene chloride (29 CFR 1910.1052), and formaldehyde (29 CFR 1910.1048). Where employers find that a different frequency of monitoring is sufficient to accurately characterize employee exposure to respirable crystalline silica, they can use that air monitoring data to meet their exposure assessment obligations under the performance option.
Commenters, including National Electrical Carbon Products, Lapp Insulators, the Indiana Manufacturers Association, ORCHSE, Murray Energy Corporation, the Motor and Equipment Manufacturers Association, IME, PCI, and NAM, urged OSHA to permit employers to cease monitoring or monitor on a reduced schedule when it has been determined it is infeasible to reduce exposures below the PEL using engineering and work practice controls (
Some commenters, including Southern Company, EEI, API, and AFPM, raised concerns about the requirement to conduct additional exposure assessments (
As described above, the requirement to reassess exposures only applies where there are changes in the workplace that may reasonably be expected to result in new or additional exposures at or above the action level or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred. OSHA does not intend for employers to conduct additional monitoring simply because a change has occurred, so long as the change is not reasonably expected to result in new or additional exposures to respirable crystalline silica at or above the action level. Thus, in some of the situations highlighted by the commenters, employers may not need to reassess exposures. For example, where a personnel change does not have an expected impact on the magnitude of employee exposure to respirable crystalline silica, the employer would not have to reassess exposures. When the environmental conditions on a construction site change in ways that would not result in new or additional exposures at or above the action level, such as a change from dry, dusty conditions to wet, rainy conditions, the employer would not have to reassess exposures. Other changes that would be reasonably expected to lower exposures to respirable crystalline silica, rather than result in new or additional exposures at or above the action level, such as moving from an indoor to an outdoor location or using a product with a lower silica content than that previously used in the same process, would not require the employer to reassess exposures.
Several commenters, including the Korte Company, AFS, TCNA, and NAM expressed concerns that the proposal placed responsibility for laboratory performance on the employers, who are not in a position to ensure that laboratories are complying with specific analytical requirements (
One stakeholder, Southern Company, recommended that OSHA require use of accredited laboratories and move all other laboratory requirements to an appendix as a guide for laboratories that analyze silica samples (Document ID 2185, p. 7). OSHA agrees with this suggestion and has decided to retain the substance of the proposed provisions addressing analysis of samples, but has moved these provisions to a new appendix. The Agency concludes that segregating these requirements in an appendix to each standard provides greater clarity for both employers and the laboratories that analyze samples. The specifications contained in Appendix A are discussed in the summary and explanation of
Commenters, including NSSGA, SCA, OSCO Industries, ORCHSE, Associated General Contractors of Michigan (AGCM), and PCI expressed concern about the availability of a sufficient number of qualified laboratories capable
OSHA expects that the additional demand for respirable crystalline silica exposure monitoring and associated laboratory analysis with the rule will be modest. Most construction employers are expected to implement the specified exposure control measures in paragraph (c) of the standard for construction, and will therefore not be required to conduct exposure monitoring. The performance option for exposure assessment provided in both the standard for general industry and maritime at paragraph (d)(2) and the standard for construction at paragraph (d)(2)(ii) also serves to lessen the future volume of exposure monitoring and associated laboratory analysis for crystalline silica. As discussed in the summary and explanation of
The provisions in the rule are identical to the proposed provisions for both general industry and maritime and construction. A number of commenters offered opinions on these provisions. For example, some commenters, including Southern Company and EEI, objected to the differences between the general industry and construction notification requirements. These stakeholders argued that establishing different reporting requirements for general industry and construction (
This issue is not unique to this rulemaking. In October 2002, OSHA published the second phase of its Standard Improvement Project (SIPS), which proposed to revise a number of health provisions in its standards for general industry, shipyard employment, and construction. The proposal was part of OSHA's effort to continue to remove and revise provisions of its standards that are outdated, duplicative, unnecessary, or inconsistent. One of the issues OSHA examined in Phase II of SIPS was the “variety of different time limits between receipt of employees' exposure monitoring results and notification of employees” in OSHA's substance specific standards. After a thorough review of the record, OSHA adopted a 15-day notification period for general industry and a 5-day period in construction. The Agency explained that its decision to set two different time frames was due, in part, to the general differences in the industries,
Some stakeholders from the construction industry, including CISC and ASA, were concerned that they could not comply with the proposed five-day notification requirement due to the often short duration of tasks and employment in this sector. They argued that employers and employees will frequently have moved to a different job before the results are available, making it difficult or impossible to reach affected employees and rendering the data irrelevant to the new project with varying conditions and circumstances (
OSHA also concludes that shortening the proposed provision in general industry to mirror that in construction would likewise make little sense, especially insofar as most of OSHA's health standards for general industry already utilize a 15-working-day period. As OSHA explained in Phase II of SIPS, “a uniform time limit for notifying employees in general industry has substantial benefits[,]” including reduced employer paperwork burdens because of simpler, uniform compliance programs and probable improvement in employee protection due to improved compliance. Therefore, OSHA finds that the reasons discussed in the SIPS rulemaking apply equally here. Consequently, OSHA has chosen to adopt the proposed 5 and 15-working-day assessment results notification periods in the rule.
OSHA has also considered commenters' concerns that the nature of construction work will make it
OSHA considers notification of assessment results to be important, even if the work conditions and circumstances have changed by the time the assessment results are available. Notification is not simply for purposes of identifying appropriate controls at the time the work is performed. The assessment results are still relevant after the exposure has occurred, to inform employees of their exposure, to provide context for future work that may be performed under similar conditions and circumstances, and to inform PLHCPs who provide medical surveillance for the employee.
NAM urged OSHA to provide flexibility as to when an assessment is deemed complete rather than obligating the employer to notify employees within five days of receiving a laboratory result (Document ID 2380, Attachment 2, p. 32). NAM argued that employers need time to perform and get the results of comprehensive surveys, perform appropriate quality assurance of those results, and meet with employees as appropriate to discuss the results. OSHA recognizes the value of these measures, but also considers the necessity of assessing exposures and notifying employees in a timely manner so that appropriate protective measures are taken. The Agency is convinced that the required notification can be made within the required 15 or 5 day time period, which are standard in OSHA health standards. Additional information that is developed from the collection of data in comprehensive surveys, any revisions to initial results as a result of quality assurance activities, or meetings to discuss the assessment results can take place at a later date.
Where the employer follows the performance option provided in paragraph (d)(2) of the standard for general industry and maritime (paragraph (d)(2)(ii) of the standard for construction), the 15 (or 5) day period commences when the employer completes an assessment of employee exposure levels (
In addition, as discussed in the summary and explanation of
The notification provisions in the rule, like those in the proposal, require employers to notify “affected” employees. As noted above, the term “affected” as used here means all employees for which an exposure assessment has been conducted, either individually or as part of a representative monitoring strategy. It includes employees whose exposure was assessed based on other employees who were sampled, and employees whose exposures have been assessed on the basis of objective data. Several commenters, including Ameren and EEI, suggested that notification should only be required where air monitoring has been performed, should not be applicable to employers who choose the performance option for meeting the exposure assessment requirement, and should already be captured by training or a written safety program (
OSHA disagrees. Notifying employees of their exposures provides them with knowledge that can permit and encourage them to be more proactive in working to control their own exposures through better and safer work practices and more active participation in safety programs. As OSHA noted with respect to its Hazard Communication Standard: “Employees provided with information and training on chemical hazards are able to fully participate in the protective measures instituted in their workplaces” (77 FR 17574, 17579 (3/26/12)). Exposures to respirable crystalline silica below the PEL may still be hazardous, and making employees aware of such exposures may encourage them to take whatever steps they can, as individuals, to reduce their exposures as much as possible. The results of exposure assessment are not specifically required to be communicated to employees under the hazard communication and employee information and training requirements in paragraph (j) of the standard for general industry and maritime (paragraph (i) of the standard for construction) nor as a part of the written exposure control plan required in paragraph (f)(2) of the standard for general industry and maritime (paragraph (g) of the standard for construction). Exposure assessments are likely to be conducted more frequently than training and, given the differences in timing, OSHA concludes that it would not make sense to incorporate them into a written exposure control plan. Thus, it is important to separate the notification of exposure assessment results from other information and training employees are required to receive under the rule.
NAM offered its opinion on what information the notification should provide to employees and urged OSHA to provide flexibility in this area:
Many employers require that air sampling results be accompanied by statements concerning the relationship of the results to existing standards, practices and procedures required as a result of the exposure levels, and a discussion of any steps the employer is taking in addition to further control exposures. OSHA acknowledges that employees benefit from having information about the exposures and potential control measures, including the use of PPE, to reduce their risk. OSHA should recognize that an assessment may include more than simple analytical results from a laboratory. Therefore, OSHA should propose language to make clear that the employers have this flexibility in communicating the results to employees (Document ID 2380, Attachment 2, p. 32).
The notification requirement specifies what information must be included; however, this does not limit employers from including the types of information described by NAM in the written notification to employees.
The standard also requires employers to either notify each affected employee in writing or post the assessment results in an appropriate location accessible to all affected employees. CPR urged OSHA to strengthen the notification requirements by requiring: Personal notification to workers in writing; notification in a language the employee can understand; and inclusion of information about the silica standard, silica-related disease from an individual or community perspective, and available health care benefits (Document ID 2351, p. 12). The Agency has determined that the notification requirements and the training requirements in the rule adequately address these suggestions. As discussed, the rule requires employers to notify employees, either in writing or by posting in an appropriate location. The training requirements in paragraph (j)(3) of the standard for general industry and maritime (paragraph (i)(2) of the standard for construction) require the employer to ensure that each covered employee can demonstrate knowledge and understanding of the silica standard, tasks that could result in exposure to respirable crystalline silica, the health hazards associated with exposure, specific procedures the employer has implemented to protect employees from exposure, and the medical surveillance provided under the rule. OSHA intends that these requirements will ensure that employees comprehend their exposure to respirable crystalline silica, the potential adverse effects of that exposure, and protective measures that are available. This would include employee understanding of any corrective action the employer is taking to reduce exposures below the PEL that is described in the written notification. The notification requirement, however, does not require that employers provide notification in a language that the employee can understand; as with other information provided to employees (
In addition, paragraph (d)(6)(ii) of the standard for general industry and maritime (paragraph (d)(2)(vi)(B) of the standard for construction) requires that whenever the PEL has been exceeded, the written notification must contain a description of the corrective action(s) being taken by the employer to reduce employee exposures to or below the PEL. Several commenters raised issues with the requirement to notify employees about corrective actions being taken where exposures are above the PEL. ASA and CISC suggested that in the construction environment, five days is not sufficient time to determine what caused the exposure, to research alternative solutions to limit future exposure, and to decide on the appropriate corrective action (Document ID 2187, p. 5; 2319, p. 87; 3442, pp. 3-4).
Similarly, in the general industry context, Newmont Mining Corporation argued that “[d]etermination of controls to reduce exposures when exposure assessments exceed the PEL may take more than 15 days” and suggested that OSHA revise the proposed language to allow employers 60 to 90 days to develop a corrective action plan and explain it to employees (Document ID 1963, p. 4). NAM also noted that the requirement to notify employees of the corrective actions being taken to reduce employee exposures below the PEL does not make sense for situations where it is infeasible to bring the exposure level down to the PEL (Document ID 2380, Attachment 2, p. 32).
OSHA disagrees. In OSHA's view, the requirement to inform employees of the corrective actions the employer is taking to reduce the exposure level to or below the PEL is necessary to assure employees that the employer is making efforts to furnish them with a safe and healthful work environment, and is required under section 8(c)(3) of the OSH Act (29 U.S.C. 657(c)(3)). OSHA understands that it may take more than 15 days to determine what engineering controls may be appropriate in a particular situation. However, the corrective action described in the written notification is not limited to engineering controls; when the exposure assessment indicates that exposures exceed the PEL, and the employer needs more than 15 days (or, in the case of the standard for construction, 5 days) to identify the engineering controls that will be necessary to limit exposures to the PEL, the employer is required to provide exposed employees with appropriate respiratory protection. In such a situation, respiratory protection is the corrective action that would be described in the written notification. Similarly, respiratory protection is the corrective action that would be described in the written notification in situations where it is infeasible to limit exposures to the PEL.
CEG and Upstate Medical University suggested that exposure assessment results should not only be reported to employees, but also should be reported to OSHA (Document ID 3586, Tr. 3321; 2244, p. 4). OSHA has not included such a requirement in the rule as such information would not be of practical use to the Agency. OSHA does not possess the resources to review and consider all of the material that will be generated by employers assessing employee exposures under the rule. OSHA would not have sufficient context to consider that material even if sufficient resources were available, given that only limited information is included in such assessments. Where such information would be of practical value to OSHA, such as when compliance staff conduct workplace inspections, the Agency is able to review exposure records in accordance with the standard addressing access to exposure and medical records (29 CFR 1910.1020).
The requirement for employers to provide employees or their representatives the opportunity to observe monitoring is consistent with the OSH Act. Section 8(c)(3) of the OSH Act mandates that regulations developed under section 6 of the Act provide employees or their representatives with the opportunity to observe monitoring or measurements (29 U.S.C. 657(c)(3)). Also, section 6(b)(7) of the OSH Act states that, where appropriate, OSHA standards are to prescribe suitable protective equipment to be used in dealing with hazards (29 U.S.C. 655(b)(7)). The provision for observation of monitoring and protection of the observers is also consistent with OSHA's other substance-specific health standards such as those for cadmium (29 CFR 1910.1027) and methylene chloride (29 CFR 1910.1052).
In his testimony, Shawn Ragle of UAW Local 974, in responding to Rebecca Reindel of AFL-CIO, described the importance of allowing the observation of monitoring:
MS. REINDEL: . . . Mr. Ragle, you mentioned that there's limited air monitoring in your plant. I was wondering, as a safety rep, have you ever been allowed to observe the air monitoring that has been done?
MR. RAGLE: . . . Actually, I've requested to be an observer for air monitoring, and the company has denied me that access. They've chosen to go with the employee that they put the monitor on.
Really, if you're doing your job, how are you going to monitor your monitor to make sure everything is going correctly? I really think that we need to have a little more voice, or at least some validation that the monitoring is being done correctly.
We shouldn't put that on the employee wearing the monitor (Document ID 3582, Tr. 1895-1896).
Similarly, James Schultz, a former foundry employee from the Wisconsin Coalition for Occupational Safety and Health, testified that he was,
. . . heartened to see that the proposal mandates that the employer provide protective clothing and equipment at no cost to the observers that are doing the observation and the monitoring of the hazards in the workplace (Document ID 3586, Tr. 3200).
Commenters, including the Korte Company and ASA, were also concerned that this requirement burdened the employer with providing the employee's representative with protective clothing or equipment whether or not the representative is trained or qualified to be wearing the required PPE (
Section 8(c)(3) of the OSH Act states that occupational safety and health standards which require employers to monitor or measure employee exposure to potentially toxic materials “shall provide employees or their representatives with an opportunity to observe such monitoring or measuring.” Provisions requiring employers to provide affected employees or their designated representatives an opportunity to observe any monitoring, as well as protective clothing or equipment where it is required, appear in 15 substance-specific health standards. Two substance-specific health standards (1,3-butadiene and methylene chloride) require employers to “provide the observer with protective clothing or equipment at no cost” (§ 1910.1051(d)(8)(ii) and § 1910.1052(d)(6)(ii)), as does this rule for respirable crystalline silica.
OSHA's policy conclusion is that employers conducting monitoring must bear the cost of complying with the standard's provisions for observer protections, even if the observer is not an employee of the employer. First, the Agency concludes that it would be an extremely rare occurrence for an observer to be unfamiliar with the use of the types of protective clothing or equipment that would be necessary for observation. In OSHA's experience, observers, whether they are another employee or a designated representative, typically have knowledge and experience such that they would already be medically cleared to use appropriate respiratory protection and may even have access to an appropriate respirator. Thus, OSHA expects the employer conducting the monitoring in these situations to communicate with the observer about what hazards are present in the workplace and what protective clothing and equipment, including medical clearances, are needed to observe the monitoring at their establishment. OSHA also expects the employer to assess whether the observer already has the necessary equipment and training to observe the monitoring. In situations where the necessary equipment is not already available to the observer, OSHA considers it to be the employer's responsibility to provide the protective clothing and equipment, as well as other training, clearance, or evaluation needed to ensure that the observer uses such clothing and equipment.
Second, OSHA recognizes that, in some situations, observers may not need to enter an area requiring the use of protective clothing or equipment in order to effectively observe monitoring. In those cases, no protective clothing or equipment is needed by the observer and OSHA would not expect or require the employer to provide such observer with any protective clothing or equipment. Some possible options to avoid exposing the observer to hazards that require the use of protective clothing or equipment include conducting the set-up for the monitoring outside of hazardous areas and ensuring that the observer can view the monitoring while remaining outside of the hazardous areas or, where exposure to respirable crystalline silica is the only hazard requiring the use of protective clothing or equipment, conducting the set-up for monitoring before the exposure-generating task is performed and ensuring that the observer can view the monitoring while remaining outside of the area of exposure.
Third, OSHA finds that employers conducting monitoring are in the best position to understand the hazards present at the workplace, including the protective clothing and equipment needed to protect against those hazards and the training, clearance, or evaluation needed to ensure that the observer is protected from those hazards. OSHA concludes that employers' familiarity with the worksite, the work, and their employees puts them in the best position to conduct exposure monitoring in a timely, effective, and safe manner. Therefore, OSHA appropriately requires the employer to bear the responsibility for ensuring that any observer in his or her establishment is adequately protected.
OSHA thus decided that employers conducting monitoring are responsible for the full costs of protecting observers, by providing the necessary equipment as well as any training, clearance, or evaluation needed to properly use the equipment, regardless of whether the observers are employees or designated representatives.
The requirements for exposure assessment in the rule are consistent with ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for
While OSHA's standard for respirable crystalline silica includes these elements, it includes a performance-oriented approach to exposure assessment that best reflects the realities of assessing exposures to respirable crystalline silica. The standard also includes a scheduled approach, which provides specific requirements for initial and periodic monitoring, for industries and tasks that can utilize such an option. Including both of these options maximizes the flexibility for employers to meet their exposure assessment obligations, and in doing so, better effectuates the purposes of the OSH Act and protects employees from exposures to respirable crystalline silica. OSHA thus concludes that the exposure assessment provision in the rule achieves the important purpose of assessing employee exposure, while providing sufficient flexibility for employers.
Paragraph (e) of the standard for general industry and maritime sets forth the requirements for regulated areas. In paragraph (e)(1), employers are required to establish regulated areas wherever an employee's exposure to airborne concentrations of respirable crystalline silica is, or can reasonably be expected to be, in excess of the permissible exposure limit (PEL). In paragraph (e)(2) and (e)(3), employers must demarcate regulated areas, and limit access to regulated areas to persons authorized by the employer and required by work duties to be present in the regulated area, persons observing exposure monitoring, or any person authorized by the Occupational Safety and Health (OSH) Act or regulations issued under it to be in a regulated area. Finally, paragraph (e)(4) requires employers to provide each employee and the employee's designated representative entering a regulated area with an appropriate respirator and require its use while in the regulated area.
The requirements for regulated areas serve several important purposes. First, requiring employers to establish and demarcate regulated areas ensures that the employer makes employees aware of the presence of respirable crystalline silica at levels above the PEL. Second, the demarcation of regulated areas must include warning signs describing the dangers of respirable crystalline silica exposure in accordance with paragraph (j) of the standard for general industry and maritime, which provides notice to employees entering or nearing regulated areas of the posted dangers. Third, limiting access to regulated areas restricts the number of people potentially exposed to respirable crystalline silica at levels above the PEL and ensures that those who must be exposed are properly protected, thereby limiting the serious health effects associated with such exposure.
The proposed requirements for regulated areas were included in paragraph (e) of both the proposed standard for general industry and maritime and the proposed standard for construction. Under proposed paragraph (e)(1), employers would have been required to establish and implement either a regulated area or an access control plan wherever an employee's exposure to airborne concentrations of respirable crystalline silica is, or reasonably could be expected to be, in excess of the PEL. The substantive requirements for the regulated area option were contained in proposed paragraph (e)(2) and those for access control plans were in proposed paragraph (e)(3). In the standard for general industry and maritime, OSHA has retained the requirement for employers to establish and implement regulated areas. However, the Agency has decided against requiring regulated areas in the standard for construction; an alternate provision has been included as a component of the written exposure control plan requirements for construction.
OSHA has concluded that requirements for regulated areas are appropriate for general industry and maritime, but not for construction, because the worksites and conditions and other factors, such as environmental variability normally present in the construction industry, differ substantially from those typically found in general industry. Commenters, including the National Council of La Raza, the National Institute for Occupational Safety and Health (NIOSH), the Associated General Contractors of America, the Small Business Administration's Office of Advocacy, and the Building and Construction Trades Department, AFL-CIO (BCTD), noted some of the differences between construction and general industry worksites, including that general industry establishments are typically more stable, are likely to be indoors, and are usually at a fixed location (
Some commenters, particularly those representing unions in general industry, supported the idea of regulated areas wherever an employee's exposure to airborne concentrations of respirable crystalline silica is, or reasonably could be expected to be, in excess of the PEL (
Other general industry stakeholders argued that establishing regulated areas would be unworkable and infeasible, particularly in foundries (Document ID 1992, p. 10; 2149, p. 2; 2248, p. 7; 2349, p. 5; 2379, Attachment B, pp. 30-31; 3584, Tr. 2669) and in certain other sectors of general industry (Document ID 1785, p. 6; 2337, p. 1; 2348, p. 36; 2380, Attachment 2, pp. 32-33). Some of these commenters focused on how an employer would be able to determine
The scenario described by AFS is not consistent with the definition of the term “regulated area” that OSHA proposed nor that of the final standard. Paragraph (b) of the proposed and final standard for general industry and maritime defines regulated area to mean “an area, demarcated by the employer where an employee's exposure to airborne concentrations of respirable crystalline silica exceeds, or can reasonably be expected to exceed, the PEL.” This definition makes clear that a regulated area is defined by employee exposure, not by which employee(s) might be in it. In other words, just because a particular employee's exposure assessment results indicate that the employee's exposure is above the PEL, that does not mean that employee exposure in every area that the employee visited on the day he or she was sampled exceeds, or can reasonably be expected to exceed, the PEL.
In the scenario posed by AFS, the employer would be required by paragraph (d)(1) of the standard for general industry and maritime to assess the exposure of each employee who is, or may reasonably be expected to be, exposed to respirable crystalline silica at or above the action level in accordance with either the performance option (
If an employee's exposure is above the PEL, paragraph (f)(1) of the standard for general industry and maritime would require the employer to use engineering and work practices to reduce and maintain employee exposure to respirable crystalline silica. In order to control exposures, the employer would need to determine where the exposures are generated. As explained by Dr. Franklin Mirer, Professor of Environmental and Occupational Health at CUNY School of Public Health, during his testimony on behalf of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), setting up a regulated area in a foundry is not complicated—employers must simply determine the extent of the dust cloud, possibly using measures like short-term or real-time monitoring or exposure mapping (Document ID 3578, Tr. 1003-1005).
Dr. William Bunn, who testified on behalf of the U.S. Chamber of Commerce, also offered testimony that suggests that some foundries are capable of establishing regulated areas. In response to questioning during the public hearings, Dr. Bunn spoke about the efficacy of OSHA inspections for aiding foundries in reducing silica exposures. Based on his experience as an employee of Navistar International and as a consultant to multiple automotive engine foundries, Dr. Bunn stated that there was no feasible way to attain compliance with the proposed PEL without using respiratory protection. However, Dr. Bunn emphasized that this occurred at certain specific, restricted areas that could be easily observed (Document ID 3576, Tr. 473). OSHA concludes from this testimony that where exposures above the PEL occur in foundries, they typically occur in limited areas that can be readily identified, and the provisions for establishment, demarcation, access restriction, and provision of respirators can be applied.
Edison Electric Institute stated that, given requirements for establishing regulated areas in other OSHA substance-specific standards, OSHA should consider creating uniform provisions for regulated areas, to minimize the complications that arise when multiple regulated substances begin to “stack” in one regulated area (Document ID 2357, pp. 32-33). OSHA recognizes that standards for asbestos, benzene, cadmium, chromium (VI), 13 carcinogens, methylenedianiline, and others also contain requirements for regulated areas; however, these requirements are not in conflict with one another. Where an employer establishes a regulated area for multiple substances, the employer can and must comply with the requirements for each applicable standard for that regulated area. Persons allowed access to the regulated area include employees who are performing tasks required by work duties subject to the regulated area requirements of another standard even if that exposure (
Other general industry commenters felt that regulated areas were unnecessary. For example, Morgan Advanced Materials asserted that regulated areas or access control programs may be appropriate for areas where the conditions may cause an immediate health effect or injury, but are not appropriate for chronic hazards like respirable crystalline silica, especially since “. . . nearly everyone is exposed to some level of crystalline silica on a daily basis” (Document ID 2337, pp. 1-2). OSHA rejects Morgan Advanced Materials' position because, unlike “everyone” who is exposed to background levels, employees who are exposed to respirable crystalline silica at levels exceeding the revised PEL are at significant risk of developing silica-related disease; this risk cannot be ignored simply because silica exposure does not cause an immediate death or injury. Regulated areas are an effective means of limiting the risk associated with respirable crystalline silica exposure, and are therefore appropriate for protecting employees.
Paragraph (e)(2) of the standard for general industry and maritime includes requirements for demarcation of regulated areas. The proposed provision on demarcation would have required employers to demarcate regulated areas from the rest of the workplace in any manner that adequately establishes and alerts employees to the boundary of the regulated area. The proposed provision also stipulated that the demarcation minimize the number of employees exposed to respirable crystalline silica within regulated areas. In the proposed
A number of stakeholders submitted comments on the proposed provision. For example, the AFL-CIO argued that other health standards that regulate carcinogens require warning signs at regulated areas, and that OSHA provided no justification for departing from this precedent (Document ID 4204, pp. 56-57). Many other stakeholders were supportive of warning sign requirements and submitted specific language for inclusion on signs that demarcate regulated areas (Document ID 2163, Attachment 1, p. 15; 2178, pp. 2-3; 2282, Attachment 3, p. 25; 2310, Attachment 2, p. 1; 2371, Attachment 1, p. 36; 2373, p. 2; 3582, Tr. 1920-1921; 4030, Attachment 1, p. 3; 4030, Exhibit D; 4073, Exhibit 15b, p. 18). For example, BCTD and the International Union of Operating Engineers encouraged OSHA to review the discussion of regulated areas in Ontario's Guideline on Silica Construction Projects with respect to ropes and barriers (Document ID 4073, Attachment 15b; 4234, Attachment 2, p. 57). Ontario's Guideline states that:
Ropes or barriers do not prevent the release of contaminated dust or other contaminants into the environment. However, they can be used to restrict access of workers who are not adequately protected with proper PPE, and also prevent the entry of workers not directly involved in the operation. Ropes or barriers should be placed at a distance far enough from the operation that allows the silica-containing dust to settle. If this is not achievable, warning signs should be posted at the distance where the silica-containing dust settles to warn that access is restricted to persons wearing PPE (Document ID 4073, Ex.15 b).
Others identified particular topics that should be covered by the signs without proposing language. For example, Upstate Medical University argued that all regulated areas should have warning signs addressing the hazards of silica dust (Document ID 2244, p. 4).
As is further explained in the summary and explanation of
The rulemaking record also indicates that use of signs is also consistent with general industry practices. For example, a plan developed by the National Service, Transmission, Exploration, and Production Safety Network (STEPS Network) for the hydraulic fracturing industry recommends signs to warn of potential silica exposure and the requirement for respirator use near exposure zones (Document ID 4024, Attachment 1, p. 1; Attachment 2, p. 1).
The Unified Abrasives Manufacturers Association argued that demarcation of regulated areas would require the construction of a complete physical separation between the regulated area and adjacent areas (Document ID 3398, p. 1). Aside from the requirement of specific language for posting signs, however, the standard does not specify the method of demarcation; cones, stanchions, tape, barricades, lines, or textured flooring may each be effective means of demarcating the boundaries of regulated areas. As in the proposed rule, therefore, so long as the demarcation is accomplished in a manner that minimizes the number of employees exposed to respirable crystalline silica within the regulated area, the employer will be in compliance, without necessarily installing a complete physical separation in the workplace.
Factors that OSHA considers to be appropriate considerations for employers when they are determining how to demarcate regulated areas include the configuration of the area, whether the regulated area is permanent, the airborne respirable crystalline silica concentration, the number of employees in adjacent areas, and the period of time the area is expected to have exposure levels above the PEL. Permitting employers to choose how best to demarcate regulated areas is consistent with OSHA's use of performance-based approaches where the Agency has determined that employers, based on their knowledge of the specific conditions of their workplaces, are in the best position to make such determinations.
The flexibility of this provision aims to address some of the concerns identified by commenters. For example, National Electrical Carbon Products commented that:
The concept seems to be that there are hazardous areas where access must be restricted. In reality: there are hazardous exposures, where exposures must be controlled . . . Exposure to airborne crystalline silica, on the other hand, is most typically associated with intermittent activities that are not necessarily associated with a location (Document ID 1785, p. 6).
A few commenters expressed concern that provisions for demarcation of regulated areas may interfere with heat stress programs currently in place as well as the current sanitation standard in general industry (29 CFR 1910.141) (Document ID 2379, Appendix 1, p. 59; 3577, Tr. 751-752; 3586, Tr. 3370). The AFS stated that:
Foundries often have areas with high heat exposures and encourage workers to drink water. The proposal [is] not clear on hygiene rules for regulated areas. The final rule must not be drafted in a way that could be interpreted to ban drinking water in a regulated area (Document ID 2379, Appendix 1, p. 59).
OSHA's standards addressing sanitation in general industry and maritime with respect to consumption of food and beverages are unchanged by this rulemaking. The standards in paragraphs 29 CFR 1910.141(g)(2) and 1917.127(c) prohibit consumption of food or beverage in any area exposed to a toxic material. OSHA appreciates the importance of providing access to drinking water, particularly in hot work environments, and recognizes that in many cases employees will need access to drinking water in order to remain
Paragraph (e)(3) of the standard for general industry and maritime requires employers to limit access to regulated areas. As in the proposed rule, employers are required to limit access to: (A) Persons authorized by the employer and required by work duties to be present in the regulated area; (B) any person entering such an area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring procedures under paragraph (d) of this section; and (C) any person authorized by the OSH Act or regulations issued under it to be in a regulated area.
The first group, persons the employer authorizes or requires to be in a regulated area to perform work duties, includes employees and other persons whose jobs involve operating machinery, equipment, and processes located in regulated areas; performing maintenance and repair tasks on machinery, equipment, and processes in those areas; conducting inspections or quality control tasks; and supervising those who work in regulated areas. Persons allowed access to the regulated area include employees who are performing tasks required by work duties subject to the regulated area requirements of another standard even if that exposure is unrelated to tasks that generate silica exposures.
The second group is made up of persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring under paragraph (d) of the standard for general industry and maritime. As explained in the summary and explanation of
The third group consists of persons authorized by law to be in a regulated area. This category includes persons authorized to enter regulated areas by the OSH Act, OSHA regulations, or any other applicable law. OSHA compliance officers fall into this group.
Some commenters expressed concerns about restricting access to regulated areas. For example, OSCO Industries argued that control of ingress and egress from regulated areas would be very problematic because of high traffic volumes, indicating, for example, that it may be necessary to reroute pedestrian and fork truck traffic outside the building in order to avoid the regulated area (Document ID 1992, p. 10). Similarly, a representative of the Non-Ferrous Founders' Society (NFFS) testified that smaller foundries would experience difficulty in establishing and restricting access to regulated areas (Document ID 3584, Tr. 2814).
Other commenters indicated that restricted areas were already in place at their workplaces. For example, Kenny Jordan, Executive Director of the Association of Energy Service Companies, testified that restricted areas with limited access are already used in hydraulic fracturing operations (Document ID 3589, Tr. 4066-4067). Mr. Jordan went on to describe how the presence of these restricted areas is communicated to other employees on the multiemployer worksite (Document ID 3589, Tr. 4079-4080).
OSHA finds that requirements for establishing and limiting access to regulated areas are reasonable and generally feasible for general industry and maritime workplaces. With regard to the concerns expressed by OSCO Industries about rerouting traffic to avoid regulated areas, the intent of the standard is to restrict unnecessary pedestrian and vehicle traffic in areas where exposures exceed the PEL; employees who would otherwise be exposed when traversing the regulated area will thus be better protected. Where work duties require these employees to enter the regulated area, the standard provides for access, with appropriate respiratory protection. OSHA also considers that the exposure assessment performed in accordance with paragraph (d) of the standard for general industry and maritime will provide a basis for establishing the boundaries of the regulated area, and thus establishment of regulated areas will not be as problematic as NFFS suggests.
Paragraph (e)(4) of the standard for general industry and maritime requires employers to provide each employee and the employee's designated representative entering a regulated area with an appropriate respirator in accordance with paragraph (g) of the standard. The provision also mandates that employers require each employee or employee representative to use the respirator while in the regulated area. The provision in the standard requiring use of respirators in regulated areas is identical to the proposed provision. The boundary of the regulated area indicates where respirators must be donned prior to entering, and where respirators can be doffed, or removed, upon exiting the regulated area. This provision was intended to establish a clear and consistent requirement for respirator use for all employees who enter a regulated area, regardless of the duration of their presence in the regulated area.
OSHA received comments from stakeholders in both construction and general industry, generally opposing this requirement (
After reviewing these comments, OSHA has decided to retain the requirement for employers to provide and require the use of respirators in regulated areas in the standard for general industry and maritime. Although OSHA recognizes that some employees entering regulated areas may not be exposed above the PEL (expressed as an 8-hour TWA), many
In the proposed rule, OSHA also included a provision related to protective work clothing. Proposed paragraph (e)(2)(v)(A) would have required employers to either provide protective clothing or provide other means of removing excessive silica dust from contaminated clothing. Under proposed paragraph (e)(2)(v)(B), employers would have been required to ensure that clothing was removed or cleaned upon exiting a regulated area when there was potential for employees' clothing to become “grossly contaminated” by fine particles of crystalline silica that could become airborne and inhaled. The purpose was not to protect employees from dermal exposure to silica, but rather to protect the employee from those situations wherein contamination of clothing has the potential to contribute significantly to employee inhalation of respirable crystalline silica.
The proposed provision for protective clothing was more limited than similar provisions in other OSHA substance-specific standards. As noted in the preamble of the Notice of Proposed Rulemaking OSHA limited the proposed provision for protective clothing to regulated areas because dermal exposure to crystalline silica is not associated with adverse health effects. Nonetheless, OSHA solicited information from stakeholders regarding protective clothing for respirable crystalline silica, largely because a provision for protective clothing had been recommended by the Agency's Advisory Committee on Construction Safety and Health.
Several employees in silica-exposed industries described the extent of contamination to their clothing by silica dust and how this dust would even be brought home with them (Document ID 3571, Attachment 7, p. 1; 3581, Tr. 1595, 1599-1600; 3582, Tr. 1840). OSHA heard testimony from Dan Smith, Director of Training for the Bay Area Roofers and Waterproofers Training Center in Livermore, California and member of the National Curriculum Development Committee of the United Union of Roofers, Waterproofers and Allied Workers, which represents roughly 25,000 workers. Mr. Smith said:
Some years back, one of my members walked into my office with a very unusual object: a plumbing trap. [He] handed it to me. First thing I noticed, it was pretty heavy, two to three pounds. He said, `That's from my shower at home.' At the time, he had been in the tile industry, cutting tile for about 10 years. He said, `My drain kept getting clogged. No matter what I put in there, I couldn't get it unclogged. I called the plumber. He couldn't get it unclogged. He took it off. I looked inside. It was filled with . . . what I would call reconstituted cement.' This came off of his body (Document ID 3581, Tr. 1599-1600).
OSHA received comments supporting a requirement for employer provision of work clothing, or storage, handling, removal and cleaning responsibilities for contaminated work clothing (Document ID 2212, p. 2; 2256, Attachment 2, p. 11; 2277, p. 4; 2310, Attachment 1, pp. 2-4; 2315, p. 9; 3586, Tr. 3199-3200). For example, the International Safety Equipment Association requested that OSHA require employers to provide protective garments at no cost to the employee, indicating that this would be consistent with other OSHA standards that require employers to pay for personal protective equipment (Document ID 2212, p. 2).
However, numerous comments received on the provision for protective work clothing in regulated areas were opposed to OSHA's proposed requirement for employers to either provide protective clothing or other means of removing excessive silica dust from contaminated clothing, and to ensure that clothing is removed or cleaned upon exiting a regulated area when there is potential for employees' clothing to become grossly contaminated by silica dust (Document ID 1785, p. 8; 2116, Attachment 1, p. 11; 2187, p. 6; 2195, p. 7; 2296, p. 40; 2319, pp. 90-91; 2337, p. 2; 2339, p. 8; 2357, pp. 29-30; 2363, p. 6; 3577, Tr. 713-714; 3580, Tr. 1376-1377; 3584, Tr. 2669; 4035, p. 9). Many contended that the language in the provision was vague or subjective. For example, the Tile Council of North America, the National Tile Contractors Association, and Morgan Advanced Materials argued that the term “
The American Society of Safety Engineers (ASSE) indicated that no special clothing should be required, as crystalline silica does not present a hazard from skin contact. Instead, ASSE suggested that employers need to implement programs to assure employees whose clothing is contaminated with crystalline silica do not create exposure issues outside of the workplace (Document ID 2339, p. 8). NAHB argued that protective clothing such as coveralls would be difficult for workers in residential construction to use because coveralls frequently restrict movement, are often not durable enough for the conditions encountered in construction, and could contribute to heat stress (Document ID 2296, p. 40).
The evidence regarding the extent to which dust-contaminated clothing may exacerbate employee exposure to respirable crystalline silica is mixed. NIOSH stated that past studies have shown a significant increase in workers' respirable dust exposure from contaminated work clothing, referencing a Bureau of Mines study involving highly-exposed machine operators bagging mineral products into paper bags (Document ID 2177, Attachment B, p. 15). On the other hand, the National Industrial Sand Association (NISA) stated that:
NISA member companies have years of experience conducting root cause analyses of exceedances of the PEL. In that experience, contaminated work clothing can be the source of such an exceedance, but such circumstances are uncommon (Document ID 2195, p. 37).
OSHA agrees that contaminated work clothing can contribute to respirable dust exposures in some circumstances, as NIOSH indicated. However, OSHA concludes that the evidence in the rulemaking record does not show that contaminated work clothing contributes appreciably to employee exposures to respirable crystalline silica in workplace conditions covered by this rule. OSHA is therefore not including a requirement for protective clothing in the rule because it is unable to determine that the use of protective clothing would
Protective clothing is primarily designed to mitigate against dermal hazards, which are not the problem here; nor is dermal exposure (as opposed to respiratory exposure) the mechanism by which silica causes its adverse health effects. Therefore, special or employer-provided protective clothing would be no more protective than ordinary clothing in this context. Moreover, OSHA understands the practical difficulty that employers would encounter in attempting to determine when clothing is sufficiently contaminated to trigger a requirement for protective measures. Therefore, OSHA has not included a requirement for employers to provide protective work clothing or other means of removing silica dust from clothing in the rule. There may be instances where providing protective clothing or other means of removing excessive silica dust from clothing are feasible methods of limiting employee exposures to respirable crystalline silica; in such cases, these methods become an option for complying with the requirement to limit employee exposures to the PEL.
OSHA has also decided not to include the proposed option to establish and implement an access control plan in lieu of a regulated area in the rule. As noted above, paragraph (e)(1) of the proposed standards for general industry/maritime and construction would have required the establishment and implementation of either a regulated area or an access control plan wherever an employee's exposure to airborne concentrations of respirable crystalline silica is, or reasonably could be expected to be, in excess of the PEL. OSHA recognized that establishing regulated areas in some workplaces might be difficult. As such, the Agency proposed an option for establishing and implementing a written access control plan in lieu of a regulated area.
The option for a written access control plan contained provisions for: A competent person to identify the presence and location of areas where respirable crystalline silica exposures exceed the PEL; notifying employees and demarcating such areas; communicating with other employers on multi-employer worksites; limiting access to areas where exposures exceed the PEL; providing respirators; and addressing measures regarding contaminated work clothing. The proposed rule also included a requirement for an annual employer review and evaluation of the written access control plan, and the plan was to be made available upon request for examination and copying to employees, their representatives, and the Assistant Secretary and the Director.
The intent of the provision for establishing written access control plans in lieu of regulated areas was to provide employers with flexibility to adapt to the particular circumstances of their worksites while maintaining equivalent protection for employees. The option for establishing a written access control plan was thought to be best suited for changing or mobile worksites such as those found in construction and utilities.
The North American Insulation Manufacturers Association supported the option for a written access control plan, claiming that it is similar to current mineral wool industry practices for limiting access (Document ID 2348, p. 36). The National Concrete Masonry Association and approximately five of its member companies stated that access control plans may be effective for tasks in which personal protective equipment is needed (
Commenters including American Subcontractors Association (ASA), Leading Builders of America (LBA), NAHB, and the Construction Industry Safety Coalition (CISC), thought that a written access control plan was impractical in the construction industry, stating reasons such as uncertainty about its requirements or how such plans would differ from a regulated area (
OSHA concludes that the option for a written access control plan may prove less protective and would be difficult to enforce, so has decided not to include the option for employers to develop and maintain written access control plans in lieu of regulated areas in the rule. OSHA no longer views a written access control plan to be a viable substitute for establishment and maintenance of regulated areas in the rule, especially in light of its decision not to include a regulated areas requirement in the standard for construction. The requirement for a competent person in paragraph (g)(4) of the standard for construction provides an alternate approach to restricting access to areas where high exposures can occur, and OSHA's expectation is that it will achieve a comparable level of protection without imposing the burden of maintaining a written access control plan.
The decision not to require regulated areas in the standard for construction reflects OSHA's acknowledgment of the impracticality of establishing and demarcating regulated areas in many construction industry workplaces. However, as described in further detail in the summary and explanation of
Commenters from the construction industry submitted comments on the regulated area option. Some of the comments were generally supportive (Document ID 2169, p. 4; 2177, Attachment B, p. 14; 2262, pp. 43-44; 2339, p. 4). However, other stakeholders felt that OSHA's proposed requirements for regulated areas would be unworkable and infeasible in construction (
The Interlocking Concrete Pavement Institute indicated that other construction trade workers labor in the same area from 10 to 90 percent of the time, and that efforts by OSHA to restrict access among trades on a job site would result in chaos (Document ID 2246, p. 11). The LBA added that, although OSHA's proposed requirements might be suitable for a single-employer setting where working conditions are somewhat consistent, they were unworkable in the construction industry (Document ID 2269, p. 8).
OSHA received feedback from employee representatives and public health advocates indicating support for a requirement that employers establish and limit access to areas where high exposures may occur in the construction industry (Document ID 2177, Attachment B, p. 14; 2371, Attachment 1, pp. 17-19; 3589, Tr. 4263; 4223, p. 102). For example, the Laborers Health and Safety Fund of North America argued that regulated areas are helpful because they provide a visible indicator that a hazardous area exists for employees in different trades who may be on the worksite but would not otherwise be aware of the potential for exposure to respirable crystalline silica in that area (Document ID 3589, Tr. 4263). NIOSH supported the need to protect workers on a construction site from exposure via regulated areas and/or a written access control plan. NIOSH also noted the importance of competent persons and how they play an integral role in establishing regulated areas (Document ID 2177, Attachment B, pp. 8-10, 14).
Several commenters representing public health organizations and unions opined that construction employers could implement regulated areas on construction sites without a great deal of difficulty (Document ID 3585, Tr. 3090-3091; 4234, Part 1, pp. 24-25). The American Industrial Hygiene Association (AIHA) suggested how an employer might determine whether a regulated area needs to be established:
Utilization of the Table 1 as a compliance option when respirators are required means the surrounding area must be considered a regulated area or under an access control plan. This combined with the engineering controls can help address the common problem of adjacent workers being inadvertently exposed to silica particulates. The need for a regulated area or control plan would now be an objective determination by the competent person. This in turn would help identify workers or areas where inadvertent exposure may occur and consequently allow procedures to be implemented to prevent this (Document ID 2169, p. 4).
Other commenters indicated that, to an extent, regulated areas already exist on construction sites. At the public hearings, the Mason Contractors Association of America provided testimony pointing out that a vast majority of masonry work is already carried out in restricted zones, and that access to these zones by other workers is limited. They noted that access to these restricted work zones was ultimately controlled by the general contractor (Document ID 3585, pp. 2933-2934). BCTD noted that Kevin Turner of Hunt Construction Group, testifying on behalf of CISC, indicated that contractors creating a hazard on construction worksites identify their work areas to avoid putting other workers at risk, and explained how different contractors on a multi-employer site routinely establish exclusion zones to exclude other workers from hazardous areas. BCTD argued that there is no reason why such an approach would not work for areas with high silica exposure as well (Document ID 4223, p. 102-105). ASSE indicated that, while the organization recognized the potential value of establishing regulated areas where silica overexposures are anticipated, there may be valid, practical reasons for exempting short-term construction worksites from this requirement as long as alternative worker protections are in place (Document ID 3430, p. 3)
After a review of these comments submitted on the proposed rule by construction industry stakeholders, OSHA concludes that a requirement for regulated areas is not appropriate for the construction standard. OSHA proposed to require regulated areas wherever an employee's exposure to respirable crystalline silica is, or can reasonably be expected to be, in excess of the PEL. However, OSHA expects that a majority of the regulated community in construction will implement the specified exposure control methods presented in paragraph (c) of the standard for construction (
In addition, OSHA basis its decision not to require regulated areas in the standard for construction in part on its recognition that conditions at construction worksites present challenges to establishing regulated areas for respirable crystalline silica exposure due to the varied and changing nature of construction work. Various commenters representing construction interests expressed how factors such as environmental variability normally present in construction differ substantially from those typically found in general industry and maritime workplaces. These commenters noted that construction tasks are often of relatively short duration; they are commonly performed outdoors, sometimes under adverse environmental conditions; and they are normally performed at non-fixed workstations or worksites. These factors make establishment of regulated areas impractical for many construction tasks. Silica-generating tasks in construction often involve movement to different locations during the workday, and respirable crystalline silica may be subject to changes in wind currents, meaning that exposure patterns may frequently shift. Accordingly, in the typical construction project involving silica-generating tasks, it is difficult to determine appropriate boundaries for regulated areas because the work and worksite are varied and subject to environmental influences (
OSHA finds the evidence of the particular and varying nature of construction work persuasive. Furthermore, the requirement for a competent person as part of the written exposure control plan requirements in paragraph (g)(4) of the standard for construction provides that a designated competent person on the worksite will have the responsibility to restrict access to work areas, where necessary, to limit exposures to respirable crystalline silica. OSHA concludes that this requirement will achieve the primary objectives of a regulated area.
OSHA realizes that in some cases general industry work tasks and work environments may be comparable to those found in construction. Although no exceptions have been carved out of the requirement in the standard for general industry and maritime, where the general industry or maritime employer can show compliance is not feasible, regulated areas will not have to be established insofar as infeasibility is a complete defense to an OSHA citation.
ASTM E 1132-06 and ASTM E 2625-09 do not include requirements for regulated areas. However, both industry consensus standards indicate that workers should not work in areas where visible dust is generated from crystalline silica-containing materials without the use of respiratory protection, unless proven protective measures are used or sampling shows exposure is below the exposure limit (
Paragraph (f)(1) of the standard for general industry and maritime (paragraph (d)(3)(i) of the standard for construction) establishes a hierarchy of controls that employers must use to reduce and maintain exposures to respirable crystalline silica to or below the permissible exposure limit (PEL) of 50 μg/m
OSHA's long-standing hierarchy of controls policy was supported by many commenters including the National Institute for Occupational Safety and Health (NIOSH), the American Society of Safety Engineers (ASSE), the American Industrial Hygiene Association, the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the American Public Health Association (APHA), the National Asphalt Pavement Association (NAPA), the National Utility Contractors Association, the American Road and Transportation Builders Association (ARTBA), and the International Safety Equipment Association (ISEA) (
[The hierarchy of controls] is the first thing we are supposed to do. Whenever feasible, eliminate the hazard. PPE is and always should be the last line of defense. Switching it is going backwards . . . (Document ID 3585, Tr. 3070).
Many industry commenters, including trade associations, generally objected to OSHA's proposed application of the hierarchy of controls in the rule. These commenters included the U.S. Chamber of Commerce (the Chamber), Associated
OSHA's preference for controls other than respirators is based on a policy that was adopted decades ago, and fails to take into account changes in respirator technology that have resulted in improved performance, improved reliability, improved worker acceptance, and increased protection (Document ID 3487, p. 25).
Other commenters pointed to the disadvantages of engineering controls. The Construction Industry Safety Coalition (CISC), NAM, PCI, and AFS noted that engineering controls are subject to human error and maintenance concerns (Document ID 2319, p. 95; 2380, Attachment 2, p. 22; 3487, p. 25; 3581, Tr. 1738, 1762; 3589, Tr. 4357). The Tile Roofing Institute (TRI), National Roofing Contractors Association (NRCA), National Association of Home Builders (NAHB), CISC, and NAM described situations where the use of engineering and work practice controls could present other hazards, such as falls (Document ID 2191, pp. 9-10; 2214, pp. 3-4; 2296, p. 28; 2319, p. 93; 3587, Tr. 3593-3594; 4225, p. 2; 4226, p. 3). OSCO Industries (OSCO) commented that where ventilation requires all doors and windows to be closed, engineering controls can put physiological and psychological strain on employees (Document ID 1992, p. 10).
NIOSH provided evidence that recent improvements in PAPRs have not eliminated all of their disadvantages. NIOSH cited several studies suggesting that psychological issues, medical disqualifications, communication impairment, hearing degradation, and visual impairment remained even for PAPRs (Document ID 4233, Attachment 1, pp. 17-20). NIOSH also noted that there are no maximum weight requirements for PAPRs, some of which can be fairly heavy (Document ID 4233, Attachment 1, p. 18). When questioned about the use of PAPRs in the brick industry, Thomas Brown, the Director of Health and Safety at Acme Brick Company, testified that:
No, we have not used [PAPRs]. And the reason why [is] it would be almost virtually impossible to wear those type[s] of respirators and perform the tasks that they are doing (Document ID 3577, Tr. 752).
No commenter representing employees or public health organizations agreed that PAPRs have improved to the point that they have become preferable to engineering controls. For example, when asked whether PAPRs should be viewed as an alternative to engineering controls and treated on the same level in the hierarchy of controls, Frank Hearl, Chief of Staff at NIOSH, testified that, “. . . in terms of the PAPR and other respirators, it all sort of falls into the hierarchy of controls and suffers the same problems as the other respirators in that it doesn't control the entire environment” (Document ID 3579, Tr. 233). The Building and Construction Trades Department, AFL-CIO (BCTD) testified that PAPRs are not an adequate alternative given that they do not “. . . control the hazards at the source for all workers” (Document ID 3581, Tr. 1668-1669). Similarly, ISEA commented that “. . . the association does not believe PAPRs can be used as engineering controls” since they do not remove hazards from the workplace (Document ID 4227, p. 1).
NIOSH, public health organizations, labor unions, individual employees, trade associations, public interest organizations and employers also provided additional evidence of the discomfort and difficulties experienced by employees who wear respirators (
In addition, NIOSH and other public health professionals described how respirators are more prone to misuse or other human error, as they depend on human behavior to achieve beneficial results (Document ID 2374, Attachment 1, pp. 5-6; 3577, Tr. 848-849; 3579, Tr. 183-184). On the other hand, engineering controls are easier to monitor and maintain. As Dr. Celeste Monforton testified:
It is illogical to suggest that diligently meeting all the laborious requirements necessary for an effective respiratory protection program for a whole crew of employees is easier than ensuring that a handful of silica-generating pieces of equipment are maintained (Document ID 3577, Tr. 849).
Various individuals and organizations detailed the lack of adequate fit testing and respiratory protection programs in practice, which can significantly impact respirator effectiveness. These included Dr. Monforton, ASSE, the National Council of La Raza, the National Consumers League (NCL), APHA, the National Council for Occupational Safety and Health, NRCA, and Arch Masonry as well as workers, including James Schultz and Allen Schultz (Document ID 2166, p. 3; 2173, p. 5; 2178, Attachment 1, pp. 3-4; 2373, pp. 3-4; 3577, Tr. 848-849; 3578, Tr. 1040-1041, 1042-1043; 3586, Tr. 3161, 3213-3214, 3236-3237, 3253-3254; 3587, Tr. 3625, 3680-3681; 3955, Attachment 1, p. 2). Workers, including James Schultz, Jonass Mendoza, Santiago Hernandez, Juan Ruiz, Norlan Trejo and Jose Granados described their negative experiences with respirator use, including the lack of fit testing, training, and proper maintenance (Document ID 3571, Attachment 2, p. 3; 3571, Attachment 3, p. 2; 3571, Attachment 5, p. 1; 3571, Attachment 7, p. 1; 3583, Tr. 2487; 3586, Tr. 3201-3202;). Dr. Laura Welch, representing BCTD, testified that in her experience, respiratory protection does not prevent employees from developing lung disease, but that engineering controls are effective (Document ID 3581, Tr. 1648-1649).
Further, NIOSH, labor organizations (
Every other trade has to walk through the cloud [of dust] to get in and out of the building to use the outhouses or to go to the coffee truck or even go home at the end of the day . . . [T]hey have no choice but to walk through the dust (Document ID 3585, Tr. 3068).
Some of the same industry commenters advocating for the use of PAPRs in place of engineering controls have acknowledged the importance of engineering controls to protect employees from exposures to respirable crystalline silica. For example, AFS, in its
OSHA concludes that requiring primary reliance on engineering controls and work practices is necessary and appropriate because reliance on these methods is consistent with good industrial hygiene practice, and with the Agency's experience in ensuring that employees have a healthy workplace. The Agency finds that engineering controls: (1) Control crystalline silica-containing dust particles at the source; (2) are reliable, predictable, and provide consistent levels of protection to a large number of employees; (3) can be monitored continually and relatively easily; and (4) are not as susceptible to human error as is the use of personal protective equipment. The use of engineering controls to prevent the release of silica-containing dust particles at the source also minimizes the silica exposure of other employees in surrounding work areas who are not directly involved in the task that is generating the dust, and
Under the hierarchy of controls, respirators can be another effective means of protecting employees from exposure to air contaminants. However, to be effective, respirators must be individually selected, fitted and periodically refitted, conscientiously and properly worn, regularly maintained, and replaced as necessary. In many workplaces, these conditions for effective respirator use are difficult to achieve. The absence of any one of these conditions can reduce or eliminate the protection the respirator provides to some or all of the employees. For example, certain types of respirators require the user to be clean shaven to achieve an effective seal where the respirator contacts the employee's skin. Failure to ensure a tight seal due to the presence of facial hair compromises the effectiveness of the respirator.
Respirator effectiveness ultimately relies on the good work practices of individual employees. In contrast, the effectiveness of engineering controls does not rely so heavily on actions of individual employees. Engineering and work practice controls are capable of reducing or eliminating a hazard from a worksite, while respirators protect only the employees who are wearing them correctly. Furthermore, engineering and work practice controls permit the employer to evaluate their effectiveness directly through air monitoring and other means. It is considerably more difficult to directly measure the effectiveness of respirators on a regular basis to ensure that employees are not unknowingly being overexposed. OSHA therefore continues to consider the use of respirators to be the least satisfactory approach to exposure control.
In addition, use of respirators in the workplace presents other safety and health concerns. Respirators can impose substantial physiological burdens on employees, including the burden imposed by the weight of the respirator; increased breathing resistance during operation; limitations on auditory, visual, and olfactory sensations; and isolation from the workplace environment. Job and workplace factors such as the level of physical work effort, the use of protective clothing, and temperature extremes or high humidity can also impose physiological burdens on employees wearing respirators. These stressors may interact with respirator use to increase the physiological strain experienced by employees.
Certain medical conditions can compromise an employee's ability to tolerate the physiological burdens imposed by respirator use, thereby placing the employee wearing the respirator at an increased risk of illness, injury, and even death. These medical conditions include cardiovascular and respiratory diseases (
In addition, safety problems created by respirators that limit vision and communication must always be considered. In some difficult or dangerous jobs, effective vision or communication is vital. Voice transmission through a respirator can be difficult, annoying, and fatiguing. In addition, movement of the jaw in speaking can cause leakage, thereby reducing the efficiency of the respirator and decreasing the protection afforded the employee. Skin irritation can result from wearing a respirator in hot, humid conditions. Such irritation can cause considerable distress to employees and can cause employees to refrain from wearing the respirator, thereby rendering it ineffective.
These potential burdens placed on employees by the use of respirators were acknowledged in OSHA's revision of its respiratory protection standard, and are the basis for the requirement (29 CFR 1910.134(e)) that employers provide a medical evaluation to determine the employee's ability to wear a respirator before the employee is fit tested or required to use a respirator in the workplace (
While OSHA acknowledges that certain types of respirators, such as PAPRs, may lessen problems associated with breathing resistance and skin discomfort, they do not eliminate them. OSHA concludes that respirators do not provide employees with a level of protection that is equivalent to engineering controls, regardless of the type of respirator used. It is well-recognized that certain types of respirators are superior to other types of respirators with regard to the level of protection offered, or impart other advantages like greater comfort. OSHA has evaluated the level of protection provided by different types of respirators in the Agency's Assigned Protection Factors rulemaking (68 FR 34036 (06/06/03)). Even in situations where engineering controls are not sufficiently effective to reduce exposure levels to or below the PEL, the reduction in exposure levels benefits employees by reducing the required protection factor of the respirator, which provides a wider range of options in the type of respirators that can be used. For example, for situations in which dust concentrations are reduced through use of engineering controls to levels that are less than ten times the PEL, employers would have the option of providing approved half-mask respirators with an assigned protection factor (APF) of 10 that may be lighter and easier to use when compared with full-facepiece respirators.
All OSHA substance-specific health standards have recognized and required employers to observe the hierarchy of controls, favoring engineering and work practice controls over respirators. OSHA's PELs, including the previous PELs for respirable crystalline silica, also incorporate this hierarchy of controls. The Agency's adherence to the hierarchy of controls has been successfully upheld by the courts (
As explained in Section II, Pertinent Legal Authority, the very concept of technological feasibility for OSHA standards is grounded in the hierarchy of controls. The courts have clarified that a standard is technologically feasible if OSHA proves a reasonable possibility,
While labor groups were opposed to any exemptions from the hierarchy of controls (Document ID 3586, Tr. 3235-3237), industry commenters, including both individual employers and trade associations, urged OSHA to consider making exemptions to the hierarchy in various situations. Commenters, including the Edison Electric Institute (EEI), Dal-Tile, the Glass Association of North America (GANA), the Tile Council of North America, the Non-Ferrous Founders' Society (NFFS), PCI, and the Chamber, argued that employers need flexibility to determine when enough engineering controls have been added and when respirators can be used (Document ID 2147, p. 3; 2215, p. 6; 2276, p. 6; 2357, pp. 25-26; 2363, p. 4; 3491, p. 4; 3576, Tr. 466; 3589, Tr. 4364). NAM echoed this, arguing that employers will never know when or if they are in compliance with the requirement to incorporate all feasible engineering and work practice controls and the Agency should thus base its requirements on objective criteria, while allowing flexibility to achieve compliance (Document ID 3581, Tr. 1738). Lapp Insulators, the Indiana Manufacturing Association, Murray Energy Corporation, BCI, Rheem Manufacturing Company, MEMA, IME, CISC, AFS, NFFS, and NAM urged OSHA to permit the use of respirators to satisfy the obligation to control exposures where feasible engineering and work practice controls are insufficient to bring exposure levels to or below the PEL (Document ID 1801, pp. 3-4; 2102, p. 2; 2130, pp. 1-2; 2151, p. 1; 2213, pp. 3-4; 2319, p. 95; 2325, p. 2; 2326, p. 2; 2361, p. 3; 2380, Appendix 2, pp. 22-23; 3486, p. 2; 3491, pp. 4-5; 3581, Tr. 1752-1753; 4226, p. 2). This concern was echoed by other commenters who encouraged OSHA to permit the use of respirators in industries using large amounts of crystalline silica (
OSHA disagrees. Instead, the Agency considers engineering controls to be the most effective method of protecting employees and allows respiratory protection only after all feasible engineering controls and work practices have been implemented or where such controls have been found infeasible. If an employer has adopted all feasible engineering controls, and no other feasible engineering controls are available, the rule would permit the use of respirators. On the other hand, if feasible engineering controls are available that would reduce respirable crystalline silica exposures that exceed the PEL, then these controls are required. Thus, OSHA has concluded these engineering controls better protect employees.
Commenters, including CISC and OSCO, urged OSHA to permit the use of respirators for short duration, intermittent, or non-routine tasks (Document ID 1992, pp. 3, 5; 2319, pp. 95, 115; 3580, Tr. 1463-1464). Others, such as the Glass Packaging Institute (GPI) and NAM, argued that OSHA should permit the use of respirators for maintenance activities (Document ID 2290, pp. 2, 3; 2380, Attachment 2, pp. 14-15; 3493, pp. 2-3). Verallia North America recommended that respirators be allowed in all refractory repairs (Document ID 3584, Tr. 2848).
Where OSHA requires respirator use in this rule, the requirement is tied to expected or recorded exposures above the PEL, not categorically to specific operations or tasks per se. The rule permits the use of respirators where exposures exceed the PEL during tasks for which engineering and work practice controls are not feasible. Some tasks, such as certain maintenance and repair activities, may present a situation where engineering and work practice controls are not feasible. For example, GPI noted that respirators are needed to address failures of any conveyance system (elevators, conveyors, or pipes), failures of dust collecting bag systems, or section head failures at glass plant facilities (Document ID 3493, p. 3). OSCO described how engineering controls are not feasible for cupola (furnace) repair work and baghouse maintenance activities (Document ID 1992, pp. 3, 5). The Agency agrees that for tasks, such as certain maintenance and repair activities, where engineering and work practice controls are not feasible, the use of respirators is permitted.
The Chamber and the American Subcontractors Association (ASA) suggested that the hierarchy of controls is not appropriate for silica exposures in construction workplaces (Document ID 2187, p. 6; 2283, p. 3). While ASSE generally supported the hierarchy of controls, it acknowledged that there might be practical issues with implementation on short-term construction worksites (Document ID 2339, p. 4). More specifically, the Mason Contractors Association of America and Holes Incorporated urged OSHA to consider the approach taken by the ASTM standard for the construction industry (ASTM E 2625-09), which provides an exception to the hierarchy for brief, intermittent silica generating tasks of 90 minutes or less per day (Document ID 3580, Tr. 1453; 3585, Tr. 2882). Conversely, BCTD argued that even for silica dust-generating tasks of short duration where respiratory protection is employed, a failure to employ engineering controls could result in dangerous exposures (Document ID 4219, p. 17). They contended that:
There is no evidence in the record that exposures of only 90 minutes a day pose a lower risk of harm, such that respirators would provide sufficient protection. Moreover . . . the industry failed to prove that it is infeasible—or even difficult—to use engineering controls in most silica-generating tasks (Document ID 4223, p. 88).
OSHA finds, as discussed above, that primary reliance on respirators to protect employees is inappropriate when feasible engineering and work practice controls are available. This is as true for the construction industry, as it is for other industries with respirable crystalline silica exposures. Even where employees are conducting intermittent silica generating tasks for 90 minutes or less per day, if the exposures are above the PEL and feasible engineering and work practice controls are available, they must be applied. Further, although an exemption for employees conducting silica generating tasks for 90 minutes or less per day is included in the ASTM standard for the construction industry, the standard also includes the hierarchy of controls, as well as task-based methods of compliance based on engineering and work practice controls
AFS, NISA, GANA, EEI, the North American Insulation Manufacturers Association (NAIMA), and the Asphalt Roofing Manufacturers Association urged OSHA to consider allowing employers to use respirators to achieve compliance for operations where exposures exceed the PEL for 30 days or less per year (Document ID 4229, p. 11; 2195, pp. 7, 38-39; 2215, pp. 9-10; 2291, pp. 2, 18; 2348, Attachment 1, pp. 17, 26-28, 40; 2357, p. 26; 2379, Appendix 1, pp. 48, 68-69; 3487, pp. 22-23). Similarly, NAM proposed that OSHA could establish a maximum number of days a year when respirators can be used in place of engineering controls (Document ID 2380, Attachment 2, pp. 24-25).
Many of the examples mentioned by the commenters supporting this exemption described maintenance and repair activities, such as baghouse cleaning and furnace rebuilds. As discussed above, some tasks, such as certain maintenance and repair activities, may present a situation where engineering and work practice controls are not feasible. OSHA agrees that, for tasks of this nature where engineering and work practice controls are not feasible, the use of respirators is permitted. Permitting employers to use respirators instead of feasible engineering and work practice controls for exposures occurring for 30 days or less per year does not best effectuate the purpose of the rule—to protect employees from exposures to respirable crystalline silica. Thus, the Agency concludes that the hierarchy of controls is appropriate whenever feasible engineering and work practice controls are available.
The American Composite Manufacturers Association suggested that small businesses be exempt from the hierarchy of controls (Document ID 3588, Tr. 3933-3936). Bret Smith urged OSHA to allow small entities to use respiratory protection temporarily to allow time to prepare for the costs of implementation (Document ID 2203). OSHA does not agree that there should be a distinction between the protection employees receive in a small business or a large business. Protecting the safety and health of employees is part of doing business. Thus, exposures to respirable crystalline silica above the PEL, wherever they occur, must first be controlled using all feasible engineering and work practice controls available, before turning to respiratory protection. For the reasons previously discussed, implementing and maintaining a comprehensive respiratory protection program is a considerable undertaking for many employers, and likely even more so for small businesses. If employers are unable to properly train and fit employees and maintain the equipment, respirators will not effectively protect employees from exposures to respirable crystalline silica.
NAM proposed that OSHA adopt language to allow respirators to be used when exposures are below a specified level:
Where airborne exposures to RCS on a time-weighted-average basis are below XX milligrams per cubic meter, employers may require the use of respirators in accordance with the requirements of 1910.134. Where exposures exceed this level, employers are required to adopt engineering and administrative controls to reduce exposures (Document ID 2380, Attachment 2, pp.24-25).
As discussed above, this approach is in conflict with the concept of technological feasibility for OSHA standards. Technological feasibility is determined based on the ability of a typical firm to develop and install engineering controls and work practice controls that can meet the PEL without regard to the use of respirators. The approach advanced by NAM would permit the use of respirators to achieve the PEL, even where exposures reached 100 times the PEL. If technological feasibility were based solely on the ability of respirators to meet the PEL, OSHA could determine that a much lower PEL would indeed be feasible. Further, a failure of respiratory protection in situations where exposures reach 100 times the PEL could result in extremely dangerous exposures.
Therefore, OSHA rejects the various comments recommending upsetting the long-established hierarchy of controls. Because engineering and work practice controls are capable of reducing or eliminating a hazard from the workplace, while respirators protect only the employees who are wearing them and depend on the selection and maintenance of the respirator and the actions of employees, OSHA holds to the view that engineering and work practice controls offer more reliable and consistent protection to a greater number of employees, and are therefore preferable to respiratory protection. Thus, the Agency continues to conclude that engineering and work practice controls provide a more protective first line of defense than respirators and must be used first when feasible.
Substitution refers to the replacement of a toxic material with another material that reduces or eliminates the harmful exposure. OSHA considers substitution to be an ideal control measure if it replaces a toxic material in the work environment with a non-toxic material, thus eliminating the risk of adverse health effects.
As indicated in Chapter IV of the Final Economic Analysis and Final Regulatory Flexibility Analysis (FEA), employers use substitutes for crystalline silica in a variety of operations. For example, some employers use substitutes in abrasive blasting operations, repair and replacement of refractory materials, operations performed in foundries, and in the railroad transportation industry. Commenters, such as NIOSH, John Adams, Vice President of the American Federation of Government Employees Local 2778, Kyle Roberts, and the National Automobile Dealers Association (NADA) also identified several situations where substitute materials and products were available or used in place of silica-containing products, including: The use of plastic curbs in place of concrete curbs to repair a highway overpass; the use of materials containing aluminum oxide instead of crystalline silica in dental labs; the use of aluminum pellets instead of sand in hydraulic fracturing operations; the availability of silica-free OEM and auto-refinish paint systems; and the availability of silica-free body fillers and silica-free abrasives for auto
Commenters also identified many situations where no substitute materials and products were available to replace silica-containing materials and products. For example, Grede Holdings and AFS noted that there were no substitutes for sand for most foundry applications (Document ID 2298, p. 2; 2379, Appendix 1, pp. 14-16; 3486, p. 4). The General Contractors Association of New York, ASA, CISC, and NAHB noted that the construction industry cannot select alternate materials to avoid silica exposure, since nearly all construction materials and products contain silica (Document ID 2187, p. 6; 2314, pp. 1-2; 2296, pp. 7, 35; 2319, pp. 93-34). AAR and the American Short Line and Regional Railroad Association noted that substitute ballast materials with lower silica content cannot be used because they introduce safety hazards for employees and the public (Document ID 2366, pp. 5-6). GANA and NAIMA noted that silica is indispensable to the flat glass industry (Document ID 2215, p. 5; 2348, Attachment 1, pp. 8-10). NAM noted that viable alternatives of lower silica content are not available for some products made by their members (Document ID 3581, Tr. 1728). The Porcelain Enamel Institute noted that there are no proven replacements for mill-added crystalline silica for wet-applied enamel systems, given that the technical advantages offered by silica cannot be practically and economically achieved with other materials (Document ID 2281, p. 3).
The American College of Occupational and Environmental Medicine (ACOEM), the Mount Sinai-Irving J. Selikoff Centers for Occupational and Environmental Medicine, and Samantha Gouveia urged OSHA to more explicitly encourage the use of substitution where feasible (Document ID 1771, p. 1; 2080, pp. 4-5; 2208).
Commenters also expressed concerns about the safety of substitutes (Document ID 2080, pp. 4-5; 2187, p. 6; 2278, pp. 3-4). ACOEM suggested that OSHA only endorse the use of substitutes when they have been demonstrated to be safe in short- and long-term inhalation toxicology studies and urged OSHA to request that NIOSH conduct a periodic assessment that evaluates substitutes to determine which ones have been found to be safe based upon results of inhalation toxicity and epidemiologic studies (Document ID 2080, pp. 4-5). Dr. George Gruetzmacher, an industrial hygiene engineer, urged OSHA to encourage the use of alternative materials to silica when feasible, but only when the substitute has been demonstrated to be safe in short- and long-term inhalation toxicology studies or to prohibit the substitution of materials which have not been demonstrated to be less toxic by inhalation (Document ID 2278, pp. 3-4).
While OSHA finds that substitution can be an ideal control measure in certain circumstances, the Agency recognizes that this approach may not be feasible or safer in many others. Because some alternatives to silica or silica-containing materials may present health risks, OSHA is not implying that any particular alternative is an appropriate or safe substitute for silica. In its technological feasibility analyses, the Agency identified information about situations where substitution may be an available control strategy. OSHA strongly encourages employers to thoroughly evaluate potential alternatives, where available, to determine if a substitute can mitigate employees' exposure to respirable crystalline silica without posing a greater or new significant hazard to employees. Additionally, when substituting, employers must comply with Section 5(a)(1) of the OSH Act (29 U.S.C. 654(a)(1)), which prohibits occupational exposure to “recognized hazards that are causing or are likely to cause death or serious physical harm,” and with applicable occupational safety and health standards. For example, with respect to chemical hazards, OSHA's hazard communication standard imposes specific requirements for employee training, safety data sheets, and labeling (
Isolation,
Ventilation is another engineering control method used to minimize airborne concentrations of a contaminant by supplying or exhausting air. Two types of systems are commonly used: Local exhaust ventilation (LEV) and dilution ventilation. LEV is used to remove an air contaminant by capturing it at or near the source of emission, before the contaminant spreads throughout the workplace. Dilution ventilation allows the contaminant to spread over the work area but dilutes it by circulating large quantities of air into and out of the area. Consistent with past recommendations such as those included in the chromium (VI) standard, OSHA prefers the use of LEV systems to control airborne toxics because, if designed properly, they efficiently remove contaminants and provide for cleaner and safer work environments.
Dust suppression methods are generally effective in controlling respirable crystalline silica dust, and they can be applied to many different operations such as material handling, rock crushing, abrasive blasting, and operation of heavy equipment (Document ID 1147). Dust suppression can be accomplished by one of three systems: Wet dust suppression, in which a liquid or foam is applied to the surface of the dust-generating material; airborne capture, in which moisture is dispensed into a dust cloud, collides with particles, and causes them to drop from the air; and stabilization, which holds down dust particles by physical or chemical means (lignosulfonate, calcium chloride, and magnesium chloride are examples of stabilizers).
The most common dust suppression controls are wet methods (
Work practice controls can also enhance the effects of engineering controls. For example, to ensure that LEV is working effectively, an employee would position the LEV equipment so that it captures the full range of dust created, thus minimizing silica exposures. For many operations, a combination of engineering and work practice controls reduces silica exposure levels more effectively than a single control method.
The requirement to use engineering and work practice controls is consistent with ASTM E 1132-06 and ASTM E 2625-09, the national consensus standards for controlling occupational exposure to respirable crystalline silica in general industry and in construction, respectively. Each of these standards has explicit requirements for the methods of compliance to be used to reduce exposures below exposure limits. These voluntary standards specifically identify several controls, which include use of properly designed engineering controls such as ventilation or other dust suppression methods and enclosed workstations such as control booths and equipment cabs; requirements for maintenance and evaluation of engineering controls; and implementation of certain work practices such as not working in areas where visible dust is generated from respirable crystalline silica containing materials without use of respiratory protection. For employers in general industry and maritime, as well as those in construction following paragraph (d) for tasks not listed in Table 1 or where the employer does not fully and properly implement the engineering controls, work practices, and respiratory protection described in Table 1, OSHA similarly requires the use of engineering and work practices controls to reduce employee exposures to or below the PEL; however, this is a performance requirement and does not specify any particular engineering and work practice controls that must be implemented.
Paragraph (f)(2)(i) of the standard for general industry and maritime (paragraph (g)(1) of the standard for construction) requires that employers establish and implement a written exposure control plan. Paragraphs (f)(2)(i)(A)-(C) (paragraphs (g)(1)(i)-(iv) of the standard for construction) specify the contents for written exposure control plans. Paragraph (f)(2)(ii) (paragraph (g)(2) of the standard for construction) specifies requirements for the employer to review the plan at least annually and update it as needed. Paragraph (f)(2)(iii) (paragraph (g)(3) of the standard for construction) requires the employer to make the plan available to employees, employee representatives, OSHA, and NIOSH. Details about the written exposure control plan, including comments from stakeholders and OSHA's responses to those comments, are included in the summary and explanation of
OSHA received feedback from several commenters who supported establishing SECALs (
Other commenters did not favor establishing SECALs. CISC stated that it did not support the concept of SECALs, but that CISC would continue to examine whether a SECAL was appropriate for the construction industry (Document ID 2319, p. 128). NIOSH did not support the use of SECALs and stated that the requirement to meet the PEL for silica generating processes should be maintained (Document ID 2177, Attachment B, p. 16).
OSHA stresses that, where incorporated in a standard, a SECAL is intended for application to discrete processes and operations within an industry, rather than application to an entire industry, as some supporters of SECALs seemed to suggest. For example, in OSHA's cadmium standard, OSHA established SECALs for certain plating and other processes in a few affected industries. OSHA did not receive evidence to support establishing a SECAL for any discrete task or operation within a particular industry in the respirable crystalline silica rule. OSHA therefore has not established SECALs in the rule.
In this provision addressing abrasive blasting, the proposed standard referred to “where abrasive operations are conducted,” but for simplicity, this standard refers to “where abrasive blasting is conducted.” OSHA intends this change to be editorial only, and does not intend a substantive change from the proposed requirements.
In addition, paragraph (f)(3) of the standard for general industry and maritime indicates that the employer must comply with the requirements of 29 CFR 1910.94 (Ventilation), 29 CFR 1915.34 (Mechanical paint removers) and 29 CFR 1915 Subpart I, as applicable, where abrasive blasting is conducted using crystalline silica-containing blasting agents, or where abrasive blasting is conducted on substrates that contain crystalline silica. Paragraph (d)(3)(ii) of the standard for construction indicates that the employer must comply with the requirements of 29 CFR 1926.57 (Ventilation) in such circumstances.
OSHA's general industry (29 CFR 1910.94) and construction ventilation standards (29 CFR 1926.57), as well as the standards for mechanical paint removers (29 CFR 1915.34) and personal protective equipment for shipyard employment (29 CFR 1915 subpart I) provide requirements for respiratory protection for abrasive blasting operators and others involved in abrasive blasting. This rule includes cross-references to these standards. Employers using abrasive blasting need to consult these referenced standards to ensure that they comply with their provisions for personal protective equipment and ventilation, and other operation-specific safety requirements.
ISEA urged OSHA to add a reference to the APF table at 29 CFR 1910.134(d)(3)(i)(A) in the general industry and construction standards for ventilation, and to require that if the employer has no sampling data to support the use of an abrasive blasting respirator with an APF of 25, the employer must select a respirator with an APF of 1,000 (Document ID 2212, p. 1). The 3M Company similarly questioned the respirator requirements under the ventilation standards, arguing that without considering the performance (APF) of the respirator, some employees could be overexposed to silica (Document ID 2313, pp. 1, 5-6). Charles Gordon, a retired occupational safety and health attorney, commented that even with the reference to the ventilation standards, the provision is not protective enough. He encouraged the Agency to require the most protective abrasive blasting hood and respirators and require the best work practices (Document ID 2163, Attachment 1, p. 19).
Given the high levels of hazardous dust generated during abrasive blasting, OSHA has concluded, for reasons discussed in its technological feasibility analyses for construction and for certain general industry sectors like foundries and shipyards that perform abrasive blasting in their operations, that respiratory protection will continue to be necessary to reduce silica exposure below the PEL, even with engineering and work practice controls in place (see the discussion of abrasive blasting in Chapter IV of the FEA). This standard also takes respirator use into account by cross-referencing the specific respirator requirements already in place for abrasive blasting. Employers are also required to comply with the requirements of 29 CFR 1910.134 whenever respiratory protection is required by this section. Under 29 CFR 1910.134, the employer is required to select and provide an appropriate respirator based on the respiratory hazards to which the employee is exposed and is required to use the APF table at 29 CFR 1910.134(d)(3)(i)(A). This includes note four of the APF table, which requires the employer to have evidence to support an APF of 1000 for helmet/hood respirators. In addition, paragraph (d) of the standard for general industry and maritime and paragraph (d)(2) of the standard for construction require employers to assess the exposure of each employee who is or may reasonably be expected to be exposed to respirable crystalline silica at or above the action level, which will provide employers with information to make appropriate respirator selection decisions. OSHA concludes that these requirements, including the referenced provisions in other OSHA standards, will adequately protect employees from exposures to respirable crystalline silica during abrasive blasting.
Many commenters, including NIOSH, labor unions, public health organizations, trade associations, occupational health medical professionals, and public interest organizations, urged OSHA to ban the use of silica sand as an abrasive blasting agent (Document ID 2167; 2173, p. 4; 2175, pp. 7-8; 2177, Attachment B, p. 37; 2178, Attachment 1, p. 3; 2212, p. 1; 2240, p. 2; 2244, p. 2; 2256, Attachment 2, pp. 12-13; 2282, Attachment 3, pp. 2, 18; 2341, p. 3; 2371, Attachment 1, p. 31; 2373, p. 3; 3399, p. 6; 3403, p. 7; 3577, Tr. 779-780, 785, 790; 3586, Tr. 3319-3320, 3163; 3588, Tr. 3752; 4204, p. 81; 4223, pp. 104-106). Some noted that 4 countries (Great Britain, Germany, Sweden, and Belgium), several U.S. military departments, and 23 state Departments of Transportation have already banned the practice (Document ID 2167; 2175, pp. 7-8; 2178, Attachment 1, p. 3; 2256, Attachment 2, pp. 12-13; 2212, p. 1; 2282, Attachment 3, p. 18; 2371, Attachment 1, p. 31; 2373, p. 3; 3399, p. 6; 4204, p. 76).
Fann Contracting, Dr. Kenneth Rosenman, an expert in occupational and environmental disease, and Novetas Solutions noted the broad trend of abrasive blasting operations moving away from sand (Document ID 2116, Attachment 1, pp. 31-32; 3577, Tr. 858; 3588, Tr. 3992-3993). The American Federation of State, County and Municipal Employees reported that several local Maryland unions no longer use silica-based blasting agents and have substituted other materials, such as aluminum shot (Document ID 2106, p. 2). Sarah Coyne, a former painter and current Health and Safety Director for IUPAT, discussed how their signatory contractors have largely transitioned from silica sand to coal slag for abrasive blasting (Document ID 3581, Tr. 1644). API noted that many oil and gas companies have limited or eliminated respirable crystalline silica exposure in sandblasting operations by using media options that do not contain silica (Document ID 2301, Attachment 1, p. 5). NADA also noted that product substitution has minimized potential exposures to airborne crystalline silica-containing media (Document ID 2358, p. 4). The Interstate Natural Gas Association of America stated that members utilize other abrasives to the extent feasible, including fused glass in limited applications (Document ID 2081, p. 2).
As OSHA indicated in its NPRM, the use of silica sand for abrasive blasting operations is decreasing (Document ID 1420). This reduction might reflect the use of alternative blasting media, the increased use of high-pressure water-jetting techniques, and the use of cleaning techniques that do not require open sand blasting. Several substitutes for silica sand are available for abrasive blasting operations, and current data indicate that the abrasive products with the highest U.S. consumptions are: Coal slag, copper slag, nickel slag, garnet, staurolite, olivine, steel grit, and crushed glass. Several commenters (Adam Webster, Charles Gordon, and the Association of Occupational and Environmental Clinics) also noted the general availability of alternative abrasive blast media, including baking soda, water, dry ice, coal/copper slag, glass beads, walnut shells, and carbon dioxide (Document ID 2163, p. 19; 2167; 3399, p. 6). Additional alternatives are discussed and evaluated in Chapter IV of the FEA. On the other hand, PCI commented that the use of alternative abrasive blast media was precluded in the precast concrete structures industry, since many alternatives will not meet aesthetic requirements, are not aggressive enough to provide the desired finished, or are simply cost prohibitive (Document ID 2276, p. 9). Furthermore, CISC warned about possible hazards associated with the substitutes for silica sand (Document ID 2319, p. 37). PCI and Novetas Solutions cautioned that coal and copper slags, commonly used as a substitute for silica sand in abrasive blasting, contain hazardous substances such as beryllium that cause adverse health effects in employees (Document ID 2276, p. 9; 3588, Tr. 3992-4004). Meeker
A NIOSH study compared the short-term pulmonary toxicity of several abrasive blasting agents (Document ID 1422). This study reported that specular hematite and steel grit presented less short-term in vivo toxicity and respirable dust exposure in comparison to blast sand. Overall, crushed glass, nickel glass, staurolite, garnet, and copper slag were similar to blast sand in both categories. Coal slag and olivine showed more short-term in vivo toxicity than blast sand and were reported as similar to blast sand regarding respirable dust exposure. This study did not examine long-term hazards or non-pulmonary effects.
Additionally, another NIOSH study monitored exposures to several OSHA-regulated toxic substances that were created by the use of silica sand and substitute abrasive blasting materials (Document ID 0772). The study showed that several substitutes create exposures or potential exposures to various OSHA-regulated substances, including: (1) Arsenic, when using steel grit, nickel slag, copper slag and coal slag; (2) beryllium, when using garnet, copper slag, and coal slag; (3) cadmium, when using nickel slag and copper slag; (4) chromium, when using steel grit, nickel slag, and copper slag; and (5) lead, when using copper slag. Since these studies were performed, OSHA has learned that specular hematite is not being manufactured in the United States due to patent-owner specification. In addition, the elevated cost of steel has a substantial impact on the availability to some employers of substitutes like steel grit and steel shot.
Evidence in the rulemaking record indicates that elevated silica exposures have been found during the use of low-silica abrasives as well, even when blasting on non-silica substrates. For example, the use of the blasting media Starblast XL (staurolite), which contains less than one percent quartz according to its manufacturer, resulted in a respirable quartz level of 1,580 μg/m
After considering the arguments for and against prohibition, OSHA concludes that prohibiting the use of silica sand as an abrasive blasting agent is not appropriate. In so concluding, the Agency considered whether such a prohibition is an effective risk mitigation measure, as well as the technological feasibility of substitutes. The Agency finds that many of the silica sand substitutes used in abrasive blasting can create hazardous levels of toxic dust other than silica, as documented in studies conducted by NIOSH on the toxicity of silica sand substitutes for abrasive blasting; NIOSH found that many, including coal slag, garnet, copper and nickel slags, olivine, and crushed glass, produced lung damage and inflammatory reactions in rodent lung similar to that of silica sand, indicating that use of such materials would present lung disease risks to employees (Document ID 3857; 3859). OSHA further finds that additional toxicity data are necessary before the Agency can reach any conclusions about the hazards of these substitutes relative to the hazards of silica. Given the concerns about potential harmful exposures to other substances that the alternatives might introduce in a workplace, as well as the potential for continued exposure to respirable crystalline silica, OSHA concludes that banning the use of silica sand as an abrasive blasting agent would not necessarily effectively mitigate risk. OSHA also concludes, as detailed in the FEA, that the general prohibition of silica sand in abrasive blasting is not technologically or economically feasible. Thus, the Agency has decided against a ban or limitation on the use of silica sand as an abrasive blasting agent in the rule.
BCTD urged OSHA to ban the use of silica sand as an abrasive blasting agent, but said that if banning the use of silica sand as an abrasive blasting agent was not possible, OSHA should prohibit the use of dry silica sand as an abrasive blasting agent (Document ID 2371, Attachment 1, p. 31). However, PCI noted that wet blasting with silica sand cannot be used to finish concrete surfaces (Document ID 2276, p. 9). CISC noted the problems associated with excessive water application on some worksites and argued that different environments and conditions had not been analyzed to determine the effectiveness of wet methods for abrasive blasting (Document ID 2319, p. 36).
OSHA finds that a separate requirement for the use of wet blasting methods when silica sand is used as a blasting agent is neither necessary nor appropriate. Under paragraph (f)(1) of the standard for general industry and maritime (paragraph (d)(3)(i) of the standard for construction), employers are required to use engineering and work practice controls, which include wet methods, to reduce and maintain employee exposure to respirable crystalline silica at or below the PEL, unless the employer can demonstrate that such controls are not feasible. Therefore, where employee exposures exceed the PEL from abrasive blasting with silica sand, employers must implement wet blasting methods whenever such methods are feasible and would reduce exposures, even if implementing this control does not reduce exposures to or below the PEL. By not specifically mandating the use of wet methods whenever sand is used as a blasting agent, the rule gives employers who cannot feasibly use wet methods flexibility to determine what controls to implement in order with comply with the PEL.
Charles Gordon argued for a partial ban on the use of silica sand as an abrasive blasting agent:
Abrasive blasting with crystalline silica should be banned in confined spaces and in the maritime industry. That is where acute silicosis was most common and where it is hardest to protect adjacent workers.
In all other areas and operations, the employer must consult MSDS's for substitutes for crystalline silica. If it is reasonable to conclude that a substitute for crystalline silica is a safer blasting media and will lead to a reasonable surface, then the employer must adopt the substitute. If the employer concludes that there is no safer reasonable substitute for crystalline silica, then the employer must keep a brief written record of that determination (Document ID 2163, Attachment 1, pp. 18-19).
CISC questioned the application of the hierarchy of controls to abrasive blasting, given the Agency's acknowledgement that respiratory protection will still be necessary in many situations even after implementing engineering and work practice controls (Document ID 2319, p. 37). As discussed above, the Agency maintains its position that adherence to the hierarchy of controls, which includes, where appropriate and feasible, substitutes for silica sand, wet blasting, LEV, proper work practices and housekeeping practices that reduce dust emissions, is essential to help reduce the extremely high exposures to respirable crystalline silica experienced by abrasive blasting workers and workers who may be near them. The FEA describes how extremely high exposures associated with dry abrasive blasting were significantly reduced where controls, such as wet blasting and non-silica containing abrasive blast media, were used (see Chapter IV of the FEA for further discussion). By using engineering controls to reduce these exposures, employees will be able to wear less restrictive respirators and will be better protected if their respiratory protection fails. Engineering controls also help protect others on the worksite from exposure to respirable crystalline silica. Therefore, requiring the use of controls, even where respiratory protection will also be required, is reasonably necessary and appropriate to protect employees from exposures to respirable crystalline silica.
The requirements in the rule for abrasive blasting are consistent with ASTM E 1132—06 and ASTM E 2625—09, the national consensus standards for controlling occupational exposure to respirable crystalline silica in general industry and in construction, respectively. Each of these standards clarifies that the hierarchy of controls (
A prohibition on employee rotation to achieve compliance with the PEL was supported by EEI, Dr. George Gruetzmacher, and James Schultz (Document ID 2278, p. 4; 2357, p. 30; 3586, Tr. 3200). However, many commenters representing employers from the concrete, brick, tile, construction, electric utility, and foundry industries, over 20 trade associations, ASSE, and academics from the George Washington University Regulatory Studies Center urged OSHA to reconsider this prohibition (
Some commenters misunderstood the prohibition on employee rotation to achieve compliance with the PEL, or believed that the provision could be misunderstood by the regulated community. These commenters were concerned that the prohibition would preclude the use of rotation for other reasons, such as limiting exposure to physical hazards (
NISA and the Chamber argued that if the risks of silicosis are subject to a threshold, then rotation to maintain exposures at low levels could only be protective (Document ID 2195, p. 39; 2288, p. 12; 4194, p. 12). ASSE argued that job rotation may be warranted as an alternative to burdensome engineering and administrative controls or PPE for tasks that involve some levels of exposure to silica, but are performed on an infrequent basis (Document ID 2339, p. 4; 3578, Tr. 1035-1036, 1044). ASSE, as well as Dal-Tile, noted that since silica is a ubiquitous substance and present in many raw materials, virtually all employees would be exposed to some level of respirable crystalline silica. Therefore, they argued that a prohibition on rotation in this circumstance does not make sense (Document ID 2147, p. 4; 2339, p. 4). In addition, AFS indicated that rotation as an administrative control is permitted by Canadian provinces with exposure limits for respirable crystalline silica (Document ID 4035, p. 14). OSHA also notes that the industry consensus standards for respirable crystalline silica, ASTM E 1132-06 and ASTM E 2625-09, expressly permit employee rotation as an administrative control to limit exposures (Document ID 1466, p. 4; 1504, pp. 3, 7).
OSHA does not consider employee rotation to be an acceptable alternative to avoid the costs associated with implementation of engineering and administrative controls, nor does the Agency consider that pervasive exposures to respirable crystalline silica justify allowing rotation. OSHA has nonetheless concluded that there may be situations where employee rotation
OSHA also recognizes that a provision prohibiting employee rotation to achieve the PEL has little practical application for purposes of enforcement. Because the prohibition is limited to rotation for the sole purpose of achieving the PEL, an employer can provide any other reason to justify employee rotation. As described above, there are many legitimate reasons for an employer to rotate employees. As a result, OSHA has almost never cited employers for violating provisions prohibiting employee rotation for achieving the PEL. For the 7 standards that contain these provisions, which have been in effect for periods ranging from 8 to 29 years, Federal OSHA has only cited one of these provisions on one occasion.
For the reasons described above, OSHA has determined that a prohibition on employee rotation to achieve the PEL is not reasonably necessary or appropriate for the silica rule. The Agency recognizes that this determination differs from the determinations made in previous rulemakings addressing carcinogens. This is not intended as a reversal of OSHA's prior practice of prohibiting employee rotation to achieve the PEL for carcinogens, nor a precedent that will control future rulemakings, which necessarily will be based on different rulemaking records. Nevertheless, in this rule OSHA expects that the majority of employers covered by the rule will implement all feasible engineering and work practice controls to achieve the PEL (as the rule requires), and rotation will generally be used to limit use of respiratory protection that is triggered by working more than four hours in conditions where exposures are expected above the PEL even with the full implementation of engineering and work practice controls. OSHA finds that these factors justify omitting the prohibition on rotation from this rule. Therefore, the prohibition, which was included in the proposed rule, is not included in the final rule.
Paragraph (g) of the standard for general industry and maritime (paragraph (e) of the standard for construction) establishes requirements for the use of respiratory protection, to which OSHA's respiratory protection standard (29 CFR 1910.134) also applies. Specifically, respirators are required under the rule: Where exposures exceed the PEL during periods necessary to install or implement engineering and work practice controls; where exposures exceed the PEL during tasks, such as certain maintenance and repair tasks, for which engineering and work practice controls are not feasible; and during tasks for which all feasible engineering and work practice controls have been implemented but are not sufficient to reduce exposure to or below the PEL. The standard for general industry and maritime also requires respiratory protection during periods when an employee is in a regulated area. The standard for construction also requires respiratory protection where specified by Table 1 of paragraph (c), but does not include a requirement to establish a regulated area, and thus does not contain a provision requiring the use of respirators in regulated areas.
These provisions of the rule for the required use of respirators are consistent with those proposed and are generally consistent with other OSHA health standards, such as methylene chloride (29 CFR 1910.1052) and chromium (VI) (29 CFR 1910.1026). They reflect the Agency's determination that, as discussed in the summary and explanation of
Paragraph (e)(1) of the standard for construction is revised from the proposed standard in order to clarify where respiratory protection is required. Paragraph (e)(1)(i) of the standard for construction provides that, for employers following the specified exposure control methods approach set forth in paragraph (c) of the standard for construction, respiratory protection is required under the standard where specified by Table 1. Table 1 in paragraph (c) of the standard for construction specifies respirator use for certain listed tasks; employers whose employees are engaged in those tasks have the option of following Table 1 in order to comply with the standard. The specific respiratory protection and minimum assigned protection factors (APF) for the tasks listed on Table 1 are discussed in the summary and explanation of
Paragraph (g)(1)(i) of the standard for general industry and maritime (paragraph (e)(1)(ii)(A) of the standard for construction) requires the use of respirators in areas where exposures exceed the PEL during periods when feasible engineering and work practice controls are being installed or implemented. OSHA recognizes that respirators may be needed to achieve the PEL under these circumstances. During these times, employees will have to use respirators for temporary protection until the hierarchy of controls has been implemented, at which point respirators will not be needed, provided the PEL is no longer exceeded. Employers must follow the
OSHA anticipates that engineering controls will be in place by the dates specified in paragraphs (l)(2) and (l)(3) of the general industry and maritime standard (paragraph (k)(2) of the standard for construction) (
Paragraph (g)(1)(ii) of the general industry and maritime standard (paragraph (e)(1)(ii)(B) of the standard for construction) requires respiratory protection in areas where exposures exceed the PEL during tasks in which engineering and work practice controls are not feasible. OSHA anticipates that there will be few situations where no feasible engineering or work practice controls are available to limit employee exposure to respirable crystalline silica. However, the Agency recognizes that it may be infeasible to control respirable crystalline silica exposure with engineering and work practice controls during certain tasks, such as maintenance and repair tasks, and permits the use of respirators in these situations. For example, maintenance and repair to address temporary failures in operating systems or control systems to achieve the PEL such as failures of conveyance systems (elevators, conveyors, or pipes), failures of dust collecting bag systems, and section head failures at glass plant facilities as well as cupola (furnace) repair work and baghouse maintenance activities, may present a situation where engineering and work practice controls are not feasible and the use of respirators is permitted (Document ID 3493, p. 3; 1992, pp. 3, 5). In situations where respirators are used as the only means of protection, the employer must be prepared to demonstrate that engineering and work practice controls are not feasible.
Paragraph (g)(1)(iii) of the standard for general industry and maritime (paragraph (e)(1)(ii)(C) of the standard for construction) requires the use of respirators for supplemental protection in circumstances where feasible engineering and work practice controls alone are not sufficient to reduce exposure levels to or below the PEL. The employer is required to install and implement all feasible engineering and work practice controls, even if these controls alone cannot reduce employee exposures to or below the PEL. Whenever respirators are used as supplemental protection, the burden is on the employer to demonstrate that engineering and work practice controls alone are insufficient to achieve the PEL.
Paragraph (g)(1)(iv) of the standard for general industry and maritime requires employers to provide respiratory protection during periods when an employee is in a regulated area. Paragraph (e) of the standard for general industry and maritime requires employers to establish a regulated area wherever an unprotected employee's exposure to airborne concentrations of respirable crystalline silica is, or can reasonably be expected to be, in excess of the PEL. OSHA included the provision requiring respirator use in regulated areas to make it clear that each employee is required to wear a respirator when present in a regulated area, regardless of the duration of time spent in the area. Because of the potentially serious results of exposure, OSHA has concluded that this provision is necessary and appropriate because it would limit unnecessary exposures to employees who enter regulated areas, even if they are only in a regulated area for a short period of time. The standard for construction does not include a requirement to establish a regulated area and thus, does not contain a similar provision in the respiratory protection section of the standard. Further discussion about this can be found in the summary and explanation of
OSHA proposed to require the use of respiratory protection when specified by the written access control plan—an option given to employers in the proposed rule as an alternative to establishing regulated areas. The Agency is not including an access control plan option in the rule (
Commenters, including Charles Gordon, a retired occupational safety and health attorney, and the American Industrial Hygiene Association recommended that OSHA require employers to provide employees with respirators upon request in certain situations where they are not required under the rule (
While the Agency considers the level of risk remaining at the PEL to be significant, OSHA is not including a provision in this rule permitting employees to request and receive a respirator in situations where they are not required under the rule, nor is OSHA requiring respiratory protection and a respiratory protection program at the action level. There has been significant residual risk below the PEL in many previous health standards, but OSHA has only rarely included provisions permitting employees to request and receive a respirator to mitigate this risk (cotton dust (29 CFR 1910.1043(f)(1)(v)), lead (29 CFR 1910.1025(f)(1)(iii)), cadmium (29 CFR 1910.1027(g)(1)(v))) and the Agency has never established a requirement for respiratory protection and a respiratory protection program at a standard's action level.
OSHA anticipates that most construction employers covered by the rule will choose to implement the control measures specified in paragraph (c) of the standard for construction. Employers who implement the specified exposure control methods will not be required to assess employee exposures to respirable crystalline silica. Therefore, many employers covered by
With regard to permitting employees to request respirators for Table 1 tasks where respiratory protection is not specified, OSHA has relied on its technological feasibility analyses to determine which tasks can be performed at or below the PEL most of the time with the use of engineering and work practice controls only (
If respirators were mandated at the action level or available upon employee request in situations where they are not required under the rule, employers would need to have respirators available at all times. Moreover, they would need to establish and implement a full respiratory protection program for all employees exposed to silica—a considerable undertaking for many employers that involves not only the purchase and retention of suitable respirators but an ongoing program of training, fit-testing, and maintenance. OSHA concludes that “on request” respirator use or requiring respiratory protection at the action level is not a practical or responsible approach to occupational safety and health regulation, and requiring such an investment in respirators would divert resources from the development and implementation of engineering controls that could more effectively reduce exposure levels to or below the PEL. Thus, OSHA's approach for reducing employee exposure to respirable crystalline silica in this and all other standards for air contaminants is to focus on engineering controls, rather than additional requirements for respiratory protection. For these reasons, OSHA has determined that a requirement for employers to provide respirators to employees upon request in situations where they are not required under the rule, or a requirement to provide respirators to employees exposed at or above the action level, is not reasonably necessary and appropriate for this respirable crystalline silica rule.
At the same time, OSHA does not prohibit employers from supplying or employees from using respirators outside the requirements of the rule. Therefore, although this rule does not include a provision providing employees with a right to request and receive respirators where not required by the rule, or requiring respiratory protection at the action level, employers may continue to provide respirators at the request of employees or permit employees to use their own respirators in situations where respirator use is not required, as provided for in the respiratory protection standard (29 CFR 1910.134(c)(2)(i)). OSHA's understanding, however, is that such use beyond what is required in a comprehensive OSHA standard is not a common occurrence, and the Agency does not expect non-mandated respirator use to proliferate with respect to this rule, as might well be the case if a provision requiring employers to provide respirators “on request” was written into the rule and would certainly be the case if the action level were used as the trigger for respirator use.
Industry commenters, including the Construction Industry Safety Coalition, OSCO Industries, American Foundry Society, National Association of Manufacturers, Glass Packaging Institute, American Composite Manufacturers Association, Small Business Administration's Office of Advocacy, U.S. Chamber of Commerce, and American Subcontractors Association, urged OSHA to consider discarding the hierarchy of controls and permitting the use of respirators in lieu of engineering and work practices controls in various circumstances, including: During short duration tasks performed intermittently (Document ID 1992, pp. 3, 5; 2319, p. 115); where exposures exceed the PEL for 30 days or less per year (Document ID 4229, p. 11); where exposures are below the respirable dust PEL of 5 mg/m
Paragraph (g)(2) of the general industry and maritime standard (paragraph (e)(2) of the standard for construction) requires the employer to implement a comprehensive respiratory protection program in accordance with OSHA's respiratory protection standard (29 CFR 1910.134) whenever respirators are used to comply with the requirements of the respirable crystalline silica standard. As contemplated in the NPRM, a respiratory protection program that complies with the respiratory protection standard will ensure that respirators are properly used in the workplace and are effective in protecting employees. In accordance with that standard, the program must include: Procedures for selecting respirators for use in the workplace; medical evaluation of employees required to use respirators; fit-testing procedures for tight-fitting respirators; procedures for proper use of respirators in routine and reasonably
Many employers commented that they already have respiratory protection programs in place to protect employees from exposures to respirable crystalline silica (Document ID 1964; 2183, p. 1; 2276, p. 5; 2292, p. 2; 2301, Attachment 1, p. 5, 37; 2338, p. 2; 2366, p. 3; 3577, Tr. 711; 3583, Tr. 2386-2387). The International Union of Bricklayers and Allied Craftworkers and the International Union of Operating Engineers also indicated that their members' employers have established respiratory protection programs (Document ID 2329, p. 7; 3583, Tr. 2342, 2367).
The American Association of Occupational Health Nurses, Ameren Corporation, 3M Company, and Dr. George Gruetzmacher supported the reference to the respiratory protection standard (Document ID 2134; 2278, p. 3; 2313, p. 6; 2315, p. 4). For example, the 3M Company, which manufactures respirators, stated:
3M believes that by not requiring separate, individual respiratory protection provisions for respirable crystalline silica, the . . . rule should enhance consolidation and uniformity of the 1910.134 respirator requirements and could result in better compliance concerning the use of respiratory protection. Many of our customers use respirators to help protect workers from exposures to multiple contaminants and the reference in the respirable crystalline silica standard to the requirements of 1910.134 brings uniformity that could likely result in better compliance and protection for workers with exposures to silica and other materials (Document ID 2313, p. 6).
OSHA concludes that referencing the requirements in the respiratory protection standard is important for ensuring that respirators are properly used in the workplace and are effective in protecting employees. Simply cross-referencing these requirements merely brings the applicable requirements to the attention of the employer; the cross-reference does not add to the employer's existing legal obligations, but it makes it more likely that the employer covered by this standard will meet all its obligations with regard to providing respirators when required to do so. Thus, the Agency has incorporated in the rule the reference to the respiratory protection standard that was proposed.
A representative of a local union and individual employees recommended specific respirators that they believed should be used to protect employees exposed to respirable crystalline silica (Document ID 1763, p. 3; 1798, p. 6; 2135). OSHA is not singling out silica-specific respirators but concludes instead that, for purposes of consistency and to ensure that the appropriate respirator is used, the provisions of the respiratory protection standard should apply to substance-specific standards unless there is convincing evidence that alternative respirator selection requirements are justified. The commenters who recommended specific respirators did not provide any evidence to support their recommendations. As no basis has been established for distinguishing respirator requirements for respirable crystalline silica from other air contaminants, OSHA finds it appropriate to adopt its usual policy of requiring employers to follow the provisions of the respiratory protection standard.
Paragraph (e)(3) of the standard for construction states that, for the tasks listed in Table 1 in paragraph (c), if the employer fully and properly implements the engineering controls, work practices, and respiratory protection described in Table 1, the employer shall be considered to be in compliance with paragraph (e)(1) of the standard for construction and with the requirements for selection of respirators in paragraphs (d)(1)(iii) and (d)(3) of 29 CFR 1910.134. Employers following Table 1 must still comply with all other provisions of 29 CFR 1910.134. Paragraphs (d)(1)(iii) and (d)(3) of 29 CFR 1910.134 require the employer to evaluate respiratory hazards in the workplace, identify relevant workplace and user factors, and base respirator selection on these factors. Because Table 1, in specifying the required respiratory protection and minimum APF for a particular task, has already done this, employers following Table 1 are considered to be in compliance with paragraphs (d)(1)(iii) and (d)(3) of 29 CFR 1910.134 for exposure to respirable crystalline silica. While not required for employers fully and properly implementing Table 1, paragraph (d)(3)(i)(A) of the respiratory protection standard (29 CFR 1910.134), which includes a table that can be used to determine the type or class of respirator that is expected to provide employees with a particular APF, can help employers determine the type of respirator that would meet the required minimum APF specified by Table 1. For example, Table 1 requires employers to provide employees with respiratory protection with an APF of 10 for some of the listed tasks. An employer could consult the table in 29 CFR 1910.134(d)(3)(i)(A) to find the types of respirators (
Unions, labor groups, and others urged OSHA to include a provision in the rule that allows employees to choose a powered air-purifying respirator (PAPR) in place of a negative pressure respirator (Document ID 2106, p. 3; 2163, Attachment 1, pp. 15-16; 2173, p. 5; 2244, p. 4; 2253, p. 7; 2256, Attachment 2, pp. 13-14; 2336, p. 7; 2371, Attachment 1, pp. 33-34; 3581, Tr. 1668-1669; 3955, Attachment 1, p. 2; 4204, pp. 78-79). They asserted that employees are more likely to get better protection from PAPRs, since they are more comfortable and thus, more likely to be used. They also argued that this will allow employees who may encounter breathing resistance or other difficulty in wearing a negative pressure respirator the ability to continue working in a job where silica exposures cannot feasibly be controlled below the PEL using engineering and work practice controls, without revealing their health status or health condition to their employer. They noted that previous health standards, such as the standards for asbestos (29 CFR 1910.1001(g)(2)(ii)) and cadmium (29 CFR 1910.1027(g)(3)(ii)), include provisions that allow employees to request and obtain a PAPR without revealing their health status or health condition to their employer.
In some cases, employers are already providing PAPRs to employees who request them. The North American Insulation Manufacturers Association reported that some member companies provide PAPRs upon employee request in certain circumstances, including accommodating religious practices and where the work is physically taxing (Document ID 4213, pp. 4-5). James Schultz, a former foundry employee from the Wisconsin Coalition for Occupational Safety and Health, testified that he was able to get his employer to provide a PAPR in some, but not all, instances when he requested one (Document ID 3586, Tr. 3201).
OSHA has long understood that it is good industrial hygiene practice to provide a respirator that the employee
With regard to employees who have difficulty breathing when using a negative pressure respirator or cannot wear such a respirator, the respiratory protection standard requires employers to provide a PAPR if the employee's health is at increased risk if a negative pressure respirator is used (29 CFR 1910.134(e)(6)(ii)). Under the medical surveillance provisions of this rule, as well as the medical determination provisions of the respiratory protection standard (29 CFR 1910.134(e)(6)), the PLHCP's written medical opinion for the employer must contain any recommended limitations on the employee's use of respirators. Thus, including a provision in this rule that provides employees the ability to choose a PAPR in place of a negative pressure respirator would not appreciably add a benefit to what is already provided pursuant to required medical determinations. Therefore, OSHA finds that a provision specific to this rule permitting employees to request and receive a PAPR in place of a negative pressure respirator is neither necessary nor appropriate in this rule.
These requirements are consistent with ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities, the national consensus standards for controlling occupational exposure to respirable crystalline silica in general industry and in construction, respectively. Each of these standards requires respirators to be used in work situations in which engineering and work practice controls are not sufficient to reduce exposures of employees to or below the PEL. Like the consensus standards, where the use of respirators is required, the standards that comprise this rule require employers to establish and enforce a respiratory protection program, as specified in 29 CFR 1910.134.
Paragraph (h) of the standard for general industry and maritime (paragraph (f) of the standard for construction) requires employers to adhere to housekeeping practices. This is a new paragraph in the rule, but it is derived from the proposed requirements for cleaning methods (included in the Methods of Compliance paragraph in the proposed rule) and revised in response to further analysis and public comments. The requirements apply to all employers covered under this rule, including where the employer has fully and properly implemented the control methods specified in Table 1 in the standard for construction.
OSHA proposed a requirement that accumulations of crystalline silica be cleaned by high-efficiency particulate air (HEPA)-filter vacuuming or wet methods where such accumulations could, if disturbed, contribute to employee exposure that exceeds the PEL. The proposed rule would also have prohibited the use of compressed air, dry sweeping, and dry brushing to clean clothing or surfaces contaminated with crystalline silica where such activities could contribute to exposures exceeding the PEL. OSHA included these provisions in the proposed rule because evidence shows that use of HEPA-filtered vacuums and wet methods instead of dry sweeping, dry brushing and blowing compressed air effectively reduces worker exposure to respirable crystalline silica during cleaning activities. For example, a study of Finnish construction workers compared respirable crystalline silica exposure levels during dry sweeping to exposure levels when using alternative cleaning methods. Compared with dry sweeping, estimated worker exposures were about three times lower when workers used wet sweeping and five times lower when they used vacuums (Document ID 1163).
Some commenters, including the International Union of Bricklayers and Allied Craftworkers (BAC), the United Steelworkers (USW), the Building and Construction Trades Department, AFL-CIO (BCTD), the United Automobile, Aerospace and Agricultural Implement Workers of America (UAW), BlueGreen Alliance (BGA), and Upstate Medical University, expressed support for the proposed requirement to use HEPA-filtered vacuums and wet methods and to prohibit the use of compressed air and dry sweeping for cleaning activities (
The National Institute for Occupational Safety and Health (NIOSH) also supported OSHA's proposed requirement to use wet methods and HEPA-filtered vacuums and prohibit the use of dry sweeping and compressed air during cleaning activities. In its written comments and testimony during the hearings, NIOSH cited U.S. Bureau of Mines research indicating that dry sweeping can increase respirable dust exposures, and provided several recommendations, including using water to wash down facilities that may have silica contamination, and using portable or centralized vacuum systems to clean off equipment (Document ID 2177, Attachment B, p. 38; 3579, p. 142).
Other commenters, such as Ameren, Acme Brick, the American Iron and Steel Institute (AISI), Fann Contracting, Inc., Leading Builders of America (LBA), Edison Electric Institute (EEI),
For example, AISI indicated that using wet methods in areas of steel making facilities where molten metal is present creates the potential for a significant and immediate safety hazard from steam explosions (Document ID 2261, p. 3; 3492, p. 2). The National Concrete Masonry Association argued that wet methods cannot generally be used in concrete block and brick plants:
In general, wet methods to control dust are NOT appropriate in the concrete masonry as a replacement for dry-sweeping . . . Not only do wet floors create fall hazards, any dust or debris that contains cement dust will react and harden in the presence of water, creating additional problems in concrete block production facilities (Document ID 2279, pp. 7-8).
NAHB indicated that use of wet methods in residential construction would damage many surfaces and could lead to structural problems, indoor air quality degradation, and the development of molds (Document ID 2296, p. 37). It argued that there are many circumstances in residential construction where dry sweeping is the only alternative for cleanup activities (Document ID 2296, pp. 41-42). LBA indicated that HEPA-filter vacuums will not collect large debris and that, during the collection process, dirt will clog the HEPA filter, preventing cleaning. It stressed that dry sweeping must be used (Document ID 2269, pp. 4, 22-23). Ameren and EEI argued that dry sweeping should be allowed because wet methods cannot be used around certain electrical equipment and when temperatures are below freezing (Document ID 2315, p. 8; 2357, pp. 7, 24-25). Fann Contracting said that it is necessary to dry sweep at the end of the milling process when milling roadways in order to clean the loose leftover material. It indicated that if water is used, it would create a thin layer of mud on the bottom of the milled trench, which would interfere with the paving process (Document ID 2116, Attachment 1, pp. 9-10, 32-33).
Commenters representing foundries argued that wet methods and HEPA-filtered vacuuming were not appropriate for cleaning in foundries. For example, Accurate Castings explained that wet methods would result in water going into the shell sand mold and would eventually lead to an explosion when molten metal enters the mold. It stressed that it must use compressed air for these applications (Document ID 2381, p. 2). Similarly, ESCO Corporation commented that it cannot use water in foundries due to potential for fire and explosion hazards. ESCO Corportation stressed that it also must use compressed air to clean castings (Document ID 3372, pp. 2-3). AFS also argued that the use of wet methods in foundries increases the likelihood of explosions as well as tripping hazards (Document ID 3490, p. 3). OCMA argued that vacuums can cause damage to molds and using wet methods would damage equipment, make floors slippery, and cause explosions (Document ID 2119, Attachment 3, p. 7). NFFS argued that compressed air is “the only viable means of cleaning complex or intricate castings” (Document ID 2247, p. 8; 2248, p. 8). AFS argued that a ban on dry sweeping would require the vacuuming of hundreds of tons per week in many foundry operations, and that collecting this amount of sand with a vacuum system is not feasible. AFS also expressed concern that the proposed rule would prohibit use of operator-driven power (dry) sweepers in foundries, arguing that power sweepers substantially reduce the release of fugitive dust from aisles and other vehicle traffic areas and that these machines cannot be replaced with wet sweepers because the quantity of material handled would gum up the sweeping mechanism with sludge (Document ID 2379, Attachment B, pp. 33-34).
Several commenters indicated that compressed air is needed to clean difficult to reach places (
After reviewing the evidence in the record, OSHA concludes that use of wet methods and HEPA-filter vacuums, as proposed, is highly effective in reducing respirable crystalline silica exposures during cleaning and that compressed air, dry sweeping, and dry brushing can contribute to employee exposures. However, OSHA finds convincing evidence that wet methods and HEPA-filtered vacuums are not safe and effective in all situations. Therefore, the Agency has revised the proposed language to take these situations into account. Paragraph (h)(1) of the standard for general industry and maritime (paragraph (f)(1) for construction) allows for the use of dry sweeping and dry brushing in the limited circumstances where wet methods and HEPA-filtered vacuuming are not feasible. Paragraph (h)(2) of the standard for general industry and maritime (paragraph (f)(2) for construction) allows employers to use compressed air for cleaning where the compressed air is used in conjunction with a ventilation system that effectively captures the dust cloud created by the compressed air, or where no alternative method is feasible. These limited exceptions will encompass the situations described above by commenters, and give them the necessary flexibility in permitting the use of compressed air, dry sweeping, or dry brushing in situations where wet methods or HEPA-filtered vacuums are infeasible, or where the dust cloud created by use of compressed air is
Although OSHA is allowing for dry sweeping and dry brushing and the use of compressed air for cleaning clothing and surfaces under these limited circumstances, the Agency anticipates that these circumstances will be extremely limited. The “unless” clause indicates that the employer bears the burden of showing that wet methods are not feasible in a particular situation, and OSHA expects that the vast majority of operations will use wet methods that minimize the likelihood of exposure. Where the employer uses dry sweeping, therefore, the employer must be able to demonstrate that HEPA-filtered vacuuming, wet methods, or other methods that minimize the likelihood or exposure are not feasible. Similarly, where compressed air is used to clean clothing and surfaces without a ventilation system designed to capture the dust cloud created, the employer must be able to demonstrate that no alternative cleaning method is feasible.
OSHA has also revisited the triggers for these provisions based on stakeholder comments. Some stakeholders disagreed with triggering these provisions based on the PEL. For example, the American Federation of State, County, and Municipal Employees (AFSCME), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), BCTD, BAC, UAW, USW, and others argued that dry sweeping and use of compressed air should be prohibited at any exposure level, not just where the use of such measures contributes to exposures that exceed the PEL (
OSHA has determined that exposure at the PEL still poses a significant risk to workers. All feasible efforts should be made to reduce those risks. OSHA should follow the well-established approach in its other health standard[s] and prohibit practices of dry sweeping, [use of] compressed [air] and require HEPA-filter[ ] vacuuming or wet methods whenever silica dust is present (Document ID 2257, Attachment 2, p. 13).
Similarly, AFSCME indicated that there is no reason why cleaning methods need to be tied to the PEL. It argued that requiring that all accumulations be dealt with in a uniform way would provide clarity for employers and employees alike (Document ID 2142, p. 3). BCTD argued that OSHA's proposed requirements would be unenforceable because they are tied to overexposure (Document ID 2371, Attachment 1, p. 33). Finally, AFL-CIO also recommended that OSHA expand the proposed requirements to require that accumulations of dust be kept as low as practicable. It noted that this requirement has appeared in previous OSHA health standards that regulate exposure to dusts, such as asbestos (29 CFR 1910.1001), lead (29 CFR 1910.1025), and cadmium (29 CFR 1910.1027).
On the other hand, the Precast/Prestressed Concrete Institute (PCI) argued that a general prohibition on the use of compressed air, dry brushing, and dry sweeping to clean areas where silica-containing material has accumulated is too broad, and not directly related to a particular exposure risk. It maintained that the use of compressed air and dry sweeping should be permitted as long as silica exposures are below the PEL (Document ID 4029, Cover Letter 1, p. 3). Similarly, the National Tile Contractors Association (NTCA) and TCNA both recommended that the proposed language be changed to read as follows:
To the extent practical compressed air, dry sweeping, and dry brushing shall not be used to clean clothing or surfaces contaminated with crystalline silica where such activities could contribute to employee exposure to respirable crystalline silica that exceeds the PEL (Document ID 2267, p. 3; 2363, p. 3).
After consideration of these comments, OSHA has decided to revise the trigger for the housekeeping provisions in the rule to apply to situations where dry sweeping, dry brushing or use of compressed air could contribute to employee exposure to respirable crystalline silica, regardless of whether that exposure exceeds the PEL. OSHA finds this change is necessary because the risk of material impairment of health remains significant at and below the revised PEL of 50 μg/m
OSHA has decided not to include an affirmative requirement to clean accumulations of crystalline silica that could, if disturbed, contribute to employee exposure that exceeds the PEL. In addition, the Agency has determined that it is not appropriate for the respirable crystalline silica rule to require accumulations of dust to be kept at the lowest level practicable. As noted above, OSHA recognizes that exposure to respirable crystalline silica is hazardous at concentrations below the PEL. However, crystalline silica is ubiquitous in many work environments. Crystalline silica is a component of the soil and sand at many construction sites and other outdoor workplaces, and may be present in large quantities at many other workplaces such as foundries and oil and gas drilling sites where hydraulic fracturing is performed. For purposes of cleaning, the employer may not be able to distinguish large crystalline silica particles from the fine particles which can, if airborne, be respirable. In many cases, the employer may not be able to distinguish crystalline silica particles from other workplace dusts. Because of these factors, many unique to respirable crystalline silica, OSHA is convinced that the best approach to address potentially hazardous exposures from cleaning is by requiring proper housekeeping practices to minimize exposure to respirable crystalline silica.
OSHA also received a number of miscellaneous comments on the proposed provisions, including suggestions for items the Agency should or should not include in the final rule and questions about the application of the proposed provisions to particular situations. For example, ARMA argued that OSHA should not require HEPA filters on central vacuum systems that discharge outdoors or into a non-occupied area, such as a baghouse (Document ID 2291, pp. 19-20). GPI also indicated it uses central vacuum systems, and argued that OSHA should allow for vacuum systems that discharge outside the facility (Document ID 2290, pp. 4-5). OSHA agrees that a prohibition on central vacuum systems that discharge respirable crystalline silica outside of the workplace is unnecessary, because such systems do not contribute to employee exposure. OSHA clarifies that the rule therefore
Occupational & Environmental Health Consulting Services (OEHCS) urged OSHA to require vacuums that meet the definition of a Portable High-Efficiency Air Filtration (PHEAF) device (Document ID 1953, Comment 1, pp. 4-6). This suggested revision would involve a requirement for field testing of portable air filtration devices using a laser particle counter to ensure that HEPA filters function as intended. OEHCS argued that, in many cases, HEPA filters do not perform effectively in the field due to inadequate, damaged, or deteriorating sealing surfaces; replacement filters that do not fit correctly; filter cabinets that are damaged; filters that are punctured; and other problems (Document ID 1953, Comment 1, p. 2). OEHCS further indicated that it is participating in an ongoing, multi-year research effort with the National Institutes of Health to test HEPA-filtered equipment (Document ID 1953, Comment 1, p. 2). However, OEHCS did not provide documentation to support the use and effectiveness of meeting the requirements and definition of this device, nor is there other evidence in the rulemaking record supporting such a requirement. OSHA encourages employers to ensure that HEPA filters function as intended in the field. However, lacking adequate documentation and support in the record, OSHA has concluded that it is not appropriate to include a requirement that HEPA vacuums meet the PHEAF standards in the rule.
OSHA also received a few comments related to the use of compressed air, dry sweeping, and dry brushing to clean clothing. Specifically, NIOSH and ASSE maintained that there are ways that clothing can be safely cleaned using compressed air. The two organizations advocated for the use of clothes cleaning booths, also referred to as mobile air showers (Document ID 2177, Attachment B, pp. 15, 38; 3403, p. 5; 2339, p. 9). This technology uses compressed air to clean clothes by blowing dust from an employee's clothing in an enclosed booth. Dust is blown out of the employee's breathing zone and is captured by a filter. NIOSH argued that the booths adequately capture the dust and prevent exposure to employees and the environment (Document ID 3403, p. 5). OSHA recognizes that this technology may be useful for cleaning dust off of clothing, and the rule does not prohibit the use of such systems. Clothes cleaning booths that use compressed air to clean clothing are permitted under the rule, as long as the compressed air is used in conjunction with a ventilation system that effectively captures the dust cloud created by the compressed air. The provision has been modified from that proposed to clearly allow the use of compressed air in conjunction with a ventilation system that effectively captures the dust cloud that is created, preventing it from entering the employee's breathing zone.
In addition, the American Subcontractors Association (ASA) offered a comment related to dry brushing. It argued that the term “dry brushing” could be misunderstood, and that an employer could receive a citation if an employee reflexively brushes visible dust off clothing (Document ID 2187, p. 6). OSHA's intent in the proposed rule was to restrict dry brushing activity that was comparable to dry sweeping, such as using a brush as a tool to clean clothing or surfaces. OSHA clarifies that the rule does not prohibit employees from using their hands to remove small amounts of visible dust from their clothing.
Finally, OSHA received comments on how often or at what point employers need to clean up dust in their facility. For instance, HalenHardy, a firm that provides products and services to limit exposures to dangerous dusts, argued that there should be some visible evidence of silica dust in order to require cleaning (Document ID 3588, Tr. 3920-3922). NCMA commented that dry sweeping can produce dust and indicated that best practices suggest that it is important to prevent the dust or debris from reaching the floor. If not cleaned regularly, this can lead to buildups of dust on the floor (Document ID 2279, p. 7).
The proposed rule would have required accumulations of crystalline silica to be cleaned by HEPA-filtered vacuuming or wet methods where such accumulations could, if disturbed, contribute to employee exposure to respirable crystalline silica that exceeds the PEL. As explained above, OSHA's final rule does not require employers to clean up dust. However, OSHA agrees that housekeeping is an important work practice to be used to limit employee exposures. And, as discussed in Chapter IV of the Final Economic Analysis and Final Regulatory Flexibility Analysis, some employers will need to perform housekeeping in order to limit employee exposures to the PEL. In recognition of this fact and because some cleaning methods can contribute to employee exposure, OSHA has included housekeeping as one of the items employers must address in their written exposure control plans (
Moreover, for employers following the general industry and maritime standard and, in construction, for tasks not listed in Table 1, or where the employer does not fully and properly implement the control methods described in Table 1, the rule requires employers to assess the exposure of each employee who is or may reasonably be expected to be exposed to respirable crystalline silica at or above the action level. Where exposure assessment reveals that an employee's exposure exceeds the PEL, the rule requires employers to use engineering and work practice controls to reduce and maintain employee exposure to or below the PEL, unless the employer can demonstrate that such controls are not feasible. Good housekeeping is one such work practice control that employers should consider. And, as NCMA suggests, employers may choose to clean up dust regularly as a best practice.
In addition, paragraph (c) of the standard for construction includes several housekeeping provisions that apply to employers who choose to follow Table 1. For instance, paragraphs (c)(1)(vii) and (c)(1)(viii) of the standard for construction require employers whose employees are engaged in a task using handheld or stand-mounted drills (including impact and rotary hammer drills) or dowel drilling rigs for concrete to use a HEPA-filtered vacuum when cleaning holes. Similarly, under paragraph (c)(1)(xiii), when using a walk-behind milling machine or floor grinder indoors or in an enclosed area, milling debris must be cleaned up using a HEPA-filtered vacuum prior to making a second pass over an area. This prevents the milling debris from interfering with the seal between machine and floor and minimizes the gap. Additionally, it prevents debris from being re-suspended and acting as another source of exposure.
If an employer chooses to follow paragraph (c) of the standard for construction, then the employer must implement any applicable housekeeping measures specified in Table 1. An employer who does not do so has not fully and properly implemented the controls identified on Table 1 and, thus, will be required to assess and limit the
While the paragraph on housekeeping (paragraph (f) of the construction standard) also applies when employers are following paragraph (c), the employer must ensure that all of the engineering controls and work practices specified on Table 1 are implemented. For example, paragraph (f)(2)(i) of the construction standard permits the use of compressed air when used in conjunction with a ventilation system that effectively captures the dust cloud. However, to fully and properly implement the controls on Table 1, an employer using compressed air when cleaning holes drilled by handheld or stand-mounted drills or dowel drilling rigs for concrete must use a HEPA-filtered vacuum to capture the dust, as specified in paragraphs (c)(1)(vii) and (c)(1)(viii), not just a ventilation system as specified in paragraph (f)(2)(i).
The housekeeping requirements of the rule are generally consistent with the provisions of the industry consensus standards, ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica, and ASTM E 2626-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities. Both consensus standards specify that compressed air shall not be used to blow respirable crystalline silica-containing materials from surfaces or clothing, unless the method has been approved by an appropriate Regulatory agency (4.4.3.3. and 4.4.3.2, respectively). Both consensus standards also list HEPA vacuums, water spray, and wet floor sweepers among available means to reduce exposure to dust (4.4.3.6. and 4.4.3.5, respectively). In addition, ASTM E 1132-06 includes restrictions on dry sweeping (4.4.3.2).
Paragraph (f)(2) of the standard for general industry and maritime (paragraph (g) of the standard for construction) sets forth the requirements for written exposure control plans, which describe methods used to identify and control workplace exposures, such as engineering controls, work practices, and housekeeping measures. OSHA did not propose a requirement for a written exposure control plan, but raised it as an issue in the preamble of the Notice of Proposed Rulemaking (NPRM) in Question 53 under
The only written plan that OSHA proposed was an access control plan, which was an alternative approach to establishing regulated areas; it described methods for identifying areas where exposures exceeded the permissible exposure limit (PEL), limiting access to those areas, communicating with others on the worksite, and providing personal protective equipment (PPE) to individuals entering those areas. Several stakeholders commented on the proposed written access control plans, whether or not the rule should contain a written plan, and their preference for the type of written plan.
A number of commenters questioned the practicality of a written access control plan in workplaces with continually changing tasks, conditions, or materials, which they argued can lead to the need for multiple plans and subsequent costs. The National Stone, Sand, and Gravel Association (NSSGA) commented that written access control plans and establishing boundaries are not feasible in many workplaces, such as aggregate facilities or large construction sites, because of varying silica amounts in materials (Document ID 2327, Attachment 1, p. 20). The Construction Industry Safety Coalition (CISC) stated that a written access control plan is impractical in construction and especially difficult and costly for small businesses because a different plan would need to be developed for each project, as a result of changing materials, tasks, and environmental conditions (Document ID 2319, pp. 5-6, 91-92). Associated Builders and Contractors, Inc. (ABC), Associated General Contractors of America, and American Society of Safety Engineers (ASSE) expressed similar concerns about constantly changing conditions on construction sites (Document ID 2289, pp. 6-7; 2323, p. 1; 4201, p. 2). The National Federation of Independent Business and Leading Builders of America also expressed concerns about time and resource burdens that a requirement for a written access control plan would impose on construction companies or small businesses (Document ID 2210, Attachment 1, p. 7; 2269, p. 22). ABC and CISC further stated that a written access control plan is not needed if employees are trained (Document ID 2289, pp. 6-7; 4217, p. 25).
CISC noted that section 4.2.5 of the ASTM standard E 2625-09 limits the need for a written exposure control plan to areas where overexposures are persistent, and contemplated that it is not needed when the PEL may be exceeded on a particular day because of conditions such as weather or silica content in a material. CISC stated that OSHA's requirement for a regulated area or written access control plan when exposures can reasonably be expected to exceed the PEL deviated from section 4.2.5 of the ASTM standard (Document ID 2319, p. 89; 1504, p. 2). OSHA clarifies that a written access control plan, which describes specified methods for limiting access to high-exposure areas, is different from a written exposure control plan, which can address specified protections for controlling exposure other than limiting access to high-exposure areas.
Commenters representing industry, labor, and employee health advocate groups addressed the issue of what, if any, type of written plan should be required and what level of respirable crystalline silica exposure should trigger that requirement. Some industry representatives favored a written access control plan over a regulated area, while others opposed a written exposure control plan. For example, in comparing regulated areas and the written access control plan, Edison Electric Institute favored the flexibility of the written access control plan and stated that it might use that option in larger areas or for activities that can change over time. It opposed a written exposure control plan, asserting that the training required by OSHA's hazard communication standard (HCS) was sufficient to keep employees informed (Document ID 2357, pp. 33, 37). The Non-Ferrous Founders' Society expressed concerns about costs if a consulting industrial hygienist would need to be hired to develop a written access control plan (Document ID 2248, p. 13). The National Association of Home Builders (NAHB) stated that some of its members would
Commenters from labor organizations and employee health advocate groups supported the inclusion of a written exposure control plan. For example, BCTD stated that the proposed written access control plan could be used as a starting point for the development of a written exposure control plan, which it said should be required for every employer that has employees who may be exposed to respirable crystalline silica (Document ID 2371, Attachment 1, pp. 14-16). International Union of Operating Engineers (IUOE), Public Citizen, American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), and International Union of Bricklayers and Allied Craftworkers (BAC) also supported a requirement for a written plan for all covered employers and not just those with regulated areas or exposures exceeding the PEL (Document ID 2262, p. 42; 2249, p. 3; 4204, p. 62; 4219, pp. 25-26; 4223, p. 119).
Other commenters, such as ASSE, favored a written exposure control plan for suspected or documented overexposure scenarios (Document ID 2339, p. 8). The National Industrial Sand Association (NISA) originally opposed a written exposure control program in its prehearing comments (Document ID 2195, p. 38). However, in its post-hearing comments, it supported one, stating that formulating and writing down an exposure control program would ensure that an employer thinks through the engineering and administrative controls required to achieve compliance in situations with persistent overexposures. NISA also stated that the plan would help employers defend against potential liability by documenting due care (Document ID 4208, pp. 20-21).
The American Foundry Society (AFS) disagreed with the need for a separate written exposure control plan and instead called for planning as part of other business initiatives. It supported written exposure control plans in enforcement situations. AFS favored an approach similar to that in the ASTM standard. AFS stated that the ASTM's approach, which involves identifying and analyzing dust sources in scenarios with overexposures to determine effective controls, was more effective in reducing exposures than requiring controls to be installed by a certain date (Document ID 2379, Appendix 1, pp. 61-62; 4229, p. 26).
Advocates of written exposure control plans explained why they supported those plans. The National Institute for Occupational Safety and Health (NIOSH) stated that written exposure control plans could be a simple mechanism for ensuring performance of maintenance checks and, for construction employers, maintaining Table 1 conditions (Document ID 2177, Attachment B, pp. 16-17). Dr. Paul Schulte, Director of the Education and Information Division at NIOSH, testified that “. . . a written plan would greatly improve reliability of the protection provided.” (Document ID 3403, p. 5). AFL-CIO, NISA, and BCTD agreed (Document ID 4204, p. 61; 4208, pp. 20-21; 4223, p. 74). Eileen Betit, representing BCTD, testified:
Written exposure control plans are important for identifying operations that will result in exposures, the specific control measures, and how they will be implemented and the procedures for determining if controls are being properly used and maintained. Such plans also facilitate the communication of this information to other employers on multi-employer worksites so that they, in turn, can take steps to protect their employees. Without such plans, there's no assurance that employers and employees will take a systematic and comprehensive approach to identifying, controlling, and sharing information about silica exposures on job sites (Document ID 3581, Tr. 1569-1570).
BlueGreen Alliance, UAW, USW, and AFL-CIO also supported a written plan because requiring the written plan would be consistent with the many other OSHA substance-specific standards that include written plans or programs (Document ID 2176, p. 3; 2282, Attachment 3, p. 17; 3584, Tr. 2540; 4204, p. 62). In addition, commenters observed that other U.S. and Canadian regulatory agencies require written plans. Frank Hearl, Chief of Staff at NIOSH, stated that the Mine Safety and Health Administration requires a dust control plan to be filed at coal mines (Document ID 3579, Tr. 235-236). In addition, AFL-CIO and BCTD noted that written dust or silica control plans are included in a proposed standard for the Canadian Province of British Columbia and a standard promulgated in the Canadian Province of Newfoundland (Document ID 4204, p. 61; 4223, p. 73 Fn. 14; 4072, Attachment 38, pp. 6-7, Attachment 41, p. 7).
BCTD stated that a requirement for a written exposure control plan would not be unduly burdensome to employers because creating such plans is an extension of planning functions in construction (Document ID 4223, pp. 74-80). In fact, several hearing participants testified that written safety or hazard control plans are already being developed and used in the construction industry (Document ID 4223, pp. 74-80; 3580, Tr. 1383-1385; 3583, Tr. 2267-2268, 2385; 3585, Tr. 3093-3094; 3587, Tr. 3560). For example, Kevin Turner, Director of Safety at Hunt Construction Group and representing CISC testified: “. . . we require a site-specific safety plan which addresses the hazards dealt with in that [particular] contractor's scope of work.” (Document ID 3580, Tr. 1383).
In addition, written plans are consistent with general industry practices. For example, the National Service, Transmission, Exploration, and Production Safety Network (STEPS Network), whose members are involved in the oil and gas industry, recommends a written plan that describes how exposures to respirable crystalline silica will be reduced or prevented (Document ID 4024, Attachment 2, p. 1). Member companies of the National Ready Mix Concrete Association, who hire third-party contractors to chip out their drum mixers, follow strict written practices and procedures to ensure that exposures do not exceed the PEL. Specifically, they require the contractors to submit to them a company-approved safety and health policy and procedures and plans (Document ID 2305, pp. 8-9). AFL-CIO
BCTD stressed that preparing a written exposure control plan does not have to be burdensome and, along with BAC and AFL-CIO, pointed to online tools that are available to help users create written exposure control plans, such as the CPWR-Center for Construction Research and Training (CPWR) tool, available free of charge, on the silica-safe.org Web site (Document ID 2329, p. 5; 4204, p. 61; 4223, pp. 80-81; 4073, Attachment 5a and 5b). AFL-CIO and BCTD also pointed to guidance products and model exposure control plans from the Canadian Province of British Columbia as additional resources for assisting users in developing written exposure control plans (Document ID 4204, p. 61; 4223, p. 81; 4072, Attachment 14, 19, 20). Industry associations are another resource to help employers prepare written plans. For example, Anthony Zimbelman, general contractor, representing NAHB, testified that his industry association teaches courses and helps businesses develop safety plans (Document ID 3587, Tr. 3559-3560).
OSHA finds the evidence on the benefits of a written exposure control plan—as distinct from the proposed written access control plan—convincing and has concluded that a requirement for a written exposure control plan is needed for both the standard for general industry/maritime and the standard for construction because the plan will improve employee protections. OSHA agrees with commenters who stated that a written plan should not be limited to scenarios where the PEL is exceeded. Therefore, OSHA concludes that it is appropriate for the rule to require a written exposure control plan, instead of a written access control plan that would only apply to restricting access to areas where exposures to respirable crystalline silica exceed the PEL. Requiring a written exposure control plan for all employers covered by the rule is more protective than the ASTM approach of only requiring written exposure control plans for persistent overexposures. Even if exposures are below the PEL due to the use of engineering controls or work practices, a systematic approach for ensuring proper function of engineering controls and effective work practices is crucial for ensuring that those controls and practices remain effective. Thus, OSHA finds that a written exposure control plan is integral to preventing overexposures from occurring.
OSHA agrees with NISA that requiring employers to articulate conditions resulting in exposure and how those exposures will be controlled will help to ensure that they have a complete understanding of the controls needed to comply with the rule. OSHA expects a written exposure control plan will be instrumental in ensuring that employers comprehensively and consistently protect their employees. Even in cases where employees are well trained, the written plan can help to ensure that controls are consistently used and become part of employees' routine skill sets. Employers could opt to use the plans to ensure that maintenance checks are routinely performed and optimal conditions are maintained. In addition, OSHA concludes the written plans are a useful method for communicating protections to employees.
Requiring a written plan maintains consistency with the majority of OSHA substance-specific standards for general industry and construction, such as lead (29 CFR 1910.1025 and 1926.62) and cadmium (29 CFR 1910.1027 and 1926.1127), which require written compliance plans. A requirement for a written exposure control plan is also consistent with Canadian standards. In addition, it is generally consistent with industry practices, as evidence in the record indicates that some employers in general industry and construction are already developing and using written plans. OSHA concludes that even for small businesses, preparing a written exposure control plan based on identifying and controlling respirable crystalline silica hazards will not be unduly burdensome, because of the widespread availability of tools and guidance from groups such as CPWR and the Canadian government. In addition, OSHA anticipates that industry associations will provide guidance on developing written exposure control plans for respirable crystalline silica.
Contrary to the concerns indicated by comments from representatives from the construction industry, OSHA does not intend or expect that employers will need to develop a new written plan for each job or worksite. Many of the same tasks will be conducted using the same equipment and materials at various worksites. For example, a stationary masonry saw used outdoors to cut concrete will perform similarly in any outdoor setting. Most construction employers are expected to use the specified exposure control methods in Table 1 of paragraph (c), which will help them identify tasks and controls to be included in the written exposure control plan. Table 1 does not usually specify different controls for different types of crystalline silica-containing materials, thus supporting the conclusion that a new plan does not need to be continually developed. Table 1 does list some conditions, such as time performing tasks or use of equipment in enclosed areas, that would require respirator use in addition to the specified controls; those different scenarios can be indicated in the written exposure control plan, as applicable. Therefore, the written exposure control plan does not have to be limited by materials, tasks, and conditions for a particular job site and can include all materials, tasks, and conditions typically encountered. In many cases there will be no need to modify the written plan just because the location has changed. However, the plan must address all materials, tasks, and conditions that are relevant to the work performed by a particular company. OSHA is including in the docket a sample written exposure control plan for a bricklaying company for reference.
OSHA concludes that it is appropriate to include a requirement for a written exposure control plan in the respirable crystalline silica standards for general industry/maritime and construction. Therefore paragraph (f)(2)(i) of the standard for general industry and maritime (paragraph (g)(1) of the standard for construction) requires the employer to establish and implement a written exposure control plan that contains at least the elements specified in paragraphs (f)(2)(i)(A)-(C) of the standard for general industry and maritime (paragraph (g)(1)(i)-(iv) of the standard for construction). This provision not only requires that a written exposure control plan be established but also implemented. OSHA does not consider it sufficient to develop a plan and have a copy of it on a shelf. It must be followed in the day-to-day performance of tasks identified.
OSHA considered existing written exposure control plans, such as the ASTM plans, and commenter suggestions to determine what should be included in a written exposure control plan. Section 4.2.5 of ASTM standard E 2625-09 concerning construction and demolition provides:
In areas where overexposures are persistent, a written exposure control plan shall be established to implement engineering, work practice, and administrative controls to reduce silica exposures to below the PEL, or other elected limit, whichever is lower, to the extent feasible. Conduct a root cause analysis for all exposures in excess of the PEL that cannot be accounted for. Root cause analysis
The exposure control plan described in section 4.2.6 of ASTM standard E 1132-06 is substantively consistent with the approach described by section 4.2.5 of ASTM standard E 2625-09 (Document ID 1466, p. 2; 1504, p. 2).
Several stakeholders commented on what should be included in provisions for a written exposure control plan. ASSE described an approach similar to that in the ASTM standards, and AFS preferred the ASTM approach during enforcement actions (Document ID 2339, p. 8; 2379, Appendix 1, pp. 61-62).
NIOSH stated that the exposure control plan could be based on OSHA's
Some labor unions, such as AFL-CIO and BCTD, recommended more extensive requirements for a written exposure control or compliance program that included identification of exposures and controls, in addition to exposure assessment methods or results, and descriptions of the respiratory protection, medical surveillance, and training programs (Document ID 2371, Attachment 1, pp. 16-17; 4204, p. 62; 4223, p. 82).
Commenters such as Public Citizen, USW, UAW, and BCTD all agreed that the value of a written exposure control plan is that it allows for consistent identification and control of respirable crystalline silica hazards (Document ID 2249, p. 2; 2336, pp. 8-9; 2282, Attachment 3, p. 17; 3581, Tr. 1569-1571; 4204, p. 60). OSHA affirms that the purpose of the written exposure control plan is the consistent identification and control of respirable crystalline silica hazards, and it is basing the requirements for a written exposure control plan on that purpose.
As discussed more fully below, the written exposure control plan required under this rule for respirable crystalline silica is similar to the ASTM standards in most, but not all, respects. The major difference between the written plans in the ASTM standards and in this rule is that written exposure control plans in this rule are not limited to overexposure scenarios.
OSHA thus considered the ASTM standards and commenter suggestions to develop requirements for a written exposure control plan. The Agency also considered which aspects of the proposed written access control plan should be retained or modified. Therefore, the requirement for a written exposure control plan evolved from comments on OSHA's proposed written access control plan and in response to OSHA raising the possible inclusion of a written exposure control plan as an issue.
Paragraph (f)(2)(i)(A) of the standard for general industry and maritime (paragraph (g)(1)(i)) of the standard for construction) requires a description of tasks involving exposures to respirable crystalline silica. The proposed written access control plan called for identification of areas where respirable crystalline silica exposure may exceed the PEL. Communication Workers of America (CWA), Public Citizen, USW, AFL-CIO, NISA, and BCTD recommended that the written exposure control plan describe tasks, operations, or work processes that result in exposures to respirable crystalline silica (Document ID 2240, p. 2; 2249, p. 3; 2336, p. 9; 4204, p. 62; 4208, p. 21; 4223, p. 82). A description of tasks involving exposures to respirable crystalline silica is consistent with the first step of the root cause analysis in the ASTM exposure control plans, which involves investigating sources of overexposures (Document ID 1466, p. 2; 1504, p. 2). It is also consistent with the identification of tasks and hazards in the OSHA
Paragraph (f)(2)(i)(A) of the standard for general industry and maritime (paragraph (g)(1)(i) of the standard for construction) reflects OSHA's agreement with commenters that it is important for employers to consistently identify tasks resulting in exposure to ensure that appropriate employee protections are applied when needed. The identification of tasks with potential respirable crystalline silica exposure is no longer limited to exposures above the PEL, as it was in the proposed written access control plan. This is more protective because it identifies all tasks that could contribute to employee exposures, thereby furthering the purpose of the rule.
In preparing this section of the written plan, employers must list all tasks that employees perform that could expose them to respirable crystalline silica dust. This section of the written plan could include a description of factors that affect exposures, such as types of silica-containing materials handled in those tasks (
Paragraph (f)(2)(i)(B) of the standard for general industry and maritime (paragraph (g)(1)(ii) of the standard for construction) requires a description of engineering controls, work practices, and respiratory protection used to limit employee exposure to respirable crystalline silica for each task. CWA, Public Citizen, USW, AFL-CIO, NISA, and BCTD requested that the written plan describe controls for managing exposures. Engineering and work practice controls were specifically mentioned by Public Citizen, USW, AFL-CIO, and BCTD (Document ID 2240, p. 2; 2249, pp. 3-4; 2336, p. 9; 4204, p. 62; 4208, p. 21; 4223, p. 82). AFL-CIO further recommended that the written plan describe jobs where respiratory protection is required (Document ID 4204, p. 62). BCTD also requested that the written plan describe procedures for implementing the controls and for determining if the
Paragraph (f)(2)(i)(B) of the standard for general industry and maritime (paragraph (g)(1)(ii) of the standard for construction) reflects OSHA's agreement that the written exposure control plan must address controls, work practices, and respiratory protection used to manage exposures for each task identified in paragraph (f)(2)(i)(A) of the standard for general industry and maritime (paragraph (g)(1)(i) of the standard for construction). The purpose of this requirement is to ensure that exposures to respirable crystalline silica hazards are consistently controlled. Therefore, written exposure control plans must include information such as types of controls used (
OSHA also agrees with NIOSH and BCTD about the necessity of addressing the proper implementation and maintenance of controls for each task. This is reflected in paragraph (c) of the standard for construction, in the Table 1 requirements to operate or maintain tools according to manufacturers' instructions. Proper implementation and maintenance of controls is also necessary to meet the PEL under paragraph (c) of the standard for general industry and maritime and paragraph (d)(1) of the standard for construction for construction employers who choose or are required to follow the alternative exposure control methods. Therefore, to help ensure compliance with the rule, the employer, in this section of the written exposure control plan, could indicate signs that controls may not be working effectively (
OSHA finds the written exposure control plan especially important for construction employers who use the specified exposure control methods in Table 1 of paragraph (c). For them, the description of engineering controls, work practices, and respiratory protection is especially necessary to ensure adequate protection of employees and the use of controls according to the manufacturer's instructions, since employers are not required to conduct exposure assessments to verify that controls are working properly. In cases where the employer owns a particular type of equipment and it is repeatedly used at different job sites, describing the manufacturer's instructions for operating the dust controls in a written exposure control plan will demonstrate that the employer has a complete understanding of and is applying those specifications needed to control dust emissions. Describing those specifications in the written exposure control plans will also serve as a convenient reference for employees.
As an example, in completing this section of the written plan, an employer whose employees use a Stihl® Model TS 410 saw to cut concrete could consult the user's manual to list or summarize those instructions in his or her written exposure control plan. Based on the user's manual, this section of the plan could indicate that (1) before using a Stihl® Model TS 410 saw for cutting concrete, the employee must examine the diamond cutting wheel for signs of excessive wear, damage, or “built-up edges” (
Paragraph (f)(2)(i)(C) of the standard for general industry and maritime (paragraph (g)(1)(iii) of the standard for construction) requires a description of the housekeeping measures used to limit employee exposure to respirable crystalline silica. BCTD requested that the exposure control plan describe housekeeping methods (Document ID 2371, Attachment 1, pp. 16-17). Similarly, CWA and USW recommended that the written plan describe procedures for preventing the migration of silica, and USW further noted that the plan should address keeping surfaces visibly clean (Document ID 2240, p. 2; 2336, p. 9). USW also requested that the written exposure control plan describe procedures for removing, laundering, storing, cleaning, repairing, or disposing of protective clothing and equipment (Document ID 2336, p. 9).
Paragraph (f)(2)(i)(C) of the standard for general industry and maritime (paragraph (g)(1)(iii)) of the standard for construction) reflects OSHA's agreement that housekeeping needs to be addressed in the written exposure control plan because some cleaning methods can contribute to employee exposure to respirable crystalline silica. OSHA intends this requirement to help ensure that employers identify and implement appropriate cleaning methods so that employees are protected from respirable crystalline silica dust that can become airborne while performing housekeeping activities. Ensuring safe housekeeping methods helps to consistently control exposures and hazards related to respirable crystalline silica. Housekeeping is another type of work practice to be used to limit employee exposures, and thus, it is consistent with the written exposure control plans in the ASTM standards, which call for implementing work practices to decrease exposures (Document ID 1466, p. 2; 1504, p. 2). It is also consistent with OSHA's
OSHA concludes that requiring the written exposure control plan to include a description of housekeeping methods is important because acceptable housekeeping methods can vary among different companies. As described more fully in the summary and explanation of
To ensure that cleaning methods used comply with paragraph (h) of the standard for general industry and maritime (paragraph (f) of the standard for construction), this section of the written plan could include a description of acceptable and prohibited cleaning methods used by the employer to minimize generation of airborne dust and special instructions regarding cleaning methods (
Paragraph (g)(1)(iv) of the standard for construction requires a description of the procedures used to restrict access to work areas, when necessary, to limit the number of employees exposed to respirable crystalline silica and the levels to which they are exposed, including exposures generated by other employers or sole proprietors. No such requirement is included in the written exposure control plan provision for general industry and maritime. The reasons for the differing requirements in the two standards are discussed below.
The proposed written access control plans for general industry and maritime and construction called for procedures for notifying employees about the presence and location of areas where respirable crystalline silica concentrations are or can be reasonably expected to exceed the PEL and for demarcating those areas from the workplace if needed. Also included in the proposed access control plan were provisions for limiting access to areas where respirable crystalline silica exposures may exceed the PEL, in order to minimize the numbers of employees exposed and employee exposure levels.
AFL-CIO and BCTD recommended that written plans describe procedures that employers will use to limit exposure to employees who are not performing respirable crystalline silica-related tasks (Document ID 4204, p. 63; 4223, p. 82). Similarly, BAC stated that the written plan should contain provisions for a regulated area (Document ID 2329, p. 5). USW requested the written plan address labeling of areas with potential respirable crystalline silica exposure (Document ID 2336, p. 14).
Paragraph (g)(1)(iv) of the standard for construction reflects OSHA's agreement that written exposure control plans must address limiting exposure to construction employees who are not engaged in respirable crystalline-silica-related tasks. However, as explained in the summary and explanation of
The exposure control plans in the ASTM standards do not specifically call for procedures used to restrict access. However, they do call for a description of administrative controls used to reduce exposures (Document ID 1466, p. 2; 1504, p. 2). An example of an administrative control that can be used to minimize the number of employees exposed to respirable crystalline silica is scheduling high-exposure tasks when others will not be in the area (Document ID 3583, Tr. 2385-2386). For example, Anthony Zimbelman stated that when granite countertops are being installed, silica dust may be generated when drilling holes for plumbing fixtures or grinding to make adjustments, but the installers are usually the only employees at the job site at that time (Document ID 3521, pp. 6-7). CISC stated that in lieu of developing a written access control plan, employers could instruct employees to stay out of areas where dust is generated or, if employees have to be in those areas, to avoid dust clouds (Document ID 2319, pp. 91-92). OSHA considers the CISC recommendation to be an additional example of administrative controls for limiting access or exposures that could be addressed in the written exposure control plan. Similarly, a written exposure control plan could include guidance requiring employees to maintain a safe distance from dust created by the use of explosives in demolition and to stay out of the affected area until the dust sufficiently dissipates; this would also serve as an acceptable administrative control. Therefore, a requirement for the written plan in the construction standard to address minimizing the number of employees exposed and their exposure levels is consistent with the exposure control plans in the ASTM standards.
OSHA concludes that the written exposure control plan for the construction standard must address restricting access of those employees who are not engaged in tasks that generate respirable crystalline silica (
Such a situation might occur when an employee engaged in a Table 1 task with fully and properly implemented controls is exposed to clearly visible dust emissions by an employee or sole proprietor who is performing a task not listed on Table 1, is not fully and properly implementing Table 1 controls, or is performing a Table 1 task requiring a higher level of respiratory protection. In that case, the competent person would assess the situation to determine if it presents a reasonably anticipated hazard, and if it does, take immediate and effective steps to protect employees by implementing the procedures described in the written exposure control plan. Actions by the competent
This approach is consistent with current industry practices. For example, Anthony Zimbelman testified that in his experience, implementing a safety plan was sufficient to protect employees in situations where subcontractors that are not required to comply with the Occupational Safety and Health (OSH) Act are working alongside employees. Mr. Zimbelman further testified that in the home building industry, this situation does not happen often and contractors would stop working with a subcontractor who does not comply with OSHA standards (Document ID 3587, Tr. 3547-3549). OSHA expects that excessive exposures created by sole proprietors not covered by the respirable crystalline silica rule will be an infrequent occurrence because, as CISC indicated in its post-hearing brief, employers and general contractors will likely demand that everyone on the site follow regulatory requirements (Document ID 4217, Appendix B, p. 16). OSHA thus expects that the employers or their competent persons will work with general contractors of construction sites to avoid high exposures of employees working alongside others generating respirable crystalline silica. For example, the competent person could ask the general contractor to schedule high-exposure tasks when employees will not be in the area.
OSHA is not retaining the proposed requirement in the written access control plan that the employer describe how employees will be notified about respirable crystalline silica exposures and how areas will be demarcated. The requirements of the written exposure control plan are more performance-oriented to permit each employer to address unique scenarios of worksites. Demarcation (
As noted above, the standard for general industry and maritime does not require the written exposure control plan to address how access to high-exposure areas or employee exposures will be limited. As described in more detail in the summary and explanation of
The proposed written access control plan called for a description of the methods that employers at multi-employer sites would use to notify other employers about the presence and location of areas where respirable crystalline silica may exceed the PEL and any precautionary methods needed to protect employees. AFL-CIO, BAC, and BCTD commented that written plans should provide for a method of communication at multi-employer sites (Document ID 4204, pp. 62-63; 4219, pp. 25-27; 4223, pp. 83-84). BCTD stated that a requirement for a written plan to describe methods of communication at multi-employer sites was not sufficient and requested that employers also be required to give their written plan to a general contractor or other “controlling employer” at a multi-employer construction site. The controlling employer would be required to share that information with other employers or use the plan to coordinate activities to reduce exposures to employees (Document ID 4223, pp. 118-123). AFL-CIO and BAC endorsed BCTD's approach and/or recommended a similar method for using the written exposure control plan to communicate at multi-employer worksites (Document ID 4204, p. 63; 4219, pp. 25-27). Similarly, ASSE stated that employers who generate respirable crystalline silica exposures at multi-employer sites should inform the general contractor or host employer about the need for access control and work cooperatively with the general contractor or host employer to ensure compliance and notify other employers at the site (Document ID 2339, p. 8).
In contrast, NSSGA commented that the HCS already requires employers to establish methods for communicating hazards to employees of other employers (Document ID 2327, Attachment 1, p. 11). NAHB commented that “. . . the imposition of multi-employer burdens in the proposed rule is inconsistent with the clear wording of § 1910.12(a) requiring a construction employer to protect `each of
OSHA nonetheless concludes that the written exposure control plan need not specify communication methods at multi-employer sites, or require that employers share their written exposure control plans at multi-employer sites. Communication at multi-employer worksites is already addressed in the HCS. As part of the written hazard communication program required under the HCS, employers who use hazardous chemicals in such a way that employees of other employers may be exposed must include specific information in the written hazard communication program. This includes methods the employer will use to inform the other employers of any precautionary measures that need to be taken to protect employees (29 CFR 1910.1200(e)(2)(ii)). Because the provisions for a written hazard communication program under the HCS already require employers to share relevant information on hazards and protective measures with other employers in multi-employer workplaces, OSHA does not find it necessary to restate a requirement for sharing of information between employers in the respirable crystalline silica rule. However, as discussed above, written exposure control plans are useful for communicating information, and employers may decide that they are a convenient way for sharing information with other employers at multi-employer workplaces.
Additional provisions that were part of the proposed access control plan but
Some commenters requested that written plans address additional topics and requirements. For example, Public Citizen, BCTD, and AFL-CIO, requested that the written exposure control plan describe exposure assessment methods or programs (
OSHA disagrees with commenters that the written exposure control plan needs to address these topics. The major purpose of a written exposure control plan is to ensure that respirable crystalline silica hazards are consistently identified and controlled. OSHA concludes that this purpose is best served if the written plan is limited to information useful for the employer or the employer's designated representative who will conduct inspections on job sites to ensure that employees are adequately and consistently protected. Requiring a written exposure control plan to contain information that is not directly relevant to identifying and controlling hazards at job sites would needlessly increase the burdens to employers preparing the written plans and could make the plans cumbersome for them to use on job sites. In addition, OSHA does not see the need for including a description of the respiratory protection program because employers are already required to develop a written respiratory protection program under the respiratory protection standard (29 CFR 1910.134(c)). Recordkeeping requirements are clearly specified for fit testing and medical evaluations in the respiratory protection standard (29 CFR 1910.134) and for medical examinations and exposure assessments in this rule. The respirable crystalline silica rule does not require employers to keep training records. As explained in more detail in the summary and explanation of
Therefore, OSHA is neither requiring nor precluding employers to include in written exposure control plans descriptions of exposure assessment methods and results or information on respiratory protection, medical surveillance, and training programs. Requiring information, such as highly technical details on analytical methods, would increase the likelihood that small employers would need to hire a safety and health professional to develop the plans, thus increasing the costs and burdens to those employers. Although OSHA encourages companies to seek professional assistance when needed to develop the plans, requiring a plan that is so complex that many employers would not develop it themselves defeats the advantage of employers gaining an increased understanding of the rule by articulating its requirements. The additional information may be useful as part of a compliance plan, and employers have the option to develop such a plan if they find it helpful.
Paragraph (f)(2)(ii) of the standard for general industry and maritime (paragraph (g)(2) of the standard for construction) requires the employer to review and evaluate the effectiveness of the written exposure control plan at least annually and update it as necessary. A similar requirement was included in the proposed written access control plan. Public Citizen requested revisions of written exposure control plans as needed, including after annual review of exposure assessment methods (Document ID 2249, p. 4). OSHA agrees with Public Citizen that the written exposure control plan needs to be periodically reviewed and updated as needed because work conditions can change (
Paragraph (f)(2)(iii) of the standard for general industry and maritime (paragraph (g)(3) of the standard for construction) requires that the employer make the written exposure control plan readily available for examination and copying, upon request, to each employee covered by this section, his or her designated representative, the Assistant Secretary (
BCTD also requested that the rule require employers to address in their written plans how temporary workers will be protected and that the rule require staffing agencies and employers who use temporary staff to share their written exposure control plans (Document ID 4223, pp. 83-84). OSHA disagrees with BCTD that the rule needs to include a requirement for host employers and temporary staffing agencies to share their written exposure control plans with each other. However, OSHA agrees with the importance of ensuring that temporary workers receive the protections they are entitled to under the OSH Act. As BCTD noted in its comments, OSHA addresses the issue of temporary employee protections in its July 15, 2014, memorandum titled
OSHA included a competent person requirement in the draft general industry/maritime and construction standards presented for review to the Small Business Regulatory Enforcement Fairness Act (SBREFA) review panel. In the draft standards submitted for SBREFA review, duties of the competent person included evaluating workplace exposures and the effectiveness of controls, implementing corrective measures to maintain exposures at or below the PEL, establishing and maintaining boundaries of regulated areas, and evaluating alternate media for abrasive blasting operations. Small entity representatives (SERs) from the construction industry who reviewed the SBREFA draft standard found the requirements for a competent person hard to understand, reasoning that (1) the competent person required a high skill level, (2) a large proportion of their employees would need to be trained, and (3) the requirements would be costly and difficult to comply with (78 FR at 56443-56444).
OSHA's Advisory Committee on Construction Safety and Health (ACCSH), made up of representatives of employees, employers, and state and federal governments, recommended that the Agency retain a competent person requirement in the proposed construction standard because many OSHA standards include that requirement, it is an accepted approach for construction, many small construction employers do not have full-time health and safety staff, it can ensure that designated employees get training on hazards and proper use of controls, and it can increase confidence that controls and PPE are being used and maintained correctly (Document ID 4073, Attachment 14g, pp. 2-3).
OSHA included a competent person provision in the proposed standards, but the only duty that OSHA proposed for the competent person was identifying areas where respirable crystalline silica concentrations are, or could reasonably be expected to be, in excess of the PEL when the employer chose to develop a written access control plan in lieu of establishing regulated areas. OSHA proposed this limited competent person duty because the Agency thought that provisions of the proposed standard, such as requirements for engineering controls and work practices to reduce and maintain employee exposure to respirable crystalline silica at or below the PEL, would effectively communicate the requirements of the rule, without involvement of a designated competent person. However, the Agency was aware that competent person requirements have been included in other health and safety standards and that some parties thought such requirements would be useful in the silica rule (78 FR at 56443-56444). Therefore, OSHA requested comments regarding the appropriateness of the limited competent person requirement, whether a competent person provision should be included, and if the proposed duties for a competent person should be modified or deleted (78 FR at 56288).
Many commenters representing labor unions and employee health advocate groups disagreed with OSHA proposing to include only a limited role for the competent person in construction. Commenters such as NIOSH, the Laborers' Health and Safety Fund of North America (LHSFNA), ASSE, IUOE, and BCTD supported an expanded competent person role because many construction companies are small and cannot afford safety or health professionals, but as NIOSH stated, small companies can have trained and authorized employees ensure employee protections (Document ID 3403, p. 4;
The need for expanding the duties of the silica-competent person is especially important when employers plan to rely on Table 1 because it is less likely that an industrial hygienist will visit the project to evaluate the job, collect air samples, or check the effectiveness of controls. Effectiveness deteriorates when controls or personal protective equipment (PPE) are not maintained; this performance degradation may not be obvious to workers using the devices (Document ID 3403, p. 4).
The American Industrial Hygiene Association (AIHA), IUOE, and BCTD agreed that a competent person is needed to ensure that Table 1 controls are functioning effectively (Document ID 3578, Tr. 1030; 3583, Tr. 2347; 4223, pp. 109-110). BCTD stated:
Exposure variability in construction is another reason that commenters cited in support of expanded competent person duties. For example, ASSE commented that varying silica exposures can occur as a result of wind pattern and geological changes as contractors move from one site to another or to a new area at the same site (Document ID 4201, p. 2). LHSFNA explained that a competent person can help to reduce exposure variability by identifying major sources of variability and ensuring that controls are used and maintained effectively (Document ID 4207, p. 4). Similarly, NIOSH stated that a competent person could reduce exposure variability by recognizing sources of variability, such as tasks done in an enclosed area or equipment that is not working correctly (Document ID 3579, Tr. 175-176, 194-195). In explaining how a competent person could reduce exposure variability, Kyle Zimmer, Director of Health and Safety for IUOE Local 478, testified that the competent person could respond to changing conditions by repositioning equipment so that employees are upwind of the dust created, adjusting water controls based on environmental factors, or addressing an unexpected encounter of a concrete sub-base during asphalt milling (Document ID 3583, Tr. 2351-2352).
Commenters also addressed a competent person's role regarding bystanders (
Another reason why commenters stated that a competent person is needed in construction is because they thought that employers are not adequately recognizing respirable crystalline silica-related health hazards. As evidence that employers do not believe that respirable crystalline silica is an issue, Chris Trahan, CIH, representing BCTD, pointed to the volume of testimony claiming that declining silicosis mortality rates are evidence that silicosis is not a problem and that respirable crystalline silica is an “alleged carcinogen.” Ms. Trahan disagreed with these commenters and said their testimony demonstrates the hurdles that the industry must overcome before silica is recognized as a hazard and controlled (Document ID 3581, Tr. 1641-1642; 4223, pp. 108-109). LHSFNA claimed that most contactors have not adequately addressed respirable crystalline silica-related health hazards because of the long latency of silica-related disease compared to the common short tenure of employment at any one company. LHSFNA commented that this blunted the ability of workers' compensation to provide an incentive for disease prevention (Document ID 4207, p. 3). In support of the importance of a competent person for preventing disease, LHSFNA and BCTD pointed to the following statement in the AIHA White Paper on competent persons (Document ID 3589, Tr. 4199; 4223, p. 106).
A key component in preventing overexposure to silica and subsequent disease is to have at least one individual on the jobsite who is capable of recognizing and evaluating situations where overexposure may be occurring; who knows how to evaluate the exposure potential; and who can make an initial recommendation on how to control that exposure. This is the role of the silica competent person (Document ID 4076, p. 3).
Commenters stressed that the competent person is a well-known concept in construction. LHSFNA and BCTD commented that requiring a competent person under the silica regulation maintains consistency with 19 OSHA construction standards (Document ID 4207, p. 3; 4223, p. 107). Standards requiring a competent person include asbestos (29 CFR 1926.1101), lead (29 CFR 1926.62), and cadmium (29 CFR 1926.1127) (Document ID 4223, p. 107). In addition, NIOSH and LHSFNA commented that competent person provisions are commonly included in American National Standard Institute (ANSI) standards for construction (Document ID 2177, Attachment B, p. 8; 3589, Tr. 4200). NIOSH further said that it and its state partners routinely recommend the need for, and role of, designated competent persons in investigation reports conducted under NIOSH's Fatality Assessment and Control Evaluation program (Document ID 2177, Attachment B, p. 8).
The competent person requirement is also consistent with construction industry practices. For example, Donald Hulk testified that at Manafort Brothers construction sites, a highly trained person has the authority to ensure that best practices are implemented (Document ID 3583, Tr. 2380). Anthony Zimbelman testified that owners or competent persons of subcontracting companies conduct assessments and develop procedures for controlling dust before remodeling or construction of homes (Document ID 3587, Tr. 3538-3539). Safety Director Francisco Trujillo from Miller and Long, Inc. testified “. . . we have competent persons for almost everything . . .” and explained that competent persons are required to
Specific duties for a competent person were recommended by a diverse group of commenters, including AIHA, NIOSH, National Asphalt Pavement Association (NAPA), IUOE, National Rural Electric Cooperative Association (NRECA), retired occupational safety and health attorney Charles Gordon, LHSFNA, and BCTD (Document ID 2169, p. 5; 2177, Attachment B, pp. 9-10, 14; 2181, pp. 10-11; 2262, pp. 38-39, 42-43; 2365, pp. 19-20; 3588, Tr. 3800-3801; 3589, Tr. 4197-4201; 4223, pp. 106-114). BCTD, which had among the most extensive recommendations, noted that OSHA standards for lead, asbestos, and cadmium specify duties for a competent person (Document ID 4223, p. 112). For the respirable crystalline silica standard, BCTD requested that the employer designate a competent person to be on site whenever work covered by the standard is being conducted to ensure that the employer's written exposure control plan is implemented, and to:
NIOSH recommended similar duties in addition to indicating that the competent person should assure proper hygiene to prevent employees from taking home silica dust on clothing and to conduct daily checks of engineering controls and respirators in abrasive blasting operations involving sand (Document ID 2177, Attachment B, pp. 9-10, 14). IUOE stated that the competent person could assist with employee training, ensure good housekeeping in heavy equipment cabs, and assume responsibility for exposure assessments (Document ID 2262, p. 41; 3583, Tr. 2369-2370; 3583, Tr. 2345). NISA stated that a competent person could conduct qualitative objective exposure assessments or determine frequency of exposure estimates under the performance option (Document ID 2195, pp. 35-36).
CISC opposed a requirement for a competent person and stated that thorough training eliminated the need for a competent person and access control plan (Document ID 4217, pp. 25-26). In disputing the value of expanding the competent person role in the standard, CISC claimed that the ubiquitous presence of silica in construction precluded the need for a designated person who is capable of identifying existing and predictable respirable crystalline silica hazards and has authorization to take prompt corrective actions (Document ID 2319, p. 127).
Commenters also addressed the practicality of a competent person requirement. IUOE commented that an employer would not need to hire additional personnel to serve as silica competent persons because they could designate a competent person to oversee more than one construction activity or task, as long as that person is able to identify existing and predictable hazards and is authorized to take prompt corrective action (Document ID 4234, Part 3, pp. 62-63). In contrast, CISC commented that requiring a competent person at all construction sites is not realistic for small companies and pointed to testimony from Kellie Vazquez, Vice President of Holes Incorporated, as an example (Document ID 4217, pp. 26-27). Ms. Vazquez testified:
OSHA observes that the description of Ms. Vazquez's employees is consistent with the definition of a competent person for safety issues (
In addition, any prompt corrective measures that competent persons would take to eliminate or minimize respirable crystalline silica hazards would likely have minimal impact on work activities in most cases. Such measures might include briefly stopping work to clear a clogged water line on a tool with wet method controls or clean a filter on a tool with vacuum controls if the competent person sees signs that controls are not functioning effectively. OSHA concludes that even for small businesses, a competent person requirement will not be unduly burdensome because knowledgeable employees, who will already be on site, can be designated as competent persons.
OSHA concludes that the ubiquitous presence of respirable crystalline silica and the many variables that can affect employee exposure when performing construction tasks justify a requirement for a competent person in construction, who is not only trained to identify and correct respirable crystalline silica hazards, but also is authorized to take immediate corrective actions to eliminate or minimize them.
Exposures and hazards can vary according to environmental conditions such as wind and humidity, geological profile of soil, if work is performed indoors or outdoors, or how well exposure controls are maintained. Consequently, there is an obvious need for a competent person to frequently inspect the construction job site, identify respirable crystalline silica hazards, and verify that effective control measures are being used. Site assessment is a continuous process because of changing environmental and work conditions as a construction job is being completed. In cases where the competent person is the only person from his or her company on a job site, frequent inspections of the job site would equate to continuous assessment of variables associated with the job that the competent person is conducting (
OSHA agrees with commenters that a competent person is needed in construction because employers who use the specified exposure control methods in Table 1 are not required to conduct exposure assessments and because large numbers of small construction companies do not typically employ health and safety professionals. Another reason for including a competent person provision in the construction standard is because at multi-employer worksites, the actions of one employer may expose employees of other employers to hazards. For these reasons, OSHA agrees with ACCSH and commenters from NIOSH, labor unions, and employee health advocate groups that a requirement for a designated competent person is needed and will improve employee protections in construction.
In addition, as noted above, a requirement for a competent person is consistent with OSHA substance-specific standards for construction, such as lead (29 CFR 1926.62), asbestos (29 CFR 1926.1101), and cadmium (29 CFR 1926.1127). OSHA's general safety and health provisions for construction require the employer to initiate and maintain programs for accident prevention, as may be necessary, and such programs require frequent and regular inspections of job sites, materials, and equipment by a designated competent person (29 CFR 1926.20(b)(1) and (2)). Designating a competent person is consistent with current construction industry practices because, as the record indicates, employers in the construction industry are already using competent persons.
OSHA is requiring that the competent person implement the written exposure control plan because, as discussed above, the plan specifies what must be done to consistently identify and control respirable crystalline silica hazards on a job site. In construction, a competent person is needed to ensure that the requirements of the written exposure control plan are being met under variable conditions. The subjects that must be described in the written exposure control plan for construction—tasks involving exposure to respirable crystalline silica; engineering controls, work practices, and respiratory protection; housekeeping methods for limiting exposure; and procedures for restricting access when needed to minimize exposures or numbers of employees exposed—are consistent with the duties of a competent person suggested by representatives from NIOSH, labor unions, employee health advocates, and some industries. Therefore, having the competent person implement the written exposure control plan is consistent with many of the competent person duties recommended by commenters. It also makes the competent person requirements easy to understand.
Implementation of the written exposure control plan does not address every competent person duty that was recommended by commenters, such as training or specific duties related to abrasive blasting with sand. OSHA is not mandating that the competent person conduct training because training could, in many cases, be performed by other individuals. For example, ensuring that an employee can demonstrate knowledge and understanding of health hazards, contents of the rule, and medical surveillance, and providing the employee with any needed training, may be better addressed by an individual other than the designated competent person, or at another location before the employee reports to the job site. A competent person could use the written exposure control plan to recognize employees who are not knowledgeable about full and proper implementation of controls or work practices and take appropriate action, such as reminding them of proper practices or recommending additional training to the employer.
The standard does not specify a duty for the competent person regarding abrasive blasting with sand, but unique aspects of that operation, such as more frequent checks of controls, could be specified in the written exposure control plan. OSHA reasons that evaluating alternate media for use in abrasive blasting, as was recommended in the draft standard for SBREFA, requires specialized knowledge in toxicology or a related science, and is thus beyond the knowledge of a typical employee who would be designated a competent person and unduly burdensome to employers. Also, as discussed in the summary and explanation section of
In its prehearing comments, BCTD also requested that the exposure control plan list the identity of the competent person (Document ID 2371, Attachment 1, pp. 16-17). OSHA is not requiring that the written exposure control plan include the identity of the competent person because it is both impractical and unnecessary. Construction companies could have more than one designated competent person because they need a backup competent person or they have jobs being conducted at various construction sites. Therefore the identity of the competent person could change from day to day if employees work at different job sites, or if a backup person is sent to a particular job site. However, it is important for employees to be able to identify the competent person. Therefore, OSHA is requiring that employers covered by the standard for construction notify employees about the identity of the competent person as part of the training provision under paragraph (i)(2)(i)(E). OSHA expects this could simply involve announcing the identity of the competent person at the start of each work shift.
As stated above, paragraph (b) (
OSHA received many comments regarding knowledge and competencies for a competent person. IUOE recommended inclusion of specific training requirements for competent persons in the standard for construction
NIOSH requested that OSHA require competency training, as it did for asbestos (29 CFR 1926.1101(o)(4)), and list requirements for silica-specific training and capabilities for competent persons in the standard or an appendix of the standard. NIOSH further stated that “OSHA could consider allowing appropriate experience to qualify (
IUOE, ASSE, LHSFNA, and BCTD endorsed the competency objectives set forth in an AIHA White Paper as a minimum body of knowledge for a silica competent person (Document ID 4201, p. 6; 4207, p. 3; 4223, pp. 113-114). BCTD requested that the White Paper be included as a non-mandatory appendix to the rule (Document ID 4223, pp. 113-114). The AIHA White Paper indicates that a silica competent person can demonstrate competency by completing a training course addressing the criteria in the White Paper or successfully demonstrating the capabilities described in the White Paper through training or direct job experience. The competency objectives listed in the AIHA White Paper include an understanding of (a) the role of a competent person; (b) what silica is and where it is found; (c) silica hazards and exposures, occupational exposure limits, and regulations; (d) how to determine if silica is present through bulk sample analyses, safety data sheets, or material checklists; (e) exposure ranges for common construction tasks in the absence of controls and under conditions that can result in higher exposures, and recognition of situations when a qualified person needs to be called in; (f) effective use of controls to reduce exposures and basic understanding of respiratory protection; (g) understanding of need for oversight and quality assurance, including review of exposure monitoring by a qualified person and communication to other employers on a multi-employer sight; (h) understanding of OSHA standard; and (i) understanding of authority, responsibilities and procedures (
Commenters further elaborated on training requirements and competencies for a silica competent person. ASSE requested that OSHA give clear guidance on what qualifies an individual to be designated a competent person, asserted that certification in safety or industrial hygiene should presume competency, recommended similar competency requirements as the AIHA White Paper, and suggested that OSHA include training competency requirements in a non-mandatory appendix. ASSE also noted that the asbestos standard, 29 CFR 1926.1101(o)(4), requires competent persons to complete an Environmental Protection Agency course, and although an equivalent course does not exist for crystalline silica, training to address competencies for a silica competent person could be added to a 30-hour course for construction (Document ID 4201, pp. 2-6).
As discussed in detail in the summary and explanation of
LHSFNA indicated that competent person training should be tailored based on needs and exposure potential (Document ID 4207, p. 5). Other commenters provided numerous examples of unique training requirements for heavy equipment operators. For example, Gary Fore, retired Vice President for Health, Safety, and Environment for NAPA, referenced best practices for inspection of controls on asphalt milling machines by competent persons and testified that those machines are very complicated and sophisticated (Document ID 3583, Tr. 2182-2183). Therefore, training is required to detect issues requiring maintenance, such as a plugged or inappropriately placed nozzle (Document ID 2181, p. 10). IUOE commented that a competent person must have the knowledge to make informed judgments about the potential for silica exposures to exceed the action level (Document ID 2262, pp. 42-43). Martin Turek, Assistant Coordinator and Safety Administrator for IUOE Local 150, and Kyle Zimmer gave several examples of variables that could affect silica exposures in earth moving tasks, such as weather (
NRECA commented that a competent person for rural electric utilities should be trained in setting up air monitoring, setting boundaries for control zones, physical characteristics of crystalline silica, and PPE such as respirators (Document ID 2365, pp. 19-20). Francisco Trujillo testified that a competent person should have knowledge of work processes and their associated hazards and possibly, some knowledge of previous sampling evaluations to know if employees might be overexposed (Document ID 3585, Tr. 2980-2981). Upstate Medical University recommended that the competent person be trained on the respirable crystalline silica standard, the hierarchy of controls, exposure determinants, and the written control plan (Document ID 2244, p. 4).
Ameren Corporation opposed specific training requirements for a competent person (Document ID 2315, p. 2). CISC stated that if OSHA does include a competent person requirement in the
An individual's experience, job training, and silica awareness training, in the CISC's view, will provide the capabilities envisioned by OSHA for a competent person with respect to crystalline silica. For silica in construction, the CISC respectfully believes that no specific training for a “competent person” is required. Furthermore, the Agency has traditionally not included specific competent person training requirements in its construction standards, instead taking a performance-oriented approach to the requirements and definition. There is nothing unique about silica that would cause the Agency to deviate from this past approach (Document ID 2319, pp. 127-128).
OSHA concludes, after consideration of all the comments, that it is not practical to specify in the rule the elements and level of training required for a competent person. The Agency does not find it appropriate to mandate a “one size fits all” set of training requirements to establish the competency of competent persons in every conceivable construction setting. Therefore, the training requirement for a competent person is performance-oriented. This approach is consistent with most OSHA construction standards, such as cadmium (29 CFR 1926.1127) and lead (29 CFR 1926.62), which include a performance-based approach by not specifying training or qualifications required for a competent person.
It is evident from the comments that controlling respirable crystalline silica exposures involves tailoring controls and work practices to each particular work setting. Moreover, training is addressed by the HCS and paragraph (i) of the standard for construction. The HCS and paragraph (i) require that employees be trained on subjects that overlap with competencies listed in the AIHA White Paper. For example paragraph (h)(3)(i) of the HCS (29 CFR 1910.1200) requires training of covered employees on methods to detect the release of hazardous chemicals (in this case, respirable crystalline silica). The respirable crystalline silica standard for construction requires training on health hazards, tasks that could result in exposures, engineering and work practice controls and respiratory protection, and the contents of the standard (paragraphs (i)(2)(i)(A-D)).
OSHA concludes that successful completion of training requirements in the HCS and the standard for construction impart a high level of competency to employees. The training focuses on general requirements that apply to most construction settings and should be sufficient to provide an employee with the knowledge and ability to be designated a competent person at some companies. Competent persons might require more knowledge and training in certain circumstances, but that would vary widely among construction companies. For example, competent persons at a small residential construction company might only need training on controls for power tools that they do not typically use to perform their own tasks, so that they could assist employees with questions about or problems with dust controls on those tools. In contrast, a competent person for heavy equipment tasks may require more specialized training in heavy equipment inspection or identifying various soil types to estimate exposure potential. Because companies covered under the construction standard conduct a wide range of tasks involving unique scenarios, training requirements will vary widely among different companies. It is, therefore, the employer's responsibility to identify and provide any additional training that the competent person needs to implement the employer's written exposure control plan.
Finally, a compliance officer could ascertain whether the employer is in compliance with the competent person requirement by asking questions to assess whether the competent person has adequate knowledge to perform his or her duties, such as an understanding of engineering controls and how to recognize if they are not functioning properly. As is the case with training of all employees, the employer is responsible for determining that a competent person is adequately trained and knowledgeable to perform his or her duties.
OSHA is not requiring a competent person for the general industry and maritime standard. OSHA has determined that in most cases, general industry scenarios are not as variable as those in construction. For example, most work is performed indoors and therefore, not subject to variables such as wind shifts and moving exposure sources that could significantly affect exposures or complicate establishment of regulated areas. In general industry and maritime, controls are not usually built into tools that require action by the individual employees who use them to function effectively. The exposure assessments that employers in general industry and maritime are required to conduct will verify that controls are functioning effectively. Employers covered under the general industry and maritime standard are more likely to have health and safety professionals on staff who could assist with implementation of the standard. Finally, competent persons have not been included in other OSHA substance-specific standards for general industry. For example, a competent person requirement was included in the construction standard for cadmium because of environmental variability and the presence of multiple employers on the job site, but a competent person requirement was not included in the general industry standard for cadmium (29 CFR 1910.1027; 29 CFR 1926.1127; 57 FR 42101, 42382 (9/14/1992)). Moreover, as explained in the summary and explanation of
The requirements of the rule for respirable crystalline silica better protect employees and, therefore, better effectuate the purposes of the OSH Act of 1970 than the ASTM standards. Because the written plans are required for all workplaces covered by the rule, they help to maintain comprehensive and consistent controls, which can prevent overexposures from occurring. The provision for annual review ensures that the plans remain effective, and the provision for making the plans available to employees helps to make employees aware of the protections they should expect. More details about how the requirements of the rule better effectuate the requirements of the OSH Act are discussed above.
Paragraph (i) of the standard for general industry and maritime (paragraph (h) of the standard for construction) sets forth requirements for the medical surveillance provisions. The paragraph specifies which employees must be offered medical surveillance, as well as the frequency and content of medical examinations. It also sets forth the information that the physician or other licensed health care professional (PLHCP) is to provide to the employee and employer.
The purpose of medical surveillance for respirable crystalline silica is, where reasonably possible, (1) to identify respirable crystalline silica-related adverse health effects so that appropriate intervention measures can be taken; (2) to determine if an employee can be exposed to respirable crystalline silica in his or her workplace without increased risk of experiencing adverse health effects, or in other words, to determine if an employee has any condition, regardless of the cause, that might make him or her more sensitive to respirable crystalline silica exposure; and (3) to determine the employee's fitness to use respirators. The inclusion of medical surveillance in this rule is consistent with Section 6(b)(7) of the Occupational Safety and Health (OSH) Act (29 U.S.C. 655(b)(7)) which requires that, where appropriate, medical surveillance programs be included in OSHA standards to determine whether the health of employees is adversely affected by exposure to the hazard addressed by the standard. Almost all other OSHA health standards have also included medical surveillance requirements and OSHA finds that a medical surveillance requirement is appropriate for the respirable crystalline silica rule because of the health risks resulting from exposure.
Some employers and industry representatives questioned the general need for medical surveillance or expressed their concerns with the medical surveillance requirement. For example, OSCO Industries, Inc. argued that medical surveillance would not identify many employees with silicosis and OSCO Industries and National Association of Home Builders (NAHB) emphasized the progress that has already been made in eliminating silicosis (Document ID 1992, p. 11; 2296, p. 43). Fann Contracting, Inc. stated that medical surveillance is not needed because employees exposed above the permissible exposure limit (PEL) are required to wear respirators and they should therefore be protected (Document ID 2116, Attachment 1, p. 43).
OSHA does not find these comments persuasive. As discussed in Section VI, Final Quantitative Risk Assessment and Significance of Risk, OSHA has found that employees exposed to respirable crystalline silica at the preceding PELs are at significant risk of material impairment of health. Although the revised PEL of 50 μg/m
Even employees required to wear respiratory protection in high exposure environments are at risk of developing disease. As OSHA notes in the summary and explanation of
Employers also expressed concern about responsibility for exposures occurring through other employment or non-occupational sources (
OSHA stresses that the main purposes of medical surveillance are early detection of disease related to respirable crystalline silica exposure so appropriate intervention methods can be taken, to let employees know if they have a condition that might make them more sensitive to respirable crystalline silica exposure, and to assess fitness to wear a respirator. The purpose of medical surveillance is not to identify which employer is responsible for illnesses resulting from respirable crystalline silica exposures or must offer financial compensation. OSHA agrees with the Building Construction and Trades Department, AFL-CIO (BCTD), which stated that “[e]arly detection of silica-related medical conditions will enable employees to make informed decisions about their work, their medical care and their lifestyles” (Document ID 4223, p. 123). For example, as the American College of Occupational and Environmental Medicine (ACOEM) and the National Institute for Occupational Safety and Health (NIOSH) stated, an early diagnosis allows an employee to consider employment choices that minimize or eliminate respirable crystalline silica exposure to decrease the risk of progression or exacerbation of disease (Document ID 1505, p. 3; 3579, Tr. 257). In another example, an early diagnosis of silicosis allowed bricklayer Dennis Cahill, representing the International Union of Bricklayers and Allied Craftworkers (BAC), to manage his health by getting flu and pneumonia shots, avoiding the public during cold season, and staying indoors during periods of high air pollution (Document ID 3585, Tr. 3089, 3104). OSHA finds that although medical surveillance does not reduce exposures, like engineering controls do, it is nonetheless an integral component of this (and most) occupational safety and health standards and important in its own right for safeguarding the health of employees exposed to respirable crystalline silica.
OSHA also agrees with the viewpoint expressed so well by Mr. Cahill, that employees who are knowledgeable about their health risks will take actions in response to information from medical surveillance. Such actions will likely benefit not only the employees but also employers because their employees are likely to be healthier. Members of the medical community, labor unions, employee health advocate groups, and industry groups emphasized the value of early detection for intervention purposes (
Some commenters representing the construction industry questioned the practicality of medical surveillance for construction employees due to a number of particular difficulties, such as the short-term nature and high turnover rate of construction jobs (
After considering these comments, OSHA concludes that the necessity for medical surveillance is not negated by the practical challenges of tracking medical surveillance in a mobile work force. OSHA has included medical surveillance in other health standards where construction has been a primary industry impacted by those rules (
In the proposed standards, OSHA specified that employers must “make medical surveillance available” to those employees who would be occupationally exposed to respirable crystalline silica above the PEL for 30 or more days a year. The Agency received a variety of comments on this provision. First, NAHB expressed concern about employees refusing to participate in medical surveillance (Document ID 2296, p. 32). OSHA emphasizes that the mandate to offer medical surveillance to eligible employees does not include a requirement for employee participation, and no liability for non-participation arises so long as the employer does not discourage such participation.
Second, OSHA received numerous comments related to the proposed triggers for determining which employees should be provided medical surveillance. Some commenters focused on the level of exposure at which medical surveillance should be triggered. For example, Ameren Corporation agreed with the proposed PEL trigger, noting that it is consistent with the asbestos standard (Document ID 2315, p. 9). Some stakeholders from industry, the medical community, and employee health advocate groups also supported a trigger based on a PEL (
Other commenters advocated that medical surveillance should be triggered on an action level. However, these stakeholders disagreed on what the action level should be. For example, some commenters, like the National Industrial Sand Association (NISA), American Petroleum Institute, and other employers and industry groups, advocated an action level trigger of 50 μg/m
Other stakeholders, including representatives of labor unions, the medical community, and other employee health advocate groups, stated that the proposed action level of 25μg/m
American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) supported an action level trigger of 25 μg/m
OSHA also received comments on whether medical surveillance should be triggered by a number of days of exposure at a certain level. For example, NISA objected to the proposed 30-day exposure-duration trigger for medical surveillance and stated that it should be offered to all employees with likely exposure to respirable crystalline silica above the action level (Document ID 4208, p. 8, Fn 12). The Asphalt Roofing Manufacturers Association (ARMA) supported the 30-day exposure-duration trigger for medical surveillance because some employees are only infrequently exposed above the PEL as a result of scheduled maintenance tasks performed once or twice per year or when filling in for other employees, and the 30-day trigger would exclude employees with lower average exposures (Document ID 2291, p. 26). Other commenters representing industry or the medical community also agreed with the 30-day exposure-duration trigger (
OSHA agrees with the majority of commenters who indicated that maintaining the 30-day exposure-duration trigger is appropriate for general industry and maritime because the health effects of respirable crystalline silica occur as a result of repeated exposures and concludes that a 30-day trigger is a reasonable benchmark for capturing cumulative effects caused by repeated exposures. Including a 30-day exposure-duration trigger also maintains consistency with other OSHA standards, such as chromium (VI) (29 CFR 1910.1026), cadmium (29 CFR 1910.1027), lead (29 CFR 1910.1025), and asbestos (29 CFR 1910.1001). OSHA also agrees with commenters who indicated that triggering medical surveillance at the action level of 25 μg/m
OSHA intends to conduct a retrospective review five years after the action level trigger is fully implemented (
Construction industry representatives, employee health advocates, and others also commented on OSHA's proposed use of the PEL to trigger medical surveillance in the standard for construction. The Center for Progressive Reform (CPR) and Charles Gordon, a retired occupational safety and health attorney, advocated an action level trigger for medical surveillance; Mr. Gordon also requested that conducting Table 1 activities trigger medical surveillance (Document ID 2351, p. 13; 4236, pp. 3-4). Fann Contracting supported a PEL trigger for medical surveillance (Document ID 2116, Attachment 1, p. 42). BAC and BCTD supported the PEL (as determined by monitoring) or Table 1 tasks requiring respirator use as triggers for medical surveillance in construction because employees using Table 1 would not be required to conduct exposure assessments and therefore would not know if exposures exceed the action level (Document ID 4219, p. 29; 4223, p. 124). [Note 1 for proposed Table 1 indicated that required respirator use in Table 1 presumed exposures exceeding the PEL (78 FR 56273, 56499 (9/12/13))]. In prehearing comments, LHSFNA supported a PEL trigger as a practical approach and requested that medical surveillance be triggered by tasks (Document ID 2253, p. 5). In its post-hearing comments, however, LHSFNA recommended that medical surveillance be required for employees who are required to wear a respirator since those employees would already need to undergo a medical evaluation to make sure they can safely wear a respirator (as required by the respiratory protection standard) (Document ID 4207, pp. 4-5).
After reviewing these comments, OSHA concludes that an action level trigger is not practical in the construction industry because many employers will be using Table 1, and, therefore, will not have an exposure assessment indicating if the action level is met or exceeded. OSHA acknowledges that some construction employees who are not required to use respirators for 30 or more days per year are at significant risk, but has decided that triggering medical surveillance based on respirator use is the most practical trigger for the construction standard. Triggering medical surveillance in this manner is consistent with the proposed rule, because respirator use under Table 1 is based on tasks in which exposures consistently (more often than not) exceed the revised PEL, as found in OSHA's technological feasibility analyses of the various tasks included in Table 1 (
Some commenters expressed concerns about the practicality of requiring employers to offer medical surveillance for exposures exceeding a trigger level for 30 days or more in the construction industry. George Kennedy, Vice President of Safety for the National Utility Contractors Association, testified that they do not know what employees are doing in the field each day and so will have to assume that they are exposed and, therefore, offer medical surveillance to every employee (Document ID 3583, Tr. 2245). BCTD questioned the feasibility of the 30-day exposure-duration trigger because the transient nature of construction work makes it difficult to predict if an employee will be exposed for 30 days; the American Industrial Hygiene Association (AIHA), AFL-CIO, and LHSFNA expressed similar views (Document ID 2169, p. 6; 4204, p. 81; 4207, p. 4; 4223, p. 125). CISC and some of its member companies questioned how an employer would know if employees were exposed above the PEL for 30 or more days a year unless they were following Table 1 or conducting near continuous monitoring (Document ID 2269, pp. 6-7; 2289, p. 8; 2319, p. 116). CISC and AIHA questioned how OSHA could verify the number of days an employee was exposed (Document ID 2169, p. 6; 2319, p. 116). Larger employers, such as Fann Contracting, expressed the challenges of tracking employee exposures due to large numbers of employees and various ongoing projects (
OSHA acknowledges that tracking exposures in construction can be challenging but observes that some employers are currently able to track employee exposures to determine which employees should be offered medical surveillance. For example, Kevin Turner, Director of Safety at Hunt Construction Group and representing CISC, testified that safety representatives on job sites keep track of exposures based on employees' schedules, and the company provides medical surveillance for employees exposed above the preceding construction PEL for 30 or more days a year (Document ID 3580, Tr. 1535-1536). Francisco Trujillo, Safety Director at Miller and Long, Inc., testified that at his company, they conduct hazard assessments based mainly on the tasks the employees will be performing, to determine which employees are likely to be exposed above the preceding PEL, and they offer those employees medical evaluations as part of the company's respiratory protection program. The company has a system that monitors participating employees' training, medical evaluations, and fit tests. The system sends email reminders to company
After reviewing the comments and testimony submitted on the proposed construction trigger, OSHA concludes that the special circumstances in construction, such as lack of exposure data for employees using Table 1 or difficulties in tracking exposures for numerous short-term assignments conducted at various sites, warrant a simpler approach for triggering medical surveillance. Therefore, OSHA revised paragraph (h)(1)(i) of the standard for construction to require that employers offer medical surveillance to employees who will be required to wear a respirator under this standard for 30 or more days a year to limit exposure to respirable crystalline silica. Under the standard for construction, employees must wear a respirator when required to do so under Table 1 (paragraph (c)) or when, pursuant to the performance option or the scheduled monitoring option set forth in paragraph (d)(2), their exposures exceed the PEL (paragraph (e)(1)(ii)). Respirator use under Table 1 is equivalent to the PEL because the tasks that require respirator use are those that, in its technological feasibility analysis of the construction industry, OSHA has determined result in exposures exceeding 50 μg/m
OSHA concludes that a trigger based on respirator use will greatly simplify determining which employees covered by the construction standard must be offered medical surveillance. Consistent with the approach described by Kevin Turner above, company personnel on site, such as supervisors, could easily record or estimate when employees perform, or will perform, tasks requiring respirator use. Such information could be conveyed to a company employee who tracks it. Despite testifying that he would have a hard time tracking a greater number of employees who may require medical surveillance if the PEL or action level in effect at that time were lowered, Francisco Trujillo, from Miller and Long, a company with approximately 1,500 field employees, indicated that his company has a system that monitors and sends emails when employees are due for another medical examination (Document ID 3585, Tr. 3008-3010). OSHA sees no reason why this system could not be applied to larger numbers of employees, and this shows that it is possible for large companies to track exposures for numerous employees. Tracking exposures or days of respirator use will likely be easier for smaller companies who have fewer employees to track; OSHA estimates from existing data that approximately 93 percent of construction companies covered by the respirable crystalline silica standard have fewer than 20 employees (
Fann Contracting asked how a trigger for medical surveillance would apply to employees, such as heavy machine operators, who may briefly use respirators, such as when outside a cab for 30 minutes (Document ID 2116, Attachment 1, p. 3). OSHA clarifies that if an employee is required to wear a respirator at any time during a given day, whether to comply with the specified exposure control methods in paragraph (c) or to limit exposure to the PEL under the construction standard for respirable crystalline silica, that day counts toward the 30-day threshold.
Commenters also questioned the appropriateness of a 30-day exposure-duration trigger for construction. For example, American Society of Safety Engineers (ASSE) voiced concerns about the standard not addressing temporary employees who are continually exposed from job to job but may never stay with an employer for a full 30 days (Document ID 2339, p. 5). Conversely, CISC questioned why OSHA diverged from the ASTM exposure-duration trigger of 120 days, which would reduce the need to make medical surveillance available for short-term employees, and stated that OSHA needed to explain how this would improve the health of employees (Document ID 2319, p. 118; 1504, pp. 4-5). Members of the ASTM committee that developed the ASTM E 2625-09 standard testified that a 120-day exposure-duration trigger was selected so that employers did not have to provide medical surveillance to transient employees and that even a trigger of less than 90 days was considered but would have resulted in too much pressure and cost for employers because of the transient nature of construction work (Document ID 3580, Tr. 1452-1453; 3585, Tr. 2919-2920).
OSHA understands that offering medical surveillance for a transient workforce may be challenging, especially for small companies. However, the requirement to offer periodic medical examinations every three years rather than annually will reduce the cost and burden of providing such examinations considerably (
Commenters also raised other issues regarding the 30-day exposure-duration trigger that could apply to both the general industry and maritime standard and the construction standard. One concern was that inclusion of a 30-day trigger would result in discriminatory actions by employers in order to avoid offering medical surveillance. For example, Dr. Daniel Anna, Vice President of AIHA, was concerned that employers might refuse to hire someone approaching 30 days of exposure (Document ID 3578, Tr. 1048-1049); BAC also expressed concerns about employers terminating employees approaching their 30th day of exposure (Document ID 4219, p. 29). In addition, BAC noted that employers rotating employees to maintain employee exposure below 30 days might result in more employees being exposed to silica (Document ID 2329, p. 8).
Comments indicating that an employer might refuse to hire employees approaching their 30th day of exposure are based on an interpretation that medical surveillance is triggered by a total of 30 days of exposure per year with any employer. Such an interpretation was conveyed by the Shipbuilders Council of America and ASSE who commented that employers would need to know employee exposures with past employers when determining total days of exposure above the PEL (Document ID 2255, p. 3; 3578, Tr. 1048). That is not OSHA's intent, and OSHA clarifies that exposures occurring with past employers do not count towards the 30-day-per-year exposure-duration trigger with the current employer (
Charles Gordon suggested that employers give each departing employee a card indicating the number of days they were exposed above the trigger point so that future employers would have a better idea if the employee was eligible for another medical examination based on 30 days of exposure (Document ID 4236, pp. 3-4). Such a record of past exposure with any prior employer is not necessary because of OSHA's decision to not consider exposures with past employers when triggering medical surveillance. Requiring employers to record exposures with past employers and to give employees a card indicating the number of days they were exposed above the trigger point increases recordkeeping and paperwork burdens for employers. It also imposes a burden on employees because it gives them an additional document that they need to maintain. To avoid these added burdens and for the reasons previously given for not counting exposures with other employers towards an employee's medical surveillance requirement, OSHA rejects Mr. Gordon's suggestion.
NIOSH and Fann Contracting questioned the 30-day-per-year exposure-duration trigger because employees who have been exposed to silica for years, but are not currently exposed 30 days per year, would be at risk of developing lung diseases (Document ID 2116, Attachment 1, p. 41; 2177, Attachment B, pp. 39-40). NIOSH recommended that medical surveillance continue after an employee is no longer exposed to respirable crystalline silica but continues to work for the same employer (Document ID 2177, Attachment B, p. 39). James Schultz, safety director at Navistar Waukesha Foundry and representing the Wisconsin Coalition for Occupational Safety and Health (WisCOSH), testified that medical surveillance should continue after employees have left “this type of work environment” (Document ID 3586, Tr. 3200-3201). However, NIOSH also stated that considerations for continued medical surveillance include the number of years an employee was required to be monitored and if the employee is showing signs of silica-related illness (Document ID 2177, Attachment B, p. 39).
OSHA agrees with NIOSH that silica is retained in the lungs and can cause progressive damage after exposures end. However, the lack of clear criteria in the record for determining when continued medical surveillance would be beneficial precludes OSHA from mandating continued medical surveillance after exposure ends. In addition, OSHA policy is clear that requirements are imposed on current employers. In the benzene standard, OSHA articulated that policy in deciding not to mandate continued medical surveillance for employees who are no longer exposed above the trigger, noting administrative difficulties in keeping track of employees who had moved on to other jobs (52 FR 34460, 34550 (9/11/1987)).
CISC, American Subcontractors Association, OSCO Industries, and Holes Incorporated questioned why medical surveillance is needed for younger employees when respirable crystalline silica-related diseases take years to develop (Document ID 1992, p. 11; 2187, p. 7; 2319, pp. 116-117; 3580, Tr. 1471). CISC recommended that OSHA trigger medical surveillance after a minimum duration of exposure or when a silica-related disease is diagnosed. In contrast, Andrew O'Brien, Vice President of Safety and Health at Unimin Corporation and representing NISA, emphasized the importance of establishing a baseline for future measurement (Document ID 3577, Tr. 570). When asked if age or duration of exposures should be considered in determining frequency of medical surveillance, Dr. Laura Welch, occupational physician with BCTD, responded:
When a BAC panel was asked if 20 years after first exposure is the appropriate time to start medical surveillance, terrazzo worker Sean Barret responded:
According to their 20-year standard, you wouldn't even find out I was sick until next year. I was sick a year ago, and it probably showed five years before that. So, I mean, that's ludicrous (Document ID 3585, Tr. 3055).
OSHA agrees that employees' baseline findings are important for future diagnoses and notes Dr. Welch's testimony that other silica-related diseases, such as chronic obstructive pulmonary disease (COPD), develop in shorter times than silicosis. Based on such evidence, OSHA concludes that it is appropriate to start medical surveillance in young or newly exposed
Paragraph (i)(1)(ii) of the standard for general industry and maritime (paragraph (h)(1)(ii) of the standard for construction) requires that the medical examinations made available under the rule be performed by a PLHCP, who is defined (
The American Public Health Association (APHA) requested changes to the definition of PLHCP that would require the PLHCP to be licensed for independent practice (Document ID 2178, Attachment 1, p. 5). OSHA finds that requested change to be too restrictive. To assure competency while providing for increased flexibility, OSHA continues to find it appropriate to allow any professional to perform medical examinations and procedures made available under the standard when he or she is licensed by state law to do so. In this respect, which and how a health care professional can function as a PLHCP under the rule may vary from state to state depending on each state's licensing requirements and laws governing what diagnostic examinations and procedures they are permitted to perform. In no case, however, is the authorization in this rule to use any PLHCP narrower or stricter than what is authorized in the particular state where an examination occurs.
Some commenters expressed concern about the availability of PLHCPs or other medical professionals in certain geographical locations. For example, Fann Contracting and the National Rural Electric Cooperative Association commented that PLHCPs who can offer the required examinations or occupational health resources may not be available for employers located in rural areas or near retirement communities (Document ID 2116, Attachment 1, p. 43; 2365, p. 10). Under the rule, a PLHCP, as defined, does not have to be an occupational medicine physician or even a physician to conduct the initial and periodic examinations required by the rule, but can be any health care professional who is state-licensed to provide or be delegated the responsibility to provide those services. The procedures required for initial and periodic medical examinations are commonly conducted in the general population (
Newmont Mining Corporation, Nevada Mining Association, and Distribution Contractors Association (DCA) questioned whether recent or future exposures should be considered in triggering certain aspects of the initial examination (
In the preamble of the Notice of Proposed Rulemaking (NPRM), OSHA indicated that where an examination that complies with the requirements of the standard has been provided in the past three years, an additional initial examination would not be needed (78 FR at 56468). Ameren agreed with OSHA's preliminary determination on this issue and asked the Agency to verify that examinations conducted in the last three years could be supplemented with any additional requirements of the rule, such as tuberculosis testing (Document ID 2315, p. 4). OSHA agrees that this is a reasonable approach. For example, if an employee received an examination that met all the requirements of the initial medical examination, with the exception of a tuberculosis test, within the last three years, the employer could supplement that examination by offering only the tuberculosis test. That same employer or a future employer could then offer a periodic medical examination, which does not require a tuberculosis test, three years from the last medical examination. New hires, who received medical surveillance that met the requirements of the respirable crystalline silica rule from a past employer, should have a copy of the PLHCP's written medical opinion for the employer, which the employer must ensure that the employee receives
Commenting on the three year period in which the result of a prior examination can substitute for a new initial (baseline) examination, APHA, Collegium Ramazzini, and the American Federation of State, County and Municipal Employees (AFSCME) opined that three years between examinations is an excessive time period because it does not provide for an adequate baseline; Collegium Ramazzini further commented that medical findings and medical or work histories can change in three years and that spirometry performed at other locations does not provide an adequate baseline (Document ID 2178, Attachment 1, p. 4; 3541, pp. 4-5; 4203, p. 6). Dr. Celeste Monforton, from George Washington University School of Public Health, agreed with APHA (Document ID 3577, Tr. 846). OSHA disagrees. The three-year interval is consistent with the frequency of periodic examinations, and the reasons for this interval, such as the typical slow progression of respirable crystalline silica-related diseases, are discussed below.
The American Foundry Society (AFS) supported the 30-day period for offering medical surveillance, stating that it addressed the turnover rates in its industry because employees who work 30 days are likely to continue their employment (Document ID 2379, Appendix 1, p. 71). AESC requested that OSHA allow medical examinations to be provided within 90 days of assignment to address the turnover rate in its industry (Document ID 2344, p. 2). The National Stone, Sand and Gravel Association (NSSGA) noted difficulties in scheduling medical examinations within 30 days in remote locations because testing vans that offer medical examinations might not be available within that time period (Document ID 3583, Tr. 2316-2317). Because a 30-day period for offering medical examinations is reasonable for AFS, which represents an industry with high turnover rates, OSHA concludes that a 30-day period should be reasonable in most general industry settings. OSHA does not agree with AESC that the period to offer medical surveillance should be extended to 90 days in the standard for general industry and maritime. That longer time period to offer medical surveillance would exclude and leave unprotected many employees who may be exposed to significant amounts of silica while working short-term assignments, for periods up to 90 days, for numerous companies within the same industry.
Representatives from the construction industry also commented on the 30-day period to offer medical surveillance. BAC and BCTD recommended that medical examinations be made available as soon as practicable, instead of within 30 days after assignment, in the construction industry because it would be difficult for employers to predict if an employee would be exposed for 30 days or more during the upcoming year, and it could encourage employers to terminate employees before the 30-day period ends (Document ID 4219, p. 29; 4223, p. 125). Fann Contracting suggested that a better trigger would be after the employee has been exposed for 30 days instead of within the first 30 days of assignment (Document ID 2116, Attachment 1, p. 43).
OSHA rejects this reasoning, and is maintaining the requirement to offer medical surveillance within 30 days of assignment for the construction standard. The requirement better assures that medical examinations will be offered within a reasonable time period than allowing the employer to offer them “as soon as practicable.” As noted above, employers can determine who will be eligible for medical surveillance based on required respirator use under Table 1 or similar task-based approaches. Even at the time of initial assignment, OSHA expects that employers will know the tasks that the employee will be performing, and in the case of short-term employees, the approximate duration the employee will be with the company. In addition, terminating employees to avoid offering medical surveillance would not be cost effective because the employer would incur more costs from constantly having to train new employees.
The Precast/Prestressed Concrete Institute commented that local union halls from which they hire employees and the Americans with Disability Act may prohibit pre-hire medical testing (Document ID 2276, p. 10). National Electrical Contractors Association expressed concern about economic burdens associated with pre- and post-employment medical evaluations in transient or temporary employees (Document ID 2295, p. 2). OSHA clarifies that no pre-hire or post-employment testing is required in the respirable crystalline silica rule, which requires that medical examinations related to respirable crystalline silica exposure be offered within 30 days after initial assignment to employees who will meet the trigger for medical surveillance.
OSHA received a range of comments related to the contents of the initial examination. Some stakeholders, including NIOSH and commenters representing the medical community, labor unions, and industry, supported the contents of medical surveillance that OSHA proposed, though some wanted to expand the contents, as addressed below (
However, not all stakeholders agreed that the list of proposed initial examination contents was appropriate. For example, Fann Contracting favored
OSHA finds that X-rays alone are not sufficient because, as explained in more detail below, some employees may have symptoms or abnormal lung function that are not detected by X-ray but may become evident by other tests, such as spirometry. The Agency also finds that the evaluations offered under the respiratory protection standard are insufficient because the information gathered under that standard is limited and may not involve examinations, while the respirable crystalline silica rule requires examinations that include objective measures, such as physical examinations, spirometry testing and X-rays, that may detect early disease in asymptomatic employees. In addition, OSHA does not agree that all required tests should be left to the discretion of the PLHCP because the Agency has determined that employees who must be offered medical surveillance are at risk of developing respirable crystalline silica-related diseases, and the required tests are the minimum tests needed to screen for those diseases. Therefore, OSHA concludes that limiting medical surveillance to only X-rays, the evaluations performed under the respiratory protection standard, or only tests selected by the PLHCP is not sufficiently protective.
The first item required as part of the initial medical examination is a medical and work history, with emphasis on: Past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and symptoms of respiratory disease (
Because symptoms may be the earliest sign of disease and to allow for consistent and comprehensive data collection, Collegium Ramazzini recommended that an appendix with a standardized questionnaire be included; it also recommended that the questionnaire address non-respiratory effects, such as renal disease and connective tissue disorders (Document ID 3541, pp. 3, 6). While not going as far as this recommendation, OSHA includes in the rule an appendix for medical surveillance (Appendix B), which gives PLHCPs detailed information on what is to be collected as part of the medical history. The appendix recommends collecting information on renal disease and connective tissue disorders. OSHA intends for this approach to allow PLHCPs to easily standardize their method for gathering information for work and medical histories related to respirable crystalline silica exposure.
Newmont Mining and Nevada Mining Association objected to a requirement for a medical and work history, asserting that a personal medical history is not related to silica exposure (Document ID 1963, p. 2; 2107, p. 3). Commenters, including DCA and International Brotherhood of Teamsters, objected to employees revealing medical and work history information not related to respirable crystalline silica exposure because of privacy concerns (
As discussed below, OSHA is addressing employee privacy issues by reducing the information to be included in the PLHCP's written medical opinion for the employer without the employee's permission (paragraphs (i)(6)(i)(A)-(C) of the standard for general industry and maritime and paragraphs (h)(6)(i)(A)-(C) of the standard for construction); under those paragraphs, the only medically related information that is to be reported to the employer without authorization from the employee is limitations on respirator use. Personal habits, such as smoking, are not included in the medical opinion for the employer. Therefore, employees' privacy will not be compromised as a result of the information collected as part of the exposure and medical history.
The second item required as part of the initial medical examination is a physical examination that focuses on the respiratory system (paragraph (i)(2)(ii) of the standard for general industry and maritime, paragraph (h)(2)(ii) of the standard for construction), which is known to be susceptible to respirable crystalline silica toxicity. OSHA finds that aspects of the physical examination, such as visual inspection, palpation, tapping, and listening with a stethoscope, allow the PLHCP to detect abnormalities in chest shape or lung sounds that are associated with compromised lung function (Document ID 1514, p. 74; 1517, pp. 26-27). Dr. Michael Fischman, occupational and environmental physician/toxicologist and professor at the University of California, representing ACOEM, strongly endorsed a physical examination and noted that another valuable aspect is that it allows the employee to have a face-to-face interaction with the clinician to talk about symptoms or other concerns (Document ID 3577, Tr. 767). OSHA agrees and concludes that the physical examination is necessary.
The third item required as part of the initial medical examination is a chest X-ray, specifically a single posteroanterior radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems, interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader (paragraph (i)(2)(iii) of the standard for general industry and maritime, paragraph (h)(2)(iii) of the standard for construction). The proposed rule
Medical experts including ACOEM, the American Thoracic Society (ATS), and NIOSH recommend X-rays as part of medical examinations for employees exposed to respirable crystalline silica (
As noted above, OSHA proposed that the required chest X-ray be interpreted and classified according to ILO International Classification of Radiographs of Pneumoconiosis by a NIOSH-certified B Reader. The ILO system was designed to assess X-ray and digital radiographic image quality and to describe radiographic findings of pneumoconiosis in a simple and reproducible way by comparing an employee's X-ray to a standard X-ray to score opacities according to shape, size, location, and profusion (Document ID 1475, p. 1; 1511, pp. 64-68; 1514, pp. 77-78). A NIOSH-certified B Reader is a physician who has demonstrated competency in the ILO classification system by passing proficiency and periodic recertification examinations (Document ID 1498, p. 1). The NIOSH certification procedures were designed to improve the proficiency of X-ray and digital radiographic image readers and minimize variability of readings.
In 2011, the ILO made standard digital radiographic images available and published guidelines on the interpretation and classification of digital radiographic images (Document ID 1475). The guidelines included requirements for display monitors. NIOSH also published guidelines for conducting digital radiography and displaying digital radiographic images in a manner that will allow for classification according to ILO guidelines (Document ID 1513). Based on these developments, OSHA stated in the preamble of the NPRM that digital X-rays could now be evaluated according to the same guidelines as film X-rays and could therefore be considered equivalent diagnostic tests. The Agency also noted several advantages of digital X-rays: Compared to film X-rays, digital imaging systems offer more consistent image quality, faster results, increased ability to share images with multiple readers, simplified storage of images, and reduced risk for technicians and the environment due to the elimination of chemicals for developing film (Document ID 1495, p. 2).
Commenters, such as Collegium Ramazzini, NIOSH, and the Dow Chemical Company, agreed with OSHA that digital radiographic images are equivalent to conventional X-rays; NIOSH and Dow Chemical suggested OSHA clarify that the proposed requirement for chest X-rays may be satisfied either with conventional film-based technology or with digital technology; and NIOSH and Collegium Ramazzini referred OSHA to an interim final regulation for coal miners that allows for digital technology (Document ID 2177, Attachment B, pp. 40-41; 2270, p. 13; 3541, p. 7). After reviewing the record evidence on this issue, OSHA reaffirms its preliminary conclusion that X-rays recorded on digital radiography systems are equivalent to those recorded on film. Therefore, OSHA has revised paragraph (i)(2)(iii) of the standard for general industry and maritime (paragraph (h)(2)(iii) of the standard for construction) to indicate that X-rays can be recorded on either film or digital systems, using language that is consistent with that in the interim final regulation for coal miners (42 CFR part 37.2 (10-1-13 Edition)).
NSSGA commented that good quality digital images reproduced on film should also be considered acceptable as equivalent to X-rays (Document ID 2327, Attachment 1, p. 23). OSHA disagrees. The Agency does not recommend classification using hard copies printed from digital images because a 2009 study by Franzblau
As indicated above, the proposed rule called for the chest X-ray to be interpreted and classified by a NIOSH-certified B reader. A number of commenters offered opinions on this requirement. For example, Dow Chemical urged OSHA to allow board certified radiologists to interpret the X-rays because it claimed that insufficient numbers of B Readers would lead to a backlog of X-ray interpretation that would make it impossible for B Readers to get their reports back to PLHCPs within the required 30 days (Document ID 2270, p. 9). Other representatives from industry, such as the Mason Contractors Association of America, ARMA, and the North American Insulation Manufacturers Association, expressed similar concerns about numbers of B Readers (
The rulemaking record contains ample evidence of sufficient numbers of B Readers and the value of B Reader interpretation according to ILO methods. CISC and NIOSH estimated demands on B Readers based on OSHA's estimate in the preamble of the NPRM that 454,000 medical examinations would be required in the first year after the rule is promulgated (78 FR at 56468). Based on the 242 B Readers accounted for as of February 12, 2013 (78 FR at 56470), CISC estimated 1,876 chest X-rays for each B Reader, requiring each B Reader to interpret more than five chest X-rays per day, which CISC claimed would result in a backlog (Document ID 2319, p. 118). However, Dr. David Weissman, Director of NIOSH's Division of Respiratory Disease Studies, indicated that a B Reader can easily classify 10 images in an hour (Document ID 3579, Tr. 196, Attachment 2, p. 1). NIOSH estimated that a B Reader working 1 hour per day, 5 days per week, 50 weeks per year can classify 2,500 images and that 182 B Readers working a minimum of 1 hour per day and 50 weeks per year would be needed to classify X-rays for 454,000 employees (Document ID 4233, Attachment 1, p. 40). As of May 19, 2014, there were 221 certified B Readers in the United States, an adequate number to meet the demands for the respirable crystalline silica rule (Document ID 3998, Attachment 15, p.
Dr. Weissman testified that the number of B Readers is driven by supply and demand created by a free market and that many physicians choose to become B Readers based on demands for such services (Document ID 3579, Tr. 197-198, Attachment 2, p. 1). He went on to state that NIOSH provides several pathways for physicians to become B Readers, such as free self-study materials by mail or download and free B Reader examinations. In addition, courses and examinations for certification are offered for a fee every three years through the American College of Radiology. Dr. Robert Cohen, pulmonary physician and clinical professor at the University of Illinois, representing ATS, agreed that NIOSH is able to train enough B Readers to handle any potential increase in demand (Document ID 3577, Tr. 777). Moreover, even if B Readers are scarce in certain geographical locations, digital X-rays can easily be transmitted electronically to B Readers located anywhere in the U.S. (Document ID 2116, Attachment 1, p. 43; 3580, Tr. 1471-1472; 3585, Tr. 2887; 2270, p. 13; 2195, p. 44; 3577, Tr. 817-818). Based on this information, OSHA concludes that numbers of B Readers in the U.S. are adequate to interpret X-rays conducted as part of the respirable crystalline silica rule.
Some commenters questioned the value of requiring B Readers. Dow Chemical claimed that board certified radiologists are able to provide interpretations of X-rays that are consistent with those of B Readers and that such an approach is consistent with that of the OSHA Asbestos standard (29 CFR 1910.1001, Appendix E) (Document ID 2270, pp. 9-10). Dow Chemical also stated that digital radiography has improved interpretation accuracy for radiologists who are not B Readers. American Road and Transportation Builders Association (ARTBA) commented that inadequate numbers of B Readers could result in misinterpretations of X-rays. It also cited a study by Gitlin
Based on record evidence, OSHA finds that the requirement for B Readers to demonstrate proficiency in ILO methods results in more consistent X-ray interpretation. For example, guidelines by the World Health Organization (WHO) acknowledge the value of consistent, high-quality X-rays for reducing interpretation variability and note that B Reader certification may also improve consistency of X-ray interpretation (Document ID 1517, p. 21). Robert Glenn, Certified Industrial Hygienist representing the Brick Industry Association and previously in charge of the B Reader program at NIOSH, said he thought the reduced variability (
The evidence discussed above supports OSHA's conclusions that adequate numbers of B Readers are available locally or by electronic means to interpret chest X-rays of respirable crystalline silica-exposed employees and that B Reader certification improves the quality of X-ray interpretation. OSHA concludes that standardized procedures for the evaluation of X-ray films and digital images by certified B Readers is warranted based on the seriousness of silicosis and is therefore retaining that requirement in the rule.
OSHA noted in the preamble for the NPRM that CT or HRCT scans could be considered “equivalent diagnostic studies.” CT and HRCT scans are superior to chest X-ray in the early detection of silicosis and the identification of progressive massive fibrosis. However, CT and HRCT scans have risks and disadvantages that include higher radiation doses and current unavailability of standardized methods for interpreting and reporting the results (78 FR at 56470). Because of these concerns, OSHA specifically sought comment on whether CT and HRCT scans should be considered equivalent diagnostic studies under the rule, and a number of stakeholders provided comments on this issue.
In its prehearing comments, ATS stated that despite the lack of standardized interpretation and reporting methods, CT or HRCT are reasonable “equivalent diagnostic studies” to standard chest X-rays because they are more sensitive than X-rays for early detection of diseases, such as silicosis and lung cancer; however, the group's representative, Dr. Robert Cohen, later testified that HRCT is not ready as a screening technique but is a useful diagnostic tool (Document ID 2175, p. 6; 3577, Tr. 825). USW noted that interpretation methods are being developed for the evaluation of pneumoconiosis by CT scan and suggested approaches for the use of low dose CT (LDCT) scans to evaluate silicosis and lung cancer in some employees (Document ID 4214, pp. 9-12).
Physicians, such as those representing ACOEM, Collegium Ramazzini, and NIOSH, did not consider CT or HRCT to be equivalent diagnostic studies because of the lack of a widely-accepted standardized system of interpretation, such as the ILO method (
NIOSH and Collegium Ramazzini also commented on the increased sensitivity of CT scans in detecting abnormalities that require follow-up, which they cited as another reason why CT scans should not be considered equivalent to X-rays (Document ID 2177, Attachment B, p. 40; 3541, p. 7). NIOSH said the abnormalities can suggest lung cancer, but most are found to be “false positives” (Document ID 2177, Attachment B, p. 40). Detection of abnormalities that might suggest cancer can lead to anxiety in patients; it can also lead to follow-up with more imaging tests that increase radiation exposures or invasive biopsy procedures
ACOEM, NIOSH, APHA, NSSGA, EEI, and AFL-CIO stated that CT scans are appropriate in some cases, such as a part of follow-up examinations or if recommended by the PLHCP (Document ID 2080, p. 8; 2177, Attachment B, pp. 40-41; 2178, Attachment 1, p. 6; 2327, Attachment 1, p. 26; 2357, pp. 34-35; 4204, p. 82). Dr. David Weissman and Dr. Rosemary Sokas, occupational physician from Georgetown University, representing APHA, indicated that if an employee happens to have had a CT scan that was conducted as part of a clinical workup or diagnosis, it should be accepted in place of X-rays (Document ID 3577, Tr. 792; 3579, Tr. 256).
After reviewing the record on this issue, OSHA has determined that CT or HRCT scans should not be considered “equivalent diagnostic studies” to conventional film or digital chest X-rays for screening of silicosis because of higher radiation exposures, lack of a standardized classification system for pneumoconiosis, increased false positive findings, higher costs, and limited availability in some areas. OSHA also agrees with commenters that CT scans may be useful for follow-up purposes, as determined on a case-by-case basis by the PLHCP. For example, the PLHCP could request a CT scan to diagnose possible abnormalities detected by X-ray or other testing done as part of surveillance, and the rule gives the PLHCP this option (paragraph (i)(2)(vi) of the standard for general industry and maritime, paragraph (h)(2)(vi) of the standard for construction). However OSHA does not agree that a CT scan conducted within the past three years can meet the requirement for an X-ray because the CT scan cannot be evaluated according to ILO methods.
OSHA also received comments on the use of CT scans to screen for lung cancer, and those comments are discussed below, as part of the Agency's discussion of additional tests that commenters proposed for inclusion in medical examinations.
In sum, unlike the proposed rule, paragraph (i)(2)(iii) of the standard for general industry and maritime (paragraph (h)(2)(iii) of the standard for construction) specifically allows for digital X-rays, but does not allow for an equivalent diagnostic study. The rule was revised to allow for digital radiography because OSHA determined that digital X-rays are equivalent to film X-rays. The rule was also revised to remove the allowance for equivalent diagnostic studies because OSHA determined that CT scans are not equivalent to X-rays for screening purposes and no other imaging tests are equivalent to film or digital X-rays interpreted by ILO methods at this time. The provision for X-rays does not contain any other substantive changes compared to the proposed provision.
The fourth item required as part of the initial medical examination is a pulmonary function test, including forced vital capacity (FVC), forced expiratory volume in one second (FEV
Some industry representatives, such as Fann Contracting and CISC, opposed the requirement for spirometry testing because reduced pulmonary function can be related to smoking or exposures other than respirable crystalline silica (Document ID 2116, Attachment 1, Page 39; 2319, pp. 118-119). CISC further commented that OSHA did not address statements in the ASTM standard about the non-specificity of lung function changes to respirable crystalline silica exposure, and a lack of evidence that routine spirometry is useful for detecting respirable crystalline silica-related diseases in early stages.
In contrast, commenters, such as Collegium Ramazzini and NIOSH, noted that spirometry is useful for detecting lung function changes associated with COPD, a disease outcome related to respirable crystalline silica exposure (Document ID 3541, p. 8; 3579, Tr. 255). ACOEM and Collegium Ramazzini explained that respirable crystalline silica exposures can result in lung function changes in the absence of radiological abnormalities, and spirometry is important for detecting those changes in the early stages of disease; ACOEM further commented that early detection of abnormal lung function is important to fully assess employees' health and apply protective intervention methods (Document ID 2080, p. 8; 3541, p. 8).
ASSE and some industry representatives, including Newmont Mining, NISA and AFS, also supported spirometry testing (
After reviewing the comments submitted, OSHA reaffirms that spirometry testing should be included in the rule. OSHA concludes that even though declines in lung function may not always be related to respirable crystalline silica exposure, the test results are nonetheless useful for detecting lung function abnormalities that can worsen with further exposure to respirable crystalline silica, providing a baseline of lung function status against which to assess any subsequent changes, and assessing the health of employees who wear respirators. The requirement for lung function testing is also consistent with other OSHA standards, such as asbestos (29 CFR 1910.1001) and cadmium (29 CFR 1910.1027). Thus, OSHA decided to retain the proposed requirement for a pulmonary function test in the rule.
OSHA proposed that spirometry be administered by a spirometry technician with current certification from a NIOSH-approved spirometry course. NIOSH recommended changing “current certification” to “a current certificate” to clarify that NIOSH does not certify individual technicians (Document ID 2177, Attachment B, p. 43). OSHA agrees with NIOSH that the change provides clarity, without modifying the original meaning of the provision, and thus made the change to the proposed provision.
Some stakeholders questioned whether a certificate from a NIOSH-approved course should be required. For
Dr. James Cone noted an example in which a NIOSH Health Hazard Evaluation at a foundry found that the company had recorded abnormal pulmonary function test results for 43 employees; however, spirometry testing later conducted by NIOSH found that only 9 of those same employees had abnormal pulmonary function results. Dr. Cone thought that the difference in findings most likely resulted from differences in equipment and test procedures used to motivate and elicit cooperation of employees during testing (Document ID 2157, pp. 4-5). He concluded:
The difference does suggest that proper equipment, certification and training of pulmonary technicians, and standardized reading of pulmonary function tests are important to maintain uniformity and comparability of such tests (Document ID 2157, p. 5).
Some commenters, including Collegium Ramazzini, suggested other ways that the rule for respirable crystalline silica could improve quality of spirometry results. It recommended that the rule specify spirometry conducted according to ATS/European Respiratory Society (ERS) or similar guidelines, that spirometers meet ATS/ERS recommendations, and that the third National Health and Nutrition Examination Survey (NHANES III) reference values be used for interpretation of results (Document ID 3541, pp. 8-10). Collegium Ramazzini emphasized that quality spirometry results depend on standardized equipment, test performance, and interpretation of results, including criteria, such as acceptability and reproducibility of results (Document ID 3541, p. 8). Labor unions, such as LHSFNA and BCTD, also supported more stringent spirometry requirements (Document ID 3589, Tr. 4205; 4223, pp. 129-130). ACOEM, NIOSH, and BCTD recommended that reference values or other spirometry guidelines be added to the appendix on medical surveillance (Document ID 2080, p. 9; 2177, Attachment B, pp. 45-46; 4223, pp. 128-129).
After considering the record to determine what the rule must include to improve spirometry quality, OSHA concludes that requiring technicians to have a current certificate from a NIOSH-approved spirometry course is essential for maintaining and improving spirometry quality. The purpose of requiring spirometry technicians to have a current certificate from a NIOSH-approved spirometry course is to improve their proficiency in generating quality results that are interpreted in a standardized way. OSHA included the certification requirement in the proposed rule because spirometry must be conducted according to strict standards for quality control and results must be consistently interpreted. The NIOSH-approved spirometry training is based upon procedures and interpretation standards developed by the ATS/ERS and addresses factors, such as instrument calibration, testing performance, data quality, and interpretation of results (Document ID 3625, pp. 2-3).
NIOSH approves a spirometry training course if it meets the minimum OSHA/NIOSH criteria for performance of spirometry testing in the cotton textile industry. Since these course criteria are based on recommendations from ATS/ERS, they are applicable to spirometry testing in all industries. The curriculum of NIOSH-approved courses encompasses ATS/ERS recommendations on instrument accuracy (
In considering the alternative suggestions, OSHA concludes that requiring a current certificate from a NIOSH-approved course is a better approach than mandating requirements for equipment, testing procedures, reference values, and interpretation of results, which could become outdated. OSHA fully expects that the NIOSH-approved initial and periodic refresher courses required to maintain a current certificate under this rule will ensure that technicians keep up-to-date on the most recent ATS/ERS recommendations on spirometry equipment and procedures as technology and methods evolve over time.
In addition, OSHA agrees with commenters that the NHANES III reference values should be used to interpret spirometry results because they are the most widely endorsed for use in the U.S. (Document ID 3630, p. 28-29). In cross-sectional testing to evaluate lung function at a single point in time, spirometry results are compared to reference values (
OSHA received one comment regarding the practicality of requiring a current certificate from a NIOSH-approved course. Dow Chemical claimed that availability of NIOSH-approved courses may be limited
The fifth item required as part of the initial medical examination is a test for latent tuberculosis infection (paragraph (i)(2)(v) of the standard for general industry and maritime, paragraph (h)(2)(v) of the standard for construction). This provision is unchanged from the proposed rule. “Latent” refers to a stage of infection that does not result in symptoms or possible transmission of the disease to others. OSHA proposed the inclusion of a test for latent tuberculosis infection because exposure to respirable crystalline silica increases the risk of a latent tuberculosis infection becoming active (
OSHA sought comment on its preliminary determination that all employees receiving an initial medical examination should be tested for latent tuberculosis infection. A number of stakeholders, including Dr. James Cone, ATS, NIOSH, APHA, NISA, NSSGA, ASSE, BCTD, and ACOEM agreed with OSHA's preliminary conclusion that testing for latent tuberculosis infection should be part of the initial examination (
After reviewing the comments on this issue, OSHA affirms its conclusion that testing for latent tuberculosis infections is a necessary and important part of the initial examination. As noted above, evidence demonstrates that exposure to respirable crystalline silica increases the risk for developing active pulmonary tuberculosis infection in individuals with latent tuberculosis infection, independent of the presence of silicosis (Document ID 0360; 0465; 0992, pp. 1461-1462). Active tuberculosis cases are prevented by identifying and treating those with latent tuberculosis infections. Therefore, OSHA concludes it is appropriate to test for latent tuberculosis infection in all employees who will be exposed to respirable crystalline silica and are eligible for medical surveillance, for their protection and to prevent transmission of an active, potentially fatal infection to their coworkers. Any concerns about a lack of good methods for calculating benefits associated with latent tuberculosis infection testing do not negate the scientific evidence demonstrating that exposure to respirable crystalline silica increases the risk of a latent infection becoming active.
Newmont Mining, Nevada Mining Association, and Fann Contracting did not support testing for latent tuberculosis infection because employees with the infection may not have contracted it in an occupational setting (Document ID 1963, p. 2; 2107, p. 3; 2116, Attachment 1, p. 38). While that may be true, testing for latent tuberculosis infection provides another example and support for two of the main objectives of medical surveillance: (1) To identify conditions that might make employees more sensitive to respirable crystalline silica exposure; and (2) to allow for intervention methods to prevent development of serious disease. Employees with latent tuberculosis infections are at greater risk of developing active disease with exposure to respirable crystalline silica, and informing them that they have a latent infection allows for intervention in the form of treatment to eliminate the infection. Treating latent tuberculosis disease before it becomes active and can be transmitted to coworkers (and others) is in the best interest of both the employer and the affected employee.
Dr. James Cone and APHA have stated that a positive boosted or initial test for tuberculosis infection warrants medical referral for further evaluation (Document ID 2157, p. 6; 2178, Attachment 1, p. 5). Ameren commented that a positive tuberculosis test warrants medical removal (Document ID 2315, p. 9). OSHA agrees that employees who test positive for active tuberculosis should be referred to their local public health departments as required by state public health law (Document ID 2177, Attachment B, p. 50). Those employees will need treatment and, if necessary, to be quarantined until they are no longer contagious. That is the appropriate action for employees with active tuberculosis to prevent infection of coworkers and others, according to procedures established by state public health laws. In the case of latent tuberculosis, the PLHCP may refer the employee to the local public health department, where the employee may get recommendations or prescriptions for treatment. Removal is not necessary for latent tuberculosis infections because employees with latent tuberculosis infections are not contagious. More information about testing for latent tuberculosis infections is included in Appendix B.
The sixth and final item required as part of the initial medical examination is any other test deemed appropriate by the PLHCP (paragraph (i)(2)(vi) of the standard for general industry and maritime, paragraph (h)(2)(vi) of the standard for construction). This provision, which is unchanged from the proposed rule, gives the examining PLHCP the flexibility to determine additional tests deemed to be appropriate. While the tests conducted under this section are for screening purposes, diagnostic tests may be necessary to address a specific medical complaint or finding related to respirable crystalline silica exposure (Document ID 1511, p. 61). For example, the PLHCP may decide that additional tests are needed to address abnormal findings in a pulmonary function test. OSHA considers the PLHCP to be in the best position to decide if any additional medical tests are necessary for each individual examined. Under this provision, if a PLHCP decides another
Finally, some stakeholders suggested additional tests to be included as part of medical examinations. OSHA did not propose a requirement for the initial examination to include a CT scan to screen for lung cancer, but a number of commenters thought the rule should contain such a requirement. UAW requested that OSHA consider LDCT scanning for lung cancer, with guidance from NIOSH and other medical experts (Document ID 2282, Attachment 3, pp. 19-20). Charles Gordon asked Dr. David Weissman if OSHA should consider CT scans for lung cancer screening of silica-exposed employees, as has been recently recommended by the U.S. Preventive Service Task Force (USPSTF) for persons at high risk of lung cancer. Dr. Weissman responded:
Well, the recommendation that you're referring to related to very heavy cigarette smokers, people who are age 55 to 80, had a history of smoking I believe at least 30 pack-years and had smoked as recently as 15 years ago. That group has a very, very high risk of lung cancer, and as of this time, there are no recommendations that parallel that for occupational carcinogens (Document ID 3579, Tr. 159-160, Attachment 2, p. 2).
Collegium Ramazzini and USW asked OSHA to consider various scenarios for LDCT lung cancer screening of employees exposed to respirable crystalline silica; the different scenarios considered age (as a proxy for latency), smoking history, and other risk factors, such as non-malignant respiratory disease (Document ID 4196, pp. 5-6; 4214, pp. 10-12). Both groups recommended screening in non-smokers, and Collegium Ramazzini also recommended screening in employees less than 50 years of age; both groups cited National Comprehensive Cancer Network (NCCN) guidelines as a basis for one or more recommendations, and Collegium Ramazzini also cited the American Association for Thoracic Surgery (AATS) guidelines. The Communication Workers of America (CWA) requested LDCT scans every three years for silica-exposed employees over 50 years of age (Document ID 2240, p. 3). Consistent with one scenario presented by USW, AFL-CIO requested that OSHA require LDCT scans if recommended by the PLHCP or specialist, and AFL-CIO also requested that OSHA include a provision (for employees exposed to respirable crystalline silica) to allow for regular LDCT scans if recommended by an authoritative group (Document ID 4204, p. 82). Dr. Rosemary Sokas and Dr. James Melius, occupational physician/epidemiologist for LHSFNA, requested that OSHA reserve the right to allow for adoption of LDCT scans (Document ID 3577, Tr. 793; 3589, Tr. 4205-4206). Dr. Sokas went on to say that OSHA should start convening agencies and organizations to look at levels of risk that warrant LDCT (Document ID 3577, Tr. 793).
In addition to the issues that Dr. Weissman testified about regarding the USPSTF recommendations, OSHA notes that the USPSTF recommendations are based on modeling studies to determine optimum ages and frequency for screening and the scenarios in which benefits of LDCT screening (
Both NCCN and AATS guidelines recommend screening scenarios that are similar to the USPSTF guideline (
OSHA agrees that employees exposed to respirable crystalline silica are at increased risk of developing lung cancer, as addressed in Section V, Health Effects. However, OSHA has two major concerns that preclude the Agency from requiring LDCT screening for lung cancer under the respirable crystalline silica rule. The first concern is that availability of LDCT is likely to be limited. Few institutions that offer LDCT have the specialization to effectively conduct screening for lung cancer. The second major concern is the lack of a risk-benefit analysis. There is no evidence in the rulemaking record showing that the benefits of lung cancer screening using LDCT in respirable crystalline silica-exposed employees outweigh the risks of lung cancer from radiation exposure. OSHA has also not identified authoritative recommendations based on risk-benefit analyses for LDCT scanning for lung cancer in persons who do not smoke or are less than 50 years of age. OSHA concludes that without authoritative risk-benefit analyses, the record does not support mandating LDCT screening for respirable crystalline silica-exposed employees.
Some commenters disagreed with the proposed three-year interval for periodic medical examinations. WisCOSH and Charles Gordon thought that medical examinations should be offered more often than every three years (Document ID 3586, Tr. 3200-3201; 2163, Attachment 1, p. 14). Other commenters, including AFSCME and some employee health advocates and labor unions, requested that one or more components of medical examinations be offered annually (Document ID 1960; 2208; 2240, p. 3; 2351, p. 15; 4203, p. 6). Collegium Ramazzini recommended annual medical surveillance consisting of medical and work history and spirometry testing to better characterize symptoms, changes in health and work history that could be forgotten, and lung function changes (Document ID 3541, p. 12). CISC stated that OSHA did not explain why it found an examination every three years necessary and appropriate (Document ID 2319, p. 119).
ATS, NIOSH, USW, and AFS supported the three-year frequency requirement for medical surveillance (Document ID 2175, p. 6; 2177, Attachment B, pp. 38-39; 2336, p. 11; 2379, Appendix 1, p. 70). NSSGA, however, recommended examinations every three to five years (Document ID 2327, Attachment 1, p. 24). Although WHO guidelines recommend an annual history and spirometry test, the guidelines state that if that is not possible, those examinations can be conducted at the same frequency they recommend for X-rays (every 2-to-5 years) (Document ID 1517, p. 32). In support of triennial medical examinations, ATS commented that an examination provided every three years is appropriate to address a lung disease that typically has a long latency period (Document ID 2175, p. 6).
ACOEM agreed with a frequency of every three years for a medical examination, provided that a second baseline examination (excluding X-rays) is conducted at 18 months following the initial baseline examination; this approach was recommended to detect possible symptoms of acute silicosis and to more effectively establish a spirometry baseline since rapid declines in lung function can occur in dusty work environments (Document ID 2080, pp. 5-6). Dr. Celeste Monforton agreed with a follow-up examination at 18 months (Document ID 3577, Tr. 846).
APHA, AFL-CIO, BAC, and BCTD also agreed with ACOEM's suggestion for a follow-up examination within 18-months, adding that a three-year interval between examinations is acceptable if medical examinations are offered to employees experiencing signs and symptoms related to respirable crystalline silica exposure (Document ID 2178, Attachment 1, pp. 4-5; 4204, pp. 81-82; 4219, pp. 30-31; 4223, pp. 127-128). BlueGreen Alliance, UAW, Center for Effective Government (CEG), CPR, WisCOSH, and AFSCME also requested that medical surveillance be offered for employees experiencing symptoms (Document ID 2176, p. 2; 2282, Attachment 3, pp. 22-23; 2341, pp. 2-3; 2351, p. 15, Fn 29; 3586, Tr. 3200-3201; 4203, p. 6). The AFL-CIO and UAW stated that a symptom trigger is appropriate based on the high level of risk remaining at OSHA's proposed action level and PEL (Document ID 2282, Attachment 3, p. 22; 4204, p. 81). APHA, CEG, and BCTD also argued that employees should be allowed to see a PLHCP if they are concerned about excessive exposure levels or their ability to use a respirator (Document ID 2178, p. 5: 2341, pp. 2-3; 4223, pp. 127-128).
After considering all comments on this issue, OSHA concludes that the record supports requiring periodic examinations to be offered to employees at least every three years after the initial (baseline) or most recent periodic medical examination for employees who are eligible for initial and continued medical surveillance under the rule. Accordingly, paragraph (i)(3) of the standard for general industry and maritime (paragraph (h)(3) of the standard for construction) requires periodic examinations at least every three years, or more frequently if recommended by the PLHCP. One of the main goals of periodic medical surveillance for employees exposed to respirable crystalline silica is to detect adverse health effects, such as silicosis and other non-malignant lung diseases, at an early stage so that medical and other appropriate interventions can be taken to improve health. Consistent with the NIOSH and ATS comments, OSHA finds that medical examinations offered at a frequency of at least every three years is appropriate for most employees exposed to respirable crystalline silica in light of the slow progression of most silica-related diseases. This decision is also consistent with ASTM standards E 1132-06 and E 2625-09 (Section 4.6.5), which recommend that medical surveillance be conducted no less than every three years (Document ID 1466, p. 5; 1504, p. 5).
OSHA declines to adopt ACOEM's recommendation for a second baseline examination at 18 months. As noted above, this request was based upon detection of possible acute silicosis symptoms. Considering that acute silicosis and the rapid declines in lung function associated with it, as a result of extremely high exposures, are rare, OSHA determines that this extra examination would not benefit the vast majority of employees exposed to respirable crystalline silica. However, as noted above, paragraph (i)(3) of the standard for general industry and maritime (paragraph (h)(3) of the standard for construction) authorizes the PLHCP to recommend, and requires the employer to make available, increased frequency of medical surveillance. OSHA agrees with Dr. James Melius that more frequent medical examinations are appropriate if requested by the PLHCP based on abnormal findings or signs of possible illness, and the Agency agrees with ACOEM that the PLHCP may recommend more frequent medical surveillance based on an exposure history indicating unknown or high exposure to respirable crystalline silica (Document ID 2080, p. 6; 3589, Tr. 4203). OSHA concludes that allowing the PLHCP to determine when increased frequency of medical examinations is needed is a better approach than requiring all employees to receive annual medical examinations or a second baseline examination at 18 months.
OSHA did not include a symptom trigger because symptoms of silica-related lung diseases (
AIHA recommended that OSHA consider decreased frequency of testing in employees with less than 10 to 15 years of experience because of the small chance of finding disease, and it noted
In addition to the above general comments as to the appropriate frequency of periodic examinations, some stakeholders offered comments on particular components of periodic examinations, in particular chest X-rays and pulmonary function tests. As noted above, chest X-rays are included in the periodic, as well as initial (baseline), medical examinations. Periodic chest X-rays are appropriate tools for detecting and monitoring the progression of silicosis and possible complications, such as mycobacterial disease, including tuberculosis infection (Document ID 1505, p. 3; 1511, pp. 63, 79). Safety professional Albert Condello III stated that X-rays should be offered annually (Document ID 1960). OSHA concludes that every three years is an appropriate interval for X-ray examinations. The frequency is within ranges recommended by ACOEM, IMA/MSHA, NISA, and WHO (Document ID 1505, pp. 3-4; 1511 pp. 78-79; 1514, pp. 109-110; 1517, p. 32). Commenters representing NIOSH, the medical community, and industry agreed that a frequency of every three years is appropriate for X-rays (Document ID 2157, p. 6; 2177, Attachment B, pp. 38-39; 2315, p. 9; 2327, Attachment 1, p. 25; 2379, Appendix 1, p. 70; 3541, p. 5).
OSHA also received comments on the inclusion of pulmonary function (
The proposed interval of three years for spirometry testing was an issue in the rulemaking. OSHA proposed this interval because exposure to respirable crystalline silica does not usually cause severe declines in lung function over short time periods. Spirometry testing conducted every three years is within ranges of recommended frequencies, based on factors such as age and exposure duration or intensity, in guidelines by ACOEM and BCTD, although ACOEM and BCTD recommend an evaluation at 18 months following the baseline test (Document ID 1505, p. 3; 1509, p. 15; 2080, pp. 5-6; 4223, p. 128). Guidelines from WHO recommend yearly spirometry tests, but indicate that if that is not possible, spirometry can be conducted at the same frequency as X-rays (every 2-to-5 years) (Document ID 1517, p. 32).
OSHA specifically requested comment on the appropriate frequency of lung function testing, which it proposed at intervals of every three years. ASSE agreed that spirometry testing every three years is consistent with most credible occupational health programs for respirable crystalline silica exposure (Document ID 2339, p. 9). Industry stakeholders, such as Ameren, NSSGA, and AFS, also supported conducting spirometry testing every three years (Document ID 2315, p. 9; 2327, Attachment 1, pp. 24-25; 2379, Appendix 1, p. 70).
Collegium Ramazzini stated that spirometry testing should be conducted annually rather than triennially (Document ID 3541, pp. 12-13). In support of its statement, Collegium Ramazzini interpreted data from a Wang and Petsonk (2004) study to mean that an FEV
The Wang and Petsonk 2004 study was designed to measure lung function changes in coal miners over 6- to 12-month intervals. The study authors reported that in the group of coal miners studied, a year-to-year decline in lung function (
OSHA notes that, in fact, Figure 1 of the Wang and Petsonk study shows that lung function loss measured over a 5-year period in that cohort of miners is much less variable than changes measured over 6- to 12-month intervals. OSHA therefore finds that this study indicates that long-term measurements in lung function are more reliable for assessing the level of lung function decline over time. Based on Table 1 of the Wang and Petsonk study, mean annual FEV
However, even among workers in our study who met this >8% or >330 mL criterion, many did not show accelerated declines over the entire 5 years of follow up (data not shown), emphasizing that a finding of an increased year-to-year decline in an individual requires further assessment and confirmation (Document ID 3636, p. 595).
In sum, OSHA finds that the Wang and Petsonk study is not a basis for concluding that triennial spirometry
Collegium Ramazzini also cited a 2012 Hnizdo study that demonstrated greater stability and predictability for excessive loss of lung function with more frequent testing. In that study, spirometry data were useful for predicting decline only after the fourth or fifth year of follow-up; Collegium Ramazzini stated that only two spirometry tests would be available in six years if employees are tested every three years (Document ID 3541, p. 13; 3627, p. 1506). OSHA notes that three spirometry reports would be available following six years of triennial testing (the initial examination, the three-year examination, and the six-year examination). In addition, Hnizdo concluded that annual spirometry was best, but even in employees tested every three years, useful clinical data were generated with five to six years of follow-up (Document ID 3627, p. 1511).
The ATS committee also reviewed the Hnizdo study and concluded that precision in determining rate of FEV
After consideration of the rulemaking evidence on this issue, OSHA concludes that spirometry testing every three years is appropriate to monitor employees' lung function and that the frequency is well supported in the record. Therefore, consistent with its proposed rule, OSHA is including a frequency of at least every three years for spirometry testing.
As discussed above in connection with the initial testing requirement, spirometry usually involves cross-sectional testing for assessing lung function at a single time point. Longitudinal spirometry testing that compares employees' lung function to their baseline levels is also useful for detecting excessive declines in lung function that could lead to severe impairment over time. OSHA did not propose a requirement to assess longitudinal changes in lung function. Commenters including Collegium Ramazzini, LHSFNA, and BCTD requested that the standard include requirements or instructions for longitudinal testing to compare an employee's current lung function value to his or her baseline value (Document ID 3541, p. 10; 3589, Tr. 4205; 4223, p. 129). As noted by Dr. L. Christine Oliver, associate clinical professor of medicine at Harvard Medical School, representing Collegium Ramazzini:
Excessive loss of lung function may indicate early development of silica-related disease, even in the absence of an abnormal test result. So spirometry at one point in time may be normal, but compared to the baseline of that individual, there may have been a decline. So even though the test result itself is normal, it doesn't mean that there is not something going on with regard to that individual's lung function (Document ID 3588; Tr. 3855).
Both Collegium Ramazzini and BCTD requested that the standard require referral to a specialist for excessive losses of pulmonary function. Collegium Ramazzini recommended specialist referral for a year-to-year decline in FEV
OSHA endorses in principle the value of longitudinal spirometry analyses to compare employees' lung function to their baseline values, but is not adopting the specific recommendation to incorporate it into the rule. Based on a review of the available evidence, OSHA is concerned about several challenges in determining an employee's change from baseline values, which preclude the Agency from requiring longitudinal analyses with an across-the-board trigger of 8-to-10 percent loss of baseline lung function for specialist referral. First, a lung function loss of 8-to-10 percent is more stringent than general recommendations from ACOEM and ATS. OSHA notes that the complete ACOEM recommendation for evaluating longitudinal changes in lung function states:
When high-quality spirometry testing is in place, ACOEM continues to recommend medical referral for workers whose FEV
The ACOEM recommendation is based on ATS guidelines indicating that year-to-year changes in lung function exceeding 15 percent are probably unusual in healthy individuals. A recent ATS committee restated that position:
ATS recommends that a decline of 15% or more over a year in otherwise healthy individuals be called “significant,” beyond what would be expected from typical variability (Document ID 3632, p. 989).
As ATS indicated, actual lung function losses must be distinguished from measurement variability. Variability in spirometry findings can occur as a result of technical factors (
Collegium Ramazzini noted that spirometry performed at a location other than that of the first employer may not provide an adequate baseline to evaluate lung function changes in the absence of quality control and standardized equipment, methodology, and interpretation (Document ID 3541, p. 5). OSHA is concerned about the ability to differentiate lung function changes from variability, even with standardization and quality control. ACOEM has concluded that frequent changing of spirometry providers may prevent a meaningful evaluation of longitudinal testing results (Document ID 3633, p. 1309). OSHA recognizes that changes in spirometry providers could preclude evaluating changes in lung function from baseline values and that employees in high-turnover industries,
In addressing the issue of construction employees frequently changing employers, Dr. L. Christine Oliver recommended storing spirometry results in a central database or providing them to employees to allow
In sum, OSHA recognizes the value of longitudinal analyses that compare an individual's lung function to their baseline values. Recent studies have shown that excessive decline in lung function can be an early warning sign for risk of COPD development (Document ID 1516). Therefore, identifying employees who are at risk of developing severe decrements in lung function can allow for interventions to possibly prevent or slow progression of disease and thus justifies periodic spirometry. But because of the complexities and challenges described above, OSHA is not mandating testing to compare employees' lung function values to baseline values or specifying a lung function loss trigger for referral to a specialist. OSHA concludes that spirometry conducted every three years is appropriate to detect the possible development of lung function impairment. However, the PLHCP is in the best position to determine how spirometry results should be evaluated. Under paragraph (i)(5)(iv) of the standard for general industry and maritime (paragraph (h)(5)(iv) of the standard for construction), PLHCPs have the authority to recommend referral to a specialist if “otherwise deemed appropriate,” and an informed judgment or suspicion that excessive lung function loss or an actual lung function abnormality has occurred would be an appropriate reason for referral to a specialist with the necessary skills and capability to make that evaluation.
Some of these provisions reflect minor edits from the proposed rule. In paragraphs (i)(4)(i) and (iv) of the standard for general industry and maritime (paragraphs (h)(4)(i) and (iv) of the standard for construction), OSHA changed “affected employee” to “employee.” OSHA removed the word “affected” because it is clear that the provisions refer to employees who will be undergoing medical examinations. In paragraph (i)(4)(iii) of the standard for general industry and maritime (paragraph (h)(4)(iii) of the standard for construction), OSHA changed “has used the equipment” to “has used or will use the equipment” to make it consistent with the earlier part of the provision that states “personal protective equipment used or to be used.” These non-substantive changes simply remove superfluous language or clarify OSHA's intent, which has not changed from the proposed rule.
OSHA received few comments regarding information to be supplied to the PLHCP. NAHB was concerned about obtaining or verifying information, such as PPE use, exposure information, and medical information, from past employers to give to the PLHCP (Document ID 2296, p. 31). Paragraph (i)(4)(iv) of the standard for general industry and maritime (paragraph (h)(4)(iv) of the standard for construction) is explicit, however, that employers must only provide the information within their control. Employers are not expected to provide information to PLHCPs on exposures experienced by employees while the employees were working for prior employers. Similarly, OSHA intends that where the employer does not have information on the employee's past or current exposure level, such as when a construction employer uses Table 1 in lieu of exposure monitoring, providing the PLHCP with an indication of the exposure associated with the task (
OSHA identifies the information that the employer must provide to the PLHCP, along with information collected as part of the exposure and work history, as relevant to the purposes of medical surveillance under the rule because it can assist the PLHCP in determining if symptoms or a health finding may be related to respirable crystalline silica exposure or if the employee might be particularly sensitive to such exposure. For example, a finding of abnormal lung function caused by asthma might indicate increased sensitivity to a workplace exposure. The information will also aid the PLHCP's evaluation of the employee's health in relation to recommended limitations on the employee's use of respirators or exposure to respirable crystalline silica. For these reasons, OSHA is retaining the proposed provisions detailing information to be provided to the PLHCP in the rule.
OSHA proposed that the employer obtain from the PLHCP a written medical opinion containing: (1) A description of the employee's health condition as it relates to exposure to respirable crystalline silica, including any conditions that would put the employee at increased risk of material impairment of health from further exposure to respirable crystalline silica; (2) recommended limitations on the employee's exposure to respirable crystalline silica or use of PPE, such as respirators; (3) a statement that the employee should be examined by a pulmonary disease specialist if the X-ray is classified as 1/0 or higher by the B reader, or if referral to a pulmonary disease specialist is otherwise deemed appropriate by the PLHCP; and (4) a statement that the PLHCP explained to the employee the medical examination results, including conditions related to respirable crystalline silica exposure that require further evaluation or treatment and any recommendations related to use of protective clothing or equipment. The proposed rule would also have required the employer to ensure that the PLHCP did not include findings unrelated to respirable crystalline silica exposure in the written medical opinion provided to the employer or otherwise reveal such findings to the employer. OSHA raised the contents of the PLHCP's written medical opinion, including privacy concerns, as an issue in the preamble of the NPRM in Question 71 in the “Issues” section (78 FR at 56290).
OSHA received a number of comments on these provisions. The majority of these comments related to the proposed contents of the PLHCP's written medical opinion and its transmission to the employer. For example, Dr. Laura Welch expressed concern that the provision that would have required the PLHCP to disclose “a medical condition that puts him or her at risk of material impairment to health from exposure to silica” could be read to require disclosure of the employee's medical diagnosis (Document ID 3581, Tr. 1580). Dr. Steven Markowitz, physician and director of the Center for Biology of Natural Systems at Queens College, representing USW, explained:
So, for example, if I were the examining healthcare provider and I saw an employee, and he had what I identified as idiopathic pulmonary fibrosis, which is diffuse scarring of the lungs with an unknown cause, in this case, not silica, is that information that I would need to turn over to the employer because further exposure to silica might impair that person's health or not? Or what if the worker has emphysema, which is a silica-related condition, and the provider believes that that emphysema is not due to silica exposure but to the employee's long-time smoking history. Is that information that the healthcare provider is supposed to turn over to the employer? It isn't at all clear (Document ID 3584, Tr. 2518-2519).
Some commenters offered suggestions to address privacy concerns regarding the content of the proposed PLHCP's written medical opinion for the employer and the proposed requirement that the opinion be given to the employer instead of the employee. One suggestion advocated by UAW, LHSFNA, AFSCME, AFL-CIO, and BCTD was for OSHA to use a model based on the black lung rule for coal miners (Document ID 2282, Attachment 3, pp. 20-21; 3589, Tr. 4207; 4203, p. 6; 4204, p. 88; 4223, p. 134). Under the coal miner regulations, miners receive the medical information and employers are prohibited from requiring that information from miners (30 CFR 90.3). Commenters including BlueGreen Alliance, CWA, USW, and Collegium Ramazzini also urged OSHA to require that findings from medical surveillance only be given to employers upon authorization by the employee (Document ID 2176, p. 2; 2240, pp. 3-4; 2336, p. 12; 3541, p. 13). UAW, AFL-CIO, and BCTD referred OSHA to ACOEM's recommendations for workplace confidentiality of medical information (Document ID 2282, Attachment 3, p. 20; 3578, Tr. 929; 3581, Tr. 1579-1580). The ACOEM guidelines state:
Physicians should disclose their professional opinion to both the employer and the employee when the employee has undergone a medical assessment for fitness to perform a specific job. However, the physician should not provide the employer with specific medical details or diagnoses unless the employee has given his or her permission (Document ID 3622, p. 2).
Although HIPAA regulations allow medical providers to provide medical information to employers for the purpose of complying with OSHA standards (Document ID 4214, p. 7), OSHA has accounted for stakeholder privacy concerns in devising the medical disclosure requirements in the rule. OSHA understands that the need to inform employers about a PLHCP's recommendations on work limitations associated with an employee's exposure to respirable crystalline silica must be balanced against the employee's privacy interests. As discussed in further detail below, OSHA finds it appropriate to distinguish between the PLHCP's recommendations and the underlying medical reasons for those recommendations. In doing so, OSHA intends for the PLHCP to limit disclosure to the employer to what the employer needs to know to protect the employee, which does not include an employee's diagnosis. Contrary to some of the comments, it was not OSHA's intent, either in the proposed rule or in earlier standards that require information on an employee's medical or health condition, to transmit diagnostic information to the employer; OSHA intended for the PLHCP merely to convey whether or not the employee is at increased risk from exposure to respirable crystalline silica (or other workplace hazards in other standards) based on any medical condition, whether caused by such exposure or not. In re-evaluating how to express this intent, however, OSHA concludes that the employer primarily needs to know about any recommended limitations without conveying the medical reasons for the limitations. Thus, in response to the weight of opinion in this rulemaking record and to evolving notions about where the balance between preventive health policy and patient privacy is properly struck, OSHA is taking a more privacy- and consent-based approach regarding the contents of the PLHCP's written medical opinion for the employer compared to the proposed requirements and earlier OSHA standards. These changes, which are reflected in paragraph (i)(6) of the standard for general industry and maritime (paragraph (h)(6) of the standard for construction), and the comments that led to these changes, are more fully discussed below.
Reinforcing the privacy concerns, various stakeholders, including labor unions, physicians, and employees,
The same is true with occupational illnesses, that the last thing that a worker wants is to have any information that he's somehow compromised because, even though we want to think the best of the employer, that somebody wouldn't take action against that individual, we know for a fact that it happens. It's happened to our membership (Document ID 3581, Tr. 1656).
Industry representatives indirectly confirmed that discrimination based on medical results was possible. For example, CISC noted that some employers might refuse to hire an employee with silicosis because they might have to offer workers' compensation or be held liable if the disease progresses (Document ID 4217, pp. 22-23).
Evidence in the record demonstrates that a likely outcome of employees' reluctance to let employers know about their health status is refusal to participate in medical surveillance. For example, Dr. Rosemary Sokas stated that employees who lack job security would likely avoid medical surveillance if the employer receives the results (Document ID 3577, Tr. 819-820). In discussing the Coal Workers' Health Surveillance Program, Dr. David Weissman stated that maintaining confidentiality is critical because:
One of the biggest reasons in focus groups that miners have given for not participating in surveillance is fear of their medical information being shared without their permission (Document ID 3579, Tr. 169).
When asked if employees would participate in medical surveillance that lacked both employee confidentiality and anti-retaliation and discrimination protection, employees Sarah Coyne, Deven Johnson, and Dale McNabb stated that they would not (Document ID 3581, Tr. 1657; 3585, Tr. 3053-3054). BAC and BCTD emphasized that employees must choose to participate in medical surveillance in order for it to be successful (Document ID 4219, p. 31; 4223, p. 131).
Industry groups, such as OSCO Industries and NAHB, commented that they or employers from their member companies are reluctant to handle or maintain confidential medical information (Document ID 1992, p. 12; 2296, p. 32). NAHB indicated:
Members have expressed strong concerns that much of [the medical information], if not all, would be covered by privacy laws and should be between a doctor and patient. . . . Moreover, the PLHCP should provide a copy of the written medical opinion to the employee directly, not the employer, once it is written (Document ID 2296, pp. 31-32).
However, other industry groups asserted that employers should receive detailed information from medical surveillance. In particular, NISA argued that reporting medical surveillance findings to employers would facilitate epidemiological studies to better understand hazards and the effectiveness of a new standard (Document ID 4208, p. 14).
OSHA agrees that epidemiology studies are important; indeed its health effects and significant risk findings in this rule are overwhelmingly based on epidemiological studies. However, as noted above, it was never OSHA's intent for the PLHCP's written medical opinion on respirable crystalline silica to contain specific diagnoses or detailed findings that might be useful for an epidemiology study. As noted in the summary and explanation of
CISC also noted that in past standards, the purpose of medical surveillance was to improve health practices by allowing employers to understand effects of hazards and, therefore, make changes to the worksite, such as implementing controls or removing employees from exposure (Document ID 4217, p. 24). Attorney Brad Hammock, representing CISC at the public hearing, stated that if OSHA expects employers to make placement decisions based on health outcomes and exposure, then there would be some value in an employer receiving the PLHCP's opinion. However, Mr. Hammock further explained that if the purpose of surveillance is simply to educate employees about their health situation, then there would be arguably little value in the employer receiving the opinion (Document ID 3580, Tr. 1466-1467). Other commenters, including ACOEM, AOEC, and NISA, also noted the importance of medical surveillance for identifying adverse health effects among employees in order to make workplace changes or evaluate the effectiveness of regulations or workplace programs (Document ID 2080, pp. 9-10; 3577, Tr. 784; 4208, pp. 13, 16-17). Andrew O'Brien testified that if employers are not allowed to see medical findings, the first time they are made aware of a problem is when they receive a letter from the compensation system. Mr. O'Brien stated:
Without access to that data, you can't . . . potentially see disease beginning and take preventative action to prevent it from actually having a negative health effect (Document ID 3577, Tr. 614).
In contrast to those views, USW questioned the value in providing employers with the PHLCP's medical opinion. It stated:
Exactly what corrections in the workplace will the employer make based on newfound knowledge that one of his workers has a silica-related condition? Silicosis occurs 15 or more years following onset of exposure, so that today's silicosis is due to exposure that likely occurred decades ago. (Exceptions are acute and accelerated silicosis, which are rare and are not expected to occur at the recommended PEL.) What inference is the employer supposed to make about the magnitude or effect of current exposures under these circumstances? Indeed, to make sense of the issue, the employer would have to know about the worker's prior silica exposures, quite often at different workplaces. But the employer and, quite likely, even the worker are unlikely to have high quality data on exposures to silica that occurred decades ago. In the absence of such information, it is unclear how an employer can properly interpret current exposures as causing silicosis. By contrast, the best information on current exposures derives from current exposure monitoring, and the notion that documenting silicosis can somehow provide useful information about current exposures above and beyond what proper exposure monitoring is ill-conceived (Document ID 4214, p. 8).
OSHA agrees that because of the long latency period of most respirable crystalline silica-related diseases, a diagnosis of such an illness in an employee will not provide useful information about current controls or exposure conditions. Employers should be basing their actions on exposure assessments and ensuring properly functioning controls, such as those listed and required for employers using Table 1. In the case where an employee may have disease related to respirable crystalline silica and the employer has properly implemented engineering controls, the only further action by the employer would be to follow PLHCP recommendations to protect the worker who may be especially sensitive to continuing exposure and need special accommodations. Such recommendations could include limitations on respirator use; they might also include specialist referral or limitations on respirable crystalline silica exposure (if the employee gives authorization for the employer to receive this information) (paragraph (i)(6)(i)(C) or (ii)(A) and (B) of the standard for general industry and maritime and paragraph (h)(6)(i)(C) or (ii)(A) and (B) of the standard for construction).
In taking a more consent-based approach than in the proposed rule regarding the PLHCP's written medical opinion for the employer, OSHA considered the countervailing factor that employers will not be able to report occupational illnesses to OSHA if they are not given medical surveillance information. USW refuted the utility of employer reporting of workplace illnesses, stating:
However, this loss is minor, because few believe that such employer-generated reporting of chronic occupational conditions does, or even could, under the best of circumstances, provide proper counts of occupational illnesses (Document ID 4214, p. 8).
This rule does not change OSHA reporting or recording requirements, and employers who need more information on recording or reporting of occupational illnesses should refer to OSHA's standard on recording and reporting occupational injuries and illnesses (29 CFR 1904). OSHA finds that if employees do not participate in medical surveillance because of discrimination or retaliation fears, illnesses associated with respirable crystalline silica would generally not be identified. Although not disclosing medical information to employers appears inconsistent with the objective of recording illnesses, the net effect of that decision is improving employee protections due to more employees participating in medical surveillance. Also, as noted above, OSHA never intended for employers to get specific information, such as diagnoses, and this would further limit employers' ability to report disease. Although state surveillance systems are likely to underestimate silicosis cases (see Section V, Health Effects), they are still likely to be a better way to get information on trends of silicosis cases than employer reports. Reporting of silicosis cases by health care providers is required by 25 states (
An additional consideration relating to what information, if any, goes to the employer is that withholding information, such as conditions that might place an employee at risk of health impairment with further exposure, may leave employers with no medical basis to aid in the placement of employees. Although NSSGA did not want to receive confidential medical records, it stressed the importance of continuing to receive information concerning how the workplace could affect an employee's condition and on recommended respirator restrictions (Document ID 3583, Tr. 2315-2316; 4026, p. 5). NISA stated that employers should receive the results of medical surveillance because employers might be held liable if employees choose to keep working in settings that might aggravate their illnesses (Document ID 4208, p. 14). However, labor unions, such as USW, BAC, and BCTD, strongly opposed employers making job placement decisions based on employees' medical findings (Document ID 4214, pp. 7-8; 4219, pp. 31-32; 4223, p. 133). USW and BCTD noted that as long as employees are capable of performing their work duties, decisions to continue working should be theirs; BCTD further noted that the employee should make such decisions with guidance from the PLHCP, and USW noted that the employee should decide because of the significance of job loss or modifications (Document ID 2371, Attachment 1, pp. 45-46; 4214, pp. 7-8). Sarah Coyne agreed that employees should make decisions about placement. Ms. Coyne stated, “I might have silicosis. I might have asbestosis. I know if I can work or not. Let me decide” (Document ID 3581, Tr. 1656).
OSHA agrees that employees have the most at stake in terms of their health and employability, and they should not have to choose between continued employment and the health benefits offered by medical surveillance, which they are entitled to under the OSH Act. OSHA agrees that employees should make employment decisions, following discussions with the PLHCP that include the risks of continued exposure. Before that can happen, however, employees need to have confidence that participation in medical surveillance will not threaten their livelihoods. After considering the various viewpoints expressed during the rulemaking on these issues, OSHA concludes that the best way to maximize employee participation in medical surveillance, therefore promoting the protective and preventative purposes of this rule, is by limiting required disclosures of information to the employer to only the bare minimum of what the employer needs to know to protect employee health—recommended restrictions on respirator use and, only with consent of the employee, the PLHCP's recommended limitations on exposure to respirable crystalline silica and specialist referrals. Thus, OSHA views this consent-based approach to reporting of medical surveillance findings critical to the ultimate success of this provision, which will be measured not just in the participation rate, but in the benefits to participating employees—early detection of silica-related disease so that employees can make employment, lifestyle, and medical decisions to mitigate adverse health effects and to possibly retard progression of the disease.
Expressing a different view, CISC stated that OSHA lacks the legal
NISA supported providing the proposed medical opinion to employers, partly because some employers might have a better understanding of medical surveillance results than employees, who might not have the training or understanding to make health-protective decisions based on those results (Document ID 4208, pp. 13-14). OSHA recognizes that larger companies that employ health, safety, and medical personnel may have in-house expertise to answer employee questions and stress the importance of protective measures, such as work practices or proper use of respirators. However, it is not likely that owners or management of small companies would have a better understanding than their employees or would be able to provide them any additional guidance. Consequently, OSHA does not find the fact some employers might have a better understanding of medical surveillance results than employees to be a compelling argument against limiting the information that is to be reported to the employer in the absence of employee consent. In addition, OSHA expects that the training required under the rule will give employees knowledge to understand protective measures recommended by the PLHCP.
In sum, OSHA concludes that the record offers compelling evidence for modifying the proposed content of the PLHCP's written medical opinion for the employer. The evidence includes privacy concerns expressed by both employees and employers, as well as evidence on the limited utility for giving medical surveillance findings to employers. OSHA is particularly concerned that the proposed requirements would have led to many employees not participating in medical surveillance and therefore not receiving its benefits. OSHA therefore has limited the information to be given to the employer under this rule, but is requiring that the employee receive a separate written medical report with more detailed medical information.
The requirements for the type of information provided to the employer are different from requirements of other OSHA standards, which remain in effect for those other standards. The requirements for this rule are based on the evidence obtained during this rulemaking for respirable crystalline silica, in particular that many employees would not take advantage of medical surveillance without privacy protections and because the findings of medical examinations would not likely reflect current workplace conditions in most cases. The action taken in this rulemaking does not preclude OSHA from adopting its traditional approach, or any other approach for reporting of medical findings to employers, in the future when it concludes, based on health effects information, that such an approach would contribute information that is relevant to current workplace conditions and would allow for design or implementation of controls to protect other employees.
The contents of the PLHCP's written medical report for the employee are set forth in paragraphs (i)(5)(i)-(iv) of the standard for general industry and maritime (paragraphs (h)(5)(i)-(iv) of the standard for construction). They include: The results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment of health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment; any recommended limitations on the employee's use of respirators; any recommended limitations on respirable crystalline silica exposure; and a statement that the employee should be examined by a specialist if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B reader, or if referral to a specialist is deemed appropriate by the PLHCP. Appendix B contains an example of a PLHCP's written medical report for the employee.
The health-related information in the PLHCP's written medical report for the employee is generally consistent with the proposed PLHCP's written medical opinion for the employer, with two notable exceptions. Because only the employee will be receiving the PLHCP's written medical report, the written medical report may include diagnoses and specific information on health conditions, including those not related to respirable crystalline silica, and medical conditions that require further evaluation or follow-up are not limited to those related to respirable crystalline silica exposure. Although the focus of the examination is on silica-related conditions, the PLHCP may happen to detect health conditions that are not related to respirable crystalline silica exposure during the examination, and could include information about such conditions in the written medical report for the employee. The employer, however, is not responsible for further evaluation of conditions not related to respirable crystalline silica exposure. A minor difference from the proposed written medical opinion for the employer and the written medical report for the employee in the rule is that it specifies limitations on respirator use rather than PPE because respirators are the only type of PPE required by the rule. The requirements for the PLHCP's written medical report for the employee are consistent with the overall goals of medical surveillance: To identify respirable crystalline silica-related adverse health effects so that the employee can consider appropriate steps to manage his or her health; to let the employee know if he or she can be exposed to respirable crystalline silica in his or her workplace without increased risk of experiencing adverse health effects; and to determine the employee's fitness to use respirators. By providing the PLHCP's written medical report to employees, those who might be at increased risk of health impairment from respirable crystalline silica exposure will be able to consider interventions (
The requirement for a verbal explanation in paragraph (i)(5) of the standard for general industry and maritime (paragraph (h)(5) of the standard for construction) allows the employee to confidentially ask questions or discuss concerns with the PLHCP. The requirement for a written medical report ensures that the employee receives a record of all findings. As noted by BCTD, giving the employee the written report will ensure the employee understands medical conditions that require follow-up and could affect decisions of where and how to work; BCTD also noted that employees would be able to provide the PLHCP's written medical report to future health care providers (Document ID 2371, Attachment 1, p. 48); this would include PLHCPs conducting subsequent periodic examinations under the rule.
BCTD further noted that the medical surveillance model it is recommending for respirable crystalline silica presents a different circumstance than what it advocated for regarding asbestos in
Based on record evidence, OSHA has determined that for the respirable crystalline silica rule, the PLHCP's written medical opinion for the employer must contain only the date of the examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the employee's use of respirators. These requirements are laid out in paragraphs (i)(6)(i)(A)-(C) of the standard for general industry and maritime (paragraphs (h)(6)(i)(A)-(C) of the standard for construction). OSHA is persuaded by arguments to include limitations on respirator use, and no other medically-related information, in the PLHCP's written medical opinion for the employer. The Agency notes that the limitation on respirator use is consistent with information provided to the employer under the respiratory protection standard (29 CFR 1910.134). OSHA concludes that only providing information on respirator limitations in the PLHCP's written medical opinion for the employer is consistent with the ACOEM confidentiality guidelines that recommend reporting of health and safety concerns to the employer (Document ID 3622, p. 2). The date and statement about the examination meeting the requirements of this section are to provide both the employer and employee with evidence that requirements for medical surveillance are current. Employees would be able to show this opinion to future employers to demonstrate that they have received the medical examination, as was recommended by LHSFNA and BCTD (Document ID 4207, p. 5; 4223, p. 125).
Paragraphs (i)(6)(ii)(A)-(B) of the standard for general industry and maritime (paragraphs (h)(6)(ii)(A)-(B) of the standard for construction) state that if the employee provides written authorization, the written medical opinion for the employer must also contain either or both of the following: (1) Any recommended limitations on exposure to respirable crystalline silica; (2) a statement that the employee should be examined by a specialist if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B reader, or if referral to a specialist is otherwise deemed appropriate by the PLHCP. OSHA intends for this provision to allow the employee to give authorization for the PLHCP's written medical opinion for the employer to contain only the recommendation on exposure limitations, only the recommendation for specialist referral, or both recommendations. The Agency expects that the written authorization could easily be accomplished through the use of a form that allows the employee to check, initial, or otherwise indicate which (if any) of these items the employee wishes to be included in the PLHCP's written medical opinion for the employer. An example of an authorization form is included in Appendix B.
OSHA is convinced that routinely including recommended limitations on respirable crystalline silica exposure and specialist referrals in the PLHCP's written medical opinion for the employer could adversely affect employees' willingness to participate in medical surveillance. The requirements for this paragraph are consistent with recommendations from labor unions. For example, UAW, BAC, and BCTD suggested letting the employee decide to forward the recommendation for an examination by a specialist if the employee wanted the employer to cover the costs of that examination (Document ID 3582, Tr. 1909; 4219, p. 32; 4223, pp. 133-134). BAC and BCTD also stated the employee should decide whether recommended accommodations (
OSHA finds that this new format for the PLHCP's medical opinion for respirable crystalline silica will better address concerns of NAHB and Dow Chemical, who feared they would be in violation if the PLHCP's written medical opinion for the employer included information that OSHA proposed the PLHCP not report to the employer, such as an unrelated diagnosis (Document ID 2270, p. 4; 2296, pp. 31-32). OSHA finds that removing the prohibition on
OSHA recognizes that some employees might be exposed to multiple OSHA-regulated substances at levels that trigger medical surveillance and requirements for written opinions. The PLHCP can opt to prepare one written medical opinion for the employer for each employee that addresses the requirements of all relevant standards, as noted in preambles for past rulemakings, such as chromium (VI) (71 FR 10100, 10365 (2/28/06)). However, the combined written medical opinion for the employer must include the information required under each relevant OSHA standard. For example, if the PLHCP opts to combine written medical opinions for an employee exposed to both chromium (VI) and respirable crystalline silica in a workplace covered by construction standards, then the combined opinion to the employer must contain the information required by paragraphs (i)(5)(A)-(C) of the chromium (VI) standard for construction (29 CFR 1926.1126) and the information required by paragraphs (h)(6)(i)(A)-(C) (and paragraphs (h)(6)(ii)(A)-(B), with written authorization from the employee) of the respirable crystalline silica standard for construction.
Other commenter recommendations for information to be included in the PLHCP's written medical opinion for the employer were not adopted by OSHA. Collegium Ramazzini and BCTD requested that the PLHCP's written medical opinion for the employer contain a statement that the employee was informed that respirable crystalline silica increases the risk of lung cancer, and Collegium Ramazzini also requested that the opinion indicate that the employee was told that smoking can compound the risk of developing lung cancer with exposure to respirable crystalline silica (Document ID 3541, p. 14; 4223, p. 137). On a similar note, Collegium Ramazzini also requested that employers establish smoking cessation programs (Document ID 3541, p. 4). OSHA notes that training provisions in paragraph (j)(3)(i)(A) of the standard for general industry and maritime (paragraph (i)(2)(i)(A) of the standard for construction) already require employers to ensure that each employee can demonstrate knowledge of the health hazards associated with exposure to respirable crystalline silica, which include lung cancer. OSHA concludes that the training required under the respirable crystalline silica rule is sufficient to inform employees about lung cancer risk.
Labor unions including UAW, CWA, USW, AFL-CIO, and BCTD requested that the rule prohibit employers from asking employees or the PLHCP for medical information (Document ID 2282, Attachment 3, p. 21; 2240, pp. 3-4; 2336, p. 12; 4204, p. 90; 4223, p. 134); as most of these commenters noted, a similar prohibition is included in the black lung rule for coal miners (30 CFR 90.3). OSHA is not including such a prohibition in the rule because employers may have legitimate reasons for requesting medical information, such as X-ray findings, to conduct epidemiology studies, and if employees are not concerned about discrimination or retaliation, they could authorize the employer to receive such information.
The proposed written medical opinion for the employer called for a statement that the PLHCP had explained to the employee the results of the medical examination, including findings of any medical conditions related to respirable crystalline silica exposure that require further evaluation or treatment, and any recommendations related to use of protective clothing or equipment. As noted above, OSHA has retained the requirement that the employer ensure that the PLHCP explains the results to the employee in paragraph (i)(5) of the standard for general industry and maritime (paragraph (h)(5) of the standard for construction), but no longer requires the PLHCP to include a statement of this fact in the written medical opinion for the employer. OSHA is not mandating how the employer ensures that the employee gets the required information because there are various ways this could be done, such as in a contractual agreement between the employer and PLHCP. PLHCPs could still include the verification in the PLHCP's written medical opinion for the employer if that is a convenient method for them to do so.
Paragraph (i)(6)(iii) of the standard for general industry and maritime (paragraph (h)(6)(iii) of the standard for construction) requires the employer to ensure that employees receive a copy of the PLHCP's written medical opinion for the employer within 30 days of each medical examination performed. OSHA is requiring that employees receive a copy of the PLHCP's written medical opinion for the employer because they can present it as proof of a current medical examination to future employers. This is especially important in industries with high turnover because employees may work for more than one employer during a three-year period and this ensures that tests, such as X-rays, are not performed more frequently than required.
As indicated above, the rule requires that employers ensure that employees get a copy of the PLHCP's written medical report and opinion and that they get a copy of the PLHCP's opinion within 30 days of each medical examination (paragraphs (i)(5), (6)(i), and (6)(iii) of the standard for general industry and maritime, paragraphs (h)(5), (6)(i), and (6)(iii) of the standard for construction). By contrast, the proposed rule would have required that the employer obtain the PLHCP's written medical opinion within 30 days of the medical examination and then provide a copy to the employee within 2 weeks after receiving it. Dow Chemical expressed concern about compliance if a PLHCP took more than 30 days to deliver the PLHCP's written medical opinion, which is a situation that is out of the employer's control (Document ID 2270, p. 4). Ameren and EEI requested 30 days for the employer to give the employee a copy of the PLHCP's written medical opinion (Document ID 2315, p. 4; 2357, p. 35).
The purpose of these requirements is to ensure that the employee and employer are informed in a timely manner. To ensure timely delivery and demonstrate a good faith effort in meeting the requirements of the standard, the employer could inform PLHCPs about the time requirements and follow-up with PLHCPs if there is concern about timely delivery of these documents. Similar 30-day requirements are included in other OSHA standards, such as chromium (VI) (1910.1026) and methylene chloride (1910.1052). Because the PLHCP will be providing the employee with a copy of the PLHCP's written medical report, he or she could give the employee a copy of the written medical opinion at the same time. This would eliminate the need for the employer to give the employee a copy of the PLHCP's written medical opinion for the employer, but the employer would still need to ensure timely delivery.
OSHA proposed referral to a specialist under two circumstances: (1) Where a B reader classifies an employee's chest X-ray as 1/0 or higher and (2) where the PLHCP determines referral is otherwise appropriate. The first trigger point for specialist referral relates to the interpretation and classification of the chest X-ray employees receive as part of their initial or periodic medical examination. The second trigger point empowers the PLHCP to refer the employee to a specialist for any other appropriate reason. After considering the comments on the proposed rule (discussed below), OSHA retained the triggers for referral in Paragraphs (i)(5)(iv) and (i)(6)(ii)(B) of the standard for general industry and maritime (paragraphs (h)(5)(iv) and (h)(6)(ii)(B) of the standard for construction).
As discussed above, paragraph (i)(2)(iii) of the standard for general industry and maritime (paragraph (h)(2)(iii) of the standard for construction) requires that X-rays be interpreted according to the ILO classification system. The ILO's system is a standardized manner of classifying opacities seen in chest radiographs. It describes the presence and severity of pneumoconiosis on the basis of size, shape, and profusion (concentration) of small opacities, which together indicate the severity and extent of lung involvement (Document ID 1475). The profusion of opacities seen on chest radiographs is compared to standard X-rays and classified on a 4-point category scale (0, 1, 2, or 3), with each category representing increasing profusion of small opacities. Each category is divided into two subcategories, giving a 12-subcategory scale between 0/− and 3/+. The first subcategory value represents the B Reader's first choice for profusion rating and the second subcategory value represents the B Reader's second choice for profusion rating. CDC/NIOSH considers a category 1/0 X-ray to be consistent with silicosis (Document ID 1711, p. 41).
The respirable crystalline silica rule's 1/0 category trigger point for referral is lower than in the ASTM standards, which recommend that employees with profusion opacities greater than 1/1 be evaluated at a frequency determined by a physician qualified in pulmonary disease (Section 4.7.1 of E 1132-06 and E 2625-09) and receive annual counseling by a physician or other person knowledgeable in occupational safety and health (Section 4.7.2 of E 1132-06 and E 2625-09) (Document ID 1466, p. 5; 1504, p. 5). CISC questioned what medical evidence OSHA had that a specialist is necessary at this stage and stated that OSHA did not explain why it deviated from the ASTM standard (Document ID 2319, p. 120). However, ACOEM agreed with a cut-off point of 1/0 for abnormality, and ATS agreed with specialist referral at a category of 1/0 (Document ID 2080, p. 7; 2175, p. 6).
Other evidence in the record also weighs in favor of referral where an employee's X-ray is classified as 1/0 or higher. For example, a study by Hnizdo et al. (1993) compared X-rays read by B Readers to autopsy findings and demonstrated that a classification of 1/0 is highly specific for radiological silicosis, with 89 percent of 1/0 readings of radiological silicosis found to be true positives (Document ID 1050, pp. 427, 440). Based on the high level of specificity for 1/0 readings,
OSHA also decided to retain the second referral trigger point contained in the proposed rule: Referral to a specialist if otherwise deemed appropriate by the PLHCP. Such referrals based on a PLHCP's written medical opinion for the employer allow potential findings of concern to be investigated further. Together, the two triggers for specialist referral in this rule are intended to ensure that employees with abnormal findings can be given the opportunity to be seen by an American Board Certified Specialist with expertise in pulmonary disease or occupational medicine, who can provide not only expert medical judgment, but also counseling regarding work practices and personal habits that could affect these individuals' respiratory health.
As indicated above, the employee must provide written authorization before the PLHCP's written medical opinion for the employer may include a recommendation for specialist examination (paragraph (i)(6)(ii)(B) of the standard for general industry and maritime, paragraph (h)(6)(ii)(B) of the standard for construction). If the employer's opinion contains a recommendation for specialist referral, then paragraph (i)(7)(i) of the standard for general industry and maritime (paragraph (h)(7)(i) of the standard for construction) requires the employer to make available a medical examination by a specialist within 30 days after receiving the PLHCP's written medical opinion. If the employer does not receive the PLHCP's referral because the employee did not authorize the employer to receive it, then the employer is not responsible for offering additional examinations and covering their costs.
Although the criteria for referral,
Paragraph (i)(7)(i) of the standard for general industry and maritime (paragraph (h)(7)(i) of the standard for construction) sets time limits for additional examinations to be made available. Specifically, it requires that the employer make available a medical examination by a specialist within 30 days of receiving a written medical opinion in which the PLHCP recommends that the employee be examined by a specialist. This requirement is unchanged from the proposed rule. Some commenters, including Dow Chemical, Ameren, and EEI, commented that it might take more than 30 days to get an appointment with a specialist (
Under paragraph (i)(7)(ii) of the standard for general industry and maritime (paragraph (h)(7)(ii) of the standard for construction), the employer must provide the specialist with the same information that is provided to the PLHCP (
Under paragraph (i)(7)(iii) of the standard for general industry and maritime (paragraph (h)(7)(iii) of the standard for construction), the employer must ensure that the specialist explains medical findings to the employee and gives the employee a written medical report containing results of the examination, including conditions that might increase the employee's risk from exposure to respirable crystalline silica, conditions requiring further follow-up, recommended limitations on respirator use, and recommended limitations on respirable crystalline silica exposure. The reasons why the specialist is to give the employee this information and the changes from the proposed rule are discussed above, under the requirements for the PLHCP's written medical report for the employee. For the same reasons as addressed above, paragraph (i)(7)(iv) of the standard for general industry and maritime (paragraph (h)(7)(iv) of the standard for construction) requires the specialist to provide the employer with a written medical opinion indicating the date of the examination, any recommended limitations on the employee's use of respirators, and with the written authorization of the employee, any recommended limitations on the employee's exposure to respirable crystalline silica.
The rule does not address further communication between the specialist and the referring PHLCP. OSHA expects that because the PLHCP has the primary relationship with the employer and employee, the specialist may want to communicate his or her findings to the PLHCP and have the PLHCP simply update the original written medical report for the employee and written medical opinion for the employer and employee. This is permitted under the rule, so long as all requirements and time deadlines are met.
OSHA did not include a provision for MRP in the proposed rule because the Agency preliminarily concluded that there would be few instances where temporary removal and MRP would be useful. However, OSHA asked for comment on whether the rule should include an MRP provision, which medical conditions or findings should trigger temporary removal, and what should be the maximum period for receiving benefits (78 FR at 56291).
Labor groups, industry representatives, the medical community, and other employee health advocates offered comments on this issue. NIOSH, ASSE, and some employers and industry groups agreed with OSHA's preliminary findings that MRP or temporary removal from exposure is not appropriate for the respirable crystalline silica rule (
CWA, UAW, USW, and AFL-CIO advocated for the inclusion of MRP (in the general industry and maritime standard) with provisions for multiple physician review, similar to MRP in cadmium (Document ID 2240, p. 4; 2282, Attachment 3, pp. 23-24; 3584, Tr. 2541-2546; 4204, pp. 91-98). None of the labor groups requested an MRP provision for the construction standard. According to Collegium Ramazzini and AFL-CIO, benefits of MRP include: Encouraging employees to participate in medical surveillance and allowing for transfer when an employee is unable to wear a respirator (
OSHA did not propose MRP for respirable crystalline silica because the adverse health effects associated with respirable crystalline silica exposure (
OSHA has declined to adopt MRP provisions in other health standards under similar circumstances. For example, in its chromium (VI) standard, OSHA did not include an MRP provision because chromium (VI)-related health effects are either chronic conditions that will not be improved by temporary removal from exposure (
Similarly, the 1,3-butadiene standard, which primarily addresses irreversible effects, such as cancer, does not include MRP provisions (61 FR 56746 (11/4/96)).
OSHA recognizes that some employees might benefit from removal from respirable crystalline silica exposure to possibly prevent further progression of disease. However, the health effects evidence suggests that crystalline silica-related diseases are permanent (Document ID 2177, Attachment B, p. 39). Thus, to be beneficial, any such removals would have to be permanent, not temporary. Even in cases where employees might benefit from temporary removal, such as to alleviate exacerbation of COPD symptoms, COPD itself is not reversible. In response to commenters indicating that temporary removal might alleviate COPD symptoms, OSHA anticipates that periods of exacerbation will continue to recur absent permanent removal from respirable crystalline silica exposure. OSHA views MRP as a tool for dealing with temporary removals only, as reflected in the Agency's decisions not to adopt MRP in the chromium (VI), ethylene oxide, and 1,3-butadiene standards. Workers' compensation is the appropriate remedy when permanent removal from exposure is required.
When the D.C. Circuit Court reviewed OSHA's initial decision not to include MRP in its formaldehyde standard, it remanded the case for OSHA to consider the appropriateness of MRP for permanently removed employees (
Given that MRP benefits apply only to a temporary period, it is logical that eligibility be limited to employees with a temporary need for removal, as has been done in a number of standards, such as cadmium (1910.1027(l)(12)), benzene (1910.1028(i)(9)) and methylene chloride (1910.1052(j)(12)). Temporary wage and benefit protections may address the concerns of employees who fear temporary removal, but employees who fear permanent removal are unlikely to be persuaded by a few months of protection. The evidence in the record does not demonstrate that affected employees are unlikely to participate in medical surveillance absent wage and benefit protection. In contrast, extensive evidence in the record demonstrates that lack of confidentiality regarding medical findings would more likely lead to employees refusing medical examinations (
A major reason for inclusion of MRP in the formaldehyde standard is that medical surveillance depends on employee actions. The formaldehyde standard does not have a medical examination trigger, such as an action level, but instead relies on annual medical questionnaires and employee reports of signs and symptoms. Thus, the approach is completely dependent on employee cooperation (57 FR at 22293). Unlike the formaldehyde standard, respirable crystalline silica medical surveillance programs for the general industry/maritime and construction standards are not entirely dependent on employee reports of signs and symptoms. The respirable crystalline silica standard for general industry and maritime requires that regular medical examinations be offered to employees exposed at or above the action level for 30 or more days per year, and the construction standard requires that medical examinations be offered to employees required to wear a respirator for 30 or more days a year. Both standards mandate that those examinations include a physical examination, chest X-ray, and spirometry testing. Independent of any subjective symptoms that may or may not be reported by the employee, PLHCPs conducting these examinations can make necessary medical findings based on objective findings from the physical examination, X-ray, and spirometry tests.
Lead is another example of a standard in which medical surveillance findings may be influenced by employee actions. In the lead standard, OSHA adopted an MRP provision in part due to evidence that employees were using chelating agents to achieve a rapid, short-term reduction in blood lead levels because they were desperate to avoid economic loss, despite the possible hazard to their health from the use of chelating agents. In the case of the lead standard, successful periodic monitoring of blood lead levels depends on employees not attempting to alter their blood lead levels (43 FR 54354, 54446 (11/21/78)).
Other reasons OSHA has cited for needing to include MRP in its health standards are similarly inapplicable to respirable crystalline silica. In lead, for example, OSHA explained that the new blood lead level removal criteria for the lead standard were much more stringent than criteria being used by industry at that time. Therefore, many more temporary removals would be expected under the new standard, thereby increasing the utility of MRP (43 FR at 54445-54446). There are no criteria in this new rule that are likely to increase the number of medical removals that may be occurring.
OSHA adopted MRP in the lead standard because it “. . . anticipate[d] that MRP w[ould] hasten the pace by which employers compl[ied] with the new lead standard” (43 FR at 54450). OSHA reasoned that the greater the degree of noncompliance, the more employees would suffer health effects necessitating temporary medical removal and the more MRP costs the employer would be forced to incur. OSHA thought that MRP would serve as an economic stimulus for employers to protect employees by complying with the standard. With respect to respirable crystalline silica, its disease outcomes (
In addition, although OSHA required medical removal in the benzene standard after referral to a specialist (1910.1028(i)(8)(i)), the circumstances there are also distinguishable from respirable crystalline silica. MRP was required in the benzene standard because some benzene-related blood abnormalities could rapidly progress to serious and potentially life threatening disease, and continued benzene exposure could affect progression (52 FR at 34555). With the exception of acute silicosis, which is rare, silica-related diseases progress slowly over a span of years. Thus, in most cases, there is no urgent need for removal from respirable crystalline silica exposure while awaiting a specialist determination.
OSHA also notes that there are three health standards that provide limited MRP under their requirements for respiratory protection. They are asbestos, (1910.1001(g)(2)(iii)), cotton dust (1910.1043(f)(2)(ii)), and cadmium (29 CFR 1910.1027(l)(ii)). These standards require MRP when a medical determination is made that an employee who is required to wear a respirator is not medically able to wear the respirator and must be transferred to a position with exposures below the PEL, where respiratory protection is not required. OSHA has determined that such a provision is unnecessary for the respirable crystalline silica rule because OSHA has since revised its respiratory protection standard to specifically deal with the problem of employees who are medically unable to wear negative pressure respirators by requiring the employer to provide a powered air-purifying respirator (29 CFR 1910.134(e)(6)). Such an approach has been used by employers who are unable to move employees to jobs with lower exposure (Document ID 3577, p. 610). In this rule, OSHA requires employers to comply with 29 CFR 1910.134, including medical evaluations mandated under that standard.
In summary, OSHA finds MRP to be neither reasonably necessary nor appropriate for the respirable crystalline silica rule. In other health standards, OSHA has stated that the purpose of MRP is to encourage employees to participate in medical surveillance by assuring them that they will not suffer wage or benefit loss if they are temporarily removed from further exposure as a result of findings made in the course of medical surveillance. OSHA's primary reason for not including MRP in the respirable crystalline silica rule is that the Agency does not expect a significant number of employees to benefit from temporary removal from their jobs as a result of medical surveillance findings. In addition, the medical surveillance program in the respirable crystalline silica rule is less dependent on employee action that could influence medical surveillance findings than the programs in some other health standards that include MRP, such as lead and formaldehyde. Other considerations that have led OSHA to use MRP in the past are also not applicable in the context of respirable crystalline silica. OSHA expects that respirable crystalline silica-related health effects would result in very few temporary medical removals, and the evidence demonstrates that any removals that would occur would likely need to be permanent. OSHA concludes that the evidence in the record, relevant court decisions, and the criteria OSHA has previously applied to determine necessity for MRP do not support a finding that MRP is reasonably necessary or appropriate for the respirable crystalline silica rule.
To address the possibility that some employees may decline to participate in medical surveillance because of fear of retaliation or discrimination, NISA suggested that OSHA require employee participation in medical surveillance, as well as include a prohibition on discrimination in the rule or clarify that Section 11(c) of the OSH Act applies to discrimination based on medical surveillance findings. NISA requested that OSHA at least confirm that employers are free to require medical surveillance as a condition of employment (Document ID 4208, pp. 15-18).
As indicated in the NISA comments, Section 11(c) of the OSH Act prohibits discharge or discrimination against any
Although acknowledging that the 11(c) protections are important because they establish that employees cannot be discriminated against for exercising their rights under the Act, Peg Seminario, on behalf of the AFL-CIO, stated that the enforcement mechanisms are very weak. Ms. Seminario pointed to the lack of an administrative process through the Review Commission, such as exists for compliance violations under standards, and she also stated that very few 11(c) cases are moved forward. In addition, Ms. Seminario testified that 11(c) deals with individual cases but does not address broad practices (Document ID 3578, Tr. 981-982). BCTD pointed to testimony given by Professor Emily Spieler before a Senate Subcommittee on Employment and Workplace Safety that described weaknesses of 11(c) and gave recommendations for improving it (Document ID 4072, Attachment 27; 4223, p. 138). BCTD concluded that an anti-discrimination/retaliation provision might provide employees with “an alternative, and potentially quicker, mechanism for gaining the Act's protections” (Document ID 4223, p. 139).
OSHA recognizes that Section 11(c) of the Act has been an imperfect avenue for preventing retaliation and addressing employee complaints of discharge or discrimination for exercising rights afforded by the Act. For this reason, separate from this rulemaking, OSHA has made considerable efforts in recent years to enhance the effectiveness of its Section 11(c) program to protect employees from retaliation for exercising their rights under the OSH Act and other anti-retaliation statutes enforced by OSHA. These efforts include administrative restructuring to create a separate Directorate of Whistleblower Protection Programs as one of eight Directorates in OSHA; adding additional investigators; and providing additional training for investigators and Labor Department solicitors who work on whistleblower cases. The Agency's Whistleblower Investigations Manual updated procedures and provided further guidance to help ensure consistency and quality of investigations (
In response to the suggestion that OSHA prohibit employees from opting out of medical surveillance, OSHA observes that Section (6)(c)(7) of the OSH Act specifies that medical examinations or other tests “be made available,” not that they be required. OSHA considers the medical surveillance offered under the rule to offer important protections for employees, and the Agency encourages all eligible employees to take advantage of these protections. However, the Agency recognizes that employees may choose not to take advantage of medical surveillance for a variety of reasons. OSHA does not find it appropriate to require all eligible employees to receive medical surveillance simply to preclude the possibility that an employer might discriminate against those who receive medical surveillance. The Agency also notes that Section 20(a)(5) of the OSH Act generally precludes OSHA from requiring medical surveillance for those who object on religious grounds. At the same time, nothing in the rule precludes an employer from requiring participation in medical surveillance programs as appropriate under applicable laws and/or labor-management contracts.
The ASTM standards require that medical surveillance be triggered by the PEL or other occupational exposure limit, but for the general industry and maritime standard, OSHA is triggering medical surveillance at the action level because of remaining significant risk, exposure variability, and increased sensitivity of some employees. The ASTM standards recommend medical examinations before placement but OSHA allows the examinations to be conducted within 30 days to offer more flexibility.
The ASTM standards recommend tuberculosis testing for employees with radiographic evidence of silicosis, but the rule requires tuberculosis testing in the initial examination for all employees who qualify for medical surveillance. OSHA's requirement is based on evidence that exposure to respirable crystalline silica increases the risk for a latent tuberculosis infection becoming active, even in the absence of silicosis. The ASTM standards do not specifically
Lastly, the E 1132-06 standard allows the health provider to report information to the employer, such as if the employee has a condition that might put him or her at risk for health impairment or if limitations on respirator use are related to medical or emotional reasons. Under the rule for respirable crystalline silica, medical findings are withheld from the employer and only reported to the employee because of privacy concerns and discrimination/retaliation fears that might prevent participation in medical surveillance. Both ASTM standards require the employer to follow the physician's placement or job assignment recommendations; the OSHA rule differs from the ASTM standards in this respect by allowing employees to make their own placement decisions if they are able to do the work.
Paragraph (j) of the standard for general industry and maritime (paragraph (i) of the standard for construction) sets forth requirements intended to ensure that the dangers of respirable crystalline silica exposure are communicated to employees. Employees need to know about the hazards to which they are exposed, along with associated protective measures, in order to understand how they can minimize potential health hazards. As part of an overall hazard communication program, training serves to explain and reinforce the information presented on labels and in safety data sheets (SDSs). These written forms of communication will be effective and relevant only when employees understand the information presented and are aware of the actions to be taken to avoid or minimize exposures, thereby reducing the possibility of experiencing adverse health effects. Numerous commenters, including industry stakeholders and dozens of construction employees and concerned individuals, generally supported inclusion of a hazard communication requirement in the rule (
Paragraph (j)(1) of the standard for general industry and maritime (paragraph (i)(1) of the standard for construction) requires the employer to (1) include respirable crystalline silica in the program established to comply with the hazard communication standard (HCS) (29 CFR 1910.1200); (2) ensure that each employee has access to labels on containers of crystalline silica and SDSs, and is trained in accordance with the provisions of the HCS and the provisions on employee information and training (contained in paragraph (j)(3) of the standard for general industry and maritime, paragraph (i)(2) of the standard for construction), and (3) ensure that at least the following hazards are addressed: Cancer, lung effects, immune system effects, and kidney effects. These requirements remain unchanged from the proposed rule, after OSHA considered comments addressing these requirements (discussed below).
The approach in paragraph (j)(1) of the standard for general industry and maritime (paragraph (i)(1) of the standard for construction) is consistent with other OSHA substance-specific health standards, which were revised as part of the 2012 update of the HCS to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The 2012 update of the substance-specific standards involved revising the hazard communication requirements to refer to the HCS requirements for labels, SDSs, and training, and to identify the hazards that need to be addressed in the employer's hazard communication program for each substance-specific standard. In applying the approach described in paragraph (j)(1) of the standard for general industry and maritime (paragraph (i)(1) of the standard for construction), OSHA intends for the hazard communication requirements in the respirable crystalline silica rule to be substantively as consistent as possible with the HCS, while including additional specific requirements needed to protect employees exposed to respirable crystalline silica. A goal of this approach is to avoid a duplicative administrative burden on employers who must comply with both the HCS and this rule.
Some stakeholders agreed with OSHA that additional hazard communication provisions are needed in this rule. For example, the National Industrial Sand Association (NISA) generally agreed with OSHA's approach for communication of hazards to employees and indicated that the generic training elements of the HCS alone are insufficient (Document ID 2195, p. 45). In addition, labor unions such as the United Automobile, Aerospace and Agricultural Implement Workers of America (UAW), International Union of Operating Engineers (IUOE), American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), International Union of Bricklayers and Allied Craftworkers (BAC), and Building and Construction Trades Department, AFL-CIO (BCTD) generally agreed that employees exposed to respirable crystalline silica need additional information and training (Document ID 2282, Attachment 3, p. 24; 3583, Tr. 2367; 4204, p. 98; 4219, p. 22; 4223, p. 114).
However, other stakeholders expressed the view that OSHA's existing HCS requirements are sufficient, and that hazard communication provisions in this rule are not warranted. For example, the National Stone, Sand, and Gravel Association (NSSGA) asserted that requiring information and training under the respirable crystalline silica rule would be duplicative and unnecessary because OSHA's existing HCS adequately addresses communication of hazards and training of employees (Document ID 2327, Attachment 1, p. 11). The Portland Cement Association and National Association of Home Builders (NAHB) expressed similar views (Document ID 2284, p. 6; 2296, p. 44).
OSHA understands that the HCS already addresses communication of hazards but, after reviewing rulemaking record comments, reaffirms that employees exposed to respirable crystalline silica need additional training and information. Therefore, OSHA has decided to include in the rule the approach set forth in the proposed rule. The rule thus requires compliance with the HCS and the additional requirements that address aspects of employee protection that are not specified in the HCS but are relevant to these standards; examples of these provisions include health hazards specific to respirable crystalline silica, signs at entrances to regulated areas, training on medical surveillance, and training on engineering controls. Specific comments on these requirements and OSHA's rationale for their inclusion in the rule are discussed below. OSHA expects this approach will reduce the administrative burden on employers who must comply with both the HCS and this rule, while providing employees with adequate information and effective training on respirable crystalline silica hazards.
Which hazards should be addressed in employers' HCS programs was a
OSHA does not find these arguments persuasive. As discussed in Section V, Health Effects, OSHA evaluated the best available published, peer-reviewed literature on respirable crystalline silica and considered comments from stakeholders to determine that exposure to respirable crystalline silica is associated with silicosis and other non-malignant respiratory disease, lung cancer, immune system effects, and kidney effects. Inclusion of a minimum list of health effects to address as part of hazard communication, based primarily on information from OSHA's rulemakings, is consistent with the 2012 revision of all substance-specific standards (77 FR 17574, 17749-17751, 17778-17785 (3/26/2012)). Therefore, the Agency concludes that including a list of hazards to be addressed, and the specific hazards listed, are appropriate.
Commenters such as the United Steelworkers (USW) and the American Federation of State, County, and Municipal Employees (AFSCME) requested that the rule require training on tuberculosis (Document ID 2336, pp. 14-15; 4203, p. 7). OSHA did not specifically list tuberculosis as a health hazard to be addressed because initial tuberculosis infection is not related to respirable crystalline silica exposure. In addition, the HCS describes health hazards in terms of target organs affected, such as lungs, or specific endpoints, such as carcinogenicity. Tuberculosis is not an endpoint listed in the HCS; thus, listing it in this rule would be inconsistent with the HCS. Consequently, OSHA has decided not to add tuberculosis to the list of hazards that must be addressed. However, because respirable crystalline silica exposure increases the risk of a latent tuberculosis infection becoming active, OSHA encourages employers to address tuberculosis as part of their hazard communication program.
Paragraph (j)(2) of the standard for general industry and maritime requires employers to post signs at all entrances to regulated areas. Although OSHA proposed a requirement for demarcating regulated areas, the Agency did not propose a requirement for warning signs at entrances to regulated areas, and instead noted that the areas could be effectively demarcated by signs, barricades, lines, or textured flooring (78 FR at 56273, 56450 (9/12/13)). The AFL-CIO argued that warning signs are an important method of making employees aware of potential hazards and noted that warning signs are required at entrances to regulated areas by many OSHA standards (Document ID 4204, pp. 100-101). A number of commenters, including the Communication Workers of America (CWA), Upstate Medical University, the American Public Health Association (APHA), UAW, and HalenHardy, agreed that warning signs must be required at regulated areas (
OSHA finds these arguments persuasive and agrees that it is appropriate to require signs at entrances to regulated areas, which are required only in the general industry and maritime standard (
The required language for the signs is consistent with labeling requirements in Appendix C of the HCS, which specifies standardized language to communicate information to employees. The revised HCS requires the use of one of two signal words—“Danger” or “Warning”—on labels of hazardous chemicals. The word “Danger” is used for more severe hazard categories, such as carcinogens. OSHA is requiring the word “Danger” based on the evidence of lung toxicity and carcinogenicity of respirable crystalline silica. “Danger” is used to alert employees that they are in an area where the permissible exposure limit (PEL) is or can reasonably be expected to be exceeded and to emphasize the importance of the message that follows.
Charles Gordon requested that warning signs also warn about kidney hazards (Document ID 4236, p. 6). The hazard statements about cancer and lung damage required on signs are the minimum requirements and focus on the most prominent adverse health effects associated with respirable crystalline silica exposure. OSHA concludes that it is unnecessary to list every relevant hazard warning on signs at entrances to regulated areas because other sources of information, such as SDSs and training, will provide more comprehensive information to employees. In addition, addressing cancer and lung damage is conceptually consistent with specific wording
The warning sign must include notice about the need for respiratory protection in regulated areas required under the general industry and maritime standards. As explained in the summary and explanation of
Some labor unions that represent construction employees, such as BCTD, IUOE, and BAC, asked OSHA to include requirements for warning signs in the construction standard to warn employees about health hazards or requirements for control measures (
As discussed in the summary and explanation of
IUOE requested a requirement to affix warning labels listing the health hazards of respirable crystalline silica on enclosed cabs to remind operators not to work with windows open (Document ID 2262, pp. 34-35). Where enclosed cabs are used to limit exposures to respirable crystalline silica, the employer must ensure that these controls are properly implemented (paragraph (c)(1) of the standard for construction) and that employees can demonstrate knowledge of the controls (paragraph (i)(2)(i)(C) of the standard for construction). Therefore, OSHA concludes that a general requirement to affix warning labels to cabs is unwarranted and construction employers are in the best position to determine if there is a need for warning labels in their workplaces as a reminder to properly implement controls. As a result, OSHA has not included such a requirement in the standard.
Proposed paragraph (i)(2)(i) included the requirements related to employee information and training. The proposed rule called for the employer to ensure that each “affected employee” can demonstrate knowledge of the specified training elements discussed below. OSHA defined “affected employee” as any employee who may be exposed to respirable crystalline silica under normal conditions of use or in a foreseeable emergency. OSHA received several comments related to a trigger for training requirements. For example, the American Iron and Steel Institute (AISI) commented that the terms “each employee” and “each affected employee” were used interchangeably in the proposed rule and that OSHA needed to clarify which employees needed to receive training; both Newport News Shipbuilding and AISI commented that training should be limited to those employees who could foreseeably be exposed above the PEL (Document ID 2144, p. 2; 3492, p. 3). Southern Company was concerned that training would be required for all employees potentially exposed to silica, and although disagreeing with an action level of 25 micrograms per cubic meter of air (μg/m
OSHA has clarified the trigger for training requirements in the rule by aligning these requirements with the scope of the rule. Paragraph (j)(3)(i) of the standard for general industry and maritime (paragraph (i)(2)(i) of the standard for construction) requires training for each employee covered by the rule. Consistent with the scope provision in paragraph (a)(2) of the standard for general industry and maritime, training is required for each employee, unless the employer has objective data demonstrating that exposures will remain below 25 μg/m
Stakeholders also offered comments on the proposed requirement that employers ensure that affected employees can “demonstrate knowledge” of the training subjects in proposed paragraphs (i)(2)(i)(A)-(D). The proposed rule did not specify precisely how training should be accomplished. Instead, it defined the hazard communication requirements in terms of objectives meant to ensure that employees are made aware of the hazards associated with respirable crystalline silica in their workplace and how they can help to protect themselves. The proposed rule's performance-oriented approach was consistent with the HCS and many of OSHA's substance-specific standards.
Some stakeholders commented on OSHA's performance-based approach to training. For example, Diane Matthew Brown, Health and Safety Specialist from AFSCME, testified that training should be as interactive as possible to allow for different learning styles (Document ID 3585, Tr. 3115). CISC supported the performance-oriented approach to training but also stated it would support a requirement that employees be able to ask questions during training (Document ID 4217). IUOE recommended interactive training so that employees could have their questions answered during the training (Document ID 3583, Tr. 2369). Although agreeing with the importance of a knowledgeable person to answer trainee questions, Ameren Corporation considered it burdensome to have someone immediately available to answer questions (Document ID 2315, p. 4). The Laborers' Health and Safety Fund of North America (LHSFNA) indicated that hands-on training is the best approach to training an employee who performs tasks that generate dust in the proper operation of a tool and associated engineering controls (Document ID 3589, Tr. 4220-4221).
After considering the comments on this issue, OSHA has decided that the training requirements under the respirable crystalline silica rule, like those in the HCS, are best accomplished when they are performance-oriented. OSHA concludes that the employer is in the best position to determine how the training can most effectively be accomplished. Hands-on training, videotapes, slide presentations, classroom instruction, informal discussions during safety meetings, written materials, or any combination of these methods may be appropriate. However, to ensure that employees comprehend the material presented during training, it is critical that trainees have the opportunity to ask questions and receive answers if they do not fully understand the material that is presented to them. OSHA reiterates that when videotape presentations or computer-based programs are used, this requirement may be met by having a qualified trainer available to address questions after the presentation, or providing a telephone hotline so that trainees will have direct access to a qualified trainer. Although it is important that employees be able to ask questions, OSHA finds that the employer is in the best position to determine whether an instructor must be available for questions during training or if a trainer can answer questions after the training session. Such performance-oriented requirements are intended to encourage employers to tailor training to the needs of their workplaces, thereby resulting in the most effective training program for each workplace.
In addition to asking about how training should be accomplished, stakeholders posed questions about how employers can determine that they have fulfilled the training requirements. For example, the American Foundry Society stated that the term “demonstrate knowledge” is vague and requested that the rule include language to specify when a training requirement is met (Document ID 2379, Appendix 1, p. 72). OSHA concludes that employers can determine whether employees have the requisite knowledge through methods such as discussion of the required training subjects, written tests, or oral quizzes. Retired industrial hygienist Bill Kojola, testifying on behalf of the National Council for Occupational Safety and Health (NCOSH), suggested that compliance officers could question employees to determine if they know about medical surveillance and work practices or engineering controls to reduce exposures (Document ID 3586, Tr. 3259). Similarly, UAW coordinator, Andrew Comai, and a private citizen, Cara Ivens, opined that compliance officers could ask employees if they are aware that they are working with hazardous chemicals or know about the health effects of respirable crystalline silica (Document ID 1801, p. 4; 3582, Tr. 1869). OSHA concludes that employers can similarly assess their employees' knowledge and understanding of training topics.
The proposed rule did not include a provision that required training to be conducted in a language and manner that the employee understands. A number of labor unions and employee advocate groups requested that the rule include a requirement for training to be conducted in a language and manner that employees understand (
OSHA agrees. Paragraph (j)(3)(i) of the standard for general industry and maritime (paragraph (i)(2)(i) of the standard for construction) requires the employer to ensure that each employee covered by the standard demonstrates knowledge and understanding of the required training subjects. The requirement for employers to ensure that the employee demonstrates knowledge in the training subjects obligates the employer to provide training in a language and manner that the employee understands. The employee must understand training in order to demonstrate knowledge of the specified training elements. To clarify this requirement, OSHA has revised the proposed text to require the employer to ensure that employees demonstrate understanding, in addition to knowledge. This requirement is consistent with Assistant Secretary David Michaels' memorandum to OSHA Regional Administrators (Document ID 1499). The memorandum explains that because employees have varying educational levels, literacy, and language skills, training must be presented in a language, or languages, and at a level of understanding that accounts for these differences in order to ensure that employees understand the training. As stated by Assistant Secretary Michaels:
This may mean, for example, providing materials, instruction, or assistance in Spanish rather than English if the employees being trained are Spanish-speaking and do not understand English. However, the employer is not required to provide
Proposed paragraphs (i)(2)(i)(A)-(D) specified the contents of training for affected employees. The proposed list included training on operations that could result in exposures and methods for protecting employees from exposure, the contents of the respirable crystalline silica rule, and the purpose and a description of the employer's medical surveillance program. The proposed rule did not contain a provision requiring training on health effects. However, under the HCS, employers would have to train employees on the health hazards associated with chemicals in the work area (29 CFR 1910.1200(h)(3)(ii)). In addition, the preamble to the proposed rule mentioned that training on medical surveillance under proposed paragraph (i)(2)(i)(D) should cover the signs and symptoms of respirable crystalline silica-related health effects (78 FR at 56474).
OSHA asked for comments on the scope and depth of the proposed training requirements and whether additional training provisions needed to be added (78 FR at 56291). Stakeholders offered a number of comments on these proposed provisions. For example, concerned individuals, a medical school, and labor unions requested that training address the health effects associated with respirable crystalline silica exposure (
Several commenters stated that employees would not ask for or use appropriate protection without knowledge of health hazards (
I had a dust mask and a pair of safety glasses for my protection. . . . We were not offered better personal protection gear and did not request any as we were not made aware of the risks of silica exposure (Document ID 1758).
Operating engineer Keith Murphy, representing IUOE, testified that employees will wear respirators if informed that they are exposed to dangerous concentrations of respirable crystalline silica (Document ID 3583, Tr. 2375-2376). In testifying about her experiences in training construction employees, Marién Casillas Pabellón, Director of New Labor, stated:
[Seventy percent] of these workers were not able to say what silica was or if they were . . . exposed to it. When they learned about the long term effects to their health many were alarmed. Training has been key in getting workers to demand . . . the right equipment and tools to complete their task safely. Always after trainings we follow up with the participants to measure the impact of the trainings. [Fifty-five percent] of the workers that received training around these issues expressed that they have demanded personal protective equipment and other tools to do their work safely after the training (Document ID 3571, Attachment 6, p. 2).
Based on the evidence showing the need for and positive impact of health hazard training and to ensure that covered employees receive that training, OSHA is requiring training on health hazards specifically associated with respirable crystalline silica. The requirement is contained in paragraph (j)(3)(i)(A) of the standard for general industry and maritime (paragraph (i)(2)(i)(A) of the standard for construction).
Proposed paragraph (i)(2)(i)(A) required that employees be trained on specific operations in the workplace that could result in exposure to respirable crystalline silica, especially operations where exposures may exceed the PEL. BCTD recommended that “tasks” rather than “operations” be used, because operations could include various tasks; it also requested that OSHA remove the statement “especially operations where exposure may exceed the PEL” (Document ID 2371, Attachment 1, pp. 23, 35). OSHA agrees that “tasks” is the more appropriate term. The Agency also agrees that employers and employees must understand all sources of potential respirable crystalline silica exposure and, therefore, removed the phrase “especially operations where exposure may exceed the PEL.” Therefore, OSHA has revised the proposed language so that paragraph (j)(3)(i)(B) of the standard for general industry and maritime (paragraph (i)(2)(i)(B) of the construction standard) now requires training on specific workplace tasks that could result in exposure to respirable crystalline silica.
Proposed paragraph (i)(2)(i)(B) required that employees be trained on procedures implemented by the employer to protect them from respirable crystalline silica exposure, including appropriate work practices and use of personal protective equipment (PPE), such as respirators and protective clothing. Labor unions and employee advocate groups, such as CWA, UAW, USW, NCOSH, AFSCME, IUOE, and BCTD, requested that OSHA also specify training on engineering controls (Document ID 2240, p. 4; 2282, Attachment 3, p. 24; 2336, p. 15; 3955, Attachment 2, p. 2; 4203, p. 7; 4025, Attachment 1, p. 2; 4223, p. 118). The value of training on engineering controls is demonstrated by the testimony of construction employee and New Labor Safety Liaison, Norlan Trejo, who stated that because of his training, he is aware of the types of engineering controls needed on job sites and he requests such controls if the employer does not provide them (Document ID 3583, Tr. 2462-2463).
Because engineering controls are a vital aspect of reducing exposures, OSHA has concluded that employees covered by this rule must understand how they work in order to use the appropriate work practices to fully and properly implement those controls and to be able to recognize if engineering controls are malfunctioning. Therefore, OSHA has revised the proposed provision to also require training on engineering controls. OSHA has also removed the term “appropriate” because it is implicit that any work practice or other methods used to protect employees be appropriate. In addition, “personal protective equipment” and “protective clothing” were removed from the paragraph because respirators are the only type of PPE required by the rule. Thus, paragraph (j)(3)(i)(C) of the standard for general industry and maritime (paragraph (i)(2)(i)(C) of the standard for construction) requires training on specific measures implemented by the employer to protect employees from respirable crystalline silica exposure, including engineering controls, work practices, and respirators to be used.
Several labor unions that represent employees in the construction industry highlighted additional training that they thought necessary for some construction employees. For example, BCTD requested that OSHA establish tiered training requirements in the construction standard to include: (1) Basic awareness training for all
In supporting a tiered approach, BCTD noted “the effectiveness of the standard and the engineering controls used to limit silica exposure depend heavily on how the controls are used.” (Document ID 4223, p. 117). Dr. Paul Schulte, Director of the Education and Information Division at the National Institute for Occupational Safety and Health, testified that engineering controls listed in Table 1 are only effective if they are maintained and employees are trained on their correct use (Document ID 3403, p. 6). Similar views regarding training and effectiveness of controls were expressed by Joel Guth, President of iQ Power Tools, Bill Kojola, and Tom Nunziata, instructor/training coordinator for LHSFNA; Mr. Nunziata also noted the importance of hands-on training (Document ID 3585, Tr. 2982-2983; 3586, Tr. 3204-3206; 3589, Tr. 4220-4221).
Evidence in the record further demonstrates knowledge of work practices that employees must have for controls to function effectively. For example, the user's manual for Stihl's gasoline-powered hand-held portable saws recommends training of operators, and it indicates that operators need to know minimum water flow rates, how to control flow rate to ensure an adequate volume of water to the cutting area, and to rinse the screen if no or little water is fed to the cutting wheel during use (Document ID 3998, Attachment 12a, pp. 3, 15, 23). Similarly, the effectiveness of local exhaust ventilation systems, another common method used to control exposures to respirable crystalline silica, is often enhanced by the use of proper work practices. For instance, when tuckpointing, employees should ensure that the shroud surrounding the grinding wheel remains flush against the working surface, when possible, to minimize the amount of dust that escapes from the collection system. Operating the grinder in one direction (counter to the direction of blade rotation) is effective in directing mortar debris into the exhaust system, and backing the blade off before removing it from the slot permits the exhaust system to clear accumulated dust (78 FR at 56474). Employees using vacuum controls also need to be aware of appropriate ways to clean the filter, such as using a valve on the vacuum to clean the filter with backpressure instead of pounding the filter on a surface (Document ID 3998, Attachment 13b, p. 460).
The record also contains evidence demonstrating the importance of employees understanding how to effectively operate and maintain controls on heavy equipment to prevent exposures to respirable crystalline silica in the construction industry. For example, IUOE noted that the role of operating engineers in ensuring integrity of enclosed cabs includes keeping windows and doors closed, maintaining good housekeeping practices, cleaning dust from boots before entering the cab, and reporting malfunctioning seals and air conditioning (Document ID 2262, pp. 35-36). In addition, IUOE noted that operator control of water flow rates for dust suppression is important for protecting employees from exposure and preventing excessive water runoff into the environment (Document ID 4234, Part 1, pp. 27-28). Anthony Bodway, Special Projects Manager at Payne & Dolan, Inc., representing the National Asphalt Pavement Association (NAPA), noted that all Payne & Dolan's operators have been trained to conduct daily maintenance checks of their equipment (Document ID 3583, Tr. 2194-2195). A best practices bulletin developed in part by NAPA requires machine operators to demonstrate knowledge of the machine's dust suppression system including flow rates, maintenance, troubleshooting, and visual inspections; in addition a letter from manufacturer Wirtgen America stressed the importance of operator training on operating and maintaining machines to minimize respirable dust (Document ID 2181, pp. 25, 52).
OSHA agrees that actions, such as controlling water flow rates, ensuring integrity of controls, addressing a non-functioning control, and proper housekeeping in cabs, are work practices that promote effectiveness of controls. However, the Agency does not agree that construction employees who perform tasks that generate respirable crystalline silica dust require training beyond what paragraph (i)(2)(i)(C) of the standard for construction already requires. As noted above, paragraph (i)(2)(i)(C) of the standard for construction requires employers to ensure that employees covered by the standard can demonstrate knowledge and understanding of specific measures the employer has implemented to protect them from respirable crystalline silica exposure, including engineering controls, work practices, and respirators to be used. Under this provision, the knowledge required of each employee depends on the tasks he or she performs. That was the intent of the proposed standard and it has not changed in the standard. OSHA concludes that this provision, as written, requires employers to provide employees with the different types and levels of training they need, depending on the types of tasks they conduct. For example, laborers who do not operate equipment that generates respirable crystalline silica dust would only need to be aware of the general types of controls used, such as water and local exhaust. However, those laborers would need to know about work practices for tasks they perform, such as appropriate clean-up of respirable crystalline silica dust accumulations. On the other hand, employees who operate tools with built-in controls, such as saws with integrated water delivery systems, would need to demonstrate knowledge and understanding of the full and proper implementation of the controls on those tools.
OSHA is also not mandating additional training for a competent person in paragraph (i) of the standard for construction. As discussed in more detail in the summary and explanation of
AFL-CIO and USW requested that the standard for general industry also mandate a tiered approach that includes a higher level of training for employees who perform silica dust-generating tasks and training of a competent person; both those groups and UAW noted the importance of workplace- or job-specific training on engineering controls and work practices (Document ID 2282, Attachment 3, p. 24; 4204, p. 99; 4214, p. 14).
OSHA concludes that employees are already required to demonstrate workplace- and job-specific knowledge and understanding of work practices associated with the tasks they conduct under paragraph (j)(3)(i)(C) of the standard for general industry and maritime. That was the intent of the proposed standard and it has not changed in the standard. Engineering controls in general industry commonly involve measures such as ventilation systems that protect several employees, and are often not subject to the direct control of the employee performing the task (
Training of a competent person is not applicable to the general industry and maritime standard because OSHA is not requiring a competent person. As explained in the summary and explanation of
OSHA has retained the proposed requirement for training on the contents of the respirable crystalline silica rule in paragraph (j)(3)(i)(D) of the standard for general industry and maritime (paragraph (i)(2)(i)(D) of the standard for construction). This paragraph parallels the HCS requirement to inform employees about the requirements of the HCS section (29 CFR 1910.1200(h)(2)(i)), and similar paragraphs have been included in all OSHA substance-specific standards.
Proposed paragraph (i)(2)(i)(D) required employers to train employees about the purpose and description of the medical surveillance program, and OSHA has retained that requirement in the rule under paragraph (j)(3)(i)(E) of the standard for general industry and maritime (paragraph (i)(2)(i)(F) of the standard for construction). Paragraph (i) of the standard for general industry and maritime (paragraph (h) of the standard for construction) describes the requirements of the medical surveillance program, such as the examinations that must be offered to qualifying employees. OSHA finds that employees will benefit from learning about the purpose of medical surveillance and symptoms associated with respirable crystalline silica-related diseases, as described in the summary and explanation of
The proposed rule did not require employees to be trained on the identity of the competent person. Several labor unions, including IUOE, LHSFNA, BAC, and BCTD requested that employees receive training on the written exposure control plan or identity of the competent person (Document ID 3583, Tr. 2367-2368; 3589, Tr. 4222; 2329, p. 5; 4223, p. 118). Paragraph (g)(4) of the standard for construction requires employers to designate a competent person to make frequent and regular inspections of job sites, materials, and equipment to implement the written exposure control plan. The written exposure control plan in the construction standard describes tasks in the workplace that involve exposure to respirable crystalline silica; engineering controls, work practices, and respiratory protection used to limit employee exposures; housekeeping methods used to limit employee exposures; and procedures used to restrict access, when necessary, to minimize employees exposed and their level of exposure, including exposures generated by other employers or sole proprietors (paragraph (g)(1)(i)-(iv)). OSHA is not requiring the identity of the competent person to be listed in the written exposure control plan because it could change daily. However, construction employees must be able to identify the competent person in situations where they have a question or concern about the subjects covered in the written exposure control plan. For example, if an engineering control is not working properly, an employee may need to contact the competent person for help in addressing the problem. Therefore, paragraph (i)(2)(i)(E) of the standard for construction requires employees to be informed of the competent person's identity. However, OSHA is not specifying training on the written exposure control plan because the contents of that plan, including its availability to employees, is already addressed by training on the contents of this section under paragraph (i)(2)(i)(D) of the standard for construction.
Some stakeholders requested that OSHA provide greater specificity on training requirements. For example, Fann Contracting, Inc. asked OSHA to spell out what training is required for different industries (Document ID 2116, Attachment 1, p. 46). NAHB stated that specifying training requirements would simplify training for construction employers (Document ID 2296, p. 44). John Scardella, Program Administrator for USW, testified that training should not be left to the discretion of employers because they might not prioritize employee health and safety (Document ID 3479, p. 2). USW and LHSFNA requested more detailed training requirements, such as those of the asbestos standard (29 CFR 1910.1001; 1926.1101) that specify what is to be addressed under each major training topic (Document ID 2336, pp. 14-15; 3589, Tr. 4219).
Although OSHA agrees with these commenters that comprehensive training is a key part of hazard communication, the Agency recognizes that it is difficult to provide more specificity as a result of unique scenarios among different employers and industries. However, to help employers develop training programs that are comprehensive for general training subjects that apply to most covered industries, OSHA has developed a number of guidance products that are already available
Commenters also argued that OSHA should include requirements for training on other topics. For example, IUOE requested training on topics such as SDSs, signs, use and care of respiratory protection, and work practices for heavy machine operators (Document ID 2262, pp. 36-38; 4025, Attachment 1, p. 2). LHSFNA and BCTD requested training on exposure assessment (Document ID 3589, Tr. 4222; 4223, p. 118). AFSCME requested training on personal hygiene (Document ID 4203, p. 7).
OSHA concludes, however, that the employee information and training provisions in the respirable crystalline silica rule and the HCS are sufficiently informative. For example, the HCS requires employers to provide training on SDSs and on the signal words and hazard statements that are used on the signs required by the general industry and maritime standard. Under the HCS, employers must also train employees about the location and availability of the written HCS program, including the required list(s) of hazardous chemicals and SDSs. The HCS also requires employers to train employees on the methods and observations that may be used to detect the presence or release of a hazardous chemical in the work area; in the case of respirable crystalline silica, this could include a description of the employer's exposure assessments methods (
Because employers must meet the requirements of the HCS, OSHA does not find it necessary to repeat the training requirements of that standard in their entirety in the respirable crystalline silica rule. Moreover, even if all training requirements of the HCS were repeated in the respirable crystalline silica rule, most employers would still have to consult the hazard communication requirements of other hazardous chemicals, because they have employees exposed to other chemicals in their workplace. Consequently, OSHA concludes that these provisions, and the other requirements of the HCS and this standard, are sufficient.
OSHA also concludes that additional training on respiratory protection or personal hygiene is unnecessary. Training on the use and care of respiratory protection is already required under the respiratory protection standard (29 CFR 1910.134). OSHA similarly concludes that training in personal hygiene is not needed as a required training topic in this rule because personal hygiene measures relevant to respirable crystalline silica exposure, such as avoiding use of compressed air as a method to clean dust off of clothing, are adequately addressed by other requirements of the rule and are covered by training on work practices. Some training topics suggested by commenters, such as communication methods for employees in enclosed cabs, are specific to certain work scenarios. OSHA has concluded that employers are in the best position to determine which additional, unique training requirements are relevant to their type of industry. For example, in construction, the competent person might be able to identify situations where employees need more training because they are not demonstrating knowledge and understanding of a specific measure the employee has implemented to protect them.
OSHA's proposed rule required the employer to make a copy of the standard readily available without cost to each employee covered by the respirable crystalline silica rule, and OSHA has retained this requirement in paragraph (j)(3)(ii) of the standard for general industry and maritime (paragraph (i)(2)(ii) of the standard for construction). This is a common requirement in OSHA standards such as chromium (VI) (29 CFR 1910.1026), acrylonitrile (29 CFR 1910.1045), and cotton dust (29 CFR 1910.1043). The provision leaves employers free to determine the best way to make the standard available, such as a printed or electronic copy in a central location that employees can easily access. OSHA concludes that employees need to be familiar with and have access to the respirable crystalline silica standard for general industry and maritime or construction, as applicable, and be aware of the employer's obligations to comply with it.
OSHA did not propose a requirement for labels or signs in languages other than English. Ameren requested the rule include a requirement that labels include appropriate languages for employees who do not understand English (Document ID 2315, p. 4). Charles Gordon and BAC requested that warning signs be presented in a language or manner that employees can understand, and, as noted by BAC, the method could include graphics (Document ID 3588, Tr. 3805; 4219, p. 27). Requirements for labels on hazardous chemicals are set forth in paragraph (f) of the HCS, which does not require languages other than English. However, the HCS requires the inclusion of certain information on labels on shipped containers, including pictograms (29 CFR 1910.1200(f)(1)(iv)), and mandates that containers in the workplace be labeled either in accordance with the rules for shipping containers or with product identifier and combinations of words, pictures, or symbols to warn of hazards. OSHA has concluded that with training required under the HCS (29 CFR 1910.1200(h)(3)(iv)), even employees who are not literate in English will have sufficient knowledge of respirable crystalline silica hazards. Likewise, with training, employees will be able to recognize the meaning of signs at the entrances to regulated areas and the need for respiratory protection in these areas.
OSHA's proposed rule did not specify when and how often employees must be trained. Some stakeholders offered opinions about when an employer's obligation to train covered employees should begin. For example, USW, NCOSH, and LHSFNA requested that the rule for respirable crystalline silica require training before or at the time employees are assigned or placed in a job with respirable crystalline silica exposure (Document ID 3479, p.1; 3955, Attachment 2, p. 1; 3589, Tr. 4222). CWA, Upstate Medical College, UAW, AFSCME, AFL-CIO, and BCTD requested that the rule for respirable crystalline silica require training before employees are assigned to or placed in a job or task with respirable crystalline silica exposure (Document ID 2240, p. 4; 2244, p. 4; 2282, Attachment 3, pp. 24-25; 4203 p. 7; 4204, p. 99; 4223, p. 117).
OSHA agrees that each employee needs to be trained sufficiently to understand the specified training elements at the time of initial assignment to a position involving exposure to respirable crystalline silica. The rule requires the employer to ensure that each employee can demonstrate knowledge and understanding of the specified training elements; this requirement applies from the time that the employee is covered by the rule. This requirement is consistent with the HCS, which requires that employers provide employees with
Stakeholders also commented on how often employers should be required to train their employees. CWA, Upstate Medical College, UAW, NCOSH, AFSCME, and LHSFNA recommended periodic refresher training and additional training if methods, equipment, or controls change (Document ID 2240, p. 4; 2244, p. 4; 2282, Attachment 3, pp. 24-25; 3955, Attachment 2, p. 2; 4203 p. 8; 3589, Tr. 4222). Similarly, USW and AFL-CIO asked that OSHA require periodic refresher training (Document ID 3479, p.1; 4204, p. 99). In addition, BCTD recommended additional training when the employer believes an employee requires more training because of a lack of skill or understanding (Document ID 4223, p. 117).
OSHA agrees with commenters that additional or repeated training may be necessary under certain circumstances but does not consider it appropriate to impose a fixed schedule of periodic training. Therefore, the requirement for training is performance-oriented in order to allow flexibility for employers to provide training as needed to ensure that each employee can demonstrate the knowledge and understanding required under the rule. For example, if an employer observes an employee engaging in activities that contradict knowledge gained through training, it is a sign to the employer that the employee may require a reminder or periodic retraining on work practices.
Because paragraph (j)(3)(i)(C) of the standard for general industry and maritime (paragraph (i)(2)(i)(C) of the standard for construction) requires training on the specific measures the employee has implemented to protect employees, additional training is already required after new engineering controls are installed, new work practices are implemented, or employees are given new types of respirators. Because this provision requires employers to provide additional training following changes in protective measures or equipment, they ensure that employees are able to properly use the new controls, implement work practices relating to those controls, and properly use respirators to actively protect themselves under the conditions found in the workplace, even if those conditions change.
OSHA did not include a requirement for employees to be certified as having received training in the proposed rule. Commenters including Dr. Ruth Ruttenberg, representing the AFL-CIO, have voiced support for a portable training record or certification-based approach; Dr. Ruttenberg noted that this would reduce costs by avoiding the need for each new employer to conduct full training (Document ID 1950, pp. 11-12; 2256, Attachment 4, p. 5; 4235, p. 14). OSHA is not including a requirement for a portable training record in the rule. This approach is consistent with the HCS, which neither requires nor precludes a training record that could be portable. Employee training requirements might be partially fulfilled by training obtained through trade associations, unions, colleges, or professional schools. However, the employer is always ultimately responsible for ensuring that employees are adequately trained, regardless of the method relied upon to comply with the training requirements.
OSHA concludes that a portable training record is unlikely to eliminate the need for employer-specific or site-specific training. For example, Barbara McCabe, Program Manager for IUOE, testified that IUOE local unions train employees but employees would need site-specific training when they report to the worksite (Document ID 3583, Tr. 2368). An example of a case where site-specific training is needed was noted by BAC, who commented that an employee who operated a saw with water controls at one site may be given a saw with vacuum controls at another site (Document ID 4219, p. 23).
OSHA concludes that some site-specific or employer-specific training is always necessary, such as training on specific tasks that could result in exposures, controls or work practices that the employer has implemented, or the identity of the competent person (paragraphs (j)(3)(i)(B) and (C) of the standard for general industry and maritime and paragraphs (i)(2)(i)(B), (C), and (E) of the standard for construction). Full training would not be required if an employee is already able to demonstrate knowledge in health hazards, the contents of the respirable crystalline silica rule, or medical surveillance for respirable crystalline silica (paragraphs (j)(3)(i)(A), (D), and (E) of the standard for general industry and maritime, paragraphs (i)(2)(i)(A), (D) and (F) of the standard for construction). Site-specific training is unlikely to be costly or time-consuming. OSHA concludes that assessing an employee's knowledge to determine the type and level of additional training required is more meaningful than simply accepting a certificate of training.
Bill Kojola requested that the rule specify that training be provided at no cost to the employee and during work hours (Document ID 3955, Attachment 2, p. 2). In addition, Norlan Trejo from New Labor testified that he never saw an employer pay for training (Document ID 3583, Tr. 2469). As stated above, an employer may rely on an employee's previous training, if the employee can demonstrate knowledge in training requisites. Any training provided by the employer to meet the requirements of the rule must be provided at no cost to the employee. Employees must also be paid for time spent in training. This is consistent with other OSHA standards that do not include an explicit requirement for employer payment for training in the regulatory text,
In the Notice of Proposed Rulemaking, OSHA asked whether labeling of substances containing more than 0.1 percent crystalline silica was appropriate, as required by the HCS, or if the threshold for labeling should be greater than 1 percent crystalline silica (78 FR at 56291). A number of industry groups suggested a threshold for including respirable crystalline silica on labels or SDSs. With the exception of NISA, who favored a 0.1 percent threshold, the commenters requested a threshold of 1 percent or greater or thought that a 0.1 percent threshold could be problematic (Document ID 1785, p. 4; 2179, pp. 3-4; 2101, pp. 8-9; 2284, p. 10; 2296, p. 44; 2312, p. 3; 2317, p. 3; 2319, p. 120; 2327, Attachment 1, p. 14; 4208, pp. 19-20). The International Diatomite Producers Association agreed with NISA that the threshold for hazard communication should be 0.1 percent for respirable crystalline silica but requested an exception for respirable crystalline silica in natural (uncalcined) diatomaceous earth, according to OSHA's current policy (Document ID 4212, pp. 6-7).
The classification of hazardous chemicals, including chemicals containing silica, is determined by the HCS. As explained in Section V, Health Effects, OSHA has determined, consistent with the National Toxicology Program and International Agency for Research on Cancer classifications, that respirable crystalline silica is a carcinogen. Under the HCS, a mixture that contains a carcinogen must itself be classified as a carcinogen when at least one ingredient in it has been classified as a Category 1 or Category 2 carcinogen
OSHA also did not propose requirements related to the creation and retention of training records, but some commenters expressed opinions on this issue. For example, CISC commented that they would agree to document that employees completed training and demonstrated knowledge (Document ID 4217, p. 25). Consistent with the HCS, employers are not required to keep records of training under the rule for respirable crystalline silica, but employers may find it valuable to do so. Comments on this issue and OSHA's rationale for this decision are discussed in the summary and explanation of
ASTM standards. The training requirements in the respirable crystalline silica standards are generally consistent with but differ slightly from ASTM International (ASTM) standards ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica and ASTM E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities (Section 4.8 in both E 1132-06 and E 2625-09) (Document ID 1466, p. 6; 1504, p. 6). The E 1132-06 standard requires training for employees exposed at any level and the E 2625-09 standard for construction and demolition requires training for employees potentially exposed to high levels. The ASTM standards also include: (1) More specificity on training requirements such as annual training (E 1132-06 only), training when employees demonstrate unsafe work practices, training in an appropriate language and manner, and documentation of training (certification in the case of E 1132-06); (2) training on tuberculosis and relationships between smoking and silica exposure in both standards and no training for autoimmune and kidney hazards in E 2625-09; (3) training on respirator use and hygiene; and (4) warning signs for construction and demolition workplaces in E 2625-09.
OSHA is requiring that each employee covered by the rule receive training; employees may be at significant risk even if they are not exposed to “high levels” of respirable crystalline silica. In comparison to the ASTM standards, the requirements for training under the respirable crystalline silica rule are more performance-based in terms of when training is required. The health hazards addressed in the rule are based upon OSHA's health effects assessments and consistency with health hazard classification in the HCS. OSHA already requires training on respirator use under its respiratory protection standard (29 CFR 1910.134). The rule does not specify training on hygiene because personal hygiene is addressed by other requirements of the rule and training on work practices. OSHA is not requiring warning signs in the standard for construction because employers are in the best position to determine if and when signs are appropriate for restricting access to work areas to limit employee exposure to respirable crystalline silica. For the reasons described above, OSHA concludes that the requirements of the rule better effectuate the purposes of the OSH Act of 1970 than the ASTM standards.
Paragraph (k) of the standard for general industry and maritime (paragraph (j) of the standard for construction) requires employers to make and maintain air monitoring data, objective data, and medical surveillance records. The recordkeeping requirements are in accordance with section 8(c) of the Occupational Safety and Health (OSH) Act (29 U.S.C. 657(c)), which authorizes OSHA to require employers to keep and make available records as necessary or appropriate for the enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational accidents and illnesses.
Paragraph (k)(1)(i) of the standard for general industry and maritime (paragraph (j)(1)(i) of the standard for construction) is substantively unchanged from the proposed rule. It requires the employer to make and maintain accurate records of all exposure measurements taken to assess employee exposure to respirable crystalline silica, as prescribed in paragraph (d) of the standard for general industry and maritime (paragraph (d)(2) of the standard for construction). OSHA has added the words “make and” prior to “maintain” in order to clarify that the employer's obligation is to create and preserve such records. This clarification has also been made for other records required by the silica rule. In addition, OSHA now refers to “measurements taken to assess employee exposure” rather than “measurement results used or relied on to characterize employee exposure.” This change is editorial, and is intended to clarify OSHA's intent that all measurements of employee exposure to respirable crystalline silica be maintained. Paragraph (k)(1)(ii) of the standard for general industry and maritime (paragraph (j)(1)(ii) of the standard for construction) requires that such records include the following information: The date of measurement for each sample taken; the task monitored; sampling and analytical methods used; the number, duration, and results of samples taken; the identity of the laboratory that performed the analysis; the type of personal protective equipment, such as respirators, worn by the employees monitored; and the name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
OSHA has made one editorial modification that differs from the proposed rule in paragraph (k)(1)(ii)(B) of the standard for general industry and maritime (paragraph (j)(1)(ii)(B) of the standard for construction) and that is to change “the operation monitored” to “the task monitored.” Both “task” and “operation” are commonly used in describing work. However, OSHA uses the term “task” throughout the rule, and the Agency is using “task” in the recordkeeping provision for consistency and to avoid any potential misunderstanding that could result from using a different term. This editorial change neither increases nor decreases an employer's obligations as set forth in the proposed rule.
The recordkeeping provision that received the most comments was proposed paragraph (j)(1)(ii)(G) (now paragraph (k)(1)(ii)(G) of the standard for general industry and maritime, paragraph (j)(1)(ii)(G) of the standard for construction), which, consistent with existing recordkeeping requirements in OSHA health standards, requires the employer to include in the standard's mandated records the employee's social security number. Morgan Electro Ceramics, National Electrical Carbon Products, Inc. (NECP), Southern Company, the National Tile Contractors
OSHA has considered the comments it received on this issue and has decided to retain the requirement for including the employee's social security number in the recordkeeping requirements of the rule. The requirement to use an employee's social security number is a long-standing OSHA practice, based on the fact that it is a number that is both unique to an individual and is retained for a lifetime, and does not change as an employee changes employers. The social security number is therefore a useful tool for tracking employee exposures, particularly where exposures are associated with diseases such as silicosis that generally have a long latency period and can develop over a period of time during which an employee may have several employers.
OSHA is cognizant of the privacy concerns expressed by commenters regarding this requirement, and understands the need to balance that interest against the public health interest in requiring the social security identifier. Instances of identity theft and breeches of personal privacy are widely reported and concerning. However, OSHA has concluded that this rule should adhere to the past, consistent practice of requiring employee social security numbers on exposure records mandated by every OSHA substance-specific health standard, and that any change to the Agency's requirements for including employee social security numbers on exposure records should be comprehensive. Some employers who are covered by this rule, such as employers who perform abrasive blasting on surfaces coated with lead, cadmium, or chromium (VI), will be covered by more than one OSHA standard. OSHA examined alternative forms of identification in Phase II of the Agency's Standards Improvement Project, but did not revise requirements for the use of social security numbers (70 FR 1111-1144 (1/5/2005)). Nevertheless, given increasing concerns regarding identity theft and privacy issues, as evidenced by stakeholder comments in this rulemaking record, OSHA intends to examine the requirements for social security numbers in all of its substance-specific health standards in a future rulemaking. In the meantime, the requirement to use and retain social security numbers to comply with this rule remains.
The remaining requirements of paragraph (k)(1)(ii) of the standard for general industry and maritime (paragraph (j)(1)(ii) of the standard for construction) are generally consistent with those found in other OSHA standards, such as the standards for methylene chloride (29 CFR 1910.1052) and chromium (VI) (29 CFR 1910.1026). The additional requirement to include the identity of the laboratory that performed the analysis of exposure measurements is for the reason stated in the preamble to the Notice of Proposed Rulemaking (NPRM), which is that analysis of crystalline silica samples must conform with the requirements listed in the rule (
Fann Contracting, Inc. commented that OSHA's proposed rule would create a “recordkeeping nightmare” and raised concerns about the difficulties of managing air monitoring data for over 200 employees scattered around the state, with 7 to 8 ongoing projects and 12 to 15 total projects per year (Document ID 2116, Attachment 1, p. 11). The American Subcontractors Association expressed concerns about the high costs of transferring data to new technology or keeping records in paper format (Document ID 2187, p. 7).
OSHA understands that, as with any recordkeeping requirement in a comparable rule, there will be time, effort, and expense involved in developing and maintaining records. However, OSHA expects that even employers who manage multiple projects will have a system for maintaining these records, just as they do for their other business records. As for high expenses of transferring data to new technology, the Agency understands that there are multiple ways to maintain these records and there are expenses involved in doing so. Therefore, the Agency is allowing employers the option to use whatever method works best for them, paper or electronic.
Paragraph (k)(1)(iii) of the standard for general industry and maritime (paragraph (j)(1)(iii) of the standard for construction) is unchanged from the proposed rule. It requires the employer to ensure that exposure records are maintained and made available in accordance with OSHA's access to employee exposure and medical records standard, which specifies that exposure records must be maintained for 30 years (29 CFR 1910.1020(d)(i)(ii)). Commenters addressed the issue of how long an employer should maintain exposure records. The National Industrial Sand Association (NISA) noted that its occupational health program requires NISA members to retain employee air monitoring records indefinitely (Document ID 2195, p. 35). NISA supported the proposed requirement that air monitoring records be retained for 30 years (Document ID 2195, p. 46). Other commenters advocated recordkeeping durations ranging from 10 years to 40 years (
After reviewing the comments in this record, OSHA has concluded that the best approach is to maintain consistency with 29 CFR 1910.1020 and its required time period for retention of exposure records of 30 years. OSHA explained in that rulemaking that it is necessary to keep exposure records for this extended time period because of the long latency period between exposure and development of silica-related disease (45 FR 35212, 35268-35271 (5/23/80)). For example, silicosis is often not detected until 20 years or more after initial exposure. The extended record retention period is therefore needed because establishing causality of disease in employees is assisted by, and in some cases can only be made by, having present and past exposure data (as well as any objective data relied on by the employer and present and past medical surveillance records, as discussed below).
In retaining the 30-year retention period, OSHA does not agree with commenters who recommended extending it to at least 40 years, or even indefinitely. The Agency concludes that the 30-year retention period specified in 29 CFR 1910.1020 represents a reasonable balance between the need to maintain exposure records and the administrative burdens associated with maintaining those records for extended time periods. Because the 30-year records-retention requirement is included in 29 CFR 1910.1020, this duration is consistent with longstanding Agency and employer practice. Other substance-specific rules are also subject to the retention requirements of 29 CFR 1910.1020, such as the standards addressing exposure to methylene chloride (29 CFR 1910.1052) and chromium (VI) (29 CFR 1910.1026). The Agency also disagrees that the 30-year retention requirement will lead to a “staggering” amount of paperwork, as NFIB commented (Document ID 2210, Attachment 1, p. 8). Electronic recordkeeping has become commonplace. Commenters such as the Association of Energy Service Companies and ASSE support the use of electronic or digital records to ease paperwork burdens (Document ID 2344, p. 2; 2339, p. 5). Thus, OSHA finds that the 30-year retention period is necessary and appropriate for air monitoring data.
Paragraph (k)(2)(i) of the standard for general industry and maritime (paragraph (j)(2)(i) of the standard for construction) is substantively unchanged from the proposed rule. It requires employers who rely on objective data to keep accurate records of the objective data. Paragraph (k)(2)(ii) of the standard for general industry and maritime (paragraph (j)(2)(ii) of the standard for construction) requires the record to include: The crystalline silica-containing material in question; the source of the objective data; the testing protocol and results of testing; a description of the process, task, or activity on which the objective data were based; and other data relevant to the process, task, activity, material, or exposures on which the objective data were based. Paragraphs (k)(2)(ii)(D) and (E) of the standard for general industry and maritime (paragraphs (j)(2)(ii)(D) and (E) of the standard for construction) have been modified from the proposed rule to substitute the word “task” for “operation” and to clarify the requirements for records of objective data. These changes are editorial, and do not affect the employer's obligations as set forth in the proposed rule.
Since the rule allows objective data to be used to exempt the employer from monitoring requirements and to provide a basis for selection of respirators, OSHA considers it critical that the use of objective data be documented. As authorized in the rule, reliance on objective data is intended to provide the same degree of assurance that employer monitoring of employee exposures by taking air samples does. The specified content elements are required to ensure that the records are capable of demonstrating to OSHA a reasonable basis for the conclusions drawn by the employer from the objective data.
OSHA considers objective data to be employee exposure records that must be maintained. Paragraph (k)(2)(iii) of the standard for general industry and maritime (paragraph (j)(2)(iii) of the standard for construction) is unchanged from the proposed rule. It requires the employer to ensure that objective data are maintained and made available for 30 years in accordance with 29 CFR 1910.1020(d)(1)(ii)).
The National Asphalt Pavement Association recommended that OSHA clarify that “. . . for an operation provided the controls outlined in Table 1, no further records of objective data would be required” (Document ID 2181, p. 13). OSHA confirms that an employer who fully and properly implements the control measures in Table 1 does not need to have objective data since no exposure assessment (including those based on objective data) is required when the employer is following Table 1. Therefore, following Table 1 does not trigger a recordkeeping or retention requirement.
Associated Builders and Contractors, Inc. (ABC) and ASSE addressed the issue of retaining objective data records for 30 years (Document ID 2289, p. 8; 2339, p. 10). ABC expressed concerns that data could be lost or destroyed during the 30-year period, and thought it would be difficult to enforce this provision. Furthermore, it commented that there is a “. . . large and burdensome amount of records that an employer would need to store and maintain” (Document ID 2289, p. 8). ABC did not make a recommendation on how long employers should maintain objective data records. ASSE commented that 30 years is too short and recommended that objective data records be retained for 40 years or the duration of the employment plus 20 years, whichever is longer, due to latency periods of some silica-related illnesses (Document ID 2339, p. 10). For the same reasons noted in the explanation above for retaining air monitoring data pursuant to paragraph (k)(1)(iii) of the standard for general industry and maritime (paragraph (j)(1)(iii) of the standard for construction), OSHA finds that the 30-year retention period is necessary and appropriate for objective data.
Paragraph (k)(3)(i) of the standard for general industry and maritime (paragraph (j)(3)(i) of the standard for construction) requires the employer to make and maintain an accurate record for each employee subject to medical surveillance under paragraph (i) of the standard for general industry and maritime (paragraph (h) of the standard for construction). Paragraph (k)(3)(ii) of the standard for general industry and maritime (paragraph (j)(3)(ii) of the standard for construction) lists the categories of information that an employer is required to record: The name and social security number of the employee; a copy of the PLHCPs' and specialists' written medical opinions for the employer; and a copy of the information provided to the PLHCPs and specialists where required by paragraph (i)(4) of the standard for general industry and maritime (paragraph (h)(4) of the standard for construction). The information provided to the PLHCPs and specialists includes the employee's duties as they relate to crystalline silica exposure, crystalline silica exposure levels, descriptions of personal protective equipment used by the employee, and information from employment-related medical
In paragraph (k)(3)(ii)(B) of the standard for general industry and maritime (paragraph (j)(3)(ii)(B) of the standard for construction), OSHA has changed the “PLHCP's and pulmonary specialist's written opinions” to the “PLHCPs' and specialists' written medical opinions.” The change, consistent with paragraph (i) of the standard for general industry and maritime (paragraph (h) of the standard for construction), is made to reflect the revised definition for the term “specialist” included in the rule.
Paragraph (k)(3)(iii) of the standard for general industry and maritime (paragraph (j)(3)(iii) of the standard for construction) is unchanged from the proposed rule. It requires that medical records must be maintained for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.1020(d)(1)(i), which governs application of the retention requirements in this rule. Pursuant to 29 CFR 1910.1020(d)(1)(i)(C), medical records of employees who have worked for less than one year for the employer need not be retained beyond the term of employment if they are provided to the employee upon the termination of employment. This exception allows employers flexibility and the option not to retain medical records in these circumstances (53 FR 38140, 38153-38155 (9/29/88)). This provision greatly reduces the recordkeeping burden on employers of short-term employees, including many construction employees covered by this rule. Of course, neither this rule nor 29 CFR 1910.1020 prohibits employers from keeping the medical records of employees who worked less than one year, and some employers may choose to keep the records. As indicated earlier, employers have the option to keep records in electronic or paper form.
The employer is responsible for the maintenance of records in his or her possession (
Commenters objecting to the recordkeeping requirements for medical records were concerned with privacy and costs. OSCO Industries asserted that the medical recordkeeping provisions would be subject to the Health Insurance Portability and Accountability Act (HIPAA), and thus employers would be denied access to the records (Document ID 1992, p. 12). The National Electrical Contractors Association (NECA) also expressed concerns about the application of HIPAA (Document ID 2295, p. 2). NECA indicated that the recordkeeping requirements would “. . . inundate most businesses with paperwork . . .” and would be “. . . an economic burden to employers in the construction industry . . .” (Document ID 2295, p. 2). Fann Contracting and Leading Builders of America said that medical records would be very expensive and difficult to maintain (Document ID 2116, Attachment 1, p. 11; 2269, p. 19). Fann Contracting commented that they have multiple projects, as many as 7 to 8 ongoing and 12 to 15 per year, with over 200 employees scattered around the state, which makes the new requirements “a recordkeeping nightmare” (Document ID 2116, Attachment 1, p. 11).
As to the expense and difficulty of maintaining the medical records, OSHA recognizes that there will be time, effort, and expense involved in maintaining medical records. However, as stated earlier, OSHA expects that employers who manage multiple projects will have a system for maintaining these records, just as they do for their other business records. The adverse health effects associated with crystalline silica are very serious, and OSHA has concluded that the recordkeeping requirements are necessary to ensure that records are available to assist PLHCPs in identifying health conditions that may place employees at increased risk from exposure, as well as identifying and treating adverse health effects that may develop among employees. Therefore, OSHA concludes that the requirements for making and maintaining medical records are reasonable, and are essential for the health and safety of employees.
As to the concerns expressed regarding the application of HIPAA, the requirement for retention of medical records in this standard (like those in other OSHA standards) is consistent with HIPAA. HIPAA allows for disclosure of certain health information to an employer where needed to comply with OSHA requirements for medical surveillance (45 CFR 164.512). Moreover, this standard's requirement that medical surveillance reports be provided to workers rather than to employers eliminates much of this concern.
Morgan Electro Ceramics, NECP, Southern Company, NTCA, Dow Chemical, ARMA, API, the Marcellus Shale Coalition, Ameren, NAIMA, EEI, TCNA, AFS, NMA, NM and others also questioned the requirement that the employee's social security number be included in medical records (Document ID 1772, p. 1; 1785, pp. 9-10; 2185, pp. 8; 2267, p. 7; 2270, p. 3; 2291, p. 26; 2301, Attachment 1, pp. 80-81; 2311, p. 3; 2315, p. 7; 2348, Attachment 1, p. 39; 2357, pp. 36-37; 2363, p. 7; and 2379, Appendix 1, p. 73; 2107, p. 4; 1963, p. 3).
As noted above in the discussion on air monitoring data, OSHA finds the privacy and security issues associated with the required use of social security numbers are of concern. However, for the same reasons discussed above with regard to employee exposure records, the Agency has decided to retain the requirement for use of social security numbers in medical records. As stated above, OSHA intends separately from this rulemaking to examine the requirements for social security numbers in all of its substance-specific health standards in order to address the issue comprehensively and ensure consistency among standards.
In total, the recordkeeping requirements fulfill the purposes of Section 8(c) of the OSH Act, and help protect employees because such records contribute to the evaluation of employees' health and enable employees and their healthcare providers to make informed health care decisions. These records are especially important when an employee's medical condition places him or her at increased risk of health impairment from further exposure to respirable crystalline silica. Furthermore, the records can be used by the Agency and others to identify illnesses and deaths that may be attributable to respirable crystalline silica exposure, evaluate compliance programs, and assess the efficacy of the standard. OSHA concludes that medical surveillance records, like exposure records, are necessary and appropriate
Commenters, such as NISA and ASSE, addressed the issue of duration of retention of medical records (Document ID 2339, p. 10; 2195, p. 35). NISA indicated that 30 years is an appropriate retention period (Document ID 2195, p. 35). ASSE indicated that medical records should be retained for 40 years or the duration of the employment plus 20 years, whichever is longer, due to latency periods of some silica-related illnesses (Document ID 2339, p. 10).
As with exposure records and objective data records, OSHA has concluded that the best approach is to maintain consistency with 29 CFR 1910.1020 and its required retention period for medical records; that period is the duration of employment plus 30 years. It is necessary to keep medical records for this extended time period because of the long latency period between exposure and development of silica-related disease (45 FR at 35268-35271). OSHA recognizes that in some cases, the latency period for silica-related diseases may extend beyond 30 years. However, the Agency concludes that the retention period specified in 29 CFR 1910.1020 represents a reasonable balance between the need to maintain records and the administrative burdens associated with maintaining those records for extended time periods. Because the duration of employment plus the 30-year records retention requirement is currently included in 29 CFR 1910.1020, this time period is consistent with longstanding Agency and employer practice.
Charles Gordon, a retired occupational safety and health attorney, advocated for a provision for trade associations, unions, and medical practices to provide medical exams and keep medical records (Document ID 2163, Testimony 1, p. 14). After considering this suggestion, OSHA decided not to incorporate it into the rule. OSHA anticipates that, in some cases, employers may be able to work with unions or trade associations to ensure that medical examinations are provided that meet the requirements of the rule, and that records are maintained. However, in many cases, unions and trade associations will not be available to provide such services. And in any case, the employer is ultimately responsible for ensuring that medical examinations are provided in accordance with the rule. Consistent with OSHA's access to employee exposure and medical records standard (29 CFR 1910.1020), the rule therefore requires the employer to maintain such records, and the employer must ensure the PLHCP retains the medical records for the employee's duration of employment plus 30 years. As stated earlier, the employer can generally fulfill this obligation by including the retention requirement in the contractual agreement between the employer and the PLHCP.
Commenters such as the International Union of Bricklayers and Allied Craftworkers (BAC) and ASSE stated that records should be made available to the employee and the employee's designated representative(s), at the request of the employee (
Commenters such as the Building and Construction Trades Department, AFL-CIO (BCTD) and BAC requested the addition of a provision for retaining training records in the rule (
OSHA is not including a provision for retaining training records in the rule because the Agency has concluded that requiring such records is not necessary. The performance-oriented requirements for training in paragraph (j) of the standard for general industry and maritime (paragraph (i) of the standard for construction) specify that employees must be able to demonstrate knowledge of the health hazards associated with exposure to respirable crystalline silica; tasks that could result in exposure; procedures to protect employees from exposure; as well as the silica standard and the medical surveillance program it requires. These requirements will be sufficient to ensure that employees are adequately trained with regard to recognizing silica hazards and taking protective measures. Moreover, adding a provision for retention of training records would involve additional paperwork burdens for employers. The absence of a requirement for retention of training records in the rule is consistent with OSHA's hazard communication standard (29 CFR 1910.1200), addressing training for all hazardous chemicals, as well as the most recent OSHA substance-specific health standards, addressing exposure to 1,3-butadiene (29 CFR 1910.1051), methylene chloride (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1026).
The recordkeeping requirements of the rule are also generally consistent with the recordkeeping provisions of the industry consensus standards, ASTM E 1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica and ASTM E 2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities. The main substantive differences are related to the use of social security numbers and duration of retention of records. ASTM E 1132-06 and ASTM E 2625-09 specify that the employer should include an identification number for each employee monitored for dust exposure, but do not indicate that the number must be a social security number, whereas OSHA's rule requires the employer to include the employee's social security number. As noted above, although OSHA intends to reconsider this policy for all standards in a future rulemaking, the Agency has determined that the use of social security numbers is appropriate for this rule. ASTM E 1132-06 specifies that medical and exposure records should be retained for 40 years or the duration of employment plus 20 years, whichever is longer. ASTM E 2625-09 does not specify a duration for retaining exposure or medical records. OSHA has determined that the retention requirements of 29 CFR 1910.1020 are appropriate for exposure and medical records collected under this rule, because the requirements represent a reasonable balance between the need to maintain records and the administrative burdens associated with maintaining those records, and are consistent with longstanding practice by the Agency with which employers are familiar and to which they are accustomed; changing the duration of retention requirement for this one rule could therefore cause confusion.
Paragraph (l) of the standard for general industry and maritime (paragraph (k) of the standard for construction) sets forth the effective date of the standard and the date(s) for
The United Steelworkers supported the proposed effective and start-up dates, arguing that they provide adequate time for employers to come into compliance with the rule (Document ID 2336, p. 16). Employers and industry representatives such as the American Exploration and Production Council, the Tile Council of North America, and Ameren requested that the effective date of the rule be extended (
OSHA sets the effective date to allow sufficient time for employers to obtain the standard, read and understand its requirements, and undertake the necessary planning and preparation for compliance. Section 6(b)(4) of the OSH Act allows the effective date of a standard to be delayed for up to 90 days from the date of publication in the
Paragraphs (l)(2), (3) and (4) of the standard for general industry and maritime (paragraphs (k)(2) and (3) of the standard for construction) establish dates for compliance with the requirements of the standard. Employers and industry representatives such as the American Petroleum Institute, the National Industrial Sand Association, Dow Chemical Company, the Glass Association of North America (GANA), and the American Foundry Society (AFS) contended that substantially more time was needed to implement engineering controls than the one year from the effective date that had been proposed (
General industry employers and trade associations were concerned with the length of time needed for the design, approval, and installation of engineering controls. For example, the AFS provided examples of how implementation of engineering controls could take longer than one year for foundries:
The proposed compliance period fails to account for the substantial time required for a comprehensive engineering evaluation of the overall silica exposure at the facility and the design of a proposed engineering control system. The engineering phase alone for a 10,000 cfm or larger system typically takes 4 to 6 months—longer for large or complex exposure problems. This issue is further complicated by the fact that the current national economy has substantially reduced the number of firms offering these environmental services, and all of the affected foundries will be competing for these limited services. The compliance period also fails to take into effect the fact that to attempt to meet the proposed PEL with local exhaust ventilation would require custom control equipment (primarily baghouses) which are not stock items and are custom built for each application. These control systems typically require a minimum of 2 to 4 months for manufacture after the completion of the engineering specifications and submission of an order. This period is significantly longer for specialized or large orders (Document ID 2379, Attachment B, p. 37).
Another issue raised by general industry representatives and employers such as Morgan Electro Ceramics, the Asphalt Roofing Manufacturers Association, the Fertilizer Institute, and the National Association of Manufacturers, was the potential length of time involved in environmental permitting processes (
Because many of the controls involve additions or changes to ventilation systems, OSHA must recognize the additional time required for modelling and permitting by state or federal EPA authorities. The proposed one year compliance period is totally unrealistic. In some states, the mandatory permitting requirement for both new and modified systems requires up to 18 months, and this does not include the design and modelling work necessary to prepare the permit application, or the construction and installation time after approval. For foundries which have a Title V permit, the approval includes an additional time period for the US EPA to review and make comments, and if the facility is subject to the federal Prevention of Significant Deterioration (PSD) or Lowest Achievable Emission Rate (LAER) rules the permit approval can take an additional 6 to 18 months for the detailed review and approval necessary (Document ID 3487, p. 26).
OSHA is persuaded that the concerns expressed by commenters regarding the time needed to implement engineering controls are reasonable, and is extending the compliance deadline for general industry and maritime to allow two years from the effective date for employers to comply with the standard. In extending the proposed compliance date for engineering controls in the general industry and maritime standard by one year, OSHA has concluded that engineering controls can be implemented within two years of the effective date in most general industry and maritime workplaces. However, because permit requirements and application processes vary by jurisdiction, OSHA is willing to use its enforcement discretion in situations where an employer can show it has made good faith efforts to implement engineering controls, but has been unable to implement such controls due to the time needed for environmental permitting.
OSHA understands that some general industry employers may face difficulties in implementing engineering controls due to continuous operation of facilities in particular industries. Trade associations such as the North American Insulation Manufacturers Association (NAIMA) and the GANA noted that their industries have plants that run constantly and shut down only on rare occasions, making installation of engineering controls, which would require a shutdown, unusually difficult and expensive (
Paragraph (l)(3)(ii) of the standard for general industry and maritime allows five years from the effective date—four years more than the proposed standard—for employers to comply with obligations for engineering controls in hydraulic fracturing operations in the
Paragraph (k)(2) of the standard for construction allows one year after the effective date to come into compliance with all obligations other than the requirements for methods of sample analysis. This extends the time (one year compared to 180 days) for compliance with the standard's ancillary provisions and retains the one year period after the effective date for engineering controls. Commenting on the proposed compliance dates for construction work, several stakeholders raised issues that might impact the ability of employers to implement engineering controls within one year after the effective date (
In requiring that general industry and maritime employers comply with most obligations of the standard two years after the effective date, and in requiring that construction employers comply with all ancillary and engineering controls one year after the effective date, OSHA has aligned the compliance dates for other provisions of the standards with the compliance dates for engineering controls. This will allow employers to focus their efforts on implementation of engineering controls. OSHA decided that staggering the compliance dates for some provisions of the rule could serve to divert attention and resources away from the implementation of engineering controls. For example, if respiratory protection were to be required six months after the effective date (as OSHA proposed), employers would need to assess employee exposures, and would need to develop a respiratory protection program and provide appropriate respirators to employees exposed above the PEL, while simultaneously working to implement engineering controls. A requirement for respiratory protection prior to implementation of engineering controls would be particularly problematic where construction employers implement the controls specified in paragraph (c) of the construction standard. This is because those employers would not otherwise be required to assess employee exposures.
In determining the compliance dates for provisions other than engineering controls, OSHA considered the relatively short time period before engineering controls must be implemented in construction work. The Agency recognizes the longer time period allowed for general industry and maritime employers to implement engineering controls. However, general industry employers must comply with a PEL that is approximately equivalent to 100 μg/m
The issue of how much time to allow for laboratories to come into compliance with respect to methods of sample analysis received considerable comment during the rulemaking. Employers and trade and professional associations such as the National Tile Contractors Association, the Fertilizer Institute, OSCO Industries, Edison Electric Institute, and Fann Contracting, Inc. expressed concerns about the proposed rule's provisions that gave all employers one year to implement engineering controls and allowed two years before employers would be required to follow requirements for methods of sample analysis (
OSHA is giving laboratories 2 years to improve their procedures for accurate silica analysis. However, OSHA is requiring foundries to install expensive engineering controls within one year, before accurate exposure levels are available. This does not make sense, especially when it could involve millions of dollars (Document ID 2149, p. 2).
In proposing to require employers to implement engineering controls and comply with other provisions of the rule before the laboratory requirements came into effect, OSHA intended to allow time for laboratory capacity to develop. As indicated in Chapter IV of the FEA, OSHA finds that it is feasible to measure exposures to respirable crystalline silica at the revised PEL and action level with a reasonable degree of accuracy and precision using methods that are currently available. Many laboratories are capable of analyzing samples in accordance with the laboratory requirements of the silica rule; OSHA
OSHA anticipates that the additional demand for respirable crystalline silica exposure monitoring and associated laboratory analysis with the rule will be modest. Most construction employers are expected to implement the specified exposure control measures in paragraph (c) of the construction standard, and will therefore not be required to assess employee exposures, thus placing no demands on laboratories. The performance option for exposure assessment provided in both the general industry and maritime standard at paragraph (d)(2) and the construction standard at paragraph (d)(2)(ii) also serves to lessen the anticipated volume of exposure monitoring. The additional time allowed for compliance with the general industry and maritime standard further serves to diminish concerns about laboratory capacity by providing additional time for laboratory capacity to increase and distributing demand for sample analysis over an extended period of time. OSHA therefore concludes that the compliance date for methods of sample analysis of two years after the effective date is reasonable in both the general industry/maritime and construction standards. OSHA also anticipates that construction employers who perform air monitoring before the laboratory requirements go into effect (
Paragraph (l)(4) of the standard for general industry and maritime specifies that obligations in paragraph (i)(1)(i) regarding medical surveillance take effect for employees who will be occupationally exposed to respirable crystalline silica above the PEL for 30 or more days per year beginning two years after the effective date. Obligations in paragraph (i)(l)(i) for employees who will be occupationally exposed to respirable crystalline silica at or above the action level (but at or below the PEL) for 30 or more days per year will commence four years after the effective date. In other words, medical surveillance will be triggered by exposures above the PEL for 30 or more days per year, beginning two years after the effective date and continuing through four years after the effective date, and will then be triggered by exposures at or above the action level for 30 or more days per year beginning four years after the effective date. As indicated in the Summary and Explanation for
Commenters such as NAIMA and the National Concrete Masonry Association voiced concerns about the proposed rule's effects on small businesses, and asked for compliance extensions for small businesses (
OSHA also considered comments from the U.S. Chamber of Commerce and the National Stone, Sand, and Gravel Association, among others, expressing concern that the rule would create increased demand for health and safety professionals and for medical professionals; they alleged there are not enough professionals in those fields to service the demand that would be created by the rule (
Thus, the effect of changes made to the proposed rule is that: (1) All obligations (
Appendix A, which specifies methods of sample analysis, is included as part of each standard, 29 CFR 1910.1053 and 29 CFR 1926.1153. Employers must ensure that all samples taken to satisfy monitoring requirements of the standards are evaluated by a laboratory that analyzes air samples for respirable crystalline silica in accordance with the
OSHA proposed analysis requirements that it had included as part of paragraph (d) of both standards. The Southern Company recommended that OSHA require use of accredited laboratories and move all other laboratory requirements to an Appendix as a guide for laboratories that analyze silica samples (Document ID 2185, p. 7).
OSHA has retained the substance of the proposed provisions addressing analysis of samples, but has moved these provisions to a new appendix in each standard. The Agency has decided that segregating these specifications in an appendix to each final standard provides greater clarity for both employers and the laboratories that analyze samples.
Appendix A specifies procedures for the laboratories conducting the analysis, but employers must ensure samples taken to satisfy the monitoring requirements of the standard are analyzed by an accredited laboratory using the methods and quality control procedures described in this Appendix. Putting the requirements in a separate appendix, rather than in the regulatory text, facilitates the communication of these requirements to the laboratory analyzing samples. The appendix approach is also meant to clarify that an employer who engages a laboratory to analyze respirable crystalline silica samples may rely on an assurance from that laboratory that the specified requirements were met. For example, the laboratory could include a statement that it complied with the requirements of the standard along with the sampling results provided to the employer, or the employer could obtain the information from the laboratory or industrial hygiene service provider.
Appendix A to the final standards describes the specific analytical methods to be used, as well as the qualifications of the laboratories at which the samples are analyzed. As discussed in greater detail in Chapter IV of the Final Economic Analysis and Final Regulatory Flexibility Analysis (FEA), the sampling and analysis methods required by the rule are technologically feasible in that they are widely used and accepted as the best available methods for measuring individual exposures to respirable crystalline silica. The Agency has determined that the provisions in Appendix A are needed to ensure the accuracy of monitoring required by the rule to measure employee exposures.
OSHA has typically included specifications for the accuracy of exposure monitoring methods in substance-specific standards, but has not always specified the analytical methods to be used or the qualifications of the laboratory that analyzes the samples. Exceptions are the asbestos standards for general industry (29 CFR 1910.1001, Appendix A) and construction (29 CFR 1926.1101, Appendix A), which specify the sampling and analytical methods to be used, as well as quality control procedures to be implemented by laboratories.
Consistent with the evaluation of sampling and analysis methods in the FEA, under the Appendix (A.1), all samples taken to satisfy the monitoring requirements of this section must be evaluated using the procedures specified in one of the following analytical methods: OSHA ID-142; NMAM 7500, NMAM 7602; NMAM 7603; MSHA P-2; or MSHA P-7. OSHA has determined based on inter-laboratory comparisons that laboratory analysis by either X-ray diffraction (XRD) or infrared (IR) spectroscopy is required to ensure the accuracy of the monitoring results. The specified analytical methods are the XRD or IR methods for analysis of respirable crystalline silica that have been established by OSHA, NIOSH, or MSHA.
To ensure the accuracy of air sampling data relied on by employers to achieve compliance with the standard, the standard requires that employers must have air samples analyzed only at laboratories that meet requirements listed in A.2 through A.6.3. The requirements were developed based on recommendations for quality control procedures to improve agreement in analytical results obtained by laboratories (Eller
A.2 requires employers to ensure that samples taken to monitor employee exposures are analyzed by a laboratory that is accredited to ANS/ISO/IEC Standard 17025 “General requirements for the competence of testing and calibration laboratories” (EN ISO/IEC 17025:2005) by an accrediting organization that can demonstrate compliance with the requirements of ISO/IEC 17011 “Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies” (EN ISO/IEC 17011:2004). ANS/ISO/IEC 17025 is a consensus standard that was developed by the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) and approved by the American Society for Testing and Materials (ASTM). This standard establishes criteria by which laboratories can demonstrate proficiency in conducting laboratory analysis through the implementation of quality control measures. To demonstrate competence, laboratories must implement a quality control (QC) program that evaluates analytical uncertainty and provides employers with estimates of sampling and analytical error (SAE) when reporting samples. ISO/IEC 17011 establishes criteria for organizations that accredit laboratories under ISO/IEC 17025. For example, the AIHA accredits laboratories for proficiency in the analysis of crystalline silica using criteria based on the ISO 17025 and other criteria appropriate for the scope of the accreditation.
Appendix A.3-A.6.3 contain additional quality control procedures for laboratories that have been demonstrated to improve accuracy and reliability through inter-laboratory comparisons. The proposed rule would have required that laboratories participate in a round robin testing program with at least two other independent laboratories at least every six months. OSHA deleted this requirement in the final rule since accredited laboratories must participate in the AIHA PAT program. The laboratory must use the most current National Institute of Standards and Technology (NIST) or NIST-traceable standards for instrument calibration or instrument calibration verification (Appendix A.3). The laboratory must have an internal quality control (QC) program that evaluates analytical uncertainty and provides employers with estimates of sampling and analytical error (Appendix A.4). The
Several stakeholders commented that requiring employers to analyze samples for all polymorphs (
Appendix B of each standard, 29 CFR 1910.1053 and 29 CFR 1926.1153, contains medical surveillance guidelines to assist in complying with the medical surveillance provisions and provides other helpful recommendations and information. Appendix B is for informational and guidance purposes only and none of the statements in Appendix B should be construed as imposing a mandatory requirement on employers that is not otherwise imposed by the standard. In addition, this appendix is not intended to detract from any obligation that the rule imposes. American College of Occupational Medicine (ACOEM), National Institute for Occupational Safety and Health (NIOSH), American Public Health Association, and the National Consumers League supported the inclusion of an appendix for medical surveillance guidelines (Document ID 2080, p. 2; 2177, Attachment B, p. 41; 2178, Attachment 1, p. 4; 2373, p. 4).
The medical surveillance guidelines were in Appendix A of each proposed standard but were moved to Appendix B of the final standards, following the addition of Appendix A for methods of sample analysis. OSHA received some comments recommending corrections or clarifications to Appendix B. For example, NIOSH and the National Industrial Sand Association requested that OSHA update the discussion of digital radiography to include the most recent International Labour Office policy, as was done in the preamble, and NIOSH suggested several clarifications to the discussions on silicosis, specialists and specialist referrals, and tuberculosis (Document ID 2177, Attachment B, pp. 41, 48-50; 2195, pp. 44, 46). OSHA considered those comments and made changes as needed. In addition, OSHA revised Appendix B to make it consistent with the updates to the rule.
American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) requested that the appendix discuss medical confidentiality and provide guidance on information that may be provided to the employer without the employee's informed consent (Document ID 4204, p. 90). OSHA agrees that it is important to discuss this type of information in Appendix B because the information that the physician or licensed health care professional (PLHCP) is to provide to the employer under the standards has changed substantially from the proposal, and Appendix B may serve as the PLHCP's primary source of information about medical surveillance under the standards. Therefore OSHA has included a discussion on medical confidentiality. In addition, OSHA has included examples of the PLHCP's written medical report for the employee, the PLHCP's written medical opinion for the employer, and an authorization form to allow limitations on respirable crystalline silica exposure or recommendations for a specialist examination to be reported to the employer. OSHA expects the example report, opinion, and authorization form will greatly clarify the type of information that is to be reported to the employer.
Some commenters requested that additional information be added to the appendix. ACOEM, NIOSH and Building and Construction Trades Department, AFL-CIO requested that the appendix include spirometry guidelines or reference values (Document ID 2080, p. 9; 2177, Attachment B, pp. 45-46; 4223, pp. 128-130). Collegium Ramazzini requested that the appendix include a standardized medical and exposure history (Document ID 3541, pp. 3, 6). AFL-CIO recommended that the appendix include a discussion on low dose computed tomography (LDCT) screening for lung cancer (Document ID, 4204, p. 82). OSHA is not including the information requested by these commenters in Appendix B for reasons discussed more fully in the summary and explanation for
Cancer, Chemicals, Cristobalite, Crystalline silica, Hazardous substances, Health, Lung Diseases, Occupational safety and health, Quartz, Reporting and recordkeeping requirements, Silica, Silicosis, Tridymite.
This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.
The Agency issues the sections under the following authorities: Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); section 107 of the Contract Work
For the reasons set forth in the preamble, 29 CFR parts 1910, 1915, and 1926, of the Code of Federal Regulations are amended as follows:
Secs. 4, 6, 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911. All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act of 1970, except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under section 6(a) (29 U.S.C. 655(a)).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under 29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
The revisions and addition read as follows:
The revisions and addition read as follows:
(a)
(i) Construction work as defined in 29 CFR 1910.12(b) (occupational exposures to respirable crystalline silica in construction work are covered under 29 CFR 1926.1153);
(ii) Agricultural operations covered under 29 CFR part 1928; and
(iii) Exposures that result from the processing of sorptive clays.
(2) This section does not apply where the employer has objective data demonstrating that employee exposure to respirable crystalline silica will remain below 25 micrograms per cubic meter of air (25 μg/m
(3) This section does not apply if the employer complies with 29 CFR 1926.1153 and:
(i) The task performed is indistinguishable from a construction task listed on Table 1 in paragraph (c) of 29 CFR 1926.1153; and
(ii) The task will not be performed regularly in the same environment and conditions.
(b)
(c)
(d)
(2)
(3)
(ii) If initial monitoring indicates that employee exposures are below the action level, the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring.
(iii) Where the most recent exposure monitoring indicates that employee exposures are at or above the action level but at or below the PEL, the employer shall repeat such monitoring within six months of the most recent monitoring.
(iv) Where the most recent exposure monitoring indicates that employee exposures are above the PEL, the employer shall repeat such monitoring within three months of the most recent monitoring.
(v) Where the most recent (non-initial) exposure monitoring indicates that employee exposures are below the action level, the employer shall repeat such monitoring within six months of the most recent monitoring until two consecutive measurements, taken 7 or more days apart, are below the action level, at which time the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this section.
(4)
(5)
(6)
(ii) Whenever an exposure assessment indicates that employee exposure is above the PEL, the employer shall describe in the written notification the corrective action being taken to reduce employee exposure to or below the PEL.
(7)
(ii) When observation of monitoring requires entry into an area where the use of protective clothing or equipment is required for any workplace hazard, the employer shall provide the observer with protective clothing and equipment at no cost and shall ensure that the observer uses such clothing and equipment.
(e)
(2)
(ii) The employer shall post signs at all entrances to regulated areas that bear the legend specified in paragraph (j)(2) of this section.
(3)
(A) Persons authorized by the employer and required by work duties to be present in the regulated area;
(B) Any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring procedures under paragraph (d) of this section; and
(C) Any person authorized by the Occupational Safety and Health Act or regulations issued under it to be in a regulated area.
(4)
(f)
(2)
(A) A description of the tasks in the workplace that involve exposure to respirable crystalline silica;
(B) A description of the engineering controls, work practices, and respiratory protection used to limit employee exposure to respirable crystalline silica for each task; and
(C) A description of the housekeeping measures used to limit employee exposure to respirable crystalline silica.
(ii) The employer shall review and evaluate the effectiveness of the written exposure control plan at least annually and update it as necessary.
(iii) The employer shall make the written exposure control plan readily available for examination and copying, upon request, to each employee covered by this section, their designated representatives, the Assistant Secretary and the Director.
(3)
(g)
(i) Where exposures exceed the PEL during periods necessary to install or implement feasible engineering and work practice controls;
(ii) Where exposures exceed the PEL during tasks, such as certain maintenance and repair tasks, for which engineering and work practice controls are not feasible;
(iii) During tasks for which an employer has implemented all feasible engineering and work practice controls and such controls are not sufficient to reduce exposures to or below the PEL; and
(iv) During periods when the employee is in a regulated area.
(2)
(h)
(2) The employer shall not allow compressed air to be used to clean clothing or surfaces where such activity could contribute to employee exposure to respirable crystalline silica unless:
(i) The compressed air is used in conjunction with a ventilation system that effectively captures the dust cloud created by the compressed air; or
(ii) No alternative method is feasible.
(i)
(ii) The employer shall ensure that all medical examinations and procedures required by this section are performed by a PLHCP as defined in paragraph (b) of this section.
(2)
(i) A medical and work history, with emphasis on: Past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and symptoms of respiratory disease (
(ii) A physical examination with special emphasis on the respiratory system;
(iii) A chest X-ray (a single posteroanterior radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems), interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader;
(iv) A pulmonary function test to include forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(v) Testing for latent tuberculosis infection; and
(vi) Any other tests deemed appropriate by the PLHCP.
(3)
(4)
(i) A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
(ii) The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
(iii) A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
(5)
(i) A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment;
(ii) Any recommended limitations on the employee's use of respirators;
(iii) Any recommended limitations on the employee's exposure to respirable crystalline silica; and
(iv) A statement that the employee should be examined by a specialist (pursuant to paragraph (i)(7) of this section) if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B Reader, or if referral to a specialist is otherwise deemed appropriate by the PLHCP.
(6)
(A) The date of the examination;
(B) A statement that the examination has met the requirements of this section; and
(C) Any recommended limitations on the employee's use of respirators.
(ii) If the employee provides written authorization, the written opinion shall also contain either or both of the following:
(A) Any recommended limitations on the employee's exposure to respirable crystalline silica;
(B) A statement that the employee should be examined by a specialist (pursuant to paragraph (i)(7) of this section) if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B Reader, or if referral to a specialist is
(iii) The employer shall ensure that each employee receives a copy of the written medical opinion described in paragraph (i)(6)(i) and (ii) of this section within 30 days of each medical examination performed.
(7)
(ii) The employer shall ensure that the examining specialist is provided with all of the information that the employer is obligated to provide to the PLHCP in accordance with paragraph (i)(4) of this section.
(iii) The employer shall ensure that the specialist explains to the employee the results of the medical examination and provides each employee with a written medical report within 30 days of the examination. The written report shall meet the requirements of paragraph (i)(5) (except paragraph (i)(5)(iv)) of this section.
(iv) The employer shall obtain a written opinion from the specialist within 30 days of the medical examination. The written opinion shall meet the requirements of paragraph (i)(6) (except paragraph (i)(6)(i)(B) and (i)(6)(ii)(B)) of this section.
(j)
(2) Signs. The employer shall post signs at all entrances to regulated areas that bear the following legend:
(3)
(A) The health hazards associated with exposure to respirable crystalline silica;
(B) Specific tasks in the workplace that could result in exposure to respirable crystalline silica;
(C) Specific measures the employer has implemented to protect employees from exposure to respirable crystalline silica, including engineering controls, work practices, and respirators to be used;
(D) The contents of this section; and
(E) The purpose and a description of the medical surveillance program required by paragraph (i) of this section.
(ii) The employer shall make a copy of this section readily available without cost to each employee covered by this section.
(k)
(ii) This record shall include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task monitored;
(C) Sampling and analytical methods used;
(D) Number, duration, and results of samples taken;
(E) Identity of the laboratory that performed the analysis;
(F) Type of personal protective equipment, such as respirators, worn by the employees monitored; and
(G) Name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer shall ensure that exposure records are maintained and made available in accordance with 29 CFR 1910.1020.
(2)
(ii) This record shall include at least the following information:
(A) The crystalline silica-containing material in question;
(B) The source of the objective data;
(C) The testing protocol and results of testing;
(D) A description of the process, task, or activity on which the objective data were based; and
(E) Other data relevant to the process, task, activity, material, or exposures on which the objective data were based.
(iii) The employer shall ensure that objective data are maintained and made available in accordance with 29 CFR 1910.1020.
(3)
(ii) The record shall include the following information about the employee:
(A) Name and social security number;
(B) A copy of the PLHCPs' and specialists' written medical opinions; and
(C) A copy of the information provided to the PLHCPs and specialists.
(iii) The employer shall ensure that medical records are maintained and made available in accordance with 29 CFR 1910.1020.
(l)
(2) Except as provided for in paragraphs (l)(3) and (4) of this section, all obligations of this section commence June 23, 2018.
(3) For hydraulic fracturing operations in the oil and gas industry:
(i) All obligations of this section, except obligations for medical surveillance in paragraph (i)(1)(i) and engineering controls in paragraph (f)(1) of this section, commence June 23, 2018;
(ii) Obligations for engineering controls in paragraph (f)(1) of this section commence June 23, 2021; and
(iii) Obligations for medical surveillance in paragraph (i)(1)(i) commence in accordance with paragraph (l)(4) of this section.
(4) The medical surveillance obligations in paragraph (i)(1)(i) commence on June 23, 2018, for employees who will be occupationally exposed to respirable crystalline silica above the PEL for 30 or more days per year. Those obligations commence June 23, 2020, for employees who will be occupationally exposed to respirable crystalline silica at or above the action level for 30 or more days per year.
This appendix specifies the procedures for analyzing air samples for respirable crystalline silica, as well as the quality control procedures that employers must ensure that laboratories use when performing an analysis required under 29 CFR 1910.1053 (d)(5). Employers must ensure that such a laboratory:
1. Evaluates all samples using the procedures specified in one of the following analytical methods: OSHA ID-142; NMAM 7500; NMAM 7602; NMAM 7603; MSHA P-2; or MSHA P-7;
2. Is accredited to ANS/ISO/IEC Standard 17025:2005 with respect to crystalline silica analyses by a body that is compliant with ISO/IEC Standard 17011:2004 for implementation of quality assessment programs;
3. Uses the most current National Institute of Standards and Technology (NIST) or NIST traceable standards for instrument calibration or instrument calibration verification;
4. Implements an internal quality control (QC) program that evaluates analytical uncertainty and provides employers with estimates of sampling and analytical error;
5. Characterizes the sample material by identifying polymorphs of respirable crystalline silica present, identifies the presence of any interfering compounds that might affect the analysis, and makes any corrections necessary in order to obtain accurate sample analysis; and
6. Analyzes quantitatively for crystalline silica only after confirming that the sample matrix is free of uncorrectable analytical interferences, corrects for analytical interferences, and uses a method that meets the following performance specifications:
The purpose of this Appendix is to provide medical information and recommendations to aid physicians and other licensed health care professionals (PLHCPs) regarding compliance with the medical surveillance provisions of the respirable crystalline silica standard (29 CFR 1910.1053). Appendix B is for informational and guidance purposes only and none of the statements in Appendix B should be construed as imposing a mandatory requirement on employers that is not otherwise imposed by the standard.
Medical screening and surveillance allow for early identification of exposure-related health effects in individual employee and groups of employees, so that actions can be taken to both avoid further exposure and prevent or address adverse health outcomes. Silica-related diseases can be fatal, encompass a variety of target organs, and may have public health consequences when considering the increased risk of a latent tuberculosis (TB) infection becoming active. Thus, medical surveillance of silica-exposed employees requires that PLHCPs have a thorough knowledge of silica-related health effects.
This Appendix is divided into seven sections. Section 1 reviews silica-related diseases, medical responses, and public health responses. Section 2 outlines the components of the medical surveillance program for employees exposed to silica. Section 3 describes the roles and responsibilities of the PLHCP implementing the program and of other medical specialists and public health professionals. Section 4 provides a discussion of considerations, including confidentiality. Section 5 provides a list of additional resources and Section 6 lists references. Section 7 provides sample forms for the written medical report for the employee, the written medical opinion for the employer and the written authorization.
Silicosis is an irreversible, often disabling, and sometimes fatal fibrotic lung disease. Progression of silicosis can occur despite removal from further exposure. Diagnosis of silicosis requires a history of exposure to silica and radiologic findings characteristic of silica exposure. Three different presentations of silicosis (chronic, accelerated, and acute) have been defined. Accelerated and acute silicosis are much less common than chronic silicosis. However, it is critical to recognize all cases of accelerated and acute silicosis because these are life-threatening illnesses and because they are caused by substantial overexposures to respirable crystalline silica. Although any case of silicosis indicates a breakdown in prevention, a case of acute or accelerated silicosis implies current high exposure and a very marked breakdown in prevention.
In addition to silicosis, employees exposed to respirable crystalline silica, especially those with accelerated or acute silicosis, are at increased risks of contracting active TB and other infections (ATS 1997; Rees and Murray 2007). Exposure to respirable crystalline silica also increases an employee's risk of developing lung cancer, and the higher the cumulative exposure, the higher the risk (Steenland
1.2.1. Symptoms—shortness of breath and cough, although employees may not notice any symptoms early in the disease. Constitutional symptoms, such as fever, loss of appetite and fatigue, may indicate other diseases associated with silica exposure, such as TB infection or lung cancer. Employees with these symptoms should immediately receive further evaluation and treatment.
1.2.2. Physical Examination—may be normal or disclose dry rales or rhonchi on lung auscultation.
1.2.3. Spirometry—may be normal or may show only a mild restrictive or obstructive pattern.
1.2.4. Chest X-ray—classic findings are small, rounded opacities in the upper lung fields bilaterally. However, small irregular opacities and opacities in other lung areas can also occur. Rarely, “eggshell calcifications” in the hilar and mediastinal lymph nodes are seen.
1.2.5. Clinical Course—chronic silicosis in most cases is a slowly progressive disease. Under the respirable crystalline silica standard, the PLHCP is to recommend that employees with a 1/0 category X-ray be referred to an American Board Certified Specialist in Pulmonary Disease or Occupational Medicine. The PLHCP and/or Specialist should counsel employees regarding work practices and personal habits that could affect employees' respiratory health.
1.3.1. Symptoms—shortness of breath, cough, and sometimes sputum production. Employees with exposure to respirable crystalline silica, and especially those with accelerated silicosis, are at high risk for activation of TB infections, atypical mycobacterial infections, and fungal superinfections. Constitutional symptoms, such as fever, weight loss, hemoptysis (coughing up blood), and fatigue may herald one of these infections or the onset of lung cancer.
1.3.2. Physical Examination—rales, rhonchi, or other abnormal lung findings in relation to illnesses present. Clubbing of the digits, signs of heart failure, and cor pulmonale may be present in severe lung disease.
1.3.3. Spirometry—restrictive or mixed restrictive/obstructive pattern.
1.3.4. Chest X-ray—small rounded and/or irregular opacities bilaterally. Large opacities and lung abscesses may indicate infections, lung cancer, or progression to complicated silicosis, also termed progressive massive fibrosis.
1.3.5. Clinical Course—accelerated silicosis has a rapid, severe course. Under the respirable crystalline silica standard, the PLHCP can recommend referral to a Board Certified Specialist in either Pulmonary Disease or Occupational Medicine, as deemed appropriate, and referral to a Specialist is recommended whenever the diagnosis of accelerated silicosis is being considered.
1.4.1. Symptoms—sudden, progressive, and severe shortness of breath. Constitutional symptoms are frequently present and include fever, weight loss, fatigue, productive cough, hemoptysis (coughing up blood), and pleuritic chest pain.
1.4.2. Physical Examination—dyspnea at rest, cyanosis, decreased breath sounds, inspiratory rales, clubbing of the digits, and fever.
1.4.3. Spirometry—restrictive or mixed restrictive/obstructive pattern.
1.4.4. Chest X-ray—diffuse haziness of the lungs bilaterally early in the disease. As the disease progresses, the “ground glass” appearance of interstitial fibrosis will appear.
1.4.5. Clinical Course—employees with acute silicosis are at especially high risk of TB activation, nontuberculous mycobacterial infections, and fungal superinfections. Acute silicosis is immediately life-threatening. The employee should be urgently referred to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for evaluation and treatment. Although any case of silicosis indicates a breakdown in prevention, a case of acute or accelerated silicosis implies a profoundly high level of silica exposure and may mean that other employees are currently exposed to dangerous levels of silica.
PLHCPs who manage silica medical surveillance programs should have a thorough understanding of the many silica-related diseases and health effects outlined in Section 1 of this Appendix. At each clinical encounter, the PLHCP should consider silica-related health outcomes, with particular vigilance for acute and accelerated silicosis. In this Section, the required components of medical surveillance under the respirable crystalline silica standard are reviewed, along with additional guidance and recommendations for PLHCPs performing medical surveillance examinations for silica-exposed employees.
2.1.1. The respirable crystalline silica standard requires the following: A medical and work history, with emphasis on: Past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and symptoms of respiratory disease (
2.1.2. Further, the employer must provide the PLHCP with the following information:
2.1.2.1. A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
2.1.2.2. The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
2.1.2.3. A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
2.1.2.4. Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
2.1.3. Additional guidance and recommendations: A history is particularly important both in the initial evaluation and in periodic examinations. Information on past and current medical conditions (particularly a history of kidney disease, cardiac disease, connective tissue disease, and other immune diseases), medications, hospitalizations and surgeries may uncover health risks, such as immune suppression, that could put an employee at increased health risk from exposure to silica. This information is important when counseling the employee on risks and safe work practices related to silica exposure.
2.2.1. The respirable crystalline silica standard requires the following: A physical examination, with special emphasis on the respiratory system. The physical examination must be performed at the initial examination and every three years thereafter.
2.2.2. Additional guidance and recommendations: Elements of the physical examination that can assist the PHLCP include: An examination of the cardiac system, an extremity examination (for clubbing, cyanosis, edema, or joint abnormalities), and an examination of other pertinent organ systems identified during the history.
2.3.1. The respirable crystalline silica standard requires the following: Baseline testing for TB on initial examination.
2.3.2. Additional guidance and recommendations:
2.3.2.1. Current CDC guidelines (
2.3.2.2. PLHCPs may use alternative TB tests, such as interferon-γ release assays (IGRAs), if sensitivity and specificity are comparable to TST (Mazurek
2.3.2.3. The silica standard allows the PLHCP to order additional tests or test at a greater frequency than required by the standard, if deemed appropriate. Therefore, PLHCPs might perform periodic (
2.3.2.4. Employees with positive TB tests and those with indeterminate test results should be referred to the appropriate agency or specialist, depending on the test results and clinical picture. Agencies, such as local public health departments, or specialists, such as a pulmonary or infectious disease specialist, may be the appropriate referral. Active TB is a nationally notifiable disease. PLHCPs should be aware of the reporting requirements for their region. All States have TB Control Offices that can be contacted for further information. (
2.3.2.5. The following public health principles are key to TB control in the U.S. (ATS-CDC-IDSA 2005):
(
(
(
(
2.4.1. The respirable crystalline silica standard requires the following: Pulmonary function testing must be performed on the initial examination and every three years thereafter. The required pulmonary function test is spirometry and must include forced vital capacity (FVC), forced expiratory volume in one second (FEV
2.4.2. Additional guidance and recommendations: Spirometry provides information about individual respiratory status and can be used to track an employee's respiratory status over time or as a surveillance tool to follow individual and group respiratory function. For quality results, the ATS and the American College of Occupational and Environmental Medicine (ACOEM) recommend use of the third National Health and Nutrition Examination Survey (NHANES III) values, and ATS publishes recommendations for spirometry equipment (Miller
2.5.1. The respirable crystalline silica standard requires the following: A single posteroanterior (PA) radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems. A chest X-ray must be performed on the initial examination and every three years thereafter. The chest X-ray must be interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader.
Chest radiography is necessary to diagnose silicosis, monitor the progression of silicosis, and identify associated conditions such as TB. If the B reading indicates small opacities in a profusion of 1/0 or higher, the employee is to receive a recommendation for referral to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine.
2.5.2. Additional guidance and recommendations: Medical imaging has largely transitioned from conventional film-based radiography to digital radiography systems. The ILO Guidelines for the Classification of Pneumoconioses has historically provided film-based chest radiography as a referent standard for comparison to individual exams. However, in 2011, the ILO revised the guidelines to include a digital set of referent standards that were derived from the prior film-based standards. To assist in assuring that digitally-acquired radiographs are at least as safe and effective as film radiographs, NIOSH has prepared guidelines, based upon accepted contemporary professional recommendations (
Once the medical surveillance examination is completed, the employer must ensure that the PLHCP explains to the employee the results of the medical examination and provides the employee with a written medical report within 30 days of the examination. The written medical report must contain a statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment. In addition, the PLHCP's written medical report must include any recommended limitations on the employee's use of respirators, any recommended limitations on the employee's exposure to respirable crystalline silica, and a statement that the employee should be examined by a Board Certified Specialist in Pulmonary Disease or Occupational medicine if the chest X-ray is classified as 1/0 or higher by the B Reader, or if referral to a Specialist is otherwise deemed appropriate by the PLHCP.
The PLHCP should discuss all findings and test results and any recommendations regarding the employee's health, worksite safety and health practices, and medical referrals for further evaluation, if indicated. In addition, it is suggested that the PLHCP offer to provide the employee with a complete copy of their examination and test results, as some employees may want this information for their own records or to provide to their personal physician or a future PLHCP. Employees are entitled to access their medical records.
Under the respirable crystalline silica standard, the employer must ensure that the PLHCP provides the employer with a written medical opinion within 30 days of the employee examination, and that the employee also gets a copy of the written medical opinion for the employer within 30 days. The PLHCP may choose to directly provide the employee a copy of the written medical opinion. This can be particularly helpful to employees, such as construction employees, who may change employers frequently. The written medical opinion can be used by the employee as proof of up-to-date medical surveillance. The following lists the elements of the written medical report for the employee and written medical opinion for the employer. (Sample forms for the written medical report for the employee, the written medical opinion for the employer, and the written authorization are provided in Section 7 of this Appendix.)
3.1.1. The written medical report for the employee must include the following information:
3.1.1.1. A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment;
3.1.1.2. Any recommended limitations upon the employee's use of a respirator;
3.1.1.3. Any recommended limitations on the employee's exposure to respirable crystalline silica; and
3.1.1.4. A statement that the employee should be examined by a Board Certified Specialist in Pulmonary Disease or Occupational Medicine, where the standard requires or where the PLHCP has determined such a referral is necessary. The standard requires referral to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for a chest X-ray B reading indicating small opacities in a profusion of 1/0 or higher, or if the PHLCP determines that referral to a Specialist is necessary for other silica-related findings.
3.1.2. The PLHCP's written medical opinion for the employer must include only the following information:
3.1.2.1. The date of the examination;
3.1.2.2. A statement that the examination has met the requirements of this section; and
3.1.2.3. Any recommended limitations on the employee's use of respirators.
3.1.2.4. If the employee provides the PLHCP with written authorization, the written opinion for the employer shall also contain either or both of the following:
3.1.2.5. In addition to the above referral for abnormal chest X-ray, the PLHCP may refer an employee to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for other findings of concern during the medical surveillance examination if these findings are potentially related to silica exposure.
3.1.2.6. Although the respirable crystalline silica standard requires the employer to ensure that the PLHCP explains the results of the medical examination to the employee, the standard does not mandate how this should be done. The written medical opinion for the employer could contain a statement that the PLHCP has explained the results of the medical examination to the employee.
3.2.1. The employer must provide the following information to the Board Certified Specialist in Pulmonary Disease or Occupational Medicine:
3.2.1.1. A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
3.2.1.2. The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
3.2.1.3. A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
3.2.1.4. Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
3.2.2. The PLHCP should make certain that, with written authorization from the employee, the Board Certified Specialist in Pulmonary Disease or Occupational Medicine has any other pertinent medical and occupational information necessary for the specialist's evaluation of the employee's condition.
3.2.3. Once the Board Certified Specialist in Pulmonary Disease or Occupational Medicine has evaluated the employee, the employer must ensure that the Specialist explains to the employee the results of the medical examination and provides the employee with a written medical report within 30 days of the examination. The employer must also ensure that the Specialist provides the employer with a written medical opinion within 30 days of the employee examination. (Sample forms for the written medical report for the employee, the written medical opinion for the employer and the written authorization are provided in Section 7 of this Appendix.)
3.2.4. The Specialist's written medical report for the employee must include the following information:
3.2.4.1. A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment;
3.2.4.2. Any recommended limitations upon the employee's use of a respirator; and
3.2.4.3. Any recommended limitations on the employee's exposure to respirable crystalline silica.
3.2.5. The Specialist's written medical opinion for the employer must include the following information:
3.2.5.1. The date of the examination; and
3.2.5.2. Any recommended limitations on the employee's use of respirators.
3.2.5.3. If the employee provides the Board Certified Specialist in Pulmonary Disease or Occupational Medicine with written authorization, the written medical opinion for the employer shall also contain any recommended limitations on the employee's exposure to respirable crystalline silica.
3.2.5.4. Although the respirable crystalline silica standard requires the employer to ensure that the Board Certified Specialist in Pulmonary Disease or Occupational Medicine explains the results of the medical examination to the employee, the standard does not mandate how this should be done. The written medical opinion for the employer could contain a statement that the Specialist has explained the results of the medical examination to the employee.
3.2.6. After evaluating the employee, the Board Certified Specialist in Pulmonary Disease or Occupational Medicine should provide feedback to the PLHCP as appropriate, depending on the reason for the referral. OSHA believes that because the PLHCP has the primary relationship with the employer and employee, the Specialist may want to communicate his or her findings to the PLHCP and have the PLHCP simply update the original medical report for the employee and medical opinion for the employer. This is permitted under the standard, so long as all requirements and time deadlines are met.
The information that is provided from the PLHCP to the employee and employer under the medical surveillance section of OSHA's respirable crystalline silica standard differs from that of medical surveillance requirements in previous OSHA standards. The standard requires two separate written communications, a written medical report for the employee and a written medical opinion for the employer. The confidentiality requirements for the written medical opinion are more stringent than in past standards. For example, the information the PLHCP can (and must) include in his or her written medical opinion for the employer is limited to: The date of the examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the employee's use of respirators. If the employee provides written authorization for the disclosure of
The standard also places limitations on the information that the Board Certified Specialist in Pulmonary Disease or Occupational Medicine can provide to the employer without the employee's written authorization. The Specialist's written medical opinion for the employer, like the PLHCP's opinion, is limited to (and must contain): The date of the examination and any recommended limitations on the employee's use of respirators. If the employee provides written authorization, the written medical opinion can (and must) also contain any limitations on the employee's exposure to respirable crystalline silica.
The PLHCP should discuss the implication of signing or not signing the authorization with the employee (in a manner and language that he or she understands) so that the employee can make an informed decision regarding the written authorization and its consequences. The discussion should include the risk of ongoing silica exposure, personal risk factors, risk of disease progression, and possible health and economic consequences. For instance, written authorization is required for a PLHCP to advise an employer that an employee should be referred to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for evaluation of an abnormal chest X-ray (B-reading 1/0 or greater). If an employee does not sign an authorization, then the employer will not know and cannot facilitate the referral to a Specialist and is not required to pay for the Specialist's examination. In the rare case where an employee is diagnosed with acute or accelerated silicosis, co-workers are likely to be at significant risk of developing those diseases as a result of inadequate controls in the workplace. In this case, the PLHCP and/or Specialist should explain this concern to the affected employee and make a determined effort to obtain written authorization from the employee so that the PLHCP and/or Specialist can contact the employer.
Finally, without written authorization from the employee, the PLHCP and/or Board Certified Specialist in Pulmonary Disease or Occupational Medicine cannot provide feedback to an employer regarding control of workplace silica exposure, at least in relation to an individual employee. However, the regulation does not prohibit a PLHCP and/or Specialist from providing an employer with general recommendations regarding exposure controls and prevention programs in relation to silica exposure and silica-related illnesses, based on the information that the PLHCP receives from the employer such as employees' duties and exposure levels. Recommendations may include increased frequency of medical surveillance examinations, additional medical surveillance components, engineering and work practice controls, exposure monitoring and personal protective equipment. For instance, more frequent medical surveillance examinations may be a recommendation to employers for employees who do abrasive blasting with silica because of the high exposures associated with that operation.
ACOEM's Code of Ethics and discussion is a good resource to guide PLHCPs regarding the issues discussed in this section (
5.1. American College of Occupational and Environmental Medicine (ACOEM):
5.2. Center for Disease Control and Prevention (CDC)
5.3. International Labour Organization
5.4. National Institute of Occupational Safety and Health (NIOSH)
5.5. National Industrial Sand Association:
5.6. Occupational Safety and Health Administration (OSHA)
5.7. Other
Three sample forms are provided. The first is a sample written medical report for the employee. The second is a sample written medical opinion for the employer. And the third is a sample written authorization form that employees sign to clarify what information the employee is authorizing to be released to the employer.
Section 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; 29 CFR part 1911.
Sections 1915.120 and 1915.152 of 29 CFR also issued under 29 CFR part 1911.
The revisions and additions should read as follows:
The requirements applicable to shipyard employment under this section are identical to those set forth at § 1910.1053 of this chapter.
Section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); and Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and 1926.65 also issued under 5 U.S.C. 553 and 29 CFR part 1911.
Section 1926.61 also issued under 49 U.S.C. 1801-1819 and 6 U.S.C. 553.
Section 1926.62 also issued under section 1031 of the Housing and Community Development Act of 1992 (42 U.S.C. 4853).
Section 1926.65 also issued under section 126 of the Superfund Amendments and Reauthorization Act of 1986, as amended (reprinted at 29 U.S.C.A. 655 Note), and 5 U.S.C. 553.
The revisions and additions read as follows:
Section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); and Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
Section 1926.1102 not issued under 29 U.S.C. 655 or 29 CFR part 1911; also issued under 5 U.S.C. 553.
(a)
(b)
(c)
(2) When implementing the control measures specified in Table 1, each employer shall:
(i) For tasks performed indoors or in enclosed areas, provide a means of exhaust as needed to minimize the accumulation of visible airborne dust;
(ii) For tasks performed using wet methods, apply water at flow rates sufficient to minimize release of visible dust;
(iii) For measures implemented that include an enclosed cab or booth, ensure that the enclosed cab or booth:
(A) Is maintained as free as practicable from settled dust;
(B) Has door seals and closing mechanisms that work properly;
(C) Has gaskets and seals that are in good condition and working properly;
(D) Is under positive pressure maintained through continuous delivery of fresh air;
(E) Has intake air that is filtered through a filter that is 95% efficient in the 0.3-10.0 µm range (
(F) Has heating and cooling capabilities.
(3) Where an employee performs more than one task on Table 1 during the course of a shift, and the total duration of all tasks combined is more than four hours, the required respiratory protection for each task is the respiratory protection specified for more than four hours per shift. If the total duration of all tasks on Table 1 combined is less than four hours, the required respiratory protection for each task is the respiratory protection specified for less than four hours per shift.
(d)
(1)
(2)
(ii)
(iii)
(B) If initial monitoring indicates that employee exposures are below the action level, the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring.
(C) Where the most recent exposure monitoring indicates that employee exposures are at or above the action level but at or below the PEL, the employer shall repeat such monitoring within six months of the most recent monitoring.
(D) Where the most recent exposure monitoring indicates that employee exposures are above the PEL, the employer shall repeat such monitoring within three months of the most recent monitoring.
(E) Where the most recent (non-initial) exposure monitoring indicates that employee exposures are below the action level, the employer shall repeat such monitoring within six months of the most recent monitoring until two consecutive measurements, taken seven or more days apart, are below the action level, at which time the employer may discontinue monitoring for those employees whose exposures are represented by such monitoring, except as otherwise provided in paragraph (d)(2)(iv) of this section.
(iv)
(v)
(vi) Employee notification of assessment results. (A) Within five working days after completing an exposure assessment in accordance with paragraph (d)(2) of this section, the employer shall individually notify each affected employee in writing of the results of that assessment or post the results in an appropriate location accessible to all affected employees.
(B) Whenever an exposure assessment indicates that employee exposure is above the PEL, the employer shall describe in the written notification the corrective action being taken to reduce employee exposure to or below the PEL.
(vii)
(B) When observation of monitoring requires entry into an area where the use of protective clothing or equipment is required for any workplace hazard, the employer shall provide the observer with protective clothing and equipment at no cost and shall ensure that the observer uses such clothing and equipment.
(3)
(ii)
(e)
(i) Where specified by Table 1 of paragraph (c) of this section; or
(ii) For tasks not listed in Table 1, or where the employer does not fully and properly implement the engineering controls, work practices, and respiratory protection described in Table 1:
(A) Where exposures exceed the PEL during periods necessary to install or implement feasible engineering and work practice controls;
(B) Where exposures exceed the PEL during tasks, such as certain maintenance and repair tasks, for which engineering and work practice controls are not feasible; and
(C) During tasks for which an employer has implemented all feasible engineering and work practice controls and such controls are not sufficient to reduce exposures to or below the PEL.
(2)
(3)
(f)
(2) The employer shall not allow compressed air to be used to clean clothing or surfaces where such activity could contribute to employee exposure to respirable crystalline silica unless:
(i) The compressed air is used in conjunction with a ventilation system that effectively captures the dust cloud created by the compressed air; or
(ii) No alternative method is feasible.
(g)
(i) A description of the tasks in the workplace that involve exposure to respirable crystalline silica;
(ii) A description of the engineering controls, work practices, and respiratory protection used to limit employee exposure to respirable crystalline silica for each task;
(iii) A description of the housekeeping measures used to limit employee exposure to respirable crystalline silica; and
(iv) A description of the procedures used to restrict access to work areas, when necessary, to minimize the number of employees exposed to respirable crystalline silica and their level of exposure, including exposures generated by other employers or sole proprietors.
(2) The employer shall review and evaluate the effectiveness of the written exposure control plan at least annually and update it as necessary.
(3) The employer shall make the written exposure control plan readily available for examination and copying, upon request, to each employee covered by this section, their designated representatives, the Assistant Secretary and the Director.
(4) The employer shall designate a competent person to make frequent and regular inspections of job sites, materials, and equipment to implement the written exposure control plan.
(h)
(ii) The employer shall ensure that all medical examinations and procedures required by this section are performed by a PLHCP as defined in paragraph (b) of this section.
(2)
(i) A medical and work history, with emphasis on: Past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and
(ii) A physical examination with special emphasis on the respiratory system;
(iii) A chest X-ray (a single posteroanterior radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems), interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader;
(iv) A pulmonary function test to include forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(v) Testing for latent tuberculosis infection; and
(vi) Any other tests deemed appropriate by the PLHCP.
(3)
(4)
(i) A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
(ii) The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
(iii) A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
(5)
(i) A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment;
(ii) Any recommended limitations on the employee's use of respirators;
(iii) Any recommended limitations on the employee's exposure to respirable crystalline silica; and
(iv) A statement that the employee should be examined by a specialist (pursuant to paragraph (h)(7) of this section) if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B Reader, or if referral to a specialist is otherwise deemed appropriate by the PLHCP.
(6)
(A) The date of the examination;
(B) A statement that the examination has met the requirements of this section; and
(C) Any recommended limitations on the employee's use of respirators.
(ii) If the employee provides written authorization, the written opinion shall also contain either or both of the following:
(A) Any recommended limitations on the employee's exposure to respirable crystalline silica;
(B) A statement that the employee should be examined by a specialist (pursuant to paragraph (h)(7) of this section) if the chest X-ray provided in accordance with this section is classified as 1/0 or higher by the B Reader, or if referral to a specialist is otherwise deemed appropriate by the PLHCP.
(iii) The employer shall ensure that each employee receives a copy of the written medical opinion described in paragraph (h)(6)(i) and (ii) of this section within 30 days of each medical examination performed.
(7)
(ii) The employer shall ensure that the examining specialist is provided with all of the information that the employer is obligated to provide to the PLHCP in accordance with paragraph (h)(4) of this section.
(iii) The employer shall ensure that the specialist explains to the employee the results of the medical examination and provides each employee with a written medical report within 30 days of the examination. The written report shall meet the requirements of paragraph (h)(5) (except paragraph (h)(5)(iv)) of this section.
(iv) The employer shall obtain a written opinion from the specialist within 30 days of the medical examination. The written opinion shall meet the requirements of paragraph (h)(6) (except paragraph (h)(6)(i)(B) and (ii)(B)) of this section.
(i)
(2)
(A) The health hazards associated with exposure to respirable crystalline silica;
(B) Specific tasks in the workplace that could result in exposure to respirable crystalline silica;
(C) Specific measures the employer has implemented to protect employees from exposure to respirable crystalline silica, including engineering controls, work practices, and respirators to be used;
(D) The contents of this section;
(E) The identity of the competent person designated by the employer in accordance with paragraph (g)(4) of this section; and
(F) The purpose and a description of the medical surveillance program required by paragraph (h) of this section.
(ii) The employer shall make a copy of this section readily available without cost to each employee covered by this section.
(j)
(ii) This record shall include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task monitored;
(C) Sampling and analytical methods used;
(D) Number, duration, and results of samples taken;
(E) Identity of the laboratory that performed the analysis;
(F) Type of personal protective equipment, such as respirators, worn by the employees monitored; and
(G) Name, social security number, and job classification of all employees represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer shall ensure that exposure records are maintained and made available in accordance with 29 CFR 1910.1020.
(2)
(ii) This record shall include at least the following information:
(A) The crystalline silica-containing material in question;
(B) The source of the objective data;
(C) The testing protocol and results of testing;
(D) A description of the process, task, or activity on which the objective data were based; and
(E) Other data relevant to the process, task, activity, material, or exposures on which the objective data were based.
(iii) The employer shall ensure that objective data are maintained and made available in accordance with 29 CFR 1910.1020.
(3)
(ii) The record shall include the following information about the employee:
(A) Name and social security number;
(B) A copy of the PLHCPs' and specialists' written medical opinions; and
(C) A copy of the information provided to the PLHCPs and specialists.
(iii) The employer shall ensure that medical records are maintained and made available in accordance with 29 CFR 1910.1020.
(k)
(2) All obligations of this section, except requirements for methods of sample analysis in paragraph (d)(2)(v), shall commence June 23, 2017.
(3) Requirements for methods of sample analysis in paragraph (d)(2)(v) of this section commence June 23, 2018.
This This appendix specifies the procedures for analyzing air samples for respirable crystalline silica, as well as the quality control procedures that employers must ensure that laboratories use when performing an analysis required under 29 CFR 1926.1153 (d)(2)(v). Employers must ensure that such a laboratory:
1. Evaluates all samples using the procedures specified in one of the following analytical methods: OSHA ID-142; NMAM 7500; NMAM 7602; NMAM 7603; MSHA P-2; or MSHA P-7;
2. Is accredited to ANS/ISO/IEC Standard 17025:2005 with respect to crystalline silica analyses by a body that is compliant with ISO/IEC Standard 17011:2004 for implementation of quality assessment programs;
3. Uses the most current National Institute of Standards and Technology (NIST) or NIST traceable standards for instrument calibration or instrument calibration verification;
4. Implements an internal quality control (QC) program that evaluates analytical uncertainty and provides employers with estimates of sampling and analytical error;
5. Characterizes the sample material by identifying polymorphs of respirable crystalline silica present, identifies the presence of any interfering compounds that might affect the analysis, and makes any corrections necessary in order to obtain accurate sample analysis; and
6. Analyzes quantitatively for crystalline silica only after confirming that the sample matrix is free of uncorrectable analytical interferences, corrects for analytical interferences, and uses a method that meets the following performance specifications:
The purpose of this Appendix is to provide medical information and recommendations to aid physicians and other licensed health care professionals (PLHCPs) regarding compliance with the medical surveillance provisions of the respirable crystalline silica standard (29 CFR 1926.1153). Appendix B is for informational and guidance purposes only and none of the statements in Appendix B should be construed as imposing a mandatory requirement on employers that is not otherwise imposed by the standard.
Medical screening and surveillance allow for early identification of exposure-related health effects in individual employee and groups of employees, so that actions can be taken to both avoid further exposure and prevent or address adverse health outcomes. Silica-related diseases can be fatal, encompass a variety of target organs, and may have public health consequences when considering the increased risk of a latent tuberculosis (TB) infection becoming active. Thus, medical surveillance of silica-exposed employees requires that PLHCPs have a thorough knowledge of silica-related health effects.
This Appendix is divided into seven sections. Section 1 reviews silica-related diseases, medical responses, and public health responses. Section 2 outlines the components of the medical surveillance program for employees exposed to silica. Section 3 describes the roles and responsibilities of the PLHCP implementing the program and of other medical specialists and public health professionals. Section 4 provides a discussion of considerations, including confidentiality. Section 5 provides a list of additional resources and Section 6 lists references. Section 7 provides sample forms for the written medical report for the employee, the written medical opinion for the employer and the written authorization.
Silicosis is an irreversible, often disabling, and sometimes fatal fibrotic lung disease. Progression of silicosis can occur despite removal from further exposure. Diagnosis of silicosis requires a history of exposure to silica and radiologic findings characteristic of silica exposure. Three different presentations of silicosis (chronic, accelerated, and acute) have been defined. Accelerated and acute silicosis are much less common than chronic silicosis. However, it is critical to recognize all cases of accelerated and acute silicosis because these are life-threatening illnesses
In addition to silicosis, employees exposed to respirable crystalline silica, especially those with accelerated or acute silicosis, are at increased risks of contracting active TB and other infections (ATS 1997; Rees and Murray 2007). Exposure to respirable crystalline silica also increases an employee's risk of developing lung cancer, and the higher the cumulative exposure, the higher the risk (Steenland
1.2.1. Symptoms—shortness of breath and cough, although employees may not notice any symptoms early in the disease. Constitutional symptoms, such as fever, loss of appetite and fatigue, may indicate other diseases associated with silica exposure, such as TB infection or lung cancer. Employees with these symptoms should immediately receive further evaluation and treatment.
1.2.2. Physical Examination—may be normal or disclose dry rales or rhonchi on lung auscultation.
1.2.3. Spirometry—may be normal or may show only a mild restrictive or obstructive pattern.
1.2.4. Chest X-ray—classic findings are small, rounded opacities in the upper lung fields bilaterally. However, small irregular opacities and opacities in other lung areas can also occur. Rarely, “eggshell calcifications” in the hilar and mediastinal lymph nodes are seen.
1.2.5. Clinical Course—chronic silicosis in most cases is a slowly progressive disease. Under the respirable crystalline silica standard, the PLHCP is to recommend that employees with a 1/0 category X-ray be referred to an American Board Certified Specialist in Pulmonary Disease or Occupational Medicine. The PLHCP and/or Specialist should counsel employees regarding work practices and personal habits that could affect employees' respiratory health.
1.3.1. Symptoms—shortness of breath, cough, and sometimes sputum production. Employees with exposure to respirable crystalline silica, and especially those with accelerated silicosis, are at high risk for activation of TB infections, atypical mycobacterial infections, and fungal superinfections. Constitutional symptoms, such as fever, weight loss, hemoptysis (coughing up blood), and fatigue may herald one of these infections or the onset of lung cancer.
1.3.2. Physical Examination—rales, rhonchi, or other abnormal lung findings in relation to illnesses present. Clubbing of the digits, signs of heart failure, and cor pulmonale may be present in severe lung disease.
1.3.3. Spirometry—restrictive or mixed restrictive/obstructive pattern.
1.3.4. Chest X-ray—small rounded and/or irregular opacities bilaterally. Large opacities and lung abscesses may indicate infections, lung cancer, or progression to complicated silicosis, also termed progressive massive fibrosis.
1.3.5. Clinical Course—accelerated silicosis has a rapid, severe course. Under the respirable crystalline silica standard, the PLHCP can recommend referral to a Board Certified Specialist in either Pulmonary Disease or Occupational Medicine, as deemed appropriate, and referral to a Specialist is recommended whenever the diagnosis of accelerated silicosis is being considered.
1.4.1. Symptoms—sudden, progressive, and severe shortness of breath. Constitutional symptoms are frequently present and include fever, weight loss, fatigue, productive cough, hemoptysis (coughing up blood), and pleuritic chest pain.
1.4.2. Physical Examination—dyspnea at rest, cyanosis, decreased breath sounds, inspiratory rales, clubbing of the digits, and fever.
1.4.3. Spirometry—restrictive or mixed restrictive/obstructive pattern.
1.4.4. Chest X-ray—diffuse haziness of the lungs bilaterally early in the disease. As the disease progresses, the “ground glass” appearance of interstitial fibrosis will appear.
1.4.5. Clinical Course—employees with acute silicosis are at especially high risk of TB activation, nontuberculous mycobacterial infections, and fungal superinfections. Acute silicosis is immediately life-threatening. The employee should be urgently referred to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for evaluation and treatment. Although any case of silicosis indicates a breakdown in prevention, a case of acute or accelerated silicosis implies a profoundly high level of silica exposure and may mean that other employees are currently exposed to dangerous levels of silica.
PLHCPs who manage silica medical surveillance programs should have a thorough understanding of the many silica-related diseases and health effects outlined in Section 1 of this Appendix. At each clinical encounter, the PLHCP should consider silica-related health outcomes, with particular vigilance for acute and accelerated silicosis. In this Section, the required components of
2.1.1. The respirable crystalline silica standard requires the following: A medical and work history, with emphasis on: Past, present, and anticipated exposure to respirable crystalline silica, dust, and other agents affecting the respiratory system; any history of respiratory system dysfunction, including signs and symptoms of respiratory disease (
2.1.2. Further, the employer must provide the PLHCP with the following information:
2.1.2.1. A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
2.1.2.2. The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
2.1.2.3. A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
2.1.2.4. Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
2.1.3. Additional guidance and recommendations: A history is particularly important both in the initial evaluation and in periodic examinations. Information on past and current medical conditions (particularly a history of kidney disease, cardiac disease, connective tissue disease, and other immune diseases), medications, hospitalizations and surgeries may uncover health risks, such as immune suppression, that could put an employee at increased health risk from exposure to silica. This information is important when counseling the employee on risks and safe work practices related to silica exposure.
2.2.
2.2.1. The respirable crystalline silica standard requires the following: A physical examination, with special emphasis on the respiratory system. The physical examination must be performed at the initial examination and every three years thereafter.
2.2.2. Additional guidance and recommendations: Elements of the physical examination that can assist the PHLCP include: An examination of the cardiac system, an extremity examination (for clubbing, cyanosis, edema, or joint abnormalities), and an examination of other pertinent organ systems identified during the history.
2.3.1. The respirable crystalline silica standard requires the following: Baseline testing for TB on initial examination.
2.3.2. Additional guidance and recommendations:
2.3.2.1. Current CDC guidelines (
2.3.2.2. PLHCPs may use alternative TB tests, such as interferon-γ release assays (IGRAs), if sensitivity and specificity are comparable to TST (Mazurek
2.3.2.3. The silica standard allows the PLHCP to order additional tests or test at a greater frequency than required by the standard, if deemed appropriate. Therefore, PLHCPs might perform periodic (
2.3.2.4. Employees with positive TB tests and those with indeterminate test results should be referred to the appropriate agency or specialist, depending on the test results and clinical picture. Agencies, such as local public health departments, or specialists, such as a pulmonary or infectious disease specialist, may be the appropriate referral. Active TB is a nationally notifiable disease. PLHCPs should be aware of the reporting requirements for their region. All States have TB Control Offices that can be contacted for further information. (
2.3.2.5. The following public health principles are key to TB control in the U.S. (ATS-CDC-IDSA 2005):
2.4.1. The respirable crystalline silica standard requires the following: Pulmonary function testing must be performed on the initial examination and every three years thereafter. The required pulmonary function test is spirometry and must include forced vital capacity (FVC), forced expiratory volume in one second (FEV
2.4.2. Additional guidance and recommendations: Spirometry provides information about individual respiratory status and can be used to track an employee's respiratory status over time or as a surveillance tool to follow individual and group respiratory function. For quality results, the ATS and the American College of Occupational and Environmental Medicine (ACOEM) recommend use of the third National Health and Nutrition Examination Survey (NHANES III) values, and ATS publishes recommendations for spirometry equipment (Miller
2.5.1. The respirable crystalline silica standard requires the following: A single posteroanterior (PA) radiographic projection or radiograph of the chest at full inspiration recorded on either film (no less than 14 x 17 inches and no more than 16 x 17 inches) or digital radiography systems. A chest X-ray must be performed on the initial examination and every three years thereafter. The chest X-ray must be interpreted and classified according to the International Labour Office (ILO) International Classification of Radiographs of Pneumoconioses by a NIOSH-certified B Reader.
Chest radiography is necessary to diagnose silicosis, monitor the progression of silicosis, and identify associated conditions such as TB. If the B reading indicates small opacities in a profusion of 1/0 or higher, the employee is to receive a recommendation for referral to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine.
2.5.2. Additional guidance and recommendations: Medical imaging has largely transitioned from conventional film-based radiography to digital radiography systems. The ILO Guidelines for the Classification of Pneumoconioses has historically provided film-based chest radiography as a referent standard for comparison to individual exams. However, in 2011, the ILO revised the guidelines to include a digital set of referent standards that were derived from the prior film-based standards. To assist in assuring that digitally-acquired radiographs are at least as safe and effective as film radiographs, NIOSH has prepared guidelines, based upon accepted contemporary professional recommendations (
Once the medical surveillance examination is completed, the employer must ensure that the PLHCP explains to the employee the results of the medical examination and provides the employee with a written medical report within 30 days of the examination. The written medical report must contain a statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment. In addition, the PLHCP's written medical report must include any recommended limitations on the employee's use of respirators, any recommended limitations on the employee's exposure to respirable crystalline silica, and a statement that the employee should be examined by a Board Certified Specialist in Pulmonary Disease or Occupational medicine if the chest X-ray is classified as 1/0 or higher by the B Reader, or if referral to a Specialist is otherwise deemed appropriate by the PLHCP.
The PLHCP should discuss all findings and test results and any recommendations regarding the employee's health, worksite safety and health practices, and medical referrals for further evaluation, if indicated. In addition, it is suggested that the PLHCP offer to provide the employee with a complete copy of their examination and test results, as some employees may want this information for their own records or to provide to their personal physician or a future PLHCP. Employees are entitled to access their medical records.
Under the respirable crystalline silica standard, the employer must ensure that the PLHCP provides the employer with a written medical opinion within 30 days of the employee examination, and that the employee also gets a copy of the written medical opinion for the employer within 30 days. The PLHCP may choose to directly provide the employee a copy of the written medical opinion. This can be particularly helpful to employees, such as construction employees, who may change employers frequently. The written medical opinion can be used by the employee as proof of up-to-date medical surveillance. The following lists the elements of the written medical report for the employee and written medical opinion for the employer. (Sample forms for the written medical report for the employee, the written medical opinion for the employer, and the written authorization are provided in Section 7 of this Appendix.)
3.1.1. The written medical report for the employee must include the following information:
3.1.1.1. A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to respirable crystalline silica and any medical conditions that require further evaluation or treatment;
3.1.1.2. Any recommended limitations upon the employee's use of a respirator;
3.1.1.3. Any recommended limitations on the employee's exposure to respirable crystalline silica; and
3.1.1.4. A statement that the employee should be examined by a Board Certified Specialist in Pulmonary Disease or Occupational Medicine, where the standard requires or where the PLHCP has determined such a referral is necessary. The standard requires referral to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for a chest X-ray B reading indicating small opacities in a profusion of 1/0 or higher, or if the PHLCP determines that referral to a Specialist is necessary for other silica-related findings.
3.1.2. The PLHCP's written medical opinion for the employer must include only the following information:
3.1.2.1. The date of the examination;
3.1.2.2. A statement that the examination has met the requirements of this section; and
3.1.2.3. Any recommended limitations on the employee's use of respirators.
3.1.2.4. If the employee provides the PLHCP with written authorization, the written opinion for the employer shall also contain either or both of the following:
3.1.2.5. In addition to the above referral for abnormal chest X-ray, the PLHCP may refer an employee to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for other findings of concern during the medical surveillance examination if these findings are potentially related to silica exposure.
3.1.2.6. Although the respirable crystalline silica standard requires the employer to ensure that the PLHCP explains the results of the medical examination to the employee, the standard does not mandate how this should be done. The written medical opinion for the employer could contain a statement that the PLHCP has explained the results of the medical examination to the employee.
3.2.1. The employer must provide the following information to the Board Certified Specialist in Pulmonary Disease or Occupational Medicine:
3.2.1.1. A description of the employee's former, current, and anticipated duties as they relate to the employee's occupational exposure to respirable crystalline silica;
3.2.1.2. The employee's former, current, and anticipated levels of occupational exposure to respirable crystalline silica;
3.2.1.3. A description of any personal protective equipment used or to be used by the employee, including when and for how long the employee has used or will use that equipment; and
3.2.1.4. Information from records of employment-related medical examinations previously provided to the employee and currently within the control of the employer.
3.2.2. The PLHCP should make certain that, with written authorization from the employee, the Board Certified Specialist in Pulmonary Disease or Occupational Medicine has any other pertinent medical and occupational information necessary for the specialist's evaluation of the employee's condition.
3.2.3. Once the Board Certified Specialist in Pulmonary Disease or Occupational Medicine has evaluated the employee, the employer must ensure that the Specialist explains to the employee the results of the medical examination and provides the employee with a written medical report within 30 days of the examination. The employer must also ensure that the Specialist provides the employer with a written medical opinion within 30 days of the employee examination. (Sample forms for the written medical report for the employee, the written medical opinion for the employer and the written authorization are provided in Section 7 of this Appendix.)
3.2.4. The Specialist's written medical report for the employee must include the following information:
3.2.4.1. A statement indicating the results of the medical examination, including any medical condition(s) that would place the employee at increased risk of material impairment to health from exposure to
3.2.4.2. Any recommended limitations upon the employee's use of a respirator; and
3.2.4.3. Any recommended limitations on the employee's exposure to respirable crystalline silica.
3.2.5. The Specialist's written medical opinion for the employer must include the following information:
3.2.5.1. The date of the examination; and
3.2.5.2. Any recommended limitations on the employee's use of respirators.
3.2.5.3. If the employee provides the Board Certified Specialist in Pulmonary Disease or Occupational Medicine with written authorization, the written medical opinion for the employer shall also contain any recommended limitations on the employee's exposure to respirable crystalline silica.
3.2.5.4. Although the respirable crystalline silica standard requires the employer to ensure that the Board Certified Specialist in Pulmonary Disease or Occupational Medicine explains the results of the medical examination to the employee, the standard does not mandate how this should be done. The written medical opinion for the employer could contain a statement that the Specialist has explained the results of the medical examination to the employee.
3.2.6. After evaluating the employee, the Board Certified Specialist in Pulmonary Disease or Occupational Medicine should provide feedback to the PLHCP as appropriate, depending on the reason for the referral. OSHA believes that because the PLHCP has the primary relationship with the employer and employee, the Specialist may want to communicate his or her findings to the PLHCP and have the PLHCP simply update the original medical report for the employee and medical opinion for the employer. This is permitted under the standard, so long as all requirements and time deadlines are met.
The information that is provided from the PLHCP to the employee and employer under the medical surveillance section of OSHA's respirable crystalline silica standard differs from that of medical surveillance requirements in previous OSHA standards. The standard requires two separate written communications, a written medical report for the employee and a written medical opinion for the employer. The confidentiality requirements for the written medical opinion are more stringent than in past standards. For example, the information the PLHCP can (and must) include in his or her written medical opinion for the employer is limited to: The date of the examination, a statement that the examination has met the requirements of this section, and any recommended limitations on the employee's use of respirators. If the employee provides written authorization for the disclosure of any limitations on the employee's exposure to respirable crystalline silica, then the PLHCP can (and must) include that information in the written medical opinion for the employer as well. Likewise, with the employee's written authorization, the PLHCP can (and must) disclose the PLHCP's referral recommendation (if any) as part of the written medical opinion for the employer. However, the opinion to the employer must not include information regarding recommended limitations on the employee's exposure to respirable crystalline silica or any referral recommendations without the employee's written authorization.
The standard also places limitations on the information that the Board Certified Specialist in Pulmonary Disease or Occupational Medicine can provide to the employer without the employee's written authorization. The Specialist's written medical opinion for the employer, like the PLHCP's opinion, is limited to (and must contain): The date of the examination and any recommended limitations on the employee's use of respirators. If the employee provides written authorization, the written medical opinion can (and must) also contain any limitations on the employee's exposure to respirable crystalline silica.
The PLHCP should discuss the implication of signing or not signing the authorization with the employee (in a manner and language that he or she understands) so that the employee can make an informed decision regarding the written authorization and its consequences. The discussion should include the risk of ongoing silica exposure, personal risk factors, risk of disease progression, and possible health and economic consequences. For instance, written authorization is required for a PLHCP to advise an employer that an employee should be referred to a Board Certified Specialist in Pulmonary Disease or Occupational Medicine for evaluation of an abnormal chest X-ray (B-reading 1/0 or greater). If an employee does not sign an authorization, then the employer will not know and cannot facilitate the referral to a Specialist and is not required to pay for the Specialist's examination. In the rare case where an employee is diagnosed with acute or accelerated silicosis, co-workers are likely to be at significant risk of developing those diseases as a result of inadequate controls in the workplace. In this case, the PLHCP and/or Specialist should explain this concern to the affected employee and make a determined effort to obtain written authorization from the employee so that the PLHCP and/or Specialist can contact the employer.
Finally, without written authorization from the employee, the PLHCP and/or Board Certified Specialist in Pulmonary Disease or Occupational Medicine cannot provide feedback to an employer regarding control of workplace silica exposure, at least in relation to an individual employee. However, the regulation does not prohibit a PLHCP and/or Specialist from providing an employer with general recommendations regarding exposure controls and prevention programs in relation to silica exposure and silica-related illnesses, based on the information that the PLHCP receives from the employer such as employees' duties and exposure levels. Recommendations may include increased frequency of medical surveillance examinations, additional medical surveillance components, engineering and work practice controls, exposure monitoring and personal protective equipment. For instance, more frequent medical surveillance examinations may be a recommendation to employers for employees who do abrasive blasting with silica because of the high exposures associated with that operation.
ACOEM's Code of Ethics and discussion is a good resource to guide PLHCPs regarding the issues discussed in this section (
5.1. American College of Occupational and Environmental Medicine (ACOEM):
5.2. Center for Disease Control and Prevention (CDC)
5.3. International Labour Organization
5.4. National Institute of Occupational Safety and Health (NIOSH)
5.5. National Industrial Sand Association:
5.6. Occupational Safety and Health Administration (OSHA)
5.7. Other
Three sample forms are provided. The first is a sample written medical report for the employee. The second is a sample written medical opinion for the employer. And the third is a sample written authorization form that employees sign to clarify what information the employee is authorizing to be released to the employer.
Drug Enforcement Administration, Department of Justice.
Notice of order with opportunity for comment.
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between April 1, 2013, and December 31, 2015, as listed below, were accepted for filing and have been approved or denied as indicated.
Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). Electronic comments must be submitted, and written comments must be postmarked, on or before May 24, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
To ensure proper handling of comments, please reference “Docket No. DEA-372” on all correspondence, including any attachments. The Drug Enforcement Administration (DEA) encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to
Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document is available at
The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for purpose of this action. 21 U.S.C. 801-971. The DEA published the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.
The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.
Section 201 of the CSA (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain compounds, mixtures, or preparations containing a controlled substance, if she finds that such compounds, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).
The Deputy Assistant Administrator received applications between April 1, 2013, and September 17, 2015, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. Pursuant to the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Deputy Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart I below is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or animal and either: (1) Contains no narcotic controlled substance and is packaged in such a form or concentration that the packaged
Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), and in accordance with 21 CFR 1308.23 and 21 CFR 1308.24, the Deputy Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by the DEA, are exempt, to the extent described in 21 CFR 1308.24, from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the date that was provided in the approval letters to the individual requesters.
The Deputy Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart II below is not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23. Accordingly, the Deputy Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II below and specifically described in the application materials received by the DEA, are not exempt from application of any part of the CSA or from application of any part of the CFR, with regard to the requested exemption pursuant to 21 CFR 1308.23, as of the date that was provided in the determination letters to the individual requesters.
The exemptions are applicable only to the precise preparation or mixture described in the application submitted to DEA in the form(s) listed in this order and only for those sections of the CSA and the CFR that are specifically identified. In accordance with 21 CFR 1308.24(h), any change in the quantitative or qualitative composition of the preparation or mixture, or change in the trade name or other designation of the preparation or mixture after the date of application requires a new application. In accordance with 21 CFR 1308.24(g), the DEA may prescribe requirements other than those set forth in 21 CFR 1308.24 (b) through (e) on a case-by-case basis for materials exempted in bulk quantities. Accordingly, in order to limit opportunity for diversion from the larger bulk quantities, the DEA has determined that each of the exempted bulk products listed in this order may only be used in-house by the manufacturer, and may not be distributed for any purpose, or transported to other facilities.
Additional exempt chemical preparation requests received between April 1, 2013, and December 31, 2015, and not otherwise referenced in this order may remain under consideration until the DEA receives additional information required, in accordance with 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. The DEA's order on such requests will be communicated to the public in a future
The DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR 1308.24(a). All other requirements of the CSA and the CFR apply, including registration as an importer as required by 21 U.S.C. 957.
The statutory authority for exempt chemical preparations is based on the control status of substances contained within a preparation, the intended administration of a preparation, and the packaged form of a preparation. The DEA conducts a case-by-case analysis of each application for exemption to determine whether exemption of a preparation from certain provisions of the CSA is appropriate pursuant to the specified statutory and regulatory requirements.
Most exempt chemical preparations have remained effective until the holder of a specific exempt chemical preparation specifically requested that the exemption be terminated. The CSA allows for modifications to the controlled substances schedules to add, remove, or change the schedule of substances thus resulting in periodic modifications to the control status of various substances. 21 U.S.C. 811(a). Since the CSA was enacted in 1970, the DEA has on several occasions added to, removed from, or modified the schedules of controlled substances in accordance with the CSA. Such changes may result in the non-compliance of exempt chemical preparations with current statutes or regulations if chemical preparations that have already obtained exempt status contain newly controlled substances. For example, although an exempt chemical preparation may continue to be packaged in the same manner as when it was approved, non-controlled substances in the preparation may become controlled, thus prompting the need for a new application for exemption of the chemical preparation to ensure continued compliance. Other preparations that previously contained no controlled substances may contain newly controlled substances and thus would require an application for exemption.
The DEA reviews applications for chemical preparation exemptions based on the statutes and regulations that are in place at the time of the application, including the control status of substances included in the preparation. The DEA must remain vigilant to ensure that exempt chemical preparations remain consistent with the standards set
In accordance with 21 CFR 1308.23, any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed.
A list of all current exemptions, including those listed in this order, is available on the DEA's Web site at
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to require use of the electronic contract attachments accessible via the Product Data Reporting and Evaluation Program to record and track warranty data and source of repair information for serialized items.
Effective March 25, 2016.
Ms. Jo Ann Reilly, telephone 571-372-6176.
DoD published a proposed rule in the
There are two editorial changes from the proposed rule made in the final rule. The title “International Standards Organization/International Electrotechnical Commission” is spelled out in lieu of the acronym ISO/IEC in the definition of “issuing agency” at DFARS 246.701 and 252.246-7006(a). In addition, the list of examples of organizations that are responsible for assigning globally unique identifiers to an enterprise is removed from the definition of “issuing agency” at DFARS 246.701, 252.211-7003(a), and 252.246-7006(a), because a full list is available in the Register of Issuing Agency Codes for ISO/IEC 15459, the link for which is already provided in the definition.
The provision at DFARS 252.246-7005, Notice of Warranty Tracking and Serialized Items, and the clause at DFARS 252.246-7006, Warranty Tracking of Serialized Items, are prescribed for use when the solicitation includes the clause at 252.211-7003, Item Unique Identification and Valuation, and it is anticipated that the resulting contract will include a warranty for serialized items. The clause at 252.211-7003 is applicable to acquisitions valued at or below at or below the simplified acquisition threshold and for commercial items, including commercially available off-the-shelf items, involving the furnishing of supplies, unless the conditions in DFARS 211.274-2(b) apply. This rule does not change prescriptions for the provision at 252.246-7005 and the clause at 252.246-7006; rather, this rule merely require use of the electronic contract attachments to record and track warranty data and source of repair information for serialized items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD has prepared a final regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act 5.U.S.C. 601,
The objective of the rule is to improve the process of collecting and sharing data on warranties provided by contractors on serialized items procured by DoD. Use of the electronic formats available via the Product Data Reporting and Evaluation Program (PDREP) ensures the data elements for warranty terms are effectively transmitted through various systems, such as Electronic Document Access, Wide Area WorkFlow, the Invoice, Receipt, Acceptance and Property Transfer module, and the PDREP Warranty Tracking database.
The final rule requires the use of the electronic formats for the “Warranty Tracking Information” and “Source of Repair Instructions” attachments, which are used to track the warranties of serialized items in accordance with the provision at DFARS 252.246-7005, Notice of Warranty Tracking of Serialized Items, and the clause at DFARS 252.246-7006, Warranty Tracking of Serialized Items. This rule is also necessary to provide clear guidance on the requirements for completion and submission of the warranty attachments.
There were no issues raised by the public in response to the initial regulatory flexibility analysis provided in the proposed rule.
According to data available in the Federal Procurement Data System, in fiscal year (FY) 2014 DoD awarded 5,807 contracts that contain one or more warranty clauses. Subject matter experts within DoD estimate that almost twice as many solicitations (11,500) issued by DoD in FY 2014 may have contained a warranty clause. It is also estimated that an average of four offers may have been received in response those solicitations, or 46,000 total offers. Of those responses, approximately 85 percent, or 39,100 responses, are estimated to be received from small businesses.
It is estimated that fifty percent of the time (for approximately 5,750 solicitations) the Government will specify the desired warranty terms, in which case the contractor provides the remaining data elements on the “Warranty Tracking Information” attachment and the “Source of Repair Instructions” attachment with its proposal, at contract award, or at the point of delivery. The other fifty percent of the time, the contractor will be required to specify all the warranty terms on the “Warranty Tracking Information” attachment and the “Source of Repair Instructions” attachment.
This rule does not create any new reporting or recordkeeping requirements. Offerors and contractors are already required to complete the attachments in accordance with the provision at DFARS 252.246-7005, Notice of Warranty Tracking of Serialized Items, and the clause at DFARS 252.246-7006, Warranty Tracking of Serialized Items. This rule merely requires contractors and offerors
No known alternatives to the rule have been identified that would achieve the stated objectives.
The rule contains information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. chapter 35); however, these changes to the DFARS do not impose additional information collection requirement to the paperwork burden previously approved under OMB Control Number 0704-0481, entitled “Warranty Tracking of Serialized Items.” The rule clarifies existing requirements for completion and submission of warranty attachments and requires electronic submission of those attachments by using the formats available in the Product Data Reporting and Evaluation Program.
Government procurement.
Therefore, 48 CFR parts 246 and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As used in this subpart—
(3) When the solicitation includes the clause at 252.211-7003, Item Unique Identification and Valuation, which is prescribed in 211.274-6(a), and it is anticipated that the resulting contract will include a warranty for serialized items—
(i) Use the provision at 252.246-7005, Notice of Warranty Tracking of Serialized Items, in the solicitation if the Government does not specify a warranty and offerors will be required to enter data with the offer;
(ii) Use the clause at 252.246-7006, Warranty Tracking of Serialized Items, in the solicitation and contract; and
(iii) Include the following warranty attachments, available at
(A) Warranty Tracking Information.
(B) Source of Repair Instructions.
Follow the procedures at PGI 246.710-70 regarding warranty attachments.
The revision reads as follows:
(a) * * *
The revisions read as follows:
(a)
(b)
(2) The successful offeror will be required to provide the following information no later than when the warranted items are presented for receipt and/or acceptance, in accordance with the clause at 252.246-7006—
(i) The unique item identifier for each warranted item required by the attachment entitled “Warranty Tracking Information;” and
(ii) All information required by the attachment entitled “Source of Repair Instructions” for each warranted item.
(3) For additional information on warranty attachments, see the “Warranty and Source of Repair” training and “Warranty and Source of Repair Tracking User Guide” accessible on the Product Data Reporting and Evaluation Program (PDREP) Web site at
The revision reads as follows:
(a) * * *
(b)
(2) The Contractor shall provide the following information no later than when the warranted items are presented for receipt and/or acceptance—
(i) The unique item identifier for each warranted item required by the attachment entitled “Warranty Tracking Information;” and
(ii) The warranty repair source information and instructions for each warranted item required by the attachment entitled “Source of Repair Instructions.”
(3) The Contractor shall submit the data for warranty tracking to the Contracting Officer with a copy to the requiring activity and the Contracting Officer Representative.
(4) For additional information on warranty attachments, see the “Warranty and Source of Repair” training and “Warranty and Source of Repair Tracking User Guide” accessible on the Product Data Reporting and Evaluation Program (PDREP) Web site at
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2015 that amended a section of the National Defense Authorization Act for Fiscal Year 2010, to extend and modify contract authority for advanced component development and prototype units.
Effective March 25, 2016.
Ms. Janetta Brewer, telephone 571-372-6104.
DoD published a proposed rule in the
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD has prepared a Final Regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is necessary to implement section 811 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2015 (Pub. L. 113-291). Section 811 amends paragraphs (a) and (b) of section 819 of the NDAA for FY 2010 (10 U.S.C. 2302 note). The objective of this rule is to provide authority for the inclusion of a contract line item (possibly an option) for advanced component development and prototype units to go to initial production without further competition.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
The rule will apply to DoD major defense acquisition program contractors and subcontractors. Most major defense acquisition programs are awarded to large concerns as they are of a scope too large for any small business to perform. As such, it is not expected that this rule will have a significant impact on a significant number of small entities.
This rule does not impose new recordkeeping or reporting requirements. There are no known significant alternative approaches to the rule that would meet the requirements of the statute.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 217 and 234 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(2) See 234.005-1 for limitations on the use of contract options for the provision of advanced component development, prototype, or initial production of technology developed under the contract or the delivery of initial or additional items.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify clauses and their prescriptions for small business programs and to create basic and alternate clauses structured in a manner to facilitate use of automated contract writing systems.
Effective March 25, 2016.
Ms. Jennifer Johnson, telephone 571-372-6100.
DoD published a proposed rule in the
This rule does not change the prescription for DFAR clause 252.219-7003, Small Business Subcontracting Plan (DoD Contracts); rather, the rule merely clarifies the use of the clause and the way it is displayed in the regulations. DFARS clause 252.219-7003 is used in conjunction with FAR clause 52.219-9, Small Business Subcontracting Plan, and applies to solicitations and contracts for commercial items, including commercially available off-the-shelf items. The clause is not applicable to acquisitions valued at or below the simplified acquisition threshold, because the FAR clause is only used in acquisitions expected to exceed $700,000.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This final rule clarifies: (1) DFARS clause, 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), which has an alternate, and (2) DFARS clause 252.219-7010, now titled “Notification of Competition Limited to Eligible 8(a) Concerns—Partnership Agreement,” which is an alternate to a FAR clause. The basic and alternate clauses will be full, separate clauses for ease of use by the contracting officers. This rule also explains the appropriate
The objective of this rule is to clarify the use of each clause by giving the basic and alternate clauses a separate prescription describing when to use the clause for the small business programs. This does not change the applicability of the basic or alternate clause. The basic and alternate clauses will each appear in full text, which will facilitate use of the automated contract writing systems.
No comments were received from the public in response to the initial regulatory flexibility analysis.
DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), and its alternate are prescribed to be used with FAR 52.219-9 and its alternates. FAR 52.219-9 does not apply to small business concerns; therefore, there is no burden on any small business for this rule.
DFARS 252.219-7010, now titled “Notification of Competition Limited to Eligible 8(a) Concerns—Partnership Agreement,” is the alternate for FAR 52.219-18, Notification of Competition Limited to Eligible 8(a) Concerns. This clause only affects 8(a) concerns when competing for an 8(a) award. Currently, there are approximately 5,217 active concerns registered in SAM that are certified in the 8(a) program. Nothing substantive will change in solicitations or contracts for potential offerors; only the way the clause alternates are presented in solicitations and contracts will be changed. This rule will result in potential offerors, including small businesses, expending less time to review and understand the solicitation and contract. The rule anticipates saving contractors' time by making all paragraph substitutions from the basic clause and by not requiring offerors to read inapplicable paragraphs contained in the basic clauses where alternates are used in the solicitations and contracts.
The rule does not impose any additional reporting, recordkeeping, or other compliance requirements.
No alternatives were identified that will accomplish the objectives of the rule.
The rule contains information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. chapter 35); however, these changes to the DFARS do not impose additional information collection requirement to the paperwork burden previously approved under OMB Control Number 0704-0386, entitled “Small Business Programs and Associated Clauses in part 252.219.” The rule merely clarifies the use of two DFARS clauses and the way the clauses are displayed in the regulation.
Government procurement.
Therefore, 48 CFR parts 212, 219, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(f) * * *
(vii)
(
(
(b)(1)(A) Use the basic or alternate clause at 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, that contain the clause at FAR 52.219-9, Small Business Subcontracting Plan.
(
(
(2) Use the clause at 252.219-7010, Notification of Competition Limited to Eligible 8(a) Concerns—Partnership Agreement, in lieu of the clause at FAR 52.219-18, Notification of Competition Limited to Eligible 8(a) Concerns, in competitive solicitations and contracts when the acquisition is accomplished using the procedures of FAR 19.805 and processed in accordance with the PA cited in 219.800.
The revisions read as follows:
This clause supplements the Federal Acquisition Regulation 52.219-9, Small Business Subcontracting Plan, clause of this contract.
(a)
(b) Subcontracts awarded to workshops approved by the Committee for Purchase from People Who are Blind or Severely Disabled (41 U.S.C. 8502-8504), may be counted toward the Contractor's small business subcontracting goal.
(c) A mentor firm, under the Pilot Mentor-Protege Program established under section 831 of Public Law 101-510, as amended, may
(1) Protege firms which are qualified organizations employing the severely disabled; and
(2) Former protege firms that meet the criteria in section 831(g)(4) of Public Law 101-510.
(d) The master plan is approved by the Contractor's cognizant contract administration activity.
(e) In those subcontracting plans which specifically identify small businesses, the Contractor shall notify the Administrative Contracting Officer of any substitutions of firms that are not small business firms, for the small business firms specifically identified in the subcontracting plan. Notifications shall be in writing and shall occur within a reasonable period of time after award of the subcontract. Contractor-specified formats shall be acceptable.
(f)(1) For DoD, the Contractor shall submit reports in eSRS as follows:
(i) The Standard Form 294, Subcontracting Report for Individual Contracts, shall be submitted in accordance with the instructions on that form.
(ii) An SSR for other than a commercial subcontracting plan, or construction and related maintenance repair contracts, shall be submitted in eSRS to the department or agency within DoD that administers the majority of the Contractor's individual subcontracting plans. An example would be Defense Finance and Accounting Service or Missile Defense Agency.
(2) For DoD, the authority to acknowledge receipt or reject reports in eSRS is as follows:
(i) Except as provided in paragraph (f)(2)(ii) of this clause, the authority to acknowledge receipt or reject SSRs in eSRS resides with the SSR Coordinator at the department or agency that administers the majority of the Contractor's individual subcontracting plans.
(ii) The authority to acknowledge receipt or reject SSRs for construction and related maintenance and repair contracts resides with the SSR Coordinator for each department or agency.
As prescribed in 219.811-3(2), use the following clause:
(a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA's 8(a) Program and which meet the following criteria at the time of submission of offer:
(1) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan.
(2) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by the SBA.
(3) If the competition is to be limited to 8(a) concerns within one or more specific SBA regions or districts, then the offeror's approved business plan is on the file and serviced by ____.
(b) By submission of its offer, the Offeror represents that it meets all of the criteria set forth in paragraph (a) of this clause.
(c) Any award resulting from this solicitation will be made directly by the Contracting Officer to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.
(d)(1)
(i) The SBA has determined that there are no small business manufacturers or processors in the Federal market place in accordance with FAR 19.502-2(c);
(ii) The acquisition is processed under simplified acquisition procedures and the total amount of this contract does not exceed $25,000, in which case a small business concern may furnish the product of any domestic firm; or
(iii) The acquisition is a construction or service contract.
(2) The ____
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify how the clause prescription addresses applicability when an exception to the Buy American statute or Balance of Payments Program applies.
Effective March 25, 2016.
Mr. Christopher Stiller, telephone 571-372-6176.
DoD published a proposed rule in the
The clause at DFARS 252.225-7001, Buy American Act and Balance of Payments Program, applies to acquisitions at or below the simplified acquisition threshold and for commercial items, including commercially available off-the-shelf items. This rule merely clarifies when it is appropriate to omit DFARS clause 252.225-7001 in accordance with existing exceptions to the Buy American statute and Balance of Payment Program.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is necessary to ensure that contracting officers do not mistakenly omit the clause at DFARS 252.225-7001, Buy American and Balance of Payments Program, when it is appropriate for inclusion in a solicitation and contract. The objective of the rule is to clarify the prescription for use of DFARS clause 252.225-7001 to state that the clause does not apply when the acquisition is for supplies for use either within the United States and an exception to the Buy American statute applies, or outside the United States and an exception to the Balance of Payments Program applies.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
This rule will apply to small entities that are awarded contracts that contain DFARS clause 252.225-7001; however, there is no impact on these small entities because the rule merely clarifies the clause prescription to correctly address applicability when an exception to the Buy American statute or Balance of Payments Program applies.
The rule does not impose any additional reporting, recordkeeping, or other compliance requirements.
No alternatives were identified that will accomplish the objectives of the rule.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 225 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revision and addition read as follows:
(2)(i) * * *
(C) The acquisition is for supplies for use within the United States and an exception to the Buy American statute applies,
(D) The acquisition is for supplies for use outside the United States and an exception to the Balance of Payments Program applies (see 225.7501);
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to delete obsolete text requiring the use of fire-resistant rayon fiber.
Effective March 25, 2016.
Mr. Christopher Stiller, at 571-372-6176.
DFARS 225.7016 prohibits requiring the use of fire-resistant rayon fiber in any solicitation issued before January 1, 2015. This prohibition was implemented in accordance with section 821 of the National Defense Authorization Act for Fiscal Year 2011. Since the effective period imposed by the statute has passed, the DFARS text is now obsolete. Therefore, this final rule removes DFARS 225.7016 and the cross reference at 211.170.
The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is 41 U.S.C. 1707 entitled “Publication of proposed regulations.” Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because it merely removes obsolete text from the DFARS and affects only the internal operating procedures of the Government. As such, the change has no significant cost or administrative impact on contractors or offerors.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant DFARS revision within the meaning of FAR 1.501-1, and 41 U.S.C. 1707 does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 211 and 225 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2012 that amended title 10 of the United States Code by prohibiting any form of cost-plus contracting for military construction projects or military family housing projects.
Comments on the proposed rule should be submitted in writing on or before May 24, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2015-D040, using any of the following methods:
○ Regulations.gov:
○
○
○
Comments received generally will be posted without change to
Mr. Christopher Stiller, telephone 571-372-6176.
DoD is proposing to revise the DFARS to implement section 2801 of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112-81). Section 2801 entitled “Prohibition on Use of Any Cost-Plus System of Contracting for Military Construction and Military Family Housing Projects” amends section 2306 of title 10, United States Code (U.S.C.), by prohibiting any form of cost-plus contracting for military construction projects or military family housing projects.
The rule proposes to amend DFARS 216.301-3, Limitations, to prohibit the use of any form of cost-plus contract type for contracts in connection with a military construction project or military family housing project. The placement of the text aligns with general limitations provided at FAR 16.301-3 on cost-reimbursement contracts. Because 10 U.S.C. 2306(c) prohibits several distinct kinds of cost-plus type contracts, the prohibition does not align with any specific cost-plus type as implemented at FAR 16.301-3.
The prohibition at 10 U.S.C. 2306(c) is broader in scope than the prohibition currently implemented at DFARS 216.306; therefore, the language at DFARS 216.306 is revised to add a cross reference to the proposed revision at DFARS 216.301-3. The proposed rule adds a new section at DFARS 236.215 to align with FAR 36.215 and provide a cross reference to DFARS 216.301-3. Finally, a cross reference is also added at DFARS 236.271 to 216.301-3.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 2801 of the National Defense Authorization Act for Fiscal Year 2012, which amends 10 U.S.C. 2306, to prohibit any form of cost-plus contracting for military construction projects or military family housing projects.
There is an existing prohibition at DFARS 216.306 on using certain cost-plus-fixed-fee contracts funded by a military construction appropriations acts. This proposed rule expands this prohibition to all cost-plus contract types in connection with a military construction project or military family housing project.
There is minimal impact anticipated on small entities as a result of the proposed rule. Based on data available in the Federal Procurement Data System, there were only 19 cost-reimbursement type construction acquisitions awarded in fiscal year 2015, two of which were awarded to small businesses. There is already a general prohibition at DFARS 216.306 on certain cost-plus-fixed-fee contracts funded by a military construction appropriations act. The proposed rule expands this prohibition to all cost-plus contract types in connection with a military construction project or a military family housing project.
There are no new projected reporting, recordkeeping, and other compliance requirements of the rule.
The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternatives to this rule.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2015-D040), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 216 and 236 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Contracts in connection with a military construction project or a military family housing project shall not use any form of a cost-plus contract type (10 U.S.C. 2306(c)). This applies notwithstanding a declaration of war or the declaration by the President of a national emergency under section 201 of the National Emergencies Act (50 U.S.C. 1621) that includes the use of the armed forces.
(c)
See 216.301-3 for the prohibition on the use of any form of a cost-plus contract in connection with a military construction project or a military family housing project.
Annual military construction appropriations acts restrict the use of cost-plus-fixed-fee contracts (see 216.306(c)). See also 216.301-3 regarding the prohibition against the use of any form of a cost-plus contract in connection with a military construction project or military family housing project.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to add instructions for utilizing the Wide Area WorkFlow Reparable Receiving Report.
Comments on the proposed rule should be submitted in writing to the address shown below on or before May 24, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D004, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Ms. Jo Ann Reilly, telephone 571-372-6176.
DoD is proposing to revise Appendix F of the DFARS to add instructions for the use, preparation, and distribution of the Wide Area WorkFlow (WAWF) Reparable Receiving Report (RRR) that has been created to differentiate between deliveries of new Government assets (new procurements) and the return of Government property that has been repaired or overhauled. The WAWF RRR creates an acceptance transaction for use in paying for the repair service and property transfers, moving the asset back to the Government, and reporting the movement to the Item Unique Identification (IUID) registry. Without the RRR, the contractor would have to take multiple actions to comply with the DFARS clauses at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports; 252.211-7003, Item Unique Identification and Valuation; and 252.211-7007, Reporting of Government-Furnished Property. In addition, this proposed rule would improve reporting efficiency by eliminating manual intervention that is currently required to ensure accurate information flow between different Government reporting systems.
DoD is proposing to make the following changes to DFARS Appendix F to provide guidance on the use of the WAWF RRR as follows:
• F-101—states that the WAWF RRR is the electronic equivalent of the DD Form 250 for repair, maintenance, or overhaul of Government furnished property (GFP).
• F-103—adds new guidance on the use of the WAWF RRR as a multipurpose report. Adds a new paragraph (e)(3) to state that use of the
• F-104—adds paragraph (b) to permit use of the WAWF RRR or DD Form 250 for delivery of services for repair, overhaul, or maintenance.
• Part 3—adds WAWF RRR to the title of part 3.
• F-301—adds paragraphs (b)(15)(ii)(A) and (B), to provide WAWF RRR completion instructions.
• F-301(b)(18)—adds clarifying information for entering unit prices when using the WAWF RRR.
• F-303—adds use of the WAWF RRR for consolidated shipments.
• F-304—adds WAWF RRR correction instructions for contracts administered by the Defense Contract Management Agency and paid by the Mechanization of Contract Administration Services system.
• F-306—provides information on printing capability when using the WAWF RRR as a packing list.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have an economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD is proposing to revise the Defense Federal Acquisition Regulation Supplement (DFARS), Appendix F, to add the instructions for utilizing the Wide Area WorkFlow (WAWF) Reparable Receiving Report (RRR).
The objective of this rule is to provide instructions for the use, preparation, and distribution of the electronic WAWF RRR that has been created to differentiate between deliveries of new Government assets (new procurements) and the return of Government property that has been repaired or overhauled. This rule proposes to improve reporting efficiency by eliminating manual intervention that is currently required to ensure accurate information flows between different Government property reporting systems.
The number of small entities affected is unknown. However, DoD expects this rule to have a positive economic impact on contractors, including small businesses, because the proposed rule would reduce the reporting burden for Government property repair or overhaul contracts. For example, DFARS clause 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports, requires the use of WAWF by contactors in preparing and submitting receiving reports; 252.211-7003, Item Unique Identification and Valuation, requires all delivered items with an item unique identification (IUID) be reported to the IUID registry; and 252.211-7007, Reporting of Government-Furnished Property, requires Government furnished property be reported to the IUID registry, specifically the return to the Government of serially managed assets. With the proposed rule, contractors would only use the WAWF RRR system to meet the reporting requirements for Government property repair or overhaul contracts, instead of taking multiple actions to comply with the DFARS clauses above.
The projected recordkeeping and reporting is unchanged from current requirements, and only the method of submitting the reports for the return of Government property that has been repaired or overhauled has changed. Reporting and recordkeeping is limited to that required to properly record material inspection and receiving report information using the WAWF RRR under Government contracts. Preparation of these records requires clerical and analytical skills to create the electronic documents in the WAWF system.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no significant alternatives to the proposed rule that accomplish the stated objectives.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2016-D004), in correspondence.
The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 0704-0248 entitled “Material Inspection and Receiving Report.” The projected recordkeeping and reporting is unchanged from current requirements, and only the method of submitting the reports for the return of Government property that has been repaired or overhauled has changed.
Government procurement.
Therefore, 48 CFR chapter 2, subchapter I, is proposed to be amended in appendix F as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revisions and additions read as follows:
(a) * * * The WAWF RRR is the electronic equivalent of the DD Form 250 for repair, maintenance, or overhaul of Government-furnished property.
(e) * * *
(3) Reporting of Government-Furnished Property, when the clause at DFARS 252.211-7007, Reporting of Government-Furnished Property, is used in the contract, use of the WAWF RRR will capture the shipment of Government-furnished property items after acceptance of repair services and forward the data to the IUID registry. WAWF is the only way a contractor can report the transfer of Government-furnished property items in the IUID registry.
(a) * * *
(b)
(b) * * *
(15) * * *
(ii) For service line items, select SV for “SERVICE” in the type field followed by as short a description as is possible in the description field. Some examples of service line items are maintenance, repair, alteration, rehabilitation, engineering, research, development, training, and testing
(A) For RRRs, the “Ship To” code is the DoDAAC, MAPAC, or CAGE code from the contract or shipping instructions.
(B) For service line items not using a RRR, the “Ship To” code and the “Unit” shall be filled out. The “Ship To” code is the destination Service Acceptor Code for WAWF. If source inspected and accepted, enter the service performance location as the “Ship To” code.
(18) UNIT PRICE. The contractor shall enter unit prices on all WAWF RR copies. When using the WAWF RRR, the unit price is the price of the repair, overhaul, or maintenance service from the contract.
Functionality for correcting a WAWF RR or WAWF RRR is available for DCMA administered contracts paid using the Mechanization of Contract Administration Services (MOCAS) system with source acceptance. Preparation instructions and training for corrections is available at
Contractors may also use a WAWF processed RR, including the WAWF RRR, as a packing list. WAWF provides options to print the RR. These printed RRs may also be used if a signed copy is required.
(a) WAWF provides a print capability for its RR. The WAWF printed RR can be identified by its distinctive format and by the text title at the top of each printed page “Material Inspection and Receiving Report in accordance with DFARS Appendix F. Paper DD Form 250 is usable in lieu of this document on an exception basis.” (See DFARS 252.232-7003(c).) This printed copy can be used as a packing list. If needed, the signature can be verified by reviewing the signed RR in WAWF.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 to provide that contracts executed by DoD as a result of the transfer of contracts from the General Services Administration, or for which DoD serves as an item manager for products on behalf of the General Services Administration, shall not be subject to certain domestic source restrictions, to the extent that such contracts are for the purchase of products by other Federal agencies or State or local governments.
Comments on the proposed rule should be submitted in writing to the address shown below on or before May 24, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D009, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Ms. Amy G. Williams, telephone 571-372-6106.
DoD is proposing to amend the DFARS to implement section 897 of the National Defense Authorization Act for Fiscal Year 2016 (Pub. L. 114-92). Section 897 entitled “Treatment of Interagency and State and Local Purchases” provides that contracts executed by DoD as a result of the
10 U.S.C. chapter 148 includes domestic source restrictions at 10 U.S.C. 2533a (Berry Amendment), 10 U.S.C. 2533b (specialty metals), and 10 U.S.C. 2534 (miscellaneous domestic source restrictions), which are implemented in DFARS subpart 225.70 as follows:
• 225.7002 (Berry Amendment).
• 225.7003 (specialty metals purchased directly by DoD or aircraft, missile or space systems, ships, tank or automotive items, weapon systems, or ammunition containing specialty metals).
• 225.7004 (buses).
• 225.7005 (certain chemical weapons antidotes).
• 225.7006 (air circuit breakers for naval vessels).
• 225.7010 (certain naval vessel components).
DoD reviewed the domestic source restrictions in 10 U.S.C. chapter 148 as implemented in DFARS subpart 225.70. DoD proposes to amend DFARS 225.7002-2, which implements 10 U.S.C. 2533a (Berry Amendment), to include an exception in a new paragraph (o) to implement section 897.
DoD does not propose to amend DFARS 225.7003, which implements 10 U.S.C. 2533b (specialty metals), because these restrictions apply to direct purchase of specialty metals by DoD or acquisition of items (
DoD also does not propose to amend DFARS 225.7004 (buses), 225.7005 (certain chemical weapons antidotes), 225.7006 (air circuit breakers for naval vessels), or 225.7010 (certain naval vessel components), which implement 10 U.S.C. 2534. With the exception of buses, these are items for which GSA does not contract. Furthermore, 10 U.S.C. 2534(f) sets forth a principle of statutory construction, which requires a subsequent law to specifically reference 10 U.S.C. 2534 in order to modify it. Section 897 does not specifically reference 10 U.S.C. 2534, so there is not the required indication that section 897 is authorizing a modification to 10 U.S.C. 2534. Applying section 897 to 10 U.S.C. 2534, while not directly changing the language of 10 U.S.C. 2534, would change the way DoD currently applies 10 U.S.C. 2534.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule implements section 897 of the National Defense Authorization Act for Fiscal Year 2016. The objective of this rule is to eliminate the domestic source restrictions of 10 U.S.C. chapter 148 when contracts executed by DoD as a result of the transfer of contracts from the General Services Administration (GSA) or for which DoD serves as an item manager for products on behalf of GSA, to the extent that such contracts are for the purchase of products by other Federal agencies or State or local governments.
DoD does not anticipate frequent application of this rule. The rule removes a limitation on potential sources for the specified items. In the rare instance in which the circumstances of the statute apply, it is possible that an item could be acquired from a foreign source, rather than a domestic source, which could potentially be a small business. It is not possible to estimate the number of small entities that may be affected, because it is unknown the extent to which the given circumstances may occur.
There are no projected reporting, recordkeeping, or other compliance requirements.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
DoD has not identified any alternatives which would minimize any economic impact on small entities and still meet the requirements of the statute.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2016-D009), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 225 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(o) Acquisitions that are interagency, State, or local purchases that are
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that amends the allowability of costs of counterfeit electronic parts or suspect counterfeit electronic parts and the cost of rework or corrective action that may be required to remedy the use or inclusion of such parts.
Comments on the proposed rule should be submitted in writing to the address shown below on or before May 24, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D010, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Ms. Amy G. Williams, telephone 571-372-6106.
DoD is proposing to amend the DFARS to implement section 885(a) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92). Section 885(a) provides that the costs of counterfeit parts or suspect counterfeit parts and the cost of rework or corrective action that may be required to remedy the use or inclusion of such parts may be allowable if—
• The counterfeit electronic parts or suspect counterfeit electronic parts were obtained by the contractor in accordance with the regulations described in paragraph (c)(3) of section 818 of the NDAA for FY 2012, as amended;
• The contractor discovers the counterfeit electronic parts or suspect counterfeit electronic parts; and
• The contractor provides timely (
A final rule is in process under DFARS Case 2014-D005, Detection and Avoidance of Counterfeit Parts—Further Implementation, to implement section 818(c)(3) of the NDAA for FY 2012, as amended. A proposed rule was published under DFARS Case 2014-D005 in the
This rule proposes to amend the cost principle at DFARS 231.205-71 to incorporate the new provisions of section 885(a) of the NDAA for FY 2016.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This proposed rule implements section 885(a) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92).
The objective of this rule is to amend the allowability of costs for counterfeit parts or suspect counterfeit parts and the cost of rework or corrective action that may be required to remedy the use or inclusion of such parts. Such costs may be allowable if—
• The parts were obtained by the contractor/subcontractor in accordance with the regulations described at section 818(c)(3) of the NDAA for FY 2012, as amended (such regulations will be published as a final rule under DFARS Case 2014-D005);
• The contractor discovers the counterfeit electronic parts or suspect counterfeit electronic parts; and
• The contractor provides timely notice to the Government.
DoD is unable to estimate the number of small entities that will be impacted by this rule. This rule will apply to all DoD prime and subcontractors with cost contracts. This rule will only impact cost allowability if the contractor or subcontractor has complied with DFARS 246.870, but nevertheless acquired, used, or included counterfeit electronic parts or suspect counterfeit electronic parts in performance of a DoD contract or subcontract, and has
There is no change to the projected reporting, recordkeeping, or other compliance requirements associated with the rule.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
DoD has not identified any alternatives that are consistent with the stated objectives of the applicable statute. However, DoD notes that the impacts of this rule are expected to be beneficial, because it expands the allowability of costs for counterfeit parts or suspect counterfeit parts and the cost of rework or corrective action that may be required to remedy the use or inclusion of such parts.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2016-D010), in correspondence.
The rule does not contain information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 231 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(a)
(b) The costs of counterfeit electronic parts and suspect counterfeit electronic parts and the costs of rework or corrective action that may be required to remedy the use or inclusion of such parts are unallowable, unless—
(1) The contractor has an operational system to detect and avoid counterfeit parts and suspect counterfeit electronic parts that has been reviewed and approved by DoD pursuant to 244.303;
(2) The counterfeit electronic parts or suspect counterfeit electronic parts are Government-furnished property as defined in FAR 45.101 or were obtained by the contractor in accordance with the clause at DFARS 252.246-70XX, Sources of Electronic Parts [as proposed to be added at 80 FR 56939, September 21, 2015]; and
(3) The contractor—
(i) Discovers the counterfeit electronic parts or suspect counterfeit electronic parts; and
(ii) Provides timely (
Department of Defense (DoD).
Notice.
DoD is publishing the updated annual list of product categories for which the Federal Prison Industries' share of the DoD market is greater than five percent.
Effective April 7, 2016.
Sheila Harris, telephone 703-614-1333.
On November 19, 2009, a final rule was published in the
The Director, Defense Procurement and Acquisition Policy (DPAP), issued a memorandum dated March 8, 2016, that provided the current list of product categories for which FPI's share of the DoD market is greater than five percent based on fiscal year 2015 data from the Federal Procurement Data System. The product categories to be competed effective April 7, 2016, are the following:
The DPAP memorandum with the current list of product categories for which FPI has a significant market share is posted at:
The statute, as implemented, also requires DoD to—
(1) Include FPI in the solicitation process for these items. A timely offer from FPI must be considered and award procedures must be followed in accordance with existing policy at Federal Acquisition Regulation (FAR) 8.602(a)(4)(ii) through (v);
(2) Continue to conduct acquisitions, in accordance with FAR subpart 8.6, for items from product categories for which FPI does not have a significant market share. FAR 8.602 requires agencies to conduct market research and make a written comparability determination, at the discretion of the contracting officer. Competitive (or fair opportunity) procedures are appropriate if the FPI product is not comparable in terms of price, quality, or time of delivery; and
(3) Modify the published list if DoD subsequently determines that new data requires adding or omitting a product category from the list.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |