| Page Range | 2193-2848 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 2217 - Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems | |
| 82 FR 2218 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB-, 5F-AMB, 5F-APINACA, ADB-FUBINACA, NDMB-CHMICA and MDMB-FUBINACA) Into Schedule I | |
| 82 FR 2193 - Scope of Sections 202(a) and (b) of the Packers and Stockyards Act | |
| 82 FR 2193 - Revisions to Operational Requirements for the Use of Enhanced Flight Vision Systems (EFVS) and to Pilot Compartment View Requirements for Vision Systems | |
| 82 FR 2397 - Sunshine Act Meeting | |
| 82 FR 2362 - Sunshine Act Meetings | |
| 82 FR 2218 - 22 CFR Part 241 | |
| 82 FR 2393 - Sunshine Act Meeting | |
| 82 FR 2383 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Advanced Education Nursing Traineeship (AENT) Program Specific Data Collection Forms | |
| 82 FR 2280 - Schedules of Controlled Substances: Temporary Placement of Six Synthetic Cannabinoids (5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) Into Schedule I | |
| 82 FR 2326 - Sunshine Act Meetings Notice (Correction) | |
| 82 FR 2193 - Hazardous Substances and Articles: Administration and Enforcement Regulations | |
| 82 FR 2335 - Comprehensive Centers Program; CFDA Number: 84.283B | |
| 82 FR 2327 - Proposed Collection; Comment Request | |
| 82 FR 2333 - List of Correspondence From January 1, 2015 Through March 31, 2015 and April 1, 2015 Through June 30, 2015 | |
| 82 FR 2397 - Reno Creek In Situ | |
| 82 FR 2336 - Applications for New Awards; High School Equivalency Program | |
| 82 FR 2399 - Category 3 Source Security and Accountability | |
| 82 FR 2328 - Applications for New Awards; College Assistance Migrant Program | |
| 82 FR 2390 - 60-Day Notice of Proposed Information Collection: Supportive Services Demonstration Resident Assessment Form | |
| 82 FR 2295 - Air Quality Plans; Tennessee; Infrastructure Requirements for the 2012 PM2.5 | |
| 82 FR 2354 - Granting Petitions To Add n-Propyl Bromide to the List of Hazardous Air Pollutants | |
| 82 FR 2395 - Records Management; General Records Schedule (GRS); GRS Transmittal 27 | |
| 82 FR 2389 - Revision of Agency Information Collection Activity Under OMB Review: Security Threat Assessment for Individuals Applying for a Hazardous Materials Endorsement for a Commercial Driver's License | |
| 82 FR 2325 - Proposed Information Collection; Comment Request; Computer and Internet Use Supplement to the Census Bureau's Current Population Survey | |
| 82 FR 2323 - Proposed Information Collection; Comment Request; Foreign Fishing Vessel Permits, Vessel, and Gear Identification, and Reporting Requirements | |
| 82 FR 2327 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Formula Grant EASIE (Electronic Application System for Indian Education) | |
| 82 FR 2311 - Foreign-Trade Zone (FTZ) 44-Morris County, New Jersey; Notification of Proposed Production Activity; AGFA Corporation (Aluminum Digital Printing Plates); Branchburg, New Jersey | |
| 82 FR 2311 - Foreign-Trade Zone (FTZ) 20-Newport News, Virginia; Authorization of Production Activity; Canon Virginia, Inc.; Subzone 20D (Toner Cartridges); Newport News, Virginia | |
| 82 FR 2334 - Agency Information Collection Activities; Comment Request; High School Equivalency Program (HEP) Annual Performance Report | |
| 82 FR 2324 - Proposed Information Collection; Comment Request; Management and Oversight of the National Estuarine Research Reserve System | |
| 82 FR 2311 - Foreign-Trade Zone (FTZ) 221-Mesa, Arizona; Notification of Proposed Production Activity; Apple Inc. (Data Server Cabinets); Mesa, Arizona | |
| 82 FR 2368 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | |
| 82 FR 2443 - Notice and Request for Public Comment | |
| 82 FR 2322 - Stainless Steel Plate in Coils From Belgium, South Africa, and Taiwan: Continuation of Antidumping Duty Orders and Countervailing Duty Order | |
| 82 FR 2319 - Multilayered Wood Flooring From the People's Republic of China: Preliminary Results of Countervailing Duty Administrative Review, Rescission of Review, in Part, and Intent To Rescind the Review in Part; 2014 | |
| 82 FR 2317 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Preliminary Results of the Countervailing Duty Administrative Review and Preliminary Intent To Rescind, in Part; 2014 | |
| 82 FR 2309 - Rural Broadband Access Loans and Loan Guarantees Program | |
| 82 FR 2435 - Rate for Assessment on Direct Payment of Fees to Representatives in 2017 | |
| 82 FR 2438 - Qualification of Drivers; Exemption Applications; Vision | |
| 82 FR 2440 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 82 FR 2439 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 82 FR 2385 - Modification and Clarification of the National Customs Automation Program Tests Regarding Post-Summary Corrections and Periodic Monthly Statements; Republication With Correction and Further Clarification | |
| 82 FR 2392 - Endangered and Threatened Wildlife and Plants; Notice of Availability of Polar Bear Conservation Management Plan | |
| 82 FR 2393 - Hardwood Plywood From China | |
| 82 FR 2436 - Motorcyclist Advisory Council to the Federal Highway Administration | |
| 82 FR 2350 - Viridity Energy Solutions Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
| 82 FR 2352 - NEP Energy Services, Ltd.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 2354 - Approved Energy II LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
| 82 FR 2345 - Combined Notice of Filings #2 | |
| 82 FR 2342 - Combined Notice of Filings #1 | |
| 82 FR 2435 - Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98 | |
| 82 FR 2323 - Pacific Fishery Management Council; Public Meeting | |
| 82 FR 2325 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Data Scoping Webinar for South Atlantic Red Grouper; Public Meeting | |
| 82 FR 2436 - Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics Plenary | |
| 82 FR 2366 - Request for Information | |
| 82 FR 2394 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application for Federal Firearms License (ATF F 7(5310.12)/7 CR (5310.16)) | |
| 82 FR 2291 - Special Local Regulation; Manatee River; Bradenton, FL | |
| 82 FR 2380 - Determination of Regulatory Review Period for Purposes of Patent Extension; EMPLICITI | |
| 82 FR 2285 - Proximity Detection Systems for Mobile Machines in Underground Mines | |
| 82 FR 2284 - Exposure of Underground Miners to Diesel Exhaust | |
| 82 FR 2396 - Freedom of Information Act (FOIA) Advisory Committee; Meeting | |
| 82 FR 2426 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Relating to the Listing and Trading of Shares of SolidX Bitcoin Trust Under NYSE Arca Equities Rule 8.201 | |
| 82 FR 2425 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings to Determine Whether to Approve or Disapprove a Proposed Rule Change, as Modified by Amendment No. 1, to BZX Rule 14.11(e)(4), Commodity-Based Trust Shares, to List and Trade Winklevoss Bitcoin Shares Issued by the Winklevoss Bitcoin Trust | |
| 82 FR 2418 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing of Proposed Rule Change To Amend Rules 501, 507, 508, 510, and 511 | |
| 82 FR 2433 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rules To Extend a Pilot Program | |
| 82 FR 2427 - Self-Regulatory Organizations; NYSE MKT LLC; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Introducing NYSE OptX | |
| 82 FR 2417 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Introducing NYSE OptX | |
| 82 FR 2428 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Related to the Exchange's Equity Options Platform To Adopt a Price Improvement Auction, the Bats Auction Mechanism | |
| 82 FR 2378 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE | |
| 82 FR 2367 - Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period | |
| 82 FR 2312 - Order Renewing Order Temporarily Denying Export Privileges | |
| 82 FR 2402 - Tribal Policy Statement | |
| 82 FR 2385 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 2384 - Center for Scientific Review; Notice of Closed Meeting | |
| 82 FR 2384 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 2444 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment Request | |
| 82 FR 2369 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability | |
| 82 FR 2442 - Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes; Cancellation of Pilot Program Testing Electronic Collection of Import Data | |
| 82 FR 2381 - Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments | |
| 82 FR 2362 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 82 FR 2442 - Transfer of Federally Assisted Land or Facility | |
| 82 FR 2351 - American Municipal Power, Inc. v. Midcontinent Independent System Operator, Inc.; Notice of Complaint | |
| 82 FR 2351 - Great River Energy; Notice of Filing | |
| 82 FR 2344 - Transcontinental Gas Pipe Line Company, LLC; Notice of Availability of the Final Environmental Impact Statement for the Proposed Atlantic Sunrise Project | |
| 82 FR 2343 - Records Governing Off-the-Record Communications; Public Notice | |
| 82 FR 2345 - WBI Energy Transmission, Inc.; Supplemental Notice of Intent To Prepare an Environmental Assessment for the Planned Valley Expansion Project and Request for Comments on Environmental Issues | |
| 82 FR 2353 - Enel Trading North America, Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 2352 - Gulf South Pipeline Company, LP; Notice of Schedule for Environmental Review of the St. Charles Parish Expansion Project | |
| 82 FR 2348 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Atlantic Coast Pipeline, Supply Header Project, and Capacity Lease Proposal | |
| 82 FR 2352 - Old Dominion Electric Cooperative and Direct Energy Business, LLC on Behalf of Itself and Its Affiliate, Direct Energy Business Marketing, LLC and American Municipal Power, Inc. v. PJM Interconnection, L.L.C.; Notice Of Complaint | |
| 82 FR 2343 - Northern Illinois Municipal Power Agency v. PJM Interconnection, L.L.C.; Notice of Complaint | |
| 82 FR 2353 - Nogales Transmission, L.L.C., Nogales Frontier Operations, L.L.C.; Notice of Petition for Declaratory Order | |
| 82 FR 2305 - Approval of Arizona Air Plan Revisions, Arizona Department of Environmental Quality and Pinal County Air Quality Control District | |
| 82 FR 2294 - Nondiscrimination in Programs or Activities Receiving Federal Assistance From the Environmental Protection Agency | |
| 82 FR 2251 - Announcement Type: Notice and Request for Information | |
| 82 FR 2293 - Electronic Induction (eInduction®) Option | |
| 82 FR 2363 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations | |
| 82 FR 2193 - Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010; Approval of Information Collection Request | |
| 82 FR 2193 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” | |
| 82 FR 2249 - General Services Administration Acquisition Regulation (GSAR); Fair Opportunity Complaints on GSA Contracts | |
| 82 FR 2248 - Amendments to Regulations Governing Access to Commission Information and Records; Freedom of Information Act | |
| 82 FR 2254 - Mallows Bay-Potomac River National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management Plan | |
| 82 FR 2269 - Wisconsin-Lake Michigan National Marine Sanctuary; Notice of Proposed Rulemaking and Availability of Draft Environmental Impact Statement and Management Plan | |
| 82 FR 2230 - Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits; Procedures for Decisionmaking | |
| 82 FR 2239 - Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction | |
| 82 FR 2308 - Approval of Arizona Air Plan Revisions; Ajo and Morenci, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plans and Technical Correction | |
| 82 FR 2237 - Approval and Promulgation of Implementation Plans; Rhode Island; Clean Air Act Infrastructure State and Federal Implementation Plans | |
| 82 FR 2221 - Updating Regulations Issued Under the Fair Labor Standards Act, Service Contract Act, Davis-Bacon and Related Acts, Contract Work Hours and Safety Standards Act, the Family and Medical Leave Act, Employee Polygraph Protection Act, and the Migrant and Seasonal Agricultural Worker Protection Act | |
| 82 FR 2810 - Standards for Accessible Medical Diagnostic Equipment | |
| 82 FR 2760 - Addition of a Subsurface Intrusion Component to the Hazard Ranking System | |
| 82 FR 2470 - Occupational Exposure to Beryllium |
Food and Nutrition Service
Grain Inspection, Packers and Stockyards Administration
Rural Utilities Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Army Department
Federal Energy Regulatory Commission
Agency for Toxic Substances and Disease Registry
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Transportation Security Administration
U.S. Customs and Border Protection
Fish and Wildlife Service
Alcohol, Tobacco, Firearms, and Explosives Bureau
Drug Enforcement Administration
Mine Safety and Health Administration
Occupational Safety and Health Administration
Wage and Hour Division
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
Alcohol and Tobacco Tax and Trade Bureau
Community Development Financial Institutions Fund
Comptroller of the Currency
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.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Food and Nutrition Service, USDA.
Final rule; notice of approval of Information Collection Request (ICR).
The final rule titled Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010 was published on July 29, 2016. The Office of Management and Budget (OMB) cleared the associated information collection requirements (ICR) on September 12, 2016. This document announces approval of the ICR.
Effective January 9, 2017. The ICR associated with the final rule published in the
Tina Namian, School Programs Branch, Policy and Program Development Division, Food and Nutrition Service, at (703) 305-2590.
In rule document 2016-30424, appearing on pages 92566 through 92594 in the issue of Tuesday, December 20, 2016, make the following correction:
On page 92566, in the first column, in the
In rule document 2016-28714 appearing on pages 90126-90177 in the issue of Tuesday, December 13, 2016, make the following correction:
“(iii) At 100 feet above the touchdown zone elevation of the runway of intended landing and below that altitude, the flight visibility must be sufficient for one of the following visual references to be distinctly visible and identifiable to the pilot without reliance on the EFVS—”
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
This rule is effective February 8, 2017.
For access to the docket to read background documents or
Bryant Godfrey or Darin Achilles, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373,
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amends the FD&C Act and provides FDA with the authority to regulate tobacco products. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Excluded from the definition of a tobacco product is any article that is a drug, device, or combination product. Any article that is a drug, device, or combination product will be regulated as such rather than as a tobacco product.
Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, FDA is taking this action to provide clarity regarding our interpretation of the drug and device definitions in the FD&C Act with respect to products made or derived from tobacco. This final rule will provide assistance for entities intending to market products made or derived from tobacco. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. The final rule is also intended to increase clarity regarding the intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug, device, or combination product, helping consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses.
In addition, FDA is taking the opportunity to make changes to existing regulations at §§ 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices generally.
Conceptually, the final rule follows the disease prong and the structure/function prong (with certain specified limitations) of the statutory definitions of “drug” and “device” (section 201(g) and (h) of the FD&C Act). Under the final rule, a product made or derived from tobacco and intended for human consumption is regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product.
In addition, FDA is amending its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the final rule to clarify the interplay between these regulations and this final rule. FDA has made further changes to conform §§ 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.
The final rule clarifies the regulatory status of products made or derived from tobacco and our interpretation and application of the existing intended use regulations. This will reduce the ambiguity and may create some efficiency gains associated with submitting an application for approval or marketing authorization of a new tobacco-derived product, or with initiating research for a new tobacco-derived product. In addition, we assume that the regulation will clarify for consumers when products made or derived from tobacco are intended for medical uses rather than for other uses.
We assume that all tobacco-derived product manufacturers would incur one-time costs to learn the rule. There may also be a one-time cost incurred by a small number of manufacturers of tobacco products to review and revise product communications such as labeling and associated promotional materials. The following table reports these one-time costs.
In the
The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-31), amending the FD&C Act and providing FDA with the authority to regulate tobacco products. Section 101(a) of the Tobacco Control Act amends section 201 of the FD&C Act by adding paragraph (rr), which defines the term “tobacco product.” In general, a “tobacco product” is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Section 201(rr)(2) of the FD&C Act excludes from the definition of a tobacco product any article that is defined as a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). Section 201(rr)(3) of the FD&C Act explains that any article that is a drug, device, or combination product shall be subject to chapter V of the FD&C Act (the authorities for drugs and devices) rather than chapter IX (the authorities for tobacco products).
As noted in section I.A, the definition of “tobacco product” excludes anything that is a “drug,” “device,” or “combination product” under the FD&C Act. The FD&C Act defines “drug” (in relevant part) as an article intended either: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease (referred to as the “disease prong” of the definition) or (2) to affect the structure or any function of the body (the “structure/function prong”) (section 201(g)(1) of the FD&C Act). The FD&C Act defines a “device” (in relevant part) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended either: (1) For use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes (section 201(h) of the FD&C Act).
FDA had previously interpreted the exclusion in the tobacco product definition to mean that if a product made or derived from tobacco is determined to have a drug or device “intended use,” it will be regulated as a medical product, not as a tobacco product. As discussed in greater detail in this document, this interpretation was qualified in
In determining a product's intended use, the Agency may look to “any . . . relevant source,” including but not limited to the product's labeling, promotional claims, and advertising (see,
For example, FDA may take into account any claim or statement made by or on behalf of a manufacturer that explicitly or implicitly promotes a product for a particular use (see,
To establish a product's intended use, FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective
Thus, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it is regulated as a medical product, subject to the limitations discussed further in this document. Courts have recognized that products made or derived from tobacco marketed with “disease” claims and certain “structure/function” claims are drugs (see
Comments were received from tobacco product manufacturers, retailers, academia, medical professionals, advocacy groups, and consumers. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before each comment, and the word “Response,” in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments; the numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment. In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received many general comments expressing support or opposition to the rule. These comments express broad policy views and do not address specific points related to this rulemaking. Therefore, these general comments do not require a response. Other comments outside the scope of this rulemaking also have not been addressed here. Summaries of the remaining comments, as well as FDA's responses, are included in this document.
(Comment 1) At least one comment stated that FDA is not permitted to regulate the nicotine in cigarettes as a drug and should not be permitted to regulate electronic nicotine delivery systems (ENDS) as medical products.
(Response) FDA disagrees. Section 201(g) of the FD&C Act defines “drug” as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or any function of the body of man or other animals. Section 201(h) of the FD&C Act defines “device” (in relevant part) as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory,” that is intended “for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . . to affect the structure or any function of the body,” and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes. As explained in this final rule, FDA has the authority to regulate a product made or derived from tobacco, including cigarettes and ENDS, as a medical product if it is distributed or marketed for an intended use that falls within the drug/device definitions, unless the product is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
(Comment 2) Several comments stated that there is no need to clarify the medical product and tobacco product definitions that govern FDA regulation of these products. One of those comments also went on to state that there is a clear difference between drug product claims and “consumer-oriented marketing statements” about smoking cessation.
(Response) FDA disagrees that there is no need for additional clarity in this area. The Agency frequently receives inquiries regarding jurisdictional distinctions for products made or derived from tobacco, and given the broad range of intended uses for products made or derived from tobacco and the increasing variety of such products on the market, FDA believes that the potential for consumer confusion is increasing. This is especially true when tobacco-derived products that may otherwise appear to be products intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction.
FDA considers claims about smoking cessation to be more than simply “consumer-oriented marketing statements.” As noted in the preamble to the proposed rule, claims related to smoking cessation have long been recognized as evidence of intended use, conferring drug or device jurisdiction, and smoking cessation claims also have long been associated with the intended uses of curing or treating nicotine addiction and its symptoms. For example, smoking cessation claims have appeared on the approved labeling for nicotine replacement therapies since the mid-1990s. FDA believes it is important to clarify and reiterate that smoking cessation claims on any product can render that product subject to FDA's medical products authorities.
(Comment 3) Comments had differing opinions on whether ENDS meet the definition of “tobacco product” as defined in the FD&C Act. Several comments stated that ENDS fall under the definition of “tobacco product” as defined in the FD&C Act if they contain nicotine derived from tobacco and are not intended to be drugs or devices. However, other comments stated that ENDS, including vaping hardware, do not fall within the definition of “tobacco product.”
(Response) FDA agrees that ENDS meet the definition of “tobacco product” if they are not drugs, devices, or combination products. The term “tobacco product” is defined in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to mean any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product), and excluding drugs, devices, and
FDA disagrees with comments stating that vaping hardware does not fall within the definition of “tobacco product.” As the Agency explained in the final deeming regulation,
Although the courts have recognized that tobacco-derived products can be regulated as medical products under the FD&C Act in certain circumstances, courts have also held that there are limitations on how the drug and device definitions can be applied to products made or derived from tobacco. This section provides a summary of FDA regulatory action and related litigation relevant to those limitations.
In 1996, FDA issued a regulation restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents (the 1996 rule) (61 FR 44396, August 28, 1996). This rule included FDA's determination that it had jurisdiction over cigarettes and smokeless tobacco under the FD&C Act. The basis for this determination was that cigarettes and smokeless tobacco were intended to affect the structure or function of the body, within the FD&C Act definitions of the terms “drug” and “device,” because nicotine has significant pharmacological effects. In addition, FDA found that cigarettes and smokeless tobacco were combination products consisting of the drug nicotine and device components intended to deliver nicotine to the body. In the 1996 rule, FDA concluded that cigarettes and smokeless tobacco should be regulated under the device authorities of the FD&C Act. The 1996 rule was challenged in court by a group of tobacco manufacturers, retailers, and advertisers on the grounds that FDA lacked jurisdiction to regulate tobacco products “as customarily marketed;” that the regulations exceeded FDA's authority to regulate devices; and that the advertising restrictions violated the First Amendment.
The Supreme Court struck down the 1996 rule in
In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, two of the importers who were affected by this action sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those products into the United States.
The Court in
Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, we are issuing this final rule to provide clarity regarding our interpretation of the drug/device definitions in the FD&C Act with respect to products made or derived from tobacco. We believe that this final regulation will provide assistance for entities intending to market products made or derived from tobacco and for entities that plan to study these products. For example, the rule is expected to help sponsors determine which FDA Center should be consulted as they develop their products and make appropriate premarket submissions to bring new products to market. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. In addition, we believe it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other uses. The rule is expected to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug or device, which we expect will help consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses. Finally, the rule is intended to provide clarity for drug and device manufacturers generally regarding FDA's interpretation and application of its existing intended use regulations.
In both the
As discussed in section I.B, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs, devices, or combination products under the FD&C Act. Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to bring products within FDA's “disease prong” jurisdiction.
FDA has also taken enforcement action against products made or derived from tobacco that were marketed with claims of therapeutic benefit but that did not have approved new drug applications (NDAs). For example, FDA seized cigarettes on the grounds that they were misbranded drugs when the manufacturer represented that the cigarettes were effective in preventing respiratory diseases, common cold, influenza, pneumonia, and various other ailments (
The “claims of therapeutic benefit” language used by the
Given the availability of FDA-approved drugs for smoking cessation,
FDA will treat several other categories of claims for products made or derived from tobacco as evidence of intended use that brings the products within the disease prong of the drug/device definition. These categories of claims are discussed further in section IV, Description of the Final Rule). We note that sections 911(c) and 918 of the FD&C Act (21 U.S.C. 387k(c) and 387r), as amended by the Tobacco Control Act, contemplate that products intended for the treatment of tobacco dependence and for relapse prevention, among other things, may be subject to FDA's drug/device jurisdiction.
With this final rule, FDA is also clarifying the relationship between FDA's regulation of a certain category of tobacco products—modified risk tobacco products (MRTPs)—and FDA's regulation of medical products that are intended to mitigate disease. MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). Tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products means a tobacco product:
(1) That represents in its label, labeling, or advertising, either implicitly or explicitly, that:
• The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
• the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
• the tobacco product or its smoke does not contain or is free of a substance;
(2) That uses the descriptors “light,” “mild,” “low,” or similar descriptors in its label, labeling, or advertising; or
(3) For which the tobacco product manufacturer has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.
See section 911(b)(2) of the FD&C Act.
Because MRTPs have the potential to be marketed as less harmful than other tobacco products, including as presenting a lower risk of tobacco-related disease than another tobacco product, FDA recognizes that there might be questions about how these products relate to FDA's medical product jurisdiction over products made or derived from tobacco that are intended for use in disease mitigation and prevention. MRTPs may have the ultimate effect of lowering disease risk for users who would otherwise use another, more harmful tobacco product. However, an important distinction between MRTPs and medical products is that, while medical products approved/cleared for disease mitigation or prevention act affirmatively to combat a disease or health condition, MRTPs present
For purposes of illustration, claims of modified risk might include claims like “contains less nicotine than [tobacco product X]”, “using [MRTP] reduces your risk of lung cancer compared to using [tobacco product X]”, and “lower level of nitrosamines than other smokeless tobacco products.” In contrast, a claim that a product “inhibits the progression of disease in adult patients with chronic obstructive pulmonary disease” is evidence of intended uses that would bring the product within drug/device jurisdiction.
(Comment 4) At least one comment remarked that research studies and public opinion may come to reflect that a tobacco product appears to have properties similar to those of a medical drug or MRTP. The comment asserted that acceptance of these properties by the scientific and medical community or by the public should not subject the product to regulation as a medical product or MRTP in the absence of any specific claims by the manufacturer.
(Response) As explained in this final rule, with certain exceptions, products made or derived from tobacco are subject to regulation as medical products if they are distributed for an intended use that falls within the FD&C Act's drug/device definitions, and the Agency may look to any relevant source to determine intended use. To the extent this comment suggests that manufacturer claims are always necessary to establish a medical product's intended use, FDA disagrees. As discussed at various points in this final rule (for example, in response to Comment 18), FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Nevertheless, FDA agrees with the comment that neither the opinions of the scientific and medical communities nor public opinion considered alone should dictate when a product made or derived from tobacco is regulated as a medical product or MRTP. In general, FDA would not regard a manufacturer as intending a medical use for a product made or derived from tobacco based solely on study findings or widespread belief that the product appears to have properties similar to those of a medical product. Similarly, FDA would not regard a manufacturer of a product made or derived from tobacco as selling or distributing a product for use to reduce harm or the risk of tobacco-related disease based solely on study findings
As discussed in section I.B, the drug/device definitions in the FD&C Act include articles “intended to affect the structure or any function of the body,” and FDA's assertion of jurisdiction over cigarettes and smokeless tobacco in 1996 was predicated on the pharmacological effects of nicotine on the structure or function of the body. In addition, as explained previously, the Court in
Based on the
For example, as discussed in the 1996 rulemaking, claims related to satisfaction, pleasure, enjoyment, and refreshment are euphemisms for the delivery of a pharmacologically active dose of nicotine and thus relate to effects on the structure or function of the body (61 FR 44396 at 45101 and 45175-45178). Nonetheless, FDA does not consider these tobacco satisfaction and enjoyment claims to bring products within its drug and device regulatory authority because these are structure/function claims related to the effects of nicotine and were commonly and legally made before March 21, 2000. Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to bring a tobacco product within its drug and device authority.
The
Similarly, “maintain memory”—another example of a potential intended structure/function effect mentioned in the proposed rule (80 FR 57756 at 57760)—was (as FDA's 1996 rulemaking observed) a pharmacological effect that Philip Morris researchers attributed to nicotine and that R.J. Reynolds Tobacco asserted as a “benefit” in court filings (61 FR 44396 at 44857-44858 and 45029). But once again, absent evidence that “maintaining memory” is both a structure/function effect related to nicotine, and was commonly and legally claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to “maintain memory,” to be medical products.
Different facts but a similar analysis apply to the proposed rule's other examples of potential intended structure/function effects, “maintain healthy lung function” and “support the immune system.” (80 FR 57760). In contrast to its findings for “stimulation,” “sedation,” and “weight loss,” (61 FR 44396 at 44667), FDA's 1996 rulemaking did not identify “maintain healthy lung function” or “support the immune system” as intended structure/function effects of cigarettes or smokeless tobacco products. But as with those other potential intended uses, absent evidence that “maintaining healthy lung function” or “supporting the immune system” are both structure/function effects related to nicotine, and were commonly claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to achieve such structure/function effects, to be medical products.
FDA believes that it is important to recognize structure/function intended uses that were not commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the decision in
FDA believes this final rule will provide clarity to manufacturers about how products made or derived from tobacco will be regulated if they are marketed or distributed for certain intended uses. This clarification will allow regulated industry to plan accordingly during the product development and postmarketing phases and will help researchers understand the applicable regulatory requirements associated with the investigational use of products made or derived from tobacco.
In addition, we believe this final rule will help to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use (
(Comment 5) At least one comment agreed with FDA that the
(Response) FDA agrees that the lack of definitions of the terms “customarily marketed” and “claims of therapeutic benefit” as they apply to products made or derived from tobacco in the relevant case law has created ambiguity and resulted in confusion among regulated industry, which has led FDA to promulgate this rule. Specifically, in the absence of clear judicial direction about what might constitute “claims of therapeutic benefit” and the relationship between tobacco products “as customarily marketed” and the structure/function prong of the drug/device definitions, the Agency believes it is important to clarify its statutory interpretations of the drug/device definitions with respect to products made or derived from tobacco in light of these terms used by the courts.
(Comment 6) Several comments supported FDA's proposal to treat satisfaction, smoking alternative, and nicotine fix claims as tobacco product claims. However, these comments assert that all products derived from tobacco that lack express therapeutic claims must be regulated as tobacco products. These comments maintained that FDA's proposed approach—which provides that some structure/function claims will cause products derived from tobacco to be regulated as drugs, devices, or combination products—is inconsistent with the
Specifically, the comments argued that neither decision “indicates that `customarily marketed' means anything other than `not marketed with therapeutic claims'.” They maintained that the
(Response) FDA disagrees with these comments and declines to adopt their overly narrow reading of
In addition, as noted in section I.C of the proposed rule, as well as section I.D, neither the
Having given FDA regulatory authority over tobacco products, if Congress thought that products made or derived from tobacco should never be regulated as drugs or devices under the structure/function prong of the drug or device definitions in the wake of
(Comment 7) At least one comment disagreed with some of the examples in the proposed rule of structure/function intended uses that FDA believes remain within its drug/device jurisdiction under the proposal. Specifically, the comment argued that claims about nicotine's stimulant and weight-loss structure/function effects “remain permissible `tobacco product' claims,” because FDA's 1996 rulemaking found that stimulant and weight-loss structure/function effects were among the intended uses of cigarettes and smokeless tobacco products (citing 61 FR 44396 at 44630, 44632).
(Response) FDA disagrees with this comment. In the 1996 rulemaking, FDA found that, in addition to causing and sustaining addiction, nicotine in cigarettes and smokeless tobacco causes other psychoactive (mood-altering) effects, including tranquilization and stimulation; and that nicotine in cigarettes and smokeless tobacco controls weight (61 FR 44396 at 44630). The rulemaking further found that these were intended structure/function effects for cigarettes and smokeless tobacco products (id. at 44632). But the central holding of
Sponsors should also keep in mind that, regardless of whether a product is regulated as a tobacco product or a medical product, the claims made for the product would misbrand the product and subject manufacturers to enforcement action if the claims are false or misleading in any particular, including if the claims are unsubstantiated. Thus, if a particular claim related to the effects of nicotine was used in the marketing of a tobacco product prior to March 21, 2000, but that claim is not substantiated by appropriate evidence, the use of such a claim in current labeling or advertising would likely misbrand the product. In addition, both medical products and tobacco products would be subject to enforcement action under section 201(n) of the FD&C Act if their labeling or advertising fails to reveal facts material in the light of the representations made or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates.
(Comment 8) Several comments argued that the proposed rule was an improper attempt to undermine the court's holding in
(Response) FDA disagrees with these comments. Although the
Moreover, the comments appear to misunderstand the nature of determinations of intended use with respect to FDA-regulated products. As discussed elsewhere in this document, intended use is a case-by-case, fact-specific inquiry in which the Agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence. See,
(Comment 9) Several comments asserted that claims that use euphemisms for the delivery of a pharmacologically active dose of nicotine, or state that a tobacco product provides an alternative way of obtaining the effects of nicotine or will provide the same effects as another tobacco product, do not fall within FDA's medical product authority. Four comments took the opposite view. Three of these latter comments remarked that excluding such claims from FDA's medical product authority would authorize manufacturers to continue using claims that were found to be fraudulent and deceptive by the U.S. District Court for the District of Columbia in
(Response) The Agency disagrees with any suggestion that FDA is authorizing fraudulent claims. The purpose of this rule is to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a tobacco product versus as a drug, device, or combination product. Regardless of the outcome of that jurisdictional question, the FD&C Act prohibits false and misleading claims in FDA-regulated labeling and advertising (see sections 502(a), 502(n), 502(r), 903(a)(1), and 903(a)(7) (21 U.S.C. 352(a), 352(n), 352(r), 387c(a)(1), and 387c(a)(7)). Similarly, in concluding that certain claims involving “satisfaction,” “pleasure,” “enjoyment,” and “refreshment” are claims about the pharmacological effects of nicotine that were commonly and legally made prior to March 21, 2000, FDA is not authorizing such claims. Rather, the Agency is explaining in more detail its understanding of how the D.C. Circuit's interpretation of the Tobacco Control Act in
(Comment 10) Comments expressed different opinions about the intended uses of products made or derived from tobacco, primarily e-cigarettes, and whether consumers are able to distinguish products that are intended for medical use from products marketed for other uses. Several comments asserted that e-cigarettes are not intended for use as smoking cessation aids, whereas many other comments asserted that e-cigarettes are vital smoking cessation aids. One comment averred that there is no evidence that consumers are confusing e-cigarette products with products that are marketed, labeled, and sold as medical products. Two other comments, however, cited studies that purportedly show many consumers believe e-cigarettes and smokeless tobacco products are effective smoking cessation aids.
(Response) FDA continues to believe that there is consumer confusion about the intended uses of marketed products made or derived from tobacco. Evidence that at least some consumers are confused about the intended uses of products can be found in the comments themselves. We received many comments from individuals who began using e-cigarettes because they believed that e-cigarettes would help them quit smoking. Moreover, as noted in two comments, studies have shown that many consumers are using e-cigarettes to attempt to quit smoking (Ref. 2) despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.
(Comment 11) Several comments expressed concern that this regulation would increase consumer confusion by not allowing ENDS manufacturers to communicate truthful claims to their customers. These comments believed that the regulation would harm, rather than protect public health. Comments also expressed concern that ENDS manufacturers would not be able to state that e-cigarettes could be used for smoking cessation, and ENDS manufacturers would be forced to deceptively market their products. Several comments discussed FDA's authority under section 911 of the FD&C Act to require premarket authorization of modified risk tobacco products. Some commenters urged FDA to implement section 911 in a manner that does not restrict truthful and non-misleading speech.
(Response) FDA disagrees with concerns that ENDS manufacturers will not be able to make claims that accurately represent their products' intended uses. Manufacturers are free to decide how they would like to market their products, but must meet the appropriate statutory and regulatory standards governing the regulatory pathway they choose. Additionally, the proposed rule would not force e-vapor manufacturers to “deceptively” market their products or risk “being categorized as unapproved medical products and forced off the market.” FDA believes that manufacturers of products made or derived from tobacco, including e-vapor manufacturers, could make many types of claims under the rule that would subject them only to tobacco product jurisdiction; the preamble to the proposed rule provides examples of such tobacco product claims, but is not intended to be an exhaustive list. Moreover, section 911 of the FD&C Act allows manufacturers to make truthful and non-misleading modified risk claims with appropriate authorization. Manufacturers that have data to substantiate modified risk claims for a particular product can submit an MRTP application so that FDA can determine whether the product meets the statutory standard and if appropriate, can issue an order authorizing it to be marketed as an MRTP.
FDA continues to believe that smoking cessation claims require close examination. FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction to be evidence of intended uses that confer drug or device jurisdiction. Manufacturers that have data to substantiate cessation claims for a particular product can submit an NDA so that FDA can determine whether the product meets the statutory standard and can approve the application, if appropriate. The rule's treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products. Treating these products as medical products will help assure that such claims are supported by data demonstrating that a product is safe and effective for this intended use. Otherwise, consumers may attempt to quit smoking with unproven products, threatening both individual consumers' health and the public health generally.
(Comment 12) At least one comment suggested that a disclaimer stating that FDA has not approved e-cigarettes for medical use would be sufficient to mitigate any confusion over the intended use of such products. In contrast, several comments argued that disclaimers are insufficient to mitigate any confusion over whether a product made or derived from tobacco is intended for medical use. One of these comments suggested that disclaimers would foster confusion because they often contain statements that conflict with claims that are made elsewhere in the marketing materials and labeling for e-cigarettes and other products.
(Response) FDA does not believe that disclaimers will be sufficient in most cases to mitigate consumer confusion about whether a product made or derived from tobacco is intended for medical use. Studies have shown that disclaimers are frequently ineffective and can actually increase confusion for consumers (Refs. 3 and 4). Thus, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically.
(Comment 13) Several comments suggested that excluding claims that are euphemisms for the delivery of a pharmacologically active dose of nicotine and those that suggest a tobacco product provides an alternative way of obtaining the effects of nicotine from regulation under the Agency's drug/device authorities would create consumer confusion because such claims may not be distinguishable from drug or device claims related to the symptoms of nicotine addiction or could be perceived as modified risk claims.
(Response) As stated previously in this section, FDA has determined that
FDA is also making changes to §§ 201.128 and 801.4. First, the final rule inserts a reference to § 1100.5 to clarify the interplay between these regulations and the final rule. Second, as discussed previously, the Agency does not, absent extraordinary circumstances, regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that the product was being prescribed or used by doctors for such use (see Ref. 1). Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA's interpretation and application of these regulations. These changes do not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.
Among the provisions that provide authority for this final rule are sections 201, 503(g), and 701(a) of the FD&C Act (21 U.S.C. 321, 353(g), 371(a)). Section 201 of the FD&C Act defines “drug,” “device,” and “tobacco product” (subsections (g)(1), (h), and (rr)(1) to (rr)(2)), and section 503(g) of the FD&C Act provides that combination products are those “that constitute a combination of a drug, device, or biological product.” Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act. FDA believes this rule will assist the Agency with efficient enforcement of the FD&C Act because it provides increased clarity to stakeholders, particularly regulated entities, regarding FDA's interpretation of which regulatory framework will apply to particular products and will help consumers differentiate between products that are intended for medical use and products marketed for other uses.
FDA regulates the manufacture, sale, and distribution of drugs, devices, combination products, and tobacco products under the authority of the FD&C Act. Although the regulatory pathways for each product category differ, each product category is subject to similar types of regulatory requirements. For example, FDA's regulatory authority for drugs, devices, combination products, and tobacco products includes authority to review and authorize the marketing of new products as well as to oversee product labeling and advertising. Thus, whether a product meets the definition of a drug, device, or tobacco product under the FD&C Act and this final regulation, the manufacture, sale, and distribution of the product are subject to the applicable requirements of the FD&C Act.
(Comment 14) At least one comment stated that the proposed rule exceeds FDA's authority.
(Response) FDA disagrees. As described in the proposed rule, FDA has the authority to regulate as a medical product any product that meets the definition of drug, device, or combination product in the FD&C Act, including cigarettes and other tobacco-derived products unless their intended use was the subject of claimed structure/function effects of nicotine commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. FDA also has tobacco product jurisdiction over all other products made or derived from tobacco intended for human consumption. The final rule seeks to clarify how products containing nicotine derived from tobacco will be regulated.
As described in section II, the goal of this final rule is to provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act. In describing these intended uses, the final rule aims to assist regulated entities in the research and development of products made or derived from tobacco by clarifying which regulatory framework (
The codified language states the circumstances in which a product made or derived from tobacco would be excluded from the definition of “tobacco product” and be subject to regulation as a drug, device, or combination product. Under the final rule, this exclusion could apply in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
Conceptually, the codified language follows the disease prong and the structure/function prong (with certain limitations) of the drug and device definitions.
Section 1100.5(a) follows the disease prong. The paragraph elaborates on the statutory language for the disease prong by describing several categories of intended uses that would cause a product made or derived from tobacco to be regulated as a medical product. The categories identified in § 1100.5(a) are not intended to constitute an exhaustive list; nor are these categories necessarily mutually exclusive. In addition, these categories are intended to capture concepts, rather than to suggest that the use (or omission) of
Section 1100.5(b) follows the structure/function prong, but with some changes to reflect the court decisions in
FDA believes that it is important to include a date limitation in § 1100.5(b) to provide greater certainty about the universe of historic structure/function claims the Agency intends to consider when determining whether an intended use of a product made or derived from tobacco is different from effects related to nicotine that were commonly and legally claimed for “customarily marketed” cigarettes and smokeless tobacco products. This bright-line limitation also avoids creating a shifting standard that will cause confusion among consumers and regulated industry. FDA intends to look to the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, to determine the types of structure/function claims that constitute customary tobacco product marketing. Cigarettes and smokeless tobacco products provide a reasonable proxy for determining how nicotine-related structure/function claims were conveyed in tobacco product marketing generally. The codified language, however, applies to all products made or derived from tobacco, not just cigarettes and smokeless tobacco.
As noted in section I.B.2, intended use may be determined from any relevant source and is not based solely on claims made in a product's labeling or advertising materials. For purposes of illustration, however, claims such as “treatment of tobacco dependence,” “wean yourself off of nicotine,” “for people who wish to quit smoking,” “stop smoking aid,” “prevent relapse,” or “stay quit” generally will bring a product within the intended uses described in § 1100.5(a).
Claims such as “to reduce withdrawal symptoms,” “helps reduce symptoms including things like [list of withdrawal symptoms]” and “relieve withdrawal symptoms when you are prohibited from smoking” would be associated with an intended use for relief of nicotine withdrawal symptoms, and would also fall within the intended uses described in § 1100.5(a). Withdrawal symptoms that are medically recognized as relevant to nicotine addiction may be determined by reference to standard classification and diagnostic tools such as the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
Certain structure/function claims that were not commonly and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, such as “promotes weight loss,” would fall within the intended uses described in § 1100.5(b).
In contrast to the examples of medical product intended use claims given in the previous paragraphs, certain other claims made about products made or derived from tobacco would not on their own create an intended use that falls within the codified language.
For products made or derived from tobacco that are intended for investigational use, FDA will consider whether the product is being used in a clinical investigation for an intended use that brings it within the codified language. If it is, the product would meet the definition of “investigational new drug” in § 312.3 (21 CFR 312.3), and the clinical investigation would be subject to the applicable requirements in part 312 (21 CFR part 312).
In the proposed rule, FDA proposed certain changes to FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses (see § 201.128 (drugs), § 801.4 (devices)). These changes were intended to revise the language of the regulations to better reflect how the Agency applies them. As explained in the preamble to the proposed rule, these amendments were intended to clarify FDA's existing position on intended use, not to change it (80 FR 57756 at 57761). Some comments, however, misunderstood FDA's proposal, particularly with respect to the proposed deletion of the last sentence of both regulations (§§ 201.128 and 801.4). FDA has now determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than deleting them.
Accordingly, the last sentence of § 201.128 is amended to provide that if
Similarly, the last sentence of § 801.4 is amended to provide that if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the FD&C Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for the device adequate labeling that accords with such other intended uses.
As described in the preamble to the proposed rule, FDA's longstanding position is that, in determining a product's intended use, the Agency may look to any relevant source of evidence. This position has solid support in the case law (see,
In the preamble to the proposed rule, FDA also stated “the Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use” (80 FR 57756 at 57757). Health care providers prescribe or use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients.
Before FDA issued the proposed rule, some drug sponsors had expressed concern with the last sentence of § 201.128. That sentence provided, “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses.” (Section 801.4 contains comparable language.) They asserted that, literally read, this sentence would require that, whenever a manufacturer knew that its approved drug was being prescribed for an unapproved use, it would be required to alter the labeling of a drug to provide adequate directions for an off-label use. They further asserted that this addition to FDA-approved labeling would transform the drug into a new drug that cannot be sold without first obtaining approval of a supplemental new drug application pursuant to 21 U.S.C. 321(p) and 355(a). From this they concluded that, under the last sentence of § 201.128, a manufacturer's mere knowledge of an unapproved use of its approved drug automatically triggers requirements for new labeling that in turn render distribution of that approved product unlawful without approval of a supplemental NDA.
In the proposed rule, the proposed deletion of the last sentence of §§ 201.128 and 801.4 was intended to clarify the following: Where a manufacturer is distributing an approved or cleared medical product, evidence that the manufacturer knows that health care providers are prescribing or using that approved or cleared medical product for an unapproved use would not, by itself, automatically trigger obligations for the manufacturer to provide labeling for the uses for which the health care providers are prescribing or using the product.
FDA's clarification of its position and proposed deletion of the last sentence of these regulations in the proposed rule did not suggest that FDA sought to otherwise narrow the scope of evidence of intended use that FDA may consider. However, some of the comments misunderstood the proposal. For example, some comments asserted—incorrectly—that FDA intended to eliminate manufacturer knowledge altogether as a source of evidence of intended use.
FDA has determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than by deleting them. The amended language no longer suggests that a manufacturer's mere knowledge that its approved or cleared product was being prescribed or used for an unapproved use was sufficient to trigger the requirement to provide adequate labeling. In addition, this amended language provides further clarification by reminding manufacturers that, where the totality of evidence is sufficient to establish a new intended use for a medical product, relevant provisions of the FD&C Act and its implementing regulations will be triggered.
In addition, these amendments reflect FDA's longstanding position, upheld by the courts, that FDA may consider a variety of direct and circumstantial evidence to establish intended use. For example, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (see,
(Comment 15) Some comments stated that this clarification of the Agency's interpretation and application of the intended use regulations (§§ 201.128 and 801.4) was helpful because it clarifies a point that has been confusing to industry. Another comment stated that the proposed changes to §§ 201.128 and 801.4 provide less information to manufacturers, not more clarity.
(Response) FDA agrees that clarification was warranted because of the apparent confusion over this point. With this final rule, the Agency is making additional changes to the codified language and providing more explanation to further clarify the meaning of the regulations.
(Comment 16) Some comments asserted that FDA should eliminate another reference to “knowledge” in § 201.128. Before the amendments implemented by this rule, both §§ 201.128 and 801.4 contained the following sentence: “[Intended use] may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.” The comments recommended that FDA delete either the phrase “with the knowledge of such person or their representatives” or the entire sentence from the regulation. At least one comment asserted that its recommended change to delete that phrase is consistent with FDA's intent in amending the regulations.
(Response) FDA disagrees with these comments. It was not the Agency's intention to entirely remove manufacturer knowledge from the types of evidence that may be considered in determining a product's intended use. FDA's proposed and final rule not only retained this sentence containing the other reference to “knowledge” in the text of both §§ 201.128 and 801.4, but also added “for example” to emphasize that FDA may rely on
In the context of medical products, generally, varied types of evidence, including evidence of a manufacturer's knowledge that a product is being used for an unapproved use, often enables FDA to pursue medical product manufacturers who attempt to evade FDA jurisdiction by avoiding express claims with respect to their products. In addition, as courts have recognized, evidence of a manufacturer's knowledge that a product is being used for an unapproved use can also be used to corroborate other evidence of intended use (see,
FDA's intention in proposing to amend §§ 201.128 and 801.4 was more focused than these comments suggest. First, FDA's statement about not relying solely on manufacturer knowledge was limited to
(Comment 17) At least one comment suggested that the First Amendment requires the exclusion of knowledge as a category of evidence that may be considered as evidence of intended use.
(Response) FDA disagrees. The First Amendment protects, among other things, freedom of speech, and knowledge and speech are not coextensive. A variety of direct and circumstantial evidence can establish a person's knowledge; a person's speech can be one source—but is not the only source—of evidence of that person's knowledge. Thus, the inclusion of evidence of knowledge within the types of evidence that may be relevant to establishing intended use does not in itself implicate the First Amendment.
(Comment 18) At least one comment asserted that, under relevant statutory text, legislative history, and case law, evidence of intended use is limited to a manufacturer's promotional claims. Another comment similarly proposed that the Agency focus principally on statements in the product labeling to establish intended use (using advertising material only to a lesser extent). In contrast, still another comment urged FDA to consider manufacturer statements in a variety of contexts, including advertising; press statements; official or unofficial statements made by corporate officials; statements made in social media and other online arenas; and statements made in point-of-sale locations (both traditional retail and online).
(Response) FDA disagrees with the comments urging FDA to narrow the scope of evidence it will consider in determining intended use, and FDA agrees with the comment asserting that evidence relevant to intended use should include a manufacturer's statements in a variety of contexts. Under the former set of comments, FDA could not consider, for example, evidence of a manufacturer's marketing plans or directions to its sales force, evidence of the well-known uses and abuses of its products, and circumstantial evidence relating to the sale and distribution of the product. These comments' suggested narrow view of evidence of intended use would not only create a loophole for manufacturers and distributors to evade FDA oversight of the marketing of approved/cleared medical products for unapproved uses but would also open the door to the marketing of wholly unapproved medical products—all to the detriment of the public health.
As courts have recognized, “[s]elf-serving labels cannot be allowed to mask the vendor's true intent as indicated by the overall circumstances” (
Nothing in the statute requires the narrow scope the comments suggest. As four justices of the Supreme Court recognized in rejecting the arguments reflected in these comments, “The [FD&C Act] . . . does not use the word `claimed'; it uses the word `intended' ” (
FDA also disagrees that the case law requires that evidence of intended use be limited to marketing representations by firms, to the exclusion of other types of evidence such as internal firm documents and circumstances surrounding the sale of products. Courts have repeatedly held that intended use is determined by looking to all relevant evidence, including statements and circumstances surrounding the manufacture and distribution of a medical product (see,
Indeed, courts have rejected the comments' proposition that evidence of intended use is limited to a manufacturer's public claims concerning a device or drug (see
(Comment 19) At least two comments asserted that FDA should significantly contract its proposed definitions of “intended uses” because the First Amendment protects truthful speech. One comment stated that, under
Similarly, another comment urged FDA to confirm that truthful and non-misleading speech cannot form the basis of a manufacturer's intended use of a medical product. That comment asserted that courts have recently held that enforcement actions based on truthful, non-misleading speech to health care professionals violates core First Amendment values, citing
(Response) FDA is separately examining its rules and policies relating to firm communications regarding unapproved uses of approved/cleared medical products, with the goal of determining how best to integrate the significant and sometimes competing public health and safety interests served by FDA's regulatory approach related to unapproved uses of medical products with ongoing developments in science and technology, medicine, health care delivery, and constitutional law. To that end, FDA held a two-day public hearing on November 9 and 10, 2016, to obtain input on these issues, and created a docket for the submission of written comments (see,
The broader policy questions and the related First Amendment issues are thus being considered in a separate proceeding. Nevertheless, it is important to note here that we do not agree with the assertion that the current case law allows FDA to consider speech as evidence of intended use only when it is false or misleading. Courts have held that the government's reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment based on Supreme Court precedent establishing that “[t]he First Amendment . . . does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent” (
Although the district court in
In addition, FDA's consideration of speech as evidence of intended use under its statutory and regulatory framework advances substantial public health interests relevant to analyses under
At the same time, health care providers also prescribe and use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients. Scientific or medical information regarding unapproved uses of products may in some cases help health care providers make better decisions regarding patients, such as where the patient has a disease for which there is no approved/cleared treatment, where the patient is part of a population that has not been studied, or where all approved/cleared treatments have been exhausted. However, in other cases, the use of approved/cleared medical products for unapproved uses has also been associated with significant harm to patients, fraud, and waste of health care resources.
FDA's current implementation approach seeks to integrate the complex mix of numerous and sometimes competing interests at play while also taking into account First Amendment issues. For example, FDA has issued guidance documents to describe some of the circumstances when it would not consider a firm's distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved/cleared medical products to be evidence of intended use; and issued a draft guidance on unsolicited requests, confirming FDA's longstanding position that it would not consider a firm's providing truthful, balanced, non-misleading, and non-promotional scientific or medical information (including information about an unapproved use) that is responsive to unsolicited requests for information about FDA-regulated medical products to be evidence of intended use. FDA takes the same view of firms' presenting truthful and non-misleading scientific information about unapproved uses at medical or scientific conferences when done in non-promotional settings and not accompanied by promotional materials.
There are several points worth noting regarding the
(Comment 20) Several comments asserted that FDA should take this opportunity to bring other related regulations and guidance documents into conformance with modern First Amendment case law. These comments suggested, for example, that FDA reconsider its approach to substantial evidence to support manufacturer communications to health care professionals about approved drugs, reconsider its interpretation of the term
(Response) To the extent these comments propose that FDA consider, in this rulemaking, issues that are beyond the scope of this rulemaking, FDA declines the suggestion. FDA agrees with the comment that suggests that broader First Amendment issues should be considered in the context of separate proceedings. FDA notes that there are separate proceedings that are currently ongoing (see,
In addition, FDA notes its disagreement with certain characterizations of the existing case law. First, as discussed earlier, the court in
In
Third, we disagree with the one comment that asserts, quoting
(Comment 21) Several comments suggested that FDA replace the phrase “is intended for use” in the first sentence of § 1100.5 with other phrases, such as “is commonly used” or “is primarily used.”
(Response) FDA declines this suggestion. The phrase “is intended for use” is necessary because it reflects the fact that FDA's regulatory authority over a product made or derived from tobacco is, in the context of regulating them as medical products, dependent upon the product's intended use.
(Comment 22) Several comments urged FDA not to consider a manufacturer's knowledge when determining a manufacturer's intent with respect to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The comments also request that the Agency use notice and comment rulemaking instead of guidance to make changes regarding manufacturer intent related to HCT/Ps.
(Response) These comments concern regulations and guidance documents relating specifically to HCT/Ps and are outside the scope of this rulemaking.
(Comment 23) At least one comment suggested that FDA amend § 1100.5(a) to incorporate the following points: (1) Products intended for use in the cure and treatment of smoking or any other tobacco product use are subject to regulation as medical products; (2) products intended for use for the prevention of relapse into any smoking, tobacco product, or nicotine relapse are subject to regulation as medical products; and (3) relief from nicotine withdrawal symptoms also includes relief from smoking or tobacco use withdrawal symptoms.
(Response) FDA agrees that the three uses identified in the comment appear to be intended uses that would render the products subject to regulation as medical products. Section 1100.5(a) explains that a product made or derived from tobacco is subject to regulation as a medical product if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. For illustrative purposes, the section also provides several examples of intended uses that will subject a product to regulation as a medical product. We believe the list of examples, which is not intended to be exhaustive, adequately illustrates the types of intended uses that will subject a product made or derived from tobacco to regulation as a medical product. Thus, while we agree that the three identified uses appear to be intended uses that would render the products subject to regulation as medical products, we decline to amend the list to incorporate the uses identified by the comment.
(Comment 24) At least one comment objected that the rule would limit e-cigarettes to marketing claims of “smoking pleasure” and “smoking satisfaction” since that is how traditional tobacco products were “customarily marketed” prior to March
(Response) FDA disagrees. As explained elsewhere in this document, we believe that the rule gives manufacturers and retailers ample flexibility to market e-cigarettes in a manner that is distinct from how cigarettes were marketed prior to March 21, 2000. The date of March 21, 2000, is relevant only to considering claims about a product's effects related to nicotine on the structure or function of the body as evidence of a product's intended use. E-cigarette manufacturers' and retailers' claims related to customizability, number of puffs per cartridge or charge, and various other differentiating features that do not relate to nicotine structure/function effects, irrespective of whether such claims were customarily and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, should generally not affect the determination of a product's intended use. A manufacturer's making a modified risk claim for a specific tobacco product renders the product an MRTP, which can be marketed only after the manufacturer substantiates any modified risk claims in an MRTP application and after FDA determines that the product meets the statutory standard. Additionally, if a manufacturer intends that its product be used for cessation, it can submit an NDA, Abbreviated New Drug Application (ANDA), Premarket Approval Application (PMA), or premarket notification submission so that FDA can determine whether the product meets the statutory standard and can approve the application or clear the submission, if appropriate.
(Comment 25) At least one comment questioned whether the marketing for tobacco products that are not MRTPs may contain useful contextual information (
(Response) This comment is outside the scope of this rulemaking because it does not relate to the circumstances in which a product that is made or derived from tobacco will be regulated as a medical product or a tobacco product.
(Comment 26) Several comments stated that ENDS manufacturers need to be able to inform and explain how to properly use vaping devices to help novices to prevent them from having accidents. The comments stated that vape shops need to be able to correctly educate consumers on how to use the products they sell.
(Response) FDA agrees. FDA recognizes that manufacturers may wish to provide instructions to consumers on how to use novel tobacco products, and instructions may be helpful in some cases in preventing consumer injury, such as nicotine poisoning or injuries from exploding batteries. Manufacturers may provide instructions to the consumer in many ways, including verbal instruction. However, if the instructions provided by the manufacturer convey that the product is to be used as a cessation device, then the product will generally be regulated as a medical product. Additionally, if the instructions make a modified risk claim, then the manufacturer must submit an MRTP application so that FDA can determine whether the product meets the statutory standard and can issue an order authorizing it to be marketed as an MRTP.
(Comment 27) Several commenters noted that tobacco products are advertised in a variety of media, including traditional print or mainstream media, blogs, social media, testimonials, and links to studies or media reports on Web sites. One comment observed that manufacturers of ENDS products often use online blogs as a way to make implicit or explicit cessation claims, and in some cases such assertions run counter to disclaimers posted on the same Web site that hosts the blog. Another comment noted that manufacturers used consumer testimonials that make cessation or MRTP claims on their company Web sites. Commenters observed that conflicting claims in advertising caused confusion among consumers regarding whether ENDS products are FDA-approved smoking cessation aids.
(Response) FDA agrees. Tobacco products are advertised in a variety of media, and advertisements may include conflicting information regarding whether the product is a recreational tobacco product or an FDA-approved smoking cessation product. When conflicting claims are made to the consumer, consumers can be confused by those claims. Thus, FDA believes that manufacturers' making smoking cessation claims for any product creates a strong suggestion of therapeutic benefit to the user that would subject the product to regulation under FDA's medical products authority. Such a suggestion generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose. As discussed in response to Comment 12, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion related to the intended therapeutic use of the product.
(Comment 28) Several comments stated that adolescent smokers are especially vulnerable to cessation and therapeutic claims in tobacco product marketing. These comments believe that adolescents misperceive the supposed benefits and underestimate the relative harms, risks, and addictive properties of e-cigarettes and other non-cigarette products.
(Response) FDA agrees that youth and young adults generally “underestimate the tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose” (Ref. 14). For example, one survey found that “nearly 60 percent of adolescents believed that they could smoke for a few years and then quit” (Ref. 15). FDA also believes that unsubstantiated cessation claims that reach adolescents may confuse teens and lead teens to believe that these products are FDA-approved smoking cessation products. For example, a teenager in a recent qualitative study said, “I heard that the only reason they were made is to help people get off from cigarettes for people that want to quit. You would use an e-cigarette to help you quit supposedly. It was on the news” (Ref. 16). FDA believes it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other tobacco product uses among both adolescents and adults, and this rule will help consumers.
(Comment 29) At least one comment stated that users consider ENDS and smokeless tobacco products effective cessation interventions. The comment believed that many people use these products to try to stop smoking because they are influenced by manufacturers' and sellers' marketing messages that
(Response) FDA agrees that marketing can influence how consumers perceive tobacco products, and products advertised with cessation claims can lead consumers to believe that the product is an FDA-approved smoking cessation device. FDA also agrees that many consumers are using ENDS products for therapeutic purposes. One study concluded that, among State tobacco cessation quitline callers, the most common reported reason for using e-cigarettes was to cut down on, or quit, traditional tobacco use (Ref. 17). Another study concluded that some smokers who were interested in quitting were using ENDS for cessation purposes, possibly discouraging the use of proven smoking cessation treatments, delaying cessation, and thus prolonging exposure to harmful agents in combusted tobacco as an unintended consequence. Additionally, FDA received a large number of comments from individuals using ENDS for therapeutic purposes. One purpose of this regulation is to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use versus for a recreational use.
(Comment 30) At least one comment expressed concern that since the
(Response) FDA disagrees with the comment to the extent that the comment suggests that tobacco products properly regulated as MRTPs be regulated as drugs or devices in the absence of an MRTP order. Tobacco products making modified risk claims are regulated under the tobacco product authorities in the FD&C Act, and an MRTP marketed without an MRTP order would be subject to enforcement as a tobacco product, rather than subject to regulation as a drug or medical device product. With respect to enforcement generally, FDA notes that it is issuing this rule to clarify its interpretation of the drug and device definitions with respect to products made or derived from tobacco, and that it expects this clarification to assist industry in determining the applicable regulatory framework for particular products and help consumers differentiate between products that are intended for medical use and products intended for other uses.
(Comment 31) At least one comment observed that researchers may wish to study the effects that a product made or derived from tobacco has on health outcomes (
(Response) The regulations in part 312 set forth the circumstances in which an IND is required for clinical investigations in which a drug is administered to human subjects. The IND requirement applies irrespective of whether the investigation is sponsored by a manufacturer or an academic institution. A study involving a product made or derived from tobacco will generally require an IND if the product, as used in the study, is subject to regulation as a drug. Whether the product, as used in the study, is subject to regulation as a drug depends on whether the product is being investigated for any of the purposes described in § 1100.5(a) or (b) of this rule. To determine if a product made or derived from tobacco is being investigated for one of these purposes, FDA generally would review the protocol for the study, including the proposed methods and measures. In the Agency's experience, the proposed methods and measures for a study can provide insight into the purposes for which a product is being investigated. Ultimately, however, whether a product is being investigated for a therapeutic purpose, and thus whether the study requires an IND, is a fact-specific, case-by-case inquiry. Additional information about the IND requirement can be found in the FDA guidance document entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” We encourage researchers to review this guidance document, which is available on FDA's Web site at
(Comment 32) At least one comment encouraged FDA to coordinate between centers to promote development of safer tobacco products as well as more effective medical products for the treatment of nicotine addiction. This comment also argued that FDA should not allow similar or identical products to be marketed as both tobacco products and medical products, and should consider approving categories of products, rather than individual products, for smoking cessation. This comment also expressed concern about dual use between tobacco product categories.
(Response) FDA agrees with this comment to the extent the comment considers the proposed rule to promote effective coordination between centers by clarifying which center should take the lead in review of premarket applications and postmarketing regulation of particular products. We note that FDA currently interprets the standards in various medical and tobacco product premarket review pathways to refer to individual products rather than product categories, and the question of whether a particular product could obtain marketing authorization as both a tobacco product and as a medical product is beyond the scope of this rule. By clarifying the jurisdictional lines between tobacco and medical products, FDA believes that finalization of this rule will make it less likely that manufacturers will attempt to market products made or derived from tobacco both as tobacco products and as medical products—for example, if a tobacco product manufacturer attempts to add claims to a currently marketed tobacco product that would require the product to be regulated as drug, device, or combination product.
(Comment 33) Several comments recommended that the Center for Tobacco Products (CTP) have sole regulatory jurisdiction over tobacco and nicotine-containing products and provided suggestions for how CTP should structurally reorganize itself to better regulate these products.
(Response) CTP oversees the regulation of products made or derived from tobacco that are intended for human consumption. As stated in this preamble, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it would be regulated as a medical product unless it is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000. In this situation, one of FDA's medical product
(Comment 34) At least one comment suggested that FDA create a separate regulatory category for e-cigarettes that is based on the Agency's medical product regulations, but with less stringent quality standards.
(Response) This recommendation is not consistent with the statutory definitions in the FD&C Act. Under the FD&C Act, a product made or derived from tobacco is subject to regulation as a tobacco product unless it meets the definition of a drug or device or is a combination product, in which case it is subject to regulation as a medical product.
(Comment 35) Several comments stated that the cost and resources required to complete FDA's drug application process would be simply too great and would shut down many small manufacturers.
(Response) This regulation simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product; it does not create new jurisdictional lines or impose new obligations on product manufacturers. Because the jurisdictional lines already exist, tobacco product manufacturers currently making claims that would render their product subject to regulation as a medical product or who wish to make such claims in the future are within FDA's drug and device jurisdiction, absent limited exceptions, and they must follow the applicable statutory and regulatory requirements.
(Comment 36) Many comments believed that the regulation would make e-cigarettes less available to consumers.
(Response) FDA disagrees. This regulation simply clarifies the circumstances under which a product made or derived from tobacco will be regulated as a drug, device, or combination product, and the circumstances under which it will be regulated as a tobacco product. This regulation will not add any additional burden to manufacturers who sell ENDS for recreational use. However, if a manufacturer is selling ENDS and making medical product claims, then the product would be subject to regulation as a drug, device, or combination product if those claims are not structure/function claims related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000.
(Comment 37) At least one comment suggested that the final rule should include a discussion of how the regulation will affect public health.
(Response) The preamble to the proposed rule contained some discussion of this topic, and this preamble to the final rule further expands on various public health protections.
(Comment 38) FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence. One comment asserted that promoting a product as suitable for continued nicotine use after stopping smoking traditional cigarettes is the functional equivalent of a “smoking alternative” claim, which FDA has said does not fall within the Agency's medical product authority, and, therefore, should not subject the product to regulation as a medical product.
(Response) Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons (Ref. 18). Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence may be developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in § 1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction.” FDA intends to closely scrutinize “smoking cessation” claims to ensure that consumers are not misled about the intended use of a product made or derived from tobacco.
(Comment 39) One comment stated that this regulation should not require companies that handle raw materials to determine whether those raw materials would be used in tobacco products or whether those materials would be used in medical products. The comment stated that the intended use of the product is completely within the discretion of the sellers and distributors of the finished products, and the Agency should not extend regulations to cover companies that handle raw materials.
(Response) This comment is beyond the scope of this rule. This regulation does not create new jurisdictional lines or impose new obligations on product manufacturers or companies that handle raw materials. Rather, this rulemaking simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product. If FDA were to consider extending its authority in such a way that would place additional requirements on companies handling raw materials, the Agency would do so through a separate rulemaking.
To eliminate redundancy, we deleted “or prevention or mitigation of disease” from the end of § 1100.5(a), as the opening text already includes similar language. Because of this deletion, we inserted the word “or” in front of “relief of nicotine withdrawal symptoms.”
This final rule will become effective 30 days after the date of its publication in the
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule does not contain policies that would have substantial direct effects 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. Accordingly, the Agency concludes that the final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
We have analyzed this rule in accordance with the principles set forth
FDA has determined under 21 CFR 25.30(h) and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because, as described in detail in the section entitled “Final Small Entity Analysis” in the full analysis of economic impacts available in the docket for this final rule (Ref. 19) and at
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in expenditure in any year that meets or exceeds this amount.
The final rule will reduce ambiguity in the market for products made or derived from tobacco and clarify FDA's interpretation and application of its existing intended use regulations. The rule clarifies the intended uses and supporting evidence that would result in these products being regulated as drugs, devices, or combination products rather than tobacco products. Products derived from tobacco that are intended to: (1) Diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation or (2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000, such as an intended use for improving respiratory function, will be subject to regulation as drugs, devices, or combination products. We estimate that there would be one-time costs for tobacco manufacturers to evaluate current product communications such as labeling and associated promotional materials in light of the clarifications in this final rule, and to revise them if needed. We expect that only a small number of product communications such as labeling and associated materials will undergo a one-time change as a result of this rule.
The final rule will provide greater clarity to producers regarding the regulatory requirements for products made or derived from tobacco and to consumers to distinguish products intended for medical uses from those marketed for other uses. The reduction in ambiguity will enhance consumers' understanding of the products they purchase and may increase consumer welfare as a result.
The full analysis of economic impacts is available in the docket for this final rule (Ref. 19) and at
FDA concludes that this final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
The following references are on display in the Division of Dockets Management (see
Drugs, Labeling, Reporting and recordkeeping requirements.
Labeling, Medical devices, Reporting and recordkeeping requirements.
Combination products, Devices, Drugs, Smoking, Tobacco.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter 1 is amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
The words
21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
The words
21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d), Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55, 17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321, 353(g), and 371(a); 21 CFR 1.1.
If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be subject to regulation as a drug, device, or combination product.
(a) The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (
(b) The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
In rule document 2016-31670 beginning on page 96366 in the issue of Friday, December 30, 2016, make the following correction:
On page 96372, in the second column, in the 25th, 51st, and 67th lines, and in the third column, in the tenth line, “June 28, 2018” should read “July 1, 2019”.
Document 2016-30595 was inadvertently classified a rule and published in the Rules and Regulations section in the issue of December 21, 2016, beginning on page 93595. It should have appeared in the Proposed Rules section.
As a result of the error, an amendment was made to 21 CFR 1308.11 which the DEA did not intend. This classification correction removes added paragraphs (h)(23) through (28) from 21 CFR 1308.11.
Accordingly, 21 CFR part 1308 is corrected as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
Agency for International Development (USAID).
Final rule.
This regulation prescribes the procedures and standard terms and conditions applicable to loan guarantees to be issued for the benefit of the Republic of Iraq pursuant to the Further Continuing and Security Assistance Appropriations Act, 2017.
Effective January 9, 2017.
D. Bruce McPherson, Office of the General Counsel, U.S. Agency for International Development, Washington, DC 20523-6601; tel. 202-712-1611, fax 202-216-3055.
Pursuant to the Further Continuing and Security Assistance Appropriations Act, 2017 (Pub. L. 114-254), the United States of America, acting through the U.S. Agency for International Development, may issue certain loan guarantees applicable to sums borrowed by the Republic of Iraq (the “Borrower”), not exceeding an aggregate total of U.S. $1 billion in principal amount. Upon issuance, the loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings and the full faith and credit of the United States of America shall be pledged for the full payment and performance of such guarantee obligations.
This rulemaking document is not subject to rulemaking under 5 U.S.C. 553 or to regulatory review under Executive Order 12866 because it involves a foreign affairs function of the United States. The provisions of the Paperwork Reduction Act (44 U.S.C. 3501
Foreign aid, Foreign relations, Guaranteed loans, Loan programs—foreign relations.
Security Assistance Appropriations Act, 2017 (Div. B, Pub. L. 114-254).
The purpose of the regulations in this part is to prescribe the procedures and standard terms and conditions applicable to loan guarantees issued for the benefit of the Borrower, pursuant the Further Continuing and Security Assistance Appropriations Act, 2017 (Pub. L. 114-254) (the “Authority”). The loan guarantees will be issued as provided herein pursuant to the Loan Guarantee Agreement, executed in January 2017, between the United States of America and the Republic of Iraq (the “Loan Guarantee Agreement”). The loan guarantee will apply to sums borrowed during a period beginning on the date that the Loan Guarantee Agreement enters into force and ending thirty days after such date, not exceeding an aggregate total of one billion United States Dollars ($1,000,000,000) in principal amount. The loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings. The full faith and credit of the United States of America is pledged for the full payment and performance of such guarantee obligations.
Wherever used in the standard terms and conditions set out in this part:
(1) Defaulted Payment unpaid as of the Date of Application,
(2) Further Guaranteed Payments unpaid as of the Date of Application, and
(3) Interest accrued and unpaid at the Interest Rate(s) specified in the Eligible Note(s) on the Defaulted Payment and Further Guaranteed Payments, in each case from the date of default with respect to such payment to and including the date on which full payment thereof is made to the Noteholder.
Subject to the terms and conditions set out in this part, the United States of America, acting through USAID, guarantees to Noteholders the Borrower's repayment of 100% of principal and interest due on Eligible Notes. Under this Guarantee, USAID agrees to pay to any Noteholder compensation in Dollars equal to such Noteholder's Loss of Investment under its Eligible Note; provided, however, that no such payment shall be made to any Noteholder for any such loss arising out of fraud or misrepresentation for which such Noteholder is responsible or of which it had knowledge at the time it became such Noteholder. This Guarantee shall apply to each Eligible Note registered on the Note Register required to be maintained by the Fiscal Agent.
(a) Eligible Notes only are guaranteed hereunder. Notes in order to achieve Eligible Note status:
(1) Must be signed on behalf of the Borrower, manually or in facsimile, by a duly authorized representative of the Borrower;
(2) Must contain a certificate of authentication manually executed by the Fiscal Agent whose appointment by the Borrower is consented to by USAID in the Fiscal Agency Agreement; and
(3) Shall be approved and authenticated by USAID by either:
(i) The affixing by USAID on the Notes of a guarantee legend incorporating these Standard Terms and Conditions signed on behalf of USAID by either a manual signature or a facsimile signature of an authorized representative of USAID; or
(ii) The delivery by USAID to the Fiscal Agent of a guarantee certificate incorporating these Standard Terms and Conditions signed on behalf of USAID by either a manual signature or a facsimile signature of an authorized representative of USAID.
(b) The authorized USAID representatives for purposes of the regulations in this part whose signature(s) shall be binding on USAID shall include the USAID Chief and Deputy Chief Financial Officer, Assistant Administrator and Deputy, Bureau for the Middle East, Mission Director and Acting Mission Director for USAID/Iraq, and such other individual(s) designated in a certificate executed by an authorized USAID Representative and delivered to the Fiscal Agent. The certificate of authentication of the Fiscal Agent issued pursuant to the Fiscal Agency Agreement shall, when manually executed by the Fiscal Agent, be conclusive evidence binding on USAID that an Eligible Note has been duly executed on behalf of the Borrower and delivered.
After issuance of a Guarantee, that Guarantee will be an unconditional, full faith and credit obligation of the United States of America, and will not be affected or impaired by any subsequent condition or event. This non-impairment of the guarantee provision shall not, however, be operative with respect to any loss arising out of fraud or misrepresentation for which the claiming Noteholder is responsible or of which it had knowledge at the time it became a Noteholder. Moreover, the Guarantee shall not be affected or impaired by:
(a) Any defect in the authorization, execution, delivery or enforceability of any agreement or other document executed by a Noteholder, USAID, the Fiscal Agent or the Borrower in connection with the transactions contemplated by this Guarantee; or
(b) The suspension or termination of the program pursuant to which USAID is authorized to guarantee the Eligible Notes.
A Noteholder may assign, transfer or pledge an Eligible Note to any Person, provided that such transfer is permitted under applicable law and regulation, including, without limitation, the Office of Foreign Assets Control (OFAC) regulations. Any such assignment, transfer or pledge shall be effective on the date that the name of the new Noteholder is entered on the Note Register required to be maintained by
Failure of the Fiscal Agent to perform any of its obligations pursuant to the Fiscal Agency Agreement shall not impair any Noteholder's rights under this Guarantee, but may be the subject of action for damages against the Fiscal Agent by USAID as a result of such failure or neglect. A Noteholder may appoint the Fiscal Agent to make demand for payment on its behalf under this Guarantee.
At any time after an Event of Default, as this term is defined in an Eligible Note, any Noteholder hereunder, or the Fiscal Agent on behalf of a Noteholder hereunder, may file with USAID an Application for Compensation in the form provided in Appendix A to this part. USAID shall pay or cause to be paid to any such Applicant any compensation specified in such Application for Compensation that is due to the Applicant pursuant to the Guarantee as a Loss of Investment not later than the Guarantee Payment Date. In the event that USAID receives any other notice of an Event of Default, USAID may pay any compensation that is due to any Noteholder pursuant to a Guarantee, whether or not such Noteholder has filed with USAID an Application for Compensation in respect of such amount.
Eligible Notes shall not be subject to acceleration, in whole or in part, by USAID, the Noteholder or any other party. USAID shall not have the right to pay any amounts in respect of the Eligible Notes other than in accordance with the original payment terms of such Eligible Notes.
If a Noteholder shall, as a result of USAID paying compensation under this Guarantee, receive an excess payment, it shall refund the excess to USAID.
In the event of payment by USAID to a Noteholder under this Guarantee, USAID shall be subrogated to the extent of such payment to all of the rights of such Noteholder against the Borrower under the related Note.
After payment by USAID to an Applicant hereunder, USAID shall have exclusive power to prosecute all claims related to rights to receive payments under the Eligible Notes to which it is thereby subrogated. If a Noteholder continues to have an interest in the outstanding Eligible Notes, such a Noteholder and USAID shall consult with each other with respect to their respective interests in such Eligible Notes and the manner of and responsibility for prosecuting claims.
No Noteholder will consent to any change or waiver of any provision of any document contemplated by this Guarantee without the prior written consent of USAID.
Any controversy or claim between USAID and any Noteholder arising out of this Guarantee shall be settled by arbitration to be held in Washington, DC in accordance with the then prevailing rules of the American Arbitration Association, and judgment on the award rendered by the arbitrators may be entered in any court of competent jurisdiction.
Any communication to USAID pursuant to this Guarantee shall be in writing in the English language, shall refer to the Republic of Iraq Loan Guarantee Number inscribed on the Eligible Note and shall be complete on the day it shall be actually received by USAID at the Office of Development Credit, Bureau for Economic Growth, Education and Environment, United States Agency for International Development, Washington, DC 20523-0030. Other addresses may be substituted for the above upon the giving of notice of such substitution to each Noteholder by first class mail at the address set forth in the Note Register.
This Guarantee shall be governed by and construed in accordance with the laws of the United States of America governing contracts and commercial transactions of the United States Government.
To Whom It May Concern: You are hereby advised that payment of $____ (consisting of ____ of principal, ____ of interest and $____ in Further Guaranteed Payments, as defined in § 241.2 of the Standard Terms and Conditions of the above-mentioned Guarantee) was due on ____, 20_, on $____ Principal Amount of Notes issued by the Republic of Iraq (the “Borrower”) held by the undersigned. Of such amount $____ was not received on such date and has not been received by the undersigned at the date hereof. In accordance with the terms and provisions of the above-mentioned Guarantee, the undersigned hereby applies, under § 241.8 of said Guarantee, for payment of $____, representing $____, the Principal Amount of the presently outstanding Note(s) of the Borrower held by the undersigned that was due and payable on ____ and that remains unpaid, and $____, the Interest Amount on such Note(s) that was due and payable by the Borrower on ____ and that remains unpaid, and $____ in Further Guaranteed Payments,
All capitalized terms herein that are not otherwise defined shall have the meanings assigned to such terms in the Standard Terms and Conditions of the above-mentioned Guarantee.
Wage and Hour Division, Department of Labor.
Final rule; technical corrections.
In this final rule, the Department of Labor (DOL or Department) revises regulations issued pursuant to the Fair Labor Standards Act of 1938 (FLSA), the Davis-Bacon and Related Acts (DBRA), the Service Contract Act (SCA), Contract Work Hours and Safety Standards Act (CWHSSA), Family and Medical Leave Act (FMLA), Employee Polygraph Protection Act (EPPA), and the Migrant and Seasonal Agricultural Worker Protection Act (MSPA) that include reference to the “Employment Standards Administration” at the DOL. The Employment Standards Administration was eliminated as part of agency reorganization in 2009 and its authorities and responsibilities were devolved into its constituent components, including the Wage and Hour Division (WHD). This action deletes reference to the Employment Standards Administration in the regulations administered by WHD. Additionally, this action updates Office of Management and Budget (OMB) control numbers associated with information collections in the appropriate regulations. WHD was assigned new control numbers by OMB and this action updates those references in the regulations to the current corresponding OMB control number. Further, this action updates cross-references that were not revised in the FMLA Final Rule published February 25, 2015.
Effective January 9, 2017.
Robert Waterman, Compliance Specialist, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW., Washington, DC 20210, telephone: (202) 693-0406 (this is not a toll-free number) or email:
The Department is eliminating references to the Employment Standards Administration at the DOL. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009. In addition, the Department is updating references to OMB information collection control numbers. OMB has assigned different information collection control numbers to WHD information collections and the Department is updating these references in the appropriate regulations so the reader can find the information collection corresponding to a specific regulation.
The Department is also correcting cross-references to the FMLA's definitions section in two sections of its FMLA regulations, § 825.104(b) and § 825.209(a). A recent rulemaking moved the definitions section of the FMLA regulations from § 825.800 to § 825.102 but did not update the cross-references to the definitions section in § 825.104(b) and § 825.209(a). Additionally, the Department is updating the reference in 29 CFR 3.3 to the Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed. Finally, the Department is replacing the term firefighter with the term employee engaged in fire protection activities in two sections of its regulations, 29 CFR 553.221 and 553.231, to conform to an amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities. The Department published an FLSA Final Rule on April 5, 2011 (76 FR 18832) that incorporated the new definition into the regulations and made several conforming revisions in part 553, subpart C, but did not conform the language of these provisions.
Section 553(b)(3) of the Administrative Procedure Act (APA) provides that an agency is not required to publish a notice of proposed rulemaking in the
Section 553(d) of the APA also provides that substantive rules should take effect not less than 30 days after the date they are published in the
In 29 CFR 1.2, 1.5, 4.1a, 4.3, 4.5, 4.6, 4.10, 4.11, 4.12, 4.101, 4.191, 5.2, 5.12, 5.13, 6.2, 500.7, 500.20, 500.41, 500.56, 500.215, 505.2, 520.300, 525.22, 530.1, 530.101, 530.102, 530.403, 570.1, 575.2, 575.3, 578.2, 580.1, 801.2, 801.7, and 825.401, the Department has removed the reference to the Employment Standards Administration and replaced it with the Wage and Hour Division where appropriate. In 29 CFR 519.11, the Department has removed the reference to the Assistant Secretary for Employment Standards. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009.
In 29 CFR 3.3, the Department has updated the referenced Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed.
In 29 CFR 3.4, 5.15, 505.5, 520.403, 520.405, 520.501, 520.502, 525.16, 530.3, 530.4, 547.1, 549.1, 570.6, 570.36, 570.37 and 801.30, the Department has updated the OMB control number where the public may access the relevant information collection approved by OMB under the Paperwork Reduction Act. In 29 CFR 4.6, 5.5 and 516.0, the Department has provided updated information collection requests tables showing the current OMB control numbers associated with the referenced recordkeeping requirements. OMB changed the agency information collection control numbers. The correction will allow the public to access the currently approved information collection.
In 29 CFR 553.221 and 553.231, the Department has replaced references to firefighters with references to employees engaged in fire protection activities to conform to a recent amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities.
In 29 CFR 825.104 and 825.209, the Department has corrected cross-references to the definitions section of the FMLA regulations. On February 6, 2013, the Department published a final rule under the FMLA. In that rule, the Department moved the FMLA definitions section from the end of the regulations in § 825.800 to the front of the regulations in § 825.102. However, the Department did not update the cross-references to the definitions section in §§ 825.104 and 825.109. The Department is making this correction so the reader may easily locate the definitions section of the regulations currently located in § 825.102.
This rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulations. The agency has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, there is no requirement for an assessment of potential costs and benefits under section 6(a)(3) of that order.
This action is not classified as a “rule” under Chapter 8 of the Small Business Regulatory Enforcement Fairness Act of 1996, because it is pertaining to agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties. See 5 U.S.C. 804(3)(C).
Because no notice of proposed rulemaking is required for this rule under section 553(b) of the Administrative Procedure Act (APA), the requirements of the Regulatory Flexibility Act (5 U.S.C. 601) pertaining to regulatory flexibility do not apply to this rule. See 5 U.S.C. 601(2).
This final rule is not subject to section 350(h) of the Paperwork Reduction Act (44 U.S.C. 3501) since it does not contain any new collection of information requirements. The final rule does, however, update the information collection control numbers assigned by OMB to allow the reader to locate the collections where referenced in the regulations. The information collections referenced herein are not subject to OMB review as they do not amend information collection requirements.
This Final Rule has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA). 2 U.S.C. 1501
The Department has reviewed this rule in accordance with the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This rule does not have federalism implications as outlined in E.O. 13132. The rule does not have substantial direct effects 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.
The Department has reviewed this rule under the terms of Executive Order 13175 (65 FR 67249, November 6, 2000) and determined it did not have “tribal implications.” The 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.” As a result, no Tribal summary impact statement has been prepared.
The Department certifies that this rule will not adversely affect the well-being of families, as discussed under section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277).
The Department has reviewed this rule under the terms of Executive Order 13045 (62 FR 19885, April 21, 1997, as amended by 68 FR 19931, April 18, 2003) and determined this action is not subject to E.O. 13045 because it is not economically significant as defined in E.O. 12866 and it does not impact the environmental health or safety risks of children.
The Department has reviewed this rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321
The Department has determined that this rule is not subject to Executive Order 13211 (66 FR 28355, May 18, 2001). It will not have a significant adverse effect on the supply, distribution, or use of energy.
The Department has determined that this rule is not subject to Executive Order 12630 (53 FR 8859, March 15, 1988) because it does not involve implementation of a policy “that has taking implications” or that could impose limitations on private property use.
The Department drafted and reviewed this Final Rule in accordance with Executive Order 12988 (61 FR 4729, February 5, 1996) and determined that the rule will not unduly burden the Federal court system. The rule was: (1) Reviewed to eliminate drafting errors and ambiguities; (2) written to minimize litigation; and (3) written to provide a clear legal standard for affected conduct and to promote burden reduction.
Administrative practice and procedure, Construction industry, Government contracts, Minimum wages.
Community facilities, Construction industry, Federal buildings and facilities, Government contracts, Grant programs, Loan programs, Minimum wages, Reporting and recordkeeping requirements.
Administrative practice and procedure, Employee benefit plans, Government contracts, Law enforcement, Minimum wages, Occupational safety and health, Reporting and recordkeeping requirements.
Administrative practice and procedure, Construction industry, Employee benefit plans, Government contracts, Law enforcement, Minimum wages, Reporting and recordkeeping requirements.
Administrative practice and procedure, Construction industry, Employee benefit plans, Government contracts, Minimum wages, Occupational safety and health.
Administrative practice and procedure, Aliens, Housing, Insurance, Intergovernmental relations, Investigations, Migrant labor, Motor vehicle safety, Occupational safety and health, Reporting and recordkeeping requirements, Wages.
Arts and crafts, Grant programs—education, Minimum wages, National Foundation on Arts and Humanities, Occupational safety and health, Reporting and recordkeeping requirements.
Minimum wages, Reporting and recordkeeping requirements, Wages.
Agriculture, Colleges and universities, Minimum wages, Students, Reporting and recordkeeping requirements.
Manpower training programs, Minimum wages, Reporting and recordkeeping requirements, Students.
Administrative practice and procedure, Individuals with disabilities, Minimum wages, Reporting and recordkeeping requirements, Vocational rehabilitation.
Administrative practice and procedure, Clothing, Homeworkers, Indian—arts and crafts, Penalties, Reporting and recordkeeping requirements, Surety bonds, Watches and jewelry.
Employee benefit plans, Reporting and recordkeeping requirements.
Employee benefit plans, Reporting and recordkeeping requirements, Trusts and trustees.
Firefighters, Government employees, Intergovernmental relations, Law enforcement officers, Prisons, Reporting and recordkeeping requirements, Volunteers, Wages.
Administrative practice and procedure, Agriculture, Child labor, Intergovernmental relations, Occupational safety and health, Reporting and recordkeeping requirements.
Agriculture, Child labor, Reporting and recordkeeping requirements.
Penalties, Wages.
Administrative practice and procedure, Child labor, Penalties, Wages.
Administrative practice and procedure, Employment, Lie detector tests, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Airmen, Employee benefit plans, Health insurance, Health, Labor management relations, Maternal and child health, Penalties, Reporting and recordkeeping requirements, Teachers.
5 U.S.C. 301; R.S. 161, 64 Stat. 1267; Reorganization Plan No. 14 of 1950, 5 U.S.C. appendix; 40 U.S.C. 3141
(c) The term
(b)(1) If a general wage determination is not available, the Federal agency shall request a wage determination under the Davis-Bacon Act or any of its related prevailing wage statutes by submitting Form SF-308 to the Department of Labor at this address: U.S. Department of Labor, Wage and Hour Division,
R.S. 161, sec. 2, 48 Stat. 848; Reorg. Plan No. 14 of 1950, 64 Stat. 1267; 5 U.S.C. 301; 40 U.S.C. 3145; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014).
(b) Each contractor or subcontractor engaged in the construction, prosecution, completion, or repair of any public building or public work, or building or work financed in whole or in part by loans or grants from the United States, shall furnish each week a statement with respect to the wages paid each of its employees engaged on work covered by this part 3 and part 5 of this title during the preceding weekly payroll period. This statement shall be executed by the contractor or subcontractor or by an authorized officer or employee of the contractor or subcontractor who supervises the payment of wages, and shall be on the back of Form WH 347, “Payroll (For Contractors Optional Use)” or on any form with identical wording. Copies of WH 347 may be obtained from the Government contracting or sponsoring agency or from the Wage and Hour Division Web site at
41 U.S.C. 351
(b)
(c)
(e) Wage determinations will be available for public inspection during business hours at the Wage and Hour Division, U.S. Department of Labor, Washington, DC, and copies will be made available upon request at Regional Offices of the Wage and Hour Division. In addition, most prevailing wage determinations are available online from WDOL. Archived versions of SCA wage determinations that are no longer current may be accessed in the “Archived SCA WD” database of WDOL for information purposes only. Contracting officers should not use an archived wage determination in a contract action without prior approval of the Department of Labor.
(a) * * *
(1) Any wage determination from the Wage and Hour Division, Department of Labor, responsive to the contracting agency's submission of an e98 or obtained through WDOL under § 4.4; or
(b) * * *
(2) * * *
(ii) Such conforming procedure shall be initiated by the contractor prior to the performance of contract work by such unlisted class of employee. A written report of the proposed conforming action, including information regarding the agreement or disagreement of the authorized representative of the employees involved or, where there is no authorized representative, the employees themselves, shall be submitted by the contractor to the contracting officer no later than 30 days after such unlisted class of employees performs any contract work. The contracting officer shall review the proposed action and promptly submit a report of the action, together with the agency's recommendation and all pertinent information including the position of the contractor and the employees, to the Wage and Hour Division, U.S. Department of Labor, for review. The Wage and Hour Division will approve, modify, or disapprove the action or render a final determination in the event of disagreement within 30 days of receipt or will notify the contracting officer within 30 days of receipt that additional time is necessary.
(3) If, as authorized pursuant to section 4(d) of the Service Contract Act of 1965 as amended, the term of this contract is more than 1 year, the minimum monetary wages and fringe benefits required to be paid or furnished thereunder to service employees shall be subject to adjustment after 1 year and not less often than once every 2 years, pursuant to wage determinations to be issued by the Wage and Hour Division of the Department of Labor as provided in such Act.
(g)(1) The contractor and each subcontractor performing work subject to the Act shall make and maintain for 3 years from the completion of the work records containing the information specified in paragraphs (g)(1)(i) through (vi) of this section for each employee subject to the Act and shall make them available for inspection and transcription by authorized representatives of the Wage and Hour Division of the U.S. Department of Labor: * * *
(r) * * *
(b) * * *
(1)(i) A request for a hearing under this section may be made by the contracting agency or other person affected or interested, including contractors or prospective contractors and associations of contractors, representatives of employees, and other interested Governmental agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and shall include the following:
(b) * * *
(1) * * * Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210. * * *
(c)(1) A request for a determination under this section may be made by any interested party, including contractors or prospective contractors, and associations of contractors, representatives of employees, and interested Government agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.
(g) It should not be assumed that the lack of discussion of a particular subject in this subpart indicates the adoption of any particular position by the Department of Labor with respect to such matter or to constitute an interpretation, practice, or enforcement policy. If doubt arises or a question exists, inquiries with respect to matters other than safety and health standards should be directed to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, or any regional office of the Wage and Hour Division. Safety and health inquiries should be addressed to the Assistant Secretary for Occupational Safety and Health, U.S. Department of Labor, Washington, DC 20210, or to any OSHA regional office. A full description of the facts and any relevant documents should be submitted if an official ruling is desired.
(d) In the event that an Assistant Regional Administrator for the Wage and Hour Division, is notified of a breach or violation which also involves safety and health standards, the Regional Administrator of the Wage and Hour Division shall notify the appropriate Regional Administrator of the Occupational Safety and Health Administration who shall with respect to the safety and health violations take action commensurate with his responsibilities pertaining to safety and health standards.
5 U.S.C. 301; R.S. 161, 64 Stat. 1267; Reorganization Plan No. 14 of 1950, 5 U.S.C. appendix; 40 U.S.C. 3141
(b) The term
(a) * * *
(1) * * *
(i) All laborers and mechanics employed or working upon the site of the work (or under the United States Housing Act of 1937 or under the Housing Act of 1949 in the construction or development of the project), will be paid unconditionally and not less often than once a week, and without subsequent deduction or rebate on any account (except such payroll deductions as are permitted by regulations issued by the Secretary of Labor under the Copeland Act (29 CFR part 3)), the full amount of wages and bona fide fringe benefits (or cash equivalents thereof) due at time of payment computed at rates not less than those contained in the wage determination of the Secretary of Labor which is attached hereto and made a part hereof, regardless of any contractual relationship which may be alleged to exist between the contractor and such laborers and mechanics. Contributions made or costs reasonably anticipated for bona fide fringe benefits under section 1(b)(2) of the Davis-Bacon Act on behalf of laborers or mechanics are considered wages paid to such laborers or mechanics, subject to the provisions of paragraph (a)(1)(iv) of this section; also, regular contributions made or costs incurred for more than a weekly period (but not less often than quarterly) under plans, funds, or programs which cover the particular weekly period, are deemed to be constructively made or incurred during such weekly period. Such laborers and mechanics shall be paid the appropriate wage rate and fringe benefits on the wage determination for the classification of work actually performed, without regard to skill, except as provided in § 5.5(a)(4). Laborers or mechanics performing work in more than one classification may be compensated at the rate specified for each classification for the time actually worked therein:
(ii) * * *
(B) If the contractor and the laborers and mechanics to be employed in the classification (if known), or their representatives, and the contracting officer agree on the classification and wage rate (including the amount designated for fringe benefits where appropriate), a report of the action taken shall be sent by the contracting officer to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210. The Administrator, or an authorized representative, will approve, modify, or disapprove every additional classification action within 30 days of receipt and so advise the contracting officer or will notify the contracting officer within the 30-day period that additional time is necessary.
(c) * * *
(c) Any person or firm debarred under paragraph (a)(1) of this section may in writing request removal from the debarment list after six months from the date of publication by the Comptroller General of such person or firm's name on the ineligible list. Such a request should be directed to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and shall contain a full explanation of the reasons why such person or firm should be removed from the ineligible list. In cases where the contractor or subcontractor failed to make full restitution to all underpaid employees, a request for removal will not be considered until such underpayments are made. In all other cases, the Administrator will examine the facts and circumstances surrounding the violative practices which caused the debarment, and issue a decision as to whether or not such person or firm has demonstrated a current responsibility to comply with the labor standards provisions of the statutes listed in § 5.1, and therefore should be removed from the ineligible list. Among the factors to be considered in reaching such a decision are the severity of the violations, the contractor or subcontractor's attitude towards compliance, and the past compliance history of the firm. In no case will such removal be effected unless the Administrator determines after an investigation that such person or firm is in compliance with the labor standards provisions applicable to Federal contracts and Federally assisted construction work subject to any of the applicable statutes listed in § 5.1 and other labor statutes providing wage protection, such as the Service Contract Act, the Walsh-Healey Public Contracts Act, and the Fair Labor Standards Act. If the request for removal is denied, the person or firm may petition for review by the Administrative Review Board pursuant to 29 CFR part 7.
(d) * * *
(3)(i) A request for a determination of interest (or substantial interest, as appropriate), may be made by any interested party, including contractors or prospective contractors and associations of contractor's representatives of employees, and interested Government agencies. Such a request shall be submitted in writing to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.
All questions relating to the application and interpretation of wage determinations (including the classifications therein) issued pursuant to part 1 of this subtitle, of the rules contained in this part and in parts 1 and 3, and of the labor standards provisions of any of the statutes listed in § 5.1 shall be referred to the Administrator for appropriate ruling or interpretation. The rulings and interpretations shall be authoritative and those under the Davis-Bacon Act may be relied upon as provided for in section 10 of the Portal-to-Portal Act of 1947 (29 U.S.C. 259). Requests for such rulings and interpretations should be addressed to the Administrator, Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210.
Secs. 4 and 5, 79 Stat. 1034, 1035 as amended by 86 Stat. 789, 790, 41 U.S.C. 353 and 354; 5 U.S.C. 301; Reorg. Plan No. 14 of 1950, 64 Stat. 1267, 5 U.S.C. Appendix; 46 Stat. 1494, as amended by 49 Stat. 1011, 78 Stat. 238, 40 U.S.C. 276a-276a-7; 76 Stat. 357-359, 40 U.S.C. 327-332; 48 Stat. 948, as amended by 63 Stat. 108, 72 Stat. 967, 40 U.S.C. 276c.
(a)
Pub. L. 97-470, 96 Stat. 2583 (29 U.S.C. 1801-1872); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 28 U.S.C. 2461 Note (Federal Civil Penalties Inflation Adjustment Act of 1990); and Pub. L. 114-74, 129 Stat 584.
(c) Any person may report a violation of the Act or these regulations to the Secretary by advising any local office of the Employment Service of the various States, or any office of the Wage and Hour Division, U.S. Department of Labor, or any other authorized
(a)
(b) Farm Labor Contractor Employee Certificate of Registration is valid only during the period in which the holder is an employee of the registered farm labor contractor named on the Farm Labor Contractor Employee Certificate. If prior to the expiration of the Employee Certificate, the holder through a change in employment, should become an employee of a different registered farm labor contractor, a replacements Employee Certificate which names the new employer may be obtained by submitting to the regional office that issued the original employee certificate or to any regional office of the Wage and Hour Division, a written statement that includes the date of the change in employment status and the name, the permanent place of residence and certificate registration number of the new employer. Any such change should be reported immediately.
If a Certificate of Registration or a Farm Labor Contractor Employee Certificate is lost or destroyed, a duplicate certificate may be obtained by the submission to the regional office that issued it or to any regional office of the Wage and Hour Division, of a written statement explaining its loss or destruction, indicating where the original application was filed and requesting that a duplicate be issued.
(b) The notification required in paragraph (a) of this section shall be in writing, by certified mail and addressed to the Administrator, Wage and Hour Division, 200 Constitution Avenue NW, Washington, DC 20210.
Sec. 5(j), Pub. L. 89-209, 79 Stat. 848 (20 U.S.C. 954(i)); sec. 7(g), Pub. L. 94-462, 90 Stat. 1971, as amended by sec. 107(4), Pub. L. 99-194, 99 Stat. 1337 (20 U.S.C. 956(g)); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); Secretary's Order 01-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012).
(c) The term
Sec. 11, 52 Stat. 1066, as amended, 29 U.S.C. 211. Section 516.28 also issued under Pub. L. 104-188, 2105(b); Pub. L. 110-28, 121 Stat. 112. Section 516.33 also issued under 52 Stat. 1060, as amended; 29 U.S.C. 201
Secs. 11 and 14, 52 Stat. 1068; sec. 11, 75 Stat. 74; secs. 501 and 602, 80 Stat. 843, 844 (29 U.S.C. 211, 214).
(a)
Sec. 14, 52 Stat. 1062, 1064 (29 U.S.C. 214); secs. 2-12, 60 Stat. 237-244; (5 U.S.C. 1001-1011); 52 Stat. 1068, as amended, 29 U.S.C. 214.
52 Stat. 1060, as amended (29 U.S.C. 201-219); Pub. L. 99-486, 100 Stat. 1229 (29 U.S.C. 214).
(a) Any employee receiving a special minimum wage at a rate specified pursuant to subsection 14(c) of FLSA or the parent or guardian of such an employee may petition the Secretary to obtain a review of such special minimum wage rate. No particular form of petition is required, except that a petition must be signed by the individual, or the parent or guardian of the individual, and should contain the name and address of the employee and the name and address of the employee's employer. A petition may be filed in person or by mail with the Administrator of the Wage and Hour Division, U.S. Department of Labor, Room S3502, 200 Constitution Avenue NW., Washington, DC 20210. The petitioner may be represented by counsel in any stage of such proceedings. Upon receipt, the petition shall be forwarded immediately to the Chief Administrative Law Judge.
Sec. 11, 52 Stat. 1066 (29 U.S.C. 211) as amended by sec. 9, 63 Stat. 910 (29 U.S.C. 211(d)); Secretary's Order No. 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at § 701, 129 Stat 584.
(b)
(c) Certificates authorizing such employment may be issued on the following terms and conditions upon written application to the Administrator, Wage and Hour Division, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.
The initial request for certification or renewal application shall be signed by the employer and shall contain the name of the firm, its mailing address, the physical location of the firm's principal place of business and a description of the business operations and items produced. In addition, the initial or renewal application shall contain the names, addresses, and languages (if other than English) spoken by the homeworkers that are currently employed (if any) or expected to be employed. The employer shall also provide the Administrator, within thirty (30) days, a notice of each change of address of the principal place of business. The notification shall be in writing and addressed to the Administrator, Wage and Hour Division, 200 Constitution Avenue NW., Washington, DC 20210.
(a) Except in the case of an emergency revocation under § 530.411 of this subpart, a request for an administrative hearing on a determination referred to in § 530.402 of this subpart shall be made in writing to the Administrator of the Wage and Hour Division, U.S. Department of Labor, Washington, DC 20210, and must be received no later than thirty (30) days after issuance of the notice referred to in § 530.402 of this subpart.
Sec. 7, 52 Stat. 1063, as amended; 29 U.S.C. 207.
Sec. 7, 52 Stat. 1063, as amended; 29 U.S.C. 207.
Secs. 1-19, 52 Stat. 1060, as amended (29 U.S.C. 201-219); Pub. L. 99-150, 99 Stat. 787 (29 U.S.C. 203, 207, 211). Pub. L. 106-151, 113 Stat. 1731 (29 U.S.C. 203(y)).
(a) The general rules on compensable hours of work are set forth in 29 CFR part 785 which is applicable to employees for whom the section 7(k) exemption is claimed. Special rules for sleep time (§ 553.222) apply to both law enforcement and employees in fire protection activities for whom the section 7(k) exemption is claimed. Also, special rules for meal time apply in the case of employees in fire protection activities (§ 553.223). Part 785 does not discuss the special provisions that apply to State and local government workers with respect to the treatment of substitution, special details for a separate and independent employer, early relief, and work performed on an occasional or sporadic and part-time basis, all of which are covered in this subpart.
(b) Section 7(k) permits public agencies to balance the hours of work over an entire work period for law enforcement and fire protection employees. For example, if an employee engaged in fire protection activities' work period is 28 consecutive days, and he or she works 80 hours in each of the first two weeks, but only 52 hours in the third week, and does not work in the fourth week, no overtime compensation (in cash wages or compensatory time) would be required since the total hours worked do not exceed 212 for the work period. If the same employee in fire protection activities had a work period of only 14 days, overtime compensation or compensatory time off would be due for 54 hours (160 minus 106 hours) in the first 14 day work period.
Secs. 3, 11, 12, 52 Stat. 1060, as amended, 1066, as amended, 1067, as amended; 29 U.S.C. 203, 211, 212.
(g)
29 U.S.C. 203(l), 211, 212.
29 U.S.C. 203(l), 212, 213(c).
Secs. 11, 12, 13, 18, 52 Stat. 1067, 1069, as amended; 29 U.S.C. 211, 212, 213, 218; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014).
(a) An application for a waiver shall be filed with the Administrator of the Wage and Hour Division, United States Department of Labor, Washington, DC 20210. To permit adequate time for processing, it is recommended that such applications be filed 6 weeks prior to the period the waiver is to be in effect.
Sec. 9, Pub. L. 101-157, 103 Stat. 938, sec. 3103, Pub. L. 101-508, 104 Stat. 1388-29 (29 U.S.C. 216(e)), Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note), as amended by Pub. L. 104-134, section 31001(s), 110 Stat. 1321-358, 1321-373, and Pub. L. 114-74, 129 Stat. 584.
(b)
29 U.S.C. 9a, 203, 209, 211, 212, 213(c), 216; Reorg. Plan No. 6 of 1950, 64 Stat. 1263, 5 U.S.C. App; secs. 25, 29, 88 Stat. 72, 76; Secretary's Order 01-2014 (Dec. 19, 2014), 79 FR 77527 (Dec. 24, 2014); 5 U.S.C. 500, 503, 551, 559; 103 Stat. 938.
Pub. L. 100-347, 102 Stat. 646, 29 U.S.C. 2001-2009; 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990); Pub. L. 114-74 at § 701, 129 Stat. 584.
The revision reads as follows:
(h)
(d) Any person may report a violation of the Act or these regulations to the Secretary by advising any local office of the Wage and Hour Division, U.S. Department of Labor, or any authorized representative of the Administrator. The office or person receiving such a report shall refer it to the appropriate office of the Wage and Hour Division for the region or area in which the reported violation is alleged to have occurred.
29 U.S.C. 2654; 28 U.S.C. 2461 Note (Federal Civil Penalties Inflation Adjustment Act of 1990); and Pub. L. 114-74 at § 701.
(b) The terms commerce and industry affecting commerce are defined in accordance with section 501(1) and (3) of the Labor Management Relations Act of 1947 (LMRA) (29 U.S.C. 142(1) and (3)), as set forth in the definitions at § 825.102 of this part. For purposes of the FMLA, employers who meet the 50-employee coverage test are deemed to be engaged in commerce or in an industry or activity affecting commerce.
(a) During any FMLA leave, an employer must maintain the employee's coverage under any group health plan (as defined in the Internal Revenue Code of 1986 at 26 U.S.C. 5000(b)(1) on the same conditions as coverage would have been provided if the employee had been continuously employed during the entire leave period. All employers covered by FMLA, including public agencies, are subject to the Act's requirements to maintain health coverage. The definition of group health plan is set forth in § 825.102. For purposes of FMLA, the term group health plan shall not include an insurance program providing health coverage under which employees purchase individual policies from insurers provided that:
(1) No contributions are made by the employer;
(2) Participation in the program is completely voluntary for employees;
(3) The sole functions of the employer with respect to the program are, without endorsing the program, to permit the insurer to publicize the program to employees, to collect premiums through payroll deductions and to remit them to the insurer;
(4) The employer receives no consideration in the form of cash or otherwise in connection with the program, other than reasonable compensation, excluding any profit, for administrative services actually rendered in connection with payroll deduction; and,
(5) The premium charged with respect to such coverage does not increase in the event the employment relationship terminates.
(a) A complaint may be filed in person, by mail or by telephone, with the Wage and Hour Division, U.S. Department of Labor. A complaint may be filed at any local office of the Wage and Hour Division; the address and telephone number of local offices may be found in telephone directories or on the Department's Web site.
Environmental Protection Agency (EPA).
Final rule.
This final rule revises the Environmental Protection Agency's (“EPA”) Consolidated Rules of Practice governing the administrative assessment
This rule is effective on March 10, 2017.
Michael B. Wright, Office of Administrative Law Judges, U.S. Environmental Protection Agency, Ronald Reagan Building, Room M1200, 1300 Pennsylvania Ave. NW., Washington, DC 20004, phone number (202) 564-3247 or by email at
Today's final rule is limited to procedural requirements for administrative adjudicatory hearings and appeals from such hearings and from permit decisions. Under the Administrative Procedure Act, an agency may issue “rules of agency organization, procedure, or practice” without first proposing such rules for public comment. 5 U.S.C. 553(b). Accordingly, public comment is not required.
This action affects parties involved in EPA administrative adjudicatory proceedings for the assessment of civil penalties, issuance of various compliance orders, and termination or suspension of certain permits, under part 22 of title 40 of the CFR.
Part 22 of Title 40 of the CFR establishes procedures governing administrative adjudicatory proceedings to assess administrative civil penalties, to issue various compliance orders, and to terminate or suspend certain permits. 40 CFR 22.1. These proceedings are conducted under a variety of environmental statutes, including the Clean Air Act, the Clean Water Act, the Solid Waste Disposal Act, and the Federal Insecticide, Fungicide, and Rodenticide Act, among others. Such cases are generally heard by the Administrative Law Judges (ALJs) within the EPA's Office of Administrative Law Judges or Regional Judicial Officers. The part 22 regulations are titled the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits” (“Rules of Practice”).
The EPA promulgated the Rules of Practice to establish uniform procedural rules for administrative proceedings required to be held on the record after opportunity for a hearing in accordance with section 554 of the Administrative Procedure Act, 5 U.S.C. 551
Part 124 of Title 40 of the CFR establishes rules governing the EPA's issuance, modification, and revocation of permits under the Resource Conservation and Recovery Act, the Underground Injection Control program of the Safe Drinking Water Act, the Prevention of Significant Deterioration program of the Clean Air Act, and the National Pollutant Discharge Elimination System program of the Clean Water Act. These permit rules include procedures for appealing permit decisions by the EPA's regional offices to the Environmental Appeals Board.
This action makes several minor changes to part 22 procedures. Many of these changes pertain to the electronic filing and service of documents.
Section 22.5(a) currently allows a Presiding Officer or the Environmental Appeals Board to “authorize” filing of documents by “facsimile or electronic filing.” 40 CFR 22.5(a). The EPA is amending this section to also allow a Presiding Officer or the Environmental Appeals Board to “require” filing by “facsimile or an electronic filing system.” Both the Office of the Administrative Law Judges and the Environmental Appeals Board have an operational electronic filing system. This section is also being amended to standardize the Environmental Appeals Board filing methods under part 22 with those currently in the EPA's permit regulations in part 124.
Section 22.5(b)(2) is modified to allow parties to agree with other parties to service by facsimile or other electronic means, including but not necessarily limited to email. A party's consent to such methods of service must be in writing and the party must file acknowledgement of such consent with the Clerk for the Presiding Officer or the Environmental Appeals Board, whichever is appropriate. This section is also modified to allow the Presiding Officer or the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including but not necessarily limited to email. To facilitate electronic service, § 22.5(b)(4) is modified to require that a party include an email address in the first document it files in a proceeding.
The EPA emphasizes that the rules on electronic delivery of documents differ depending on whether the document is being
Additionally, the EPA is revising § 22.5(b) to clarify that in cases before the Environmental Appeals Board, documents a party files with the Board need not also be served on the Board.
Section 22.6 is amended to allow the Regional Hearing Clerk, the Headquarters Hearing Clerk, or the Clerk of the Environmental Appeals Board to serve rulings, orders, decisions, or other documents by electronic means (including but not necessarily limited to facsimile and email).
Section 22.7(c) addresses when service is considered complete and includes a provision allowing an additional period of time for response to documents served using certain procedures.
The EPA has also modified the so-called “mailbox rule” in § 22.7(c) providing for additional days to respond to documents served using certain procedures. As modified, the revised mailbox rule in § 22.7(c) allows an additional three days to the time allowed for response to documents served by U.S. mail, the EPA's internal mail,
However, sections 22.4(a) and 22.16(c) currently specify, among other things, that the Environmental Appeals Board will act as Presiding Officer in proceedings under part 22 commenced at EPA Headquarters until the respondent files an answer.
This rule amendment modifies § 22.4(a) and § 22.16(c) to authorize an Administrative Law Judge to serve as the Presiding Officer in part 22 proceedings commenced at EPA Headquarters from the time a complaint is filed. The Environmental Appeals Board will no longer be assigned as a Presiding Officer for the period between the filing of a complaint and the filing of an answer. Rather, an Administrative Law Judge will serve as the Presiding Officer both prior to and after the filing of the answer. Removing the Environmental Appeals Board from the initial stage of enforcement proceedings will enhance the efficiency of proceedings commenced at EPA Headquarters because a single entity will exercise the role of Presiding Officer. This also eliminates the possibility that the Environmental Appeals Board could be asked to review on appeal its own decision on a preliminary motion (filed before an answer is filed).
Additionally, the EPA is making a series of changes to § 22.30 to clarify various issues relating to appeals to the Environmental Appeals Board.
Most of the revisions to part 124 also concern filing and service issues. Section 124.19(i) addresses filing and service requirements in permit appeal proceedings before the Environmental Appeals Board. This section has been modified to add language clarifying when service is complete. Specifically, service is complete upon mailing for U.S. mail and EPA internal mail, when placed in the custody of a reliable commercial deliver service, or upon transmission for facsimile or email. This new language is similar to that in Rule 5(b)(2) of the Federal Rules of Civil Procedure and Environmental Appeals Board decisions. Fed. R. Civ. P. 5(b)(2); s
The EPA has also made several changes to part 124 on service and filing that duplicate the changes made to part 22: (1) Requiring that a party's first filing contain an email address (§ 124.19(i)(3)(i)); (2) authorizing the Environmental Appeals Board to require that parties file documents by facsimile or through use of the Board's electronic filing system (§ 124.19(i)(2)); (3) allowing the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including email (§ 124.19(i)(3)(ii)); and (4) authorizing the Board to serve rulings, orders, and decisions on the parties by electronic means (including but not necessarily limited to facsimile and email). (§ 124.19(i)(3)(iii).
Section 124.19(b)(1) and (2) are modified so that the deadlines for filing a response to a petition for review are based on the date the petition is served, rather than filed. This provides for appropriate notice of the petition for review in advance of the deadline for a response.
Similar to the changes made in the mailbox rule in § 22.7(c), discussed above, the EPA has modified § 124.20(d) to specify that three days are added to a prescribed period of time to act when service is made by U.S. mail, the EPA's internal mail, or a reliable, commercial delivery service. Three days are not added to the prescribed time to act when service is made by personal delivery or electronic transmission (
The EPA has also added word/page limitations to § 124.19(f) for motions mirroring the word/page limitations added to § 22.30. Finally, the EPA has amended § 124.19(a)(4)(ii) and (b) to further clarify that parties are to provide in their briefs appropriate reference to the administrative record (
This action is exempt from review by the Office of Management and Budget (OMB) because it is limited to agency organization, management, or personnel matters.
This action does not impose an information collection burden under the PRA. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Specifically, the modifications to the Rules of Practice will codify the electronic service of documents between parties and by EPA adjudicative bodies. In addition, the modifications will facilitate the efficient issuance of rulings on motions by substituting an Administrative Law Judge for the Environmental Appeals Board to serve as the presiding officer in civil penalty cases initiated at EPA Headquarters before an answer is filed.
This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule pertains to agency management or personnel, which the APA expressly exempts from notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have 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.
This action does not have tribal implications, as specified in Executive Order 13175. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources.
This rule is exempt from the CRA because it is a rule relating to agency management or personnel.
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Hazardous waste, Penalties, Pesticides and pests, Poison prevention, Water pollution control.
Environmental protection, Administrative practice and procedures.
For the reasons set out in the preamble, 40 CFR parts 22 and 124 are amended as follows:
7 U.S.C. 1361; 15 U.S.C. 2615; 33 U.S.C. 1319, 1342, 1361, 1415 and 1418; 42 U.S.C. 300g-3(g), 6912, 6925, 6928, 6991e and 6992d; 42 U.S.C. 7413(d), 7524(c), 7545(d), 7547, 7601 and 7607(a), 9609, and 11045.
(a)
(a)
(b)
(2)
(c) * * *
(4) The first document filed by any person shall contain the name, mailing address, telephone number, and email address of an individual authorized to receive service relating to the proceeding on behalf of the person. Parties shall promptly file any changes in this information with the Headquarters or Regional Hearing Clerk or the Clerk of the Board, as appropriate, and serve copies on the Presiding Officer and all parties to the proceeding. If a party fails to furnish such information and any changes thereto, service to the party's last known address shall satisfy the requirements of paragraph (b)(2) of this section and § 22.6.
All rulings, orders, decisions, and other documents issued by the Regional Administrator or Presiding Officer shall be filed with the Headquarters or Regional Hearing Clerk, as appropriate, in any manner allowed for the service of such documents. All rulings, orders, decisions, and other documents issued by the Environmental Appeals Board shall be filed with the Clerk of the Board. The Clerk of the Board, the Headquarters Hearing Clerk, or the Regional Hearing Clerk, as appropriate, must serve copies of such rulings, orders, decisions and other documents on all parties. Service may be made by U.S. mail (including by certified mail or return receipt requested, Overnight Express and Priority Mail), EPA's internal mail, any reliable commercial delivery service, or electronic means (including but not necessarily limited to facsimile and email).
(c)
(c)
(a)
(2)
(b)
(2)
(a)
(ii)
(iii)
(iv)
(2)
(3)
(ii)
(b)
(c)
(d)
(e)
(2)
(3)
Resource Conservation and Recovery Act, 42 U.S.C. 6901
The addition and revisions read as follows:
(a) * * *
(4) * * *
(ii) Petitioners must demonstrate, by providing specific citation or other appropriate reference to the administrative record (
(b)
(2) In all other permit appeals under this section, the Regional Administrator must file a response to the petition, a certified index of the administrative record, and the relevant portions of the administrative record within 30 days after the service of a petition.
(f) * * *
(5)
(i)
(2)
(3)
(ii)
(iii)
(d) When a party or interested person may or must act within a prescribed period after being served and service is made by U.S. mail, EPA's internal mail, or reliable commercial delivery service, 3 days shall be added to the prescribed time. The prescribed period for acting after being served is not expanded by 3 days when service is made by personal delivery, facsimile, or email.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is removing several obsolete Federal Implementation Plans (FIPs) for the State of Rhode Island. These FIPs address Clean Air Act (CAA) infrastructure State Implementation Plan (SIP) requirements that have since been addressed by Rhode Island in its SIP. Therefore, EPA is removing from the Code of Federal Regulations (CFR) the corresponding FIPs. This action is being taken in accordance with the CAA.
This rule is effective on February 8, 2017.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2015-0402. All documents in the docket are listed on the
Richard P. Burkhart, Air Quality Planning Unit, Air Programs Branch (Mail Code OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston, Massachusetts, 02109-3912; (617) 918-1664;
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Organization of this document. The following outline is provided to aid in locating information in this preamble.
This rulemaking addresses infrastructure SIP submissions from the State of Rhode Island for the 1997 fine particle matter (PM
On April 20, 2016, EPA took final action on the vast majority of the elements included in these submittals (see 81 FR 23175). In today's action, EPA is taking final action on its proposal to remove the following sections from the Code of Federal Regulations (CFR): 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). As discussed in detail in the NPR, these sections related to the public
EPA did not receive any comments in response to the NPR.
EPA is removing the following sections from the CFR: 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). The Federal Implementation Plan requirements in these sections are no longer necessary since EPA has since approved the relevant Clean Air Act infrastructure SIP revisions submitted by Rhode Island (see 81 FR 23175; April 20, 2016). A detailed discussion of the rationale for our action is included in the NPR (see 81 FR 10168; February 29, 2016).
This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under EOs 12866 and 13563 (76 FR 3821, January 21, 2011).
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. Entities potentially affected directly by this rule include state, local and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this rule.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects 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, as specified in E.O. 13132.
This action does not have tribal implications as specified in E.O. 13175. These regulation revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes.
The EPA interprets E.O. 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the E.O. has the potential to influence the regulation. This action is not subject to E.O. 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This action is not subject to E.O. 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under E.O. 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action is not subject to E.O. 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action is a procedural change and does not have any impact on human health or the environment.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Direct final rule and technical correction.
The Environmental Protection Agency (EPA) is approving the second 10-year maintenance plans for the Ajo and Morenci areas in Arizona for the 1971 National Ambient Air Quality Standards (NAAQS or “standards”) for sulfur dioxide (SO
This rule is effective March 10, 2017, without further notice, unless we receive adverse comments by February 8, 2017. If the EPA receives adverse comments, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0287 at
You may inspect and copy the rulemaking docket for this notice at the following location during normal business hours: Environmental Protection Agency, Region IX, Air Division, Air Planning Office (AIR-2), 75 Hawthorne Street, San Francisco, CA 94105-3901. Copies of the State Implementation Plan materials are also available for inspection at the address listed here: Arizona Department of Environmental Quality, 1110 W. Washington Street, First Floor, Phoenix, AZ 85007, Phone: (602) 771-4335.
Wienke Tax, EPA Region IX, (415) 947-4192,
Elsewhere in this
We are approving the second 10-year maintenance plans for the Ajo and Morenci, Arizona SO
Sulfur dioxide (SO
In 1971, the EPA established both short- and long-term primary NAAQS
In 2010, the EPA revised the primary SO
The Clean Air Act (CAA or “Act”) requires states to attain and maintain ambient air quality equal to or better than the NAAQS. The state's commitments for attaining and maintaining the NAAQS are outlined in the State Implementation Plan (SIP) for that state. The SIP is a planning document that, when implemented, is designed to ensure the achievement of the NAAQS. The Act requires that SIP revisions be made periodically as necessary to provide continued compliance with the standards.
SIPs include, among other things, the following: (1) An inventory of emission sources; (2) statutes and regulations adopted by the state legislature and executive agencies; (3) air quality analyses that include demonstrations that adequate controls are in place to meet the NAAQS; and (4) contingency measures to be undertaken if an area fails to attain the standard or make reasonable progress toward attainment by the required date, or a contingency plan if the area fails to maintain the NAAQS once redesignated. The state must make the SIP available for public review and comment through a public hearing and the SIP must be adopted by the state and submitted to us by the governor or her/his designee.
The EPA takes action on the SIP submittal, thus rendering the rules and regulations federally enforceable. The approved SIP serves as the state's commitment to take actions that will reduce or eliminate air quality problems. Any subsequent revisions to the SIP must go through the formal SIP revision process specified in the Act.
Ajo is located in northwestern Pima County. On March 3, 1978, at 43 FR 8968, for lack of a State recommendation, we designated Pima County as a primary SO
Morenci is a town in eastern Greenlee County near the border of Arizona and New Mexico. On March 3, 1978, at 43 FR 8968, for lack of a state recommendation, we designated Greenlee County as a primary SO
On the date of enactment of the 1990 CAA Amendments, SO
In 2004, we redesignated the Ajo and Morenci areas under the criteria used for areas with shut-down smelters and discontinued monitoring described in a memorandum from John Seitz to Regional Office Air Division Directors titled “Redesignation of Sulfur Dioxide Nonattainment Areas in the Absence of Monitored Data,” dated October 18, 2000 (“Seitz Memo”).
Phelps Dodge Mining Company's Ajo Incorporated (PDAI) operation was the largest point source in the Ajo SO
The Phelps Dodge Morenci Incorporated (PDMI) operation was the largest SO
On December 31, 1984, the PDMI smelter was permanently deactivated. Dismantling of the Morenci facility began in 1995 and was complete by December 1996. On October 29, 1997, ADEQ confirmed that the facility was dismantled and no longer existed at the former site. On April 26, 2004, the EPA finalized approval of the maintenance
The Ajo and Morenci areas remain sparsely settled, and only minor industrial or commercial activities that produce small quantities of SO
In Ajo, the only remaining SO
Currently, no ambient SO
Minor industrial or commercial activities such as Freeport-McMoRan mining operations and emergency generators for the Morenci wastewater treatment plant operate in the area. The 50 km area around the nonattainment area also contains a construction company, well fields, and several other sources that all still have active permits and together produce about 135 tpy of SO
Currently, no ambient SO
Section 175A of the CAA provides the general framework for maintenance plans. The initial 10-year maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, including any additional control measures as may be necessary to ensure such maintenance. In addition, maintenance plans are to contain such contingency provisions as we deem necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the state will implement all control measures contained in the nonattainment SIP prior to redesignation.
Section 175A(b) of the CAA requires states to submit a subsequent maintenance plan revision (second 10-year maintenance plan) eight years after redesignation. The Act requires only that this second 10-year maintenance plan maintain the applicable NAAQS for ten years after the expiration of the first 10-year maintenance plan. Beyond these provisions, however, section 175A of the CAA does not define the content of a second 10-year maintenance plan.
Our primary general guidance on maintenance plans and redesignation requests is a September 4, 1992 memo from John Calcagni, titled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni Memo”). Specific guidance on SO
Guidance on SO
While the Seitz Memo primarily addresses redesignations, we find it is appropriate to apply the Seitz Memo to second 10-year maintenance plans for areas that were redesignated in accordance with the memo and continue to experience similar conditions to those at the time of redesignation.
Our historic redesignation policy for SO
(1) Emissions inventories representing actual emissions when violations occurred; current emissions; and emissions projected to the 10th year after redesignation; all three inventories should include estimates of emissions in a 50 km buffer zone around the nonattainment area;
(2) dispersion modeling showing that no NAAQS violations will occur over the next 10 years and that the shut-down source was the dominant cause of the high concentrations in the past;
(3) evidence that if the shut-down source resumes operation, it would be considered a new source and be required to obtain a permit under the Prevention of Significant Deterioration (PSD) provisions of the CAA; and
(4) a commitment to resume monitoring before any major SO
On February 22, 2013, ADEQ submitted to the EPA the “Final Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Planning Area (1971 NAAQS)” (“2013 Ajo Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2013 Ajo Maintenance Plan, which includes the notice of public hearing, the agenda for the February 7, 2013 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.
On August 22, 2013, the 2013 Ajo Maintenance Plan was deemed complete by operation of law. See 40
On December 18, 2014, ADEQ submitted to the EPA the “Proposed Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Planning Area (1971 NAAQS)” (“2014 Morenci Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2014 Morenci Maintenance Plan, which includes the notice of public hearing, the agenda for the December 15, 2014 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.
On May 10, 2015, the 2014 Morenci Maintenance Plan was deemed complete by operation of law. See 40 CFR part 51, appendix V, for the EPA's completeness criteria, which must be satisfied before EPA formal review.
As discussed above, the only major source of SO
As discussed above, the only major source of SO
The 2013 Ajo Maintenance Plan and 2014 Morenci Maintenance Plan both extend the maintenance period for ten years after the expiration of the first 10-year maintenance plans, as required by Section 175A(b) of the CAA. As discussed below, the State has addressed the requirements in the Seitz Memo for emissions inventories, modeling, permitting of major new sources, and agreement to commence monitoring if a new major source locates in either the Ajo or Morenci areas. Therefore, the State has met the specific criteria in the Seitz Memo for approval of maintenance plans and redesignation requests where a single source was the historic cause of violations and the source is now shut down. We provide more details on each requirement and how the 2013 Ajo Maintenance Plan and the 2014 Morenci Maintenance Plan meet each requirement in the following sections.
In addition to reproducing the emissions inventories in the Ajo Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (June 18, 2002) (“2002 Ajo maintenance plan”), the 2013 Ajo Maintenance Plan includes new emissions inventories for 2008, representing an updated “current” emissions inventory (the most recent National Emissions Inventory (NEI) available at the time), 2010, 2015, 2020, and 2025 for the second 10-year maintenance period.
The emissions inventories in the 2013 Ajo Maintenance Plan include estimates of SO
Area and mobile sources in ADEQ's 2008 and subsequent year inventories were derived from the EPA's NEI and local agency records. Historical and 2008 emissions inventories demonstrate that no significant area or mobile sources existed in the Ajo area prior to or subsequent to the smelter operation, which closed in 1985.
Based on our review of the emissions inventories in the 2013 Ajo Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.
Past EPA policy memoranda on SO
For the 2002 Ajo Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model run with conservative assumptions about source parameters and meteorology. At the time of the 2002 Ajo Maintenance Plan, the Ajo nonattainment area had one minor point source of SO
The Seitz Memo also requires a modeling analysis that shows that the point sources that were shutdown were the dominant sources contributing to high SO
ADEQ did not conduct a new modeling analysis for the 2013 Ajo Maintenance Plan. As described above, the modeling for the 2002 Ajo Maintenance Plan modeled the existing two sources at maximum projected emissions rates from 2004 to 2015 and showed the area would not exceed 66% of the NAAQS. Since that modeling analysis was conducted, the Phelps-Dodge Generating Station has shut down, the Gila Bend Regional Landfill was never constructed, and the permit for the landfill was allowed to expire.
Currently, only two sources operate within the nonattainment area (
ADEQ proposes, and we concur, that because current emissions in the maintenance area and the 50 km buffer are a small fraction of modeled emissions from 2002, the ambient SO
In nonattainment areas, section 172(c)(5) of the CAA requires New Source Review (NSR) permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure that projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.
ADEQ and the PDEQ have PSD permitting programs (
The PSD program has applied to any major source or major modification in the Ajo area since the area was redesignated to attainment for SO
ADEQ commits to resume monitoring before any major source of SO
The 2014 Morenci Maintenance Plan includes historical inventories that were submitted as part of the Morenci Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (submitted June 21, 2002) (“2002 Morenci maintenance plan”) as well as a current-year inventory for 2011 (the most recent NEI available at the time), and projected inventories for 2015, 2020, 2025, and 2030 for the second 10-year maintenance period.
The emissions inventories in the 2014 Morenci Maintenance Plan include estimates of SO
Area and mobile source emissions in ADEQ's 2011 and subsequent year inventories were derived from the NEI. The year 2011 was a historically high wildfire year, and included the largest wildfire in Arizona history (
Based on our review of the emissions inventories in the 2014 Morenci Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.
The EPA policy memoranda on SO
The Seitz Memo also requires a modeling analysis that shows point sources that were shutdown were the dominant sources contributing to high SO
For the 2014 Morenci Maintenance Plan, ADEQ conducted a modeling analysis similar to the analysis in the 2002 Morenci Maintenance Plan. The two largest sources in the maintenance area and within the 50 km buffer area were modeled. The two sources are Freeport-McMoRan Morenci Mine (FMMM) in the maintenance area, with a PTE of 88 tpy SO
The EPA dispersion model AERSCREEN (version 11126) was used to conservatively estimate the impact of FMMM and FMSM on maintenance in the Morenci planning area.
In nonattainment areas, section 172(c)(5) of the CAA requires NSR permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.
ADEQ has a PSD permitting program (
ADEQ commits to resume monitoring before any major source of SO
As discussed above, section 175A of the CAA sets forth the statutory requirements for maintenance plans, and the Calcagni, Seitz and Shaver Memos cited above contain specific EPA guidance. The only maintenance plan element not covered by the Seitz Memo is the contingency provisions. Section 175A(d) of the CAA requires that maintenance plans contain contingency provisions deemed necessary by the Administrator to assure that the state will promptly correct any violation of the standard which occurs after the redesignation of the area as an attainment area.
The 2013 Ajo Maintenance Plan includes the State's commitment to continue to track maintenance of the SO
Since the primary cause of future violations of the 1971 SO
The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO
The 2014 Morenci Maintenance Plan includes the State's commitment to continue to demonstrate maintenance of the SO
Since the primary cause of future violations of the 1971 SO
The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO
Conformity is required under section 176(c) of the CAA to ensure that federal actions are consistent with (“conform to”) the purpose of the SIP. Conformity to the purpose of the SIP means that federal activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS or interim reductions and milestones. Conformity applies to areas that are designated nonattainment and to maintenance areas. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded, or approved under Title 23 U.S.C. and the Federal Transit Act (“Transportation conformity”) as well as to other federally supported or funded projects (“general conformity”).
Transportation conformity applies to projects that require Federal Highway Administration or Federal Transit Administration funding. 40 CFR part 93 describes the requirements for federal actions related to transportation plans, programs, and projects to conform to the purposes of the SIP. Because the EPA does not consider SO
Section 176(c)(4) of the CAA establishes the framework for general conformity. Besides ensuring that federal actions not covered by the transportation conformity rule will not interfere with the SIP, the general conformity regulations encourage consultation between the federal agency and the state or local air pollution control agencies before and during the environmental review process, as well as public notification of and access to federal agency conformity determinations, and allows for air quality review of individual federal actions.
Section 176(c) of the CAA required the states to revise their SIPs to establish criteria and procedures to ensure that federally supported or funded projects in nonattainment and maintenance areas “conform” to the air quality planning goals in the applicable SIP. SIP revisions intended to meet the conformity requirements in section 176(c) are referred to as “conformity SIPs.” In 2005, Congress amended section 176(c), and under the amended conformity provisions, states are no longer required to submit conformity SIPs for general conformity, and the conformity SIP requirements for transportation conformity have been reduced to include only those relating to consultation, enforcement, and enforceability. CAA section 176(c)(4)(E).
The EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of a redesignation request under section 107(d)(3)(E)(v) because state conformity rules are still required after redesignation and Federal conformity rules apply where state rules have not been approved.
Criteria for making determinations and provisions for general conformity are contained in Arizona Administrative Code R18-2-1438. Arizona has an approved general conformity SIP.
ADEQ commits in the 2013 Ajo Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area.
ADEQ commits in the 2014 Morenci Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area.
On November 3, 2003, the EPA finalized approval of the maintenance plan and redesignation request for the Ajo area, effective January 2, 2004 (
Section 110(k)(6) of the CAA provides that when the EPA's action approving any plan or plan revision (or part thereof), area designation, redesignation, classification, or reclassification was in error, the EPA may in the same manner revise such action. Under the EPA's authority under section 110(k)(6) of the Act, we are taking direct final action to amend the Arizona-SO
The maintenance area consists of townships T11S, R6W; T11S, R5W; T12S, R6W; T12S, R5W; and T13S, R6W. In addition, townships T13S, R5W; T11S, R7W; T12S, R7W; and T13S, R7W are listed in 40 CFR 81.303 as “cannot be classified,” as they were upon the Ajo area's original designation in 1979.
We are approving the second 10-year SO
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, the 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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 10, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of this
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.
Environmental protection, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.
Chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
The additions read as follows:
(e) * * *
42 U.S.C. 7401
Federal Maritime Commission.
Final rule.
The Federal Maritime Commission amends its regulations for processing requests for information and records under the Freedom of Information Act (FOIA). The regulations are being revised to incorporate changes brought by amendments to the FOIA under the FOIA Improvement Act of 2016. The Act requires agencies to review their FOIA regulations and issue regulations implementing the amendments no later than 180 days after enactment.
This rule is effective January 30, 2017.
On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016. The Act prescribes a range of procedural requirements that affect the Commission's FOIA regulations, and which this final rule implements, including requirements that the Commission:
• Provide publically available documents and its FOIA Annual Reports in an electronic format;
• provide FOIA requesters the right to seek dispute resolution services from the Commission's FOIA Public Liaison and/or the Office of Government Information Services during the FOIA process;
• provide a minimum of 90 days for FOIA requesters to file an administrative appeal; and
• not apply the deliberative process privilege to records created 25 years or more before the date on which the records were requested.
The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities and prepare an initial regulatory flexibility analysis, unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities. This final rule will affect only persons who file FOIA requests, and therefore, the Commission certifies that this final rule will not have a significant or negative economic impacts on a substantial number of small entities.
The Paperwork Reduction Act of 1995 requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before making most requests for information if the agency is requesting information from more than ten persons. 44 U.S.C. 3507. The agency must submit collections of information in proposed rules to OMB in conjunction with the publication of the proposed rulemaking. 5 CFR 1320.11. This final rule does not impose any collections of information, as defined by 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).
This final rule will have no physical impact upon the environment, and therefore, will not require any further review under NEPA.
The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document may be used to find this action in the Unified Agenda, available at
Administrative practices and procedures, Archives and records, Classified information, Confidential business information, Freedom of information, Information, Privacy, Records, Reporting and recordkeeping requirements, Sunshine Act.
For the reasons set forth in the preamble, the Federal Maritime Commission amends 46 CFR part 503 as follows:
5 U.S.C. 552, 552a, 552b, 553; 31 U.S.C. 9701; E.O. 13526, 75 FR 707, 3 CFR, 2010 Comp., p. 298.
(a) The Commission, as required by the Freedom of Information Act, 5 U.S.C. 552, is responsible for determining which of its records must be made publicly available, for identifying additional records of interest to the public that are appropriate for public disclosure, for posting and indexing such records, and for reviewing and updating posted records and indices on an ongoing basis. The Commission makes the following materials available for public inspection in electronic format on its Web site at
(c) The Commission maintains and makes available for public inspection in an electronic format, a current log or index providing identifying information for the public as to any matter which is issued, adopted, or promulgated, and which is required by paragraph (a) of this section to be made available or published.
(a) * * *
(1) Such determination shall be made by the Secretary within twenty (20) business days after receipt of such request, except as provided in paragraphs (b) and (e)(4) of this section, and the Secretary shall immediately notify the requester of:
(i) Such determination and the reasons therefor;
(ii) The right of such person to seek assistance from the agency's FOIA Public Liaison; and
(iii) In the case of an adverse determination, the right of such
(2) Upon granting a request, the Secretary shall promptly make records available to the requestor. Upon denial of such a request the Secretary shall promptly notify the requestor of the determination, explain the reason for denial, give an estimate of the volume of matter denied, and set forth the names and titles or positions of each person responsible for the denial of the request.
(3)(i) * * *
(B) Be filed not later than 90 days following receipt of notification of full or partial denial of records requested.
(b) * * *
(3) If the time limit is extended as prescribed under this section, and the request cannot be processed within the extended time limit, the Secretary shall notify the requestor, and either provide the requestor with an opportunity to limit the scope of the request so that it may be processed within the time limit, or provide the requestor an opportunity to arrange with the Secretary an alternative time frame for processing the request or a modified request. To aid the requester, the Commission will make available its FOIA Public Liaison, who shall assist in the resolution of any dispute between the requester and the Commission, and notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services.
(a) * * *
(5) Inter-agency or intra-agency memoranda or letters that would not be available by law to a party other than an agency in litigation with the Commission, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested.
(8) Contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or
(9) Geological and geophysical information and data, including maps, concerning wells.
(b) Each such report shall be made available to the public in electronic format.
By the Commission.
Office of Acquisition Policy, General Services Administration (GSA).
Final rule.
The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) to clarify that the ordering-agency task and delivery order Ombudsman has jurisdiction and responsibility to review and resolve fair opportunity complaints on tasks and delivery orders placed against GSA multiple-award contracts.
For clarification of content, contact Ms. Dana Davis, General Services Acquisition Policy Division, GSA, by telephone at 202-357-9652 or by email at
The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) part 552, Solicitation Provisions and Contract Clauses at 552.216-74 Task and Delivery Orders. The final rule clarifies that the jurisdiction and responsibility to review and resolve fair opportunity complaints placed against GSA multiple-award contracts lies with the ordering-agency task and delivery order Ombudsman. Also, the final rule requires the ordering agency to include contact information for their task and delivery order Ombudsman when placing task or delivery orders against GSA multiple-award contracts. Finally, so that GSA can maintain insight into fair opportunity complaints that arise on orders other agencies place against these contracts, the final rule requires the contractor to provide a copy of its complaint to the GSA Procurement Ombudsman for informational purposes, at the same time the contractor files its complaint to the ordering agency for action.
41 U.S.C. 1707, Publication of proposed regulations, applies to the publication of the General Services Administration Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure, or form (including amendment or modification thereof) must be published for public comment if it 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 does not have a significant impact on the public, contractors or offerors. This rule brings internal GSAR policy up-to-date with FAR policy. The change clarifies internal operating procedures by the Government by clarifying GSA's jurisdiction regarding fair opportunity complaints. The proposed rule comment period is impracticable as the FAR has already directed specific regulatory action.
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
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant GSAR revision and 41 U.S.C. 1707 does not require publication for public comment.
This final rule does not contain any information collection that requires additional approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Government procurement.
Therefore, GSA amends 48 CFR parts 516 and 552 as set forth below:
40 U.S.C. 121(c).
The revision and addition reads as follows:
(b) In solicitations and contracts for multiple-award contracts where GSA is the only ordering activity, or for GSA orders placed against a GSA multiple-award contract, insert clause 552.216-74, GSA Task-Order and Delivery-Order Ombudsman. This clause shall not be included in GSA-awarded contracts available for multiple agency use (
(d) Insert clause 552.216-76, Ordering Agency Task-Order and Delivery-Order Ombudsman in all GSA-awarded contracts available for multiple agency use (
(c) The GSA Task-Order and Delivery-Order Ombudsman is located at the General Services Administration (GSA), Office of Government-wide Policy (OGP), Office of Acquisition Policy (MV). Contact information for the GSA Task-Order and Delivery-Order Ombudsman can be found at:
As prescribed in 516.506(d), insert the following provision:
(a)
(b)
(c) If the contractor is not satisfied with the resolution of its complaint by the Ordering Agency Task-Order and Delivery-Order Ombudsman, the contractor may follow the procedures outlined in FAR subpart 33.1, as applicable (
The Community Development Financial Institutions Fund (CDFI Fund), Department of the Treasury, requests comments from the public regarding the current policies and procedures to certify an organization as a Community Development Financial Institution (CDFI). Capitalized terms found in this notice are defined in the regulations that govern the CDFI Program, in our regulations.
Written comments must be received on or before March 10, 2017 to be assured of consideration.
Submit your comments via email to David Meyer, Certification, Compliance Monitoring and Evaluation (CCME) Manager, CDFI Fund, at
David Meyer, CCME Manager, CDFI Fund, 1500 Pennsylvania Avenue NW., Washington, DC 20220 or email to
Pursuant to the CDFI Fund's authorizing statute (the Community Development and Regulatory Improvement Act of 1994, 12 U.S.C. 4701
In accordance with the statutory definition, the CDFI Fund has established seven tests, described below, to certify an Applicant financial entity as a CDFI. Applicants provide legal documentation, narratives and financial data to demonstrate their ability to meet the certification criteria. Applications are accepted on a rolling basis and may be submitted more than once, if declined. Certified CDFIs must complete an annual recertification process to update the financial and organization data contained in the original certification application. CDFI certification application and supplemental information can be found on the CDFI Fund Web site.
With this Request for Information (RFI), the CDFI Fund is embarking on a review of its CDFI certification tests to ensure that they continue to meet the statutory and regulatory requirements and the evolving nature of an industry that has changed significantly since the CDFI Fund's establishment in 1994. Since the first CDFIs were certified, the universe of certified CDFIs has grown from 196 in 1997 to over a 1,000 in number today, with over $100 billion in total assets and headquarters in all fifty states and several territories. It is a goal of the CDFI Fund to foster a diversity of CDFI types, activities, and geographies, and to enable market-driven solutions to emerge in a constantly changing economic environment.
In addition, the significance of CDFI certification has increased over the years. While CDFI certification continues to make an entity eligible for various programs at the CDFI Fund (CDFI Program, Native American CDFI Assistance Program, Capital Magnet Fund, and the CDFI Bond Guarantee Program), because it is seen as indicating a strong community development mission, it also has come to serve as a qualifier for other Federal government programs and benefits. These include, among others, the Small Business Administration's Community Advantage program and Federal Home Loan Bank membership, as well as consideration for certain investments under the Community Reinvestment Act and, pursuant to 12 CFR 1026.43(a)(3)(v)(A), an exemption from the Consumer Financial Protection Bureau's “Ability to Repay” rule. The CDFI Fund believes that it is important that certification remain a mark of confidence in an organization's commitment to a community development mission.
It also is imperative that CDFI certification criteria continue to support, rather than inhibit, the growth and reach of CDFIs, especially as it relates to their ability to take advantage of new technologies. These new technologies create the potential for mission-driven organizations like CDFIs to extend their reach and impact in order to improve access to financial products and services for underserved communities and populations wherever they are. This raises questions, however, of whether CDFI certification—particularly in terms of a CDFI's ability to define a Target Market and demonstrate accountability to that Target Market—is currently designed to enable such scope, which was neither possible nor envisioned when the criteria were first established.
Through this RFI, the CDFI Fund seeks feedback from the public on certain aspects of the certification criteria and process, as listed in Sections I and II. We also seek any additional information beyond these questions that members of the public believe would assist in updating the CDFI Fund's certification policies. The CDFI Fund intends to consider the feedback received through this RFI as it reexamines its current criteria and proposes any revisions to its CDFI certification policies. In making any changes to the existing criteria, the CDFI Fund will seek to ensure that certification continues to foster a diversity of CDFI types, activities, and geographies; allows for innovation that supports the growth and reach of CDFIs; and signifies confidence in a strong community development mission.
A.
1. The statute does not indicate how long an organization must be in existence to be considered a “person (other than an individual).” Should there be a minimum period of time an organization should be in existence before applying for CDFI certification? If so, how long? If not, why not?
2. Is there additional documentation, beyond an organization's establishing documents filed with State jurisdictions, that should be accepted to demonstrate that an organization is a legal entity?
B.
1. Should the currently required board-approved documentation and narrative statement be sufficient to demonstrate an Applicant's primary mission, or should the CDFI Fund apply a more prescriptive primary mission test? For example, should the CDFI Fund provide a more explicit, possibly quantitative, definition of what it means to “promote community development” that Applicants would be required to meet? If so, what should be the definition and what test should be applied? Are there criteria that the CDFI Fund should not consider and why?
2. Should there be different standards for meeting the primary mission test for nonprofit versus for-profit organizations, particularly for-profits that are not Insured Depository Institutions? If so, what different standards should be applied?
3. What evidence can the CDFI Fund use to confirm an Applicant's adherence to a stated community development mission? For example, how can the CDFI Fund distinguish between an organization that is fully committed to a community development mission and one that targets the same communities or populations as a CDFI and claims a community development mission, but whose actions do not demonstrate intent to create community development and/or are predatory in nature?
4. To what extent should the CDFI Fund evaluate the Financial Products and/or Financial Services offered by an Applicant to determine its ability to meet the primary mission test? What test would the CDFI Fund apply in any such evaluation of Financial Products and/or Financial Services?
5. Currently, by statute, Depository Institution Holding Companies wishing to be certified as CDFIs must provide documentation that their parent, Subsidiaries, and Affiliate organizations collectively meet the primary mission test. Should the CDFI Fund also make this a requirement for Non-Regulated CDFIs, for example, a Non-Regulated for-profit financial institution? Why or why not?
C.
1. The CDFI Fund does not currently define the term “predominance,” but in practice accepts a plurality of assets as meeting this criterion. Should the term “predominance” be defined more specifically, and if so, how?
2. Should entities that provide less than a plurality of financing activity ever be considered Financing Entities? If so, under what circumstances and is there a minimum level of activity that should be required?
3. Currently, the amount of assets and staff time dedicated to financing activities are used to measure the level of a CDFI's financing activity. How else could a CDFI's level of financing activity be measured?
4. For Non-Regulated CDFIs, is the current “predominance of assets” test appropriate, or should alternatives or additional considerations be permitted?
5. Should Non-Regulated CDFIs be permitted to include the financing or Financial Services activity of a mission-driven Subsidiary as part of the assessment of the parent CDFI's financing activities?
6. Should Non-Regulated CDFIs be permitted to rely upon the financing or Financial Services activity of a parent CDFI as part of the assessment of the Subsidiary's or Affiliate's financing activities?
7. Should an organization applying for CDFI certification be required to transact a minimum number or dollar amount of loan or equity investments to be considered a financing entity? Should the Applicant be required to have at least one or more years of loan or equity investment origination? If so, what should those rules be?
8. Should an organization that only services loans or Equity Investments or has very few transactions be considered a financing entity?
9. Should certified CDFIs be required to offer loans or Equity Investments each year, in order to maintain certification status?
10. Currently, non-arms-length transactions do not contribute to meeting the financing entity criteria. For example, transactions made with Subsidiaries and/or Affiliates are not considered to be arms-length transactions. Should some transactions with Affiliates be permissible as evidence of an organization being a financing entity? If so, which ones? How should an “arms-length transaction” be defined?
11. Should Applicants be required to disclose the expected amount and types of lending that may be made to Affiliates and Insiders in their certification applications? Should such transactions be limited as a condition of certification? Why or why not?
12. Current CDFI Program regulations use the term “similar financing activities” in its definition of the term “Financial Products.” How should the CDFI Fund determine what is included in “similar financing activities?”
D.
1. Threshold Target Market Test: Although no threshold level of service is indicated in the statute or regulation, current CDFI Fund policy requires that an organization must serve at least one eligible Target Market and must direct at least 60 percent of all of its Financial Product activities to one or more eligible Target Market to qualify for certification. In general, both the number and dollar amount of the organization's Financial Product activities should be at least 60 percent of all of its Financial Product activities in the most recent fiscal year. If an organization does not meet the 60 percent threshold in terms of either number or dollar amount of transactions (but not both), the organization can
a. Is the current standard that 60 percent of a CDFI's Financial Product activities must be in qualified Target Markets the right standard? If not, what percentage of transactions should be in and/or to a qualified Target Market to demonstrate that an organization serves that Target Market and why?
b. Should there be different thresholds for different institution types (
c. The CDFI Fund currently relies on self-reported summary data submitted by Applicants to demonstrate that they meet the Target Market threshold test. Should statistical sampling of transactions be required to establish a current baseline of activity and document the Target Markets that they are serving?
d. The August 31, 2015 Interim CDFI Program Regulations added the provision of Financial Services as a means of demonstrating that an applicant serves a Target Market. However, the CDFI Fund does not currently have a method of recognizing or applying the provision of Financial Services toward the current 60 percent threshold test for certification. In addition to the level of Financial Products provided by an Applicant, how should an Applicant receive credit for the provision of Financial Services toward meeting any threshold test? How should this be measured? If an Applicant requests credit for providing Financial Services, should there be a separate minimum level of Financial Products that must be provided by the Applicant?
e. The CDFI Fund currently first considers an Applicant's financial activity during its most recent fiscal year in determining whether it meets the threshold test. Is this the appropriate time period to consider, or should a longer period of time be considered? If so, should the applicant be required to meet the threshold in each year of the test, for a time period, or should an average be considered? Should the CDFI Fund consider an Applicant's portfolio of loans outstanding?
2. Investment Areas: The statute requires that an Investment Area must meet at least one of the economic distress criteria (poverty rate greater than 20 percent; Median Family Income (MFI) at 80 percent or below specific MFI benchmarks; unemployment rate 1.5 times the national average) and has significant unmet needs for Financial Products and Services, or is wholly located within an Empowerment Zone or Enterprise Community.
a. The CDFI Fund's current practice is to define Investment Areas that are composed of one or more units of geography that meet certain distress criteria. Units include but are not limited to counties, census tracts, and Indian Reservations. Should the CDFI Fund change this practice? If so, how?
b. Currently the CDFI Fund allows Investment Areas to be composed of a set of contiguous geographic units that may include a small portion of units that individually do not qualify as Investment Areas. Should the CDFI Fund continue this practice, or should all units within the Investment Area meet the Investment Area qualifications?
3. Targeted Populations: Targeted Populations include Low Income Targeted Populations (LITP) and Other Targeted Populations (OTP) for a specific geographic unit. LITP, for a specified geographic unit, by statute includes individuals whose family income (adjusted for family size) is 80 percent of the area MFI (for metropolitan areas). LITP in non-Metropolitan Areas is the greater of 80 percent of the area MFI; or 80 percent of the statewide non-Metropolitan Area MFI. The CDFI Fund currently includes, for a specific geographic unit(s), African-Americans, Hispanics, Native Americans, Native Alaskans, Native Hawaiians, and Other Pacific Islanders among the groups automatically considered eligible for an OTP Target Market. Applicants are permitted to seek OTP recognition for other populations by demonstrating that the group lacks access to capital.
a. Should the Targeted Populations be expanded to automatically accept more specifically defined Other Targeted Populations that are eligible for other Federal programs that support economic development in Low-Income communities? If so, which ones and why?
b. CDFIs currently are approved to serve Targeted Populations within a defined geographic unit at below and up to a national level. Should all Applicants proposing to serve Targeted Populations be approved to serve such Target Markets nationally?
4. National Target Markets: Currently, in order to be certified with a Target Market national in geographic scope, CDFIs need to show that they have conducted their financing activities broadly across the variously defined regions of the country, (
a. Given that it is unlikely that most CDFIs that work broadly across the nation will complete transactions in every State every year, how can organizations demonstrate that they serve a national Target Market, whether for an Investment Area or for a Targeted Population? Should there be a certain minimum geographic dispersion of actual investments?
b. Some CDFIs serve multiple markets that are part of a multi-State region or are comprised of geographically unconnected markets. When should the CDFI Fund recognize these practices as constituting a national Target Market?
E.
1. Should the CDFI Fund more explicitly define Development Services? If so, how should it be defined?
2. Should the CDFI Fund require CDFIs to provide a corresponding Development Service for each Financial Product and Financial Service?
3. Should a certified CDFI be required to offer each Development Service each year to maintain certification status?
F.
1. What percentage of a CDFI's board members should satisfy accountability rules? Should different percentages apply to different types of boards,
2. Is representation on an advisory board sufficient to demonstrate accountability?
3. Should CDFIs be able to demonstrate accountability through means other than board membership? If so, how?
4. Is a business plan and a stratified, statistically significant random sample
5. Should accountability requirements differ based on a CDFI's type of Target Market, and if so, how?
6. How should the CDFI Fund assess accountability if a CDFI's Target Market includes borrowers or investees who are not members of a Targeted Population themselves (
7. How should a CDFI demonstrate accountability to a national Target Market, in particular an Investment Area national in scope? Should there be a requirement to have local accountability to supplement a national governing or advisory board? In this context, how should the term “local” be defined?
8. How should an Applicant that utilizes a web-based lending platform, especially one that serves a national Target Market, demonstrate accountability?
G.
1. Are the current standards for establishing that an Applicant is not owned or controlled by a governmental entity sufficient?
2. Are there additional or alternative questions and/or documentation the CDFI Fund should require to determine if an Applicant is an agency or instrumentality of a Federal, State or local government?
A. Should the CDFI Fund request information on the reason for applying for certification and intended use (
B. Are there additional sources of data collected by other federal agencies that can be used to meet any of the seven certification tests? If so, please describe.
A. “Community-based” is a term often used to describe CDFIs. How should “community-based” be defined and what does it mean for CDFIs to be “community-based?”
B. Although not defined in statute, the CDFI Fund allows Applicants that serve Native communities to self-designate themselves as Native CDFIs and apply for Financial Assistance and Technical Assistance through the Native CDFI Program. Applicants that self-designate as a Native CDFI must attest to providing 50 percent or more of their products and services to Native lands or Native populations. Should the CDFI Fund continue to allow Applicants to self-designate as Native CDFIs or should there be more defined standards that the CDFI Fund should verify? If so, what should they be?
C. Should CDFIs be allowed to be composed of multiple legal entities (Subsidiaries and/or Affiliates)? And if so, must a CDFI include all of its Subsidiaries and/or Affiliates for consideration?
D. Should CDFI certification standards have more “bright-line” tests,
E. In addition to earlier questions regarding potentially different Primary Mission or Target Market standards based on institution type, are there other CDFI certification criteria standards that should vary based on institution type or the type of CDFI?
F. Should “start-up” entities be able to be certified? How should the term “start-up” be defined?
G. Are there additional areas of CDFI certification policy or the CDFI certification application review process that could use improvement? If so, how?
12 U.S.C. 4701
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Proposed rule.
The National Oceanic and Atmospheric Administration (NOAA) proposes to designate approximately 52 square miles of waters encompassing and surrounding Maryland's Mallows Bay as the Mallows Bay—Potomac River National Marine Sanctuary (MPNMS or sanctuary). NOAA also proposes regulations to implement the sanctuary designation and establish the sanctuary's terms of designation to protect historical, archeological, and cultural resources of national significance. A draft environmental impact statement (DEIS) and draft management plan (DMP) have also been prepared for this proposed action. The purpose of this action is to supplement and complement current Maryland state regulations and resource protection efforts to ensure long term protection of the nationally significant collection of historic shipwrecks and other maritime cultural heritage resources. NOAA is soliciting public comment on the proposed rule, draft environmental impact statement, and draft management plan. NOAA will also begin consultations under Section 106 of the National Historic Preservation Act (NHPA) and solicit public comments specifically related to the identification and assessment of the historic properties within the affected area in compliance with Section 106 review process.
NOAA will consider all comments received by March 31, 2017. Public meetings will be held on the following dates:
(1) March 7, 2017, 6:00 p.m. to 9:00 p.m., La Plata, MD, and
(2) March 9, 2017, 6:00 p.m. to 9:00 p.m., Arnold, MD.
You may submit comments on this document, identified by NOAA-
•
•
Copies of the proposed rule, DEIS, and DMP can be downloaded or viewed on the internet at
The public meeting locations are:
Paul Orlando, Regional Coordinator, Northeast and Great Lakes Region at (240) 460-1978,
The National Marine Sanctuaries Act (NMSA; 16 U.S.C. 1431
NOAA is considering the Mallows Bay area of the tidal Potomac River for designation as a national marine sanctuary. The area is 40 miles south of Washington, DC, located off the Nanjemoy Peninsula of Charles County, Maryland. This is an area of national significance featuring unique historical, archaeological, cultural, ecological, and esthetic resources and qualities, which offer opportunities for conservation, education, recreation, and research. Its maritime landscape is home to a diverse collection of historic shipwrecks that date back to the Civil War and potentially date to the American Revolutionary War, totaling nearly 200 known vessels including the remains of the largest “Ghost Fleet” of World War I, wooden steamships built for the U.S. Emergency Fleet. The fleet was constructed at more than 40 shipyards in 17 states as part of the massive national wartime preparation. The area's archaeological and cultural resources cover centuries of history from the earliest American Indian presence in the region about 12,000 years ago to the Revolutionary, Civil and two World Wars, as well as successive regimes of Potomac fishing industries.
The Maryland Department of Natural Resources (DNR), Maryland Historical Trust, Maryland Department of Tourism, and Charles County, MD, have worked together with community partners to initiate conservation and compatible public access strategies in and around Mallows Bay, consistent with numerous planning and implementation documents. In 2010, DNR purchased a portion of land adjacent to Mallows Bay and made it available to Charles County to create and manage Mallows Bay County Park, the main launch point for access to the historic shipwrecks. Pursuant to the NHPA, Maryland Historical Trust has stewardship and oversight responsibility for the shipwrecks, along with hundreds of other historic sites around the state. DNR manages the waterbody and associated ecosystem resources, including land use, resource conservation and extraction activities. The lands on either side of Mallows Bay County Park are held by the U.S. Department of Interior's Bureau of Land Management and a private citizen.
On September 16, 2014, pursuant to section 304 of the National Marine Sanctuaries Act and the Sanctuary Nomination Process (SNP; 79 FR 33851), a coalition of community groups submitted a nomination asking NOAA to designate Mallows Bay—Potomac River as a national marine sanctuary. The nomination cited conservation goals to protect and conserve the fragile remains of the Nation's cultural heritage as well as the opportunities to expand public access, recreation, tourism, research, and education to the area. The nomination was endorsed by a diverse coalition of organizations and individuals at local, state, regional, and national levels including elected officials, businesses, Native American, environmental, recreation, conservation, fishing, tourism, museums, historical societies, and education groups. The nomination identified opportunities for NOAA to protect, study, interpret, and manage the area's unique resources, including by building on existing local, county, and State of Maryland efforts to manage the area for the protection of shipwrecks. NOAA's review of the nomination against the criteria and considerations of the SNP, including the requirement for broad-based community support indicated strong merit in proposing this area as a national marine sanctuary. Therefore, NOAA completed its review of the nomination and, on January 12, 2015, added the area to the inventory of nominations that are eligible for designation. All nominations submitted to NOAA can be found at:
NOAA began the sanctuary designation process for Mallows Bay—Potomac River National Marine Sanctuary on October 7, 2015 with the publication of a notice of intent (NOI; 80 FR 60634) to prepare a DEIS and the initiation of a public process, as required under the NMSA and the National Environmental Policy Act (NEPA). The DEIS evaluates alternatives related to the proposed designation of Mallows Bay—Potomac River National Marine Sanctuary, including a no action alternative. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of the NHPA.
The proposed designation would allow NOAA to complement current state-led efforts to conserve and manage the nationally significant maritime cultural heritage resources while
The proposed sanctuary would concentrate on the protection, access and interpretation of the maritime cultural features of the area, including the Ghost Fleet, other vessels of historic significance, and related maritime infrastructure. The State of Maryland currently has a comprehensive set of management measures for the protection of the natural environment, including wildlife, fish, birds, water quality, and habitat. As such, NOAA's proposed sanctuary regulations would focus only on the protection of the shipwrecks and associated maritime cultural heritage resources.
NOAA's proposed management actions will be primarily non-regulatory in nature with a concise set of regulations focused on protecting the maritime cultural heritage resources. Although the Maryland Submerged Archeological Historic Property Act (Md. Code Ann., State Fin. & Proc. sections 5A-333
The National Marine Sanctuaries Act authorizes NOAA to identify, designate, and protect areas of the marine and Great Lakes environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archaeological, educational, or aesthetic qualities as national marine sanctuaries. NOAA may identify areas to consider for national marine sanctuary designation through the community-based Sanctuary Nomination Process as described in the final rule (79 FR 33851) establishing the process. The NMSA process for designating a new national marine sanctuary has four steps:
On October 7, 2015, NOAA initiated the public scoping process with the publication of a NOI in the
During the public comment period, NOAA solicited input on the range of issues to be considered in an environmental impact statement to designate this area as a national marine sanctuary. NOAA specifically asked for information that would assist in the development of alternatives including proposed regulations and boundaries. NOAA accepted public comments through a web-based portal and by mail from October 7, 2015 through January 15, 2016, and hosted two public scoping meetings. During the scoping comment period, NOAA received approximately 264 comments from individuals, businesses, organizations, and local, state, and federal agencies. The first scoping meeting was held on November 4, 2015 in La Plata, MD, where approximately 125 people attended and 51 oral and written comments were received. The second meeting was held on November 10, 2015 in Annapolis, MD. Approximately 100 people attended that meeting, and 23 oral and written comments were received.
The written comments received included 141 from individuals, nine from businesses, 46 from organizations, two from local agencies, two from state agencies, and four from federal agencies. Comments were also submitted by U.S. Representative Steny Hoyer and U.S. Senator Ben Cardin. All comments are available for review online at
The majority of comments received during the scoping period generally support the proposed sanctuary designation based on the considerable value and significance of the natural, maritime, archaeological, and cultural resources within the area including those related to Native American history and activities, the immense potential for ecological and archaeological research of the area's resources, and the economic and educational benefits of increased tourism and public access and awareness. The public comments also identified several additional potential benefits, including restoration of the Chesapeake watershed, economic revitalization of the local area, and promoting heritage and ecotourism.
Several comments opposed the nomination predominantly citing opposition to the possibility of increased government intervention, specifically regarding fossil collection and fishing activities that could
The comments also identified boundary alternatives for consideration during the designation process. Several comments supported the boundary proposed in the sanctuary nomination package, intended to align with the boundary of the Mallows Bay—Widewater Archaeological and Historic District submitted by the State of Maryland (National Register Listing Number 15000173, April 24, 2015). However, the majority of comments supported an expanded boundary. Several comments supported a northward expansion to Mattawoman Creek, but most of the comments supported a larger boundary extending from Chapman Park in the North to Chapel point in the South. One comment suggested an even larger northern boundary extending to Piscataway Creek. Most of the support for the expanded boundaries was based on the benefits of the additional protection that the commenters felt a larger boundary would provide to the significant natural and maritime cultural heritage resources in the area.
Several comments did not support a boundary expansion citing issues related to management, local impact, and government overreach. Some comments expressed concerns regarding how the boundaries would affect the Commonwealth of Virginia's interests and one comment noted that Virginia should be excluded from the sanctuary boundary.
Additional comments addressed regulatory frameworks, access issues, migratory bird protections, designation timeline goals, intergovernmental collaboration, infrastructure, education and outreach programing, and interpretation plans.
NOAA used these public comments to inform the preparation of the draft management plan, draft environmental impact statement, and the proposed sanctuary regulations. The proposed designation reflects the general public support for the protection of all nationally significant maritime cultural heritage resources in the area. It also incorporates the need for enhanced recreation and access to the proposed sanctuary to support tourism and the local economy.
In this proposed rule, NOAA is proposing to regulate damage to the maritime cultural heritage resources in a 52-square mile area of Maryland waters of the Potomac River as described below. The proposed boundaries were expanded beyond the initially nominated area and the National Register Historic District based on public comments, additional research conducted related to the historical and archaeological resources of the area, and input from Maryland Department of Natural Resources, Maryland Historical Trust, and Charles County.
The environmental effects of this proposed designation and alternatives are analyzed in a DEIS published concurrently with this proposed rule summary statement. NOAA has also developed an associated draft management plan describing comprehensive proposed management framework envisioned for the area, including non-regulatory programs and activities actions and strategies to promote opportunities for research, education, and recreation in the area. NOAA is seeking public comment on the proposed rule, DEIS, and draft management plan, which are available at
NOAA is proposing to amend 15 CFR part 922 by adding a new subpart (subpart S) that contains site-specific regulations for MPNMS. This subpart would include the proposed boundary, contain definitions of common terms used in the new subpart, provide a framework for co-management of the sanctuary, identify prohibited activities and exceptions, and establish procedures for certification of existing uses, permitting otherwise prohibited activities, and emergency regulation procedures. Several conforming changes would also be made to the national regulations as described detail below.
NOAA is concurrently working on designating a separate new national marine sanctuary in Wisconsin's Lake Michigan waters as part of a separate rulemaking process, and those regulations would be published in their own new subpart (subpart T). As such, in this rulemaking, NOAA proposes to add and reserve subpart T for any future site-specific regulations that might be issued. NOAA would later harmonize the regulations for the Wisconsin Lake Michigan designation process with any final rule associated with this action.
NOAA has proposed to name the sanctuary the “Mallows Bay—Potomac River National Marine Sanctuary (MPNMS)” based on the nomination submitted by the community. The name aptly identifies the area where the proposed sanctuary is located. NOAA has also selected the acronym of “MPNMS” to avoid having a longer acronym, such as “MBPRNMS,” and avoid duplication with an acronym already in use within the national marine sanctuary system, such as “MBNMS” used for Monterey Bay National Marine Sanctuary. NOAA is asking for public input on this proposed name. The public may also suggest an alternative name and state the reasons for suggesting an alternative name.
NOAA is proposing to designate an area of approximately 52 square miles of the Potomac River as MPNMS. The northern boundary of the area would extend approximately 200 yards upstream of the Dominion Power lines near Ben Doane Road, Maryland to Possum Nose, Virginia. The southern boundary would extend from the end of Owens Drive east of Chotank Creek, Virginia to Benny Gray Point, Maryland. The boundary would encompass all tidal waters within this boundary from mean high tide in Maryland to mean low tide in Virginia, which serves as the boundary between Maryland and Virginia. Areas where the Virginia state line is otherwise delineated, the Quantico exclusion zone, and the area around the Quantico marina would be excluded from the sanctuary. The detailed legal boundary description is included in section 922.200 and the coordinates are located in 15 CFR part 922, subpart S, appendix A. A map of the area is shown in the DEIS.
The proposed MPNMS would include all of the known WWI-era U.S. Emergency Fleet Corporation vessels in Maryland waters, as well as a number of historically, archaeologically, and recreationally significant shipwrecks not currently included in the National Register Historic District that is located within the proposed area. The area incorporates marine battlescapes such as the land-sea engagements in the Civil War, among the first in that conflict, and one Revolutionary War battlescape; the site of the first military balloon launch from a purpose built “aircraft carrier” in history; the site of two major amphibious invasion operations: Butler's attack from Budd's Ferry to Quantico Creek on March 9, 1861, and the Liverpool Point to Aquia Creek crossings during the Fredericksburg Campaign; several wharves, landings, navigational aids of historic note; Confederate communications and contraband water routes during the Civil War, and the overall scene of the
The proposed boundary was developed based on the nomination submitted by the State of Maryland and expanded based on additional information and suggestions received during the public comment period. NOAA's adjustments include moving both the northern and southern boundary lines to incorporate additional maritime culture heritage resources.
NOAA is proposing to narrowly define “sanctuary resources” for MPNMS to include only the maritime cultural heritage resources of the sanctuary area in accordance with the purpose of the proposed designation. The definition would not include biological and ecological resources of the area already managed by the State of Maryland. Creating this new site-specific definition requires NOAA to modify the national definition of “sanctuary resource” in the national regulations at section 922.3 to add an additional sentence that defines the term for MPNMS at section 922.201(a). This is similar to the approach taken for other national marine sanctuaries that do not share the full “sanctuary resource” definition such as Thunder Bay National Marine Sanctuary.
Additionally NOAA would add a definition in the MPNMS regulations at section 922.201(a) for sanctuary resource that uses the national definition for “historical resources” and expands it to specifically provide examples of the types of resources in this sanctuary that fall within that definition. The national definition of “historical resources” at section 922.3 describes the resource within the definition of “historical resource” to include resources that possess historical, cultural, archaeological or paleontological significance, such as sites, contextual information, structures, districts, and objects significantly associated with or representative of earlier people, cultures, maritime heritage, and human activities and events. These historical resources also include “cultural resources,” “submerged cultural resources,” and also include “historical properties,” as defined in the National Historic Preservation Act.
The new MPNMS definition of sanctuary resources would then be defined in section 922.201 to include historical resources as defined by section 922.3. This would include any sunken watercraft and any associated rigging, gear, fittings, trappings, and equipment. It would also include personal property of the officers, crew, and passengers, and any cargo, as well as and any submerged or partially submerged prehistoric, historic cultural remains, such as docks, piers, fishing-related remains (
This proposed rule incorporates and adopts other common terms defined in the existing national regulations at section 922.3; some of those definitions include: “Cultural resources,” which means any historical or cultural feature, including archaeological sites, historic structures, shipwrecks, and artifacts; and “National Marine Sanctuary” or “Sanctuary,” which means an area of the marine environment of special national significance due to its resource or human-use values, which is designated as such to ensure its conservation and management.
In order to further enhance the strong engagement forged by the State of Maryland and Charles County in nominating this area as a proposed national marine sanctuary and in contributing to the development of the draft designation documents, NOAA proposes to manage the sanctuary collaboratively with the state and county. NOAA proposes to establish the framework for co-management of the sanctuary at section 922.202 and intends to work out the operational details of the collaboration in a Memorandum of Understanding (MOU). Details on the execution of sanctuary management such as activities, programs, and permitting programs would be included in the MOU and can be updated to adapt to changing conditions or threats to the sanctuary resources. Any significant changes to the regulations or management plan would not only be jointly coordinated but also subject to public review.
NOAA is proposing to supplement and complement existing management of this area by proposing three regulations to protect the sanctuary resources in section 922.203(a).
As a complement to existing protections under state law and NHPA regulations, NOAA is proposing to prohibit damaging a sanctuary resource. The proposed regulation would prohibit moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource. The sanctuary prohibition on possessing a sanctuary resources would not apply to historical resources removed from the Sanctuary before the designation is complete. However, Maryland state regulations related to the limited removal of historical resources have been in effect since July 1, 1988 currently apply to these resources and will continue to do so. In the case of sanctuary resources that are covered under the Sunken Military Craft Act (SMCA; Pub. L. 108-375, Tit. XIV; 10 U.S.C. 113 note), NOAA and the U.S. Navy would cooperate on protecting those resources using the policy and procedures described in the 2015 Memorandum of Agreement (MOA). NOAA and the Maryland Historical Trust have tentatively identified one shipwreck as covered under the SMCA. A copy of the MOA is available at:
In addition to prohibiting damage to sanctuary resources, NOAA is also proposing to prohibit damage to sanctuary signs, notices, placards, monuments, stakes, posts, buoys, or boundary markers. These materials are part of the management of the sanctuary and may contribute to education and outreach programs. The materials are also federal property and therefore NOAA proposes to prohibit damage from marking, defacing or altering the materials in any way.
NOAA is proposing a regulation to prohibit interfering with sanctuary enforcement activities. This regulation will assist in NOAA's enforcement of the sanctuary regulations and strengthen sanctuary management.
NOAA is proposing to include an exemption from the three regulations described above for activities the respond to emergencies that threaten lives, property or the environment, or are necessary for law enforcement purposes.
NOAA is also proposing that Department of Defense (DOD) activities be carried out in a manner that avoids
As part of the proposed designation, NOAA is proposing to give the sanctuary authority to issue emergency regulations. Emergency regulations are used in limited cases and under specific conditions when there is an imminent risk to sanctuary resources and a temporary prohibition would prevent the destruction or loss of those resources. Under the NMSA, NOAA only issues emergency regulations that address an imminent risk for a fixed amount of time with a maximum of 6 months that can only be extended a single time. A full rulemaking process must be undertaken, including a public comment period, to consider making an emergency regulation permanent. NOAA would add the authority to issue emergency regulations by modifying the national regulations at section 922.44 to include MPNMS in a list of sanctuaries that have site-specific regulations related to emergency regulations, and adding detailed site-specific emergency regulations to the MPNMS regulations at section 922.204.
NOAA is proposing to include the authority to issue permits to allow certain activities that would otherwise violate the prohibition in MPNMS. Similar to other national marine sanctuaries, NOAA is proposing to consider these permits only for education, research, or management.
To address the above additions to the ONMS general permit authority for MPNMS, NOAA would amend regulatory text in the program-wide regulations in part 922, subpart E, to add references to subpart S, as appropriate. NOAA would also add a new section 922.205 in subpart S titled “Permit procedures and review criteria” that would address site-specific permit procedures for MPNMS.
Because of the possibility that preexisting activities, right of subsistence use or access permitted by other federal, state, local, or tribal agencies might be occurring within the MPNMS area that would otherwise be prohibited by MPNMS regulations, NOAA would add language at section 922.206 describing the process by which it can certify existing activities within the expansion area. In compliance with the NMSA, MPNMS regulations at section 922.206 would state that certification is the process by which permitted activities existing prior to the designation of the sanctuary that violate sanctuary prohibitions may be allowed to continue, provided certain conditions are met. Applications for certifying permitted existing uses would have to be received by NOAA within 180 days of the effective date of the designation.
NOAA also proposes to provide MPNMS with the authority to consider allowing an otherwise prohibited activity if such activity is specifically authorized by any valid Federal, state, or local lease, permit, license, approval, or other authorization issued after sanctuary designation. Authorization authority is intended to streamline regulatory requirements by reducing the need for multiple permits and would apply to all proposed prohibitions at section 922.203. As such, NOAA proposes to amend the regulatory text at section 922.49 to add reference to subpart S.
NOAA has the authority under the NMSA to issue special use permits (SUPs) at national marine sanctuaries as established by Section 310 of the NMSA. SUPs can be used to authorize specific activities in a sanctuary if such authorization is necessary (1) to establish conditions of access to and use of any sanctuary resource; or (2) to promote public use and understanding of a sanctuary resource. The activities that qualify for a SUP are set forth in the
SUP applications are reviewed to ensure that the activity is compatible with the purposes for which the sanctuary is designated and that the activities carried out under the SUP be conducted in a manner that do not destroy, cause the loss of, or injure sanctuary resources. NOAA also requires SUP permittees to purchase and maintain comprehensive general liability insurance, or post an equivalent bond, against claims arising out of activities conducted under the permit. The NMSA allows NOAA to assess and collect fees for the conduct of any activity under a SUP. The fees collected could be used to recover the administrative costs of issuing the permit, the cost of implementing the permit, monitoring costs associated with the conduct of the activity, and the fair market value of the use of sanctuary resources.
The general regulations in part 922, subpart A, for general information and part 922, subpart E, for regulations of general applicability would also have to be amended so that the regulations are accurate and up-to-date. The 10 sections that will need to be updated to reflect the increased number of sanctuaries or to add subpart S to the list of sanctuaries. The modified sections to conform to adding a new sanctuary are:
Section 304(a)(4) of the National Marine Sanctuaries Act (NMSA) requires that the terms of designation include the geographic area included within the sanctuary; the characteristics of the area that give it conservation, recreational, ecological, historical, research, educational, or aesthetic value; and the types of activities that will be subject to regulation by the Secretary of Commerce to protect these characteristics. Section 304(a)(4) also specifies that the terms of designation may be modified only by the same procedures by which the original designation was made. Thus, the terms of designation serve as a constitution for the Sanctuary.
NOAA is proposing to establish terms to designation that describe the geographic area, resources, and activities as described in details above. NOAA would add the terms of designation language as Appendix B to the MPNMS regulations at 15 CFR part 922, subpart S.
NOAA has determined that the designation of the Mallows Bay—Potomac River National Marine Sanctuary will not have a negative impact on the National Marine Sanctuary System and that sufficient resources exist to effectively implement sanctuary management plans and to update site characterizations. The finding for NMSA section 304(f) is published on the ONMS Web site for the Mallows Bay—Potomac River designation at
NOAA has prepared a draft environmental impact statement to evaluate the environmental effects of the proposed rulemaking and alternatives as required by NEPA (42 U.S.C. 4321
Section 307 of the Coastal Zone Management Act (CZMA; 16 U.S.C. 1456) requires Federal agencies to consult with a state's coastal program on potential Federal regulations having an effect on state waters. Because MPNMS encompasses a portion of the Maryland State waters and is adjacent to the Commonwealth of Virginia lands and waters, NOAA intends to submit a copy of this proposed rule and supporting documents to the Maryland Coastal Zone Management Program and Virginia Coastal Zone Management Program for evaluation of Federal consistency under the CZMA. NOAA will publish the final rule and designation only after completion of the consultation requirements under the CZMA.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
NOAA has concluded that this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132 because NOAA supplements and complements state and local laws under the NMSA.
The National Historic Preservation Act (NHPA; 16 U.S.C. 470
The Small Business Administration has established thresholds on the designation of businesses as “small entities”. A finfish fishing businesses is considered a small business if it has annual receipts of less than $20.5 million. Scenic and Sightseeing and Recreational industries are considered small businesses if they have annual receipts not in excess of $7.5 million. According to these limits, each of the businesses potentially affected by the proposed rule would most likely be small businesses. However, as further discussed below, these regulations will not have a significant economic impact on the affected small entities, and the Chief Counsel for Regulations for the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have significant economic impact on a substantial number of small entities. Thus, NOAA is not required to and has not prepared an initial regulatory flexibility analysis.
Small business user groups include commercial fishing operation, recreation-tourism related businesses, and land use and development
NOAA assessed three types of regulations included in the proposed action; (1) moving, removing, recovering, altering, inuring, etc., (2) marking, defacing or damaging etc., and (3) interfering with obstructing, etc. (see section 922.203 for full details).
The expected impact to all these business in the preferred alternative is “no impact”. The gear likely to be used to commercially fish or recreationally fish in the sanctuary will not be impacted by this regulation. Therefore, commercial fishing operations and for-hire operations are not expected to be impacted. Education and outreach will be used to educate user groups about the location of the sanctuary resources to prevent anchor damage. Divers will still be able to use the resource, but not able to take sanctuary resources, therefore the impact for this user group is also “no impact”.
ONMS has a valid Office of Management and Budget (OMB) control number (0648-0141) for the collection of public information related to the processing of ONMS permits across the National Marine Sanctuary System. NOAA's proposal to create MPNMS would likely result in an increase in the number of requests for ONMS general permits, special use permits, certifications, and authorizations because this action proposes to add general permits and special use permits, certifications, appeals, and the authority to authorize other valid federal, state, or local leases, permits, licenses, approvals, or other authorizations. An increase in the number of ONMS permit requests would require a change to the reporting burden certified for OMB control number 0648-0141. An update to this control number for the processing of ONMS permits would be requested as part of the final rule for sanctuary expansion.
Nationwide, NOAA issues approximately 500 national marine sanctuary permits each year. Of this amount, MPNMS is expected to add 4 to 5 permit requests per year. The public reporting burden for national marine sanctuaries permits is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the collection of information.
Send comments regarding the burden estimate for this data collection requirement, or any other aspect of this data collection, including suggestions for reducing the burden, to NOAA (see
Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.
NOAA requests comments on this proposed rule by March 31, 2017. In additional to requesting comments on this proposed rule, NOAA is also soliciting input on the DEIS and DMP. In addition NOAA would like the public comments on the proposed name for the sanctuary.
Administrative practice and procedure, Coastal zone, Historic preservation, Intergovernmental relations, Marine resources, Natural resources, Penalties, Recreation and recreation areas, Reporting and recordkeeping requirements, Wildlife.
Accordingly, for the reasons discussed in the preamble, the National Oceanic and Atmospheric Administration proposes to amend 15 CFR part 922 as follows:
16 U.S.C. 1431
Unless noted otherwise, the regulations in subparts A, D, and E of this part apply to all National Marine Sanctuaries and related site-specific regulations set forth in this part. Subparts B and C of this part apply to the sanctuary nomination process and to the designation of future Sanctuaries.
The purpose of the regulations in this subpart and in the site-specific subparts is to implement the designations of the National Marine Sanctuaries by regulating activities affecting them, consistent with their respective terms of designation in order to protect, preserve and manage and thereby ensure the health, integrity and continued availability of the conservation, ecological, recreational, research, educational, historical and aesthetic resources and qualities of these areas. Additional purposes of the regulations implementing the designation of the Florida Keys and Hawaiian Islands Humpback Whale National Marine Sanctuaries are found at §§ 922.160 and 922.180, respectively.
The boundary for each of the National Marine Sanctuaries is set forth in the site-specific regulations covered by this part.
All activities (
The site-specific regulations applicable to the activities specified therein are set forth in the subparts covered by this part.
(a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality, or minimize the imminent risk of such destruction, loss, or injury, any and all such activities are subject to immediate temporary regulation, including prohibition.
(b) The provisions of this section do not apply to the following national marine sanctuaries with site-specific regulations that establish procedures for issuing emergency regulations:
(1) Cordell Bank National Marine Sanctuary, § 922.112(e).
(2) Florida Keys National Marine Sanctuary, § 922.165.
(3) Hawaiian Islands Humpback Whale National Marine Sanctuary, § 922.185.
(4) Thunder Bay National Marine Sanctuary, § 922.196.
(5) Mallows Bay—Potomac River National Marine Sanctuary, § 922.204.
(6) [Reserved]
(b) The prohibitions listed in subparts F through P and R through T of this part do not apply to any activity authorized by a valid lease, permit, license, approval or other authorization in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and issued by any Federal, State or local authority of competent jurisdiction, or by any valid right of subsistence use or access in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, provided that the holder of such authorization or right complies with certification procedures and criteria promulgated at the time of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and with any terms and conditions on the exercise of such authorization or right imposed by the Director as a condition of certification as the Director deems necessary to achieve the purposes for which the Sanctuary was designated.
(a) A person may conduct an activity prohibited by subparts F through O and S and T of this part, if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under this section and subparts F through O and S and T, as appropriate. For the Florida Keys National Marine Sanctuary, a person may conduct an activity prohibited by subpart P of this part if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.166. For the Thunder Bay National Marine Sanctuary and Underwater Preserve, a person may conduct an activity prohibited by subpart R of this part in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.195.
(b) Applications for permits to conduct activities otherwise prohibited by subparts F through O and S and T of this part, should be addressed to the Director and sent to the address specified in subparts F through O of this part, or subparts R through T of this part, as appropriate. An application must include:
(1) A detailed description of the proposed activity including a timetable for completion;
(2) The equipment, personnel and methodology to be employed;
(3) The qualifications and experience of all personnel;
(4) The potential effects of the activity, if any, on Sanctuary resources and qualities; and
(5) Copies of all other required licenses, permits, approvals or other authorizations.
(c) Upon receipt of an application, the Director may request such additional information from the applicant as he or she deems necessary to act on the application and may seek the views of any persons or entity, within or outside the Federal government, and may hold a public hearing, as deemed appropriate.
(d) The Director, at his or her discretion, may issue a permit, subject to such terms and conditions as he or she deems appropriate, to conduct a prohibited activity, in accordance with the criteria found in subparts F through O of this part, or subparts R through T of this part, as appropriate. The Director shall further impose, at a minimum, the conditions set forth in the relevant subpart.
(e) A permit granted pursuant to this section is nontransferable.
(f) The Director may amend, suspend, or revoke a permit issued pursuant to
(a) A person may conduct an activity prohibited by subparts L through P of this part, or subparts R through T of this part, if such activity is specifically authorized by any valid Federal, State, or local lease, permit, license, approval, or other authorization issued after the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary after the effective date of the regulations in subpart P, provided that:
(1) The applicant notifies the Director, in writing, of the application for such authorization (and of any application for an amendment, renewal, or extension of such authorization) within fifteen (15) days of the date of filing of the application or the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P of this part, whichever is later;
(2) The applicant complies with the other provisions of this section;
(3) The Director notifies the applicant and authorizing agency that he or she does not object to issuance of the authorization (or amendment, renewal, or extension); and
(4) The applicant complies with any terms and conditions the Director deems reasonably necessary to protect Sanctuary resources and qualities.
(b) Any potential applicant for an authorization described in paragraph (a) of this section may request the Director to issue a finding as to whether the activity for which an application is intended to be made is prohibited by subparts L through P of this part, or subparts R through T of this part, as appropriate.
(c) Notification of filings of applications should be sent to the Director, Office of National Marine Sanctuaries at the address specified in subparts L through P of this part, or subparts R through T of this part, as appropriate. A copy of the application must accompany the notification.
(d) The Director may request additional information from the applicant as he or she deems reasonably necessary to determine whether to object to issuance of an authorization described in paragraph (a) of this section, or what terms and conditions are reasonably necessary to protect Sanctuary resources and qualities. The information requested must be received by the Director within 45 days of the postmark date of the request. The Director may seek the views of any persons on the application.
(e) The Director shall notify, in writing, the agency to which application has been made of his or her pending review of the application and possible objection to issuance. Upon completion of review of the application and information received with respect thereto, the Director shall notify both the agency and applicant, in writing, whether he or she has an objection to issuance and what terms and conditions he or she deems reasonably necessary to protect Sanctuary resources and qualities, and reasons therefor.
(f) The Director may amend the terms and conditions deemed reasonably necessary to protect Sanctuary resources and qualities whenever additional information becomes available justifying such an amendment.
(g) Any time limit prescribed in or established under this section may be extended by the Director for good cause.
(h) The applicant may appeal any objection by, or terms or conditions imposed by, the Director to the Assistant Administrator or designee in accordance with the provisions of § 922.50.
(a)(1) Except for permit actions taken for enforcement reasons (see subpart D of 15 CFR part 904 for applicable procedures), an applicant for, or a holder of, a National Marine Sanctuary permit; an applicant for, or a holder of, a Special Use permit issued pursuant to section 310 of the Act; a person requesting certification of an existing lease, permit, license or right of subsistence use or access under § 922.47; or, for those Sanctuaries described in subparts L through P and R through T of this part, an applicant for a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction (hereinafter appellant) may appeal to the Assistant Administrator:
(i) The granting, denial, conditioning, amendment, suspension or revocation by the Director of a National Marine Sanctuary or Special Use permit;
(ii) The conditioning, amendment, suspension or revocation of a certification under § 922.47; or
(iii) For those Sanctuaries described in subparts L through P and R through T of this part, the objection to issuance of or the imposition of terms and conditions on a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction.
(2) For those National Marine Sanctuaries described in subparts F through K and S and T of this part, any interested person may also appeal the same actions described in paragraphs (a)(1)(i) and (ii) of this section. For appeals arising from actions taken with respect to these National Marine Sanctuaries, the term “appellant” includes any such interested persons.
(b) An appeal under paragraph (a) of this section must be in writing, state the action(s) by the Director appealed and the reason(s) for the appeal, and be received within 30 days of receipt of notice of the action by the Director. Appeals should be addressed to the Assistant Administrator for Ocean Services and Coastal Zone Management, NOAA 1305 East-West Highway, 13th Floor, Silver Spring, MD 20910.
(c)(1) The Assistant Administrator may request the appellant to submit such information as the Assistant Administrator deems necessary in order for him or her to decide the appeal. The information requested must be received by the Assistant Administrator within 45 days of the postmark date of the request. The Assistant Administrator may seek the views of any other persons. For the Monitor National Marine Sanctuary, if the appellant has requested a hearing, the Assistant Administrator shall grant an informal hearing. For all other National Marine Sanctuaries, the Assistant Administrator may determine whether to hold an informal hearing on the appeal. If the Assistant Administrator determines that an informal hearing should be held, the Assistant Administrator may designate an officer before whom the hearing shall be held.
(2) The hearing officer shall give notice in the
(d) The Assistant Administrator shall decide the appeal using the same regulatory criteria as for the initial decision and shall base the appeal decision on the record before the Director and any information submitted regarding the appeal, and, if a hearing has been held, on the record before the hearing officer and the hearing officer's recommended decision. The Assistant Administrator shall notify the appellant of the final decision and the reason(s) therefore in writing. The Assistant Administrator's decision shall constitute final agency action for the purpose of the Administrative Procedure Act.
(e) Any time limit prescribed in or established under this section other than the 30-day limit for filing an appeal may be extended by the Assistant Administrator or hearing office for good cause.
The Mallows Bay—Potomac River National Marine Sanctuary consists of an area of approximately 39 square nautical miles (nmi 2) (52 sq. mi) of waters of the state of Maryland in the Potomac River and the submerged lands thereunder, over, around, and under the underwater cultural resources in the Potomac River. The precise boundary coordinates are listed in appendix A to this subpart. The southern and western boundary of the sanctuary approximates the border between the Commonwealth of Virginia and the State of Maryland along the western side of the Potomac River and begins at Point 1 east of Choptank Creek in King George County near Hooes, VA. From this point the boundary continues to the west passing through the points in numerical order until it reaches Point 237 at Bull Bluff on the southern side of the mouth of Potomac Creek. From this point the boundary continues north across the mouth of Potomac Creek to Point 238 near Marlboro Point in Stafford, VA. and once again follows the points in numerical order until it reaches Point 269 at the southern side of the mouth of Aquia Creek. From this point the boundary continues north across the mouth of Aquia Creek to Point 270 near Brent Point in Stafford, VA. The boundary then continues north passing through the points in numerical order until it reaches Point 312 north of Tank Creek near the restricted area in the Potomac River around Marine Base Quantico at the mouth of Chopawamsic Creek. From this point the boundary continues outside of and around the restricted area to the east and then north again passing through the points in numerical order until it reaches Point 343 south of Quantico Marina. From this point the boundary continues to the east, then north and west around the marina and then north again following the points in numerical order until it reaches Point 365 at Shipping Point on the southern side of the mouth of Quantico Creek in Quantico, VA. From this point the boundary moves to the NNE across the mouth of Quantico Creek to Possum Point near Dumfries, VA. From this point the boundary continues north passing through the points in numerical order until it reaches Point 390 SE of Southbridge, VA. From this point the boundary moves SE towards Point 391 in a straight line crossing the Potomac River until it intersects the shoreline of the river at Moss Point on the Maryland side at mean high water near Indian Head, MD just north of Goose Bay. From this intersection the boundary then follows the shoreline initially to the SW cutting across the mouths of creeks and streams along the eastern side of the Potomac River, then south past Sandy Point and around Mallows Bay. The boundary then continues following the shoreline south past Smith Point and Thomas Point where it turns to the SE and then east around Maryland Point. From here the boundary continues to follow the shoreline to the ENE past Riverside, MD until it intersects the line formed between Point 392 and Point 393 at Benny Gray Point on the western side of the mouth of Nanjemoy Creek on Tayloe Neck in Maryland. Finally, from this intersection the boundary crosses the Potomac River to the SE in a straight line and continues to Point 393 east of Choptank Creek on the Virginia side of the Potomac River.
(a) The following terms are defined for purposes of this subpart:
(1)
(2) [Reserved]
(b) All other terms appearing in the regulations in this subpart are defined at 15 CFR 922.3, and/or in the Marine Protection, Research, and Sanctuaries Act, as amended, 33 U.S.C. 1401
NOAA has primary responsibility for the management of the Sanctuary pursuant to the Act. However, NOAA shall co-manage the Sanctuary in collaboration with the State of Maryland and Charles County. The Director shall enter into a Memorandum of Understanding regarding this collaboration that shall address, but not be limited to, such aspects as areas of mutual concern, including Sanctuary programs, permitting, activities, development, and threats to Sanctuary resources.
(a) Except as specified in paragraphs (b) and (c) of this section, the following activities are prohibited and thus are unlawful for any person to conduct or to cause to be conducted:
(1) Moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a Sanctuary resource. This prohibition does not apply to possessing historical resources removed from the Sanctuary area before the effective date of the Sanctuary designation.
(2) Marking, defacing, or damaging in any way, or displacing or removing or
(3) Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation or any permit issued under the Act.
(b) The prohibitions in paragraphs (a)(1) through (3) of this section do not apply to any activity necessary to respond to an emergency threatening life, property or the environment; or to activities necessary for valid law enforcement purposes.
(c)(1) Department of Defense activities must be carried out in a manner that avoids to the maximum extent practicable any adverse impacts on Sanctuary resources.
(2) In the event of destruction of, loss of, or injury to a Sanctuary resource resulting from an incident, including but not limited to discharges, deposits, and groundings, caused by a Department of Defense activity, the Department of Defense, in coordination with the Director, must promptly prevent and mitigate further damage and must restore or replace the Sanctuary resource in a manner approved by the Director.
(a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource, or to minimize the imminent risk of such destruction, loss, or injury, any and all activities are subject to immediate temporary regulation, including prohibition. An emergency regulation shall not take effect without the approval of the Governor of Maryland or her/his designee or designated agency.
(b) Emergency regulations remain in effect until a date fixed in the rule or six months after the effective date, whichever is earlier. The rule may be extended once for not more than six months.
(a)
(1) The provisions of subpart E of this part; and
(2) The relevant site specific regulations appearing in this subpart.
(b)
(1) Research—activities that constitute scientific research on or scientific monitoring of national marine sanctuary resources or qualities;
(2) Education—activities that enhance public awareness, understanding, or appreciation of a national marine sanctuary or national marine sanctuary resources or qualities; or
(3) Management—activities that assist in managing a national marine sanctuary.
(c)
(1) The proposed activity will be conducted in a manner compatible with the primary objective of protection of national marine sanctuary resources and qualities, taking into account the following factors:
(i) The extent to which the conduct of the activity may diminish or enhance national marine sanctuary resources and qualities; and
(ii) Any indirect, secondary or cumulative effects of the activity.
(2) It is necessary to conduct the proposed activity within the national marine sanctuary to achieve its stated purpose.
(3) The methods and procedures proposed by the applicant are appropriate to achieve the proposed activity's stated purpose and eliminate, minimize, or mitigate adverse effects on sanctuary resources and qualities as much as possible.
(4) The duration of the proposed activity and its effects are no longer than necessary to achieve the activity's stated purpose.
(5) The expected end value of the activity to the furtherance of national marine sanctuary goals and purposes outweighs any potential adverse impacts on sanctuary resources and qualities from the conduct of the activity.
(6) The applicant is professionally qualified to conduct and complete the proposed activity.
(7) The applicant has adequate financial resources available to conduct and complete the proposed activity and terms and conditions of the permit.
(8) There are no other factors that would make the issuance of a permit for the activity inappropriate.
(a) A person may conduct an activity prohibited by § 922.203(a)(1) through (3) if such activity is specifically authorized by a valid Federal, state, or local lease, permit, license, approval, or other authorization, or tribal right of subsistence use or access in existence prior to the effective date of sanctuary designation and within the sanctuary designated area and complies with § 922.49 and provided that the holder of the lease, permit, license, approval, or other authorization complies with the requirements of paragraph (e) of this section.
(b) In considering whether to make the certifications called for in this section, the Director may seek and consider the views of any other person or entity, within or outside the Federal government, and may hold a public hearing as deemed appropriate.
(c) The Director may amend, suspend, or revoke any certification made under this section whenever continued operation would otherwise be inconsistent with any terms or conditions of the certification. Any such action shall be forwarded in writing to both the holder of the certified permit, license, or other authorization and the issuing agency and shall set forth reason(s) for the action taken.
(d) Requests for findings or certifications should be addressed to the Director, Office of National Marine Sanctuaries; ATTN: Sanctuary Superintendent, Mallows Bay—Potomac National Marine Sanctuary, 1305 East West Hwy., 11th Floor, Silver Spring, MD 20910. A copy of the lease, permit, license, approval, or other authorization must accompany the request.
(e) For an activity described in paragraph (a) of this section, the holder of the authorization or right may conduct the activity prohibited by § 922.203(a)(1) through (3) provided that:
(1) The holder of such authorization or right notifies the Director, in writing, within 180 days of the effective date of Sanctuary designation, of the existence of such authorization or right and requests certification of such authorization or right;
(2) The holder complies with the other provisions of this section; and
(3) The holder complies with any terms and conditions on the exercise of such authorization or right imposed as a condition of certification, by the Director, to achieve the purposes for which the Sanctuary was designated.
(f) The holder of an authorization or right described in paragraph (a) of this section authorizing an activity prohibited by § 922.203 may conduct the activity without being in violation of applicable provisions of § 922.203, pending final agency action on his or her certification request, provided the holder is otherwise in compliance with this section.
(g) The Director may request additional information from the certification requester as he or she deems reasonably necessary to condition appropriately the exercise of the certified authorization or right to achieve the purposes for which the Sanctuary was designated. The Director must receive the information requested within 45 days of the postmark date of the request. The Director may seek the views of any persons on the certification request.
(h) The Director may amend any certification made under this section whenever additional information becomes available that he/she determines justifies such an amendment.
(i) Upon completion of review of the authorization or right and information received with respect thereto, the Director shall communicate, in writing, any decision on a certification request or any action taken with respect to any certification made under this section, in writing, to both the holder of the certified lease, permit, license, approval, other authorization, or right, and the issuing agency, and shall set forth the reason(s) for the decision or action taken.
(j) The holder may appeal any action conditioning, amending, suspending, or revoking any certification in accordance with the procedures set forth in § 922.50.
(k) Any time limit prescribed in or established under this section may be extended by the Director for good cause.
Coordinates listed in this appendix are unprojected (Geographic) and based on the North American Datum of 1983.
The coordinates in the table above marked with an asterisk (*) are not a part of the sanctuary boundary. These coordinates are landward reference points used to draw a line segment that intersects with the shoreline.
Under the authority of the National Marine Sanctuaries Act, as amended (the “Act” or “NMSA”), 16 U.S.C. 1431
The NMSA authorizes the issuance of such regulations as are necessary and reasonable to implement the designation, including managing and protecting the historical resources and recreational, research, and educational qualities of the Mallows Bay—Potomac River National Marine Sanctuary (the “Sanctuary”). Section 1 of Article IV of this Designation Document lists those activities that may have to be regulated on the effective date of designation, or at some later date, in order to protect Sanctuary resources and qualities. Listing an activity does not necessarily mean that it will be regulated; however, if an activity is not listed it may not be regulated, except on an emergency basis, unless Section 1 of Article IV is amended by the same procedures by which the original Sanctuary designation was made.
The Mallows Bay—Potomac River National Marine Sanctuary consists of an area of approximately 39 square nautical miles (nmi 2) (52 sq. mi) of waters of the state of Maryland in the Potomac River and the submerged lands thereunder, over, around, and under the underwater cultural resources in the Potomac River. The southern and western boundary of the sanctuary approximates the border between the Commonwealth of Virginia and the State of Maryland for roughly 29 miles along the western side of the Potomac River and begins east of Choptank Creek in King George County near Hooes, VA. From this point the boundary approximates the border west and then north cutting across the mouths of Choptank Creek, Potomac Creek, and Aquia Creek. The boundary then continues past Widewater, VA and around the Marine Base Quantico restricted area to the east and then continues north again cutting across the mouth of Quantico Creek. From a point just north of Quantico Creek and Possum Point near Dumfries, VA the boundary crosses the Potomac to the southeast until it intersects the Maryland shoreline at Moss Point near Indian Head, MD. From this point the eastern and northern boundary of the sanctuary, approximately 21 miles in length, follows the Maryland shoreline south past Sandy Point and Mallows Bay cutting across the mouths of streams and creeks. The boundary then continues following the shoreline south past Smith Point and Thomas Point where it turns to the east around Maryland Point. From here the boundary continues to follow the shoreline past Riverside, MD to a location at Benny Gray Point on the western side of the mouth of Nanjemoy Creek on Tayloe Neck in Maryland. From here the boundary crosses the Potomac River again to the south back to its point of origin east of Choptank Creek on the Virginia side of the river. The boundary encompasses all tidal waters within this boundary from mean high tide in Maryland to mean low tide in Virginia. Excluded from the sanctuary are areas where the Virginia state line is otherwise delineated, the Quantico exclusion zone, and the area around the Quantico marina.
Mallows Bay—Potomac River National Marine Sanctuary and its surrounding waters contain a diverse collection of nearly 200 known historic shipwreck vessels dating back to the Civil War and potentially dating back to the Revolutionary War as well as archaeological artifacts dating back 12,000 years indicating the presence of some of the region's earliest American Indian cultures, including the Piscataway Indian Nation and the Piscataway Conoy Tribe of Maryland. The area is most renowned for the remains of over 100 wooden steamships, known as the “Ghost Fleet,” that were built for the U.S. Emergency Fleet between 1917-1919 as part of U.S. engagement in World War I. Their construction at more than 40 shipyards in 17 states reflects the massive national wartime effort that drove the expansion and economic development of communities and related maritime service industries including the present-day Merchant Marines. The area is contiguous to the Captain John Smith Chesapeake National Historic Trail, the Star Spangled Banner National Historic Trail, the Potomac Heritage National Scenic Trail and the Lower Potomac Water Trail which offer meaningful educational and recreational opportunities centered on the region's culture, heritage and history. Additionally, the structure provided by the vessels and related infrastructure serve as important habitat to thriving populations of recreational fisheries, bald eagles, and other aquatic species. The area's listing on the National Historical Register of Places in 2015 codifies the historical, archaeological and recreational significance of the Ghost Fleet and related maritime heritage sites in and around Mallows Bay—Potomac River National Marine Sanctuary.
Section 1. Activities Subject to Regulation. The following activities are subject to regulation, including prohibition, to the extent necessary and reasonable to ensure the protection and management of the historical resources and recreational, research and educational qualities of the area:
a. Damaging sanctuary resources.
b. Damaging sanctuary property.
c. Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation issued under the Act.
Section 2. Emergencies. Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource; or minimize the imminent risk of such destruction, loss, or injury, any activity, including those not listed in Section 1, is subject to immediate temporary regulation. An emergency regulation shall not take effect without the approval of the Governor of Maryland or her/his designee or designated agency.
Section 1. Fishing Regulations, Licenses, and Permits. Fishing in the Sanctuary shall not be regulated as part of the Sanctuary management regime authorized by the Act. However, fishing in the Sanctuary may be regulated by other Federal, State, Tribal and local authorities of competent jurisdiction, and designation of the Sanctuary shall have no effect on any regulation, permit, or license issued thereunder.
Section 2. Other Regulations, Licenses, and Permits. If any valid regulation issued by any Federal, state, Tribal, or local authority of
Section 3. Defense Activities. Department of Defense activities must be carried out in a manner that avoids to the maximum extent practicable any adverse impacts on Sanctuary resources and qualities.
The terms of designation may be modified only by the same procedures by which the original designation is made, including public meetings, consultation according to the NMSA.
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Proposed rule.
The National Oceanic and Atmospheric Administration (NOAA) is proposing to designate an area of 1,075 square miles of Wisconsin state waters as the Wisconsin—Lake Michigan National Marine Sanctuary (WLMNMS or sanctuary). NOAA also proposes regulations to implement the sanctuary designation and establish the sanctuary's terms of designation. A draft environmental impact statement and draft management plan have also been prepared for this proposed action. The purpose of this action is to supplement current Wisconsin state regulations and resource protection efforts in a way that will ensure long term protection of the nationally significant collection of historic shipwrecks and other maritime heritage resources in the area. NOAA is soliciting public comment on the proposed rule, draft environmental impact statement (DEIS), and draft management plan (DMP). NOAA will also begin consultations under Section 106 of the National Historic Preservation Act (NHPA) and solicit public comments specifically related to the identification and assessment of the historic properties within the affected area in compliance with Section 106 review process.
NOAA will consider all comments received by March 31, 2017. Public meetings will be held on the following dates:
(1) March 13, 2017, 6:30 p.m. to 8:30 p.m., Algoma, WI;
(2) March 14, 2017, 6:30 p.m. to 8:30 p.m., Manitowoc, WI;
(3) March 15, 2017, 6:30 p.m. to 8:30 p.m., Sheboygan, WI; and
(4) March 16, 2017, 6:30 p.m. to 8:30 p.m., Port Washington, WI.
You may submit comments on this document, identified by NOAA-NOS-2016-0150, by any of the following methods:
•
•
Copies of the proposed rule, DEIS, and DMP can be downloaded or viewed on the internet at
The public meeting locations are:
Russ Green, Regional Coordinator, Northeast and Great Lakes Region at (920) 459-4425 or
The National Marine Sanctuaries Act (NMSA; 16 U.S.C. 1431
The 1,075-square-mile area proposed for designation as the Wisconsin—Lake Michigan National Marine Sanctuary
The area includes a nationally significant collection of maritime heritage resources, including 37 known shipwrecks, about 80 suspected shipwrecks, and numerous other historic maritime-related features such as historic cribs, docks, and piers. The historic shipwrecks in the proposed sanctuary are representative of the vessels that sailed and steamed this corridor, carrying grain and raw materials east as other vessels came west loaded with coal, manufactured goods, and people. Eighteen of the 37 shipwreck sites are listed on the National Register of Historic Places. Many of the shipwrecks in the proposed sanctuary retain an unusual degree of architectural integrity, with 14 vessels nearly intact. Well preserved by Lake Michigan's cold, fresh water, the shipwrecks and related maritime heritage sites in and around the proposed Wisconsin—Lake Michigan National Marine Sanctuary possess exceptional historical, archaeological and recreational value.
On December 2, 2014, pursuant to section 304 of the NMSA and the Sanctuary Nomination Process (SNP; 79 FR 33851), Wisconsin Governor Scott Walker, on behalf of the State of Wisconsin; the Cities of Two Rivers, Manitowoc, Sheboygan, and Port Washington; the Counties of Ozaukee, Sheboygan, and Manitowoc, submitted a nomination asking NOAA to consider designating this area of Wisconsin's Lake Michigan waters as a national marine sanctuary. The State of Wisconsin's selection of this geographic area for the nomination drew heavily from a 2008 report conducted by the Wisconsin History Society and funded by the Wisconsin Coastal Management Program (
NOAA began the sanctuary designation process for Wisconsin—Lake Michigan National Marine Sanctuary on October 7, 2015 with the publication of a notice of intent (NOI; 80 FR 60631) to prepare a DEIS and the initiation of a public process, as required under the NMSA and the National Environmental Policy Act (NEPA). The DEIS evaluates alternatives related to the proposed designation of the area, including a preferred alternative. The NOI also announced NOAA's intent to fulfill its responsibilities under the requirements of the NHPA.
A duplicate version of the notice for intent was published in error two days earlier on October 5, 2015 (80 FR 60132). That publication contained the exact same content as the official version made available for public inspection and published on October 7, 2015 (80 FR 60631). Any comments received in connection with the publication in error on October 5, 2015 were accepted and considered by NOAA.
Establishing a national marine sanctuary in Wisconsin waters would complement and supplement existing state-led preservation efforts, research programs, and public outreach initiatives. Threats to the nationally significant resources in the area include both human activities and natural processes. Natural process include the damaging impacts of wind, waves, storms, and ice, as well as the impact of invasive species such as zebra and quagga mussels that today cover most of Lake Michigan's shipwrecks. Human threats to underwater cultural resources include looting and altering sanctuary shipwreck sites and damaging sites by anchoring. These processes threaten the long term sustainability of historic shipwrecks and other underwater cultural resources, and negatively impact their recreational and archaeological value. Examples of these impacts include: Anchor damage from visiting dive boats, damage due to unpermitted and poorly attached mooring lines, artifacts being looted, artifacts being moved within a shipwreck site, a remotely-operated vehicle tether entangled within a shipwreck, fishing gear entangled within a shipwreck, increased invasive mussel coverage, and the disturbance and natural deterioration of newly uncovered shipwrecks within the boundary's large swaths of shallow, sandy lakebottom.
The sanctuary would enhance and facilitate broader lake conservation efforts as well as heritage tourism within the many communities that have embraced their centuries-long maritime relationship with Lake Michigan, the Great Lakes region, and the nation. A sanctuary designation would enhance existing comprehensive management programs. The presence of a sanctuary would provide access to NOAA's extended network of scientific expertise and technological resources, enhance ongoing research, and provide an umbrella for the coordination of these activities. It would support and build on existing educational initiatives and provide programming and technology for K-12, post-graduate, and the general public across the state. A sanctuary designation, the local commitment to the sanctuary, the existing state agency interest, and NOAA's existing network of affiliated programs has the potential to create synergies that reach far beyond the proposed sanctuary boundaries.
NOAA may identify areas to consider for national marine sanctuary designation through the community-based SNP described above. The process for designating a new national marine sanctuary is described in the NMSA and has four steps:
On October 7, 2015 NOAA initiated the public scoping process with the publication of the NOI in the
During the public comment period, NOAA hosted three public meetings in November 2015 and provided additional opportunity for comments through a web-based portal [
During this period, approximately 135 individuals provided input. Comments were overwhelmingly supportive of the goals of sanctuary designation, including the rationale for conservation of nationally-significant resources, considerations that enhance public use and recreation, considerations that enhance tourism and the local economy, and as a venue for education, science and interpretation as described in the community nomination.
The comments underscored the need for conservation and interpretation, particularly the importance of educating users about the importance of the Great Lakes and the role that shipbuilding and shipping commerce has played in the history of the region and our nation. There was strong support from local communities, governments, and organizations supporting sanctuary designation and offering opportunities to partner for education, research, outreach and other activities.
Several commenters who otherwise supported sanctuary designation expressed concern that designation should not in any way disrupt existing lake commerce. Specific concerns focused on the need for continued ability to dredge and maintain ports and the continued ability for ships to ballast in port and in open water.
The few comments in opposition to sanctuary designation were concerned about the cost of implementation, the possibility that designation would make metal detecting illegal, and that designation would be an unneeded level of government intervention.
There were several requests that NOAA consider expanding the proposed boundaries. Several comments suggesting expansion north to include shipwrecks in Kewaunee County, and one commenter requested inclusion of Green Bay.
NOAA used the public comments submitted during the scoping process to inform the preparation of the DMP, DEIS, and the proposed sanctuary regulations. In response to many of these comments, this proposed rule proposes to provide additional protection to maritime heritage resources, particularly the nationally significant collection of historic shipwrecks. The environmental effects of these proposed designations are analyzed in a DEIS published concurrently with this proposed rule. NOAA has also developed an associated DMP describing sanctuary management activities in the area proposed for designation. NOAA is seeking public comment on the proposed rule, DEIS, and DMP, which are available at
NOAA is proposing to amend 15 CFR part 922 by adding a new subpart (subpart T) that contains site-specific regulations for WLMNMS. This subpart would include the proposed boundary, contain definitions of common terms used in the new subpart, provide a framework for co-management of the sanctuary, identify prohibited activities and exceptions, and establish procedures for certification of existing uses, permitting otherwise prohibited activities, and emergency regulation procedures. Several conforming changes would also be made to the national sanctuary regulations as described below.
NOAA is concurrently working on designating a separate new national marine sanctuary in Mallows Bay—Potomac River waters as part of a separate rulemaking process, and those regulations would be published in their own new subpart (subpart S). As such, in this rulemaking, NOAA proposes to add and reserve subpart S for any future site-specific regulations that might be issued. NOAA would harmonize the regulations for the Mallows Bay-Potomac River designation process with any final rule associated with this action.
NOAA has proposed to name the sanctuary the “Wisconsin—Lake Michigan National Marine Sanctuary (WLMNMS)” based on the nomination submitted by the community. This name aptly identifies both the lake and state where the proposed sanctuary is located. NOAA is asking for the public to provide input on this proposed name. The public may also suggest an alternative name and state the reasons for suggesting an alternative name.
NOAA is proposing to designate a 1,075-square mile area of Lake Michigan waters off Ozaukee, Sheboygan, and Manitowoc Counties as WLMNMS. The sanctuary's shoreward boundary would be defined by the Ordinary High Water Mark as defined by the state of Wisconsin, while the lakeward boundary would be drawn to include all known shipwrecks in each county, extending 16 miles offshore at its greatest extent. The harbors and marinas of Two Rivers, Manitowoc, Sheboygan, and Port Washington would not be included in the sanctuary. The detailed legal boundary description is included in section 922.210 and the coordinates are located in 15 CFR part 922, subpart T, appendix A. A map of the area is shown in the DEIS.
Within this proposed boundary are 37 known shipwrecks, including 18 on the National Register of Historic Places. The sanctuary would provide comprehensive protection of underwater cultural resources as well as develop partnerships and resources for education, interpretation, personnel, research, and administration. This would provide enhanced management of underwater cultural resources, as well as potential economic benefits to the coastal communities from Mequon to Two Rivers.
The proposed boundary reflects the boundary the State of Wisconsin submitted to NOAA in the nomination with an adjustment based on discussions with the State of Wisconsin. The State submitted an 875-square-mile boundary in the nomination. NOAA's adjustments result in a 1,075-square-mile boundary, and includes moving the southern and northern boundary lines to
NOAA is proposing a site-specific definition of “sanctuary resources” for the WLMNMS to be tailored to include only the underwater cultural resources found in this area in accordance with the purpose of the proposed designation. The definition would not include biological and ecological resources of the area. Creating this new site-specific definition requires NOAA to modify the national definition of “sanctuary resource” in the national regulations at section 922.3 to add an additional sentence that defines the term for WLMNMS at section 922.211(a). This is similar to the approach taken for other national marine sanctuaries that do not share the full “sanctuary resource” definition such as Thunder Bay National Marine Sanctuary.
The new WLMNMS definition of “sanctuary resources” would be all prehistoric, historic, archaeological, and cultural sites and artifacts within the sanctuary boundary, including but not limited to, all shipwrecks and related components.
Additionally NOAA would add a definition for “shipwreck site” in the WLMNMS regulations at Section 922.211(a) that would define a subset of the “sanctuary resources.” The definition for “shipwreck site” would be more narrowly focused than the broader “sanctuary resource” definition and would be used in one of the prohibited activities regulations. “Shipwreck site” is defined as any sunken watercraft, its components, cargo, contents, and associated debris field.
This proposed rule incorporates and adopts other common terms defined in the existing national regulations at section 922.3. One of the common terms adopted (without modification) is “National Marine Sanctuary” or “Sanctuary,” which means an area of the marine environment of special national significance due to its resource or human-use values, which is designated as such to ensure its conservation and management.
In order to further enhance the engagement forged by the State of Wisconsin in nominating this area to become a national marine sanctuary, NOAA is proposing to manage the sanctuary collaboratively with the State of Wisconsin. NOAA proposes to establish the framework for co-management of the sanctuary at section 922.212 and intends to work out the operational details of the collaboration in a Memorandum of Understanding (MOU). Details on the execution of sanctuary management such as activities, programs, and permitting programs would be included in the MOU and can be updated to adapt to changing conditions or threats to the sanctuary resources. Any significant changes to the regulations or management plan would not only be jointly coordinated but also subject to public review.
NOAA is proposing to supplement and complement existing management of this area by proposing three regulations to protect the sanctuary resources in section 922.213(a).
As a complement to existing protections under state law and NHPA regulations, NOAA is proposing to prohibit moving, removing, recovering, altering, destroying, possessing or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource. This sanctuary prohibition would supplement the existing Wisconsin regulations that prohibit damaging shipwrecks. Since 1991 Wisconsin has had state regulations related to removing or damaging shipwrecks that currently apply to the proposed area and would continue to apply to these resources after sanctuary designation.
NOAA is proposing to prohibit the use of grappling hooks and anchoring devices into shipwreck sites to protect fragile shipwrecks within the sanctuary from damage. To provide the public adequate notice of shipwreck sites, NOAA will prepare and make available sanctuary maps with known and suspected shipwreck sites. Shipwreck sites not listed on maps would still be sanctuary resources and the prohibition on anchoring and grappling would still apply. The proposed management plan includes activities related to surveying the sanctuary area and identifying additional shipwreck sites. As appropriate, and in consideration of resource management conflicts, NOAA would update the maps as new shipwreck sites are found by the sanctuary, the Wisconsin Historical Society, or other public or private groups and individuals. Because NOAA seeks to promote public access, while also ensuring sound resource protection, an initial focus of the sanctuary management plan will be the installation of permanent mooring systems at sanctuary shipwreck sites. The moorings will provide a secure and convenient anchoring point for users, eliminating the need for grappling, and providing additional notice of the location of any known shipwreck site. NOAA is proposing to publish guidelines on best practices for anchoring near shipwrecks sites to avoid violating this prohibition. An example of a best practice could include instructions on using a weighted line, with a suggested maximum weight of 15 pounds, and surface float to mark a wreck for divers to descend and ascend. But the line would not use as an anchoring line; it would need to be continuously tended and removed before the dive boat leaves the area.
NOAA is proposing a regulation to prohibit interfering with sanctuary enforcement activities. This regulation will assist in NOAA's enforcement of the sanctuary regulations and strengthen sanctuary management.
NOAA is proposing to include an exemption from the three regulations described above for activities that respond to emergencies that threaten lives, property or the environment, or are necessary for law enforcement purposes.
As part of the proposed designation, NOAA is proposing to give the sanctuary authority to issue emergency regulations. Emergency regulations are used in limited cases and under specific conditions when there is an imminent risk to sanctuary resources and a temporary prohibition would prevent the destruction or loss of those resources. Under the NMSA, NOAA only issues emergency regulations that address an imminent risk for a fixed amount of time with a maximum of 6 months that can be extended a single time. A full rulemaking process must be undertaken, including a public comment period, to consider making an emergency regulation permanent. NOAA would add the authority to issue emergency regulations by modifying the national regulations at section 922.44 to include WLMNMS in a list of sanctuaries that have site-specific regulations related to emergency
NOAA is proposing to include the authority to issue permits to allow certain activities that would otherwise violate the prohibitions in WLMNMS regulations. Similar to other national marine sanctuaries, NOAA is proposing to consider these permits for the purposes of education, research, or management.
To address the above additions to the ONMS general permit authority for WLMNMS, NOAA would amend regulatory text in the program-wide regulations in part 922, subpart E, to add references to subpart T, as appropriate. NOAA would also add a new section 922.215 in subpart T titled “Permit procedures and review criteria” that would address site-specific permit procedures for WLMNMS.
Because of the possibility that preexisting activities, right of subsistence use or access permitted by other federal, state, local, or tribal agencies might be occurring within the WLMNMS area that would otherwise be prohibited by WLMNMS regulations, NOAA would add language at section 922.216 describing the process by which it can certify existing activities within the WLMNMS area. In compliance with the NMSA, WLMNMS regulations at section 922.216 would state that certification is the process by which permitted activities existing prior to the designation of the sanctuary that violate sanctuary prohibitions may be allowed to continue, provided certain conditions are met. Applications for certifying permitted existing uses would have to be received by NOAA within 180 days of the effective date of the designation.
NOAA also proposes to provide WLMNMS with the authority to consider allowing an otherwise prohibited activity if such activity is specifically authorized by any valid Federal, state, or local lease, permit, license, approval, or other authorization issued after sanctuary designation. Authorization authority is intended to streamline regulatory requirements by reducing the need for multiple permits and would apply to all proposed prohibitions at section 922.213. As such, NOAA proposes to amend the regulatory text at section 922.49 to add reference to subpart T.
NOAA has the authority under the NMSA to issue special use permits (SUPs) at national marine sanctuaries as established by Section 310 of the NMSA. SUPs can be used to authorize specific activities in a sanctuary if such authorization is necessary (1) to establish conditions of access to and use of any sanctuary resource; or (2) to promote public use and understanding of a sanctuary resource. The activities that qualify for a SUP are set forth in the
SUP applications are reviewed to ensure that the activity is compatible with the purposes for which the sanctuary is designated and that the activities carried out under the SUP be conducted in a manner that do not destroy, cause the loss of, or injure sanctuary resources. NOAA also requires SUP permittees to purchase and maintain comprehensive general liability insurance, or post an equivalent bond, against claims arising out of activities conducted under the permit. The NMSA allows NOAA to assess and collect fees for the conduct of any activity under a SUP. The fees collected could be used to recover the administrative costs of issuing the permit, the cost of implementing the permit, monitoring costs associated with the conduct of the activity, and the fair market value of the use of sanctuary resources.
The general regulations in part 922, subpart A, for general information and part 922, subpart E, for regulations of general applicability would also have to be amended so that the regulations are accurate and up-to-date. The 10 sections that will need to be updated to reflect the increased number of sanctuaries or to add subpart T to the list of sanctuaries. The modified sections to conform to adding a new sanctuary are:
Section 304(a)(4) of the National Marine Sanctuaries Act (NMSA) requires that the terms of designation include the geographic area included within the sanctuary; the characteristics of the area that give it conservation, recreational, ecological, historical, research, educational, or aesthetic value; and the types of activities that will be subject to regulation by the Secretary of Commerce to protect these characteristics. Section 304(a)(4) also specifies that the terms of designation may be modified only by the same procedures by which the original designation was made. Thus, the terms of designation serve as a constitution for the Sanctuary.
NOAA is proposing to establish terms to designation that describe the geographic area, resources, and activities as described in details above. NOAA would add the terms of designation language as appendix B to the WLMNMS regulations at 15 CFR part 922, subpart T.
NOAA has determined that the designation of the Wisconsin—Lake Michigan National Marine Sanctuary will not have a negative impact on the National Marine Sanctuary System and that sufficient resources exist to effectively implement sanctuary management plans and to update site characterizations. The finding for NMSA section 304(f) is published on the ONMS Web site for Wisconsin-Lake Michigan designation at
NOAA has prepared a draft environmental impact statement to evaluate the environmental effects of the proposed rulemaking and alternatives as required by NEPA (42 U.S.C. 4321
Section 307 of the Coastal Zone Management Act (CZMA; 16 U.S.C. 1456) requires Federal agencies to consult with a state's coastal program on potential Federal regulations having an effect on state waters. Because WLMNMS encompasses a portion of the Wisconsin State waters, NOAA intends to submit a copy of this proposed rule and supporting documents to the State of Wisconsin Coastal Zone Management Program for evaluation of Federal consistency under the CZMA. NOAA will publish the final rule and designation only after completion of the consultation requirements under the CZMA.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
NOAA has concluded that this regulatory action does not have federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132 because NOAA supplements and complements state and local laws under the NMSA.
The National Historic Preservation Act (NHPA; 16 U.S.C. 470
This analysis seeks to fulfill the requirements of Executive Order 12866 and the Regulatory Flexibility Act. The Small Business Administration has established thresholds on the designation of businesses as “small entities”. A finfish fishing businesses is considered a small business if it has annual receipts of less than $20.5 million. Scenic and Sightseeing and Recreational industries are considered small businesses if they have annual receipts not in excess of $7.5 million. According to these limits, each of the businesses potentially affected by the proposed rule would most likely be small businesses. However, as further discussed below, these regulations will not have a significant economic impact on the affected small entities, and the Chief Counsel for Regulations for the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have significant economic impact on a substantial number of small entities. Thus, NOAA is not required to and has not prepared an initial regulatory flexibility analysis.
Small business user groups include commercial fishing operation, recreation-tourism related businesses, and land use and development businesses. Other user groups not included here are research and education, people who receive passive economic use value from stabilization or improvement to the proposed sanctuary resources, none of whom are small businesses.
Thus, the overall expected impact to all these business in the preferred alternative is “no impact,” and the Chief Counsel for Regulations for the Department of Commerce has certified that this rule will not have a significant economic impact on a substantial number of small entities.
ONMS has a valid Office of Management and Budget (OMB) control number (0648-0141) for the collection of public information related to the processing of ONMS permits across the National Marine Sanctuary System. NOAA's proposal to create WLMNMS would likely result in an increase in the number of requests for ONMS general permits, special use permits, certifications, and authorizations because this action proposes to add general permits and special use permits, certifications, appeals, and the authority to authorize other valid federal, state, or local leases, permits, licenses, approvals, or other authorizations. An increase in the number of ONMS permit requests would require a change to the reporting burden certified for OMB control number 0648-0141. An update to this control number for the processing of ONMS permits would be requested as part of the final rule for sanctuary expansion.
Nationwide, NOAA issues approximately 500 national marine sanctuary permits each year. Of this amount, WLMNMS is expected to add 4 to 5 permit requests per year. The public reporting burden for national marine sanctuaries permits is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the collection of information.
Send comments regarding the burden estimate for this data collection requirement, or any other aspect of this data collection, including suggestions for reducing the burden, to NOAA (see
NOAA requests comments on this proposed rule by March 31, 2017. In additional to requesting comments on this proposed rule, NOAA is also soliciting input on the DEIS and DMP. In addition NOAA would like the public comments on the proposed name for the sanctuary.
Administrative practice and procedure, Coastal zone, Historic preservation, Intergovernmental relations, Marine resources, Natural resources, Penalties, Recreation and recreation areas, Reporting and recordkeeping requirements, Wildlife.
Accordingly, for the reasons discussed in the preamble, the National Oceanic and Atmospheric Administration proposes to amend 15 CFR part 922 as follows:
16 U.S.C. 1431
Unless noted otherwise, the regulations in subparts A, D, and E of this part apply to all National Marine Sanctuaries and related site-specific regulations set forth in this part. Subparts B and C of this part apply to the sanctuary nomination process and to the designation of future Sanctuaries.
The purpose of the regulations in this subpart and in the site-specific subparts is to implement the designations of the National Marine Sanctuaries by regulating activities affecting them, consistent with their respective terms of designation in order to protect, preserve and manage and thereby ensure the health, integrity and continued availability of the conservation, ecological, recreational, research, educational, historical and aesthetic resources and qualities of these areas. Additional purposes of the regulations implementing the designation of the Florida Keys and Hawaiian Islands Humpback Whale National Marine Sanctuaries are found at §§ 922.160 and 922.180, respectively.
The boundary for each of the National Marine Sanctuaries is set forth in the site-specific regulations covered by this part.
All activities (
The site-specific regulations applicable to the activities specified therein are set forth in the subparts covered by this part.
(a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality, or minimize the imminent risk of such destruction, loss, or injury, any and all such activities are subject to immediate temporary regulation, including prohibition.
(b) The provisions of this section do not apply to the following national marine sanctuaries with site-specific regulations that establish procedures for issuing emergency regulations:
(1) Cordell Bank National Marine Sanctuary, § 922.112(e).
(2) Florida Keys National Marine Sanctuary, § 922.165.
(3) Hawaiian Islands Humpback Whale National Marine Sanctuary, § 922.185.
(4) Thunder Bay National Marine Sanctuary, § 922.196.
(5) [Reserved]
(6) Wisconsin—Lake Michigan National Marine Sanctuary, § 922.214.
(b) The prohibitions listed in subparts F through P and R through T of this part do not apply to any activity authorized by a valid lease, permit, license, approval or other authorization in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and issued by any Federal, State or local authority of competent jurisdiction, or by any valid right of subsistence use or access in existence on the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, provided that the holder of such authorization or right complies with certification procedures and criteria promulgated at the time of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, and with any terms and conditions on the exercise of such authorization or right imposed by the Director as a condition of certification as the Director deems necessary to achieve the purposes for which the Sanctuary was designated.
(a) A person may conduct an activity prohibited by subparts F through O and S and T of this part, if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under this section and subparts F through O and S and T, as appropriate. For the Florida Keys National Marine Sanctuary, a person may conduct an activity prohibited by subpart P of this part if conducted in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.166. For the Thunder Bay National Marine Sanctuary and Underwater Preserve, a person may conduct an activity prohibited by subpart R of this part in accordance with the scope, purpose, terms and conditions of a permit issued under § 922.195.
(b) Applications for permits to conduct activities otherwise prohibited by subparts F through O and S and T of this part, should be addressed to the Director and sent to the address specified in subparts F through O of this part, or subparts R through T of this part, as appropriate. An application must include:
(1) A detailed description of the proposed activity including a timetable for completion;
(2) The equipment, personnel and methodology to be employed;
(3) The qualifications and experience of all personnel;
(4) The potential effects of the activity, if any, on Sanctuary resources and qualities; and
(5) Copies of all other required licenses, permits, approvals or other authorizations.
(c) Upon receipt of an application, the Director may request such additional information from the applicant as he or she deems necessary to act on the application and may seek the views of any persons or entity, within or outside the Federal government, and may hold a public hearing, as deemed appropriate.
(d) The Director, at his or her discretion, may issue a permit, subject to such terms and conditions as he or she deems appropriate, to conduct a prohibited activity, in accordance with the criteria found in subparts F through O of this part, or subparts R through T of this part, as appropriate. The Director shall further impose, at a minimum, the conditions set forth in the relevant subpart.
(e) A permit granted pursuant to this section is nontransferable.
(f) The Director may amend, suspend, or revoke a permit issued pursuant to this section for good cause. The Director may deny a permit application pursuant to this section, in whole or in part, if it is determined that the permittee or applicant has acted in violation of the terms and conditions of a permit or of the regulations set forth in this section or subparts F through O of this part, or subparts R through T of this part or for other good cause. Any such action shall be communicated in writing to the permittee or applicant by certified mail and shall set forth the reason(s) for the action taken. Procedures governing permit sanctions and denials for enforcement reasons are set forth in subpart D of 15 CFR part 904.
(a) A person may conduct an activity prohibited by subparts L through P of this part, or subparts R through T of this part, if such activity is specifically authorized by any valid Federal, State, or local lease, permit, license, approval, or other authorization issued after the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary after the effective date of the regulations in subpart P, provided that:
(1) The applicant notifies the Director, in writing, of the application for such authorization (and of any application for an amendment, renewal, or extension of such authorization) within fifteen (15) days of the date of filing of the application or the effective date of Sanctuary designation, or in the case of the Florida Keys National Marine Sanctuary the effective date of the regulations in subpart P, whichever is later;
(2) The applicant complies with the other provisions of this section;
(3) The Director notifies the applicant and authorizing agency that he or she does not object to issuance of the authorization (or amendment, renewal, or extension); and
(4) The applicant complies with any terms and conditions the Director deems reasonably necessary to protect Sanctuary resources and qualities.
(b) Any potential applicant for an authorization described in paragraph (a)
(c) Notification of filings of applications should be sent to the Director, Office of National Marine Sanctuaries at the address specified in subparts L through P of this part, or subparts R through T of this part, as appropriate. A copy of the application must accompany the notification.
(d) The Director may request additional information from the applicant as he or she deems reasonably necessary to determine whether to object to issuance of an authorization described in paragraph (a) of this section, or what terms and conditions are reasonably necessary to protect Sanctuary resources and qualities. The information requested must be received by the Director within 45 days of the postmark date of the request. The Director may seek the views of any persons on the application.
(e) The Director shall notify, in writing, the agency to which application has been made of his or her pending review of the application and possible objection to issuance. Upon completion of review of the application and information received with respect thereto, the Director shall notify both the agency and applicant, in writing, whether he or she has an objection to issuance and what terms and conditions he or she deems reasonably necessary to protect Sanctuary resources and qualities, and reasons therefor.
(f) The Director may amend the terms and conditions deemed reasonably necessary to protect Sanctuary resources and qualities whenever additional information becomes available justifying such an amendment.
(g) Any time limit prescribed in or established under this section may be extended by the Director for good cause.
(h) The applicant may appeal any objection by, or terms or conditions imposed by, the Director to the Assistant Administrator or designee in accordance with the provisions of § 922.50.
(a)(1) Except for permit actions taken for enforcement reasons (see subpart D of 15 CFR part 904 for applicable procedures), an applicant for, or a holder of, a National Marine Sanctuary permit; an applicant for, or a holder of, a Special Use permit issued pursuant to section 310 of the Act; a person requesting certification of an existing lease, permit, license or right of subsistence use or access under § 922.47; or, for those Sanctuaries described in subparts L through P and R through T of this part, an applicant for a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction (hereinafter appellant) may appeal to the Assistant Administrator:
(i) The granting, denial, conditioning, amendment, suspension or revocation by the Director of a National Marine Sanctuary or Special Use permit;
(ii) The conditioning, amendment, suspension or revocation of a certification under § 922.47; or
(iii) For those Sanctuaries described in subparts L through P and subpart R through T, the objection to issuance of or the imposition of terms and conditions on a lease, permit, license or other authorization issued by any Federal, State, or local authority of competent jurisdiction.
(2) For those National Marine Sanctuaries described in subparts F through K and S and T of this part, any interested person may also appeal the same actions described in paragraphs (a)(1)(i) and (ii) of this section. For appeals arising from actions taken with respect to these National Marine Sanctuaries, the term “appellant” includes any such interested persons.
(b) An appeal under paragraph (a) of this section must be in writing, state the action(s) by the Director appealed and the reason(s) for the appeal, and be received within 30 days of receipt of notice of the action by the Director. Appeals should be addressed to the Assistant Administrator for Ocean Services and Coastal Zone Management, NOAA 1305 East-West Highway, 13th Floor, Silver Spring, MD 20910.
(c)(1) The Assistant Administrator may request the appellant to submit such information as the Assistant Administrator deems necessary in order for him or her to decide the appeal. The information requested must be received by the Assistant Administrator within 45 days of the postmark date of the request. The Assistant Administrator may seek the views of any other persons. For the Monitor National Marine Sanctuary, if the appellant has requested a hearing, the Assistant Administrator shall grant an informal hearing. For all other National Marine Sanctuaries, the Assistant Administrator may determine whether to hold an informal hearing on the appeal. If the Assistant Administrator determines that an informal hearing should be held, the Assistant Administrator may designate an officer before whom the hearing shall be held.
(2) The hearing officer shall give notice in the
(d) The Assistant Administrator shall decide the appeal using the same regulatory criteria as for the initial decision and shall base the appeal decision on the record before the Director and any information submitted regarding the appeal, and, if a hearing has been held, on the record before the hearing officer and the hearing officer's recommended decision. The Assistant Administrator shall notify the appellant of the final decision and the reason(s) therefore in writing. The Assistant Administrator's decision shall constitute final agency action for the purpose of the Administrative Procedure Act.
(e) Any time limit prescribed in or established under this section other than the 30-day limit for filing an appeal may be extended by the Assistant Administrator or hearing office for good cause.
The Wisconsin-Lake Michigan National Marine Sanctuary consists of an area of approximately 812 square nautical miles (nmi2) (1,075 sq. mi) of
(a) The following terms are defined for purposes of this subpart:
(1)
(2)
(b) All other terms appearing in the regulations in this subpart are defined at 15 CFR 922.3, and/or in the Marine Protection, Research, and Sanctuaries Act, as amended, 33 U.S.C. 1401
NOAA has primary responsibility for the management of the Sanctuary pursuant to the Act. However, as the Sanctuary is in state waters, NOAA will co-manage the Sanctuary in collaboration with the State of Wisconsin. The Director may enter into a Memorandum of Understanding regarding this collaboration that may address, but not be limited to, such aspects as areas of mutual concern, including Sanctuary resource protection, programs, permitting, activities, development, and threats to Sanctuary resources.
(a) Except as specified in paragraph (b) of this section, the following activities are prohibited and thus are unlawful for any person to conduct or to cause to be conducted:
(1) Moving, removing, recovering, altering, destroying, possessing, or otherwise injuring, or attempting to move, remove, recover, alter, destroy, possess or otherwise injure a sanctuary resource.
(2) Grappling into or anchoring on shipwreck sites.
(3) Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation or any permit issued under the Act.
(b) The prohibitions in paragraphs (a)(1) through (3) of this section do not apply to any activity necessary to respond to an emergency threatening life, property or the environment; or to activities necessary for valid law enforcement purposes.
(a) Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource, or to minimize the imminent risk of such destruction, loss, or injury, any and all activities are subject to immediate temporary regulation, including prohibition. An emergency regulation shall not take effect without the approval of the Governor of Wisconsin or her/his designee or designated agency.
(b) Emergency regulations remain in effect until a date fixed in the rule or six months after the effective date, whichever is earlier. The rule may be extended once for not more than six months.
(a)
(1) The provisions of subpart E of this part; and
(2) The relevant site specific regulations appearing in this subpart.
(b)
(1) Research—activities that constitute scientific research on or scientific monitoring of national marine sanctuary resources or qualities;
(2) Education—activities that enhance public awareness, understanding, or appreciation of a national marine sanctuary or national marine sanctuary resources or qualities; or
(3) Management—activities that assist in managing a national marine sanctuary.
(c)
(1) The proposed activity will be conducted in a manner compatible with the primary objective of protection of national marine sanctuary resources and qualities, taking into account the following factors:
(i) The extent to which the conduct of the activity may diminish or enhance national marine sanctuary resources and qualities; and
(ii) Any indirect, secondary or cumulative effects of the activity.
(2) It is necessary to conduct the proposed activity within the national marine sanctuary to achieve its stated purpose.
(3) The methods and procedures proposed by the applicant are appropriate to achieve the proposed activity's stated purpose and eliminate, minimize, or mitigate adverse effects on sanctuary resources and qualities as much as possible.
(4) The duration of the proposed activity and its effects are no longer than necessary to achieve the activity's stated purpose.
(5) The expected end value of the activity to the furtherance of national marine sanctuary goals and purposes outweighs any potential adverse impacts on sanctuary resources and qualities from the conduct of the activity.
(6) The applicant is professionally qualified to conduct and complete the proposed activity.
(7) The applicant has adequate financial resources available to conduct and complete the proposed activity and terms and conditions of the permit.
(8) There are no other factors that would make the issuance of a permit for the activity inappropriate.
(a) A person may conduct an activity prohibited by § 922.213(a)(1) through (3) if such activity is specifically authorized by a valid Federal, state, or local lease, permit, license, approval, or other authorization, or tribal right of subsistence use or access in existence prior to the effective date of sanctuary designation and within the sanctuary designated area and complies with § 922.49 and provided that the holder of the lease, permit, license, approval, or other authorization complies with the requirements of paragraph (e) of this section.
(b) In considering whether to make the certifications called for in this section, the Director may seek and consider the views of any other person or entity, within or outside the Federal government, and may hold a public hearing as deemed appropriate.
(c) The Director may amend, suspend, or revoke any certification made under this section whenever continued operation would otherwise be inconsistent with any terms or conditions of the certification. Any such action shall be forwarded in writing to both the holder of the certified permit, license, or other authorization and the issuing agency and shall set forth reason(s) for the action taken.
(d) Requests for findings or certifications should be addressed to the Director, Office of National Marine Sanctuaries; ATTN: Sanctuary Superintendent, Wisconsin-Lake Michigan National Marine Sanctuary, 1305 East-West Hwy, 11th Floor, Silver Spring, MD 20910. A copy of the lease, permit, license, approval, or other authorization must accompany the request.
(e) For an activity described in paragraph (a) of this section, the holder of the authorization or right may conduct the activity prohibited by § 922.213(a)(1) through (3) provided that:
(1) The holder of such authorization or right notifies the Director, in writing, within 180 days of the effective date of Sanctuary designation, of the existence of such authorization or right and requests certification of such authorization or right;
(2) The holder complies with the other provisions of this section; and
(3) The holder complies with any terms and conditions on the exercise of such authorization or right imposed as a condition of certification, by the Director, to achieve the purposes for which the Sanctuary was designated.
(f) The holder of an authorization or right described in paragraph (a) of this section authorizing an activity prohibited by § 922.213 may conduct the activity without being in violation of applicable provisions of § 922.213, pending final agency action on his or her certification request, provided the holder is otherwise in compliance with this section.
(g) The Director may request additional information from the certification requester as he or she deems reasonably necessary to condition appropriately the exercise of the certified authorization or right to achieve the purposes for which the Sanctuary was designated. The Director must receive the information requested within 45 days of the postmark date of the request. The Director may seek the views of any persons on the certification request.
(h) The Director may amend any certification made under this section whenever additional information becomes available that he/she determines justifies such an amendment.
(i) Upon completion of review of the authorization or right and information received with respect thereto, the Director shall communicate, in writing, any decision on a certification request or any action taken with respect to any certification made under this section, in writing, to both the holder of the certified lease, permit, license, approval, other authorization, or right, and the issuing agency, and shall set forth the reason(s) for the decision or action taken.
(j) The holder may appeal any action conditioning, amending, suspending, or revoking any certification in accordance with the procedures set forth in § 922.50.
(k) Any time limit prescribed in or established under this section may be extended by the Director for good cause.
Coordinates listed in this appendix are unprojected (Geographic) and based on the North American Datum of 1983.
The coordinates in the table above marked with an asterisk (*) are not a part of the sanctuary boundary. These coordinates are landward reference points used to draw a line segment that intersects with the shoreline.
Terms of Designation for the Proposed Wisconsin-Lake Michigan National Marine Sanctuary Under the authority of the National Marine Sanctuaries Act, as amended (the “Act” or “NMSA”), 16 U.S.C. 1431
The NMSA authorizes the issuance of such regulations as are necessary and reasonable to implement the designation, including managing and protecting the historical resources and recreational, research, and educational qualities of the Wisconsin-Lake Michigan National Marine Sanctuary (the “Sanctuary”). Section 1 of Article IV of this Designation Document lists those activities that may have to be regulated on the effective date of designation, or at some later date, in order to protect Sanctuary resources and qualities. Listing an activity does not necessarily mean that it will be regulated; however, if an activity is not listed it may not be regulated, except on an emergency basis, unless Section 1 of Article IV is amended by the same procedures by which the original Sanctuary designation was made.
The Wisconsin-Lake Michigan National Marine Sanctuary consists of an area of approximately 812 square nautical miles (nmi2) (1,075 sq. mi) of Lake Michigan waters within the state of Wisconsin and the submerged lands thereunder, over, around, and under the submerged underwater cultural resources in Lake Michigan. The eastern boundary of the sanctuary begins approximately 9.5 miles east of the Wisconsin shoreline in Lake Michigan roughly on the border between Manitowoc and Kewaunee County. From this point the boundary continues in Lake Michigan roughly to the SSW until it intersects the border between Ozaukee and Milwaukee County at a point approximately 13 miles east of the shoreline. The southern boundary continues west approximating the border between these same two counties until it intersects the shoreline near Mequon, WI. The western boundary continues north following the shoreline for approximately 90 miles cutting across the mouths of rivers and streams; specifically those of Sauk Creek at Port Washington, the Sheboygan River at Sheboygan, Manitowoc Harbor as Manitowoc, and East Twin River at Two Rivers as well as any other smaller streams and creeks. The western boundary ends at roughly the border between Manitowoc and Kewaunee County along the shoreline near Twin Creeks, WI. The northern boundary continues from the shoreline east approximating the border between these same two counties back to its point of origin 9.5 miles offshore.
The historic shipwrecks in the Wisconsin-Lake Michigan National Marine Sanctuary are representative of vessels that sailed and steamed the Lake Michigan corridor, carrying grain and raw materials east as other vessels came west loaded with coal, manufactured good, and immigrants. Eighteen of the 37 shipwrecks are listed on the National Register of Historic Places. Many of the shipwrecks in the proposed sanctuary retain an unusual degree of architectural integrity, with 14 vessels virtually intact. Well preserved by Lake Michigan's cold, fresh water, the shipwrecks and related underwater cultural sites in and around the Wisconsin-Lake Michigan National Marine Sanctuary possess exceptional historical, archaeological and recreational value.
Section 1. Activities Subject to Regulation. The following activities are subject to regulation, including prohibition, to the extent necessary and reasonable to ensure the protection and management of the historical resources and recreational, research and educational qualities of the area:
a. Damaging sanctuary resources.
b. Using grappling hooks and anchors at shipwreck sites.
c. Interfering with, obstructing, delaying or preventing an investigation, search, seizure or disposition of seized property in connection with enforcement of the Act or any regulation issued under the Act.
d. Reporting shipwreck discoveries and locations to the sanctuary.
Section 2. Emergencies. Where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource or quality; or minimize the imminent risk of such destruction, loss, or injury, any activity, including those not listed in Section 1, is subject to immediate temporary regulation. An emergency regulation shall not take effect without the approval of the Governor of Wisconsin or her/his designee or designated agency.
Section 1. Fishing Regulations, Licenses, and Permits. Fishing in the Sanctuary shall not be regulated as part of the Sanctuary management regime authorized by the Act. However, fishing in the Sanctuary may be regulated by other Federal, State, Tribal and local authorities of competent jurisdiction, and designation of the Sanctuary shall have no effect on any regulation, permit, or license issued thereunder.
Section 2. Other Regulations, Licenses, and Permits. If any valid regulation issued by any Federal, state, Tribal, or local authority of competent jurisdiction, regardless of when issued, conflicts with a Sanctuary regulation, the regulation deemed by the Director of the Office of National Marine Sanctuaries, National Oceanic and Atmospheric Administration, or designee, in consultation with the State of Wisconsin, to be more protective of Sanctuary resources and qualities shall govern. Pursuant to section 304(c)(1) of the Act, 16 U.S.C. 1434(c)(1), no valid lease, permit, license, approval, or other authorization issued by any Federal, State, Tribal, or local authority of competent jurisdiction, or any right of subsistence use or access, may be terminated by the Secretary of Commerce, or designee, as a result of this designation, or as a result of any Sanctuary regulation, if such lease, permit, license, approval, or other authorization, or right of subsistence use or access was issued or in existence as of the effective date of this designation. However, the Secretary of Commerce or designee, in consultation with the State of Wisconsin, may regulate the exercise of such authorization or right consistent with the purposes for which the Sanctuary is designated.
The terms of designation may be modified only by the same procedures by which the original designation is made, including public meetings, consultation according to the NMSA.
Drug Enforcement Administration, Department of Justice.
Notice of intent.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule six synthetic cannabinoids: Methyl 2-(1-(5-fluoropentyl)-1
January 9, 2017.
Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Any final order will be published in the
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. 21 U.S.C. 801-971. 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 the purpose of this action. The DEA publishes 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 providing 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.
Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of any intention to temporarily place a substance into schedule I of the CSA.
To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).
Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these synthetic cannabinoids (SCs) have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
SCs are substances synthesized in laboratories that mimic the biological effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. It is believed that SCs were first introduced on the designer drug market in several European countries as “herbal incense” before the initial encounter in the United States by U.S. Customs and Border Protection (CBP) in November 2008. From 2009 to the present, misuse and abuse of SCs has increased in the United States with law enforcement encounters describing SCs applied onto plant material and in designer drug products intended for human consumption. It has been demonstrated that the substances and the associated designer drug products are abused for their psychoactive properties. With many generations of SCs having been encountered since 2009, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are some of the latest, and the abuse of these substances is negatively impacting communities.
As observed by the DEA and CBP, SCs originate from foreign sources, such as China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. According to online discussion boards and law enforcement encounters,
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA have no accepted medical use in the United States. Use of these specific SCs has been reported to result in adverse effects in humans including deaths (see 3-Factor document in “Supporting and Related Material” section). Use of other SCs has resulted in signs of addiction and withdrawal, and based on the similar pharmacological profile of these six substances, it is believed that there will be similar observed adverse effects.
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are SCs that have pharmacological effects similar to the schedule I hallucinogen delta-Δ-tetrahydrocannabinol (THC) and temporarily and permanently controlled schedule I synthetic cannabinoid substances. In addition, the misuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have been associated with either overdoses requiring emergency medical intervention or death (see factor 6). With no approved medical use and limited safety or toxicological information, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have emerged on the designer drug market, and the abuse of these substances for their psychoactive properties is concerning. The DEA's analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at
Synthetic cannabinoids have been developed over the last 30 years as tools for investigating the endocannabinoid system (
Research and clinical reports have demonstrated that SCs are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and/or psychoactive “high,” believed to be similar to marijuana. Data gathered from published studies, supplemented by discussions on Internet discussion Web sites, demonstrate that these products are being abused mainly by smoking for their psychoactive properties. The adulterated products are marketed as “legal” alternatives to marijuana. In recent overdoses, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been shown to be applied onto plant material, similar to the SCs that have been previously available.
Law enforcement personnel have encountered various application methods including buckets or cement mixers in which plant material and one or more SCs (including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA) are mixed together, as well as large areas where the plant material is spread out so that a dissolved SC mixture can be applied directly. Once mixed, the SC plant material is then allowed to dry before manufacturers package the product for distribution, ignoring any control mechanisms to prevent contamination or to ensure a consistent, uniform concentration of the substance in each package. Adverse health consequences may also occur from directly ingesting the substance(s) during the manufacturing process. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, similar to other SCs, have been encountered in form of dried leaves or herbal blends.
The designer drug products laced with SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, are often sold under the guise of “herbal incense” or “potpourri,” use various product names, and are routinely labeled “not for human consumption.” Additionally, these products are marketed as a “legal high” or “legal alternative to marijuana” and are readily available over the Internet, in head shops, or sold in convenience stores. There is an incorrect assumption that these products are safe, that they are a synthetic form of marijuana, and that labeling these products as “not for human consumption” is a legal defense to criminal prosecution.
A major concern, as reiterated by public health officials and medical professionals, is the targeting and direct marketing of SCs and SC-containing products to adolescents and youth. This is supported by law enforcement encounters and reports from emergency departments; however, all age groups have been reported by media as abusing these substances and related products. Individuals, including minors, are purchasing SCs from Internet Web sites, gas stations, convenience stores, and head shops.
SCs, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, continue to be encountered on the illicit market regardless of scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Numerous substances are encountered each month, differing only by small modifications intended to avoid prosecution while maintaining the pharmacological effects. Law enforcement and health care professionals continue to report abuse of these substances and their associated products.
As described by the National Institute on Drug Abuse (NIDA), many substances being encountered in the illicit market, specifically SCs, have been available for years but have reentered the marketplace due to a renewed popularity.
The threat of serious injury to the individual following the ingestion of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA and other SCs persists. Numerous calls have been received by poison centers regarding the abuse of products potentially laced with SCs that have resulted in visits to emergency departments. Law enforcement continues to encounter novel SCs on the illicit market, including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA (see factor 5 in “Supporting and Related Material”).
The following information details information obtained through NFLIS
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have all been identified in overdose and/or cases involving death attributed to their abuse. Adverse health effects reported from these incidents involving 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA have included: nausea, persistent vomiting, agitation, altered mental status, seizures, convulsions, loss of consciousness and/or cardio toxicity. Large clusters of overdoses requiring medical care have been reported involving 5F-AMB, MDMB-FUBINACA, MDMB-CHMICA and 5F-ADB. Reported deaths involving these SCs have included 5F-ADB (8); 5F-AMB (6); 5F-APINACA (1); ADB-FUBINACA (2); MDMB-CHMICA (4), European Monitoring Centre for Drugs and Drug Addiction has reported an additional 12 deaths involving MDMB-CHMICA; and MDMB-FUBINACA (1) (see factor 6 in “Supporting and Related Material”).
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA indicate that these SCs have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 22, 2016, notified the Assistant Secretary of the DEA's intention to temporarily place these six substances in schedule I.
This notice of intent initiates a temporary scheduling action and provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h). In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule methyl 2-(1-(5-fluoropentyl)-1
Because the Administrator hereby finds that it is necessary to temporarily place these SCs into schedule I to avoid an imminent hazard to the public safety, any subsequent final order temporarily scheduling these substances will be effective on the date of publication in the
The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the
Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator will take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order.
Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget.
This action will not have substantial direct effects 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. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
(h) * * *
Mine Safety and Health Administration, Labor.
Request for information; reopening of the comment period.
In response to requests from the public, the Mine Safety and Health Administration (MSHA) is reopening the proposed rulemaking record for public comment on the Agency's request for information on Exposure of Underground Miners to Diesel Exhaust.
The comment period for the request for information, published on June 8, 2016 (81 FR 36826), and closed
Submit comments and informational materials for the rulemaking record, identified by RIN 1219-AB86 or Docket No. MSHA-2014-0031, by one of the following methods:
•
•
•
•
•
Sheila A. McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
On June 8, 2016 (81 FR 36826), MSHA published a request for information (RFI) on Exposure of Underground Miners to Diesel Exhaust. The RFI sought input from the public that will help MSHA evaluate the Agency's existing standards and policy guidance on controlling miners' exposures to diesel exhaust to evaluate the effectiveness of the protection now in place to preserve miners' health.
On June 27, 2016, (81 FR 41486), MSHA published a notice in the
During the comment period, MSHA received requests for MSHA and the National Institute for Occupational Safety and Health (NIOSH) to convene a Diesel Exhaust Health Effects Partnership (Partnership) with the mining industry, diesel engine manufacturers, academia and representatives of organized labor to gather information regarding the complex questions contained in the RFI. In response to these requests, MSHA and NIOSH agreed to form a Partnership that includes all relevant stakeholders from the mining community to come together to understand the health effects from underground miners' exposure to diesel exhaust. The Partnership will also provide stakeholders an opportunity to consider best practices and new technologies including engineering controls that enhance control of diesel exhaust exposures to improve protections for miners.
The first meeting of the Diesel Exhaust Health Effects Partnership was held on December 8, 2016, in Washington, Pennsylvania.
During the comment period and at the Partnership meeting, MSHA received requests from stakeholders to reopen the rulemaking record for comment on the RFI and allow the comment period to remain open during the Partnership proceedings. In response to these requests, MSHA is reopening the record for comment and extending the comment period to January 9, 2018. The reopening of the record for comment will allow all interested parties an additional opportunity to re-evaluate all issues related to miners' exposure to diesel exhaust and to determine if improvements can be made.
Mine Safety and Health Administration, Labor.
Proposed rule; reopening the comment period.
The Mine Safety and Health Administration (MSHA) is reopening the rulemaking record and requesting additional comments on the Agency's proposed rule on Proximity Detection Systems for Mobile Machines in Underground Mines which was published in the
The comment period for the proposed rule published September 2, 2015 (80 FR 53070) is reopened. Comments must be received by midnight Daylight Saving Time on February 8, 2017.
Submit comments and informational materials, identified by RIN 1219-AB78 or Docket No. MSHA-2014-0019 by one of the following methods:
•
•
•
•
•
Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
On September 2, 2015, MSHA published a proposed rule, Proximity Detection Systems for Mobile Machines in Underground mines (80 FR 53070). MSHA is reopening the rulemaking record and requesting comments on issues that were raised by commenters during the comment period and on issues that developed after the record closed.
MSHA also observed the operation of proximity detection systems on both continuous mining machines and mobile machines (shuttle cars, ram cars and scoops) on working sections in the United States and South Africa after the record closed. There are 106 mobile machines operating on working sections equipped with proximity detection systems in the United States. MSHA visited six mines that operated 79 of these machines. These mines varied by physical, geological, and environmental conditions. MSHA is also including in the rulemaking record MSHA's field-trip report on the use of proximity detection in South Africa's underground coal mines and materials presented at the National Institute for Occupational Safety and Health (NIOSH) Proximity Detection Partnership Meeting held on June 22, 2016.
Proposed § 75.1733(b)(1) would require that a proximity detection system cause a machine to stop before contacting a miner except for a miner who is in the on-board operator's compartment. MSHA requested comments on the types of machine movement the proximity detection system should stop. Commenters did not support the total de-energization of all functions of the equipment. One commenter noted that a “stop all machine movement” requirement cannot be applied universally to all mobile equipment covered by this proposed rule. The commenter noted that mine operators need the flexibility to configure proximity detection systems and machine responses based on the individual applications needed underground. In support of this comment, the commenter stated that machines that interact with other equipment, machines that require a ground-standing operator to be in contact with the machine, and machines that lack specific capabilities for motion control may need allowances outside of prescriptive requirements. As an example, the commenter stated that shuttle cars and ram cars do not require a miner to stand on the ground nearby to perform required tasks; however, scoops require a miner to touch or be near the machine to do certain work.
One commenter also noted that proximity detection systems present significant problems for performing trouble-shooting and maintenance activities. The commenter provided an example of a mechanic trying to identify a leaking hydraulic hose; the mechanic must remove the miner-wearable component for the machine to be started because the mechanic has to be inside a red zone to diagnose the source of the leak.
The National Institute for Occupational Safety and Health (NIOSH) also commented that requiring all machine movement to stop would potentially limit the development and application of advanced technology for selective shutdown features. NIOSH stated that currently available systems are not capable of providing the level of protection required in the industry while maintaining the operator's freedom to efficiently perform the job. NIOSH further stated that to be acceptable to the miners and to avoid false alarms, a proximity detection system must provide the necessary protection while still allowing normal operation of the machine.
MSHA observed mobile machines with proximity detection systems operating during coal production on working sections. These proximity detection systems functioned as designed to prevent pinning, crushing, and striking accidents. Four of the six mines that MSHA visited in the United States, after the record closed, had proximity detection systems on mobile machines and continuous mining machines on the working section except for full-face mining machines. The mobile machines included shuttle cars, ram cars, and scoops. These mine operators provided all miners on these working sections with miner-wearable components.
MSHA solicits additional comments on whether currently available proximity detection systems are capable of preventing coal hauling machines and scoops from pinning, crushing, and striking miners while maintaining the machine operator's freedom to efficiently perform the job.
Under proposed § 75.1733(b)(1), MSHA would consider stopping a coal hauling machine or scoop to consist of causing it to cease tramming or articulating any part of a machine that could cause the machine to contact a miner. Tramming means to move the machine in a forward or reverse direction. Articulating includes an act of moving or pivoting at a joint, such as when a mobile machine may pivot towards a rib such that the movement could result in pinning, striking, or crushing a miner. Under the proposal, the machine would remain stopped while any miner is within a programmed stop zone. Unexpected tramming and articulation in the direction of a miner may be hazardous. However, MSHA is considering whether it is necessary to stop the movement of all parts of the machine, such as auxiliary movements, as long as the tramming and articulating machine motion that can pin, crush, or strike a miner is stopped. In MSHA's experience, striking, pinning, or crushing hazards are not caused by auxiliary functions such as operation of a pump motor or diesel engine, ram extension, winch movement, vertical bucket movement, or battery lift.
MSHA is also aware of proximity detection system features that only allow authorized miners to perform maintenance. For example, an authorized miner may swipe an identification card over a card reader mounted on the machine or have a separate miner-wearable component that is programmed to allow a miner to perform maintenance. The proximity detection system records each time
MSHA is considering a revision to proposed § 75.1733(b)(1) that would require a proximity detection system to stop a machine from tramming or articulating before contacting a miner except for a miner who (i) is in the on-board operator's compartment, or (ii) performing maintenance with the proximity detection system in maintenance mode.
MSHA observed a miner and a scoop operator perform maintenance by changing the battery on a scoop equipped with a proximity detection system. The miner stayed near the scoop, directed the scoop operator's movement of the machine, and maintained a safe position outside of the proximity detection system's warning zone. MSHA also observed a ram car equipped with a proximity detection system that was installed and programmed to modify its warning and shutdown zone dimensions to allow miners to safely approach the machine to perform maintenance and repairs without causing it to shut down. The warning and shutdown zones extended around the entire machine perimeter during normal operation; however, activating the parking brake reduced these zones to encompass only the pinch point areas around the articulation joint.
MSHA solicits comments on the types of machine movement a proximity detection system should allow for miners to perform necessary maintenance without exposing them to pinning, crushing, or striking hazards. MSHA also solicits comments on miners' and mine operators' experiences with proximity detection systems that allow a miner to conduct maintenance on a machine without activating the stop movement function.
Several commenters also noted that sudden stopping of equipment presents hazards for on-board machine operators. A commenter noted that sudden stops and equipment shut downs, like any other unexpected operations, could put the operator of the machine at risk of injury or death based on the size and speed of the machine, and other related factors. One commenter stated concerns that the requirement to stop the machine before contacting a miner could create a hazard for machine operators, especially diesel-powered machine operators since their ground speed is typically faster than electric-powered machines. However, another commenter stated that MSHA should not require that machines slow down before stopping because some machines, such as battery-powered direct current traction drives, do not have this capability; in some cases, it is more important to stop the machine as fast as possible to prevent contact with miners.
NIOSH commented that field tests of proximity detection systems on continuous mining machines and input from stakeholders found that detection range, environmental effects/limitations, detection accuracy, and system repeatability are considered critical parameters. MSHA observed mobile machines operating in mines in the United States with properly functioning proximity detection systems of various manufacturers with appropriate zone dimensions. These mobile machines worked in a range of seam heights, in dry and wet conditions, on varying grades, with and without wire mesh, with various mine ventilation controls. In MSHA's experience, mine operators work with machine manufacturers and proximity detection system manufacturers to determine the appropriate warning and shutdown zones for the specific mining conditions and practices that the machine encounters. MSHA is aware that proximity detection system manufacturers provide site-specific testing during commissioning of proximity detection systems. MSHA also observed proximity detection system testing used to confirm appropriate zone dimensions for the equipment and the mining conditions at the time of commissioning. MSHA solicits additional comments on appropriate warning and stopping zones for each type of machine movement and various mining conditions including any differences in cost for differing conditions or machines.
Current NIOSH research is identifying critical parameters that impact the performance of proximity detection systems on mobile machines, such as stopping distances and deceleration rates. MSHA is aware that NIOSH research on proximity detection systems for underground mobile equipment is scheduled to conclude in September, 2018. Several commenters expressed concern that the Agency will require proximity detection systems to be installed on coal haulage machines and scoops before the findings from NIOSH research on proximity detection systems on underground mobile machines are released. MSHA is also aware that some mine operators have installed and are operating proximity detection systems on mobile machines. MSHA observed variations in the installation, maintenance and performance of these systems. MSHA anticipates that a final rule would provide minimum standards for installation, performance, maintenance, and recordkeeping to assure that miners are adequately protected. MSHA observed several dynamic tests of mobile machines equipped with proximity detection systems in which the machine decelerated to a full stop without injury to the on-board operator. MSHA also observed warning and shutdown zone incursions on mobile machines equipped with proximity detection systems that are being used on working sections during normal mine production operations. These proximity detection systems appropriately slowed and/or stopped these mobile machines without injuring the on-board machine operator. MSHA is not aware of any on-board operator injuries resulting from a proximity detection system decelerating and/or stopping a mobile machine.
MSHA will continue to work with original equipment manufacturers, proximity detection system manufacturers, NIOSH, States, and mine operators to consider the benefits and timing of requiring proximity detection systems on mobile machines in underground coal mines.
MSHA solicited and received several comments on how the use of proximity detection systems and the overlap of proximity detection system protection zones on multiple types of machines operating on the same working section might affect miners' work positions. One commenter stated that testing, which was conducted in a controlled environment, demonstrated that it was impossible to provide full coverage on the rear section of the coal hauler without creating a shutdown zone in the locations where the continuous mining machine operator was required to stand. A modification to the system allowed the shutdown zone to shrink as the coal hauler backed into the loading position. Due to the shape of the zone, however, the modification removed protective coverage of the rear corners of the coal hauler.
MSHA observed continuous mining machines and mobile machines equipped with proximity detection systems successfully interact during production on working sections where all of the miners had miner-wearable components. MSHA solicits additional information regarding how coal hauling machines using proximity detection systems work with continuous mining machines equipped with proximity
Another commenter observed, during tests of proximity detection systems on continuous mining machines and battery haulers, instances in which miners (primarily continuous mining machine operators) could not properly perform necessary tasks without getting closer to the continuous mining machine than the proximity detection system allowed. The commenter noted that without the capability to temporarily bypass proximity detection, these personnel would either be forced to operate equipment without a clear line of sight or they would need to stand in conditions that pose different hazards, such as roof or rib hazards, or in locations that are not permitted under other regulations. The commenter recommended that the proximity detection system regulation for mobile equipment allow for personnel to temporarily bypass proximity detection when such conditions are encountered.
MSHA may consider such a feature and seeks comment on the availability, use, and appropriateness of a temporary bypass feature. MSHA solicits information regarding how this feature could work with existing proximity detection systems and specific benefits or hazards that could result.
One commenter noted that coal haulers and scoops would encounter sensors (miner-wearable components) much more frequently during operation than would continuous mining machines. Thus, there is an increased potential for nuisance tripping caused by inadvertent exposure into the detection zones of coal haulers, scoops, and other equipment. The commenter further noted the operation of equipment during the mining process requires multiple machines to operate, often in close proximity and can result in cross zone interference and nuisance tripping. As an example, the commenter noted a mine had to install additional equipment to help alleviate the cross zone interference issue. MSHA is aware that proximity detection system manufacturers must consider the interaction of machines with on-board operators to prevent unnecessary shut downs. MSHA observed a loading machine on which proximity detection equipment was installed to provide a silent zone for the on-board loading machine operator. This silent zone allowed the shuttle car to approach the loading machine without the loading machine operator causing the shuttle car to stop. MSHA is also aware that proximity detection system manufacturers have addressed this situation through programming miner-wearable components with specific permissions.
In addition, MSHA received a comment from a machine manufacturer stating that its field testing experience with coal customers within the United States demonstrates measurable section production tonnage drops, within five to ten percent of normal production levels, when proximity detection is active on haulage equipment.
MSHA is aware of mine operators that installed proximity detection systems on all mobile machines on the working section and experienced production decreases. Two of these mine operators reported that production later returned to pre-installation levels. MSHA observed that miners with experience working with mobile machines equipped with proximity detection systems are aware of the warning and shutdown zone locations and position themselves to minimize machine shutdowns. MSHA did observe a proximity detection system provide both a warning and then shut down the machine while the miner-wearable component was physically located outside the established warning and shutdown zones. This mine operator reported working with the proximity detection system manufacturer to resolve this type of occurrence. MSHA is aware of proximity detection system manufacturers that have mitigated nuisance alarms and other issues through engineering solutions. MSHA is also aware that proximity detection system manufacturers continue to improve their technology and develop solutions to minimize unwarranted warnings and shutdowns.
MSHA solicits definitive data, including cost and time estimates, on delays in production caused by proximity detection system alarms due to cross zone interference and nuisance tripping as well as data on the length of time to return to pre-installation production levels. MSHA also seeks information on how to reduce or eliminate production delays when working with mobile machines equipped with proximity detection systems.
MSHA solicits comments on how miners can place themselves in a safe work position to avoid causing nuisance alarms when one or more machines with proximity detection systems are on the working section. MSHA also solicits comments on miners' and mine operators' experiences when more than one miner may be in close proximity to one or more machines with proximity detection systems.
MSHA solicited and received several comments on proposed training for miners who operate or work near machines equipped with proximity detection systems. NIOSH commented that gaining an in-depth view of miners' perspectives and how their job tasks and environment could be or are affected and then incorporating that information into training may help to prevent accidents and injuries that have been labeled as human error in the workplace. NIOSH further commented that studies of continuous mining machine operators have found that unintended consequences, such as a disruption in situational awareness, risks, hazards, and decision-making capabilities, can be avoided if human factors considerations are integrated into each stage of the technology design and implementation process. In addition, NIOSH stated that each piece of equipment needs to have a uniquely prescribed proximity system and the methods and amounts of training for each system should be designed specifically for each system and common platforms established where possible.
One commenter stated that it has been evaluating and testing proximity detection system technologies since 2011. The commenter further stated that inadequate situational awareness is one of the primary factors in incidents attributed to human error and that the primary purpose of any proximity detection system/collision avoidance technology is to enhance situational awareness.
Another commenter stated that proximity detection system technology has the potential to dangerously change how miners interact with mobile equipment in underground mines. The commenter further stated that it has witnessed multiple instances where miners have taken higher risks because of a false sense of security and that implementation of proximity detection systems on all mobile machines will lead miners to unsafely rely on the devices and act contrary to their intuition and training. In addition, the commenter stated that the first priority [of the final rule] should be a safe working position for a miner or machine operator, and second a noncontact rule.
MSHA has observed miners relocate themselves to safer locations because of proximity detection system visible and
MSHA is interested in receiving additional information on miners' and mine operators' experiences with the effect that proximity detection systems have on miners' and machine operators' situational awareness and any examples where reliance on proximity detection technology may cause the miner to develop work practices that introduce additional hazards.
MSHA observed representatives of mine operators and proximity detection system manufacturers provide instruction and task training to miners on the working section where proximity detection systems have been installed on mobile machines. Miners have demonstrated their knowledge of the installation, maintenance, and use of proximity detection systems to MSHA personnel. For example, MSHA observed one mine operator instruct miners to move into a crosscut adjacent to a coal haulage travelway. This increased their distance from the coal haulage travelway, averted unwanted proximity zone incursions, and ultimately placed the workers in a safer location. MSHA also observed a South African mine operator utilize data reports from the proximity detection systems to reinforce safe work practices specified in company policy. These data reports logged the instances when miner-wearable components entered the established warning and shutdown zones.
MSHA is also interested in miners', mine operators' and proximity detection system manufacturers' experiences with training that could be done to increase miners' and machine operators' situational awareness around machines with proximity detection systems.
Electrical systems used in the mine, including proximity detection systems, can adversely affect the function of other electrical systems through the generation of electromagnetic interference. Several commenters noted that electromagnetic interference generated from a variety of external sources can adversely affect the performance of proximity detection systems. Several commenters stated that electromagnetic interference prevents proximity detection systems from functioning as designed. Another commenter stated that, because of electromagnetic interference, the proximity detection system failed to locate the miner-wearable component with any level of accuracy or consistency. The commenter further stated that, as a result, it was nearly impossible for the coal hauler to work in close proximity to the continuous miner or operator.
In addition, on April 6, 2016, MSHA was made aware of concerns from mine operators regarding electromagnetic interferences with proximity detection systems from respirable coal mine dust sampling devices. On April 15 and May 2, 2016, MSHA notified underground coal mine operators who have a proximity detection system installed on any equipment that they should identify sources of any electromagnetic interference that adversely affect the performance of the proximity detection system. The above-referenced notices are included in the rulemaking record.
Proposed § 75.1733(b)(5) would require a mine operator to install a proximity detection system to prevent interference that adversely affects performance of any electrical system. MSHA clarifies that proposed § 75.1733(b)(5) would require mine operators to prevent electromagnetic interference from affecting the operation of the proximity detection system or any other electrical system. MSHA intends that the system would be installed, maintained and operated in such a way that no electrical systems would be adversely affected due to interference. This would require periodic post-installation evaluation of all new potential sources of electromagnetic interference.
To clarify this intent, MSHA is considering a revision to proposed § 75.1733(b)(5) that would require proximity detection systems to be both installed and operated in a manner that prevents interferences that adversely affect the performance of any electrical system, including the proximity detection system. The operation of other electrical systems and equipment must not interfere with the performance of the proximity detection system, and the proximity detection system must not interfere with the performance of other electrical systems.
MSHA has found that one type of common interference can be identified when electrical devices are placed within several inches of the miner-wearable component of the proximity detection system. Electromagnetic interference between these two systems can be mitigated by maintaining a minimum distance between a miner-wearable component and electrical devices. MSHA's technical staff estimated that each mine would require an average of 20 hours for a mining engineer to identify sources of electromagnetic interference and the minimum distance needed to mitigate the interference. Mining engineers will test the compatibility between electrical devices and proximity detection system components. Tests will be based on equipment use and mining conditions. MSHA anticipates that mining engineers will conduct physical tests for compatibility, review equipment user manuals, and consult with the original equipment manufacturers and the proximity detection system manufacturer.
Based on MSHA's mine visits, the Agency estimated that mine operators are likely, on average, to introduce new electrical equipment twice per year. This would require a mining engineer two hours to identify and mitigate adverse interference from the new electrical equipment.
Holding all other variables of the preliminary regulatory economic analysis constant, MSHA estimated that, on average, it would cost each mine operator $3,500 over ten years to comply with proposed § 75.1733(b)(5). MSHA seeks comments on the cost drivers for compatibility testing and the Agency's cost estimate for proposed § 75.1733(b)(5).
MSHA is aware of best practices that mine operators and proximity detection system manufacturers have established to minimize the effects of electromagnetic interference. MSHA is aware that proximity detection system manufacturers have stated that minimum separation distances need to be maintained between miner-wearable components and other electrical equipment. During mine visits, miners have demonstrated the ability to maintain sufficient separation between miner-wearable components and other equipment to ensure proper proximity detection system function. MSHA is also aware of mine operators that have added inline filters on variable frequency drive shuttle cars to reduce electromagnetic emission interference. MSHA is aware of an electrical equipment manufacturer that added material designed to provide electromagnetic shielding to its gas detection equipment which reportedly reduced interference with proximity detection systems.
MSHA solicits comments on the methods and practices mine operators have used or could use to identify sources of electromagnetic interference. MSHA is also interested in receiving information on the actions an operator has taken or could take to prevent such interference and how electromagnetic interference can be mitigated in instances where a miner needs to wear
MSHA has observed that wire mesh and metallic equipment can affect the proximity detection systems' warning and stopping zones. MSHA has also received reports of some pyrite deposits within coal seams affecting the use of the proximity detection system, but has not observed this effect first-hand. MSHA solicits information and data from mine operators and proximity detection system manufacturers on best practices to minimize the effects of these non-electrical interferences.
Since the record closed, MSHA became aware of a proximity detection system design feature on a miner-wearable component that determines if the magnetic field sensing coils have been affected by electromagnetic interference and can no longer detect the magnetic field generated by the machine-mounted components. This feature provides a distinct audible and visible alarm on the miner-wearable component to alert miners when it is not functioning properly due to electromagnetic interference. MSHA is considering requiring this design feature for all miner-wearable components.
MSHA solicits comments on the cost and availability of, and experience with, any proximity detection system feature or other technology that automatically alerts the miner or machine operator when the miner-wearable component or proximity detection system is not functioning properly due to electromagnetic interference.
Proposed § 75.1733(c)(1) would require that a mine operator designate a person to perform a check of machine-mounted components of the proximity detection system to verify that components are intact and the system is functioning properly, and to take action to correct defects. MSHA clarifies that under proposed paragraph (c)(1), the check would include verification that the warning and shutdown zones are set for the established proximity detection field distances and to meet the performance requirements under proposed § 75.1733(b)(1) and (b)(2). Under proposed § 75.1733(c)(1), the person designated to perform the check would verify that the machine-mounted components are intact and correctly mounted and the system is operating properly to identify a miner-wearable component and stop the machine. The check assures that the warning and shutdown zones around the perimeter of the machine are set according to a mine operator's specifications. In MSHA's experience, proximity detection system manufacturers have determined the type of checks that should be conducted to assure that their system is functioning properly. Mine operators are expected to follow the check procedures suggested by the manufacturers. MSHA has observed that a check of the warning and shutdown zones can be made by a miner walking around the machine with a miner-wearable component to confirm proper zone range. MSHA has also observed checking the machine shutdown function of the proximity detection system. This check involves placing a miner wearable component inside the shutdown zone and then attempting to initiate machine movements such as tramming. If the proximity detection system prevents machine movement, the system is functioning properly.
The check would also include an examination of the machine-mounted components to assure that the field generators, antennas, cabling, and other components are undamaged and correctly mounted. The check would also assure that appropriate audible and visual warning signals are working as required. MSHA solicits comments on how the warning and shutdown zones can be checked, or tested, without putting machine operators at risk.
With the clarification in this notice, MSHA estimates that the average time required for a check, which includes a verification that the warning and shutdown zones are set to meet the performance requirements under proposed § 75.1733(b)(1) and (b)(2), would increase from 20 seconds to 6 minutes. MSHA's revised estimate of 6 minutes reflects the time needed to: (1) Verify that the machine-mounted components are intact and correctly mounted and the system is operating properly to identify a miner-wearable component and stop the machine, and (2) test and validate that the warning and stopping zones meet performance requirements. MSHA substituted the 6 minutes into the calculations of the proposed rule, held all other variables constant, and calculated that the average 10-year cost per mine increase would be $182,000. Many other assumptions and data values will be updated in a final regulatory analysis. MSHA seeks comments on the Agency's revisions to its proposed time estimate to comply with § 75.1733(c)(1).
The rulemaking record includes MSHA's Field-Trip Report on Proximity Detection Use in South Africa. On April 2 through April 13, 2016, MSHA and NIOSH representatives visited South Africa to investigate the progress of proximity detection system technology in South Africa. The group visited two proximity detection system manufacturing facilities and observed proximity detection system performance in three underground coal mines. In addition, the group met with a proximity detection system technology developer with experience in proximity detection system development in South Africa and other countries. Among other topics, they discussed the developer's experiences with proximity detection system interference in South Africa.
MSHA and NIOSH also met with representatives of South Africa's Department of Mineral Resources on the implementation of proximity detection systems on electric-powered, trackless mobile machinery in South Africa's surface and underground mines. MSHA's report and presentation materials from the South Africa trip are included in the rulemaking record and available for comment.
MSHA has also included in the rulemaking record materials from the NIOSH Proximity Detection Partnership Meeting. On June 22, 2016, NIOSH held a partnership meeting that included representatives from MSHA, industry, labor, and proximity detection system manufacturers. Materials presented during the partnership meeting are included in the rulemaking record and available for comment.
MSHA initially estimated that the proposed rule would cost mine operators, over ten years, approximately $536,000 per mine. MSHA has revised estimates for two provisions to reflect the Agency's clarification on the proposed requirements. Table 1 summarizes the changes to estimated cost for these two provisions.
The rulemaking record and comment period for the proposed rule is reopened until February 8, 2017. MSHA solicits comments on all aspects of the proposed rule. The Agency requests that comments be specific as possible and include any technological and economic feasibility data.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a special local regulation for certain waters of the Manatee River during the Bradenton Area River Regatta. This action is necessary to protect the safety of race participants, participant vessels, spectators, and the general public on these navigable waters of the United States during the event. The special local regulation would restrict vessel traffic in the waters of the Manatee River in the vicinity of Bradenton, Florida. It would establish the following three areas: Two spectator areas, where all vessels must be anchored or operate at No Wake Speed; and an enforcement area where designated representatives may control vessel traffic as determined by the prevailing conditions.
Comments and related material must be received by the Coast Guard on or before February 8, 2017.
You may submit comments identified by docket number USCG-2016-0940 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Boatswain's Mate First Class Tyrone J. Stafford, Sector St. Petersburg Prevention Department, Coast Guard; telephone 813-228-2191, email
The Coast Guard proposes to establish a special local regulation on the waters of the Manatee River, Bradenton, Florida during the Bradenton Area River Regatta. This event is a high speed boat race with approximately 12 Formula 2 Class boats, traveling at speeds in excess of 100 miles per hour. There will also be approximately 14, 1000 cc Hydrocross jet skis participating in scheduled races during this event. Additionally, there will be a jet ski and water ski exhibition located within the regulated area. It is anticipated that 250 spectator vessels will be present along the race course. The race is scheduled to take place annually from approximately 9 a.m. to 9 p.m. during the first Saturday of February.
This proposed rulemaking is necessary to provide for the safety of race participants, participant vessels, spectators, and the general public on these navigable waters of the United States during the Bradenton Area River Regatta. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233.
This proposed rulemaking would encompass certain waters of the Manatee River in Bradenton, Florida. The special local regulation would be enforced from 9 a.m. to 9 p.m. normally occurring during the first Saturday of February. The special local regulation would establish the following three areas: (1) Two spectator areas, where all vessels must be anchored or operate at No Wake Speed; and (2) an enforcement area that encompasses all race courses and demonstrations, where designated representatives may control vessel traffic as determined by the prevailing conditions.
Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port St. Petersburg by telephone at 727-824-7506, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port St. Petersburg or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port St. Petersburg or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and/or on-scene designated representatives.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only twelve hours; (2) although persons and vessels are prohibited to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port St. Petersburg or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the regulated area or anchor in the sponsor's designated spectator area, during the enforcement period if authorized by the Captain of the Port St. Petersburg or a designated representative; and (4) the Coast Guard will provide advance notification of the special local regulations to the local maritime community by Local Notice to Mariners and/or Broadcast Notice to Mariners.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Manatee River, Bradenton, Florida, encompassed within the special local regulation from 9 a.m. until 9 p.m. annually on the first Saturday of February. For the reasons stated in section IV.A above, this rule will not have a significant economic impact on a substantial number of small entities.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect 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. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph (34)(h) of Figure 2-1 of Commandant Instruction M16475.lD. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comments can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(1)
(2)
(3)
(b)
(c)
(1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the enforcement area unless authorized by the Captain of the Port St. Petersburg or a designated representative.
(2) Designated representatives may control vessel traffic throughout the enforcement area as determined by the prevailing conditions.
(3) All vessels are to be anchored and/or operate at a No Wake Speed in the spectator area. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated areas by contacting the Captain of the Port St. Petersburg by telephone at 727-824-7506, or a designated representative via VHF radio on channel 16.
(d)
Postal Service
Proposed rule.
The Postal Service proposes to revise
Submit comments on or before February 8, 2017.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.
Direct questions or comments to Heather Dyer by email at
The Electronic Induction (eInduction) option is a process that streamlines the preparation and induction (how and where the mail physically enters the Postal Service mailstream) of drop shipments and expedited plant load mailings. eInduction links scans of Intelligent Mail container barcodes (IMcb) to the electronic documentation (eDoc) information, allowing the Postal Service to verify that postage was paid prior to accepting a mailer shipped container. eInduction eliminates the need for paper PS Forms 8125, 8125-CD, and 8017, and manual reconciliation at the entry facility. Correct postage payment is verified both at the entry facility and during post-induction processing in
Mailers who would like to use the eInduction option must meet eligibility requirements and request authorization by contacting the Facility Access Shipping Tracking, (FAST)® Helpdesk. Business Mailer Support will provide final authorization. Additional information, including information regarding verification and associated assessments, is provided in Publication 6850,
Administrative practice and procedure, Postal Service.
Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comments on the following proposed revisions to
Accordingly, 39 CFR part 111 is proposed to be amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
[
Electronic Induction (eInduction) is an electronic alternative to using the following paper PS Forms 8125, 8125C, 8125CD, and 8017 for all containers entered at the dock of a processing facility or claiming a Destination Delivery Unit (DDU) discount. eInduction uses Intelligent Mail container barcode (IMcb) scans to determine container payment and delivery status, and verifies payment and entry location by matching IMcb scan data to electronic documentation (eDoc) information. Containers are eligible for eInduction at certain designated facilities. Additional information, including information regarding verification and associated assessments, is provided in Publication 6850,
Mailers must be authorized by the USPS to participate in the eInduction program.
First-Class Mail, Periodicals, Standard Mail letters and flats, and Bound Printed Matter presorted or carrier route barcoded flats and packages are eligible for eInduction. All containers entered under eInduction must:
a. Be labeled with a USPS placard and a unique Intelligent Mail container barcode. All required pallets and similar containers (such as all-purpose containers, hampers, and gaylords) and all containers prepared under 8.0 must display container placards that include accurately encoded Intelligent Mail container barcodes (IMcb) as described in 708.6.6. Mailing documentation must indicate each container participating in eInduction. b. Be part of a mailing using an approved electronic method to transmit a postage statement and mailing documentation to the
c. Not include containers included on paper PS Forms 8125/8017.
d. Be included on a scheduled FAST appointment when entered at a USPS processing facility.
Mailers who cannot generate a finalized postage statement two hours before container entry may request approval for an eInduction Continuous Mailer ID, (MID). Once approved, mailers using an authorized MID in the IMcb may enter any container with the approved MID in the IMcb prior to the receipt of electronic documentation. Mailers are required to submit an eDoc and generate a finalized postage statement for all eInduction MID containers within one calendar day of the unload scan. Mailers may request authorization for an MID through the Business Customer Gateway. The USPS must approve the mailer request before the mailer may participate in the MID process.
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes, if our proposal is adopted.
Environmental Protection Agency (EPA).
Proposed rule; withdrawal.
The Environmental Protection Agency (EPA) is withdrawing a proposed rule for which the EPA no longer intends to issue a final rule. This document identifies the proposed rule and explains the EPA's decision to withdraw the proposal. The withdrawal of this proposed rule does not preclude the EPA from initiating the same or similar rulemaking at a future date. It does, however, close out the entry for this proposed rule in the EPA Semi-Annual Regulatory Agenda, published as part of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). Should the EPA decide at some future date to initiate the same or similar rulemaking, it will add an appropriate new entry to the EPA Semi-Annual Regulatory Agenda to reflect the initiation of the action.
The EPA is withdrawing the proposed rule as of January 9, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OA-2013-0031. All documents in the docket are listed on the
Kurt Temple, Environmental Protection Agency, Office of Civil Rights, (Mail
This action is directed to the public in general, and may be of particular interest to those persons who follow proposed rules related to the EPA's regulations about Nondiscrimination in Programs or Activities Receiving Federal Assistance from the EPA. Since others may also be interested, the EPA has not attempted to describe all the specific entities potentially interested.
This document announces to the public that the EPA is withdrawing a certain proposed rule for which the EPA no longer intends to issue a final rule.
For the reasons described in this document, the EPA has decided not to finalize this rulemaking at this time. By withdrawing the proposed rule, the EPA is eliminating the pending nature of the regulatory action. Should the EPA determine to pursue anything in these areas in the future, it will issue a new proposed rule and invite public comment through notice in the
2.
Nonetheless, the EPA received several adverse comments about this proposed amendment; especially regarding the proposal to remove numeric deadlines from the administrative complaint processing regulations. The EPA has considered all comments received. Although the EPA continues to believe that the proposed amendments, including the elimination of the numeric deadlines, are needed in order to better position the EPA to strategically manage and individually tailor resolution approaches to its administrative investigation of complaints and compliance reviews, the EPA has decided to withdraw the proposed amendments.
Instead of continuing to pursue this rulemaking, the EPA will implement and evaluate the ability of its internal procedural guidance documents and accountability measures that were finalized in December 2016 (including the Case Resolution Manual and the EPA's OCR External Compliance Program Strategic Plan) to achieve prompt effective, and efficient docket management. Based on its evaluation, the EPA may decide at some future date to initiate a new rulemaking to amend its non-discrimination regulation. The EPA is withdrawing the proposed amendments, as opposed to leaving them inactive, to promote transparency and certainty with regard to the status of its non-discrimination regulation.
Environmental protection, Administrative practice and procedure, Age discrimination, Civil rights, Equal employment opportunity, Individuals with disabilities, Reporting and recordkeeping requirements, Sex discrimination.
Environmental protection, Control number, Office of Management and Budget, and Paperwork Reduction Act.
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve the State Implementation Plan (SIP) submission, submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), on December 16, 2015, for inclusion into the Tennessee SIP. This proposal pertains to the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2012 Annual Fine Particulate Matter (PM
Written comments must be received on or before February 8, 2017.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2014-0430 at
Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta 30303-8960. Ms. Bell can be reached via electronic mail at
On December 14, 2012 (78 FR 3086, January 15, 2013), EPA promulgated a revised primary annual PM
This rulemaking is proposing to approve portions of Tennessee's December 16, 2015 PM
Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains.
More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The requirements are summarized below and in EPA's September 13, 2013, memorandum entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).”
EPA is acting upon the SIP submission from Tennessee that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2012 Annual PM
EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions.
Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.
The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP requirements.
Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.
Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.
EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD
Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.
Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.
As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's implementation plan appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (
As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in sections 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and new source review (NSR) pollutants, including greenhouse gases (GHG). By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the 2012 PM
For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes,
With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Thus, EPA believes it may
EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.
For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).
Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.
The Tennessee infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.
1. 110(a)(2)(A)
In this action, EPA is not proposing to approve or disapprove any existing state provisions with regard to excess emissions during start up, shut down, and malfunction (SSM) operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and the Agency is addressing such state regulations in a separate action.
Additionally, in this action, EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.
2. 110(a)(2)(B)
3. 110(a)(2)(C)
EPA has made the preliminary determination that Tennessee's SIP is adequate for program enforcement of control measures, regulation of minor sources and modifications, and preconstruction permitting of major sources and major modifications related to the 2012 Annual PM
4. 110(a)(2)(D)(i)(I) and (II)
5. 110(a)(2)(D)(ii):
6. 110(a)(2)(E)
In support of EPA's proposal to approve sub-elements 110(a)(2)(E)(i) and (iii), TCA 68-201-105,
TAPCR 1200-03-26,
TCA 68-201-115,
TCA 68-201-115 also directs TDEC to “frequently determine whether or not any exempted municipality or county meets the terms of the exemption granted and continues to comply with this section.” If TDEC determines that the local program does not meet the terms of the exemption or does not otherwise comply with the law, the Board may suspend the exemption in whole or in part until the local program complies with the State standards.
As evidence of the adequacy of TDEC's resources with respect to sub-elements (i) and (iii), EPA submitted a letter to Tennessee on June 30, 2015, outlining section 105 grant commitments and the current status of these commitments for fiscal year 2015. The letter EPA submitted to Tennessee can be accessed at
Section 110(a)(2)(E)(ii) requires that the state comply with section 128 of the CAA. Section 128 requires that the SIP provide: (a)(1) the majority of members of the state board or body which approves permits or enforcement orders represent the public interest and do not derive any significant portion of their income from persons subject to permitting or enforcement orders under the CAA; and (a)(2) any potential conflicts of interest by such board or body, or the head of an executive agency with similar powers be adequately disclosed. Section 110(a)(2)(E)(ii) obligations for the 2012 Annual PM
EPA has made the preliminary determination that the State has adequately addressed the requirements of section 128, and accordingly has met the requirements of section 110(a)(2)(E)(ii) with respect to infrastructure SIP requirements. Therefore, EPA is proposing to approve Tennessee's infrastructure SIP submission as meeting the requirements of sub-elements 110(a)(2)(E)(i), (ii) and (iii).
7. 110(a)(2)(F)
Additionally, Tennessee is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the AERR on December 5, 2008, which modified the requirements for collecting and reporting air emissions data (73 FR 76539). The AERR shortened the time states had to report emissions data from 17 to 12 months, giving states one calendar year to submit emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through EPA's online Emissions Inventory System. States report emissions data for the six criteria pollutants and the precursors that form them—nitrogen oxides, sulfur dioxides, ammonia, lead, carbon monoxide, particulate matter, and volatile organic compounds. Many states also voluntarily report emissions of hazardous air pollutants. Tennessee made its latest update to the 2011 NEI on April 9, 2014. EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the Web site
Regarding credible evidence, TAPCR 1200-3-10-04,
8. 110(a)(2)(G):
Regarding the public welfare and environment, TCA 68-201-106,
9. 110(a)(2)(H)
Section 68-201-105(a) of the Tennessee Air Quality Act authorizes the Tennessee Air Pollution Control Board to promulgate rules and regulations to implement this State statute, including setting and implementing ambient air quality standards, emission standards, general policies or plans, a permits system, and a schedule of fees for review of plans and specifications, issuance or renewal of permits, and inspection of sources. EPA has made the preliminary determination that Tennessee's SIP and practices adequately demonstrate a commitment to provide future SIP revisions related to the 2012 Annual PM
10. 110(a)(2)(J)
11. 110(a)(2)(K)
12. 110(a)(2)(L)
In Tennessee, funding for review of PSD and NNSR permits comes from permit-specific fees that are charged to new applicants and from annual emission fees charged to existing title V emission sources that are applying for major modifications under PSD or NNSR. The cost of reviewing, approving, implementing, and enforcing PSD and major NNSR permits are covered under the following State regulations: (1) TAPCR 1200-03-26-.02(5) requires each new major stationary source to pay a construction permit application filing/processing fee and (2) TAPCR 1200-03-26-.02(9),
13. 110(a)(2)(M)
With the exception of interstate transport provisions pertaining to the contribution to nonattainment or interference with maintenance in other states and visibility protection requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), EPA is proposing to approve Tennessee's infrastructure submission submitted on December 16, 2015, for the 2012 Annual PM
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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
• 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 CAA; and
• does not provide 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, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Arizona State Implementation Plan (SIP). These revisions include a state statute and certain state rules that govern air pollution sources under the Arizona Department of Environmental Quality (ADEQ) and the Pinal County Air Quality Control District (PCAQCD). These revisions concern emissions of particulate matter (PM) from construction sites, agricultural activity and other fugitive dust sources. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Any comments must arrive by February 8, 2017.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0702 at
Christine Vineyard, EPA Region IX, (415) 947-4125,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the statute and rules addressed by this proposal with the dates that they were adopted by the state or local air agency and submitted by the ADEQ.
On March 21, 2016, the EPA determined that the submitted revisions from ADEQ and PCAQCD listed in Table 1 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
There are no previous versions of PCAQCD Chapter 4, Articles 1 and 3 in the SIP. Table 2 lists versions of the statute and rules EPA has previously approved into the SIP.
In addition, we note that SIP-approved rule R18-2-610, “Definitions for R18-2-611,” has the same AAC number as new rule R18-2-610, “Definitions for R18-2-610.01 R18-2-610.02, and R18-2-610.03,” but is not superseded by the new rule.
Particulate matter, including PM equal to or less than 2.5 microns in diameter (PM
• New rule applies to open areas/vacant lots, unpaved roads, unpaved lots and paved public roadways.
• Establishes a 20 percent opacity limit.
• Requires no trespassing signs, physical barriers or other effective control measures upon evidence of trespass.
• Limits silt content on unpaved lots and roads to eight percent and six percent respectively.
• New rule designed to regulate PM
• Limits opacity to 20 percent.
• Revised rule extends the requirement to develop and disseminate air quality dust forecasts to the Maricopa County PM
• Revised rule reflects updated 40 CFR 81.303 as amended July 1, 2014.
• New rule provides definitions for commercial farms general permit rule and applies to general permit rules in other specified nonattainment areas.
• New menu-based rule requires a general permit for commercial farms in the Pinal County PM Nonattainment Area.
• Requires implementation of at least one (best management practice) BMP in the following five categories: Tillage, ground operations and harvest, noncropland, commercial farm roads, and cropland. Beginning in calendar year 2017, and no more than once every subsequent three years, requires facility response to an ADEQ survey on BMP implementation.
• New rule provides definitions for R18-2-612.01.
• New menu-based rule requires a general permit for irrigation districts in nonattainment areas designated after June 1, 2009.
• Requires implementation of at least one BMP in the following three categories: unpaved operation and maintenance roads, canals, and unpaved utility access roads.
• Beginning in calendar year 2017, and no more than once every subsequent three years, requires irrigation district response to an ADEQ survey on BMP implementation.
• Revised rule adds section L: 40 CFR 51.128 Appendix A (1)(B) and section M: Silt Content Test Method.
The EPA's technical support documents (TSDs) have more information about these rules.
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and are limited in how they can modify certain SIP control requirements in nonattainment areas (see CAA section 193).
In addition, generally, SIP rules must implement Reasonably Available Control Measures (RACM), including Reasonably Available Control Technology (RACT), in moderate PM
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).
3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).
4. “PM-10 Guideline Document,” EPA 452/R-93-008, April 1993.
5. “Fugitive Dust Background Document and Technical Information Document for Best Available Control Measures,” EPA 450/2-92-004, September 1992.
We believe these rules and statute are consistent with CAA requirements and relevant guidance and fulfill the evaluation criteria. The statute and rules are clear and contain adequate testing, recordkeeping and reporting requirements to be sufficiently enforceable. The statute and rules strengthen effective requirements (
The TSDs have more information on our evaluation.
The TSDs describe additional rule revisions that we recommend for the next time the state and local agency modifies the rules.
As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rules and statute because we believe they fulfill all relevant requirements. We will accept comments from the public on this proposal until February 8, 2017. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate these rules and statute into the federally-enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the PCAQCD/ADEQ rules/statute as described in Table 1 of this notice. The EPA has made, and will continue to make, these documents available electronically through
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 proposed action merely proposes to approve state law as meeting federal requirements and does
• 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 disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve the second ten-year maintenance plans for the Ajo and Morenci areas in Arizona for the 1971 National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO
Any comments on this proposal must arrive by February 8, 2017.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0287 at
Wienke Tax, EPA Region IX, (415) 947-4192,
Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses the second ten-year maintenance plans submitted by the Arizona Department of Environmental Quality to address the 1971 SO
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
Rural Utilities Service, USDA.
Notice of Solicitation of Applications (NOSA).
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), announces that it is accepting applications for fiscal year (FY) 2017 for the Rural Broadband Access Loan and Loan Guarantee program (the Broadband Program). There will be two application windows for FY 2017.
In addition to announcing the application windows, RUS announces the minimum and maximum amounts for broadband loans for FY 2017.
Unless otherwise extended by a notice of funds availability, applications for the first application window under this NOSA must be submitted from March 1, 2017, through March 31, 2017, and for the second application window from September 1, 2017, through September 30, 2017. Applications can only be submitted through the Agency's online application system during the periods specified above; however, applicants may begin working on their applications in the online system as outlined below.
For further information contact Shawn Arner, Deputy Assistant Administrator, Loan Originations and Approval Division, Rural Utilities Service, Room 2844, STOP 1597, 1400 Independence Avenue SW., Washington, DC 20250-1597, Telephone: (202) 720-0800, or email:
The Rural Broadband Access Loan and Loan Guarantee Program (the “Broadband Program”) is authorized by the Rural Electrification Act (7 U.S.C. 901
During FY 2017, loans will be made available for the construction, improvement, and acquisition of facilities and equipment to provide service at the broadband lending speed for eligible rural areas. Applications are subject to the requirements of 7 CFR 1738.
Since the implementation of the requirements of the 2014 Farm Bill, RUS has held two application windows. After reviewing the applications for eligibility, RUS has determined that there is considerable misunderstanding of the revised requirements for the Broadband Program. Under the two previous windows, once an application was submitted, RUS could not contact an applicant for additional information and the application had to be evaluated on the information that was submitted. If incorrect or inadequate information was submitted or a regulatory requirement was not met, an applicant did not have the ability to adjust its application and RUS was forced to reject it as incomplete or inadequate. In order to break with the pattern of wide scale applications that do not meet the regulation's requirements, RUS will place additional emphasis on providing assistance to applicants with submitting complete applications. As a result, RUS will open pre-application periods, in which National Office staff as well as the General Field Representative assigned to the project will be able to review the draft application, provide detailed comments, and identify when an application is not meeting eligibility requirements for funding. The online application system will allow RUS staff to assist an applicant with completing every part of an application as it is being developed.
The first pre-application window will open on January 9, 2017, and application assistance will be available until the application is formally submitted for consideration by the applicant, but no later than midnight, Eastern Time, on March 24, 2017. Once the application is formally submitted, RUS will be unable to provide additional assistance with completing the application and will begin reviewing the application for conformance with the broadband regulation with respect to eligibility and technical and financial feasibility. In addition, once an application is formally submitted through the online system, the applicant can no longer submit supporting information. For assistance with an application, please contact Shawn Arner, Deputy Assistant Administrator, Loan Originations and Approval Division, Rural Utilities Service, Room 2844, STOP 1597, 1400 Independence Avenue SW., Washington, DC 20250-1597, Telephone: (202) 720-0800, or email:
The second pre-application window will open on July 1, 2017, and application assistance will be available until the application is formally submitted for consideration by the applicant, but not later than midnight, Eastern Time, on September 22, 2017. As with the first pre-application window, once an application is formally submitted, RUS will be unable to provide additional assistance with completing the application and will begin reviewing the application for conformance with the broadband regulation with respect to eligibility and technical and financial feasibility. In addition, once an application is formally submitted through the online system, the applicant can no longer submit supporting information. Please contact Shawn Arner at the above contact information if you would like assistance with your application. If an application is ultimately found to be incomplete or inadequate, a detailed explanation will be provided to the applicant.
To further assist in the preparation of applications, an application guide is available online at:
•
•
•
•
•
Loans under this authority will not be made for less than $100,000. The maximum loan amount that will be considered for FY 2017 is $10,000,000.
The regulation for the Broadband Program requires that certain definitions affecting eligibility be revised and published from time to time by the agency in the
Applications for FY 2017 will be accepted from March 1, 2017, through March 30, 2017, for the first application window and from September 1, 2017, through September 30, 2017, for the second application window. Although review of applications will start when they are submitted for each window, all applications submitted for the first application period will be evaluated and ranked together based on the percentage of unserved households in the proposed funded service area. Likewise, all applications submitted for the second window will be evaluated and ranked together based on the percentage of unserved households in the proposed funded service area. Subject to available funding, eligible applications that propose to serve the highest percentage of unserved households will receive funding offers before other eligible applications that have been submitted. The amount available for each window will be published on the Agency Web page once the annual appropriation process has been completed.
Applications will not be accepted after September 30, 2017, until a new funding window has been opened with the publication of an additional NOSA in the
In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with Broadband loans, as covered in this NOSA, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0572-0130.
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
(1)
(2)
(3)
USDA is an equal opportunity provider, employer, and lender.
The City of Mesa Office of Economic Development, grantee of FTZ 221, submitted a notification of proposed production activity to the FTZ Board on behalf of Apple Inc. (Apple), located in Mesa, Arizona. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on December 27, 2016.
Apple already has authority to produce certain components for consumer electronics within Subzone 221A. The current request would add finished products and foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Apple from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, Apple would be able to choose the duty rate during customs entry procedures that applies to finished server assembly cabinets (duty-free) for the foreign-status materials/components noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The materials/components sourced from abroad include: Tape; plastic boxes; polyethylene bags; plastic bags; plastic packing; plastic washers; rubber washers; rubber spacers; steel screw hooks; steel screws; steel nuts; steel standoff; steel spring washers; steel washers, not spring/lock type; steel rivets; steel cotter pins; steel springs; steel springs, of wire; steel baffles; copper washers; copper boss; copper nuts; nickel fasteners; aluminum screws; aluminum hooks; metal hinges; metal brackets; fans; fan blades, fan unit housings; servers; input/output units; storage units; smart cables; card readers; server housing/enclosures; printed circuit board assemblies; electric motors; transformers; static converters; inductors; magnets; lithium batteries; lithium polymer batteries; routers and network switches; microphones; CDs, software; solid state drives; semiconductor media; monitors; capacitors; fuses; circuit breakers; power strips; relays; switches; electrical connectors; optical fiber cable connectors; terminals; power strips with rack mounts; diodes; transistors; thyristors; LEDs; electronic integrated circuits; infrared LED strips; data server cables; copper and power cables; cables; optical fiber cables; metal furniture; and, server rack rails (duty rate ranges from duty-free to 8.6%).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is February 21, 2017.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
For further information, contact Elizabeth Whiteman at
On September 2, 2016, Canon Virgina, Inc., submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility within Subzone 20D, in Newport News, Virginia.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
AGFA Corporation (AGFA) submitted a notification of proposed production
A separate application for subzone designation at the AGFA facility has been submitted and is being processed under Section 400.31 of the FTZ Board's regulations (S-152-2016). The facility is used for the production of aluminum digital printing plates used in the commercial printing industry. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status component and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt AGFA from customs duty payments on the foreign-status components used in export production. On its domestic sales, AGFA would be able to choose the duty rate during customs entry procedures that applies to aluminum digital printing plates (duty free) for foreign-status aluminum coils (duty rate 3%). Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is February 21, 2017.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Diane Finver at
Pursuant to Section 766.24 of the Export Administration Regulations, 15 CFR parts 730-774 (2016) (“EAR” or the “Regulations”),
On March 17, 2008, Darryl W. Jackson, the then-Assistant Secretary of Commerce for Export Enforcement (“Assistant Secretary”), signed a TDO denying Mahan Airways' export privileges for a period of 180 days on the grounds that its issuance was necessary in the public interest to prevent an imminent violation of the Regulations. The TDO also named as denied persons Blue Airways, of Yerevan, Armenia (“Blue Airways of Armenia”), as well as the “Balli Group Respondents,” namely, Balli Group PLC, Balli Aviation, Balli Holdings, Vahid Alaghband, Hassan Alaghband, Blue Sky One Ltd., Blue Sky Two Ltd., Blue Sky Three Ltd., Blue Sky Four Ltd., Blue Sky Five Ltd., and Blue Sky Six Ltd., all of the United Kingdom. The TDO was issued
The TDO subsequently has been renewed in accordance with Section 766.24(d), including most recently on July 7, 2016.
On May 21, 2015, the TDO was modified to add Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading as respondents. Sky Blue Bird Group and its chief executive officer Issam Shammout were added to the TDO as related persons as part of the July 13, 2015 renewal order.
On December 13, 2016, BIS, through its Office of Export Enforcement (“OEE”), submitted a written request for renewal of the TDO. The written request was made more than 20 days before the scheduled expiration of the current TDO, which issued on July 7, 2016. Notice of the renewal request also was provided to Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading in accordance with Sections 766.5 and 766.24(d) of the Regulations. No opposition to the renewal of the TDO has been received. Furthermore, no appeal of the related person determinations made as part of the September 3, 2010, February 25, 2011, August 24, 2011, April 9, 2012, February 4, 2013, and July 13, 2015 renewal or modification orders has been made by Kosarian Fard, Mahmoud Amini, Kerman Aviation, Sirjanco Trading LLC, Ali Eslamian, Mahan Air General Trading LLC, Skyco (UK) Ltd., Equipco (UK) Ltd., Mehdi Bahrami, Sky Blue Bird Group, or Issam Shammout.
Pursuant to Section 766.24, BIS may issue or renew an order temporarily denying a respondent's export privileges upon a showing that the order is necessary in the public interest to prevent an “imminent violation” of the Regulations. 15 CFR 766.24(b)(1) and 766.24(d). “A violation may be `imminent' either in time or degree of likelihood.” 15 CFR 766.24(b)(3). BIS may show “either that a violation is about to occur, or that the general circumstances of the matter under investigation or case under criminal or administrative charges demonstrate a likelihood of future violations.”
OEE's request for renewal is based upon the facts underlying the issuance of the initial TDO and the TDO renewals in this matter and the evidence developed over the course of this investigation indicating a blatant disregard of U.S. export controls and the TDO. The initial TDO was issued as a result of evidence that showed that Mahan Airways and other parties engaged in conduct prohibited by the EAR by knowingly re-exporting to Iran three U.S.-origin aircraft, specifically Boeing 747s (“Aircraft 1-3”), items subject to the EAR and classified under Export Control Classification Number (“ECCN”) 9A991.b, without the required U.S. Government authorization. Further evidence submitted by BIS indicated that Mahan Airways was involved in the attempted re-export of three additional U.S.-origin Boeing 747s (“Aircraft 4-6”) to Iran.
As discussed in the September 17, 2008 renewal order, evidence presented by BIS indicated that Aircraft 1-3 continued to be flown on Mahan Airways' routes after issuance of the TDO, in violation of the Regulations and the TDO itself.
The March 9, 2010 Renewal Order also noted that a court in the United Kingdom (“U.K.”) had found Mahan Airways in contempt of court on February 1, 2010, for failing to comply with that court's December 21, 2009 and January 12, 2010 orders compelling Mahan Airways to remove the Boeing 747s from Iran and ground them in the Netherlands. Mahan Airways and the Balli Group Respondents had been litigating before the U.K. court concerning ownership and control of Aircraft 1-3. In a letter to the U.K. court dated January 12, 2010, Mahan Airways' Chairman indicated,
The September 3, 2010 renewal order discussed the fact that Mahan Airways' violations of the TDO extended beyond operating U.S.-origin aircraft and
Moreover, in a January 24, 2011 filing in the U.K. court, Mahan Airways asserted that Aircraft 1-3 were not being used, but stated in pertinent part that the aircraft were being maintained in Iran especially “in an airworthy condition” and that, depending on the outcome of its U.K. court appeal, the aircraft “could immediately go back into service . . . on international routes into and out of Iran.” Mahan Airways' January 24, 2011 submission to U.K. Court of Appeal, at p. 25, ¶¶ 108, 110. This clearly stated intent, both on its own and in conjunction with Mahan Airways' prior misconduct and statements, demonstrated the need to renew the TDO in order to prevent imminent future violations. Two of these three 747s subsequently were removed from Iran and are no longer in Mahan Airways' possession. The third of these 747s, with Manufacturer's Serial Number (“MSN”) 23480 and Iranian tail number EP-MNE, remained in Iran under Mahan's control. Pursuant to Executive Order 13324, it was designated a Specially Designated Global Terrorist (“SDGT”) by the U.S. Department of the Treasury's Office of Foreign Assets Control (“OFAC”) on September 19, 2012.
In addition, as first detailed in the July 1, 2011 and August 24, 2011 orders, and discussed in subsequent renewal orders in this matter, Mahan Airways also continued to evade U.S. export control laws by operating two Airbus A310 aircraft, bearing Mahan Airways' livery and logo, on flights into and out of Iran.
The August 2012 renewal order also found that Mahan Airways had acquired another Airbus A310 aircraft subject to the Regulations, with MSN 499 and Iranian tail number EP-VIP, in violation of the TDO and the Regulations.
The February 4, 2013 Order laid out further evidence of continued and additional efforts by Mahan Airways and other persons acting in concert with Mahan, including Kral Aviation and another Turkish company, to procure U.S.-origin engines—two GE CF6-50C2 engines, with MSNs 517621 and 517738, respectively—and other aircraft parts in violation of the TDO and the Regulations.
On December 31, 2013, Kral Aviation was added to BIS's Entity List, Supplement No. 4 to Part 744 of the Regulations.
The July 31, 2013 Order detailed additional evidence obtained by OEE showing efforts by Mahan Airways to obtain another GE CF6-50C2 aircraft engine (MSN 528350) from the United States via Turkey. Multiple Mahan employees, including Mehdi Bahrami, were involved in or aware of matters related to the engine's arrival in Turkey from the United States, plans to visually inspect the engine, and prepare it for shipment from Turkey.
Mahan sought to obtain this U.S.-origin engine through Pioneer Logistics Havacilik Turizm Yonetim Danismanlik (“Pioneer Logistics”), an aircraft parts supplier located in Turkey, and its director/operator, Gulnihal Yegane, a Turkish national who previously had conducted Mahan related business with Mehdi Bahrami and Ali Eslamian. Moreover, as referenced in the July 31, 2013 Order, a sworn affidavit by Kosol Surinanda, also known as Kosol Surinandha, Managing Director of Mahan's General Sales Agent in Thailand, stated that the shares of Pioneer Logistics for which he was the listed owner were “actually the property of and owned by Mahan.” He further stated that he held “legal title to the shares until otherwise required by Mahan” but would “exercise the rights granted to [him] exactly and only as instructed by Mahan and [his] vote and/or decisions [would] only and exclusively reflect the wills and demands of Mahan[.]”
The January 24, 2014 Order outlined OEE's continued investigation of Mahan Airways' activities and detailed an attempt by Mahan, which OEE
The July 22, 2014 Order discussed open source evidence from the March-June 2014 time period regarding two BAE regional jets, items subject to the Regulations, that were painted in the livery and logo of Mahan Airways and operating under Iranian tail numbers EP-MOK and EP-MOI, respectively.
The January 16, 2015 Order detailed evidence of additional attempts by Mahan Airways to acquire items subject the Regulations in further violation of the TDO. Specifically, in March 2014, OEE became aware of an inertial reference unit bearing serial number 1231 (“the IRU”) that had been sent to the United States for repair. The IRU is subject to the Regulations, classified under ECCN 7A103, and controlled for missile technology reasons. Upon closer inspection, it was determined that IRU came from or had been installed on an Airbus A340 aircraft bearing MSN 056. Further investigation revealed that as of approximately February 2014, this aircraft was registered under Iranian tail number EP-MMB and had been painted in the livery and logo of Mahan Airways.
The January 16, 2015 Order also described related efforts by the Departments of Justice and Treasury to further thwart Mahan's illicit procurement efforts. Specifically, on August 14, 2014, the United States Attorney's Office for the District of Maryland filed a civil forfeiture complaint for the IRU pursuant to 22 U.S.C. 401(b) that resulted in the court issuing an Order of Forfeiture on December 2, 2014. EP-MMB remains listed as active in Mahan Airways' fleet.
Additionally, on August 29, 2014, OFAC blocked the property and interests in property of Asian Aviation Logistics of Thailand, a Mahan Airways affiliate or front company, pursuant to Executive Order 13224. In doing so, OFAC described Mahan Airways' use of Asian Aviation Logistics to evade sanctions by making payments on behalf of Mahan for the purchase of engines and other equipment.
The May 21, 2015 modification order detailed the acquisition of two aircraft, specifically an Airbus A340 bearing MSN 164 and an Airbus A321 bearing MSN 550, that were purchased by Al Naser Airlines in late 2014/early 2015 and are currently located in Iran under the possession, control, and/or ownership of Mahan Airways.
The May 21, 2015 modification order also laid out evidence showing the respondents' attempts to obtain other controlled aircraft, including aircraft physically located in the United States in similarly-patterned transactions during the same recent time period. Transactional documents involving two Airbus A320s bearing MSNs 82 and 99, respectively, again showed Ali Abdullah Alhay signing sales agreements for Al Naser Airlines.
The July 13, 2015 Order outlined evidence showing that Al Naser Airlines' attempts to acquire aircraft on behalf of Mahan Airways extended beyond MSNs 164 and 550 to include a total of nine aircraft.
The January 7, 2016 Order discussed evidence that Mahan Airways had begun actively flying EP-MMD, another of the aircraft Mahan had obtained from Al Naser Airlines (as discussed in the July 13, 2015 renewal order), on international routes into and out of Iran, including from/to Bangkok, Thailand. Additionally, the January 7, 2016 Order described publicly available aviation database and flight tracking information indicating that Mahan Airways was continuing its efforts to acquire Iranian tail numbers and press into active service under Mahan's livery and logo at least two more of the Airbus A340 aircraft it had obtained from or through Al Naser Airlines: EP-MME (MSN 371) and EP-MMF (MSN 376), respectively. Since January 2016, EP-MME has logged flights to and from Tehran, Iran involving various destinations, including Guangzhou, China and Dubai, United Arab Emirates in further violation of the TDO and the Regulations.
The July 7, 2016 Order described Mahan Airways' acquisition of a BAE Avro RJ-85 aircraft (MSN E2392) in violation of the TDO and its subsequent registration under Iranian tail number EP-MOR.
The December 13, 2016 renewal request discusses OEE's on-going concerns that Mahan Airways has continued to utilize aircraft, engines, and other aircraft parts that it previously acquired in violation of the TDO. This conduct includes, but is not limited to, operating aircraft originally obtained from or through Al Naser Airlines on international flights into and out of Iran. Publicly available flight tracking information shows that since December 20, 2016, EP-MMD (MSN 164), EP-MMF (MSN 376), and EP-MMH (MSN 391) has each been flown on routes into or out of Tehran, Iran, including from/to Beijing, China, Kuala Lumpur, Malaysia, and Istanbul, Turkey.
Mahan's acquisition of these aircraft from or through Al Naser Airlines and their subsequent registration in Iran were detailed in the July 13, 2015 and January 7, 2016 renewal orders, respectively. Both Mahan Airways and Al Naser Airways remain subject to an on-going investigation by OEE.
Under the applicable standard set forth in Section 766.24 of the Regulations and my review of the entire record, I find that the evidence presented by BIS convincingly demonstrates that the denied persons have acted in violation of the Regulations and the TDO; that such violations have been significant, deliberate and covert; and that given the foregoing and the nature of the matters under investigation, there is a likelihood of future violations. Therefore, renewal of the TDO is necessary to prevent imminent violation of the Regulations and to give notice to companies and individuals in the United States and abroad that they should continue to cease dealing with Mahan Airways, Al Naser Airlines, and the other denied persons under the TDO in connection with export and reexport transactions involving items subject to the Regulations.
IT IS THEREFORE ORDERED:
FIRST, that MAHAN AIRWAYS, Mahan Tower, No. 21, Azadegan St., M.A. Jenah Exp. Way, Tehran, Iran; PEJMAN MAHMOOD KOSARAYANIFARD A/K/A KOSARIAN FARD, P.O. Box 52404, Dubai, United Arab Emirates; MAHMOUD AMINI, G#22 Dubai Airport Free Zone, P.O. Box 393754, Dubai, United Arab Emirates, and P.O. Box 52404, Dubai, United Arab Emirates, and Mohamed Abdulla Alqaz Building, Al Maktoum Street, Al Rigga, Dubai, United Arab Emirates; KERMAN AVIATION A/K/A GIE KERMAN AVIATION, 42 Avenue Montaigne 75008, Paris, France; SIRJANCO TRADING LLC, P.O. Box 8709, Dubai, United Arab Emirates; ALI ESLAMIAN, 33 Cavendish Square, 4th Floor, London W1G0PW, United Kingdom, and 2 Bentinck Close, Prince Albert Road St. Johns Wood, London NW87RY, United Kingdom; MAHAN AIR GENERAL TRADING LLC, 19th Floor Al Moosa Tower One, Sheik Zayed Road, Dubai 40594, United Arab Emirates; SKYCO (UK) LTD., 33 Cavendish Square, 4th Floor, London, W1G 0PV, United Kingdom; EQUIPCO (UK) LTD., 2 Bentinck Close, Prince Albert Road, London, NW8 7RY, United Kingdom; and MEHDI BAHRAMI, Mahan Airways- Istanbul Office, Cumhuriye Cad. Sibil Apt No: 101 D:6, 34374 Emadad, Sisli Istanbul, Turkey; AL NASER AIRLINES A/K/A AL-NASER AIRLINES A/K/A ALNASER AIRLINES AND AIR FREIGHT LTD., Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside Al Jadirya Private Hospital, Baghdad, Iraq, and Al Amirat Street, Section 309, St. 3/H.20, Al Mansour, Baghdad, Iraq, and P.O. Box 28360, Dubai, United Arab Emirates, and P.O. Box 911399, Amman 11191, Jordan; ALI ABDULLAH ALHAY A/K/A ALI ALHAY A/K/A ALI ABDULLAH AHMED ALHAY, Home 46, Al-Karrada, Babil Region, District 929, St 21, Beside
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 EAR, or in any other activity subject to the EAR; 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 EAR, or in any other activity subject to the EAR.
SECOND, that no person may, directly or indirectly, do any of the following:
A. Export or reexport to or on behalf of a Denied Person any item subject to the EAR;
B. Take any action that facilitates the acquisition or attempted acquisition by a Denied Person of the ownership, possession, or control of any item subject to the EAR that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby a 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 a Denied Person of any item subject to the EAR that has been exported from the United States;
D. Obtain from a Denied Person in the United States any item subject to the EAR 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 EAR that has been or will be exported from the United States and which is owned, possessed or controlled by a Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by a Denied Person if such service involves the use of any item subject to the EAR that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
THIRD, that, after notice and opportunity for comment as provided in section 766.23 of the EAR, any other person, firm, corporation, or business organization related to a Denied Person by affiliation, ownership, control, or position of responsibility in the conduct of trade or related services may also be made subject to the provisions of this Order.
FOURTH, that this Order does not prohibit any export, reexport, or other transaction subject to the EAR where the only items involved that are subject to the EAR are the foreign-produced direct product of U.S.-origin technology.
In accordance with the provisions of Sections 766.24(e) of the EAR, Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and/or Bahar Safwa General Trading may, at any time, appeal this Order by filing a full written statement in support of the appeal with the Office of the Administrative Law Judge, U.S. Coast Guard ALJ Docketing Center, 40 South Gay Street, Baltimore, Maryland 21202-4022. In accordance with the provisions of Sections 766.23(c)(2) and 766.24(e)(3) of the EAR, Pejman Mahmood Kosarayanifard, Mahmoud Amini, Kerman Aviation, Sirjanco Trading LLC, Ali Eslamian, Mahan Air General Trading LLC, Skyco (UK) Ltd., Equipco (UK) Ltd., Mehdi Bahrami, Sky Blue Bird Group, and/or Issam Shammout may, at any time, appeal their inclusion as a related person by filing a full written statement in support of the appeal with the Office of the Administrative Law Judge, U.S. Coast Guard ALJ Docketing Center, 40 South Gay Street, Baltimore, Maryland 21202-4022.
In accordance with the provisions of Section 766.24(d) of the EAR, BIS may seek renewal of this Order by filing a written request not later than 20 days before the expiration date. A renewal request may be opposed by Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and/or Bahar Safwa General Trading as provided in Section 766.24(d), by filing a written submission with the Assistant Secretary of Commerce for Export Enforcement, which must be received not later than seven days before the expiration date of the Order.
A copy of this Order shall be provided to Mahan Airways, Al Naser Airlines, Ali Abdullah Alhay, and Bahar Safwa General Trading and each related person, and shall be published in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells), from the People's Republic of China (PRC). The period of review (POR) is January 1, 2014, through December 31, 2014. Interested parties are invited to comment on these preliminary results.
Effective January 9, 2017.
Gene Calvert, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of
On December 7, 2012, the Department issued a countervailing duty (CVD) order on solar cells from the PRC.
The merchandise subject to the
The Department is conducting this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily find that there is a subsidy, (
The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. Jinko Solar Co., Ltd., JinkoSolar (U.S.) Inc., Jinko Solar Import and Export Co., Ltd., JinkoSolar International Limited, Zhejiang Jinko Solar Co., Ltd. (collectively, the Jinko Solar Companies); Yingli Green Energy Holding Company Limited (Yingli); ERA Solar Co. Limited (ERA Solar); Zhejiang Sunflower Light Energy Science & Technology Limited Liability Company (Zhejiang Sunflower); and JA Solar Technology Yangzhou Co., Ltd., Shanghai JA Solar Technology Co., Ltd., and JingAo Solar Co., Ltd. (collectively, the JA Solar Companies) timely withdrew their requests for review.
As a result of this review, we preliminarily determine the countervailable subsidy rates to be:
For the companies for which a review was requested that were not selected as mandatory company respondents, and for which we did not receive a timely request for withdrawal of review, and which we are not finding to be cross-owned with the mandatory company respondents, we are preliminarily basing the subsidy rate on the weighted-average of the subsidy rates calculated for Canadian Solar and Trina Solar. These rates were above
The Department will disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days of
Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system.
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act, the Department intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, within 120 days after publication of these preliminary results.
In accordance with 19 CFR 351.221(b)(4)(i), we assigned a subsidy rate for each producer/exporter subject to this administrative review. Upon issuance of the final results, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue instructions to CBP 15 days after publication of the final results of review.
Pursuant to section 751(a)(2)(C) of the Act, the Department also intends to instruct CBP to collect cash deposits of estimated countervailing duties, in the amounts shown above for each of the respective companies shown above, on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits at the most-recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.
These preliminary results of review are issued and published in accordance with sections 751(a)(l) and 777(i)(l) of the Act and 19 CFR 351.213 and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of multilayered wood flooring (wood flooring) from the People's Republic of China (PRC). The period of review (POR) is January 1, 2014, through December 31, 2014.
Effective January 9, 2017.
Dennis McClure or Sergio Balbontin, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-5973 or 202-482-6478, respectively.
The product covered by the Order is wood flooring from the PRC. For a complete description of the scope of this administrative review,
The Preliminary Decision Memorandum is a public document and is on file electronically
A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice.
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. This review was initiated on February 9, 2016. One PRC producer/exporter of wood flooring, Jiangsu Keri Wood Co., Ltd. (Jiangsu Keri), withdrew its request for review on February 22, 2016, which was within the 90-day deadline. Therefore, in accordance with 19 CFR 351.213(d)(1), and consistent with our practice, we are rescinding this review with respect to Jiangsu Keri.
We received timely filed no-shipment certifications from six companies.
With respect to Dalian Xinjinghua, Henan Xingwangjia, and Xuzhou Antop, we preliminarily determine that there is sufficient evidence on the record of this review to conclude that these companies had reviewable transactions during the POR.
The Department is conducting this countervailing duty (CVD) review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy,
In making these preliminary results, the Department relied, in part, on facts otherwise available.
There are 104 companies for which a review was requested and not rescinded, but were not selected as mandatory respondents. For these companies, we calculated the non-selected rate by averaging the rates of mandatory respondents Dalian Penghong Floor Products Co., Ltd. and Fine Furniture (Shanghai) Limited, based on their publicly ranged sales data for the POR, instead of weight-averaging based on their proprietary sales data for the POR, which would risk disclosure of proprietary information. For further information on the calculation of the non-selected rate, refer to the section in the Preliminary Decision Memorandum entitled, “Preliminary Ad Valorem Rate for Non-Selected Companies Under Review.”
In accordance with 19 CFR 351.221(b)(4)(i), we calculated a countervailable subsidy rate for each of the mandatory respondents, Dalian Penghong Floor Products Co., Ltd. (Penghong) and Fine Furniture (Shanghai) Limited (Fine Furniture), and their cross-owned affiliates where applicable.
We preliminarily find the countervailable subsidy rates for the mandatory respondents under review to be as follows:
Review-Specific Average Rate Applicable to the Following Non-Selected Companies:
We will disclose to parties in this proceeding the calculations performed in reaching the preliminary results within five days of publication of these preliminary results.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined.
Parties are reminded that briefs and hearing requests are to be filed electronically using ACCESS and that electronically filed documents must be received successfully in their entirety by 5 p.m. Eastern Time on the due date.
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act, we intend to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, within 120 days after publication of these preliminary results.
Consistent with section 751(a)(1) of the Act, upon issuance of the final results, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue instructions to CBP 15 days after publication of the final results of this review.
In accordance with section 751(a)(1) of the Act, the Department intends to instruct CBP to collect cash deposits of
This administrative review and notice are in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the Department of Commerce (Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on stainless steel plate in coils (SSPC) from Belgium, South Africa, and Taiwan, and the countervailing duty (CVD) order on SSPC from South Africa, would likely lead to a continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, the Department is publishing a notice of continuation of the AD orders and the CVD order.
Effective January 9, 2017.
Victoria Cho or Yasmin Bordas, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2312 or (202) 482-3813, respectively.
On July 1, 2016, the Department published the notice of initiation of the third sunset reviews of the AD orders on SSPC from Belgium, South Africa, and Taiwan, and the CVD order on SSPC from South Africa, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
The product covered by these orders is certain stainless steel plate in coils. Stainless steel is alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject plate products are flat-rolled products, 254 mm or over in width and 4.75 mm or more in thickness, in coils, and annealed or otherwise heat treated and pickled or otherwise descaled. The subject plate may also be further processed (
Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to these orders is dispositive.
As a result of the determinations by the Department and the ITC that revocation of the AD orders and the CVD order would likely lead to a continuation or recurrence of dumping and countervailable subsidies and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on SSPC from Belgium, South Africa, and Taiwan, and the CVD order on SSPC from South Africa.
U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the orders will be the date of publication in the
These five-year sunset reviews and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Pacific Fishery Management Council's (Pacific Council) Highly Migratory Species Advisory Subpanel (HMSAS) will hold a webinar, which is open to the public.
The HMSAS webinar will be on Tuesday, January 31, 2017, from 1:30 to 3:30 p.m. Pacific Time, or when business for the day is complete.
To attend the HMSAS webinar visit this link:
Kit Dahl, Pacific Council; telephone: (503) 820-2422.
The HMSAS will be briefed on proposed changes to the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP). Changes are proposed in Chapters 1, 4, 6, and 8. These changes are not intended to change the management framework described in the FMP or any related policies; rather, edits to update descriptive information and improve the readability of the document.
Although nonemergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during the meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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.
PC-based attendees: Windows® 7, Vista, or XP operating system required. Mac®-based attendees: Mac OS® X 10.5 or newer required. Mobile attendees: iPhone®, iPad®, Android
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280 at least 10 days prior to the meeting date.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 10, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Christopher Rogers, Office for International Affairs and Seafood Inspection (F/IS5), 1315 East-West Highway, Silver Spring, Maryland 20910, 301-427-8350 or
This request is for extension of a currently approved information collection. The National Marine Fisheries Service (NMFS) issues permits, under the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801
Foreign fishing activity reports are made by radio when fishing begins or ceases, to report on transfers of fish, and to file weekly reports on the catch or receipt of fish. Weekly reports may be submitted by fax or email. Recordkeeping requirements for foreign vessels include a communications log, a transfer log, a daily fishing log, a consolidated fishing or joint venture log, and a daily joint venture log. These records must be maintained for three years. Paper forms are used for foreign fishing vessel permit applications. No information is submitted to NMFS for the vessel and gear marking requirements.
Comments are invited on: (a) Whether the proposed collection of information is 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 (including hours and cost) 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.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 10, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Erica Seiden, 240-533-0781,
This request is for extension of a current information collection.
The Coastal Zone Management Act of 1972 (CZMA; 16 U.S.C. 1461
Respondents have a choice of either electronic or paper submissions. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.
Comments are invited on: (a) Whether the proposed collection of information is 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 (including hours and cost) 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.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 53 Assessment webinar.
The SEDAR 53 assessment of the South Atlantic stock of red grouper will consist of a series webinars. See
A SEDAR 53 Assessment webinar will be held Wednesday, February 1, 2017, from 9 a.m. to 12 p.m.
The meeting will be held via webinar. 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. The product of the SEDAR webinar series will be a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. 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 in the Assessment webinar are as follows:
1. Participants will continue discussions to develop population models to evaluate stock status, estimate population benchmarks, and project future conditions, as specified in the Terms of Reference.
2. Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters.
3. Participants will prepare a workshop report and determine whether the assessment(s) are adequate for submission for review.
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
National Telecommunications and Information Administration (NTIA).
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Submit comments on or before March 10, 2017.
Direct all written comments to Jennifer Jessup, Departmental
NTIA has made a copy of the proposed information collection instrument available at
NTIA proposes to add 58 questions to the U.S. Census Bureau's November 2017 Current Population Survey (CPS) to gather reliable data on broadband (also known as high-speed Internet) use by U.S. households through the Computer and Internet Use Supplement (“the Supplement”). The planned Supplement will be the fourteenth since NTIA began sponsoring such surveys in November 1994. Since that time, NTIA has continually revised the Supplement to reflect developments in Internet technology, applications, and connected devices.
As the digital economy's accelerating growth reinforces the Internet's importance to the nation's economic prosperity, policymakers, businesses, non-profits, communities, and other stakeholders increasingly rely on data about whether and how Americans use broadband in their routine activities. Recognizing that digitally-connected Americans provide the modern workforce, creative innovation, and growing customer base to help sustain our nation's global competitiveness, the Supplement will yield data that can inform investment decisions and resource allocations to advance full participation in the digital economy.
NTIA is working with Congress, the Federal Communications Commission (FCC), other federal agencies, state and local governments, as well as with industry and non-profits to develop and promote policies that foster broadband deployment and adoption. These policies help to ensure that the nation's businesses and consumers can obtain competitively priced high-speed Internet access and that everyone is able to gain the skills necessary to use the technology. Collecting current, systematic, and comprehensive information on broadband use and non-use by U.S. households is critical to enabling policymakers to gauge progress made to date, and also to identify specific areas and demographic groups in which broadband adoption is a concern with a specificity that permits carefully targeted and cost-effective responses.
The U.S. Census Bureau is widely regarded as a premier data collector based on centuries of experience and rigorous scientific methods. Collection of NTIA's requested broadband usage data will occur in conjunction with the U.S. Census Bureau's scheduled November 2017 CPS, thereby significantly reducing the potential burdens on the U.S. Census Bureau and on surveyed households.
The U.S. government has an increasingly pressing need for comprehensive broadband data. The U.S. Government Accountability Office (GAO), NTIA, and the FCC have issued reports noting the importance of useful broadband adoption data for policymakers. Moreover, Congress passed legislation—the Broadband Data Improvement Act in 2008 and the American Recovery and Reinvestment Act in 2009—wholly or in part to address this deficiency. Modifying the November 2017 CPS to include NTIA's requested broadband questions will enable the Commerce Department and NTIA to respond to congressional concerns and directives.
The Supplement will be administered through personal visits and live telephone interviews using computer-assisted telephone interviewing and computer-assisted personal interviewing.
Comments are invited on: (a) Whether the proposed collection of information is 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 (including hours and cost) 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 on respondents of providing the requested information, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will be a matter of public record.
Wednesday, January 11, 2017, 9:30 a.m.-12:30 p.m.
Hearing Room 420, Bethesda Towers, 4330 East-West Highway, Bethesda, Maryland.
Commission Meeting—Open to the Public.
A live webcast of the Meeting can be viewed at
Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814, (301) 504-7923.
Department of the Army, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by March 10, 2017.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Department of the Army, Army Safety Office, Chief of Staff, DACS-SF, 9351 Hall Rd, Fort Belvoir, VA 22060, ATTN: Mr. Timothy Mikulski at (703) 697-1321.
The Army radiation permit application will specify the effective date and duration for the Army radiation permit and describe the purposes for which the Army radiation permit is being sought. The application will include identification of the trained operating personnel who will be responsible for implementation of the activities authorized by the permit and a summary of their professional qualifications; the point-of-contact name and phone number for the application; the applicant's radiation safety Standing Operating Procedures (SOPs); storage provisions when the radiation source is not in use; and procedures for notifying the installation of reportable incidents/accidents.
Office of Elementary and Secondary Education (OESE), 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 February 8, 2017.
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 Kimberly Smith, 202-453-6469.
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
Office of Elementary and Secondary Education, Department of Education.
Notice.
College Assistance Migrant Program (CAMP).
Notice inviting applications for new awards for fiscal year (FY) 2017.
This priority is:
For applicants with an expiring CAMP project, the Secretary will consider the applicant's prior experience in implementing its expiring CAMP project, based on information contained in documents previously provided to the Department, such as annual performance reports, project evaluation reports, site visit reports, and the previously approved CAMP application.
Under this competition, we also are particularly interested in applications that address the following invitational priorities.
These priorities are:
Projects that are designed to address one or more of the following priority areas:
(a) Providing students with increased access to rigorous and engaging coursework in STEM.
(b) Increasing the number and proportion of students prepared for postsecondary or graduate study and careers in STEM, with a specific focus on an increase in the number and proportion of students so prepared who are from groups traditionally underrepresented in STEM careers, including minorities, individuals with disabilities, and women.
Applicants could, for example, propose providing students with increased access to coursework in STEM through such activities as mentoring, counseling, and tutoring in ways that motivate participants to pursue postsecondary education in the areas of STEM. Similarly, applicants could propose increasing the number and proportion of students prepared for postsecondary or graduate study and careers in STEM through activities such as referrals to STEM-oriented work-based learning experiences, exposure to academic programs and careers in STEM-related fields, and providing support services. These could include services to improve participants' academic skills and knowledge so that they may pursue studies and careers in STEM-related fields.
Applications that propose to engage faith-based and community organizations in the delivery of services under this program.
The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
1.
2.
3.
1.
To obtain a copy via the Internet, use the following address:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.a.
• 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, headings, footnotes, quotations, references, and captions. However, you may single space all text in charts, tables, figures, and graphs. Charts, tables, figures, and graphs presented in the application narrative count toward the page limit.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch) throughout the entire application package.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted. The 25-page limit for the application narrative does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract. However, the page limit does apply to all of the application narrative.
Appendices must be limited to 20 pages and must include the following: Resumes, if applicable, and job descriptions of key personnel. Job descriptions must include duties and minimum qualifications. Items in the appendices will only be used by the program office; the items will not be read by reviewers.
b.
Because we plan to make successful applications available to the public you may wish to request confidentiality of business information.
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.
Applications for grants under this competition must be submitted electronically using the
We will 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
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), 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,
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
7.
a.
Applications for grants under CAMP, CFDA number 84.149A, must be submitted electronically using the Governmentwide
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 CAMP at
Please note the following:
• When you enter the
• Applications received by
• 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
• You should review and follow the Education Submission Procedures for
• 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 read-only Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, 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
• Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• 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
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
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• 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: Emily Bank, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E338, Washington, DC 20202-6135. FAX: (202) 205-0089.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
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: U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.149A, LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
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.
c.
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: U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.149A, 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
(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.
2.
In addition, in making a competitive grant award, the Secretary 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.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection
4.
Applicants must propose annual targets for these measures in their applications. The national target for GPRA measure 1 for FY 2017 is that 86 percent of CAMP participants will complete the first academic year of their postsecondary program. The national target for GPRA measure 2 for FY 2017 is that 85 percent of CAMP participants continue their postsecondary education after completing the first academic year of college. The national targets for subsequent years may be adjusted based on additional baseline data. The panel readers will score related selection criteria on the basis of how well an applicant addresses these GPRA measures. Therefore, applicants will want to consider how to demonstrate a sound capacity to provide reliable data on the GPRA measures, including the project's annual performance targets for addressing the GPRA performance measures, as is required by the Office of Management and Budget approved annual performance report that is included in the application package. All grantees will be required to submit, as part of their annual performance report, information with respect to these GPRA performance measures.
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).
Emily Bank, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E338, Washington, DC 20202-6135. Telephone: (202) 453-6389 or by email:
If you use a TDD or TYY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Secretary is publishing the following list of correspondence from the U.S. Department of Education (Department) received by individuals during the first and second quarters of 2015. The correspondence describes the Department's interpretations of the Individuals with Disabilities Education Act (IDEA) or the regulations that implement the IDEA. This list and the letters or other documents described in this list, with personally identifiable information redacted, as appropriate, can be found at:
Jessica Spataro or Mary Louise Dirrigl. Telephone: (202) 245-7605.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), you can call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of this list and the letters or other documents described in this list in an accessible format (
The following list identifies correspondence from the Department issued from January 1, 2015 through March 31, 2015 and April 1, 2015 through June 30, 2015. Under section 607(f) of the IDEA, the Secretary is required to publish this list quarterly in the
• Dear Colleague Letter dated April 15, 2015, providing guidance on best practices for the appropriate use of IDEA's dispute resolution procedures and the importance of avoiding conflicting decisions when a public agency files a due process complaint on the same issues that are the subject of a parent's pending State complaint.
• Letter dated May 19, 2015, to Mississippi Department of Education, Special Assistant Attorney General Heather S. Deaton, regarding the State's
• Letter dated January 7, 2015, to Minnesota attorney Margaret O'Sullivan Kane, regarding two issues related to due process hearings in Minnesota.
• Letter dated February 23, 2015, to individual Debbie Baus, regarding a parent's right to request an independent educational evaluation at public expense in an area that was not previously assessed by the public agency, and the public agency's responsibilities after the parent makes the request.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education (OESE), 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 March 10, 2017.
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 Tara Ramsey, 202-260-2063.
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.
The proposed changes to the 2017 HEP APR are changes to the HEP
Office of Elementary and Secondary Education, Department of Education.
Notice.
The Secretary proposes to waive the requirements in 34 CFR 75.250(a) and 75.261(c)(2) of the Education Department General Administrative Regulations (EDGAR). Respectively, these provisions generally prohibit project periods exceeding five years and project period extensions involving the obligation of additional Federal funds. The proposed waivers would enable the 22 grantees under the Comprehensive Centers program that received awards in the fiscal year (FY) 2012 grant competition to continue to receive Federal funding for up to 24 months beyond the five-year limitation contained in 34 CFR 75.250(a).
We must receive your comments on or before February 8, 2017.
Address all comments about these proposed waivers to Britt Jung, Office of Elementary and Secondary Education, U.S. Department of Education, 400 Maryland Ave. SW., Room 3E206, Washington, DC 20202-6400.
Britt Jung. Telephone: (202) 205-4513 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
During and after the comment period, you may inspect all public comments about this notice of proposed waivers by accessing
The purpose of these centers is to provide technical assistance to States as States work to help local educational agencies (LEAs) and schools to close achievement gaps in core content areas and raise student achievement in schools. We are especially interested in helping LEAs that are implementing comprehensive support and improvement activities and targeted support and improvement activities under section 1111(d) of the Elementary and Secondary Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA).
Eligible applicants for Comprehensive Center grants are research organizations, institutions, agencies, institutions of higher education, partnerships among these types of entities, or individuals with the demonstrated ability or capacity to carry out the activities described in the notice inviting applications published in the
We are proposing to waive the requirements in 34 CFR 75.250(a), which prohibit project periods exceeding five years, and the requirements in 34 CFR 75.261(c)(2), which limit the extension of a project period if the extension involves the obligation of additional Federal funds. This would allow the 22 current Comprehensive Center grantees to continue to receive Federal funding annually for project periods through FY 2017 and possibly through FY 2018.
We are proposing these waivers because we do not believe it would be in the public interest to hold a new competition under the Comprehensive Centers program until after the finalization of the Department's new regulations and guidance on the ESEA, as amended by the ESSA. One of the primary purposes of the Comprehensive Centers program is to provide technical assistance to States regarding the administration and implementation of programs under the ESEA. Delaying the next competition until after the Department has finished implementing the ESEA, as amended by the ESSA, would allow applicants to familiarize themselves with the new statutory requirements under the ESSA and submit proposals that will best serve States.
We have also concluded that it would be contrary to the public interest to have a lapse in the work of the Comprehensive Centers while the Department implements the components of the ESSA described above.
We intend to fund the extended project period for either one or two years by using the FY 2017 and, if necessary, FY 2018 funds that Congress appropriates under the current statutory authority.
Under this proposed waiver and extension of the project period—
(1) Current grantees will be authorized to receive continuation awards annually for up to two years.
(2) We would not announce a new competition or make new awards under the Comprehensive Centers program in FY 2017.
(3) During the extension period, any activities carried out must be consistent with, or be a logical extension of the scope, goals, and objectives of the grantee's approved application from the 2012 Comprehensive Centers competition.
(4) Each grantee who receives a continuation award must also continue to comply with the requirements established in the program regulations and the 2012 NIA.
The proposed waivers of 34 CFR 75.250(a) and 75.261(c)(2) would not affect the applicability of the requirements in 34 CFR 75.253 (continuation of a multi-year project
In addition, these proposed waivers would not exempt current Comprehensive Centers grantees from the account-closing provisions in 31 U.S.C. 1552(a), nor would they extend the availability of funds previously awarded to current Comprehensive Centers grantees. Under 31 U.S.C. 1552(a) appropriated funds may be used for payment of valid obligations for only five years after the expiration of their period of availability for Federal obligation. After that time, the U.S. Department of Education will cancel and return the unexpended balance of those funds to the U.S. Treasury Department and these funds will be unavailable for restoration for any purpose. The waivers proposed in this notice would not change this requirement.
Implementing these waivers, therefore, would ensure that the important services provided by the current Comprehensive Centers grantees can be continued uninterrupted, as the Department releases final regulations and guidance to support States in their transition to the ESSA. During this extension period the activities of the current Comprehensive Centers grantees would be modified through work plans, as necessary, to support States as they begin to implement the ESSA.
We will announce the final waivers, if any, in a notice in the
For the 22 Comprehensive Centers grantees that received awards in the FY 2012 competition, the Secretary proposes to waive the requirements in 34 CFR 75.250(a) and 75.261(c)(2) that prohibit project periods exceeding five years and extensions of project periods that involve the obligation of additional Federal funds.
The Secretary certifies that these proposed waivers would not have a significant economic impact on a substantial number of small entities.
The small entities that would be affected by these proposed waivers are:
(a) The FY 2012 grantees currently receiving Federal funds; and
(b) Entities that otherwise would have been eligible to apply for an award in FY 2017 under the Comprehensive Centers program if the Department had held that competition.
The Secretary certifies that the proposed waivers would not have a significant economic impact on these entities because the proposed waivers and the activities required to support the additional years of funding would not impose excessive regulatory burdens or require unnecessary Federal supervision. The proposed waivers would impose minimal requirements to ensure the proper expenditure of program funds, including requirements that are standard for continuation awards.
This notice of proposed waivers does not contain any information collection requirements.
This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive Order is to foster an intergovernmental partnership and a strengthened federalism. The Executive Order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education, Department of Education.
Notice.
This priority is:
For applicants with an expiring HEP project, the Secretary will consider the applicant's prior experience in implementing its expiring HEP project, based on information contained in documents previously provided to the Department, such as annual performance reports, project evaluation reports, site visit reports, and the previously approved HEP application.
Under this competition, we also are particularly interested in applications that address the following invitational priorities.
These priorities are:
Projects that are designed to address one or more of the following priority areas:
(a) Providing students with increased access to rigorous and engaging coursework in STEM.
(b) Increasing the opportunities for high-quality preparation of, or professional development for, teachers or other educators of STEM subjects.
Applicants could, for example, consider activities to better prepare program participants to transition into postsecondary education, such as preparing students to pass the sections of college entrance examinations in STEM-related subjects or providing mentoring, counseling, and tutoring services designed to motivate participants to pursue postsecondary education in STEM-related fields. Similarly, for the professional development priority area, applicants could propose activities to increase the opportunities for high-quality professional development for HSE instructors of STEM-related subjects that include, for example, training in intensive science teaching techniques presented by a professionally credentialed expert in science education.
Applications that propose to engage faith-based and community organizations in the delivery of services under this program.
The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
The Department is not bound by any estimates in this notice.
1.
2.
3.
1.
To obtain a copy via the Internet, use the following address:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2. a.
• 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, headings, footnotes, quotations, references, and captions. However, you may single space all text in charts, tables, figures, and graphs. Charts, tables, figures, and graphs presented in the application narrative count toward the page limit.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch) throughout the entire application package.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The 25-page limit for the application narrative does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract. However, the page limit does apply to all of the application narrative.
Appendices must be limited to 20 pages and must include resumes, if applicable, and job descriptions of key personnel. Job descriptions must include duties and minimum qualifications. Items in the appendices will only be used by the program office; the items will not be read by reviewers.
b.
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.
Applications for grants under this competition must be submitted electronically using the
We will 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
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), 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,
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
7.
a.
Applications for grants under HEP, CFDA number 84.141A, must be submitted electronically using the Governmentwide
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 HEP at
Please note the following:
• When you enter the
• Applications received by
• 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
• You should review and follow the Education Submission Procedures for submitting an application through
• 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 Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only 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
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• 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
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
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• 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: Emily Bank, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E338, Washington, DC 20202-6135. FAX: (202) 205-0089.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
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: U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.141A, LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
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.
c.
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:
U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.141A, 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
(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.
2.
In addition, in making a competitive grant award, the Secretary 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.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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) Under 34 CFR 75.250(b), 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.
Applicants must propose annual targets for these measures in their applications. The national target for GPRA measure 1 for FY 2017 is that 69 percent of HEP program participants exit the program having received an HSE credential. The national target for GPRA measure 2 for FY 2017 is that 80 percent of HEP HSE diploma recipients will enter postsecondary education or training programs, upgraded employment, or the military. The national targets for subsequent years may be adjusted based on additional baseline data. The panel readers will score related selection criteria on the basis of how well an applicant addresses these GPRA measures. Therefore, applicants will want to consider how to demonstrate a sound capacity to provide reliable data on the GPRA measures, including the project's annual performance targets for addressing the GPRA performance measures, as is required by the Office of Management and Budget approved annual performance report that is included in the application package. All grantees will be required to submit, as part of their annual performance report, information with respect to these GPRA performance measures.
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).
If you use a TDD or TYY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate 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 December 21, 2016, pursuant to sections 206, 306, and 309 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h, and Rules 206 and 212 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and 385.212, Northern Illinois Municipal Power Agency (Complainant) filed a formal complaint against PJM Interconnection, L.L.C. (Respondent) alleging that Respondent is assessing duplicative congestion charges for pseudo-tied resources located in the adjoining balancing area of the Midcontinent Independent System Operator, Inc., all as more fully explained in the complaint.
Complainant certify that copies of the complaint were served on the 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 Complainant.
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
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final environmental impact statement (EIS) for the Atlantic Sunrise Project, proposed by Transcontinental Gas Pipe Line Company, LLC (Transco) in the above-referenced docket. Transco requests authorization to expand its existing pipeline system from the Marcellus Shale production area in northern Pennsylvania to deliver an incremental 1.7 million dekatherms per day of year-round firm transportation capacity to its existing southeastern market areas.
The final EIS assesses the potential environmental effects of the construction and operation of the project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the project would result in some adverse environmental impacts; however, most of these impacts would be reduced to less-than-significant levels with the implementation of Transco's proposed mitigation and the additional measures recommended in the final EIS.
The U.S. Army Corps of Engineers and the U.S. Department of Agriculture's Natural Resources Conservation Service participated as cooperating agencies in the preparation of the final EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis. Although the U.S. Army Corps of Engineers and the Natural Resources Conservation Service provided input to the conclusions and recommendations presented in the final EIS, the agencies will present their own conclusions and recommendations in their respective records of decision or determinations for the project.
The final EIS addresses the potential environmental effects of the construction and operation of about 199.4 miles of pipeline composed of the following facilities:
• 185.9 miles of new 30- and 42-inch-diameter natural gas pipeline in Pennsylvania;
• 11.0 miles of new 36- and 42-inch-diameter pipeline looping in Pennsylvania;
• 2.5 miles of 30-inch-diameter replacements in Virginia; and
• associated equipment and facilities.
The project's proposed aboveground facilities include two new compressor stations in Pennsylvania; additional compression and related modifications to three existing compressor stations in Pennsylvania and Maryland; two new meter stations and three new regulator stations in Pennsylvania; and minor modifications at existing aboveground facilities at various locations in Pennsylvania, Virginia, Maryland, North Carolina, and South Carolina to allow for bi-directional flow and the installation of supplemental odorization, odor detection, and/or odor masking/deodorization equipment.
The FERC staff mailed copies of the final EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. Paper copy versions of this EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the final EIS is available for public viewing on the FERC's Web site (
In accordance with the Council on Environmental Quality's (CEQ) regulations implementing NEPA, no agency decision on a proposed action may be made until 30 days after the U.S. Environmental Protection Agency publishes a notice of availability of the final EIS in the
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings
Take notice that the Commission received the following electric rate 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:
On November 23, 2016, the Commission issued a “
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Valley Expansion Project involving construction and operation of facilities by WBI Energy Transmission, Inc. (WBI Energy) in Clay County, Minnesota and Cass, Burleigh, Stutsman, and Barnes Counties, North Dakota. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. The NOI identified December 23, 2016 as the close of the scoping period. Please note that the scoping period is now extended and will close on January 27, 2017.
If you sent comments on this project to the Commission before the opening of this docket on October 17, 2016, you will need to file those comments in Docket No. PF16-10-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this planned project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the planned facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” is available for viewing on the FERC Web site (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (PF16-10-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
WBI Energy plans to construct 38 miles of new 16-inch-diameter pipeline between Mapleton, North Dakota and Felton, Minnesota. WBI Energy also plans to construct a new 2,600-horsepower electric-driven compressor station in Cass County, North Dakota, farm taps, valve settings, and ancillary facilities. Additionally, WBI Energy plans to replace two existing town border station delivery points and construct one regulator station in Burleigh, Stutsman, and Barnes Counties, North Dakota in order to increase in the maximum allowable operating pressure of a portion of its Line Section 24. According to WBI Energy, the project would provide an additional 40 million cubic feet per day of firm transportation on its system.
The general location of the project facilities is shown in appendix 1.
Construction of the project would affect a total of about 530 acres of land, including the pipeline construction right-of-way, additional temporary workspace, staging areas, temporary and permanent access roads, and aboveground facilities. The total acreage required for operation of the project is approximately 235 acres, including the new permanent pipeline easement, permanent access roads, and permanent aboveground facilities' footprint.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA, we will discuss impacts that could occur as a result of the construction and operation of the planned project under these general headings:
• Geology and soils;
• water resources, fisheries, and wetlands;
• vegetation and wildlife;
• endangered and threatened species;
• cultural resources;
• socioeconomics;
• land use;
• air quality and noise;
• public safety; and
• cumulative impacts.
We will also evaluate possible alternatives to the planned project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
Although no formal application has been filed, we have already initiated our NEPA review under the Commission's pre-filing process. The purpose of the
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before we make our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues related to this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Offices (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
We have already identified several issues that we think deserve attention based on a preliminary review of the planned facilities and the environmental information provided by WBI Energy. This preliminary list of issues may change based on your comments and our analysis, but currently includes:
• Drain tiles;
• deep topsoil and poor quality subsoils (salinity/sodium or lime);
• prime farm land;
• federally listed species, including the whooping crane, gray wolf, Dakota skipper, northern long-eared bat, western prairie fringed orchid, and the powershiek skipperling;
• cultural resources; and
• crossing methods of the Rush River, Red River of the North, and the Buffalo River.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the planned project.
If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
Once WBI Energy files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription, which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public meetings or site visits will be posted on the Commission's calendar located at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Atlantic Coast Pipeline (ACP) and Supply Header Project (SHP) as proposed by Atlantic Coast Pipeline, LLC (Atlantic) and Dominion Transmission, Inc. (DTI), respectively, in the above-referenced dockets. Atlantic and DTI request authorization to construct and operate a total of 641.3 miles of natural gas transmission pipeline and associated facilities, and three new natural gas-fired compressor stations, and to modify four existing compressor stations. The projects would provide about 1.44 billion cubic feet per day of natural gas to electric generation, distribution, and end use markets in Virginia and North Carolina. In addition, Atlantic and Piedmont Natural Gas Co., Inc. (Piedmont) request authorization to allow Atlantic to lease capacity on Piedmont's existing pipeline distribution system in North Carolina for use by Atlantic (Capacity Lease Proposal). No construction or facility modifications are proposed with the Capacity Lease Proposal.
The draft EIS assesses the potential environmental effects of the construction and operation of the projects in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the projects would have some adverse and significant environmental impacts; however, the majority of impacts would be reduced to less-than-significant levels with the implementation of the Atlantic's and DTI's proposed mitigation and the additional measures recommended in the draft EIS.
The U.S. Department of Agriculture—Forest Service (FS); U.S. Army Corps of Engineers; U.S. Environmental Protection Agency; U.S. Fish and Wildlife Service—Great Dismal Swamp National Wildlife Refuge; West Virginia Department of Environmental Protection; and West Virginia Division of Natural Resources participated as cooperating agencies in the preparation of the draft EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposals and participate in the NEPA analysis. Further, the FS may use the EIS when it considers amendments to Land and Resource Management Plans (LRMPs) for the proposed crossings of the Monongahela National Forest (MNF) and George Washington National Forest (GWNF). Although the cooperating agencies provide input to the conclusions and recommendations presented in the draft EIS, each agency will present its own conclusions and recommendations in its respective record of decision or determination for the projects.
The draft EIS addresses the potential environmental effects of the construction and operation of the following proposed project facilities:
The ACP includes:
• 519.1 miles of new 42- and 36-inch-diameter natural gas pipeline in West Virginia, Virginia, and North Carolina;
• 84.6 miles of 20- and 16-inch-diameter natural gas pipeline in Virginia and North Carolina;
• three new compressor station in Lewis County, West Virginia; Buckingham County, Virginia; and Northampton County, North Carolina; and
• nine meter stations, along with pig launchers/receivers and mainline valves.
The SHP includes:
• 37.5 miles of new 36-inch-diameter natural gas pipeline in Pennsylvania and West Virginia;
• modifications at four existing compressor stations in Westmoreland and Green Counties Pennsylvania and Marshall and Wetzel Counties West Virginia;
• abandonment of existing compressor units and associated facilities in Wetzel County, West Virginia; and
• one meter station, along with pig launchers/receivers and mainline valves.
The FS's purpose and need for the proposed action is to respond to a special use application submitted by Atlantic on November 12, 2015, to allow the construction and operation of the ACP on national forest system (NFS) lands managed by the MNF and the GWNF. If the FS decides to authorize the pipeline crossing of NFS lands and issue a special use permit, the FS has determined that amendments to each national forest LRMP would be needed.
Project-specific plan amendments would be needed to deviate from the precise wording of forest plan standards for the construction and operation of the ACP. These amendments are considered “project-specific” amendments because they would not change FS requirements for other projects or authorize any other actions. Additionally, if the proposed route is authorized and a special use permit issued, the GWNF LRMP would need to be amended to change the current management prescriptions in the pipeline's operational corridor to Management Prescription Area (Rx) 5C-Designated Utility Corridors. The MNF does not have LRMP direction that would require a similar plan amendment to reallocate management prescriptions. Therefore, this amendment is considered a “plan-level” amendment and would change future management direction for the lands reallocated to the new management prescription. The FS has also identified other potential amendments that may be required, pending survey information and analyses that are not currently available.
Pursuant to Title 40 of the Code of Federal Regulations, Part 1506.3(c) (40 CFR 1506.3(c)), the FS may adopt and use the EIS developed by FERC to consider authorization for the construction and operation of the ACP crossing NFS lands. Further, the FS may use this EIS when it considers amendments to the LRMPs that would be required for the proposed crossings of the MNF and GWNF. The FS will prepare separate Records of Decision for the authorization decision and for the plan amendments decisions, after issuance of the FERC final EIS.
The following amendments have been proposed by the FS as part of the proposed action in the FERC draft EIS:
The type of amendment applicable to the MNF would be a project-specific amendment. This amendment would not change FS requirements for other projects or authorize any other actions.
Other potential amendments may be needed pending the outcome of ongoing analyses and development of project design and mitigation.
The first type of LRMP amendment applicable to the GWNF would be a plan-level amendment that would change land allocations. This would change future management direction for the lands reallocated to the new Rx and is required by LRMP Standards FW-243 and FW-244.
Rx 5C-Designated Utility Corridors contains special uses which serve a public benefit by providing a reliable supply of electricity, natural gas, or water essential to local, regional, and national economies. The new Rx 5C land allocation would be 53.5 feet wide, the width of the final operational right-of-way of the ACP. The area would not cross into the Rx 4A-Appalachian National Scenic Area but would stop and start at the existing Rx 4A boundary. The Rx4A would continue to be managed for the Appalachian National Scenic Trail.
The second type of amendment applicable to the GWNF would be a project-specific amendment that would apply only to the construction and operation of the ACP. The following standards would require a temporary waiver to allow the project to proceed. These amendments would not change LRMP requirements for other projects or authorize any other actions.
The FS is requesting public comments on the authorization of the ACP on NFS lands and the draft proposed and potential amendments of the LRMPs that would allow the ACP to cross the MNF and GWNF. All comments must be submitted to the FERC as directed in this notice. The FS decision to authorize the ACP will be subject to FS predecisional administrative review procedures established in 36 CFR 218. The MNF Potential Amendment 1, GWNF Proposed Amendments 2 and 3, and Potential Amendments 4, 5, and 6 were developed in accordance with 36 CFR 219 (2012 version) regulations but will be subject to the administrative review procedures under 36 CFR 218 regulations Subparts A and B, per 36 CFR 219.59(b). GWNF Proposed Amendment 1 was developed in accordance to 36 CFR 219 (2012) regulations and will be subject to the administrative review procedures under 36 CFR 219 Subpart B. Refer to the applicable administrative review regulations for eligibility requirements.
All comments must be submitted to the FERC, the lead federal agency, within the timeframe stated in this Notice of Availability. Refer to Docket No. CP15-554-000 (ACP) in all correspondence to ensure that your comments are correctly filed in the record. You may submit your comments to the FERC using one of the four methods listed below.
The FERC staff mailed copies of the draft EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project areas; and parties to this proceeding. Paper copy versions of this draft EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the draft EIS is available for public viewing on the FERC's Web site (
Any person wishing to comment on the draft EIS may do so. To ensure consideration of your comments on the proposals in the final EIS, it is important that the Commission receive your comments by April 6, 2017.
For your convenience, there are four methods you can use to submit your comments to the Commission. In all instances, please reference the appropriate docket numbers (CP15-554-000 and CP15-554-001 for ACP; CP15-555-000 for SHP; or CP15-556-000 for Capacity Lease) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature on the Commission's Web site (
(2) You can file your comments electronically by using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address:
(4) In lieu of sending written or electronic comments, the Commission invites you to attend one of the public comment sessions its staff will conduct in the project area to receive comments on the draft EIS. We encourage interested groups and individuals to attend and present oral comments on
There will not be a formal presentation by Commission staff at any of the ten public comment sessions, although a format outline handout will be made available. All sessions will begin at 5:00 p.m., with the exception of the session on Thursday, February 16, 2017, which will begin at 5:30 p.m. If you wish to provide verbal comments, the Commission staff will hand out numbers in the order of your arrival. Number distribution will be discontinued at 8:00 p.m. in order to ensure all comments are received by the session closing time. Comments will be taken until 9:00 p.m. (or 9:30 p.m. at the February 16 session). However, if no additional numbers have been handed out
The primary goal of the public sessions is to allow individuals to provide verbal comments on the draft EIS. Individual verbal comments will be taken on a one-on-one basis with a Court Reporter (with FERC staff or representative present), called up in the order of the numbers received. Because we anticipate considerable interest from concerned citizens, this format is designed to receive the maximum amount of verbal comments, in a convenient way during the timeframe allotted. If many people are interested in providing verbal comments in the one-on-one setting at any particular session, a time limit of 3 minutes may be implemented for each commenter.
Your verbal comments will be recorded by the Court Reporter. Transcripts of all comments from the sessions will be placed into the dockets for the projects, which are accessible for public viewing on the FERC's Web site (at
Commission staff will be available at each venue of the public sessions to answer questions about our environmental review process. It is important to note that written comments mailed to the Commission and those submitted electronically are reviewed by staff with the same scrutiny and consideration as the verbal comments given at the public sessions.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR part 385.214).
Additional information about the projects is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
This is a supplemental notice in the above-referenced proceeding of Viridity Energy Solutions Inc.’s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on December 19, 2016, pursuant to Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and sections 206 and 309 of the Federal Power Act, (FPA)
The Complainant certifies that a copies of the complaint were served on the contacts for MISO 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, 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 December 29, 2016, Great River Energy submitted an updated revenue requirement for Reactive Power Service provided under Schedule 2 of the Midwest ISO Tariff.
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, 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. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
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 December 23, 2016, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h, and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Old Dominion Electric Cooperative (ODEC) and Direct Energy Business, LLC, on behalf of itself and its affiliate, Direct Energy Business Marketing, LLC, and American Municipal Power, Inc. (collectively, Complainants) filed a formal complaint against PJM Interconnection, L.L.C. (PJM or Respondent) alleging, among other things, that certain provisions in the Respondent's Open Access Transmission Tariff and the Reliability Assurance Agreement among Load Serving Entities in the PJM Region, regarding Seasonal Capacity Performance Resources in the RPM auctions, are no longer just and reasonable, all as more fully explained in the complaint.
Complainants certify that copies of the complaint were served on the 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 Complainant.
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
This is a supplemental notice in the above-referenced proceeding of NEP Energy Services, Ltd.’s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 23, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
On July 11, 2016, Gulf South Pipeline Company, LP (Gulf South) filed an application in Docket No. CP16-478-000 requesting a Certificate of Public Convenience and Necessity pursuant to section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project is known as the St. Charles Parish Expansion (Project), and involves the construction and operation of natural gas pipeline and compression facilities by Gulf South in St. Charles and St. John the Baptist Parishes, Louisiana.
On July 18, 2016, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
The Project purpose is to provide 133,333 dekatherms per day to serve Entergy Louisiana, LLC's proposed natural gas-fired power plant facility located near Montz, Louisiana. Gulf South proposes to construct a new 5,000 horsepower compressor station near Montz, Louisiana (Montz Compressor Station), about 900 feet of new 16-inch-diameter pipeline, and auxiliary facilities.
The proposed Montz Compressor Station would be on the border of St. Charles and St. John the Baptist Parishes. Gulf South plans to begin construction of the Project in the fall of 2017 and place the facilities in-service by September 1, 2018.
On August 24, 2016, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
This is a supplemental notice in the above-referenced proceeding of Enel Trading North America, Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 17, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on December 21, 2016, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure,
Any person desiring to intervene or to protest in this proceeding 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) on or before 5:00 p.m. Eastern time on the specified comment date. 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. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Approved Energy II LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is January 23, 2017.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Environmental Protection Agency (EPA).
Notice; request for public comment.
The Environmental Protection Agency (EPA) is publishing a draft notice of the rationale for granting petitions to add n-propyl bromide (nPB), also known as 1-bromopropane (1-BP), (Chemical Abstract Service No. 106-94-5) to the list of hazardous air pollutants (HAP) contained in section 112(b)(1) of the Clean Air Act (CAA). The Halogenated Solvents Industry Alliance (HSIA) and New York State Department of Environmental Conservation (NYSDEC) submitted petitions requesting that nPB be added to the list of HAP. In response to the EPA requests for additional data, HSIA subsequently supplemented its petition. Petitions to add a substance to the list of HAP are permitted under the CAA section 112(b)(3).
Based on the EPA's evaluation of the petitioners' showing concerning potential hazards, emissions, and atmospheric dispersion modeling that provided estimates of ambient concentrations of nPB, the EPA has determined that there is adequate evidence to support a determination that emissions and ambient concentrations of nPB may reasonably be anticipated to cause adverse health effects.
Comments must be received on or before March 10, 2017.
For questions about this proposed action, contact Ms. Elineth Torres, Sector Policies and Programs Division, Policies and Strategies Group (D205-02), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-4347; email address:
Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. If you submit a CD-ROM or disk that does not contain CBI, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information marked as CBI
If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the
In addition to being available in the docket, the electronic copy of this document will be available on the World Wide Web. Following signature, a copy of this document will be posted on at the following address:
The list of HAP, which can be found in CAA section 112(b)(1), is a list of a wide variety of organic and inorganic substances that Congress identified as hazardous air pollutants in the 1990 CAA Amendments. These HAP have been associated with a wide variety of adverse health effects, including cancer, neurological effects, reproductive effects, and developmental effects. The health effects associated with various HAP differ depending upon the toxicity of the individual HAP and the particular circumstances of exposure, such as the amount of chemical present, the length of time a person is exposed, and the stage of life at which the person is exposed. The CAA directs the EPA to first identify and list source categories that emit HAP and then to set emission standards for those listed source categories. Standards promulgated under CAA section 112(d) are commonly referred to as National Emission Standards for Hazardous Air Pollutants (NESHAP).
CAA section 112(b)(3)(A) specifies that any person may petition the Administrator to modify the list of HAP contained in CAA section 112(b)(1) by adding or deleting a substance. CAA section 112(b)(3)(B) sets out the substantive criteria for granting a petition. It calls for the Administrator to add a substance to the CAA section 112(b)(1) list “upon a showing by the petitioner or on the Administrator's own determination that the substance is an air pollutant and that emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects.” The Administrator is required under CAA section 112(b)(3)(A) to either grant or deny a petition within 18 months of the receipt of a complete petition by publishing a written explanation of the reasons for the Administrator's decision. The Administrator may not deny a petition solely on the basis of inadequate resources or time for review.
CAA section 112(b)(2) gives the Administrator authority to add to the CAA section 112(b)(1) list “pollutants which present, or may present through inhalation or other routes of exposure, a threat of adverse human health effects (including, but not limited to, substances, which are known to be, or may reasonably be anticipated to be, carcinogenic, mutagenic, teratogenic, neurotoxic, which cause reproductive dysfunction or which are acutely or chronically toxic) or adverse environmental effects whether through ambient concentrations, bioaccumulation, deposition or otherwise.” CAA section 302(k) defines an air pollutant as “any air pollution agent or combination of such agents, including any physical, chemical, biological, radioactive . . . substance or matter which is emitted into or otherwise enters the ambient air.” CAA section 112(a)(7) specifically defines the term “adverse environmental effect” as “any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”
The EPA reviews petitions to add substances to the HAP list in two phases: (1) A completeness determination and (2) a substantive technical review. During the completeness determination, we conduct a broad review of the petition to determine whether the necessary subject areas have been addressed and whether reasonable information and analyses are present for each of the subject areas. Once we determine the petition complete, we publish a notice of receipt of a complete petition in the
During the technical review, we conduct an evaluation of both the petition and the information received from the public in response to the
Finally, under CAA section 112(e)(4), the Administrator's action to add a pollutant to the CAA section 112(b)(1) HAP list is not a final agency action subject to judicial review, except that any such action may be reviewed when the Administrator promulgates applicable CAA section 112(d) standards for the pollutant. Thus, any final decision to grant petitions to add nPB to the HAP list would not be subject to review until the Administrator promulgates applicable CAA section 112(d) standards addressing emissions of nPB.
As previously explained, CAA section 112(b)(3)(A) allows any person to petition the EPA to modify the CAA section 112(b)(1) list of HAP by adding or deleting a substance. A petitioner must make “a showing . . . that there is adequate data on the health or environmental effects of the pollutant or other evidence adequate to support the petition.” CAA section 112(b)(3)(A). Thus, this section places the burden on a petitioner to demonstrate that the data sufficiently support an affirmative determination that the substantive criteria contained in CAA section 112(b)(3)(B) have been met. In other words, a petitioner bears the burden of showing that emissions, ambient concentrations, bioaccumulation or deposition of a substance are known to cause or may reasonably be anticipated to result in adverse human health or environmental effects. “The statutory language unambiguously places on a [ ]listing petitioner the burden to make a `showing' that `there is adequate data' about a substance to determine exposure to it `may . . . reasonably be anticipated to cause' adverse effects.”
As previously noted, CAA section 112(b)(3)(B) calls for the Administrator to add to the CAA section 112(b)(1) list of HAP a substance that is shown to be “an air pollutant and that emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects.” CAA section 112(b)(2) provides additional guidance on how the Administrator's decision is to be formed by identifying carcinogenicity, mutagenicity, teratogenicity, neurotoxicity, reproductive dysfunction, and acute or chronic toxicity as types of adverse health effects. Further, the language used in CAA section 112(b)(3)(B) does not call for either complete substantiation or require absolute certainty that a substance will cause adverse effects to human health or the environment. In fact, it calls for listing a substance that “may reasonably be anticipated to cause” certain impacts. The EPA interprets this language as recognizing the limitations and difficulties associated with information on public health and environment. Typically, questions as to whether a substance presents adverse health and welfare effects and the types of effects border on the frontiers of scientific knowledge and are given to uncertainty because there is either insufficient or inconsistent data. For example, there might be limited scientific knowledge of exposure effects on human health and the environment. Some substances have no known safe level. There might also be limited emissions data on a substance that is considered for addition to the list given that it would be largely unregulated.
Moreover, the CAA is a protective or preventive statute. One of its stated purposes is “to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare.” CAA section 101(b)(1). Relevant legislative history also provides support for this stated purpose. (The CAA is “to assure that regulatory action can effectively prevent harm before it occurs; to emphasize the predominant value of protection of public health.” H.R. Rep. No. 95-294, 95th Cong., 1st Sess. 49 (1977)). Such statutes do not call for certainty of harm, but rather accord a decision maker flexibility in taking regulatory action that is protective of public health and the environment. They allow a decision maker to exercise discretion when forming her judgement, which would likely involve balancing of factors that are uniquely within her expertise and policy choices, and predictions on the frontiers of scientific knowledge. (“[A]n agency [has] latitude to exercise its discretion in accordance with the remedial purposes of the controlling statute where relevant facts cannot be ascertained or are on the frontiers of scientific inquiry.”
Further, requiring data/information that provides absolute certainty of the adverse health effects of a substance would likely result in making listing decisions similar to the risk- and health-based approach employed prior to the 1990 CAA Amendments. See S. Rep. No. 101-228 at 3, 128 (1989); see also H.R. Rep. No. 101-490, pt. 1, at 322 (1990). Up until then, the EPA was required to list HAP for regulation based on a conclusion that they could “cause or contribute to, an increase in mortality, an increase in serious irreversible, or incapacitating reversible illness.” Section 112(a)(1), CAA, Pub. L. 91-604, 84 Stat. 1676, 1685 (1970).
We note that the Administrator's discretion is neither unbounded nor limitless, but rather constrained by the EPA's duty to protect human health and welfare. See
In summary, we read CAA section 112(b)(3)(B) as allowing the Administrator to exercise her expertise to decide, based on all relevant considerations, whether the data presented in a petition are adequate to support a decision to add a substance to the CAA section 112(b)(1) list of HAP. In other words, to determine whether a petitioner has shown that emissions of a substance cause or may reasonably be anticipated to cause adverse effects to human health or the environment. The Administrator would also likely assess potential or probable public health and environmental risks rather than proof of actual harm and consider necessary policy issues. The burden, however, remains on a petitioner to provide data sufficient to support an affirmative determination that emissions of a substance may cause or may reasonably be anticipated to cause adverse human health or environmental effects. Thus, a petitioner must provide a detailed assessment of the available data concerning the substance's potential adverse human health and environmental effects and, where appropriate, characterize the potential for human and environmental exposures resulting from emissions of the substance. We expect that such data would most likely demonstrate that emissions, ambient concentrations, bioaccumulation, or deposition of the substance may reasonably be anticipated to cause adverse effects to human health or the environment. We believe this is a reasonable and proper manner of giving effect to the Administrator's duty to address public health and environmental effects under CAA section 112(b)(3).
HSIA and NYSDEC submitted petitions to add nPB, also known as 1-BP, to the CAA section 112(b)(1) list of HAP on October 28, 2010, and November 24, 2011, respectively. On November 28, 2012, in response to the EPA's requests for additional data, HSIA supplemented its petition. The petitions to add nPB to the list of HAP presented the following information:
• Background data on nPB, including chemical properties, physical properties, production data, and use data;
• Toxicological evidence describing the human health effects of nPB;
• Estimation of an inhalation unit risk;
• nPB emissions estimates and atmospheric dispersion modeling estimating potential ambient concentrations of nPB adjacent to facilities that emit it; and
• Characterization of potential risks to human health due to potential exposure to ambient air concentrations of nPB.
We discuss in detail the information presented in the petitions in section IV of this document, titled EPA's Technical Review of the Petitions.
Following the receipt of the petitions, the EPA conducted a review to determine whether the petitions were complete according to the agency criteria. After reviewing these petitions and supplemental information, the EPA determined that the petitions addressed all of the necessary subject areas for the agency to assess whether emissions, ambient concentrations, bioaccumulation, or deposition of nPB are known to cause or may reasonably be anticipated to cause adverse human health effects or adverse environmental effects. The EPA determined the petitions to add nPB to the list of HAP to be complete and published a notice of receipt of a complete petition in the
We received 17 submissions in response to the request for comments and additional information. The submissions are in the docket. Almost all the submissions agreed with the EPA's completeness determination of the petitions to add nPB to the CAA section 112(b)(1) HAP list. The majority of commenters referenced the National Toxicology Program (NTP) Report on Carcinogens (RoC), 13th Edition, 2014 (NTP, 2014) in which the NTP classified nPB, identified as 1-BP, as being reasonably anticipated to be a human carcinogen.
Both petitioners, HSIA and NYSDEC, provided comments and additional information on occupational hazards and toxicity of nPB to support their petitions. Albemarle Corporation and Enviro Tech International (ETI), a manufacturer and a supplier of nPB respectively, disagreed with the EPA's completeness determination and provided their own evaluation of the emissions estimates, nPB carcinogenicity, as well as the exposure and cancer risk assessment included in the HSIA petition. Both Albemarle and ETI did not support the granting of petitions to add nPB to the HAP list based on their risk assessment. Submissions from various states, the city of Philadelphia, and groups representing state air pollution control agencies supported the EPA's completeness determination, presented state-specific information regarding the uses of nPB in dry cleaning and as a solvent in adhesives and degreaser operations, provided information on nPB state-specific studies and regulations, and supported the granting of the petitions to add nPB to the HAP list.
Submissions from national environmental organizations and other members of the public provided the EPA with additional references to studies on nPB's carcinogenic potential and neurotoxicity as well as information relevant to the NTP's peer-reviewed report on the carcinogenicity of nPB, and to the occupational exposure limits for nPB. These commenters also referenced the EPA's addition of nPB to the list of toxic chemicals subject to reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). We considered all comments in our technical review.
In this section, we present the EPA's evaluation of the evidence provided by the petitioners and information submitted by commenters beyond what was provided in the petitions relevant to our technical review. The purpose of this evaluation is to determine whether the data, analyses, interpretations, and conclusions in the petitions are adequate and whether they support a determination under CAA section 112(b)(3) that the substance is an air
The EPA's technical review focuses on the evidence provided by petitioners and commenters regarding emissions, ambient concentrations, and health effects of nPB. We are seeking comments on the EPA's technical review of the HSIA and NYSDEC petitions, on whether the criteria for listing have been met, and the agency's rationale for the decision to grant these petitions.
nPB, also known as 1-BP or 1-propyl bromide (CAS # 106-94-5), is a brominated organic colorless liquid that is insoluble in water, but soluble in ethanol and ether. Both petitioners and public commenters provided background information regarding nPB's chemical properties, physical properties, production, and usage. nPB is used as an intermediate chemical in the manufacture of pharmaceuticals and agricultural products, as well as a carrier solvent in aerosols and adhesives. The petitioners presented information on specific applications of nPB, including its use in aerosol solvents, adhesives, dry cleaning, and for open vapor degreasing applications in electronic, metal, and precision cleaning operations. Many commenters raised concerns with the use of nPB as a replacement of perchloroethylene (PERC), a HAP, in the dry cleaning industry and as replacement for HAP chlorinated solvents, like trichloroethylene (TCE), in solvent cleaning operations. Commenters pointed out that nPB's vapor pressure (146 millimeters of mercury (mm Hg) at 20 °C) is higher than the vapor pressure for PERC (14 mm Hg at 20 °C) and TCE (58 mm Hg at 20 °C) and that indoor and outdoor air emissions associated with nPB use are likely to be higher than those caused by similar use of other solvents with lower vapor pressure.
The petitioners expressed the difficulty in obtaining data on production, uses, and emissions of nPB due to the lack of publically available data. HSIA estimated the global production of nPB in 2007 was 20,000-30,000 metric tons and projected the use of nPB as a solvent in the U.S. to be growing at a rate of 15-20 percent per year (5,000 metric tons or 5,511 short tons). ETI commented on the HSIA's estimates and presented its own data on the use of nPB in the U.S. in the precision cleaning industry sector, dry cleaning industry, and the adhesive, coatings, and inks sectors. Per ETI, in 2014 the U.S. used a total of 4,080 short tons of nPB within these three sectors.
The EPA agrees with the petitioners that since nPB has not been a regulated pollutant under CAA section 112 and reporting data under the Toxics Release Inventory (TRI) Program will not be available until July 2017,
To assess nPB air emissions, HSIA estimated nPB emissions for five facilities: A narrow tube manufacturing/degreasing operation, two dry cleaners, and two furniture manufacturing/spray adhesive facilities. HSIA's emission estimates are based on the internal concentration of nPB as measured by industrial hygiene studies or based on permit files and assuming that nPB is emitted in quantities similar to what would be expected for volatile organic compounds, TCE, or PERC. HSIA acknowledged in their petition that since the emission estimates have been made without access to the facilities, specific nPB use data provided by the facilities, or stack testing data, actual nPB emissions for these facilities could be different from the emission estimates. In their comments, Albemarle presented their own nPB emissions estimates for the same facilities included in the HSIA petition. The EPA believes the emissions estimates provided by HSIA and Albemarle represent a reasonable range of potential nPB emissions, with HSIA providing more conservative (higher) emissions estimates. The EPA finds that HSIA has presented adequate evidence to support the determination that nPB is an air pollutant as defined by CAA section 302(k).
To support their request for listing nPB as a HAP, the petitioners provided citations for peer-reviewed published papers and reports describing health effects of nPB. The summary from HSIA's original petition focused on reproductive effects, carcinogenicity, and neurotoxicity. When the EPA requested additional information, HSIA supplemented the information with additional scientific literature on these primary health outcomes. The NYSDEC's petition addressed these same health effects. The petitioners submitted summaries of 2-year bioassays in rats and mice, along with recommendations of the NTP Technical Reports Review Subcommittee, as evidence of carcinogenic activity (NTP, 2011). Claims of neurotoxicity are supported by the laboratory animal studies, as well as occupational studies and case reports of altered peripheral nerve function in workers exposed to concentrations of nPB as low as 1-3 parts per million (ppm). Developmental and reproductive effects, which were described by the EPA SNAP rule (72 FR 30142, May 30, 2007), were referenced by the petitioners. The petitioners claimed that the data are sufficient to conclude that nPB can and does produce adverse human health outcomes. Public comments mostly concurred with this description of health effects. In particular, Dr. Adam Finkel (a subject-matter expert on chemical toxicology) provided comments expanding upon the submitted evidence to lend more support and explanations of nPB toxicity. Regarding these health effects, Albemarle provided comments and summaries of additional studies to refute conclusions of carcinogenicity and to discount methods used in one human occupational study.
The petitions included a draft report of the NTP Technical Reports Review Subcommittee, followed by the final NTP report summarizing the carcinogenicity bioassays in rats and mice (NTP, 2011).
Comments submitted by Albemarle regarding these HAP listing petitions are the same as those submitted on the EPA's proposed TRI action (80 FR 20189, April 15, 2015). Detailed responses by the EPA to these comments are described therein. Albemarle disputed the use of the alveolar/bronchiolar adenomas in the cancer assessment, suggesting a lack of human relevance of these mouse tumors. While this topic has been debated in the scientific literature and was the topic of a technical workshop convened by the EPA (U.S. EPA, 2014),
In a previous SNAP ruling (72 FR 30142, May 30, 2007), the EPA reviewed a two-generation study (WIL Research, 2001) and concluded that reproductive toxicity, specifically changes in sperm motility and estrus cycles, was the most sensitive effect of nPB. The petition repeated this information, added references to literature studies that replicated these changes, and suggested that a metabolite may be responsible for the spermatotoxicity (Liu et al., 2009; Banu et al., 2007; Garner et al., 2007; Yamada et al., 2003). These effects are reported at inhalation exposures ≥ 200 ppm in rats and ≥ 50 ppm in mice. The petition also summarized the deliberations of the NTP Center for the Evaluation of Risks of Human Reproduction (NTP-CERHR), an expert panel that evaluated the available scientific literature on the potential for nPB to adversely affect human reproduction or development (NTP-CERHR, 2003). That monograph summarized nPB effects, including alterations in sperm count and motility, estrus cyclicity, follicular count, and reproductive organ weights. The impact of these changes is evident in the two-generation study that reported decreased fertility, increased post-implantation loss, and decreased number of litters, and live litter size. Decreased fetal weight and skeletal abnormalities, as well as depressed postnatal weight gain have also been reported in the literature. Using a weight-of-evidence approach, the panel concluded that there is clear evidence of adverse developmental/reproductive toxicity in laboratory animals and serious concern for adverse effects in humans at levels of occupational exposures.
The EPA has previously reviewed the reproductive and developmental data and agreed with the NTP panel's conclusions. In its SNAP ruling (72 FR 30142, May 30, 2007), the descriptions and evaluations of these data were provided in considerable detail. At that time the data on sperm counts and estrus cyclicity were used for derivations of acceptable exposure levels. In a recent draft report (81 FR 12099, March 8, 2016), the EPA again described nPB-induced reproductive and developmental toxicity, supplemented with studies made available after the 2003 NTP report (NTP-CERHR, 2003). These studies confirm and extend the findings of spermatotoxicity, alterations in estrous cycles, and decreased reproductive organ weights. In this recent report, the EPA considered decreased live litter size (WIL Research, 2001) to be among the most sensitive endpoints for dose-response modeling. Public comments received on the
Given the available information in the petitions, and as described by the EPA in other agency actions on nPB,
The petitions presented data from published studies in humans and laboratory animals that demonstrate that both the peripheral and central nervous systems are sensitive targets of nPB exposure. The petitions described case reports of severe neurotoxicity requiring hospitalization and potentially irreversible effects (Perrone et al., 2008; Majersik et al., 2007; Sclar, 1999). There are also epidemiological studies that describe concentration-related neurological impacts at relatively low levels; these findings were initially reported in small worker populations while later studies expanded testing to larger groups from several Chinese production facilities (Li et al., 2010; Ichihara et al., 2004; Ichihara et al., 2002). Measurements used in these occupational studies included tuning fork vibration sensitivity and neurophysiological measures of
The petitions also referenced a number of animal studies showing hind limb weakness, altered neurophysiological measures, and ataxic gait from nPB exposure, which are qualitatively similar to the reported human neurological outcomes. Behavioral measures of neuromuscular function are sensitive measures of nPB neurotoxicity (Banu et al., 2007; Honma et al., 2003; Ichihara et al., 2000). Significant changes were documented at exposures as low as 50 ppm for 21 days (Honma et al., 2003) and changes may be slow or not reversible (Banu et al., 2007). Motor nerve conduction velocity and latency measured in the rat tail nerve were altered at higher concentrations with progressive changes from 4 to 12 weeks of exposure (Yu et al., 2001; Ichihara et al., 2000). Studies of very high exposures report severely altered gait, weakness or loss of hind limb control, convulsions, and death (Banu et al., 2007; Yu et al., 2001; Ichihara et al., 2000; Ohnishi et al., 1999), as well as peripheral nerve degeneration, myelin sheath abnormalities, and spinal cord axonal swelling (Wang et al., 2002; Yu et al., 2001; Ichihara et al., 2000). The petitions included studies of potential mechanisms including neurotransmitter dysregulation (Suda et al., 2008; Wang et al., 2002) and disinhibition in paired-pulse stimulation of hippocampal slices (Fueta et al., 2007).
Some of these neurotoxic effects were described in the EPA's SNAP ruling (72 FR 30142, May 30, 2007), and the conclusions of that review are in agreement with the claims of the petitioners. Since then, the EPA has reviewed the larger literature on the neurotoxicity of nPB and has described the physiological, behavioral, and biochemical measures that characterize and develop exposure-response data for neurological effects (81 FR 12098, March 8, 2016). The EPA has concluded that the concordance of outcomes across humans and laboratory rodents provides striking evidence of neurotoxic effects.
One commenter (Albemarle) expressed concerns regarding the validity and conduct of the tuning fork test of peripheral neuropathy (Li et al., 2010) for risk assessment purposes. The EPA is not persuaded by these objections given that electrophysiological measures of peripheral nerve function were also altered in that and other studies, and, furthermore, considerations regarding hazard do not rely solely on that endpoint. The conclusion of nPB neurotoxicity is supported by the EPA's review of numerous human reports and the preponderance of studies in laboratory animals.
HSIA and Albemarle each submitted separate quantitative estimates of cancer unit risk. In addition, the 2010 HSIA petition recommended a non-cancer reference value based on a larger composite uncertainty factor than was used in the SNAP rule's acceptable exposure level. When using quantitative reference values for determining risk from chronic cancer and non-cancer effects, for CAA section 112 actions, the EPA uses only final values that have undergone a rigorous development and review process,
The petition submitted by HSIA, including supplemental information and analyses submitted through February 2016, contains an exposure assessment and estimates of lifetime potential cancer risks for populations downwind of the five facilities discussed in section IV.A of this document. The petitioner's assessment used the latest version of the EPA's Human Exposure Model (HEM)
A commenter (Albemarle) noted issues with several aspects of the estimation of ambient concentration and potential cancer risks originally submitted by the petitioner, including the use of an outdated model, which used old census and meteorological data, failure to consider the urban heat island effect, incorrect source release parameters, and failure to diurnally vary source emissions. Most of the concerns raised by this commenter have been addressed by the petitioner's use of the latest model version in its most recently submitted assessment, which used current census data, recent meteorological data from a larger library of meteorological stations, and specified urban or rural dispersion for each facility. Although the petitioner did not make any revisions to source release parameters nor temporalize source emissions, the EPA concludes that the petitioner's assessment is to be viewed less as a refined assessment of these specific facilities, but rather as an indication that it is reasonable that nPB emissions and ambient concentrations have the potential to cause elevated risks. It is important to note that the commenter's own assessment of the facilities modeled by the petitioner indicate cancer risk estimates as high as 10-in-1 million.
Moreover, as explained earlier in section II.C of this document, CAA section 112(b)(3)(B) does not specifically require an exposure assessment as a criterion for listing a substance. Rather it requires the EPA to consider whether “emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be
Thus, the EPA concludes that the petitioners have met the CAA section 112(b)(3)(A) requisite showing of adequate data by estimating nPB emissions and ambient concentrations that are likely to result beyond a facility's fence line and providing adequate evidence of adverse health effects of nPB. Because the EPA is granting the petition for reasons stated above, the agency does not find it necessary to make determinations regarding other elements of the petition, such as a petitioner's noncancer hazards and quantitative cancer risk evaluation, or whether nPB presents adverse environmental effects.
Based on the EPA's evaluation of the petitions submitted by HSIA and NYSDEC, we conclude that the petitioners have provided sufficient information demonstrating the adverse health effects of nPB. The documented adverse health effects of nPB, which are based on established sound scientific principles, include carcinogenicity, reproductive toxicity, and neurotoxicity. The EPA also concludes that the petitioner's assessment regarding estimates of potential ambient concentrations of nPB that are likely to result at a facility's fence line and process emissions related information and chemical usage information representative of normal operating conditions are reasonable. The EPA concludes that there is adequate evidence to support a determination that nPB is an air pollutant and that emissions and ambient concentrations of nPB may reasonably be anticipated to cause adverse effects to human health. As mentioned above, we are seeking comments on all aspects of this notice, including EPA's technical review of the HSIA and NYSDEC petitions, whether the criteria for listing have been met, and the agency's rationale for the decision to grant these petitions.
Additional information about this Executive Order can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel legal or policy issues. Any changes made in response to OMB recommendations have been documented in the docket.
Accordingly, the EPA is issuing this draft notice announcing the decision to grant petitions to add nPB to the CAA section 112(b)(1) HAP list.
Federal Election Commission.
Thursday, January 12, 2017 at 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Acting Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS)
Notice with comment period; withdrawal.
The Agency for Toxic Substances and Disease Registry (ATSDR) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on December 30, 2016 for public comment.
Effective January 9, 2017.
Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
On December 30, 2016 ATSDR published a notice in the
A new and corrected notice published on January 3, 2017 under the same title
Centers for Medicare & Medicaid Services (CMS), HHS.
Extension of temporary moratoria.
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.
Effective January 29, 2017.
Steve Manning, (410) 786-1691.
News media representatives must contact CMS' Public Affairs Office at (202) 690-6145 or email them at
Under the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act), the Congress provided the Secretary with new tools and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Section 6401(a) of the Affordable Care Act added a new section 1866(j)(7) to the Social Security Act (the Act) to provide the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid or CHIP providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. Section 6401(b) of the Affordable Care Act added specific moratorium language applicable to Medicaid at section 1902(kk)(4) of the Act, requiring States to comply with any moratorium imposed by the Secretary unless the State determines that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care. Section 6401(c) of the Affordable Care Act amended section 2107(e)(1) of the Act to provide that all of the Medicaid provisions in sections 1902(a)(77) and 1902(kk) are also applicable to CHIP.
In the February 2, 2011
In accordance with section 1866(j)(7)(B) of the Act, there is no judicial review under sections 1869 and 1878 of the Act, or otherwise, of the decision to impose a temporary enrollment moratorium. A provider or supplier may use the existing appeal procedures at 42 CFR part 498 to administratively appeal a denial of billing privileges based on the imposition of a temporary moratorium; however the scope of any such appeal is limited solely to assessing whether the temporary moratorium applies to the provider or supplier appealing the denial. Under § 424.570(c), CMS denies the enrollment application of a provider or supplier if the provider or supplier is subject to a moratorium. If the provider or supplier was required to pay an application fee, the application fee will be refunded if the application was denied as a result of the imposition of a temporary moratorium (see § 424.514(d)(2)(v)(C)).
Based on this authority and our regulations at § 424.570, we initially imposed moratoria to prevent enrollment of new home health agencies, subunits, and branch locations
In imposing these enrollment moratoria, CMS considered both qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse. CMS relied on law enforcement's longstanding experience with ongoing and emerging fraud trends and activities through civil, criminal, and administrative investigations and prosecutions. CMS' determination of a high risk of fraud, waste, or abuse in these provider and supplier types within these geographic locations was then confirmed by CMS' data analysis, which relied on factors the agency identified as strong indicators of risk. (For a more detailed explanation of this determination process and of these authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475)).
Because fraud schemes are highly migratory and transitory in nature, many of CMS' program integrity authorities and anti-fraud activities are designed to allow the agency to adapt to emerging fraud in different locations. The laws and regulations governing CMS' moratoria authority give us flexibility to use any and all relevant criteria for future moratoria, and CMS may rely on additional or different criteria as the basis for future moratoria.
The February 2, 2011, final rule also implemented section 1902(kk)(4) of the Act, establishing new Medicaid regulations at § 455.470. Under § 455.470(a)(1) through (3), the Secretary may impose a temporary moratorium, in accordance with § 424.570, on the enrollment of new providers or provider types after consulting with any affected State Medicaid agencies. The State Medicaid agency must impose a temporary moratorium on the enrollment of new providers or provider types identified by the Secretary as posing an increased risk to the Medicaid program unless the State determines that the imposition of such moratorium would adversely affect Medicaid beneficiaries' access to medical assistance and so notifies the Secretary. The final rule also implemented section 2107(e)(1)(D) of the Act by providing, at § 457.990 of the regulations, that all of the provisions that apply to Medicaid under sections 1902(a)(77) and 1902(kk) of the Act, as well as the implementing regulations, also apply to CHIP.
Section 1866(j)(7) of the Act authorizes imposition of a temporary enrollment moratorium for Medicare, Medicaid, and/or CHIP, “if the Secretary determines such moratorium is necessary to prevent or combat fraud, waste, or abuse under either such program.” While there may be exceptions, CMS believes that generally, a category of providers or suppliers that poses a risk to the Medicare program also poses a similar risk to Medicaid and CHIP. Many of the new anti-fraud provisions in the Affordable Care Act reflect this concept of “reciprocal risk” in which a provider that poses a risk to one program poses a risk to the other programs. For example, section 6501 of the Affordable Care Act titled, “Termination of Provider Participation under Medicaid if Terminated Under Medicare or Other State Plan,” which amends section 1902(a)(39) of the Act, requires State Medicaid agencies to terminate the participation of an individual or entity if such individual or entity is terminated under Medicare or any other State Medicaid plan. Additional provisions in title VI, Subtitles E and F of the Affordable Care Act also support the determination that categories of providers and suppliers pose the same risk to Medicaid as to Medicare. Section 6401(a) of the Affordable Care Act required us to establish levels of screening for categories of providers and suppliers based on the risk of fraud, waste, and abuse determined by the Secretary. Section 6401(b) of the Affordable Care Act required State Medicaid agencies to screen providers and suppliers based on the same levels established for the Medicare program. This reciprocal concept is also reflected in the Medicare moratoria regulations at § 424.570(a)(2)(ii) and (iii), which permit CMS to impose a Medicare moratorium based solely on a State imposing a Medicaid moratorium. Accordingly, CMS has determined that there is a reasonable basis for concluding that a category of providers or suppliers that poses a risk to Medicare also poses a similar risk to Medicaid and CHIP, and that a moratorium in all of these programs is necessary to effectively combat this risk.
In consultation with the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ), CMS previously identified two provider and supplier types in nine geographic locations that warrant a temporary enrollment moratorium. For a more detailed discussion of this consultation process, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).
In addition to consulting with law enforcement, CMS also analyzed its own data to identify specific provider and supplier types within geographic locations with significant potential for fraud, waste or abuse, therefore warranting the imposition of enrollment moratoria.
Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its State partners, and CMS carefully evaluated access for the target moratorium locations with every imposition and extension of the moratoria. Prior to imposing and extending these moratoria, CMS reviewed Medicare data for these areas and found no concerns with beneficiary access to HHAs or ground ambulance suppliers. CMS also consulted with the appropriate State Medicaid Agencies and with the appropriate State Departments of Emergency Medical Services to determine if the moratoria would create access to care concerns for Medicaid and CHIP beneficiaries. All of CMS' State partners were supportive of CMS' analysis and proposals, and together with CMS, determined that
Under § 424.570(a)(1)(iii), a temporary moratorium does not apply to any of the following: (1) Changes in practice location (2) changes in provider or supplier information, such as phone number or address; or (3) changes in ownership (except changes in ownership of HHAs that require initial enrollment under § 424.550). Also, in
In accordance with § 424.570(b), a temporary enrollment moratorium imposed by CMS will remain in effect for 6 months. If CMS deems it necessary, the moratorium may be extended in 6-month increments. CMS will evaluate whether to extend or lift the moratorium before the end of the initial 6-month period and, if applicable, any subsequent moratorium periods. If one or more of the moratoria announced in this document are extended, CMS will publish a document regarding such extensions in the
As provided in § 424.570(d), CMS may lift a moratorium at any time if the President declares an area a disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, if circumstances warranting the imposition of a moratorium have abated, if the Secretary has declared a public health emergency, or if, in the judgment of the Secretary, the moratorium is no longer needed.
Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to CMS' high screening level under §§ 424.518(c)(3)(iii) and 455.450(e)(2) for 6 months from the date the moratorium was lifted.
CMS currently has in place moratoria on newly enrolling HHAs in Florida, Illinois, Michigan, and Texas and Part B non-emergency ambulance suppliers in New Jersey, Pennsylvania, and Texas.
As provided in § 424.570(b), CMS may deem it necessary to extend previously-imposed moratoria in 6-month increments. Under this authority, CMS is extending the temporary moratoria on the Medicare enrollment of HHAs and Part B non-emergency ground ambulance providers and suppliers in the geographic locations discussed herein. Under the regulations at § 455.470 and § 457.990, these moratoria also apply to the enrollment of HHAs and non-emergency ground ambulance providers and suppliers in Medicaid and CHIP in those locations. Under § 424.570(b), CMS is required to publish a document in the
CMS consulted with the HHS-OIG regarding the extension of the moratoria on new HHAs and Part B non-emergency ground ambulance providers and suppliers in all of the moratoria states, and HHS-OIG agrees that a significant potential for fraud, waste, and abuse continues to exist regarding those provider and supplier types in these geographic areas. The circumstances warranting the imposition of the moratoria have not yet abated, and CMS has determined that the moratoria are still needed as we monitor the indicators and continue with administrative actions to combat fraud and abuse, such as payment suspensions and revocations of provider/supplier numbers. (For more information regarding the monitored indicators, see the February 4, 2014 moratoria document (79 FR 6475)).
Based upon CMS' consultation with the relevant State Medicaid agencies, CMS has concluded that extending these moratoria will not create an access to care issue for Medicaid or CHIP beneficiaries in the affected states at this time. CMS also reviewed Medicare data for these states and found there are no current problems with access to HHAs or ground ambulance providers or suppliers. Nevertheless, the agency will continue to monitor these locations to make sure that no access to care issues arise in the future.
Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.
CMS is executing its authority under sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Act to extend and implement temporary enrollment moratoria on HHAs for all counties in Florida, Illinois, Michigan, and Texas, as well as Part B non-emergency ground ambulance providers and suppliers for all counties in New Jersey, Pennsylvania, and Texas.
Section 1866(j)(7)(B) of the Act states that there shall be no judicial review under section 1869, section 1878, or otherwise, of a temporary moratorium imposed on the enrollment of new providers of services and suppliers if the Secretary determines that the moratorium is necessary to prevent or combat fraud, waste, or abuse. Accordingly, our regulations at 42 CFR 498.5(l)(4) state that for appeals of denials based on a temporary moratorium, the scope of review will be limited to whether the temporary moratorium applies to the provider or supplier appealing the denial. The agency's basis for imposing a temporary moratorium is not subject to review. Our regulations do not limit the right to seek judicial review of a final agency decision that the temporary moratorium applies to a particular provider or supplier. In the preamble to the February 2, 2011 (76 FR 5918) final rule with comment period establishing this regulation, we explained that “a provider or supplier may administratively appeal an adverse determination based on the imposition of a temporary moratorium up to and including the Department Appeal Board (DAB) level of review.” We are clarifying that providers and suppliers that have received unfavorable decisions in accordance with the limited scope of review described in § 498.5(l)(4) may seek judicial review of those decisions after they exhaust their administrative appeals. However, we reiterate that section 1866(j)(7)(B) of the Act precludes judicial review of the agency's basis for imposing a temporary moratorium.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
CMS has examined the impact of this document as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. Individuals and states are not included in the definition of a small entity. CMS is not preparing an analysis for the RFA because it has determined, and the Secretary certifies, that this document will not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if an action may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, CMS defines a small rural hospital as a hospital that is located outside of a metropolitan statistical area (MSA) for Medicare payment purposes and has fewer than 100 beds. CMS is not preparing an analysis for section 1102(b) of the Act because it has determined, and the Secretary certifies, that this document will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed regulatory action (and subsequent final action) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Because this document does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget.
Administration for Children and Families (ACF), Department of Health and Human Services (HHS).
Request for information (RFI).
This Request for Information (RFI) seeks recommendations for future work with and on behalf of American Indian and Alaska Native (AI/AN) leadership, tribes, tribal organizations, and populations in accord with ACF's vision of “children, youth, families, individuals, and communities who are resilient, safe, healthy, and economically secure.”
Submit responses by March 10, 2017.
Written comments may be submitted through any of the methods specified below. However, electronic submission is preferred. Please do not submit duplicate comments.
All comments received before the close of the comment period will be available for public inspection, including any information that is included in a comment. All electronically submitted comments posted through the
Camille Loya, Director, Division of Policy, Administration for Native Americans,
Executive Order 13175, dated November 6, 2000, established policymaking criteria applicable to federal agencies, to the extent permitted by law, when formulating and implementing policies that have tribal implications, including special requirements for legislative proposals and consultation. Subsequently, President Obama issued a Presidential Memorandum on Tribal Consultation, dated November 5, 2009, affirming that “meaningful dialogue between Federal officials and tribal officials has greatly improved Federal policy toward Indian
Consistent with the above affirmative statements of the value of feedback from AI/AN partners and stakeholders, ACF is requesting information from AI/AN tribes, tribal organizations, and stakeholders (including grantees). The purpose is to identify issues and challenges facing AI/AN populations as well as to inform ACF of tribes' and tribal organizations' recommendations, promising practices, and innovations to address the needs of AI/AN children, youth, families, and communities. This information may, in turn, be used by ACF in the development of future rulemaking and technical assistance, formation of legislative proposals and research agendas, and strategic planning in consultation with tribes.
As President Obama stated in his Presidential Proclamation—National Native American Heritage Month (2016):
Let us continue to build on the advancements we have made, because enduring progress will depend on our dedication to honoring our trust and treaty responsibilities. With sustained effort and unwavering optimism, we can ensure a vibrant and resilient Indian Country filled with possibility and prosperity.
In this RFI, we seek feedback and recommendations related to how ACF partners with tribes and how to make progress in the future. The following questions are not exhaustive, and we encourage commenters to provide any additional information they believe relevant to ACF's work with and on behalf of American Indians and Alaska Natives. You may provide general comments, respond to all questions posed in section II of this RFI, or respond to one or more questions. If you respond to any of the questions in section II, please identify the number that corresponds to the question(s) you are responding to. Include our agency name and the docket number on all submissions. Please do not include confidential information, or otherwise sensitive or protected information with your responses.
(1) Are there challenges to AI/AN tribes and tribal organizations posed by non-federal match or cost sharing requirements in any applicable ACF programs? Please be specific as to the program or programs you are referring to as well as provide as much detail as possible in describing challenges or difficulties posed and any specific recommendations you wish to provide.
(2) Are there challenges to AI/AN tribes and tribal organizations posed by administrative cost caps required under some ACF grant programs? Please be specific as to the program or programs you are referring to as well as provide as much detail as possible in describing challenges or difficulties posed and any specific recommendations you wish to provide.
(3) Are there instances for which you believe waiver authority, additional waiver authority allowed under block grants, would benefit tribes under any ACF programs? Please be specific as to the program or programs you are referring to as well as provide as much detail as possible in describing challenges or difficulties posed and any specific recommendations you wish to provide.
(4) For ACF programs that currently have waiver authority for tribes, do you recommend ACF streamline the processes under which AI/AN tribes and tribal organizations apply for or request waivers of statutory or regulatory requirements across ACF grant programs? Please be specific as to the program or programs you are referring to as well as provide as much detail as possible in describing where you believe additional streamlining is needed, along with any specific recommendations you wish to provide.
(5) Are there regulatory or administrative barriers that present challenges to AI/AN tribes and tribal organizations in the implementation of ACF grant programs? Please be specific about what those regulatory or administrative barriers are as well as recommendations for addressing them.
(6) Can you identify practices, policies, and procedures in ACF or elsewhere that are particularly effective in meeting the needs of AI/AN tribes, tribal organizations, families, and communities? Please be specific as to the program or programs you are referring to as well as provide as much detail as possible in describing effective and responsive practices, policies, and procedures.
(7) Related to data, what would you recommend ACF either collect (if it does not already) or analyze that would be most useful to inform our work withAI/AN tribes and tribal organizations? Please be specific and provide as much detail as possible.
(8) Do you have recommendations for how ACF could better share data related to AI/AN grantee program performance, outcomes, and sustainability? Please be specific, including recommended use of technological or other means of data sharing.
(9) Are there elements of the application process that could potentially discourage AI/AN tribes or organizations from applying for ACF grants? If so, please specify what those elements are and explain why those elements could potentially discourage prospective AI/AN applicants and any recommendations for addressing such barriers.
Because of the large number of public comments we normally receive, we are not able to acknowledge or respond to them individually. However, comments will be accepted on this RFI through
Food and Drug Administration, HHS.
Notice of availability; extension of comment period.
The Food and Drug Administration (FDA) is extending the comment period for the notice of revised draft guidance availability that appeared in the
FDA is extending the comment period on the notice of revised draft guidance availability published on November 25, 2016 (81 FR 85226). Submit either electronic or written comments by March 27, 2017.
You may submit comments by any of the following methods:
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 submissions in the following ways:
•
• 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
Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-796-3257 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
In the
FDA is extending the comment period for an additional 60 days, until March 27, 2017. The Agency believes that a 60-day extension of the comment period for the notice of revised draft guidance availability will provide adequate time for interested persons to submit comments without significantly delaying Agency decision making on these important issues.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
The meeting will be held on February 23, 2017, from 8 a.m. to 6 p.m.
Hilton Washington, DC/North, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002,
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by ELITechGroup Inc. Molecular Diagnostics. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
The Authorization is effective as of December 9, 2016.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of Zika virus subject to the terms of the Authorization. The Authorization in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for ADYNOVATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these Acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product ADYNOVATE (antihemophilic factor (recombinant), PEGylated). ADYNOVATE is indicated in adolescent and adult patients (12 years and older) with Hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes. Subsequent to this approval, the USPTO received patent term restoration applications for ADYNOVATE (U.S. Patent Nos. 7,199,223 and 8,247,536) from Nektar Therapeutics, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ADYNOVATE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ADYNOVATE is 1,061 days. Of this time, 707 days occurred during the testing phase of the regulatory review period, while 354 days occurred during the approval phase. These periods of
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 708 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for EMPLICITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product EMPLICITI (elotuzumab). EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Subsequent to this approval, the USPTO received a patent term restoration application for EMPLICITI (U.S. Patent No. 7,709,610) from AbbVie Biotherapeutics, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of EMPLICITI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for EMPLICITI is 3,400 days. Of this time, 3,245 days occurred during the testing phase of the regulatory review period, while 155 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,095 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice; request for information and comments.
The Food and Drug Administration (FDA) is seeking information and public comment, in anticipation of the passage of Generic Drug User Fee Amendments reauthorization (GDUFA II), relevant to FDA's planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This includes requests for comment and information regarding FDA's initial inventory of approved abbreviated new drug application sponsors and application numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA program fees in a timely manner.
Submit written or electronic comments and information by March 10, 2017.
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
Kristan Callahan, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7900,
In anticipation of the enactment and implementation of GDUFA II, FDA has begun taking steps to ensure efficient administration of GDUFA for FY 2018. It is projected that the GDUFA II legislation will include an annual program fee for which holders of approved abbreviated new drug applications (ANDAs) will be responsible.
Under GDUFA II, it is anticipated that affiliated companies will be grouped together and counted as a single entity for purposes of assessing the program fee. The proposed legislation defines the term “affiliate” in the same way it was defined in GDUFA. An “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities. As set forth in the proposed legislation, the program fee will be allocated among three tiers of application holders:
• Large (companies with 20 or more approved ANDAs);
• Medium (companies with between 6 and 19 approved ANDAs); and,
• Small (companies with 5 or fewer approved ANDAs).
To assess program fees in an accurate and timely manner if these provisions are enacted, FDA seeks to identify how many approved ANDAs belong to each application holder, and which application holders are affiliates for purposes of assessing GDUFA II program fees. In furtherance of this effort, FDA requests comments and information regarding FDA's initial inventory of approved ANDA sponsors and application numbers. The current spreadsheet containing this initial inventory and instructions on how to use it are available at
FDA is seeking information and public comment, in anticipation of the passage of GDUFA II, relevant to FDA's planned approach for administering generic drug program fees under that legislation for FY 2018. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. Interested persons are invited to comment, in general, on any aspect of FDA's planned approach for administering these generic drug program fees under GDUFA II. FDA is particularly interested in comments and information addressing the accuracy and completeness of the information in the previously mentioned spreadsheet containing FDA's initial inventory of approved ANDA sponsors and application numbers. In addition, FDA is interested in any information that could be relevant to determining whether two or more companies that are currently listed separately in that spreadsheet should be considered to be affiliated for purposes of assessing the anticipated program fee. As a general matter, FDA does not consider affiliates
After receiving feedback and comments on the spreadsheet, FDA anticipates publishing a
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than February 8, 2017.
Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at
Eligible state government entities include the 50 states, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
Total estimated annualized burden hours:
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
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.
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.
U.S. Customs and Border Protection, Department of Homeland Security.
General notice; republication with correction and further clarification.
On December 12, 2016, U.S. Customs and Border Protection (CBP) published in the
Subsequently, CBP decided to remove the restriction imposed on all PSC filings to make payments within three business days of submitting the PSC, with the exception of entry type 03 filings, and to remove the prohibition of filing additional PSCs until additional
The changes made by this notice are effective January 14, 2017.
Comments concerning these test programs may be submitted via email to Monica Crockett at
For policy-related questions, contact Randy Mitchell, Director, Commercial Operations, Trade Policy and Programs, Office of Trade, at
On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
This document also provides the correct CBP point of contact for making a deposit, and clarifies the method and location of payment of additional deposits of duties, fees and taxes. In addition, this notice clarifies how CBP will determine the time of payment of duties, fees and taxes.
For ease of reference, the December 12 document is republished below with the aforementioned changes.
The National Customs Automation Program (NCAP) was established by Subtitle B of Title VI—Customs Modernization in the North American Free Trade Agreement (NAFTA) Implementation Act (Customs Modernization Act) (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (19 U.S.C. 1411). Through NCAP, the thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS) as the CBP-authorized electronic data interchange (EDI) system. ACE is an automated and electronic system for commercial trade processing which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for CBP and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions. CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace specific legacy ACS functions and add new functionality. Section 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)) provides for the testing of NCAP components.
On June 24, 2011, CBP published a notice in the
On February 4, 2004, CBP published a notice in the
This document announces numerous modifications and clarifications to the PSC and PMS tests. Each modification and clarification is discussed separately below. This document supersedes the December 12 notice and, except to the extent expressly announced or modified by this document, all aspects, rules, terms, requirements, obligations and conditions announced in notices previous to this notice and the December 12 publication regarding the PSC and PMS tests remain in effect.
This document announces that CBP is expanding the type of entries that may be corrected by filing a PSC, in addition to the current entry types 01 (Consumption—Free and Dutiable) and 03 (Consumption—Antidumping/Countervailing Duty). The additional entry types are as follows:
• 02—Consumption—Quota/Visa.
• 06—Consumption—Foreign Trade Zone (FTZ).
• 07—Consumption—Antidumping/Countervailing Duty and Quota/Visa Combination.
• 21—Warehouse.
• 22—Re-Warehouse.
• 23—Temporary Importation Bond (TIB).
• 31—Warehouse Withdrawal—Consumption.
• 32—Warehouse Withdrawal—Quota.
• 34—Warehouse Withdrawal—Antidumping/Countervailing Duty.
• 38—Warehouse Withdrawal—Antidumping/Countervailing Duty & Quota/Visa Combination.
• 51—Defense Contract Administration Service Region (DCASR).
• 52—Government—Dutiable.
When filing a PSC for an entry of merchandise subject to quota, the date and time of submission will be considered the date and time of presentation of the merchandise to CBP. If a PSC is filed on an entry with merchandise subject to quota, and the quota is full or nearly full at threshold, the PSC filer must do two things. The filer must follow the Entry Summary Business Rules and Process Document on
This document announces that when a PSC is filed declaring an increase in the importer's liability for antidumping or countervailing duties and associated fees and taxes, the importer must mail or deliver a check to the CBP port of entry with those additional antidumping or countervailing duties and associated fees and taxes within three business days of submitting the PSC. Furthermore, CBP will no longer reject a PSC declaring an increase in liability for antidumping or countervailing duties and associated fees and taxes when the additional duties, fees and taxes are not deposited at the time of submitting the PSC. This is a change in CBP policy.
If a check is mailed, CBP will consider the additional deposit made based on the date of postmark indicating the check was mailed. When a PSC is filed that results in an increase in the importer's liability for regular duties, fees and taxes and the importer wishes to deposit them, the importer must mail or deliver a check to the port of entry.
Previously, a filer under the PSC test could not change a type 03 entry to a type 01 entry.
On June 24, 2011, CBP announced in the
On November 19, 2013, CBP published a notice in the
This notice announces that CBP will consider a PMS as paid, in the event the importer uses the Automated Clearing House (ACH) debit process, when CBP receives confirmation from the Treasury Department that funds are available and transferred to CBP from the financial institution designated by the importer for payment of the ACH debit authorization. Prior to this modification, CBP considered a PMS as paid when CBP transmitted the debit authorization to the designated financial institution.
A chronological listing of
• ACE Portal Accounts and Subsequent Revision Notices: 67 FR 21800 (May 1, 2002); 69
• ACE System of Records Notice: 71 FR 3109 (January 19, 2006).
• Terms/Conditions for Access to the ACE Portal and Subsequent Revisions: 72 FR 27632 (May 16, 2007); 73 FR 38464 (July 7, 2008).
• ACE Non-Portal Accounts and Related Notice: 70 FR 61466 (October 24, 2005); 71 FR 15756 (March 29, 2006).
• ACE Entry Summary, Accounts and Revenue (ESAR I) Capabilities: 72 FR 59105 (October 18, 2007).
• ACE Entry Summary, Accounts and Revenue (ESAR II) Capabilities: 73 FR 50337 (August 26, 2008); 74 FR 9826 (March 6, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR III) Capabilities: 74 FR 69129 (December 30, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR IV) Capabilities: 76 FR 37136 (June 24, 2011).
• Post-Entry Amendment (PEA) Processing Test: 76 FR 37136 (June 24, 2011).
• ACE Announcement of a New Start Date for the National Customs Automation Program Test of Automated Manifest Capabilities for Ocean and Rail Carriers: 76 FR 42721 (July 19, 2011).
• ACE Simplified Entry: 76 FR 69755 (November 9, 2011).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS): 77 FR 20835 (April 6, 2012).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Simplified Entry: Modification of Participant Selection Criteria and Application Process: 77 FR 48527 (August 14, 2012).
• Modification of National Customs Automation Program (NCAP) Test Regarding Reconciliation for Filing Certain Post-Importation Preferential Tariff Treatment Claims under Certain FTAs: 78 FR 27984 (May 13, 2013).
• Modification of Two National Customs Automation Program (NCAP)
• Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS) and Simplified Entry (SE); Correction: 78 FR 53466 (August 29, 2013).
• Modification of National Customs Automation Program Test Concerning Automated Commercial Environment (ACE) Cargo Release (formerly known as Simplified Entry): 78 FR 66039 (November 4, 2013).
• Post-Summary Corrections to Entry Summaries Filed in ACE Pursuant to the ESAR IV Test: Modifications and Clarifications: 78 FR 69434 (November 19, 2013).
• National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Environmental Protection Agency and the Food Safety and Inspection Service Using the Partner Government Agency Message Set Through the Automated Commercial Environment (ACE): 78 FR 75931 (December 13, 2013).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release for Ocean and Rail Carriers: 79 FR 6210 (February 3, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release to Allow Importers and Brokers to Certify From ACE Entry Summary: 79 FR 24744 (May 1, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release for Truck Carriers: 79 FR 25142 (May 2, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System: 79 FR 36083 (June 25, 2014).
• Announcement of eBond Test: 79 FR 70881 (November 28, 2014).
• eBond Test Modifications and Clarifications: Continuous Bond Executed Prior to or Outside the eBond Test May Be Converted to an eBond by the Surety and Principal, Termination of an eBond by Filing Identification Number, and Email Address Correction: 80 FR 899 (January 7, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System Relating to Animal and Plant Health Inspection Service (APHIS) Document Submissions: 80 FR 5126 (January 30, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the use of Partner Government Agency Message Set through the Automated Commercial Environment (ACE) for the Submission of Certain Data Required by the Environmental Protection Agency (EPA): 80 FR 6098 (February 4, 2015).
• Announcement of Modification of ACE Cargo Release Test to Permit the Combined Filing of Cargo Release and Importer Security Filing (ISF) Data: 80 FR 7487 (February 10, 2015).
• Modification of NCAP Test Concerning ACE Cargo Release for Type 03 Entries and Advanced Capabilities for Truck Carriers: 80 FR 16414 (March 27, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test: 80 FR 39790 (July 10, 2015).
• National Customs Automation Program (NCAP) Concerning Remote Location Filing Entry Procedures in the Automated Commercial Environment (ACE) and the Use of the Document Image System for the Submission of Invoices and the Use of eBonds for the Transmission of Single Transaction Bonds: 80 FR 40079 (July 13, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Partner Government Agency (PGA) Message Set Regarding Types of Transportation Modes and Certain Data Required by the National Highway Traffic Safety Administration (NHTSA): 80 FR 47938 (August 10, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Vessel Cargo Test: 80 FR 50644 (August 20, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Food and Drug Administration (FDA) Using the Partner Government Agency Message Set through the Automated Commercial Environment (ACE): 80 FR 52051 (August 27, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Rail Cargo Test: 80 FR 54305 (September 9, 2015).
• Modification of the National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Document Image System (DIS) Regarding Future Updates and New Method of Submission of Accepted Documents: 80 FR 62082 (October 15, 2015).
• Modification of the National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Cargo Release for Entry Type 52 and Certain Other Modes of Transportation: 80 FR 63576 (October 20, 2015).
• Modification of the National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Entry Summary, Accounts and Revenue (ESAR) Test of Automated Entry Summary Types 51 and 52 and Certain Modes of Transportation: 80 FR 63815 (October 21, 2015).
• Modification of the National Customs Automation Program Test Concerning the Automated Commercial Environment Portal Account to Establish the Exporter Portal Account: 80 FR 63817 (October 21, 2015).
• Modification of National Customs Automation Program Test Concerning the Automated Commercial Environment Partner Government Agency Message Set Regarding the Toxic Substances Control Act Certification Required by the Environmental Protection Agency: 81 FR 7133 (February 10, 2016).
• Notice Announcing the Automated Commercial Environment (ACE) as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings: 81 FR 10264 (February 29, 2016).
• Modification of the National Customs Automation Program (NCAP); Test Concerning the Partner Government Agency Message Set for Certain Data Required by the Environmental Protection Agency (EPA): 81 FR 13399 (March 14, 2016).
• Cessation of National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Food and Drug Administration (FDA) Using the Partner Government Agency (PGA) Message Set Through the Automated Commercial Environment (ACE): 81 FR 18634 (March 31, 2016).
• Automated Commercial Environment (ACE); Announcement of National Customs Automation Program Test of the In-Transit Manifest Pilot Program: 81 FR 24837 (April 27, 2016).
• Announcement of National Customs Automation Program (NCAP) Test Concerning the Submission through the Automated Commercial Environment (ACE) of Certain Import
• Notice Announcing the Automated Commercial Environment (ACE) as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings Accompanied by Food and Drug Administration (FDA) Data: 81 FR 30320 (May 16, 2016).
• Notice Announcing the Automated Commercial Environment (ACE) as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Electronic Entry and Entry Summary Filings: 81 FR 32339 (May 23, 2016).
• Notice Announcing the Automated Commercial Environment (ACE) Protest Module as the Sole CBP-Authorized Method for Filing Electronic Protests: 81 FR 49685 (July 28, 2016).
• Modification of the National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Portal Accounts to Establish the Protest Filer Account and Clarification that the Terms and Conditions for Account Access Apply to all ACE Portal Accounts: 81 FR 52453 (August 8, 2016).
• National Customs Automation Program (NCAP) Test Concerning Electronic Filing of Protests in the Automated Commercial Environment (ACE): 81 FR 53497 (August 12, 2016).
• Modification of the National Customs Automation Program (NCAP) Test Regarding Reconciliation and Transition of the Test From the Automated Commercial System to the Automated Commercial Environment (ACE): 81 FR 89486 (December 12, 2016).
• Modification and Clarification of the National Customs Automation Program (NCAP) Test Regarding Post-Summary Corrections and Periodic Monthly Statements: 81 FR 89482 (December 12, 2016).
• Effective Date for the Automated Commercial Environment (ACE) Being the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Electronic Drawback and Duty Deferral Entry and Entry Summary Filings: 81 FR 89486 (December 12, 2016).
Transportation Security Administration, DHS.
30-day Notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0027, abstracted below to OMB for review and approval of a revision of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a
Send your comments by February 8, 2017. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement 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;
(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 are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
TSA is revising the collection of information to allow for recurrent criminal history vetting. Applicants' fingerprints and associated information will be provided to the Federal Bureau of Investigation (FBI) for the purpose of comparing their fingerprints to other fingerprints in the FBI's Next Generation Identification (NGI) system or its successor systems, including civil, criminal, and latent fingerprint repositories. The FBI may retain applicants' fingerprints and associated information in NGI after the completion of their application and, while retained, their fingerprints may continue to be compared against other fingerprints submitted to or retained by NGI. TSA will also transmit applicants' biometrics for enrollment into the Department of Homeland Security Automated Biometrics Identification System (IDENT).
In addition, TSA is revising the collection of information to expand enrollment options and the potential use of biographic and biometric (
TSA is currently revising its fee for the HME Threat Assessment Program as well as the fee for comparable security threat assessments in light of changes to the FBI's fingerprint processing fee and TSA's costs related to conducting the security threat assessment (STA). The FBI's fee and STA fee are two out of three segments of the HME Threat Assessment Program's overall fee. The HME fee contains segments for enrollment, the STA, and FBI fees, most recently $38.00 for vendor enrollments (amount varies by State for State enrollments), $34.00 for the STA of each applicant and $14.50 for the FBI processing each enrollment, respectively.
On February 1, 2015, the FBI reduced its fingerprint-based criminal history record check fee by $1.75 based on recommendations from a required user fee study (75 FR 18751). Effective October 1, 2016, the FBI again reduced its fingerprint-based criminal history record check fee, this time by $2.75 based on recommendations from a required user fee study (81 FR 45535). Section 1572.501(b)(3) states that if the FBI amends its fee for criminal history records checks, TSA will collect the amended FBI fee. By contrast, TSA will increase the STA segment of the standard HME fee in the amount of $3.00. TSA has identified, in accordance with the methodologies described in the 2013 final fee rule, threat assessment service costs related to the STA segment of the standard HME fee that exceed the expected STA segment revenue. The majority of these costs relate to technology infrastructure and operating costs. In addition to increased technology costs, the number of HME applicants has been in decline, leaving fewer applicants from which costs may be recovered. These two factors necessitate an increase in cost recovery in the ongoing operation of the HME program. The enrollment segment of the HME Threat Assessment Program's overall fee will remain at $38.00 for enrollments conducted by TSA's vendor. As a result of the FBI's fee decreases ($4.50 over the FBI's past two fee changes) and the increase in the STA segment of the standard HME fee ($3.00), the overall HME standard enrollment fee ($86.50) for applicants enrolled by TSA's vendor will be reduced by $1.50 to the new fee of $85.00 ($10.00 + $37.00 + $38.00), effective upon publication of TSA's Notice of Fee Adjustment. For applicants who enroll through a State in States that choose not to use TSA's enrollment vendor, the revised fees for the FBI and STA segments of the overall fee for State enrollments will be the same as for enrollments conducted by TSA's vendor ($10.00 and $37.00, respectively); however, because each State that conducts its own enrollments charges its own fee (over which TSA has no control) TSA cannot provide a revised overall enrollment fee for State enrollments.
TSA will also decrease the amount of the STA segment of the reduced HME fee by $1.00, from $29.00 to $28.00, which applies to both vendor and state enrollment methods. TSA is decreasing this segment of the reduced HME fee because TSA has identified, in accordance with the methodologies described in the 2013 final fee rule, threat assessment service revenue related to the STA segment of the reduced fee that exceeds the expected STA segment costs. Thus, the HME reduced enrollment fee ($67.00) will be reduced to the new fee of $66.00 for vendor enrollments, effective upon publication of TSA's Notice of Fee Adjustment. Again, because each state that conducts its own enrollments charges its own fee for its enrollment segment, it is not possible to give a revised overall reduced HME fee for state enrollments.
Office of Policy Development and Research, 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 comments 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: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-5534 (this is not a toll-free number) or email at
Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
Conducting this research will require the Implementation Team (The Lewin Group and our partners from Leading Age and the National Center for Healthy Aging, under HUD contract HHSP23337002T) to collect self-reported information from demonstration participants. The Implementation Team will leverage existing validated tools combined together in one comprehensive Resident Needs Assessment. The Resident Needs Assessment requests information on demographics, health status and ability to complete Activities of Daily Living (ADLs), and Instrumental Activities of Daily Living (IADLs), as well as other social and medical service information.
The Resident Needs Assessment will occur face-to-face in a private setting administered by trained enhanced service coordinators or wellness nurses. The assessment interview is expected to last an average of 90 minutes.
Information will be collected in a secure web-based platform that meets all required federal regulations to track general health and service use information. Information will be attributed to individuals by name. Names and information collected in a project-specific web-based platform will link to HUD's administrative data, which HUD can be linked to Medicare and possibly Medicaid data for program evaluation purposes. All collected information will be self-reported and will inform the development of individualized healthy aging plans and property-wide health education/promotion activities and programs, including selection of specific evidence-based interventions to be implemented within demonstration sites. Additionally, results will support the evaluation of the demonstration in meeting HUD's goals and desired outcomes for the national demonstration.
The table below estimates the total burden to the public for the proposed information collection, assuming an hourly cost per response, based on the income levels of respondents. Hourly costs were estimated using FY 2016 income limits from the Office of Policy Development and Research through HUD's Web site located at
HUD tiers the income levels for funded recipients at three levels: Extremely low, very low, and low. For purposes of burden estimate, we selected the “low income” tier to identify a median income level.
Further delineation of the burden estimates requires income adjustments based on the number of individuals residing with the respondent. Using HUD data to conduct data analysis, we estimate that:
For HUD, the baseline for median income is based on a four-person household. For FY 2016 this was adjusted at $65,800. Adjustments for number of residents are legislated by Congress.
These income adjustments, based on both probability of residence status as well as adjustments based on the income baseline, are used to estimate burden of information collection in the table below.
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 document availability.
We, the U.S. Fish and Wildlife Service, announce the availability of our Polar Bear Conservation Management Plan (Polar Bear Plan). The polar bear is listed as threatened under the Endangered Species Act of 1973, as amended (ESA), and is also considered “depleted” under the Marine Mammal Protection Act of 1972, as amended (MMPA). The Polar Bear Plan identifies objective, measurable ESA recovery criteria, site-specific recovery actions, as well as time and cost estimates. It also serves as an MMPA conservation plan.
An electronic copy of the Polar Bear Plan is available for viewing at
Hilary Cooley, Polar Bear Lead, Marine Mammals Management, by telephone at 907-786-3800; by U.S. mail at Marine Mammals Management, U.S. Fish and Wildlife Service, 1011 East Tudor Road, Anchorage, AK 99503; or by email at
We announce the availability of our Polar Bear Conservation Management Plan (Polar Bear Plan). The polar bear (
We listed the polar bear as threatened under the ESA on May 15, 2008 (73 FR 28212). For a description of the taxonomy, distribution, status, breeding biology, and habitat, and a summary of factors affecting the species, please see Appendix A of the Polar Bear Plan. Recovery of endangered or threatened animals and plants is a primary goal of our endangered species program and the ESA. To help guide the recovery effort, we prepare recovery plans for most listed species native to the United States. Further, the ESA requires that we develop recovery plans for listed species, unless such a plan would not promote the conservation of a particular species, and that we provide public notice and an opportunity for public review and comment during recovery plan development. Recovery plans describe actions considered necessary for the conservation and survival of the species, establish criteria for delisting listed species, and estimate time and cost for implementing needed recovery measures.
MMPA Conservation Plans have the purpose of conserving and restoring a species or stock to its optimum sustainable population. The MMPA further provides that Conservation Plans shall be modeled on ESA recovery plans. Therefore, the Polar Bear Plan provides recommended management actions for the survival and recovery of the species and to conserve and restore the species to its optimum sustainable population.
To invite public review and comment on the draft Polar Bear Plan, we published a notice of availability initiating a 45-day public comment period for the draft Polar Bear Plan on July 6, 2015 (80 FR 38458); we extended that comment period an additional 30 days on August 14, 2015 (80 FR 48908). The final Polar Bear Plan and the associated documents reflect the comments and recommendations the U.S. Fish and Wildlife Service received on that draft.
Polar bears evolved to utilize the Arctic sea ice niche. They are distributed throughout most ice-covered seas of the United States, Canada, the Russian Federation, Norway, and Greenland/Denmark (collectively the Range States), in the Northern Hemisphere and are managed in 19 subpopulations around the Arctic (see Figure 1 of the Polar Bear Plan). The current global polar bear population is estimated to be 22,000 to 31,000.
Ongoing and projected loss of the polar bear's crucial sea ice habitat threatens the species throughout all of its range. The projected loss of sea ice will diminish productivity, abundance, and availability of ice seals, the polar bear's primary prey base, and increase energetic requirements of polar bears for movement and obtaining food. It will also affect access to traditional denning areas. In turn, these factors will cause declines in the condition of polar bears from nutritional stress and reduced productivity. The eventual effect of this loss of sea ice is that the polar bear population will decline. The rate and magnitude of decline will vary geographically, based on differences in the rate, timing, and magnitude of impacts. However, within the foreseeable future, the worldwide population will be affected, and the species is likely to become in danger of extinction throughout all of its range (73 FR 28292-28293, May 15, 2008). Global climate change resulting from greenhouse gas emissions is the root cause of the loss of Arctic sea ice.
The Polar Bear Plan addresses both the MMPA and the ESA, as they relate to polar bear conservation and recovery; it also reflects the input and values of stakeholders closely connected with polar bears and their habitat, including the State of Alaska, the North Slope Borough, Alaska Native peoples, the Polar Bear Range States, conservation groups, and the oil and gas industry, as well as the general public. All of these sources informed the Polar Bear Plan's fundamental goals, which focus on conservation of polar bears while recognizing values associated with subsistence take, human safety, and economic activity. The goals will be used to guide management, research, monitoring, and communication into the future. Although the fundamental goals target three geographic scales (rangewide, intermediate (ecoregion), and subpopulation (stock)), specific actions under the Polar Bear Plan pertain primarily to the polar bear subpopulations present in Alaska. The Polar Bear Plan also contains specific recovery criteria, expressed in fundamental, demographic, and threats-based terms, to determine when the polar bear should be considered for delisting under the ESA and fundamental and demographic criteria to guide conservation efforts associated with the MMPA.
Conservation and recovery actions are specified in the Polar Bear Plan. The single most important action for the recovery of polar bears is global reduction of atmospheric greenhouse gases, which, if achieved, should result in reduced global climate change, including Arctic warming and sea ice loss. Along with communicating that fact, the Polar Bear Plan identifies a suite of high-profile actions designed to ensure that polar bears remain in sufficient number and diversity so that they are in a position to recover once climate change is addressed. Those actions include the following:
• Limit global atmospheric levels of greenhouse gases to levels appropriate for supporting polar bear recovery and conservation, primarily by reducing greenhouse gas emissions;
• Support international conservation efforts through the Range States relationships;
• Manage human-bear conflicts;
• Collaboratively manage subsistence harvest;
• Protect denning habitat;
• Minimize risks of contamination from spills;
• Conduct strategic monitoring and research.
The full cost of implementing the Polar Bear Plan over the next 5 years is approximately $66,720,000.
We developed our Polar Bear Plan under the authority of ESA section 4(f), 16 U.S.C. 1533(f), as well as section 115(b) of the MMPA, 16 U.S.C. 1383b(b). We publish this notice under ESA section 4(f) (16 U.S.C. 1531
United States International Trade Commission.
January 18, 2017 at 9:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On November 18, 2016, the Coalition for Fair Trade of Hardwood Plywood and its individual members
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on January 3, 2017. The views of the Commission are contained in USITC Publication 4661 (January 2017), entitled
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until February 8, 2017.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Tracey Robertson, Chief, Federal Firearms Licensing Center, either by mail at 244 Needy Road, Martinsburg, WV 25405, or by email at
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:
• 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;
• 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;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and
• 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,
Overview of this information collection:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.
National Archives and Records Administration (NARA).
Notice of new General Records Schedule (GRS) Transmittal 27.
NARA is issuing a new set of General Records Schedules (GRS) via GRS Transmittal 27. The GRS provides mandatory disposition instructions for administrative records common to several or all Federal agencies. Transmittal 27 announces changes we have made to the GRS since we published Transmittal 26 in August and September 2016. We are concurrently disseminating Transmittal 27 (the memo and the accompanying records schedules and documents) directly to each agency's records management official and have also posted it on NARA's Web site.
This transmittal is effective the date it publishes in the
You can find this transmittal on NARA's Web site at
For more information about this notice or to obtain paper copies of the GRS, contact Kimberly Keravuori, External Policy Program Manager, at
You may contact NARA's GRS Team with general questions about the GRS at
Your agency's records officer may contact the NARA appraiser or records analyst with whom your agency normally works for support in carrying out this transmittal and the revised portions of the GRS. You may access a list of the appraisal and scheduling work group and regional contacts on our Web site at
GRS Transmittal 27 announces changes to the General Records Schedules (GRS) made since NARA published GRS Transmittal 26 in September 2016. The GRS provide mandatory disposition instructions for records common to several or all Federal agencies. We are more than half-way through a 5-year plan to completely rewrite the GRS. With Transmittal 27, 61% of old items are now superseded.
Transmittal 27 introduces a significant change in the way we publish transmittals and indeed the entire GRS. Transmittal 26 included all current schedules: new schedules (with new-to-old crosswalks and Frequently Asked Questions [FAQs]), old schedules annotated for supersession by new schedules, and an old-to-new crosswalk for the entire old GRS. Transmittal 27 includes only schedules newly issued or updated since the last transmittal (with new-to-old crosswalks and FAQs for each).
Users may find the entire set of GRS at
GRS Transmittal 27 publishes five new schedules:
It also publishes new or updated items in four schedules:
This transmittal also updates the general FAQs on Deviations, clarifying the definition of a deviation to the GRS, and how GRS deviations differ from GRS notifications.
We added one new item (001) to cover financial management and reporting administrative records.
We added two news items (050 and 051) for records created by phased retirement programs.
We added one new item (001) to cover technology management administrative records.
We added two new items. Item 001 covers administrative records on FOIA, Privacy Act, and classified documents. Item 180 covers virtual public access library records. Also, we slightly altered titles of items 060, 061, 120, and 121 from what appeared in Transmittal 26 to match the titles under which they were approved in ERA. The new titles alter neither meaning nor coverage of the items.
Many old GRS items are superseded by new GRS items. A few old items, however, have outlived their usefulness and cannot be crosswalked to new items. The table below lists old items newly rescinded by GRS Transmittal 27.
Rescinded items are shown in context of their schedules in the old-to-new crosswalk.
When you send records to an FRC for storage, you should cite the records' legal authority—the “DAA” number—in the “Disposition Authority” column of the table. For informational purposes, please include schedule and item number. For example, “DAA-GRS-2013-0001-0004 (GRS 4.3, item 020).”
NARA regulations (36 CFR 1226.12(a)) require agencies to disseminate GRS changes within six months of receipt.
Per 36 CFR 1227.12(a)(1), you must follow GRS dispositions that state they must be followed without exception.
Per 36 CFR 1227.12(a)(3), if you have an existing schedule that differs from a new GRS item that does
If you do not have an already existing agency-specific authority but wish to apply a retention period that differs from that specified in the GRS, you must submit a records schedule to NARA for approval via the Electronic Records Archives.
You can download the complete current GRS, in PDF format, from NARA's Web site at
Writing and maintaining the GRS is the responsibility of the GRS Team. You may contact the team with general questions about the GRS at
Your agency's records officer may contact the NARA appraiser or records analyst with whom your agency normally works for support in carrying out this transmittal. A list of the appraisal and scheduling work group and regional contacts is on the NARA Web site at
National Archives and Records Administration (NARA).
Notice of Federal Advisory Committee Meeting.
In accordance with the Federal Advisory Committee Act (5 U.S.C. App) and the second United
The meeting will be on January 26, 2017, from 10:00 a.m. to 1:00 p.m. EDT. You must register for the meeting by 5:00 p.m. EDT on January 23, 2017.
Kate Russ, Designated Federal Officer for this committee, by mail at National Archives and Records Administration; Office of Government Information Services; 8601 Adelphi Road—OGIS; College Park, MD 20740-6001, by telephone at 202-741-5770, or by email at
This program will be live-streamed on the US National Archives' YouTube channel,
January 9, 16, 23, 30, February 6, 13, 2017.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of January 16, 2017.
There are no meetings scheduled for the week of January 30, 2017.
There are no meetings scheduled for the week of February 6, 2017.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0981 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
Final supplemental environmental impact statement; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing the Final Supplemental Environmental Impact Statement (SEIS) (NUREG-1910, Supplement 6) for the Reno Creek
NUREG-1910, Supplement 6, is available December 16, 2016.
Please refer to Docket ID NRC-2013-0164 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:
•
•
•
Jill Caverly, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7674; email:
Under the NRC's environmental protection regulations in part 51 of title 10 of the
In May 2009, the NRC staff issued NUREG-1910, “Generic Environmental Impact Statement for
The final SEIS was prepared in response to an application submitted by AUC LLC (the applicant) by letter dated October 3, 2012. The applicant proposes the construction, operation, aquifer restoration, and decommissioning of an in situ recovery facility to recover uranium.
The final SEIS was prepared by the NRC and its contractor, the Center for Nuclear Waste Regulatory Analyses, in compliance with NEPA (as amended, and the NRC's regulations for implementing NEPA (10 CFR part 51).
The proposed Reno Creek ISR Project will be located in Campbell County between the communities of Wright, Edgerton, and Gillette and would encompass approximately 2,451 hectares (6,057 acres).
The final SEIS is being issued as part of the NRC's process to decide whether to issue a license to AUC LLC pursuant to 10 CFR part 40. In this final SEIS, the NRC staff has assessed the potential environmental impacts from the construction, operation, aquifer restoration, and decommissioning of the proposed Reno Creek ISR Project. The NRC staff assessed the impacts of the proposed action and its alternative on land use; historical and cultural resources; visual and scenic resources; climatology, meteorology and air quality; geology, minerals, and soils; water resources; ecological resources; socioeconomics; environmental justice; noise; traffic and transportation; public and occupational health and safety; and waste management. Additionally, the final SEIS analyzes and compares the benefits and costs of the proposed action. In preparing this final SEIS, the NRC staff also considered, evaluated, and addressed the public comments received on the draft SEIS published on July 7, 2016 (81 FR 44333). Appendix D of final SEIS captures the public's comments and the NRCs responses.
In doing so, the NRC staff evaluated site-specific data and information from the Reno Creek ISR Project to determine if AUC LLC's proposed activities and the site characteristics were consistent with those evaluated in the GEIS. The NRC then determined which relevant sections of, and impact conclusions in, the GEIS could be incorporated by reference. The NRC staff also determined if additional data or analysis was needed to assess the potential environmental impacts for a specific environmental resource area. The NRC documented its assessments and conclusions in the final SEIS.
In addition to the action proposed by AUC LLC, the NRC staff addressed the no-action alternative which serves as a baseline for comparison of the potential environmental impacts of the proposed action.
After weighing the impacts of the proposed action and comparing the alternative, the NRC staff, in accordance with 10 CFR 51.71(f), sets forth its recommendation regarding the proposed action. Unless safety issues mandate otherwise, the NRC staff recommends that the proposed action be approved (
The final SEIS for the proposed Reno Creek ISR Project may be accessed on the internet at
For the U.S. Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Source protection; public meetings and request for comment.
On October 18, 2016, the U.S. Nuclear Regulatory Commission (NRC) issued a Staff Requirements Memorandum (SRM) for COMJMB-16-0001 and directed NRC staff to take specific actions to evaluate whether it is necessary to revise NRC regulations or processes governing source protection and accountability. Specifically, the Commission asked the staff to conduct an evaluation of, among other things, the pros and cons of different methods of requiring transferors of Category 3 quantities of radioactive material to verify the validity of a transferee's license prior to transfer, the pros and cons of including Category 3 sources in the National Source Tracking System (NSTS), and the risks posed by aggregation of Category 3 sources into Category 2 quantities. As part of this evaluation, the NRC is seeking input from licensees, Agreement States, and the public to inform the staff's assessment of potential revisions to regulations or processes requiring Category 3 source protection and accountability.
Submit comments by March 10, 2017. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Irene Wu, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1951; email:
Please refer to Docket ID NRC-2016-0276 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2016-0276 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In 2007, the Government Accountability Office (GAO) conducted an investigation (GAO-07-1038T) on NRC's licensing program and was able to obtain a radioactive materials license using a fictitious company and place orders that would have resulted, if actually obtained, in receipt of an aggregated Category 3 quantity of radioactive material. After the 2007 investigation, the NRC and the Agreement States made a number of important changes to strengthen the licensing and regulatory processes to prevent malevolent individuals from obtaining a radioactive material license. The NRC staff submitted an Action Plan (SECY-07-0147) (ADAMS Accession No. ML072360206) to the Commission to respond to recommendations for addressing security issues in the National Materials Program. The Commission approved the staff's Action Plan, which included a consideration of expanding the NSTS to include Category 3 sources plus a subset of “high-end” Category 4 sources (SRM-SECY-07-0147) (ADAMS Accession No. ML072620088). The proposed rule on Expansion of NSTS to include additional nationally tracked sources was published in the
In January 2009, licensees began reporting Category 1 and 2 source information to the NSTS. The NRC staff submitted a request to the Commission to defer further expansion of the NSTS to allow staff to monitor operation of the NSTS for one year and to apply insights gained for the decision on system expansion (SECY-09-0011) (ADAMS Accession No. ML083540566). This request for deferral was not approved, so in June 2009, the staff requested approval of the final rule amending parts 20 and 32 title 10 of the
In 2014, the GAO initiated an audit of the materials licensing program to determine whether the licensing vulnerabilities identified in their 2007 investigation had been addressed by the regulatory framework and other improvements implemented by the NRC and the Agreement States. In 2015, as part of the audit, GAO conducted an investigation that attempted to obtain radioactive materials licenses from one NRC regional office and two separate Agreement States. The investigation sought approval of licenses authorizing the procurement of one Category 3 source using a fictitious company. The 2015 investigation went beyond the 2007 investigation in its sophistication and planning, such that GAO rented storefront/warehouse space to demonstrate their legitimacy during pre-licensing visits. Despite this level of effort, the GAO was unsuccessful in two of three attempts; however, the GAO was able to acquire a license for a Category 3 well logging source in one attempt. GAO successfully placed an order for one Category 3 source using the license, then altered it and used it to place an order for a second Category 3 source. The investigation demonstrated that GAO could have acquired an aggregated Category 2 quantity of material, although at no point in the investigation were radioactive materials actually shipped to the fictitious company. Once notified of the investigation by GAO in October 2015, the NRC and Agreement States took a number of actions, one of which included forming two NRC-Agreement State working groups to evaluate vulnerabilities identified as a result of the 2015 GAO investigation. Specifically, one working group considered enhancements to the pre-licensing guidance while the second working group evaluated the need for enhancements to existing requirements or guidance for license verification and source tracking beyond Category 1 and Category 2 thresholds.
On July 15, 2016, the GAO published its final report of the material licensing audit and investigation, GAO-16-330, entitled “Nuclear Security: NRC Has Enhanced the Controls of Dangerous Radioactive Materials, but Vulnerabilities Remain.” The report made three recommendations:
1. Take steps needed to include Category 3 sources in the NSTS and add Agreement State Category 3 licenses to the Web-based Licensing System as quickly as reasonably possible.
2. At least until such time that Category 3 licenses can be verified using the License Verification System, require that transferors of Category 3 quantities of radioactive materials confirm the validity of a would-be purchaser's radioactive materials license with the appropriate regulatory authority before transferring any Category 3 quantities of licensed materials.
3. As part of the ongoing efforts of NRC working groups meeting to develop enhancements to the pre-licensing requirements for Category 3 licenses, consider requiring that an on-site security review be conducted for all unknown applicants of Category 3 licenses to verify that each applicant is prepared to implement the required security measures before taking possession of licensed radioactive materials.
Given the NRC's operating experience with higher-risk sources and in response to the findings by GAO, the Commission directed the staff to take specific actions to evaluate whether it is necessary to revise NRC regulations or processes governing source protection and accountability. Specifically, on October 18, 2016, the Commission issued its SRM for COMJMB-16-0001, “Proposed Staff Re-Evaluation of Category 3 Source Accountability” (ADAMS Accession No. ML16292A812). The SRM required the staff to conduct the following tasks:
1. An evaluation of the pros and cons of different methods of requiring transferors of Category 3 sources to verify the validity of a transferee's license prior to transfer;
2. An evaluation of the pros and cons of including Category 3 sources in NSTS;
3. An assessment, based on these evaluations, of these and any additional options that the staff identifies for addressing the source accountability recommendations made by the GAO;
4. A vulnerability assessment which identifies changes in the threat environment between 2009 and today that argue in favor of or against expansion of the NSTS to include Category 3 sources;
5. A regulatory impact analysis of the accrued benefit and costs of the change, to include impacts to the NRC, Agreement States, non-Agreement States, and regulated entities;
6. A discussion of potential regulatory actions that would not require changes to our regulations that arose from or were considered by the staff working groups, to include changes to guidance, training, and other program improvements such as more closely monitoring the implementation of the staff recommendations using the Integrated Materials Performance Evaluation Program process; and
7. Any other factors arising from the staff's currently ongoing assessment that the staff concludes would bear on the Commission's deliberation on the proposed change.
The SRM also directed the staff to assess the risks posed by the aggregation of Category 3 sources into Category 2 quantities and to collaborate with its Agreement State partners, non-Agreement States, regulated entities, public interest groups, industry groups, and the reactor community.
Additionally, the SRM directed the staff to consider the results of the assessment of the security requirements in 10 CFR part 37, “Physical Protection of Category 1 and 2 Quantities of Radioactive Material,” as required by the Energy and Water Development and Related Agencies Appropriations Bills for Fiscal Year 2015, as a means to inform the staff's evaluation. This assessment, referred to as the “program review” of 10 CFR part 37, encompassed an evaluation of nine review areas related to implementation of the security requirements in the rule. These areas included the results of inspections conducted of NRC licensees in the first two years of rule implementation, as well as an evaluation of events reported under the provisions of the rule. The program review also included consideration of the definition of aggregation as it applies to well logging sources and an evaluation of enhanced tracking and accounting of radioactive sources. A report detailing the program review was provided to Congress on December 14, 2016 (ADAMS Accession No. ML16348A230).
In the interest of fully informing the public of the staff's evaluation of Category 3 source security and accountability, the staff is issuing this notice to request specific feedback from stakeholders. The information received from this request will help to fully assess the regulatory impact for any recommendations related to Category 3 source security and accountability and will be documented in a paper that will be provided to the Commission in August 2017.
The NRC has developed specific questions that are separated into sections based on the topics and applicability to relevant stakeholders. These include: general questions related to license verification, general questions related to the NSTS, specific questions for licensees related to license verification, specific questions for licensees related to the NSTS, specific questions for Agreement States related to license verification, specific
The NRC is requesting comments on license verification involving transfers of Category 3 quantities of radioactive material and the inclusion of Category 3 sources in the NSTS. Please note that Table 1 of Appendix A to 10 CFR part 37 provides the thresholds for Category 1 and Category 2 quantities of radioactive material and Appendix E of 10 CFR part 20 provides the thresholds for Category 1 and 2 sources included in NSTS. The list of radionuclides subject to physical security requirements in 10 CFR part 37 is different than the list of radionuclides included in NSTS. NRC regulations do not include a definition for Category 3 but the NRC has historically considered the Category 3 threshold to be greater than 1/10th of the Category 2 threshold but less than the Category 2 threshold.
1. Should the current methods for verification of licenses prior to transferring Category 3 quantities of radioactive material listed in 10 CFR 30.41(d)(1)-(5), 10 CFR 40.51(d)(1)-(5), and 10 CFR 70.42(d)(1)-(5) be changed such that only the methods prescribed in 10 CFR 37.71 are allowed?
2. Would there be an increase in safety and/or security if the regulations were changed to only allow license verification through the NRC's License Verification System (LVS) or the transferee's license issuing authority for transfers of Category 3 quantities of radioactive material? If so, how much of an increase would there be?
3. If the NRC changed the regulations to limit license verification only through the LVS or the transferee's license issuing authority for transfers of Category 3 quantities of radioactive material, should licensees transferring Category 3 quantities to manufacturers and distributors be excepted from the limitation?
4. Is there anything else we should consider when evaluating different methods of license verification prior to transferring Category 3 quantities of radioactive material?
1. Should Category 3 sources be included in the NSTS? Please provide a rationale for your answer.
2. If Category 3 sources are included in the NSTS, should the NRC consider imposing the same reporting requirements currently required for Category 1 and 2 sources (10 CFR 20.2207(f))?
3. Should the NRC consider alternatives to the current NSTS reporting requirements for Category 1 and 2 sources to increase the immediacy of information availability, such as requiring the source transfers to be reported prior to, or on the same day as, the source shipment date?
4. Would there be an increase in safety and/or security if the regulations were changed to include Category 3 sources in the NSTS? If so, how much of an increase would there be?
5. Is there anything else we should consider as part of our evaluation of including Category 3 sources in the NSTS?
1. It currently takes approximately one month to get credentialed to access the LVS. If you currently do not have online access to LVS, and NRC establishes new requirements for license verification involving Category 3 quantities of radioactive material, would you be inclined to sign up for online access, or would you use alternative methods for license verification such as emailing the NRC Form 748 “Manual License Verification Report” to the LVS Help Desk or calling the license-issuing regulatory authority directly?
2. Approximately how many transfers involving Category 3 quantities of radioactive material do you do monthly? What percentage involves transfers directly to/from a manufacturer?
3. Should license verification be required when transferring to an established manufacturer?
4. Do you have online access to LVS? If so, have you experienced any issues with the LVS? Do you have any recommendations on how to improve LVS?
1. It currently takes approximately one month to get credentialed to access the NSTS. If you currently do not have online access to the NSTS and NRC establishes new requirements for the tracking of Category 3 sources in the NSTS, would you be inclined to sign up for online access or would you use alternative methods for NSTS reporting such as emailing or faxing the NRC Form 748 “National Source Tracking Transaction Report” to the NSTS Help Desk?
2. Do you have online access to the NSTS? If so, have you experienced any issues with the NSTS? Do you have any recommendations on how to improve the NSTS?
1. Approximately how many licenses do you authorize for Category 1, 2, and 3 quantities of radioactive material?
2. If license verification through the LVS or the transferee's license issuing authority is required for transfers involving Category 3 quantities of radioactive material, would you encourage the use of LVS among your licensees, or plan for the additional burden imposed by the manual license verification process?
3. If license verification through the LVS or the transferee's license issuing authority is required for transfers involving Category 3 quantities of radioactive material, would you consider adopting the Web-Based Licensing System (WBL) to ensure that the most up-to-date licenses are available for license verification using the LVS or voluntarily provide your Category 3 licenses (similar to what some Agreement States do now for Category 1 and 2 licenses) to be included in WBL, or would you do neither and prefer licensees to use the manual license verification process?
4. What would the impact in time and resources be on your program to handle the additional regulatory oversight needed for Category 3 licensees if license verification through the LVS or the transferee's license issuing authority was required for transfers involving Category 3 quantities of radioactive material?
1. The NRC currently administers the annual inventory reconciliation process on behalf of the Agreement States. This process involves providing hard copy inventories to every licensee that possesses nationally tracked sources at the end of the year, processing corrections to inventories, and processing confirmations of completion of the reconciliation into the NSTS. The process involves a significant amount of staff time and resources from November to February. If the Agreement States were to adopt administration of the annual inventory reconciliation process and if Category 3 sources were included in the NSTS, what would the additional regulatory burden be on the Agreement States to perform the annual inventory reconciliation for Category 1, 2, and 3 sources?
1. Should physical security requirements for Category 1 and 2 quantities of radioactive material be expanded to include Category 3 quantities?
2. Some Category 3 sources are covered under a general license (10 CFR 31.5). Should the NRC consider establishing maximum quantities in general licensed devices, thereby reserving authorization to possess Category 1, 2, and 3 quantities of radioactive material to specific licensees?
The NRC is committed to keeping the public informed and values public involvement in its assessment effort. Responses to this solicitation will be considered by NRC in preparing a report to the Committees on Appropriations of the House of Representatives and the Senate, pursuant to Public Law 113-235, Section 403 and will inform staff consideration of the regulatory impacts for any recommendations related to Category 3 source security and accountability, which will be documented in a paper to be provided to the Commission in August 2017. The NRC, however, does not intend to provide specific responses to comments or other information submitted in response to this request.
The NRC plans to hold three public meetings and two webinars during the public comment period for this action. The first public meeting is scheduled for January 31, 2017, at NRC Headquarters. The two other public meetings will be held outside of the Washington DC area. The webinars are scheduled for February 21, 2017 and March 2, 2017. The public meetings and webinars will provide forums for the NRC staff to discuss the issues and questions with members of the public. The information received will be used by NRC to develop a report to the Commission. The NRC does not intend to provide any responses to comments submitted during the public meetings and webinars. Each public meeting and webinar will be noticed on the NRC's public meeting Web site at least 10 calendar days before the meeting. Members of the public should monitor the NRC's public meeting Web site for additional information about the public meetings at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Policy statement; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Statement of Policy to set forth principles to be followed by the NRC staff to promote effective government-to-government interactions with American Indian and Alaska Native Tribes, and to encourage and facilitate Tribal involvement in the areas over which the Commission has jurisdiction. It provides agencywide guidelines that achieve consistency, but also encourage custom-tailored approaches to consultation and coordination that reflect the circumstances of each situation and the preference of each Tribal government. It is the NRC's expectation that all program and regional office consultation and coordination practices will be consistent with or adhere to the NRC Tribal Policy Statement.
This policy statement is effective on January 9, 2017.
Please refer to Docket ID NRC-2012-0235 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Kevin O'Sullivan, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8112, email:
The purpose of the NRC Tribal Policy Statement is to establish policy principles to be followed by the NRC to promote effective government-to-government interactions with Indian Tribes, and to encourage and facilitate Tribal involvement in the areas over which the Commission has jurisdiction. The NRC licenses and regulates the Nation's civilian use of radioactive materials to protect public health and safety, common defense and security, and the environment under the Atomic Energy Act of 1954, as amended (AEA) (42 U.S.C. 2011). Other statutory provisions such as the National Historic Preservation Act (NHPA) (54 U.S.C. 300101) can require Tribal consultation as part of the NRC's evaluation of agency activities during licensing actions, rulemaking, or policy development. The NRC complies with statutory provisions and NRC regulatory
Historically, the NRC has had limited, but significant, interactions with Indian Tribes. The Commission has upheld statutory obligations to consult with Tribes under Federal law and acted in a manner consistent with the spirit of certain Presidential initiatives pertaining to Tribal consultation and coordination. However, the NRC has not previously formalized an agencywide policy statement.
Many Federally recognized Tribes have an interest in public health and safety and environmental protection associated with NRC regulatory activities that include uranium recovery, commercial nuclear power, and nuclear waste transportation, disposal, and storage activities. The NRC has exercised its Trust Responsibility in the context of its authorizing statutes, including the AEA. The NRC Tribal Policy Statement formally reflects the NRC's recognition of the Federal Trust Responsibility and the NRC's commitment to a government-to-government relationship, which is distinct from interactions with members of the public, with Federally recognized Tribes. The NRC will make efforts to consult in good faith with Indian Tribes on agency actions that have substantial direct effects on one or more Indian Tribes as well as those regulatory actions for which Tribal consultation is required under Federal Statute. Under the NRC's policy, the NRC or Tribal governments can request consultation on regulatory activities that have Tribal implications. The NRC's policy is to consult on a government-to-government basis with Tribal governments as soon as practicable on NRC regulatory actions with Tribal implications.
On November 6, 2000, President Clinton issued Executive Order (EO) 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249). Executive Order 13175 states, “`Policies that have Tribal implications' refers to regulations, legislative comments or proposed legislation, and other policy statements or actions that 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.” Executive Order 13175, established the following principles to guide agencies when forming and implementing policies with potential Tribal implications:
• The United States has a unique legal relationship with Indian Tribal governments as set forth in the Constitution of the United States, treaties, statutes, EOs, and court decisions. The Federal government recognizes Indian Tribes as domestic dependent nations under its protection and has enacted statutes and promulgated regulations that establish and define a trust relationship with Indian Tribes.
• The Federal government has recognized the right of Indian Tribes to self-government with inherent sovereign powers over their members and territory. The United States continues to work with Indian Tribes on a government-to-government basis to address issues concerning Tribal self-government, Tribal trust resources, and Indian Tribal treaty and other rights.
• The United States recognizes the right of Indian Tribes to self-government and supports Tribal sovereignty and self-determination.
As an independent regulatory agency, the NRC is exempt from the requirements of certain EOs, including EO 13175. However, on January 26, 2001, the Commission sent correspondence to the Office of Management and Budget stating that “. . . in exercising its regulatory authority this agency [NRC] acts in a manner consistent with the fundamental precepts expressed in the Order [EO 13175]” (ADAMS Accession No. ML010260297). To that end, the Commission has developed agency practices for Tribal consultation consistent with the principles articulated in EO 13175.
The NRC's past practice for government-to-government interaction with Federally recognized Tribes has reflected the spirit of the relevant EOs, without establishing a formal policy. The NRC has interacted with Tribal governments on a case-by-case basis, allowing the NRC and the Tribes to initiate communication and consultation. The NRC staff has also maintained working relationships with Tribal governments and Tribal organizations that have an interest in NRC regulated activities.
In SECY-96-187, “Policy Issues Raised in Meeting with Prairie Island Dakota Indian Representatives” (ADAMS Accession No. ML16293A128), the NRC staff provided to the Commission an analysis of Tribal issues. The paper centered on issues raised by representatives from the Prairie Island Dakota Indian Community including: (1) Entering into a Memorandum of Understanding with the NRC; 2) allowing Tribal representatives to observe inspections at the Prairie Island Nuclear Generating Plant; and 3) developing a formal policy on cooperation with Federally recognized Tribes. In the Staff Requirements Memorandum (SRM) dated November 13, 1996, the Commission approved the staff's recommendation not to develop a formal policy on cooperation with Federally recognized Tribal governments at that time, but to continue addressing Native American issues on a case-by-case basis and operating with Tribal governments on a government-to-government basis (ADAMS Accession No. ML16293A154).
On January 8, 2009, the Commission issued SRM-M081211, from the December 11, 2008, “Briefing on Uranium Recovery,” directing the NRC staff to develop and implement an internal protocol for interaction with Native American Tribal Governments that would allow for custom tailored approaches to address both the NRC and Tribal interests on a case-by-case basis (ADAMS Accession No. ML090080206). The Commission also directed the NRC staff to assess what policies other Federal agencies have for interactions with Native American Tribal Governments and to report those findings, which could determine the efficacy of an NRC Tribal Policy Statement, to the Commission. The NRC staff responded to this Commission direction in SECY-09-0180, “U.S. Nuclear Regulatory Commission Interaction with Native American Tribes” (ADAMS Accession No. ML092920384). The staff communicated the determination that the NRC's case-by-case approach to interaction was effective and met the needs of the Commission and the Tribes. The staff concluded that Tribal interactions would not benefit from a formal Tribal policy at that time. The NRC staff also developed NUREG-2173, “NRC Tribal Protocol Manual: Guidance for NRC Employees,” as an internal protocol for interacting with Tribal governments (ADAMS Accession No. ML092990559).
On May 22, 2012, the Commission issued the SRM for COMWDM-12-0001, “Tribal Consultation Policy Statement and Protocol” (ADAMS Accession No. ML121430233), directing the NRC staff to provide a proposed Policy Statement and protocol on consultation with Tribal governments. The Commission also directed the NRC staff to do the following when developing the proposed policy
The NRC staff formed an agency working group to develop a proposed NRC Tribal Policy Statement and to revise the NRC Tribal Protocol Manual. On October 12, 2012 (77 FR 62269), the NRC requested public comment on the NRC Tribal Protocol Manual and requested suggestions for the development of a proposed NRC Tribal Policy Statement to establish policy principles to be followed by the NRC to promote effective government-to-government interactions with Indian Tribes, and to encourage and facilitate involvement by Indian Tribes in the areas over which the Commission has jurisdiction. The public comment period was open for 180 days, and the NRC received a total of six comment letters from two Tribal governments, two mining associations, one inter-Tribal organization, and a Tribal college.
Informed by internal working group representatives, external outreach, and review of similar policies at other Federal agencies, the NRC developed the proposed NRC Tribal Policy Statement. The NRC engaged with Tribal governments and other interested parties by: (1) Collaborating with the National Congress of American Indians to conduct mass mailings to Federally recognized Tribes; and (2) participating in Tribal meetings hosted by Tribal organizations and other Federal agencies (these meetings included attendees from Federally recognized and State-recognized Tribes). Additionally, the NRC staff reviewed Tribal policy statements of executive departments, their related agencies, and other independent agencies and provided their findings to the Commission.
The proposed NRC Tribal Policy Statement was consistent with the language of EO 13175 and was intended to cover a broad range of Tribal consultations, outreach, and interactions conducted by NRC staff. The proposed NRC Tribal Policy Statement applied to Federally recognized Indian Tribes as defined by the Federally Recognized Indian Tribe List Act of 1994 (25 U.S.C. 479a). It also encouraged participation by State-recognized Tribes in the NRC's regulatory process. On December 1, 2014, the NRC published the proposed NRC Tribal Policy Statement in the
After the December 2014 publication of the proposed NRC Tribal Policy Statement in the
The final NRC Tribal Policy Statement reflects responses to both internal and external comments. The final NRC Tribal Policy Statement applies to all NRC staff and activities within the NRC's regulatory jurisdiction. The NRC Tribal Policy Statement is written at a high level to cover a wide variety of interactions, consultation, and outreach to Indian Tribes, including Federally recognized American Indian and Alaska Native Tribes.
Within the context of this discussion, the following definitions will apply unless otherwise indicated:
On December 1, 2014 (79 FR 71136), the NRC published a
The NRC received nine comment submissions, including comments from two representatives from Federally recognized Tribes, two representatives from inter-Tribal organizations, a Federal agency, an electric utility company, and three individuals who did not provide an organizational affiliation.
Comments and responses related to the proposed NRC Tribal Policy Statement are listed in this section, and comments are quoted directly from comment submissions. The NRC Tribal Protocol Manual was published concurrently with the proposed Policy Statement in the
The following table lists the commenter's name and affiliation, ADAMS accession number for the comment submission, and the document related to each comment.
The NRC has reviewed every comment submission and has identified 42 unique comments requiring NRC consideration and response. Comments and the NRC responses are presented in this section. The comments generally fell within the following categories: NRC's Trust Responsibility as a Federal agency; suggested changes to the language of the NRC Tribal Policy Statement; NRC's Tribal outreach and consultation; and NRC's government-to-government relationship with Tribes. Commenters provided additional comments that did not fall within those categories as well as comments that were out of scope of the NRC Tribal Policy Statement; these comments have been included at the end of this section, along with NRC responses.
Multiple commenters provided input related to the NRC's Trust Responsibility to Federally recognized Tribes as a Federal agency.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The NRC Tribal Policy Statement has been revised to reflect the comment, in part.
While the comment related to the Tribal Advance Notification Rule is out of scope of the NRC Tribal Policy Statement, the NRC believes the Tribal Advance Notification Rule is consistent with the NRC Tribal Policy Statement because it requires Tribal governments to opt-in to participate in the advanced notification program. The Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste (Tribal Advance Notification Rule) amends NRC rules to require licensees to provide advance notification to participating Federally recognized Tribal governments regarding shipments of irradiated reactor fuel and certain types of nuclear waste for any shipment that passes within or across their reservations (77 FR 34194). After reviewing public comments received during the development of the Tribal Advance Notification Rule, the NRC staff concluded that Tribes should have the option of whether to opt into the program because the program requires training, certain equipment, and has civil and criminal penalties for non-compliance.
The NRC Tribal Policy Statement has been revised to reflect the comment, in part.
The NRC Tribal Policy Statement has been revised to reflect the comment.
“The `trust responsibility' that the federal government owes to Indian tribes imposes both substantive and procedural duties on the federal government.”
Other procedural components for carrying out interactions with Tribal governments are articulated in the Tribal Protocol Manual and specific agency regulations and guidance documents.
The NRC Tribal Policy Statement has been revised to reflect the comment.
The NRC Tribal Policy Statement has been revised to reflect the comment.
Multiple commenters proposed changes to the language of the NRC Tribal Policy Statement or to the discussion section that defines terms utilized throughout the NRC Tribal Policy Statement.
7.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
Section 274b. of the AEA authorizes the NRC to enter into agreements with States so that the NRC relinquishes, and the State assumes, regulatory authority over the radioactive material and activities specified in the agreement. The NRC approves the agreement if the NRC finds the State program adequate to protect public health and safety and compatible with the NRC's regulatory program. The NRC periodically reviews the State's program, but the NRC does not mandate to the State how they should interact with Tribal governments when implementing these regulatory requirements and the States apply their own laws to implement their radiation control program for the specified AEA radioactive materials covered in the Agreement.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The NRC Tribal Policy Statement has been revised to reflect the comment.
The NRC Tribal Policy Statement has been revised to reflect the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The discussion section related to the NRC Tribal Policy Statement has been revised as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The NRC agrees that a definition of
The NRC disagrees that the NRC Tribal Policy Statement's discussion of outreach should include Native Hawaiian Organizations. The Tribal Policy Statement pertains to consultation with Tribal Governments recognized by the Federally Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a. (See response to Comment 4.1 for additional information regarding the Native Hawaiian Organizations.)
The NRC Tribal Policy Statement has been revised as a result of the comment.
The NRC Tribal Policy Statement has been revised to address this comment, in part.
“Principles 3 and 4 of the Policy are potentially confusing as they use the terms `consult' and `outreach' interchangeably. In addition, these Principles state that they apply to `regulatory actions' without clarifying whether what is meant are policy setting, rulemaking, issuing guidance, or a licensing action. As reflected in Section 1.D and associated note 25 of the Manual, as a regulatory agency, the NRC fulfills the fiduciary obligation to Tribes by ensuring uniform treatment action in providing protection under its implementing regulations. On the other hand, where the NRC is engaged in setting policy, issuing rules, or providing guidance that directly impact Tribes, consultation on subjects within the scope of the impact may be appropriate where the impact is significant. To minimize confusing ambiguity, the following clarifications are suggested:
(1) In Principle 3, replace `consult' with `inform' in the first sentence and replace `NRC regulatory actions that have substantial direct impacts on one or more Indian Tribe' with `NRC regulatory actions, including licensing actions, in which one or more Indian Tribes have an interest.' This clarification ensures that outreach to Indian Tribes will include any regulatory action of interest to a Tribe.”
The NRC Tribal Policy Statement has been revised as a result of the comment.
The NRC Tribal Policy Statement has been revised to address the comment, in part.
The NRC Tribal Policy Statement has been revised to reflect part of the comment.
Multiple commenters provided input related to the use of the terms “outreach” and “consultation” in the policy principles of the NRC Tribal Policy Statement.
The NRC Will Conduct Outreach to Indian Tribes.
The NRC will consult and coordinate with Indian Tribes, as appropriate, related to its regulatory actions with Tribal implications and will seek additional opportunities for general outreach. The NRC will participate in national and regional Tribal conferences and summits hosted by Federal agencies and Tribal organizations, and will seek Tribal representation in NRC meetings and advisory committees concerning NRC regulatory actions that have substantial direct effects on one or more Indian Tribes.
While the NTAA supports Principle No. 3, it does not find that current NRC outreach to Indian Tribes is being done or happening in a timely manner. For example, apart from some local efforts, the NTAA is unaware of any venue where Tribes are being brought together to discuss radiation issues and air quality impacts from the nuclear program. The NTAA finds that NRC must be more diligent in conducting outreach on all issues as they are brought to the attention of the NRC by Tribes, the NTAA, or other Tribal organizations.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
1. Develop guidance on how the NRC intends to assure that consultation meetings result in meaningful dialogue rather than simply pro forma consultation;
3. Provide adequate time to Tribes to review and provide comments concerning proposed NRC actions well beyond the 30- to 60-day periods provided to the public to make its comments.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
“Attending major tribal conferences and meetings is an excellent way of interacting with Indian tribes. As well, NRC staff should endeavor to attend meetings of other federal agencies that attract tribal representatives.
“. . . [I]t is important to recognize that while there might not be delineated reservation or Trust lands in a given area that does not necessarily mean that there are no tribes interested in or impacted by NRC regulatory actions. Many tribes were forcibly removed from their ancestral lands or ceded vast tracts of land to the federal government through treaties and have retained or reserved rights (fishing, hunting, gathering) for these lands or these lands contain archaeological, cultural or historical resources, including important sacred sites.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The NRC agrees with the comment, “the NRC should avoid homogenizing Native American Tribes” and recognizes distinctions between Federally
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No changes were made to the NRC Tribal Policy Statement or Tribal Protocol Manual as a result of the comment.
“It should be noted that there are differences among tribes and that there is no `one size, fits all' approach when it comes to interacting with and understanding Indian tribes. Each tribe is unique and should be treated as such. There should not be a `standard process' as recommended by some commenters.”
No changes were made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of this comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No changes were made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
“We understand that the NRC may possibly be developing a guidance document pertaining to the National Historic Preservation Act (NHPA) Section 106 consultation. We applaud this effort. We recommend that the NRC work with tribes, the Advisory Council on Historic Preservation (ACHP), industry (limited participation), and possibly other federal agencies to develop this guidance document.
“Finalizing and fully implementing the Tribal Protocol Manual will also help NRC staff to be informed on tribal issues. Training, awareness, and continuity of staff are also key elements of an effective tribal program.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
The NRC has an obligation under the NHPA to ensure that its actions do not have adverse impacts. The NRC also has an obligation to federally recognized Indian tribes.
With regard to tribes delaying the process or lacking incentive to work with the NRC, it should be noted that it can be a burden (financially and technically) to effectively participate in NRC proceedings.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
“Yet, the NRC claims that `there are no tribes that have the prerequisite required to receive advance notifications.' (“Tribal Advance Notification” at
“Nuclear waste is being transported through a number of reservations weekly by unmarked trucks (
“The NTAA has also seen several inconsistencies in the reporting of the number of regulated facilities in Indian Country. The NTAA finds that, an update of NRC's maps or inventories of regulated facilities, would help the NRC to more effectively contact and identify Tribes about NRC regulatory and non-regulatory actions having substantial air quality and other direct effects on one or more Tribes.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
“Many transport routes go through Native communities, and are not part of the DOE-EM START [Stakeholder Tool for Assessing Radioactive Transportation] programming. It may be missing out of other regulatory components as 108(c) under DOE for transport. Consideration for links for the public with RECA [Radiation Exposure Compensation Act] benefits and DownWinder Web sites under NRC is important as many suffer the health devastation of cancer due to radiation.”
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
No change has been made to the NRC Tribal Policy Statement as a result of the comment.
This final NRC Tribal Policy Statement is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
This Policy Statement does not contain new or amended information collection requirements and, therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
For the Nuclear Regulatory Commission.
The purpose of this Tribal Policy Statement is to set forth principles to be followed by the U.S. Nuclear Regulatory Commission (NRC) to promote effective government-to-government interactions with Federally recognized American Indian and Alaska Native Tribes, and to
The following principles will guide the NRC's interaction with Indian Tribes:
The NRC shares the Federal government's unique Trust Relationship with, and Trust Responsibility to, Indian Tribes. Under the Federal Trust Doctrine, the United States—and the individual agencies of the Federal government—owe a fiduciary duty to Indian Tribes. The nature of that duty depends on the underlying substantive laws (
The NRC recognizes the right of each Indian Tribe to self-governance and supports Tribal sovereignty and self-determination. The NRC recognizes Tribal governments as dependent domestic sovereign nations, independent from State governments, with separate and distinct authorities with inherent sovereign powers over their members and territory, consistent with applicable statutes and authorities.
The NRC will conduct outreach to keep Indian Tribes informed about the agency's actions and plans, as appropriate, related to its regulatory actions that have substantial direct effects on one or more Indian Tribes. The NRC will participate in national and regional Tribal conferences and summits hosted by Federal agencies, Tribal governments, and Tribal organizations, as appropriate. The NRC will encourage Tribal governments to communicate their preferences to NRC staff during outreach activities and will seek to provide information about opportunities for Tribal participation in NRC meetings and advisory committees concerning NRC regulatory actions that have substantial direct effects on one or more Indian Tribes, as appropriate.
The NRC will provide timely notice and consult in good faith with Tribal governments on NRC's regulatory actions that have substantial direct effects on one or more Indian Tribes as well as those regulatory actions for which Tribal consultation is required under Federal statute.
Tribal officials may also request that the NRC engage in consultation with them on matters that have not been identified by the NRC to have substantial direct effects on one or more Indian Tribes as well as those regulatory actions for which Tribal consultation is not required under Federal statute. The NRC will make efforts to grant such requests, taking into consideration the nature of the activity at issue, past consultation efforts, available resources, timing issues, and other relevant factors.
The NRC will establish early communications and begin consultation as soon as practicable. The NRC will consult in good faith throughout the agency decisionmaking process and develop and maintain effective communication, coordination, and cooperation with Indian Tribes. The NRC representatives for consultations with Tribal officials or representatives will be of an appropriate rank and the level of interaction will be commensurate with the circumstances. The appropriate level of interaction will be determined by a discussion between the NRC and Tribal governments, and program office consultation procedures and guidance. Participating Tribal and NRC representatives will serve as respective decisionmakers, based on the established agenda and to the extent possible.
When the Commission's action involves other Federal agencies, the NRC will perform its Tribal consultation jointly with other Federal agencies, as appropriate and to the extent possible.
The NRC recognizes the distinction between Indian Tribes who are Federally recognized and those who are not. The NRC will reach out to States to identify the appropriate State-recognized Tribes to invite to participate in its regulatory process, including opportunities related to rulemaking, licensing and decommissioning.
The Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs serves as the NRC's designated official for Tribal consultations. The designated official will ensure that the agency program personnel have considered the Tribal implications related to their responsibilities within the NRC's jurisdiction. The designated official will also make efforts to facilitate meaningful and timely consultation and coordination regarding NRC's regulatory actions that have substantial direct effects on one or more Indian Tribes as well as those regulatory actions for which Tribal consultation is required under Federal statute.
The designated official will be supported by staff who have functional responsibility to serve as intergovernmental liaisons to Indian Tribes. These NRC Tribal liaisons will facilitate government-to-government consultation by serving as the agency's primary points of contact for Indian Tribes, coordinating with the appropriate office or personnel
On November 3, 2016, NYSE Arca, Inc. (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to introduce NYSE OptX, an order entry platform that will allow OTP Holders
According to the Exchange, NYSE OptX is an order entry platform that will utilize a combination of Instant Messaging (“IM”) and browser-based technology to allow OTPs to submit QCC Orders for execution on the Exchange's trading system.
According to the Exchange, NYSE OptX is designed as an alternative to front end order management systems and the use of telephones for the sending of QCC Orders to the Exchange.
The Exchange stated that it will announce the effective date of NYSE OptX in a Trader Update to be published no later than 90 days following approval of this proposal, and that such effective date will be no later than 270 days following publication of the Trader Update.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of Section 6 of the Act
In particular, the Commission notes that, according to the Exchange, NYSE OptX will provide OTPs an alternative to third-party front end order management systems and the use of telephones to send QCC Orders to the Exchange.
IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the Act,
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 Exchange proposes to amend Rule 501 (Specialist Appointment), Rule 507 (Application for Approval as an SQT, RSQT, or RSQTO and Assignment in Options), Rule 508 (Transfer Application), Rule 510 (SQT and RSQT Performance Evaluation), and Rule 511 (Specialist Allocation and Performance Evaluation).
The text of the proposed rule change is available on the Exchange's 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 Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend: (1) Rule 501 to delete a reference to a back-up specialist; (2) Rule 507 to: Update the reference to “Board” to permit the Board to appoint a panel; update the composition of the review committee; and update the reference to Rule 510; (3) Rule 508 to delete the reference to “lease” and the cross-reference to Rule 511; (4) Rule 510 to re-entitle the rule “Good Standing for Specialist, SQT, and RSQT,”
Rules 501, 507, 508, 510, and 511 are part of the 500 series of rules in the Rules of the Exchange (the “Series 500 Rules”), which are entitled “Allocation, SQT, RSQT, and Evaluation Rules (Rule 500-599).”
The Exchange proposes in Rule 501 to delete the reference to a back-up specialist.
Currently, Rule 501 states that initial application(s) to become a specialist unit shall include information regarding the specialist, back-up specialist unit and a substitute specialist unit. With the development of liquidity-enhancing electronic market makers on the Exchange such as RSQTs, which make markets in the same options issues as specialists, and the diminution of the
The Exchange proposes in Rule 507 to update the reference to “Board,” update the composition of the review committee, and update the reference to Rule 510.
First, Rule 507(a) currently states that the Board has the ability to perform functions such as deferring or limiting approval of SQTs or RSQTs. The Exchange proposes to replace the role of the Board with Exchange staff. The Exchange may therefore defer, for a period to be determined in the Exchange's discretion, approval of qualifying applications for SQT or RSQT status pending any action required to address the issue of concern to the Exchange. The Exchange's Membership department
Second, Rule 507(e) currently states that an appeal to the Board from a decision of the Exchange regarding an SQT, RSQT, or RSQTO
Third, Rule 507(b) currently states that, when making a decision concerning an application for assignment in an option, the Exchange shall consider the applicant's prior performance as a specialist, SQT, or RSQT based on evaluations conducted pursuant to Exchange Rule 510.
The Exchange proposes in Rule 508 to delete the reference to “lease” and to Rule 511.
First, Rule 508 currently refers to “lease.” Leasing is no longer practiced on the Exchange, and for this reason the Exchange is proposing to delete this obsolete term from Rule 508. This is similar to a recent proposal wherein the Exchange noted that leasing is an obsolete term that should be deleted.
Second, Rule 508 currently refers to Rule 511, regarding specialists. The Exchange proposes to delete the Rule 508 reference to Rule 511. This is because, as discussed below, Rule 511 is proposed to be deleted as the language of Rule 510 is proposed to be modified to include specialists.
The Exchange proposes to entitle Rule 510 “Good Standing for Specialist, SQT, and RSQT” and to add relevant good standing language.
First, Rule 510 currently applies only to SQTs and RSQTs. The Exchange proposes to change the language of Rule 510 to indicate that this rule will also be applicable to specialists. Thus, the Exchange proposes to entitle Rule 510 as “Good Standing for Specialist, SQT, and RSQT.” The good standing requirement, which is discussed below, is a continuous requirement rather than a periodic evaluation requirement as in current Rules 510 and 511.
Second, Rule 510 currently is written in terms of doing performance evaluations for SQTs and RSQTs. Currently, Rule 507 has a very detailed process for applying for and approving SQTs and RSQTs, and for assigning options to SQTs and RSQTs. In addition, today Rule 501 defines the application and approval process for specialists.
For obligations of BX Options Market Makers,
The BX Options Market Maker obligations are similar in nature to those of Phlx specialists, which can be found in Phlx Rule 1014, entitled “Obligations and Restrictions Applicable to Specialists and Registered Options Traders,” and include: Maintain a fair and orderly market; not enter into transactions or make bids or offers that are inconsistent with such a course of dealings; quote a two-sided market; and maintain a two-sided market.
The proposed new language is similar, in all material respects,
(i) Continue to meet the requirements established in SEC Rule 15c3-1(a)(6)(i),
(ii) continue to satisfy the specialist, SQT or RSQT qualification and market making requirements specified by the Exchange, as amended from time to time;
(iii) comply with the Rules of the Exchange and the Options Rules
(iv) pay on a timely basis such member, transaction and other fees as the Exchange shall prescribe.
These proposed requirements to remain in good standing on the Exchange are not periodic, as are the evaluation and performance concepts in current Rules 510 and 511, but rather are continuous in nature.
Third, the Exchange notes that with the proposed new good standing requirements, specialist and other market maker (
For the market making obligations of SQTs and RSQTs (including Directed SQT or DRSQTs [sic], and Directed RSQTs or DRSQTs), which remain unchanged,
Fourth, the proposed new language in Rule 510(b) states that the good standing of a specialist (including Remote Specialist), SQT, or RSQT may be suspended, terminated or otherwise withdrawn, as provided in the Exchange's rules, if any of these conditions for approval cease to be maintained or the specialist, SQT, or RSQT violates any of its agreements with the Exchange or any of the provisions of the Rules of the Exchange or of the Options Rules. The Exchange is proposing to add an Informal Meeting process and appeal rights, which do not exist in Rule 510 for specialists at this time.
The Informal Meeting process proposed in Rule 510 is based on the Informal Meeting process in current Rules 510 (for SQTs and RSQTs) and 511 (for specialists), which is in respect of performance evaluations. The Informal Meeting process proposed in Rule 510 is, however, in respect of good standing. Specifically, the Exchange proposes to amend Rule 510 to adopt the following language in Rule 510(b)(i): The Exchange will provide written notice to a specialist (including Remote Specialist), SQT, or RSQT of a contemplated action regarding good standing pursuant to this Rule 510. A specialist (including Remote Specialist), SQT, or RSQT may request and the Exchange may hold an informal meeting to discuss the alleged failure to remain in good standing and to explore possible appropriate remedies. Written notice of the date and time of the meeting will be given to the specialist (including Remote Specialist), SQT, or RSQT and no verbatim record will be kept. If the Exchange believes there are no mitigating circumstances that would demonstrate substantial improvement of or reasonable justification for the failure to meet the good standing requirements of this Rule 510, the Exchange may take appropriate action pursuant to subsection (b) of this Rule 510. Nothing in this Informal Meeting process limits the Exchange from enforcing the rules of the Exchange, which may include a disciplinary action pursuant to such rules. The Regulatory staff may, for example, initiate a disciplinary action pursuant to Rule 960.3 against a member for failure to meet continuous quoting obligations in Rule 1014.
The memorialization of appeal rights in proposed Rule 510(c) is done to ensure that if the good standing of a specialist, SQT, or RSQT is suspended, terminated or otherwise withdrawn then they have a clear way to initiate and prosecute an appeal regarding such decision. The proposed due process methodology is similar to other rules of the Exchange. By proposing new language in Rule 510(a) and (b) regarding specialists, SQTs, and RSQTs regarding good standing, which is similar to that of BX Options, the continuous good standing rules of the Exchange and BX Options will be more aligned and easier to apply. Proposed Rule 510 describes an Informal Meeting process and appeal rights applicable to specialists (including Remote Specialists), SQTs, and RSQTs. The Exchange is replacing the current
The Exchange has concluded that, with the placement of the good standing concepts into proposed Rule 510 in such a way that they include specialist (and Remote Specialist), Rule 511 is no longer needed. In Rule 510, as discussed, in lieu of the current language, the Exchange is proposing to adopt new language indicating how a member of the Exchange can remain in good standing.
The proposed new language in Rule 510 is, in all material respects, similar to the BX Options rule at Chapter VII, Section 4. Because of this proposed new language in Rule 510, which addresses specialists (as also Remote Specialists, RSQTs, and SQTs), the Exchange proposes to delete Rule 511 in its entirety. The Exchange believes that, within the effort to update and consolidate the Series 500 Rules as discussed, it is reasonable and proper to delete Rule 511. This rule was established decades ago for the purpose of dealing with the extensive on-floor open outcry specialist system, with multiple competing specialist units. Since the implementation of Rule 511, the open outcry options floor has evolved into a robust and competitive principally electronic system, and the remaining hybrid options floor does not have numerous competing specialists as was the case when Rule 511 was instituted.
The Exchange believes that under the circumstances, and because specialists are proposed to be covered in Rule 510 in terms of good standing, and continue to be covered in the Series 500 Rules and other rules of the Exchange,
As discussed, the Exchange is deleting the performance evaluation structure of Rule 511 and is proposing to relocate the concept within Rule 510 with the proposed good standing requirement and appeal rights applicable to specialists, SQTs, and RSQTs. The Exchange believes that the proposed good standing approach, which is applicable to specialists, SQTs, and RSQTs, enhances the current rule because unlike the periodic nature of the performance evaluation structure the proposed good standing approach would have continuous requirements that must be maintained in order to remain in good standing on the Exchange (
As discussed, options trading on the Exchange has developed into a robust hybrid system that is currently largely electronic and off-floor. The Exchange continues to have an open outcry trading floor, however, rather than a proliferation of competitive specialists on the options floor as was the case when Rule 511 was instituted: There is currently one specialist unit on the options floor and therefore Rule 511 is not needed. In the past, when so many specialists conducted business on the options floor, Rule 511 served a purpose. Today, Rule 511, with its specialist evaluation process and allocation process constructed for multiple competitive specialists on the floor, is no longer needed with one specialist unit on the floor.
The many rules that continue to apply to specialists discuss topics such as application, approval, allocation, re-allocation, market making, and obligations of specialists. For example, Rule 501 as proposed discusses the specialist allocation process and specialist approval process. To be an approved specialist unit and retain the privilege of such status, for example, a specialist unit must maintain the approved clearing arrangements and capital structure stated on their application and changes regarding certain requirements must be submitted and approved by the Exchange. In addition, each unit must consist of at least one head specialist and one assistant specialist that must be associated with the specialist unit; the Exchange, in its discretion, may require a unit to obtain additional staff depending upon the number of assigned options classes and associated order flow. Rule 506 discusses allocation application, reallocation of a previously allocated options, and transfer of allocated options.
The Exchange believes that the changes to the noted rules in the Series 500 Rules will make remaining Rules 501, 507, 508, and 510 easier to apply, clearer and better.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
In particular, the Exchange is proposing to change Rule 501 to delete reference to a back-up specialist. With the development of liquidity-enhancing electronic market makers on the Exchange such as RSQTs, which make markets in the same options issues as specialists, and the diminution of the role that the specialist plays in managing the order book on the Exchange, both a back-up specialist and substitute specialist are no longer needed. The Exchange believes that this proposal amendment is consistent with the Act because the advent of streaming quote traders on the Exchange served to perfect the mechanism of a free and open market because of the liquidity that such participants brought to Phlx. These participants are obligated to continuously quote in the market and have filled a role which was previously reliant on a back-up specialist and a substitute specialist.
Obsolete language in Rule 501 in respect of back-up specialists, which includes Commentary .01 to Rule 501, is proposed to be deleted from Rule 501. Similarly, the Exchange is proposing to change Rule 508 to delete the cross reference to Rule 511 and references to “lease.” As discussed, with the change in Rule 510 to the good standing standard that applies to specialists as well as SQTs and RSQTs, Rule 511 is proposed to be deleted and therefore the reference is no longer needed. Moreover, leasing is no longer permitted on the Exchange, and for this reason the Exchange is proposing to delete this obsolete term from Rule 508. The Exchange believes it is consistent with the Act to delete obsolete references which serve to confuse members within the Rulebook.
The Exchange is proposing to amend Rule 507(a) to permit the Exchange, instead of the Board to defer approval of qualifying applications for SQT or RSQT status pending any action required to address the issue of concern to the Exchange. The applicant would have a right of appeal to the Board or a Board Panel of any action of Exchange staff pursuant to Rule 507(e). The Exchange believes that the application process should be handled by staff initially with appellate rights to the Board or a Board Panel. Currently Rule 507 states that the Board has the ability to perform functions such as deferring or limiting approval of SQTs or RSQTs. The Exchange believes that this amendment is consistent with the Act because it will change [sic] will promote just and equitable principles of trade by serving the administration and application of Rule 507 and permitting a right of appeal as provided in Rule 507(e).
With respect to Rule 507(e), the Exchange proposes to expand the appeal to either the Board or a Board Panel. Currently, Rule 507(e) states that an appeal shall be heard by a special committee of the Directors composed of three Directors, of whom at least one (1) shall be an Independent. The Exchange proposes to state that the appeal may be heard by a panel appointed by the Board composed of three (3) members not materially involved in the Exchange decision appealed from. If a panel is appointed by the Board, three persons shall be selected to serve on the panel and in making such selections the Board shall, to the extent practicable, choose individuals whose background, experience and training qualify them to consider and make determinations regarding the subject matter to be presented to the panel. The panel shall consist of two members of the Exchange, or general partners or officers of member organizations and one other person who would qualify as a public member as defined in Article I of the By-Laws, whom the Board considers to be qualified. The Exchange believes that this amendment is consistent with the Act because the Board or a Board Panel
Also, currently Rule 507(b) states that when making a decision concerning an application for assignment in an option the Exchange shall consider the applicant's prior performance as a specialist, SQT or RSQT based on evaluations conducted pursuant to Exchange Rule 510. The Exchange proposes to update Rule 510 so that in lieu of the current formulaic language in the rule, there is new language that accentuates the good standing of members. In light of this, the Exchange proposes to update the 507(b) reference to state that the Exchange can consider the applicant's prior performance as a specialist, SQT or RSQT based on “good standing pursuant to Rule 510.” The Exchange believes that this amendment is consistent with the Act because it will consider a more holistic approach in evaluating members that engage in market making activities. The Exchange believes that this approach is broader and will take new factors into account which would serve to promote just and equitable principles of trade in evaluating market participants that engage in market making activities by considering their obligations and past performance.
The Exchange is proposing to update Rule 510 to give it a new title, “Good Standing for Specialist, SQT, and RSQT,” to add relevant good standing language, and appeal rights. The Exchange proposes to amend the language of Rule 510 to indicate that, with the deletion of Rule 511, Rule 510 will also be applicable to specialists. The Exchange proposes to change the language of Rule 510 to more closely align the Exchange with BX Options by adopting language from the BX Options rule at Chapter VII, Section 4. BX Options Market Makers are held to good standing standards per the BX Options rule. Specialists on Phlx are another type of market maker. The Exchange believes that these amendments are consistent with the Act because these changes serve to add clarity and transparency to the rule text.
The Exchange is adopting language from BX Options at Chapter VII, Section 4. Specifically, the Exchange proposes new language in Rule 510(a) to state that to remain in good standing on the Exchange as a specialist (including Remote Specialist), SQT, or RSQT, the specialist, SQT, or RSQT must meet specific requirements set forth in the rule.
The Exchange is proposing to add an Informal Meeting process and appeal rights, which do not exist in Rule 510 for specialists; as discussed, the appeal rights now in Rule 510 are regarding SQTs and RSQTs only in respect of performance evaluations. These proposed appeal rights for a specialist (including Remote Specialist), SQT, or RSQT, which are set forth in Rule 510(c) for, are adopted from Rule 511. The memorialization in Rule 510 of Informal Meeting process and appeal rights is done to affirm that if the good standing of a specialist, SQT, or RSQT is suspended, terminated or otherwise withdrawn then they have a clear way to meet with the Exchange to discuss the issue and initiate and prosecute an appeal regarding such decision. The Exchange's proposal to expand the role of the Board to permit an appeal to be heard by a Board Panel appointed by the Board composed of three (3) members not materially involved in the Exchange decision appealed from is consistent with the Act because the Board or a Board Panel would allow a path of impartial appeal for the applicant.
The Exchange has concluded that, with the placement of the good standing concepts into proposed Rule 510 in such a way that they include a specialist (and Remote Specialist), Rule 511 is no longer needed and is therefore proposed to be deleted in its entirety (with transfer of specialist appeal rights from Rule 511 to Rule 510).
The Exchange is proposing to delete Rule 511. This rule was established decades ago for the purpose of dealing with the extensive on-floor open outcry specialist system, with multiple competing specialist units. Since the implementation of Rule 511, the open outcry options floor has evolved into a robust and competitive system that is principally electronic, and the remaining hybrid options floor does not have numerous competing specialists as was the case when Rule 511 was instituted. The Exchange believes that because of the extensive changes on the option floor (from having numerous competitive specialist units on the old options floor to having a specialist unit on the current options floor), and because specialists are proposed to be covered in Rule 510 in terms of good standing and continue to be covered in the Series 500 Rules and other rules of the Exchange, it is consistent with the Act and promotes just and equitable principles of trade to delete Rule 511.
Furthermore, numerous rules in the Phlx Rulebook continue to apply to specialists (as well as to other registered options traders). For example, Rule 501 as proposed discusses the specialist allocation process and specialist approval process. Rule 506 discusses allocation application, reallocation of previously allocated options, and transfer of allocated options. Rule 508 as proposed discusses the Exchange approval process if there is agreement between or among specialist units to transfer one or more options classes already allocated to a specified specialist unit. Rule 513, which is not proposed to be amended with this filing, discusses the process if an option specialist unit voluntarily resigns from allocation in a particular option and there is a future allocation regarding that option. Rule 1014 discusses the obligations and restrictions, including specific market making requirements, that are applicable to specialists each trading day. Finally, Rule 1022 discusses proper identification of accounts, reporting of options, and orders of underlyings in respect of securities accounts and orders of specialists and ROTs.
The Exchange believes that the changes to the noted rules in the Series 500 Rules will make remaining Rules 501, 507, 508, and 510 easier to apply, clearer and more transparent. Such proposed changes are in consistent with the Act, the public interest, and continue to serve to protect investors.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. While the Exchange does not believe that the proposed change is a burden on competition, or is competitive in nature, the Exchange believes that clearer, updated, modernized, and better-conforming rules that do not refer to obsolete concepts are always beneficial to market participants, are in the public interest, and serve to protect investors.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
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.
On June 30, 2016, Bats BZX Exchange, Inc. filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On August 23, 2016, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider this proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 13, 2016, NYSE Arca, Inc. filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On September 6, 2016, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider this proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On November 3, 2016, NYSE MKT LLC, on behalf of NYSE Amex Options (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to introduce NYSE OptX, an order entry platform that will allow ATP Holders to submit QCC Orders and CUBE Orders (collectively, “paired orders”) to the Exchange.
According to the Exchange, NYSE OptX is an order entry platform that will utilize a combination of Instant Messaging (“IM”) and browser-based technology to allow ATP Holders to submit paired orders for execution on the Exchange's trading system.
According to the Exchange, NYSE OptX is designed as an alternative to front end order management systems and the use of telephones for the sending of paired orders to the Exchange.
The Exchange stated that it will announce the effective date of NYSE OptX in a Trader Update to be published no later than 90 days following approval of this proposal, and that such effective date will be no later than 270 days following publication of the Trader Update.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of Section 6 of the Act
In particular, the Commission notes that, according to the Exchange, NYSE OptX will provide ATP Holders an alternative to third-party front end order management systems and the use of telephones to send paired orders to the Exchange.
IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 16, 2016, Bats EDGX Exchange, Inc. (the “Exchange” or “EDGX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
EDGX proposes to establish a price-improvement auction, the Bats Auction Mechanism (“BAM,” “BAM Auction,” or “Auction”) on the Exchange's equity options platform, in which an Exchange Member (an “Initiating Member”) may electronically submit for execution a two-sided paired order, where one side is an order it represents as agent on behalf of a Priority Customer,
All options traded on the Exchange are eligible for BAM.
To initiate the Auction, the Initiating Member must mark the Agency Order for Auction processing, and specify either: (A) A single price at which it seeks to execute the Agency Order (a “single-price submission”); (B) that it is willing to automatically match as principal or as agent on behalf of an Initiating Order the price and size of all BAM Auction Notification responses (“BAM responses”) and other trading interest (“auto-match”) as follows: (i) Stopping the entire order at a single stop price and auto-matching BAM responses and other trading interest at all prices that improve the stop price to a specified price; or (ii) stopping the entire order at a single stop price and auto-matching all BAM responses and other trading interest at all prices that improve the stop price. Once the Initiating Member has submitted an Agency Order for exposure in the Auction, such Agency Order may not be modified or cancelled.
Under no circumstances will the Initiating Member receive an allocation percentage, at the final price point, of more than 50% of the initial Agency Order in the event there is one competing quote, order, or BAM response or 40% of the initial Agency Order in the event there are multiple competing quotes, orders, or BAM responses.
When the Exchange receives an Agency Order for Auction processing, an auction notification message detailing the side, size, price, and options series of the Agency Order would be sent over the Exchange's Multicast PITCH Feed and Auction Feed. BAM Auctions would be for a specified duration of no less than one hundred milliseconds and no more than one second, as determined by the Exchange and announced on the Exchange's Web site.
A BAM response with a size greater than the size of the Agency Order will be capped at the size of the Agency Order (
The BAM Auction would conclude at the earlier of: (i) The end of the Auction period; (ii) upon receipt by the Exchange of a Priority Customer order on the same side of the market and at the stop price of the Agency Order that is to be posted to the EDGX Options Book; (iii) upon receipt by the Exchange of an unrelated order or quote that is not a Priority Customer order that is on the same side of the market as the Agency Order that would cause the Agency Order's stop price to be outside of the EDGX BBO; (iv) at the close of trading; or (v) any time there is a trading halt on the Exchange in the affected series.
If the BAM Auction concludes earlier than the end of the prescribed Auction period for any of the reasons described
Any unexecuted BAM responses will be cancelled.
At the conclusion of the Auction, the Agency Order will be allocated at the best price(s), pursuant to the priority set forth in proposed EDGX Rule 21.19(b)(4).
If the Initiating Member selected the
If the Initiating Member selected the
After Public Customers and the Initiating Participant receive their allocations, and for classes designated by the Exchange as eligible for “Priority Order” status, Users with resting quotes and orders that were at a price that is equal to the Initial NBBO on the opposite side of the market from the Agency Order (“Priority Orders”) would have priority up to their size in the Initial NBBO at each price level at or better than such Initial NBBO. Priority Orders and BAM responses submitted by Users with Priority Order Status will be allocated pursuant to the algorithm set forth in EDGX Rule 21.8(c).
Finally, after Priority Customers, the Initiating Member, and Users with Priority Orders, if applicable, have received allocations, all other interest will be allocated pursuant to Rule 21.8(c).
The Exchange also proposes, in lieu of the BAM Auction procedures set forth in proposed paragraphs (a)-(b) to EDGX Rule 21.19, to allow an Initiating Member to enter an Agency Order for the account of a Priority Customer paired with an order for the account of another Priority Customer, and such paired orders will be automatically executed without an Auction. In its proposal, the Exchange notes that it would be a violation of EDGX Rule 22.12 for an Options Member to circumvent EDGX Rule 22.12 by providing an opportunity for (i) a Priority Customer affiliated with the Options Member, or (ii) a Priority Customer with whom the Options Member has an arrangement that allows the Options Member to realize similar economic benefits from the transaction as the Options Member would achieve by executing agency orders as principal, to regularly execute against agency orders handled by the firm immediately upon their entry as BAM Priority Customer-to-Priority Customer immediate crosses.
Subject to a pilot program expiring January 18, 2017,
The Exchange represented that it will provide the following additional information on a monthly basis:
(i) The number of contracts (of orders of 50 contracts or greater) entered into BAM Auctions;
(ii) The number of contracts (of orders of fewer than 50 contracts) entered into BAM Auctions;
(iii) The number of orders of 50 contracts or greater entered into BAM Auctions; and
(iv) The number of orders of fewer than 50 contracts entered into BAM Auctions.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange and, in particular, with Section 6(b) of the Act.
In particular, the Commission notes that, in order to initiate an Auction, the Initiating Member must stop the entire Agency Order as principal or with a solicited order at a price in an increment of $0.01 such that if the Agency Order is for less than 50 option contracts and the difference between the NBB and NBO is $0.01, the Initiating Member must stop the entire Agency Order at one minimum price improvement increment better than the NBBO, which increment shall be determined by the Exchange but may not be smaller than $0.01. The Commission believes that guaranteed price improvement for Agency Orders of fewer than 50 contracts when the difference between the NBB and NBO is $0.01 will benefit such Agency Orders. The Commission notes further that, for any other Agency Order, the Initiating Member must stop the entire Agency Order at the better of the NBBO or the Agency Order's limit price (if the order is a limit order). Accordingly, the proposed rule change will provide customers with an opportunity for price improvement over the NBBO in those instances.
If the EDGX BBO on the same side of the market as the Agency Order represents a Priority Customer order on the book, the stop price must be at least $0.01 better than the booked order's limit price. If the EDGX BBO on the same side of the market as the Agency Order represents a quote or order that is not a Priority Customer order on the book, the stop price must be at least $0.01 better than the booked order's limit price unless the Agency Order is a Priority Customer order and the Customer Overlay set forth in Exchange Rule 21.8(d)(1) is in effect. The Commission notes that the Exchange has represented that this condition is consistent with the operation of the Exchange generally, where the Customer Overlay is currently in effect with respect to all options traded on the Exchange, and Priority Customer Orders have first priority over other orders at the same price.
With respect to Agency Orders for less than 50 contracts, only one BAM Auction may be ongoing at any given time in a series and Auctions in the same series may not queue or overlap in any manner. However, BAM Auctions for Agency Orders of 50 contracts or more will be allowed to occur at the same time as other Auctions in the same series. The Commission notes that the BAM rules regarding the processing of overlapping BAM Auctions for Agency Orders of 50 contracts or more have been made transparent in the proposed rule change and are reasonable, given that the electronic nature of BAM makes the sequence of auction start times readily discernable.
All BAM Auctions will last for a period of no less than 100 milliseconds and no more than one second, as determined by the Exchange and announced on the Exchange's Web site. As the Exchange discussed in its proposal, the Exchange conducted a survey of active EDGX market maker firms and other active liquidity providers inquiring as to the timeframe within which these market participants respond to an auction with a duration time ranging from less than fifty (50) milliseconds to more than one (1) second. According to the Exchange, a majority of the market maker firms and active liquidity providers on EDGX Options that responded to the survey indicated that they were capable of responding to auctions with a duration time of at least 50 milliseconds.
The Commission believes that the Exchange's proposed matching algorithm is sufficiently clear regarding how orders are to be allocated in the BAM Auction and is designed in a manner that should facilitate a competitive auction process. The Commission further believes that permitting Priority Orders to have enhanced priority may encourage EDGX Users to quote aggressively with additional size outside of the BAM Auction and, therefore, may enhance competition and liquidity on the EDGX market.
Under the proposal, the BAM Auction would be available for orders of fewer
Section 11(a)(1) of the Act
The Rule's first condition is that orders for covered accounts be transmitted from off the exchange floor. In the context of automated trading systems, the Commission has found that the off-floor transmission requirement is met if a covered account order is transmitted from a remote location directly to an exchange's floor by electronic means.
Second, the Rule requires that the member and any associated person not participate in the execution of its order after the order has been transmitted. The Exchange represents that at no time following the submission of an order is a Member able to acquire control or influence over the result or timing of the order's execution.
Third, Rule 11a2-2(T) requires that the order be executed by an exchange member who is unaffiliated with the member initiating the order. The Commission has stated that this requirement is satisfied when automated exchange facilities, such as the BAM mechanism, are used, as long as the design of these systems ensures that members do not possess any special or unique trading advantages in handling their orders after transmitting them to the exchange.
Fourth, in the case of a transaction effected for an account with respect to which the initiating member or an associated person thereof exercises investment discretion, neither the initiating member nor any associated person thereof may retain any compensation in connection with effecting the transaction, unless the person authorized to transact business for the account has expressly provided otherwise by written contract referring to Section 11(a) of the Act and Rule 11a2-2(T) thereunder.
The Commission finds good cause, pursuant to Section 19(b)(2) of the Exchange Act, to approve the proposal, as modified by Amendment No. 1, prior to the 30th day after publication of Amendment No. 1 in the
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether Amendment No. 1 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.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549-1090, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. 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-BatsEDGX-2016-41 and should be submitted on or before January 30, 2017.
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 Exchange proposes to amend its rules to extend a pilot program to quote and to trade certain options classes in penny increments.
The text of the proposed rule change is available on the Exchange's 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
Under the Penny Pilot Program, the minimum price variation for all participating options classes, except for the Nasdaq-100 Index Tracking Stock (“QQQQ”), the SPDR S&P 500 Exchange Traded Fund (“SPY”) and the iShares Russell 2000 Index Fund (“IWM”), is $0.01 for all quotations in options series that are quoted at less than $3 per contract and $0.05 for all quotations in options series that are quoted at $3 per contract or greater. QQQQ, SPY and IWM are quoted in $0.01 increments for all options series. The Penny Pilot Program is currently scheduled to expire on December 31, 2016.
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.
In accordance with Section 6(b)(8) of the Act,
No written comments were either solicited or received.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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 under Section 19(b)(2)(B)
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.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Social Security Administration (SSA).
Notice.
We are announcing that the assessment percentage rate under sections 206(d) and 1631(d)(2)(C) of the Social Security Act (Act), 42 U.S.C. 406(d) and 1383(d)(2)(C), is 6.3 percent for 2017.
Jeffrey C. Blair, Associate General Counsel for Program Law, Office of the General Counsel, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401. Phone: (410) 965-3157, email
A claimant may appoint a qualified individual as a representative to act on his or her behalf in matters before the Social Security Administration (SSA). If the claimant is entitled to past-due benefits and was represented either by an attorney or by a non-attorney representative who has met certain prerequisites, the Act provides that we may withhold up to 25 percent of the past-due benefits and use that money to pay the representative's approved fee directly to the representative.
When we pay the representative's fee directly to the representative, we must collect from that fee payment an assessment to recover the costs we incur in determining and paying representatives' fees. The Act provides that the assessment we collect will be the lesser of two amounts: A specified dollar limit; or the amount determined by multiplying the fee we are paying by the assessment percentage rate. (Sections 206(d), 206(e), and 1631(d)(2) of the Act, 42 U.S.C. 406(d), 406(e), and 1383(d)(2).)
The Act initially set the dollar limit at $75 in 2004 and provides that the limit will be adjusted annually based on changes in the cost-of-living. (Sections 206(d)(2)(A) and 1631(d)(2)(C)(ii)(I) of the Act, 42 U.S.C. 406(d)(2)(A) and 1383(d)(2)(C)(ii)(I).) The maximum dollar limit for the assessment currently is $91, as we announced in the
The Act requires us each year to set the assessment percentage rate at the lesser of 6.3 percent or the percentage rate necessary to achieve full recovery of the costs we incur to determine and pay representatives' fees. (Sections 206(d)(2)(B)(ii) and 1631(d)(2)(C)(ii)(II) of the Act, 42 U.S.C. 406(d)(2)(B)(ii) and 1383(d)(2)(C)(ii)(II).)
Based on the best available data, we have determined that the current rate of 6.3 percent will continue for 2017. We will continue to review our costs for these services on a yearly basis.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98.
The FAA is issuing this notice to advise the public of a meeting of Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98.
The meeting will be held March 14-17, 2017 09:00 a.m.-05:00 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.
Rebecca Morrison at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Tenth RTCA SC-229 406 MHz ELT Plenary Joint with WG-98. The agenda will include the following:
Attendance is open to the interested public for plenary discussion, but limited to space availability. Registration for this meeting is required. Working group of the whole items are closed to the public. With the approval of the chairman, members of the public may present oral statements at the plenary meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics Plenary.
The FAA is issuing this notice to advise the public of a meeting of Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics Plenary.
The meeting will be held February 07-09, 2017, 08:30 a.m.-04:30 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.
Rebecca Morrison at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Ninth RTCA SC-233 Addressing Human Factors/Pilot Interface Issues for Avionics Plenary. The agenda will include the following:
Attendance is open to the interested public for plenary items, but limited to space availability. Working group of the whole items are closed to the public. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Highway Administration (FHWA), DOT.
Notice of Establishment of the Motorcyclist Advisory Council to the Federal Highway Administration; Request for Nominations.
The FHWA announces the establishment of the Motorcyclist Advisory Council (MAC) for a 2-year period. The MAC will coordinate with and advise the FHWA Administrator on infrastructure issues of concern to motorcyclists, including: (1) Barrier design; (2) road design, construction, and maintenance practices; and (3) the architecture and implementation of intelligent transportation system technologies. The FHWA seeks member nominations for the MAC.
The deadline for nominations for MAC membership is February 23, 2017.
All nomination materials should be emailed to
Mr. Michael Griffith, Office of Safety, (202) 366-9469 or
Section 1426 of the Fixing America's Surface Transportation Act (Pub. L. 114-94) requires the establishment of a Motorcyclist Advisory Council (MAC). The Secretary, acting through the Administrator of the FHWA, is required
(1) Barrier design;
(2) Road design, construction, and maintenance practices; and
(3) The architecture and implementation of intelligent transportation system technologies.
Pursuant to Section 9(a)(2) of the Federal Advisory Committee Act (FACA), and in accordance with 41 CFR 102-3.65, and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the MAC will be established for up to a 2-year period.
The MAC shall comprise not more than 10 members appointed by the Secretary of Transportation for terms of up to 2 years. Members serve at the pleasure of the Secretary. The Secretary may extend appointments and may appoint replacements for members who have resigned outside of a stated term, as necessary. Members may continue to serve until their replacements have been appointed.
The MAC seeks to have a fairly balanced membership with expertise in highway engineering, safety analysis, and motorcycling. Specifically, the following are the categories of members that shall be included in the MAC:
(1) Experts from State/local government in highway engineering issues, including:
(A) Barrier design;
(B) Road design, construction, maintenance; and/or
(C) Intelligent Transportation Systems;
(2) State/local traffic and safety engineers, design engineers, or other transportation department officials who are motorcyclists;
(3) A representative from a national motorcyclist association;
(4) A roadway safety data expert on crash testing/analysis; and
(5) A member of a national safety organization that represents the traffic safety systems industry.
This document gives notice of this process to potential participants and affords them the opportunity to request representation on the MAC. The procedure for requesting such representation is set out below. The FHWA is aware that there are many more potential organizations and participants than there are membership slots on the MAC. Organizations and participants should be prepared to support their participation on the MAC.
It is important to recognize that interested parties who are not selected to membership on the MAC can make valuable contributions to the work of the MAC in any of several ways. Interested persons shall be permitted to attend, appear before, or file statements with any advisory committee, subject to such reasonable rules or regulations as the Administrator may prescribe.
Any member of the public is welcome to attend the MAC meetings, and, as provided in FACA, speak to the MAC. Time will be set aside during each meeting for this purpose, consistent with the MAC's need for sufficient time to complete its deliberations.
The MAC meetings will be held approximately twice per Federal fiscal year, once in-person and once by web conference. Notice of each meeting shall be published in the
Every effort will be made to select MAC members who are objective and support the functions to be performed by the MAC. A balance is needed and weight is given to a variety of factors including, but not limited to, geographical distribution, gender, minority status, organization, and expertise. Some MAC members may be appointed as Special Government Employees and will be subject to certain ethical restrictions, and such members will be required to submit certain information in connection with the appointment process. With the exception of travel and per diem for official travel, members will serve without compensation.
A potential member may self-nominate or be nominated by an interested organization. Each nomination for membership should submit a letter of application that includes the following:
(1) The name, title, and relevant contact information (including phone and email address) of the nominee;
(2) a brief statement detailing interest for involvement in the MAC;
(3) A brief professional summary or résumé, including years of experience; relevant professional experience; geographic representation; and examples of previous leadership role in related committees, organizations, or advisory panels;
(4) A detailed description of the nominee's experience and expertise of the subject matter categories described above;
(5) Evidence that the nominee is authorized to represent parties related to the interest the person proposes to represent;
(6) An affirmative statement that the nominee meets all MAC eligibility requirements; and
(7) Optional support materials to emphasize interest and experience. This may include letters of recommendations, up to 3 references, publications and/or research.
Please do not send company, trade association, or organization brochures or any similar information. Should more information be needed, DOT staff will contact the nominee, obtain information from the nominee's past affiliations, or obtain information from publicly available sources, such as the Internet.
Nominations may be emailed to
A selection team comprising representatives from DOT offices will review the nomination packages. The Federal Highway Administrator will submit a list of recommended candidates to the Secretary of Transportation for review and selection of MAC members. The selection team will make recommendations regarding membership to the Secretary of Transportation through the Federal Highway Administrator based on criteria including: (1) Professional or academic expertise, experience, and knowledge relevant to the MAC activities described above; (2) the member categories described above; and (3) availability and willingness to serve.
Nominations are open to all individuals without regard to race, color, religion, sex, national origin, age, mental or physical handicap, marital status, or sexual orientation. To ensure that recommendations to the Secretary take into account the needs of the diverse groups served by DOT, membership shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 38 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Each group of renewed exemptions was effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below.
Ms. 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 15, 2016, FMCSA published a notice announcing its decision to renew exemptions for 38 individuals from the vision requirement in 49 CFR 391.41(b)(10) to operate a CMV in interstate commerce and requested comments from the public (81 FR 80161). The public comment period ended on December 15, 2016, and no comments were received.
As stated in the previous notice, FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(10).
The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to driver a CMV 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.
FMCSA received no comments in this preceding.
As of November 9, 2016, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 36 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (63 FR 196; 63 FR 30285; 65 FR 20245; 65 FR 33406; 65 FR 57230; 65 FR 57234; 65 FR 66293; 66 FR 53826; 66 FR 66966; 67 FR 46016; 67 FR 57266; 67 FR 57267; 67 FR 67234; 68 FR 69434; 69 FR 51346; 69 FR 52741; 69 FR 53493; 69 FR 62741; 69 FR 62742; 70 FR 74102; 71 FR 50970; 71 FR 53489; 71 FR 62147; 71 FR 62148; 73 FR 35196; 73 FR 36955; 73 FR 46973; 73 FR 48270; 73 FR 48275; 73 FR 51336; 73 FR 51689; 73 FR 54888; 73 FR 61925; 73 FR 63047; 73 FR 74565; 75 FR 25919; 75 FR 36779; 75 FR 39725; 75 FR 39729; 75 FR 44051; 75 FR 47883; 75 FR 50799; 75 FR 52061; 75 FR 52062; 75 FR 52063; 75 FR 54958; 75 FR 59327; 75 FR 61833; 75 FR 63257;75 FR 64396; 75 FR 66423; 75 FR 70078; 77 FR 7657; 77 FR 22059; 77 FR 27852; 77 FR 38384; 77 FR 39379; 77 FR 40946; 77 FR 46153; 77 FR 48590; 77 FR 52381; 77 FR 52388; 77 FR 52389; 77 FR 60010; 77 FR 64582; 77 FR 64583; 77 FR 64841; 77 FR 68199; 77 FR 68200; 79 FR 27681; 79 FR 35212; 79 FR 35218; 79 FR 38649; 79 FR 38659; 79 FR 45868; 79 FR 46153; 79 FR 46300; 79 FR 47175; 79 FR 51643; 79 FR 53514; 79 FR 56097; 79 FR 56099; 79 FR 56104; 79 FR 56117; 79 FR 58856; 79 FR 59348; 79 FR 59357; 79 FR 64001; 79 FR 68199; 79 FR 70928; 79 FR 72754:
The drivers were included in one of the following dockets: Docket Nos. FMCSA-1998-3637; FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2000-8203; FMCSA-2001-10578; FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-2008-0106; FMCSA-2008-0231; FMCSA-2008-0266; FMCSA-2010-0082; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-2010-0201; FMCSA-2011-0324; FMCSA-2012-0105; FMCSA-2012-
As of November 22, 2016 and in accordance with 49 U.S.C. 31136(e) and 31315, the following 2 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (79 FR 63211; 80 FR 2471):
The drivers were included in Docket No. FMCSA-2014-0297. Their exemptions are effective as of November 22, 2016, and will expire on November 22, 2018.
In accordance with 49 U.S.C. 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (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 prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions of 11 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before February 8, 2017.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2011-0389; FMCSA-2012-0294; FMCSA-2013-0109; FMCSA-2013-0442 using any of the following methods:
•
•
•
•
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years 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 two-year period.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person:
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
The 11 individuals listed in this notice have requested renewal of their exemptions from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the 11 applicants has satisfied the conditions for obtaining an exemption from the Epilepsy and Seizure Disorder requirements and were published in the
The 11 drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. FMCSA has concluded that renewing the exemptions for each of these applicants is likely to achieve a level of safety equal to that existing without the exemption. Therefore, FMCSA has decided to renew each exemption for a two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each driver has received a renewed exemption.
As of April 8, 2016, the following four individuals have satisfied the renewal conditions for obtaining an exemption from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from driving CMVs in interstate commerce (79 FR 70917; 79 FR 23054): Jeffrey Ballweg (WI); Michael Ranalli (PA); Lonnie Reicker (IL); and Jay Whitehead (NY). These drivers were included in FMCSA-2011-0389; and FMCSA-2012-0294; FMCSA-2013-0109. The exemptions were effective on April 8, 2016, and will expire on April 8, 2018.
As of April 23, 2016, the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from driving CMVs in interstate commerce (79 FR 73690):
These drivers were included in FMCSA-2013-0442. The exemptions were effective on April 23, 2016, and will expire on April 23, 2018.
The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded 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(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 11 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the Epilepsy and Seizure Disorders requirement in 49 CFR 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions of four individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions were effective on November 6, 2015. The exemptions will expire on November 6, 2017. Comments must be received on or before February 8, 2017.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2013-0107 using any of the following methods:
•
•
•
•
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years 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 two-year period.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person:
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
The four individuals listed in this notice have requested renewal of their exemptions from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the four applicants has satisfied the conditions for obtaining an exemption from the Epilepsy and Seizure Disorder requirements and were published in the
The four drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. FMCSA has concluded that renewing the exemptions for each of these applicants is likely to achieve a level of safety equal to that existing without the exemption. Therefore, FMCSA has decided to renew each exemption for a two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each driver has received a renewed exemption.
As of November 6, 2015, the following four drivers has satisfied the renewal conditions for obtaining an exemption from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from driving CMVs in interstate commerce (78 FR 67449): Christopher Bird (OH); Edward Nissenbaum (PA); Stephen Stawinsky (PA); and George Webb (MA). The drivers were included in FMCSA-2013-0107. The exemptions were effective on November 6, 2015, and will expire on November 6, 2017.
The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded 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(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the four exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the Epilepsy and Seizure Disorders requirement in 49 CFR 391.41 (b)(8). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Transit Administration, DOT.
Notice of intent to transfer Federally assisted land or facility.
Section 5334(h) of the Federal Transit Laws, as codified, 49 U.S.C. 5301,
Interested parties should notify the Regional Office by writing to Marisol R. Simón, Regional Administrator, Federal Transit Administration, 200 West Adams, Suite 320, Chicago, IL 60606.
Kathryn Loster, Regional Counsel, at 312-353-3869.
49 U.S.C. Section 5334(h) provides guidance on the transfer of assets no longer needed. Specifically, if a recipient of FTA assistance decides an asset acquired at least in part with federal assistance is no longer needed for the purpose for which it was acquired, the Secretary of Transportation may authorize the recipient to transfer the asset to a local governmental authority to be used for a public purpose with no further obligation to the Government. 49 U.S.C. Section 5334(h)(l).
The Secretary may authorize a transfer for a public purpose other than public transportation only if the Secretary decides:
(A) The asset will remain in public use for at least 5 years after the date the asset is transferred;
(B) There is no purpose eligible for assistance under this chapter for which the asset should be used;
(C) The overall benefit of allowing the transfer is greater than the interest of the Government in liquidation and return of the financial interest of the Government in the asset, after considering fair market value and other factors; and
(D) Through an appropriate screening or survey process, that there is no interest in acquiring the asset for Government use if the asset is a facility or land.
This document implements the requirements of 49 U.S.C. Section 5334(h)(l)(D). Accordingly, FTA hereby provides notice of the availability of the Facility further described below. Any Federal agency interested in acquiring the affected facility should promptly notify the FTA.
If no Federal agency is interested in acquiring the existing Facility, FTA will make certain that the other requirements specified in 49 U.S.C. Section 5334(h)(1)(A) through (C) are met before permitting the asset to be transferred.
The facility is located at 308 Miami Street, Urbana, Ohio and consists of approximately a 14,850 square foot, one-story, concrete block, 12-bay transit garage building. The building was built in 1994 being approximately and has poured concrete footers and concrete slab floor. Other site improvements consist of a concrete apron on approximately 3,262 SF which has approximately 8 lined diagonal spaces of parking and 145 lineal feet of guard rail along the rear of the building.
If no Federal agency is interested in acquiring the existing Facility, FTA will make certain that the other requirements specified in 49 U.S.C. Section 5334(h)(1)(A) through (C) are met before permitting the asset to be transferred.
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Notice of cancellation of pilot program.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is cancelling a pilot program in which importers, U.S. Customs and Border Protection (CBP), and TTB tested, as part of the International Trade Data System (ITDS) project, the electronic collection of import-related data required by TTB and the transfer of that data to TTB. TTB has amended its regulations to permanently provide importers with the option to file import-related data electronically along with the filing of the entry or entry summary with CBP, making the pilot program no longer necessary.
The cancellation of the pilot program is effective December 31, 2016.
John Kyranos, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; telephone (202) 453-1039, extension 001; or email
For technical questions related to the Automated Commercial Environment (ACE) or Automated Broker Interface (ABI) transmissions, contact Steven Zaccaro at
In Notice No. 156, a
Notice No. 156 also announced the availability of, and requested comment on, a draft of the ACE Filing Instructions for TTB-Regulated Commodities (Filing Instructions), which contains instructions for proper electronic filing of import data for TTB-regulated commodities. TTB requested comment on the draft Filing Instructions for 60 days ending October 6, 2015. TTB received no written comments by that date. However, TTB's experience administering the pilot program led us to make several changes to the Filing Instructions.
In Industry Circular 2015-01, issued on October 21, 2015, TTB described how importers participating in the pilot program would submit specific information through ACE, either as an approved alternative to procedures prescribed in the TTB regulations or as a means to fulfill or demonstrate compliance with regulatory requirements. At the time, most TTB regulations that required the submission of information to CBP at importation required importers to submit paper documents or paper copies of those documents to CBP. Industry Circular 2015-01 also provided specific information about how to apply to participate in the pilot program.
In T.D. TTB-145, a final rule published in the
For this reason, this document announces the cancellation of the pilot program and Industry Circular 2015-01, effective December 31, 2016. On that date, importers who have been participating in the pilot program must follow TTB's regulations with regard to submitting data through ACE for importation of TTB-regulated commodities. Importers who have not been participating in the pilot program also must follow TTB's amended regulations to submit required information on paper or electronically.
In addition to the changes TTB made to the Filing Instructions due to the experience gained through the pilot program, TTB has also updated the Filing Instructions to reflect the regulatory changes made in T.D. TTB-145. The latest version of the Filing Instructions can be found on
TTB notes that transmissions to ACE must be through a CBP-approved electronic data interchange system. For more information on submission of import-related information and forms through ACE, please see CBP's home page on use of ACE at
For more general information on TTB's implementation of ITDS, see
Andrew Malone of the Regulations and Rulings Division drafted this notice.
The U.S. 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). Currently, the Community Development Financial Institutions Fund (CDFI Fund), U.S. Department of the Treasury, is soliciting comments concerning the New Markets Tax Credit Program (NMTC Program) Allocation Application.
Written comments must be received on or before March 10, 2017 to be assured of consideration.
Submit your comments via email to Robert Ibanez, NMTC Program Manager, CDFI Fund, at
Robert Ibanez, NMTC Program Manager, CDFI Fund, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220. The NMTC Allocation Application may be obtained from the CDFI Fund's Web site at
The tax credit provided to the investor totals 39 percent of the amount of the investment and is claimed over a seven-year period. In each of the first three years, the investor receives a credit equal to five percent of the total amount paid for the stock or capital interest at the time of purchase. For the final four years, the value of the credit is six percent annually. Investors may not redeem their investments in CDEs prior to the conclusion of the seven-year period without forfeiting any credit amounts they have received.
The CDFI Fund is responsible for certifying organizations as CDEs, and administering the competitive allocation of tax credit authority to CDEs, which it does through annual allocation rounds. As part of the award selection process, CDEs are required to prepare and submit an Allocation Application, which consists of five key sections: Business Strategy; Community Outcomes; Organization Capacity; Capitalization Strategy; and Previous Allocations and Awards. This request for public comment seeks to gather information on the NMTC Allocation Application.
26 U.S.C. 45D; 26 CFR 1. 45D-1.
Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice and request for comment.
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995, the OCC, the Board, and the FDIC (the “agencies”) 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. On August 15, 2016, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), requested public comment for 60 days on a proposal for a new Consolidated Reports of Condition and Income for Eligible Small Institutions (FFIEC 051). The proposed FFIEC 051 is a streamlined version of the existing Consolidated Reports of Condition and Income for a Bank with Domestic Offices Only (FFIEC 041), which was created by (1) removing certain existing schedules and data items and replacing them with a limited number of data items in a new supplemental schedule, (2) eliminating certain other existing data items, and (3) reducing the reporting frequency of certain data items. The FFIEC 051 generally would be available to institutions with domestic offices only and assets of less than $1 billion, which currently file the FFIEC 041. Of the nearly 6,000 insured depository institutions, approximately 5,200 would be eligible to file the proposed FFIEC 051. When compared to the existing FFIEC 041, the proposed FFIEC 051 shows a reduction in the number of pages from 85 to 61. This decrease is the result of the removal of approximately 950 or about 40 percent of the nearly 2,400 data items in the FFIEC 041. Of the data items remaining from the FFIEC 041, the agencies have reduced the reporting frequency for approximately 100 data items in the proposed FFIEC 051. In addition, the FFIEC and the agencies requested public comment on proposed revisions to the FFIEC 041 and the Consolidated Reports of Condition and Income for a Bank with Domestic and Foreign Offices (FFIEC 031), which are currently approved collections of information. The Consolidated Reports of Condition and Income are commonly referred to as the Call Report.
The comment period for the August 2016 notice ended on October 14, 2016. As described in the
The agencies also are giving notice that they have sent the collection to OMB for review.
Comments must be submitted on or before February 8, 2017.
Interested parties are invited to submit written comments to any or all of the agencies. All comments, which should refer to the OMB control number(s), will be shared among the agencies.
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.
•
•
•
•
•
All public comments are available from the Board's Web site at
•
•
•
•
•
Additionally, commenters may send a copy of their comments to the OMB desk officer for the agencies by mail to the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503; by fax to (202) 395-6974; or by email to
For further information about the proposed revisions to the Call Report described in this notice, please contact any of the agency staff whose names follow. In addition, copies of the FFIEC 031 and FFIEC 041 Call Report forms and the proposed FFIEC 051 report form can be obtained at the FFIEC's Web site (
The agencies are proposing to create a new Call Report for eligible small institutions, the foundation for which is a currently approved collection of information for each agency. In addition, the agencies are proposing revisions to data items reported on the FFIEC 041 and FFIEC 031 Call Reports.
The estimated average burden hours collectively reflect the estimates for the FFIEC 031, the FFIEC 041, and the proposed FFIEC 051 reports. When the estimates are calculated by type of report across the agencies, the estimated average burden hours per quarter are 128.05 (FFIEC 031), 74.88 (FFIEC 041) and 44.94 (FFIEC 051). Furthermore, the estimated burden per response for the quarterly filings of the Call Report is an average that varies by agency because of differences in the composition of the institutions under each agency's supervision (
The agencies received ten comments on the burden estimates. One commenter recommended including time to review instructions for the applicable form, even if data items in that form are not applicable to the institution. The agencies also received comments from institutions with estimates of the time it takes their institutions to prepare the current FFIEC 041 Call Report. The majority of these estimates ranged from 40-80 hours per quarter, with one response of 268 hours per quarter. Three commenters stated that preparing the Call Report costs approximately $1,000 annually for software. In response to the comments on methodology, the agencies have revised their calculation for their burden estimates. In addition to the estimated time for gathering and maintaining data in the required form and completing those Call Report data items for which an institution has a reportable (nonzero) amount, which have been included in the agencies' burden estimates, the revised methodology incorporates time for reviewing instructions for all items, even if the institution determines it does not have a reportable amount. The agencies have also added estimated burden hours for verifying the accuracy of amounts reported in the Call Report. As stated earlier, the agencies are also separating the estimated burden by type of report, to highlight the estimated burden reduction between the FFIEC 041 and FFIEC 051 reports. While the agencies' burden estimates are on the lower end of the ranges provided by commenters, these estimates are based on average times to complete each data item factoring in the varying levels of automation versus manual interventions
One commenter estimated that the incremental burden associated with the one-time conversion from the FFIEC 041 to the FFIEC 051 would be approximately 160 hours, primarily for training, and approximately $350 for software. Due to the various factors that could affect the time and cost of switching to the FFIEC 051, including training needs, the type of existing systems and automation at an institution, and any cost from software vendors to enable an institution to file the new form, the agencies have not provided an estimate of this conversion burden. The agencies reiterate that adopting the FFIEC 051 form is optional, and each institution should weigh the estimated time savings from using that form with the one-time burden to switch to the FFIEC 051 from the FFIEC 041.
Institutions submit Call Report data to the agencies each quarter for the agencies' use in monitoring the condition, performance, and risk profile of individual institutions and the industry as a whole. Call Report data serve a regulatory or public policy purpose by assisting the agencies in fulfilling their missions of ensuring the safety and soundness of financial institutions and the financial system and protecting consumer financial rights. The data also serve public policy purposes associated with agency-specific missions affecting national and state-chartered institutions,
These information collections are mandatory: 12 U.S.C. 161 (for national banks), 12 U.S.C. 324 (for state member banks), 12 U.S.C. 1817 (for insured state nonmember commercial and savings banks), and 12 U.S.C. 1464 (for federal and state savings associations). At present, except for selected data items and text, these information collections are not given confidential treatment.
On August 15, 2016, the agencies requested comment for 60 days on a proposal for a new Consolidated Reports of Condition and Income for Eligible Small Institutions (FFIEC 051) along with various proposed revisions to the existing Call Report requirements (FFIEC 031 and FFIEC 041).
The comment period for the August 2016 notice ended on October 14, 2016. General comments on the notice are summarized in Section II. In Section III, the agencies provide more details on the comments received on the FFIEC 051 and any changes the agencies are making in response to those comments. In Section IV, the agencies address comments on the proposed changes to the FFIEC 031 and FFIEC 041 Call Reports. In Section V, the agencies provide information about additional specific suggestions received from commenters to improve all versions of the Call Report and any changes the agencies are making in response to those comments. With OMB approval, the effective date for the initial implementation of the FFIEC 051 and the revisions to the existing FFIEC 041 and FFIEC 031 would be March 31, 2017.
The agencies collectively received comments on the proposal from approximately 1,100 entities, including individuals, banking organizations, bankers' associations, and a government entity.
Commenters expressed mixed opinions on the proposed FFIEC 051. Approximately 25 commenters representing banking organizations, bankers' associations, and a government entity supported the effort put forth by the agencies. One bankers' association stated that the initial proposal was “a positive step in an ongoing, iterative process” that shows a “modest but material burden relief to institutions eligible to file the [FFIEC 051] report.” One institution stated that the proposed FFIEC 051 would assist small banks by reducing preparation time and minimizing confusion by removing schedules related to activities in which the bank does not engage. Another commenter stated that this proposal was a good start by removing items that have no relationship with the reporting institution. Another commenter agreed with the proposal to shorten the length of the Call Report and the instructions, which would reduce the time spent reviewing updates to determine items that may or may not be applicable to the bank. One commenter stated the reduction and the removal of non-relevant data items for noncomplex institutions saves both time and money. The government entity stated it uses certain data items in the Call Report in preparing national economic reports, and encouraged the agencies to continue collecting those items.
On the other hand, the majority of commenters from banking organizations and bankers' associations responded that there was no perceived impact by adopting the FFIEC 051. Many of the banking organizations stated that the data items proposed to be removed were not reported currently by their institutions; therefore, the changes would not impact their burden in preparing the Call Report. Three of the bankers' associations stated that the
The agencies recognize that not all community institutions eligible to file the FFIEC 051 will see an immediate and large reduction in burden by switching to that form. Some of the items that were removed from the FFIEC 041 to create the FFIEC 051 only needed to be reported by institutions with assets of $1 billion or more. Other items not included in the FFIEC 051 applied to institutions of all sizes, but may not have applied to every community institution, due to the nature of each institution's activities. Approximately 100 data items would be collected at a reduced frequency in the FFIEC 051. For example, in creating the FFIEC 051, the agencies have removed from the FFIEC 041 the data items on Schedule RC-L, Derivatives and Off-Balance Sheet Items, in which the more than 700 eligible institutions that have derivative contracts have been required to report the gross positive and negative fair values of these contracts. The agencies also have reduced from quarterly to semiannually the reporting frequency in the FFIEC 051 of Schedule RC-C, Part II, Loans to Small Businesses and Small Farms, which is applicable to the approximately 5,200 institutions eligible to file the FFIEC 051,
A majority of the commenters that did not favor the proposed FFIEC 051 suggested the agencies adopt a “short-form” Call Report to be filed in the first and third quarters. The short-form Call Report recommended by commenters would consist only of an institution's balance sheet, income statement, and statement of changes in equity capital. The institution would file a full Call Report including all supporting schedules in the second and fourth quarters.
The agencies recognize that the information requested in the Call Report is often more granular than information presented in standard financial statements, including the notes to the financial statements, and can require refining or subdividing the information contained in accounts reported in an institution's general ledger system or core processing systems. This process may be burdensome, particularly when account balances have not materially changed from the prior quarter. However, one element that sets banking apart from other industries is the regulatory framework, particularly the provision of Federal deposit insurance and the important role of financial intermediation, which requires safety and soundness supervision and examination. A key component of bank supervision is reviewing granular financial data about an institution's activities to identify changes in those activities and in the institution's condition, performance, and risk profile from quarter to quarter that suggest areas for further investigation by the institution's supervisory agency. For example, granular data on loan categories, past due and nonaccrual loans, and loan charge-offs and recoveries
In addition to supporting the identification of higher-risk situations, enabling timely corrective action for such cases, and justifying the extended examination cycle, the quarterly reporting of the more granular Call Report items also aids in the identification of low-risk areas prior to on-site examinations, allowing the agencies to improve the allocation of their supervisory resources and increase the efficiency of supervisory assessments, which reduces the scope of examinations in these areas, thereby reducing regulatory burden. While the quarterly monitoring process enabled by the more granular Call Report items historically has focused on raising “red flags,” similar emphasis has also been placed on the identification of low-risk situations. A six-month reporting cycle for the more granular Call Report items would hamper the agencies' ability to form timely risk assessments and so could stymie efforts to improve the focus of on-site examinations for low-risk institutions. In this manner, an effort to reduce regulatory burden by lengthening the reporting cycle for the more granular Call Report items could limit the agencies' opportunities to reduce burden for on-site examinations.
In addition to safety and soundness data, other data items are required quarterly due to various statutes or regulations. Leverage ratios based on average quarterly assets and risk-based capital ratios are necessary under the prompt corrective action framework established under 12 U.S.C. 1831o.
Further, the public availability of most quarterly Call Report information from institutions that are not publicly held is desired by their depositors (particularly those whose deposits are not fully insured), other creditors, investors, and other institutions. An institution's depositors and other creditors may use quarterly Call Report information to perform their own assessments of the condition of the institution. Existing and potential investors may evaluate Call Report data to assess an institution's condition and future prospects; the absence of quarterly information could impair the institution's ability to raise capital or could limit the liquidity of the institution's shares for existing stockholders. Other institutions that engage in transactions with the reporting institution may utilize Call Report information to assess the condition of their counterparties to these transactions. In addition, some institutions use peer analysis to benchmark against local competitors using data obtained from their Call Reports directly, or by using third-party vendors who often leverage information from the agencies' repository of Call Report data. For example, as part of their financial control structures, some institutions analyze their allowance for loan and lease losses (ALLL) by comparing their delinquency ratios and their ratios of ALLL to loans and leases to peer group ranges and averages.
While the agencies understand the commenters' desire for a “short-form” Call Report, for the reasons stated above, the agencies did not adopt this suggestion. In addition to the basic financial statements, the most streamlined quarterly report possible must also include quarterly data required by statute or regulation, along with quarterly data necessary for adequate supervision by the agencies. However, as part of the continuing burden reduction efforts, the agencies will continue to review the quarterly data collected in the proposed FFIEC 051 and existing FFIEC 031 and FFIEC 041 reports that go beyond the statutory or regulatory requirements or essential supervisory needs. For example, as described in Section III, the agencies are revising Schedule RC-C, Part II, in the FFIEC 051 to reduce its reporting frequency from quarterly to semiannual for all institutions that file the FFIEC 051.
The agencies are still engaged in the statutorily mandated review of the existing Call Report data items (Full Review).
The agencies received comments about the burden reduction initiative and the Full Review. On the timing of future revisions, one commenter stated that it would not matter, while another commenter wanted the changes implemented as soon as possible. Three commenters recommended adopting all of the changes at once. These commenters stated it is more burdensome to deal with more frequent changes to the Call Report, even if those changes would reduce burden. Six commenters sought a better understanding for the agencies' use of the Call Report data items submitted by institutions. Two bankers' associations requested a published report of how the data are used either by individual line item or by schedule.
The agencies are cognizant of the burden caused by frequent changes to the Call Report, but also must consider the ongoing burden imposed until the completion of the review by collecting data items the agencies have agreed are no longer necessary. In an attempt to balance those concerns, the agencies plan to propose changes related to the user surveys in two future notices. The agencies already included the results from the first three user surveys in the August 2016 notice. The next notice would include changes from a second set of user surveys and is expected to be issued in early 2017. The last notice would include any changes from a third and final set of user surveys and is expected to be issued in late 2017. The proposed effective date for changes in both future notices would be March 31, 2018.
As described earlier in this section and in response to specific comments in Sections III and V, a significant amount of the data collected in the Call Report is used for safety and soundness purposes, especially for quarterly off-site monitoring and reviews between on-site examinations. Additional data items are required by statute or regulation. A lesser number of data items are used for consumer financial protection purposes or for specific agency missions, such as deposit insurance and monetary policy. To provide additional detail on the uses of Call Report schedules and data elements, the agencies are including, in Appendix A, a summary of the FFIEC member entities' uses of specific schedules and data items from the first three user surveys conducted in the Full Review. The agencies plan to publish similar summaries when proposing additional changes based on the results of the second two sets of Full Review surveys in future notices.
Finally, while it may not directly reduce burden at this time, as described in the August 2016 notice, the agencies will apply a set of guiding principles in evaluating potential future additions and revisions to the Call Report. Those principles are: (1) The data items serve a long-term regulatory or public policy purpose by assisting the FFIEC member entities in fulfilling their missions of ensuring the safety and soundness of financial institutions and the financial system and the protection of consumer financial rights, as well as agency-specific missions affecting national and state-chartered institutions; (2) the data items to be collected maximize practical utility and minimize, to the extent practicable and appropriate, burden on financial institutions; and (3) equivalent data items are not readily available through other means. The agencies intend to apply these principles with rigor for items proposed to be added to the Call Reports, with the goal of minimizing future burden increases.
The agencies proposed to make the FFIEC 051 available as an option to eligible small institutions. For purposes of the FFIEC 051 Call Report, the agencies proposed to define “eligible small institutions” as institutions with total assets less than $1 billion and domestic offices only. Total assets for eligibility would be measured as of June 30 each year to determine the institution's eligibility to file the FFIEC 051 beginning in March of the following year. In addition, for an institution otherwise eligible to file the FFIEC 051, the institution's primary federal regulatory agency, jointly with the state chartering authority, if applicable, may require the institution to file the FFIEC 041 instead based on supervisory needs. In making this determination, the appropriate agency will consider criteria including, but not limited to, whether the eligible institution is significantly engaged in complex, specialized, or other higher risk activities.
The agencies received numerous comments on eligibility for the FFIEC 051. Eight commenters supported expanding the threshold. One commenter suggested using the FDIC's definition of a “community bank” (from the FDIC's Community Banking Study), which is based on deposit and lending activity and certain other criteria rather than solely asset size, while another commenter suggested expanding the FFIEC 051 to all institutions that do not engage in complex activities. Another commenter suggested tying the asset threshold to the definition of “small bank” under the Community Reinvestment Act (currently, $1.216 billion and indexed for inflation). Two commenters recommended using a $10 billion asset threshold, with one of those commenters suggesting that the asset threshold be automatically adjusted for inflation in the future.
At this time, the agencies are retaining their proposed $1 billion asset-size threshold to be eligible for the FFIEC 051. This threshold is consistent with one of the eligibility criteria established by Congress for community institutions to be eligible for an 18-month examination cycle rather than the standard 12-month cycle.
The agencies also asked whether filing the FFIEC 051 by eligible institutions should be mandatory or optional. Six commenters supported allowing the FFIEC 051 to be optional. The agencies agree with the commenters and will continue to offer it as an option to eligible small institutions that would otherwise need to file the FFIEC 041. If an institution is eligible for and chooses to adopt the FFIEC 051, the agencies expect the institution will continue filing that version of the report going forward as long as it remains eligible.
The agencies received three comments on the proposed reservation of authority for filing the FFIEC 051. Two commenters opposed this reservation of authority, stating that the language was too broad and would allow too much discretion to examiners to arbitrarily make institutions change their version of the Call Report. One of these commenters suggested a process where any determination by an examiner that an institution must revert to the FFIEC 041 should be automatically appealable to the agency's Ombudsman. The other commenter recommended more clearly defining and limiting the scenarios in which the agencies would consider making an institution revert to filing the FFIEC 041. The agencies acknowledge the criteria to use the reservation of authority listed in the notice could be interpreted more broadly than the agencies intended. The agencies would consider using the reservation of authority if an institution has a large amount of activity in one or more complex activities that would be reported on one of the schedules or items proposed to be eliminated in the FFIEC 051. These schedules include Schedules RC-D (trading activity), RC-L (off-balance sheet derivatives), RC-P (mortgage banking), RC-Q (fair value measurements), RC-S (servicing, securitization, and asset sale activities), and RC-V (variable interest entities). The agencies do not intend to use this reservation of authority widely, or to apply it to institutions that engage only in activities that are fully reported on the FFIEC 051. Furthermore, the exercise of the reservation of authority would require a decision by a member of the appropriate agency's senior management and would not be at the discretion of examination staff.
The agencies proposed implementing the FFIEC 051 beginning March 31, 2017, for all eligible small institutions. Nine commenters indicated the lead time was sufficient because most of the changes between the FFIEC 041 and FFIEC 051 did not affect their institutions. Three commenters suggested delaying the implementation date. One commenter suggested setting
The agencies believe that it is important to offer this new report form as an option as early as feasibly possible, to reduce burden for those eligible institutions that are able to switch to the FFIEC 051 beginning with the March 31, 2017, report date. The conversion to the FFIEC 051 is optional, and initial eligibility would be determined by an institution's asset size as of June 30, 2016. For an institution that qualifies to use the FFIEC 051 and desires to use that form, but is unable to do so for the March 31, 2017, report date, the institution may begin reporting on the FFIEC 051 as of the June 30, 2017, report date or in a subsequent quarter of 2017. Alternatively, the institution could wait until March 31, 2018, to begin reporting on the FFIEC 051, assuming it continues to meet the eligibility criteria.
The agencies received approximately 30 comment letters that highlighted the burden required to prepare Schedule RC-R, Regulatory Capital. The agencies received similar comments during their banker outreach efforts, as well as in comment letters submitted under a review of agency regulations required by the Economic Growth and Regulatory Paperwork Reduction Act (EGRPRA).
An institution must calculate its capital ratios quarterly pursuant to the prompt corrective action provisions of statute and the agencies' regulations. The agencies revised Schedule RC-R in March 2015 to include the data items that would be necessary for an institution to calculate its regulatory capital ratios under the agencies' revised capital rules. The greater detail of those rules requires a degree of categorization, recordkeeping, and reporting that is greater than under the previously applicable capital rules. While many of the data fields on Schedule RC-R may not be applicable to community institutions not engaged in complex activities, some community institutions do engage in activities that would need to be reported in those fields to perform the correct calculation under the capital rules. The agencies are developing responses to the concerns about the burden of the regulatory capital rules raised during the EGRPRA comment process and the associated reporting requirements on Schedule RC-R. If the agencies propose modifications to the regulatory capital rules, the agencies would also propose modifications to the associated reporting requirements on Schedule RC-R.
Twelve commenters emphasized Schedule RC-C as a significant contributor to the reporting burden for smaller institutions. Five banking organizations specifically highlighted Schedule RC-C, Part II, Loans to Small Businesses and Small Farms, as particularly burdensome and suggested eliminating the schedule or reducing the frequency of the data collected. During the agencies' banker outreach efforts, community institutions similarly highlighted the burden of Schedule RC-C, and particularly Part II of the schedule.
In developing the proposed FFIEC 051, the agencies removed 38 items from Schedule RC-C, Part I, that are currently reported in the FFIEC 041 and were identified as having lesser utility for institutions eligible to file the new report.
The remaining loan and lease data in Schedule RC-C, Part I, are critical inputs to assessing the safety and soundness of individual institutions through analysis of the institutions' credit risk, interest rate risk, and liquidity risk, including the identification and analysis of lending concentrations. The granularity of the loan categories is also essential for peer group analysis and industry analysis. Loan and lease information is also an important component of agency statistical models that assess the risk profile of an institution. In addition, many community institutions use the Call Report loan categories when they measure the estimated credit losses that have been incurred on groups of loans with similar risk characteristics in their calculations of the ALLL each quarter under U.S. generally accepted accounting principles (GAAP).
Finally, loan and lease information assists the agencies in fulfilling their specific missions. The Board, as part of its monetary policy mission, relies on the loan data in Schedule RC-C, Part I, to provide information on credit availability and lending conditions not available elsewhere. Loan and lease detail at all sizes of institutions is necessary for monitoring the overall health of the economy. Reducing loan detail or data frequency for smaller institutions would limit the ability to monitor credit availability and lending conditions widely, including in response to any changes in monetary policy. At times, loan availability and lending conditions may be different at smaller institutions than at larger institutions. Furthermore, Schedule RC-C, Part I, data are used to benchmark weekly loan data collected by the Board from a sample of both small and large institutions; the weekly data are used to estimate weekly loan aggregates for the banking sector as a whole to provide more timely input for the purposes of monitoring the macroeconomy.
The FDIC's deposit insurance assessment system for “established small banks” relies on information reported by individual institutions for the Schedule RC-C, Part I, standardized loan categories in the determination of the loan mix index in the financial ratios method, which is used to determine assessment rates for such institutions.
The data collected in Schedule RC-C, Part II, is based on a statutory requirement to collect data on small business and small farm loans on an annual basis and began in 1993.
The agencies received five comments stating that Schedule RC-C, Part II, was particularly burdensome for their institutions due to the level of manual
Two commenters from multibank holding companies stated that the FFIEC 051 does not provide any relief for their institutions, because many of the items removed from the FFIEC 041 must still be reported on the holding company's FR Y-9C
Four commenters stated that the agencies should reduce duplication between the Call Report and other regulatory reports collected by the agencies. Commenters noted perceived duplication of one or more data items with the following reports: FR 2900,
The agencies proposed revisions to some of the schedules in the FFIEC 041 and FFIEC 031 Call Reports in response to the findings of the first three user surveys at FFIEC member entities conducted under the Full Review. Specifically, the following schedules in the FFIEC 041 and FFIEC 031 versions of the Call Report would have data items removed or subject to new or higher reporting thresholds as a result of these surveys (see Appendices C and D for a complete listing of the affected data items based on the September 30, 2016, FFIEC 031 and FFIEC 041 Call Reports, respectively):
The agencies did not receive any comments on the specific changes to the FFIEC 041 and FFIEC 031 in the proposal, and plan to implement those changes as proposed.
Twelve commenters recommended additional specific changes for the agencies to consider on various schedules of the Call Report. Many of these commenters did not direct their comments at a specific version of the Call Report, so the agencies considered these comments to improve both the existing FFIEC 031 and FFIEC 041 Call Reports and proposed FFIEC 051.
One commenter suggested the agencies revise Schedule RI-C (Disaggregated Data on the Allowance for Loan and Lease Losses) to align with the loan categories reported on Schedule RC-C, Part I. The agencies did not adopt this suggestion. Aligning the categories would require collecting additional granular data on Schedule RI-C, adding approximately 20 categories and 60 total items. The agencies proposed collecting disaggregated ALLL data for key Schedule RC-C, Part I, loan categories when they proposed to add Schedule RI-C to the Call Report in 2011. However, commenters on that proposal questioned the reporting of ALLL data for these key Call Report loan categories. They recommended reducing the number of loan categories and using broader portfolio segments that would better align with their loan loss allowance methodologies, which the agencies did in the final implementation of Schedule RI-C in 2013. The agencies do not believe that changing the schedule to require additional granularity of data is necessary for the supervision of the institutions to which this schedule is currently applicable. In this regard, the agencies do not collect Schedule RI-C from institutions with assets less than $1 billion and it would not be included in the FFIEC 051.
Three commenters suggested revisions to Schedule RI-E (Explanations). One commenter suggested adjusting the criteria to separately disclose individual components of other noninterest income and other noninterest expense. The agencies' current criteria require separate disclosure if a component within one of those income statement categories is greater than $100,000 and 3 percent of the total balance of that category.
One commenter suggested the agencies review the intangible asset breakout on Schedule RC, item 10, and Schedule RC-M, item 2, and suggested combining goodwill and other intangible assets on Schedule RC. The agencies need additional time to consider this request, and will consider it within the next set of proposed Call Report revisions.
Six commenters stated that Schedule RC-E (Deposit Liabilities) and RC-O (Other Data for Deposit Insurance and FICO Assessments) were particularly burdensome and suggested simplifying or consolidating the deposit data on these schedules. Some commenters specifically noted the breakout of deposit information by source, use, and balance as time-consuming, especially for Memorandum items 1 through 4 on Schedule RC-E. Two commenters noted that the FDIC's deposit insurance assessments currently are calculated based on average total assets and average tangible equity, so the deposit data is not necessary for the vast majority of banks.
Schedule RC-E categorizes deposits based on source (brokered or non-brokered) and type of account (time deposit, demand deposit, savings deposit), and by deposit size within certain of those categories. The reporting of deposit data for some of these categories is required by statute.
One commenter stated that the data on Schedules RC-F (Other Assets) and RC-G (Other Liabilities) did not change significantly for community banks from quarter to quarter and should be reported annually instead. The agencies did propose reducing the frequency by which institutions must report the significant components of all other assets and all other liabilities on these two schedules to semiannual in the FFIEC 051 in the August 2016 notice. The agencies will be considering both the data items and frequency of reporting for these two schedules for all versions of the Call Report in the Full Review, and will consider the commenter's suggestions in that process.
One commenter stated that Schedule RC-K (Quarterly Averages) was particularly burdensome, as the bank's general ledger provides point-in-time
Three commenters stated that Schedule RC-L (Derivatives and Off-Balance Sheet Items) was particularly difficult to complete, as some items defined in that schedule do not align with definitions for similar items in Schedule RC-R, particularly for over-the-counter (OTC) derivatives. The commenters also noted certain items included in Schedule RC-L, such as “commitments to make a commitment,” are difficult to define and track. One commenter suggested lining up the loan commitment categories on Schedule RC-L with the loan categories on Schedule RC-C, Part I. The agencies are investigating alternatives to the current definitions in Schedule RC-L, and whether they can be more closely aligned with definitions used in the agencies' regulatory capital rules, which is the basis for Schedule RC-R, for inclusion in a future notice. The agencies do not plan to align the loan categories between Schedules RC-L and RC-C, Part I. The loan categories on Schedule RC-C, Part I, are much more granular than in Schedule RC-L. Reducing the granularity of categories on Schedule RC-C, Part I, would impair the agencies' ability to use that data for safety and soundness monitoring, while increasing the granularity on Schedule RC-L would impose additional burden to collect items the agencies do not believe are necessary.
One commenter recommended reducing the frequency of certain data items in Schedule RC-M (Memoranda) to annual. Specifically, items 7 through 9, 11, and 12 do not change from quarter to quarter at the commenter's bank. Item 7 collects data on assets under management in proprietary mutual funds and annuities. Item 8 collects information on an institution's internet Web site addresses and trade names. Item 9 asks about internet Web site transactional capability. Items 11 and 12 collect information on certain bank powers. The agencies proposed in the August 2016 notice to reduce the frequency for items 7, 9, 11, and 12 from quarterly to annual. The agencies will continue collecting item 8 on a quarterly basis to provide more accurate, timely, and complete information to the FDIC, depositors, and the general public on the insured status of entities identifying themselves as FDIC-insured depository institutions than would occur through annual reporting.
One commenter requested that the agencies add control totals to Schedule RC-N for past due and nonaccrual loans, leases, and other assets to allow easier validation of the accuracy of the reported data to the institution's own records. The agencies also noted during their on-site banker outreach efforts that some institutions appended their own control totals on this form. The agencies agree with the suggestion, and plan to revise Schedule RC-N on the FFIEC 031, 041, and 051. For the same reason, the agencies will also revise Schedule RC-C, Part I, and Schedule RC-N to add control totals for troubled debt restructurings in Memorandum item 1 of each schedule. While these changes would add additional data items to these two schedules, the data items would be simple mathematical totals of existing data items and would not require the institution to obtain any additional data.
Five commenters requested that the agencies improve the clarity and usefulness of the Call Report instructions and highlight any changes made to the instructions each quarter. One commenter also recommended improving internal consistency within the Call Report. The agencies agree that the current Call Report instructions could be made more useful, and will start by incorporating hyperlinks to cited documents in the instructions for the FFIEC 051.
Public comment is requested on all aspects of this joint notice. Comment is invited on:
(a) Whether the proposed revisions to the collections of information that are the subject of this notice are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;
(b) The accuracy of the agencies' estimates of the burden of the information collections as they are proposed to be revised, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections 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.
Comments submitted in response to this joint notice will be shared among the agencies. All comments will become a matter of public record.
Schedule RC collects high-level information on various balance sheet categories, including assets, liabilities, and equity accounts every quarter. These categories are aligned with the categories typically reported on a basic balance sheet prepared under U.S. generally accepted accounting principles (GAAP).
Schedule RI collects information on various income and expense categories every quarter. In general, these categories are aligned with the categories typically reported on a basic income statement and in the notes to the financial statements prepared under U.S. GAAP.
The Memorandum items collect an assortment of information on items related to the income statement. Some items provide additional detail for certain categories of income or expense, while other items are not directly tied to earnings measures. Memorandum items on tax-exempt income and nondeductible interest expense are used to convert components of reported earnings to a tax-equivalent basis to improve the comparability of income statement information across institutions for purposes
Schedule RC-C, Part I, requests information on loan and lease financing activities, segmented into detailed loan categories. The memoranda items request additional information, including scheduled maturities and repricing dates for certain loan types and fair value estimates.
Schedule RC-C details loan volumes, segmentations, and structures, all of which facilitate the assessment of an institution's inherent risk, performance risk, and structure risk in its primary earning assets and its primary source of credit risk. Schedule RC-C is often reviewed in conjunction with Schedules RI, RI-B, and RC-N. This granular data enables examiners to analyze and assess the institution's loan portfolio diversification, credit quality, concentration exposure, and overall risk profile. These schedules are critical to the credit quality analysis performed by examiners to identify early warning signs of deterioration in the financial condition of institutions. Asset quality ratios from the Uniform Bank Performance Report (UBPR) that are calculated using data from Schedule RC-C and related loan schedules are also helpful to examiners in determining how an institution is performing relative to its peers and relative to its own risk profile based on its loan portfolio composition. In addition, these ratios are useful to examiners in assessing the institution's credit risk management practices relative to its peers. Elevated charge-offs or increases in nonaccrual loans in relation to loan balances provide information to users of the data on potential weak underwriting in prior periods, deterioration of asset quality, or the indication that the institution is recovering from a period of stress. If there are concerns about the allowance for loan and lease losses (ALLL) methodology or the appropriateness of the ALLL level, then there is a focus on the provision expense relative to the charge-offs as well as to the growth and quality of certain portfolios, depending on the institution's risk characteristics. All of these inputs are essential in the review of the balance sheet, the liquidity of the institution, and the asset-liability management of the institution.
The data on Schedule RC-C are needed for on-site and off-site examination purposes and also are used in the systemic analysis of the banking system. Because the loan portfolio is the primary source of credit risk in institutions, the breakdown of the portfolio by loan type is essential in the review of asset quality. An understanding of an institution's lending activity is needed to ensure the safety and soundness of the financial institution by indicating whether the institution is increasing concentrations or incorporating a change to its lending strategy. The loan segmentation information is essential for planning and staffing examinations by considering each institution's lending activities. The information also allows the examination teams to determine if the lending volume constitutes a concentration of credit, which could require additional monitoring, measuring, and risk mitigation strategies by bank management. In addition, the loan detail is important for loan scoping and trend analysis of the entire portfolio, which are essential in determining an institution's risk profile. On a broader perspective, the loan segmentation allows regulatory staff to identify concentration risks across institutions.
Along with related data in Schedule RC-N, information about troubled debt restructurings in compliance with their modified terms can assist the assessment of management's ability to work out different categories of problem loans.
Maturity and repricing information on loans and leases, together with the maturity and repricing information collected in other schedules for other types of assets and liabilities, are needed to evaluate the liquidity and interest rate risk of the institution and to aid in evaluating the strategies institutions take to mitigate these risks. Liquidity and interest rate risk indicators that are calculated by agency models from an institution's Call Report data and exceed specified parameters or change significantly between examinations are red flags that call for timely examiner off-site review. The institution's risk profile in these areas is considered during pre-examination planning to determine the appropriate scoping and staffing for examinations.
In addition, Schedule RC-C and related loan schedules assisted the Consumer Financial Protection Bureau's (CFPB) efforts to develop required estimates for various Title XIV mortgage reform rulemakings under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203) (Dodd-Frank Act). Going forward, data items in these schedules are critical for continuous monitoring of the mortgage market. The CFPB uses these items to understand the intricacies of the mortgage market that are essential to assessing institutional participation in regulated consumer financial services markets and to assess regulatory impact associated with recent and proposed policies, as required by that agency's statutory mandate.
Finally, loan and lease information assists the agencies in fulfilling their specific missions. The Board, as part of its monetary policy mission, relies on institution-specific Call Report data to provide information on credit availability and lending conditions not available elsewhere. Loan and lease detail at all sizes of institutions is necessary for monitoring economic conditions.
Reducing loan detail or data frequency for smaller institutions would limit the ability to monitor credit availability and lending conditions widely, including changes in credit and lending related to changes in monetary policy. At times, loan availability and lending conditions may be different at smaller institutions than at larger institutions. Furthermore, Schedule RC-C, Part I, data are used to benchmark weekly loan data collected by the Board from a sample of both small and large institutions; the weekly data are used to estimate weekly loan aggregates for the banking sector as a whole to provide a more timely input for purposes of monitoring the macroeconomy.
The FDIC's deposit insurance assessment system for “established small banks” relies on information reported by individual institutions for the Schedule RC-C, Part I, standardized loan categories in the determination of the loan mix index in the financial ratios method, as recently amended, which is used to determine assessment rates for such institutions.
Schedule RC-C, Part II, requests data on loans to small businesses and small farms, including stratification by original loan amount.
Call Report small business and small farm lending data are an invaluable resource for understanding credit conditions facing these sectors of the economy. Quarterly collection of these data improves the Board's ability to monitor credit conditions facing small businesses and small farms and significantly contributes to its ability to develop policies intended to address any problems that arise in credit markets. The institution-level Call Report data provide information that cannot be obtained from other indicators of small business and small farm credit conditions. For example, during a period of credit contraction, the Call Report data can be used to identify which types of institutions are reducing the volume of their loans to small businesses and small farms. This is important information for the Board, as having detailed data on the characteristics of affected institutions is crucial to building a sufficiently informative picture of the strength of economic activity. Moreover, there is evidence that small business lending by small institutions does not correlate with lending by larger institutions.
Monetary policymaking benefits importantly from timely information on small business credit conditions and flows. To determine how best to adjust the federal funds rate over time, the Board must continuously assess the prospects for real economic activity and inflation in coming
Schedule RC-N requests data on past due and nonaccrual assets by detailed categories for loans and leases and, on a combined basis, for debt securities and other assets.
Data collected on Schedule RC-N is essential to the oversight function of the FFIEC member entities. The loan portfolio is the largest asset type and the primary source of credit risk at most financial institutions. Past due and nonaccrual loan information provides significant insights into the overall credit quality of a financial institution's loan portfolio and potential areas of credit quality concerns on which to focus for monitoring and assessing the credit risk management and overall safety and soundness of an institution. A high level of past due or nonaccrual loans often precedes adverse changes in an institution's earnings, liquidity, and capital adequacy. This information can also have an impact on consumer protection law compliance and agency rulemaking.
Information collected on Schedule RC-N is integral to both on-site and off-site review processes at the FFIEC member entities. Trends in past due and nonaccrual loans alert examiners to possible weaknesses in bank management's loan underwriting and credit administration practices. This information is a significant factor in assessing the portfolio's collectability and in estimating the appropriate level for an institution's ALLL, as well as the adequacy of its capital levels. The ability to compare results and trends across financial institutions is important to distinguish systemic issues from institution-specific concerns. Past due and nonaccrual loan information can serve as an indicator of areas of increasing credit risk within the loan portfolio. The segmentation of past due and nonaccrual information by loan category is necessary to pinpoint where the credit risk in an institution's loan portfolio exists. Comparing the past due level in different loan portfolios to other risk characteristics in that portfolio such as concentration, charge-offs, or growth can help to determine the overall level of risk to the safety and soundness of an institution. This data can also provide more insight on credit risks or weak underwriting practices associated with a specific loan category, which helps direct the scope of an exam.
Memorandum items in Schedule RC-N also provide important information about credit risk management, including the past due or nonaccrual status of troubled debt restructurings, which can assist the assessment of management's ability to work out different categories of problem loans. Data regarding delinquent derivative contracts provides important information for assessing a financial institution's asset quality, capital level, earnings, market risk, and operational risk.
Past due and nonaccrual information is also utilized in the assessment of compliance with consumer protection laws and regulations. Items reported on Schedule RC-N are used to inform rule writing and policy efforts, including the CFPB's Title XIV mortgage reform rulemakings under the Dodd-Frank Act. Past due information can identify potential areas of disparate treatment in relation to the Fair Housing Act (Pub. L. 90-284). Additionally, past due levels can highlight areas of potential unfair practices under the principles in section 1031 of the Dodd-Frank Act, which are similar to those under section 5 of the Federal Trade Commission Act (15 U.S.C. 45).
Schedule RI-B, Part I, collects information on charge-offs and recoveries on loans and leases, while Part II collects information on changes in the ALLL during the year-to-date reporting period in a manner consistent with the disclosure of the activity in the allowance required under U.S. GAAP.
The data items on Schedule RI-B provide information critical to the missions of the FFIEC member entities. Charge-off amounts, in conjunction with any associated recoveries, for the various loan categories are needed to assess the safety and soundness of the financial institution by indicating the credit quality of the loan portfolio and the potential credit risk of the institution. The data items are also used to assess the strength of the institution's credit administration practices, along with the institution's loan underwriting practices. The data items also support the agencies' rule writing and policy efforts.
Schedule RI-B data play an integral role in reviewing the asset quality of an institution. The net charge-offs help in the assessment of the level of credit risk in the loan portfolio, both in aggregate and by loan type. Above average or increasing net charge-offs may be a signal of weak underwriting in prior periods, which in turn may be an indicator of future risks to earnings and capital. In addition, the separate reporting of gross charge-offs and recoveries allows users of the data to evaluate whether high recovery rates are masking underlying loss levels and trends, which may have future earnings implications, and the charge-off and recovery data also aid in the planning of on-site examinations and in the scoping of the loan review to be conducted during these examinations.
Schedule RI-B is also important in assessing the strength of an institution's underwriting and credit administration practices. The data items allow for the agencies to highlight loan categories with a large or sudden change in charge-off rates, which is often a key indicator of weaknesses in these areas, while information on recoveries provides support in evaluating an institution's ability to collect on prior charge-offs.
The segmentation of the charge-off and recovery data by loan category in Schedule RI-B is essential for many reasons. Consistent segmentation by loan category allows for comparability between institutions, as well as within an institution from quarter to quarter, allowing for the evaluation of changes and trends in charge-offs and recoveries that may or may not be institution-specific. This evaluation facilitates on-site examination planning. It also allows for better off-site monitoring of the existing types of lending and shifts in types of lending. The granularity and consistency of data items helps in the determination of whether weaknesses are confined to a particular portfolio segment and are unique to the institution or whether they are representative of a more widespread systemic weakness in a particular loan category. The detail by loan category is critical as losses in certain portfolios vary based on several factors and aggregating the data items would impair the ability to analyze data by loan category. The Memorandum items request further detail on charge-offs and recoveries or additional loan categories, which assists in the assessment of credit risk in these areas.
Schedule RI-B data items are used in rule writing and policy efforts. In particular, the items are used to assess institutional participation in regulated consumer financial services markets and to assess regulatory impact associated with recent and proposed policies, as required by the CFPB's mandate. Also, the information reported in Schedule RI-B, Part I, was integral in various Title XIV mortgage reform rulemakings under the Dodd-Frank Act and continues to be critical for the continuous monitoring of the mortgage markets.
Schedule RC-E, Part I, requests data on deposits, segmented between transaction and nontransaction accounts. The Memoranda section of the schedule requests additional detail on retirement account deposits, brokered deposits, deposit size, and time deposit maturity and repricing dates. Schedule RC-E, Part II, requests data on foreign deposits and is included only in the FFIEC 031.
Schedule RC-E, Part I, provides detail necessary for supervisory purposes, including for identifying material deposit elements and providing detail needed to analyze cost of funds. Deposit detail as to the type, nature, and maturity of deposits, including deposits from non-core sources, is critical to the agencies' asset-liability management, interest rate risk, and liquidity analyses. A number of agency analysis tools routinely use quarterly deposit data for trend analysis and timely identification of deposit shifts, including changes in an institution's use of brokered and listing service deposits. Schedule RC-E, Part I, data are also used to estimate the contribution to the U.S. monetary aggregates for over 1,000 depository institutions that do not file these data directly to the Board.
The Schedule RC-E, Part I, Memorandum items provide information needed for off-site monitoring and pre-examination planning, particularly for analyses related to brokered deposits and time deposits, the results of which may signal the existence of higher-risk funding strategies. The resolution process for failed institutions requires sufficient deposit detail to estimate the least costly alternative to liquidation. Brokered deposit data are used as inputs in the calculation of deposit insurance assessment rates and to assure compliance with safety and soundness regulations tied to limits on those types of deposits.
Maturity and repricing information on time deposits, together with the maturity and repricing information collected in other schedules for other types of assets and liabilities, are needed to evaluate the liquidity and interest rate risk of the institution and to aid in evaluating the strategies institutions take to mitigate these risks. Liquidity and interest rate risk indicators that are calculated by agency models from an institution's Call Report data and exceed specified parameters or change significantly between examinations are red flags that call for timely examiner off-site review. The institution's risk profile in these areas is considered during pre-examination planning to determine the appropriate scoping and staffing for examinations.
Schedule RC-E, Part II, data on foreign deposits provides the extent of and exposure to such balances, and is used in similar analyses for institutions with foreign operations.
Schedule RC-O requests data for deposit insurance purposes and serves three primary purposes for the FDIC: Calculating the FDIC's DIF reserve ratio, calculating the assessment base of FDIC-insured institutions, and calculating the risk-based assessment rate of FDIC-insured institutions.
Schedule RC-O data are collected in the Call Report to provide unique information used in the calculation of the FDIC's reserve ratio to satisfy the statutory requirements related to maintaining the DIF. Information related to deposit liabilities on Schedule RC-O is needed to estimate insured deposits. Schedule RC-O is the only place on the Call Report where information is available to estimate insured and uninsured deposits for individual institutions and equivalent data items are not readily available from other sources.
Schedule RC-O data that are not available elsewhere enable the FDIC to calculate the quarterly deposit insurance assessment base for each FDIC-insured institution. Pursuant to the Dodd-Frank Act, the assessment base is defined as average consolidated total assets minus average tangible equity, both of which are reported in Schedule RC-O. Custodial banks and banker's banks also receive an additional adjustment to the assessment base using Schedule RC-O data. The FDIC must be able to calculate the assessment base in order to meet the statutory requirements for collecting quarterly insurance assessments from all FDIC-insured institutions.
Most of the data reported on Schedule RC-O is used to determine the risk-based insurance assessment for individual institutions in accordance with FDIC regulations implementing the statutory requirement for risk-based assessments first enacted in 1991. With the adoption of the risk-based scorecards for large and highly complex institutions, additional reporting is required on Schedule RC-O in data items applicable only to these institutions. In addition, some Schedule RC-O data items are used for determining the assessment rate of all FDIC-insured institutions.
Supervisory uses of Schedule RC-O data include incorporating the data on the maturity structure of external borrowings in agency interest rate risk models to determine the impact of interest rate movements on income and economic value of equity. Interest rate risk indicators that exceed specified parameters or change significantly between examinations are triggers for timely off-site review. The indicated level of interest rate risk is considered during pre-examination planning to determine the appropriate scoping and staffing for examinations. Data on reciprocal brokered deposits supplements on- and off-site analyses of liquidity ratios, including the net non-core funding dependence and net short-term non-core funding dependence, both of which include brokered deposits in their calculation, because reciprocal brokered deposits may have characteristics that differ from other brokered deposits.
1. Schedule RC-C, Part II—Loans to Small Businesses and Small Farms—For all institutions that file the FFIEC 051, the frequency of collection will move from quarterly to semiannual (June and December).
2. Schedule RC-A—Cash and Balances Due from Depository Institutions—Institutions with less than $300 million in total assets are already exempt from completing this schedule. For all other FFIEC 051 filers, the frequency of collection will move from quarterly to semiannual (June and December).
In the following list of “Data Items Removed” from the proposed FFIEC 051, existing FFIEC 041 data items that institutions with less than $1 billion in total assets are currently exempt from reporting are marked with an asterisk (“ *”). In addition, the list excludes two Call Report data items that have been approved for removal by OMB effective March 31, 2017, in accordance with the agencies' July 13, 2016,
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 beryllium and beryllium compounds. OSHA has determined that employees exposed to beryllium 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 beryllium are at increased risk of developing chronic beryllium disease and lung cancer. This final rule establishes new permissible exposure limits of 0.2 micrograms of beryllium per cubic meter of air (0.2 μg/m
OSHA is issuing three separate standards—for general industry, for shipyards, and for construction—in order to tailor requirements to the circumstances found in these sectors.
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 Maureen Ruskin, 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 beryllium follows this outline:
Introduction
In the docket for the beryllium 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). In a citation that contains two or more document ID numbers, the document ID numbers are separated by semi-colons. 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: (Deubner
This final rule establishes new permissible exposure limits (PELs) for beryllium of 0.2 micrograms of beryllium per cubic meter of air (0.2 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 beryllium. OSHA has also developed estimates of the risk of beryllium-related diseases, assuming exposure over a working lifetime, at the preceding PELs as well as at the revised PELs and action level. Comments received on OSHA's preliminary analysis, and the Agency's final findings, are discussed in Section V, Health Effects, Section VI, Risk Assessment, and Section VII, Significance of Risk. OSHA finds that employees exposed to beryllium at the preceding PELs are at an increased risk of developing chronic beryllium disease (CBD) and lung cancer. As discussed in Section VII, OSHA concludes that exposure to beryllium 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 TWA PEL to still be significant. However, OSHA did not adopt a lower TWA PEL because the Agency could not demonstrate technological feasibility of a lower TWA PEL. The Agency has adopted the STEL and ancillary provisions of the rule to further reduce the remaining significant risk.
OSHA's examination of the technological and economic feasibility of the rule is presented in the Final Economic Analysis and Regulatory Flexibility Analysis (FEA), and is summarized in Section VIII of this preamble. OSHA concludes that the final PELs are technologically feasible for all affected industries and application groups. Thus, OSHA concludes that engineering and work practice controls will be sufficient to reduce and maintain beryllium exposures to the new PELs or below in most operations most of the time in the affected industries. For those few operations within an industry or application group where compliance with the PELs cannot be achieved even when employers implement all feasible engineering and work practice controls, use of respirators will be required.
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 XVI, Summary and Explanation of the Standards. OSHA also presented a number of regulatory alternatives in the Notice of Proposed Rulemaking (80 FR 47566, 47729-47748 (8/7/2015). Where the Agency received substantive comments on a regulatory alternative, those comments are also discussed in Section XVI. A full discussion of all regulatory alternatives can be found in Chapter VIII of the Final Economic Analysis (FEA).
The final medical surveillance provisions have been revised to provide enhanced privacy for employees. The rule requires the employer to obtain a written medical opinion from a licensed physician for medical examinations provided under the rule but limits the information provided to the employer to the date of the examination, a statement that the examination has met the requirements of the standard, any recommended limitations on the employee's use of respirators, protective clothing, and equipment, and a statement that the results of the exam have been explained to the employee. The proposed rule would have required that such opinions contain additional information, without requiring employee authorization, such as the physician's opinion as to whether the employee has any detected medical condition that would place the employee at increased risk of CBD from further exposure, and any recommended limitations upon the employee's exposure to beryllium. In the final rule, the written opinion provided to the employer will only include recommended limitations on the employee's exposure to beryllium, referral to a CBD diagnostic center, a recommendation for continued periodic medical surveillance, or a recommendation for medical removal if the employee provides written authorization. The final rule requires a separate written medical report provided to the employee to include this additional information, as well as detailed information related to the employee's health.
The proposed rule would have required that the licensed physician provide the employer with a written medical opinion within 30 days of the examination. The final rule requires that the licensed physician provide the employee with a written medical report and the employer with a written medical opinion within 45 days of the examination, including any follow-up beryllium lymphocyte proliferation test (BeLPTs).
The final rule also adds requirements for the employer to provide the CBD diagnostic center with the same information provided to the physician or other licensed health care professional who administers the medical examination, and for the CBD diagnostic center to provide the employee with a written medical report and the employer with a written medical opinion. Under the final standard, employees referred to a CBD diagnostic center can choose to have future evaluations performed there. A requirement that laboratories performing BeLPTs be certified was also added to the final rule.
The proposed rule would have required that employers provide low dose computed tomography (LDCT) scans to employees who met certain exposure criteria. The final rule requires LDCT scans when recommended by the physician or other licensed healthcare professional administering the medical exam, after considering the employee's history of exposure to beryllium along with other risk factors.
OSHA has revised the proposed compliance dates. The final rule is effective 60 days after publication. All obligations for compliance commence one year after the effective date, with two exceptions: The obligation for change rooms and showers commences two years after the effective date; and the obligation for engineering controls commences three 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 VIII, 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 VIII 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 90 fatalities and 46 new cases of CBD annually once the full effects are realized, and the estimated cost of the rule is $73.9 million annually. Also as shown in Table I-1, the discounted monetized benefits of the rule are estimated to be $560.9 annually, and the rule is estimated to generate net benefits of approximately $487 annually; however, there is a great deal of uncertainty in those benefits due to assumptions made about dental workers' exposures and reductions; see Section VIII of this preamble. As that section shows, benefits significantly exceed costs regardless of how dental workers' exposures are treated.
The purpose of the Occupational Safety and Health Act (29 U.S.C. 651
The Act provides that in promulgating standards dealing with toxic materials or harmful physical agents, such as beryllium, 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)). 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 beryllium and beryllium compounds and conducted its rulemaking pursuant to section 6(b)(5) of the Act ((29 U.S.C. 655(b)(5)). The preceding beryllium standard, however, was adopted under the Secretary's authority in section 6(a) of the OSH Act (29 U.S.C. 655(a)), to adopt national consensus and established Federal standards within two years of the Act's enactment (
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 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 evaluate whether “significant risk[ ]” exists under current conditions and to then determine whether that risk can be “eliminated or lessened” through regulation (
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 . . . (
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 (
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
The courts of appeals have afforded OSHA similar latitude to issue health standards in the face of scientific uncertainty. The Second Circuit, in upholding the vinyl chloride standard, stated: “[T]he 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” (
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 rules on occupational exposure to Chromium (VI) (71 FR 10100, 10337-10338 (2/28/2006) and Respirable Crystalline Silica (81 FR 16285, 16576-16575 (3/25/2016); see also 62 FR 1494, 1575 (1/10/97) (methylene chloride)). In its decision upholding the chromium (VI) standard, including the uniform PEL, the Court of Appeals for the Third Circuit addressed this issue as one of deference, stating “OSHA's decision to select a uniform exposure limit is a legislative policy decision that we will uphold as long as it was reasonably drawn from the record” (Chromium (VI), 557 F.3d at 183 (3d Cir. 2009)); see also
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 (
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 (
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” (
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 profitability of the industry and the likely effect of such costs on unit consumer prices . . .” (
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 (
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) (
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 (
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 discussion in Section XVI. Summary and Explanation of the Standards, Methods of Compliance). The hierarchy of controls focuses on removing harmful airborne materials at their source “to prevent atmospheric contamination” to which the employee would be exposed, rather than relying on the proper functioning of a respirator as the primary means of protecting the employee (see 29 CFR 1910.134, 1910.1000(e), 1926.55(b)).
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.
The OSH Act compels OSHA to require all feasible measures for reducing significant health risks (29 U.S.C. 655(b)(5);
The first occupational exposure limit for beryllium was set in 1949 by the Atomic Energy Commission (AEC), which required that beryllium exposure in the workplaces under its jurisdiction be limited to 2 µg/m
In 1956, the American Industrial Hygiene Association (AIHA) published a Hygienic Guide which supported the AEC exposure limits. In 1959, the American Conference of Governmental Industrial Hygienists (ACGIH®) also adopted a Threshold Limit Value (TLV®) of 2 µg/m
In 1971, OSHA adopted, under Section 6(a) of the Occupational Safety and Health Act of 1970, and made applicable to general industry, the ANSI standard (Document ID 1303). Section 6(a) provided that in the first two years after the effective date of the Act, OSHA was 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, in 1971, OSHA promulgated approximately 425 PELs for air contaminants, including beryllium, 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, in turn, had been adopted primarily from ACGIH®'s TLV®s as well as several from United States of America Standards Institute (USASI) [later the American National Standards Institute (ANSI)].
The National Institute for Occupational Safety and Health (NIOSH) issued a document entitled
In October 1975, OSHA proposed a new beryllium standard for all industries based on information from studies finding that beryllium caused cancer in animals (40 FR 48814 (10/17/75)). Adoption of this proposal would have lowered the 8-hour TWA exposure limit from 2 µg/m
In 1977, NIOSH recommended an exposure limit of 0.5 µg/m
In 1999, the Department of Energy (DOE) issued a Chronic Beryllium Disease Prevention Program (CBDPP) Final Rule for employees exposed to beryllium in its facilities (Document ID 1323). The DOE rule set an action level of 0.2 μg/m
Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial, Chemical and Energy Workers International Union (PACE) (Document ID 0069) and by Dr. Lee Newman and Ms. Margaret Mroz, from the National Jewish Health (NJH) (Document ID 0069), to promulgate an Emergency Temporary Standard (ETS) for beryllium in the workplace. In 2001, OSHA was petitioned for an ETS by Public Citizen Health Research Group and again by PACE (Document ID 0069). In order to promulgate an ETS, the Secretary of Labor must prove (1) that employees are exposed to grave danger from exposure to a hazard, and (2) that such an emergency standard is necessary to protect employees from such danger (29 U.S.C. 655(c) [6(c)]). The burden of proof is on the Department and because of the difficulty of meeting this burden, the Department usually proceeds when appropriate with ordinary notice and comment [section 6(b)] rulemaking rather than a 6(c) ETS. Thus, instead of granting the ETS requests, OSHA instructed staff to further collect and analyze research regarding the harmful effects of beryllium in preparation for possible section 6(b) rulemaking.
On November 26, 2002, OSHA published a Request for Information (RFI) for “Occupational Exposure to Beryllium” (Document ID 1242). The RFI contained questions on employee exposure, health effects, risk assessment, exposure assessment and monitoring methods, control measures and technological feasibility, training, medical surveillance, and impact on small business entities. In the RFI, OSHA expressed concerns about health effects such as chronic beryllium disease (CBD), lung cancer, and beryllium sensitization. OSHA pointed to studies indicating that even short-term exposures below OSHA's PEL of 2 µg/m
On November 15, 2007, OSHA convened a Small Business Advocacy Review Panel for a draft proposed standard for occupational exposure to beryllium. OSHA convened this panel under Section 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601
The Panel included representatives from OSHA, the Solicitor's Office of the Department of Labor, the Office of Advocacy within the Small Business Administration, and the Office of Information and Regulatory Affairs of the Office of Management and Budget. Small Entity Representatives (SERs) made oral and written comments on the draft rule and submitted them to the panel.
The SBREFA Panel issued a report on January 15, 2008 which included the SERs' comments. SERs expressed concerns about the impact of the ancillary requirements such as exposure monitoring and medical surveillance. Their comments addressed potential costs associated with compliance with the draft standard, and possible impacts of the standard on market conditions, among other issues. In addition, many SERs sought clarification of some of the ancillary requirements such as the meaning of “routine” contact or “contaminated surfaces.”
OSHA then developed a draft preliminary beryllium health effects evaluation (Document ID 1271) and a draft preliminary beryllium risk assessment (Document ID 1272), and in 2010, OSHA hired a contractor to oversee an independent scientific peer review of these documents. The contractor identified experts familiar with beryllium health effects research and ensured that these experts had no conflict of interest or apparent bias in performing the review. The contractor selected five experts with expertise in such areas as pulmonary and occupational medicine, CBD, beryllium sensitization, the Beryllium Lymphocyte Proliferation Test (BeLPT), beryllium toxicity and carcinogenicity, and medical surveillance. Other areas of expertise included animal modeling, occupational epidemiology, biostatistics, risk and exposure assessment, exposure-response modeling, beryllium exposure assessment, industrial hygiene, and occupational/environmental health engineering.
Regarding the preliminary health effects evaluation, the peer reviewers concluded that the health effect studies were described accurately and in sufficient detail, and OSHA's conclusions based on the studies were reasonable (Document ID 1210). The reviewers agreed that the OSHA document covered the significant health endpoints related to occupational beryllium exposure. Peer reviewers considered the preliminary conclusions regarding beryllium sensitization and CBD to be reasonable and well presented in the draft health evaluation section. All reviewers agreed that the scientific evidence supports sensitization as a necessary condition in the development of CBD. In response to reviewers' comments, OSHA made revisions to more clearly describe certain sections of the health effects evaluation. In addition, OSHA expanded its discussion regarding the BeLPT.
Regarding the preliminary risk assessment, the peer reviewers were highly supportive of the Agency's approach and major conclusions (Document ID 1210). The peer reviewers stated that the key studies were appropriate and their selection clearly explained in the document. They regarded the preliminary analysis of these studies to be reasonable and scientifically sound. The reviewers supported OSHA's conclusion that substantial risk of sensitization and CBD were observed in facilities where the highest exposure generating processes had median full-shift exposures around 0.2 µg/m
In February 2012, the Agency received for consideration a draft recommended standard for beryllium (Materion and USW, 2012, Document ID 0754). This draft standard was the product of a joint effort between two stakeholders: Materion Corporation, a leading producer of beryllium and beryllium products in the United States, and the United Steelworkers, an international labor union representing workers who manufacture beryllium alloys and beryllium-containing products in a number of industries. They sought to craft an OSHA-like model beryllium standard that would have support from both labor and industry. OSHA has considered this proposal along with other information submitted during the development of the Notice of Proposed Rulemaking (NPRM) for beryllium. As described in greater detail in the Introduction to the Summary and Explanation of the final rule, there was substantial agreement between the submitted joint standard and the OSHA proposed standard.
On August 7, 2015, OSHA published its NPRM in the
The NPRM invited interested stakeholders to submit comments on a variety of issues and indicated that OSHA would schedule a public hearing upon request. Commenters submitted information and suggestions on a variety of topics. In addition, in response to a request from the Non-Ferrous Founders' Society, OSHA scheduled an informal public hearing on the proposed rule. The Agency invited interested persons to participate by providing oral testimony and documentary evidence at the hearing. OSHA also welcomed presentation of data and documentary evidence that would provide the Agency with the best available evidence to use in determining whether to develop a final rule.
The public hearing was held in Washington, DC on March 21 and 22, 2016. Administrative Law Judge William Colwell presided over the hearing. The Agency heard testimony from several organizations, such as public health groups, the Non-Ferrous Founders' Society, other industry representatives, and labor unions. Following the hearing, participants who had filed notices of intent to appear were allowed 30 days—until April 21, 2016—to submit additional evidence and data, and an additional 15 days—until May 6, 2016—to submit final briefs, arguments, and summations (Document ID 1756, Tr. 326).
In 2016, in an action parallel to OSHA's rulemaking, DOE proposed to update its action level to 0.05 μg/m
In all, the OSHA rulemaking record contains over 1,900 documents, including all the studies OSHA relied on in its preliminary health effects and risk assessment analyses, the hearing transcript and submitted testimonies, the joint Materion-USW draft proposed standard, and the pre- and post-hearing comments and briefs. The final rule on occupational exposure to beryllium and beryllium compounds is thus 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. Based on this comprehensive record, OSHA concludes that employees exposed to beryllium and beryllium compounds are at significant risk of material impairment of health, including chronic beryllium disease and lung cancer. The Agency concludes that the PEL of 0.2 μg/m
Beryllium (Be; CAS Number 7440-41-7) is a silver-grey to greyish-white, strong, lightweight, and brittle metal. It is a Group IIA element with an atomic weight of 9.01, atomic number of 4, melting point of 1,287 °C, boiling point of 2,970 °C, and a density of 1.85 at 20 °C (Document ID 0389, p. 1). It occurs naturally in rocks, soil, coal, and volcanic dust (Document ID 1567, p. 1). Beryllium is insoluble in water and soluble in acids and alkalis. It has two common oxidation states, Be(0) and Be(+2). There are several beryllium compounds with unique CAS numbers and chemical and physical properties. Table IV-1 describes the most common beryllium compounds.
The physical and chemical properties of beryllium were realized early in the 20th century, and it has since gained commercial importance in a wide range of industries. Beryllium is lightweight, hard, spark resistant, non-magnetic, and has a high melting point. It lends strength, electrical and thermal conductivity, and fatigue resistance to alloys (Document ID 0389, p. 1). Beryllium also has a high affinity for oxygen in air and water, which can cause a thin surface film of beryllium oxide to form on the bare metal, making it extremely resistant to corrosion. These properties make beryllium alloys highly suitable for defense, nuclear, and aerospace applications (Document ID 1342, pp. 45, 48).
There are approximately 45 mineralized forms of beryllium. In the United States, the predominant mineral form mined commercially and refined into pure beryllium and beryllium alloys is bertrandite. Bertrandite, while containing less than 1% beryllium compared to 4% in beryl, is easily and efficiently processed into beryllium hydroxide (Document ID 1342, p. 48). Imported beryl is also converted into beryllium hydroxide as the United States has very little beryl that can be economically mined (Document ID 0616, p. 28).
Materion Corporation (Materion), formerly called Brush Wellman, is the only producer of primary beryllium in the United States. Beryllium is used in a variety of industries, including aerospace, defense, telecommunications, automotive, electronic, and medical specialty industries. Pure beryllium metal is used in a range of products such as X-ray transmission windows, nuclear reactor neutron reflectors, nuclear weapons, precision instruments, rocket propellants, mirrors, and computers (Document ID 0389, p. 1). Beryllium oxide is used in components such as ceramics, electrical insulators, microwave oven components, military vehicle armor, laser structural components, and automotive ignition systems (Document ID 1567, p. 147). Beryllium oxide ceramics are used to produce sensitive electronic items such as lasers and satellite heat sinks.
Beryllium alloys, typically beryllium/copper or beryllium/aluminum, are manufactured as high beryllium content or low beryllium content alloys. High content alloys contain greater than 30% beryllium. Low content alloys are typically less than 3% beryllium. Beryllium alloys are used in automotive electronics (
Beryllium is also found as a trace metal in materials such as aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive blasting grits such as coal slag and copper slag contain varying concentrations of beryllium, usually less than 0.1% by weight. The burning of bituminous and sub-bituminous coal for power generation causes the naturally occurring beryllium in coal to accumulate in the coal fly ash byproduct. Scrap and waste metal for smelting and refining may also contain beryllium. A detailed discussion of the industries and job tasks using beryllium is included in the Preliminary Economic Analysis (Document ID 0385, 0426).
Occupational exposure to beryllium can occur from inhalation of dusts, fume, and mist. Beryllium dusts are created during operations where beryllium is cut, machined, crushed, ground, or otherwise mechanically sheared. Mists can also form during operations that use machining fluids. Beryllium fume can form while welding with or on beryllium components, and from hot processes such as those found in metal foundries.
Occupational exposure to beryllium can also occur from skin, eye, and mucous membrane contact with beryllium particulate or solutions.
As discussed in detail throughout this section (section V, Final Health Effects) and in Section VI, Final Quantitative Risk Assessment and Significance of Risk, OSHA finds, based upon the best available evidence in the record, that exposure to soluble and poorly soluble forms of beryllium are associated with several adverse health outcomes including sensitization, chronic beryllium disease, acute beryllium disease and lung cancer.
The findings and conclusions in this section are consistent with those of the National Academies of Sciences (NAS), 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), the Agency for Toxic Substance and Disease Registry (ATSDR), the European Commission on Health, Safety and Hygiene at Work, and many other organizations and individuals, as evidenced in the rulemaking record and further discussed below. Other scientific organizations and governments have recognized the strong body of scientific evidence pointing to the health risks of exposure to beryllium and have deemed it necessary to take action to reduce those risks. In 1999, the Department of Energy (DOE) updated its airborne beryllium concentration action level to 0.2 μg/m
In finalizing this Health Effects preamble section for the final rule, OSHA updated the preliminary Health Effects section published in the NPRM based on the stakeholder response received by the Agency during the public comment period and public hearing. OSHA also corrected several non-substantive errors that were published in the NPRM as well as those identified by NIOSH and Materion including several minor organizational changes made to sections V.D.3 and V.E.2.b (Document ID 1671, pp. 10-11; 1662, pp. 3-5). A section titled “Dermal Effects” was added to V.F.5 based on comments received by the American Thoracic Society (ATS), National Jewish Health, and the National Supplemental Screening Program (Document ID 1688, p. 2; 1664, p. 5; 1677, p. 3). Additionally, the Agency responded to relevant stakeholder comments contained in specific sections.
In developing its review of the preliminary health effects from beryllium exposure and assessment of risk for the NPRM, OSHA prepared a
Overall, the peer reviewers found that the OSHA draft health effects evaluation described the studies in sufficient detail, appropriately addressed their strengths and limitations, and drew scientifically sound conclusions. The peer reviewers were also supportive of the Agency's preliminary risk assessment approach and the major conclusions. OSHA provided detailed responses to reviewer comments in its publication of the NPRM (80 FR 47646-47652, 8/7/2015). Revisions to the draft health effects evaluation and preliminary risk assessment in response to the peer review comments were reflected in sections V and VI of the same publication (80 FR 47581-47646, 8/7/2015). OSHA received public comment and testimony on the Health Effects and Preliminary Risk Assessment sections published in the NPRM, which are discussed in this preamble.
The Agency received a wide variety of stakeholder comments and testimony for this rulemaking on issues related to the health effects and risk of beryllium exposure. Statements supportive of OSHA's Health Effects section include comments from NIOSH, the National Safety Council, the American Thoracic Society (ATS), Representative Robert C. “Bobby” Scott, Ranking Member of Committee on Education and the Workforce, the U.S. House of Representatives, national labor organizations (American Federation of Labor—Congress of Industrial Organizations (AFL-CIO), North American Building Trades Unions (NABTU), United Steelworkers (USW), Public Citizen, ORCHSE, experts from National Jewish Health (Lisa Maier, MD and Margaret Mroz, MSPH), the American Association for Justice, and the National Council for Occupational Safety and Health.
For example, NIOSH commented in its prepared written hearing testimony:
OSHA has appropriately identified and documented all critical health effects associated with occupational exposure to beryllium and has appropriately focused its greatest attention on beryllium sensitization (BeS), chronic beryllium disease (CBD) and lung cancer . . .
The National Safety Council, a congressionally chartered nonprofit safety organization, also stated that “beryllium represents a serious health threat resulting from acute or chronic exposures.” (Document ID 1612, p. 5). Representative Robert C. “Bobby” Scott, Ranking Member of Committee on Education and the Workforce, the U.S. House of Representatives, submitted a statement recognizing that the evidence strongly supports the conclusion that sensitization can occur from exposure to soluble and poorly soluble forms of beryllium (Document ID 1672, p. 3).
OSHA also received supporting statements from ATS and ORCHSE on the inclusion of beryllium sensitization, CBD, skin disease, and lung cancer as major adverse health effects associated with beryllium exposure (Document ID 1688, p. 7; 1691, p. 14). ATS specifically stated:
Dr. Lisa Maier and Ms. Margaret Mroz of National Jewish Health testified about the health effects of beryllium in support of the beryllium standard:
We know that chronic beryllium disease often will not manifest clinically until irreversible lung scarring has occurred, often years after exposure, with a latency of 20 to 30 years as discussed yesterday. Much too late to make changes in the work place. We need to look for early markers of health effects, cast the net widely to identify cases of sensitization and disease, and use screening results in concert with exposure sampling to identify areas of increased risk that can be modified in the work place. (Document ID 1756, Tr. 102; 1806).
Unlike many toxins, there is no threshold below which no worker will become sensitized to beryllium. Worker sensitization to beryllium is a precursor to CBD, but not cancer. The symptoms of chronic beryllium disease (CBD) are part of a continuum of disease that is progressive in nature. Early recognition of and treatment for CBD may lead to a lessening of symptoms and may prevent the disease from progressing further. Symptoms of CBD may occur at exposure levels well below the proposed permissible exposure limit of .2 µg/m
In addition to the comments above and those noted throughout this Health Effects section, Materion submitted their correspondence to the National Academies (NAS) regarding the company's assessment of the NAS beryllium studies and their correspondence to NIOSH regarding the Cummings 2009 study (Document 1662, Attachments) to OSHA. For the NAS study, Materion included a series of comments regarding studies included in the NAS report. OSHA has reviewed these comments and found that the comments submitted to the NAS critiquing their review of the health effects of beryllium were considered and incorporated where appropriate. For the NIOSH study Materion included comments regarding 2 cases of acute beryllium disease evaluated in a study published by Cummings
Beryllium-associated health effects, including acute beryllium disease (ABD), beryllium sensitization (also referred to in this preamble as “sensitization”), chronic beryllium disease (CBD), and lung cancer, can lead to a number of highly debilitating and life-altering conditions including pneumonitis, loss of lung capacity (reduction in pulmonary function leading to pulmonary dysfunction), loss of physical capacity associated with reduced lung capacity, systemic effects related to pulmonary dysfunction, and decreased life expectancy (NIOSH, 1972, Document ID 1324, 1325, 1326, 1327, 1328; NIOSH, 2011 (0544)).
This Health Effects section presents information on beryllium and its compounds, the fate of beryllium in the body, research that relates to its toxic mechanisms of action, and the scientific literature on the adverse health effects associated with beryllium exposure, including ABD, sensitization, CBD, and lung cancer. OSHA considers CBD to be a progressive illness with a continuous spectrum of symptoms ranging from no symptomatology at its earliest stage following sensitization to mild symptoms such as a slight almost imperceptible shortness of breath, to loss of pulmonary function, debilitating lung disease, and, in many cases, death. This section also discusses the nature of these illnesses, the scientific evidence that they are causally associated with occupational exposure to beryllium, and the probable mechanisms of action with a more thorough review of the supporting studies.
Beryllium has two oxidative states: Be(0) and Be(2
Beryllium shows a high affinity for oxygen in air and water, resulting in a thin surface film of beryllium oxide on the bare metal. If the surface film is disturbed, it may become airborne and cause respiratory tract exposure or dermal exposure (also referred to as dermal contact). The physical properties of solubility, particle surface area, and particle size of some beryllium compounds are examined in more detail below. These properties have been evaluated in many toxicological studies. In particular, the properties related to the calcination (firing temperatures) and differences in crystal size and solubility are important aspects in their toxicological profile.
The effect and potency of beryllium and its compounds, as for any toxicant, immunogen, or immunotoxicant, may be dependent upon the physical state in which they are presented to a host. For occupational airborne materials and surface contaminants, it is especially critical to understand those physical parameters in order to determine the extent of exposure to the respiratory tract and skin since these are generally the initial target organs for either route of exposure.
For example, solubility has an important part in determining the toxicity and bioavailability of airborne materials as well. Respiratory tract retention and skin penetration are directly influenced by the solubility and reactivity of airborne material. Large particles may have less of an effect in the lung than smaller particles due to reduced potential to stay airborne, to be inhaled, or be deposited along the respiratory tract. In addition, once inhalation occurs particle size is critical in determining where the particle will deposit along the respiratory tract.
These factors may be responsible, at least in part, for the process by which beryllium sensitization progresses to CBD in exposed workers. Other factors influencing beryllium-induced toxicity include the surface area of beryllium particles and their persistence in the lung. With respect to dermal contact or exposure, the physical characteristics of the particle are also important since they can influence skin absorption and bioavailability. This section addresses certain physical characteristics (
Solubility has been shown to be an important determinant of the toxicity of airborne materials, influencing the deposition and persistence of inhaled particles in the respiratory tract, their bioavailability, and the likelihood of presentation to the immune system. A number of chemical agents, including metals that contact and penetrate the skin, are able to induce an immune response, such as sensitization (Boeniger, 2003, Document ID 1560; Mandervelt
In biological systems, solubility is used to describe the rate at which a material will undergo chemical clearance and dissolve in a fluid (airway lining, inside phagolysomes) relative to the rate of mechanical clearance. For example, in the lung a “poorly soluble” material is one that dissolves at a rate slower than the rate of mechanical removal via the mucociliary escalator. Examples of poorly soluble forms of beryllium are beryllium silicates, beryllium oxide, and beryllium metal and alloys (Deubner
Beryllium salts, including the chloride (BeCl
Beryllium oxide (BeO), hydroxide (Be(OH)
Investigators have also attempted to determine how biological fluids can dissolve beryllium materials. In two studies, poorly soluble beryllium, taken up by activated phagocytes, was shown to be ionized by myeloperoxidases (Leonard and Lauwerys, 1987, Document ID 1293; Lansdown, 1995 (1469)). The positive charge resulting from ionization enabled the beryllium to bind to receptors on the surface of cells such as lymphocytes or antigen-presenting cells which could make it more biologically active (NAS, 2008, Document ID 1355). In a study utilizing phagolysosomal-simulating fluid (PSF) with a pH of 4.5, both beryllium metal and beryllium oxide dissolved at a greater rate than that previously reported in water or SUF (simulant fluid) (Stefaniak
In a recent study investigating the dissolution and release of beryllium ions for 17 beryllium-containing materials (ore, hydroxide, metal, oxide, alloys, and processing intermediates) using artificial human airway epithelial lining fluid, Stefaniak
Huang
In an
In summary, studies have shown that soluble forms of beryllium readily dissolve into ionic components making them biologically available for dermal penetration and activation of immune cells (Stefaniak
OSHA received comments from the Non-Ferrous Founders' Society (NFFS) contending that the scientific evidence does not support insoluble beryllium as a causative agent for sensitization and CBD (Document ID 1678, p. 6). The NFFS contends that insoluble beryllium is not carcinogenic or a sensitizer to humans, and argues that based on this information, OSHA should consider a bifurcated standard with separate PELs for soluble and poorly soluble beryllium and beryllium compounds and insoluble beryllium metallics (Document ID 1678, p. 7). As evidence supporting its conclusion, the NFFS cited a 2010 statement written by Dr. Christian Strupp commissioned by the beryllium industry (Document ID 1785, 1814), which reviewed selected studies to evaluate the toxic potential of beryllium metal and alloys (Document ID 1678, pp. 7). The Strupp and Furnes statement (2010) cited by the NFFS is the background material and basis of the Strupp (2011a and 2011b) studies in the docket (Document ID 1794; 1795). In response to Strupp 2011 (a and b), Aleks Stefaniak of NIOSH published a letter to the editor refuting some of the evidence presented by Strupp (2011a and b, Document ID 1794; 1795). The first study by Strupp (2011a) evaluated selected animal studies and concluded that beryllium metal was not a sensitizer. Stefaniak (2011) evaluated the validity of the Strupp (2011a) study of beryllium toxicity and noted numerous deficiencies, including deficiencies in the study design, improper administration of beryllium test compounds, and lack of proper controls (Document ID 1793). In addition, Strupp (2011a) omitted numerous key animal and epidemiological studies demonstrating the potential of poorly soluble beryllium and beryllium metal as a sensitizing agent. One such study, Tinkle
The toxicity of beryllium as exemplified by beryllium oxide is dependent, in part, on the particle size, with smaller particles (less than 10 μm in diameter) able to penetrate beyond the larynx (Stefaniak
The temperature at which beryllium oxide is calcined influences its particle size, surface area, solubility, and ultimately its toxicity (Delic, 1992, Document ID 1547). Low-fired (500 °C) beryllium oxide is predominantly made up of poorly crystallized small particles, while higher firing temperatures (1000-1750 °C) result in larger particle sizes (Delic, 1992, Document ID 1547).
In order to determine the extent to which particle size plays a role in the toxicity of beryllium in occupational settings, several key studies are reviewed and detailed below. The findings on particle size have been related, where possible, to work process
Numerous studies have been conducted evaluating the particle size generated during basic industrial and machining operations. In a study by Cohen
A recent study by Virji
To summarize, particle size influences deposition of beryllium particles in the lung, thereby influencing toxicity. Studies by Stefaniak
Particle surface area has been postulated as an important metric for beryllium exposure. Several studies have demonstrated a relationship between the inflammatory and tumorigenic potential of ultrafine particles and their increased surface area (Driscoll, 1996, Document ID 1539; Miller, 1995 (0523); Oberdorster
Finch
Several studies have investigated the lung toxicity of beryllium oxide calcined at different temperatures and generally have found that those calcined at lower temperatures have greater toxicity and effect than materials calcined at higher temperatures. This may be because beryllium oxide fired at the lower temperature has a loosely formed crystalline structure with greater specific surface area than the fused crystal structure of beryllium oxide fired at the higher temperature. For example, beryllium oxide calcined at 500 °C has been found to have stronger pathogenic effects than material calcined at 1,000 °C, as shown in several of the beagle dog, rat, mouse and guinea pig studies discussed in the section on CBD pathogenesis that follows (Finch
Stefaniak
Beryllium enters the body by inhalation, absorption through the skin, or ingestion. For occupational exposure, the airways and the skin are the primary routes of uptake.
The respiratory tract, especially the lung, is the primary target of inhalation exposure in workers. Disposition (deposition and clearance) of the particle or droplet along the respiratory tract influences the biological response to the toxicant (Schlesinger
Particles depositing in the lung and along the entire respiratory tract may encounter immunologic cells or may move into the vascular system where they are free to leave the lung and can contribute to systemic beryllium concentrations.
Beryllium is removed from the respiratory tract by various clearance mechanisms. Soluble beryllium is removed from the respiratory tract via absorption or chemical clearance (Schlesinger, 1997, Document ID 1290). Sparingly soluble or poorly soluble beryllium is removed via mechanical mechanisms and may remain in the
Due to physiological differences, clearance rates can vary between humans and animal species (Schlesinger, 1997, Document ID 1290; Miller, 2000 (1831)). However, clearance rates are also dependent upon the solubility, dose, and size of the inhaled beryllium compound. As reviewed in a WHO Report (2001) (Document ID 1282), more soluble beryllium compounds generally tend to be cleared from the respiratory system and absorbed into the bloodstream more rapidly than less soluble compounds (Van Cleave and Kaylor, 1955, Document ID 1287; Hart
Evidence from animal studies suggests that greater amounts of beryllium deposited in the lung may result in slower clearance times. Acute inhalation studies performed in rats and mice using a single dose of inhaled aerosolized beryllium metal showed that exposure to beryllium metal can slow particle clearance and induce lung damage in rats and mice (Finch
Beryllium absorbed from the respiratory system was shown to distribute primarily to the tracheobronchial lymph nodes via the lymph system, bloodstream, and skeleton (Stokinger
Systemic distribution of the more soluble compounds was shown to be greater than that of the poorly soluble compounds (Stokinger
Beryllium was later mobilized from the liver and transferred to the skeleton (IARC, 1993, Document ID 1342). A half-life of 450 days has been estimated for beryllium in the human skeleton (ICRP, 1960, Document ID 0248). This indicates the skeleton may serve as a repository for beryllium that may later be reabsorbed by the circulatory system, making beryllium available to the immunological system (WHO, 2001, Document ID 1282). In a recent review of the information, the American Conference of Governmental Industrial Hygienists (ACGIH, 2010) was not able to confirm the association between occupational inhalation and urinary excretion (Document ID 1662, p. 4). However, IARC (2012) noted that an accidental exposure of 25 people to beryllium dust reported in a study by Zorn
Based on these studies, OSHA finds that the respiratory tract is a primary pathway for beryllium exposure. While particle size and surface area may contribute to the toxicity of beryllium, there is not sufficient evidence for OSHA to regulate based on size and surface area. However, the Agency finds that both soluble and poorly soluble forms of beryllium and beryllium compounds can contribute to exposure via the respiratory system and therefore can be causative agents of sensitization and CBD.
Beryllium compounds have been shown to cause skin irritation and sensitization in humans and certain animal models (Van Ordstrand
Although its precise role remains to be elucidated, there is evidence that dermal exposure can contribute to beryllium sensitization. As early as the 1940s it was recognized that dermatitis experienced by workers in primary beryllium production facilities was linked to exposures to the soluble beryllium salts. Except in cases of wound contamination, dermatitis was rare in workers whose exposures were restricted to exposure to poorly soluble beryllium-containing particles (Van Ordstrand
In a study by Ivannikov
A study by Deubner
A study conducted by Day
The same group of investigators extended their work on investigating multiple exposure pathways contributing to sensitization and CBD (Armstrong
OSHA received comments regarding the potential for dermal penetration of poorly soluble particles. Materion contended there is no supporting evidence to suggest that insoluble or poorly soluble particles penetrate skin and stated:
As summarized above, poorly soluble beryllium particles have been shown to solubilize in biological fluids (
[T]he particles can actually dissolve when they're in contact with liquids on the skin, like sweat. So we've actually done a series of studies, using a simulant of sweat, but it had characteristics that very closely matched human sweat. We see in those studies that, in fact, beryllium particles, beryllium oxide, beryllium metal, beryllium alloys, all these sort of what we call insoluble forms actually do in fact dissolve very readily in analog of human sweat. And once beryllium is in an ionic form on the skin, it's actually very easy for it to cross the skin barrier. And that's been shown many, many times in studies that beryllium ions can cross the skin and induce sensitization. (Document ID 1755, Tr. 36-37).
Based on information from various studies demonstrating that poorly soluble particles have the potential to penetrate skin, that skin as a barrier is rarely intact (especially in industrial settings), and that beryllium particles can readily dissolve in sweat and other biological fluids, OSHA finds that dermal exposure to poorly soluble beryllium can cause sensitization (Rossman,
According to the WHO Report (2001), gastrointestinal absorption of beryllium can occur by both the inhalation and oral routes of exposure (Document ID 1282). In the case of inhalation, a portion of the inhaled material is transported to the gastrointestinal tract by the mucociliary escalator or by the swallowing of the poorly soluble material deposited in the upper respiratory tract (Schlesinger, 1997, Document ID 1290). Animal studies have shown oral administration of beryllium compounds to result in very limited absorption and storage (as reviewed by U.S. EPA, 1998, Document ID 0661). Oral studies utilizing radio-labeled beryllium chloride in rats, mice, dogs, and monkeys, found the majority of the beryllium was unabsorbed by the gastrointestinal tract and was eliminated in the feces. In most studies, less than 1 percent of the administered radioactivity was absorbed into the bloodstream and subsequently excreted in the urine (Crowley
Further studies suggested that beryllium absorbed into the bloodstream is primarily excreted via urine (Crowley
In summary, animal studies evaluating the absorption, distribution and excretion of beryllium compounds found that, in general, poorly soluble beryllium compounds were not readily absorbed in the gastrointestinal tract and was mostly excreted via feces (Hart
Beryllium and its compounds may not be metabolized or biotransformed, but soluble beryllium salts may be converted to less soluble forms in the lung (Reeves and Vorwald, 1967, Document ID 1309). As stated earlier, solubility is an important factor for persistence of beryllium in the lung. Poorly soluble phagocytized beryllium particles can be dissolved into an ionic form by an acidic cellular environment and by myeloperoxidases or macrophage phagolysomal fluids (Leonard and Lauwerys, 1987, Document ID 1293; Lansdown, 1995 (1469); WHO, 2001 (1282); Stefaniak
The forms and concentrations of beryllium across the workplace vary substantially based upon location, process, production and work task. Many factors may influence the potency of beryllium including concentration, composition, structure, size, solubility and surface area of the particle.
Studies have demonstrated that beryllium sensitization can occur via the skin or inhalation from soluble or poorly soluble beryllium particles. Beryllium must be presented to a cell in a soluble form for activation of the immune system (NAS, 2008, Document ID 1355), and this will be discussed in more detail in the section to follow. Poorly soluble beryllium can be solubilized via intracellular fluid, lung fluid and sweat to release beryllium ions (Sutton
Some animal and epidemiological studies suggest that the form of beryllium may affect the rate of development of BeS and CBD. Beryllium in an inhalable form (either as soluble or poorly soluble particles or mist) can deposit in the respiratory tract and interact with immune cells located along the entire respiratory tract (Scheslinger, 1997, Document ID 1290). Interaction and presentation of beryllium (either in ionic or particulate form) is discussed further in Section V.D.1.
Acute beryllium disease (ABD) is a relatively rapid onset inflammatory reaction resulting from breathing high airborne concentrations of beryllium. It was first reported in workers extracting beryllium oxide (Van Ordstrand
ABD involves an inflammatory or immune-mediated reaction that may include the entire respiratory tract, involving the nasal passages, pharynx, bronchial airways and alveoli. Other tissues including skin and conjunctivae may be affected as well. The clinical features of ABD include a nonproductive cough, chest pain, cyanosis, shortness of breath, low-grade fever and a sharp drop in functional parameters of the lungs. Pathological features of ABD include edematous distension, round cell infiltration of the septa, proteinaceous materials, and desquamated alveolar cells in the lung. Monocytes, lymphocytes and plasma cells within the alveoli are also characteristic of the acute disease process (Freiman and Hardy, 1970, Document ID 1527).
Two types of acute beryllium disease have been characterized in the literature: A rapid and severe course of acute fulminating pneumonitis generally developing within 48 to 72 hours of a massive exposure, and a second form that takes several days to develop from exposure to lower concentrations of beryllium (still above the levels set by regulatory and guidance agencies) (Hall, 1950, Document ID 1494; DeNardi
Materion submitted post-hearing comments regarding ABD (Document ID 1662, p. 2; Attachment A, p. 1). Materion contended that only soluble forms of beryllium have been demonstrated to produce ABD at exposures above 100 µg/m
Additional comments from Materion regarding ABD criticized the study by Cummings
In response to Materion's contention that OSHA should eliminate the section on ABD because this disease is no longer a concern today (Document ID 1661, p. 2), OSHA notes that the discussion on ABD is included for thoroughness in review of the health effects caused by exposure to beryllium. As indicated above, the Agency acknowledges that ABD is extremely rare, but not non-existent, in workplaces today due to the more stringent exposure controls implemented since OSHA's inception (OSHA, 1971, see 39 FR 23513).
This section provides an overview of the immunology and pathogenesis of BeS and CBD, with particular attention to the role of skin sensitization, particle size, beryllium compound solubility, and genetic variability in individuals' susceptibility to beryllium sensitization and CBD.
Chronic beryllium disease (CBD), formerly known as “berylliosis” or “chronic berylliosis,” is a granulomatous disorder primarily affecting the lungs. CBD was first described in the literature by Hardy and Tabershaw (1946) as a chronic granulomatous pneumonitis (Document ID 1516). It was proposed as early as 1951 that CBD could be a chronic disease resulting from sensitization to beryllium (Sterner and Eisenbud, 1951, Document ID 1396; Curtis, 1959 (1273); Nishimura, 1966 (1435)). However, for a time, there remained some controversy as to whether CBD was a delayed-onset hypersensitivity disease or a toxicant-induced disease (NAS, 2008, Document ID 1355). Wide acceptance of CBD as a hypersensitivity lung disease did not occur until bronchoscopy studies and bronchoalveolar lavage (BAL) studies were performed demonstrating that BAL cells from CBD patients responded to beryllium challenge (Epstein
CBD shares many clinical and histopathological features with pulmonary sarcoidosis, a granulomatous lung disease of unknown etiology. These similarities include such debilitating effects as airway obstruction, diminishment of physical capacity associated with reduced lung function, possible depression associated with decreased physical capacity, and decreased life expectancy. Without appropriate information, CBD may be difficult to distinguish from sarcoidosis. It is estimated that up to 6 percent of all patients diagnosed with sarcoidosis may actually have CBD (Fireman
Clinical signs and symptoms of CBD may include, but are not limited to, a simple cough, shortness of breath or dypsnea, fever, weight loss or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats, cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes or loss of pulmonary function also occur with CBD such as decrease in vital capacity, reduced diffusing capacity, and restrictive breathing patterns. The signs and symptoms of CBD constitute a continuum of symptoms that are progressive in nature with no clear demarcation between any stages in the disease (Pappas and Newman, 1993, Document ID 1433; Rossman, 1996 (1283); NAS, 2008 (1355)). These symptoms are consistent with the CBD symptoms described during the public hearing by Dr. Kristin Cummings of NIOSH and Dr. Lisa Maier of National Jewish Health (Document ID 1755, Tr. 70-71; 1756, Tr. 105-107).
Besides these listed symptoms from CBD patients, there have been reported cases of CBD that remained asymptomatic (Pappas and Newman, 1993, Document ID 1433; Muller-Querheim, 2005 (1262); NAS, 2008 (1355); NIOSH, 2011 (0544)). Asymptomatic CBD refers to those patients that have physiological changes upon clinical evaluation yet exhibit no outward signs or symptoms (also referred to as subclinical CBD).
Unlike ABD, CBD can result from inhalation exposure to beryllium at levels below the preceding OSHA PEL, can take months to years after initial beryllium exposure before signs and symptoms of CBD occur (Newman 1996, Document ID 1283, 2005 (1437) and 2007 (1335); Henneberger, 2001 (1313); Seidler
In contrast to some occupationally related lung diseases, the early detection of chronic beryllium disease may be useful since treatment of this condition can lead not only to regression of the signs and symptoms, but also may prevent further progression of the disease in certain individuals (Marchand-Adam
A study by Pappas and Newman (1993) observed that patients with known prior beryllium exposure and identified as confirmed positive for beryllium sensitization through the beryllium lymphocyte proliferation test (BeLPT) screening were evaluated for physiological changes in the lung. Pappas and Newman categorized the patients as being either “clinically identified,” meaning they had known physiological abnormalities (
OSHA was unable to find any controlled studies to determine the optimal treatment for CBD (see Rossman, 1996, Document ID 1425; NAS 2008 (1355); Sood, 2009 (0456)), and none were added to the record during the public comment period. Management of CBD is generally modeled after sarcoidosis treatment. Oral corticosteroid treatment can be initiated in patients with evidence of disease (either by bronchoscopy or other diagnostic measures before progression of disease or after clinical signs of pulmonary deterioration occur). This includes treatment with other anti-inflammatory agents (NAS, 2008. Document ID 1355; Maier
Sensitization to beryllium is an essential step for worker development of CBD. Sensitization to beryllium can result from inhalation exposure to beryllium (Newman
Sensitization is currently detected using the BeLPT (a laboratory blood test) described in section V.D.5. Although there may be no clinical symptoms associated with beryllium sensitization, a sensitized worker's immune system has been activated to react to beryllium exposures such that subsequent exposure to beryllium can progress to serious lung disease (Kreiss
While various mechanisms or pathways may exist for beryllium sensitization, the most plausible mechanisms supported by the best available and most current science are discussed below. Sensitization occurs via the formation of a beryllium-protein complex (an antigen) that causes an immunological response. In some instances, onset of sensitization has been observed in individuals exposed to beryllium for only a few months (Kelleher
Beryllium presentation to the immune system is believed to occur either by direct presentation or by antigen processing. It has been postulated that beryllium must be presented to the immune system in an ionic form for cell-mediated immune activation to occur (Kreiss
Because of their strong positive charge, beryllium ions have the ability to haptenate and alter the structure of peptides occupying the antigen-binding cleft of major histocompatibility complex (MHC) class II on antigen-presenting cells (APC). The MHC class II antigen-binding molecule for beryllium is the human leukocyte antigen (HLA) with specific alleles (
Once the beryllium-MHC-APC complex is established, the complex binds to a T-cell receptor (TCR) on a naïve T-cell which stimulates the proliferation and accumulation of beryllium-specific CD4
As CD4
In summary, OSHA concludes that sensitization is a necessary and early functional change in the immune system that leads to the development of CBD.
The continued presence of residual beryllium in the lung leads to a T-cell maturation process. A large portion of beryllium-specific CD4
CD4
The development of granulomatous inflammation in the lung of CBD patients has been associated with the accumulation of beryllium responsive CD4
The cascade of events described above results in the formation of a noncaseating granulomatous lesion. Release of cytokines by the accumulating T cells leads to the formation of granulomatous lesions that are characterized by an outer ring of histiocytes surrounding non-necrotic tissue with embedded multi-nucleated giant cells (Saltini
Over time, the granulomas spread and can lead to lung fibrosis and abnormal
As previously mentioned, the uptake of beryllium may lead to an aberrant apoptotic process with rerelease of beryllium ions and continual stimulation of beryllium-responsive CD4
In summary, the persistent presence of beryllium in the lung of a sensitized individual creates a progressive inflammatory response that can culminate in the granulomatous lung disease, CBD.
Evidence from a variety of sources indicates genetic susceptibility may play an important role in the development of CBD in certain individuals, especially at levels low enough not to invoke a response in other individuals. Early occupational studies proposed that CBD was an immune reaction based on the high susceptibility of some individuals to become sensitized and progress to CBD and the lack of CBD in others who were exposed to levels several orders of magnitude higher (Sterner and Eisenbud, 1951, Document ID 1396). Recent studies have confirmed genetic susceptibility to CBD involves either, HLA variants, T-cell receptor clonality, tumor necrosis factor (TNF-α) polymorphisms and/or transforming growth factor-beta (TGF-β) polymorphisms (Fontenot
Potential sources of variation associated with genetic susceptibility have been investigated. Single Nucleotide Polymorphisms (SNPs) have been studied with regard to genetic variations associated with increased risk of developing CBD. SNPs are the most abundant type of human genetic variation. Polymorphisms in MHC class II and pro-inflammatory genes have been shown to contribute to variations in immune responses contributing to the susceptibility and resistance in many diseases including auto-immunity, beryllium sensitization, and CBD (McClesky
HLA-DPB1 (one of 2 subtypes of HLA-DP) with a glutamic acid at amino position 69 (Glu69) has been shown to confer increased risk of beryllium sensitization and CBD (Richeldi
In contrast, the HLA-DRB1 allele, which lacks Glu69, has also been shown to increase the risk of developing sensitization and CBD (Amicosante
TNF alpha (TNF-α) polymorphisms and TGF beta (TGF-β) polymorphisms have also been shown to confer a genetic susceptibility for developing CBD in certain individuals. TNF-α is a pro-inflammatory cytokine that may be associated with a more progressive form of CBD (NAS, 2008). Beryllium exposure has been shown to upregulate transcription factors AP-1 and NF-κB (Sawyer
Other genetic variations have been shown to be associated with increased risk of beryllium sensitization and CBD (NAS, 2008, Document ID 1355). These include TGF-β (Gaede
In addition to the genetic factors which may contribute to the susceptibility and severity of disease, other factors such as smoking and sex may play a role in the development of CBD (NAS, 2008, Document ID 1355). A recent longitudinal cohort study by Mroz
Sensitization to beryllium is currently detected in the workforce with the beryllium lymphocyte proliferation test (BeLPT), a laboratory blood test developed in the 1980s, also referred to as the LTT (Lymphocyte Transformation Test) or BeLTT (Beryllium Lymphocyte Transformation Test). In this test, lymphocytes obtained from either bronchoalveolar lavage fluid (the BAL BeLPT) or from peripheral blood (the blood BeLPT) are cultured
CBD can be detected at an asymptomatic stage by a number of techniques including bronchoalveolar lavage and biopsy (Cordeiro
CBD has a clinical spectrum ranging from evidence of beryllium sensitization and granulomas in the lung with little symptomatology to loss of lung function and end stage disease, which may result in the need for lung transplantation and decreased life expectancy. Unfortunately, there are very few published clinical studies describing the full range and progression of CBD from the beginning to the end stages and very few of the risk factors for progression of disease have been delineated (NAS, 2008, Document ID 1355). OSHA requested additional information in the NPRM, but no additional studies were added during the public comment period. Clinical management of CBD is modeled after sarcoidosis where oral corticosteroid treatment is initiated in patients who have evidence of progressive lung disease, although progressive lung disease has not been well defined (NAS, 2008, Document ID 1355). In advanced cases of CBD, corticosteroids are the standard treatment (NAS, 2008, Document ID 1355). No comprehensive studies have been published measuring the overall effect of removal of workers from beryllium exposure on sensitization and CBD (NAS, 2008, Document ID 1355) although this has been suggested as part of an overall treatment regime for CBD (Mapel
Materion commented that sensitization should be defined as a test result indicating an immunological sensitivity to beryllium without identifiable adverse health effects or other signs of illness or disability. It went on to say that, for these reasons, sensitization is not on a pathological continuum with CBD (Document ID 1661, pp. 4-7). Other commenters disagreed. NIOSH addressed whether sensitization should be considered an adverse health effect and said the following in their written hearing testimony:
Some have questioned whether BeS should be considered an adverse health effect. NIOSH views it as such, since it is a biological change in people exposed to beryllium that is associated with increased risk for developing CBD. BeS refers to the immune system's ability to recognize and react to beryllium. BeS is an antigen-specific cell mediated immunity to beryllium, in which CD4+ T cells recognize a complex composed of beryllium ion, self-peptide, and major histocompatibility complex (MHC) Class II molecule on an antigen-presenting cell [Falta
The American College of Occupational and Environmental Medicine (ACOEM) also commented that the term pathological “continuum” should only refer to signs and symptoms associated with CBD because some sensitized workers never develop CBD (Document ID 1685, p. 6). However, Dr. Newman, testifying on behalf of ACOEM, clarified that not all members of the ACOEM task force agreed:
So I hope I'm reflecting to you the range and variety of outcomes relating to this. My own view is that it's on a continuum. I do want to reflect back that the divided opinion among people on the ACOEM task force was that we should call it a spectrum because not everybody is necessarily lock step into a continuum that goes from sensitization to fatality. (Document ID 1756, Tr. 133).
OSHA agrees that not every sensitized worker develops CBD, and that other factors such as extent of exposure, particulate characteristics, and genetic susceptibility influence the development and progression of disease. The mechanisms by which beryllium sensitization leads to CBD are described in earlier sections and are supported by numerous studies (Newman
This section describes the human epidemiological data supporting the mechanistic overview of beryllium-induced disease in workers. It has been divided into reviews of epidemiological studies performed prior to development and implementation of the BeLPT in the late 1980s and after wide use of the BeLPT for screening purposes. Use of the BeLPT has allowed investigators to screen for beryllium sensitization and CBD prior to the onset of clinical symptoms, providing a more sensitive and thorough analysis of the worker population. The discussion of the studies has been further divided by manufacturing processes that may have similar exposure profiles. Table A.1 in the Supplemental Information for the Beryllium Health Effects Section summarizes the prevalence of beryllium sensitization and CBD, range of exposure measurements, and other salient information from the key epidemiological studies (Document ID 1965).
It has been well-established that beryllium exposure, either via inhalation or skin, may lead to beryllium sensitization, or, with inhalation exposure, may lead to the onset and progression of CBD. The available published epidemiological literature discussed below provides strong evidence of beryllium sensitization and CBD in workers exposed to airborne beryllium well below the preceding OSHA PEL of 2 μg/m
Some of the epidemiological studies presented in this section suffer from challenges common to many published epidemiological studies: Limitations in study design (particularly cross-sectional); small sample size; lack of personal and/or short-term exposure data, particularly those published before the late 1990s; and incomplete information regarding specific chemical form and/or particle characterization. Challenges that are specific to beryllium epidemiological studies include: uncertainty regarding the contribution of dermal exposure; use of various BeLPT protocols; a variety of case definitions for determining CBD; and use of various exposure sampling/assessment methods (
First reports of CBD came from studies performed by Hardy and Tabershaw (1946) (Document ID 1516). Cases were observed in industrial plants that were refining and manufacturing beryllium metal and beryllium alloys and in plants manufacturing fluorescent light bulbs (NAS, 2008, Document ID 1355). From the late 1940s through the 1960s, clusters of non-occupational CBD cases were identified around beryllium refineries in Ohio and Pennsylvania, and outbreaks in family members of beryllium factory workers were assumed to be from exposure to contaminated clothes (Hardy, 1980, Document ID 1514). It had been established that the risk of disease among beryllium workers was variable and generally rose with the levels of airborne concentrations (Machle
The difficulties in distinguishing lung disease caused by beryllium from other lung diseases led to the establishment of the BCR in 1952 to identify and track cases of ABD and CBD. A uniform diagnostic criterion was introduced in 1959 as a way to delineate CBD from sarcoidosis. Patient entry into the BCR required either: Documented past exposure to beryllium or the presence of beryllium in lung tissue as well as clinical evidence of beryllium disease (Hardy
The BCR listed the following criteria for diagnosing CBD (Eisenbud and Lisson, 1983, Document ID 1296):
(1) Establishment of significant beryllium exposure based on sound epidemiologic history;
(2) Objective evidence of lower respiratory tract disease and clinical course consistent with beryllium disease;
(3) Chest X-ray films with radiologic evidence of interstitial fibronodular disease;
(4) Evidence of restrictive or obstructive defect with diminished carbon monoxide diffusing capacity (DL
(5) Pathologic changes consistent with beryllium disease on examination of lung tissue; and
(6) Presence of beryllium in lung tissue or thoracic lymph nodes.
Prevalence of CBD in workers during the time period between the 1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson, 1983, Document ID 1296). In a 1969 study, Stoeckle
The criteria for diagnosis of CBD have evolved over time as more advanced diagnostic technology, such as the blood BeLPT and BAL BeLPT, has become available. More recent diagnostic criteria have both higher specificity than earlier methods and higher sensitivity, identifying subclinical effects. Recent studies typically use the following criteria (Newman
(1) History of beryllium exposure;
(2) Histopathological evidence of non-caseating granulomas or mononuclear cell infiltrates in the absence of infection; and
(3) Positive blood or BAL BeLPT (Newman
The availability of transbronchial lung biopsy facilitates the evaluation of the second criterion, by making histopathological confirmation possible in almost all cases.
A significant component for the identification of CBD is the demonstration of a confirmed abnormal BeLPT result in a blood or BAL sample (Newman, 1996, Document ID 1283). Since the development of the BeLPT in the 1980s, it has been used to screen beryllium-exposed workers for sensitization in a number of studies to be discussed below. The BeLPT is a non-invasive
Early versions of the BeLPT test had high variability, but the use of tritiated thymidine to identify proliferating cells has led to a more reliable test (Mroz
Screenings for beryllium sensitization have been conducted using the BeLPT in several occupational surveys and surveillance programs, including nuclear weapons facilities operated by the Department of Energy (Viet
In order to investigate the reliability and laboratory variability of the BeLPT, Stange
The Middleton
Still, there has been criticism regarding the reliability and specificity of the BeLPT as a screening tool and that the BeLPT has not been validated appropriately (Cher
Materion objected to OSHA treating “two or three uninterpretable or borderline abnormal BeLPT test results as confirmation of BeS for the purposes of the standard” (Document ID 1808, p. 4). In order to address some criticism regarding the PPV of the BeLPT, Middleton
Materion further contended that “[w]hile some refer to BeLPT testing as a `gold' standard for BeS, it is hardly `golden,' as numerous commentators have noted.” (Document ID 1808, p. 4). NIOSH submitted testimony to OSHA comparing the use of the BeLPT for determining beryllium sensitization to other common medical screening tools such as mammography for breast cancer, tuberculin skin test for latent tuberculosis infection, prostate-specific antigen (PSA) for prostate cancer, and fecal occult blood testing for colon cancer. NIOSH stated that “[a]lthough there is no gold standard test to identify beryllium sensitization, BeLPT has been estimated to have a sensitivity of 66-86% and a specificity of >99% for sensitization [Middleton
Since there are currently no alternatives to the BeLPT in a beryllium sensitization screening program, many programs rely on a second test to confirm a positive result (NAS, 2008). Various expert organizations support the use of the BeLPT (with a second confirmational test) as a screening tool for beryllium sensitization and CBD. The American Thoracic Society (ATS), based on a systematic review of the literature, noted that “the BeLPT is the cornerstone of medical surveillance” (Balmes
The epidemiological studies presented in this section utilized the BeLPT as either a surveillance tool or a screening tool for determining sensitization status and/or sensitization/CBD prevalence in workers for inclusion in the published studies. Most epidemiological studies have reported rates of sensitization and disease based on a single screening of a working population (“cross-sectional” or “population prevalence” rates). Studies of workers in a beryllium machining plant and a nuclear weapons facility have included follow-up of the population originally screened, resulting in the detection of additional cases of sensitization over several years (Newman
Mining and extraction of beryllium usually involves the two major beryllium minerals, beryl (an aluminosilicate containing up to 4 percent beryllium) and bertrandite (a beryllium silicate hydrate containing generally less than 1 percent beryllium) (WHO, 2001, Document ID 1282). The United States is the world leader in beryllium extraction and also leads the world in production and use of beryllium and its alloys (WHO, 2001, Document ID 1282). Most exposures from mining and extraction come in the form of beryllium ore, beryllium salts, beryllium hydroxide (NAS, 2008, Document ID 1355) or beryllium oxide (Stefaniak
Deubner
There was no sensitization or CBD among those who worked only at the mine where exposure to beryllium resulted solely from working with bertrandite ore. The authors concluded that the results of this study indicated that beryllium ore and salts may pose less of a hazard than beryllium metal and beryllium hydroxide. These results are consistent with the previously discussed animal studies examining solubility and particle size.
Kreiss
The authors characterized exposures at the plant using industrial hygiene (IH) samples collected between 1980 and 1993. The exposure samples and the plant's formulas for estimating workers' DWA exposures were used, together with study participants' work histories, to estimate their cumulative and average beryllium exposure levels. Exposure concentrations reflected the high exposures found historically in beryllium production and processing. Short-term BZ measurements had a median of 1.4 μg/m
Of 655 workers employed at the time of the study, 627 underwent BeLPT screening. Blood samples were divided and split between two labs for analysis, with repeat testing for results that were abnormal or indeterminate. Thirty-one workers had an abnormal blood test result upon initial testing and at least one of two subsequent test results for each of those workers confirmed the worker as sensitized. These workers, together with 19 workers who had an initial abnormal result and one subsequent indeterminate result, were offered clinical evaluation for CBD including the BAL-BeLPT and transbronchial lung biopsy. Nine workers with an initial abnormal test followed by two subsequent normal tests were not clinically evaluated, although four were found to be sensitized upon retesting in 1995. Of 47 workers who proceeded with evaluation for CBD (3 of the 50 initial workers with abnormal results declined to participate), 24 workers were diagnosed with CBD based on evidence of granulomas on lung biopsy (20 workers) or on other findings consistent with CBD (4 workers) (Kreiss
Kreiss
Bailey
In a cross-sectional/longitudinal hybrid study, Bailey
An enhanced preventive program including particle migration control, respiratory and dermal protection, and process enclosure was implemented in 2000, with continuing improvements made to the program in 2001, 2002-2004, and 2005. Workers hired during this period were longitudinally surveyed for sensitization using the BeLPT. Both the pre-program and program survey of worker sensitization status utilized split-sample testing to verify positive test results using the BeLPT. Of the total 660 workers employed at the production plant, 258 workers participated from the pre-program group while 290 participated from the program group (206 partial program, 84 full program). Prevalence comparisons of the pre-program and program groups (partial and full) were performed by calculating prevalence ratios. A 95 percent confidence interval (95 percent CI) was derived using a cohort study method that accounted for the variance in survey techniques (cross-sectional versus longitudinal) (Bailey
Rosenman
Rosenman
Blood samples for the BeLPT were collected from the former workers between 1996 and 2001 and were evaluated at a single laboratory. Individuals with an abnormal test result were offered repeat testing, and were classified as sensitized if the second test was also abnormal. Sixty workers with two positive BeLPTs and 50 additional workers with chest radiography suggestive of disease were offered clinical evaluation, including bronchoscopy with bronchial biopsy and BAL-BeLPT. Seven workers met both criteria. Only 56 (51 percent) of these workers proceeded with clinical evaluation, including 57 percent of those referred on the basis of confirmed abnormal BeLPT and 47 percent of those with abnormal radiographs (Document ID 1352).
Of the 577 workers who were evaluated for CBD, 32 (5.5 percent) with evidence of granulomas were classified as “definite” CBD cases (as identified by bronchoscopy). Twelve (2.1 percent) additional workers with positive BAL-BeLPT or confirmed positive BeLPT and radiographic evidence of upper lobe fibrosis were classified as “probable” CBD cases. Forty workers (6.9 percent) without upper lobe fibrosis who had confirmed abnormal BeLPT, but who were not biopsied or who underwent biopsy with no evidence of granuloma, were classified as sensitized without disease. It is not clear how many of those 40 workers underwent biopsy. Another 12 (2.1 percent) workers with upper lobe fibrosis and negative or unconfirmed positive BeLPT were classified as “possible” CBD cases. Nine additional workers who were diagnosed with CBD before the screening were included in some parts of the authors' analysis (Document ID 1352).
The authors reported a total prevalence of 14.5 percent for CBD (definite and probable) and sensitization. This rate, considerably higher than the overall prevalence of sensitization and disease in several other worker cohorts as described earlier in this section, reflects in part the very high exposures experienced by many workers during the plant's operation in the 1950s, 1960s and 1970s. A total of 115 workers had mean DWAs above the preceding OSHA PEL of 2 μg/m
Although most of the workers in this study had high exposures, sensitization and CBD also were observed within the small subgroup of participants believed to have relatively low beryllium exposures. Thirty-three cases of CBD and 24 additional cases of sensitization occurred among 339 workers with mean DWA exposures below OSHA's PEL of 2.0 μg/m
Follow-up time for sensitization screening of workers in this study who became sensitized during their employment had a minimum of 20 years to develop CBD prior to screening. In this sense the cohort is especially well suited to compare the exposure patterns of workers with CBD and those sensitized without disease, in contrast to several other studies of workers with only recent beryllium exposures. Rosenman
Cumulative, mean, peak, and duration of exposure were found to be comparable for workers with CBD and workers without sensitization or CBD (“normal” workers). Cumulative, peak, and duration of exposure were significantly lower for sensitized workers without disease than for normal workers. Rosenman
A follow-up was conducted of the cross-sectional study of a population of workers first evaluated by Kreiss
In the companion study by Virji
Newman
Engineering and administrative controls, rather than PPE, were primarily used to control beryllium exposures at the plant (Madl
All workers at the plant participated in a beryllium disease surveillance program initiated in 1994, and were screened for beryllium sensitization with the BeLPT beginning in 1995. A BeLPT result was considered abnormal if two or more of six stimulation indices exceeded the normal range (see section
Kelleher
Twenty workers with beryllium sensitization or CBD (cases) were compared to 206 workers (controls) for the case-control analysis from the study evaluating workers originally conducted by Newman
Kelleher
Citing an 11.5 percent prevalence of beryllium sensitization or CBD among machinists as compared with 2.9 percent prevalence among workers with no machinist work history, the authors concluded that the risk of sensitization and CBD is increased among workers who machine beryllium. Although differences between cases and controls in median cumulative exposure did not achieve conventional thresholds for statistical significance, the authors noted that cumulative exposures were consistently higher among cases than controls for all categories of exposure estimates and for all particle sizes, suggesting an effect of cumulative exposure on risk. The levels at which workers developed CBD and sensitization were predominantly below OSHA's preceding PEL of 2 μg/m
In 2007, Madl
Based on the history of the plant's control efforts and their analysis of historical IH data, Madl
Based on their estimates of workers' upper level exposures, Madl
Kreiss
BeLPT tests were administered to all 505 participants in the 1989-1990 screening period and evaluated at a single lab. Seven workers had confirmed abnormal BeLPT results and were identified as sensitized; these workers were also diagnosed with CBD based on findings of granulomas upon clinical evaluation. Radiograph screening led to clinical evaluation and diagnosis of two additional CBD cases, who were among three participants with initially abnormal BeLPT results that could not be confirmed on repeat testing. In addition, nine workers had been previously diagnosed with CBD, and another five were diagnosed shortly after the screening period, in 1991-1992.
Eight of the 9 CBD cases identified in the screening population were hired before the plant stopped producing beryllium ceramics in 1975, and were among the 216 participants who had reported having been near or exposed to beryllium dust. Particularly high CBD rates of 11.1 to 15.8 percent were found among screening participants who had worked in process development/engineering, dry pressing, and ventilation maintenance jobs believed to have high or uncontrolled dust exposure. One case (0.6 percent) of CBD was diagnosed among the 171 study participants who had been hired after the plant stopped producing beryllium ceramics. Although this worker was hired eight years after the end of ceramics production, he had worked in an area later found to be contaminated with beryllium dust. The authors concluded that the study results suggested an exposure-response relationship between beryllium exposure and CBD, and recommended beryllium exposure control to reduce workers' risk of CBD.
Kreiss
One hundred thirty-six of the 139 workers employed at the plant at the time of the Kreiss
Kreiss
In 1998, Henneberger
The authors estimated workers' cumulative, average, and peak beryllium exposures based on the plant's formulas for estimating job-specific DWA exposures, participants' work histories, and area and short-term task-specific BZ samples collected from the start of full production at the plant in 1981 to 1998. The long-term workers, who were hired before the 1992 study was conducted, had generally higher estimated exposures (median—0.39 μg/m
Fifteen cases of sensitization were found in the 151 study participants (15/151; 9.9%), including seven among short-term (7/74; 9.5%) and eight among long-term workers (8/77; 10.4%). There were eight cases of CBD (8/151; 5.3%) identified in the study. One sensitized short-term worker developed CBD (1/74; 1.4%). Seven of the eight sensitized long-term workers developed CBD (7/77; 9.1%). The other sensitized long-term worker declined to participate in the clinical evaluation.
Henneberger
The cumulative incidence of sensitization and CBD was investigated in a cohort of 136 workers at the beryllium ceramics plant previously studied by the Kreiss and Henneberger groups (Schuler
Following the 1998 survey, the company continued efforts to reduce exposures and risk of sensitization and CBD by implementing additional engineering, administrative, and PPE measures (Cummings
To test the efficacy of the new measures instituted after 1998, in January 2000 the company began screening new workers for sensitization at the time of hire and at 3, 6, 12, 24, and 48 months of employment. These more stringent measures appear to have substantially reduced the risk of sensitization among new employees. Of 126 workers hired between 2000 and 2004, 93 completed BeLPT testing at hire and at least one additional test at 3 months of employment. One case of sensitization was identified at 24 months of employment (1 percent of 126 workers). This worker had experienced a rash after an incident of dermal exposure to lapping fluid through a gap between his glove and uniform sleeve, indicating that he may have become sensitized via the skin. He was tested again at 48 months of employment, with an abnormal result.
A second worker in the 2000-2004 group had two abnormal BeLPT tests at the time of hire, and a third had one abnormal test at hire and a second abnormal test at 3 months. Both had normal BeLPTs at 6 months, and were not tested thereafter. A fourth worker had one abnormal BeLPT result at the time of hire, a normal result at 3 months, an abnormal result at 6 months, and a normal result at 12 months. Four additional workers had one abnormal result during surveillance, which could not be confirmed upon repeat testing.
Cummings
The authors also estimated an incidence rate (IR) of 5.6 per 1,000 person-months for workers hired between 1993 and the 1998 survey. This estimated IR was based on one BeLPT screening, rather than BeLPTs conducted throughout the workers' employment. The denominator in this case was the total months of employment until the 1998 screening. Because sensitized workers may have been sensitized prior to the screening, the denominator may overestimate sensitization-free time in the legacy group, and the actual sensitization IR for legacy workers may be somewhat higher than 5.6 per 1,000 person-months. Based on comparison of the IRs, the authors concluded that the addition of respirator use, dermal protection, and particle migration control (housekeeping) improvements appeared to have reduced the risk of sensitization among workers at the plant, even though airborne beryllium levels in some areas of the plant had not changed significantly since the 1998 survey.
Schuler
Following the 1999 diagnosis of a worker with CBD, the company surveyed the workforce, offering all current employees BeLPT testing in 2000 and offering sensitized workers clinical evaluation for CBD, including BAL and transbronchial biopsy. Of the facility's 185 employees, 152 participated in the BeLPT screening. Samples were split between two laboratories, with additional draws and testing for confirmation if conflicting tests resulted in the initial draw. Ten participants (7 percent) had at least two abnormal BeLPT results. The results of nine workers who had abnormal BeLPT results from only one laboratory were not included because the authors believed the laboratory was experiencing technical problems with the test (Schuler
Schuler
The authors reported that eight of the ten sensitized employees, including all six CBD cases, had worked in both major production areas during their tenure with the plant. The 7 percent prevalence (6 of 81 workers) of CBD among employees who had ever worked in rod and wire was statistically significantly elevated compared with employees who had never worked in rod and wire (p <0.05), while the 6 percent prevalence (6 of 94 workers) among those who had worked in strip metal was not significantly elevated compared to workers who had never worked in strip metal (p > 0.1). Based on these results, together with the higher exposure levels reported for the rod and wire production area, Schuler
As has been seen in other studies, beryllium sensitization and CBD were found among workers who were typically exposed to low time-weighted average airborne concentrations of beryllium. While jobs in the rod and wire area had the highest exposure levels in the plant, the median personal sample value was only 0.12 μg/m
After the BeLPT screening was conducted in 2000, the company began implementing new measures to further reduce workers' exposure to beryllium (Thomas
To test the efficacy of the new measures in preventing sensitization and CBD, in June 2000 the facility began an intensive BeLPT screening program for all new workers. The company screened workers at the time of hire; at intervals of 3, 6, 12, 24, and 48 months;
Thomas
Stanton
Stanton
Eighty-eight of the 100 workers (88 percent) employed at the three centers at the time of the study participated in screening for beryllium sensitization. Blood samples were collected between November 2000 and March 2001 by the company's medical staff. Samples collected from employees of the strip metal centers were split and evaluated at two laboratories, while samples from the bulk product center workers were evaluated at a single laboratory. Participants were considered to be “sensitized” to beryllium if two or more BeLPT results, from two laboratories or from repeat testing at the same laboratory, were found to be abnormal. One individual was found to be sensitized and was offered clinical evaluation, including BAL and fiberoptic bronchoscopy. He was found to have lung granulomas and was diagnosed with CBD.
The worker diagnosed with CBD had been employed at a strip metal distribution center from 1978 to 2000 as a shipper and receiver, loading and unloading trucks delivering materials from a beryllium production facility and to the distribution center's customers. Although the LP samples collected for his job between 1996 and 2000 were generally low (n = 35, median 0.01 µg/m
Primary exposure from nuclear weapons production facilities comes from beryllium metal and beryllium alloys. A study conducted by Kreiss
Kreiss
In 1991, the Beryllium Health Surveillance Program (BHSP) was established at the Rocky Flats Nuclear Weapons Facility to offer BeLPT screening to current and former employees who may have been exposed to beryllium (Stange
Stange
Viet
Estimated mean and cumulative exposure levels and duration of employment were found to be significantly higher for CBD cases than for controls. Estimated mean exposure levels were significantly higher for sensitization cases than for controls but no significant difference was observed for estimated cumulative exposure or duration of exposure. Similar results were found using logistic regression analysis, which identified statistically significant relationships between CBD and both cumulative and mean estimated exposure, but did not find significant relationships between estimated exposure levels and sensitization without CBD. Comparing CBD with sensitization cases, Viet
Johnson
Arjomandi
The mean duration of employment at the facility was 18 years, and the mean latency period (from first possible exposure) to time of evaluation and diagnosis was 32 years. There was no available exposure monitoring in the breathing zone of workers at the facility, but the authors believed beryllium levels were relatively low (possibly less than 0.1 μg/m
Bauxite ore, the primary source of aluminum, contains naturally occurring beryllium. Worker exposure to beryllium can occur at aluminum smelting facilities where aluminum extraction occurs via electrolytic reduction of aluminum oxide into aluminum metal. Characterization of beryllium exposures and sensitization prevalence rates were examined by Taiwo
Of the 3,185 workers determined to be potentially exposed to beryllium, 1,932 (60 percent) agreed to participate in a medical surveillance program between 2000 and 2006. The medical surveillance program included BeLPT analysis, confirmation of an abnormal BeLPT with a second BeLPT, and follow-up of all confirmed positive BeLPT results by a pulmonary physician to evaluate for progression to CBD.
Eight-hour TWA exposures were assessed utilizing 1,345 personal samples collected from the 9 smelters. The personal beryllium samples obtained showed a range of 0.01-13.00 μg/m
The authors concluded that compared with beryllium-exposed workers in other industries, the rate of sensitization among aluminum smelter workers appears lower. The authors speculated that this lower observed rate could be related to a more soluble form of beryllium found in the aluminum smelting work environment as well as the consistent use of respiratory protection. However, the authors also speculated that the low participation rate of 60 percent may have underestimated the sensitization rate in this worker population.
A study by Nilsen
This section reviews the relevant animal studies supporting the biological mechanisms outlined above. In order for an animal model to be useful for investigating the mechanisms underlying the development of CBD, the model should include: The demonstration of a beryllium-specific immune response; the formation of immune granulomas following inhalation exposure to beryllium; and progression of disease as observed in human disease. While exposure to beryllium has been shown to cause chronic granulomatous inflammation of the lung in animal studies using a variety of species, most of the granulomatous lesions were not immune-induced reactions (which would predominantly consist of T-cells or lymphocytes), but were foreign-body-induced reactions, which predominantly consist of macrophages and monocytes, with only a small numbers of lymphocytes. Although no single model has completely mimicked the disease process as it progresses in humans, animal studies have been useful in providing biological plausibility for the role of immunological alterations and lung inflammation and in clarifying certain specific mechanistic aspects of beryllium disease, such as sensitization and CBD. However, there is no dependable animal model that mimics all facets of the human response, and studies thus far have been limited by single dose experiments, too few animals, or abbreviated observation periods. Therefore, the utility of this data is limited. The following is a discussion of the most relevant animal studies regarding the mechanisms of sensitization and CBD development in humans. Table A.2 in the Supplemental Information for the Beryllium Health Effects Section summarizes species, route, chemical form of beryllium, dose levels, and pathological findings of the key studies (Document ID 1965).
Harmsen
BAL content was collected at 30, 60, 90, 180, and 210 days after exposure, and lavage fluid and cellular content was evaluated for neutrophilic and lymphocytic infiltration. In addition, BAL cells were evaluated at the 210 day period to determine activation potential by phytohemagglutinin (PHA) or beryllium sulfate as mitogen. BAL neutrophils were significantly elevated only at 30 days with exposure to either dose of 500 °C beryllium oxide. BAL lymphocytes were significantly elevated at all time points of the high dose of beryllium oxide. No significant effect of 1,000 °C beryllium oxide exposure on mitogenic response of any lymphocytes was seen. In contrast, peripheral blood lymphocytes from the 500 °C beryllium oxide exposed groups were significantly stimulated by beryllium sulfate compared with the phytohemagglutinin exposed cells. Only the BAL lymphocytes from animals exposed to the 500 °C beryllium oxide responded to stimulation by either PHA or beryllium sulfate.
In a series of studies, Haley
Haley
In a follow-up experiment, control dogs and those exposed to beryllium oxide calcined at 500 °C were allowed to rest for 2.5 years, and then re-exposed to filtered air (controls) or beryllium oxide calcined at 500 °C (cases) for an initial lung burden target of 50 μg beryllium oxide/kg body weight (Haley
In a comparison study of dogs and monkeys, Conradi
A 1994 study by Haley
As discussed earlier in this Health Effects section, at the cellular level, beryllium dissolution may be necessary in order for either a dendritic cell or a macrophage to present beryllium as an antigen to induce the cell-mediated CBD immune reactions (NAS, 2008, Document ID 1355). Several studies have shown that low-fired beryllium oxide, which is predominantly made up of poorly crystallized small particles, is more immunologically reactive than beryllium oxide calcined at higher firing temperatures that result in less reactivity due to increasing crystal size (Stefaniak
In a later study, beryllium metal appeared to induce a greater toxic response than beryllium oxide following intrabronchiolar instillation in cynomolgus monkeys, as evidenced by more severe lung lesions, a larger effect on BAL lymphocyte counts, and a positive response in the BeLPT with BAL lymphocytes only after exposure to beryllium metal (Haley
Genetic studies in humans led to the creation of an animal model containing different human HLA-DP alleles inserted into FVB/N mice for mechanistic studies of CBD. Three strains of genetically engineered mice (transgenic mice) were created that conferred different risks for developing CBD based on human studies (Weston
In order to validate the transgenic model, Tarantino-Hutchison
There is substantial evidence that skin and inhalation exposure to beryllium may lead to sensitization (section V.D.1) and that inhalation exposure, or skin exposure coupled with inhalation exposure, may lead to the onset and progression of CBD (section V.D.2). These conclusions are supported by extensive human studies (section V.D.5). While all facets of the biological mechanism for this complex disease have yet to be fully elucidated, many of the key events in the disease sequence have been identified and described in the earlier sections (sections V.D.1-5). Sensitization is considered to be a necessary first step to the onset of CBD (NAS, 2008, Document ID 1355; ERG, 2010 (1270)). Sensitization is the process by which the immune system recognizes beryllium as a foreign substance and responds in a manner that may lead to development of CBD. It has been documented that a substantial proportion of sensitized workers exposed to airborne beryllium can progress to CBD (Rosenman
The epidemiological evidence presented in section V.D.5 demonstrates that sensitization and CBD are continuing to occur from exposures below OSHA's preceding PEL. The prevalence of sensitization among beryllium-exposed workers, as measured by the BeLPT and reported in 16 surveys of occupationally exposed cohorts reviewed by the Agency, ranged from 0.3 to 14.5 percent (Deubner
Longitudinal studies of sensitized workers found early signs of asymptomatic CBD that can progress to clinical disease in some individuals. One study found that 31 percent of beryllium-exposed sensitized employees progressed to CBD with an average follow-up time of 3.8 years (Newman, 2005, Document ID 1437). However, Newman (2005) went on to suggest that if follow-up times were much longer, the rate of progression from
A study of sensitized workers believed to have been exposed to low levels of airborne beryllium metal (
Beryllium exposure is associated with a variety of adverse health effects, including lung cancer. The potential for beryllium and its compounds to cause cancer has been previously assessed by various other agencies (EPA, ATSDR, NAS, NIEHS, and NIOSH), with each agency identifying beryllium as a potential carcinogen. In addition, IARC did an extensive evaluation in 1993 (Document ID 1342) and reevaluation in April 2009 (IARC, 2012, Document ID 0650). In brief, IARC determined beryllium and its compounds to be carcinogenic to humans (Group 1 category), while EPA considers beryllium to be a probable human carcinogen (EPA, 1998, Document ID 0661), and the National Toxicology Program (NTP) classifies beryllium and its compounds as known carcinogens (NTP, 2014, Document ID 0389). OSHA has conducted an independent evaluation of the carcinogenic potential of beryllium and these compounds. The following is a summary of the studies used to support the Agency's finding that beryllium and its compounds are human carcinogens.
Genotoxicity can be an important indicator for screening the potential of a material to induce cancer and an important mechanism leading to tumor formation and carcinogenesis. In a review conducted by the National Academy of Science, beryllium and its compounds have tested positively in nearly 50 percent of the genotoxicity studies conducted without exogenous metabolic activity. However, they were found to be non-genotoxic in most bacterial assays (NAS, 2008, Document ID 1355).
Non-mammalian test systems (generally bacterial assays) are often used to identify genotoxicity of a compound. In bacteria studies evaluating beryllium sulfate for mutagenicity, all studies performed utilizing the Ames assay (Simmon, 1979, Document ID 0434; Dunkel
Mutations using
Data from
In summary, genetic mutations have been observed in mammalian systems (
This section describes the human epidemiological data supporting the mechanistic overview of beryllium-induced lung cancer in workers. It has been divided into reviews of epidemiological studies by industry and beryllium form. The epidemiological studies utilizing data from the BCR, in general, focus on workers mainly exposed to soluble forms of beryllium. Those studies evaluating the epidemiological evidence by industry or process are, in general, focused on exposures to poorly soluble or mixed (soluble and poorly soluble) compounds. Table A.3 in the Supplemental Information for the Beryllium Health Effects Section summarizes the important features and characteristics of each study discussed herein (Document ID 1965).
Two studies evaluated participants in the BCR (Infante
Steenland and Ward (1991) (Document ID 1400) extended the work of Infante
Several epidemiological cohort studies have reported excess lung cancer mortality among workers employed in U.S. beryllium production and processing plants during the 1930s to 1960s.
Bayliss
Mancuso (1970, Document ID 1453; 1979, (0529); 1980 (1452)) and Mancuso and El-Attar (1969) (Document ID 1455) performed a series of occupational cohort studies on a group of workers (primarily white males) employed in the beryllium manufacturing industry during 1937-1948. The cohort identified in Mancuso and El-Attar (1969) was a study of 3,685 workers (primarily white males) while Mancuso (1970, 1976, 1980) continued the study follow-up with 3266 workers due to several limitations in identifying specific causes for mortality as identified in Mancuso and El-Attar (1969). The beryllium production facilities were located in Ohio and Pennsylvania and the records for the employees, including periods of employment, were obtained from the Social Security Administration. These studies did not include analyses of mortality by job title or exposure category (exposure data was taken from a study by Zielinsky
Wagoner
One occupational nested case-control study evaluated lung cancer mortality in a cohort of 3,569 male workers employed at a beryllium alloy production plant in Reading, PA, from 1940 to 1969 and followed through 1992 (Sanderson
The largest and most comprehensive study investigated the mortality experience of 9,225 workers employed in 7 different beryllium processing plants over a 30-year period (Ward
A different analysis of the lung cancer mortality in this cohort using various local reference populations and alternate adjustments for smoking generally found smaller, non-significant rates of excess mortality among the beryllium-exposed employees (Levy
Levy
The EPA Integrated Risk Information System (IRIS), IARC, and California EPA Office of Environmental Health Hazard Assessment (OEHHA) all based their cancer assessments on the Ward
Sanderson
Results of a conditional logistic regression analysis indicated that there was an increased risk of lung cancer in workers with higher exposures when dose estimates were lagged by 10 and 20 years (Sanderson
Schubauer-Berigan
Unadjusted analyses showed little evidence of lung cancer risk associated with beryllium occupational exposure using cumulative exposure until a 20-year lag was used. Adjusting for either birth cohort or hire age attenuated the risk for lung cancer associated with cumulative exposure. Using a 10- or 20-year lag in workers born after 1900 also showed little evidence of lung cancer risk, while those born prior to 1900 did show a slight elevation in risk. Unlagged and lagged analysis for average exposure showed an increase in lung cancer risk associated with occupational exposure to beryllium. The finding was consistent for either workers adjusted or unadjusted for birth cohort or hire age. Using a 10-year lag for average exposure showed a significant effect by birth cohort.
Schubauer-Berigan
Hollins
Schubauer-Berigan
Overall mortality in the cohort compared with the U.S. population was elevated for lung cancer (SMR 1.17; 95% CI 1.08 to 1.28), COPD (SMR 1.23; 95% CI 1.13 to 1.32), and the categories containing CBD (SMR 7.80; 95% CI 6.26 to 9.60) and cor pulmonale (SMR 1.17; 95% CI 1.08 to 1.26) (Schubauer-Berigan
The authors concluded that the findings from this reanalysis reaffirmed that lung cancer and CBD are related to beryllium exposure. The authors went on to suggest that beryllium exposures may be associated with nervous system and urinary tract cancers and that cigarette smoking and other lung carcinogens were unlikely to explain the increased incidences in these cancers. The study corrected an error that was discovered in the indirect smoking adjustment initially conducted by Ward
A study by Boffetta
To summarize, most of the epidemiological studies reviewed in this section show an elevated lung cancer rate in beryllium-exposed workers compared to control groups. While exposure data was incomplete in many studies inferences can be made based on industry profiles. Specifically, studies reviewing excess lung cancer in workers registered in the BCR found an elevated lung cancer rate in those patients identified as having acute beryllium disease (ABD). ABD patients are most closely associated with exposure to soluble forms of beryllium (Infante
Taken collectively, the Agency finds that the epidemiological data presented in the reviewed studies provides sufficient evidence to demonstrate carcinogenicity in humans of both soluble and poorly soluble forms of beryllium.
This section reviews the animal literature used to support the findings for beryllium-induced lung cancer. Early animal studies revealed that some beryllium compounds are carcinogenic when inhaled (ATSDR, 2002, Document ID 1371). Lung tumors have been induced via inhalation and intratracheal administration of beryllium to rats and monkeys, and osteosarcomas have been induced via intravenous and intramedullary (inside the bone) injection of beryllium in rabbits and mice. In addition to lung cancer,
In an inhalation study assessing the potential tumorigenicity of beryllium, Schepers
Schepers (1962) (Document ID 1414) reviewed 38 existing beryllium studies that evaluated seven beryllium compounds and seven mammalian species. Beryllium sulfate, beryllium fluoride, beryllium phosphate, beryllium alloy (BeZnMnSiO
In another study, Vorwald and Reeves (1959) (Document ID 1482) exposed Sherman albino rats via the inhalation route to aerosols of 0.006 mg beryllium/m
In the first of two articles, Reeves
The animals entered the exposure chamber at 6 weeks of age and were exposed 7 hours per day/5 days per week for up to 2,400 hours of total exposure time. An equal number of unexposed controls were held in a separate chamber. Three male and three female rats were sacrificed monthly during the 72-week exposure period. Mortality due to respiratory or other infections did not appear until 55 weeks of age, and 87 percent of all animals survived until their scheduled sacrifices.
Average lung weight towards the end of exposure was 4.25 times normal with progressively increasing differences between control and exposed animals. The increase in lung weight was accompanied by notable changes in tissue texture with two distinct pathological processes—inflammatory and proliferative. The inflammatory response was characterized by marked accumulation of histiocytic elements forming clusters of macrophages in the alveolar spaces. The proliferative response progressed from early epithelial hyperplasia of the alveolar surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia (cellular dedifferentiation) (after 32-40 weeks of exposure), and finally to lung tumors.
Although the initial proliferative response occurred early in the exposure period, tumor development required considerable time. Tumors were first identified after nine months of beryllium sulfate exposure, with rapidly increasing rates of incidence until tumors were observed in 100 percent of exposed animals by 13 months. The 9-to-13-month interval is consistent with earlier studies. The tumors showed a high degree of local invasiveness. No tumors were observed in control rats. All 56 tumors studied appeared to be alveolar adenocarcinomas and 3 were “fast-growing” tumors that reached a very large size comparatively early. About one-third of the tumors showed small foci where the histologic pattern differed. Most of the early tumor foci appeared to be alveolar rather than bronchiolar, which is consistent with the expected pathogenesis, since permanent deposition of beryllium was more likely on the alveolar epithelium rather than on the bronchiolar epithelium. Female rats appeared to have an increased susceptibility to beryllium exposure. Not only did they have a higher mortality (control males [n = 8], exposed males [n = 9] versus control females [n = 4], exposed females [n = 17]) and body weight loss than male rats, but the three “fast-growing” tumors occurred in females.
In the second article, Reeves
There was no apparent correlation between the extent and severity of pulmonary pathology and total lung load. However, when the beryllium content of the excised tumors was compared with that of surrounding nonmalignant pulmonary tissues, the former showed a notable decrease (0.50 ± 0.35 μg beryllium/gram versus 1.50 ± 0.55 μg beryllium/gram). This was believed to be largely a result of the dilution factor operating in the rapidly growing tumor tissue. However, other factors, such as lack of continued local deposition due to impaired respiratory function and enhanced clearance due to high vascularity of the tumor, may also have played a role. The portion of inhaled beryllium retained in the lungs for a longer duration, which is in the range of one-half of the original pulmonary load, may have significance for pulmonary carcinogenesis. This pulmonary beryllium burden becomes localized in the cell nuclei and may be an important factor in eliciting the carcinogenic response associated with beryllium inhalation.
Groth
To test this hypothesis, transplantation experiments involving the suspicious nodules were conducted in nine rats. Seven of the nine suspected tumors grew upon transplantation. All transplanted tumor types metastasized to the lungs of their hosts. Lung tumors were observed in rats injected with both the high and low doses of beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. No lung tumors were observed in rats injected with the other compounds. Of a total of 32 lung tumors detected, most were adenocarcinomas and adenomas; however, two epidermoid carcinomas and at least one poorly differentiated carcinoma were observed. Bronchiolar alveolar cell tumors were frequently observed in rats injected with beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. All stages of cuboidal, columnar, and squamous cell metaplasia were observed on the alveolar walls in the lungs of rats injected with beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. These lesions were generally reduced in size and number or absent from the lungs of animals injected with the other alloys (BeCu, BeCuCo, BeNi).
The extent of alveolar metaplasia could be correlated with the incidence of lung cancer. The incidences of lung tumors in the rats that received 2.5 mg of beryllium metal, and 2.5 and 0.5 mg of passivated beryllium metal, were significantly different (p ≤0.008) from controls. When autopsies were performed at the 16-to-19-month interval, the incidence (2/6) of lung tumors in rats exposed to 2.5 mg of beryllium-aluminum alloy was statistically significant (p = 0.004) when compared to the lung tumor incidence (0/84) in rats exposed to BeCu, BeNi, and BeCuCo alloys, which contained much lower concentrations of Be (Groth
Finch
Lung burdens of beryllium measured in wild-type mice at 7 days post exposure were approximately 70-90 percent of target levels. No exposure-related effects on body weight were observed in mice; however, lung weights and lung-to-body-weight ratios were somewhat elevated in 60 μg target ILB
During the public comment period Materion submitted correspondence from Dr. Finch speculating on the reason for the less-robust lung cancer response observed in mice (versus that observed in rats) (Document ID 1807, Attachment 11, p. 1). Materion contended that this was support for their assertion of evidence that “directly contradicts the claims that beryllium metal causes cancer in animals” (Document ID 1807, p. 6). OSHA reviewed this correspondence and disagrees with Materion's assertion. While Dr. Finch did suggest that the mouse lung cancer response was less robust, it was still present. Dr. Finch went on to suggest that while the rat has a more profound neutrophilic response (typical of a “foreign body response), the mouse has a lung response more typical of humans (neutrophilic and lymphocytic) (Document ID 1807, Attachment 11, p. 1).
Nickell-Brady
To examine genetic alterations, DNA isolation and sequencing techniques (PCR amplification and direct DNA sequence analysis) were performed on wild-type rat lung tissue (
No transforming mutations of the K-
Belinsky
The inactivation of the
Building on the rat model for lung cancer and associated findings from Swafford
The overall findings of this study suggest that inactivation of the
Wagner
As previously described, Conradi
To summarize, animal studies show that multiple forms of beryllium, when inhaled or instilled in the respiratory tract of rats, mice, and monkeys, lead to increased incidence of lung tumors. Animal studies have demonstrated a consistent scenario of beryllium exposure resulting in chronic pulmonary inflammation and tumor formation at levels below overload conditions (Groth
The exact mechanism by which beryllium induces pulmonary neoplasms in animals remains unknown (NAS 2008, Document ID 1355). Keshava
Keshava
Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph
In summary,
OSHA has determined that substantial evidence in the record indicates that beryllium compounds should be regarded as occupational lung carcinogens. Many well-respected scientific organizations, including IARC, NTP, EPA, NIOSH, and ACGIH, have reached similar conclusions with respect to the carcinogenicity of beryllium.
While some evidence exists for direct-acting genotoxicity as a possible mechanism for beryllium carcinogenesis, the weight of evidence suggests that an indirect mechanism, such as inflammation or other epigenetic changes, may be responsible for most tumorigenic activity of beryllium in animals and humans (IARC, 2012, Document ID 0650). Inflammation has been postulated to be a key contributor to many different forms of cancer (Jackson
In addition to a T-cell-mediated immunological response, beryllium has been demonstrated to produce an inflammatory response in animal models similar to the response produced by other particles (Reeves
It has been hypothesized that the recruitment of neutrophils during the inflammatory response and subsequent release of oxidants from these cells play an important role in the pathogenesis of rat lung tumors (Borm
During the public comment period OSHA received several comments on the carcinogenicity of beryllium. The NFFS agreed with OSHA that “the science is quite clear in linking these soluble Beryllium compounds” to lung cancer (Document ID 1678, p. 6). It also, however, contended that there is considerable scientific dispute regarding the carcinogenicity of beryllium metal (
The contentions of both Materion and NFFS regarding scientific findings from the EU is directly contradicted by the document submitted to the docket by the European Commission on Health, Safety and Hygiene at Work, discussed above. This document states that the European Chemicals Agency (ECHA) has determined that all forms of beryllium (soluble and poorly soluble) are carcinogenic (Category 1B) with the exception of aluminum beryllium silicates (which have not been allocated a classification) (Document ID 1692, pp. 2-3).
OSHA also disagrees with NFFS's other contention that there is a scientific dispute regarding the carcinogenicity of poorly soluble forms of beryllium. In coming to the conclusion that all forms of beryllium and beryllium compounds are carcinogenic, OSHA independently evaluated the scientific literature, including the findings of authoritative entities such as NIOSH, NTP, EPA, and IARC (see section V.E). The evidence from human, animal, and mechanistic studies together demonstrates that both soluble and poorly soluble beryllium compounds are carcinogenic (see sections V.E.2, V.E.3, V.E.4). The well-respected scientific bodies mentioned above came to the same conclusion: That both soluble and poorly soluble beryllium compounds are carcinogenic to humans.
As supporting documentation the NFFS submitted an “expert statement” by Strupp and Furnes (2010), which reviews the toxicological and epidemiological information regarding beryllium carcinogenicity. Based on select information in the scientific literature on lung cancer, the Strupp and Furnes (2010) study concluded that there was insufficient evidence in humans and animals to conclude that insoluble (poorly soluble) beryllium was carcinogenic (Document ID 1678, Attachment 1, pp. 21-23). Strupp and Furnes (2010) asserted that this was based on criteria established under
The Strupp and Furnes statement also did not include the more recent studies by Schubauer-Berigan
The Strupp (2011b) review of the epidemiological evidence for lung carcinogenicity of beryllium contained fundamental mischaracterizations of the findings of the NIOSH cohort and nested case-control studies (Ward
Strupp's epidemiology summary mentions two papers that were critical of the Sanderson
NIOSH went on to state that while the Sanderson
The Strupp and Furnes (2010) statement provided insufficient information on the extraction of beryllium metal for OSHA to fully evaluate the merit of the studies regarding potential genotoxicity of poorly soluble beryllium (Document ID 1678, Attachment 1, pp. 18-20). In addition, Strupp and Furnes did not consider the peer-reviewed published studies evaluating the genotoxicity of beryllium metal (see section V.E.1 and V.E.2).
In coming to the conclusion that the evidence is insufficient for classification under GHS, Strupp and Furnes failed to consider the full weight of evidence in their evaluation using the criteria set forth under Annex VI of Directive 67/548/EEC which establishes criteria for classification and labelling of hazardous substances under the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (Document ID 1678, attachment 1, pp. 21-23). Thus, the Agency concludes that the Strupp and Furnes statement does not constitute the best available scientific evidence for the evaluation of whether poorly soluble forms of beryllium cause cancer.
Materion also submitted comments indicating there is an ongoing scientific debate regarding the relevance of the rat lung tumor response to humans with respect to poorly soluble beryllium compounds (Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)), Materion contended that the increased lung cancer risk in beryllium-exposed animals is due to a particle overload phenomenon, in which lung clearance of beryllium particles initiates a non-specific neutrophilic response that results in intrapulmonary lung tumors. The materials cited by Materion as supportive of its argument—Obedorster (1995), a 2009 working paper to the UN Subcommittee on the Globally Harmonized System of Classification and Labelling of Chemicals (citing ILSI (2000) as supporting evidence for poorly soluble particles), Snipes (1996), the Health Risk Assessment Guidance for Metals, ICMM (2007), and ECETOC (2013)—discuss the inhalation of high exposure levels of poorly soluble particles in rats and the relevance of these studies to the human carcinogenic response (Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)). Using particles such as titanium dioxide, carbon black, non-asbestiform talc, coal dust, and diesel soot as models, ILSI (2000) and ECETOC (2013) describe studies that have demonstrated that chronic inhalation of poorly soluble particles can result in pulmonary inflammation, fibrosis, epithelial cell hyperplasia, and adenomas and carcinomas in rats at exposure levels that exceed lung clearance mechanisms (the “overload” phenomenon) (ILSI (2000)
However, these expert reports indicate that the “overload” phenomenon caused by biologically inert particles (poorly soluble particles of low cytotoxicity for which there is no evidence of genotoxicity) is relevant only to the rat species. (Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)). OSHA finds that this model is not in keeping with the data presented for beryllium for several reasons. First, beryllium has been shown to be a “biologically active” particle due to its ability to induce an immune response in multiple species including humans, has been shown to be genotoxic in certain mammalian test systems, and induces epigenetic changes (
In addition, IARC and NAS performed an extensive review of the available animal studies and their findings were supportive of the OSHA findings of carcinogenicity (IARC, 2012, Document ID 0650; NAS, 2008 (1355)). OSHA performed an independent evaluation as outlined in section V.E.3 and found sufficient evidence of tumor formation in multiple species (rats, mice, and monkeys) after inhalation at levels below overload conditions. The Agency has found evidence supporting the hypothesis that multiple mechanisms may be at work in the development of cancer in experimental animals and humans and cannot dismiss the roles of inflammation (neutrophilic and T-cell mediated), genotoxicity, and epigenetic factors (see section V.E.1, V.E. 3, V.E.4). After evaluating the best scientific evidence available from epidemiological and animal studies (see section V.E) OSHA concludes the weight of evidence supports a mechanistic finding that both soluble and poorly soluble forms of beryllium and beryllium-containing compounds are carcinogenic.
Past studies on other health effects have been thoroughly reviewed by several scientific organizations (NTP, 1999, Document ID 1341; EPA, 1998 (0661); ATSDR, 2002 (1371); WHO, 2001 (1282); HSDB, 2010 (0533)). These studies include summaries of animal studies,
Beryllium has been shown to accumulate in the liver and a correlation has been demonstrated between beryllium content and hepatic damage. Different compounds have been shown to distribute differently within the hepatic tissues. For example, in one study, beryllium phosphate accumulated almost exclusively within sinusoidal (Kupffer) cells of the liver, while beryllium sulfate was found mainly in parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes were rapidly excreted (Skilleter and Paine, 1979, Document ID 1410).
According to a few autopsies, beryllium-laden livers had central necrosis, mild focal necrosis and inflammation, as well as, occasionally, beryllium granuloma (Sprince
Severe cases of CBD can result in cor pulmonale, which is hypertrophy of the right heart ventricle. In a case history study of 17 individuals exposed to beryllium in a plant that manufactured fluorescent lamps, autopsies revealed right atrial and ventricular hypertrophy (Hardy and Tabershaw, 1946, Document ID 1516). It is not likely that these cardiac effects were due to direct toxicity to the heart, but rather were a response to impaired lung function. However, an increase in deaths due to heart disease or ischemic heart disease was found in workers at a beryllium manufacturing facility (Ward
Animal studies performed in monkeys indicate heart enlargement after acute inhalation exposure to 13 mg beryllium/m
Renal or kidney stones have been found in severe cases of CBD that resulted from high levels of beryllium exposure. Renal stones containing beryllium occurred in about 10 percent of patients affected by high exposures (Barnett
Soluble and poorly soluble beryllium compounds have been shown to cause ocular irritation in humans (VanOrdstrand
The mucosa (mucosal membrane) is the moist lining of certain tissues/organs including the eyes, nose, mouth, lungs, and the urinary and digestive tracts. Soluble beryllium salts have been shown to be directly irritating to mucous membranes (HSDB, 2010, Document ID 0533).
Several commenters suggested OSHA add dermal effects to this Health Effects section. National Jewish Health noted that rash and granulomatous reactions of the skin still occur in occupational settings (Document ID 1664, p. 5). The National Supplemental Screening Program also recommended including skin conditions such as dermatitis and nodules (Document ID 1677, p. 3). The American Thoracic Society also recommended including “beryllium sensitization, CBD, and skin disease as the major adverse health effects
As summarized in Epstein (1991), skin exposure to soluble beryllium compounds (mainly beryllium fluoride but also beryllium metal which may contain beryllium fluoride) resulted in irritant dermatitis with inflammation, and local edema. Beryllium oxide, beryllium alloys and nearly pure beryllium metal did not produce such responses in the skin of workers (Epstein, 1991, Document ID 0526). Skin lacerations or abrasions contaminated with soluble beryllium can lead to skin ulcerations (Epstein, 1991, Document ID 0526). Soluble and poorly soluble beryllium-compounds that penetrate the skin as a result of abrasions or cuts have been shown to result in chronic ulcerations and skin granulomas (VanOrdstrand
Through careful analysis of the best available scientific information outlined in this section, OSHA has determined that beryllium and beryllium-containing compounds can cause sensitization, CBD, and lung cancer. The Agency has determined through its review and evaluation of the studies outlined in section V.A.2 of this health effects section that skin and inhalation exposure to beryllium can lead to sensitization; and inhalation exposure, or skin exposure coupled with inhalation, can cause onset and progression of CBD. In addition, the Agency's review and evaluation of the studies outlined in section V.E. of this health effects section led to a finding that inhalation exposure to beryllium and beryllium-containing materials can cause lung cancer.
Through the biological and immunological processes outlined in section V.B. of the Health Effects, the Agency has concluded that the scientific evidence supports the following mechanisms for the development of sensitization and CBD.
• Inhaled beryllium and beryllium-containing materials able to be retained and solubilized in the lungs have the ability to initiate sensitization and facilitate CBD development (section V.B.5). Genetic susceptibility may play a role in the development of sensitization and progression to CBD in certain individuals.
• Beryllium compounds that dissolve in biological fluids, such as sweat, can penetrate intact skin and initiate sensitization (section V.A.2; V.B). Phagosomal fluid and lung fluid have the capacity to dissolve beryllium compounds in the lung (section V.A.2a).
• Sensitization occurs through a T-cell mediated process with both soluble and poorly soluble beryllium and beryllium-containing compounds through direct antigen presentation or through further antigen processing in the skin or lung. T-cell mediated responses, such as sensitization, are generally regarded as long-lasting (
• Beryllium sensitization and CBD are adverse events along a pathological continuum in the disease process with sensitization being the necessary first step in the progression to CBD (section V.D).
• Particle characteristics such as size, solubility, surface area, and other properties may play a role in the rate of development of beryllium sensitization and CBD. However, there is currently not sufficient information to delineate the biological role these characteristics may play.
• Animal studies have provided supporting evidence for T-cell proliferation in the development of granulomatous lung lesions after beryllium exposure (sections V.D.2; V.D.6).
• Since the pathogenesis of CBD involves a beryllium-specific, cell-mediated immune response, CBD cannot occur in the absence of beryllium sensitization (section V.D.1). While no clinical symptoms are associated with sensitization, a sensitized worker is at risk of developing CBD when inhalation exposure to beryllium has occurred. Epidemiological evidence that covers a wide variety of beryllium compounds and industrial processes demonstrates that sensitization and CBD are continuing to occur at present-day exposures below OSHA's preceding PEL (sections V.D.4; V.D.5 and section VI of this preamble).
• OSHA considers CBD to be a progressive illness with a continuous spectrum of symptoms ranging from its earliest asymptomatic stage following sensitization through to full-blown CBD and death (section V.D.7).
• Genetic variabilities appear to enhance risk for developing sensitization and CBD in some groups (section V.D.3).
In addition, epidemiological studies outlined in section V.D.5 have demonstrated that efforts to reduce exposures have succeeded in reducing the frequency of sensitization and CBD.
OSHA conducted an evaluation of the available scientific information regarding the carcinogenic potential of beryllium and beryllium-containing compounds (section V.E). Based on the weight of evidence and plausible mechanistic information obtained from
• Epidemiological cohort studies have reported statistically significant excess lung cancer mortality among workers employed in U.S. beryllium production and processing plants during the 1930s to 1970s (section V.E.2).
• Significant positive associations were found between lung cancer mortality and both average and cumulative beryllium exposures when appropriately adjusted for birth cohort and short-term work status (section V.E.2).
• Studies in which large amounts of different beryllium compounds were inhaled or instilled in the respiratory tracts in multiple species of laboratory animals resulted in an increased
• Authoritative scientific organizations, such as the IARC, NTP, and EPA, have classified beryllium as a known or probable human carcinogen (section V.E).
While OSHA has determined there is sufficient evidence of beryllium carcinogenicity, the Agency acknowledges that the exact tumorigenic mechanism for beryllium has yet to be determined. A number of mechanisms are likely involved, including chronic inflammation, genotoxicity, mitogenicity, oxidative stress, and epigenetic changes (section V.E.3).
• Studies of beryllium-exposed animals have consistently demonstrated chronic pulmonary inflammation after exposure (section V.E.3). Substantial data indicate that tumor formation in certain animals after inhalation exposure to poorly soluble particles at doses causing marked, chronic inflammation is due to a secondary mechanism unrelated to the genotoxicity of the particles (section V.E.5).
• A review conducted by the NAS (2008) (Document ID 1355) found that beryllium and beryllium-containing compounds tested positive for genotoxicity in nearly 50 percent of studies without exogenous metabolic activity, suggesting a possible direct-acting mechanism may exist (section V.E.1) as well as the potential for epigenetic changes (section V.E.4).
Other health effects are discussed in sections F of the Health Effects Section and include hepatic, cardiovascular, renal, ocular, and mucosal effects. The adverse systemic effects from human exposures mostly occurred prior to the introduction of occupational and environmental standards set in 1970-1973 (ACGIH, 1971, Document ID 0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA, 1973 (38 FR 8820)) and therefore are less relevant.
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 OSHA's practice to evaluate risk to workers and determine 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, assesses whether exposed workers' risks are significant, and determines whether a new or revised rule will substantially reduce these risks. As discussed in Section II, Pertinent Legal Authority, when determining whether a significant risk exists OSHA considers whether there is a risk of at least one-in-a-thousand of developing amaterial health impairment from a working lifetime of exposure at the prevailing OSHA standard (referred to as the “preceding standard” or “preceding TWA PEL” in this preamble). For this purpose, OSHA generally assumes that a term of 45 years constitutes a working life. The Supreme Court has found that OSHA is not required to support its finding of significant risk with scientific certainty, but may instead rely on a body of reputable scientific thought and may make conservative assumptions (
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 its 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.
OSHA's approach for the risk assessment for beryllium incorporates both: (1) A review of the literature on populations of workers exposed to beryllium at and below the preceding time-weighted average permissible exposure limit (TWA PEL) of 2 μg/m
To evaluate lung cancer risk, OSHA relied on a quantitative risk assessment published in 2011 by Schubauer-Berigan
OSHA requested input on the preliminary risk assessment presented in the NPRM, and received comments from a variety of public health experts and organizations, unions, industrial organizations, individual employers, and private citizens. While many comments supported OSHA's general approach to the risk assessment and the conclusions of the risk assessment, some commenters raised specific concerns with OSHA's analytical methods or recommended additional studies for OSHA's consideration. Comments about the risk assessment as a whole are reviewed here, while comments on specific aspects of the risk assessment are addressed in the relevant sections throughout the remainder of
The comments OSHA received on its preliminary risk analysis generally supported OSHA's overall approach and conclusions. NIOSH indicated that OSHA relied on the best available evidence in its risk assessment and concurred with “OSHA's careful review of the available literature on [beryllium sensitization] and CBD, OSHA's recognition of dermal exposure as a potential pathway for sensitization, and OSHA's careful approach to assessing risk for [beryllium sensitization] and CBD” (Document ID 1725, p. 3). NIOSH agreed with OSHA's approach to the preliminary lung cancer risk assessment (Document ID 1725, p. 7) and the selection of a 2011 analysis (Schubauer-Berigan
Other commenters also agreed with the general approach and conclusions of OSHA's preliminary risk assessment. NJH, for example, determined that “OSHA performed a thorough assessment of risk for [beryllium sensitization], CBD and lung cancer using all available studies and literature” (Document ID 1664, p. 5). Dr. Kenny Crump and Ms. Deborah Proctor commented, on behalf of beryllium producer Materion, that they “agree with OSHA's conclusion that there is a significant risk (>1/1000 risk of CBD) at the [then] current PEL, and that risk is reduced at the proposed PEL (0.2 μg/m
OSHA also received comments objecting to OSHA's conclusions regarding risk of lung cancer from beryllium exposure and suggesting additional published analyses for OSHA's consideration (
As discussed in the Health Effects section, studies of beryllium-exposed workers conducted using the beryllium lymphocyte proliferation test (BeLPT) have found high rates of beryllium sensitization and CBD among workers in many industries, including at some facilities where exposures were primarily below OSHA's preceding PEL of 2 μg/m
The Health Effects section also discusses OSHA's findings and the supporting evidence concerning the role of particle characteristics and beryllium compound solubility in the development of sensitization and CBD among beryllium-exposed workers. First, it finds that respirable particles small enough to reach the deep lung are responsible for CBD. However, larger inhalable particles that deposit in the upper respiratory tract may lead to sensitization. Second, it finds that both soluble and poorly soluble forms of beryllium are able to induce sensitization and CBD. Poorly soluble forms of beryllium that persist in the lung for longer periods may pose greater risk of CBD while soluble forms may more easily trigger immune sensitization. Although particle size and solubility may influence the toxicity of beryllium, the available data are too limited to reliably account for these factors in the Agency's estimates of risk.
Schuler
After the initial BeLPT screening was conducted in 2000, the company began implementing new measures to further reduce workers' exposure to beryllium (Thomas
To test the efficacy of the new measures in preventing sensitization and CBD, in June 2000 the facility began an intensive BeLPT screening program for all new workers (Thomas
Kreiss
Kreiss
Following the 1992 screening, the facility reduced exposures in machining areas (for example, by enclosing additional machines and installing additional exhaust ventilation), resulting in median exposures of 0.2 μg/m
Following the 1998 screening, the company continued efforts to reduce exposures, along with risk of sensitization and CBD, by implementing additional engineering and administrative controls and a comprehensive PPE program which included the use of respiratory protection (1999) and latex gloves (2000) (Cummings
Kreiss
Exposure levels at the plant between 1984 and 1993 were characterized using a mixture of general area, short-term breathing zone, and personal lapel samples (Kreiss
In 1996-1999, the company took further steps to reduce workers' beryllium exposures, including enclosure of some beryllium-releasing processes, establishment of restricted-access zones, and installation or updating of certain engineering controls (Bailey
Beginning in 2000, newly hired workers were offered periodic BeLPT testing to evaluate the effectiveness of the new exposure control program implemented by the company (Bailey
As reported by Schuler
Schuler
Materion submitted comments supporting OSHA's use of the Schuler
Proctor
Consistent with NIOSH comments discussed in the next paragraph, OSHA disagrees with this characterization of the DNEL as representing a “no effect level” for CBD or as providing a margin of safety for several reasons. The DNEL from Proctor
NIOSH commented on the results of Proctor
Newman
Between 1995 and 1999, the company built enclosures around several beryllium-releasing operations; installed or updated LEV for several machining departments; replaced pressurized air hoses and dry sweeping with wet methods and vacuum systems for cleaning; changed the layout of the plant to keep beryllium-releasing processes close together; limited access to the production area of the plant; and required the use of company uniforms. Madl
Beginning in 2000 (after the implementation of controls between 1997 and 1999), exposures in all jobs at the machining facility were reduced to
The Cullman, AL facility was also the subject of a case-control study published by Kelleher
Taiwo
All employees potentially exposed to beryllium levels at or above the action level for at least 12 days per year, or exposed at or above the STEL 12 or more times per year, were offered medical surveillance, including the BeLPT (Taiwo
The two workers with confirmed beryllium sensitization were offered further evaluation for CBD. Both were diagnosed with CBD, based on broncho-alveolar lavage (BAL) results in one case and pulmonary function tests, respiratory symptoms, and radiographic evidence in the other.
In 2010, Taiwo
In general, there appeared to be a low level of sensitization and CBD among employees at the aluminum smelters studied by Taiwo
A study by Nilsen
Viet
Using subjects from the BHSP, Viet
Viet
Arjomandi
Five of the 50 evaluated workers (10 percent) were diagnosed with CBD based on histology or high-resolution computed tomography. An additional three (who had not undergone full clinical evaluation for CBD) were identified as probable CBD cases, bringing the total prevalence of CBD and probable CBD in this group to 16 percent. OSHA notes that this prevalence of CBD among sensitized workers is lower than the prevalence of CBD that has been observed in some other worker groups known to have exposures exceeding the action level of 0.1 μg/m
The published literature on beryllium sensitization and CBD discussed above shows that risk of both health effects can be significant in workplaces in compliance with OSHA's preceding PEL (
Results from the Elmore, OH beryllium metal, alloy, and oxide production plant and Cullman, AL machining facility also showed significant risk of sensitization and CBD
There is evidence in the literature that although risk will be reduced by compliance with the new TWA PEL, significant risk of sensitization and CBD will remain in workplaces in compliance with OSHA's new TWA PEL of 0.2 μg/m
Furthermore, cases of sensitization and CBD continued to arise in the Cullman, AL machining plant after control measures implemented beginning in 1995 brought median airborne exposures below 0.2 μg/m
The experiences of several facilities in developing effective industrial hygiene programs have shown the importance of minimizing both airborne exposure and dermal contact to effectively reduce risk of sensitization and CBD. Exposure control programs that have used a combination of engineering controls and PPE to reduce workers' airborne exposure and dermal contact have substantially lowered risk of sensitization among newly hired workers.
OSHA recognizes that the studies on recent programs to reduce workers' risk of sensitization and CBD were conducted on populations with very short exposure and follow-up time. Therefore, they could not adequately address the question of how frequently workers who become sensitized in environments with extremely low airborne exposures (median <0.1 μg/m
In the NPRM, OSHA discussed an additional source of information on low-level beryllium exposure and CBD: Studies of community-acquired chronic beryllium disease (CA-CBD) in residential areas surrounding beryllium
OSHA evaluated exposure and health outcome data on a population of workers employed at the Cullman machining facility as one part of the Agency's Preliminary Risk Analysis presented in the NPRM. A summary of OSHA's preliminary analyses of these data, a discussion of comments received on the analyses and OSHA's responses to these comments, as well as a summary OSHA's final quantitative analyses, are presented in the remainder of this section. A more detailed discussion of the data, background information on the facility, and OSHA's analyses appears in the background document OSHA has placed in the record (Risk Analysis of the NJH Data Set from the Beryllium Machining Facility in Cullman, Alabama—CBD and Sensitization, OSHA, 2016).
NJH researchers, with consent and information provided by the Cullman facility, compiled a dataset containing employee work histories, medical diagnoses, and air sampling results and provided it to OSHA for analysis. OSHA's contractors from Eastern Research Group (ERG) gathered additional information about work operations and conditions at the plant, developed exposure estimates for individual workers in the dataset, and helped to conduct quantitative analyses of the data to inform OSHA's risk assessment (Document ID tbd).
The work history database contains job history records for 348 workers. ERG calculated cumulative and average exposure estimates for each worker in the database. Cumulative exposure was calculated as,
Workers who were employed for long time periods in jobs with low-level exposures tend to have low average and cumulative exposures due to the way these measures are constructed, incorporating the worker's entire work history. As discussed in the Health Effects chapter, higher-level exposures or short-term peak exposures such as those encountered in machining jobs may be highly relevant to risk of sensitization. However, individuals' beryllium exposure levels and sensitization status are not continuously monitored, so it is not known exactly when workers became sensitized or what their “true” peak exposures leading up to sensitization were. Only a rough approximation of the upper levels of exposure a worker experienced is possible. ERG attempted to represent workers' highest exposures by constructing a third type of exposure estimate reflecting the exposure level associated with the highest-exposure job (HEJ) and time period experienced by each worker. This exposure estimate (HEJ), the cumulative exposure estimate, and the average exposure were used in the quartile analysis and statistical analyses presented below.
In the database provided to OSHA, 7 workers were reported as sensitized only (that is, sensitized with no known development of CBD). Sixteen workers were listed as sensitized and diagnosed with CBD upon initial clinical evaluation. Three workers, first shown to be sensitized only, were later diagnosed with CBD. Tables VI-3, VI-4, and VI-5 below present the prevalence of sensitization and CBD cases across several categories of LTW average, cumulative, and HEJ exposure. Exposure values were grouped by quartile. For this analysis, OSHA excluded 8 workers with no job title listed in the data set (because their exposures could not be estimated); 7 workers whose date of hire was before 1969 (because this indicates they worked in the company's previous plant, for which no exposure measurements were available); and 14 workers who had zero exposure time in the data set, perhaps indicating that they had been hired but had not come to work at Cullman. After these exclusions, a total of 319 workers remained. None of the excluded workers were identified as having beryllium sensitization or CBD.
Note that all workers with CBD are also sensitized. Thus, the columns “Total Sensitized” and “Total %” refer to all sensitized workers in the dataset, including workers with and without a diagnosis of CBD.
Table VI-3 shows increasing prevalence of total sensitization and CBD with increasing LTW average exposure. The lowest prevalence of sensitization and CBD was observed among workers with average exposure levels less than or equal to 0.08 μg/m
The second quartile of LTW average exposure (0.081-0.18 μg/m
The quartile analysis of cumulative exposure also shows generally increasing prevalence of sensitization and CBD with increasing exposure. As shown in Table VI-4, the lowest prevalences of CBD and sensitization are in the first two quartiles of cumulative exposure (0.0-0.147 μg/m
A sharp increase in prevalence of sensitization and CBD occurs in the third quartile (1.468-7.008 μg/m
When workers' exposures from their highest-exposed job are considered, the exposure-response pattern is similar to that for LTW average exposure in the lower quartiles. In Table VI-5, the lowest prevalence is observed in the first quartile (0.0-0.086 μg/m
The results of this prevalence analysis support OSHA's conclusion that maintaining exposure levels below the new TWA PEL will help to reduce risk
In the course of OSHA's development of the proposed rule, OSHA's contractor (ERG) also developed a statistical analysis using the NJH data set and a discrete time proportional hazards analysis (DTPHA). This preliminary analysis predicted significant risks of both sensitization (96-394 cases per 1,000, or 9.6-39.4 percent) and CBD (44-313 cases per 1,000, or 4.4-31.3 percent) at the preceding TWA PEL of 2 μg/m
In interpreting the risk estimates, OSHA took into consideration limitations in the preliminary statistical analysis, primarily study size-related constraints. Consequently, as discussed in the NPRM, OSHA did not rely on the preliminary statistical analysis for its significance of risk determination or to develop its benefits analysis. The Agency relied primarily on the previously-presented analysis of the epidemiological literature and the prevalence analysis of the Cullman data for its preliminary significance of risk determination, and on the prevalence analysis for its preliminary estimate of benefits. Although OSHA did not rely on the results of the preliminary statistical analysis for its findings, the Agency presented the DTPHA in order to inform the public of its results, explain its limitations, and solicit public comment on the Agency's approach.
Dr. Kenny Crump and Ms. Deborah Proctor submitted comments on OSHA's preliminary risk assessment (Document ID 1660). Crump and Proctor agreed with OSHA's review of the epidemiological literature and the prevalence analysis presented previously in this section. They stated, “we agree with OSHA's conclusion that there is a significant risk (>1/1000 risk of CBD) at the [then] current PEL, and that risk is reduced at the [then] proposed PEL (0.2 μg/m
After considering comments on this preliminary model, OSHA instructed its contractor to change the statistical analysis to address technical concerns and to incorporate suggestions from Crump and Proctor, as well as NIOSH (Document ID 1660; 1725). OSHA reviews and addresses these comments on the preliminary statistical analysis and provides a presentation of the final statistical analysis in the background document (Risk Analysis of the NJH Data Set from the Beryllium Machining Facility in Cullman, Alabama—CBD and Sensitization, OSHA, 2016). The results of the final statistical analysis are summarized here.
As noted above, Dr. Roslyn Stone of University of Pittsburgh School of Public Health reanalyzed for OSHA the Cullman data set in order to address concerns raised by Crump and Proctor (Document ID 1660). The reanalysis uses a Cox proportional hazards model instead of the DTPHA. The Cox model, a regression method for survival data, provides an estimate of the hazard ratio (HR) and its confidence interval.
As in the preliminary statistical analysis, Dr. Stone used fractional polynomials
In the reanalysis of the NJH data set, the HR for sensitization increased significantly with increasing LTW average exposure (HR = 2.92, 95% CI = 1.51-5.66, p = 0.001; note that HRs are rounded to the second decimal place). Cumulative exposure was also a statistically significant predictor for beryllium sensitization, although it was not as strongly related to sensitization as LTW average exposure (HR = 1.04, 95% CI 1.00-1.07, p = 0.03). The HR for CBD increased significantly with increasing cumulative exposure (HR = 1.04, 95% CI = 1.01-1.08, p = 0.02). The HR for CBD increased somewhat with increasing LTW average exposure, but this increase was not significant at the 0.05 level (HR = 2.25, 95% CI = 0.94-5.35, p = 0.07).
None of the analyses Dr. Stone performed to check for nonlinearities in exposure-response or the effects of smoking or age substantially impacted the results of the analyses for beryllium sensitization or CBD. The sensitivity analysis recommended by Crump and Proctor, excluding workers hired prior to 1980 (see Document ID 1660, p. 11), did not substantially impact the results
Because LTW average exposure was most strongly associated with beryllium sensitization, OSHA used the final model for LTW average exposure to estimate risk of sensitization at the preceding TWA PEL, the final TWA PEL, and several alternate TWA PELs it considered. Similarly, because cumulative exposure was most strongly associated with CBD, OSHA used the final model for cumulative exposure to estimate risk of CBD at the preceding, final, and alternate TWA PELs. In calculating these risks, OSHA used a small, fixed estimate of “baseline” risk (
The Cox proportional hazards model, used with the fixed “baseline” rates of 0.5 percent and 1 percent, predicted risks of sensitization totaling 43 and 86 cases per 1,000 workers, respectively, or 4.3 and 8.6 percent, at the preceding PEL of 2 μg/m
Due to limitations in the Cox analysis, including the small size of the dataset, relatively limited exposure data from the plant's early years, study size-related constraints on the statistical analysis of the dataset, limited follow-
As discussed more fully in the Health Effects section of the preamble, OSHA has determined beryllium to be a carcinogen based on an extensive review of the scientific literature regarding beryllium and cancer (see Section V.E). This review included an evaluation of the human epidemiological, animal cancer, and mechanistic studies described in the Health Effects section of this preamble. OSHA's conclusion is supported by the findings of public health organizations such as the International Agency for Research on Cancer (IARC), which has determined beryllium and its compounds to be carcinogenic to humans (Group 1 category) (IARC 2012, Document ID 0650); the National Toxicology Program (NTP), which classifies beryllium and its compounds as known carcinogens (NTP 2014, Document ID 0389); and the Environmental Protection Agency (EPA), which considers beryllium to be a probable human carcinogen (EPA 1998, Document ID 0661).
The Sanderson
A conditional logistic regression analysis showed an increased risk of death from lung cancer in workers with higher exposures when dose estimates were lagged by 10 and 20 years (Sanderson
In formulating the final rule, OSHA was particularly interested in lung cancer risk estimates from a 45-year (
In addition, the relatively high exposures of the least-exposed workers in the study population might have created methodological issues for the lung cancer case-control study design. Mortality risk is expressed as an odds ratio that compares higher exposure quartiles to the lowest quartile. It is preferable that excess risks attributable to occupational beryllium be determined relative to an unexposed or minimally exposed reference population. However, in this study population, workers in the lowest quartile were exposed well above the preceding OSHA TWA PEL (average exposure <11.2 μg/m
In 2011, Schubauer-Berigan
OSHA received several comments about its choice of Schubauer-Berigan
According to Dr. Paolo Boffetta, who submitted comments on this study,
Because only an abstract of Boffetta
The cohort studied by Schubauer-Berigan
Workers' cumulative exposures (μg/m
As shown in Table VI-8 below, estimated exposure levels for workers from the Hazleton and Elmore plants were on average far lower than those for workers from the Reading plant (Schubauer-Berigan
Schubauer-Berigan
Because smoking information was available for only about 25 percent of the cohort (those employed in 1968), smoking could not be controlled for directly in the models. Schubauer-Berigan
The authors found that lung cancer risk was strongly and significantly related to mean, cumulative, and maximum measures of workers' exposure (all models reported in Schubauer-Berigan
Schubauer-Berigan
Schubauer-Berigan
Dr. Boffetta's comment, mentioned above, addressed the relevance of the Schubauer-Berigan
Boffetta argued that the most informative study in the modern (post-1965) beryllium industry is Boffetta
Dr. Boffetta also commented that there is a lack of evidence of increased lung cancer risk among workers exposed only to poorly soluble beryllium compounds (Document ID 1659, p. 1). To support this statement, he cited a study he published in 2014 of workers at four “insoluble facilities” (Boffetta
OSHA carefully considered Dr. Boffetta's argument regarding the status of poorly soluble beryllium compounds, and did not find persuasive evidence showing that the solubility of the beryllium to which the workers in the studies he cited were exposed accounts for the lack of statistically significantly elevated risk in the Boffetta
As discussed in Section V, Health Effects and in comments submitted by NIOSH, animal toxicology evidence shows that poorly soluble beryllium compounds can cause cancer. IARC determined that poorly soluble forms of beryllium are carcinogenic to humans in its 2012 review of Group I carcinogens (see section V.E.5 of this preamble; Document ID 1725, p. 9; IARC, 2012, Document ID 0650). NIOSH noted that poorly soluble forms of beryllium remain in the lung for longer time periods than soluble forms, and can therefore create prolonged exposure of lung tissue to beryllium (Document ID 1725, p. 9). This prolonged exposure may lead to the sustained tissue inflammation that causes many forms of cancer and is believed to be one pathway for carcinogenesis due to beryllium exposure (see Section V, Health Effects).
The comments from NIOSH also demonstrate that the available information cannot distinguish between the effects of soluble and poorly soluble beryllium. NIOSH submitted information on the solubility of beryllium in the Schubauer-Berigan
Boffetta
OSHA reviewed this study, and finds that it does not contradict the findings of the Schubauer-Berigan
Finally, the approach of Boffetta
Taken together, OSHA finds that the animal toxicology evidence on the carcinogenicity of poorly soluble beryllium forms, the long residence of poorly soluble beryllium in the lung, the likelihood that most workers in Schubauer-Berigan
Dr. Boffetta's comment also raised technical questions regarding the Schubauer-Berigan
OSHA agrees that it is difficult to distinguish a single “best” model from the set of models presented by Schubauer-Berigan
Dr. Boffetta also noted that the risk estimates provided by Schubauer-Berigan
Finally, Dr. Boffetta noted that the models that exclude professional and asbestos workers (the groups that Schubauer-Berigan
OSHA agrees with Dr. Boffetta that there is uncertainty in the Schubauer-Berigan
As described above, OSHA's risk assessment for beryllium sensitization and CBD relied on two approaches: (1) Review of the literature, and (2) analysis of a data set provided by NJH. OSHA has a high level of confidence in its finding that the risks of sensitization and CBD are above the benchmark of 1 in 1,000 at the preceding PEL, and the Agency believes that a comprehensive standard requiring a combination of more stringent controls on beryllium exposure will reduce workers' risk of both sensitization and CBD. Programs that have reduced median levels to below 0.1 μg/m
Furthermore, OSHA believes that more stringent control of airborne beryllium exposures will reduce beryllium-exposed workers' significant risk of lung cancer. The risk estimates from the lung cancer study by Schubauer-Berigan
In this section, OSHA discusses its findings that workers exposed to beryllium at and below the preceding TWA PEL face a significant risk of material impairment of health or functional capacity within the meaning of the OSH Act, and that the new standards will substantially reduce this risk. To make the significance of risk determination for a new final or proposed standard, OSHA uses the best available scientific evidence to identify material health impairments associated with potentially hazardous occupational exposures and to evaluate exposed workers' risk of these impairments assuming exposure over a working lifetime. As discussed in section II, Pertinent Legal Authority, courts have stated that OSHA should consider all forms and degrees of material impairment—not just death or serious physical harm. To evaluate the significance of the health risks that result from exposure to hazardous chemical agents, OSHA relies on epidemiological, toxicological, and experimental evidence. The Agency uses both qualitative and quantitative methods to characterize the risk of disease resulting from workers' exposure to a given hazard over a working lifetime (generally 45 years) at levels of exposure reflecting compliance with the preceding standard and compliance with the new standards (see Section II, Pertinent Legal Authority). When determining whether a significant risk exists OSHA considers whether there is a risk of at least one-in-a-thousand of developing a material health impairment from a working lifetime of exposure. The Supreme Court has found that OSHA is not required to support its finding of significant risk with scientific certainty, but may instead rely on a body of reputable scientific thought and may make conservative assumptions (
OSHA's findings in this section follow in part from the conclusions of the preceding sections V, Health Effects, and VI, Risk Assessment. In this preamble at section V, Health Effects, OSHA reviewed the scientific evidence linking occupational beryllium exposure to a variety of adverse health effects and determined that beryllium exposure causes sensitization, CBD, and lung cancer, and is associated with various other adverse health effects (see section V.D, V.E, and V.F). In this preamble at section VI, Risk Assessment, OSHA found that the available epidemiological data are sufficient to evaluate risk for beryllium sensitization, CBD, and lung cancer among beryllium-exposed workers. OSHA evaluated the risk of sensitization, CBD, and lung cancer from levels of airborne beryllium exposure that were allowed under the previous standard, as well as the expected impact of the new standards on risk of these conditions. In this section of the preamble, OSHA explains its determination that the risk of material impairments of health, particularly CBD and lung cancer, from occupational exposures allowable under the preceding TWA PEL of 2 μg/m
In the NPRM, OSHA preliminarily determined that both CBD and lung cancer are material impairments of health. OSHA also preliminarily determined that a working lifetime (45 years) of exposure to airborne beryllium at the preceding time-weighted average permissible exposure limit (TWA PEL) of 2 μg/m
Upon consideration of the entire rulemaking record, including the comments and information submitted to the record in response to the preliminary Health Effects, Risk Assessment, and Significance of Risk analyses (NPRM Sections V, VI, and VIII), OSHA reaffirms its preliminary findings that long-term exposure at the preceding TWA PEL of 2 μg/m
As discussed in Section V, Health Effects, CBD is a respiratory disease caused by exposure to beryllium. CBD develops when the body's immune system reacts to the presence of beryllium in the lung, causing a progression of pathological changes including chronic inflammation and tissue scarring. CBD can also impair other organs such as the liver, skin, spleen, and kidneys and cause adverse health effects such as granulomas of the skin and lymph nodes and cor pulmonale (
In early, asymptomatic stages of CBD, small granulomatous lesions and mild inflammation occur in the lungs. Over time, the granulomas can spread and lead to lung fibrosis (scarring) and
Dr. Lee Newman, speaking at the public hearing on behalf of the American College of Occupational and Environmental Medicine (ACOEM), testified on his experiences treating patients with CBD: “as a physician who has spent most of my [practicing] career seeing patients with exposure to beryllium, with beryllium sensitization, and with chronic beryllium disease including those who have gone on to require treatment and to die prematurely of this disease . . . [I've seen] hundreds and hundreds, probably over a thousand individuals during my career who have suffered from this condition” (Document ID 1756, Tr. 79). Dr. Newman further testified about his 30 years of experience treating CBD in patients at various stages of the disease:
. . . some of them will go from being sensitized to developing subclinical disease, meaning that they have no symptoms. As I mentioned earlier, most of those will, if we actually do the tests of their lung function and their oxygen levels in their blood, those people are already demonstrating physiologic abnormality. They already have disease affecting their health. They go on to develop symptomatic disease and progress to the point where they require treatment. And sometimes to the extent of even requiring a [lung] transplant (Document ID 1756, Tr. 131).
Dr. Newman described one example of a patient who developed CBD from his occupational beryllium exposure and “who went on to die prematurely with a great deal of suffering along the way due to the condition chronic beryllium disease” (Document ID 1756, Tr. 80).
During her testimony at the public hearing, Dr. Lisa Maier of National Jewish Health (NJH) provided an example from her experience with treating CBD patients. “This gentleman started to have a cough, a dry cough in 2011 . . . His symptoms progressed and he developed shortness of breath, wheezing, chills, night sweats, and fatigue. These were so severe that he was eventually hospitalized” (Document ID 1756, Tr. 105). Dr. Maier noted that this patient had no beryllium exposure prior to 2006, and that his CBD had developed from beryllium exposure in his job melting an aluminum alloy in a foundry casting airplane parts (Document ID 1756, Tr. 105-106). She described how her patient could no longer work because of his condition. “He requires oxygen and systemic therapy . . . despite aggressive treatment [his] test findings continue to demonstrate worsening of his disease and increased needs for oxygen and medications as well as severe side effects from medications. This patient may well need a lung transplant if this disease continues to progress . . . ” (Document ID 1756, Tr. 106-107).
The likelihood, speed, and severity of individuals' transition from asymptomatic to symptomatic CBD is understood to vary widely, with some individuals responding differently to exposure cessation and treatment than others (Sood, 2009, Document ID 0456; Mroz
Treatment of CBD using inhaled and systemic steroid therapy has been shown to ease symptoms and slow or prevent some aspects of disease progression. As explained below, these treatments can be most effectively applied when CBD is diagnosed prior to development of symptoms. In addition, the forms of treatment that can be used to manage early-stage CBD have relatively minor side effects on patients, while systemic steroid treatments required to treat later-stage CBD often cause severe side effects.
In the public hearing, Dr. Newman and Dr. Maier testified about their experiences treating patients with CBD at various stages of the disease. Dr. Newman stated that patients' outcomes depend greatly on how early they are diagnosed. “So there are those people who are diagnosed very late in the course of disease where there's little that we can do to intervene and they are going to die prematurely. There are those people who may be detected with milder disease where there are opportunities to intervene” (Document ID 1756, Tr. 132). Both Dr. Maier and Dr. Newman emphasized the importance of early detection and diagnosis, stating that removing the patient from exposure and providing treatment early in the course of the disease can slow or even halt progression of the disease (Document ID 1756, Tr. 111, 132).
Dr. Maier testified that inhaled steroids can be used to treat relatively mild symptoms that may occur in early stages of the disease, such as a cough during exercise (Document ID 1756, Tr. 139). Inhaled steroids, she stated, are commonly used to treat other health conditions and have fewer and milder side effects than forms of steroid treatment that are used to treat more severe forms of CBD (Document ID 1756, Tr. 140). Early detection of CBD helps physicians to properly treat early-onset symptoms, since appropriate forms of treatment for early stage CBD can differ from treatments for conditions it is commonly mistaken for, such as chronic obstructive pulmonary disease
CBD in later stages is often managed using systemic steroid treatments such as corticosteroids. In workers with CBD whose beryllium exposure has ceased, corticosteroid therapy has been shown to control inflammation, ease symptoms (
Treatment with corticosteroids has severe side effects (Trikudanathan and McMahon, 2008, Document ID 0366; Lipworth, 1999 (0371); Gibson
Based on the above, OSHA considers late-stage CBD to be a material impairment of health, as it involves permanent damage to the pulmonary system, causes additional serious adverse health effects, can have adverse occupational and social consequences, requires treatment that can cause severe and lasting side effects, and may in some cases cause premature death.
Furthermore, OSHA has determined that early-stage CBD, an asymptomatic period during which small lesions and inflammation appear in the lungs, is also a material impairment of health. OSHA bases this conclusion on evidence and expert testimony that early-stage CBD is a measurable change in an individual's state of health that, with and sometimes without continued exposure, can progress to symptomatic disease (
OSHA believes that while incapacitating illness and death represent one extreme of a spectrum of responses, other biological effects such as metabolic or physiological changes are precursors or sentinels of disease which should be prevented. . . . Rather than revealing the beginnings of illness the standard must be selected to prevent an earlier point of measurable change in the state of health which is the first significant indicator of possibly more severe ill health in the future. The basis for this decision is twofold—first, pathophysiologic changes are early stages in the disease process which would grow worse with continued exposure and which may include early effects which even at early stages are irreversible, and therefore represent material impairment themselves. Secondly, prevention of pathophysiologic changes will prevent the onset of the more serious, irreversible and debilitating manifestations of disease (43 FR 52952, 52954).
Since the Lead rulemaking, OSHA has also found other non-symptomatic (or sub-clinical) health conditions to be material impairments of health. In the Bloodborne Pathogens rulemaking, OSHA maintained that material impairment includes not only workers with clinically “active” hepatitis from the hepatitis B virus (HBV) but also includes asymptomatic HBV “carriers” who remain infectious and are able to put others at risk of serious disease through contact with body fluids (
OSHA finds that early-stage CBD is the type of asymptomatic health effect the Agency determined to be a material impairment of health in the Lead and Bloodborne Pathogens standards. Early stage CBD involves lung tissue inflammation without symptoms that can worsen with—or without—continued exposure. The lung pathology progresses over time from a chronic inflammatory response to tissue scarring and fibrosis accompanied by moderate to severe loss in pulmonary function. Early stage CBD is clearly a precursor of advanced clinical disease, prevention of which will prevent symptomatic disease. OSHA determined in the Lead standard that such precursor effects should be considered material health impairments in their own right, and that the Agency should act to prevent them when it is feasible to do so. Therefore, OSHA finds all stages of CBD to be material impairments of health within the meaning of section 6(b)(5) of the OSH Act (29 U.S.C. 655(b)(5)).
In reviewing OSHA's Lead standard in
OSHA has also determined that exposure to beryllium can cause beryllium sensitization. Sensitization is a precursor to development of CBD and an essential step for development of the disease. As discussed in Section V, Health Effects, only sensitized individuals can develop CBD (NAS, 2008, Document ID 1355).
As discussed in Section VI, Risk Assessment, the risk assessment for beryllium sensitization and CBD relied on two approaches: (1) OSHA's review of epidemiological studies of sensitization and CBD that contain information on exposures in the range of interest to OSHA (2 μg/m
OSHA's review of the literature includes studies of beryllium-exposed workers at a Tucson, AZ ceramics plant (Kreiss
The published literature on beryllium sensitization and CBD discussed in section VI shows that the risk of both can be significant in workplaces where exposures are at or below OSHA's preceding PEL of 2 μg/m
Results from the Elmore, OH beryllium metal, alloy, and oxide production plant and the Cullman, AL machining facility also showed significant risk of sensitization and CBD among workers with exposures below the preceding TWA PEL. Schuler
Although risk will be reduced by compliance with the new TWA PEL, evidence in the epidemiological studies reviewed in section VI, Risk Assessment, shows that significant risk of sensitization and CBD could remain in workplaces with exposures as low as the new action level of 0.1 μg/m
Furthermore, cases of sensitization and CBD continued to arise in the Cullman, AL machining plant after control measures implemented beginning in 1995 brought median airborne exposures below 0.2 μg/m
The enhanced industrial hygiene programs that have proven effective in several facilities demonstrate the importance of minimizing both airborne exposure and dermal contact to effectively reduce risk of sensitization and CBD. Exposure control programs that have used a combination of engineering controls, PPE, and stringent housekeeping measures to reduce workers' airborne exposure and dermal contact have substantially lowered risk of sensitization among newly-hired workers.
OSHA notes that the studies on recent programs to reduce workers' risk of sensitization and CBD were conducted on populations with very short exposure and follow-up time. Therefore, they could not adequately address the question of how frequently workers who become sensitized in environments with extremely low airborne exposures (median <0.1 μg/m
In summary, the epidemiological literature on beryllium sensitization and CBD that OSHA's risk assessment relied on show sufficient occurrence of sensitization and CBD to be considered significant within the meaning of the OSH Act. These demonstrated risks are far in excess of 1 in 1,000 among workers who had full-shift exposures well below the preceding TWA PEL of 2 μg/m
OSHA's conclusions on significance of risk at the final PEL and action level are further supported by its analysis of the data set provided to OSHA by NJH from which OSHA derived additional information on sensitization and CBD at exposure levels of interest. The data set describes a population of 319 beryllium-exposed workers at a Cullman, AL machining facility. It includes exposure samples collected between 1980 and 2005, and has updated work history and screening information through 2003. Seven (2.2 percent) workers in the data set were reported as sensitized only. Sixteen (5.0 percent) workers were listed as sensitized and diagnosed with CBD upon initial clinical evaluation. Three (0.9 percent) workers, first shown to be sensitized only, were later diagnosed with CBD. The data set includes workers exposed at airborne beryllium levels near the new TWA PEL of 0.2 μg/m
OSHA analyzed the prevalence of beryllium sensitization and CBD among
Tables VII-1 and VII-2 below present the prevalence of sensitization and CBD cases across several categories of lifetime-weighted (LTW) average and highest-exposed job (HEJ) exposure at the Cullman facility. The HEJ exposure is the exposure level associated with the highest-exposure job and time period experienced by each worker. The columns “Total” and “Total percent” refer to all sensitized workers in the data set, including workers with and without a diagnosis of CBD.
The preceding PEL of 2 μg/m
The new TWA PEL of 0.2 μg/m
Table VII-3 below presents the prevalence of sensitization and CBD cases across cumulative exposure quartiles, based on the same Cullman data used to derive Tables 1 and 2. Cumulative exposure is the sum of a worker's exposure across the duration of his or her employment.
A 45-year working lifetime of occupational exposure at the preceding PEL would result in 90 μg/m
Lung cancer, a frequently fatal disease, is a well-recognized material impairment of health. OSHA has determined that beryllium causes lung cancer based on an extensive review of the scientific literature regarding beryllium and cancer. This review included an evaluation of the human epidemiological, animal cancer, and mechanistic studies described in section V, Health Effects. OSHA's conclusion that beryllium is carcinogenic is supported by the findings of expert public health and governmental organizations such as the International Agency for Research on Cancer (IARC), which has determined beryllium and its compounds to be carcinogenic to humans (Group 1 category) (IARC, 2012, Document ID 0650); the National Toxicology Program (NTP), which classifies beryllium and its compounds as known carcinogens (NTP, 2014, Document ID 0389); and the Environmental Protection Agency (EPA), which considers beryllium to be a probable human carcinogen (EPA, 1998, Document ID 0661).
OSHA's review of epidemiological studies of lung cancer mortality among beryllium workers found that most of them did not characterize exposure levels sufficiently to evaluate the risk of lung cancer at the preceding and new TWA PELs. However, as discussed in this preamble at section V, Health Effects and section VI, Risk Assessment, Schubauer-Berigan
Schubauer-Berigan
The lowest estimate of excess lung cancer deaths from the six final models presented by Schubauer-Berigan
As discussed throughout this section, OSHA used the best available scientific evidence to identify adverse health effects of occupational beryllium exposure, and to evaluate exposed workers' risk of these impairments. The Agency reviewed extensive epidemiological and experimental research pertaining to adverse health effects of occupational beryllium exposure, including lung cancer, CBD, and beryllium sensitization, and has evaluated the risk of these effects from exposures allowed under the preceding and new TWA PELs. The Agency has, additionally, reviewed the medical literature, as well as previous policy determinations and case law regarding material impairment of health, and has determined that CBD, at all stages, and lung cancer constitute material health impairments.
OSHA has determined that long-term exposure to beryllium at the preceding TWA PEL would pose a risk of CBD and lung cancer greater than the risk of 1 per 1,000 exposed workers the Agency considers clearly significant, and that adoption of the new TWA PEL, action level, and dermal protection requirements of the final standards will substantially reduce this risk. OSHA believes substantial evidence supports its determinations, including its choices of the best available published studies on which to base its risk assessment, its examination of the prevalence of sensitization and CBD among workers with exposure levels comparable to the preceding TWA PEL and new TWA PEL in the NJH data set, and its selection of the Schubauer-Berigan QRA to form the basis for its lung cancer risk estimates. The previously-described analyses demonstrate that workers with occupational exposure to airborne beryllium at the preceding PEL face risks of developing CBD and dying from lung cancer that far exceed the value of 1 in 1,000 used by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's risk assessment indicates that risk of CBD and lung cancer can be significantly reduced by reduction of airborne exposure levels, and that dermal protection measures will additionally help reduce risk of sensitization and, therefore, of CBD.
OSHA's risk assessment also indicates that, despite the reduction in risk expected with the new PEL, the risks of CBD and lung cancer to workers with average exposure levels of 0.2 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 beryllium rule and evaluates regulatory alternatives to the final rule. Executive Orders 13563 and
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 lung cancer, chronic beryllium disease;
• 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 made changes to the Preliminary Economic Analysis (PEA) for several reasons:
• Changes to the rule, summarized in Section I of the preamble and discussed in detail in the Summary and Explanation;
• Comments on the 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 Final Economic Analysis contains the following chapters:
Table VIII-1 provides a summary of OSHA's best estimate of the costs and benefits of the final rule using a discount rate of 3 percent. As shown, the final rule is estimated to prevent 90 fatalities and 46 beryllium-related illnesses annually once it is fully effective, and the estimated cost of the rule is $74 million annually. Also as shown in Table VIII-1, the discounted monetized benefits of the final rule are estimated to be $561 million annually, and the final rule is estimated to generate net benefits of $487 million annually. Table VIII-1 also presents the estimated costs and benefits of the final rule using a discount rate of 7 percent.
The remainder of this section (Section VIII) of the preamble is organized as follows:
Employees in work environments addressed by the final beryllium 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 demonstrable failure of private markets to protect workers from exposure to unnecessarily high levels beryllium and that private markets, as well as information dissemination programs, workers' compensation systems, and tort liability options, each may fail to protect workers from beryllium exposure, resulting in the need for a more protective OSHA beryllium rule.
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 beryllium exposure, the final mandatory standards represent the best choice for reducing the risks to employees.
Chapter III of the FEA presents profile data for industries potentially affected by the final beryllium rule. This Chapter provides the background data used throughout the remainder of the FEA including estimates of what industries are affected, and their economic and beryllium exposure characteristics. OSHA identified the following application groups as affected by the standard:
Table VIII-3 shows the affected industries by application group and selected economic characteristics of these affected industries. Table VIII-4 provides industry-by-industry estimates of current exposure.
The OSH Act requires OSHA to demonstrate that a proposed health standard is technologically feasible (29 U.S.C. 655(b)(5)). As described in the preamble to the final rule (see Section II, Pertinent Legal Authority), technological feasibility has been interpreted broadly to mean “capable of being done” (
OSHA's technological feasibility analysis is presented in Chapter IV of the FEA. The technological feasibility analysis identifies the affected industries and application groups in which employees can reasonably be expected to be exposed to beryllium, summarizes the available air sampling data used to develop employee exposure profiles, and provides descriptions of engineering controls and other measures employers can take to reduce their employees' exposures to beryllium. For each affected industry sector or application group, OSHA provides an assessment of the technological feasibility of compliance with the final permissible exposure limit (PEL) of 0.2 μg/m
The technological feasibility analysis covers twelve application groups that correspond to specific industries or production processes that involve the potential for occupational exposures to materials containing beryllium and that OSHA has determined fall within the scope of this final beryllium standard. Within each of these application groups, exposure profiles have been developed to characterize the distribution of the available exposure measurements by job title or group of jobs. Each section includes descriptions of existing, or baseline, engineering controls for operations that generate beryllium exposure. For those job groups in which current exposures were found to exceed the final PEL, OSHA identifies and describes additional engineering and work practice controls that can be implemented to reduce exposure and achieve compliance with the final PEL. For each application group or industry, a final determination is made regarding the technological feasibility of achieving the proposed permissible exposure limits based on the use of engineering and work practice controls and without reliance on the use of respiratory protection. The determination is made based on the legal standard of whether the PEL can be achieved for most operations most of the time using such controls. In a separate chapter on short-term exposures, OSHA also analyzes the feasibility of achieving compliance with the Short-Term Exposure Limit (STEL).
The analysis is based on the best evidence currently available to OSHA, including a comprehensive review of the industrial hygiene literature, National Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluations and case studies of beryllium exposure, site visits conducted by an OSHA contractor (Eastern Research Group (ERG)), and inspection data from OSHA's Integrated Management Information System (IMIS) and OSHA's Information System (OIS). OSHA also obtained information on beryllium production processes, worker exposures, and the effectiveness of existing control measures from Materion Corporation, the primary beryllium producer in the United States, interviews with industry experts, and comments submitted to the rulemaking docket in response to the Notice of Proposed Rulemaking and informal public hearings. All of this evidence is in the rulemaking record.
The twelve application groups are:
• Primary Beryllium Production,
• Beryllium Oxide Ceramics and Composites,
• Nonferrous Foundries,
• Secondary Smelting, Refining, and Alloying, Including Handling of Scrap and Recycled Materials,
• Precision Turned Products,
• Copper Rolling, Drawing, and Extruding,
• Fabrication of Beryllium Alloy Products,
• Welding,
• Dental Laboratories,
• Abrasive Blasting,
• Coal-Fired Electric Power Generation,
• Aluminum Production
For discussion purposes, the twelve application groups are divided into four general categories based on the distribution of exposures in the exposure profiles: (1) Application groups in which baseline exposures for most jobs are already at or below the final PEL of 0.2 μg/m
The application groups in category 1, where exposures for most jobs are already at or below the final PEL of 0.2 μg/m
For application groups in category 2, where baseline exposures for one or more jobs exceed the final PEL of 0.2 μg/m
The application groups in category 3 include application groups for which the exposure profiles indicate that exposures in one or more jobs routinely exceed the preceding PEL of 2.0 μg/m
Category 4 includes application groups that encounter exposure to beryllium due to trace levels found in dust or fumes that nonetheless can exceed 0.1 μg/m
During the rulemaking process, OSHA requested and received comments regarding the feasibility of the PEL of 0.2 μg/m
The majority of commenters, including stakeholders in labor and industry, public health experts, and the general public, explicitly supported the proposed PEL of 0.2 µg/m
Based on many years' experience in controlling beryllium exposures, its vigorous product stewardship program in affected operations, and the judgment of its professional industrial hygiene staff, Materion Brush believes that the 0.2 μg/m
On the other hand, the Nonferrous Founders' Society (NFFS) asserted that OSHA had not demonstrated that the final PEL of 0.2 µg/m
However, contrary to the NFFS comments, which are addressed at greater length in Section IV-5 of the FEA, OSHA's exposure profile is based on the best available evidence for nonferrous foundries; the exposure data are taken from NIOSH surveys, an ERG site visit, and the California Cast Metals Association (Document ID 1217; 1185; 0341, Attachment 6; 0899). Materion also submitted substantial amounts of monitoring data, process descriptions and information of engineering controls that have been implemented in its facilities to control beryllium exposure effectively, including operations that involve the production of beryllium alloys using the same types of furnace and casting operations as those conducted at nonferrous foundries producing beryllium alloys (Document ID 0719; 0720; 0723). Furthermore, Materion submitted the above-referenced letter to the docket stating that, based on its many years of experience controlling beryllium exposures, a PEL of 0.2 μg/m
In the NPRM, OSHA requested that affected industries submit to the record any available exposure monitoring data and comments regarding the effectiveness of currently implemented control measures to inform the Agency's final feasibility determinations. During the informal public hearings, OSHA asked the NFFS panel to provide information on current engineering controls or the personal protective equipment used in foundries claiming to have difficulty complying with the preceding PEL, but no additional information was provided (Document ID 1756; Tr. 24-25; 1785, p. 1). Thus, the NFFS did not provide any sampling data or other evidence regarding current exposure levels or existing control measures to support its assertion that a PEL of 0.2 μg/m
In sum, while OSHA agrees that two of the operations in the nonferrous foundry industry, furnace and shakeout operations, employing a relatively small percentage of workers in the industry, may not be able to achieve the final PEL of 0.2 μg/m
OSHA also recognizes that engineering and work practice controls may not be able to consistently reduce and maintain exposures to the final PEL of 0.2 μg/m
Overall, however, based on the information discussed above and the other evidence in the record and described in Chapter IV of the FEA, OSHA has determined that for the majority of the job groups evaluated exposures are either already at or below the final PEL, or can be adequately controlled to levels below the final PEL through the implementation of additional engineering and work practice controls for most operations most of the time. Therefore, OSHA concludes that the final PEL of 0.2 μg/m
In contrast, the record evidence does not show that it is feasible for most operations in all affected industries and application groups to achieve the alternative PEL of 0.1 μg/m
Several commenters supported a PEL of 0.1 μg/m
On the other hand, the Beryllium Health and Safety Committee and NJH specifically rejected a PEL of 0.1 μg/m
Based on the record evidence, OSHA cannot conclude that the alternative PEL of 0.1 μg/m
In other cases, paucity of data or other data issues prevent OSHA from determining whether engineering and work practice controls can reduce exposures to or below 0.1 μg/m
The lack of available data has also prevented OSHA from determining whether exposures at or below of 0.1 μg/m
Most importantly for this analysis, the available evidence demonstrates that the alternative PEL of 0.1 μg/m
OSHA has also determined either that information in the rulemaking record demonstrates that 0.1 μg/m
Because of this inability to achieve 0.1 μg/m
Furthermore, OSHA concludes that it would complicate both compliance and enforcement of the rule if it were to set a PEL of 0.1 μg/m
OSHA also evaluated the technological feasibility of the final STEL of 2.0 μg/m
A number of stakeholders submitted comments related to the proposed and alternative STELs. Some of these stakeholders supported a STEL of 2.0 μg/m
Therefore, OSHA concludes that the STEL of 2.0 μg/m
After careful consideration of the record, including all available data and stakeholder comments in the record, OSHA has determined that a STEL of 2.0 μg/m
In Chapter V, Costs of Compliance, OSHA assesses the costs to general industry, maritime, and construction establishments in all affected application groups of reducing worker exposures to beryllium to an eight-hour time-weighted average (TWA) permissible exposure limit (PEL) of 0.2 μg/m
Table VIII-4 presents summary of the annualized costs. All costs in this chapter are expressed in 2015 dollars and were annualized using a discount rate of 3 percent. (Costs at other discount rates are presented in the chapter itself). Annualization periods for expenditures on equipment are based on equipment life, and one-time costs are annualized over a 10-year period. Chapter V provides detailed explanation of the basis for these cost estimates.
In Chapter VI, OSHA investigates the economic impacts of its final beryllium rule on affected employers. This impact investigation has two overriding objectives: (1) To establish whether the final rule is economically feasible for all affected application groups/industries,
Table VIII-5 presents OSHA's screening analysis, which shows costs as percentage of revenues and as a percentage of profits. The chapter explains why these screening analysis
In Chapter VII, OSHA estimates the benefits and net benefits of the final beryllium rule. The methodology for these estimates largely remains the same as in the PEA. OSHA did not receive many comments challenging any aspect
This chapter proceeds in five steps. The first step estimates the numbers of diseases and deaths prevented by comparing the current (baseline) situation to a world in which the final PEL is adopted in a final standard, and in which employees are exposed throughout their working lives to either the baseline or the final PEL. The second step also assumes that the final PEL is adopted, but uses the results from the first step to estimate what would happen under a realistic scenario in which new employees will not be exposed above the final PEL, while employees already at work will experience a combination of exposures below the final PEL and baseline exposures that exceed the final PEL over their working lifetime. The comparison of these steps is given in Table VIII-6. OSHA also presents in Chapter VII similar kinds of results for a variety of other risk assessment and population models.
The third step covers the monetization of benefits. Table VIII-7 presents the monetization of benefits at various interest rates and monetization values.
In the fourth step, OSHA estimates the net benefits of the final rule by comparing the monetized benefits to the costs presented in Chapter V of the FEA. These values are presented in Table VIII-8. The table shows that benefits exceed costs for all situations except for the low estimate of benefits using a 7 percent discount rate. The low estimate of benefits reflects the assumption that the ancillary provisions have no independent effect in reducing cases of CBD. OSHA considers this assumption to be very unlikely, based on the available evidence.
In the fifth step, OSHA provides a sensitivity analysis to explore the robustness of the estimates of net benefits with respect to many of the assumptions made in developing and applying the underlying models. This is done because the models underlying each step inevitably need to make a variety of assumptions based on limited data. OSHA invited comments on each aspect of the data and methods used in this chapter, and received none specifically on the sensitivity analysis. Because dental laboratories constituted a significant source of both costs and benefits to the proposal, the PEA indicated that OSHA was particularly interested in comments regarding the appropriateness of the model, assumptions, and data for estimating the benefits to workers in that industry. Although the Agency did not receive any comments on this question directly, the American Dental Association's comments relevant to the underlying use of beryllium alloys in dental labs are addressed in Chapter III of the FEA. The Agency has not altered its main estimates of the exposure profile for dental laboratory workers, but provides sensitivity analyses in the FEA to examine the outcome if a lower percentage of dental laboratories were to substitute materials that do not contain beryllium for beryllium-containing materials. OSHA also estimates net benefits with a variety of scenarios in which dental laboratories are not included. All of these results are presented in Chapter VII of the FEA.
Chapter VIII presents the costs, benefits and net benefits of a variety of regulatory alternatives.
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 that is required to conform to the notice-and-comment rulemaking requirements of section 553 of the Administrative Procedure Act (APA), the agency shall prepare a final regulatory flexibility analysis (FRFA). 5 U.S.C. 604(a).
However, 5 U.S.C. 605(b) of the RFA states that Section 604 shall not apply to any final rule if the head of the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. As discussed in Chapter VI of the FEA, OSHA was unable to so certify for the final beryllium rule.
For OSHA rulemakings, as required by 5 U.S.C. 604(a), the FRFA must contain:
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
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.
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(a).
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 will summarize the key aspects of OSHA's analysis as they affect small entities.
The objective of the final beryllium standard is to reduce the number of fatalities and illnesses occurring among employees exposed to beryllium. This objective will be achieved by requiring employers to install engineering controls where appropriate and to provide employees with the equipment, respirators, training, medical surveillance, and other protective measures necessary to perform their jobs safely. The legal basis for the rule is the responsibility given 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). See Section II of the preamble for a more detailed discussion.
Chronic beryllium disease (CBD) is a hypersensitivity, or allergic reaction, to beryllium that leads to a chronic inflammatory disease of the lungs. It takes months to years after final beryllium exposure before signs and symptoms of CBD occur. Removing an employee with CBD from the beryllium source does not always lead to recovery. In some cases CBD continues to progress following removal from beryllium exposure. CBD is not a chemical pneumonitis but an immune-mediated granulomatous lung disease. OSHA's final risk assessment, presented in Section VI of the preamble, indicates that there is significant risk of beryllium sensitization and chronic beryllium disease from a 45-year (working life) exposure to beryllium at the current TWA PEL of 2 μg/m
This section of the FRFA focuses only on public comments concerning significant issues raised on the Initial Regulatory Flexibility Analysis (IRFA). OSHA received only one such comment.
The Non-Ferrous Founders' Society claimed that the costs of the rule will disproportionately affect small employers and result in job losses to foreign competition (Document ID 1678, p. 3). This comment is addressed in the FEA in the section on International Trade Effects in Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility Determination. The summary of OSHA's response is that, in general, metalcasters in the U.S. have shortened lead times, improved productivity through computer design and logistics management, 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 1780, 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 that might occur due to the final rule. For a more detailed response please see the section on International Trade Effects in Chapter VI of the FEA.
The Chief Counsel for Advocacy of the Small Business Administration (“Advocacy”) did not provide OSHA with comments on this rule.
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 6.600 small business entities would be affected by the beryllium standard. Within these small entities, 33,800 workers are exposed to beryllium and would be protected by this final standard. A breakdown, by industry, of the number of affected small entities is provided in Table III-14 in Chapter III of the FEA.
OSHA estimates that approximately 5,280 very small entities—those with fewer than 20 employees—would be affected by the beryllium standard. Within these very small entities, 11,800 workers are exposed to beryllium and would be protected by the standard. A breakdown, by industry, of the number of affected very small entities is provided in Table III-15 in Chapter III of the FEA.
Tables VIII-9 and VIII-10 show the average costs of the beryllium 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 full derivation of these costs is presented in Chapter V. The cost for SBA-defined small entities ranges from a low of $832 per entity for
The annualized cost for very small entities ranges from a low of $542 for entities in NAICS 339116a: Dental Laboratories, to a high of about $34,222 for entities in NAICS 331529b: Other Nonferrous Metal Foundries (except Die-Casting).
OSHA has made a number of changes in the final beryllium rule that will serve to minimize significant impacts on small entities consistent with the objectives of the OSH Act. These changes are explained in more detail in Section XVI: Summary and Explanation in this preamble.
During the SBAR Panel, SERs requested a clearer definition of the triggers for medical surveillance. This concern was rooted in the cost of BeLPTs and the trigger of potential skin contact. For the final rule, the Agency has removed skin contact as a trigger for medical surveillance. OSHA has also reduced the frequency of medical surveillance from annually (in the proposed rule) to biennially in the final rule.
In the final rule, OSHA has added a performance option, as an alternative to scheduled monitoring, to allow employers to comply with exposure assessment requirements. This performance option should allow employers more flexibility, and often lower cost, in complying with the exposure assessment requirements.
Some SERs were already applying many of the protective controls and practices that would be required by the ancillary provisions of the standard. However, many SERs objected to the requirements regarding hygiene facilities. For this final rule, OSHA has concluded that all affected employers currently have hand washing facilities. OSHA has also concluded that no affected employers will be required to install showers. OSHA noted in the PEA that some facilities already have showers. There were no comments challenging the Agency's preliminary determinations regarding the existing availability of shower facilities or the means of preventing contamination, so the Agency concludes that all employers have showers where needed. Therefore, employers will not need to provide any new shower facilities to comply with the standard.
Similarly, in the PEA the Agency included no additional costs for readily accessible washing facilities, under the expectation that employers already have such facilities in place (PEA p. IX-19). Although the abrasive blasters exposed to beryllium in maritime and construction work may not have been expressly addressed in the PEA, OSHA notes that their employers are typically already required to provide readily accessible washing facilities to comply with other OSHA standards such as its sanitation standard at 29 CFR 1926.51(f)(1).
OSHA's shipyard standard at 29 CFR 1915.58(e) requires handwashing facilities “at or adjacent to each toilet facility” and “equipped with . . . running water and soap, or with waterless skin-cleansing agents that are capable of . . . neutralizing the contaminants to which the employee may be exposed.” OSHA's construction standard at 29 CFR 1926.51(f)(1) requires “adequate washing facilities for employees engaged in . . . operations where contaminants may be harmful to the employees. Such facilities shall be in near proximity to the worksite and shall be so equipped as to enable employees to remove such substances.”
The Agency has determined that the long-term rental of modular units was representative of costs for a range of reasonable approaches to comply with the change room part of the provision. Alternatively, employers could renovate and rearrange their work areas in order to meet the requirements of this provision.
Finally, in the final rule, OSHA has extended the compliance deadlines for change rooms from one year to two years and for engineering controls from two years to three years.
For the convenience of those persons interested only in OSHA's regulatory flexibility analysis, this section repeats the discussion presented in Chapter VIII of the FEA, but only for the regulatory alternatives to the final OSHA beryllium standard that would have lowered costs.
Each regulatory alternative presented here is described and analyzed relative to the final rule. Where appropriate, the Agency notes whether the regulatory alternative, to have been a legitimate candidate for OSHA consideration, required evidence contrary to the Agency's final findings of significant risk and feasibility. For this chapter on the Final Regulatory Flexibility Analysis, the Agency is only presenting regulatory alternatives that would have reduced costs for small entities. (See Chapter VIII for the full list of all alternatives analyzed.) There are 14 alternatives that would have reduced costs for small entities (and for all businesses in total). Using the numbering scheme from Chapter VIII of the FEA, these are Regulatory Alternatives #1a, #2a, #2b, #5, #6, #7, #8, #9, #10, #11, #12, #13, #15, #16, #18, and #22. OSHA has organized these 16 cost-reducing alternatives (and a general discussion of considered phase-ins of the rule) into four categories: (1) Scope; (2) exposure limits; (3) methods of compliance; and (4) ancillary provisions.
The scope of the beryllium final rule applies to general industry work, construction and maritime activities. In addition, the final rule provides an exemption for those working with materials containing only trace amounts of beryllium (less than 0.1% by weight) when the employer has objective data that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
The first set of regulatory alternatives would alter the scope of the final standard by differing in coverage of groups of employees and employers. Regulatory Alternatives #1a, #2a, and #2b would decrease the scope of the final standard.
Regulatory Alternative #1a would exclude all operations where beryllium exists only as a trace contaminant; that is, where the materials used contain less than 0.1% beryllium by weight, with no other conditions. OSHA has identified two industries with workers engaged in general industry work that would be excluded under Regulatory Alternative #1a: Primary aluminum production and coal-fired power generation.
Table VIII-11 presents, for informational purposes, the estimated costs, benefits, and net benefits of Regulatory Alternative #1a using alternative discount rates of 3 percent and 7 percent. In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of this alternative relative to the final rule. Table VIII-11 also breaks out costs by provision, and benefits by type of disease and by morbidity/mortality prevented. (Note: “morbidity” cases are cases where health effects are limited to non-fatal illness; in these cases there is no further disease progression to fatality).
As shown in Table VIII-11, Regulatory Alternative #1a would decrease the annualized cost of the rule from $73.9 million to $64.6 million using a 3 percent discount rate and from $76.6 million to $67.0 million using a 7 percent discount rate. Annualized benefits in monetized terms would decrease from $560.9 million to $515.7 million, using a 3 percent discount rate, and from $249.1 million to $229.0 million using a 7 percent discount rate. Net benefits would decrease from $487.0 million to $451.1 million using a 3 percent discount rate and from $172.4 million to $162.0 million using a 7 percent discount rate.
Regulatory Alternative #2a would exclude construction and maritime work from the scope of the final standard. For example, this alternative would exclude abrasive blasters, pot tenders, and cleanup staff working in
Table VIII-12 presents the estimated costs, benefits, and net benefits of Regulatory Alternative #2a using alternative discount rates of 3 percent and 7 percent. In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of these alternatives relative to the final rule. Table VIII-12 also breaks out costs by provision and benefits by type of disease and by morbidity/mortality.
As shown in Table VIII-12, Regulatory Alternative #2a would decrease costs from $73.9 million to $62.0 million, using a 3 percent discount rate, and from $76.6 million to $64.4 million using a 7 percent discount rate. Annualized benefits would decrease from $560.9 million to $533.3 million, using a 3 percent discount rate, and from $249.1 million to $236.8 million using a 7 percent discount rate. Net benefits would change from $487.0 million to $471.3 million, using a 3 percent discount rate, and is essentially unchanged at a discount rate of 7 percent, with the final rule having net benefits of $172.4 million while the alternative has $172.5 million. Thus, at a 7 percent discount rate, the costs exceed the benefits for this alternative by $0.1 million per year. However, OSHA believes that for these industries, the cost estimate is severely overestimated because 45 percent of the costs are for exposure monitoring assuming that employers use the periodic monitoring option. Employers in this sector are far more likely to use the performance based monitoring options at considerably reduced costs. If this is the case, benefits would exceed costs even at a 7 percent discount rate.
Regulatory Alternative #2b would eliminate the ancillary provisions in the final rule for the shipyard and construction sectors and for any operations where beryllium exists only as a trace contaminant. Accordingly, only the final TWA PEL and STEL would apply to employers in these sectors and operations (through 29 CFR 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A). Operations in general industry where the ancillary provisions would be eliminated under Regulatory Alternative #2b include aluminum smelting and production and coal-powered utility facilities and any other operations where beryllium is present only as a trace contaminant (in addition to all operations in construction and shipyards).
As shown in Table VIII-13, Regulatory Alternative #2b would decrease the annualized cost of the rule from $73.9 million to $53.5 million using a 3 percent discount rate, and from $76.6 to $55.6 million using a 7 percent discount rate. Annualized benefits would decrease from $560.9 million to $493.3 million, using a 3 percent discount rate, and from $249.1 million to $219.1 million, using a 7 percent discount rate. Net benefits would decrease from $487.0 million to $439.8 million, using a 3 percent discount rate, and from $172.4 million to $163.5 million, using a 7 percent discount rate.
Paragraph (c) of the three final standards establishes two PELs for beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of 0.2 μg/m
Regulatory Alternative #5 would set a higher TWA PEL at 0.5 µg/m
Table VIII-14 below presents, for informational purposes, the estimated costs, benefits, and net benefits of the final rule under the final TWA PEL of 0.2 μg/m
As Table VIII-14 shows, going from a TWA PEL of 0.5 μg/m
An Informational Analysis: This final regulation has the somewhat unusual feature for an OSHA substance-specific health standard that most of the quantified benefits that OSHA estimated would come from the ancillary provisions rather than from meeting the PEL solely with engineering controls (see Chapter VII of the FEA for a more detailed discussion). OSHA decided to analyze for informational purposes the effect of retaining the preceding PEL but applying all of the ancillary provisions, including respiratory protection. Under this approach, the TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the other final provisions (including respiratory protection) would be required with their triggers remaining the same as in the final rule—either the presence of airborne beryllium at any level (
Given the record regarding beryllium exposures, this approach is not one OSHA could legally adopt. The absence of engineering controls would not be consistent with OSHA's application of the hierarchy of controls, in which engineering controls are applied to eliminate or control hazards, before administrative controls and personal protective equipment are applied to address remaining exposures. Section 6(b)(5) of the OSH Act requires OSHA 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.” For that reason, this additional analysis is provided strictly for informational purposes. E.O. 12866 and E.O. 13563 direct agencies to identify approaches that maximize net benefits, and this analysis is purely for the purpose of exploring whether this approach would hold any real promise to maximize net benefits if it was permissible under the OSH Act. It does not appear to hold such promise because an ancillary-provisions-only approach would not be as protective and thus offers fewer benefits than one that includes a lower PEL and engineering controls. Also, OSHA estimates the costs would be about the same (or slightly lower, depending on certain assumptions) under that approach as under the traditional final approach.
When examined on an industry-by-industry basis, OSHA found that some industries would have lower costs if they could adopt the ancillary-provision-only approach. Some employers would use engineering controls where they are cheaper, even if they are not mandatory. OSHA does not have sufficient information to do an analysis employer-by-employer of when the ancillary-provisions-only approach might be cheaper. In the majority of affected industries, the Agency estimates there are no cost savings to the ancillary-provisions-only approach. However, OSHA estimates an annualized total cost saving of $2.7 million per year for entire industries where the ancillary-provisions-only approach would be less expensive.
The above discussion does not account for the possibility that the lack of engineering controls would result in higher beryllium exposures for workers in adjacent (non-production) work areas due to the increased level of beryllium in the air. Because of a lack of data, and because the issue did not arise in the other regulatory alternatives OSHA considered (all of which have a PEL of less than 2.0 µg/m
If respirators were as effective as engineering controls, the ancillary-provisions-only approach would have benefits comparable to the benefits of the final rule. However, in this alternative most exposed individuals would be required to use respirators, which OSHA considers less effective than engineering controls in preventing employee exposure to beryllium. OSHA also examined what the benefits would be if respirators were not required, were not worn, or were ineffective. OSHA found that, if all of the other aspects of the benefits analysis remained the same, the annualized benefits would be reduced by from $33.2 million using a discount rate of 3 percent, and $22.4 using a discount rate of 7 percent, largely as a result of failing to reduce deaths from lung cancer, which are unaffected by the ancillary provisions. However, there are also other reasons to believe that benefits may be even lower:
(1) As noted above, in the final rule OSHA did not consider benefits caused by reductions in exposure in non-production areas. Unless employers act to reduce exposures in the production areas, the absence of a requirement for such controls would largely negate such benefits from reductions in exposure in the non-productions areas.
(2) OSHA judges that the benefits of the ancillary provisions (a midpoint estimate of eliminating 45 percent of all remaining cases of CBD for all sectors except for abrasive blasting and coal-fired power plants, and an estimate of 11.25 percent, or one fourth of the percentage for other sectors, for abrasive blasting and coal-fired power plants) would be partially or wholly negated in the absence of engineering controls that would reduce both airborne and surface dust levels. The Agency's high estimate (90 percent for all sectors except abrasive blasting and coal fired power plants, 22.5 percent for abrasive blasting and coal-fired power plants) of the proportion of remaining CBD cases eliminable by ancillary provisions is based on data from a facility with average exposure levels of less than 0.2 µg/m
Based on these considerations, OSHA finds that the ancillary-provisions-only approach is not one that is likely to maximize net benefits. The cost savings, if any, are estimated to be small, and the difficult-to-measure declines in benefits could be substantial.
Paragraph (f)(2)(i) of the final standards contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in general industry, maritime, and construction. For each operation in a beryllium work area in general industry or where exposures are or can reasonably be expected to be above the action level in shipyards or construction, employers must ensure that one or more of the following are in place to minimize employee exposure: Material and/or process substitution; isolation, such as ventilated partial or full enclosures; local exhaust ventilation; or process controls, such as wet methods and automation. Employers are exempt from using these methods only when they can show that such methods are not feasible or where exposures are below the action level based on two exposure samples taken at least seven days apart.
OSHA believes that the methods outlined in paragraph (f)(2)(i) provide the most reliable means to control variability in exposure levels. However, OSHA also recognizes that the requirements of paragraph (f)(2)(i) are not typical of OSHA standards, which usually require engineering controls
In the PEA, OSHA had been unable to estimate the benefits of this alternative and invited public comment. The Agency did not receive public comment and therefore has not estimated the change in benefits resulting from Regulatory Alternative #6.
The final standard contains several ancillary provisions (provisions other than the exposure limits), including requirements for exposure assessment, medical surveillance, medical removal, training, competent person, and regulated areas or access control. As reported in Chapter V of the FEA, these ancillary provisions account for $61.3 million (about 83 percent) of the total annualized costs of the rule ($73.4 million) using a 3 percent discount rate. The most expensive of the ancillary provisions are the requirements for housekeeping and exposure monitoring, with annualized costs of $22.8 million and $13.7 million, respectively, at a 3 percent discount rate.
OSHA's reasons for including each of the final ancillary provisions are explained in Section XVI of the preamble, Summary and Explanation of the Standards.
OSHA has examined a variety of regulatory alternatives involving changes to one or more of the final ancillary provisions. The incremental cost of each of these regulatory alternatives and its impact on the total costs of the final rule are summarized in Table VIII-16 at the end of this section. OSHA has determined that several of these ancillary provisions will increase the benefits of the final rule, for example, by helping to ensure the TWA PEL is not exceeded or by lowering the risks to workers given the significant risk remaining at the final TWA PEL. However, except for Regulatory Alternative #7 (involving the elimination of all ancillary provisions), OSHA did not estimate changes in monetized benefits for the regulatory alternatives that affect ancillary provisions. Two regulatory alternatives that involve all ancillary provisions are presented below (#7 and #8), followed by regulatory alternatives for exposure monitoring (#9, #10, and #11), for regulated areas (#12), for personal protective clothing and equipment (#13), for medical surveillance (#14 through #20), and for medical removal protection (#22).
The SBAR Panel recommended that OSHA analyze a PEL-only standard as a regulatory alternative. The Panel also recommended that OSHA consider not applying ancillary provisions of the standard where exposure levels are low so as to minimize costs for small businesses (SBAR, 2008). In response to these recommendations, OSHA analyzed Regulatory Alternative #7, a PEL-only standard, and Regulatory Alternative #8, which would apply ancillary provisions of the beryllium standard only where exposures exceed the final TWA PEL of 0.2 μg/m
Regulatory Alternative #7 would only update 1910.1000 Tables Z-1 and Z-2, so that the final TWA PEL and STEL would apply to all workers in general industry, construction, and maritime. This alternative would eliminate all of the ancillary provisions of the final rule, including exposure assessment, medical surveillance, medical removal protection, PPE, housekeeping, training, competent person, and regulated areas or access control. Under this regulatory alternative, OSHA estimates that the costs for the final ancillary provisions of the rule (estimated at $61.4 million annually at a 3 percent discount rate) would be eliminated. In order to meet the PELs, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that, under this alternative, many employers would follow the recommendations of Materion and the United Steelworkers to provide medical surveillance, PPE, and other protective measures for their workers (Materion and United Steelworkers, 2012). OSHA has not attempted to estimate the extent to which these ancillary provision costs would be incurred if they were not formally required or whether any of
OSHA has also estimated the effect of this regulatory alternative on the benefits of the rule, presented in Table VIII-16. As a result of eliminating all of the ancillary provisions, annualized benefits are estimated to decrease 71 percent, relative to the final rule, from $560.9 million to $211.9 million, using a 3 percent discount rate, and from $249.1 million to $94.0 million using a 7 percent discount rate. This estimate follows from OSHA's analysis of benefits in Chapter VII of the FEA, which found that about 68 percent of the benefits of the final rule, evaluated at their mid-point value, were attributable to the combination of the ancillary provisions. As these estimates show, OSHA expects 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.
Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to beryllium. The stakeholders' recommended standard—that representatives of Materion, the primary beryllium producer, and the United Steelworkers union provided to OSHA—confirms the importance of ancillary provisions in protecting workers from the harmful effects of beryllium exposure (Materion and United Steelworkers, 2012). Ancillary provisions such as personal protective clothing and equipment, regulated areas, medical surveillance, hygiene areas, housekeeping requirements, and hazard communication all serve to reduce the risks to beryllium-exposed workers beyond that which the final TWA PEL alone could achieve.
Under Regulatory Alternative #8, several ancillary provisions that the current final rule would require under a variety of exposure conditions (
Regulatory Alternative #8 affects the following provisions of the final standard:
○
○
○
To estimate the cost savings for this alternative, OSHA re-estimated the group of workers that would fall under the above provisions, with results presented in Table VIII-16. Combining these various adjustments along with associated unit costs, OSHA estimates that, under this regulatory alternative, the costs for the final rule would decline from $73.9 million to $35.8 million, using a 3 percent discount rate, and from $76.6 million to $37.9 million, using a 7 percent discount rate.
The Agency has not quantified the impact of this alternative on the benefits of the rule. However, ancillary provisions that offer protective measures to workers exposed below the final TWA PEL, such as personal protective clothing and equipment, beryllium work areas, hygiene areas, housekeeping requirements, and hazard communication, all serve to reduce the risks to beryllium-exposed workers beyond that which the final TWA PEL and STEL could achieve.
The remainder of this chapter discusses additional regulatory alternatives that apply to individual ancillary provisions.
Paragraph (d) of the final standard, Exposure Assessment, allows employers to choose either the performance option or scheduled monitoring. The scheduled monitoring option requires semi-annual monitoring for those workers exposed at or above the action level but at or below the PEL and quarterly exposure monitoring for those workers exposed above the PEL. The rationale for this provision is provided in the preamble discussion of paragraph (a) in Section XVI, Summary and Explanation of the Standards.
OSHA has examined three regulatory alternatives that would modify the requirements of periodic monitoring in the final rule. Under Regulatory Alternative #9, employers would be required to perform periodic exposure monitoring annually when exposures are at or above the action level or above the STEL, but at or below the TWA PEL. As shown in Table VIII-16, Regulatory Alternative #9 would decrease the annualized cost of the final rule by about $4.3 million using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #10, employers would be required to perform periodic exposure monitoring annually when exposures are at or above the action level. As shown in Table VIII-16, Regulatory Alternative #10 would decrease the annualized cost of the final rule by about $4.9 million using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #11, employers would be required to perform annual exposure monitoring where exposures are at or above the action level but at or below the TWA PEL and STEL. When exposures are above the TWA PEL, no periodic monitoring would be required. As shown in Table VIII-16, Regulatory Alternative #11 would decrease the annualized cost of the final rule by about $5.0 million using either a 3 percent or 7 percent discount rate. OSHA is unable to quantify the effect of this change on benefits but has judged the alternative adopted necessary and protective.
Final paragraph (e) for General Industry requires employers to establish and maintain beryllium work areas in any work area containing a process or operation that can release beryllium where employees are, or can reasonably be expected to be, exposed to airborne beryllium at any level or where there is the potential for dermal contact with beryllium, and regulated areas wherever airborne concentrations of beryllium exceed, or can reasonably be expected to
The SBAR Panel report recommended that OSHA consider dropping or limiting the provision for regulated areas (SBAR, 2008). In response to this recommendation, OSHA examined Regulatory Alternative #12, which would eliminate the requirement that employers establish regulated areas in the General Industry and Maritime standards, and eliminate the competent person requirement in the Construction standard. This alternative would not eliminate the final requirement to establish beryllium work areas, where required. As shown in Table VIII-16, Regulatory Alternative #12 would decrease the annualized cost of the final rule by about $1.0 million using either a 3 or 7 percent discount rate.
Regulatory Alternative #13 would modify the requirements for personal protective equipment (PPE) by eliminating the requirement for appropriate PPE whenever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. This alternative would be narrower, and thus less protective, than the PPE requirement in the final standards, which require PPE to be used where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL, or where there is a reasonable expectation of dermal contact with beryllium.
The economic analysis for the final standard already contains costs for protective clothing, namely gloves, for all employees who can reasonably be expected to be have dermal contact with beryllium; thus OSHA estimated the cost of this alternative as the cost reduction from not providing gloves under these circumstances. As shown in Table VIII-16, Regulatory Alternative #13 would decrease the annualized cost of the final rule by about $481,000 using either a 3 percent or 7 percent discount rate.
The final requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are or are reasonably expected to be exposed to beryllium at or above the action level for more than 30 days per year, who show signs or symptoms of CBD or other beryllium-related health effects, are exposed to beryllium in an emergency, or whose more recent written medical opinion required by paragraph (k)(6) or (k)(7) recommends such surveillance, and (2) low dose CT scans for employees when recommended by the PLCHP. The final standards require biennial medical exams to be provided for eligible employees. The standards also require tests for beryllium sensitization to be provided to eligible employees biennially.
OSHA estimated in Chapter V of the FEA that the medical surveillance requirements would apply to 4,528 workers in general industry, of whom 387 already receive medical surveillance.
OSHA has examined four regulatory alternatives (#15, #16, #18, and #22) that would modify the final rule's requirements for employee eligibility, the tests that must be offered, and the frequency of periodic exams. Medical surveillance was a subject of special concern to SERs during the SBAR Panel process, and the SBAR Panel offered many comments and recommendations related to medical surveillance for OSHA's consideration. Some of the Panel's concerns have been partially addressed in this final rule, which was modified since the SBAR Panel was convened (see the preamble at Section XVI, Summary and Explanation of the Standards, for more detailed discussion). Regulatory Alternative #16 also responds to recommendations by the SBAR Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements.
OSHA has determined that a significant risk of beryllium sensitization, CBD, and lung cancer exists at exposure levels below the final TWA PEL and that there is evidence that beryllium sensitization can occur even from short-term exposures (see the preamble at Section V, Health Effects, and Section VII, Significance of Risk). The Agency therefore anticipates that more employees would develop adverse health effects without receiving the benefits of early intervention in the disease process because they are not eligible for medical surveillance (see section XVI of this preamble, the Summary and Explanation for paragraph (k)).
Regulatory Alternative #15 would decrease eligibility for medical surveillance to employees who are exposed to beryllium above the final PEL
To estimate the cost of Regulatory Alternative #15, OSHA assumed that all workers exposed above the PEL before the final rule would continue to be exposed after the standard is promulgated. Thus, this alternative eliminates costs for medical exams for the number of workers exposed between the action level and the TWA PEL. As shown in Table VIII-16, Regulatory Alternative #15 would decrease the annualized cost of the final rule by about $4.5 million using a discount rate of 3 percent, and by about $4.8 million using a discount rate of 7 percent.
In response to concerns raised during the SBAR Panel process about testing requirements, OSHA considered two regulatory alternatives that would provide greater flexibility in the program of tests provided as part of an employer's medical surveillance program. Under Regulatory Alternative #16, employers would not be required to offer employees testing for beryllium sensitization. As shown in Table VIII-16, this alternative would decrease the annualized cost of the final rule by about $2.4 million using either a 3 percent or 7 percent discount rate.
Regulatory Alternative #18 would eliminate the CT scan requirement from the final rule. This alternative would decrease the annualized cost of the final rule by about $613,000 using a discount rate of 3 percent, and by about $643,000 using a discount rate of 7 percent.
Under paragraph (l) of the final standard, Medical Removal, employees in jobs with exposure at or above the action level become eligible for medical removal when they provide their employers with a written medical report indicating they are diagnosed with CBD or confirmed positive for beryllium sensitization, or if a written medical opinion recommends medical removal
The SBAR Panel report included a recommendation that OSHA give careful consideration to the impacts that an MRP requirement could have on small businesses (SBAR, 2008). In response to this recommendation, OSHA analyzed Regulatory Alternative #22, which would remove the final requirement that employers offer MRP. As shown in Table VIII-16, this alternative would decrease the annualized cost of the final rule by about $1.2 million using a discount rate of 3 percent, and by about $1.3 million using a discount rate of 7 percent.
Table VIII-17 lists all of the SBAR Panel recommendations and OSHA's response to those recommendations.
The three final beryllium standards (collectively “the standards”) for occupational exposure to beryllium—general industry (29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyard (29 CFR 1915.1024)—contain collection of information (paperwork) requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited public comments on the Beryllium Standard for General Industry (29 CFR 1910.1024
On October 21, 2015, OMB issued a Notice of Action (NOA) assigning Beryllium Standard for General Industry new OMB Control Number 1218-0267 to use in future paperwork submissions involving this rulemaking. OMB requested that, “Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.”
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).
No public comments were received specifically in response to the proposed ICR submitted to OMB for review. However, several public comments submitted in response to the Notice of Proposed Rulemaking (NPRM), described earlier in this preamble, substantively addressed provisions containing collections of information and contained information relevant to the burden hour and costs analysis. These comments are addressed in the preamble, and OSHA considered them when it developed the revised ICR associated with these final standards.
The Department of Labor submitted the final ICR January 9, 2017 containing a full analysis and description of the burden hours and costs associated with the collections of information of the standards to OMB for approval. A copy of the ICR is available to the public at
Under the PRA, Federal agency cannot conduct or sponsor a collection of information unless it is approved by OMB under the PRA, and the collection of information notice displays a currently valid OMB control number (44 U.S.C. 3507(a)(3)). Also, notwithstanding any other provision of law, no employer shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512). The major collections of information found in the standards are listed below.
The Beryllium standards contain collection of information requirements which are essential components of the occupational safety and health standards that will assist both employers and their employees in identifying the exposures to beryllium and beryllium compounds, the medical effects of such exposures, and the means to reduce the risk of overexposures to beryllium and beryllium compounds. In the final ICR, OSHA has expanded its coverage to include the construction and shipyard industries—in order to tailor the collection of information requirements to the circumstances found in these sectors. The decision to include standards for construction and shipyards is based on information and comment submitted in response to the NPRM request for comment, and during the informal public hearing.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Below is a summary of the collection of information requirements contained in the final rule, and a brief description of the most significant changes between the proposal and the final rule portions of the regulatory text containing collection of information requirements. One of the most significant changes between the NPRM and this final rule is that OSHA extended the scope of the rule so that the most of the provisions now also apply to construction and shipyard work. As a result, while most of the provisions are identical across all three standards (general industry, construction, and shipyards), there are technically more collections of information. However, for purposes of the review and explanation that follows, OSHA has focused on the changes to the general industry provisions and has not separately identified the additions to the construction and shipyard standard unless they deviate from the requirements in the general industry standard. A more detailed discussion of all the changes made to the proposed rule, including the requirements that include identified collection of information, is in Section XVIII:
Paragraph (d) sets forth requirements for assessing employee exposures to beryllium. Consistent with the definition of “airborne exposure” in paragraph (b) of these standards, exposure monitoring results must reflect the exposure to airborne beryllium that would occur if the employee were not using a respirator.
Proposed paragraph (d) used the term “Exposure monitoring.” In the final rule, this term was changed to “Exposure assessment” throughout the paragraph. This change in the final standards was made to align the provision's purpose with the broader concept of exposure assessment beyond conducting air monitoring, including the use of objective data.
OSHA added a paragraph (d)(2) as an alternative exposure assessment method to the scheduled monitoring requirements in the proposed rule. Under this option employers must assess 8-hour TWA exposure and the 15-minute short term exposure for each employee using any combination of air monitoring data and objective data sufficient to accurately characterize airborne exposure to beryllium.
Proposed paragraph (d)(3),
Proposed paragraph (d)(4) would have required employers to conduct exposure monitoring within 30 days after a change in production processes, equipment, materials, personnel, work practices, or control methods that could reasonably be expected to result in new or additional exposures. OSHA changed the proposed requirement to require that employers perform reassessment of exposures when there is a change in “production, process, control equipment, personnel, or work practices” that may reasonably be expected to result in new or additional exposures at or above the action level or STEL. In addition, OSHA added “at or above the action level or STEL” to final paragraph (d)(4). In summary, the final rule requires that employers must perform reassessment of exposures when there is a change in production, process, control equipment, personnel, or work practices that may reasonably be expected to result in new or additional exposures at or above the action level or STEL.
Proposed paragraph (d)(5)(i), Employee Notification of Monitoring Results, would have required employers in general industry to inform their employees of results within 15 working days after receiving the results of any exposure monitoring completed under this standard. Final paragraph (d)(6),
Proposed paragraph (d)(5)(ii) (paragraph (d)(6)(ii) of the final standards) would have required that whenever an exposure assessment indicates that airborne exposure is above the TWA PEL or STEL, the employer must include in the written notification the suspected or known sources of exposure and the corrective action(s) the employer has taken or will take to reduce exposure to or below the PELs, where feasible corrective action exists but had not been implemented when the monitoring was conducted. Final paragraph (d)(6)(ii) removes the requirement that employers include suspected or known sources of exposure in the written notification.
Proposed paragraph (f)(1)(i) would have required employers to establish, implement and maintain a written control plan for beryllium work areas. OSHA has retained the requirement for a written exposure control plan and incorporated most provisions of the proposed paragraph (f)(1)(i) into the final standards for construction and shipyards, with certain modifications due to the work processes and worksites particular to these sectors.
Paragraph (f)(1)(i) differs from the proposal in that it requires a written exposure control plan for each facility, whereas the proposal would have required a written exposure control plan for beryllium work areas within each facility. OSHA has modified the requirement of a list of operations and job titles reasonably expected to have exposure to include those operations and job titles that are reasonably expected to have dermal contact with beryllium. Finally, OSHA modified the proposed requirement to inventory engineering and work practice controls required by paragraph (f)(2) of this standard to include respiratory protection.
Paragraph (f)(1)(ii) of the final standards requires the employer to review and evaluate the effectiveness of each written exposure control plan at least annually and update it when: (A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results or can reasonably be expected to result in additional or new airborne exposure to beryllium; (B) the employer is notified that an employee is eligible for medical removal in accordance with paragraph
OSHA made several changes to that paragraph. First, OSHA added a requirement to review and evaluate the effectiveness of each written exposure control plan at least annually. Second, OSHA changed the proposed language of (f)(1)(ii)(B) to reflect other changes in the standard, including a change to ensure that employers are not automatically notified of cases of sensitization or CBD among their employees. Third, OSHA modified (f)(1)(ii)(B) to clarify the Agency's understanding that signs and symptoms of beryllium exposure may be related to inhalation or dermal exposure. Finally, OSHA modified the wording of (f)(1)(ii) to require the employer to update “each” written exposure control plan rather than “the” written exposure control plan, since an employer who operates multiple facilities is required to establish, implement and maintain a written exposure control plan for each facility.
Paragraph (f)(1)(iii) of the proposed rule would have required the employer to make a copy of the exposure control plan accessible to each employee who is or can reasonably be expected to be exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)). OSHA did not receive comments specific to this provision, and has retained it in the final standard for general industry and included the paragraph in the final standards for construction and shipyards.
Proposed Paragraph (g) of the standard would have established the requirements for the use of respiratory protection. OSHA added language to paragraph (g) to clarify that both the selection and use of respiratory protection must be in accordance with the Respiratory Protection standard 29 CFR 1910.134, which is cross-referenced, and to provide a powered air-purifying respirator (PAPR) when requested by an employee. The Respiratory protection standard contains collection of information requirements, include a written respiratory protection program and fit-testing records (29 CFR 1910.134(c)). The collection of information requirements contained in the Respiratory Protection Program standard are approved under OMB Control Number 1218-0099.
Final paragraph (h)(3)(iii), like proposed paragraph (h)(3), requires employers to inform in writing the persons or the business entities who launder, clean or repair the protective clothing or equipment required by this standard of the potentially harmful effects of exposure to airborne beryllium and contact with soluble beryllium compounds and how the protective clothing and equipment must be handled in accordance with the standard.
Paragraph (j)(3) requires warning labels in accordance with the requirements in paragraph (m) when employer transfer materials containing beryllium.
In paragraphs (k)(1)(i)(A)-(D) of the proposal, OSHA specified that employers must make medical surveillance required by this paragraph available for each employee: (1) Who has worked in a regulated area for more than 30 days in the last 12 months; (2) showing symptoms or signs of CBD, such as shortness of breath after a short walk or climbing stairs, persistent dry cough, chest pain, or fatigue; or (3) exposed to beryllium during an emergency; and (4) who was exposed to airborne beryllium above .2 μg/m
Paragraph (k)(1)(i)(B) has been revised to include signs or symptoms of other beryllium-related health effects.
Proposed paragraph (k)(1)(i)(C) required employers to offer medical surveillance to employees exposed during an emergency. No revisions were made to this paragraph.
OSHA added final paragraph (k)(1)(i)(D), which requires that medical surveillance be made available when the most recent written medical opinion to the employer recommends continued medical surveillance. Under final paragraphs (k)(6) and (k)(7), the written opinion must contain a recommendation for continued periodic medical surveillance if the employee is confirmed positive or diagnosed with CBD, and the employee provides written authorization.
Proposed paragraph (k)(2)(ii) required employers to provide an examination annually (after the first examination is made available) to employees who continue to meet the criteria of proposed paragraph (k)(1)(i)(A) or (B). OSHA revised the paragraph to specify that medical examinations were to be made available “at least” every two years and to include employees who continue to meet the criteria of final paragraph (k)(1)(i)(D),
Proposed paragraph (k)(2)(iii) required the employer to offer a medical examination at the termination of employment, if the departing employee met any of the criteria of proposed paragraphs (k)(1) at the termination of employment for each employee who met the criteria of paragraphs (k)(1)(i)(A), (B), or (C), unless an examination has been provided in accordance with the standard during the 6 months prior to the date of termination.
Final paragraph (k)(2)(iii) requires the employer to make a medical examination available to each employee who meets the criteria of final paragraph (k)(1)(i) at the termination of employment, unless the employee received an exam meeting the requirements of the standards within the last 6 months. OSHA extended the requirement to employees who meet the criteria of final paragraph (k)(1)(i)(D).
Paragraphs (k)(3)(ii)(A)-(D) detail the content of the medical examination. The final rule made several changes to the content of the employee medical examination including, but not limited to, revising paragraphs: (k)(3)(ii)(A), to include emphasis on past and present airborne exposure to or dermal contact with beryllium; (k)(3)(ii)(C) to require a physical examination for skin rashes, rather than an examination for breaks and wounds; (k)(3)(ii)(E) to require the BeLPT test to be offered “at least” every two years, rather than every two years; (k)(3)(ii)(F) to include an LDCT scan when recommended by the PLHCP. With these changes, final paragraphs (k)(3)(ii)(A)-(D) require the medical examination to include: (1) Medical and work history, with emphasis on past and present airborne exposure to or dermal contact with beryllium, any history of respiratory dysfunction and smoking history, and; (2) a physical examination with emphasis on the respiratory system; (3) a physical examination for skin rashes; and (4) a pulmonary function test, performed in accordance with guidelines established by the ATS including forced vital capacity (FVC) and a forced expiratory volume in one second (FEV1). A more detailed discussion regarding all of the changes to the content of the Medical examinations may be found in section XVI,
Proposed paragraph (k)(4) detailed which information must be provided to the PHLCP. Specifically, the proposed standard required the employer to provide to the examining PLHCP the following information, if known to the employer: A description of the employee's former and current duties that relate to the employee's occupational exposure ((k)(4)(i)); the employee's former and current levels of occupational exposure ((k)(4)(ii)); a description of any personal protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that clothing and equipment ((k)(4)(iii)); and information the employer has obtained from previous medical examinations provided to the employee, that is currently within the employer's control, if the employee provides a medical release of the information ((k)(4)(iv)). OSHA made several changes to this paragraph. First, OSHA updated paragraph (k)(4)(i) to require the employer to provide a description of the employee's former and current duties that relate to both the employee's airborne exposure to and dermal contact with beryllium, instead of merely requiring the provision of information related to occupational exposure. Second, OSHA changed the requirement that the employer obtain a “medical release” from the employee to “written consent” before providing the PLHCP with information from records of employment-related medical examinations. Third, OSHA revised the provision to require that the employer ensure that the same information provided to the PLHCP is also provided to the agreed-upon CBD diagnostic center, if an evaluation is required under paragraph (k)(7) of the standard.
Paragraph (k)(5) of the proposed standard provided for the licensed physician to give a written medical opinion to the employer, but relied on the employer to give the employee a copy of that opinion; thus, there was no difference between information the employer and employee received. The final standards differentiate the types of information the employer and employee receive by including two separate paragraphs within the medical surveillance section that require a written medical report to go to the employee, and a more limited written medical opinion to go to the employer. The requirement to provide the medical opinion to the employee is in paragraph (k)(5) of the final standards; the requirement for providing documentation to the employer is in paragraph (k)(6) of the final standards. Most significantly, OSHA removed the requirement that the medical opinion pass through the employer to the employee.
Final paragraphs (k)(5)(i)-(v) provide the contents of the licensed physician's written medical report for the employee. They include: The results of the medical examination, including any medical condition(s), such as CBD or beryllium sensitization (
Paragraph (k)(5) also provides that if the employee is confirmed positive or diagnosed with CBD, or if the physician otherwise deems it appropriate, the written medical report must also contain a referral to a CBD diagnostic center, a recommendation for continued medical surveillance, and a recommendation for medical removal from airborne beryllium exposures above the action level, as described in paragraph (l) of the standard. Proposed paragraph (k)(6) also addressed information provided to employees who were confirmed positive or diagnosed with CBD, but simply required a consultation with the physician.
Paragraph (k)(6)(i) requires employers to obtain a written medical opinion from the licensed physician within 45 days of the medical examination (including any follow-up BeLPT required under (k)(3)(ii)(E)). In proposed (k)(5), the physician would have been required to share most of the information identified now provided directly to the employee per final (k)(5) with the employer, but in the final rule OSHA limited the information that could be shared with the employer. In final (k)(6) the 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 standard, and any recommended limitations on the employee's use of respirators, protective clothing, and equipment; and a statement that the PLHCP explained the results of the examination to the employee, including any tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions for use of personal protective clothing or equipment.
Paragraph (k)(6)(ii) states that if the employee provides written authorization, the written medical opinion for the employer must also contain any recommended limitations on the employee's airborne exposure to beryllium. The requirement for written authorization was not in the proposal. Paragraphs (k)(6)(iii)-(v) state that if an employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a referral for evaluation at a CBD diagnostic center and recommendations for continued medical surveillance and medical removal from airborne exposure to beryllium as described in paragraph (l).
Paragraph (k)(6)(vi) requires the employer to ensure that employees receive a copy of the written medical opinion for the employer within 45 days of any medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) performed for that employee. A similar requirement was included in proposed (k)(5)(iii), but the time period was two weeks.
Proposed paragraph (k)(7) would have required employers to convey the results of beryllium sensitization tests to OSHA for evaluation and analysis at the request of OSHA. Based on comments received during the comment period, OSHA decided not to include the proposed paragraph (k)(7) in the final standard.
Final paragraph (k)(7) requires that if the employee wants a clinical evaluation at a CBD diagnostic center, the employer must provide the examination at no cost to the employee. OSHA made several changes to final paragraph (k)(7) as compared to similar provisions in paragraph (k)(6) of the proposal. First, OSHA changed the trigger for referral to a CBD diagnostic center to include both confirmed positive and a CBD diagnosis for consistency with final paragraphs (k)(5)(iii) and (k)(6)(iii). Second, OSHA removed the requirement for a consultation between the physician and employee. However, final paragraph (k)(7)(i) requires that employers provide a no-cost evaluation at a CBD-diagnostic center that is mutually agreed upon by the employee and employer.
Final paragraph (k)(7) requires the employer to ensure that the employee receives a written medical report form the CBD diagnostic center that contains all the information required in paragraph (k)(5)(i), (ii), (iv) and (v) and that the PLHCP explains the results of the examination of the employee within 30 days of the examination.
Proposed paragraph (m)(1)(i) required chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the HCS (29 CFR 1910.1200) for beryllium. No substantive changes were made to this paragraph.
Proposed paragraph (m)(1)(ii) would have required employers to address at least the following, in classifying the hazards of beryllium: Cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation. According to the HCS, employers must classify hazards if they do not rely on the classifications of chemical manufacturers, importers, and distributors (see 29 CFR 1910.1200(d)(1)). OSHA revised the language to bring it into conformity with other substance specific standards so it is clear that chemical manufacturers, importers, and distributors are among the entities required to classify the hazards of beryllium. OSHA has chosen not to include an equivalent requirement in the final standards for construction and shipyards since employers in construction and shipyards are generally downstream users of beryllium products (blasting media) and would not therefore be classifying chemicals.
Proposed paragraph (m)(1)(iii) would have required employers to include beryllium in the hazard communication program established to comply with the HCS, and ensure that each employee has access to labels on containers and safety data sheets for beryllium and is trained in accordance with the HCS and the training paragraph of the standard. The final paragraph (m)(1)(iii) applies to the general industry, shipyards, and construction. The final provisions are substantively unchanged from the proposal.
Paragraph (n) of the final standards sets forth the employer's obligation to comply with requirements to maintain records of air monitoring data, objective data, medical surveillance, and training.
Proposed paragraph (n)(1)(i) required employers to maintain records of all measurements taken to monitor employee exposure to beryllium as required by paragraph (d) of the standard. OSHA made one minor modification in the final standard: OSHA added the words “make and” prior to “maintain” in order to clarify that the employer's obligation is to create and preserve such records.
Proposed paragraph (n)(1)(ii) required that records of all measurements taken to monitor employee exposure include at least the following information: The date of measurement for each sample taken; the operation being monitored; the sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of samples taken; the type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and the name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored. OSHA has made one editorial modification to paragraph (n)(1)(ii)(B), which is to change “operation” to “task.” Proposed paragraph (n)(1)(iii) required employers to maintain employee exposure monitoring records in accordance with 29 CFR 1910.1020(d)(1)(ii). OSHA has changed the requirement that the employer “maintain this record as required by” OSHA's Records Access standard to “ensure that exposure records are maintained and made available in accordance with” that standard.
Proposed paragraph (n)(2) contained the requirement to retain records of any historical monitoring data used to satisfy the proposed standard's the initial monitoring requirements. OSHA deleted the separate recordkeeping requirement for historical data.
As a result of deleting paragraph (n)(2) Historical Data, OSHA has included proposed paragraph (n)(3) as paragraph (n)(2) in the final standards, with minor alterations. Paragraph (n)(2) contains the requirements to keep accurate records of objective data. Paragraph (n)(2)(i) requires employers to establish and maintain accurate records of the objective data relied upon to satisfy the requirement for initial monitoring in paragraph (d)(2). Under paragraph (n)(2)(ii), the record is required to contain at least the following information: (A) The data relied upon; (B) the beryllium-containing material in question; (C) source of the data; (D) description of the process, task, or activity on which the objective data were based; (E) other data relevant to the process, task, activity, material, or airborne exposure on which the objective data were based. These requirements included minor changes in the description of the last two changes, but were not substantively different.
Paragraph (n)(2)(iii) of the final standard (paragraph (n)(3)(iii) in the proposal) requires the employer to maintain a record of objective data relied upon as required by the Records Access standard, which specifies that exposure records must be maintained for 30 years (29 CFR 1910.1020(d)(1)(ii)).
Paragraph (n)(3) of the final standards (paragraph (n)(4) in the proposal), addresses medical surveillance records. Employers must establish and maintain medical surveillance records for each employee covered by the medical surveillance requirements in paragraph (k). Paragraph (n)(3)(ii) lists the categories of information that an employer was required to record: The employee's name, social security number, and job classification; a copy of all licensed physicians' written medical opinions; and a copy of the information provided to the PLHCP. OSHA has moved the requirement that the record include copies of all licensed physicians' written opinions from proposed paragraph (n)(4)(ii)(B) to paragraph (n)(3)(ii)(B) of the final standards.
Proposed paragraph (n)(4)(iii) required the employer to maintain employee medical records in accordance with OSHA's Records Access Standard at 29 CFR 1910.1020. OSHA has added “and made available” after “maintained” in final paragraph (n)(3)(iii) of the standards, but the requirement is otherwise unchanged.
Paragraph (n)(4) of the final standards (paragraph (n)(5) of the proposal) requires employers to preserve training records, including records of annual retraining or additional training, for a period of three years after the completion of the training. At the completion of training, the employer is required to prepare a record that includes the name, social security number, and job classification of each employee trained; the date the training was completed; and the topic of the training. This record maintenance requirement also applied to records of annual retraining or additional training as described in paragraph (m)(4). This paragraph is substantively unchanged from the proposal.
Paragraph (n)(5) of the final standards (paragraph (n)(6) of the proposal), requires employers to make all records mandated by these standards available for examination and copying to the Assistant Secretary, the Director of NIOSH, each employee, and each employee's designated representative as stipulated by OSHA's Records Access standard (29 CFR 1910.1020). This paragraph is substantively unchanged from the proposal.
Paragraph (n)(6) of the final standards (paragraph (n)(6) in the proposal), requires that employers comply with the Records Access standard regarding the transfer of records, 29 CFR 1910.1020(h), which instructs employers either to transfer records to successor employers or, if there is no successor employer, to inform employees of their access rights at least three months before the cessation of the employer's business. This paragraph is substantively unchanged from the proposal.
OSHA reviewed the final beryllium rule according to the most recent Executive Order (“E.O.”) on Federalism, E.O. 13132, 64 FR 43255 (Aug. 10, 1999). The E.O. 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. The E.O. allows Federal agencies to preempt State law only with the expressed 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 (the “Act” or “OSH Act”), 29 U.S.C. 667, Congress expressly provides 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.” 29 U.S.C. 667. 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.
While OSHA wrote this final rule to protect employees in every State, Section 18(c)(2) of the OSH Act permits State-Plan States to develop and enforce their own standards, provided those standards require workplaces to be at least as safe and healthful as this final rule requires. Additionally, standards promulgated under the OSH Act do not apply to any worker whose employer is a state or local government. 29 U.S.C. 652(5).
This final rule complies with E.O. 13132. 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 rulemaking does not significantly limit State policy options to adopt stricter standards.
When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, the States and U.S. territories with their own OSHA-approved occupational safety and health plans (“State-Plan
A State-Plan State may demonstrate that a standard change is not necessary 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 makes a timely demonstration 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. The remaining six states and territories cover only public-sector employees: Connecticut, Illinois, New Jersey, Maine, New York, and the Virgin Islands.
This beryllium rule applies to general industry, construction, and shipyards. This rule requires that all State-Plan States revise their standards appropriately within six months of the date of this notice.
Under Section 202 of the Unfunded Mandates Reform Act of 1995 (“UMRA”), 2 U.S.C. 1532, an agency must prepare a written “qualitative and quantitative assessment” of any regulation creating a mandate that “may result in the expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation)” in any one year before promulgating a final rule. OSHA's rule does not place a mandate on State or local governments, for purposes of the UMRA, because OSHA cannot enforce its regulations or standards on State or local governments. 29 U.S.C. 652(5). Under voluntary agreement with OSHA, some States require public sector entities to comply with State standards, and these agreements specify that these State standards must be at least as protective as OSHA standards. The OSH Act does not cover tribal governments in the performance of traditional governmental functions, though it does cover tribal governments when they engage in commercial activity. However, the final rule will not require tribal governments to expend, in the aggregate, $100,000,000 or more in any one year for their commercial activities. Thus, the final rule does not trigger the requirements of UMRA based on its impact on State, local, or tribal governments.
Based on the analysis presented in the Final Economic Analysis (see Section VIII above), OSHA concludes that the rule would not impose a Federal mandate on the private sector in excess of $100 million (adjusted annually for inflation) in expenditures in any one year. As noted below, OSHA also reviewed this final rule in accordance with E.O. 13175 on Consultation and Coordination with Indian Tribal Governments, 65 FR 67249 (Nov. 9, 2000), and determined that it does not have “tribal implications” as defined in that Order.
E.O. 13045, 66 FR 19931 (Apr. 23, 2003), requires that Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (“OIRA”) for review pursuant to E.O. 12866, 58 FR 51735 (Oct. 4, 1993), 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. E.O. 13045 defines “covered regulatory actions” as rules that may (1) be economically significant under E.O. 12866 (
The final beryllium rule is economically significant under E.O. 12866 (see Section IX of this preamble). However, after reviewing the rule, OSHA has determined that it will not impose environmental health or safety risks to children as set forth in E.O. 13045. The final rule will require employers to limit employee exposure to beryllium and take other precautions to protect employees from adverse health effects associated with exposure to beryllium. OSHA is not aware of any studies showing that exposure to beryllium in workplaces disproportionately affects children, who typically are not allowed in workplaces where such exposure exists. OSHA is also not aware that there are a significant number of employees under 18 years of age who may be exposed to beryllium, or that employees of that age are disproportionately affected by such exposure. One commenter, Kimberly-Clark Professional, noted that children may be subject to secondary beryllium exposure due to beryllium particles being carried home on their parents' work clothing, shoes, and hair (Document ID 1962, p. 2). Commenter Evan Shoemaker also noted that “beryllium can collect on surfaces such as shoes, clothing, and hair as well as vehicles leading to contamination of the family and friends of workers exposed to beryllium” (Document ID 1658, p. 3). However, OSHA does not believe beryllium exposure disproportionately affects children or that beryllium particles brought home on work clothing, shoes, and hair result in exposures at or near the action level. Furthermore, Kimberly-Clark Professional also noted that potential secondary exposures can be controlled through the use of personal protective equipment in the workplace (Document ID 1676, p. 2). The final standards contain ancillary provisions, such as personal protective clothing and hygiene areas, which are specifically designed to minimize the amount of beryllium leaving the workplace. Therefore, OSHA believes that the final beryllium rule does not constitute a covered regulatory action as defined by E.O. 13045.
OSHA has reviewed the final beryllium rule according to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
OSHA reviewed this final rule in accordance with E.O. 13175 on Consultation and Coordination with Indian Tribal Governments, 65 FR 67249 (Nov. 9, 2000), and determined that it does not have “tribal implications” as defined in that order. The OSH Act does not cover tribal governments in the performance of traditional governmental functions, so the rule will not have substantial direct effects on one or more Indian tribes in their sovereign capacity, 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. On the other hand, employees in commercial businesses owned by tribes or tribal members will receive the same protections and benefits of the standard as all other covered employees.
OSHA proposed a standard for occupational exposure to beryllium and beryllium compounds in general industry and proposed regulatory alternatives to address beryllium exposures in the construction and maritime industries. The proposed standard for general industry was structured according to OSHA's traditional approach, with permissible exposure limits, and ancillary provisions such as exposure assessment, methods of compliance, and medical surveillance. As discussed below, OSHA based the proposal substantively on a joint industry and labor stakeholders' draft occupational health standard developed and submitted to OSHA by Materion Corporation (Materion) and the United Steelworkers (USW). The final rule, however, is based on the entirety of the rulemaking record.
In the final rule, OSHA is expanding coverage to include the construction and shipyard industries and establishing separate final standards for occupational exposure to beryllium in general industry, construction, and shipyards. In the NPRM, OSHA discussed Regulatory Alternative 2a to include both the construction and shipyard industries in the final rule (80 FR 47732-47734), presented estimated costs and benefits associated with extending the scope of the final rule, and requested comment on the alternative. The decision to include standards for construction and shipyards is based on information and comment submitted in response to this request for comment and evaluated by OSHA during the public comment periods and the informal public hearing. OSHA decided to issue three separate standards because there are some variations in the standards for each industry, although the structure of the final standards for general industry, construction, and shipyards remains generally consistent with other OSHA health standards. The most significant change is in the standard for construction where paragraph (e) Competent person, replaces paragraph (e) Beryllium work areas and regulated areas in general industry and paragraph (e) Regulated areas in shipyards.
All three final standards have a provision for methods of compliance, although in the standard for construction this provision has an additional requirement to describe procedures used by the designated competent person to restrict access to work areas, when necessary, to minimize the number of employees exposed to airborne beryllium above the PEL or STEL. This requirement allows the competent person to perform essentially the same role as the requirement governing regulated areas in general industry and shipyards, which is to regulate and minimize the number of workers exposed to hazardous levels of beryllium. OSHA decided to include a competent person provision in the final standard for construction because of the industry's familiarity with this concept and its past successful use in many OSHA construction standards and documents. “Competent person” is defined in OSHA's Safety and Health Regulations for Construction (29 CFR 1926.32(f)) as being a person who is capable of identifying existing and predictable hazards in the surroundings or working conditions which are unsanitary, hazardous, or dangerous to employees, and who has authorization to take prompt corrective measures to eliminate them. This generally applicable definition corresponds well with the definition for “competent person” in the standard for construction: In this context, “competent person” means an individual who is capable of identifying existing and foreseeable beryllium hazards in the workplace and who has authorization to take prompt corrective measures to eliminate or minimize them. The competent person must have the knowledge, ability, and authority necessary to fulfill the responsibilities set forth in paragraph (e) of this standard.
OSHA has retained, in modified form, the scope exemption from the proposed standard for materials containing less than 0.1 percent beryllium by weight in the standard for general industry and included it in the standards for construction and shipyards. The scope exemption has been modified in the final standards with the additional requirement that the employer must have objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions. The 0.1 percent exemption was generally supported by commenters from general industry and shipyards; construction employers did not comment. Other commenters, especially those representing workers or public health organizations, expressed concern that these materials, in some cases, could expose workers to hazardous levels of beryllium. As discussed in more detail in the summary and explanation for Scope and application, the objective data requirement addresses these concerns and ensures the protection of workers who experience significant exposures from materials containing trace amounts of beryllium. Employers who have objective data showing that employees will not be exposed at or above the action level under any foreseeable conditions when processing materials containing less than 0.1 percent beryllium by weight are exempt from the standard.
OSHA decided to add a performance option in paragraph (d), Exposure assessment, as an alternative exposure assessment method to the scheduled monitoring requirements in the proposed rule, based on public comment received from industry and labor. OSHA believes the performance option, which encompasses either exposure monitoring or assessments based on objective data, gives employers flexibility in determining employee exposure to beryllium based on to their unique workplace circumstances. OSHA has provided this performance option in recent health standards such as respirable crystalline silica (29 CFR 1910.1053(d)(2)) and chromium VI (29 CFR 1910.1026(d)(3)).
OSHA also received comments about other provisions in the proposed standard, and in some cases, OSHA responded with changes from the
Although details of the final standards for general industry, construction, and shipyards differ slightly, most of the requirements are the same or similar in all three standards. Therefore, the summary and explanation is organized according to the main requirements of the standards, but includes paragraph references to the standards for general industry, construction, and shipyards. The summary and explanation uses the term “standards” or “final standards” when referring to all three standards. Generally, when the summary and explanation refers to the term “standards,” it is referring to the final standards. To avoid confusion, the term “final rule” is sometimes used when making a comparison to or clarifying a change from the proposed rule.
The proposed rule applied to occupational exposure to beryllium in all forms, compounds, and mixtures in general industry, except those articles and materials exempted by proposed paragraphs (a)(2) and (a)(3) of the proposed standard. The final standards are identical in their application to occupational exposures to beryllium. In the summary and explanation sections, OSHA has changed “beryllium and beryllium compounds” or anything specifying soluble beryllium to just “beryllium.” OSHA intends the term “beryllium” to cover all forms of beryllium, including compounds and mixtures, both soluble and poorly soluble, throughout the summary and explanation sections. Other global changes in the regulatory text include changing “shall” to “must” to make it clear when a provision is a requirement and adding “personal” to “protective clothing or equipment” and “protective clothing and equipment” consistently. OSHA has changed “exposure” to “airborne exposure” to make it clear when referring to just airborne exposure, and specifically noting when OSHA intends to cover dermal contact.
As noted above, OSHA's proposed rule was based, in part, upon a draft occupational health standard submitted to the Agency by Materion, the leading producer of beryllium and beryllium products in the United States, and USW, an international labor union representing workers who manufacture beryllium alloys and beryllium-containing products in a number of industries (Document ID 0754). Materion and USW worked together to craft a model beryllium standard that OSHA could adopt and that would have support from both labor and industry. They submitted their joint draft standard to OSHA in February 2012.
Like the proposal, many of the provisions in the final rules are identical or substantively similar to those contained in Materion and USW's draft standard. For example, the final rule for general industry and the Materion/USW draft standard both include an exclusion for materials containing less than 0.1 percent beryllium; both contain many similar definitions; both contain a time weighted average (TWA) PEL of 0.2 μg/m
OSHA did not receive any additional exposure data for construction or shipyards in response to OSHA's request in the NPRM. However, since the proposal, OSHA reviewed its OIS compliance exposure database and identified personal exposure sample results on beryllium for abrasive blasting workers in construction, general industry and maritime, which can be found broken out by sector in FEA Table IV.68.
The vast majority of stakeholders who submitted comments on this issue supported extending the scope of the proposed rule to cover workers in the construction and maritime industries who are exposed to beryllium (
OSHA also heard testimony during the public hearing from Dr. Lee Newman of the American College of Occupational and Environmental Medicine (ACOEM), Peggy Mroz of National Jewish Health (NJH), Emily Gardner of Public Citizen, Mary Kathryn Fletcher of AFL-CIO, and Mike Wright of the USW that supported covering workers in the construction and maritime industries (Document ID 1756, Tr. 81; 1756, Tr. 97-98; 1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181). Peggy Mroz of NJH testified that “[b]ased on the data presented, [NJH] support[s] expanding the scope of the proposed standard to include . . . employers in construction and maritime” (Document ID 1756, Tr. 98). Emily Gardner of Public Citizen argued that “the updated standard cannot leave construction and shipyard workers vulnerable to the devastating effects of beryllium” (Document ID 1756, Tr. 175). She added that “Public Citizen urges OSHA to revise the proposed rule to cover these workers” (Document ID 1756, Tr. 175).
Several commenters specifically supported Regulatory Alternative #2a. For example, the International Union, United Automobile, Aerospace, and Agriculture Implement Workers of America (UAW) indicated its support for this alternative (Document ID 1693, p. 3 (pdf)). UAW added that Alternative #2a would cover abrasive blasters, pot tenders, and cleanup staff working in construction and shipyards who have the potential for airborne beryllium exposure during blasting operations and during cleanup of spent media (Document ID 1693, p. 3 (pdf)). Kimberly-Clark Professional (KCP) similarly indicated that it favored the adoption of this alternative (Document ID 1676, p. 1). KCP explained that “[h]azardous exposures are equally dangerous to workers regardless of whether the worker is in a factory or on a construction site, and the worker protection provided by OSHA regulations should also be equal” (Document ID 1676, p. 1). In addition, 3M Company also observed that Regulatory Alternative #2a is a more protective alternative (Document ID 1625, p. 3 (pdf)).
However, other commenters argued in favor of keeping the proposed scope unchanged (
Some of these commenters offered specific concerns with covering the construction and maritime industries, or with covering abrasive blasting in general. For instance, Jack Allen, Inc. argued against extending the proposed rule to cover the use of coal slag in the sandblasting industry because the industry already has processes and controls in place to prevent exposures to all dusts during operations (Document ID 1582). The Abrasive Blasting Manufacturers Alliance (ABMA) presented a number of arguments against the coverage of abrasive blasting. ABMA argued that regulating the trace amounts of beryllium in abrasive blasting will increase the use of silica-based blasting agents “despite OSHA's longstanding recommendation of substitution for silica-based materials” (Document ID 1673, p. 14). ABMA added that scoping in abrasive blasting would increase the amount of coal slag materials “going to landfills rather than being used for beneficial purpose” (Document ID 1673, p. 14). ABMA also cited to technological feasibility issues in sampling and analysis, noted that the proposed standard was not appropriately tailored to construction and maritime worksites, and argued that it is not appropriate to regulate abrasive blasting on a chemical-by-chemical basis (Document ID 1673, pp. 8, 21-23).
After careful consideration of these comments and those relating to Regulatory #2b discussed below, OSHA has decided to adopt Regulatory Alternative #2a to expand the proposal's scope to cover construction and shipyards. As noted by commenters like the AFL-CIO, record evidence shows that exposures above the new action level and PEL, primarily from abrasive blasting operations, occur in both the construction and shipyard industries (
OSHA disagrees with Materion's assertion that existing standards render it unnecessary to have this standard cover construction and shipyard employers whose employees are exposed to beryllium during abrasive blasting operations. The OSHA Ventilation standard referenced by Materion (29 CFR 1910.94) applies only to general industry and does not cover construction and shipyard workers. The OSHA Ventilation standard in construction (1926.57) and Mechanical paint removers standard in shipyards (1915.34) provide some general protections for abrasive blasting workers but do not provide the level of protection provided by the ancillary provisions contained in the final standards such as medical surveillance, personal protective clothing and equipment, and beryllium-specific training.
OSHA also disagreed with Jack Allen, Inc.'s assertion that the employers conducting abrasive blasting already have sufficient processes and controls in place to prevent exposures to all dusts during operations. OSHA's examination of the record identifies data on beryllium exposure in the abrasive blasting industry showing beryllium exposure above the action level and TWA PEL when beryllium-containing slags are used (
However, OSHA does agree with ABMA's observation that many of the conditions in the construction and shipyard industries are distinct from those in general industry, and agrees that the standard as proposed was not tailored to construction and shipyard worksites. The Agency has long recognized a distinction between the construction and general industry sectors and has issued standards specifically applicable to construction and shipyard work under 29 CFR part 1926 and 29 CFR part 1915, respectively. OSHA's understanding of the differences between these industries is why OSHA specifically asked stakeholders with experience and knowledge of the construction or shipyard industries to opine on whether coverage of those industries is appropriate and, if so, how the proposal should be revised to best protect workers in those industries. As discussed throughout the rest of this Summary and Explanation section, many stakeholders responded to OSHA's request.
After careful consideration of the record, OSHA finds that the unique needs of, conditions in, and challenges posed by the construction and maritime sectors, particularly concerning abrasive blasting operations at construction sites and shipyards, warrant different requirements from general industry. Therefore, OSHA is issuing three separate standards—one for each of these sectors. OSHA judges that the primary source of beryllium exposure at construction worksites and in shipyards is from abrasive blasting operations when using abrasives that contain trace amounts beryllium.
Abrasive blasters and their helpers are exposed to beryllium from coal slag and other abrasive blasting material like copper slag that may contain beryllium as a trace contaminant. The most commonly used abrasives in the construction industry include coal slag and steel grit, which are used to remove old coatings and etch the surfaces of outdoor structures, such as bridges, prior to painting (Document ID 1815, Attachment 93, p. 80). Shipyards are large users of mineral slag abrasives. In a recent survey conducted for the Navy, the use of coal slag abrasives accounted for 68 percent and copper slag accounted for 20 percent of abrasive media usage as reported by 26 U.S. shipyards and boatyards (Document ID 0767). The use of coal and copper slag abrasives has increased in recent years as industries have sought substitutes for silica sand blasting abrasives to avoid health risks associated with respirable crystalline silica (Document ID 1671, Attachment 3; 1681, Attachment 1, pp. 1-2).
OSHA's exposure profile for abrasive blasters, pot tenders/helpers, and abrasive material cleanup workers is found in Section 12 of Chapter IV in the FEA. The exposure profile for abrasive blasters shows a median of 0.2 μg/m
OSHA also received comment and heard testimony on potential beryllium exposure from other sources. NIOSH commented that construction workers may be exposed to beryllium when demolishing buildings or building equipment, based on a study of workers demolishing oil-fired boilers (Document ID 1671, Attachment 1, pp. 5, 15; 1671, Attachment 21). Peggy Mroz of NJH testified that “[n]umerous studies have documented beryllium exposure sensitization and chronic beryllium disease in construction industries, demolition and decommissioning, and among workers who use non-sparking tools” (Document ID 1756, Tr. 98). Many such cases were discovered among trade workers at Department of Energy sites from the National Supplemental Screening Program (Document ID 1756, Tr. 81-82). Ashlee Fitch from the USW testified that in addition to abrasive blasting using beryllium-contaminated slags, workers in the maritime industry use non-sparking tools that are composed of beryllium alloys. Ms. Fitch stated that these tools can create beryllium particulate when they are dressed (
Despite requesting information both in the NPRM and during the public hearing, OSHA does not have sufficient data on beryllium exposures in the construction and shipyard industries to characterize exposures of workers in application groups other than abrasive blasting with beryllium-containing slags. OSHA could not develop exposure profiles for construction and shipyard workers engaged in activities involving non-sparking tools, demolition of beryllium-contaminated buildings or equipment, and working with beryllium-containing alloys. However, OSHA acknowledges the USW's concerns about future beryllium use and recognizes that there is potential for exposure to beryllium in construction and shipyard operations other than abrasive blasting. As such, workers engaged in such operations are exposed to the same hazard of developing CBD and other beryllium-related disease, and therefore deserve the same level of protection as do workers who are engaged in abrasive blasting or covered in the general industry final rule. Therefore, although at this time OSHA cannot specifically quantify exposures in construction or shipyard operations outside of abrasive blasting, OSHA has determined that it is necessary for the final standards for construction and maritime to cover all occupational exposures to beryllium in those industries in order to ensure that the standard is broadly effective and addresses all potential harmful exposures.
Three commenters representing the maritime industry supported Regulatory Alternative #2b—adopting the new PELs for construction and maritime by updating the existing Z tables to incorporate them, but not applying the other ancillary provisions of this standard to construction and maritime (Document ID 1595, p. 2; 1618, p. 2; 1657. p. 1). The Shipbuilders Council of America (SCA) supported lowering the PEL for beryllium from 2.0 μ/m
In addition to the commenters representing the maritime industry, Ameren, an electric and natural gas public utility, also supported applying the proposed TWA PEL and STEL to all employers in general industry, construction, and maritime even where beryllium exists only as a trace contaminant (Document ID 1675, p. 3). However, not all commenters endorsed Alternative #2b. The Department of Energy's National Supplemental Screening Program (NSSP) did not support this alternative because the other provisions of the standard would only cover employers and employees within the scope of the proposed general industry rule (Document ID 1677, p. 2). Furthermore, many commenters supported extending the full protections of the standard to the construction and maritime industries as set forth in Regulatory Alternative #2a, discussed earlier, which implicitly rejects Regulatory Alternative #2b (see,
OSHA is not persuaded by the maritime industry commenters' assertions that the ancillary provisions of the beryllium standard would be redundant. While OSHA acknowledges that shipyards encounter beryllium only at trace levels in materials involved in the welding and abrasive blasting processes, OSHA disagrees with their contention that updating the PEL and STEL will provide adequate protection to shipyard workers. OSHA agrees with NSSP and all the commenters supporting Regulatory Alternative #2a that a comprehensive standard specific to beryllium will provide the important protection of ancillary provisions, such as medical surveillance and medical removal protection. OSHA intends to
Therefore, OSHA declines to adopt Regulatory Alternative #2b, which, as noted above, would have updated 29 CFR 1910.1000 Tables Z-1 and Z-2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A so that the new TWA PEL and STEL, but not the standard's ancillary provisions, would apply to all employers and employees in general industry, shipyards, and construction, including occupations where beryllium exists only as a trace contaminant. The Agency intends for employers that are exempt from the scope of these comprehensive standards in accordance with paragraph (a) to comply with the preceding TWA PEL and STEL in 29 CFR 1910.1000 Table Z-2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A, as applicable. Given that the Agency is issuing separate beryllium standards for the construction and shipyard industries, OSHA is also adding to these tables a cross-reference to the new standards and clarifying that if the new standards are stayed or otherwise not in effect, the preceding PEL and short-term ceiling limit apply.
Several commenters offered opinions on this approach. The Non-Ferrous Founders' Society (NFFS) expressed concern that beryllium metal was being treated the same as soluble beryllium compounds, such as salts, even though NFFS believes these soluble compounds are more hazardous and suggested that OSHA establish a bifurcated standard for insoluble beryllium versus soluble beryllium compounds (Document ID 1732, p. 3; 1678, p. 2; 1756, Tr. 18). In related testimony, NIOSH's Dr. Aleks Stefaniak discussed the dermal exposure mechanisms of poorly soluble beryllium through particle penetration and particle dissolving (Document ID 1755, pp. 35-39). Dr. Stefaniak testified that while “intact skin naturally has a barrier . . . [v]ery few people actually have fully intact skin, especially in an industrial environment” (Document ID 1755, p. 36). He added:
After careful consideration of the various comments on this issue, OSHA is not persuaded that there are differences in workers' health risks that justify treating poorly soluble beryllium differently than soluble compounds. The Agency is persuaded by NIOSH that poorly soluble beryllium presents a significant risk of beryllium-related disease to workers and discusses this topic further in Section V of this preamble, Health Effects. OSHA has determined that the toxicological effects of beryllium exposure on the human body are similar regardless of the form of beryllium. Therefore, the Agency concludes that the record supports issuing standards that apply to beryllium in all forms, compounds, and mixtures. Final paragraph (a)(1) is therefore substantively unchanged from the proposal in all three standards.
Commenters generally supported this proposed exemption. For example, NFFS stated that the exemption was “important and practical” (Document ID 1678, p. 2; Document ID 1756, Tr. 35-36)). However, two commenters requested minor amendments to the exemption. First, ORCHSE Strategies (ORCHSE) asked OSHA to “clarify” that proposed paragraph (a)(2) “exempts `articles' even if they are processed, unless the processing releases beryllium to an extent that negates the definition of an `article' ” (Document ID 1691, Attachment 1, p. 16). ORCHSE asserted that the standard should not apply in a workplace when “the item actually meets OSHA's definition of an article” and that OSHA should change the regulation's language accordingly (Document ID 1691, Attachment 1, pp. 16-17). Second, the American Dental Association (ADA) asked that OSHA clarify the article exemption, specifically that employers who use but do not process articles are fully exempt from all requirements of the proposed rule, including those established for recordkeeping (Document ID 1597, p. 1).
In contrast, Public Citizen objected to the inclusion of this exemption because exempting articles that are not processed does not take into consideration dermal exposure from handling articles containing beryllium (Document ID 1670, p. 7). Public Citizen pointed to OSHA's proposed rule in which OSHA acknowledged that beryllium absorbed through the skin can induce a sensitization response that is a necessary first step toward CBD and that there is evidence that the risk is not limited to soluble forms. However, during follow-up questioning at the beryllium public hearings, Dr. Almashat
In response to the ADA's request for clarification that employers who use but do not process articles are fully exempt from all requirements of the rule, OSHA notes that paragraph (a)(2) of the final standards states that the “standard does not apply” to those articles. Furthermore, the recordkeeping requirement for objective data in paragraph (n)(2) of the standards states that it applies to objective data used to satisfy exposure assessment requirements, but does not mention any data used to determine coverage under paragraph (a). Therefore, OSHA has determined that no further clarification in the regulatory text is necessary.
In response to the comment from Public Citizen, OSHA did not receive any evidence on the issue of beryllium exposure through dermal contact with unprocessed articles. Therefore, OSHA cannot find that such contact poses a risk.
Paragraph (a)(2) of the final standards therefore remains unchanged from the proposed standard. The final standards do not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process.
ABMA also supported the proposed 0.1 percent exemption, suggesting that there is a lack of evidence of significant risk from working with material containing beryllium in trace amounts and that OSHA needs substantial evidence that it is “at least more likely than not” that exposure to beryllium in trace amounts presents significant risk of harm, under court decisions concerning the Benzene rule (Document ID 1673, pp. 8-9). ABMA further argued that significant risk does not exist even below the previous PEL of 2.0 μg/m
Through the years, Alliance members have worked with and put to beneficial use over 100 million tons of slag material that would otherwise have been landfilled. Despite this extensive history, the Alliance members have no history of employees with beryllium sensitization or beryllium-related illnesses. Indeed, the Alliance members are not aware of a single documented case of beryllium sensitization or beryllium-related illness associated with coal or copper slag abrasive production among their employees, or their customers' employees working with the products of Alliance members (Document ID 1673, p. 9).
OSHA is not persuaded by these arguments. The lack of anecdotal evidence of sensitization or beryllium-related illness does not mean these workers are not at risk. As noted by Representative Robert C. “Bobby” Scott, Ranking Member of the U.S. House of Representatives Committee on Education and the Workforce the U.S. House of Representatives, “medical surveillance has not been required for beryllium-exposed workers outside of the U.S. Department of Energy. The absence of evidence is not evidence of absence” (Document ID 1672). As discussed in Section II of this preamble, Pertinent Legal Authority, courts have not required OSHA “to support its finding that a significant risk exists with anything approaching scientific certainty” (
Both NIOSH and North America's Building Trades Unions (NABTU) expressed concern that the 0.1 percent exemption would expose construction and shipyard workers conducting abrasive blasting with coal slags to beryllium in concentrations above the final PEL. NIOSH and NABTU cited a study by the Center for Construction Research and Training, and NIOSH also cited one of its exposure assessment studies of a coal slag blaster showing beryllium air concentrations exceeding the preceding OSHA PEL (Document ID 1671, Attachment 1, p. 5; 1679, pp. 3-4). In addition, NIOSH points out that although the abrasive blasting workers may use personal protective equipment that limits exposure, supervisors and other bystanders may be exposed. NIOSH gave other examples where the 0.1 percent exemption could result in workers being exposed to beryllium, such as building or building equipment demolition and work in dental offices that fabricate or modify beryllium-containing dental alloys, but did not provide reference material or exposure data for these examples (Document ID 1671, pp. 5-6). In its post-hearing brief, NIOSH also specifically disagreed with EEI's contention that compliance with the arsenic and asbestos standards satisfies the proposed regulatory requirements of the beryllium rule. NIOSH argued that, unlike arsenic and lead, beryllium is a sensitizer, and as such, necessary and sufficient controls are required to protect workers from life-long risk of beryllium sensitization and disease (Document ID 1960, Attachment 2, p. 6).
OSHA also received comment and heard testimony from Dr. Weissman of NIOSH recommending that the scope of the standard be based on employee exposures and not the concentration of beryllium in the material (Document ID 1671, pp. 5-6; Document ID 1755, Tr. 17-18). NIOSH identified coal-fired electric power generation and primary aluminum production as industries that could fall under the 0.1 percent exemption (Document ID 1671, Attachment 1, p. 6). Stating it was not aware of any medical screening of utility workers exposed to fly ash, NIOSH recommended that OSHA include coal-fired electric power generation in the scope of the standard unless and until available data can demonstrate that there is no risk of sensitization to those workers (Document ID 1671, p. 6). NIOSH did not offer specifics on the magnitude of beryllium exposure in the aluminum production industry. In its post-hearing brief, NIOSH recommended that OSHA remove the 0.1 percent exemption from the rule, allowing the rule to cover a broad range of construction, shipyard, and electric utility power generation activities that are associated with beryllium exposure, such as abrasive blasting with coal or copper slag, repairing and maintaining structures contaminated with fly ash, and remediation or demolition (Document ID 1960, Attachment 2, p. 2). And Peggy Mroz of NJH testified that beryllium sensitization and CBD have been reported in the aluminum industry and that NJH has continued to see cases of severe CBD in workers exposed to beryllium through medical recycling and metal reclamation (Document ID 1756, Tr. 98-99).
Other commenters suggested limiting the exemption, as OSHA proposed in Regulatory Alternative #1b, to require employers to demonstrate, using objective data, that the materials, when processed or handled, cannot release beryllium in concentrations at or above the action level as an 8-hour TWA under any foreseeable conditions (Document ID 1597, p. 1; 1681, pp. 5-6). For example, the Materion-USW proposed standard included the 0.1 percent exemption unless objective data or initial monitoring showed exposures could exceed the action level or STEL. USW asserted that not including this requirement in the rule would be a mistake (Document ID 1681, pp. 5-6). The AFL-CIO also supported the joint USW-Materion scope provision (Document ID 1756, Tr. 212). Mike Wright of the USW asserted that maintaining the 0.1 percent exemption would leave thousands of workers unprotected, including those performing abrasive blasting operations in general industry, ship building, and construction (Document ID 1755, Tr. 111-114). Mr. Wright argued that in the 1,3 Butadiene standard OSHA recognized that the 0.1 percent exemption would not protect some workers and therefore included additional language limiting the exemption where objective data showed “that airborne concentrations generated by such mixtures can exceed the action level or STEL under reasonably predictable conditions of processing, use or handling that will cause the greatest possible release” (Document ID 1755, Tr. 113; 29 CFR 1910.1051(a)(2)(ii)). Mr. Wright urged OSHA to include similar language in the beryllium standard (Document ID 1755, Tr. 113-114).
Some commenters endorsed a modified version of Alternative #1b. For example, the Department of Defense (DOD) supported Alternative #1b, but also suggested limiting the exemption if exposures “could present a health risk
Ameren did not agree with the objective data requirement in Regulatory Alternative #1b because it would be difficult to perform sampling in a timely manner for the many different maintenance operations that occur infrequently. This would include in the scope of the rule activities for which exposures are difficult to measure, but are less likely to cause exposure than other operations (Document ID 1675, p. 2). The NSSP also does not support Regulatory Alternative #1b because without first expanding the scope of the rule to cover the construction and maritime sectors, employers in construction and maritime would still be excluded (Document ID 1677, p. 1).
OSHA agrees with the many commenters and testimony expressing concern that materials containing trace amounts of beryllium (less than 0.1 percent by weight) can result in hazardous exposures to beryllium. We disagree, however, with those who supported completely eliminating the exemption because this could have unintended consequences of expanding the scope to cover minute amounts of naturally occurring beryllium (Ex 1756 Tr. 55). Instead, we believe that alternative #1b—essentially as proposed by Materion and USW and acknowledging that workers can have significant beryllium exposures even with materials containing less than 0.1%—is the most appropriate approach. Therefore, in the final standard, it is exempting from the standard's application materials containing less than 0.1% beryllium by weight only where the employer has objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
As noted by NIOSH, NABTU, and the AFL-CIO, and discussed in Chapter IV of the FEA, workers in abrasive blasting operations using materials that contain less than 0.1 percent beryllium still have the potential for significant airborne beryllium exposure during abrasive blasting operations and during cleanup of spent abrasive material. NIOSH and the AFL-CIO also identified coal-fired electric power generation and primary aluminum production as industries that could fall under the 0.1 percent exemption but still have significant worker exposure to beryllium. Furthermore, OSHA agrees with NIOSH that the Agency should regulate based on the potential for employee exposures and not the concentration of beryllium in the material being handled. However, OSHA acknowledges the concerns expressed by ABMA and EEI that processing materials with trace amounts of beryllium may not necessarily cause significant exposures to beryllium. OSHA does not have evidence that all materials containing less than 0.1 percent beryllium by weight can result in significant exposure to beryllium, but the record contains ample evidence that there are significant exposures in operations using materials with trace amounts of beryllium, such as abrasive blasting, coal-fired power generation, and primary aluminum production. As discussed in Section VII of this preamble, Significance of Risk, preventing airborne exposures at or above the action level reduces the risk of beryllium-related health effects to workers. OSHA is also not persuaded by comments that claim obtaining this exposure data is too difficult for infrequent or short-term tasks because employers must be able to establish their eligibility for the exemption before being able to take advantage of it. If an employer cannot establish by objective data, including actual monitoring data, that exposures will not exceed the action level, then the beryllium standards apply to protect that employer's workers.
As pointed out by commenters such as the USW, similar exemptions are included in other OSHA standards, including Benzene (29 CFR 1910.1028), Methylenedianiline (MDA) (29 CFR 1910.1050), and 1,3-Butadiene (BD) (29 CFR 1910.1051). These exemptions were established because workers in the exempted industries or workplaces were not exposed to the subject chemical substances at levels of significant risk. In the preamble to the MDA standard, OSHA states that the Agency relied on data showing that worker exposure to mixtures or materials of MDA containing less than 0.1 percent MDA did not create any hazards other than those expected from worker exposure beneath the action level (57 FR 35630, 35645-46). The exemption in the BD standard does not apply where airborne concentrations generated by mixtures containing less than 0.1 percent BD by volume can exceed the action level or STEL (29 CFR 1910.1051(a)(2)(ii)). The exemption in the Benzene standard was based on indications that exposures resulting from substances containing trace amounts of benzene would generally be below the exposure limit and on OSHA's determination that the exemption would encourage employers to reduce the concentration of benzene in certain substances (43 FR 27962, 27968).
OSHA's decision to maintain the 0.1 percent exemption and require employers to demonstrate, using objective data, that the materials, when processed or handled, cannot release beryllium in concentrations at or above the action level as an 8-hour TWA under any foreseeable conditions, is a change from proposed paragraph (a)(3) that specified only that the standard did not apply to materials containing less than 0.1 percent beryllium by weight. This is also a change from Regulatory Alternative #1b in another respect, insofar as it proposed requiring objective data demonstrating that employee exposure to beryllium will remain below both the proposed action level and STEL. OSHA removed the STEL requirement as largely redundant because if exposures exceed the STEL of 2.0 µg/m
Further, OSHA added the phrase “under any foreseeable conditions” to paragraph (a)(3) of the final standards to make clear that limited sampling results indicating exposures are below the
In sum, the proposed standard covered occupational exposures to beryllium in all forms, compounds, and mixtures in general industry. It did not apply to articles, as defined by the HCS, or to materials containing less than 0.1 percent beryllium by weight. After a thorough review of the record, OSHA has decided to adopt Regulatory Alternative #2a and include the construction and shipyard sectors within the scope of the final rule. This decision was in response to the majority of comments recommending that OSHA protect workers in these sectors under the final rule and the exposure data in these sectors contained in the record. OSHA has also decided to adopt a modified version of Regulatory Alternative #1b and limit the 0.1 percent exemption to those employers who have objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
Therefore, the final rule contains three standards—one each for general industry, construction, and shipyard. The article exemption has remained unchanged, and the 0.1 percent exemption has been limited to protect workers with significant exposures despite working with materials with trace amounts of beryllium.
Paragraph (b) includes definitions of key terms used in the standard. To the extent possible, OSHA uses the same terms and definitions in the standard as the Agency has used in other OSHA health standards. Using similar terms across health standards, when possible, makes them more understandable and easier for employers to follow. In addition, using similar terms and definitions helps to facilitate uniformity of interpretation and enforcement.
OSHA's risk assessment indicates that significant risk remains at and below the TWA PEL (see this preamble at section VII, Significance of Risk). When there is significant risk remaining at the PEL, the courts have ruled that OSHA has the legal authority to impose additional requirements, such as action levels, on employers to further reduce risk when those requirements will result in a greater than minimal incremental benefit to workers' health (
Another important reason to set an action level involves the variable nature of employee exposures to beryllium. Because of this fact, OSHA concludes that maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to beryllium above the TWA PEL on days when no exposure measurements are made. This consideration is discussed later in this section of the preamble regarding paragraph (d)(3).
The United Steelworkers (USW) commented in support of the action level, noting that it is typical in OSHA standards to have an action level at one half of the PEL (Document ID 1681, p. 11). The USW also commented that the “action level will further reduce exposure to beryllium 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” (Document ID 1681, p. 11). National Jewish Health (NJH) also supported OSHA's proposal for a more comprehensive standard and noted that the action level in the Department of Energy's beryllium standard has been “very effective at reducing exposures and rates of beryllium sensitization and chronic beryllium disease in those facilities” (Document ID 1756, p. 90).
As noted by the commenters, OSHA's decision to set an action level of one-half of the TWA PEL is consistent with previous standards, including those for inorganic arsenic (29 CFR 1910.1018), chromium (VI) (29 CFR 1910.1026), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR 1910.1047), methylene chloride (29 CFR 1910.1052), and respirable crystalline silica (29 CFR 1910.1053).
The definition of “action level” is therefore unchanged from the proposal. Some of the ancillary provisions triggered by the action level have changed since the proposal. Those changes are discussed in more detail in the Summary and Explanation sections for those provisions.
OSHA included a definition for the terms “exposure” and “exposure to beryllium” in the proposed rule, and defined the terms to mean “the exposure to airborne beryllium that would occur if the employee were not using a respirator.” In the final rule, the word “airborne” is added to the terms to make clear that they refer only to airborne beryllium, and not to dermal contact with beryllium. The modified terms replace “exposure” and “exposure to beryllium” in the rule, and the terms “exposure” and “exposure to beryllium” are no longer defined.
NJH supported OSHA's definition of the BeLPT in the NPRM (Document ID 1664, p. 5). However, OSHA has made one change from the proposed definition of the BeLPT in the NPRM to the final definition to provide greater clarity. The Agency has moved the characterization of a confirmed positive result from the BeLPT definition to the “confirmed positive” definition because it was more appropriate there.
The presence of a beryllium work area triggers a number of the requirements in the general industry standard. Under paragraph (d)(3)(i), employers must determine exposures for each beryllium work area. Paragraphs (e)(1)(i) and (e)(2)(i) require employers to establish, maintain, identify, and demarcate the boundaries of each beryllium work area. Under paragraph (f)(1)(i)(D), employers must minimize cross-contamination by preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within a beryllium work area. Paragraph (f)(1)(i)(F) states that employers must minimize migration of beryllium from the beryllium work area to other locations within and outside the workplace. Paragraph (f)(2) requires employers to implement at least one of the controls listed in (f)(2)(i)(A) through (D) for each operation in a beryllium work area unless one of the exemptions in (f)(2)(ii) applies. Paragraph (i)(1) requires employers to provide readily accessible washing facilities to employees working in a beryllium work area, and to ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet. In addition employers must ensure that these areas comply with the Sanitation standard (29 CFR 1910.141) (paragraph (i)(4)). Employers must maintain surfaces in all beryllium work areas as free as practicable of beryllium (paragraph (j)(1)(i)). Paragraph (j)(2) requires certain practices and prohibits other practices for cleaning surfaces in beryllium work areas. Under paragraph (m)(4)(ii)(B), employers must ensure workers demonstrate knowledge of the written exposure control plan with emphasis on the location(s) of beryllium work areas.
OSHA received comments from NJH and ORCHSE Strategies (ORCHSE) regarding the definition of the “CBD diagnostic center.” NJH commented that CBD diagnostic centers do not need to be able to perform the BeLPT but should be able to process the BAL appropriately and ship samples within 24 hours to a facility that can perform the BeLPT. NJH also indicated that CBD diagnostic centers should be able to perform CT scans, pulmonary function tests with DLCO (diffusing capacity of the lungs for carbon monoxide), and measure gas exchange abnormalities. NJH further indicated that CBD diagnostic centers should have a medical doctor who has experience and expertise, or is willing to obtain such expertise, in the diagnosis and treatment of chronic beryllium disease (Document ID 1664, pp. 5-6). ORCHSE argued that CBD diagnostic centers should be allowed to rely on off-site interpretation of transbronchial biopsy pathology, reasoning that this change would broaden the accessibility of CBD diagnostic centers to more affected employees (Document ID 1691, p. 3).
OSHA evaluated these recommendations and included the language regarding sample processing and removed the proposal's requirement that BeLPTs be performed on-site. The Agency also changed the requirement that pulmonary specialist perform testing as outlined in the proposal to the final definition which requires that a pulmonary specialist be on-site. This requirement addresses the concerns ORCHSE raised about accessibility of CBD diagnostic centers by increasing the number of facilities that would qualify as centers. This also preserves the expertise required to diagnose and treat CBD as stated by NJH (Document 1664, p. 6).
Paragraph (k)(7) includes provisions providing for an employee who has been confirmed positive to receive an initial clinical evaluation and subsequent medical examinations at a CBD diagnostic center.
The competent person concept has been broadly used in OSHA construction standards (
OSHA received comments from NJH, the American Thoracic Society (ATS) and ORCHSE regarding the requirement for consecutive test results within a two year time frame, and the inclusion of borderline test results (Document ID 1664, p.5; 1668, p. 2; 1691, p. 20). NJH and ATS submitted similar comments regarding the requirement of two abnormal BeLPT test results to be consecutive and within two years. According to NJH, “the definition of `confirmed positive' [should] include two abnormals, an abnormal and a borderline test result, and/or three borderline tests. This recommendation is based on studies of Middleton
These test results need not be from consecutive BeLPTs or from a second abnormal BeLPT result within a two-year period of the first abnormal result. These recommendations are based on the many studies cited in the docket, as well as those of Middleton,
Materion Corporation (Materion) opposed changing the requirement for two abnormal BeLPT results and opposed allowing two or three borderline results to determine sensitization (Document ID 1808, p. 4). Without providing scientific studies or other bases for its position, Materion argued that “[m]aking a positive BeS determination for an individual without any confirmed abnormal test result is not warranted and clearly is not justifiable from a scientific, policy or legal perspective” (Document ID 1808, p. 4).
OSHA evaluated these comments and modified the definition of “confirmed positive” accordingly for reasons described more fully within the Health Effects section of this preamble, V.D.5.b, including reliance on the Middleton studies (2008, 2011). The original definition for “confirmed positive” in the proposed standard was adapted from the model standard submitted to OSHA by Materion and the USW in 2012. Having carefully considered all these comments and their supporting evidence, where provided, the Agency finds the arguments from NJH, ATS, and ORCHSE persuasive. In particular ATS points out the Middleton
In addition, ORCHSE commented on the use of a single test result from a more reliable and accurate test (Document ID 1691, p. 20). Specifically, ORCHSE recommended revising the language to include “the result of a more reliable and accurate test such that beryllium sensitization can be confirmed after one test, indicating a person has been identified as having beryllium sensitization” (Document ID 1691, p. 20). In response to the comment from ORCHSE, the Agency has included
An emergency triggers several requirements of this standard. Under paragraph (g)(1)(iv), respiratory protection is required during emergencies to protect employees from potential overexposures. Emergencies also trigger clean-up requirements under paragraph (j)(1)(ii), and medical surveillance under paragraph (k)(1)(i)(C). In addition, under paragraph (m)(4)(ii)(D) of the standards for general industry and shipyards and paragraph (m)(3)(ii)(D) of the standard for construction, employers must train employees in applicable emergency procedures.
OSHA did not include a definition of “objective data” in the proposed rule. Use of objective data was limited in the proposed rule, and applied only to an exception from initial monitoring requirements in proposed paragraph (d)(2). Proposed paragraph (d)(2)(ii) included criteria for objective data.
The final rule allows for expanded use of objective data. Paragraph (a)(3) allows for use of objective data to support an exception from the scope of the standards. Paragraph (d)(2) allows for use of objective data as part of the performance option for exposure assessment. OSHA is therefore including a definition of “objective data” in paragraph (b) of the standards. The definition is generally consistent with the criteria included in proposed paragraph (d)(2)(ii), and with the use of this term in other OSHA substance-specific health standards such as the standards addressing exposure to cadmium (29 CFR 1910.1027), chromium (VI) (29 CFR 1010.1026), and respirable crystalline silica (29 CFR 1910.1053).
Under paragraph (k)(5) of the standards, the written medical report for the employee must be completed by a licensed physician. Under paragraph (k)(6) of the standard, the written medical opinion for the employer must also be completed by a licensed physician. However, other requirements of paragraph (k) may be performed by a PLHCP under the supervision of a licensed physician (
Allowing a PLHCP to provide some of the services required under this rule is consistent with other recent OSHA health standards, such as bloodborne pathogens (29 CFR 1910.1030), respiratory protection (29 CFR 1910.134), methylene chloride (29 CFR 1910.1052), and respirable crystalline silica (29 CFR 1910.1053). OSHA received no comments on this definition, and it is unchanged from the proposal.
Paragraphs (e)(1)(ii) and (e)(2)(ii) require employers to establish and demarcate regulated areas. Note that the demarcation requirements for regulated areas are more specific than those for other beryllium work areas (see also paragraph (m)(2) of the standards for general industry and shipyards). Paragraph (e)(3) requires employers to restrict access to regulated areas to authorized persons, and paragraph (e)(4) requires employers to provide all employees in regulated areas appropriate respiratory protection and personal protective clothing and equipment, and to ensure that these employees use the required respiratory protection and protective clothing and equipment. Paragraph (i)(5)(i) prohibits employers from allowing employees to eat, drink, smoke, chew tobacco or gum, or apply cosmetics in regulated areas. Paragraph (m)(2) requires warning signs associated with regulated areas to meet
In the proposed rule, OSHA included in the definition of the term “regulated area” that it was “an area that the employer must demarcate.” Because the requirement to demarcate regulated areas is presented elsewhere in the standards, the reference in the definition to “an area that the employer must demarcate” is redundant, and has been removed from the final definition of the term.
This definition of regulated areas is consistent with other substance-specific health standards that apply to general industry and shipyards, such as the standards addressing occupational exposure to cadmium (29 CFR 1910.1027 and 29 CFR 1915.1027), benzene (29 CFR 1910.1028 and 29 CFR 1915.1028), and methylene chloride (29 CFR 1910.1052 and 29 CFR 1915.1052).
Paragraph (c) of the standards establishes two permissible exposure limits (PELs) for beryllium in all forms, compounds, and mixtures: An 8-hour time-weighted average (TWA) PEL of 0.2 μg/m
After evaluating the record, including published studies and more recent exposure data from industrial facilities involved in beryllium work, OSHA is adopting the proposed TWA PEL of 0.2 μg/m
OSHA has determined that the new TWA PEL is feasible across all affected industry sectors (see section VIII.D of this preamble, Technological Feasibility) and that compliance with the new PEL will substantially reduce employees' risks of beryllium sensitization, Chronic Beryllium Disease (CBD), and lung cancer (see section VI of this preamble, Risk Assessment). OSHA's conclusion about feasibility is supported both by the results of the Agency's feasibility analysis and by the recommendation of the PEL of 0.2 μg/m
Materion is the sole beryllium producer in the U.S., and its facilities include some of the processes where OSHA expects it will be most challenging to control beryllium exposures. Although OSHA also found that there is significant risk at the proposed alternative TWA PEL of 0.1 μg/m
The TWA PEL was the subject of numerous comments in the rulemaking record. Comments from stakeholders in labor and industry, public health experts, and the general public supported OSHA's selection of 0.2 μg/m
In addition to their concerns about risk, Public Citizen and the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) argued that a TWA PEL of 0.1 μg/m
OSHA has determined that Public Citizen's claim that the Agency should find a PEL of 0.1 μg/m
In considering an alternative TWA PEL of 0.1 μg/m
OSHA also invited comment on and considered an alternative TWA PEL of 0.5 μg/m
Because significant risks of sensitization, CBD, and lung cancer remain at the new TWA PEL of 0.2 μg/m
OSHA believes a STEL for beryllium will help reduce the risk of sensitization and CBD in beryllium-exposed employees. As discussed in this preamble at section V, Health Effects, beryllium sensitization is the initial step in the development of CBD. Sensitization has been observed in some workers who were only exposed to beryllium for a few months (see section V.D.1 of this preamble), and tends to be more strongly associated with 'peak' and highest-job-worked exposure metrics than cumulative exposure (see section V.D.5 of this preamble). Short-term exposures to beryllium have also been shown to contribute to the development of lung disease in laboratory animals (see this preamble at section V, Health Effects). These study findings indicate that adverse effects to the lung may occur from beryllium exposures of relatively short duration. Thus OSHA expects a STEL to add further protection from the demonstrated significant risk of harm than that afforded by the new 0.2 μg/m
STEL exposures are typically associated with, and need to be measured by the employer during, the highest-exposure operations that an employee performs (see paragraph (d)(3)(ii)). OSHA has determined that the STEL of 2.0 μg/m
In contrast, NGK Metals Corporation (NGK) supported the proposed STEL of 2 μg/m
After careful consideration of the record, including all available data and stakeholder comments, OSHA has reaffirmed its preliminary determinations that a STEL of 2.0 μg/m
OSHA also received a comment from Paul Wambach, (an independent commenter) stating that a STEL should not be included in the final rule, arguing that the diseases associated with beryllium exposure are chronic in nature and therefore are not affected by brief excursions above the TWA PEL (Document ID 1591, p. 1). However, as discussed above, OSHA has determined that there is sufficient evidence that brief, high-level exposures to beryllium contribute to the development of beryllium sensitization and CBD to support inclusion of a STEL in the final rule (see this preamble at section V, Health Effects). This comment also discussed the statistical relationship between a 15-minute STEL and 8-hour TWA PEL and issues of sampling strategy, discussed in section VIII.D of this preamble, Technological Feasibility.
OSHA is revising the entry for beryllium and beryllium compounds in 29 CFR 1910.1000 Table Z-1 to cross-reference the new general industry standard, 1910.1024. A comparable revision to 29 CFR 1915.1000 Table Z
Paragraph (d) of the final standards for general industry, construction, and shipyards sets forth requirements for assessing employee exposures to beryllium. 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). Consistent with the definition of “airborne exposure” in paragraph (b) of these standards, exposure monitoring results must reflect the exposure to airborne beryllium that would occur if the employee were not using a respirator. Exposures must be assessed using the new performance option (
In the proposed exposure monitoring provision, OSHA required employers to assess the exposure of employees who are, or may reasonably be expected to be, exposed to airborne beryllium. This obligation consisted of an initial exposure assessment, unless the employer relied on objective data to demonstrate that exposures would be below the action level or the short term exposure level (STEL) under any expected conditions; periodic exposure monitoring (at least annually if initial exposure monitoring indicates that exposures are at or above the action level and at or below the time-weighted average (TWA) PEL); and additional monitoring if changes in the workplace could reasonably be expected to result in new or additional exposures to beryllium. In the proposed rule, monitoring to determine employee TWA exposures had to represent the employee's average exposure to airborne beryllium over an eight-hour workday. STEL exposures had to be characterized by sampling periods of 15 minutes for each operation likely to produce exposures above the STEL. Samples taken had to reflect the exposure of employees on each work shift, for each job classification, in each beryllium work area. Samples had to be taken within an employee's breathing zone. The proposed rule also included provisions for employee notification of monitoring results and observation of monitoring.
OSHA received comments on a variety of issues pertaining to the proposal's exposure monitoring provision. In hearing testimony, Dr. Lisa Maier from National Jewish Health (NJH) expressed general support for exposure monitoring in the workplace “to target areas that are at or above the action level and to regulate these areas to trigger administrative controls” (Document ID 1756, Tr. 108). All other comments regarding the exposure monitoring requirements focused on specific areas of those requirements and are discussed in the appropriate subject section below.
OSHA has retained the provisions related to exposure assessment in the final standards. These provisions are important because assessing employee exposure to toxic substances is a well-recognized and accepted risk management tool. As the Agency noted in the proposal, the purposes of requiring assessment of employee exposures to beryllium include determination of the extent and degree of exposure at the worksite; identification and prevention of employee overexposure; identification of the sources of exposure to beryllium; 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) or short-term exposure limit (STEL) 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 physicians or other licensed health care professionals (PLHCPs) performing medical examinations to be informed of the extent of the worker's exposure to beryllium.
In the final standards, paragraph (d) is now titled “Exposure assessment.” This change from “exposure monitoring” in the proposal to “exposure assessment” in the final standards was made to align the provision's purpose with the broader concept of exposure assessment beyond conducting air monitoring, including the use of objective data.
Proposed paragraphs (d)(1)(ii)-(v) have been moved to different paragraphs in the final standards and will be discussed in the appropriate sections below.
When the employer elects the performance option, the employer must initially conduct the exposure assessment and must demonstrate that employee exposures have been accurately characterized. As evident in final paragraph (d)(3), OSHA considers exposures to be accurately characterized when they 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 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 STEL, or when the employer has any reason to believe that new or additional exposures at or above the action level have occurred (see discussion below of paragraph (d)(4) of the final standards for general industry, construction, and shipyards).
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, an employer could use the performance option and determine that an employee's exposure is above the action level but below the PEL. Based on this exposure assessment, the employer would be required under paragraph (k)(1)(i)(A) to provide medical surveillance if the employee is exposed for more than 30 days per year.
OSHA has not included specific criteria for implementing the performance option in the final standards. Because the goal of the performance option is to give employers flexibility to accurately characterize employee exposures using whatever combination of air monitoring data and objective data is most appropriate for their circumstances, OSHA concludes it would be inconsistent to specify in the standards exactly how and when data should be collected. When an employer wants a more structured approach for meeting their exposure assessment obligations, it may opt for 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 these standards, including the prescribed accuracy and confidence requirements in paragraph (d)(5). Second, objective data can include historic air monitoring data, but that data must reflect workplace conditions closely resembling or with a higher airborne exposure potential than the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations. 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 beryllium can be found in the summary and explanation of “objective data” in paragraph (b) (“Definitions”).
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 employer to show that the exposure assessment is sufficient to accurately characterize employee exposures to beryllium.
As with the Chromium (VI) standard, 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 beryllium, 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 are between the action level and 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. The burden is on the employer to show that the data accurately characterize employee exposure to beryllium. This burden 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 standards could be
Any air monitoring data relied upon by employers must be maintained and made available in accordance with the recordkeeping requirements in paragraph (n)(1) of the final standards for general industry, construction, and shipyards. Any objective data relied upon must be maintained and made available in accordance with the recordkeeping requirements in paragraph (n)(2) of the standards.
Some commenters disagreed with the requirement to perform exposure monitoring on each work shift. NGK stated that sampling on each shift is overly burdensome and unnecessary since samples are collected from those employees who are expected to have the highest exposure (Document ID 1663, p. 1). Materion and the United Steelworkers (USW) recommended representative sampling instead of sampling all employees, and sampling from the shift expected to have the highest exposures (Document ID 1680, p. 3). Materion separately commented that monitoring on all three shifts is not warranted, would be burdensome to small businesses, and does not align well with other standards (Document ID 1661, p. 14 (pdf)). In post-hearing comments, Materion submitted an analysis of exposure variation by shift at one of their facilities and argued that the data are the best available evidence that monitoring on all three shifts is not justifiable or necessary to fulfill the requirements of the OSH Act (Document ID 1807, Attachment 1, p. 5, Attachment 7, p. 82; 1958, pp. 5-6). In an individual submission, the USW also stated that three-shift monitoring would add unnecessary compliance costs. Additionally, it commented that if the operations are identical, the shift chosen will not matter, while if they are not identical, then monitoring on the highest exposed shift will overestimate exposures on the other shifts (Document ID 1681, Attachment 1, p. 8). Conversely, the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) noted in post-hearing comments that widely accepted industrial hygiene practice includes exposure monitoring during different shifts, tasks, and times of the year and that monitoring is specifically designed this way to characterize exposure under different conditions (Document ID 1809, p. 1). During the hearings, Dr. Virji from NIOSH testified that because exposure is variable and “different things happen at different shifts,” including maintenance activities, “it is hard to . . . gauge . . . which shift [has] the highest exposure,” so “it is important that multiple shifts get representative sampling” (Document ID 1755, Tr. 50-51).
OSHA agrees with the AFL-CIO and Dr. Virji and has retained the requirement in proposed paragraphs (d)(1)(ii) and (iii) that samples reflect exposures on each shift, for each job classification, and in each work area. This requirement is included in final paragraphs (d)(3)(i) and (ii). However, in response to the comments from Materion and the USW, OSHA restructured the exposure assessment requirements in order to provide employers with greater flexibility to meet their exposure assessment obligations by using either the performance option or the scheduled monitoring option depending on the operation and information available. OSHA believes that conducting exposure assessment on a specific schedule provides employers with a workable structure to properly assess their employees' exposure to beryllium and provides sufficient information for employers to make informed decisions regarding exposure prevention measures. Alternatively, the performance option provides employers with flexibility in accurately characterizing employee exposures to beryllium on the bases of any combination of air monitoring and objective data.
Comments submitted from Mr. Paul Wambach, a private citizen, stated that the proposed short-term exposure limit (STEL) of 2 μg/m
OSHA has decided to include the scheduled monitoring option in the final standards because it provides employers with a clearly defined, structured approach to assessing employee exposures. Under paragraph (d)(3)(i) of the final standards, employers who select the scheduled monitoring option must conduct initial monitoring to determine employee exposure to beryllium. Air monitoring to determine employee exposures must represent the employee's 8-hour TWA exposure to beryllium. Final paragraph (d)(3)(ii) requires the employer to perform initial monitoring to assess the employee's 15-minute short-term exposure. Under both paragraphs (d)(3)(i) and (d)(3)(ii), samples must be taken within the employee's personal breathing zone, and must represent the employee's airborne exposure on each shift, for each job classification, in each work area. In the final standards, OSHA has changed “in each beryllium work area” to “in each work area” to avoid confusion with the beryllium work areas defined in paragraphs (b) and (e) of the final standard for general industry. In other OSHA standards, the term “work area” is used to describe the general worksite where employees are present and performing tasks or where work processes and operations are being carried out. Employers following the scheduled monitoring option should conduct initial monitoring as soon as work on a task or project involving beryllium exposure begins so they can identify situations where control measures are needed.
The USW and AFL-CIO supported the representative sampling provision in OSHA's proposed exposure monitoring requirements (Document ID 1681, p. 8; 1689, p. 11). OSHA has decided to retain the representative sampling provision in the final standards to provide employers with greater flexibility in meeting their exposure assessment obligations. Under the scheduled monitoring option, just as under the performance option, employers must accurately characterize the exposure of each employee to beryllium. In some cases, this will entail monitoring all exposed employees. In other cases, monitoring of “representative” employees is sufficient. As in the proposal, representative exposure sampling is permitted under the final standards when several employees perform the same tasks on the same shift and in the same work area. However, OSHA has not included the requirement in proposed paragraph (d)(1)(iv)(A) that employees “have similar duration and frequency of exposure” in final paragraph (d)(3)(iii). This provision is unnecessary because final paragraph (d)(3)(iii), like proposed paragraph (d)(1)(iv)(C), requires the employer to sample the employee(s) expected to have the highest exposures to beryllium. Additionally, the requirement in proposed paragraph (d)(1)(iv)(B) that employers take “sufficient breathing zone samples to accurately characterize exposure on each work shift, for each job classification, in each work area” has been removed because when performing exposure monitoring under final paragraphs (d)(3)(i) or (d)(3)(ii), employers already must assess exposures based on personal breathing zone air samples that reflect the airborne exposure of employees on each shift, for each job classification, and in each work area. Under these conditions, OSHA expects that exposures will be accurately characterized.
Finally, the proposed requirement in paragraph (d)(1)(iv)(C) that employers must monitor the employee(s) expected to have the highest exposures has been retained in the final standards. For example, this could involve monitoring the beryllium exposure of the employee closest to an exposure source. The exposure result may then be attributed to other employees who perform the same tasks on the same shift and in the same work area. Exposure assessment should include, at a minimum, one full-shift sample and one 15 minute sample taken for each job classification, in each work area, for each shift.
Where employees are not performing the same tasks on the same shift and in the same work area, representative sampling will not adequately characterize actual exposures of those employees, and individual monitoring is necessary.
In the NPRM, OSHA solicited comment on the reasonableness of discontinuing monitoring based on one sample below the action level. In response, many commenters discussed the importance of taking multiple samples to evaluate a worker's exposure even if initial results are below the action level. NJH emphasized that “[i]t is NOT reasonable to discontinue monitoring after one sample result below the action level” because “a single sample result does not reflect the random variation in sampling and analytical methods” (Document ID 1664, p. 6). NIOSH commented that, because occupational exposure distributions are right-skewed (
OSHA has considered these comments and has determined that if initial monitoring indicates that employee exposures are below the action level and at or below the STEL, no further monitoring is required. Paragraph (d)(3)(iv) of the final standards permits employers to discontinue monitoring of employees whose exposure is represented by such monitoring where initial monitoring indicates that exposure is below the action level and at or below the STEL. However, a single sample below the action level and at or below the STEL does not necessarily warrant discontinuation of exposure monitoring. OSHA has clarified in final paragraphs (d)(3)(i) and (d)(3)(ii) that any initial monitoring conducted under the scheduled monitoring option must reflect exposures on each shift, for each job classification, and in each work area. Therefore, where there is more than one shift or work area for a particular task, there will be more than one sample; accordingly, it is unlikely that an employer would be able to sufficiently characterize and assess employee
In paragraph (d)(3) of the proposed rule, periodic exposure monitoring was required at least annually if initial exposure monitoring found exposures at or above the action level and at or below the TWA PEL. In the NPRM, OSHA asked a question about the frequency of monitoring and the reasoning behind that frequency. During the hearings, Peggy Mroz with NJH testified that periodic monitoring conducted at least every 180 days when exposures are at or above the action level is “the most protective for workers” (Document ID 1756, Tr. 99-100). Ms. Mroz further stated that exposure monitoring should also be conducted at least annually for all other processes and jobs where initial monitoring shows levels below the action level since changes in working conditions can affect monitoring results, and “[i]t has already been shown that beryllium sensitization and CBD occur at measured exposures below the proposed action level” (Document ID 1756, Tr. 100). Both NIOSH and NJH recommended more frequent monitoring for employers to fully understand levels of exposure that may vary over time and to assess whether proper controls are in place after a high exposure level is documented (Document ID 1725, p. 29; 1720, p. 5). The BHSC Task Group stated that annual monitoring is inadequate, and recommended sampling more frequently than every 180 days (Document ID 1665, pp. 15, 17). And, the AFL-CIO commented that annual exposure monitoring is inadequate and does not provide the employer with enough information to make appropriate changes to prevent and minimize exposure. The AFL-CIO cited various OSHA health standards that required more frequent periodic exposure monitoring, including cadmium, asbestos, vinyl chloride, arsenic, lead, and respirable crystalline silica (Document ID 1809, pp. 1-2). In contrast, Ameren agreed with the proposal's requirement to conduct monitoring annually if exposures are at or above the action level, because the proposal already requires additional monitoring when work conditions change (Document ID 1675, p. 4). And, the Edison Electric Institute (EEI) commented that beryllium exposure in the electric utility industry occurs during maintenance outages, “which more closely align with the annual re-sampling requirements than the 180 [day] provisions in these alternatives” (Document ID 1674, p. 14).
OSHA is persuaded by the commenters recommending more frequent periodic monitoring and has changed the frequency required for exposures between the action level and the TWA PEL in the scheduled monitoring option in the final standards. Paragraph (d)(3)(v) of the final standards requires monitoring every six months if initial exposure monitoring indicates that exposures are at or above the action level but at or below the TWA PEL, which is the typical frequency in other health standards for carcinogens such as respirable crystalline silica, cadmium, vinyl chloride, and asbestos for this level of exposure. Alternatively, employers in general industry, construction, and shipyards can use the performance option in paragraph (d)(2), which provides employers greater flexibility to meet their exposure assessment obligations.
In the proposal, OSHA did not require periodic exposure monitoring if initial exposure monitoring indicated that exposures were above the TWA PEL or STEL. In response to a question in the NPRM about monitoring above the PEL, Materion commented that there is no benefit to expending time and money monitoring exposures that exceed the PEL, because it is more important that activities be directed toward the exposure control plan. Based on their experience, Materion believes that employers will conduct monitoring as often as necessary to demonstrate that exposures have been reduce to below the PEL (Document ID 1661, p. 24 (pdf)). Other commenters disagreed with OSHA's proposal not to require periodic exposure monitoring above the PEL. The DOD commented that periodic monitoring should also be performed when levels are above the PEL to ensure respiratory protection is adequate and to test the effectiveness of engineering controls (Document ID 1684, Attachment 2, p. 9). In response to a question during the hearings on the benefits of monitoring above the PEL, NIOSH's Dr. Virji testified that exposure can vary within a job and that even though an employer may know exposures are high in a particular area, the information is “useful because then it allows an understanding of what level of engineering controls that would be required to bring down the exposures to acceptable levels” (Document ID 1755, Tr. 49-50). In her testimony, Mary Kathryn Fletcher with the AFL-CIO expressed support for monitoring above the PEL, stating that “exposure monitoring is important to reevaluate control measures in cases of over-exposure,” and “[it is] important to characterize the job to know the exposures if you're going to try to reduce those exposures” (Document ID 1756, Tr. 236). Also during the hearings, Ashlee Fitch with the Health, Safety, and Environment Department of the USW responded to a similar question on the benefits of air monitoring in cases where exposures are believed to exceed the PEL. She stated, “You see oftentimes that employers used exposure rates to measure how well ventilation systems are working or what the exposure is, and after they implement engineering controls, what that exposure goes to” (Document ID 1756, Tr. 282). In her testimony, Peggy Mroz with NJH expressed support for periodic exposure monitoring every 90 days where exposures exceed the TWA PEL or STEL as “routine and regular sampling and repeated sampling should be done to assess whether proper controls are in place after a high sample is documented as we know that beryllium sensitization and chronic beryllium disease can occur within a few weeks of exposure” (Document ID 1756, Tr. 100).
Based on these comments received in the record and testimony obtained from the public hearing, OSHA's final standards require periodic exposure monitoring every three months when exposures are above the TWA PEL or STEL under the scheduled monitoring option in paragraphs (d)(3)(vi) and (d)(3)(viii). Alternatively, employers in general industry, construction, and shipyards can use the performance option in paragraph (d)(2) which provides employers with greater flexibility to meet their exposure assessment obligations.
Proposed paragraph (d) did not include a separate provision to allow employers to discontinue monitoring if exposures were subsequently reduced to below the action level, as demonstrated by periodic monitoring. In the NPRM, OSHA solicited comment on the reasonableness of discontinuing monitoring based on one sample below the action level. As discussed more fully in the explanation of final paragraph (d)(3)(iv), many commenters discussed the importance of taking multiple samples to confirm exposures are below the action level before allowing the discontinuation of monitoring. For example, ORCHSE Strategies (ORCHSE) commented that allowing discontinuation of monitoring based on one sample is not appropriate and that two consecutive samples taken at least seven days apart, that show exposure below the action level, should be required to allow monitoring to be
As stated in the explanation of final paragraph (d)(3)(iv), OSHA has carefully considered these comments and agrees that a single sample is not sufficient to allow employers to discontinue monitoring. OSHA has therefore decided to add paragraph (d)(3)(vii) to the final standards. This provision requires that, where the most recent exposure monitoring indicates that employee exposure is below the action level, the employer must repeat exposure monitoring within six months of the most recent monitoring. The employer may discontinue TWA monitoring, for those employees whose exposure is represented by such monitoring, only when two consecutive measurements, taken seven or more days apart, are below the action level, except as otherwise provided in the reassessment of exposures requirements in paragraph (d)(4) of the final standards. Additionally, OSHA has added paragraph (d)(3)(viii) to the final standards. This provision requires that, where the most recent exposure monitoring indicates that employee exposure is above the STEL, the employer must repeat exposure monitoring within three months of the most recent short-term exposure monitoring until two consecutive measurements, taken seven or more days apart, are below the STEL. At this point, the employer may discontinue monitoring for those employees whose exposure is 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 above the STEL or the employer has any reason to believe that new or additional exposures at or above the action level or above the STEL have occurred, regardless of whether the employer has ceased monitoring because exposures are below the action level or at or below the STEL under paragraphs (d)(3)(iv), (d)(3)(vii), or (d)(3)(viii) of the final standards.
During the public hearing, testimony was heard about abrasive blasting operations using slags at a shipyard facility. Mike Wright, with the USW, testified that the use of enclosure (containment) is important to prevent the escape of beryllium dust during abrasive blasting operations and that exposure monitoring could help determine the integrity of the enclosure along with establishing a perimeter where beryllium contamination is controlled (Document ID 1756, Tr. 274-275). Ashlee Fitch, also representing the USW, testified about monitoring worker exposure to beryllium in the maritime industry. Ms. Fitch stated that abrasive blasting using beryllium-containing abrasive materials should be done in full containment and that exposures outside the containment should not exceed the PEL or STEL (Document ID 1756, Tr. 244-245). Ms. Fitch recommended that in cases where full containment is used, “the employer shall do an initial monitoring for each configuration of the containment” and “if the initial monitoring shows exposures above the action level, monitoring shall be performed for every blasting operation.” She also recommended air monitoring of exposed workers outside of the containment or through monitoring of the positions where exposure is likely to be the highest, or if full containment is not used, “around any abrasive blasting operation” (Document ID 1756, Tr. 245). Representative Robert Scott, the ranking minority member on the Committee on Education and the Workforce of the U.S. House of Representatives (Representative Scott), commented that when workers are engaged in abrasive blasting and the abrasive blasting area is contained, exposure monitoring should be routinely performed when levels exceed the action level (Document ID 1672, p.4).
Substantially agreeing with these comments, in paragraph (d)(3) of the final standards, OSHA is requiring monitoring on each work shift, for each job classification, and in each work area when employers are following the scheduled monitoring option. OSHA also agrees that monitoring should be of the positions where exposure is likely to be the highest, so when employers engage in representative sampling under the scheduled monitoring option, final paragraph (d)(3)(iii) requires that they must sample the employee(s) expected to have the highest airborne exposure to beryllium. OSHA also agrees with Representative Scott that exposure monitoring should be routinely performed for abrasive blasting and all other operations exposing workers to beryllium when exposures exceed the action level. If exposures exceed the action level or STEL, the employer is required to monitor exposures at frequencies indicated in the scheduled monitoring option or using the performance option to accurately assess the beryllium exposure of their employees. However, OSHA does not consider monitoring to be necessary each time there is an abrasive blasting or other operation that fits within the profile of a previously taken representative sample.
Commenters generally advocated for monitoring to assess any new exposures. For example, in her testimony, Mary Kathryn Fletcher with the AFL-CIO expressed support for exposure monitoring even if exposure is reduced as far as feasible, because exposures can change, so “it's important to monitor as tasks change and over time, there are different procedures, different workers in the area, doing different things” (Document ID 1756, Tr. 236). Also, NJH commented that “periodic sampling, even of low exposure potential tasks, ensures that despite changes in processes, personnel, exhaust systems, and other control measures, the exposure remains low and workers remain safe” (Document ID 1664, p. 6). Therefore, the Agency has decided to retain the requirement of proposed paragraph (d)(4) that employers reassess exposures, but has made minor changes to the regulatory text. OSHA has changed the title “Additional Monitoring” in proposed paragraph (d)(4) to “Reassessment of exposures” in paragraph (d)(4) of the final standards to be consistent with the change in paragraph (d) terminology from “exposure monitoring” to “exposure assessment.” OSHA has also changed the proposed requirement that employers conduct exposure monitoring within 30 days after a change in “production processes, equipment, materials, personnel, work practices, or control methods” that could reasonably be expected to result in new or additional exposures to the requirement in the final standards that employers must perform reassessment of exposures
In addition, there may be other situations that can result in new or additional exposures that are unique to an employer's work situation. In order to cover those special situations, OSHA has retained the requirement in proposed paragraph (d)(4)(ii) that the employer must reassess exposures whenever the employer has any reason to believe that a change has occurred that may result in new or additional exposures, and has added “at or above the action level or STEL” to final paragraph (d)(4). Under this provision, for example, an employer is required to reassess exposures when an employee has a confirmed positive result for beryllium sensitization, exhibits signs or symptoms of CBD, or is diagnosed with CBD. These conditions necessitate a reassessment of exposures to ascertain if airborne exposures contributed to the beryllium-related health effects. Additionally, reassessment of exposures would be required following a process modification that increases the amount of beryllium-containing material used, thereby possibly increasing employee exposure. Reassessment of exposures will also be required when a shipyard or construction employer introduces a new beryllium-containing slag for use in an abrasive blasting operation. Once reassessment of exposures is performed and if exposures are above the action level, TWA PEL, or STEL, the employer can take appropriate action to protect exposed employees and must perform periodic monitoring as discussed above.
Under final paragraph (d)(5), the employer is required to make sure that all samples taken to satisfy the monitoring requirements of paragraph (d) are evaluated by a laboratory that can measure airborne levels of beryllium to an accuracy of plus or minus 25 percent within a statistical confidence level of 95 percent for airborne concentrations at or above the action level. The following methods meet these criteria: NIOSH 7704 (also ASTM D7202), ASTM D7439, OSHA 206, OSHA 125G, and OSHA 125G using ICP-MS. All of these methods are available to commercial laboratories analyzing beryllium samples. However, not all of these methods are appropriate for measuring beryllium oxide, so employers must verify that the analytical method used is appropriate for measuring the form(s) of beryllium present in the workplace.
In the NPRM, OSHA requested comment on whether these methods would satisfy the requirements of this paragraph, and if there were other methods that would also meet these criteria. The BHSC Task Group commented that OSHA's accuracy criteria could be met for full shift samples using available analytical methods. The BHSC Task Group agreed with the guidance in OSHA's NPRM to use ICP-MS or fluorescence to assure adequate sensitivity and analytical precision (Document ID 1655, p. 2). In response to a question on whether the current methods were sufficiently sensitive, Kevin Ashley with NIOSH testified that both the fluorescence method (NIOSH method 7704) and the inductively coupled plasma mass spectrometry (ASTM method D7439) were adequately sensitive to measure at the proposed PEL and STEL (Document ID 1755, Tr. 58). The DOD commented that the current limit of quantification (LOQ) of 0.05 µg for beryllium using the NIOSH 7300 and OSHA 125G methods would be adequate to detect exposures below the proposed action level of 0.1 µg/m
Rather than specifying a particular method that must be used, the final standards allow for a performance-oriented approach that allows the employer to use the method and analytical laboratory of its choosing as long as that method meets the accuracy specifications in paragraph (d)(5) and the reported results represent the total airborne concentration of beryllium for the worker being characterized. Other methods, such as a respirable fraction sample or size selective sample, would not provide results directly comparable to either PEL, and therefore would not be considered valid.
Proposed paragraph (d)(5)(i) required employers to notify each employee of his or her monitoring results within 15 working days after receiving the results of any exposure monitoring. Both the employees whose exposures were measured directly and those whose exposures were represented by the monitoring had to be notified. The employer had to notify each employee individually in writing or post the monitoring results in an appropriate location accessible to all employees required to be notified. Proposed paragraph (d)(5)(i) is now paragraph (d)(6)(i) in the final standards, and has
Proposed paragraph (d)(5)(ii) required that, whenever exposures exceeded the TWA PEL or STEL, the written notification required by proposed paragraph (d)(5)(i) include (1) suspected or known sources of exposure and (2) a description of the corrective action(s) that have been taken or will be taken by the employer to reduce the employee's exposure to or below the TWA PEL or STEL where feasible corrective action exists but was not implemented at the time of the monitoring. OSHA did not receive comment on this specific provision, and after reviewing the record, including comments supporting paragraph (d) generally, OSHA has decided to retain a notification requirement focused on individual exposure assessments and the corrective actions being taken for exposures above the PEL or STEL. It is necessary to assure employees that the employer is making efforts to furnish them with a safe and healthful work environment, and to provide employees with information about their exposures. Furthermore, notification to employees of exposures above a prescribed PEL and the corrective actions being taken is required under section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)). In order to provide consistency with other OSHA health standards, OSHA has removed the requirement in proposed paragraph (d)(5)(ii) that employers include suspected or known sources of exposure in the written notification. Proposed paragraph (d)(5)(ii), as revised, is now paragraph (d)(6)(ii) in the final standards.
Proposed paragraph (d)(6)(i) required the employer to provide an opportunity to observe any exposure monitoring required by the standards to each employee whose airborne exposure was measured or represented by the monitoring and to each employee's representative(s). Proposed paragraph (d)(6)(i) is now paragraph (d)(7)(i) in the final standards, and is substantively unchanged from the proposal. When observation of monitoring required entry into an area where the use of protective clothing or equipment was required, proposed paragraph (d)(6)(ii) required the employer to provide the observer with that personal protective clothing or equipment, at no cost. The employer was also required to ensure that the observer used such clothing or equipment appropriately. Proposed paragraph (d)(6)(ii) is now paragraph (d)(7)(ii) in the final standards, and is substantively unchanged from the proposal. Paragraph (d)(6)(iii) of the proposal required employers to ensure that each observer complied with all applicable OSHA requirements and the employer's workplace safety and health procedures. Proposed paragraph (d)(6)(iii) is now paragraph (d)(7)(iii) in the final standards. OSHA has changed the proposed language to require that employers ensure that each observer follows all other applicable safety and health procedures to clarify that the burden to comply with OSHA requirements remains on the employer, not the observer.
Paragraph (e) of the standards for general industry and shipyards sets forth the requirements for establishing, maintaining, demarcating, and limiting access to certain areas of the workplace to aid in minimizing employee exposure to beryllium. As discussed below, the general industry standard includes requirements for both “work areas” and “regulated areas,” which are subsets of work areas. The shipyard standard includes requirements for regulated areas, but not work areas. Paragraph (e) of the construction standard does not require either work areas or regulated areas, but instead includes requirements for a “competent person,” who has responsibility for demarcating certain areas of beryllium exposure for similar purposes.
Specifically, paragraph (e)(1)(i) and (e)(2)(i) of the standard for general industry requires employers to establish, maintain, and demarcate one or more “beryllium work area,” which is defined as a work area containing a process or operation that can release beryllium where employees are, or can reasonably be expected to be, exposed to airborne beryllium at any level or where there is the potential for dermal contact with beryllium. OSHA intends these beryllium work area provisions to apply to the area surrounding the process, operation, or task where airborne beryllium is released or the potential for dermal contact is created. Beryllium work areas are also referenced in the general industry standard in paragraphs (f)(1) (the written exposure control plan), (f)(2) (engineering and work practice controls), and (j) (housekeeping). Under paragraphs (e)(1)(ii) and (e)(1) of the standards for general industry and shipyards, respectively, employers are also required to establish and maintain regulated areas wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. As indicated and discussed in more detail below, the final standards for shipyards and construction do not contain provisions for beryllium work areas and the standard for construction does not require employers to establish regulated areas. In lieu of regulated areas, paragraph (e) of the final standard for construction, Competent Person, consists of a set of requirements designed to provide most of the same protections as regulated areas in general industry and shipyards, using a competent person instead of demarcated areas to achieve these ends.
The requirements to establish beryllium work areas and regulated areas or designate competent persons serve several important purposes. First, requiring employers to establish and demarcate beryllium work areas in general industry ensures that workers and other persons are aware of the potential for work processes to release airborne beryllium or cause dermal contact with beryllium. Second, the required demarcation of regulated areas in general industry and shipyards in accordance with the paragraph (m) requirements for warning signs ensures that all persons entering regulated areas
The remainder of this section provides detailed discussion of each provision in paragraph (e) of the final standards for general industry, shipyards, and construction, as well as comments OSHA received on paragraph (e) of the proposed standard, OSHA's response to these comments, and the reasons for OSHA's decisions regarding the provisions of paragraph (e) in each final standard.
A number of stakeholders commented on the proposed definition of a beryllium work area. Some commenters, such as NGK Metals Corporation (NGK) and ORCHSE Strategies (ORCHSE), argued that the definition of a beryllium work area is vague and requested that OSHA trigger the requirement to establish and maintain beryllium work areas at a measureable threshold, such as the action level (
Other commenters supported the proposed standard's establishment of beryllium work areas at any level of airborne beryllium exposure. For example, AWE commented that its “supervised beryllium workspaces” align with the proposal's beryllium work areas (Document ID 1615, p. 1). NIOSH observed that the proposed approach is feasible and appropriate for beryllium work settings where work such as production, processing, handling, and manufacturing of beryllium products is performed and areas where needed preventive controls can be relatively easily demarcated (Document ID 1725, pp. 29-30). Materion and USW reiterated their support for provisions related to beryllium work areas “where operations generate airborne beryllium particulate”, which were included in the recommended model standard they submitted to OSHA (Document ID 1680, p. 3).
The purpose of a beryllium work area is to establish a demarcated area in which workers and other persons authorized to be in the area are made aware of the potential for beryllium exposure and must take certain precautions accordingly. OSHA finds that establishing beryllium work areas where exposures are at the action level or above the PEL would not adequately protect exposed workers operating outside demarcated regulated areas, for which the applicable trigger is the TWA PEL or STEL. Because, as discussed in Section V, Health Effects, there is still a potential health risk to workers exposed to beryllium below the action level, the establishment and demarcation of beryllium work areas at any level of airborne exposure will provide additional protection for these workers by ensuring that they are aware of the presence of processes that release beryllium. OSHA similarly finds that Boeing's suggested trigger of 0.02 µg/m
Two electric utility companies, Southern Company and Ameren Corporation (Ameren), argued that a work area requirement defined by any level of airborne beryllium exposure was subjective and would result in their entire facility falling under this
OSHA did not intend a scenario where an entire facility becomes a beryllium work area from environmental or other non-occupational sources of beryllium. Nor did the Agency intend to cause the entirety of any worksite covered by the rule to become a beryllium work area, even where the amount of airborne beryllium is insignificant in the sense that it is residually present at very low levels in areas of a facility where work processes that release airborne beryllium do not occur. (Note that the best available scientific evidence has not identified a medically insignificant level of beryllium exposure; as discussed in Section VI, Risk Assessment, beryllium sensitization has been found among individuals whose exposures are below the action level.) Such a situation might occur in a coal-fired electric generating plant or a foundry where a very small amount of beryllium may be detectable far away from the processes that released it. To avoid these unintended consequences, OSHA has modified the beryllium work areas provision in the final standard for general industry to specify that the source of the airborne beryllium exposure and potential for dermal contact triggering the requirement for a beryllium work area must be generated from a process or operation within that area. This modification is similar to ACOEM's suggestion to define beryllium work areas as areas where beryllium or beryllium-containing materials are or have been processed (Document ID 1685, p. 2). While the trigger for beryllium work area is based on whether the beryllium is processed by controlling the release of airborne beryllium from the particular process, operation, or task, the employer can limit the size of the beryllium work area and eliminate the likelihood of an entire facility becoming a beryllium work area. OSHA believes this modified definition of beryllium work areas addresses the concerns raised by employers and ACOEM, while also maintaining the protective benefits associated with beryllium work areas for beryllium-exposed employees.
In addition to commenting on the level of exposure that should trigger the establishment and maintenance of a beryllium work area, NIOSH offered an opinion on the type of exposure that should trigger beryllium work areas. Specifically, NIOSH argued that limiting the definition of beryllium work area to employee exposure to airborne beryllium omits the potential contribution of dermal exposure to total exposure (Document ID 1725, p. 30). To support its point, NIOSH cited to Armstrong
OSHA also made two other minor, nonsubstantive changes to the proposed provision to help streamline the final general industry standard. First, instead of restating the definition of beryllium work area in paragraph (e)(1)(i) (as in the proposal), OSHA has modified final paragraph (e)(1)(i) in the proposal to merely refer to the term as defined in paragraph (b) of the standard for general industry. Second, the definition of beryllium work area in the final general industry standard includes the qualifier “where employees are, or can reasonably be expected to be, exposed to airborne beryllium at any level.” This is a modification from the proposed beryllium work area definition wording “where employees are, or can reasonably be expected to be, exposed to airborne beryllium, regardless of the level of exposure.” Both of these changes were intended only to simplify the language of the regulatory text and should not be read to suggest a change in substantive requirements or the Agency's intent.
The construction and shipyard sectors were not included in the proposed standard. However, OSHA requested comments on Regulatory Alternative #2a in the NPRM, which would apply all provisions of the proposed standard to facilities in construction and shipyards, including provisions pertaining to the establishment of beryllium work areas. Following careful consideration of the comments OSHA received from a variety of stakeholders and from NIOSH on this topic, OSHA has concluded that the requirement to establish and maintain beryllium work areas are not appropriate for construction or shipyards. The work processes (primarily abrasive blasting), worksites, and conditions in construction and shipyards differ substantially from those typically found in general industry; as discussed further below, establishment of beryllium work areas in these sectors is likely to be impractical. However, OSHA has modified the standards so that most of the protective measures related to beryllium work areas in the general industry standard apply to operations in construction and shipyards, using triggers more suitable for these sectors. Thus, OSHA believes the final standards for construction and shipyards provide employees protection similar to employees in general industry, but avoid the difficulties associated with establishment of beryllium work areas in the context of abrasive blasting operations in these sectors.
NIOSH commented that while it supported triggering the requirement to establish beryllium work areas at any level of airborne exposures, it is not clear how such a requirement would work in an outdoor environment (Document ID 1725, p. 30). It explained that it is possible that even ambient conditions could cause an outdoor work environment to qualify as a “beryllium work area” (Document ID 1725, p. 30). NIOSH also noted that it was unclear how to delineate beryllium work areas in an outdoor setting when abrasive blasting the outer hull of a large ship and questioned how the beryllium work area trigger of any level of airborne exposure to beryllium could be applied only to that specified area (Document 1755, Tr. 21). NIOSH further explained that establishing a beryllium work area for abrasive blasting in an outdoor environment is difficult because outdoor blasting operations often involve large structures and constant moving of the operation (Document ID 1755, Tr. 55).
Newport News Shipbuilding (NNS) similarly commented that since beryllium is primarily encountered in shipyards as a trace element in coal slag blasting media, the requirement to establish and maintain beryllium work areas is not appropriate for shipyards. NNS stated, “[i]t is relatively easy to control a work area to a stated number such as a permissible exposure limit or an action level, but controlling `regardless of level of exposure' for a trace contaminant in dust is impractical” (Document ID 1657, pp. 1-2).
Recognizing the difficulties described by NIOSH and NNS, the Agency decided not to require employers in construction and shipyards to establish and maintain beryllium work areas. However, OSHA has modified provisions associated with beryllium work areas in paragraph (f)(1) and paragraph (h) of the proposed standard so as to provide employees in all sectors with largely equivalent protective measures. For example, employers in all sectors are required to create, implement, and maintain a written exposure control plan that lists jobs and operations where beryllium exposure may occur, and that documents procedures for limiting cross-contamination and migration of beryllium (see Summary and Explanation of paragraph (f)(1)). Similarly, whereas employers in general industry are required under paragraph (f)(2) to take certain steps to reduce airborne beryllium in beryllium work areas where exposures meet or exceed the action level, employers in construction and shipyards have a nearly identical requirement to take steps to reduce exposures where exposures meet or exceed the action level. Thus, the only provisions related to beryllium work areas that apply in general industry but not in construction and shipyards are those OSHA is persuaded add protective value in general industry but would be unworkable or ineffective in the construction and shipyard contexts of abrasive blasting and outdoor operations,
OSHA received relatively few comments on the proposed provisions for regulated areas, which were largely similar to the regulated areas provisions included in previous substance-specific standards. In general, commenters did not oppose the concept of regulated areas. Clive LeGresly with AWE noted that their organization establishes “Controlled” beryllium workspaces that align with the final standards' regulated areas (Document ID 1615, p. 4). However, some commenters suggested modifications to OSHA's proposed definition of regulated areas. In their comments, the Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) and National Jewish Health (NJH) both supported the concept of regulated areas but recommended they be established when exposures are at or above the action level (Document ID 1655, p. 7; 1664, p. 3). Finally, the Department of Defense (DoD) argued that having both beryllium work areas and regulated areas was confusing and burdensome, and suggested that the final standard should include only areas with airborne beryllium above the TWA PEL or STEL, which they described as better defined and more enforceable than the provisions for beryllium work areas in the proposed standard (Document ID 1684, Attachment 2, p. 2). After carefully considering the record on regulated areas, OSHA has decided to modify some of the provisions associated with regulated areas to address commenters' concerns where appropriate, but to retain paragraph (e)(1)(ii) as proposed in the final standard for general industry. Thus, final paragraph (e)(1)(ii) in general industry requires employers to establish and maintain a regulated area wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. A detailed discussion of OSHA's decisions and reasoning follows.
As applied to general industry, OSHA has not accepted the DoD's suggestion that only work areas where exposures exceed the TWA PEL or STEL need to be demarcated as limited-access or regulated areas. Because employees who are exposed to airborne beryllium below the TWA PEL and STEL and who have dermal contact with beryllium are at risk of adverse health effects, OSHA finds that it is appropriate to establish and demarcate beryllium work areas wherever work processes create such exposures and are primarily located in indoor settings, as OSHA finds is typical of operations in general industry. As discussed above, the requirement for the establishment and maintenance of beryllium work areas is necessary to alert workers to the presence of beryllium and to trigger basic exposure prevention methods, such as hygiene facilities and housekeeping. However, it is also appropriate to establish regulated areas with more stringent requirements, such as respiratory protection, limited access, and warning signs, where exposures may exceed the TWA PEL or STEL. OSHA concludes that beryllium work areas and regulated areas serve distinct purposes, and each provides important protections to employees. Therefore, OSHA has decided to retain both beryllium work areas and regulated areas in the final standard for the general industry standard. As explained elsewhere in this section, OSHA finds that requirements to establish and demarcate beryllium work areas are not appropriate to operations in construction and shipyards, and that the objectives of regulated areas are better
OSHA has also carefully considered the recommendation by the BHSC Task Group and NJH to use the action level rather than the TWA PEL or STEL to trigger the provisions of the proposed standard associated with regulated areas, and finds that it has some merit. For example, in the proposed standard, employees who work in regulated areas for more than 30 days in a 12-month period would be eligible for medical surveillance. Because employees exposed to beryllium at levels below the TWA PEL are at significant risk of material impairment of health as a result of their exposure (Section VII, Significance of Risk), OSHA is persuaded that the action level is a more appropriate trigger for the provision of medical surveillance. Eligibility for medical surveillance at the action level is also consistent with previous OSHA standards where significant risk remains at the TWA PEL, such as the recently published respirable crystalline silica standard. In addition, because beryllium sensitization can occur from dermal contact with beryllium regardless of whether airborne exposures are above or below the TWA PEL or STEL, OSHA believes it is appropriate to apply PPE requirements much more broadly than the proposed standard, which relied heavily on work in regulated areas as a trigger for PPE.
However, OSHA does not believe that all provisions associated with regulated areas should apply at exposure levels below the TWA PEL and STEL. Employers are required to restrict access to regulated areas, thereby limiting the number of employees potentially exposed to beryllium at levels above the TWA PEL or STEL and limiting others' risk of serious health effects associated with such exposure. OSHA finds that lowering the exposure trigger for regulated areas could lead to the creation of large restricted areas, and therefore large numbers of employees with access to restricted areas where exposures may range anywhere between the action level and high above the final PEL. And, as discussed previously, establishing and demarcating regulated areas ensures that workers and other persons are aware of the potential presence of airborne beryllium at levels above the TWA PEL or STEL and ensures that all persons entering regulated areas are made aware of the dangers of exposure to beryllium at these levels. Moreover, in general industry, the requirement to demarcate beryllium work areas triggered by any level of beryllium exposure resulting from a process or operation, provides awareness for the potential hazard of beryllium contact or exposure at levels below the action level. For these reasons, OSHA believes that it is appropriate to retain the proposed standard's definition of regulated areas and related provisions for restricted access and demarcation.
In addition, OSHA finds that it is inappropriate to extend mandatory provision and use of respirators (triggered by work in regulated areas in the proposed standard) to all workers whose exposures meet or exceed the action level. As discussed elsewhere in this Summary and Explanation, OSHA's longstanding policy is to avoid issuing standards that result in widespread use of respiratory protection due to issues of health, safety, and effectiveness that can occur with employees' regular use of respirators (see Summary and Explanation for paragraph (f), Methods of Compliance, and paragraph (g), Respiratory Protection).
For the reasons described above, OSHA has decided to adopt more protective triggers for some of the provisions associated with regulated areas in the proposed standard. OSHA has expanded eligibility for medical surveillance to employees who work for at least 30 days in a 12-month period in operations where airborne beryllium exposures meet or exceed the action level (previously, employees who work for at least 30 days in a 12-month period in a regulated area; see Summary and Explanation for paragraph (k), Medical Surveillance). OSHA has also expanded PPE requirements to all employees whose work involves dermal contact with beryllium (see Summary and Explanation for paragraph (h), PPE). These expanded PPE requirements in recognition of the dermal risk posed by beryllium also are responsive to a request from Public Citizen that beryllium work areas and regulated areas be broadly defined in order to ensure “appropriate protections against dermal exposure to beryllium, and dermal sensitization” (Document ID 1756, Tr. 176-77).
As discussed in the Summary and Explanation of paragraph (a), Scope and application, OSHA received comments from a variety of stakeholders on Regulatory Alternative #2a presented in the NPRM, which extends all provisions of the proposed standard to the construction and shipyard sectors. Following careful consideration of these comments, OSHA determined that it is appropriate to extend all provisions of the proposed standard to cover facilities in construction and shipyards, except where some provisions of the general industry standard may be inappropriate due to the nature of workplaces or work processes in construction or shipyards. OSHA has additionally reviewed comments received on the topic of regulated areas in construction and shipyards, to determine whether it is appropriate to modify the requirements for regulated areas in these sectors. Based on its review, as well as OSHA's previous experience regulating chemical exposures in these sectors, the Agency has concluded that provisions for regulated areas (as opposed to the larger beryllium work areas) are appropriate to include in the final standard for shipyards. In construction, OSHA does not find regulated area requirements to be appropriate but has decided instead to require employers to meet the goals of the regulated areas provisions using a competent person approach, which the Agency believes will be more effective in construction work settings. OSHA's review of the record and reasons for these decisions follow.
In the NPRM, OSHA requested comment on whether the provisions of the abrasive blasting substandard in the Ventilation standard for construction (29 CFR 1926.57, paragraph (f)) and the standard for Mechanical paint removers in shipyards (29 CFR 1915.34(c)) provide adequate protection to employees exposed to beryllium from abrasive blasting operations in these sectors. As discussed previously in the Summary and Explanation for paragraph (a), Scope and application, commenters argued persuasively that these abrasive blasting standards do not adequately protect beryllium-exposed construction and shipyard employees, and that OSHA should extend all provisions of the general industry standard to these sectors (
In OSHA's view, the provisions of the abrasive blasting standards in shipyards and in construction provide important baseline requirements appropriate to any situation where abrasive blasting is conducted in these sectors. However, the abrasive blasting standards are not intended to provide comprehensive requirements for all abrasive blasting operations, because some operations may involve hazards unique to the particular process or blast media in use.
OSHA has similarly concluded that the beryllium standard should apply to construction because it will better protect employees exposed to beryllium while abrasive blasting than application of the Ventilation standard alone. However, comments in the record and OSHA's experience regulating chemical exposures in construction indicate that the establishment of regulated areas is not the most effective way to ensure that construction employees receive the protections associated with regulated areas in the general industry standard. This decision is chiefly based on the Agency's recognition that conditions at construction worksites present challenges to establishing regulated areas due to the varied and changing nature of construction work. Some of these challenges were noted in the preamble to the recent respirable crystalline silica standard (81 FR 16285) and also apply here. For example, construction tasks, and specifically abrasive blasting, are commonly performed outdoors. Exposure-generating tasks could be short or long in duration and are typically performed at non-fixed workstations or worksites. Moreover, construction tasks may move to different locations during the workday. Such conditions could make it difficult to establish and maintain regulated areas as required by the general industry and shipyard standards.
At the same time, OSHA finds that construction workers, like their counterparts in general industry and shipyards, need to be made aware of those locations in their workplace where airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL. Therefore, OSHA has decided to adopt the method that was recently included in the recent respirable crystalline silica standard for construction, as well as in some prior construction standards. There, in lieu of establishing regulated areas, the Agency included a requirement for a designated competent person to implement procedures in the written exposure control plan to restrict access to work areas, where necessary, to limit exposures to respirable crystalline silica to achieve the primary objectives of a regulated area. OSHA has concluded that a similar approach is appropriate in this rulemaking. The Agency finds that this flexible approach balances the unique conditions of the construction industry with the need to protect construction employees.
In summary, OSHA has decided to include regulated area requirements in the final standards for general industry and shipyards. The requirements to establish and maintain a regulated area wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL, can be found in paragraph (e)(1)(ii) of the standard for general industry and (e)(1) of the standard for shipyards. Other requirements related to regulated areas,
In addition, NIOSH suggested that since demarcated areas may be difficult to establish and maintain in some construction or maritime settings, OSHA could consider alternative ways to provide the protections associated with such areas to employees in these sectors. For example, respiratory protection could be triggered by exposure to a threshold airborne level, or dermal protections could be triggered based on performance of tasks involving dermal contact with beryllium (Document ID 1755, Tr. 21-22). OSHA has adopted NIOSH's suggestion to tie certain protective measures to employee inhalation exposures or dermal contact rather than using the intermediary step of establishing demarcated areas where such areas are not required in the construction or maritime sectors. For example, as explained below in the discussion of competent person requirements, respiratory protection requirements apply to employees in construction who have or may reasonably be expected to have airborne exposure above the TWA PEL or STEL. In addition, requirements for provision and use of PPE are triggered based on the potential for dermal contact with beryllium in all three standards (see the Summary and Explanation for paragraph (h), Personal protective clothing and equipment). Thus, PPE is available to all employees whose work may involve dermal contact with beryllium, irrespective of whether they work in an industry where demarcated areas are required.
OSHA received several comments on demarcation in general industry and maritime settings. First, NIOSH advocated the need for more specification on how to demarcate regulated areas (Document ID 1671, Attachment 1, p. 6). OSHA believes, however, that allowing employers to choose how to best demarcate regulated areas (as well as beryllium work areas) is consistent with its preference for performance-based approaches where, as here, the Agency has determined that employers, based on their knowledge of the specific conditions of their workplace, are in the best position to make such determinations. For example, if an employer knows that exposures in a particular work area might exceed the PEL on one particular day only, that employer might choose a temporary method of demarcation. Conversely, an employer might choose to use a more permanent method of demarcation for a beryllium work area that contains a
OSHA has identified several factors that it considers to be appropriate considerations for employers when they are determining how to demarcate beryllium work areas and regulated areas. These factors include the configuration of the beryllium work area or regulated area; whether the beryllium work area or regulated area is permanent; the airborne concentrations of beryllium in the beryllium work area or regulated area; the number of employees working in areas adjacent to any beryllium work area or regulated area; and the period of time the beryllium work area or regulated area is expected to have hazardous exposures. OSHA also notes that the use of a performance-oriented approached to the demarcation of regulated areas is consistent with previous health standards, such as respirable crystalline silica (29 CFR 1910.1053) and chromium (VI) (29 CFR 1910.1026).
Moreover, although proposed paragraph (e)(2)(ii) allowed employers to demarcate regulated areas in a variety of ways, it also contained specific requirements for the posting and wording of a warning sign in accordance with proposed paragraph (m)(2). OSHA included this requirement in the proposal because it preliminarily found that employees must recognize when they are entering a regulated area, and understand the hazards associated with the area, as well as the need for respiratory protection. Signs are an effective means of accomplishing these objectives. Therefore, OSHA included a proposed requirement for employers to post all entrances to regulated areas with signs that bear the following legend:
Commenters also opined on the signage requirement in proposed paragraph (e)(2)(ii). Specifically, the ABMA argued that the beryllium specific signs required in the proposed standard for general industry are not appropriate for use in shipyard abrasive blasting, since this operation involves potential exposure to a number of hazardous chemicals (Document ID 1673, p. 22). OSHA disagrees and is maintaining the sign requirement in the final standards (with slightly altered language, noted below). Beryllium specific signs are appropriate and necessary to inform employees and others of the specific health hazards associated with beryllium exposure. Although employees should also be made aware of other hazardous chemicals they may be occupationally exposed to, training and signage regarding these other chemicals must necessarily be addressed elsewhere, and these concerns should not preclude OSHA from requiring appropriate warning signs for beryllium exposure. OSHA notes that in comments from the U.S. House of Representatives Committee on Education and the Workforce, the committee urged OSHA to implement “demarcation (through postings of warnings) if there is abrasive blasting with beryllium containing materials” by shipyard workers (Document ID 1672, p. 4).
After carefully reviewing the record, OSHA finds that the proposed approach for the demarcation of beryllium work areas and regulated areas strikes a reasonable balance between the difficulties of establishing and maintaining these areas with the need to alert those exposed of the risks involved, to reduce the number of employees exposed to beryllium, and to protect those employees exposed to high levels of airborne beryllium. In particular, OSHA finds that the general performance-oriented approach in the proposed requirements, when coupled with the specificity of the signage requirements for regulated areas, provides employers with a good balance of direction and flexibility. The final standards do not require employers to establish and demarcate beryllium work areas or regulated areas by permanently segregating and isolating processes generating airborne beryllium. Instead, the standards allow employers to use temporary or flexible methods to demarcate beryllium work areas and regulated areas. In sum, OSHA finds that these flexible, performance-based requirements will accommodate open work spaces, changeable plant layouts, and sporadic or occasional beryllium use without imposing undue costs or burdens. Therefore, OSHA has decided to include paragraphs (e)(2)(i) and (e)(2)(ii), as proposed, in the final standard for general industry and to include regulated areas demarcation requirements in paragraph (e)(2) of the shipyard standard identical to those of paragraph (e)(2)(ii) of the general industry standard. However, OSHA notes that the required legend for the signage has been amended slightly to include the words “REGULATED AREA,” as discussed in the Summary and Explanation for paragraph (m),
Paragraph (e)(3) of the proposed standard required employers to limit access to regulated areas. Because of the serious health effects of exposure to beryllium and the need for persons entering the regulated area to be properly protected, OSHA proposed that the number of persons allowed to access regulated areas should be limited to: (i) Persons the employer authorizes or requires to be in a regulated area to perform work duties; (ii) persons entering a regulated area as designated representatives of employees for the purposes of exercising the right to observe exposure monitoring procedures under paragraph (d)(6) of this standard; and (iii) persons authorized by law 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, may include workers and other persons whose jobs involve operating machinery, equipment, and processes located in regulated areas; performing maintenance and repair operations on machinery, equipment, and processes in those areas; conducting inspections or quality control tasks; and supervising those who work in regulated areas.
The second group encompasses persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring under paragraph (d)(7). As explained in the summary and explanation section on paragraph (d) for exposure assessment, providing employees and their representatives with the opportunity to observe monitoring is consistent with the OSH Act and OSHA's other substance-specific health standards, such as those for respirable crystalline silica (29 CFR 1910.1053), cadmium (29 CFR 1910.1027), and methylene chloride (29 CFR 1910.1052).
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 would fall into this group.
As discussed in the NPRM, limiting access to regulated areas restricts the number of persons potentially exposed to beryllium at levels above the TWA PEL or STEL, and thus reduces the risk of beryllium-related health effects for employees and others who do not need access to regulated areas. As explained previously in the Summary and Explanation for paragraph (a), Scope and application, OSHA has decided to extend all provisions of the general industry standard to construction and shipyards except where the Agency finds that they are not appropriate to construction and shipyard settings. OSHA did not receive comments on this provision in the proposed standard, and did not receive comments or evidence indicating that restricted access areas are not appropriate in construction and shipyards. However, as discussed previously, OSHA has determined that protections associated with regulated areas in general industry will be more effectively accomplished with a competent person provision in construction.
OSHA has therefore decided to retain paragraph (e)(3) as proposed in the final standard for general industry, and to add an identical provision to the shipyard standard and an analogous provision to the construction standard. Thus, final paragraph (e)(3) requires employers in general industry and shipyards to limit access to regulated areas to: (i) Persons the employer authorizes or requires to be in a regulated area to perform work duties; (ii) persons entering a regulated area as designated representatives of employees for the purposes of exercising the right to observe exposure monitoring procedures under paragraph (d)(6) of this standard; and (iii) persons authorized by law to be in a regulated area. And paragraph (e) of the construction standard requires the designation of a competent person, who, among other things, will implement the written exposure control plan under paragraph (f) of this standard. As discussed in more detail below, paragraph (f)(1)(i)(H) of the construction standard requires employers to establish and implement procedures to restrict access to work areas when airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL, to minimize the number of employees exposed to airborne beryllium and their level of exposure, including exposures generated by other employers or sole proprietors.
Proposed paragraph (e)(4) required employers to provide and ensure that each employee entering a regulated area uses personal protective clothing and equipment, including respirators, in accordance with paragraphs (g) and (h) of the proposed standard. As discussed in the NPRM, provisions for respiratory protection and PPE ensure that those who must enter regulated areas are properly protected, thereby reducing the risk of serious health effects associated with airborne beryllium exposure and dermal contact with beryllium. As explained previously in the Summary and Explanation for paragraph (a), Scope and application, OSHA has decided to extend all provisions of the general industry standard to construction and shipyards except where the Agency finds that they are not appropriate to construction and shipyard settings. OSHA did not receive comments on this provision in the proposed standard for general industry, and did not receive comments or evidence indicating that restricted access areas are not appropriate in construction and shipyards. However, as discussed previously in this section, OSHA has determined that protections associated with regulated areas in general industry will be more effectively accomplished with a competent person provision in construction.
OSHA has therefore decided to retain paragraph (e)(4) as proposed in the final standard for general industry, and to add an identical provision to the shipyard standard and an analogous provision to the construction standard. Thus, final paragraph (e)(4) of the general industry and shipyard standards requires employers to provide and ensure that each employee entering a regulated area uses respiratory protection in accordance with paragraph (g) and personal protective clothing and equipment in accordance with paragraphs (h) of the final standard for general industry. Wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL in construction settings, paragraph (e) of the construction standard requires the employer to designate a competent person to ensure that all employees use respiratory protection and PPE in accordance with paragraphs (g) and (h) of the standard.
The competent person requirement is a well-known and accepted concept in OSHA standards; competent person provisions are included in at least 20 of OSHA's construction standards, including OSHA substance-specific standards for construction, such as lead (29 CFR 1926.62), asbestos (29 CFR 1926.1101), cadmium (29 CFR 1926.1127), and respirable crystalline silica (29 CFR 1926.1153). In addition, 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)).
Competent person provisions are also commonly included in American National Standard Institute (ANSI) standards for construction. NIOSH and its state partners also routinely recommend the need for, and role of, designated competent persons in investigation reports conducted under NIOSH's Fatality Assessment and Control Evaluation program. Thus, OSHA finds that the use of a competent person is consistent with current industry practices in that many construction employers are already using a designated competent person.
Moreover, although OSHA did not include a competent person requirement in the proposed rule, stakeholders indicated that such a requirement would be appropriate if the Agency chose to include the construction industry within the scope of this rulemaking. For example, North America's Building Trades Unions (NABTU) testified that beryllium construction work should be done under the supervision of a competent person (Document ID 1756, Tr. 231-232). NABTU added that the most important point of having a competent person designated in the standard is to ensure there is an agent of the employer on site who has the appropriate authority to correct hazards (Document ID 1805, Attachment 1, p. 4).
Based on these comments and the reasons described above, OSHA has decided to include competent person requirements in the final rule for construction, instead of requiring regulated areas. In paragraph (b) of the construction standard, OSHA defines competent person as an individual who is capable of identifying existing and foreseeable beryllium hazards in the workplace and who has authorization to take prompt corrective measures to eliminate or minimize them. The definition also specifies that the competent person must have the knowledge, ability, and authority necessary to fulfill the responsibilities set forth in paragraph (e) of the construction standard.
In order to craft an appropriate definition for this term, OSHA considered stakeholder comments, including NABTU's above comments on the need for a competent person in the construction standard, 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 a person 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's definition for competent person in the construction standard is consistent with the 1926.32(f) definition with several minor changes. For example, the Agency tailored this definition to beryllium by specifying “beryllium hazards” instead of “unsanitary, hazardous, or dangerous” conditions. In addition, OSHA replaced the word “one” with “individual,” which is merely an editorial change. The Agency also removed the phrase “in the surroundings or working conditions” and changed it to “in the workplace” to make it specific to the workplace. And 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. Finally, OSHA changed “predictable” to “foreseeable” to make the wording consistent with the scope of this construction standard (paragraph (a)).
OSHA also decided that it was important to detail the necessary characteristics and authority of a competent person in the standard to ensure that he or she is truly competent to carry out the tasks designated under paragraph (e). Thus, under paragraph (b) of the construction standard, the competent person must have the knowledge, ability, and authority necessary to fulfill the responsibilities set forth in paragraph (e) of the construction standard. However, OSHA has chosen not to specify particular training requirements for competent persons. The Agency finds that it is not practical to specify in the rule the elements and level of training required for a competent person. And 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), lead (29 CFR 1926.62) and respirable crystalline silica (1926.1153), which include a performance-based approach by not specifying training or qualifications required for a competent person.
Like the regulated area provisions in general industry and shipyards, paragraph (e)(1) of the construction standard applies wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. As discussed in more detail above with regard to the establishment and maintenance of regulated areas in general industry and shipyards, OSHA finds that this exposure level trigger is appropriate for provisions such as this one.
Paragraph (e) of the standard for construction further specifies that wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL, the employer shall designate a competent person to: (1) Make frequent and regular inspections of job sites, materials, and equipment; (2) implement the written exposure control plan under paragraph (f) of this standard; (3) ensure that all employees use respiratory protection in accordance with paragraph (g) of this standard; and (4) ensure that all employees use personal protective clothing and equipment in accordance with paragraph (h) of this standard. OSHA finds that these responsibilities, together, offer construction employees similar protection to those afforded to general industry and shipyard employees while offering construction employers more flexibility to suit their workplaces.
Under paragraph (e)(1) of the construction standard, the competent person must make frequent and regular
Under paragraph (e)(2) of the construction standard, OSHA is requiring that the competent person implement the written exposure control plan because the plan specifies what must be done to consistently identify and control beryllium hazards on a job site. See Summary and Explanation for paragraph (f), Written exposure control plan. 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 included in the written exposure control plan for construction are consistent with the duties of a competent person in past OSHA standards. Therefore, this requirement should be familiar to construction employers covered by this standard.
In addition, under paragraph (f)(1)(i)(I) the written exposure control plan must contain procedures used to restrict access to work areas when airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL, to minimize the number of employees exposed to airborne beryllium and their level of exposure, including exposures generated by other employers or sole proprietors. By requiring the competent person to implement these procedures, OSHA is offering similar protection to construction employees as given to general industry and shipyard employees through the regulated area provisions in the general industry and shipyard standards.
OSHA is cognizant that the written exposure control plan requirement regarding the exposures generated by other employers or sole proprietors is important in construction because at multi-employer worksites, the actions of one employer may expose employees of other employers to hazards. A competent person can help communicate hazards to other employers. OSHA expects that the employers or their competent persons will work with general contractors at construction sites to avoid high exposures of employees working alongside others by implementing administrative procedures such as scheduling high-exposure tasks when others will not be in the area. However, if this does not occur, the competent person has authority to implement other administrative procedures that would be effective for protecting employees in situations where an employer was not made aware that another employer or sole proprietor would be conducting abrasive blasting operations on the worksite. Upon encountering such situations on a worksite, the competent person is expected to remind employees to stay away from the abrasive blasting site and make sure that employees he or she oversees are positioned at a safe distance from the abrasive blasting activity
In addition to limiting access to high exposure areas, the standard for construction requires the competent person to ensure that employees use respiratory protection and personal protective clothing and equipment while in high exposure areas (paragraph (e)(3)-(4)). This is an important requirement because without demarcated regulated areas, employees would not have signs to remind them of the need to use such protective equipment. It is therefore the competent person's responsibility to provide the necessary warnings.
OSHA is not requiring a competent person for the general industry and shipyard standards. 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. Employers covered under the general industry and shipyard standards 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)). A competent person requirement was included in the construction standard for respirable crystalline silica for similar reasons (81 FR 16811). These factors explain and support OSHA's conclusion that there is no regulatory need for including a competent person requirement in the beryllium standards for general industry and shipyards.
Paragraph (f) of the standards establishes methods for reducing employee exposure to beryllium through the use of a written exposure control plan and engineering and work practice controls. Paragraph (f)(1)(i) of each of the standards requires employers to establish, implement, and maintain a written exposure control plan and specifies the information that must be included in the plan. Paragraph (f)(1)(ii) establishes requirements for employers to review their plan(s) at least annually and update it under specified circumstances. Finally, paragraph (f)(1)(iii) requires employers to make a copy of the written exposure control plan accessible to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium.
Paragraph (f)(2) of the final standards requires employers to implement engineering and work practice controls to reduce beryllium exposures to employees. Where airborne exposure exceeds the TWA PEL or STEL, the employer must implement engineering and work practice controls to reduce airborne exposure to or below the exceeded exposure limit(s). Wherever the employer demonstrates that it is not feasible to reduce airborne exposure to or below the PELs by engineering and work practice controls, the employer must implement and maintain engineering and work practice controls to reduce airborne exposure to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard. In addition,
Paragraph (f)(1)(i) of the proposed rule would have required employers to establish, implement, and maintain a written exposure control plan for beryllium work areas, containing an inventory of operations and job titles reasonably expected to have exposure at or above the action level; an inventory of operations and job titles reasonably expected to have exposure above the TWA PEL or STEL; procedures for minimizing cross-contamination, keeping surfaces in the beryllium work area as free as practicable of beryllium; minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace, and removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators; and an inventory of engineering and work practice controls required by paragraph (f)(2) of the proposed standard.
Several commenters offered broad support for the inclusion of paragraph (f)(1)'s provisions in the final rule (
OSHA agrees with the opinions expressed by these commenters. Requiring employers to articulate where exposures occur 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. Thus, OSHA expects a written exposure control plan will be instrumental in ensuring that employers comprehensively and consistently protect their employees. Consequently, the Agency has decided to include written exposure control plan requirements in paragraph (f)(1) of the final standards.
In the preamble to the proposal, OSHA explained that adherence to the written exposure control plan will help reduce skin contact with beryllium, which can lead to beryllium sensitization, and airborne exposure, which can lead to beryllium sensitization, CBD, and lung cancer (80 FR 47787). Because skin contact and airborne exposure can occur in any workplace within the scope of the standard, OSHA preliminarily decided to require a written exposure control plan for all employers within the scope of the standard.
OSHA received comments regarding the proposed trigger for written exposure control plan requirements. For example, NGK Metals Corporation (NGK) argued that requiring employers to develop and maintain a written exposure control plan for facilities where exposures are below the action level is burdensome, and recommended that the written plan be required only where exposures exceed the action level (Document ID 1663, p. 2). EEI asserted that a requirement for a written exposure control plan should apply to areas where exposures meet or exceed the action level or PEL, so as to be consistent with other health standards (Document ID 1674, p. 13).
OSHA has re-examined the provisions of (f)(1) in light of these comments and reaffirms its preliminary decision to require all employers within the scope of the standard to establish, implement, and maintain a written exposure control plan. The Agency finds that the requirements that apply where exposures are below the action level (
Proposed paragraph (f)(1)(i)(A)-(H) set forth the required contents of the written exposure control plan. Under the proposal, the employer's written exposure control plan was required to include: (1) An inventory of operations and job titles reasonably expected to have exposure; (2) an inventory of operations and job titles reasonably expected to have exposure at or above the action level; (3) an inventory of operations and job titles reasonably expected to have exposure above the TWA PEL or STEL; (4) procedures for limiting beryllium contamination, including but not limited to preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within the beryllium work area; (5) procedures for keeping surfaces in the beryllium work area as free as practicable of beryllium; (6) procedures for minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace; (7) an inventory of engineering and work practice controls used by the employer to comply with paragraph (f)(2) of this standard; and (8) procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.
Stakeholders offered comments on the proposed written control plan contents. For example, the Boeing Company suggested that OSHA should revise the proposed provision requiring “procedures for keeping surfaces in the beryllium work area as free as practicable of beryllium” to define specific surface contaminant levels (Document ID 1667, p. 4). The apparent advantage of providing a target surface contaminant level is that employers could use surface sampling to determine whether they are in compliance with the standard's requirements for surface cleaning. However, as OSHA explained
After careful consideration of the record, OSHA reaffirms the need for the written exposure control plan to contain each of the provisions included in the proposal. This written record of which operations and job titles are likely to have exposures at certain levels and which housekeeping provisions and engineering and work practice controls the company has selected to control exposures required in paragraph (f) will make it easier for employers to implement monitoring, hygiene practices, housekeeping, engineering and work practice controls, and other measures. The provisions contained in (f)(1)(i)(D), (E), (F), and (H) of the proposed rule will work to minimize the spread of beryllium throughout and outside the workplace and to reduce the likelihood of skin contact and re-entrainment of beryllium particulate.
Therefore, OSHA has decided to retain the proposed contents of the written exposure control plan in the standard for general industry, with the following revisions. First, OSHA has modified the proposed requirement to include an inventory of operations and job titles reasonably expected to have exposure, including by dermal contact. As discussed in detail in the Summary and Explanation for paragraph (h), Personal protective clothing and equipment (PPE), OSHA finds that it is important to protect employees from dermal contact with beryllium. OSHA therefore finds that the written exposure control plan should inform employees and others of jobs and operations where dermal contact with beryllium is reasonably expected, and has added dermal contact with beryllium to paragraph (f)(1)(i)(A) of the final standards. Thus, the final standard for general industry requires the employer to include a list of operations and job titles reasonably expected to involve airborne exposure to beryllium or dermal contact with beryllium in their written exposure control plan(s).
Second, OSHA modified the language of proposed paragraphs (f)(1)(i)(A), (B), (C), and (G) by replacing the term “inventory” with the term “list”. This change in wording does not imply a change in the intent of the provision. Rather, OSHA made this change to clarify the Agency's intent to require employers to simply identify jobs, operations and controls that match the criteria of these provisions, and that employers are not required to provide more extensive description of such jobs and operations. Third, OSHA modified (f)(1)(i)(D) by deleting “but not limited to” from the phrase “including but not limited to preventing the transfer of beryllium”, because the term “including” implies that the examples to follow are not intended to be exhaustive. This change in wording does not imply a change in the intent of the provision.
Fourth, OSHA has edited the proposed text, which required an “inventory” of operations and job titles reasonably expected to “have” exposure; exposure at or above the action level; and exposure above the TWA PEL or STEL. The final text requires a “list” of operations and job titles reasonably expected to “involve” airborne exposure to or dermal contact with beryllium; airborne exposure at or above the action level; and airborne exposure above the TWA PEL or STEL. This is an editorial change to provide greater clarity to better describe the actual requirement, and does not change the intent of the provision. Fifth, OSHA modified the proposed requirement to inventory engineering and work practice controls required by paragraph (f)(2) of this standard to include respiratory protection. This change ensures that the respiratory protection requirement, which is included in (f)(2)(iv) of the final standards, is treated in the same manner as the engineering and work practices control requirements in (f)(2)(i) and (f)(2)(iii).
Finally, OSHA has included one additional provision in the final rule for general industry that was not contained in the proposal. Specifically, paragraph (f)(1)(i)(H) of the final rule requires employers to include within their written exposure control plan a list of personal protective clothing and equipment required by paragraph (h) of this standard. This provision is added in recognition of the importance of personal protective clothing and equipment in protecting exposed employees, particularly those employees who may have dermal contact with beryllium. With the addition of this new provision, proposed paragraph (f)(1)(i)(H) (regarding procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators) has been redesignated as paragraph (f)(1)(i)(I) of the final rule for general industry.
OSHA has incorporated most provisions of the proposed paragraph (f)(1)(i) into the final standards for construction and shipyards, with certain modifications due to the work processes and worksites particular to these sectors. As explained in the Summary and Explanation for paragraph (j), Housekeeping, OSHA has determined that abrasive blasting operations are the primary source of beryllium exposure in the construction and shipyard sectors and has chosen not to include provisions related to surface cleaning in the final standards for these sectors due to the extreme difficulty of maintaining clean surfaces during blasting operations. OSHA has therefore decided to exclude the provision regarding procedures for keeping surfaces as free as practicable of beryllium (proposed paragraph (f)(1)(i)(E)) from the construction and shipyard standards. And due to the difficulty of controlling contamination during blasting operations, OSHA has decided to include a more performance-oriented provision on cross-contamination in the standards for construction and shipyards than in paragraph (f)(1)(i)(D) of the general industry standard. Employers are still required to establish and implement procedures for minimizing cross-contamination of beryllium in construction and shipyard industries. However, the written exposure control plan provision on cross-contamination simply requires “procedures for minimizing cross-contamination”; it does not specify “procedures for minimizing cross-contamination, including preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas” as in general industry. OSHA has included the proposed provision for minimizing the migration of beryllium in the standards for construction and shipyards, but has removed the reference to beryllium work areas since these are not established in construction
Because the requirements pertaining to surfaces contained in final paragraph (f)(1)(i)(E) of the general industry standard do not appear in the construction and shipyard standards, the numbering of the provisions differs from that of the general industry standard. For the construction and shipyard standards, requirements pertaining to the migration of beryllium appear in paragraphs (f)(1)(i)(E); requirements for a list of engineering controls, work practices, and respiratory protection are in paragraphs (f)(1)(i)(F); requirements for a list of personal protective clothing and equipment are in paragraphs (f)(1)(i)(G); and requirements pertaining to removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators, appear in paragraph (f)(1)(i)(H). Additional discussion of some of these requirements may be found in this section of the preamble, Summary and Explanation, at paragraph (h), Personal Protective Clothing and Equipment; paragraph (i), Hygiene Areas and Practices; and paragraph (j), Housekeeping.
OSHA has also included paragraph (f)(1)(i)(I) in the construction standard only, requiring employers in the construction sector to establish, implement and maintain procedures to restrict access where airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL. This addition is related to OSHA's decision, explained in the Summary and Explanation of paragraph (e), not to include a requirement to establish regulated areas in the construction standard, and to achieve the protective benefits associated with regulated areas by other means. In the general industry and shipyard standards, the employer must limit access to regulated areas to persons who are authorized or required to be in a regulated area to perform work duties, observation, or other limited circumstances. OSHA has determined that restricting access to areas where airborne exposures exceed or may reasonably be expected to exceed the TWA PEL or STEL is appropriate to reduce employees' and others' risk of adverse health effects associated with airborne beryllium exposure. OSHA has therefore established alternative methods to ensure that construction employees do not enter such areas unnecessarily. To this end, the final standard for construction includes paragraph (f)(1)(i)(I), which requires employers to establish, implement and maintain procedures used to restrict access to work areas when airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL, in order to minimize the number of employees exposed to airborne beryllium and their level of exposure, including exposures generated by other employers or sole proprietors. Significantly, the construction standard additionally includes paragraph (e), Competent Person, which requires employers to designate a competent person to implement the written exposure control plan. The competent person is therefore responsible for ensuring that the procedures to restrict access are followed in the workplace.
National Jewish Health (NJH) submitted a comment to OSHA regarding the importance of training, labeling, housekeeping measures, restricted entry to beryllium-contaminated areas, and technologies such as sticky mats and boot scrubbers in controlling employees' exposure to beryllium. NJH requested that OSHA emphasize the importance of such measures in paragraph (f) of these standards (Document ID 1664, p. 6). OSHA agrees with NJH that all of these approaches are helpful, and in some cases essential, to reducing employees' exposure. Training and some forms of labeling and access restriction are specifically required in other paragraphs of the standards. Specific tools such as sticky mats and boot scrubbers are not required in the standards, but are approaches employers should consider as part of their control procedures. All of the methods mentioned by NJH are ways to limit migration of beryllium and cross-contamination, and are therefore appropriate for inclusion in an employer's written exposure control plan(s).
The final standards' paragraph (f)(1)(i) differs from the proposal in that it requires a written exposure control plan for each facility, whereas the proposal would have required a written exposure control plan for beryllium work areas within each facility. In addition, OSHA has removed the phrase “in the beryllium work area” from provision (f)(1)(i)(E) of the final standard for general industry, so that it now reads: “Procedures for keeping surfaces as free as practicable of beryllium”. OSHA made these changes because it changed the definition of a “beryllium work area” in the proposed standard for general industry. The proposed standard defined a beryllium work area to include any area where employees are, or can reasonably be expected to be, exposed to airborne beryllium, regardless of the level of exposure. As discussed previously in the Summary and Explanation for paragraph (e), the final standard for general industry defines a beryllium work area to include only those areas containing a process or operation that releases beryllium where employees are, or can reasonably be expected to be, exposed to airborne beryllium at any level or where there is the potential for dermal contact with beryllium. Accordingly, OSHA made these changes to the wording of (f)(1)(i) and (f)(1)(i)(E) to maintain the intent of proposed paragraph (f)(1)(i)(A), to require employers to list all jobs and operations throughout their facilities involving beryllium exposure, and paragraph (f)(1)(i)(E) to control dermal contact with beryllium wherever airborne beryllium may settle on surfaces in their facilities. If employers' procedures to prevent migration of beryllium from work areas to other areas of the facility are fully effective (paragraph (f)(1)(i)(F)), further steps to keep surfaces as free as practicable of beryllium will not be necessary. However, if the employer is unable to consistently prevent transfer of beryllium from work areas to other areas of the facility, the employer must develop and implement additional procedures to keep surfaces outside of the beryllium work areas as free as practicable of beryllium.
Paragraph (f)(1)(ii) of the proposed rule would have required the employer to update the exposure control plan when: (A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results or can reasonably be expected to result in new or additional exposures to beryllium; (B) an employee is confirmed positive, is diagnosed with CBD, or shows signs or symptoms associated with exposure; or (C) the employer has any reason to believe that new or additional exposures are occurring or will occur. OSHA did not receive any comments on this provision. However, as noted in the proposal, employers such as Materion and Axsys Technologies, who have worked to identify and document the exposure sources associated with cases of sensitization and CBD in their facilities, have used this information to develop and update beryllium exposure control plans (Document ID 0634; 0473; 0599). OSHA found that this process, whereby an employer uses employee health outcome data to check and improve the effectiveness of the employer's exposure
The first modification is that OSHA added a requirement to review and evaluate the effectiveness of each written exposure control plan at least annually. OSHA finds that an annual review is appropriate because workplace conditions can change. In addition, by requiring employers to check the effectiveness of their plans annually, the standards offer employers the opportunity to better protect their employees by reflecting on any lessons learned throughout the previous year. The final annual review requirement is consistent with previous OSHA standards, such as the standards addressing bloodborne pathogens (29 CFR 1910.1030) and respirable crystalline silica (29 CFR 1910.1053).
Second, OSHA changed the proposed language of (f)(1)(ii)(B), which would have required employers to update their written exposure control plans when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows signs or symptoms associated with exposure. This change is related to another change from the proposed standard, which would have required notification of employers whenever an employee is confirmed positive for beryllium sensitization. As explained in the Summary and Explanation for paragraph (k), Medical Surveillance, OSHA has modified this provision so that employers are not automatically notified of cases of sensitization or CBD among their employees. However, employers will receive a written medical opinion from the licensed physician that may include a referral for an evaluation at a CBD Diagnostic Center (
Paragraph (f)(1)(ii) of the final standards thus requires the employer to review and evaluate the effectiveness of each written exposure control plan at least annually and update it when: (A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results or can reasonably be expected to result in new or additional airborne exposure to beryllium; (B) the employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard, referred for evaluation at a CBD Diagnostic Center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium; or (C) the employer has any reason to believe that new or additional airborne exposure is occurring or will occur.
Paragraph (f)(1)(iii) of the proposed rule would have required the employer to make a copy of the exposure control plan accessible to each employee who is or can reasonably be expected to be exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)). As discussed above and in the NPRM, access to the exposure control plan will enable employees to partner with their employers in keeping the workplace safe. OSHA did not receive comments specific to this provision, and has decided to retain it in the final standard for general industry and include it in the final standards for construction and shipyards.
Proposed paragraph (f)(2) established a hierarchy of controls that employers must use to reduce beryllium exposures. This paragraph required employers to rely on engineering and work practice controls as the primary means to reduce exposures. As a general matter, where airborne exposure exceeded the TWA PEL or STEL, proposed paragraph (f)(2) required employers to implement engineering and work practice controls to reduce airborne exposure to or below the PELs. Wherever the employer demonstrated that it is not feasible to reduce airborne exposure to or below the PELs through the use of engineering and work practice controls, the employer would have been required to implement and maintain engineering and work practice controls to reduce airborne exposure to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard. In addition, proposed paragraph (f)(2) included limited requirements for implementation of exposure controls for each operation in a beryllium work area.
OSHA's long-standing hierarchy of controls policy was supported by a number of commenters, including USW; the Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group); AWE; AFL-CIO; 3M; and National Jewish Health (
After a careful review of the record, OSHA concludes that requiring primary reliance on engineering and work practice controls is necessary and appropriate because reliance on these methods is consistent with good industrial hygiene practice, with the Agency's experience in ensuring that workers have a healthy workplace, and with OSHA's traditional adherence to a hierarchy of controls. The Agency finds that engineering controls are reliable, provide consistent levels of protection to a large number of workers, can be monitored continually and inexpensively, allow for predictable performance levels, and can efficiently remove toxic substances from the workplace. Once removed, the toxic substances no longer pose a threat to employees. The effectiveness of engineering controls does not generally depend to any substantial degree on human behavior, and the operation of control equipment is not as vulnerable to human error as is personal protective equipment.
Isolation,
Ventilation is another engineering control method used to minimize airborne concentrations of a contaminant by supplying or exhausting air. The primary type of ventilation system used to control beryllium exposure is local exhaust ventilation (LEV). 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. If designed properly, LEV systems efficiently remove contaminants and provide for cleaner and safer work environments.
Work practice controls involve adjustments in the way a task is performed. In many cases, work practice controls complement engineering controls in providing worker protection. For example, periodic inspection and maintenance of process equipment and control equipment such as ventilation systems is an important work practice control. Frequently, equipment which is in disrepair or near failure will not perform normally. Regular inspections can detect abnormal conditions so that timely maintenance can then be performed. If equipment is routinely inspected, maintained, and repaired or replaced before failure is likely, there is less chance that hazardous exposures will occur.
Workers must know the proper way to perform their job tasks in order to minimize their exposure to beryllium and to maximize the effectiveness of control measures. For example, if an exhaust hood is designed to provide local ventilation and a worker performs a task that generates a contaminant away from the exhaust hood, the control measure will be of no use. Workers can be informed of proper operating procedures through information and training. Good supervision further ensures that proper work practices are carried out by workers. By persuading a worker to follow proper procedures, such as positioning the exhaust hood in the correct location to capture the contaminant, a supervisor can do much to minimize unnecessary exposure. Employees' exposures can also be controlled by scheduling operations with the highest exposures at a time when the fewest employees are present.
Under the hierarchy of controls, respirators can be another means of providing employees effective protection 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 employers educating employees on the necessary good work practices and ensuring that employees adopt those practices. 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 (
For these reasons, 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. And the Agency's adherence to the hierarchy of controls has been successfully upheld by the courts (
Therefore, OSHA has decided to require the use of the long-established hierarchy of controls in this standard. 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.
The provisions related to engineering and work practice controls begin in paragraph (f)(2)(i). Paragraph (f)(2)(i)(A) of the proposed rule stated that, for each operation in a beryllium work area (
Because OSHA recognized that these proposed provisions are not typical for OSHA standards, which usually require engineering controls only where exposures exceed the PEL(s), the Agency asked for comments on the potential benefits of including such provisions in the beryllium standard, the potential costs and burdens associated with them, and whether OSHA should include these provisions in the final standard (80 FR 47789). In addition, the Agency examined and asked for comment on Regulatory Alternative #6, which would exclude the provisions of proposed paragraph (f)(2)(i) from the final standard.
Comments on these provisions focused mainly on the trigger for proposed paragraph (f)(2)(i) or the action level exemption in proposed paragraph (f)(2)(i)(B)(
The second set of commenters argued that the engineering and work practice controls requirement in proposed paragraph (f)(2)(i) was too narrow. These commenters objected to the exemption in proposed paragraph (f)(2)(i)(B)(2), which exempted employers from using one of the controls listed in (f)(2)(i) to the extent that the employer could demonstrate that exposures are below the action level, using no fewer than two representative personal breathing zone samples taken 7 days apart, for each affected operation. USW commented that the only legitimate reasons not to require engineering controls below the action level are if such a requirement is technologically or economically infeasible (Document ID 1681, p. 10). The AFL-CIO and National COSH similarly recommended that the final standard require engineering and work practice controls wherever airborne beryllium is present (Document ID 1689, p. 11; 1690, p. 3). The AFL-CIO based their recommendation on the capacity of beryllium at very low concentrations to cause beryllium sensitization and its carcinogenicity (Document ID 1689, p. 12).
OSHA has carefully reviewed the opinions and arguments of these commenters, and has concluded that the requirement to implement at least one form of exposure control on beryllium-releasing processes will serve to reduce the significant risk of both CBD and lung cancer remaining at the TWA PEL (
However, while the Agency upholds the importance of requiring at least one engineering or work practice control where operations release beryllium, it disagrees with comments that such controls should be required wherever there is airborne beryllium at any level. OSHA recognizes that a significant risk of developing beryllium-related adverse health effects remains at the action level. But the Agency finds that an exemption from the requirement to implement at least one of the controls listed in proposed paragraph (f)(2)(i)(A) when exposures are demonstrably below the action level strikes a reasonable balance between providing additional protection for employees who are at risk and the burdens associated with implementing controls that may provide little or no benefit (
Moreover, as discussed in the NPRM, the inclusion of the engineering and work practice control provision in proposed paragraph (f)(2)(i)(A) addresses a concern regarding the proposed PEL. OSHA expects that day-to-day changes in workplace conditions might cause frequent excursions above the PEL in workplaces where periodic sampling indicates exposures are between the action level and the PEL. Normal variability in the workplace and work processes, such as workers' positioning or patterns of airflow, can lead to excursions above the PEL. Substitution or controls such as those outlined in proposed paragraph (f)(2)(i)(A) provide the most reliable means to control variability in exposure levels. And, as noted above, they have the added benefit of further reducing beryllium exposures to employees where such means are feasible, and so reducing the significant risk of beryllium-related adverse health effects associated with airborne exposures at the TWA PEL and the action level (
OSHA has made a number of clarifying changes to the language of proposed paragraph (f)(2)(i), none of which is meant to change the meaning of the proposed language. First, OSHA revised the proposed language of (f)(2)(i)(A) (paragraph (f)(2)(i) in the final standards) by specifying that this provision applies to each operation in a beryllium work area “that releases airborne beryllium.” The proposed language could have been interpreted to require controls on operations that do not release airborne beryllium, if such operations happened to be performed in a beryllium work area; it was not OSHA's intent to require employers to apply controls to any operations that do not release beryllium. Second, OSHA added the term “airborne” preceding “exposure” in proposed (f)(2)(i)(A) and (f)(2)(i)(B)(
The fifth and sixth clarifying changes to proposed paragraph (f)(2)(i) address the types of control measures that are acceptable for complying with the provision. The Southern Company suggested that isolation/containment should be considered for inclusion in the listed controls in proposed paragraph (f)(2)(i)(A) (Document ID 1668, p. 5). OSHA agrees that isolation is an appropriate method of exposure control, and proposed paragraph (f)(2)(i)(A)(
The seventh and final clarifying change to proposed paragraph (f)(2)(i) pertains to the proposed requirement for employers to demonstrate that airborne exposures are below the action level using personal breathing zone samples taken 7 days apart. In response to a comment from Ameren Corporation, which stated that some operations are short in duration and taking samples precisely 7 days apart may not be possible (Document ID 1675, p. 5), OSHA changed the text of the standards to “at least 7 days apart”, which was the Agency's intention.
With these changes, final paragraph (f)(2)(i) of the general industry standard requires that, for each operation in a beryllium work area that releases airborne beryllium, the employer must ensure that at least one of the following is in place to reduce airborne exposure: (A) Material and/or process substitution; (B) isolation, such as ventilated partial or full enclosures; (C) local exhaust ventilation, such as at the points of operation, material handling, and transfer; or (D) process control, such as wet methods and automation. Final paragraph (f)(2)(ii) allows that an employer is exempt from using the above controls to the extent that: (A) The employer can establish that such controls are not feasible; or (B) the employer can demonstrate that airborne exposure is below the action level, using
Final paragraph (f)(2)(i) of the construction and shipyard standards also requires employers to ensure that one of the four enumerated types of control is in place to reduce airborne exposure and exempts employers who can establish that such controls are not feasible or demonstrate that airborne exposure is below the action level, using no fewer than two representative personal breathing zone samples taken at least seven days apart, for each affected operation. However, the triggers in construction and shipyards differ from that in general industry: whereas the general industry standard requires employers to put one of the controls in place for each operation in a beryllium work area that releases airborne beryllium, the construction and shipyard standards do not require the establishment of beryllium work areas. In lieu of that trigger, the construction and shipyard provision requires the placement of a control where exposures are or can reasonably be expected to be at or above the action level. OSHA selected the action level as a trigger for this requirement because, as indicated above, the Agency finds that an exemption from the requirement to implement at least one of the controls is appropriate when exposures are below the action level.
Congressman Robert C. Scott, Ranking Member of the House Committee on Education and the Workforce, recommended that the final standards should require abrasive blasting (the primary source of beryllium exposure in construction and maritime) to be conducted within containments whenever feasible (Document ID 1672, p. 4). OSHA agrees that containment is an effective approach to limit exposures outside of the blasting operation, and is protective of workers in nearby areas or performing ancillary activities. However, because abrasive blasting is performed in a wide variety of occupational settings and alternative methods of exposure control (for example, use of wet methods) may be effective in some settings, OSHA does not require the use of containment whenever feasible in blasting operations. Rather, paragraph (f)(2) is intended to provide employers flexibility to determine an appropriate approach to maintain airborne exposures below the TWA PEL and STEL and, in accordance with (f)(2)(i), reduce airborne exposures that exceed the action level.
If exposures exceed the TWA PEL or STEL after the employer has implemented the control(s) required by paragraph (f)(2)(i), paragraph (f)(2)(iii) requires the employer to implement additional or enhanced engineering and work practice controls to reduce exposures to or below the PELs. For example, an enhanced engineering control may entail a redesigned hood on a local exhaust ventilation system to more effectively capture airborne beryllium at the source. The employer must use engineering and work practice controls, to the extent that such controls are feasible, to achieve the PELs.
Whenever the employer demonstrates that it is not feasible to reduce exposures to or below the PELs using the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii), however, paragraph (f)(2)(iv) requires the employer to implement and maintain engineering and work practice controls to reduce exposures to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard. As indicated previously, OSHA's long-standing hierarchy of controls policy was supported by a number of commenters (
Finally, paragraph (f)(3) of the proposed rule would have prohibited the employer from rotating workers to different jobs to achieve compliance with the PELs. As explained in the NPRM, worker rotation can potentially reduce exposures to individual employees, but increases the number of employees exposed. Because OSHA has determined that exposure to beryllium can result in sensitization, CBD, and cancer, the Agency considers it inappropriate to place more workers at risk. Since no absolute threshold has been established for sensitization or resulting CBD or the carcinogenic effects of beryllium, it was considered prudent to limit the number of workers exposed at any concentration by prohibiting employee rotation.
This provision is not a general prohibition of worker rotation wherever workers are exposed to beryllium. It is only intended to restrict its use as a compliance method for the PEL (
Paragraph (g) of the standard establishes the requirements for the use of respiratory protection. Specifically, this paragraph requires that employers provide respiratory protection at no cost to the employee and ensure that employees utilize such protection during the situations listed in paragraph (g)(1). As detailed in paragraph (g)(2), the selection and use of required respiratory protection must comply with OSHA's Respiratory Protection standard (29 CFR 1910.134). In addition, paragraph (g)(3) requires employers to provide employees entitled to respiratory protection with a powered air-purifying respirator (PAPR) instead of a negative pressure respirator, if a PAPR is requested by the employee.
Paragraph (g)(1) requires employers to ensure that each employee required to use a respirator does so. Accordingly, simply providing respirators to employees will not satisfy an employer's obligations under paragraph (g)(1) unless the employer also ensures that each employee properly wears the respirator when required. Paragraph (g)(1) also requires employers to provide required respirators at no cost to employees. This requirement is consistent with the OSH Act's holding employers principally responsible for complying with OSHA standards, with similar provisions under other OSHA standards, and specifically with OSHA's Respiratory Protection standard, which also requires employers to provide required respiratory protection to employees at no cost (29 CFR 1910.134(c)(4)).
Paragraph (g)(1) requires appropriate respiratory protection during certain enumerated situations. Paragraph (g)(1)(i) requires respiratory protection during the installation and implementation of feasible engineering
Paragraph (g)(1)(ii) requires the provision and use of respiratory protection during any operations, including maintenance and repair operations and other non-routine tasks, when engineering and work practice controls are not feasible and airborne exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL. OSHA included this provision because the Agency realizes that certain operations may take place when engineering and work practice controls are not operational or capable of reducing exposures to or below the TWA PEL and STEL. The installation of necessary engineering controls, covered by paragraph (g)(1)(i), is a particular example of this more general circumstance. For another example, during maintenance and repair operations, engineering controls may lose their full effectiveness or require partial or total breach, bypass, or shutdown. Under these circumstances, if exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL, the employer must provide and ensure the use of respiratory protection.
Paragraph (g)(1)(iii) requires the provision and use of respiratory protection where beryllium exposures exceed the TWA PEL or STEL, even after the employer has installed and implemented all feasible engineering and work practice controls. OSHA anticipates that there will be some situations where feasible engineering and work practice controls are insufficient to reduce airborne exposure to beryllium to levels at or below the TWA PEL or STEL (see this preamble at section VIII.D, Technological Feasibility). In such cases, the standard requires that employers implement and maintain engineering and work practice controls to reduce exposure to the lowest levels feasible and supplement those controls by providing respiratory protection (paragraph (f)(2)(iv)). OSHA emphasizes that even where employers are able to demonstrate that engineering and work practice controls are not feasible or sufficient to reduce exposure to levels at or below the TWA PEL and STEL the use of respirators to achieve the PELs is only a supplement, and not a substitute for, such “lowest level feasible” controls.
Paragraph (g)(1)(iv) requires the provision and use of respiratory protection in emergencies. Under the final standards, an emergency is defined as “any uncontrolled release of airborne beryllium” (see paragraph (b) of the standards). During emergencies, engineering controls may not be functioning fully or may be overwhelmed or rendered inoperable. Also, emergencies may occur in areas where there are no engineering controls. The standard recognizes that the provision of respiratory protection is critical in emergencies, as beryllium exposures may be very high and engineering controls may not be adequate to control an unexpected release of airborne beryllium.
Boeing suggested limiting requirement of respirator use triggered by this definition of emergency, as it would not be practical to provide respirators to and train the large number of employees in the event of a fire or explosion (Document ID 1667, pp. 4-5). OSHA wishes to clarify that paragraph (g)(1)(iv) is not intended to require employers to provide respirators to all employees who may pass through areas where beryllium-releasing processes are housed, in the event of a general evacuation due to an event such as a fire or explosion. Rather, in the event that an uncontrolled release of beryllium occurs (f)(1)(iv) requires employers to provide respirators to employees who work in the vicinity of beryllium-releasing processes and employees who respond to such an emergency, because these employees will be in the immediate vicinity of an uncontrolled release.
Paragraph (g)(1)(v) requires the provision and use of respiratory protection when an employee who is eligible for medical removal under paragraph (l)(1) chooses to remain in a job with airborne exposure at or above the action level. As explained in the summary and explanation of paragraph (l), Medical Removal Protection, an employee who is diagnosed with CBD or confirmed positive for beryllium sensitization and who works in a job with airborne exposure at or above the action level is eligible for medical removal protection (MRP). An employee who is eligible for MRP may choose medical removal from jobs with exposure at or above the action level, or may choose to remain in a job with exposure at or above the action level provided that the employee uses respiratory protection in accordance with the provisions of this paragraph (g), Respiratory Protection. This provision was not included in the proposed standard. However, OSHA received comments emphasizing the importance of reducing or eliminating the exposure of sensitized employees. For example, National Jewish Health (NJH) stated that “removal from exposure is the best form of prevention” (Document ID 1664, p. 4). The United Steelworkers (USW) commented that workers who are sensitized to beryllium or are in the early stages of chronic beryllium disease can significantly benefit from a reduction in their exposure to beryllium, based on evidence reviewed in Section VIII (Significant Risk) of the NPRM (Document ID 1963, p. 13). OSHA is cognizant that employees who are MRP-eligible (
OSHA received no comments objecting to paragraph (g)(1). Therefore, except for minor edits for clarity explained in the introduction to this section, it is unchanged from the proposal.
Whenever respirators are used to comply with the requirements of this standard, paragraph (g)(2) requires that the employer implement a comprehensive written respiratory protection program in accordance with OSHA's Respiratory Protection standard (29 CFR 1910.134). The Respiratory Protection standard is designed to ensure that employers properly select and use respiratory protection in a manner that effectively protects exposed employees. Under 29 CFR 1910.134(c)(1), the employer's respiratory protection program must include:
• Procedures for selecting appropriate respirators for use in the workplace;
• Medical evaluations of employees required to use respirators;
• Respirator fit testing procedures for tight-fitting respirators;
• Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;
• Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, discarding, and otherwise maintaining respirators;
• Procedures to ensure adequate quality, quantity, and flow of breathing air for atmosphere-supplying respirators;
• Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations, and in the proper use of respirators; and
• Procedures for evaluating the effectiveness of the program.
In accordance with OSHA's policy to avoid duplication and to establish regulatory consistency, paragraph (g)(2) incorporates by reference the requirements of 29 CFR 1910.134 rather than reprinting those requirements in this standard. OSHA notes that the respirator selection provisions in 29 CFR 1910.134 include requirements for Assigned Protection Factors (APFs) and Maximum Use Concentrations (MUCs) that OSHA adopted in 2006 (71 FR 50122 (Aug. 24, 2006)). The APFs and MUCs provide employers with critical information for the selection of respirators to protect workers from exposure to atmospheric workplace contaminants. In incorporating the Respiratory Protection standard by reference, OSHA intends that any future change to that standard will automatically apply to this standard as well. As appropriate, OSHA will note the intended effect on this standard (and other standards) in either the text or preamble of the amended Respiratory Protection standard, but does not anticipate the need for a conforming amendment to this standard.
Moreover, the situations in which respiratory protection is required under these standards are generally consistent with the requirements in other OSHA health standards, such as those for chromium (VI) (29 CFR 1910.1026), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052). Those standards and this standard also reflect the Agency's traditional adherence to a hierarchy of controls in which engineering and work practice controls are preferred to respiratory protection (see the discussion of paragraph (f) earlier in this section of the preamble).
OSHA received no comments objecting to paragraph (g)(2). OSHA added language to clarify that both the selection and use of respiratory protection must be in accordance with the Respiratory Protection standard. Other than that change and some minor edits for clarity, paragraph (g)(2) is unchanged from the proposal.
Paragraph (g)(3) requires the employer to provide a powered air-purifying respirator (PAPR) instead of a negative pressure respirator at no cost to the employee when an employee entitled to respiratory protection under (g)(1) of these standards requests a PAPR. The employee may select any form of PAPR (half mask, full facepiece, helmet/hood, or loose fitting facepiece), so long as the PAPR is selected and used in compliance with the Respiratory Protection standard (29 CFR 1910.134) and provides adequate protection to the employee in accordance with paragraph (g)(2) of these standards. For example if an employee is using a half mask respirator with an APF of 10 then a loose fitting PAPR with an APF of 25 would be an appropriate alternative. However, if the employee is required to use a full face respirator with an APF of 50 then the appropriate PAPR alternative would be a tight fitting PAPR.
The requirement to provide a PAPR upon request of the employee (paragraph (g)(3)) is similar to provisions in several previous OSHA standards, including inorganic arsenic (CFR 1910.1018), lead (CFR 1910.1025), cotton dust (1910.1043), asbestos (CFR 1910.1001), and cadmium (1910.1027). In promulgating these standards, OSHA cited several reasons why PAPRs can provide employees with better protection than negative pressure respirators, including superior reliability and comfort, reduced interference with work processes, and superior protection, especially for employees who cannot obtain a good face fit with a negative pressure respirator (
The PAPR provision was not included in the proposed standard. However, OSHA solicited public comment on the issue of whether employers should be required to provide employees with PAPRs upon request. During the public comment period and public hearing for the beryllium NPRM, several commenters supported a requirement for employers to provide a PAPR upon an employee's request, including the Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) (Document ID 1655, p. 8), a representative of the Department of Defense (Document ID 1684, Attachment 2, p. 4), ORCHSE Strategies (ORCHSE) (Document ID 1691, p. 4), NJH (Document ID 1664, p. 5), Kimberly-Clark Professional (KCP) (Document ID 1676, p. 3), and North America's Building Trades Unions (NABTU) (Document ID 1679, p. 9). Dr. Lisa Maier of the NJH stated, “The beryllium standard should require employers to provide PAPRs when requested by the employee. We have consulted with clients on respiratory protection for beryllium exposure and found that employees are more likely to comply with respiratory protection requirements when they have an option regarding the type of respirator they wear” (Document ID 1664, p. 7). Joann Kline of KCP similarly commented that “[f]it, style, comfort and worker preference are significant factors in the effectiveness of protection . . . Allowing a worker to choose PPE, including PAPRs, makes it much more likely that it will be comfortable and accepted. PAPRs in particular add to worker comfort, especially in hot environments, because of the flow of
Likewise, ORCHSE commented that “[c]omfort is a significant factor in the ability of employees to wear respiratory protection consistently, especially during an entire work shift, and/or under hot or stressful conditions. Employees experiencing discomfort, which is likely with negative-pressure respirators, are more apt to remove or otherwise compromise the effectiveness of their respirators while in the workplace. It is thus prudent for employers to provide the type of respiratory protection employees are more likely to use consistently and correctly” (Document 1691, p. 4). Chris Trahan of NABTU cited the susceptibility of some employees to beryllium sensitization as a reason to require employers to provide PAPRs to employees upon their request (Document ID 1679, p. 9). As discussed in Section V, some individuals are genetically susceptible to beryllium-induced sensitization and CBD, and may develop these conditions from exposure to beryllium at levels well below the PEL and STEL included in this standard. Genetically susceptible individuals may therefore benefit from the enhanced protection provided by a PAPR, which have APFs ranging from 50 to 1000 depending on type.
OSHA also received comments opposing a requirement for employers to provide PAPRs upon employee request. For example, Julie A. Tremblay of 3M commented that the incorporation of the Respiratory Protection Standard (29 CFR 1910.134) by reference, particularly paragraph (d)(1)(i) and paragraph (e)(6)(ii), adequately addresses issues of appropriate respirator selection (Document ID 1625, Attachment 1, p. 2).
Finally, OSHA received a comment from USW (Document ID 1681) recommending that OSHA limit the type of PAPR provided under (g)(3) to types with close-fitting facepieces. USW stated that “[t]he types with close-fitting face pieces can be quite effective, but it is easy to over breathe other types, especially the loose-fitting helmets” (Document ID 1681, p. 22).
OSHA has carefully considered all comments received on the issue of requiring employers to provide employees with PAPRs upon request, and agrees with Dr. Maier of NJH, Ms. Trahan of NABTU, and other commenters who have argued that providing employees a choice in selection of respiratory protection will improve the effectiveness of respiratory protection in reducing risk of sensitization and disease from occupational beryllium exposure. While the provisions of the Respiratory Protection standard provide important baseline requirements appropriate to all situations where respiratory protection is required, as discussed above, OSHA recognizes that provisions beyond those of the Respiratory Protection standard are appropriate in some circumstances to ensure that required respiratory protection is used on a consistent basis and as effectively as possible. As discussed in section V, Health Effects and section VI, Risk Assessment of this preamble, beryllium sensitization and CBD can result from small, short-term beryllium exposure in some individuals. Accordingly, consistent and effective respirator usage has played an important role in minimizing risk among workers in occupational settings such as beryllium processing, where it has proven difficult to reduce airborne exposures below 0.2 µg/m
Paragraph (h) of the standards requires employers to provide employees with personal protective clothing and equipment (PPE) where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL and where there is reasonable expectation of dermal contact with beryllium. Paragraph (h) also contains provisions for the safe removal, storage, cleaning, and replacement of the PPE required by the standards. To protect employees from adverse health effects, these PPE requirements are intended to prevent dermal exposure to beryllium, and prevent the accumulation of airborne beryllium on clothing, shoes, and equipment, which can result in additional inhalation exposure. The requirements also protect employees in other work areas, as well as employees and other individuals outside the workplace, from exposures that could occur if contaminated clothing were to transfer beryllium to those areas. The standards require the employer to
The final provisions in paragraph (h) are the same as the proposed provisions, with several exceptions. First, in the final standards OSHA has used the term “contact” instead of “exposure” where the standards refer to the skin, so as to distinguish clearly between exposure via the skin (dermal route) and the inhalation route of exposure in the regulatory text. Second, OSHA has deleted the proposed provision in paragraph (h)(1)(ii) requiring PPE where employees' skin may become “visibly contaminated” with beryllium and instead will require use of PPE whenever there is a reasonable expectation of dermal contact with beryllium. Third, the final standards' requirements for provision and use of PPE apply where employees may reasonably be expected to have dermal contact with beryllium regardless of whether the beryllium is in a soluble or poorly soluble (sometimes called `insoluble') form, instead of just soluble beryllium compounds as in proposed paragraph (h)(1)(iii). Fourth, paragraph (h)(2)(iii) now requires that storage facilities for PPE prevent cross contamination. Finally, OSHA has made a few minor changes to clarify or streamline the regulatory text. The comments and OSHA's reasoning leading to these changes are discussed below.
Paragraph (h)(1)(i) requires the provision and use of PPE for employees exposed to any form of airborne beryllium above the TWA PEL or STEL, or where exposure can reasonably be expected to exceed the TWA PEL or STEL, because such exposure would likely result in skin contact by means of deposits on employees' skin or clothes or on surfaces touched by employees. The term “reasonably be expected” is intended to convey OSHA's intent that the requirement for provision and use of PPE is defined by an employee's potential exposure, not by any particular individual's actual exposure. For example, if one employee's exposure assessment results indicate that the employee's exposure is above the PEL, it would be reasonable to expect that another employee doing a similar task would have exposures above the PEL and thus would require PPE.
Paragraph (h)(1)(ii) requires the provision and use of PPE where employees are reasonably expected to have dermal contact with beryllium. This requirement applies to beryllium-containing dust, liquid, abrasive blasting media, and other beryllium-containing materials that can penetrate the skin, regardless of the level of airborne exposure. It is not intended to apply to dermal contact with solid objects (for example, tools made of beryllium alloy) unless the surface of such objects is contaminated with beryllium in a form that can penetrate the skin. Dermal contact with beryllium can result in absorption of beryllium through the skin and induce sensitization, a necessary precursor to CBD, as discussed further in Health Effects, section V.A.2.
As mentioned above, the requirements of paragraph (h)(1) of the final standards differ from those of the proposed standard. Paragraph (h)(1) of the proposed standard required employers to provide employees with PPE where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL; where work clothing or skin may become visibly contaminated with beryllium, including during maintenance and repair activities or during non-routine tasks; and where employees' skin is reasonably expected to be exposed to soluble beryllium compounds. In the NPRM, OSHA discussed concerns with the proposed requirements, requested public comment on proposed paragraph (h)(1), and presented Regulatory Alternative 13. Alternative 13, as described by OSHA, would replace the requirement for PPE where there is visible contamination with a requirement for appropriate PPE wherever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. OSHA requested comments on this alternative, including the benefits and drawbacks of a broader PPE requirement and any relevant data or studies the Agency should consider. As discussed below, OSHA adopted Regulatory Alternative 13 in the final standard based on comments received in the public comment period and public hearing and on the scientific evidence in the record.
The proposed requirement to use PPE where clothing or skin may become “visibly contaminated” with beryllium was a departure from most OSHA standards, which do not specify that contamination must be visible in order for PPE to be required. For example, the standard for chromium (VI) (29 CFR 1910.1026) requires the employer to provide appropriate PPE where a hazard is present or is likely to be present from skin or eye contact with chromium (VI). The lead (29 CFR 1910.1025) and cadmium (29 CFR 1910.127) standards require PPE where employees are exposed above the PEL or where there is potential for skin or eye irritation regardless of airborne exposure level. In the case of MDA (29 CFR 1910.1050), PPE must be provided where employees are subject to dermal exposure to MDA, where liquids containing MDA can be splashed into the eyes, or where airborne concentrations of MDA are in excess of the PEL. While OSHA's language regarding PPE requirements varies somewhat from standard to standard, previous standards emphasize the potential for contact with a substance that can cause health effects via dermal exposure, and do not condition the provision and use of PPE on visible contamination with the substance.
Nearly all comments OSHA received on the proposed requirement for employers to provide PPE where work clothing or skin may become “visibly contaminated” with beryllium stated that this provision would not be sufficiently protective of beryllium-exposed workers (Document ID 1615, p. 8; 1625, p. 2; 1655, pp. 9-10; 1658, p. 6; 1664, pp. 3-4; 1671, Attachment 1, p. 7; 1676, pp. 2-3; 1677, p. 2; 1679, p. 9; 1685, p. 3; 1688, p. 3; 1689, p. 12; 1691, pp. 4-5). Dr. Paul Schulte of NIOSH stated that “visibly contaminated” is not
In addition, some comments and testimony indicated that the term “visibly contaminated” is ambiguous and likely to be confusing to employers and others responsible for implementing the PPE requirements of the beryllium standards. According to Mr. Daniel Shipp of the International Safety Equipment Association (ISEA), “ ‘[v]isible contamination' is not an appropriate trigger for PPE. This term is too subjective to be useful” (Document ID 1682, p. 2).
Based on its evaluation of the evidence in the record, OSHA agrees with the commenters on these points. The Agency has determined that contact with and absorption of even minute amounts of beryllium through the skin may cause beryllium sensitization (see section V, Health Effects, subsection 2, Dermal Exposure) and that a “visibly contaminated” standard could allow for too much dermal exposure and be insufficiently protective of workers. In addition, as discussed in Section VI, Risk Assessment, studies conducted jointly by NIOSH and Materion Corporation (Materion) showed that a comprehensive approach to PPE is key to reducing risk of sensitization even in facilities that implement stringent exposure control and housekeeping programs (
Materion, whose joint submission with the United Steelworkers union of a proposed standard was the basis for the “visibly contaminated” language, discussed the use of the term in its post hearing comments (Document ID 1808, pp. 4-5). Materion indicated that the typical workplace cannot reasonably be expected to measure skin or surface contamination for the purpose of determining whether PPE use is necessary. Even if this was done, “such measures are lagging metrics which, by definition, are post potential exposure” (Document ID 1808, p. 5). Materion believed that a standard relying on visual cues to check for contamination is easily understood by workers and management and is a useful part of a beryllium worker protection model.
OSHA has considered Materion's comments supporting use of the terms “visibly contaminated” and “visibly clean.” The Agency finds that the provision in the final standard requiring PPE wherever there is a reasonable expectation of any dermal contact with beryllium more clearly conveys to employers the idea that the provision and use of PPE should be used as a precaution against potential dermal contact. OSHA believes the proposed requirements for PPE where clothing or skin may become “visibly contaminated” may be reasonably interpreted by employers to mean that PPE is only required where work processes release quantities of beryllium sufficient to create deposits visible to the naked eye. If this were the case, employers' provision of PPE to employees would certainly lag behind potential exposure, if such provision occurs at all. Additionally, National Jewish Health agreed with OSHA that small particles may not be visible to the naked eye (Document ID 1664 p. 4). Therefore, OSHA has determined that the language of the final standards is more easily understood and applied so as to preempt dermal contact with beryllium and therefore prevent adverse health effects caused by dermal contact, such as beryllium sensitization. OSHA also notes that employers are not required to measure skin or surface contamination under the provisions governing the use and handling of PPE. Thus the Agency concludes that the changes made to the proposed rule adequately address Materion's concerns and more closely express OSHA's intent.
OSHA also requested comment on proposed paragraph (h)(1)'s requirement for PPE to limit dermal contact with soluble beryllium compounds, and whether employers should also be required to provide PPE to limit dermal contact with poorly soluble (referred to as insoluble in the proposal) forms of beryllium. The solubility of beryllium was a consideration in the PPE requirements of the proposed standard because dermal absorption may occur at a greater rate for soluble beryllium than for poorly soluble beryllium.
Comments submitted on the topic of beryllium solubility and dermal absorption indicate that beryllium in poorly soluble forms, as well as soluble forms, can be absorbed through the skin and cause sensitization (Document ID 1664, p. 3; 1671, p. 7; 1688, p. 3). Dr. Schulte of NIOSH stated that PPE should be required to protect against exposure to poorly soluble compounds as these forms can produce soluble beryllium ions in sweat, and because beryllium in any form can enter the body through minor abrasions, which are commonly found on the skin of industrial employees (Document ID 1671, p. 7). (See further discussion in Section V, Health Effects, subsection 2, Dermal Exposure.)
General comments on whether OSHA should adopt more comprehensive PPE requirements similar to those specified in Regulatory Alternative 13 were, by and large, supportive. The Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) (Document ID 1655, pp. 16-17), NJH (Document ID 1664, pp. 3-4, 7), NIOSH (Document ID 1671, p. 7), Kimberly-Clark Professional (KCP) (Document ID 1676, p. 2), the DOE's National Supplemental Screening Program (NSSP) (Document ID 1677, p. 2), ISEA (Document ID 1682, p. 2), the American College of Occupational and Environmental Medicine (ACOEM) (Document ID 1685, p. 3), ATS (Document ID 1688, p. 3), the AFL-CIO (Document ID 1689, p. 12), and ORCHSE Strategies (ORCHSE) (Document ID 1691, p. 4) all urged OSHA to adopt Regulatory Alternative 13 or similar requirements. The BHSC Task Group commented that its experience at Department of Energy Sites “strongly suggests that this alternative should be adopted, since the concept of `visibly contaminated' is not sufficient to ensure an absence of such contamination on the skin” (Document ID 1655, p. 17). In addition, the BHSC Task Group noted that elimination of dermal contact with beryllium helps reduce the risk of sensitization (Document ID 1655, p. 17).
Similarly, several commenters indicated that a more appropriate trigger for the provision and use of PPE under
In contrast, Ameren Corporation (Ameren) and NGK Metals (NGK) recommended against adoption of Regulatory Alternative 13. According to Ameren, “[t]race beryllium in fly ash is unlikely to cause sensitization issues but PPE would be required under this alternative” (Document ID 1675, p. 6). Ameren, however, did not provide further information or evidence to support this claim. NGK suggested the language “visibly contaminated with beryllium particulate or solutions” as a trigger for the standards' PPE requirements, to clarify that PPE is not required when handling clean, solid materials that contain beryllium (Document ID 1663, pp. 2, 5). OSHA does not find these comments persuasive. OSHA included operations and industries where beryllium is present as a trace contaminant in the scope of the beryllium standard only when these operations and industries have the potential to release airborne exposures exceeding the action level of 0.1 μg/m
In summary, OSHA has concluded that beryllium surface contamination may not be visible yet may still cause sensitization. Because small beryllium particles can pass through intact or broken skin and cause sensitization, limiting the requirements for PPE based on surfaces that are “visibly contaminated” may not adequately protect workers from beryllium exposure. Submicron particles (less than 1 μg in diameter) are not visible to the naked eye and yet may pass through the skin and cause beryllium sensitization. And although solubility may play a role in the level of sensitization risk, the available evidence indicates that contact with poorly soluble as well as soluble beryllium can cause sensitization via dermal contact (see this preamble at section V, Health Effects). Based on these considerations, OSHA has adopted Regulatory Alternative 13 in paragraph (h)(1)(ii) of the final standards, which requires the employer to provide PPE and ensure its use wherever there is a reasonable expectation of dermal contact with beryllium to any extent and of any type.
The USW recommended further specification of the PPE provisions, requesting clarification of the terms “skin” and “exposure” in the proposed standard's PPE requirements (Document ID 1680, p. 4; 1681, p. 12). As discussed previously, the term “contact” has replaced “exposure” where the final standard refers to the skin. This change was made in order to clearly distinguish between airborne and contact exposure in the text of the standards. OSHA's intention in using the term “contact” is straightforward, meaning any instance in which beryllium touches an employee's body. “Skin” refers to the exterior surface of all parts of an employee's body including face, arms, scalp, ears, and nostrils. OSHA notes that processes that have the potential to expose workers' eyes to beryllium will generally also expose the face, and forms of PPE such as face shields used to protect the face generally also protect the eyes (
The USW also requested that OSHA include a specific requirement for provision of PPE to workers performing maintenance and repair activities and during non-routine tasks, to ensure that PPE is worn during tasks for which airborne exposure levels are not assessed (Document ID 1680, pp. 4-5; 1681, p. 12). This comment was submitted in response to the proposed standard, which would have required PPE where airborne exposures exceed the TWA PEL or STEL, but not in all cases where dermal contact occurs and airborne exposure levels are lower. OSHA believes the USW's concern has been addressed by the PPE requirements of the final standards, which apply wherever there is reasonable expectation of dermal contact with beryllium, including during maintenance and repair activities and non-routine tasks that involve beryllium-releasing processes or that are conducted in beryllium-contaminated areas.
OSHA also received a suggestion from the Boeing Company (Boeing) to amend proposed paragraph (h)(1)'s requirement to ensure use of appropriate PPE in accordance with the written exposure control plan, by adding “or equally as effective documentation” (Document ID 1667, p. 5). Boeing argued that the suggested language would allow employers to provide the required information through use of existing processes instead of through the creation of a second document (Document ID 1667, pp. 3-5). OSHA considered Boeing's comment, but decided against adding the suggested language. OSHA determined that it would create unnecessary ambiguity in the requirements for documentation in the context of both compliance and enforcement, as employers and CSHOs would need to determine what constitutes “equally effective documentation.” If an employer such as Boeing already has documents describing appropriate use of PPE that comply with the requirements of these standards, OSHA believes those documents can easily be incorporated into the employer's written exposure control plan. Taking this approach would eliminate the potential for confusion or redundancy caused by implementing multiple documents on PPE.
The employer must exercise reasonable judgment in selecting appropriate PPE. This requirement is consistent with OSHA's current standards for provision of personal protective equipment for general industry (29 CFR part 1910 Subpart I), construction (29 CFR part 1926 Subpart E), and shipyards (29 CFR part 1915 Subpart I). As described in the non-mandatory appendix providing guidance on conducting a hazard assessment for OSHA general industry standards (29 CFR 1910 Subpart I Appendix B), the employer should “exercise common sense and appropriate expertise” in assessing hazards. By “appropriate expertise,” OSHA means that individuals conducting hazard assessments must be familiar with the employer's work processes, materials, and work environment. A thorough hazard assessment should include a walk-through to identify sources of hazards to employees, wipe sampling to detect beryllium contamination on surfaces, review of injury and illness data, and employee input on the hazards to which
Based on the hazard assessment results, the employer must determine what PPE is necessary to protect employees from beryllium exposure. The requirements for choosing PPE under OSHA's personal protective equipment standards (
Although some personal protective clothing may be worn over street clothing, it is not appropriate for workers to wear protective clothing over street clothing if doing so could reasonably result in contamination of the workers' street clothes. In situations in which it is not appropriate for workers to wear protective clothing over their street clothes employers must select and ensure the use of protective clothing that is worn in lieu of (rather than over) street clothing, and must provide change rooms under paragraph (i)(2).
The Abrasive Blasting Manufacturers Alliance (ABMA) asserted that the PPE requirements under this standard are not consistent with the abrasive blasting requirements for construction and maritime (
Paragraph (h)(2) contains requirements for removal and storage of PPE. This provision is intended to reduce beryllium contamination in the workplace and limit beryllium exposure outside the workplace. Wearing contaminated clothing outside the beryllium work area could lengthen the duration of exposure and carry beryllium from beryllium work areas to other areas of the workplace. In addition, contamination of personal clothing could result in beryllium being carried to employees' cars and homes, increasing employees' exposure as well as exposing others to beryllium hazards. An NJH collaborative study with NIOSH documented inadvertent transfer of beryllium from the workplace to workers' automobiles, and stressed the need for separating clean and contaminated (“dirty”) PPE (Document ID 0474, Sanderson, 1999). Toxic metals brought by workers into the home via contaminated clothing and vehicles continue to result in exposure to children and other household members. A recent study of battery recycling workers found that lead surface contamination above the Environmental Protection Agency level of concern (≥40 μg/ft
Under paragraph (h)(2)(i), beryllium-contaminated PPE must be taken off at the end of the work shift, at the completion of tasks involving beryllium exposure, or when PPE becomes visibly contaminated with beryllium, whichever comes first. This provision is identical to the corresponding paragraph in the proposed standard, except for a slight reorganization to improve clarity and readability. Paragraph (h)(2)(i) is intended to convey that PPE contaminated with beryllium should not be worn when tasks involving beryllium exposure have been completed for the day. For example, if employees perform work tasks involving beryllium exposure for the first two hours of a work shift, and then perform tasks that do not involve exposure, they should remove their PPE after the exposure period to avoid the possibility of increasing the duration of exposure and contamination of the work area from beryllium residues on the PPE (
PPE that is visibly contaminated with beryllium should be changed at the earliest reasonable opportunity. This provision is intended to protect employees working with beryllium and their co-workers from exposure due to accumulation of beryllium on PPE, and reduces the likelihood of cross-contamination from beryllium-contaminated PPE. Unlike the “visibly contaminated” language used in paragraph (h)(1)(ii) of the proposal, which has been removed, OSHA has determined that it is appropriate to use the same language here. Because the purpose of PPE is to serve as a barrier between an employee's body and ambient or surface beryllium, PPE becomes contaminated with beryllium immediately as part of its protective function. Requiring PPE to be changed upon contamination with any amount of beryllium is unreasonable and unnecessary to protect employees. This is because contamination of PPE with beryllium during work processes does not reduce the effectiveness of PPE or create hazards to employees unless sufficient beryllium accumulates on the PPE to impair its function or create additional exposures, such as by dispersing accumulated beryllium into the air. Furthermore, the process of changing contaminated PPE can create opportunities for both inhalation exposure and dermal contact with beryllium. The use of “visibly contaminated” protects employees from potential exposures while changing PPE by limiting requirements to change PPE during work tasks involving beryllium exposure to those circumstances when changing it is necessary to maintain its protective function and prevent deposits of beryllium from accumulating and dispersing.
Using the “visible contamination” trigger in (h)(1)(ii) to determine when employees must wear PPE in the first instance would have reduced the protectiveness of the standard. Thus, OSHA determined that it would be inappropriate to use such a trigger in that context. However, as explained above, using “visibly contaminated” in
Paragraph (h)(2)(ii) requires employees to remove PPE consistent with the written exposure control plan required by paragraph (f)(1). Paragraph (f)(1) specifies that the employer's written exposure control plan must contain procedures for minimizing cross-contamination, and procedures for the storage of beryllium-contaminated PPE, among other provisions. While proposed paragraph (h)(2)(ii) only required personal protective clothing to be removed pursuant to the written exposure control plan, the final language includes personal protective equipment as well as clothing. This change was made to ensure consistency with the rest of paragraph (h) and to confirm OSHA's intent that beryllium-contaminated personal protective equipment should be treated with the same care as contaminated clothing in order to prevent additional airborne exposure and dermal contact.
Paragraph (h)(2)(iii) requires employers to ensure that protective clothing is kept separate from employees' street clothing and that storage facilities prevent cross-contamination as specified in the written exposure control plan. The language of this provision has been modified slightly from the proposed standard to emphasize prevention of cross-contamination as well as implementation of the written exposure control plan, consistent with other requirements intended to limit beryllium migration and cross-contamination. OSHA believes these provisions are necessary to prevent the spread of beryllium throughout and outside the workplace.
The remainder of paragraph (h)(2) is unchanged from the proposal and did not elicit comments from stakeholders. To further limit exposures outside the workplace, paragraph (h)(2)(iv) requires employers to ensure that beryllium-contaminated PPE is only removed from the workplace by employees who are authorized to do so for the purpose of laundering, cleaning, maintaining, or disposing of such PPE. These items must be brought to an appropriate location away from the workplace. To be an appropriate location for purposes of paragraph (h)(2)(iv), the facility must be equipped to handle beryllium-contaminated items in accordance with these standards. The standards further require in paragraph (h)(2)(v) that PPE removed from the workplace for laundering, cleaning, maintenance, or disposal be placed in closed, impermeable bags or containers. These requirements are intended to minimize cross-contamination and migration of beryllium, and to protect employees or other individuals who later handle beryllium-contaminated items. Required warning labels should alert those handling the contaminated PPE of the potential hazards of exposure to beryllium. Such labels must conform with the hazard communication standard (29 CFR 1910.1200) and paragraph (m)(3) of these standards. These warning requirements are meant to reduce confusion and ambiguity regarding critical hazard information communicated in the workplace by requiring that this information be presented in a clear and uniform manner.
Paragraph (h)(3) of the standards addresses the cleaning and replacement of PPE. Proper cleaning is necessary to ensure that neither the workers who use the PPE nor those who clean and maintain it are exposed to beryllium via inhalation or dermal contact. Proper replacement is necessary to ensure that the PPE continues to function effectively in protecting workers from exposure. Paragraph (h)(3) is unchanged from the proposal.
Paragraph (h)(3)(i) requires the employer to ensure that reusable PPE is cleaned, laundered, repaired, and replaced as needed to maintain its effectiveness. In keeping with the performance orientation of the standards, OSHA does not specify how often PPE should be cleaned, repaired, or replaced. Appropriate time intervals for these actions may vary widely based on the types of PPE used, the nature of the beryllium exposures, and other circumstances in the workplace. However, even in the absence of a mandated schedule, these requirements must be completed at a frequency, and in a manner, sufficient to ensure that PPE continues to serve its intended purpose of protecting workers from beryllium exposure.
Several commenters discussed the merits of the use of disposable PPE versus reusable PPE. These commenters indicated that OSHA should allow the use of disposable PPE, which could be both more protective and, in some cases, less costly, than reusable PPE (Document ID 1676, p. 3; 1682, p. 3). In response, OSHA notes that it is not prohibiting the use of disposable PPE. As discussed above, OSHA is leaving the decision regarding appropriate PPE to employers after they do their hazard assessments. While these commenters indicated that the regulatory text seems to focus on reusable PPE, the requirements specifically regarding reusable PPE are necessary to ensure that workers who handle this PPE downstream (for example, workers who launder or repair PPE) are protected and that reusable PPE is appropriately handled and cleaned before being reused. These provisions are not meant to indicate that OSHA prefers reusable PPE over disposable PPE.
Under paragraph (h)(3)(ii), removal of beryllium from PPE by blowing, shaking, or any other means which disperses beryllium in the air is prohibited as this practice could result in unnecessary and harmful exposure to airborne beryllium. Paragraph (h)(3)(iii) requires the employer to inform, in writing, any person or business entity who launders, cleans, or repairs PPE required by this standard of the potentially harmful effects of exposure to airborne beryllium and dermal contact with beryllium, and of the need to handle the PPE in accordance with this standard. This provision is intended to limit dermal and inhalation exposure to beryllium, and to emphasize the need for hazard awareness and protective measures consistent with these standards among persons who clean, launder, or repair beryllium-contaminated items.
Paragraph (i) of the final standards for general industry, construction, and shipyards requires that, when certain conditions are met, the employer must provide employees with readily accessible washing facilities and change rooms. Additionally, paragraph (i) of the final standard for general industry requires that, when certain conditions are met, the employer must provide showers for employee use. Paragraph (i) of all three standards also requires the employer to take certain steps to minimize exposure in eating and drinking areas, and prohibits certain practices that may contribute to beryllium exposure. The final standards' hygiene provisions are consistent with other OSHA standards providing similar protection. For example, OSHA health standards for hexavalent chromium (29 CFR 1910.1026) and lead (29 CFR
OSHA requested comment on the hygiene provisions of the proposed standard for general industry, which was similar in most respects to the hygiene provisions of the final general industry standard. It required employers to provide readily accessible washing facilities, change rooms and showers and to ensure the use of these facilities for each employee exposed to beryllium when necessary. The proposed standard also required employers to take certain steps to minimize exposure in eating and drinking areas and prohibited certain practices that may contribute to beryllium exposure. The remainder of this section discusses general comments on the hygiene section; explains the hygiene provisions of the final standards and OSHA's response to comments on each provision; and discusses differences between the proposed and final standards and differences between the final standards for each sector.
Most commenters agreed with the need for hygiene areas and practices to protect workers from airborne exposure to and dermal contact with beryllium (Document ID 1664, p. 7; 1665, pp. 10-11; 1667, pp. 5-6; 1675, p. 13; 1679, p. 9; 1680, p, 5; 1689, p. 12). However, one commenter stated that its engineering control systems eliminated the need for hygiene facilities (Document ID 1615, p. 8). OSHA disagrees that engineering controls alone are sufficient to eliminate the need for hygiene areas and practices. Because significant risk of beryllium sensitization and CBD remain below the TWA PEL in the final beryllium standards, ancillary provisions such as requirements for hygiene areas and practices are appropriate to further reduce that risk.
Another commenter noted that hygiene areas and practices specified in the proposal exceed requirements for abrasive blasting operations discussed in OSHA's Ventilation standard for construction (29 CFR 1926.57) and Mechanical paint removers standard in maritime employment (29 CFR 1915.34) (Document ID 1673, p. 23). Ancillary provisions in standards for specific substances such as beryllium complement these general OSHA standards. As OSHA noted in Section XVIII of the NPRM, the standards for abrasive blasting provide protection primarily to blasting operators, and do not apply to other employees who are likely to experience beryllium exposures, such as blasting helpers and cleanup workers. In addition, OSHA expects the hygiene provisions in the final beryllium standards to decrease the airborne exposure and dermal contact even of employees who wear respiratory protection and PPE required by other standards, and will therefore reduce significant risk of beryllium-related health effects among abrasive blasters in construction and shipyards.
Paragraph (i)(1) of the proposed standard required that employers provide, for each employee working in a beryllium work area, readily accessible washing facilities to remove beryllium from the hands, face, and neck. It also required employers to ensure that each employee exposed to beryllium use these facilities when necessary.
The requirements for washing facilities will reduce employees' skin contact with beryllium, the possibility of accidental ingestion and inhalation of beryllium, and the spread of beryllium within and outside the workplace. As discussed in Section V of this preamble, Health Effects, respiratory tract, skin, eye, or mucosal contact with beryllium can result in beryllium sensitization, which is a necessary first step toward the development of CBD. Also, beryllium can contaminate employees' clothing, shoes, skin, and hair, prolonging workers' beryllium exposure and exposing others such as family members if proper hygiene practices are not observed. A study by Sanderson
The requirements in the standards to use washing facilities are performance-oriented, simply requiring employees to use the washing facilities to remove beryllium from their skin when the criteria in paragraph (i)(1) of the standards are met. Typically, washing facilities will consist of one or more sinks, soap or another cleaning agent, and a means for employees to dry themselves after washing. OSHA does not intend to require the use of any particular soap, cleaning agent, or drying mechanism. Employers can provide whatever washing materials and equipment they choose, as long as those materials and equipment are effective in removing beryllium from the skin and do not themselves cause skin or eye problems.
Washing reduces exposure by limiting the period of time that beryllium is in contact with the skin, and helps prevent accidental ingestion. Although engineering and work practice controls and protective clothing and equipment are designed to prevent hazardous skin and eye contact, OSHA realizes that in some circumstances exposure will nevertheless occur. For example, an employee who wears gloves to protect against hand contact with beryllium may inadvertently touch his or her face with the contaminated glove during the course of the day. The purpose of requiring washing facilities is to mitigate adverse health effects when skin or eye contact with beryllium occurs.
OSHA did not receive comment on this provision. Therefore, paragraph (i)(1) of the final standards is substantively unchanged from proposed paragraph (i)(1). Paragraph (i)(1) of the final standard for general industry requires the employer to provide readily accessible washing facilities for employees who work in beryllium work areas to remove beryllium from the
Because the standards for construction and shipyards do not require beryllium work areas, the requirements for washing facilities set forth in paragraph (i)(1) of the construction and shipyard standards differ from the general industry standard in that they require employers to provide washing facilities for each employee required to wear personal protective clothing or equipment by the final standards—that is, where employees are reasonably expected to be exposed to beryllium above the TWA PEL or STEL or where there is a reasonable expectation of dermal contact with beryllium. Otherwise, the requirements for washing facilities are the same in all three standards.
Paragraph (i)(2) of the proposed standard required employers to provide affected employees with a designated change room and washing facilities in accordance with the proposed standard and the Sanitation standard where employees were required to remove their personal clothing.
Change rooms allow employees to remove their personal clothing in order to use personal protective clothing. Minimizing contamination of employees' personal clothes will also reduce the likelihood that beryllium will contaminate employees' cars and homes, and other areas outside the workplace. Requiring employers to provide employees with change rooms to change out of work clothes, which are then segregated from their street clothes, and to leave work clothing at the workplace significantly reduces the possibility of beryllium migration outside the workplace, providing added protection from take-home beryllium exposure to workers and their families.
One commenter recommended that change rooms be required only when there is required use of personal protective clothing and equipment (Document ID 1667, pp. 5-6). OSHA intends the change rooms requirement only to apply to covered workplaces where employees must change their clothing (
Another commenter stated that the final rule should require employers to develop a program that defines approved storage areas for protective apparel and personal hygiene towels, restricts access to this area, provides for employee training when handling or reusing previously used items, and establishes an objective means for determining when an item can no longer be reused and must be laundered or discarded (Document ID 1962, p. 5). OSHA agrees that employers should develop and document procedures for limiting beryllium cross-contamination and migration, and has included such requirements in paragraph (f), Methods of Compliance, and paragraph (j), Housekeeping. These paragraphs of the final standards require each employer to develop, document, and implement procedures for limiting beryllium migration and cross-contamination in their facilities, which should address storage, handling and reuse of beryllium-contaminated items and access to storage facilities for beryllium-contaminated clothing and PPE, including towels if these are contaminated with beryllium during washing and showering.
After carefully reviewing the record, OSHA has decided to keep paragraph (i)(2) substantively unchanged. Paragraph (i)(2) of the final standard for general industry requires the employer to provide a designated change room for employees who work in a beryllium work area and are required to remove their personal clothing. Paragraph (i)(2) of the final standards for construction and shipyards requires the employer to provide a designated change room for employees who are required by the final standards to wear personal protective clothing or equipment and are required to remove their personal clothing. The changed trigger for change rooms in the construction and shipyard standards is due to the fact that there are no beryllium work areas in those standards, and requiring change rooms where employees are required to wear personal protective clothing or equipment provides a similar level of protection to the general industry standard. Change rooms must be designed in accordance with the written exposure control plan required by paragraph (f)(1) of all three standards, and with the applicable Sanitation standards in general industry (29 CFR 1910.141), construction (29 CFR 1926.51), and shipyards (29 CFR 1915.88). These Sanitation standards require change rooms to be equipped with storage facilities (
As in the proposed standard for general industry, paragraph (i)(3) of the final standard for general industry requires employers in general industry to provide and ensure the use of showers if employees are or can reasonably be expected to be exposed above the TWA PEL or STEL (paragraph (i)(3)(i)(A)) and if employees' hair or body parts other than hands, face, and neck could reasonably be expected to be contaminated with beryllium (paragraph (i)(3)(i)(B)). Employers are only required to provide showers if paragraphs (i)(3)(i)(A) and (B) both apply. Paragraph (i)(3)(ii) of the final standard for general industry, like the proposed standard for general industry, requires employers to ensure that employees use the showers at the end of the work activity or shift involving beryllium if the employees reasonably could have been exposed above the TWA PEL or STEL, and if beryllium could reasonably have contaminated the employees' body parts other than hands, face, and neck. The requirement is restricted to body parts other than the hands, face, and neck because if employees have dermal contact with beryllium on their hands, faces, or necks, they must use the washing facilities required by paragraph (i)(1)(i). This language is intended to convey that showers must be used immediately after work activities involving beryllium exposure have been completed for the day. For example, if employees perform work activities involving beryllium exposure that meet the requirements for showers for the first two hours of a work shift, and then perform activities that do not involve exposure, they should shower after the exposure period to avoid increasing the duration of exposure, potential of accidental ingestion, and contamination of the work area from beryllium residue on their hair and body parts other than hands, face, and neck. If, however, employees are performing tasks involving exposure intermittently throughout the day, this provision is intended to require them to shower after the last task involving exposure, not after the completion of each such task.
The requirements of paragraph (i)(3) of the final standard for general industry are similar to requirements for provision and use of shower facilities in other substance-specific OSHA health standards, such as the standards for cadmium (29 CFR 1910.1027) and lead (29 CFR 1910.1025), which also require showers when exposures exceed the TWA PEL. OSHA's standard for coke oven emissions (29 CFR 1910.1029) requires employers to provide showers and ensure that employees working in a regulated area shower at the end of the work shift. The standard for methylenedianiline (MDA) (29 CFR 1910.1050) requires employers to ensure that employees who may potentially be exposed to MDA above the action level shower at the end of the work shift.
A majority of the comments on the proposed hygiene areas and practices provisions for general industry concerned the requirement for showers. The Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) expressed support for the mandatory use of showers for workers in beryllium regulated areas where airborne exposures can reasonably be expected to exceed the TWA PEL or STEL so that proper decontamination can occur and prevent beryllium from leaving the work area, and to ensure that workers and their families are not exposed to beryllium once workers leave their place of employment (Document ID 1665, pp. 10-11). Ameren Corporation (Ameren), the United Steelworkers (USW), and Materion Corporation (Materion) also supported the requirement for showers and their use by employees working in a beryllium regulated area (that is, where airborne exposures can reasonably be expected to exceed the TWA PEL or STEL) (Document ID 1675, p. 13; 1680, p. 5; 1681, p.12).
Some commenters supported the requirement for showers, but suggested that employers should be required to provide shower facilities to workers exposed at lower exposure levels than the TWA PEL or STEL. National Jewish Health (NJH) suggested that showers should be required for workers exposed above the action level rather than the TWA PEL or STEL and in facilities where beryllium can be expected to contaminate the employees' hair or other body parts (Document ID 1664, p. 7). The North America's Building Trades Unions (NABTU) suggested that any beryllium work area should include all necessary decontamination facilities, including showers (Document ID 1679, p. 9).
OSHA notes that NJH and NABTU's comments addressed the provisions of the proposed standard for general industry, which did not include a requirement to provide PPE wherever there is a potential for dermal contact with beryllium. As discussed previously in the Summary and Explanation for paragraph (h) of the final standards, OSHA has adopted much more comprehensive requirements for employers to provide and ensure the use of personal protective clothing and equipment (PPE) wherever exposure exceeds the TWA PEL or STEL or dermal contact with beryllium is reasonably expected to occur. The Agency believes that employees working in low-exposure contexts (where exposures do not exceed the TWA PEL or STEL) and using comprehensive PPE as required in paragraph (h) are unlikely to experience beryllium contamination that requires shower facilities to effectively remove beryllium from the hair and skin. OSHA therefore concludes that the required washing facilities and change rooms for general industry employees working in beryllium work areas in combination with the comprehensive PPE requirements described in paragraph (h) of the final standards are sufficient to protect workers in areas where exposures do not exceed the TWA PEL or STEL and where there is no reasonable expectation that body areas other than hands, face and neck will be contaminated with beryllium. OSHA therefore has decided not to require the provision of showers in general industry workplaces where exposure does not exceed the TWA PEL or STEL.
The Boeing Company (Boeing) suggested requiring showers only when beryllium visibly contaminates employees' hair or body parts other than hands, face, and neck (Document ID 1667, p. 6). However, as discussed previously in the Summary and Explanation of paragraph (h), Personal Protective Clothing and Equipment, dermal contact with beryllium can lead to adverse health effects regardless of whether sufficient beryllium-containing dust has accumulated to be visible to the naked eye. Therefore, OSHA has determined that requiring showers only where beryllium contamination is visible would not adequately protect employees from prolonged dermal contact with beryllium or adequately prevent transfer of beryllium outside the workplace.
Another commenter suggested that air showers for when employees leave the work area would be more cost effective and acceptable than water-based showers (Document ID 1596, p. 1). OSHA does not believe that air showers are appropriate for removing beryllium from workers' skin. Air showers are designed to remove accumulations of dust from the surface of work clothing, PPE, and exposed skin, but cannot remove residual beryllium as effectively as washing with water and soap. In addition, air showers can disperse beryllium-containing dust into the air and cause employees additional airborne exposure, whereas water-based showers do not re-entrain dust into the air.
OSHA has not included a requirement for showers in the final standards for construction and shipyards. Workers in these industries are exposed to beryllium primarily when an abrasive that contains trace amounts of beryllium, usually coal or copper slags, is used during abrasive blasting operations. These abrasive slags contain less than 0.1% beryllium but may result in significant airborne exposure to beryllium because of the high dust levels generated during abrasive blasting. However, workers conducting abrasive blasting with these abrasives are currently protected from dermal contact with beryllium under existing OSHA standards. The OSHA Ventilation standard for construction (29 CFR 1926.57) and the OSHA Mechanical paint removers standard for shipyard employment (29 CFR 1915.34) require personal protective clothing and respiratory protection for abrasive blasters. The Ventilation standard requires employers to use only respirators approved by NIOSH under 42 CFR part 84 for protecting employees from dusts produced during abrasive-blasting operations (29 CFR 1926.57(f)(5)(i)) and abrasive-blasting respirators must be worn by all abrasive-blasting operators (29 CFR 1926.57(f)(5)(ii)). These abrasive blasting respirators cover the entire head, neck and shoulder area to protect the worker from rebounding abrasive during these operations and prevent beryllium exposure to the head and neck area. The Mechanical paint removers standard has similar requirements for abrasive blasters including the use of hoods and airline respirators, along with protective clothing (29 CFR 1915.34(c)). Compliance with these requirements should effectively prevent contamination of abrasive blasters' bodies with beryllium; thus, use of showers to remove beryllium is unnecessary for these workers.
Abrasive blasting support workers such as pot tenders and cleanup workers are also potentially exposed to beryllium during abrasive blasting
Paragraph (i)(4) (eating and drinking areas) of OSHA's proposed rule for general industry required that whenever the employer allows employees to consume food or beverages at a worksite where beryllium is present, the employer must ensure that surfaces in eating and drinking areas are as free as practicable of beryllium to minimize the possibility of food contamination and the likelihood of additional exposure to beryllium through inhalation or ingestion. Proposed paragraph (i)(4) further required employers to ensure that no employee in eating and drinking areas is exposed to airborne beryllium at or above the action level, and that eating and drinking areas must comply with the Sanitation standard (29 CFR 1910.141). Paragraph (i)(5)(ii) (prohibited activities) of the proposed rule, also related to eating and drinking areas, required the employer to ensure that no employees enter any eating or drinking area with personal protective clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing or equipment by methods that do not disperse beryllium into the air or onto an employee's body.
A commenter with the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) recommended that OSHA develop stronger language to ensure that exposure levels are “well below” the action level for eating and drinking areas and that surfaces are truly as free as practicable of beryllium (Document ID 1689, pp. 12-13). OSHA agrees with the commenter that airborne beryllium should be maintained well below the action level in eating and drinking areas and has decided not to include the proposal's hygiene provision that no employee in eating and drinking areas is exposed to airborne beryllium at or above the action level in the final standards. OSHA believes that this language may be interpreted to allow airborne exposure levels up to the action level in eating and drinking areas, which is not OSHA's intent. The requirements to maintain surfaces in these eating and drinking areas as free as practicable of beryllium and to ensure that employees do not enter eating and drinking areas with personal protective work clothing or equipment unless beryllium has been removed will limit contamination and airborne exposure to beryllium and provide workers with safe areas to eat and drink.
In comments on surface cleanliness pertaining to eating and drinking areas, Boeing suggested that the standard should define specific surface contaminant levels or instead simply rely on the existing OSHA Sanitation standard (1910.141) (Document ID 1667, p. 6). Kimberly-Clark Professional (KCP) suggested that OSHA should set a future goal of establishing maximum allowable surface contamination standards for toxic substances (Document ID 1962, p. 3). Materion suggests that its “visibly clean” standard is analogous to OSHA's standard of “as free as practicable” and that its cleaning program ensures that surfaces remain “as free as practicable” of beryllium (Document ID 1807, p. 5). Materion and USW proposed the term “visibly clean” because they “have found it to be well understood by both workers and management” (Document ID 1808, p. 4). However, Materion also points out that the use of the term “as free as practicable” has been understood by workers, management and OSHA compliance officers and has been successfully applied and effective in practice: “[f]or decades, OSHA has used the term “as free as practicable” in its substance specific standards . . . OSHA's use of this term has been understood by workers, management and OSHA compliance officers. OSHA has successfully applied this compliance term in many prior OSHA standards which serves to demonstrate that its use is understandable and effective in practice” (Document ID 1808, p. 5). In post-hearing comments, KCP states its belief that “visibly contaminated” is an inadequate standard and should not be used as a stand-in for “as clean as practicable” (Document ID 1962, p. 2).
In developing the final standards, OSHA carefully considered these comments on the use of “as free as practicable” and alternative requirements in reference to surface cleanliness in eating and drinking areas and elsewhere in the beryllium standards, and concluded that “as free as practicable” is the most appropriate terminology for requirements pertaining to surface cleanliness. Issues related to use of “as free as practicable” and alternatives to this language are also discussed in the Summary and Explanation for paragraph (j), Housekeeping.
The requirement to maintain surfaces as free as practicable of the regulated substance is included in other OSHA health standards such as those for lead in general industry (29 CFR 1910.1025), lead in construction (29 CFR 1926.62), chromium (IV) (29 CFR 1910.1026), and asbestos (29 CFR 1910.1001). Employers therefore have the benefit of previous experience interpreting and developing methods for compliance with requirements to maintain surfaces “as free as practicable” of toxic substances, as well as guidance from OSHA on compliance with such requirements. As OSHA explained in a January 13, 2003 letter of interpretation concerning the meaning of “as free as practicable” in OSHA's Lead in Construction standard, OSHA evaluates whether a surface is “as free as practicable” of a contaminant by the rigor of the employer's program to keep surfaces clean (OSHA, 2003, Document ID 0550). A sufficient housekeeping program may be indicated by a routine cleaning schedule and the use of effective cleaning methods to minimize the possibility of exposure from accumulation of beryllium on surfaces. OSHA's compliance directive on Inspection Procedures for the Chromium (VI) Standards provides additional detail on how OSHA interprets “as free as practicable” for enforcement purposes (OSHA, 2008, Document ID 0546, pp. 45-47). As explained in the directive, if a wipe
OSHA does not set quantitative limits for surface contamination because the best available scientific evidence on adverse health effects from dermal contact with beryllium does not provide sufficient information to link risk of adverse health effects with specific levels of surface contamination. As described above, OSHA finds that wipe sampling can be helpful in determining whether an employer is in compliance with a requirement to keep surfaces as free as practicable of toxic substances, but concludes that use of a specific target level of surface contamination should not define compliance with surface cleanliness requirements of the beryllium standards.
Based on these conclusions, paragraph (i)(4) of the final standards requires that wherever the employer allows employees to consume food or beverages at a worksite where beryllium is present, the employer must ensure that surfaces in these areas are as free as practicable of beryllium. The employer must also ensure that employees do not enter eating and drinking areas with personal protective work clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing and equipment by methods that do not disperse beryllium into the air or onto an employee's body, further protecting workers from beryllium contamination in areas where eating and drinking occurs. Eating and drinking areas must further comply with the Sanitation standards (29 CFR 1910.141(g), 1926.51(g), 1915.88(h)), which prohibit consuming or storing food or beverages in a toilet area or in any area exposed to a toxic material. In the final standards, the provisions for eating and drinking areas (paragraph (i)(4) of the general industry standard, paragraph (i)(3) of the construction and shipyard standards) and prohibited activities (paragraph (i)(5) of the general industry standard and paragraph (i)(4) of the construction and shipyard standards) have been retained with one exception and one structural change. The proposed requirement to ensure that no employee in eating and drinking areas is exposed to airborne beryllium at or above the action level has been removed for the reasons already discussed above. And the requirement concerning employees entering any eating or drinking area with personal protective clothing or equipment has been moved from the prohibited activities section of the proposed rule's hygiene provision to the eating and drinking areas section in the final standards.
Paragraph (i)(4) of the final standard for general industry and paragraph (i)(3) of the final standards for construction and shipyards do not require the employer to provide separate eating and drinking areas to employees at the worksite. Employees may consume food or beverages offsite. However, where the employer chooses to allow employees to consume food or beverages at a worksite where beryllium is present, the employer is required to maintain the area in accordance with paragraph (i)(4) of the final standard for general industry or paragraph (i)(3) of the final standards for construction and shipyards, and with the applicable Sanitation standard (29 CFR 1910.141, 29 CFR 1915.1915.88, or 29 CFR 1926.51), and the employer must ensure that employees do not enter eating and drinking areas wearing contaminated personal protective clothing or equipment.
Paragraph (i)(5)(i) of the proposed standard, setting forth prohibited activities, required the employer to ensure that no employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in regulated areas. OSHA did not receive comment on this provision. Therefore, paragraph (i)(5) of the final standards is substantively unchanged from proposed paragraph (i)(5)(i). Paragraph (i)(4) of the final construction and shipyard standards is substantively identical to paragraph (i)(5) of the general industry standard.
Paragraph (i)(5) of the final standard for general industry and paragraph (i)(4) of the final standard for shipyards prohibit eating, drinking, smoking, chewing tobacco or gum, or applying cosmetics in regulated areas (areas where airborne exposure to beryllium is expected to exceed the TWA PEL or STEL). Paragraph (i)(4) of the final standard for construction differs slightly in that the employer is required to ensure that no employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in work areas where there is a reasonable expectation of exposure above the TWA PEL or STEL. This difference arises because the final standard for construction does not have a requirement for regulated areas but instead relies on a competent person provision (paragraph (e)) to restrict employee access to areas where exposures are, or can reasonably be expected to be, above the TWA PEL or STEL. Exposure at these levels creates a greater risk of beryllium contaminating the food, drink, tobacco, gum, or cosmetics. Prohibiting eating and drinking in these areas will reduce the potential for this manner of exposure.
For the foregoing reasons, OSHA has decided to promulgate all the requirements of the proposed hygiene areas and practices provisions in the beryllium final standard for general industry except for the eating and drinking areas action level limit noted above. For the final standards for construction and shipyards, OSHA has decided to include all of the hygiene areas and practices provisions proposed for general industry except for the requirement for showers and the eating and drinking areas action level limit.
Paragraph (j) of the final standard for general industry requires employers to maintain all surfaces in beryllium work areas as free as practicable of beryllium; promptly clean spills and emergency releases of beryllium; use appropriate cleaning methods; and properly dispose of materials containing or contaminated with beryllium. Paragraph (j) of the final standards for construction and shipyards requires employers to follow the written exposure control plan required under paragraph (f)(1) when cleaning beryllium-contaminated areas, use appropriate cleaning methods, and provide recipients of beryllium-containing materials for use or disposal with a copy of the warning described in paragraphs (m)(2) and (m)(3), respectively.
As discussed in more detail below, the housekeeping requirements in the final standards are similar to those included in the proposal. While some stakeholders submitted divergent opinions on certain aspects of the proposed provisions, several commenters offered broad support for the inclusion of housekeeping provisions in the final rule (
These comments support OSHA's view, as expressed in the NPRM, that these provisions are important because they minimize additional sources of exposure to beryllium that engineering controls do not completely eliminate. Good housekeeping measures are a cost-effective way to control worker exposures by removing settled beryllium that could otherwise become re-entrained into the surrounding atmosphere by physical disturbances or air currents and could enter an employee's breathing zone. Moreover, housekeeping provisions may be especially critical in the final beryllium standards because contact with contaminated surfaces can result in dermal exposure to beryllium. As discussed in this preamble at section V, Health Effects, researchers have identified skin exposure to beryllium as a pathway to sensitization. In addition, the housekeeping provisions in paragraph (j) of the standards for general industry, construction, and shipyards are generally consistent with housekeeping requirements in other OSHA standards for toxic metals, including cadmium (29 CFR 1910.1027, 1926.1127), chromium (VI) (29 CFR 1910.1026), and lead (29 CFR 1910.1025, 1926.62).
The Abrasive Blasting Manufacturers Alliance (ABMA) asserted that the proposed housekeeping requirements are not consistent with the abrasive blasting requirements for construction and shipyards (
Paragraph (j)(1)(i) of the proposed rule would have required employers to maintain all surfaces in beryllium work areas as free as practicable of accumulations of beryllium and in accordance with the exposure control plan required under paragraph (f)(1) and the cleaning methods required under paragraph (j)(2) of the proposed rule. In this context, the phrase “as free as practicable” set forth the baseline goal in the development of an employer's housekeeping program to keep work areas free from surface contamination. For a detailed discussion of the meaning of the phrase “as free as practicable,” see the discussion in the Summary and Explanation for paragraph (i), Hygiene areas and practices, in this section of the preamble.
Although this requirement is often included in OSHA's substance specific regulations, a number of commenters expressed concern about its inclusion in this rulemaking. For example, USW argued that a “requirement to maintain all surfaces in beryllium work areas as free as practicable of accumulations of beryllium could lead to difficulties in assessing compliance, since `as free as practicable' is open to interpretation”; instead, USW suggested that beryllium work areas should be required to be maintained “visibly clean” of accumulations (Document ID 1681, p. 13). Materion Corporation (Materion) also proposed the term “visibly clean” (Document ID 1808, p. 5; 1752, p. 1). However, Materion stated that OSHA has long used the term “as free as practicable” in its standards as a measure of cleanliness for work areas and eating areas, and the term is well understood by workers, management, and OSHA compliance officers. According to Materion, “visibly clean” is similar to “as free as practicable” and also well understood by workers and management (Document ID 1808, p. 5).
Kimberly-Clark Professional (KCP) stated that this “ostensible equivalence” between the “as free as practicable” and “visibly clean” standards is “unfounded,” in part, because “[i]t is practicable using readily known and available methods to make many surfaces clean beyond that which is visibly apparent” (Document ID 1962, p. 2). Instead, KCP recommended that OSHA “establish surface contamination standards such that all subjectivity of surface cleanliness is removed” (Document ID 1962, p. 2). KCP also argued that OSHA should require an employer's surface cleanliness protocol to be based on objective sampling and measurement. KCP maintained that there are many examples where surface sampling is used in economically feasible ways, including in the facilities governed by the Department of Energy (DOE). However, it acknowledged that the methods in other environments, including the DOE protocols for beryllium control in energy facilities, may not translate directly to industrial facilities. Nevertheless, KCP observed that “there is sufficient ongoing successful use of such approaches to provide a framework for a more objective, data-driven protocol for surface control than `visibly contaminated' ” (Document ID 1962, p. 3). The Boeing Company (Boeing) also requested that “as free as practicable” be replaced with defined surface contaminant levels (Document ID 1667, pp. 6).
Conversely, the Department of Defense (DOD) commented that employers should not be required to measure beryllium contamination on surfaces, as the relationship between level of surface contamination and health risk is unknown. It also stated that wipe samples are not an appropriate enforcement tool for determining that surfaces are “as free as practicable” of beryllium contamination (Document ID 1684, Attachment 1, p. 1). ORCHSE Strategies (ORCHSE) agreed that OSHA should not require measurement of beryllium contamination on surfaces (Document ID 1691, p. 18). And, the American Industrial Hygiene Association (AIHA) commented that “the evaluation of `visible' is subjective” (Document ID 1686, p. 1).
After carefully considering these comments and other evidence in the record, OSHA has chosen not to require employers to measure beryllium contamination on surfaces, as suggested by KCP, or to otherwise “define specific surface contaminant levels,” as requested by Boeing Company. As DOD explains in its comments, the relationship between a precise amount of surface contamination and health risk is unknown. Therefore, OSHA cannot find that a particular level of contamination is safe. Rather, OSHA has determined that keeping surfaces as clean as practicable is appropriate because promptly removing beryllium deposits prevents them from becoming airborne, thus reducing employees'
Therefore, OSHA has decided to retain the requirement that employers maintain all surfaces in beryllium work areas as free as practicable of beryllium in paragraph (j)(1)(i) of the final general industry standard. The term “as free as practicable” is accepted language and used in other OSHA housekeeping requirements for toxic dusts (Asbestos, 29 CFR 1910.1001 and Cadmium, 29 CFR 1910.1027). As the Agency has explained in a letter of interpretation on this term as used in the lead standard, “the requirement to maintain surfaces `as free as practicable' is performance-oriented. . . . The requirement is met when the employer is vigilant in his efforts to ensure that surfaces are kept free of accumulations of lead-containing dust. The role of the Compliance Safety and Health Officer (CSHO) is to evaluate the employer's housekeeping schedule, the possibility of exposure from these surfaces, and the characteristics of the workplace” (OSHA, Jan. 13, 2003, Letter of Interpretation.) The term “surface” has a common meaning but is not separately defined in the standard. This term has been used multiple times in OSHA's substance specific standards and OSHA has not found that it is a source of confusion for employers. As indicated in the preamble to the proposed standard, the term includes the outer parts of objects that workers come into contact with, such as equipment, floors, and items in storage facilities, as well as objects that workers may not directly contact, such as rafters and ledges. See 80 FR 47796. Because all surfaces in beryllium work areas could potentially accumulate beryllium that could become airborne or that workers could later inhale, touch, or ingest, all surfaces in beryllium works areas must be kept as free as practicable of beryllium.
OSHA has also decided to remove the phrase “accumulations of” from (j)(1)(i), because OSHA believes the reference to “accumulations” may be misinterpreted to suggest that cleaning is only required when substantial deposits of beryllium-containing material have accumulated on surfaces. As discussed previously, dermal contact with small amounts of beryllium that are not visible to the naked eye can cause beryllium sensitization. Thus, the final standard for general industry requires the employer to maintain all surfaces in beryllium work areas as free as practicable of beryllium and in accordance with the written exposure control plan required under paragraph (f)(1) and the cleaning methods required under paragraph (j)(2) of this standard.
OSHA has not included the requirement that employers maintain all surfaces in beryllium work areas as free as practicable of beryllium in the final standards for construction and shipyards because certain conditions typical in these sectors warrant different approaches in the housekeeping provisions. As discussed in the Summary and Explanation for paragraph (a), Scope and application, in this preamble, although employees in the construction and shipyard industries may be exposed to beryllium during the demolition of beryllium-contaminated buildings and metal recycling or through the dressing of non-sparking tools, the primary exposure source of beryllium at construction worksites and in shipyards is from abrasive blasting operations (Document ID 1671, Attachment 1, p. 5; 1756, Tr. 97-99). Specifically, employees in the construction and shipyard industries are typically exposed when they use abrasive blasting media that contain beryllium.
Abrasive blasting in the construction and shipyard industries often occurs outdoors (see the Final Economic Analysis (FEA), Chapter IV. The surfaces being blasted can be large structures, such as buildings or ships. The blasting process itself can be transient and may occur for short periods of time. The work can be performed in the open or in temporary work enclosures when abrading large objects or structures that cannot be transported or are fixed. These enclosures are typically constructed of tarps and regularly moved from newly abraded areas to areas needing abrasion over very large distances (Document ID 1632, p. 6).
During the abrasive blasting process, large amounts of dust become airborne and then settle on nearby surfaces. Spent blasting media containing trace amounts of beryllium is cleaned up after the blasting operation is complete and has moved to a different area of the worksite. Paragraph (j)(2) of the construction and shipyard standards requires employers to ensure that employees use methods that minimize beryllium exposure during this cleaning process. However, due to the outdoor location of many worksites in construction and shipyards, OSHA finds it is not practical to require employers to maintain all surfaces in work areas as free as practicable of beryllium in construction or shipyards as for general industry. Therefore, OSHA has not included a reference to surfaces in the provisions of in paragraph (j)(1)(i) of the final standards for construction and shipyards. OSHA has modified paragraph (j)(1)(i) of these standards to require only that the employer follow the written exposure control plan required under paragraph (f)(1) when cleaning beryllium-contaminated areas.
When beryllium is released into the workplace as a result of a spill or emergency release, paragraph (j)(1)(ii) of the final standards, like paragraph (j)(1)(ii) of the proposal, requires the employer to ensure prompt cleanup. As defined in paragraph (b) of the final standards, the term “emergency” means any uncontrolled release of airborne beryllium. An emergency could result from equipment failure, rupture of containers, or failure of control equipment, among other causes. Spills or emergency releases not attended to promptly are likely to result in additional employee exposure or skin contact.
Boeing objected to the proposed requirement that employers maintain surfaces and clean up spills or emergency releases in accordance with the written exposure control plans required by paragraph (f)(1), in part, because it did not believe OSHA should require employees to establish a written exposure control plan. Instead, Boeing suggested the Agency revise the standard to allow employers to use “existing processes, such as a written beryllium worksite control procedure” (Document ID 1667, p. 4). To that end, Boeing suggested that employers be allowed to ensure prompt and proper cleanup in accordance with the exposure control plan, “or equally as effective documentation” (Document ID 1667, pp. 6-7). As explained in the Summary and Explanation for paragraph (f), Methods of Compliance, in this preamble, OSHA disagrees with Boeing and has chosen to retain the requirement to establish, implement, and maintain a written exposure control plan. Final paragraphs (j)(1)(i) and (ii) of the standards, like proposed paragraphs (j)(1)(i) and (ii), thus require employers to perform housekeeping activities in accordance with the written exposure control plan required by paragraph (f)(1) and the cleaning methods required by paragraph (j)(2) of the standards.
Paragraph (j)(2) of the proposed rule included a few requirements regarding cleaning methods. Because OSHA recognizes that each work environment is unique, the Agency proposed
Some commenters, including NJH and USW, expressed support for the proposed requirement to use HEPA-filtered vacuuming (
KCP also indicated its support for HEPA vacuums, stating that vacuuming with HEPA filters is the safest way to remove dry contaminants from surfaces (Document ID 1676, Attachment 1, p. 5). However, KCP added that HEPA vacuums do not always work well in tight areas with recesses, crevices, and complex arrangements of equipment components and that workers are likely to use a towel to clean such areas. Because workers will naturally use nearby towels, KCP recommended that OSHA specify that towels used to clean surfaces must be wet, not dry.
The Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) also expressed concern with the proposed provision's reliance on HEPA-filtered vacuuming. The BHSC Task Group observed that although HEPA-filtered vacuuming is considered to be the most effective method for cleaning surfaces, it is not necessarily effective in minimizing the spread of contamination because the vacuums fail in various ways during use. The BHSC Task Group further suggested that if OSHA were to prescribe HEPA-filtered equipment use, it should include a requirement for particle counting during use (Document ID 1665, p. 11).
OSHA finds that HEPA-filtered vacuuming is a highly effective method of cleaning beryllium-contaminated surfaces. However, the Agency acknowledges that any housekeeping equipment may fail and that maintaining the equipment according to the manufacturer's recommendations can be a critical part of ensuring that it functions as intended. (See summary and explanation of paragraph (j)(2)(v) which addresses maintenance of cleaning equipment.) Nevertheless, OSHA believes that when HEPA vacuums are maintained in proper working condition, it is not necessary to include a requirement for particle counting during the vacuuming. In addition, the Agency agrees with KCP that in certain circumstances other cleaning methods, such as wet wiping with towels, may also be effective in minimizing the likelihood and level of airborne exposure. Thus, paragraph (j)(2)(i) of the general industry standard retains the requirement that employers must ensure that surfaces in beryllium work areas are cleaned by HEPA-filter vacuuming or other cleaning methods that minimize the likelihood and level of airborne exposure. However, as discussed in detail below, OSHA has also added provisions to accommodate situations where cleaning with HEPA-filtered vacuums or other cleaning methods that minimize airborne exposure are not effective.
As explained above, OSHA has chosen not to include a provision requiring the cleaning of surfaces in the final construction and shipyard standards. And, as explained in the Summary and Explanation for paragraph (e), the construction and shipyard standards do not include a provision establishing beryllium work areas. Thus, references to surface cleaning and beryllium work areas have been removed from paragraph (j)(2)(i) of the construction and shipyard standards. Paragraph (j)(2)(i) in these standards requires employers to ensure the use of HEPA-filter vacuuming or other methods that minimize the likelihood and level of airborne exposure when cleaning spent blast media or performing other cleaning in beryllium-contaminated areas.
Paragraph (j)(2)(ii) of the proposed rule addressed the use of dry sweeping and brushing for cleaning in beryllium work areas. This proposed provision would have disallowed the use of dry sweeping and brushing unless the employer had tried cleaning with a HEPA-filtered vacuum or another method that minimizes the likelihood and level of exposure, and found that the method attempted was not effective under the particular circumstances found in the workplace. As explained in the proposal, OSHA included this provision to provide employers flexibility when exposure-minimizing cleaning methods would not be effective. See 80 FR 47796. However, the Agency indicated it was not aware of any circumstances in which dry sweeping or brushing would be necessary and requested comment on whether either of these cleaning methods would ever be necessary, and if so, under what circumstances. See 80 FR 47574.
Some commenters expressed general support for the prohibition on dry sweeping and brushing. For example, Ashlee Fitch, representing USW and Materion, commented that HEPA vacuums should be used whenever feasible, and stated that “OSHA has appropriately characterized this provision relative to exceptions” (Document ID 1680, p. 5). ORCHSE also agreed that prohibiting dry sweeping or brushing to clean surfaces in beryllium work areas is appropriate, and that employers should only be permitted to use dry sweeping and dry brushing when HEPA-filtered vacuuming have been tried and found not effective (Document ID 1691, Attachment 1, p. 5).
Commenters AFL-CIO, AWE, the BHSC Task Group, and North America's Building Trades Unions (NABTU), recommended prohibiting the use of dry sweeping under any circumstances (Document ID 1689, p. 13; 1615, p. 1, 9; 1655, p. 11; 1679, p. 9). For example, Clive LeGresley of AWE stated that AWE does not permit dry sweeping or brushing to clean surfaces and recommended banning this practice (Document ID 1615, p. 1). The BHSC Task Group recommended that dry sweeping be prohibited because it disturbs settled beryllium on surfaces, “which can exacerbate airborne contamination” (Document ID 1655, p. 11). It also argued that dry sweeping is not an effective cleaning method, and when dry cleaning is the only available option, dry pickup cloths rather than sweeping should be used (Document ID 1655, p. 13). The AFL-CIO recommended strengthening language in the final rule to prohibit dry housekeeping methods (Document ID 1689, p. 13). In addition, the AFL-CIO pointed out that under the DOE Chronic Beryllium Disease Prevention Program, 10 CFR 850.30 (Housekeeping), the use of dry methods for cleaning floors and surfaces in areas where beryllium is present is prohibited (Document ID 1689, p. 13). NABTU argued that there are no circumstances in which dry sweeping or brushing is necessary, that these practices are unsafe, and the use of such practices would trigger the need to decontaminate entire work areas
In addition, OSHA has considered AFL-CIO's recommendation to require employers who use dry methods to provide a work process description, and finds that a work process description provides no clear benefit to workers using dry methods for cleaning. However, OSHA notes that paragraph (m) of this standard, which requires training for every employee who is or can reasonably be expected to be exposed to airborne beryllium, encompasses any use of dry cleaning methods in the demarcated beryllium work areas (or, in construction and shipyard settings, in beryllium-contaminated areas). Paragraph (m)(4) includes requirements that employees can demonstrate knowledge and understanding of hazards associated with beryllium exposure, operations that could result in airborne exposure, and measures employees can take to protect themselves from airborne exposure to and contact with beryllium. OSHA intends that employees who use dry methods for cleaning beryllium-contaminated surfaces or areas must be trained on the potential for airborne exposure during such cleaning, the hazards associated with such exposure, and the measures they can take to protect themselves, including the requirements of final paragraphs (j)(2)(iv) and (j)(2)(v) discussed later in this section. OSHA finds that these training requirements serve the purpose of providing information to employees regarding the work process, hazards and methods of protection related to dry sweeping, as OSHA believes the AFL-CIO's recommendation intended.
Several stakeholders cited problems with the use of HEPA-filtered vacuums or wet methods in particular circumstances, or noted specific circumstances where they believed the use of dry sweeping was necessary (Document ID 1676, p. 5; 1668, p. 6; 1807, pp. 2-3; 1756, Tr. 42-43). For example, as noted above, KCP argued that HEPA-filtered vacuums do not always work well in tight areas with recesses, crevices, and complex arrangements of equipment components. Materion commented that it generally prohibits the use of dry brushing or broom cleaning for cleaning but, in instances such as machining operations, the use of paint brushes to clean small chips is required. Materion also noted that some manufacturing processes may use dry brushes. It added that when it permits use of a brush, it performs an exposure assessment “to help ensure the task is well controlled” (Document ID 1807, Attachment 1, pp. 2-3). In addition, Jerrod Weaver from the Non-Ferrous Founders' Society (NFFS) testified that dry sweeping is “not unusual” in the foundry industry. He explained that the use of wet sweeping or other wet cleaning methods would be dangerous in foundries because when water hits molten metal, it can cause an explosion (Document ID 1756, Tr. 42-43).
Other stakeholders offered opinions on when the use of dry sweeping and dry brushing should be constrained. For example, the Southern Company argued that when dry sweeping does not result in exposure to beryllium above the action level, it should be considered a feasible cleaning option (Document ID 1668, p. 6). Similarly, Ameren Corporation stated that “prohibiting dry sweeping should be based on employee exposure at or above the action level, not whether it's a beryllium work area” (Document ID 1675, p. 6). As discussed in Section V, Health Effects, and Section VI, Risk Assessment, the best available scientific evidence suggests that adverse health effects such as beryllium sensitization and CBD can result from airborne exposures below the action level of 0.1 μg/m
After carefully reviewing the evidence in the record, OSHA finds that the use of dry sweeping and dry brushing can contribute to employee exposure. However, OSHA also finds convincing evidence that wet methods and HEPA-filtered vacuums may not be safe or effective in all situations in general industry. For example, wet sweeping in certain foundry work areas may be effective but is not safe because of the physical hazard created when water comes into contact with molten metal. Therefore, the Agency has retained both the prohibition on dry sweeping and dry brushing and the exceptions to that prohibition in paragraph (j)(2)(ii) of the final standard for general industry. Although OSHA has decided not to allow these methods based on a specific exposure level, OSHA has revised (j)(2)(ii) to clarify that employers may use dry sweeping or dry brushing to clean surfaces where HEPA-filtered vacuuming or other appropriate methods that minimize likelihood and level of exposure are not safe or effective. The proposed provision merely stated that employers could utilize the dry sweeping or brushing when HEPA-filtered vacuuming or the other methods were not “effective.” The Agency intended this term to encompass those situations in which HEPA-filtered vacuuming or the other chosen method would not accomplish the task at hand,
In sum, final paragraph (j)(2)(ii) of the general industry standard states that the employer must not allow dry sweeping or brushing for cleaning surfaces in beryllium work areas unless HEPA-filtered vacuuming or other methods that minimize the likelihood and level of airborne exposure are not safe or effective. In situations where HEPA-filtered vacuuming or other methods that minimize the likelihood and level of airborne exposure would be ineffective, would cause damage, or would create a hazard in the workplace, the employer is not required to use these cleaning methods. The revised paragraph (j)(2)(ii) gives employers the necessary flexibility to use dry sweeping or dry brushing in such situations.
Although OSHA is allowing for dry sweeping and brushing, the Agency anticipates that the number of circumstances where these methods are necessary will be extremely limited. Where the employer uses dry sweeping or brushing, the employer must be able to demonstrate that HEPA-filtered vacuuming or other methods, such as wet sweeping, that minimize the likelihood or exposure are not safe or effective. To comply with the final rule, it is enough for employers to demonstrate that such cleaning methods
OSHA notes that methods that minimize the likelihood and level of airborne exposure other than HEPA vacuuming may be appropriate for use in construction and shipyards. Use of wet methods, such as wet sweeping or wet shoveling, or using mechanical equipment to move wetted material, may be viable alternatives for cleaning large amounts of spent blasting media used in abrasive blasting operations.
Paragraph (j)(2)(iii) of the proposed rule would have prohibited the use of compressed air in cleaning beryllium-contaminated surfaces unless it was used in conjunction with a ventilation system designed to capture any resulting airborne beryllium. As OSHA indicated in the proposal, this provision was intended to limit airborne exposure by preventing the dispersal of beryllium into the air (80 FR 47796).
Stakeholders offered a number of comments on the use of compressed air. For example, NJH expressed support for this provision, and emphasized that compressed air should only be used in conjunction with a ventilation system (Document ID 1664, p. 7). Several commenters discussed the use of compressed air for cleaning and other processes. Materion commented that it generally prohibits the use of compressed air, but production operations may incorporate compressed air into manufacturing processes (Document ID 1807, Attachment 1, p. 3). Materion further commented that on the few occasions when it permits the use of compressed air, it performs an exposure assessment “to help ensure the task is well controlled” (Document ID 1807, Attachment 1, p. 3). Mr. Weaver, a representative of NFFS, testified that the use of compressed air in the foundry industry is “not unusual” (Document ID 1756, Tr. 42). He added that compressed air is useful for cleaning work surfaces (Document ID 1756, Tr. 42).
Some commenters, including the AFL-CIO, AWE, and United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), objected to the use of compressed air for cleaning (Document ID 1615 p. 1; 1689, p. 13; 1693, p. 4). For example, the AFL-CIO noted that the DOE Chronic Beryllium Disease Prevention Program prohibits the use of compressed air and dry methods for cleaning floors and surfaces in areas where beryllium is present (Document ID 1689, p. 13). And, UAW stated that “[c]apture hoods capable of reliably controlling particulates pushed by compressed air do not exist” (Document ID 1693, p. 4).
OSHA has carefully considered these comments and finds that the use of compressed air to clean beryllium-contaminated surfaces may occasionally be necessary in general industry; particularly in manufacturing processes. Therefore, paragraph (j)(2)(iii) of the final standards allows for the use of compressed air to clean, but only where the compressed air is used in conjunction with a ventilation system designed to capture the particulates made airborne by the use of compressed air. This provision is consistent with other recent substance-specific standards, such as the standard for respirable crystalline silica (29 CFR 1910.1053).
Because the standards for construction and shipyards do not include a provision establishing beryllium work areas, paragraph (j)(2)(iii) of these standards states that employers must not allow the use of compressed air for cleaning in beryllium-contaminated areas unless the compressed air is used in conjunction with a ventilation system designed to capture the particulates made airborne by the use of compressed air. OSHA intends this paragraph to apply when using compressed air to clean, for example, surfaces in work areas, tarps used for abrasive blasting enclosures, abrasive blasting equipment, and material designated for recycling or disposal in order to prevent dispersal of beryllium into workers' breathing zones.
OSHA recognizes that even the limited uses permitted under these standards of dry sweeping, dry brushing, and compressed air to clean can result in employee exposure to beryllium. To help mitigate the potential health risks, OSHA included a provision in the proposed rule to further protect employees who are using these cleaning methods. Under proposed paragraph (j)(2)(iv), where employees use dry sweeping, brushing, or compressed air to clean beryllium-contaminated surfaces, the employer was required to provide respiratory protection and protective clothing and equipment and ensure that each employee use this protection in accordance with paragraphs (g) and (h) of this standard. As OSHA explained in the proposal, the failure to provide proper and adequate protection to those employees performing cleanup activities would defeat the purpose of the housekeeping practices required to control beryllium exposure. See 80 FR 47796.
In its post-hearing comments, the AFL-CIO indicated support for this requirement. Specifically, the AFL-CIO argued that if dry housekeeping methods are permitted, “workers should be provided a N-95 respirator—or a higher level of protection as required based on the exposure—and personal protective clothing” (Document ID 1809, p. 2). After considering the record on this issue, OSHA concludes that requiring employers to provide respiratory protection and protective clothing and equipment in the limited situations where dry sweeping, brushing, or compressed air is used is essential to minimize exposure. Therefore, the Agency has included this provision in paragraph (j)(2)(iv) of the final standard for general industry. OSHA has also included a similar provision in paragraph (j)(2)(iv) of the final standards for construction and shipyards. Proposed paragraph (j)(2)(v) would have required employers to ensure that equipment used to clean beryllium from surfaces is handled and maintained in a manner that minimizes employee exposure and the re-entrainment of beryllium into the workplace environment. Re-entrainment occurs when particles that have settled on surfaces become airborne and remain suspended in the air. Beryllium particles that have been disturbed from surfaces and re-entrained contribute to employee's airborne beryllium exposure. Commenters generally supported the inclusion of this provision in the final rule. For example,
Paragraph (j)(3)(i) of the proposed rule would have required the employer to ensure that waste, debris, and materials visibly contaminated with beryllium and consigned for disposal were disposed of in sealed, impermeable enclosures, such as bags or containers. Paragraph (j)(3)(ii) would have further required such bags or containers to be labeled in accordance with paragraph (m)(3) of the proposed rule. Finally, paragraph (j)(3)(iii) of the proposed rule would have required materials designated for recycling that are visibly contaminated with beryllium to be either cleaned to remove visible particulate, or placed in sealed, impermeable enclosures, such as bags or containers, that are labeled in accordance with paragraph (m)(3) of the proposed rule.
OSHA intended these provisions to protect and inform workers who may be exposed to beryllium when handling waste or recycled materials. As discussed in the NPRM, alerting employers and employees who are involved in disposal to the potential hazards of beryllium exposure will better enable them to implement protective measures (80 FR 47771). OSHA reasoned that employers and employees should be similarly alerted if handling materials designated for recycling that have not been cleaned of visible particulate. The proposed requirements to use impermeable enclosures and/or clean materials of visible particulate were intended to reduce employees' risk of beryllium sensitization from dermal contact with beryllium in handling waste materials or materials designated for recycling. The options provided to employers in proposed paragraph (j)(3)(iii) were intended to allow employers flexibility to facilitate the recycling process.
In the NPRM, OSHA asked for feedback on proposed paragraph (j)(3) (80 FR 47574). A number of stakeholders responded. For example, NFFS argued that:
Some commenters, including USW, generally agreed with OSHA's proposed disposal and recycling requirements (
However, many other stakeholders argued in favor of cleaning or enclosing all beryllium-contaminated materials designated for recycling and enclosing such materials destined for disposal. For example, the BHSC Task Group, NJH, the National Institute for Occupational Safety and Health, Southern Company, NFFS, AIHA, NABTU, and ORCHSE disagreed with the proposal's use of the term “visible” when determining whether the provisions for containment and labeling included in proposed paragraph (j)(3) should apply to materials designated for recycling or disposal (
As discussed previously in the Summary and Explanation for paragraph (h), Personal protective clothing and equipment, in this preamble, OSHA finds that “visibly contaminated” is a subjective trigger for most purposes in the final standards, and dermal contact with beryllium can cause beryllium sensitization even if the beryllium is not visible to the naked eye. OSHA therefore agrees with the commenters who criticized the use of “visibly contaminated.” (see,
OSHA also agrees with ORCHSE that materials discarded from beryllium work areas in general industry should be in bags or other containers for the protection of municipal and commercial disposal workers (Document ID 1691, p. 5). However, OSHA disagrees with NFFS's comment that “sealed, impermeable enclosures” is problematically vague (Document ID 1678, p. 5). OSHA intends this term to be broad and the provision performance-oriented, so as to allow employers in a variety of industries flexibility to decide what type of enclosures (
In addition, the BHSC Task Group stated that certain beryllium-contaminated items should not be considered for recycling. According to the BHSC Task Group, only materials scheduled for use within beryllium regulated areas at other facilities, and not by the general public, should be recycled. The BHSC Task Group recommended surface wipe sampling to determine whether items should be decontaminated again and should be resampled prior to recycling; otherwise, if not meeting established limits, they should be disposed of according to “appropriate waste management practices” (Document ID 1655, p. 13). After careful consideration, OSHA has decided not to adopt the BHSC Task Group's suggestion. The Agency finds that the requirement to either clean and label or enclose and label beryllium-contaminated or containing materials designated for recycling should provide protection for later recipients of these items, as discussed in more detail below.
In addition to the previously discussed changes to the proposed rule, which were directly related to comments received by OSHA, the Agency has made several changes to better implement and communicate the intention of paragraph (j)(3). First, OSHA has modified the provisions of paragraph (j)(3) to state that it applies to materials that contain beryllium as well as materials contaminated with beryllium. OSHA finds that employers and employees who work with materials that were recycled or discarded by other facilities should be made aware of any beryllium-containing materials they process. Provisions to ensure awareness of beryllium in materials received from other facilities aid employers who otherwise might not know they are required to comply with the beryllium standard, and employees who otherwise might not be appropriately protected or adequately informed about potential beryllium exposures in their workplace.
Second, the requirements of (j)(3) regarding labeling materials designated for recycling have been modified. While the proposed rule required materials designated for recycling to be labeled in accordance with paragraph (m)(3) only if employers choose to enclose rather than clean them, the final standards require employers to label materials designated for recycling in either case. This modification, like OSHA's addition of the reference to beryllium-containing materials discussed above, ensures that employers and employees who work with materials that were recycled by other facilities are aware of any beryllium-containing materials they process. OSHA also modified the requirements of proposed paragraph (j)(3) for the construction and shipyard sectors. Paragraph (j)(3) of the construction and shipyard standards requires employers who transfer materials containing beryllium to another party for use or disposal to provide the recipient with a copy of the warning described in paragraph (m)(3) of the standards, for the same reasons this requirement was retained in the final general industry standard. However, employers in construction and shipyards are not required to place beryllium-containing materials in sealed, impermeable enclosures for use or disposal by other entities. OSHA made this change from paragraph (j)(3) of the general industry standard because the Agency believes that spent media from abrasive blasting operations will constitute the great majority of beryllium-containing materials designated for disposal or recycling in construction and shipyards and it is generally not practical for employers to enclose spent blasting media in sealed, impermeable bags or containers, because of the large volume of waste material generated in these operations OSHA finds that requiring employers in construction and shipyards to include a warning label on beryllium-containing materials designated for disposal or reuse, but not requiring them to seal such materials in impermeable enclosure, appropriately informs recipients of the potential hazards of handling the materials without imposing impractical containment requirements on these employers. In addition, these separate requirements for construction and shipyards are responsive to Materion's concern regarding the technological and economic feasibility of cleaning or enclosing materials contaminated with surface residue from abrasive blasting.
In summary, paragraph (j)(3)(i) of the final standard for general industry requires that items containing or contaminated with beryllium and designated for disposal be disposed of
Finally, USW and Materion requested that OSHA make it clear that this provision does not apply to beryllium-containing scrap metals being reused within the facility (Document ID 1680, p. 6; 1661 p. 12). USW offered the example of copper beryllium machine turnings being utilized within the same facility. The union explained: “In this example, it would not make sense to require cleaning or enclosing because they are either very clean to start with or have a thin coating of machining coolant. Requiring them to be cleaned before reuse in the facility might actually lead to greater worker exposures” (Document ID 1680, p. 6).
OSHA did not intend to require employers to clean or enclose materials designated for reuse elsewhere in the same facility. Therefore, OSHA clarifies that paragraph (j)(3)(ii)'s requirements do not apply to scrap metals designated for reuse within the same facility.
Paragraph (k) of the final standards 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 licensed physician and CBD diagnostic center is to provide to the employee and employer. Many of the provisions in the final standards are substantively consistent with the 2012 joint draft recommended standard by Materion Corporation (Materion) and the United Steelworkers (USW) (Document ID 0754).
The purposes of medical surveillance for beryllium are: (1) To identify beryllium-related adverse health effects so that appropriate intervention measures can be taken; (2) to determine if an employee has any condition that might make him or her more sensitive to beryllium exposure; and (3) to determine the employee's fitness to use personal protective equipment such as respirators. The inclusion of medical surveillance in these final standards is consistent with section 6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), which requires that, where appropriate, medical surveillance programs be included in OSHA health standards to aid in determining whether the health of employees is adversely affected by exposure to the hazards addressed by the standard. Almost all other OSHA health standards, such as Chromium (VI) (29 CFR 1910.1026), Methylene Chloride (29 CFR 1910.1052), Cadmium (29 CFR 1910.1027), and Respirable Crystalline Silica (29 CFR 1910.1053), have also included medical surveillance requirements and OSHA finds that a medical surveillance requirement is appropriate for the beryllium standards because of the health risks resulting from exposure.
OSHA clarifies that employees of beryllium vendors who qualify for benefits under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) (42 U.S.C. 7384-7385s-15) and its implementing regulations (20 CFR part 30) may also qualify for medical surveillance benefits under this final standard. Medical benefits provided to covered employees for covered beryllium diseases under the EEOICPA program are paid for by the federal government.
Employees covered by both the EEOICPA program and this final standard will not be required to choose between the programs. Rather, these dual-coverage employees may undergo medical examinations where they can receive the services and/or treatment covered under both programs. Treatment and services for covered beryllium disease of a covered beryllium employee under the EEOICPA program will be paid for by the federal government to the extent that the services provided are covered under the EEOICPA program. If this final standard requires services or treatment that are not covered by the EEOICPA program, the employer will be required to pay for these additional services.
OSHA received numerous comments during the public comment period regarding the inclusion of the medical surveillance provision for the beryllium standard. Most comments supported inclusion of medical screening or surveillance in the final beryllium standard, including those from National Safety Council (NSC), Materion, National Jewish Health (NJH), North America's Building Trades Union (NABTU), USW, the American College of Occupational and Environmental Medicine (ACOEM), the American Thoracic Society (ATS), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), ORCHSE Strategies (ORCHSE), the National Institute of Occupational Safety and Health (NIOSH), and Public Citizen (
In support of medical surveillance, the AFL-CIO and others indicated that medical surveillance is essential in screening for sensitization and preventing CBD (Document ID 1658, p. 3; 1689, p. 13). As noted in Section V, Health Effects, employees in the early stages of beryllium disease are often asymptomatic, and as a result, medical surveillance is critical to identify those employees who may benefit from interventions such as removal from exposure. ATS also commented that medical surveillance helps to identify those with sensitization and potentially CBD, as well as to define the risk of various work exposures, jobs, and tasks (Document ID 1688, p. 3). Commenter Evan Shoemaker said surveillance could “inform employers that workplace controls and safeguards need updating” (Document ID 1658, p. 3).
NJH commented that early disease detection, before symptoms occur, is the cornerstone for managing work-related disease (Document ID 1806, pp. 2-3). Studies highlighted by NJH show that medical surveillance could be important for identifying workers that might
NJH also submitted evidence showing that once employees do develop symptoms, the knowledge that the symptoms are caused by CBD could lead to treatment to improve outcome (Document ID 1806, pp. 2-3). NJH found that identifying disease at an early stage allows the use of inhaled corticosteroids for mild symptoms, which it found to be effective for reducing expected levels of lung function decline and improving lung function and cough in employees with lower lung function (Document ID 1811, Attachment 8). Early detection of beryllium disease and identification of employees who would benefit from oral corticosteroid treatment before fibrosis develops can result in regression of signs and symptoms and possibly prevent progression of the disease (Marchand-Adam
In paragraphs (k)(1)(i)(A)-(C) of the proposal, OSHA specified that employers must “make medical surveillance as required by this paragraph available” for each employee: (1) Who has worked in a regulated area for more than 30 days in the last 12 months; (2) showing signs or symptoms of CBD, such as shortness of breath after a short walk or climbing stairs, persistent dry cough, chest pain, or fatigue; or (3) exposed to beryllium during an emergency. OSHA requested comments on these triggers and also presented alternatives to expand eligibility for medical surveillance to a broader group of employees (80 FR 47565, 47571, 47576). Under Regulatory Alternative #14, medical surveillance would have been available to employees who are exposed to beryllium above the proposed permissible exposure limit (PEL), including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would have expanded eligibility for medical surveillance to employees who are exposed to beryllium above the proposed action level, including employees exposed for fewer than 30 days per year.
OSHA received numerous comments related to each of the proposed triggers. First, a number of stakeholders commented on the proposed trigger of working in a regulated area,
ATS and NJH supported expanding medical surveillance to all employees exposed to beryllium in beryllium work areas (above or below the action level), because of remaining significant risk at the PEL and because exposure monitoring is sporadic and may not always reflect higher exposures (Document ID 1664, p. 1; 1688, pp. 2, 4). Lisa Maier, M.D., from NJH further indicated that medical surveillance should be offered to these employees, regardless of the amount of time they spend in the work areas (Document ID 1756, Tr. 101-103). To support this recommendation, NJH referenced three studies (Henneberger
The National Supplemental Screening Program (NSSP), an organization that provides medical screening for former Department of Energy workers, and ACOEM supported an action level trigger, including for employees exposed for less than 30 days a year (Document ID 1677, p. 3; 1685, p. 4; 1756, Tr. 83-84). However, Lee Newman, MD, who represented ACOEM at the public hearing, testified that he personally felt that medical surveillance should be offered to anyone who has worked in a beryllium work area with measurable beryllium exposures (Document ID 1756, Tr. 84). Dr. Newman stated that his personal opinion was based upon his “30 years of experience of working with people [exposed to beryllium” and “the studies that [he and his colleagues] have done” (Document ID 1756, Tr. 84).
In contrast, Materion argued medical surveillance should be triggered by exposures above the PEL because Johnson
Based on the comments and other record evidence, OSHA finds that triggering medical surveillance at the action level of 0.1 μg/m
Moreover, OSHA finds that an action level trigger for medical surveillance encourages employers to maintain exposures below that level, which in turns provides reasonable assurance that exposures will not exceed the PEL on days when exposures are not measured (See Summary and Explanation for paragraphs (b), Definitions, and (d), Exposure Assessment). Therefore, an action level trigger in these standards is also appropriate to address stakeholder concerns, such as those raised by ATS and NJH, that exposure assessments might underestimate actual exposures due to variability in exposure levels or other factors.
Medical surveillance triggered by the action level is the norm for OSHA health standards. Materion noted two exceptions, observing that medical surveillance is not triggered at the action level in standards for formaldehyde and coke oven emissions. However, the Coke Oven Emissions standard does not include an action level, and the trigger for medical surveillance is employment in a regulated area, which is a discretely identified area on or around the coke oven battery, for at least 30 days a year (29 CFR 1910.1029). Significantly, the Coke Oven Emissions standard requires employers to assure that no employee in the regulated area is exposed to coke oven emissions at concentrations greater than the PEL (29 CFR 1910.1029(c)). Therefore, the trigger in the Coke Oven Emissions standard, which would include employees who are exposed to levels no higher than the PEL for at least 30 days per year, is more protective than a requirement that does not trigger medical surveillance until exposures exceed the PEL for 30 days a year. With the exception of formaldehyde, OSHA standards trigger medical surveillance at exposure levels at or below the PEL, and typically at the action level.
In sum, OSHA is persuaded that a lower trigger for medical surveillance is necessary because of the remaining health risk at both the action level and PEL. However, OSHA is not persuaded by those commenters who advocated triggering medical surveillance below the action level, in part, because nearly everyone in the general population is potentially exposed to beryllium as it is a naturally occurring compound in rocks and soil. In addition, the lack of conclusive evidence of non-industrial-related beryllium-related disease in the record suggests there is a level of exposure at which the risk of developing beryllium-related disease becomes negligible, but OSHA does not have information to precisely determine that level. As a result, offering medical surveillance to all potentially exposed employees would result in some low-risk employees receiving medical examinations when they have very little likelihood of benefiting from those examinations. OSHA is especially concerned by this because some medical examination components, such as the BeLPT, are invasive. In addition, OSHA finds that triggering surveillance at a level that is achievable for some employers is important because it provides employers with an incentive to keep exposures low to avoid the costs of providing medical surveillance. Employees benefit from those lower exposures because it reduces their risk of developing disease. Triggering medical surveillance at any level of exposure eliminates the incentive to keep exposures low and thus may be counterproductive to protecting employees.
In conclusion, an action level trigger is appropriate because it is a level at which risks are measurable and found to be lower than at the PEL, especially for employees who may be more susceptible to developing disease. The action level is achievable for many employers, and those employers are likely to maintain exposures below the action level to avoid the costs associated with exposure assessments and offering medical surveillance. Maintaining exposures below the action level also benefits employees because it decreases the chances that exposures will not exceed the PEL on a day on which exposure assessments are not conducted, and it lowers the risk of developing disease. For those reasons, an action level trigger is appropriate in the beryllium standard, consistent with the majority of OSHA standards.
Comments were also received on the 30-day duration as part of the medical surveillance trigger. NIOSH supported it (Document ID 1725, p. 32; 1755, Tr. 40). However, NJH, NSSP, and ACOEM did not support OSHA's proposed duration trigger of more than 30 days a year, stating that eligible employees exposed less than 30 days a year should be offered medical surveillance (Document ID 1664, p. 9; 1677, p. 3; 1685, p. 4).
Other stakeholders did not support extending medical surveillance to employees exposed for fewer than 30 days per year. For example, DOD commented that “[w]hile it is conceivable that workers can be sensitized to beryllium after brief exposures, it is unlikely that infrequent, brief exposures will cause either sensitization or chronic beryllium disease” (Document ID 1684, Attachment 2, p. 1-2).
After careful consideration of these comments and other evidence in the record, OSHA finds that maintaining the 30-day exposure-duration trigger is appropriate in the final standards because the Agency's risk assessment shows increasing risk of health effects from exposure at increasing cumulative exposures, which considers both exposure level and duration (See Section VI, Risk Assessment). OSHA finds that a 30-day trigger is a reasonable benchmark for capturing increasing risk from 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), Asbestos (29 CFR 1910.1001), and Respirable Crystalline Silica (29 CFR 1910.1053). As discussed in more detail below, OSHA notes that the triggers in final paragraphs (k)(1)(i)(B) and (C) may address employees who could be at risk, even though they may not have had repeated exposures.
Therefore, OSHA has decided to revise the first proposed medical surveillance trigger to require the offering of medical surveillance based on exposures at or above the action level, rather than the PEL (i.e, work in a regulated area). But the Agency will retain the 30-day-per-year-exposure-duration trigger. In addition, OSHA has chosen to revise the proposed trigger to require employers to make medical surveillance available to each employee “who is or is reasonably expected to be exposed . . . for more than 30 days a year,” rather than waiting for the 30th day of exposure to occur. OSHA made this revision because the proposed provision, in combination with paragraph (k)(2)(i)(A), may not have resulted in timely medical examinations for new employees who are not exposed to beryllium concentrations above the action level every day. For example, a new employee exposed to beryllium once per week would not receive a
The proposal's “regulated area” trigger corresponded to setting the trigger at the PEL, and so has been superseded by the final rule's action level trigger. The elimination of the “regulated area” trigger may also affect whether employees exposed above the short-term exposure limit (STEL) receive medical surveillance. As noted above and discussed extensively in the Summary and Explanation for paragraph (e), the proposed standard defined the term “regulated area” to mean an area that the employer must demarcate, including temporary work areas where maintenance or non-routine tasks are performed, where an employee's exposure exceeds, or can reasonably be expected to exceed, either of the permissible exposure limits (PELs). Proposed paragraphs (c) and (e) made clear that this definition included both the proposed 8-hour TWA PEL and the proposed STEL. Because the revised trigger in final paragraph (k)(1)(i)(A) focuses on the action level, rather than working in a regulated area, it does not directly require medical surveillance for employees who are exposed above the STEL, provided their airborne exposure levels do not exceed the action level for more than 30 days per year.
However, as explained in Chapter IV-Section 15 of the Final Economic Analysis and discussed in the Summary and Explanation for paragraph (c), Permissible Exposure Limits (PELs), the occurrence of one or more short-term exposures to elevated airborne concentration during a work shift can substantially increase a worker's 8-hour TWA exposure. For example, the TWA exposure of a worker who is exposed to a background level at the final action level of 0.1 μg/m
One commenter, ORCHSE, argued that a symptom trigger should only apply to confirmed positive,
After carefully considering these comments, OSHA reaffirms its preliminary finding that the proposed signs-or-symptoms trigger serves as a valuable complement to the use of airborne exposure triggers as a mechanism for initiating medical surveillance. A signs-or-symptoms trigger is appropriate for employees covered by the standard because the risk of material impairment of health remains significant at the action level (see Section VI, Risk Assessment). Consequently, even employees exposed at the action level for fewer than 30 days in a year may be at risk of developing CBD and other beryllium-related diseases and adverse health effects. In addition, beryllium sensitization and CBD could develop in employees who are especially sensitive to beryllium, may have been unknowingly exposed, or may have been exposed to greater amounts than the exposure assessment suggests. By requiring covered employers to make a medical exam available when an employee exhibits signs or symptoms, the final standard protects all employees who may have developed CBD, including employees who have been exposed to beryllium in an emergency or for less than 30 days above the action level.
OSHA also finds that signs or symptoms of beryllium-related health effects other than CBD should also trigger medical surveillance (see Section V, Health Effects). As noted by NJH and ACOEM, these signs or symptoms can be indicative of beryllium-related skin disease or a sign of exposure that could lead to sensitization. For example, dermatitis that is unresponsive to treatment but responsive to removal from exposure may be a sign of a beryllium-related health effect. Other skin symptoms, such as reddened, elevated or fluid-filled lesions following contact with soluble beryllium compounds and ulceration or granulomas from soluble or poorly soluble beryllium compounds entering through cuts or scrapes, can also be a sign of a beryllium-related health effect (See Section V, Health Effects). Therefore, OSHA has revised paragraph (k)(1)(i)(B) to include signs or symptoms of other beryllium-related health effects.
OSHA disagrees with ORCHSE's recommendation that the final standards apply this trigger only to employees who have been confirmed positive,
Second, as discussed in more detail below, under the final standards, employers do not automatically find out whether their employees have been confirmed positive. If an employee chooses not to inform his or her employer of this fact, the employer may never find out. See paragraphs (k)(6) and (k)(7) of the final standards.
Third, OSHA recognizes that signs and symptoms associated with adverse health effects of beryllium such as CBD and skin sensitization may be non-specific (
However, ORCHSE's comment does raise the concern that the non-specific signs and symptoms listed in the proposal,
Finally, OSHA emphasizes that although this provision requires employers to offer medical surveillance if persistent or recurring symptoms related to CBD or other beryllium-related health effects are reported to or observed by the employer (
Emergencies. Proposed paragraph (k)(1)(i)(C) required employers to offer medical surveillance to employees exposed during an emergency. Although an emergency trigger for medical surveillance was not included in the joint draft recommended standard by Materion and USW, none of the comments on the proposal objected to its inclusion in the final rule (Document ID 0754). At least one commenter, NJH, supported a trigger for employees exposed in an emergency (Document ID 1664, p. 4).
OSHA agrees with NJH that such a trigger is appropriate because emergency situations involve uncontrolled releases of airborne beryllium, and the significant exposures that can occur in these situations justify a requirement for medical surveillance. Therefore, OSHA has decided to include this provision as part of the final standards in paragraph (k)(1)(i)(C). As in the proposal, medical surveillance triggered by airborne exposures in emergency situations must be offered regardless of the airborne concentrations of beryllium to which these employees are routinely exposed in the workplace. The requirement for medical examinations after airborne exposure in an emergency is consistent with several other OSHA health standards, including the standards for Chromium (VI) (29 CFR 1910.1026), Methylenedianiline (29 CFR 1910.1050), 1,3-Butadiene (29 CFR 1910.1051), and Methylene Chloride (29 CFR 1910.1052).
OSHA agrees that an employee who is confirmed positive should continue to receive medical surveillance to determine if progression from sensitization to CBD occurs and to monitor the severity of disease if progression does occur. As discussed below, the standards provide for medical surveillance every 2 years in certain cases, such as when the employee continues to be exposed above the action level for more than 30 days a year, when the employee continues to have signs or symptoms of CBD or other beryllium-related health effects, or when an employee is exposed to beryllium during an emergency. However, under these first three triggers, periodic surveillance would end if an employee no longer met those triggers. Thus, an employee who was confirmed positive and no longer meets these triggers might not qualify for medical surveillance again until he or she develops signs or symptoms of disease. This gap in coverage is especially concerning considering the potentially long lag time between sensitization and the development of CBD and the benefits of early detection (see Section V, Health Effects).
To allow for continued medical surveillance to this limited group of high risk employees who would not otherwise be eligible for periodic examinations, OSHA has added final paragraph (k)(1)(i)(D), which requires that medical surveillance be made available when the most recent written medical opinion to the employer recommends continued medical surveillance. Under final paragraphs (k)(6) and (k)(7), the written opinion must contain a recommendation for continued periodic medical surveillance if the employee is confirmed positive or diagnosed with CBD, and the employee provides written authorization. Under these provisions, the employer will only receive the recommendation for continued periodic medical surveillance with the employee's written consent. However, even where the employee provides his or her written consent, the written opinion must not include any specific findings or diagnoses that led to the recommendation for continued surveillance. Instead, the licensed physician or CBD diagnostic center's written opinion would simply recommend continued periodic medical surveillance. As discussed in more detail below, OSHA chose this method to convey the need for continued medical evaluations for employees who are confirmed positive or diagnosed with CBD, while protecting the employee's privacy by not revealing to the employer the specific finding that triggered the recommendation for continuing medical examinations.
OSHA notes that although this requirement was not included in either the proposed standard or the joint draft recommended standard by Materion and USW (Document ID 0754), proposed paragraph (k)(1)(i)(D) (discussed below) would have allowed for limited medical surveillance (
OSHA received comments on this subject from a variety of stakeholders, including public health officials and representatives from industry and labor. ATS stated that due to the complex nature of CBD and sensitization, including multi-organ involvement and atypical presentations, all medical procedures should be carried out by or under the direction a licensed physician (Document ID 1688, p. 4). Similar support for medical procedures to be carried out by or under the direction of a licensed physician was expressed by NJH, Ameren, NSSP, NIOSH, and ACOEM (Document ID 1664, p. 8; 1675, p. 18; 1677, p. 7; 1755, Tr. 27; 1756, Tr. 82). Materion commented that in the joint draft recommended standard, Materion and USW intended for a licensed physician to perform certain critical aspects of medical surveillance such as diagnosis and preparation of the written medical opinion (Document ID 1661, Attachment 2, p. 7). NABTU commented that medical and nursing experts supervise medical screening of Department of Energy workers in a program that is administered by the Center for Construction Research and Training (CPWR) (Document ID 1679, p. 10).
OSHA recognizes that the requirement for a licensed physician to provide oversight and some services required under the standard departs from policy in recent standards, such as Chromium (VI) (29 CFR 1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053). In the recently promulgated Respirable Crystalline Silica standard, OSHA allowed medical services to be provided by a PLHCP, defined as an individual whose legally permitted scope of practice (
In contrast to the silica rulemaking record, the beryllium rulemaking record shows support for a licensed physician to oversee and perform certain functions of medical surveillance and lacks evidence showing that licensed physicians may be limited in certain areas. As a result, OSHA is requiring in final paragraph (k)(1)(ii) that the employer ensure that all medical examinations and procedures required by the standard are performed by, or under the direction of, a licensed physician. In the case of the beryllium standard, OSHA finds this requirement strikes an appropriate balance between ensuring that a licensed physician supervises the overall care of the employee, while giving the employer the flexibility to retain the services of a variety of qualified licensed health care professionals to perform certain other services required by paragraph (k). Therefore, final paragraph (k)(1)(ii) requires the employer to ensure that all medical examinations and procedures required by the standard are performed by, or under the direction of a licensed physician.
As noted above, a number of stakeholders supported a baseline examination. For example, ACOEM recommended that the criteria for inclusion in the medical surveillance program be revised to clearly indicate a baseline examination and BeLPT for employees assigned to regulated areas (Document ID 1685, p. 4). Similarly, NABTU and AFL-CIO commented that medical screening of employees should be done before they start working in a beryllium area (Document ID 1679, p. 12; 1689, p. 13). NJH also recommended a BeLPT at the beginning of employment but stated that some of their clients do the exams within 30 days to not influence hiring practices (Document ID 1664, p. 7). Ameren and NSSP commented that 30 days from initial assignment is a reasonable period to provide an examination; however, NSSP recommended a baseline BeLPT at the time of employment, while Ameren indicated that a baseline BeLPT should be at the employer's discretion based on employment history (Document ID 1675, pp. 15-16; 1677, p. 6). These comments run contrary to the proposed requirement allowing employers to withhold offering medical surveillance until after more than 30 days of exposure.
OSHA is persuaded that it is appropriate to trigger medical surveillance within 30 days after making the determinations described in final paragraphs (k)(2)(i)(A) and (B). As a result of changes made to final paragraph (k)(1)(i)(A), the initial exam required under final paragraph (k)(2)(i)(A) is now triggered within 30 days after the employer determines that the employee is or is reasonably expected to be exposed at or above the action level for more than 30 days of year. This revised trigger for medical surveillance in the final beryllium standard is consistent with Ameren and NSSP recommendations to provide an exam within 30 days of initial assignment. OSHA finds that it is a reasonable period to offer medical surveillance because new employees are not likely to experience signs of beryllium exposure during that time, and it provides employers with administrative convenience because it gives them time to make the appointment, in addition to maintaining consistency with most OSHA standards, such as the Respirable Crystalline Silica (29 CFR 1910.1053). In response to Ameren's comment, OSHA acknowledges that an employee who was not previously exposed to beryllium would not be at risk for sensitization. However, an employer may not have a complete occupational exposure history to rule out prior beryllium exposure of the employee, and the employee may not be aware that he or she was exposed. OSHA considers a baseline BeLPT within 30 days of when the employer determines that the employee is reasonably expected to be exposed for more than 30 days a year to be prudent to rule out sensitization in an employee who may have previously been exposed to beryllium unknowingly. Providing a baseline examination is also consistent with the joint draft recommended standard by Materion and USW, which recommended that medical surveillance including a BeLPT be made available to employees who are expected to meet the trigger for medical surveillance (Document ID 0754, pp. 7-8).
Final paragraph (k)(2)(i)(A) also differs from the proposal in that in the proposed paragraph the employer did not have to offer an examination if the employee had received an equivalent examination within the last 12 months. In the final rule, this was increased to two years to align that provision with the frequency of periodic examinations, which is every two years in the final standards. The reason why frequency of periodic examinations was changed from every year to every two years is discussed below. In sum, paragraph (k)(2)(i)(A) requires the employer to make a medical examination available to employees who meet the criteria of paragraph (k)(1)(i)(A), unless the employee received a medical examination provided in accordance with the standard, within the last two years.
As noted above, proposed paragraph (k)(2)(i)(B) would have required employers to provide medical examinations to employees exposed to beryllium during an emergency, and to those who are showing signs or symptoms of CBD, within 30 days of the employer becoming aware that these employees meet the criteria of proposed paragraph (k)(1)(i)(B) or (C), regardless of whether these employees received an exam in the previous 2 years. OSHA is not aware of any comments from stakeholders about the time period to offer medical examinations following a report of symptoms or exposure in an emergency; however the 30-day requirement to offer medical examinations to employees experiencing signs or symptoms was included in the joint draft proposal by Materion and USW (Document ID 0754, p. 7). Moreover, OSHA finds that the 30-day trigger is administratively convenient for post-emergency surveillance as well as after CBD signs or symptoms (and other beryllium-related effects like rashes) are reported, insofar as it is consistent with other OSHA standards and with other triggers in the beryllium standards. OSHA is therefore retaining paragraph (k)(2)(i)(B), as proposed, in the final rule. Proposed paragraph (k)(2)(ii) would have required employers to provide an examination annually (after the first examination is made available) to employees who continue to meet the criteria of proposed paragraph (k)(1)(i)(A) or (B). The Agency requested comment on the frequency of this medical surveillance (80 FR 47574).
Ameren agreed with the proposed frequency of annual examinations, and USW commented that the proposed medical surveillance requirements would allow for timely detection of sensitization and health outcomes (Document ID 1675, p. 16; 1681, p. 13). AWE commented that it offers annual spirometry testing to its employees with “significant likelihood for exposure” (Document ID 1615, p. 10). DOD also provides annual medical surveillance for its beryllium-exposed employees (Document ID 1684, Attachment 2, p. 1-5). NIOSH commented that OSHA should require an annual questionnaire for symptoms (Document ID 1725, p. 32). However, other commenters argued that annual surveillance was not routinely required. For example, NJH and ACOEM supported offering medical examinations to eligible employees every two years (Document ID 1664, p. 4; 1685, p. 4); NJH indicated that after initial testing, biennial medical surveillance is adequate to identify any new cases of sensitization that may develop in the workplace. In addition, NJH, NSSP, and NGK were opposed to annual BeLPTs (Document ID 1664, p. 4; 1677, p. 3; 1663, p. 5). ATS and NIOSH recommended examinations every 1 to 3 years for sensitized individuals to determine if progression is occurring (Document ID 1688, p. 3; 1725, pp. 2, 32). Finally, NABTU agreed with the proposed frequency for screening but noted that Department of Energy
After careful consideration of the record on this issue, OSHA agrees with commenters like NJH who recommended that a BeLPT every two years is appropriate. In addition, based on its review of beryllium health effects, which shows that CBD generally progresses slowly (See Section V, Health Effects), the Agency finds that a two-year frequency period is also appropriate for the remaining parts of the medical examinations. This two-year period is consistent with NJH's suggestion to offer medical examinations biennially after the initial exam and with ATS and NIOSH's recommendations for examinations every 1 to 3 years for sensitized individuals. However, OSHA disagrees with NIOSH that a yearly questionnaire for symptoms is needed because the standards already permit employees to receive medical surveillance by self-reporting signs and symptoms of CBD.
To align the requirements for BeLPTs with the medical and work history, the physical examination, and pulmonary function testing, OSHA is requiring that all those components of the examination be offered every two years. OSHA concludes that this approach is more convenient for employers to administer, while maintaining adequate protection of employees. Offering examinations every two years accomplishes the main goals of medical surveillance for employees exposed to beryllium, which are to detect beryllium sensitization before employees develop CBD, and to diagnose CBD and other adverse health effects at an early stage. Requiring examinations to be offered every two years also strikes a reasonable balance between the resources required to provide surveillance and the need to diagnose health effects at an early stage to allow for interventions.
In addition, OSHA finds that it is appropriate to extend the requirement for biennial surveillance under final paragraph (k)(2)(ii) for employees who continue to meet the criteria of final paragraph (k)(1)(i)(D),
Finally, OSHA revised proposed paragraph (k)(2)(ii) to specify that medical examinations were to be made available “at least” every two years. This change clarifies OSHA's intent that the employer need not wait precisely two years to make medical surveillance available to employees who continue to meet the criteria of (k)(1)(A), (B), or (D) of this standard.
Under the final standards, employees exposed in an emergency, who are covered by paragraph (k)(1)(i)(C), are not included in the biennial examination requirement unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B), because OSHA expects that most effects of airborne exposure will be detected during the medical examination provided within 30 days of the emergency, pursuant to paragraph (k)(2)(i)(A). This is consistent with the proposal. An exception to this is beryllium sensitization, which OSHA finds may result from exposure in an emergency, but may not be detected within 30 days of the emergency. OSHA received no comments on this issue. To address possible delayed sensitization in employees exposed in an emergency, final paragraph (k)(3)(ii)(E) requires biennial BeLPTs for employees who have not been confirmed positive, including those exposed in emergencies. This paragraph is discussed in more detail later in this section of the preamble.
Proposed paragraph (k)(2)(iii) required the employer to offer a medical examination at the termination of employment, if the departing employee met any of the criteria of proposed paragraphs (k)(1)(i)(A), (B), or (C) at the time the employee's employment was terminated. This proposed requirement was waived if the employer provided the departing employee with an exam during the six months prior to the date of termination. OSHA explained that the provision of an exam at termination was intended to ensure that no employee terminates employment while carrying a detectable, but undiagnosed, health condition related to beryllium exposure (80 FR 47798). A similar provision was included in the draft joint recommended standard by Materion and USW (Document ID 0754, p. 8).
Commenters generally supported the inclusion of this provision in the final standard. NJH and NSSP agreed with the proposed requirement to perform a BeLPT at the time of termination and Ameren stated that a BeLPT is not needed if the employee was tested within the last six months (Document ID 1664, p. 7; 1675, p. 16; 1677, p. 6). However, NABTU indicated that the BeLPT need not be repeated if the employee's last test was done within the previous 60 days because the experience of their medical professionals indicates that a different test result is unlikely to occur within that time period (Document ID 1805, Attachment 1, p. 5). After considering these comments, OSHA reaffirms its preliminary decision to require employers to make medical surveillance available at the time of termination to eligible employers. Final paragraph (k)(2)(iii) requires the employer to make a medical examination available to each employee who meets the criteria of final paragraph (k)(1)(i)—the action level/30-day-exposure based trigger, shows signs or symptoms of CBD, or is exposed during an emergency—at the termination of employment, unless the employee received an exam meeting the requirements of the standards within the last 6 months. OSHA also finds that it is appropriate to extend the requirement to employees who meet the criteria of final paragraph (k)(1)(i)(D),
As indicated in the proposal, OSHA finds that providing a BeLPT at the time of termination, unless the employee was tested within the last six months or the employee was confirmed positive, is important to ensure that no employee is unknowingly sensitized at the time he or she leaves the job. In addition, OSHA finds that the other components of the examination, such as a medical and work history, the physical examination, and lung function testing are also important to determine if an employee may have developed physical signs of disease or if existing disease may have progressed since the last examination. OSHA disagrees with NABTU that another BeLPT should be conducted if the employee's last BeLPT was done more than two months ago. Requiring another BeLPT if the employee has not had one within the past six months is an abundantly cautious approach considering that public health officials, such as NJH, recommend a BeLPT every two years, since that time period is considered adequate to identify any new cases of sensitization that may develop in the workplace (Document ID 1664, p. 4). Therefore, OSHA concludes that
OSHA recognizes, as ATS, NIOSH, and NJH commented, that physical examinations and lung function testing are not effective for detecting sensitization or CBD. However, OSHA still finds that these tests should be included as part of medical surveillance examinations of beryllium exposed workers because they accomplish important goals of medical surveillance as part of an occupational health program. As indicated above, the major purposes of medical surveillance for beryllium-exposed employees go beyond identifying disease and include identifying conditions that put employees at increased risk from beryllium exposure and determining the employee's fitness to use personal protective equipment such as respirators. The medical examination for beryllium complements the medical evaluation under the respiratory protection program that must still be conducted before an employee is fitted for a respirator or uses the respirator in the workplace (29 CFR 1910.134(e)(1)). Physical examinations and lung function tests are objective measures that are valuable in accomplishing the goals of medical surveillance for beryllium and to determine fitness to use personal protective equipment. For example, listening to heart and lung sounds with a stethoscope and conducting lung function testing might identify an impairment in an employee who is not experiencing symptoms but might be at risk with use of a negative pressure respirator. Such impairments in employees lacking symptoms may not be identified in the medical evaluation for respirator use, which typically involves administering a questionnaire and may not involve an examination. Another example of how the required tests under the beryllium standard accomplish goals of medical surveillance is that an employee who is found to have a loss in lung function can be warned that lung function loss can be compounded if that employee develops CBD.
Skin examinations are also important because skin rashes could be a sign of dermal sensitization or also a sign that exposures that put the employee at risk of becoming sensitized have occurred. However, OSHA agrees with ORCHESE that conditions such as breaks and wounds are temporary and has therefore revised the proposed paragraph so that final paragraph (k)(3)(ii)(C) requires a physical examination for skin rashes, rather than an examination for breaks and wounds. OSHA notes that PLHCPs will nonetheless detect skin injuries during the skin examination, and when doing so can take that as an opportunity to educate the employee on the importance of using protective clothing, because beryllium absorption can be increased through broken skin.
OSHA also revised proposed paragraph (k)(3)(ii)(A), which would have required, among other things, “a medical and work history, with emphasis on past and present exposure” so that final paragraph (k)(3)(ii)(A)
Under proposed paragraph (k)(3)(ii)(E), an employee would have been offered a BeLPT or an equivalent test at the first examination, and then at least every two years after the first examination, unless the employee was confirmed positive. As OSHA explained in the preamble to the proposal, the proposed requirement to test for beryllium sensitization was intended to apply whether or not an employee was otherwise entitled to a medical examination in a given year (80 FR 47799). For example, for an employee exposed during an emergency who would have normally been entitled to 1 exam within 30 days of the emergency but not annual exams thereafter, the employer would still have been required to provide this employee with a test for beryllium sensitization every 2 years. OSHA further explained that this proposed biennial requirement would have applied until the employee was confirmed positive. The Agency preliminarily found that the biennial testing required under proposed paragraph (k)(3)(ii)(E) was adequate to monitor employees at risk of developing sensitization while being sufficiently affordable for employers.
The record showed strong support for use of BeLPT, with limited exceptions. NIOSH supported the BeLPT to identify sensitized employees, citing recent evidence that the BeLPT has a sensitivity of 66 to 86% and a specificity of >99%, which it stated is superior or comparable to other common medical screening test (Document ID 1725, pp. 32-33). In responding to comparisons of the BeLPT against World Health Organization (WHO) (Wilson) criteria (see next paragraph), NIOSH concluded that current evidence supports the use of the BeLPT to benefit both the individual employee and to identify improvements that could be made in work areas to prevent other workers from becoming sensitized (Document ID 1725, p. 33). BeLPT is also supported by or used in medical screening by medical authorities, unions, and industry stakeholders including Materion, NJH, Ameren, NSSP, USW, ACOEM, ATS, and ORCHSE (Document ID 1661, Attachment 2, pp. 7-8; 1664, p. 4; 1675, p. 16; 1677, pp. 5-6; 1681, p. 25; 1685, p. 4; 1688, p. 3; 1691, Attachment 1, p. 12). Ameren also commented that a BeLPT should be provided for employees diagnosed with sarcoidosis because of the potential for a misdiagnosis of CBD (Document ID 1675, p. 16). USW supported periodic BeLPTs because workers with a history of exposure remain at risk in the future (Document ID 1681, pp. 13-14). NJH supported biennial BeLPTs, which is consistent with the draft joint recommended standard by Materion and USW (Document ID 0754; 1664, p. 4).
In contrast, based on a false positive rate reported in a review done by AWE in 1990, AWE commented that it does not routinely use BeLPT in its medical surveillance program (Document ID 1615, p. 11). DOD did not support the BeLPT, arguing that it has not been shown to meet WHO guidelines as a screening tool (often referred to as the Wilson Criteria, which evaluates factors such as reliability of the assay and its usefulness to identify disease at an early stage in which treatment would be beneficial) (Document ID 1958, p. 8).
After carefully considering these comments, OSHA agrees with NIOSH that the BeLPT is appropriate based on its sensitivity and low false positive rate that is comparable or superior to other screening tests. Unlike DOD, OSHA finds that the BeLPT does meet a number of the Wilson criteria because it is an acceptable, reliable test that allows for a serious disease to be diagnosed at an early stage, when employees with symptoms could benefit from treatment, or in the case of occupational exposures, interventions such as removal from exposure. OSHA agrees with Ameren that a BeLPT is an important component for diagnosing lung disease in beryllium-exposed employees to prevent a misdiagnosis. And OSHA reaffirms that it is important to conduct the BeLPT at least every two years to screen for beryllium sensitization, until the employee is confirmed positive. As in the proposal, the biennial requirement to test for beryllium sensitization applies regardless of whether an employee is otherwise entitled to a medical examination in a given year. OSHA concludes that this continuing requirement is important because sensitization can occur after exposures end.
OSHA finds that in general, the biennial testing required under paragraph (k)(3)(ii)(E) is adequate to monitor employees that have the potential to develop sensitization while being sufficiently affordable for employers. However, one change to this provision compared to the proposed standard is to allow the test to be offered “at least” every two years, rather than every two years as proposed. This change clarifies OSHA's intent that the employer need not wait precisely two years to make the BeLPT available to employees.
Final paragraph (3)(ii)(E) contains a number of other differences compared to the proposed requirements. Consistent with the definition in the proposed standards, the proposed paragraph considered two abnormal test results necessary to confirm a finding of beryllium sensitization when using the BeLPT (“confirmed positive”). Therefore, the proposal would have required that the BeLPT be repeated within one month of an employee receiving a single abnormal result. As discussed in more detail in the Summary and Explanation for paragraph (b), Definitions, commenters including ACOEM and ATS indicated that retesting should also be done following borderline BeLPT results, and as ACOEM noted, one borderline and one positive test or three borderline tests have a high predictive value for sensitization (Document ID 1685, p. 4; 1688, p. 2). In response to such comments, OSHA changed the definition of confirmed positive to two abnormal test results, an abnormal test result and a borderline test result, or three borderline test results. Therefore, to make this paragraph consistent with the revised definition, the text was changed to indicate that a follow-up BeLPT must be offered within 30 days for results that are “other than normal” unless the employee has been confirmed positive. This language makes it clear that not only abnormal BeLPT results, but also borderline BeLPT results must be followed up according to the definition for confirmed positive. When an other than normal result is obtained, testing is to be repeated within 30 days, unless the employee is confirmed positive. This means that follow-up can stop as soon as it is determined that the
The proposed paragraph indicated that the requirement for a repeat BeLPT was waived if a more reliable and accurate test were to become available that could confirm beryllium sensitization based on one test result. OSHA requested comments on the availability of more reliable and accurate tests than the BeLPT for identifying beryllium sensitization (80 FR 47575). ORCHSE took issue with the statement that retesting would not be required if a more reliable and accurate test became available that could confirm beryllium sensitization based on one test result. It interpreted the statement to mean that an employee who tested positive would not receive a second BeLPT or second test that is more reliable and accurate than the BeLPT, leaving the employee with only one abnormal test that was unconfirmed (Document ID 1691; Attachment 1, pp. 7-8).
To streamline the paragraph and avoid misunderstandings of the Agency's intent, OSHA removed the language waiving a second confirmatory test if a more accurate and reliable test became available that did not require retesting for confirmation of sensitization. Instead, final paragraph (k)(3)(E) requires a standardized BeLPT or equivalent test, upon the first examination and at least every two years thereafter, unless the employee is confirmed positive. If the results of the BeLPT are other than normal, a follow-up BeLPT must be offered within 30 days, unless the employee has been confirmed positive. This revision clarifies that only other than normal BeLPT results must be followed up within 30 days. Because the paragraph refers to follow-up testing for other than normal “BeLPT” results, the requirement would not apply to a more accurate and reliable test that would not require an abnormal result to be confirmed.
OSHA acknowledges that the “more accurate and reliable” alternative remains hypothetical as there are currently no tests for beryllium sensitization that allow for a confirmed diagnosis of sensitization based on one test. However, if developed and validated as described below, such a test would be an improvement because it would eliminate the need for an employee to go back to have blood drawn a second and possible third time. OSHA's intent was to allow the current BeLPT requirement to be replaced with a more accurate and reliable test that would not require retesting to confirm sensitization, if such a test were ever developed. To clarify the Agency's intent, final paragraph (k)(3)(ii)(E) now specifies that a standardized BeLPT “or equivalent test” is to be offered. OSHA considers an “equivalent test” to be a test that would accurately identify sensitization based on one test result. Thus, the original intent of that requirement is unchanged, but OSHA clarifies that an “equivalent test” could also be a validated test that is superior to the BeLPT for other reasons. For example, NJH commented that alternative tests to the BeLPT are being developed that could require less blood and less sample manipulation and provide earlier results (Document ID 1664, p. 9).
NJH commented on validating tests for beryllium sensitization that might be superior to a BeLPT (Document ID 1664, p. 9). It noted that validation could occur in a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) laboratory. Once the assay is determined to be robust and reproducible, clinical validation should then be performed using samples from patients known to be sensitized and from unexposed controls. OSHA agrees and as explained in the Summary and Explanation for paragraph (b), Definitions, before any test could be considered “equivalent” to a BeLPT for identifying sensitization but based on a single test result, the test must undergo rigorous validation to ensure that it has comparable or increased sensitivity, specificity, and positive predictive value within one test result than the BeLPT. OSHA also recommends that before any test for sensitization is considered equivalent to a BeLPT, it should be widely accepted by authoritative sources, such as CDC/NIOSH, ACOEM, and ATS, based on the validation criteria described above. Such an approach is conceptually consistent with that in the draft recommended standard by Materion and USW that required the CDC to approve a more reliable test that could eliminate the need to confirm a positive finding. The joint draft recommended standard by Materion and USW required that the BeLPT be performed in a laboratory licensed by the CDC (Document ID 0754). In contrast, OSHA's proposed provision did not require that a BeLPT be conducted by a laboratory that was licensed or accredited. OSHA requested comment on whether testing should be performed by a laboratory accredited by an organization such as CLIA (80 FR 47575).
Commenters including NJH, Ameren, NSSP, Materion and USW, ACOEM, and ORCHSE supported the inclusion of a requirement that laboratories performing BeLPT be accredited by CAP and/or CLIA (Document ID 1664, pp. 8, 9; 1675, p. 19; 1677, p. 7; 1680, p. 7; 1685, p. 5; 1691, Attachment 1, p. 13). For example, NJH commented that a CAP/CLIA certification represents the standard for oversight for clinical testing to ensure proper quality control and testing (Document ID 1664, p. 9). ACOEM further added that those laboratories should undergo periodic proficiency testing (Document ID 1685, p. 5). Materion and USW also recommended that all laboratories that conduct BeLPT have a standard procedure and algorithm and that their BeLPT be approved by the FDA, but that these issues should not delay promulgation of the rule (Document ID 1680, p. 7). However, NJH indicated that while it would be preferable, standardization of interpretation algorithms across laboratories is challenging because it is influenced by many variables such as serum and reagent lots, sample quality, use of round versus flat bottomed plates, and technician skill (Document ID 1664, p. 8). NSSP commented that all current BeLPT laboratories have certifications from CAP and/or another accreditation organization approved under CLIA and have participated in inter-laboratory split specimen testing (Document ID 1677, p. 7).
After reviewing these comments and the remainder of the record on this issue, OSHA is convinced that requiring that the BeLPT be conducted by CAP/CLIA-certified laboratories would improve quality of BeLPT results. Based on comments from NSSP, all laboratories conducting BeLPTs are currently accredited. OSHA therefore finds that accredited laboratories are currently available and including such a requirement in the standards would not delay promulgation of the rule. The Agency also finds that CAP/CLIA certification helps improve proficiency in terms of obtaining accurate results that are appropriately interpreted and ensures that quality control procedures are followed. Therefore, to improve the accuracy and reliability of BeLPTs, the standards require that samples be analyzed by a laboratory certified under CAP/CLIA guidelines to perform the BeLPT.
As a result of the changes discussed above, final paragraph (k)(3)(E) specifies that the examination must include a standardized BeLPT or equivalent test, upon the first examination and at least every two years thereafter, unless the employee is confirmed positive. If the results of the BeLPT are other than normal, a follow-up BeLPT must be
Proposed paragraph (k)(3)(ii)(F) would have required a CT scan to be offered to employees who had been exposed to beryllium at concentrations above 0.2 μg/m
OSHA requested comment on the proposed CT scan requirements, as part of the content of the medical examinations (80 FR 47574). In addition, OSHA asked stakeholders to opine on two regulatory alternatives related to CT scans: (1) Regulatory Alternative #18, which would have dropped the CT scan requirement from the proposed rule, and (2) Regulatory Alternative #19, which would have increased the frequency of periodic CT scans from biennial to annual scans (80 FR 47571).
A number of stakeholders responded to the Agency's request for comments on the proposed CT scan requirements. Two such commenters, Public Citizen and NJH, referenced criteria for low-dose CT lung cancer screening set forth by the U.S. Preventive Services Task Force (USPSTF), an independent, volunteer panel of national experts in prevention and evidence-based medicine (Document ID 1664, p. 4; 1964, p. 4). In December, 2013, the USPSTF recommended annual screening for lung cancer with LDCT for adults aged 55 to 80 years with a 30-pack-year smoking history and who either currently smoke or have quit within the past 15 years. Under USPSTF's criteria, screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (Moyer
The NLST enrolled asymptomatic men and women (n = 53,454), aged 55 to 74, that were current smokers or former smokers within the last 15 years and had a smoking history of at least 30 pack-years. The participants underwent annual lung cancer screening with either LDCT or chest radiography for three years. The results showed a statistically significant 20-percent relative reduction in lung cancer mortality with LDCT screening (Aberle,
Given these findings, the USPSTF noted, in its recommendation for lung cancer screening for high-risk individuals, the importance of shared decision making. The USPSTF advised:
Shared decision making is important for the population for whom screening is recommended. The benefit of screening varies with risk because persons who are at higher risk because of smoking history or other risk factors are more likely to benefit. Screening cannot prevent most lung cancer deaths, and smoking cessation remains essential. Lung cancer screening has substantial harms, most notably the risk for false-positive results and incidental findings that lead to a cascade of testing and treatment that may result in more harms, including the anxiety of living with a lesion that may be cancer. Overdiagnosis of lung cancer and the risks of radiation are real harms, although their magnitude is uncertain. The decision to begin screening should be the result of a thorough discussion of the possible benefits, limitations, and known and uncertain harms (Moyer,
In addition to the USPSTF, several other organizations have recommended similar lung cancer screening protocols for high-risk individuals, including the American Cancer Society, American College of Chest Physicians, American Society of Clinical Oncology, American Lung Association, National Comprehensive Cancer Network, and the American Association for Thoracic Surgery. Each organization's specific screening recommendations are summarized by the U.S. Centers for Disease Control and Prevention:
With regard to occupational exposure, OSHA is not aware of any definitive recommendations based on a large, well-conducted, randomized, controlled study examining the benefit of lung cancer screening with LDCT among occupationally-exposed workers. In its pre-hearing comments, NIOSH noted that the screened population must be at sufficiently high risk for lung cancer in order to assure that the benefit of LDCT screening for early detection exceeds the harm (Document ID 1671, Attachment 1, p. 8). NIOSH cited a report by the Finnish Institute of Occupational Health (FIOH) that recommended LDCT screening in asbestos-exposed individuals if their personal combination of risk factors, particularly smoking history, yields a risk for lung cancer equal to that needed for entry into the NLST. NIOSH noted that the absolute risk for lung cancer in the NLST and the threshold absolute risk for lung cancer proposed by FIOH as a trigger for LDCT screening was 1.34% over 6 years (Document ID 1671, Attachment 1, p. 8).
OSHA also received comments in the record pointing to the LDCT lung cancer screening recommendations of the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of 27 cancer centers (Document ID 1805, Attachment 1; Document ID 1959). In addition to recommending screening for individuals (current smokers or former smokers that have quit within the last 15 years) who are 55 to 74 years of age
Thus, the studies and recommendations discussed above indicate that age and smoking history are crucial risk factors that determine when the benefits of LDCT screening are likely to outweigh the risks from radiation exposure and false-positive results. The radiation exposure received from periodic LDCT scans increases the risk of lung and breast cancer, as well as leukemia. Public Citizen estimated the risk of these cancers that could result when workers are screened as described in OSHA's proposed rule (Document ID 1964, pp. 4-6). Public Citizen also estimated the total radiation dose received to range from 900 to 2,400 mrems, depending on age at which screening begins. The excess cancer risks resulting from these exposures, based on Public Citizen's use of the National Academies BIER VII report, ranged from 3.7 to 29.9 deaths per 1,000 workers for solid organ cancers, and from 0.5 to 2.3 deaths per 1,000 for leukemia (Document ID 1964, p. 6). These risk estimates are comparable to OSHA's estimated lung cancer mortality risk resulting from exposure to beryllium at the PEL of 0.2 μg/m
A number of rulemaking participants agreed that the lung cancer risks from beryllium exposure are, for the vast majority of workers, unlikely to be so high that LDCT screening would be beneficial, including NJH, ATS, ORCHSE, NIOSH, Public Citizen, NGK, and the Aluminum Association (Document ID 1664, pp. 1, 4; 1688, p. 2; 1691, Attachment 1, p. 1; 1671, Attachment 1, pp. 8-9; 1964, p. 4; 1663, p. 3; 1666, pp. 3-4). For example, NJH commented that the risk of lung cancer associated with exposure to beryllium at the final rule's PEL of 0.2 μg/m
The suggestion that beryllium exposure alone would lead to lung cancer risks too low to warrant LDCT screening was illustrated by NIOSH in an analysis of risk information. NIOSH used the mortality study by Schubauer-Berigan
Many of the rulemaking commenters who objected to the proposed requirement for LDCT screening also believed that the absence of any studies showing the effectiveness of LDCT screening on beryllium-exposed workers was further reason not to require LDCT screening based only on a history of beryllium exposure (Document ID 1664, p. 1; 1688, p. 2; 1691, Attachment 1, p. 1; 1756, pp. 123-125; 1806, pp. 1-2). For example, Dr. Newman, who represented ACOEM at the public hearing, in response to a question testified that
The proposed inclusion of a low dose CT scan as part of medical surveillance is entirely justified. The low dose CT scan can effectively detect lung cancer at an early stage and has been demonstrated to reduce lung cancer mortality among high risk individuals. Since lung cancer is recognized as an outcome caused by beryllium exposure, inclusion of the low dose CT scan in the proposed rule is appropriate (Document ID 1681, Attachment 1, p. 14).
In post-hearing comment, Dr. Markowitz suggested limiting the proposal's requirement to apply to workers age 50 or more, and pointed out that this was consistent with OSHA's past practice (
OSHA agrees in general that beryllium exposure should be considered as a risk factor when deciding whether LDCT screening is appropriate, and agrees that it is not appropriate to wait for specific studies to be conducted before considering that a history of beryllium exposure should be factored into a decision to undergo LDCT screening. This is, in fact, consistent with the NCCN's criteria for LDCT screening that include occupational exposures along with age, smoking history, and other risk factors. However, LDCT screening is not triggered under these criteria based on occupational exposures and age alone; there must also be a history of smoking (albeit a lower trigger than when considering only age and smoking). As discussed above, there is no evidence in the record that exposure to beryllium alone at the level used in the proposal to trigger LDCT screening results in a cancer risk sufficiently high to warrant LDCT screening.
For the final rule, OSHA considered increasing the threshold of beryllium exposure such that LDCT screening would be triggered at much higher exposures to beryllium (
Therefore, OSHA concludes that the best approach is to require LDCT screening for beryllium-exposed workers based on the recommendation of the physician conducting or overseeing the medical examination, after all relevant risk factors have been considered, and has accordingly reflected this approach in the final standards. For these reasons, paragraph (k)(3)(ii)(F) of the final standards requires the medical examination to include an LDCT scan, when recommended by the PLHCP after considering the employee's history of exposure to beryllium along with other risk factors, such as smoking history, family medical history, age, sex, and presence of existing lung disease.
The seventh and final item required as part of the medical examination under the proposal was any other test deemed appropriate by the PLHCP. OSHA explained that other types of tests and examinations not mentioned in this standard, including X-ray, arterial blood gas, diffusing capacity, and oxygen desaturation during exercise, may also be useful in evaluating the effects of beryllium exposure (80 FR 47799). In addition, OSHA noted that medical examinations that include more invasive testing, such as bronchoscopy, alveolar lavage, and transbronchial biopsy, have been demonstrated to provide additional valuable medical information. The Agency preliminarily found that the PLHCP was in the best position to decide which medical tests are necessary for each individual examined. Although a requirement for other tests deemed appropriate by the PLCHP was not included in the draft joint recommended standard by Materion and USW (Document ID 0754), similar requirements have been included in previous OSHA health standards, such as Chromium (VI) (29 CFR 1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053).
No stakeholders objected to the proposal's requirement that the medical examination include other tests deemed appropriate by the PLHCP. However, some commenters offered examples of tests that might be useful in certain situations. For example, for employees diagnosed with CBD, NJH recommended that the test battery include pulmonary function tests including diffusing capacity, exercise tolerance tests, chest X-ray or CT scan, bronchoscopy with lavage and biopsy, and bronchoalveolar lavage BeLPT (Document ID 1806, p. 12).
After reviewing the comments on this issue, OSHA reaffirms that allowing the PLHCP to select other tests is appropriate because there are no particular tests—beyond those listed in paragraph (k)(3)(ii)(A)-(E)—that are necessarily applicable to all employees covered by the medical surveillance requirements. This provision gives the examining PLHCP the flexibility to determine additional tests deemed to be appropriate for individual employees. While the tests conducted under this paragraph are for screening purposes, diagnostic tests may be necessary to address a specific medical complaint or finding related to beryllium exposure or the PLHCP may decide that the test battery needs to be expanded once an employee has been diagnosed with CBD. Although the tests suggested by NJH have been demonstrated to provide additional valuable medical information, OSHA considers the PLHCP to be in the best position to decide if any additional medical tests, especially the more invasive tests, are necessary for each individual examined. Under this provision, if a PLHCP decides another test related to beryllium exposure is medically indicated, the employer must make it available. OSHA intends the phrase “deemed appropriate” to mean that additional tests requested by the PLHCP must be both related to beryllium exposure and medically necessary, based on the findings of the medical examination.
OSHA did not receive any comments on the proposed requirement to provide information to the PLHCP. Therefore, the Agency is including it in the final standards with three modifications. First, OSHA has updated paragraph (k)(4)(i) to require the employer to provide a description of the employee's former and current duties that relate to both the employee's airborne exposure to and dermal contact with beryllium, instead of merely requiring the provision of information related to airborne exposures, as in the proposal. As indicated above with regard to the medical examination's medical and work history requirements, OSHA finds that this change is appropriate because the record indicates that dermal contact with beryllium can lead to respiratory and dermal sensitization.
Second, OSHA revised the requirement that the employer obtain a “medical release” before providing the PLHCP with information from records of employment-related medical examinations. ORCHSE recommended that paragraph (k)(4)(iv) be revised to indicate that the requirement to provide medical information to the PLHCP be waived if the employee refuses to sign a medical release (Document ID 1691, Attachment 1, pp. 10-11). After considering this comment, OSHA finds that a change to the provision is not needed because the employer can demonstrate a good faith effort in meeting this requirement by documenting the employee's refusal to provide a medical release. However, the Agency has chosen to use the phrase “written consent” instead of “medical release” in the final standards. This non-substantive change brings the language in this provision in line with the language used in final paragraphs (k)(6) and (k)(7), discussed below.
Third, OSHA revised the provision to indicate that the employer must ensure that the same information provided to the PLHCP is also provided to the agreed-upon CBD diagnostic center, if an evaluation is required under paragraph (k)(7) of this standard. OSHA made this change because the CBD diagnostic center will need the same information as the PLHCP in order to effectively evaluate the employee.
OSHA concludes that making this information available to the PLHCP and CBD diagnostic center will aid in the evaluation of the employee's health as it relates to the employee's assigned duties and fitness to use personal protective equipment, including respirators, when necessary. Providing the PLHCP and CBD diagnostic center with exposure monitoring results, as required under paragraph (k)(4)(ii), will assist them in determining if an employee is likely to be at risk of adverse effects from airborne beryllium exposure at work and indicate that information in the written medical report for the employee. A well-documented exposure history will also assist the PLCHP in determining if a condition (
Proposed paragraphs (k)(5)(i)(A)-(C) would have required the employer to obtain from the licensed physician a written medical opinion containing: (1) The licensed physician's opinion as to whether the employee has any detected medical condition that would place the employee at increased risk of CBD from further airborne exposure to beryllium; (2) any recommended limitations on the employee's airborne exposure to beryllium, including the use and limitations of protective clothing or equipment, including respirators; and (3) a statement that the PLHCP explained the results of the medical examination to the employee, including tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions related to use of protective clothing or equipment. Proposed paragraph (k)(5)(ii) would have required the employer to ensure that neither the licensed physician nor any other PLCHP revealed to the employer specific findings or diagnoses unrelated to airborne beryllium exposure or contact with soluble beryllium compounds. Finally, proposed paragraph (k)(5)(iii) would have required the employer to provide the employee with a copy of the opinion within two weeks of receiving it.
OSHA asked stakeholders to consider what if any information the PLHCP should give to the employer. Specifically, the Agency asked whether it should revise the medical surveillance provisions of the proposed standard to allow employees to choose what, if any, medical information goes to the employer from the PLHCP. For example, OSHA explained, the employer could instead be required to obtain a certification from the PLHCP stating (1) when the examination took place, (2) that the examination complied with the standard, and (3) that the PLHCP provided the licensed physician's written medical opinion to the employee. Such an approach would require the employee to provide written consent for the medical opinion or any other medical information about the employee to be sent to the employer. OSHA asked stakeholders to comment on the relative merits of the proposed standard's requirement that employers obtain the PLHCP's written opinion or an alternative that would provide employees with greater discretion over the information that goes to employers. OSHA also asked that commenters explain the basis for their position and the potential impacts of such an approach (80 FR 47575).
OSHA received a number of comments related to the proposed provisions and the issues raised. Many of these comments related to the proposed contents of the PLHCP's written medical opinion and its transmission to the employer. Some commenters offered suggestions to address privacy concerns regarding the content of the proposed licensed physician's written medical opinion and the proposed requirement that the opinion be given to the employer instead of the employee. For example, David Weissman, M.D., the director of the Respiratory Health Division at NIOSH, objected to providing a specific diagnosis to employers and urged OSHA to adopt a policy consistent with the International Code of Ethics for Occupational Health Professionals established by the International Commission on Occupational Health (Document ID 1725, p. 33; 1815, Attachment 82). The policy recommends reporting only information on fitness for work and medically related limitations to management. NIOSH, AFL-CIO, and NABTU also recommended the ACOEM guidance on confidentiality as a model for the types of information submitted to the employer (Document ID 1679, p. 13; 1689, p. 14; 1725, p. 33). 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 1815, Attachment 60, p. 1).
Dr. Weissman also expressed concerns about employers' ability to ensure the confidentiality of the medical information obtained from workers (Document ID 1725, pp. 33-34). He argued that if OSHA were to require diagnoses of beryllium sensitization to be shared with employers, provisions would be needed to ensure that sensitive information was protected (Document ID 1725, p. 34). He maintained that “[s]uch provisions are especially needed because employers are not necessarily covered entities under the Health Insurance Portability and Accountability Act (HIPPAA) Privacy Rule” (Document ID 1725, p. 34). In fact, some employers who commented during the silica rulemaking expressed concerns about having to maintain confidential medical information (81 FR 16832).
Commenters representing employee interests also objected to giving the opinion to the employer, and offered solutions. For example, AFL-CIO fellow Mary Kathryn Fletcher testified that OSHA should consider the MSHA requirements for black lung, which requires health care providers to give their opinion directly to the employee (Document ID 1756, Tr. 201-202; 30 CFR 90.3).
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 licensed physician's recommendations on work limitations associated with an employee's exposure to beryllium must be balanced against the employee's privacy interests. As discussed in further detail below, OSHA finds it appropriate to distinguish between the licensed physician's recommendations and the underlying medical reasons for those recommendations. In doing so, OSHA intends for the licensed physician 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.
OSHA concludes that the employer primarily needs to know about any recommended work-related limitations or recommendations without conveying the medical reasons for the limitations. Thus, consistent with the weight of opinion in this rulemaking record and with 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 licensed physician's written medical opinion for the employer. The approach is similar to the approach that OSHA took in the recently promulgated Respirable Crystalline Silica standard, but more privacy-based compared to the proposed beryllium requirements and OSHA standards promulgated before the Respirable Crystalline Silica standard. These changes, which are reflected in paragraph (k)(6) of the standards, and the comments that led to these changes, are more fully discussed below.
Reinforcing the privacy concerns, stakeholders testified about job loss concerns when employees are diagnosed with an illness. For example, NABTU's Chris Trahan testified that workers in the construction industry get laid off if an employer finds out they are ill (Document ID 1756, Tr. 237-238). Mike Wright, Director of the Environmental Health and Safety Department, USW, testified that he has repeatedly seen employers fire employees who are in the early stages of occupational disease (Document ID 1751, p. 284). Dr. Weissman testified that if medical results are given directly to the employer, employees may fear that it would result in loss of their jobs and that would discourage them from participating in medical surveillance (Document ID 1755, Tr. 47-48). In commenting on a proposed standard provision that required an employer to get a signed release before sending medical information to a PLHCP, ORCHSE expressed concerns that employees are not compelled to sign releases (Document ID 1691, p. 10). The ORCHSE comment suggests that employees are reluctant to automatically have their medical information shared with medical professionals, much less their own employers. These comments mirror concerns voiced in the recent silica rulemaking. As part of that rulemaking, Dr. Weissman testified that fear of medical information being shared with employers is one of the biggest reasons that miners give for not participating in medical surveillance, and a number of employees testified that they would not participate in medical surveillance that lacked both employee confidentiality and anti-
A number of stakeholders, including Southern Company, Ameren, and NSSP highlighted the importance of reporting beryllium-related findings to the employer for reasons such as evaluating the effectiveness of workplace programs and making workplace changes to protect employees (Document ID 1668, p. 7; 1675, p. 18; 1677, p. 7). NJH reflected similar views and also indicated that the employer would need medical information for medical follow-up and removal and to help the employee file for workers' compensation (Document ID 1664, p. 8). Materion opposed withholding medical information from employers. It commented that Materion has a cooperative process where employees are involved in problem identification and resolution, and when an employee is diagnosed with sensitization or CBD, senior and safety personnel conduct an investigation (Document ID 1755, Tr. 172-173; 1807, pp. 4-5). It indicated that the approach has resulted in improvements aimed at preventing other workers from developing CBD in the future (Document ID 1807, pp. 4-5).
Although USW agreed that patient confidentiality is essential, it argued in comments submitted before the hearing that the employer needs certain information to comply with the standard, identify over-exposures, and accommodate the needs of affected employees; it commented that the proposed rule struck the appropriate balance by giving the employer needed information while prohibiting the reporting of medical findings not related to beryllium exposure (Document ID 1681, p. 26). However, at the hearings USW presented a slightly different view, as Mike Wright testified:
So in this circumstance, we'd like the employer to know that there's an operation that has caused illness. In a union setting, we can usually protect people, but we only represent a fraction of the workforce. In a nonunion setting, and even in the union setting, people who report an occupational illness put their jobs at peril. So we tend to resolve that dilemma in terms of privacy (Document ID 1756, Tr. 285).
When questioned how privacy concerns could be balanced with improving the work environment, Dr. Weissman testified that medical providers could provide aggregated medical data to employers that would let employers know there may be a problem but not identify the specific employees affected (Document ID 1755, Tr. 47-49). He also said that employers could foster a strong culture of safety so that employees would be more likely to share medical findings. Dr. Maier, from NJH, suggested a similar approach of analyzing combined data based on job task with employees de-identified (Document ID 1756, p. 145). However, Terry Civic, Director of Safety Health and Regulatory Affairs from Materion, and Dr. Newman argued that such an approach may not be able to maintain employee confidentiality in many cases, such as when very few employees are involved with a process or are employed by a small company (Document ID 1755, Tr. 173-174; 1756, Tr. 145).
Mr. Wright presented another view when he testified that risk can be determined in many ways, including air sampling and analyses of work processes. He went on to say that waiting for an employee to get sick is the least effective way of determining risk (Document ID 1756, Tr. 284-285). Chris Trahan of NABTU expressed similar thoughts in her testimony (Document ID 1756, Tr. 240). Rebecca Reindel, Senior Safety and Health Specialist from AFL-CIO, added:
Employers don't need to hear about a disease in order to implement engineering controls. It's unlikely that a disease is necessarily going to trigger engineering controls more than what OSHA requires in its standards (Document ID 1756, Tr. 240).
OSHA acknowledges that identifying workers with beryllium-related disease has led to an increased understanding of exposures related to beryllium disease and development of controls to protect workers, and OSHA recognizes the efforts of employers who have promoted a strong health and safety culture and contributed to the knowledge on beryllium. However, OSHA also recognizes that many employees may fear possible repercussions of the release of medical information to their employers.
Moreover, OSHA agrees with commenters who said that employers should be basing their actions on exposure assessments and implementing controls, and it encourages employers to regularly evaluate their beryllium programs. The standards for beryllium require employers to review and evaluate the written exposure control plan if the employer is notified that an employee is eligible for medical removal, is referred to a CBD diagnostic center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium (paragraph (f)(1)(ii)(B)). OSHA also encourages analyses of aggregated data when employers have the resources to do that and are able to maintain employee confidentially, which is not always possible. However, in the case where an employee may have disease related to beryllium exposure and the employer is effectively implementing controls to maintain exposures within the PEL, the only further action required by the employer would be to follow the licensed physician's recommendations to protect the employee who may be especially sensitive to exposure and may need special accommodations such as continuing medical examinations at a CBD diagnostic center or medical removal if requested by the employee. The employer does not need the specific health findings that contributed to those recommendations.
OSHA examined a number of other factors in determining what the possible outcomes could be of not providing medical findings to employers. One possible outcome is that employers would not be able to report or record illness according to OSHA's standard on recording and reporting occupational injuries and illnesses (29 CFR 1904). OSHA notes that if employees do not participate in medical surveillance because of discrimination or retaliation fears, illnesses associated with beryllium would also 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 to guard employee privacy is improving employee protections due to more employees participating in medical surveillance.
An additional possible outcome relating to what information 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. For example, DOD opposed withholding medical information from employers because the information lets the employer know if the worker can continue to work without undue risk (Document ID 1684, Attachment 2, pp. 1-7). However, in the recent silica rulemaking, a number of stakeholders commented that because of the significance of job loss or modifications, employees that are able to perform work duties should make their own decisions on whether to continue working and that such decisions should be made with guidance from the PLHCP (81 FR
Such an approach is not inconsistent with Materion's approach of letting employees make some employment decisions after learning that they are sensitized or have CBD, although Materion strongly supports providing employers with sensitization information (Document ID 1807, pp. 4-5; Attachment 6, pp. 75-76). At Materion, the confirmed positive finding is reported to management so an investigation can be conducted, and the Materion Medical Director informs the employee about the rates of progression from sensitization to CBD based on Materion's most recent epidemiological data. If the employee is diagnosed with CBD by his or her personal pulmonologist, the employee can choose to provide the information to Materion's Medical Director. Materion reported that employees “often do [disclose their diagnosis of CBD] in choosing to apply for Materion benefits under its CBD policy” (Document ID 1807, p. 4). Under the CBD policy, employees who are physically able to perform the job are given the choice of remaining in their current job, taking a job with lower beryllium exposures, or receiving benefits for 12 months. OSHA agrees with Materion's approach of letting employees decide how to proceed if they are confirmed positive or diagnosed with CBD, but disagrees that the employer must receive specific health findings before that can happen.
In review of this evidence, OSHA concludes that if employees decide to make employment changes to protect their health, there are ways to communicate recommended limitations or medical removal, without revealing the specific medical finding leading to those recommendations. Because of evolving views on medical privacy, such as those set forth in ACOEM's Confidentiality Guidelines, OSHA does not find that medical reasons for limitations or medical removal should be automatically reported to employers. In addition, providing confidential medical information to all employers presents challenges in some cases. Unlike Materion, many employers do not have medical departments and may not therefore be aware of medical privacy laws or have the resources to maintain medical records under strict confidentiality.
Another factor that OSHA considered was the value of giving health information to all employers, when some companies, such as small businesses, may not have in-house health and safety personnel to answer employee questions or emphasize the importance of protective measures, such as work practices or proper use of respirators. In such cases, employees are not likely to benefit from having their medical findings given to employers, who may have no deeper knowledge about health risks than the employee. OSHA expects that the training required under the standards will give employees knowledge to understand protective measures recommended by the PLHCP, and will make it more likely they will authorize PLHCP recommendations to be disclosed to the employer.
As was the case in the silica rulemaking, OSHA agrees that employees exposed to beryllium 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 and protective clothing and equipment use and, only with consent of the employee, the licensed physician's recommended limitations on airborne exposure to beryllium and recommendations for evaluation at a CBD diagnostic center, continued medical surveillance, and removal from airborne exposure to beryllium. 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 beryllium-related disease so that employees can make decisions to mitigate adverse health effects and to possibly retard progression of the disease.
In sum, OSHA concludes that the record offers compelling evidence for modifying the proposed content of the licensed physician's written medical opinion for the employer. The evidence includes employee privacy concerns, as well as evidence on the limited utility for giving specific medical findings to employers. OSHA is particularly concerned that the proposed requirements would have led to many employees not participating in medical surveillance and thus 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 consistent with those in the Respirable Crystalline Silica standard (29 CFR 1910.1053), but are different from requirements in the majority of OSHA standards that were promulgated before that standard. The requirements in other standards remain in effect for those standards. The requirements for this rule are based on the evidence obtained during this rulemaking for beryllium, in particular that many employees, especially those who are not represented by a labor union or who work in a company that does not foster a strong health and safety culture, would not take advantage of medical surveillance without stronger privacy protections.
The contents of the licensed physician's written medical report for the employee are set forth in final paragraphs (k)(5)(i)-(v). They include: The results of the medical examination, including any medical condition(s), such as CBD or beryllium sensitization (
The health-related information in the licensed physician's written medical report for the employee is generally consistent with the proposed written medical opinion for the employer, with a few notable exceptions. The proposal required the written medical opinion to indicate “whether the employee had any medical condition that would place the employee at increased risk of CBD from further [airborne] exposure.” Although including a statement in the opinion that “the employee has a medical condition that places him or her at increased risk of CBD” implies that the employee is sensitized to beryllium, the proposal did not require that a specific finding such as “confirmed beryllium sensitization” be included in the opinion. Because only the employee will be receiving the written medical report, the written medical report will include any specific diagnoses, such as CBD or beryllium sensitization. OSHA added “CBD” as a condition to be included in the written medical report to the employee because employees who have CBD may be at risk of increased progression of the disease if they continue to be exposed. Including a confirmed positive finding or CBD diagnosis will also give the employee a record of his or her eligibility for medical removal. An additional change from the proposed to final requirement is that the proposed phrase of “would place the employee at risk of CBD from further [airborne] exposure” was changed to “may place the employee at increased risk from further airborne exposure.” The change of the word “would” to “may” was for clarification because the word “would” implies a certainty that does not exist.
The phrase “risk of CBD” was also changed to “risk” to clarify that risks may be increased by conditions other than CBD-related disease. For example, the employee may have lung function loss related to a disease such as chronic obstructive pulmonary disease and that lung function loss might be compounded if the employee develops CBD. As noted in the introduction to the Summary and Explanation, the word “airborne” was included as a modifier to the term “exposure” in many cases in the final standards to clarify that OSHA did not intend a change from the proposal. In this provision, OSHA included the term “airborne” to reaffirm its intent that the report must discuss any detected medical conditions that may place the employee at increased risk from further airborne exposure, rather than dermal exposure. OSHA finds that this distinction is appropriate because it is inhalation exposure and not dermal contact that increases the risk of CBD development in a sensitized employee or increases the risk of progression in an employee who has CBD. (For this same reason the word “airborne” was added to final paragraph (k)(5)(ii)(B).)
Finally, the proposed phrase “including the use and limitations of protective clothing and equipment, including respirators” was changed to “use of respirators, protective clothing or equipment” in final paragraph (k)(5)(ii)(A). That change reflected an edit to remove superfluous language and the intent of that requirement has not changed. OSHA intends this provision to cover situations where the physician might have recommendations on the use of respirators, protective clothing or equipment in general,
In addition to these changes, OSHA added a number of recommendations that the licensed physician is to include in the written medical report to the employee if the employee is confirmed positive or diagnosed with CBD: (1) Referral for an evaluation at a CBD diagnostic center (paragraph (k)(5)(iii)), (2) continued medical surveillance (paragraph (k)(5)(iv)), and (3) medical removal from airborne exposure to beryllium as described in paragraph (l) (paragraph (k)(5)(v). Aside from a confirmed positive or CBD diagnosis, if otherwise deemed appropriate by the licensed physician, the written medical report must also contain a referral for an evaluation at the CBD diagnostic center.
Each of these recommendations reflects another requirement of the final standard. For example, proposed paragraph (k)(6)(i) and (ii) indicated that an evaluation at a CBD diagnostic center was to occur when an employee was confirmed positive and agreed to the examination. OSHA updated the requirement to make it clear that an evaluation at a CBD diagnostic center should not be limited to employees who have been confirmed positive and want to find out if they have CBD, and should be extended to employees already diagnosed with CBD. Such employees would benefit from having a pulmonologist familiar with beryllium disease select appropriate tests to monitor progression of the disease. OSHA therefore expanded the trigger for referral to a CBD diagnostic center to include CBD in addition to sensitization in final paragraphs (k)(5)(iii), (k)(6)(iii), and paragraph (k)(7)(i).
The referral for continued medical surveillance for employees who are confirmed positive or have been diagnosed with CBD reflects the addition of paragraph (k)(1)(i)(D) that allows employees whose most recent medical opinion required by paragraph (k)(6) or (k)(7) recommends periodic medical surveillance to continue receiving medical examinations, even if they do not qualify under any other trigger; a more detailed discussion is included under the summary and explanation for final paragraph (k)(1)(i)(D).
Finally, the triggers for a medical removal recommendation in paragraph (k)(5)(v) reflect the triggers under paragraph (l)(1)(i) and are discussed in more detail in the summary and explanation for final paragraph (l), medical removal protection. OSHA added these recommendations to the written medical report to make it clear to the licensed physician and employee that each of these recommendations is to occur when an employee is confirmed positive or diagnosed with CBD. A similar approach is applied in the Respirable Crystalline Silica standard, where the PLHCP is to include a statement that the employee should be examined by a specialist if that employee has X-ray evidence of silicosis.
The requirements for the health-related information to be included in the written medical report for the employee are consistent with the overall goals of medical surveillance: To identify beryllium-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 beryllium in the workplace without increased risk of experiencing adverse health effects; and to determine the employee's fitness to use respirators. By providing the licensed physician's written medical report to employees, those who might be at increased risk of health impairment from airborne beryllium exposure will be able to consider interventions (
The requirement for a verbal explanation from the PLHCP in paragraph (k)(5) allows the employee to confidentially ask questions or discuss concerns with the PLHCP. It also allows the PLHCP to inform the employee about any non-occupationally related health conditions so that the employee can follow-up as needed with his or her personal healthcare provider at the employee's expense. The requirement for a written medical report ensures that the employee receives a record of all findings. Employees would also be able to provide the written medical report to future health care providers.
Based on the record evidence, OSHA has determined that for the beryllium standards, the 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 standard, and any recommended limitations on the employee's use of respirators, protective clothing, and equipment; and a statement that the PLHCP explained the results of the examination to the employee, including any tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions for use of personal protective clothing or equipment. These requirements are set forth in paragraph (k)(6)(i) of the standards.
OSHA is persuaded to include recommended limitations on the employee's use of respirators, protective clothing, and equipment, with no other medically-related information, in the written medical opinion for the employer without further consent from the employee. 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 and protective clothing and equipment limitations in the written medical opinion for the employer is consistent with the ACOEM confidentiality guidelines that address the reporting of health and safety concerns to the employer (Document ID 1815, Attachment 60, p. 1). The date and statement about the examination meeting the requirements of this standard are to provide both the employer and employee with evidence that compliance with the medical surveillance requirements are current. Employees will be able to show this opinion to future employers to demonstrate that they have received the medical examination.
Paragraph (k)(6)(ii) states that if the employee provides written authorization, the written medical opinion for the employer must also contain any recommended limitations on the employee's airborne exposure to beryllium. Paragraphs (i)(6)(iii)-(v) state that if an employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain recommendations for evaluation at a CBD diagnostic center, continued medical surveillance, and medical removal from airborne exposure to beryllium as described in paragraph (l). If otherwise deemed appropriate by the licensed physician and the employee authorizes the information to be included in the written medical opinion, the opinion must also contain a referral for an evaluation at the CBD diagnostic center. As noted above, referrals for evaluations at CBD diagnostic centers under this standard should only be given for health-related reasons that pertain to beryllium.
OSHA intends for this provision to allow the employee to give authorizations for the written medical opinion for the employer to contain only the referral for evaluation at a CBD diagnostic center, only the recommendation for continued periodic surveillance, or only the recommendation for medical removal, or both. This will allow employees to choose one or more options that best fit their needs. For example, an employee may choose to only let the employer know that he or she wants continued medical surveillance but not at the CBD diagnostic center because he or she is satisfied with the care provided by the current PLHCP. In another case, an employee may decide that he or she
OSHA is convinced that routinely including recommended limitations on airborne exposure, evaluations at a CBD diagnostic center, and especially medical removal in the written medical opinion for the employer absent employee consent could adversely affect employees' willingness to participate in medical surveillance. The requirements for this paragraph are consistent with recommendations to let employees make their own health decisions. OSHA stresses that information given to the employer should not include an underlying diagnosis—only the specific recommendation or referral called for under the standards. OSHA considers this a reasonable approach that balances the need to maintain employee confidentiality with the employer's need to know that it may want to reevaluate its beryllium program. Reporting that a referral or medical removal is recommended, when authorized by the employee, allows the employer to reevaluate its written exposure control plan, as required under paragraph (f)(1)(ii)(B).
OSHA finds that this new format for the licensed physician's medical opinion for beryllium will better address concerns of ORCHSE, who feared it would be in violation if the written medical opinion for the employer included information that OSHA proposed the licensed physician or PLHCP not report to the employer, such as an unrelated diagnosis (Document ID 1691, p. 11). OSHA finds that removing the prohibition on unrelated diagnoses and instead specifying the only information that is to be included in the written medical opinion for the employer remedies this concern because it makes the contents of the opinion easier to understand and less subject to misinterpretation.
OSHA recognizes that some employees might be exposed to multiple OSHA-regulated substances at levels that trigger medical surveillance and requirements for written opinions. For example, Newport News Shipbuilding indicated that their employees already undergo medical surveillance for arsenic (Document ID 1657, p. 2). The licensed physician 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 inorganic arsenic and beryllium, then the combined opinion to the employer must contain the information required by paragraphs (n)(6)(i) of the inorganic arsenic standard (29 CFR 1910.1018) and the information required by paragraphs (k)(6)(i) (and paragraphs (k)(6)(ii)-(v) with written authorization from the employee) of the beryllium standards.
NABTU noted that the black lung rule for coal miners protects confidentiality by prohibiting mine operators from requiring miners to provide a copy of their medical information (Document ID 1679, p. 13; 30 CFR 90.3). NABTU requested that the beryllium rule protect confidentiality by prohibiting employers from asking employees or the PLHCP for medical information (Document ID 1679, p. 13). Consistent with the Respirable Crystalline Silica standard, OSHA is not including such a prohibition in the beryllium standard because employers may have legitimate reasons for requesting medical information, such as BeLPT results. For example, employers might request such information for doing an investigation or helping employees file compensation claims. If employees are not concerned about discrimination or retaliation, or need the employer's help in filing a claim, they could provide the health information to the employer. Paragraph (k)(6)(vi) requires the employer to ensure that employees receive a copy of the written medical opinion for the employer within 45 days of any medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) performed for that employee. The reason for the 45-day deadline to provide the written medical opinion is discussed below. OSHA is requiring that employees receive a copy of the written medical opinion for the employer, in addition to the written medical report, because they can present the written medical opinion 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 two-year period and this ensures that tests are not performed more frequently than required.
On the topic of transient employment, NSC asked OSHA to consider workers employed by staffing agencies and assigned to multiple host employers and possibly employees of contractors to the host employer, who might not receive medical surveillance because of the transient nature of their employment (Document ID 1612, p. 3). OSHA's July 15, 2014, memorandum titled
As indicated above, the standards require 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 written opinion within 45 days of each medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) (paragraphs (k)(5), (k)(6)(i), (k)(6)(vi)). By contrast, the proposed rule would have required that the employer obtain the licensed physician'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. NJH commented that 45 days is a better time period for notifying employers because it can take more than 2 weeks to process the BeLPT (Document ID 1664, p. 8). ORCHSE expressed concern about the 30-day timeline, stating that the employer would be in violation if the physician took more than 30 days to deliver the report (Document ID 1691, pp. 11-12).
In light of NJH and ORCHSE's comments, OSHA has revised the proposed 30-day timeline to allow for 45 days. OSHA expects that the new 45-day period will give the licensed physician sufficient time to consider the results of any tests, including a follow-up BeLPT, done as part of the examination. OSHA finds that delivering the report to the employer within 45 days will still ensure that the employee and employer are informed in a timely manner and allows the employer to take any necessary protective measures within a reasonable time period. To ensure timely delivery of reports and opinions containing the correct information and demonstrate a good faith effort in meeting these requirements of the standard, the employer could inform licensed physicians about the time deadline and other requirements of the beryllium standard in a written agreement and follow up with the physician if there is concern about timely delivery or content of these documents. Because the licensed physician will be providing the employee with a copy of the 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 has also revised this provision to account for the time to administer any follow-up BeLPT tests required under paragraph (k)(3)(ii)(E) of these standards. As discussed above, if the results of the BeLPT are other than normal, paragraph (k)(3)(ii)(E) requires a follow-up BeLPT to be offered within 30 days, unless the employee has been confirmed positive. In order to allow for the licensed physician to consider BeLPT results and prepare the written medical opinion, the Agency must allow time for the BeLPT to be administered, processed, and interpreted. Therefore, OSHA has decided to require the employer to obtain a written medical opinion from the licensed physician within 45 days of the medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard).
OSHA asked stakeholders to comment on the proposed requirement for evaluation at a CBD diagnostic center, especially whether the requirements for mutual agreement by the employee and employer is necessary and appropriate and how the diagnostic center should be chosen if the employer and employee cannot agree. OSHA also asked whether the standard should specify that evaluation at a diagnostic center must be at a reasonable location (80 FR 47574-47575).
The term CBD diagnostic center is defined in paragraph (b), Definitions, of the standards. As provided in paragraph (b) and explained in the Summary and Explanation, the CBD diagnostic center can be a hospital or other facility that has an on-site pulmonary specialist who can interpret biopsy pathology and bronchoalveolar lavage (BAL) results. The diagnostic center must also have onsite facilities that can do a clinical evaluation for CBD that includes pulmonary function testing according to ATS guidelines, transbronchial biopsy, and BAL, with the ability to transfer BAL samples to a laboratory for diagnostic evaluation within 24 hours.
Ameren supported a specialist exam but asserted that an examination by a pulmonologist was sufficient and that the pulmonologist could be allowed to work with a CBD diagnostic center to treat a sensitized employee (Document ID 1675, p. 17). Southern Company argued that rather than requiring an evaluation at a CBD diagnostic center, the standard should instead specify the types of exams required (Document ID 1668, pp. 2-3). DOD commented that employees should be referred to a board-certified pulmonologist who is capable of doing bronchoscopy, bronchial biopsy, and broncho-alveolar lavage (Document ID 1684, Attachment 2, p. 1-6), NSSP, NABTU, ACOEM, and ATS advocated for an examination at a CBD center for sensitized employees (Document ID 1677, p. 6; 1679, p. 12; 1685, p. 5; 1688, p. 3).
OSHA is not persuaded by Southern Company's argument that the final standards should detail specific tests for confirmed positive employees, instead of requiring an examination at a CBD diagnostic center. As described above, the types of evaluations required for an employee who has a confirmed positive finding or is diagnosed with CBD must be determined on a case-by-case basis, and therefore determining appropriate testing requires a pulmonologist with the expertise described in the definition for CBD diagnostic center. In addition, many of the procedures that a pulmonologist may recommend are invasive and therefore involve risks. As a result, these tests should only be performed by a pulmonologist familiar with beryllium disease at a facility that meets the definition of a CBD diagnostic center, after the pulmonologist has carefully considered the employee's medical and occupational history. For these reasons, OSHA reaffirms that it is essential that eligible employees be evaluated at a CBD diagnostic center. Requiring that the diagnostic center be able to perform all the functions described under the Definitions section also makes the exam more convenient for the employer and the employee because the employee will not have to go to multiple facilities in order to undergo different procedures.
Southern Company disagreed with the proposed requirement that both the employee and employer agree upon the CBD diagnostic center, asserting that the requirement could conflict with selection of a physician under workers' compensation laws, because OSHA does not have a mechanism to settle disputes, and because similar requirements are not included in other OSHA standards (Document ID 1668, pp. 6-7). Ameren and ORCHSE also opposed the requirement for mutual agreement on a CBD diagnostic center and recommended that location be considered when the employee and employer cannot reach agreement
OSHA acknowledges the concerns of these stakeholders, but maintains that the employee should be given a choice in the selection of a CBD diagnostic center because of the risks involved with procedures that the employee may have to undergo and because of the life-changing decisions that the employee might have to make based on the results of the evaluation. The employer and employee should make a good faith effort to agree on a CBD diagnostic center that is acceptable to them both. In making the decision, the first consideration is identifying qualified CBD diagnostic centers. The next considerations in the decision should include requirements under other laws and geographical location. OSHA expects that once these criteria are considered, there will not be unlimited options, which will help the employee and employer come to a decision.
Although OSHA was not convinced that changes needed to be made based on public comments, OSHA did find changes were required to make the final provision consistent with other requirements of the final standard. First, OSHA changed the trigger for referral to a CBD diagnostic center to include both confirmed positive and a CBD diagnosis for consistency with paragraphs (k)(5)(iii) and (k)(6)(iii). The reasoning for this change is described above in the discussion of paragraph (k)(5)(iii). Second, OSHA removed the requirement for a consultation between the physician and employee within 30 days after the employer learned that the employee was confirmed positive. Under paragraph (k)(6)(D), the employer already must ensure that the PLHCP explains findings to the employee, including conditions related to airborne beryllium exposures that require further evaluation or treatment within 30 days of the medical examination. The discussion about recommended referral can occur as part of that conversation, and OSHA does not find that a separate consultation with the physician or PLHCP is necessary.
The third major change to this provision was detailing how the employer would be informed that the employee is eligible for an evaluation at a CBD diagnostic center. The change reflects updates made to paragraph (k)(6) to allow the employee more privacy and control over the type of information the employer receives. Under final paragraph (k)(6), the employee must authorize the written medical opinion to contain recommendations for an evaluation at a CBD diagnostic center, and the licensed physician would then provide the employer that recommendation in the written medical opinion. Under paragraph (k)(5), the employee's written medical report is to contain medical findings, including a confirmed positive test result and a CBD diagnosis. The report must also contain a referral for an evaluation at a CBD diagnostic center if the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate. The employee has the option of providing the employer with a copy of the written medical report indicating a confirmed positive finding or diagnosis of CBD, or recommending referral. OSHA is providing the option for a written medical report listing a confirmed positive finding or diagnoses of CBD to be offered as proof of eligibility for an evaluation at a CBD diagnostic center, in the event that a licensed physician did not recommend a referral to a CBD diagnostic center in either the written medical report or the written medical opinion.
As the result of the changes discussed above, final paragraph (k)(7) requires that employers provide a no-cost evaluation at a CBD-diagnostic center that is mutually agreed upon by the employee and employer within 30 days of receiving a medical opinion that recommends the referral (paragraph (k)(7)(i)(A)) or within 30 days after the employee presents the employer with a written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center (paragraph (k)(7)(i)(B)). As is the case with the PLHCP's examination, the employer is responsible for providing the employee with a medical examination at a CBD diagnostic center, at no cost, and at a reasonable time and place.
Under paragraph (k)(7)(ii) of the standards the employer must ensure that the CBD diagnostic center explains medical findings to the employee and gives the employee a written medical report within 30 days of the examination. Like the licensed physician's written medical report, the written medical report from the CBD diagnostic center must contain the results of the examination, including conditions such as sensitization or CBD that might increase the employee's risk from airborne exposure to beryllium; any medical conditions related to beryllium that require further follow-up; any recommendations on the employee's use of respirators, protective clothing, or equipment; and any recommended limitations on beryllium exposure. If the employee is confirmed positive or diagnosed with CBD, the written medical report must also contain recommendations for continued periodic medical surveillance and recommendations for removal from exposure to beryllium, as described in paragraph (l). The reasons why the CBD diagnostic center is to give the employee this information are the same as discussed above, under the requirements for the licensed physician's written medical report for the employee. This provision was added to the final standards to ensure that the employee gets a written record from the CBD diagnostic center and to allow the employee to consult with the CBD diagnostic center about the findings.
Paragraph (k)(7)(iii) requires that the CBD diagnostic center provides the employer with a written medical opinion within 30 days of the medical examination. The written medical opinion must contain the date of the examination, any recommended limitations on the employee's use of respirators, protective clothing, or equipment, and a statement that a PLHCP explained the results of the medical examination to the employee. It must also contain a statement that the examination met the requirements of the standard, if a periodic examination was conducted for an employee who chooses examinations conducted at the CBD diagnostic center as specified under paragraph (7)(iv). If the employee provides written authorization, the written medical opinion for the employer must also contain any recommended limitations on the employee's airborne exposure to beryllium. If an employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain recommendations for continued medical surveillance, and/or medical removal from exposure to beryllium, as described in paragraph (l).
This provision was not in the proposed standard or the joint draft recommended standard by Materion and USW but was added to the final standards to allow for transmittal of CBD diagnostic center recommendations to the employer without revealing the specific medical reason for those recommendations. The structure parallels the written medical opinion from the licensed physician, which was developed based on stakeholder requests to increase confidentiality of
Paragraph (k)(7)(iv) requires the employer to ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30 days of any medical examination performed for that employee. As discussed above with regard to paragraph (k)(6)(vi), requiring the provision of all written medical opinions to employees can permit employees to provide that information to future employers without divulging private medical information and also present the opinion as proof of a current examination that meets the requirements of the beryllium standard.
The deadlines for submittal of the written medical opinion and report are shorter for the CBD diagnostic center (30 days) than the licensed physician (45 days). The reasoning is because CBD diagnostic centers are not expected to routinely conduct BeLPTs, which as noted above, take 2 weeks to process. They will not, therefore, be affected by the same time limitations as licensed physicians.
In the NPRM, OSHA asked stakeholders to comment on whether sensitized employees should be given the opportunity to be examined at a CBD diagnostic center more than once and how frequently those employees should be evaluated (80 FR 47574). This provision was not included in the draft standard or the joint draft recommended standard by Materion and USW (Document ID 0754).
NABTU commented that a sensitized employee should continue to be periodically evaluated at a CBD diagnostic center because it cannot be predicted when a sensitized employee will develop CBD (Document ID 1679, p. 12). NSSP, ACOEM, and ATS agreed with continued periodic surveillance at a CBD diagnostic center for sensitized employees (Document ID 1677, p. 6; 1685, p. 5; 1688, p. 3). ATS recommended that sensitized employees be evaluated every one to three years and NSSP recommended that the original physician, CBD diagnostic center, and employee determine the frequency of medical examinations. Finally, Ameren stated that the standard should allow for follow-up based on pulmonologist recommendations (Document ID 1675, p. 16).
OSHA agrees that continued evaluation at a CBD diagnostic center is appropriate for sensitized employees and employees diagnosed with CBD. Specialized evaluation is needed to determine the appropriate tests to monitor for possible progression from sensitization to CBD and to monitor the progression of CBD if it does occur. Therefore, after considering the record, OSHA added the requirement for continued evaluation at a CBD diagnostic center for these employees.
This new requirement is contained in paragraph (k)(7)(v), which specifies that after an employee has received a clinical evaluation at a CBD diagnostic center described by paragraph (k)(7)(i) of the standards, the employee may choose to have any subsequent medical examinations for which the employee is eligible under paragraph (k) of this standard performed at a CBD diagnostic center. The evaluations must continue to be done at a CBD diagnostic center mutually agreed upon by the employee and employer and provided at no cost to the employee. To allow for continued medical surveillance for those employees who would not otherwise be entitled under (k)(1) or (k)(2), the employee must authorize the recommendation for continued periodic medical surveillance to be included in the most recent written medical opinion from the CBD diagnostic center (paragraph (k)(7)(iii)). Under paragraph (k)(2)(ii), the CBD diagnostic center can recommend continued surveillance every two years. OSHA is not including a provision for more frequent examinations because, as indicated above, surveillance done every two years is appropriate to monitor for sensitization and CBD progression in most employees.
Proposed paragraph (k)(7) had required that employers were to convey the results of beryllium sensitization tests to OSHA for evaluation and analysis at the request of OSHA. The employer was to remove all personally identifiable information (
Some commenters did not support the inclusion of this requirement in the final rule. For example, Ameren commented that the proposed requirement would be burdensome because it would be cumbersome to get signed releases for this information (Document ID 1675, p. 20). ORCHSE also argued that employees would have a difficult time complying with this requirement because employees would not likely sign a release (Document ID 1691, p. 13). DOD also claimed that the requirement would be burdensome and said that it would be better to send the results to NIOSH but not routinely (Document 1684, Attachment 2, pp. 1-7-1-8). On the other hand, NJH supported this requirement because it believed the information would help OSHA identify industries where sensitization is occurring (Document ID 1664, p. 9). However, NJH added that small companies may need help complying with this requirement (Document ID 1664, p. 9). In addition, NJH and ATS recommended that the rule specify that employers routinely and systematically analyze medical screening results along with job and exposure data to identify employees who may be at risk of sensitization and working conditions contributing to sensitization and CBD risk (Document ID 1664, p. 8; 1688, 4).
Consistent with the concerns of Ameren and ORCHSE regarding getting releases from employees, OSHA has given much thought to maintaining confidentiality of medical findings as discussed in detail above. As a result of changes made in the standards to enhance employee privacy, the Agency eliminated the proposed paragraph for the written medical opinion to the employer to include a statement about whether the employee had a condition that would put him or her at risk of developing CBD with further beryllium exposure. That provision suggested that the written medical opinion might include findings such as beryllium sensitization. In the final standard, it is explicit that the employer will not receive information about sensitization or CBD in the written medical opinion to the employer, and the employer will only receive that information when an employee presents the employer with the employee's written medical report. As a result, many employers may not have that information to submit to OSHA or to otherwise conduct a systematic analysis of medical screening results. As discussed above, even if employers were provided aggregated medical findings, it may still be difficult
OSHA has other ways to obtain medical findings if needed. For example, as noted in the Summary and Explanation for paragraph (n), Recordkeeping, OSHA's Access to Employee Exposure and Medical Records standard (29 CFR 1910.1020) requires employers to ensure that most employee medical records are retained for the duration of employment plus 30 years for employees employed more than one year, and requires that those records be made available to OSHA upon request (29 CFR 1910.1020 (d)(1)(i) and (e)(3)). OSHA therefore deleted proposed paragraph (k)(7) from the final standard.
Paragraph (l) of the standards for general industry, shipyards, and construction provide for medical removal protection (MRP). This paragraph applies only to workers with airborne exposure to beryllium at or above the action level who are diagnosed with CBD or confirmed positive and provide documentation of their diagnosis of CBD or confirmed positive status or a physician's recommendations for removal from exposure to beryllium to their employers. Under this paragraph, employees must provide eligible employees with a choice of removal from exposure at or above the action level or remaining in their job with airborne exposure at or above the action level and wearing a respirator. If the employee chooses removal, the employer is required to remove the employee to comparable work in a work environment where the airborne exposure is below the action level, if such work is available. If comparable work is not available, the employer must maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal for six months or until such time that comparable work described in paragraph (l)(3)(i) becomes available, whichever comes first. The employee's earnings under MRP can be diminished by the amount of compensation received from certain other sources.
OSHA included medical removal provisions in the proposed rule as a protective, preventative health mechanism that was intended to work in concert with the proposed medical surveillance provisions. As OSHA explained in the proposal, the Agency preliminarily found that medical removal is an important means of protecting employees who have become sensitized or developed CBD, and is an appropriate means to enable them to avoid further exposure.
OSHA solicited comments on the health effects that should trigger MRP and the proposed provisions for MRP. In addition, the Agency included several specific questions to guide stakeholders in their response, including whether beryllium sensitization and CBD are appropriate triggers for medical removal, whether there were other medical conditions or findings that should trigger medical removal, and the amount of time for which a removed employee's benefits should be extended. OSHA also included questions regarding the costs and benefits of MRP (
During the public comment periods and informal public hearing, numerous stakeholders submitted comments supporting the inclusion of MRP in this rulemaking (
Other commenters indicated that the option for removal was necessary for workers' health. For example, the USW argued that the inclusion of MRP is necessary to provide a safe and healthful workplace (Document ID 1963, p. 13). USW further commented that Section VIII (Significance of Risk) of the NPRM shows that existing evidence within the docket indicates that workers who are sensitized to beryllium or are in the early stages of chronic beryllium disease can significantly benefit from MRP (Document ID 1963, p. 13). National Jewish Health (NJH) generally agreed with USW's opinion, stating that “removal from exposure is the best form of prevention” (Document ID 1664, p. 4).
Other stakeholders indicated that the inclusion of a medical removal provision might lower exposures in the workplace as a whole. For example, USW testified that MRP provides employers with a financial incentive to keep beryllium exposures low (Document ID 1755, Tr. 167-68). Mike Wright from USW observed that this incentive helped to lower exposure levels in the context of the lead standard:
But what really, I think, best protected workers was medical removal protection because employers did not want to pay people to stay at home until their blood leads got down. So I think if you look at the real benefits of MRP, it isn't simply that it removes workers from exposure, who might be harmed by further exposure. It is that it really provides an incentive for employers to keep exposures low in the first place. And that's been our experience (Document ID 1755, Tr. 167-68).
After careful consideration of these comments, OSHA has decided to include MRP in the final standards. As noted by commenters, MRP serves three main interrelated purposes. First, it increases employee participation and confidence in the standards' medical surveillance program. Under paragraph (k)(1)(i)(B), employers must offer medical examinations to employees showing signs or symptoms of CBD. The success of that program will depend in part on employees' willingness to report their symptoms, submit to examinations, respond to questions, and comply with instructions. Guaranteeing comparable work or earnings, seniority, and other rights and benefits for a period of time can help allay an employee's fear that a CBD diagnosis or
Second, by requiring the employer to remove employees with the highest risk of suffering material impairment of health (if the employee chooses removal), MRP may benefit sensitized employees and those with CBD. OSHA notes that there remains some scientific uncertainty regarding the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD. For example, Steven Markowitz, MD, a medical consultant for USW, acknowledged during the informal public hearing that “there's a paucity of evidence that removal from exposure results in improvement of CBD” (Document ID 1755, Tr. 101). Nonetheless, most members of the medical community support removal from beryllium exposure as a prudent step in the management of beryllium sensitization and CBD. As noted above, physicians at NJH recommend that individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry should have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour TWA, which is 10 times below the action level of 0.1 micrograms per cubic meter (
Finally, MRP may provide employers with an additional incentive to keep employee exposures low. Precisely because MRP will impose additional costs on employers, MRP can increase the protection afforded workers by the beryllium standards not only directly by improving medical surveillance but also indirectly by providing employers with economic incentives to comply with other provisions of the standard. The costs of MRP are likely to decrease as employer compliance with other provisions of the standard increases. Employers who comply with other provisions of the standard may have to remove relatively few employees. With only a small number of employees requiring removal, complying employers are more likely to be able to find positions available to which removed employees can be transferred. By contrast, employers who make only cursory attempts to comply with the central provisions of these standards are likely to find that the greater their degree of noncompliance, the greater the number of employees requiring medical removal and the greater the associated MRP costs. Thus, as OSHA explained in the preambles to its substance-specific standards on Cadmium and Lead, the inclusion of MRP in a final rule can serve as a strong stimulus for employers to protect worker health and rewards employers who through innovation and creativity derive new ways of protecting worker health not contemplated by these standards (57 FR 42102, 42368 (Sep. 14, 1992); 43 FR 54354, 54450 (Nov. 21, 1978)).
OSHA has the authority to include MRP in this standard. Indeed, the Court of Appeals for the D.C. Circuit recognized the Agency's authority to adopt such provisions more than 35 years ago in its review of the Agency's Lead standard (Lead I, 647 F.2d at 1229-1236). There, the Court found that MRP “appears to lie well within the general range of OSHA's powers,” and reasonable in the case of lead because it would help prevent impermissibly high blood lead levels and mitigate potential employee concerns about cooperating with the medical surveillance program (Id. at 1232, 1237). And, in the three and a half decades since the Lead I decision, OSHA has adopted MRP in five other substance-specific health standards: Cadmium (29 CFR 1910.1027), Benzene (29 CFR 1910.1028), Formaldehyde (29 CFR 1910.1048), Methylenedianiline (29 CFR 1910.1050), and Methylene chloride (1910.1052).
Paragraph (l)(1) of the proposed standard detailed the eligibility requirements for medical removal. The provision explained that an employee would be eligible for medical removal if he or she works in a job with exposure at or above the action level and is diagnosed with CBD or confirmed positive for sensitization. OSHA specifically asked for comments on whether beryllium sensitization and CBD are appropriate triggers for medical removal and whether there are other medical conditions or findings that should trigger medical removal.
Stakeholders generally supported the proposed triggers. ORCHSE Strategies (ORCHSE) argued that confirmed beryllium sensitization and CBD are appropriate triggers for medical removal (Document ID 1691, Attachment 1, p. 15). ORCHSE explained that since CBD is a chronic, progressive lung disease with no known cure, it is imperative that signs of health impairment be found early and exposure be terminated to avoid further impairment (Document ID 1691, Attachment 1, p. 15). NJH also commented that confirmed beryllium sensitization and CBD are appropriate triggers for medical removal (Document ID 1664, p. 9). Ameren, North America's Building Trades Unions (NABTU), Materion Corporation (Materion), and USW agreed (Document ID 1675, p. 20; 1679, p. 14; 1680, p. 7; 1681, pp. 14-15). USW commented that medical removal could prevent the progression of disease in workers diagnosed with sensitization or CBD (Document ID 1681, p. 15). However the Department of Defense argued that CBD but not beryllium sensitization is an appropriate trigger for medical removal and that sensitization is an appropriate trigger for advising employees about risk and requiring use of personal protective equipment if the employee chooses to return to work (Document ID 1684, Attachment 2, p. 1-8). The American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) indicated support for the action level exposure trigger (Document ID 1809, p. 1; 1809, Attachment 2, Tr. 930-931; 942-943).
After reviewing the record on this issue, OSHA has decided that a CBD diagnosis and a confirmed positive test for sensitization are appropriate triggers for medical removal. OSHA disagrees
Final paragraph (l)(1), consistent with the proposal, states that the employee is eligible for medical removal if the employee works in a job with exposure at or above the action level, but contains more specificity about the types of documentation that are submitted to the employer to demonstrate eligibility for medical removal. This change was made to track employee privacy protections included in the licensed physician's medical opinion in paragraph (k)(6) and the CBD diagnostic center's medical opinion in paragraph (k)(7)(iii). Under paragraphs (k)(5) and (k)(7)(ii), the standards now specify that the licensed physician or CBD diagnostic center provides only the employee a medical report that contains detailed medical findings, such as confirmed positive findings or a diagnosis of CBD. In cases where the employee is confirmed positive or diagnosed with CBD, the physician or CBD diagnostic center also includes recommendations for removal from exposure in the written medical report. However, under paragraphs (k)(6) and (k)(7)(iii), employers do not receive a written medical opinion that contains an employee's medical information (other than any recommended limitations on the employee's use of respirators) without the employee's written consent. The written opinion to the employer may contain a recommendation for removal from exposure, without the medical reason for the recommendation, only if the employee authorizes that recommendation to be included in the opinion. This allows an employee who is eligible for medical removal and chooses that option to provide official documentation requesting removal, without disclosing a specific medical condition.
Thus, paragraph (l)(1) allows an employee's eligibility for removal to be established by four different types of documentation:
• The employee may provide a (k)(5) or (k)(7)(ii) written medical report indicating a confirmed positive finding or diagnoses of CBD and recommending removal because of that finding or diagnosis.
• The employee may provide a (k)(5) or (k)(7)(ii) written medical report in which the confirmed positive finding or diagnosis has been obscured or removed, but still contains the recommendation of removal because of that finding or diagnosis. An employee might do this if, consistent with the approach of paragraph (k), the employee wishes to keep the details of the condition private.
• The employee may provide any reliable medical documentation establishing a confirmed positive finding or diagnosis of CBD, regardless of whether it was issued in compliance with paragraph (k)(5). An employee might do this if, for example, the documentation predates this standard. This documentation would be a “written medical report” for purposes of (l)(1)(i)(A).
• The employer receives a (k)(6) or (k)(7)(iii) written medical opinion recommending removal from the licensed physician or CBD diagnostic center.
OSHA added the language “in accordance with paragraph (k)(5)(v) or (k)(7)(ii) of this standard” to (l)(1)(i)(B) and “in accordance with paragraph (k)(6)(v) or (k)(7)(iii) of the standard” to (l)(1)(ii) to be clear that medical removal is required under those provisions only when the removal recommendation is based on a confirmed positive finding or a diagnosis of CBD.
Paragraph (l)(2) of the proposal laid out the options for employees who are eligible for MRP. Specifically, paragraph (l)(2) required eligible employees to choose removal, as described under paragraph (l)(3), or to remain in a job with exposure at or above the action level as long as they wear a respirator in accordance with paragraph (g) of this standard. While both ORCHSE and Public Citizen supported the MRP provision, neither supported making removal optional (Document ID 1691, Attachment 1, p. 13; 1756, Tr. 189). ORCHSE specifically stated that utilizing respiratory protection as a means of protecting workers violates the hierarchy of controls and removal is most prudent for worker protection (Document ID 1691, Attachment 1, p. 13).
After careful consideration of these comments, OSHA has decided to allow employees to choose between removal and remaining in a job with airborne exposure at or above the action level, provided that the employee uses respiratory protection for exposures at or above the action level, as contemplated in the proposal. OSHA recognizes that removal may reduce the risk of the onset of CBD and lead to reduction of symptoms. However, CBD is unlike triggers for MRP in some other OSHA standards, such as lead and benzene, because CBD is not reversible. Thus, without the respirator option, mandatory removal would require that the employee switch careers permanently. OSHA believes the worker should be given a voice in such a fundamental life decision where the confirmed positive employee may be able to minimize the risk of CBD through the consistent and careful use of respiratory protection in a workplace where feasible controls are implemented to maintain exposures within the PEL. Indeed, mandatory permanent removal might lead workers to hide their symptoms or not seek treatment, which is directly contrary to the purpose of MRP. For these reasons, the Agency finds mandating removal is not appropriate in this rulemaking. Therefore, paragraph (l)(2) of the final standards requires employers to provide eligible employees with the employee's choice of: (i) Removal as described in paragraph (l)(3) of these standards; or (ii) remaining in a job with airborne exposure at or above the action level, provided that the employee uses respiratory protection that complies with paragraph (g) of these standards whenever exposures are at or above the action level.
Although paragraph (l)(2) of the final standards tracks OSHA's intent as expressed in the proposal, the final provision contains several clarifying changes. First, final paragraph (l)(2) explicitly places the responsibility for providing the choices on the employer, while the proposal merely implied that the employer would do so. OSHA believes that this clarification eliminates the possibility of confusion. Second, final paragraph (l)(2)(ii) refers to paragraph (g) of these standards, instead of referring to the Respiratory Protection standard (29 CFR 1910.134). OSHA made this second change to bring this provision into line with a similar provision in paragraph (e) of the final standards; it does not affect the employer's obligations as set forth in the proposed rule. Third, final paragraph (l)(2)(ii) expressly requires employers to ensure that employees use the respiratory protection whenever airborne exposures meet or exceed the action level. Again, this requirement was implied in the proposal, but OSHA believes that making the requirement express helps employers understand their obligations under these standards.
Proposed paragraph (l)(3) contained requirements that would have applied if an eligible employee elected removal. Under the proposal, when an employee chooses removal, the employer would have been required to remove the employee to comparable work if such work was available. Proposed paragraph (l)(3)(i) explained that comparable work is a position for which the employee is already qualified or can be trained
If comparable work was not immediately available, paragraph (l)(3)(ii) of the proposal would have required the employer to place the employee on paid leave for six months or until comparable work becomes available, whichever occurs first. Proposed paragraph (l)(3)(ii) further explained that if comparable work became available before the end of the six month paid leave period, the employer would have been obligated to offer the open position to the employee. However, OSHA explained that if the employee declined the position, the employer would have had no further obligation to provide paid leave.
Proposed paragraph (l)(3)(iii) would have continued a removed employee's rights and benefits for six months, regardless of whether the employee was removed to comparable work or placed on paid leave. The six-month period would have begun when the employee was removed, which means either the day the employer transferred the employee to comparable work, or the day the employer placed the employee on paid leave. For this period, the provision would have required the employer to maintain the employee's base earnings, seniority, and other rights and benefits of employment as they existed at the time of removal. OSHA explained that this provision is typical of medical removal provisions in other OSHA standards, such as Cadmium (29 CFR 1910.1027), Benzene (29 CFR 1910.1028), Formaldehyde (29 CFR 1910.1048), Methylenedianiline (29 CFR 1910.1050), and Methylene Chloride (29 CFR 1910.1052).
As detailed above, there is widespread support among stakeholders for the inclusion of removal and wage protection for eligible employees in this rulemaking. The provisions included in the proposal were consistent with the recommendation of beryllium health specialists in the medical community and with the draft recommended standard provided by Materion and USW (Document ID 0754). However, not all commenters agreed with the proposed provisions. One commenter, NABTU, argued that “[i]f an employer who has placed an employee at risk cannot offer alternative employment [within six months], then a better solution would be to provide MRP until the employee has obtained new and equivalent employment, provided that the employee is making
OSHA is sympathetic to NABTU's position—some employers, especially small employers, may lack the flexibility and resources to provide comparable positions for MRP-eligible employees (Document ID 0345, p. 24), and as a result, employees' base earnings and benefits would only be maintained for a six-month period. However, OSHA also recognizes that the requirement to maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal for even a six-month period may be difficult for some employers. After weighing these two concerns, OSHA finds that the requirement to provide medical removal protection for a six-month period strikes a reasonable balance between protecting employees and limiting the burden on employers. Therefore, OSHA has decided to retain these provisions in the final standard with minor edits, as follows.
First, OSHA reorganized and edited paragraph (l)(3)(i) to clarify and emphasize the employer's responsibilities. Like the proposed provision, final paragraph (l)(3) applies where an eligible employee chooses removal. If a comparable job is available where exposures to beryllium are below the action level, and the employee is qualified for that job or can be trained within one month, final paragraph (l)(3)(i) requires the employer to remove the employee to that job. Although each of these requirements was expressly stated in the NPRM in either the regulatory text or the preamble (80 FR 47802), OSHA has chosen to make its intent express in the final regulatory text. For example, the NPRM implied in regulatory text and explained in the preamble that an employer's obligation under proposed paragraph (l)(3)(i) arose where comparable work was available, but the final text makes the trigger for this obligation explicit (see 80 FR 47802; proposed paragraph (l)(3)(ii) (which applied “if comparable work is not available)).
Second, OSHA omitted the proposed requirement in paragraph (l)(3)(i) that “[t]he employee must accept comparable work if such work is available” from final paragraph (l)(3)(i). As stated in the preamble to the proposal, OSHA included this statement in proposed paragraph (l)(3)(i), in part, to make clear that if the employee declines an offer of comparable work, then the employer was not obligated to place the employee on paid leave under paragraph (l)(3)(ii) (80 FR 47802). However, because OSHA regulates employers, this requirement is better expressed as a clarification to the employer's responsibilities. OSHA concludes that the opening clause to proposed and final paragraphs (l)(3)(ii), which indicates that an employer's obligation to maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal arises “[i]f comparable work is not available” makes this sufficiently clear.
Third, OSHA eliminated proposed paragraphs (l)(3)(iii), which stated that “whether the employee is removed to comparable work or placed on paid leave, the employer shall maintain for 6 months the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.” In the final rule, proposed (l)(3)(iii)'s requirements have been incorporated into final paragraphs (l)(3)(i) and (ii). OSHA believes that this simplification will clarify the Agency's intent.
OSHA has also omitted the phrase “paid leave” from final paragraph (l)(3)(ii) because, with the incorporation of proposed paragraph (l)(3)(iii)'s temporal and benefits requirements into final paragraph (l)(3)(ii), it is unnecessary to specify what an employee who has been removed but is not working in a comparable job would be doing. In addition, OSHA wishes to give employers the flexibility to work with removed employees to create alternatives to merely placing the employee on paid leave. For example, employers might choose to offer the employee the opportunity to train for more than one month so that he or she could qualify for a different job. Provided that the employer otherwise complied with final paragraph (l)(3)(ii), such an arrangement would be permissible under the final standards.
Finally, proposed paragraph (l)(4) provided that an employer's obligation to provide MRP benefits to a removed employee would be reduced if, and to the extent that, the employee receives compensation from a publicly or employer-funded compensation program for earnings lost during the removal period, or receives income from another employer made possible by virtue of the employee's removal. OSHA retained this requirement unchanged in final paragraph (l)(4). OSHA clarifies that benefits received under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) do not constitute wage replacement; therefore, EEOICPA benefits would not offset the employee's MRP benefits.
OSHA did not receive any comments specifically directed to this provision, but, as noted above, several stakeholders commented that they supported the MRP provisions contained in the proposal as a whole (
For the reasons discussed above, OSHA finds that maintaining the MRP provision, with the clarifying changes noted above, in the final rule provides workers the incentive to participate in the medical surveillance program and provides workers with sensitization or CBD the opportunity and means to minimize further exposure to beryllium.
Paragraph (m) of the standards for general industry, construction, and shipyards sets forth the employer's obligations to comply with OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200) relative to beryllium, and to take additional steps to warn and train employees about the hazards of beryllium. Employees need to know about the hazards to which they are exposed, along with the 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 safety data sheets (SDSs). These written forms of communication will be most effective when employees understand the information presented and are aware of how to avoid or minimize exposures, thereby reducing the possibility of experiencing adverse health effects. Several commenters, including Ameren Corporation (Ameren) and United Steelworkers (USW), generally supported inclusion of a hazard communication requirement in the beryllium standards (
As a general matter, the HCS requires a comprehensive hazard evaluation and communication process, aimed at ensuring that the hazards of all chemicals are evaluated, and also requires that the information concerning chemical hazards and necessary protective measures is properly transmitted to employees. The HCS achieves this goal, in part, by requiring chemical manufacturers and importers to review available scientific evidence concerning the physical and health hazards of the chemicals they produce or import to determine if they are hazardous. For every chemical found to be hazardous, the chemical manufacturer or importer must develop a container label and an SDS, and provide both documents to downstream users of the chemical. All employers with employees exposed to hazardous chemicals must develop a hazard communication program and ensure that all containers of hazardous chemicals are labeled and employees are provided access to SDSs and are trained on the hazardous chemicals in their workplace. Because OSHA preliminarily found beryllium to be a hazardous chemical, the Agency determined that hazard communications provisions should be included in the proposal. OSHA intends for the hazard communication requirements in the final standards to be substantively as consistent as possible with the HCS, while including additional specific requirements needed to protect employees exposed to beryllium, in order to avoid duplicative administrative burden on employers who must comply with both the HCS and this rule. Proposed paragraph (m)(1)(i) required chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the HCS (29 CFR 1910.1200) for beryllium. Stakeholders did not offer any comments on this provision. After reviewing the full record, including all available evidence, and as discussed in this preamble at Section V, Health Effects, and Section VI, Risk Assessment, OSHA finds that beryllium is a hazardous chemical for purposes of the HCS. Therefore, the Agency includes paragraph (m)(1)(i) of the final standards for general industry, construction, and shipyards to require chemical manufacturers, importers, distributors, and employers to comply with their duties under HCS. The final provision in these standards is substantively unchanged from the proposed provision. Paragraph (m)(1)(ii) of the proposal required employers to address at least the following, in classifying the hazards of beryllium: Cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation. According to the HCS, employers must classify hazards if they do not rely on the classifications of chemical manufacturers, importers, and distributors (see 29 CFR 1910.1200(d)(1)). Commenters did not object to this provision. Therefore, after considering the record, including the general comments in favor of the proposed hazard communications provisions and the evidence presented in Section V, Health Effects, and Section VI, Risk Assessment, regarding the enumerated hazards of exposure to beryllium, OSHA has decided to retain this proposed provision substantively unchanged in final paragraph (m)(1)(ii) of the standards for general industry and shipyards. However, OSHA has revised the language to bring it into conformity with other substance specific standards so it is clear that chemical manufacturers, importers, and distributors are among the entities required to classify the hazards of beryllium (See 77 FR 17748-50).
OSHA has chosen not to include an equivalent requirement in the final standards for construction and shipyards since employers in construction and shipyards are downstream users of beryllium products (blasting media) and would not therefore be classifying chemicals (Chapter IV of the Final Economic Analysis).
Proposed paragraph (m)(1)(iii) required employers to include beryllium in the hazard communication program established to comply with the HCS, and ensure that each employee has access to labels on containers and safety data sheets for beryllium and is trained in accordance with the HCS and paragraph (m)(4) of this section. Stakeholders did not object to any part of this provision. After reviewing the record, OSHA reaffirms that employees
Paragraph (m)(2)(i) of the proposed standard required employers to provide and display warning signs at each approach to a regulated area so that each employee is able to read and understand the signs and take necessary protective steps before entering the area. Proposed paragraph (m)(2)(ii) of the standards required employers to ensure that warning signs are legible and readily visible, and that they bear the following legend:
OSHA has decided to retain the hazard statement about cancer as a requirement for the warning signs. As discussed in this preamble at Section V, Health Effects, and Section VI, Risk Assessment, OSHA has reviewed the scientific literature for beryllium carcinogenicity, including the Boffeta study, and has concluded that beryllium is carcinogenic. The Agency's finding is based on the best available epidemiological data, reflects evidence from animal and mechanistic research, and is consistent with the conclusions of other government and public health organizations. Furthermore, the International Agency for Research on Cancer (IARC), National Toxicology Program (NTP), and American Conference of Governmental Industrial Hygienists (ACGIH) have all classified beryllium as a known human carcinogen (Document ID 0651; 0389, pp. 1-3; 1304; 0345, p. 4). In light of this evidence, OSHA finds the comments opposing the cancer warning language on signs unpersuasive. However, with regard to Materion's suggested language, OSHA agrees that a warning that beryllium can cause damage to lungs is appropriate and retains that language, as proposed, in the final standards for general industry and shipyards.
A few other stakeholders also suggested edits or additions to the proposed sign legend. For example, NGK recommended that the phrase, WEAR RESPIRATORY PROTECTION AND PROTECTIVE EQUIPMENT IN THIS AREA be changed to WEAR RESPIRATORY PROTECTION AND PROTECTIVE EQUIPMENT PRIOR TO ENTERING THIS AREA, on warning signs to emphasize that personal protective equipment (PPE) must be put on before entering the restricted work area (Document ID 1663, p. 3). OSHA agrees that employees need to don PPE prior to entering the regulated area, but finds the suggested language requiring respiratory protection and PPE “in this area” is sufficient to alert the workers to put their equipment and respirators on prior to entering the restricted work area. Therefore, OSHA has decided to retain the text “in this area” as stated in the final standards for general industry and shipyards. OSHA also notes that this language is consistent with the HCS and other previous health standards, such as Benzene (29 CFR 1910.1028).
One stakeholder proposed a provision particular to shipyards. In hearing testimony, Ashlee Fitch of USW commented that warning signs “demarking abrasive blasting operations with beryllium-containing materials” should be posted (Document ID 1756, p. 245). OSHA has chosen not to incorporate this suggestion. The signs required by paragraph (m)(2) of this final rule are intended to serve as a warning to employees and others who may not be aware that they are entering a regulated area, and to remind them of the hazards of beryllium so that they take necessary protective steps before entering the area. These signs are also intended to supplement the training that employees must receive regarding the hazards of beryllium, since even trained employees need to be reminded of the locations of regulated areas and of the precautions necessary before entering these dangerous areas (see paragraph (m)(4) of this rule and 29 CFR 1910.1200(h) for training requirements). OSHA does not believe it is necessary for the signs to denote the precise activity occurring within the regulated area in order to accomplish these goals. However, employers may choose to include additional information on the signs required under this rule, provided that the additional information included is not confusing or misleading and does not detract from required warnings.
Thus, paragraph (m)(2)(i)) of the final standards for general industry and shipyards requires employers to provide and display warning signs at each approach to a regulated area so that each employee is able to read and understand the signs and take necessary protective steps before entering the area. Pursuant to final paragraph (m)(2)(ii), employers must ensure that these warning signs legible and readily visible and include the specified legend. The only alteration to the legend from the proposal is the addition of the words, “REGULATED AREA” following the word, “DANGER.” OSHA has not included these regulated area signage requirements in the final standard for construction, because the construction standard does not contain requirements for establishing regulated area and uses the competent person (paragraph (e) of the construction standard) to limit access to areas where exposures have the potential to be above the PEL. In summary, OSHA finds that the use of warning signs is important to make employees who are regularly scheduled to work at these sites aware of beryllium hazards, to alert employees who have limited access to these sites of beryllium hazards, and to warn those who do not require access to regulated areas to avoid those areas. Access must be limited to authorized personnel to ensure that those entering the area are adequately trained and equipped, and to limit exposure to those whose presence is absolutely necessary. By limiting access to authorized persons, employers can minimize employee exposure to beryllium in regulated areas and thereby minimize the number of employees who may require medical surveillance or may be subject to the other requirements associated with working in a regulated area.
Proposed paragraph (m)(3) required that labels be affixed to all bags and containers of clothing, equipment, and materials visibly contaminated with beryllium. OSHA also included a requirement that the labels contain the following statement:
The USW supported the proposal's requirement that bags and containers storing materials visibly contaminated with beryllium have specific warning labels to alert workers of the dangers of beryllium exposure (Document ID 1681, p. 15). However, as discussed in the Summary and Explanation on paragraph (h) on personal protective clothing and equipment, several commenters objected to the use of the term “visibly contaminated.” For example, the Non-Ferrous Founder's Society (NFFS) commented that the definition of “visibly contaminated with beryllium” was not provided in the proposed rule and was vague (Document ID 1679, p. 5). OSHA agrees that the term is ambiguous and has chosen to remove the term visibly from the final standards. OSHA has therefore relied on terminology that is commonly used in other substance specific standards for metals, such as Chromium (VI) (29 CFR 1910.1026). NGK also recommended that OSHA insert the word “particulate” (Document ID 1663, pp. 3-4). OSHA declines to adopt this suggestion. The addition of the term “particulate” is unnecessary and may cause confusion since the final standards cover beryllium in all forms, compounds, and mixtures. Several stakeholders also weighed in on other aspects of these provisions. For example, NGK and Materion offered comments on the proposed wording of the required labels, which restated their requests that the cancer warnings be struck from the proposed language (Document ID 1663, pp. 3-4; 1958, pp. 3-5). OSHA has decided to retain the cancer warning labeling requirements in the final rule for the reasons discussed in response to their comments on paragraph (m)(2) above.
ORCHSE Strategies (ORCHSE) also commented on the labeling requirements of containers and bags in paragraph (m)(3). First, it argued that the provision would require the precautionary statements “Avoid creating dust” and “Do not get on skin” for all bags and containers which it maintained is inconsistent with the HCS precautionary statements (Document ID 1691, Attachment 1, p. 23). OSHA acknowledges that these “precautionary statements” are not from Appendix C of the HCS. However, OSHA is requiring alternate language for the unique situation for bags of contaminated clothing or equipment where workers handling these materials may not have access to other more in-depth forms of information. The Agency is therefore requiring that employers place appropriate warning language on bags and containers containing beryllium-contaminated materials. This provision is consistent with other substance-specific health standards.
Second, ORSCHSE argued that the proposed labeling requirements are inconsistent with the HCS. It stated that paragraph (m)(1) required compliance with the HCS, which covers warning labels for hazardous chemicals other than beryllium, “so using the same standard for beryllium labels would promote consistency throughout the workplace.” Therefore, it suggested that paragraph (m)(3) be deleted, because paragraph (m)(1) already requires observation of “all requirements” of the HCS. Additionally, ORCHSE commented that the HCS does not require labeling for carcinogens on bags and containers unless the concentration is 1% or more (Document ID 1691, Attachment 1, pp. 23-24).
After considering these comments and the record on this issue, OSHA has decided to retain proposed paragraph (m)(3) with the minor alteration described above. The final provision, which appears in paragraph (m)(3) of the final standards for general industry and shipyards and paragraph (m)(2) of the final standard for construction, requires employers to label each bag and container of clothing, equipment, and materials contaminated with beryllium. The required label must, at a minimum, include the language specified in the proposal. The warning label language for the signal word (danger) and hazard statements (may cause cancer) are consistent with the GHS. However, OSHA has decided that the precautionary statements needed to be slightly different due to the nature of the exposure and the fact that sensitization can result from short term exposures (see Health Effects section V of this preamble).
While ORCHSE correctly notes that the HCS contains a concentration cutoff (0.1% for category 1 carcinogens, and 1% for category 2 carcinogens), that cutoff is difficult to apply in the case of clothing or other material that has been contaminated with beryllium-containing dust. As a practical matter, it may be difficult to determine whether the cutoffs have been exceeded with dust contamination. Moreover, the cutoffs were developed for mixtures that are products and more homogeneous in nature, rather than materials contaminated with dust. If contaminated clothing or other materials are handled in a way that generates dust, exposures of concern might occur more readily than with homogenous mixtures of similar concentration. OSHA believes the clearer approach is to require all contaminated materials with a uniform labelling scheme, as it has for other substance-specific standards (
The Agency finds that the final labeling requirements will help ensure that all affected employees, not only the employees of a particular employer, are apprised of the presence of beryllium-containing materials and the hazardous nature of beryllium exposure. With this knowledge, employees can take steps to protect themselves through proper work practices established by their employers. Employees are also better able to alert their employers if they believe exposures or skin contamination can occur.
Proposed paragraph (m)(4) contained requirements for employee information and training. The proposed provisions applied to each employee who is or can reasonably be expected to be exposed to airborne beryllium. ORCHSE strongly urged OSHA to rewrite this provision to align with the HCS training, arguing that “there is no need to include chemical hazard training requirements in a substance specific standard” (Document ID 1691, Attachment 1, p. 20). While OSHA agrees that the HCS is designed to cover all chemical hazards in the workplace, an employer may choose to train by specific chemical or by hazard. In this substance specific standard, OSHA find that employees need to be trained on the hazards specifically associated with beryllium, in addition to the training they receive under the HCS. These types of requirements are not uncommon in substance specific hazards. For example, the Lead standard requires annual training on the specific hazards associated with lead exposure (see 29 CFR 1910.1025 (l)(1)). Consequently, OSHA is not persuaded by ORCHSE that OSHA should substantially change the training provisions in the final rule.
The Boeing Company (Boeing) suggested that OSHA add the text “within the scope of this standard” to the end of this requirement (Document ID 1667, p. 7). It contended that its
NGK also commented on the proposed trigger. Specifically, it suggested the training requirements should be consistent with the lead standard (29 CFR 1910.1025(l)(1)(ii)) in that the training should be done for those workers exposed above the action level (Document ID 1663, p. 4). OSHA declines to adopt this suggestion. As discussed in Section V, Health Effects, and Section VI, Risk Assessment, risk of material impairment to health remains at exposure levels below the action level. Because of this risk, OSHA concludes that it is necessary and appropriate to train all employees who may be exposed to airborne beryllium at any level. The Agency finds that all such employees will benefit from this training. Therefore, OSHA is continuing to trigger the training requirements proposed in paragraph (m)(4)(i) based on airborne exposure, or anticipated exposure, at any level. The final provisions are contained in paragraph (m)(4)(i) of the standards for general industry and shipyards and paragraph (m)(3)(i) of the standard for construction.
Proposed paragraph (m)(4)(i)(A) required employers to provide employees who are or can reasonably be expected to be exposed to airborne beryllium with information and training in accordance with the requirements of the HCS (29 CFR 1910.1200(h)), including specific information on beryllium as well as any other hazards addressed in the workplace hazard communication program.
OSHA did not receive any objections to or comments on this provision. After a review of the rulemaking record, the Agency continues to believe that the provision of information and training in accordance with the HCS will benefit employees. For example, under the HCS, employers must provide their employees with information such as the location and availability of the written hazard communication program, including lists of hazardous chemicals and safety data sheets, and the location of operations in their work areas where hazardous chemicals are present. The HCS also requires employers to train their employees on ways to detect the presence or release of hazardous chemicals in the work area, such as any monitoring conducted, the physical and health hazards of the chemicals in the work area, measures employees can take to protect themselves, and the details of the employer's hazard communication program (29 CFR 1910.1200(h)(3)). Therefore, OSHA has included proposed paragraph (m)(4)(i)(A) substantively unchanged from the proposal in paragraph (m)(4)(i)(A) of the final standards for general industry and shipyards and paragraph (m)(3)(i)(A) of the final standard for construction.
Proposed paragraphs (m)(4)(i)(B) and (C) specified when an employer's obligation to train covered employees should begin and how often training should occur. Proposed paragraph (m)(4)(i)(B) required initial training by the time of initial assignment, which means before the employee's first day of work in a job that could reasonably be expected to involve exposure to airborne beryllium. Under proposed paragraph (m)(4)(i)(C), employers were required to repeat training at least annually thereafter. USW supported the requirement of initial and annual training for workers who are or can be reasonably expected to be exposed to beryllium (Document ID 1681, p. 15).
After reviewing the record on this topic, OSHA has decided to retain proposed paragraphs (m)(4)(i)(B) and (m)(4)(i)(C) in paragraph (m)(4)(i)(B) and (C) of the final standards for general industry and shipyards and paragraph (m)(3)(i)(B) and (C) of the final standard for construction. OSHA finds that initial training and annual retraining are necessary due to the serious and debilitating health effects of beryllium exposure, and for reinforcement of employees' knowledge of those hazards. The initial training requirement is consistent with the HCS, which requires that employers provide employees with effective information and training on hazardous chemicals in their work area at the time of their initial assignment (29 CFR 1910.1200(h)(1)). In addition, while the triggers may be slightly different, the initial and annual training requirement are consistent with other OSHA standards such as those for Lead (29 CFR 1910.1025), Cadmium (29 CFR 1910.1027), Benzene (29 CFR 1910.1028), Coke Oven emissions (29 CFR 1910.1029), Cotton Dust (29 CFR 1910.1043), and 1,3-Butadiene (29 CFR 1910.1051).
Proposed paragraph (m)(4)(ii) required the employer to ensure that each employee who is or can reasonably be expected to be exposed to airborne beryllium can demonstrate knowledge of nine enumerated categories of information. ORCHSE and NGK objected to this proposed requirement. ORCHSE suggested that OSHA replace “can demonstrate knowledge of” with “has been informed of” in paragraph (m)(4)(ii). ORCHSE also argued that employers can control what information they provide, but cannot control what information the employee retains, and a literal interpretation of the requirement that employees must “demonstrate knowledge of” the nine enumerated categories of information will result in citations whenever “any employee, at any moment, is unable to recite detail” on those topics (Document ID 1691, Attachment 1, pp. 21-23). Similarly, NGK commented that the requirement that employers must ensure that employees who may be exposed to beryllium can demonstrate knowledge of enumerated subjects should be replaced with a requirement that employers ensure employee participation in a training program, consistent with the lead standard (29 CFR 1910.1025(l)(1)(ii)) (Document ID 1663, p. 4).
OSHA does not find these arguments persuasive. Because beryllium is a hazardous chemical with serious and debilitating health effects, it is imperative that employers can ensure that employees can demonstrate that they understand the material and have knowledge of the topics covered during the training sessions, as previously indicated. To adjust the text to read “has been informed of” or to require the employer to ensure employee participation in training will not ensure employee comprehension and consequently could lead to employees not understanding the health effects associated with beryllium exposure and safety concerns to protect themselves from exposure. This language would also be inconsistent with the HCS, which requires effective training which OSHA indicates must be in a manner which an employee comprehends.
The Agency understands that employers would like more clarity on how to determine whether training requirements are met. However, OSHA has decided that the training requirements under the final beryllium standards, like those in HCS, are best accomplished when they are performance-oriented. But, as in past
First, although OSHA finds that the employer is in the best position to determine how the training can most effectively be accomplished, the Agency notes that hands-on training, videotapes, DVD or slide presentations, classroom instruction, informal discussions during safety meetings, written materials, or any combination of these methods may be appropriate. Second, 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. 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 the instructor must be available for questions during training or if an instructor or 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.
Third, in addition to being performance-oriented, these training requirements are also results-oriented. As discussed in the respirable crystalline silica standard, there are a variety of methods employers can use to determine whether employees have the requisite knowledge. For example, employers may choose to facilitate discussions of the required training subjects or administer written tests or oral quizzes. Any of these methods could alert an employer to an employee knowledge gap.
Finally, OSHA has included a modification in the final standards that was prompted by ORCHSE and NGK's questions. In the final standards (paragraph (m)(4)(ii) of the standards for general industry and shipyards and paragraph (m)(3)(ii) of the standard for construction), OSHA requires that the employer must ensure that employees demonstrate understanding, in addition to knowledge. As discussed above this is consistent with the HCS and emphasizes that it is not enough for an employee to simply be provided with the information; the employer must also ensure that the employee understands the topics on which he or she is trained.
This change is consistent with Assistant Secretary David Michaels' memorandum to OSHA Regional Administrators (Document ID 1754, p. 2). 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:
[A]n employer must instruct its employees using both a language and vocabulary that the employees can understand. For example, if an employee does not speak or comprehend English, instruction must be provided in a language that the employee can understand. Similarly, if the employee's vocabulary is limited, the training must account for that limitation. By the same token, if employees are not literate, telling them to read training materials will not satisfy the employer's training obligation (Document ID 1754, p. 2).
Finally, Boeing suggested that OSHA add the text “or equally as effective documentation” to paragraph (m)(4)(ii)(B), so that the employer could satisfy its obligations by ensuring that employees who are or can reasonably be expected to be exposed to airborne beryllium could demonstrate knowledge of “[t]he written exposure control plan, or equally as effective documentation, with emphasis on the location(s) of beryllium work areas, including any regulated areas, and the specific nature of operations that could result in employee exposure, especially employee exposure above the TWA PEL or STEL.” They contend that this added language would allow employers “to provide the required information through the use of existing processes instead of through the creation of a second redundant document” (Document ID 1667, p. 7).
OSHA has considered Boeing's suggestion but does not find its arguments persuasive. Paragraph (m)(4)(ii)(B) of the final standards specifically requires the employer to ensure that employees can demonstrate understanding and knowledge of the topics covered in the written control plan, not from a similar document. The suggested language makes it unclear whether the employee would get the appropriate training needed and still gain the same knowledge and understanding required by the beryllium standard. OSHA, therefore, has decided to retain paragraph (m)(4)(ii)(B)'s requirements from the proposed rule in these final standards. That said, employers are free to incorporate their current exposure control program into the written control program required by paragraph (f)(1) if their program meets the requirements of that paragraph. If they do so, and train their employees on that program, paragraph (m)(4)(ii)(B) requires no “second redundant document.”
Proposed paragraph (m)(4)(ii)(A)-(I) specified the contents of training for employees who are or can reasonably be expected to be exposed to airborne beryllium. The proposed list required employers to ensure that employees can demonstrate knowledge of: (1) The health hazards associated with exposure to soluble beryllium compounds, including the signs and symptoms of CBD; (2) the written exposure control plan, with emphasis on the location(s) of beryllium work areas, including any regulated areas, and the specific nature operations that could result in employee exposure, especially employee exposure above the TWA PEL or STEL; (3) the purpose, proper selection, fitting, proper use, and limitations of personal protective clothing and equipment, including respirators; (4) applicable emergency procedures; (5) measures employees can take to protect themselves from exposure to beryllium and contact with soluble beryllium compounds, including personal hygiene practices; (6) the purpose and a description of the medical surveillance program required by paragraph (k) of this standard, including risks and benefits of each test to be offered; (7) the purpose and a description of the medical removal protection provided under paragraph (l) of this standard; (8) the contents of this standard; and (9) the employee's right of access to records under the Records Access Standard (29 CFR 1910.1020).
Stakeholders offered several comments on these proposed training topics. For example, ORCHSE commented that the employer should just “provide information and training as specified in the HCS” (Document 1691, Attachment 1, p. 23). OSHA has chosen not to adopt this suggestion because it finds that employees need training specific to beryllium and its hazards, not only the general training
Stakeholder comments support OSHA's finding that training will lead to better work practices and hazard avoidance. For example, in hearing testimony, Chris Trahan from North America's Building Trades Unions (NABTU) commented that in construction, she does not “see a high level of awareness about hazards related to beryllium” (Document ID 1756, pp. 207-08). NABTU also commented that it “developed a survey to determine the level of awareness of beryllium hazards and knowledge of exposures among building trades trainers,” and found widespread ignorance of beryllium health risks even among survey respondents responsible for delivering hazard awareness training (Document ID 1679 p. 5). Ashlee Fitch from the USW testified that in her experience in abrasive blasting, there was no training specific to what the material contained, and “the health effects associated with . . . blasting media” were not discussed (Document ID 1756, p. 247). Thus, OSHA concludes that mandating information and training on the topics specific to beryllium as outlined in proposed paragraph (m)(4)(ii) is particularly important.
In light of these comments, OSHA reaffirms its finding that all nine of the training topics listed in proposed paragraph (m)(4)(ii)(A)-(I) should be included in the final standards. The Agency has thus retained these topics in final paragraphs (m)(4)(ii)(A)-(I) of the standards for general industry and shipyards and paragraph (m)(3)(ii)(A)-(I) of the standard for construction, with minor alterations for consistency with triggers that were updated from the proposal to the final. For example, OSHA has changed the (m)(4)(ii)(A) from “contact with soluble beryllium” to “contact with beryllium.”
OSHA is not mandating additional training for a competent person in paragraph (m) of the standards for construction. As discussed in more detail in the summary and explanation of
Proposed paragraph (m)(4)(iii) required employers to provide additional training when workplace changes (such as modification of equipment, tasks, or procedures) result in new or increased employee exposure that exceeds or can reasonably be expected to exceed either the TWA PEL or the STEL. OSHA did not receive any comments on this provision, and retains it in the final to ensure that employees are aware of new or additional hazards. This training must be provided at the time of (or prior to) the new or increased exposure, even if a year has not passed since the previous training. New training would be required under the standard if the employer changes work production operations or personnel in a way that would require equipment to be operated differently to avoid exposures above the TWA PEL or STEL. Additional training would also be required if employers introduce new production or personal protective equipment to employees who do not yet know how to properly use the new equipment. Misuse of either the new production equipment or PPE could result in new exposures above the TWA PEL or STEL. Similarly, employers must provide additional training before employees repair or upgrade engineering controls if exposures during these activities will exceed or can reasonably be expected to exceed either the TWA PEL or the STEL. OSHA has concluded that the additional training requirement in this final rule is essential because it ensures that employees are able to actively participate in protecting themselves under the conditions found in the workplace, even if those conditions change.
Proposed paragraph (m)(4)(iv) required the employer to make a copy of the standard and its appendices readily available at no cost to each employee and designated employee representative(s). OSHA did not receive any comments on this provision, and the Agency has retained the requirement in paragraph (m)(4)(iv) of the standards for general industry and shipyards and paragraph (m)(3)(iv) 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), respirable crystalline silica (29 CFR 1910.1053), and Cotton Dust (29 CFR 1910.1043). The provision leaves employers free to determine the best way to make the standard available, which could include giving the employer a copy of the standard or placing a printed or electronic copy in a central location that the employees can easily access. In order to help ensure employees are protected against beryllium hazards, they need to be familiar with and have access to the beryllium standard applicable to their workplace (general industry, shipyard, or construction), and be aware of the employer's obligations to comply with it.
Paragraph (n) of the final standards for general industry, construction, and shipyards sets forth the employer's obligation to comply with requirements to maintain records of air monitoring data, objective data, medical surveillance, and training. The recordkeeping requirements are in accordance with section 8(c) of the 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 Act or for developing information regarding the causes and prevention of occupational injuries and illnesses. The recordkeeping provisions are also consistent with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard at 29 CFR 1910.1020, which addresses access to employee exposure and medical records.
As discussed in more detail below, the recordkeeping requirements in the final standards are similar to those included in the proposal. In the proposed rule, OSHA identified recordkeeping requirements for exposure measurements, historical monitoring data, objective data, medical surveillance, and training, and required employers to comply with Record Access standard requirements regarding access to and transfer of these records. Ameren Corporation (Ameren) expressed support for these requirements (Document ID 1675, p. 7). All other comments regarding the recordkeeping requirements focused on specific areas of the recordkeeping requirements and are discussed in the appropriate subject section.
Proposed paragraph (n)(1)(i) required employers to maintain records of all
Proposed paragraph (n)(1)(ii) required that records of all measurements taken to monitor employee exposure include at least the following information: The date of measurement for each sample taken; the operation being monitored; the sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of samples taken; the type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and the name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
The Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) recommended that the recordkeeping provision should include the purpose and rationale for the sampling performed as this would show that the exposure monitoring requirements are being met (Document ID 1665, p. 2). After careful consideration, OSHA has decided not to require that records include the purpose and rationale for the sampling. The Agency points out that the purpose and rationale for the sampling performed are dictated by the exposure assessment provision in paragraph (d), which requires the employer to assess the airborne exposure of each employee who is or may reasonably be expected to be exposed to airborne beryllium in accordance with either a performance option or the scheduled monitoring option. The air monitoring requirements described in paragraph (d) and the air monitoring data retention described in this section (paragraph (n)) provide adequate information to show whether the exposure monitoring requirements are being met. Furthermore, paragraphs (n)(1)(ii)(A)-(F) of the standards are generally consistent with other OSHA standards, such as respirable crystalline silica (29 CFR 1910.1053), chromium (VI) (29 CFR 1910.1026), and methylene chloride (29 CFR 1910.1052).
OSHA received several comments regarding the requirement in paragraph (n)(1)(ii)(F) that the employer include employee social security numbers in exposure measurement records. The American Dental Association (ADA), the Boeing Company (Boeing), and ORCHSE Strategies (ORCHSE) cited employee privacy and identity theft concerns (Document ID 1597, p. 4 (pdf); 1667, pp. 7-8; 1691, Attachment 1, p. 19). Boeing and ORCHSE suggested the use of an identifier other than the social security number, such as an employee identification number or another unique personal identification number. The ADA recommended that employers with fewer than ten employees should not be required to include employee social security numbers in records required by the standard. It further stated that some state statutes “impose data security and breach notification requirements on those who collect social security numbers,” and in small businesses, “the risk to employees of identity theft outweighs the difficulty of identifying employee records” (Document ID 1597, p. 2-4 (pdf)).
OSHA has considered these comments and 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, because a social security number is unique to an individual, is retained for a lifetime, and does not change when an employee changes employers. The social security number is therefore a useful tool for evaluating an individual's exposure over time, particularly where exposures are associated with chronic beryllium disease (CBD), which has a varying rate of progression during which time an employee may have several employers or had beryllium exposure sometime in the past.
OSHA recognizes 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 breaches 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 and apply to all OSHA standards, not just the standards for beryllium.
OSHA is proposing to delete the requirement that employers include employee social security numbers in records required by its substance-specific standards in the Agency's Standards Improvement Project—Phase IV (SIP-IV) proposed rule (81 FR 68504, 68526-68528 (10/4/16)). OSHA will revisit, if necessary, its decision to require employers to maintain employee social security numbers in beryllium records in light of the decision it makes in the SIP-IV rulemaking. In the meantime, OSHA has included the requirement to use and retain social security numbers in the final standards.
The ADA also urged OSHA to pursue Regulatory Alternative #1b, which would exempt, except for recordkeeping purposes, operations where the employer can show that employee exposures will not meet or exceed the action level or exceed the STEL. It further argued under this option that OSHA should limit employers' recordkeeping requirements to those records that show that employees' exposure will not meet or exceed the action level or exceed the STEL (Document ID 1597, p. 3 (pdf)). It maintained that this is reasonable because the “employees are not at significant risk of exposure” and “the record retention period is onerous” (Document ID 1597, p. 3 (pdf)).
OSHA disagrees with this suggestion for several reasons. First, the OSH Act states that standards adopted by OSHA must require employers maintain “accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under section 6.” OSH Act § 8(c)(3). Thus, on its face, the Act requires records of all exposure measurements required by the final standards to be maintained, not just high ones. The OSH Act also requires that employees have access to exposure records, (id.), and requiring the employer to maintain those records helps to fulfill that right. Further, as discussed in Section V,
Second, employee information and training requirements under paragraph (m) of the standards apply to each employee who is or can reasonably be expected to be exposed to airborne beryllium. As discussed in paragraph (m) of the Summary and Explanation in this preamble, OSHA finds that all employees who are or can be reasonably expected to be exposed in this manner will benefit from the specified forms of training. The creation and maintenance of training records will permit both OSHA and employers to ensure that the required training has occurred on schedule. Finally, OSHA notes that employers may reduce their recordkeeping burden in some cases by ensuring their employees are only exposed below the action level. For example, under paragraph (k), employers are required to offer medical surveillance those employees who meet certain exposure thresholds. By keeping exposures level below the action level, employers decrease the likelihood that their employees will fall into one of the enumerated groups. If employers do not have any employees covered by medical surveillance under paragraph (k), then they have no medical surveillance records to retain under these standards.
As to the expense and difficulty of maintaining the records required under these standards, OSHA recognizes that there will be time, effort, and expense involved in maintaining medical records. However, as stated earlier, OSHA expects that employers will have a system for maintaining these records, just as they do for their other business records. In addition, the Agency allows employers to use whatever method works best for them in meeting these requirements, paper or electronic (29 CFR 1910.1020(d)(2)).
In summary, paragraph (n)(1)(ii) in the final standards is substantively unchanged from the proposed rule. However, OSHA has made one editorial modification to paragraph (n)(1)(ii)(B), which is to change “operation” to “task.” 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 requirements of paragraph (n)(1)(ii) are generally consistent with those found in other OSHA standards, such as the standards for respirable crystalline silica (29 CFR 1910.1053), methylene chloride (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1026).
Proposed paragraph (n)(1)(iii) required the employer to maintain exposure records in accordance with OSHA's Records Access standard, which specifies that exposure records must be maintained for 30 years (29 CFR 1910.1020(d)(1)(ii)). The Agency did not receive comment on this provision. However, OSHA has changed the requirement that the employer “maintain this record as required by” OSHA's Records Access standard to “ensure that exposure records are maintained and made available in accordance with” that standard. OSHA believes that the language of the final standard more clearly conveys the Agency's intent that in addition to maintaining records, employers must make records available to employees and others as specified in the Records Access standard. As noted above, this clarifying change is editorial and neither increases nor decreases an employer's obligations as set forth in the proposed rule. This clarification has also been made for other records required by the final beryllium standards.
Proposed paragraph (n)(2) contained the requirement to retain records of any historical monitoring data used to satisfy the proposed standard's the initial monitoring requirements. As explained in the Summary and Explanation of paragraphs (b) and (d) in this preamble, the definition of the term “objective data” in the final rule includes all information that demonstrates airborne exposure to beryllium associated with a particular product or material or a specific process, task, or activity. Historical data that reflects workplace conditions closely resembling or with a higher airborne exposure potential than the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations would be considered objective data under the final rule. The requirement to keep records of objective data is addressed under a separate paragraph. Therefore, OSHA has chosen to delete the separate recordkeeping requirement for historical data.
Proposed paragraph (n)(3) contained the requirements to keep accurate records of objective data. Proposed paragraph (n)(3)(i) required employers to establish and maintain accurate records of the objective data relied upon to satisfy the requirement for initial monitoring in proposed paragraph (d)(2). Under proposed paragraph (n)(3)(ii), the record was required to contain at least the following information: The data relied upon; the beryllium-containing material in question; the source of the data; a description of the operation exempted from initial monitoring and how the data supported the exemption; and other information demonstrating that the data met the requirements for objective data in accordance with paragraph (d)(2)(ii).
OSHA did not receive comments regarding this provision, and the Agency finds that it should be included in the final rule. Since objective data may be used to exempt the employer from certain types of monitoring, as specified in paragraph (d), it is critical that the use of these types of data be carefully documented. Objective data are intended to provide the same degree of assurance that employee exposures have been correctly characterized as would exposure assessment. 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.
Therefore, OSHA has included proposed paragraph (n)(3) as paragraph (n)(2) in the final standards, with minor alterations. Specifically, in the final standards, OSHA has changed paragraphs (n)(2)(ii)(D) to require the record to contain “[a] description of the process, task, or activity on which the objective data were based,” and paragraph (n)(2)(ii)(E) to require the
Proposed paragraph (n)(3)(iii) required the employer to maintain a record of objective data relied upon as required by the Records Access standard, which specifies that exposure records must be maintained for 30 years (29 CFR 1910.1020(d)(1)(ii)). The Agency did not receive comment on this provision. Objective data may include employee exposure records that must be maintained, and therefore, the Agency has retained it in the final standards as paragraph (n)(2)(iii). OSHA notes that this final provision, like all of the final provisions in this paragraph related to the Records Access standard, includes the non-substantive change from the proposed requirement to maintain the record as required by the Records Access standard, to the requirement to maintain and make available the record in accordance with the Records Access standard. OSHA's reasons for this change are discussed above.
Paragraph (n)(3) of the final standards, like paragraph (n)(4) of the proposal, addresses medical surveillance records. Under proposed paragraph (n)(4)(i), employers had to establish and maintain medical surveillance records for each employee covered by the medical surveillance requirements in paragraph (k) of the proposed standard. Proposed paragraph (n)(4)(ii) listed the categories of information that an employer was required to record: The employee's name, social security number, and job classification; a copy of all licensed physicians' written medical opinions; and a copy of the information provided to the PLHCP as required by paragraph (k)(4) of the proposed standard.
The ADA and ORCHSE questioned the requirement that the employee's social security number be included in medical surveillance records (Document ID 1597, pp. 2-4 (pdf); 1691, Attachment 1, p. 19). As noted above in the discussion on exposure measurement records, 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, the Agency has decided to retain the requirement for use of social security numbers in medical records. OSHA is examining the requirements for social security numbers separately from this rulemaking.
Medical records document the results of medical surveillance and are especially important when an employee's medical condition places him or her at increased risk of health impairment from further exposure to beryllium in the workplace. Furthermore, the records can be used by the Agency and others to identify illnesses and deaths that may be attributable to beryllium exposure, evaluate compliance programs, and assess the efficacy of the standards. OSHA concludes that medical surveillance records are necessary and appropriate for protection of employee health, enforcement of the standards, and development of information regarding the causes and prevention of occupational illnesses. Therefore, OSHA has decided to retain proposed paragraph (n)(4)(ii)'s requirements regarding medical surveillance records in paragraph (n)(3)(ii) of the final standards. However, OSHA has changed the requirement in proposed paragraph (n)(4)(ii)(B) that the record include copies of all licensed physicians' written opinions to the requirement that the record include copies of all licensed physicians' written medical opinions for each employee in paragraph (n)(3)(ii)(B) of the final standards. These changes are editorial and intended to clarify that employees are entitled to their own written medical opinion, not all written opinions. This change neither increases nor decreases an employer's obligations as set forth in the proposed rule.
Proposed paragraph (n)(4)(iii) required the employer to maintain employee medical records for at least the duration of the employee's employment plus 30 years in accordance with OSHA's Records Access Standard at 29 CFR 1910.1020(d)(1)(i). The ADA objected to this provision, arguing that the proposed retention period is onerous (Document ID 1597, p. 3 (pdf)). OSHA has considered this comment and concluded that the best approach is to maintain consistency with 29 CFR 1910.1020 and its required retention periods of (1) 30 years for exposure records and objective data, and (2) the duration of employment plus 30 years for medical surveillance records. It is necessary to keep medical records for these extended time periods because of the varying rate of progression for CBD and the long latency period between exposure and development of lung cancer. OSHA recognizes that in some cases, the latency period for beryllium-related cancer may extend beyond 30 years. However, the Agency concludes that the retention periods specified in 29 CFR 1910.1020 represent a reasonable balance between the need to maintain records and the administrative burdens associated with maintaining those records for extended time periods. Because the 30-year, and the duration of employment plus 30-year, record retention requirements are currently included in 29 CFR 1910.1020, these time periods are 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 respirable crystalline silica (29 CFR 1910.1053), methylene chloride (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1026). Thus, OSHA finds that the 30-year retention period is necessary and appropriate for exposure records, historical monitoring data, and objective data, and that the duration of employment plus 30-year retention period is necessary and appropriate for medical surveillance records.
Therefore, OSHA has decided to include the retention periods provided by the Records Access standard in paragraph (n)(3)(iii) of the final standards. For the reasons discussed above, OSHA has added “and made available” after “maintained” in paragraph (n)(3)(iii) of the standards. Under the final standards, the employer is responsible for the maintenance of records in his or her possession. The employer is also responsible for ensuring the retention of records in the possession of the licensed physician (
Paragraph (n)(4) of the final standards, like proposed paragraph (n)(5), addresses training records. Proposed paragraph (n)(5)(i) required employers to prepare records of any training required by these standards. At the completion of training, the employer
The ADA and ORCHSE questioned the requirement that the employee's social security number be included in training records (Document ID 1597, p. 2-4 (pdf); 1691, Attachment 1, p. 19). As noted above in the discussions on exposure measurement and medical surveillance records, 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, the Agency has decided to retain the requirement for use of social security numbers in training records. As stated above, OSHA is examining the requirements for social security numbers separately from this rulemaking. In the meantime, OSHA has retained the social security requirement in the final standards.
No other comments were received on this provision. Proposed paragraph (n)(5)(i) is now paragraph (n)(4)(i) in the final standards. Paragraph (n)(4)(i) in the final standards is substantively unchanged from the proposal.
Proposed paragraph (n)(5)(ii) required employers to retain training records, including records of annual retraining or additional training required under these standards, for a period of three years after the completion of the training. North America's Building Trades Unions (NABTU) commented that employers “must maintain documentation of [any] training” required for beryllium construction workers (Document ID 1679, p. 3). OSHA agrees. As noted above, OSHA finds that the creation and maintenance of training records will permit both OSHA and employers to ensure that the required training has occurred on schedule. Thus, the Agency has included this provision in the standard for construction, as well as the standards for general industry and shipyards. Proposed paragraph (n)(5)(ii) is now paragraph (n)(4)(ii) in the final standards, and is substantively unchanged from the proposal. The three-year time period is consistent with the Bloodborne Pathogens standard (29 CFR 1910.1030).
Paragraph (n)(5) of the final standards, like proposed paragraph (n)(6), addresses access to records. Proposed paragraph (n)(6) required employers to make all records mandated by these standards available for examination and copying to the Assistant Secretary, the Director of NIOSH, each employee, and each employee's designated representative as stipulated by OSHA's Records Access standard (29 CFR 1910.1020). OSHA did not receive comment on this provision, and includes it in the final standards to emphasize and ensure proper employee and government access to records.
Paragraph (n)(6) of the final standards, like proposed paragraph (n)(7), addresses transfer of records. Proposed paragraph (n)(7) required that employers comply with the Records Access standard regarding the transfer of records. The requirements for the transfer of records are explained in 29 CFR 1910.1020(h), which instructs employers either to transfer records to successor employers or, if there is no successor employer, to inform employees of their access rights at least three months before the cessation of the employer's business. OSHA did not receive comment on this provision, and includes it the final standards to help ensure consistent records access.
Paragraph (o) of the standards for general industry, construction, and shipyards sets forth the effective date of the standards and the dates for compliance with their requirements. OSHA proposed that the final rule would become effective 60 days after its publication in the
OSHA sets the effective date to allow sufficient time for employers to obtain the standard and read and understand its requirements. Unchanged from the proposal, paragraph (o)(1) provides that the standards will become effective on March 10, 2017.
OSHA sets the compliance dates to allow sufficient time for employers to undertake the necessary planning and preparation for compliance with the various provisions of the standards. In addition to the default compliance date of 90 days that applied to most provisions, OSHA's proposal included extended compliance dates for the provisions that require the establishment of change rooms and the implementation of engineering controls in order to give affected employers sufficient time to design and construct change rooms where necessary, and to design, obtain, and install any required control equipment. In response to comments stating that more time is necessary to prepare for compliance, the compliance dates in the final rule have been extended from those proposed.
Paragraph (o)(2) of the standards establishes the dates for compliance with the requirements of the standard. Several employers and industry representatives commented that the proposal's default compliance date (90 days after the effective date) provided inadequate time to prepare for compliance. ORCHSE Strategies (ORCHSE) commented that an additional six months are needed “to make necessary changes to facilities, broad-based exposure assessments, and delineate work and regulated areas” (Document ID 1691, Attachment 1, p. 24). Also, the Boeing Company (Boeing) commented that the standard should require compliance two years after the effective date, explaining that “it will take, for a company of our size, between 1 and 2 years to accurately and comprehensively determine what our exposures are, prior to developing and implementing an exposure plan” (Document ID 1667, p. 8).
The Sampling and Analysis Subcommittee Task Group of the Beryllium Health and Safety Committee (BHSC Task Group) also commented on the amount of time needed to comply with the “Accuracy of Measurement” requirement in paragraph (d)(1)(v) of the proposal, which has been renamed “Methods of sample analysis” and moved to paragraph (d)(5) in the final standards (Document ID 1665, p. 3). Specifically, BHSC Task Group expressed concern that laboratories would need to adopt newer analytical methods not widely used by the majority of analytical laboratories to perform beryllium measurements to the level of accuracy specified by the standard. BHSC Task Group acknowledges that although the OSHA rule does not require it, a Department of Energy requirement for accreditation that exists in their Beryllium Worker Safety and Health Program would drive laboratories to obtain accreditation by an external accrediting body to use these newer methods, which can take well over 150 days. (Document ID 1665, p. 3-4). OSHA rejects the reasoning behind BHSC Task Group's concern on the amount of time needed to comply the accuracy of measurement
Nonetheless, OSHA recognizes the concerns expressed by Boeing, ORCHSE, and BHSC Task Group that employers may need additional time to assess exposures and undertake the necessary planning and preparation for compliance with the obligations of the standards, and has determined that some of those concerns are reasonable. OSHA has therefore extended the final standards' default compliance date, which applies to all provisions except for those with separate compliance dates under paragraphs (o)(2)(i) and (o)(2)(ii), to one year from the effective date.
Paragraph (o)(2)(i) of the standards provides the date for compliance with the requirement in paragraph (i) to establish change rooms, and in the general industry standard, to provide showers. OSHA proposed a compliance date of one year after the effective date for establishing change rooms, but commenters indicated that more time was needed to modify their facilities. Boeing requested that the compliance date for establishing change rooms begin three years after the effective date, stating that “for large facilities, modifications such as showers, clothing storage and change rooms need a significant amount of time to be planned, designed, contracted, and constructed within operating factory sites” (Document ID 1667, p. 8). ORCHSE also indicated that additional time is needed to “make necessary changes to facilities” (Document ID 1691, Attachment 1, p. 24).
OSHA expects that most employers will be able to establish change rooms and showers within a year of the effective date, but the Agency understands that some employers, both large and small, may need additional time to plan and construct these areas. OSHA is persuaded by the concerns expressed by the commenters that employers may need additional time to modify their facilities, and has extended the compliance date for the general industry standard's change rooms and showers requirements to two years after the effective date. Providing an extended compliance date for establishing change rooms and providing showers is consistent with the approach taken in OSHA's general industry standard for Cadmium (29 CFR 1910.1027(p)(2)(vi)(B)).
The construction and shipyard standards do not require employers to provide showers, but OSHA recognizes that construction and shipyard employers may also need additional time to plan and establish change rooms at construction sites and shipyard industry establishments. Change room facilities in these industries may be permanent or temporary, including mobile units that can be purchased or rented. OSHA has thus set the compliance date for the construction and shipyard standards' requirement to establish change rooms to two years after the effective date.
Paragraph (o)(2)(ii) of the standards provides the date for compliance with the requirements in paragraph (f) to implement engineering controls. OSHA proposed a compliance date of two years after the effective date for employers to comply with the engineering control requirements in paragraph (f). Boeing, however, commented that the compliance date for implementing engineering controls should be extended to four years after the effective date, explaining that “for large companies, exposure assessments and feasibility studies would have to be completed on a vast scale, and then engineering controls may have to be installed,” making four years “a reasonable time frame for these compliance measures” (Document ID 1667, pp. 8). The Non-Ferrous Founders' Society (NFFS) also commented that a two-year implementation period was insufficient because it takes 12 to 24 months to obtain an Environmental Protection Agency (EPA) permit for changes to ventilation systems, and foundries cannot begin work to modify ventilation systems until they obtain a permit (Document ID 1756, Tr. 61-62).
OSHA recognizes the concerns expressed by Boeing regarding the time needed to implement engineering controls, but does not agree that four years are needed to comply with the engineering control requirements. OSHA expects that many workplaces with beryllium will already have engineering controls in place for other hazardous materials that will need only modification or updating to comply with the final standards. For new installations, most types of engineering controls for working with materials such as beryllium are readily available.
Furthermore, because beryllium is regulated under EPA rules as a “hazardous air pollutant” with a relatively low volume threshold for a permit requirement, foundries that already exhaust beryllium in any quantity would likely already be subjected to the permitting requirements. Therefore, OSHA predicts that any changes to ventilation systems to comply with the final beryllium standards would generally only be subject to routine reporting requirements or permit modifications. Cases that are unusually problematic, however, 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.
However, OSHA acknowledges that some general industry, construction and shipyard employers may need more than two years to comply with the engineering control obligations in paragraph (f), including the need to update any permits before modifying ventilation systems, and has extended the standards' compliance date for the engineering control requirements to three years from the effective date. OSHA has determined that setting a compliance date three years after the effective date will ensure that employers have sufficient time to complete the process of designing, obtaining, and installing the necessary control equipment.
OSHA's decision here to provide employers with an extended deadline for complying with engineering control requirements is consistent with what the Agency has done in health standards, including standards for respirable crystalline silica (29 CFR 1910.1053(l)), Chromium (VI) (29 CFR 1910.1026(n)(3), 29 CFR 1915.1026(l)(3), 29 CFR 1926.1126(l)(3)), and Cadmium (29 CFR 1910.1027(p)(2)(v)). Extending the compliance deadline for implementation of engineering controls will allow those firms that need extensive engineering controls time to adequately plan for and implement the controls, which will thus help to ensure that adequate protection is provided for workers. OSHA has also determined that the extension will have the ancillary benefit of limiting the economic impact of the rule by providing employers with additional time to plan for and absorb the costs associated with compliance. Based on its review of the rulemaking record, OSHA has concluded that employers will be able to implement engineering controls within the extended time frame that is established in the final rule.
Appendix A to the final standard for general industry, 29 CFR 1910.1024, provides information to employers on
The control strategies to minimize beryllium exposure were in Appendix B of the proposed rule, but proposed Appendix B has been redesignated as Appendix A in the final standard for general industry, following the deletion (discussed below) of proposed Appendix A. The information on control strategies presented in the appendix was derived from OSHA's analysis of the technological feasibility of the PELs, presented in Chapter IV of the Final Economic Analysis. The content of Appendix A of the final standard for general industry remains unchanged from that contained in Appendix B of the proposal.
The proposed rule also contained a non-mandatory appendix (designated in the proposal as Appendix A) that provided technical information on the BeLPT test. OSHA has determined that the information contained in proposed Appendix A is more suitable for separate guidance that will be issued in conjunction with the standards. OSHA will be able to more readily update this separate guidance to reflect technological advances and changes in recommendations from the medical community. Therefore, OSHA is not including proposed Appendix A in the final standards.
OSHA has also not included any appendices in the final standards for construction and shipyards since OSHA has identified only one principle operation (abrasive blasting) in these sectors involving worker exposure to beryllium.
Beryllium, Cancer, Chemicals, Hazardous substances, Health, Occupational safety and health, Reporting and recordkeeping requirements.
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: 29 U.S.C. 653, 655, 657; 40 U.S.C. 3704; 33 U.S.C. 941; Secretary of Labor's Order 1-2012 (77 FR 3912 (1/25/2012)); and 29 CFR part 1911.
For the reasons set forth in the preamble, Chapter XVII of Title 29, parts 1910, 1915, and 1926, of the Code of Federal Regulations is amended as follows:
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), 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 5101
The revisions read as follows:
(a)
(2) This standard does not apply to articles, as defined in the Hazard Communication standard (HCS) (§ 1910.1200(c)), that contain beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than 0.1% beryllium by weight where the employer has objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
(b)
(c)
(2)
(d)
(2)
(3)
(ii) The employer must perform initial monitoring to assess the short-term exposure from 15-minute personal breathing zone air samples measured in operations that are likely to produce airborne exposure above the STEL for each work shift, for each job classification, and in each work area.
(iii) Where several employees perform the same 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 the requirements of this paragraph (d)(3). In representative sampling, the employer must sample the employee(s) expected to have the highest airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is below the action level and at or below the STEL, the employer may discontinue monitoring for those employees whose airborne exposure is represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that airborne exposure is at or above the action level but at or below the TWA PEL, the employer must repeat such monitoring within six months of the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that airborne exposure is above the TWA PEL, the employer must repeat such monitoring within three months of the most recent 8-hour TWA exposure monitoring.
(vii) Where the most recent (non-initial) exposure monitoring indicates that airborne exposure is below the action level, the employer must 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 8-hour TWA exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that airborne exposure is above the STEL, the employer must repeat such monitoring within three months of the most recent short-term exposure monitoring until two consecutive measurements, taken 7 or more days apart, are below the STEL, at which time the employer may discontinue short-term exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(4)
(5)
(6)
(ii) Whenever an exposure assessment indicates that airborne exposure is above the TWA PEL or STEL, the employer must describe in the written notification the corrective action being taken to reduce airborne exposure to or below the exposure limit(s) exceeded where feasible corrective action exists but had not been implemented when the monitoring was conducted.
(7)
(ii) When observation of monitoring requires entry into an area where the use of personal protective clothing or equipment (which may include respirators) is required, the employer must provide each observer with appropriate personal protective clothing and equipment at no cost to the observer and must ensure that each observer uses such clothing and equipment.
(iii) The employer must ensure that each observer follows all other applicable safety and health procedures.
(e)
(ii) The employer must establish and maintain a regulated area wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL.
(2)
(ii) The employer must identify each regulated area in accordance with paragraph (m)(2) of this standard.
(3)
(i) Persons the employer authorizes or requires to be in a regulated area to perform work duties;
(ii) Persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring procedures under paragraph (d)(7) of this standard; and
(iii) Persons authorized by law to be in a regulated area.
(4)
(i) Respiratory protection in accordance with paragraph (g) of this standard; and
(ii) Personal protective clothing and equipment in accordance with paragraph (h) of this standard.
(f)
(A) A list of operations and job titles reasonably expected to involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination, including preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas;
(E) Procedures for keeping surfaces as free as practicable of beryllium;
(F) Procedures for minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace;
(G) A list of engineering controls, work practices, and respiratory protection required by paragraph (f)(2) of this standard;
(H) A list of personal protective clothing and equipment required by paragraph (h) of this standard; and
(I) Procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators.
(ii) The employer must review and evaluate the effectiveness of each written exposure control plan at least annually and update it, as necessary, when:
(A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results, or can reasonably be expected to result, in new or additional airborne exposure to beryllium;
(B) The employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard, referred for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium; or
(C) The employer has any reason to believe that new or additional airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control plan accessible to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (§ 1910.1020(e)).
(2)
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation, material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible; or
(B) The employer can demonstrate that airborne exposure is below the action level, using no fewer than two representative personal breathing zone samples taken at least 7 days apart, for each affected operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after implementing the control(s) required by paragraph (f)(2)(i) of this standard, the employer must implement additional or enhanced engineering and work practice controls to reduce airborne exposure to or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to reduce airborne exposure to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii) of this standard, the employer must implement and maintain engineering and work practice controls to reduce airborne exposure to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard.
(3)
(g)
(i) During periods necessary to install or implement feasible engineering and work practice controls where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities and non-routine tasks, when engineering and work practice controls are not feasible and airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all feasible engineering and work practice controls when such controls are not sufficient to reduce airborne exposure to or below the TWA PEL or STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under paragraph (l)(1) chooses to remain in a job with airborne exposure at or above the action level, as permitted by paragraph (l)(2)(ii) of this standard.
(2)
(3) The employer must provide at no cost to the employee a powered air-purifying respirator (PAPR) instead of a negative pressure respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a PAPR; and
(iii) The PAPR provides adequate protection to the employee in accordance with paragraph (g)(2) of this standard.
(h)
(i) Where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with beryllium.
(2)
(ii) The employer must ensure that each employee removes beryllium-contaminated personal protective clothing and equipment as specified in the written exposure control plan required by paragraph (f)(1) of this standard.
(iii) The employer must ensure that each employee stores and keeps beryllium-contaminated personal protective clothing and equipment separate from street clothing and that storage facilities prevent cross-contamination as specified in the written exposure control plan required by paragraph (f)(1) of this standard.
(iv) The employer must ensure that no employee removes beryllium-contaminated personal protective clothing or equipment from the workplace, except for employees authorized to do so for the purposes of laundering, cleaning, maintaining or disposing of beryllium-contaminated personal protective clothing and equipment at an appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this standard is removed from the workplace for laundering, cleaning, maintenance or disposal, the employer must ensure that
(3)
(ii) The employer must ensure that beryllium is not removed from personal protective clothing and equipment by blowing, shaking or any other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the business entities who launder, clean or repair the personal protective clothing or equipment required by this standard of the potentially harmful effects of airborne exposure to and dermal contact with beryllium and that the personal protective clothing and equipment must be handled in accordance with this standard.
(i)
(i) Provide readily accessible washing facilities in accordance with this standard and the Sanitation standard (§ 1910.141) to remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(2)
(3)
(A) Airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL; and
(B) Beryllium can reasonably be expected to contaminate employees' hair or body parts other than hands, face, and neck.
(ii) Employers required to provide showers under paragraph (i)(3)(i) of this standard must ensure that each employee showers at the end of the work shift or work activity if:
(A) The employee reasonably could have had airborne exposure above the TWA PEL or STEL; and
(B) Beryllium could reasonably have contaminated the employee's hair or body parts other than hands, face, and neck.
(4)
(i) Surfaces in eating and drinking areas are as free as practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal protective clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing or equipment by methods that do not disperse beryllium into the air or onto an employee's body; and
(iii) Eating and drinking facilities provided by the employer are in accordance with the Sanitation standard (§ 1910.141).
(5)
(j)
(ii) The employer must ensure that all spills and emergency releases of beryllium are cleaned up promptly and in accordance with the written exposure control plan required under paragraph (f)(1) and the cleaning methods required under paragraph (j)(2) of this standard.
(2)
(ii) The employer must not allow dry sweeping or brushing for cleaning surfaces in beryllium work areas unless HEPA-filtered vacuuming or other methods that minimize the likelihood and level of airborne exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for cleaning beryllium-contaminated surfaces unless the compressed air is used in conjunction with a ventilation system designed to capture the particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air to clean beryllium-contaminated surfaces, the employer must provide, and ensure that each employee uses, respiratory protection and personal protective clothing and equipment in accordance with paragraphs (g) and (h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and maintained in a manner that minimizes the likelihood and level of airborne exposure and the re-entrainment of airborne beryllium in the workplace.
(3)
(i) Materials designated for disposal that contain or are contaminated with beryllium are disposed of in sealed, impermeable enclosures, such as bags or containers, that are labeled in accordance with paragraph (m)(3) of this standard; and
(ii) Materials designated for recycling that contain or are contaminated with beryllium are cleaned to be as free as practicable of surface beryllium contamination and labeled in accordance with paragraph (m)(3) of this standard, or placed in sealed, impermeable enclosures, such as bags or containers, that are labeled in accordance with paragraph (m)(3) of this standard.
(k)
(A) Who is or is reasonably expected to be exposed at or above the action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph (k)(6) or (k)(7) of this standard recommends periodic medical surveillance.
(ii) The employer must ensure that all medical examinations and procedures required by this standard are performed by, or under the direction of, a licensed physician.
(2)
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A), unless the employee has received a medical examination, provided in accordance
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C).
(ii) At least every two years thereafter for each employee who continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D) of this standard.
(iii) At the termination of employment for each employee who meets any of the criteria of paragraph (k)(1)(i) of this standard at the time the employee's employment terminates, unless an examination has been provided in accordance with this standard during the six months prior to the date of termination.
(3)
(ii) The employer must ensure that the employee is offered a medical examination that includes:
(A) A medical and work history, with emphasis on past and present airborne exposure to or dermal contact with beryllium, smoking history, and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the guidelines established by the American Thoracic Society including forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(E) A standardized BeLPT or equivalent test, upon the first examination and at least every two years thereafter, unless the employee is confirmed positive. If the results of the BeLPT are other than normal, a follow-up BeLPT must be offered within 30 days, unless the employee has been confirmed positive. Samples must be analyzed in a laboratory certified under the College of American Pathologists/Clinical Laboratory Improvement Amendments (CLIA) guidelines to perform the BeLPT.
(F) A low dose computed tomography (LDCT) scan, when recommended by the PLHCP after considering the employee's history of exposure to beryllium along with other risk factors, such as smoking history, family medical history, sex, age, and presence of existing lung disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4)
(i) A description of the employee's former and current duties that relate to the employee's airborne exposure to and dermal contact with beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that personal protective clothing and equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining written consent from the employee.
(5)
(i) A statement indicating the results of the medical examination, including the licensed physician's opinion as to whether the employee has
(A) Any detected medical condition, such as CBD or beryllium sensitization (
(B) Any medical conditions related to airborne exposure that require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, the written report must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l) of this standard.
(6)
(A) The date of the examination;
(B) A statement that the examination has met the requirements of this standard;
(C) Any recommended limitations on the employee's use of respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the medical examination to the employee, including any tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions for use of personal protective clothing or equipment;
(ii) If the employee provides written authorization, the written opinion must also contain any recommended limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, and the employee provides written authorization, the written opinion must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l) of this standard.
(vi) The employer must ensure that each employee receives a copy of the written medical opinion described in paragraph (k)(6) of this standard within 45 days of any medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of
(7)
(A) The employer's receipt of a physician's written medical opinion to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center.
(ii) The employer must ensure that the employee receives a written medical report from the CBD diagnostic center that contains all the information required in paragraph (k)(5)(i), (ii), (iv), and (v) of this standard and that the PLHCP explains the results of the examination to the employee within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the CBD diagnostic center within 30 days of the medical examination. The written medical opinion must contain only the information in paragraph (k)(6)(i), as applicable, unless the employee provides written authorization to release additional information. If the employee provides written authorization, the written opinion must also contain the information from paragraphs (k)(6)(ii), (iv), and (v), if applicable.
(iv) The employer must ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30 days of any medical examination performed for that employee.
(v) After an employee has received the initial clinical evaluation at a CBD diagnostic center described in paragraph (k)(7)(i) of this standard, the employee may choose to have any subsequent medical examinations for which the employee is eligible under paragraph (k) of this standard performed at a CBD diagnostic center mutually agreed upon by the employer and the employee, and the employer must provide such examinations at no cost to the employee.
(l)
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(5)(v) or (k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the action level, provided that the employer provides, and ensures that the employee uses, respiratory protection that complies with paragraph (g) of this standard whenever airborne exposures are at or above the action level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to beryllium are below the action level, and the employee is qualified for that job or can be trained within one month, the employer must remove the employee to that job. The employer must maintain for six months from the time of removal the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal for six months or until such time that comparable work described in paragraph (l)(3)(i) becomes available, whichever comes first.
(4) The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal from a publicly or employer-funded compensation program, or receives income from another employer made possible by virtue of the employee's removal.
(m)
(ii) In classifying the hazards of beryllium, at least the following hazards must be addressed: Cancer; lung effects (CBD and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation.
(iii) Employers must include beryllium in the hazard communication program established to comply with the HCS. Employers must ensure that each employee has access to labels on containers of beryllium and to safety data sheets, and is trained in accordance with the requirements of the HCS (§ 1910.1200) and paragraph (m)(4) of this standard.
(2)
(ii)
(B) The employer must ensure each warning sign required by paragraph (m)(2)(i) of this standard bears the following legend:
(3)
(4)
(A) The employer must provide information and training in accordance with the HCS (§ 1910.1200(h));
(B) The employer must provide initial training to each employee by the time of initial assignment; and
(C) The employer must repeat the training required under this standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can reasonably be expected to be, exposed to airborne beryllium can demonstrate
(A) The health hazards associated with airborne exposure to and contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the location(s) of beryllium work areas, including any regulated areas, and the specific nature of operations that could result in airborne exposure, especially airborne exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and limitations of personal protective clothing and equipment, including respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne exposure to and contact with beryllium, including personal hygiene practices;
(F) The purpose and a description of the medical surveillance program required by paragraph (k) of this standard including risks and benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records Access standard (§ 1910.1020).
(iii) When a workplace change (such as modification of equipment, tasks, or procedures) results in new or increased airborne exposure that exceeds, or can reasonably be expected to exceed, either the TWA PEL or the STEL, the employer must provide additional training to those employees affected by the change in airborne exposure.
(iv)
(n)
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and
(F) The name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer must ensure that exposure records are maintained and made available in accordance with the Records Access standard (§ 1910.1020).
(2)
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(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 airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained and made available in accordance with the Records Access standard (§ 1910.1020).
(3)
(ii) The record must include the following information about each employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for each employee; and
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained and made available in accordance with the Records Access standard (§ 1910.1020).
(4)
(ii) This record must be maintained for three years after the completion of training.
(5)
(6)
(o)
(2)
(i) Change rooms and showers required by paragraph (i) of this standard must be provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this standard must be implemented by March 10, 2020.
(p)
Paragraph (f)(2)(i) of this standard requires employers to use one or more of the control methods listed in paragraph (f)(2)(i) to minimize worker exposure in each operation in a beryllium work area, unless the operation is exempt under paragraph (f)(2)(ii). This appendix sets forth a non-exhaustive list of control options that employers could use to comply with paragraph (f)(2)(i) for a number of specific beryllium operations.
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); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
The revisions read as follows:
(a)
(2) This standard does not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than 0.1% beryllium by weight where the employer has objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
(b)
(c)
(2)
(d)
(2)
(3)
(ii) The employer must perform initial monitoring to assess the short-term exposure from 15-minute personal breathing zone air samples measured in operations that are likely to produce airborne exposure above the STEL for each work shift, for each job classification, and in each work area.
(iii) Where several employees perform the same 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 the requirements of paragraph (d)(3) of this standard. In representative sampling, the employer must sample the employee(s) expected to have the highest airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is below the action level and at or below the STEL, the employer may discontinue monitoring for those employees whose airborne exposure is represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that airborne exposure is at or above the action level but at or below the TWA PEL, the employer must repeat such monitoring within six months of the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that airborne exposure is above the TWA PEL, the employer must repeat such monitoring within three months of the most recent 8-hour TWA exposure monitoring.
(vii) Where the most recent (non-initial) exposure monitoring indicates that airborne exposure is below the action level, the employer must 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 8-hour TWA exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that airborne exposure is above the STEL, the employer must repeat such monitoring within three months of the most recent short-term exposure monitoring until two consecutive measurements, taken 7 or more days apart, are below the STEL, at which time the employer may discontinue short-term exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(4)
(5)
(6)
(ii) Whenever an exposure assessment indicates that airborne exposure is above the TWA PEL or STEL, the employer must describe in the written notification the corrective action being taken to reduce airborne exposure to or below the exposure limit(s) exceeded where feasible corrective action exists but had not been implemented when the monitoring was conducted.
(7)
(ii) When observation of monitoring requires entry into an area where the use of personal protective clothing or equipment (which may include respirators) is required, the employer must provide each observer with appropriate personal protective clothing and equipment at no cost to the observer and must ensure that each observer uses such clothing and equipment.
(iii) The employer must ensure that each observer follows all other applicable safety and health procedures.
(e)
(2)
(3)
(i) Persons the employer authorizes or requires to be in a regulated area to perform work duties;
(ii) Persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring procedures under paragraph (d)(7) of this standard; and
(iii) Persons authorized by law to be in a regulated area.
(4)
(i) Respiratory protection in accordance with paragraph (g) of this standard; and
(ii) Personal protective clothing and equipment in accordance with paragraph (h) of this standard.
(f)
(A) A list of operations and job titles reasonably expected to involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination;
(E) Procedures for minimizing the migration of beryllium within or to locations outside the workplace;
(F) A list of engineering controls, work practices, and respiratory protection required by paragraph (f)(2) of this standard;
(G) A list of personal protective clothing and equipment required by paragraph (h) of this standard; and
(H) Procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators.
(ii) The employer must review and evaluate the effectiveness of each written exposure control plan at least annually and update it, as necessary, when:
(A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results, or can reasonably be expected to result, in new or additional airborne exposure to beryllium;
(B) The employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard, referred for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium; or
(C) The employer has any reason to believe that new or additional airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control plan accessible to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)).
(2)
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation, material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible; or
(B) The employer can demonstrate that airborne exposure is below the action level, using no fewer than two representative personal breathing zone samples taken at least 7 days apart, for each affected operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after implementing the control(s) required by (f)(2)(i), the employer must implement additional or enhanced engineering and work practice controls to reduce airborne exposure to or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to reduce airborne exposure to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii), the employer must implement and maintain engineering and work practice controls to reduce airborne exposure to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard.
(3)
(g)
(i) During periods necessary to install or implement feasible engineering and work practice controls where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities and non-routine tasks, when engineering and work practice controls are not feasible and airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all feasible engineering and work practice controls when such controls are not sufficient to reduce airborne exposure to or below the TWA PEL or STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under paragraph (l)(1) chooses to remain in a job with airborne exposure at or above the action level, as permitted by paragraph (l)(2)(ii).
(2)
(3) The employer must provide at no cost to the employee a powered air-purifying respirator (PAPR) instead of a negative pressure respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a PAPR; and
(iii) The PAPR provides adequate protection to the employee in accordance with paragraph (g)(2) of this standard.
(h)
(i) Where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with beryllium.
(2)
(ii) The employer must ensure that each employee removes beryllium-contaminated personal protective clothing and equipment as specified in the written exposure control plan required by paragraph (f)(1) of this standard.
(iii) The employer must ensure that each employee stores and keeps beryllium-contaminated personal
(iv) The employer must ensure that no employee removes beryllium-contaminated personal protective clothing or equipment from the workplace, except for employees authorized to do so for the purposes of laundering, cleaning, maintaining or disposing of beryllium-contaminated personal protective clothing and equipment at an appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this standard is removed from the workplace for laundering, cleaning, maintenance or disposal, the employer must ensure that personal protective clothing and equipment are stored and transported in sealed bags or other closed containers that are impermeable and are labeled in accordance with paragraph (m)(3) of this standard and the HCS (29 CFR 1910.1200).
(3)
(ii) The employer must ensure that beryllium is not removed from personal protective clothing and equipment by blowing, shaking or any other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the business entities who launder, clean or repair the personal protective clothing or equipment required by this standard of the potentially harmful effects of airborne exposure to and dermal contact with beryllium and that the personal protective clothing and equipment must be handled in accordance with this standard.
(i)
(i) Provide readily accessible washing facilities in accordance with this standard and the Sanitation standard (§ 1915.88) to remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(2)
(3)
(i) Surfaces in eating and drinking areas are as free as practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal protective clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing or equipment by methods that do not disperse beryllium into the air or onto an employee's body; and
(iii) Eating and drinking facilities provided by the employer are in accordance with the Sanitation standard (29 CFR 1915.88).
(4)
(j)
(ii) The employer must ensure that all spills and emergency releases of beryllium are cleaned up promptly and in accordance with the written exposure control plan required under paragraph (f)(1).
(2)
(ii) The employer must not allow dry sweeping or brushing for cleaning in beryllium-contaminated areas unless HEPA-filtered vacuuming or other methods that minimize the likelihood and level of airborne exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for cleaning in beryllium-contaminated areas unless the compressed air is used in conjunction with a ventilation system designed to capture the particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air to clean in beryllium-contaminated areas, the employer must provide, and ensure that each employee uses, respiratory protection and personal protective clothing and equipment in accordance with paragraphs (g) and (h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and maintained in a manner that minimizes the likelihood and level of airborne exposure and the re-entrainment of airborne beryllium in the workplace.
(3)
(k)
(A) Who is or is reasonably expected to be exposed at or above the action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph (k)(6) or (k)(7) recommends periodic medical surveillance.
(ii) The employer must ensure that all medical examinations and procedures required by this standard are performed by, or under the direction of, a licensed physician.
(2)
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A) of this standard, unless the employee has received a medical examination, provided in accordance with this standard, within the last two years; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C) of this standard.
(ii) At least every two years thereafter for each employee who continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D) of this standard.
(iii) At the termination of employment for each employee who meets any of the criteria of paragraph (k)(1)(i) of this standard at the time the employee's employment terminates, unless an examination has been provided in accordance with this standard during the six months prior to the date of termination.
(3)
(ii) The employer must ensure that the employee is offered a medical examination that includes:
(A) A medical and work history, with emphasis on past and present airborne exposure to or dermal contact with beryllium, smoking history, and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the guidelines established by the American Thoracic Society including forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(E) A standardized BeLPT or equivalent test, upon the first examination and at least every two years thereafter, unless the employee is confirmed positive. If the results of the BeLPT are other than normal, a follow-up BeLPT must be offered within 30 days, unless the employee has been confirmed positive. Samples must be analyzed in a laboratory certified under the College of American Pathologists/Clinical Laboratory Improvement Amendments (CLIA) guidelines to perform the BeLPT.
(F) A low dose computed tomography (LDCT) scan, when recommended by the PLHCP after considering the employee's history of exposure to beryllium along with other risk factors, such as smoking history, family medical history, sex, age, and presence of existing lung disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4)
(i) A description of the employee's former and current duties that relate to the employee's airborne exposure to and dermal contact with beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that personal protective clothing and equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining written consent from the employee.
(5)
(i) A statement indicating the results of the medical examination, including the licensed physician's opinion as to whether the employee has
(A) Any detected medical condition, such as CBD or beryllium sensitization (
(B) Any medical conditions related to airborne exposure that require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, the written report must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l).
(6)
(A) The date of the examination;
(B) A statement that the examination has met the requirements of this standard;
(C) Any recommended limitations on the employee's use of respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the medical examination to the employee, including any tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions for use of personal protective clothing or equipment;
(ii) If the employee provides written authorization, the written opinion must also contain any recommended limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, and the employee provides written authorization, the written opinion must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l).
(vi) The employer must ensure that each employee receives a copy of the written medical opinion described in paragraph (k)(6) of this standard within 45 days of any medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) performed for that employee.
(7)
(A) The employer's receipt of a physician's written medical opinion to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center.
(ii) The employer must ensure that the employee receives a written medical report from the CBD diagnostic center that contains all the information required in paragraph (k)(5)(i), (ii), (iv), and (v) and that the PLHCP explains the results of the examination to the employee within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the CBD diagnostic center within 30 days of the medical examination. The written medical opinion must contain only the information in paragraphs (k)(6)(i), as applicable, unless the employee provides written authorization to release additional information. If the employee provides written authorization, the written opinion must also contain the information from paragraphs (k)(6)(ii), (iv), and (v), if applicable.
(iv) The employer must ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30 days of any medical examination performed for that employee.
(v) After an employee has received the initial clinical evaluation at a CBD diagnostic center described in paragraph (k)(7)(i) of this standard, the employee may choose to have any subsequent medical examinations for which the employee is eligible under paragraph (k) of this standard performed at a CBD diagnostic center mutually agreed upon by the employer and the employee, and the employer must provide such examinations at no cost to the employee.
(l)
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(5)(v) or (k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the action level, provided that the employer provides, and ensures that the employee uses, respiratory protection that complies with paragraph (g) of this standard whenever airborne exposures are at or above the action level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to beryllium are below the action level, and the employee is qualified for that job or can be trained within one month, the employer must remove the employee to that job. The employer must maintain for six months from the time of removal the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal for six months or until such time that comparable work described in paragraph (l)(3)(i) becomes available, whichever comes first.
(4) The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal from a publicly or employer-funded compensation program, or receives income from another employer made possible by virtue of the employee's removal.
(m)
(ii) Employers must include beryllium in the hazard communication program established to comply with the HCS. Employers must ensure that each employee has access to labels on containers of beryllium and to safety data sheets, and is trained in accordance with the requirements of the HCS (29 CFR 1910.1200) and paragraph (m)(4) of this standard.
(2)
(ii)
(B) The employer must ensure each warning sign required by paragraph (m)(2)(i) of this standard bears the following legend:
(3)
(4)
(A) The employer must provide information and training in accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer must provide initial training to each employee by the time of initial assignment; and
(C) The employer must repeat the training required under this standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can reasonably be expected to be, exposed to airborne beryllium can demonstrate knowledge and understanding of the following:
(A) The health hazards associated with airborne exposure to and contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the location(s) of any regulated areas, and the specific nature of operations that could result in airborne exposure, especially airborne exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and limitations of personal protective clothing and equipment, including respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne exposure to and contact with beryllium, including personal hygiene practices;
(F) The purpose and a description of the medical surveillance program required by paragraph (k) of this
(G) The purpose and a description of the medical removal protection provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records Access standard (29 CFR 1910.1020).
(iii) When a workplace change (such as modification of equipment, tasks, or procedures) results in new or increased airborne exposure that exceeds, or can reasonably be expected to exceed, either the TWA PEL or the STEL, the employer must provide additional training to those employees affected by the change in airborne exposure.
(iv)
(n)
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and
(F) The name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer must ensure that exposure records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(2)
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(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 airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(3)
(ii) The record must include the following information about each employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for each employee; and
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(4)
(ii) This record must be maintained for three years after the completion of training.
(5)
(6)
(o)
(2)
(i) Change rooms required by paragraph (i) of this standard must be provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this standard must be implemented by March 10, 2020.
40 U.S.C. 3704; 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); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
Section 1926.61 also issued under 49 U.S.C. 5101
Section 1926.62 also issued under 42 U.S.C. 4853.
Section 1926.65 also issued under 126 of Public Law 99-499, 100 Stat. 1613.
The revisions read as follows:
40 U.S.C. 3704; 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); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
(a)
(2) This standard does not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than 0.1% beryllium by weight where the employer has objective data demonstrating that employee exposure to beryllium will remain below the action level as an 8-hour TWA under any foreseeable conditions.
(b)
(c)
(2)
(d)
(2)
(3)
(ii) The employer must perform initial monitoring to assess the short-term exposure from 15-minute personal breathing zone air samples measured in operations that are likely to produce airborne exposure above the STEL for each work shift, for each job classification, and in each work area.
(iii) Where several employees perform the same 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 the requirements of paragraph (d)(3). In representative sampling, the employer must sample the employee(s) expected to have the highest airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is below the action level and at or below the STEL, the employer may discontinue monitoring for those employees whose airborne exposure is represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that airborne exposure is at or above the action level but at or below the TWA PEL, the employer must repeat such monitoring within six months of the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that airborne exposure is above the TWA PEL, the employer must repeat such monitoring within three months of the most recent 8-hour TWA exposure monitoring.
(vii) Where the most recent (non-initial) exposure monitoring indicates that airborne exposure is below the action level, the employer must 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 8-hour TWA exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that airborne exposure is above the STEL, the employer must repeat such monitoring within three months of the most recent short-term exposure monitoring until two consecutive measurements, taken 7 or more days apart, are below the STEL, at which time the employer may discontinue short-term exposure monitoring for those employees whose exposure is represented by such monitoring, except as otherwise provided in paragraph (d)(4) of this standard.
(4)
(5)
(6)
(ii) Whenever an exposure assessment indicates that airborne exposure is above the TWA PEL or STEL, the employer must describe in the written notification the corrective action being taken to reduce airborne exposure to or below the exposure limit(s) exceeded where feasible corrective action exists but had not been implemented when the monitoring was conducted.
(7)
(ii) When observation of monitoring requires entry into an area where the use of personal protective clothing or equipment (which may include respirators) is required, the employer must provide each observer with appropriate personal protective clothing and equipment at no cost to the observer.
(iii) The employer must ensure that each observer follows all other applicable safety and health procedures.
(e)
(1) Make frequent and regular inspections of job sites, materials, and equipment;
(2) Implement the written exposure control plan under paragraph (f) of this standard;
(3) Ensure that all employees use respiratory protection in accordance with paragraph (g) of this standard; and
(4) Ensure that all employees use personal protective clothing and equipment in accordance with paragraph (h) of this standard.
(f)
(A) A list of operations and job titles reasonably expected to involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination;
(E) Procedures for minimizing the migration of beryllium within or to locations outside the workplace;
(F) A list of engineering controls, work practices, and respiratory protection required by paragraph (f)(2) of this standard;
(G) A list of personal protective clothing and equipment required by paragraph (h) of this standard;
(H) Procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators; and
(I) Procedures used to restrict access to work areas when airborne exposures are, or can reasonably be expected to be, above the TWA PEL or STEL, to minimize the number of employees exposed to airborne beryllium and their level of exposure, including exposures generated by other employers or sole proprietors.
(ii) The employer must review and evaluate the effectiveness of each
(A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results, or can reasonably be expected to result, in new or additional airborne exposure to beryllium;
(B) The employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard, referred for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium; or
(C) The employer has any reason to believe that new or additional airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control plan accessible to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)).
(2)
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation, material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible; or
(B) The employer can demonstrate that airborne exposure is below the action level, using no fewer than two representative personal breathing zone samples taken at least 7 days apart, for each affected operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after implementing the control(s) required by paragraph (f)(2)(i) of this standard, the employer must implement additional or enhanced engineering and work practice controls to reduce airborne exposure to or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to reduce airborne exposure to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii), the employer must implement and maintain engineering and work practice controls to reduce airborne exposure to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard.
(3)
(g)
(i) During periods necessary to install or implement feasible engineering and work practice controls where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities and non-routine tasks, when engineering and work practice controls are not feasible and airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all feasible engineering and work practice controls when such controls are not sufficient to reduce airborne exposure to or below the TWA PEL or STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under paragraph (l)(1) chooses to remain in a job with airborne exposure at or above the action level, as permitted by paragraph (l)(2)(ii) of this standard.
(2)
(3) The employer must provide at no cost to the employee a powered air-purifying respirator (PAPR) instead of a negative pressure respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a PAPR; and
(iii) The PAPR provides adequate protection to the employee in accordance with paragraph (g)(2) of this standard.
(h)
(i) Where airborne exposure exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with beryllium.
(2)
(ii) The employer must ensure that each employee removes beryllium-contaminated personal protective clothing and equipment as specified in the written exposure control plan required by paragraph (f)(1) of this standard.
(iii) The employer must ensure that each employee stores and keeps beryllium-contaminated personal protective clothing and equipment separate from street clothing and that storage facilities prevent cross-contamination as specified in the written exposure control plan required by paragraph (f)(1) of this standard.
(iv) The employer must ensure that no employee removes beryllium-contaminated personal protective clothing or equipment from the workplace, except for employees authorized to do so for the purposes of laundering, cleaning, maintaining or disposing of beryllium-contaminated personal protective clothing and equipment at an appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this standard is removed from the workplace for laundering, cleaning, maintenance or disposal, the employer must ensure that personal protective clothing and equipment are stored and transported in sealed bags or other closed containers that are impermeable and are labeled in accordance with paragraph (m)(2) of this standard and the HCS (29 CFR 1910.1200).
(3)
(ii) The employer must ensure that beryllium is not removed from personal protective clothing and equipment by blowing, shaking or any other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the business entities who launder, clean or repair the personal protective clothing or equipment required by this standard of the potentially harmful effects of airborne exposure to and dermal contact with beryllium and that the personal protective clothing and equipment must be handled in accordance with this standard.
(i)
(i) Provide readily accessible washing facilities in accordance with this standard and the Sanitation standard (§ 1926.51) to remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium wash any exposed skin at the end of the activity, process, or work shift and prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet.
(2)
(3)
(i) Surfaces in eating and drinking areas are as free as practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal protective clothing or equipment unless, prior to entry, surface beryllium has been removed from the clothing or equipment by methods that do not disperse beryllium into the air or onto an employee's body; and
(iii) Eating and drinking facilities provided by the employer are in accordance with the Sanitation standard (§ 1926.51).
(4)
(j)
(ii) The employer must ensure that all spills and emergency releases of beryllium are cleaned up promptly and in accordance with the written exposure control plan required under paragraph (f)(1) of this standard.
(2)
(ii) The employer must not allow dry sweeping or brushing for cleaning in beryllium-contaminated areas unless HEPA-filtered vacuuming or other methods that minimize the likelihood and level of airborne exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for cleaning in beryllium-contaminated areas unless the compressed air is used in conjunction with a ventilation system designed to capture the particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air to clean in beryllium-contaminated areas, the employer must provide, and ensure that each employee uses, respiratory protection and personal protective clothing and equipment in accordance with paragraphs (g) and (h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and maintained in a manner that minimizes the likelihood and level of airborne exposure and the re-entrainment of airborne beryllium in the workplace.
(3)
(k)
(A) Who is or is reasonably expected to be exposed at or above the action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph (k)(6) or (k)(7) recommends periodic medical surveillance.
(ii) The employer must ensure that all medical examinations and procedures required by this standard are performed by, or under the direction of, a licensed physician.
(2)
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A), unless the employee has received a medical examination, provided in accordance with this standard, within the last two years; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C).
(ii) At least every two years thereafter for each employee who continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D) of this standard.
(iii) At the termination of employment for each employee who meets any of the criteria of paragraph (k)(1)(i) of this standard at the time the employee's employment terminates, unless an examination has been provided in accordance with this standard during the six months prior to the date of termination.
(3)
(ii) The employer must ensure that the employee is offered a medical examination that includes:
(A) A medical and work history, with emphasis on past and present airborne exposure to or dermal contact with beryllium, smoking history, and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the guidelines established by the American Thoracic Society including forced vital capacity (FVC) and forced expiratory volume in one second (FEV
(E) A standardized BeLPT or equivalent test, upon the first examination and at least every two years thereafter, unless the employee is confirmed positive. If the results of the BeLPT are other than normal, a follow-up BeLPT must be offered within 30 days, unless the employee has been
(F) A low dose computed tomography (LDCT) scan, when recommended by the PLHCP after considering the employee's history of exposure to beryllium along with other risk factors, such as smoking history, family medical history, sex, age, and presence of existing lung disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4)
(i) A description of the employee's former and current duties that relate to the employee's airborne exposure to and dermal contact with beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that personal protective clothing and equipment; and
(iv) Information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining written consent from the employee.
(5)
(i) A statement indicating the results of the medical examination, including the licensed physician's opinion as to whether the employee has
(A) Any detected medical condition, such as CBD or beryllium sensitization (
(B) Any medical conditions related to airborne exposure that require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, the written report must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the written report must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l).
(6)
(A) The date of the examination;
(B) A statement that the examination has met the requirements of this standard;
(C) Any recommended limitations on the employee's use of respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the medical examination to the employee, including any tests conducted, any medical conditions related to airborne exposure that require further evaluation or treatment, and any special provisions for use of personal protective clothing or equipment;
(ii) If the employee provides written authorization, the written opinion must also contain any recommended limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD or if the licensed physician otherwise deems it appropriate, and the employee provides written authorization, the written opinion must also contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for continued periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and the employee provides written authorization, the written opinion must also contain a recommendation for medical removal from airborne exposure to beryllium, as described in paragraph (l).
(vi) The employer must ensure that each employee receives a copy of the written medical opinion described in paragraph (k)(6) of this standard within 45 days of any medical examination (including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) performed for that employee.
(7)
(A) The employer's receipt of a physician's written medical opinion to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center.
(ii) The employer must ensure that the employee receives a written medical report from the CBD diagnostic center that contains all the information required in paragraphs (k)(5)(i), (ii), (iv), and (v) of this standard and that the PLHCP explains the results of the examination to the employee within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the CBD diagnostic center within 30 days of the medical examination. The written medical opinion must contain only the information in paragraph (k)(6)(i) of this standard, as applicable, unless the employee provides written authorization to release additional information. If the employee provides written authorization, the written opinion must also contain the information from paragraphs (k)(6)(ii), (iv), and (v), if applicable.
(iv) The employer must ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30 days of any medical examination performed for that employee.
(v) After an employee has received the initial clinical evaluation at a CBD diagnostic center described in paragraph (k)(7)(i) of this standard, the employee may choose to have any subsequent
(l)
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(5)(v) or (k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending removal from airborne exposure to beryllium in accordance with paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the action level, provided that the employer provides, and ensures that the employee uses, respiratory protection that complies with paragraph (g) of this standard whenever airborne exposures are at or above the action level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to beryllium are below the action level, and the employee is qualified for that job or can be trained within one month, the employer must remove the employee to that job. The employer must maintain for six months from the time of removal the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must maintain the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal for six months or until such time that comparable work described in paragraph (l)(3)(i) becomes available, whichever comes first.
(4) The employer's obligation to provide medical removal protection benefits to a removed employee shall be reduced to the extent that the employee receives compensation for earnings lost during the period of removal from a publicly or employer-funded compensation program, or receives income from another employer made possible by virtue of the employee's removal.
(m)
(ii) Employers must include beryllium in the hazard communication program established to comply with the HCS. Employers must ensure that each employee has access to labels on containers of beryllium and to safety data sheets, and is trained in accordance with the requirements of the HCS (29 CFR 1910.1200) and paragraph (m)(4) of this standard.
(2)
(3)
(A) The employer must provide information and training in accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer must provide initial training to each employee by the time of initial assignment; and
(C) The employer must repeat the training required under this standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can reasonably be expected to be, exposed to airborne beryllium can demonstrate knowledge and understanding of the following:
(A) The health hazards associated with airborne exposure to and dermal contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the specific nature of operations that could result in airborne exposure, especially airborne exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and limitations of personal protective clothing and equipment, including respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne exposure to and dermal contact with beryllium, including personal hygiene practices;
(F) The purpose and a description of the medical surveillance program required by paragraph (k) of this standard including risks and benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records Access standard (29 CFR 1910.1020).
(iii) When a workplace change (such as modification of equipment, tasks, or procedures) results in new or increased airborne exposure that exceeds, or can reasonably be expected to exceed, either the TWA PEL or the STEL, the employer must provide additional training to those employees affected by the change in airborne exposure.
(iv)
(n)
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and
(F) The name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer must ensure that exposure records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(2)
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(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 airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(3)
(ii) The record must include the following information about each employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for each employee; and
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
(4)
(ii) This record must be maintained for three years after the completion of training.
(5)
(6)
(o)
(2)
(i) Change rooms required by paragraph (i) of this standard must be provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this standard must be implemented by March 10, 2020.
Environmental Protection Agency (EPA).
Final rule.
The U.S. Environmental Protection Agency (EPA) is adding a subsurface intrusion (SsI) component to the Hazard Ranking System (HRS), which is the principal mechanism that EPA uses to evaluate sites for placement on the National Priorities List (NPL). The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. Sites on the NPL are priorities for further investigation to determine if further response actions are warranted. The subsurface intrusion component (this addition) expands the number of available options for EPA and state and tribal organizations performing work on behalf of EPA to evaluate actual and potential threats to public health from releases of hazardous substances, pollutants, or contaminants. This addition enables EPA to directly consider human exposure to hazardous substances, pollutants, or contaminants that enter regularly occupied structures through subsurface intrusion in assessing a site's relative risk, and thus, enable sites with subsurface intrusion contamination to be evaluated for placement on the NPL.
This final rule is effective February 8, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-SFUND-2010-1086. All documents in the docket are listed on the
Terry Jeng, phone: (703) 603-8852, email:
The information presented in this preamble is organized as follows:
EPA has revised the HRS, the principal mechanism for placing sites on the NPL, to add a component for evaluating the threat or potential threat posed by subsurface intrusion to protect human health and the environment. Without an evaluation of threats posed by subsurface intrusion contamination, the HRS is not a complete assessment because it omits a known pathway of human exposure to contamination. The addition of subsurface intrusion to the HRS is compliant with Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Section 105(a)(8)(A), which requires EPA to prioritize sites based on “the population at risk, the hazard potential of hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact [and] the potential for destruction of sensitive ecosystems. This addition to the HRS also improves the agency's ability to identify priority sites for further investigation and enhances EPA's ability, in dialogue with other federal agencies and the states and tribes, to determine the most appropriate state or federal authority to address sites. For information on alternatives to this rulemaking that were considered for addressing subsurface intrusion contamination, please see the
Additionally, the Government Accountability Office (GAO) stated in its May 2010 report
EPA may not be listing some sites that pose health risks that are serious enough that the sites should be considered for inclusion on the NPL. While EPA is assessing vapor intrusion contamination at listed NPL sites, EPA does not assess the relative risks posed by vapor intrusion when deciding which sites to include on the NPL. By not including these risks, states may be left to remediate those sites without federal assistance, and given states' constrained budgets, some states may not have the ability to clean up these sites on their own . . . However, if these sites are not assessed and, if needed, listed on the NPL, some seriously contaminated hazardous waste sites with unacceptable human exposure may not otherwise be cleaned up.
The authority for these technical modifications to the HRS is in section 105(a)(8)(A) of CERCLA enacted in 1980. Under CERCLA, the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (40 CFR 300) must include criteria for determining priorities among releases or threatened releases for the purpose of taking remedial or removal actions. Section 105(a)(8)(A) of CERCLA required EPA to establish:
[C]riteria for determining priorities among releases or threatened releases [of hazardous substances] throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action. Criteria and priorities . . . shall be based upon relative risk or danger to public health or welfare or the environment. . .taking into account to the extent possible the population at risk, the hazard potential of hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact [and] the potential for destruction of sensitive ecosystems. . . .
To meet this requirement and provide criteria to set priorities, EPA adopted the HRS as Appendix A to the NCP (47 FR 31180, July 16, 1982). The HRS was last revised on December 14, 1990 (55 FR 51532) to include the evaluation of additional threats to ensure a complete assessment of the relative risk that a site may pose to the public. Section 105(a)(8)(B) of CERCLA requires that the statutory criteria described in section 105(a)(8)(A) be used to prepare a list of national priorities among the known releases, or threatened releases throughout the United States. The NPL is Appendix B of the NCP (40 CFR 300, Appendix B).
In 1986, Congress passed the Superfund Amendments and Reauthorization Act (SARA) (Pub. L. 99-499), which added section 105(c)(1) to CERCLA, requiring EPA to amend the HRS to assure “to the maximum extent feasible, that the hazard ranking system accurately assesses the relative degree of risk to human health and the environment posed by sites and facilities subject to review.” In addition, CERCLA section 115 authorizes EPA to promulgate any regulations necessary to carry out the provisions of CERCLA.
Furthermore, the Congressional Conference Report on SARA included the absolute standard against which HRS revisions could be assessed:
This standard is to be applied within the context of the purpose for the National Priorities List;
When the HRS was last revised in 1990, the technology to detect and evaluate subsurface intrusion threats was not sufficiently developed. For example, there were no health-based benchmark concentration values for residences or standardized technologies for sampling indoor air, precision of analytical equipment prior to computerization was limited, and associations between contaminated ground water and soil vapors were not well understood. However, it is now possible for subsurface intrusion threats to be evaluated in a more comprehensive manner. Therefore, it is now appropriate, given the potential that subsurface intrusion presents for direct human contact, to add to the HRS the consideration of threats due to subsurface intrusion.
This final rule ensures the HRS does not omit a known pathway of human exposure to contamination due to subsurface intrusion of released hazardous substances and provides a mechanism for assessing subsurface intrusion threats and identifying sites for placement on the NPL. Furthermore, these sites are now eligible for Superfund-financed remedial actions.
The HRS is a crucial part of the agency's program for determining which sites are a priority for further remedial investigation and possible cleanup under CERCLA. To understand the importance of this rulemaking it is necessary to understand the role of the HRS in identifying sites for the NPL, the role of the HRS in the overall site assessment and Superfund remedial process, and this final rule's impacts on current and future Superfund activities. In addition, it is also necessary to understand the impact of adding the SsI component to the HRS.
The HRS is a scoring system used to assess the relative risk associated with actual or potential releases of hazardous substances from a site based on the information that can be collected in a preliminary assessment (PA) and site inspection (SI). The HRS is not a tool for conducting a quantitative risk assessment and was designed to be a measure of relative risk among sites rather than absolute site-specific risk. As required by CERCLA, EPA has designed the Superfund program to focus its resources on the priority sites. Consequently, the initial studies—the PA and SI—which are performed on a large number of sites, are relatively modest in scope and cost compared to the remedial investigations and feasibility studies subsequently performed on NPL sites.
Because of the need to expeditiously perform PAs and SIs, Congress placed certain constraints on the data requirements for an HRS evaluation. The required HRS data should be information that, for most sites, can be collected during a screening level site inspection or that are already available. Thus, the HRS does not rely on data that require extensive sampling or repeated sampling over extended periods of time. However, EPA allows for the expansion of the typical SI to allow for additional data collection for more complex sites that cannot be adequately characterized using standard SI methodologies. The HRS has also been designed so that it can be applied consistently to a wide variety of sites, enabling sites to be
Based on the state of the science, site specific data may be collected beyond that which is normally available after a typical site inspection. In these situations, the HRS in general, and the SsI component, can incorporate that data into the HRS evaluation. For example, the SsI component can use site-specific data as follows:
• Determination of the Hazardous Waste Quantity Factor Value—If the mass of all hazardous substances can be adequately determined (
• Determining the extent of an ASC—If sufficient data are available and state of the science shows there is no unacceptable risk due to subsurface intrusion into a regularly occupied structure located within an ASC, that structure or subunit can be excluded from the ASC. Therefore, such structures would not be included in the evaluation of the Hazardous Waste Quantity Factor or in the determination of other factors evaluated based on structures or subunits within an ASC. See section 5.2.0 of the HRS.
• Populations within the ASC—If sufficient structure-specific concentration data is available and state of the science shows there is no unacceptable risk of exposure to populations in a regularly occupied structure in an ASC, those populations are not included in the evaluation of the Targets Factor Category. See section 5.2.1.3 of the HRS.
EPA notes that if other site-specific information is available that clearly demonstrates that the site does not pose an unacceptable risk to human health via subsurface intrusion, there are points during the PA or SI process, where further evaluation of the site for the subsurface intrusion threat by the Superfund program can be terminated. Please see section B. of this preamble for further information on the Site Assessment process.
As EPA explained when it originally adopted the HRS, “the HRS is a means for applying uniform technical judgment regarding the potential hazards presented by a facility relative to other facilities. It does not address the feasibility, desirability, or degree of cleanup required.” (47 FR 31220, July 16, 1982).
The HRS uses a structured value analysis approach to scoring sites. This approach assigns values to factors related to or indicative of risk. The basic elements of the HRS are factors that are based on information that can be collected in a limited screening assessment. A scale of numerical rating values is provided for each factor and a value is assigned to each factor based on conditions at the site. Individual values are then weighted. The factors are grouped into three factor categories—observed release/route characteristics, waste characteristics, and targets—and are combined to obtain factor category scores. Each factor category has a maximum value, as does each of the component factors within the category. The relevant factor category scores are multiplied together within each pathway and normalized to obtain a pathway score. The pathway scores are combined using a root-mean-square approach to calculate the overall site score; that is, the final HRS score is the square root of the sum of the squares of the pathway scores divided by the square root of the number of HRS pathways. If all pathway scores are low, the HRS score will be low. However, the final score will be relatively high even if only one pathway score is high. EPA considers this an important requirement for the HRS scoring because some extremely dangerous sites pose threats through only one migration mode. For example, at a site, leaking drums of hazardous substances may be contaminating drinking water wells, thereby posing a significant threat via the groundwater migration pathway. But if the drums are buried deeply enough and the hazardous substances are not very volatile, the drums may not release any hazardous substances and not pose a threat to the air or to surface water.
EPA emphasizes that the HRS score is a number between 0 and 100, which reflects relative risk amongst candidate NPL sites. An HRS site score is not a measure of actual site-specific risk.
EPA's Superfund remedial site assessment process evaluates sites to ascertain if further investigation is needed for determining whether an unacceptable risk is present.
The majority of sites evaluated through the EPA's site assessment program do not meet the criteria for possible placement on the NPL and are “screened out” of the Superfund Remedial process. (See Figure 1. Status of EPA's Site Assessments). Since EPA adopted the HRS, 52, 859 sites have been assessed under EPA's Superfund program. Of those sites, 1,782 were placed on the NPL, as of September 2016.
The site assessment process is structured as a series of limited investigations which may include: (1) A Pre-CERCLA screening assessment; (2) a preliminary assessment; and (3) a site inspection or expanded site inspection (Figure 2. Site Assessment Process, below, illustrates this process). If a site progresses through the site assessment process for further investigation, the requirements for documenting risk become increasingly rigorous. The following includes a summary of the major phases of the site assessment process.
• A Pre-CERCLA Screening is an initial review of existing information on a possible Superfund site. If a release of a hazardous substance has occurred or if the potential of a hazardous substance to release exists the site may be eligible for further remedial evaluation under CERCLA authority. If further evaluation is warranted the site should be entered into the remedial assessment active site inventory for further assessment.
• The PA decision process parallels an HRS analysis, but makes environmental “worst-case” assumptions of possible significant risk regarding transport of contamination to receptors based on minimal available information and professional judgment.
• The SI collects information to confirm the accuracy of the PA assumptions. The information should be sufficient to support an HRS evaluation with minimal further investigation.
• If placement on the NPL is pursued, the information collected during the SI provides the basis for supporting the HRS scoring scenario.
The following discussion provides further information on each of these phases.
A Pre-CERCLA Screening is used to establish whether:
• A release or potential release of a hazardous substance has occurred at a site;
• The site is eligible for further remedial assessment under CERCLA authority;
• The site needs further attention under Superfund or another cleanup program; and
• The site warrants entry into the federal Superfund program's active site inventory for further assessment or response.
Determining whether releases of hazardous substances, pollutants, or contaminants can be addressed by CERCLA requires the application of site-specific facts to CERCLA statutory requirements and EPA policy. The initial determination as to whether a site warrants further investigation is based on three site-specific facts including: (1) Evidence of an actual release or potential to release; (2) targets impacted by a release of contamination at the site; and (3) documentation that a target has been exposed to a hazardous substance released from the site. Examples of targets include populations, drinking water wells, drinking water surface intakes, municipal wells, fisheries and sensitive environments.
A PA uses readily available data to determine if there is evidence of a release that poses an unacceptable possible threat as specified in the NCP (40 CFR 300.420).
• The PA is a limited-scope investigation performed by States and/or EPA on every CERCLA site
• The PA may include the collection of readily available information and an on- or off-site reconnaissance may be conducted
• The PA distinguishes, based on already existing information, between sites that appear to pose little or no threat to human health and the environment and sites that require further investigation to determine if the threat to human health and the environment is unacceptable.
If based on the results of a PA, EPA determines that a site warrants further screening under the CERCLA remedial program, the agency initiates a site inspection
The purpose of the SI is to collect the data necessary to perform an HRS evaluation. An SI determines if a release of a hazardous substance poses an actual or potential threat to human health or the environment, to determine if there is an immediate threat to people or the environment in the area, and to collect sufficient data to enable the site to be scored using the HRS. EPA may expand the site inspection scope as needed. This expanded site inspection (ESI) collects additional data beyond what is collected in the standard site inspection to evaluate sites for HRS scoring. ESIs are reserved for more complex sites that cannot be adequately characterized using standard site inspection methods.
• SI investigators typically collect waste and environmental samples to determine the substances present at a site and whether they are being released to the environment, as well as other information to perform an HRS evaluation.
• EPA distinguishes, based on the information collected during the SI, between sites that appear to pose little or no threat to human health and the environment and sites that require further investigation to determine if the threat to human health and the environment exists.
• If the information indicates a threat, EPA determines the best approach for addressing the threat, which can be placement on the NPL or use of an alternative authority.
If at any time in this site assessment process, EPA determines that sufficient information indicates the site poses no unacceptable risk, or if it can be addressed under alternative authorities it can be removed from the process. Also, if an imminent or substantial endangerment to public health is identified, EPA can initiate CERCLA removal actions.
The NPL is a list of national priorities for further investigation amongst the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), is required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.
For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund section”) and one of sites that are owned or operated by other federal agencies (the “Federal Facilities section”). With respect to the Federal Facilities sites, these sites are generally being addressed by other federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL and having oversight authority at the sites for further actions.
The NPL is required to be revised annually and it is intended primarily to guide EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. This selection process is illustrated in figure 3, below. Sites with HRS scores of 28.50 or greater are eligible for placement on the NPL. Only non-Federal Facility sites on the NPL are eligible for Superfund-financed remedial actions. Once a site is determined to be NPL-caliber and a decision has been made that the federal Superfund program should manage the site cleanup, EPA regions apply a strong initial presumption in favor of placement on the NPL.
Once the site is proposed for the NPL (
This SsI addition to the HRS will have the most significant impact on EPA's Superfund cleanup program. This regulatory change expands available options for EPA and organizations performing work on behalf of EPA (state and tribal partners) to evaluate actual and potential threats to public health and the environment from subsurface intrusion contamination. This modification to the HRS, by itself, only augments the criteria for applying the HRS. It has no effect on small businesses.
This final rule will not affect the status of sites currently on or proposed to the NPL. Sites that are currently on or proposed to the NPL have already been evaluated under another pathway (
The possible impact on federal agencies other than EPA performing Superfund actions will be less than that on private sites being addressed by EPA. Federal agencies currently address subsurface intrusion issues as part of their environmental programs and authorities. Executive Order 12580 delegates broad CERCLA authority to federal agencies for responding to actual and potential releases of hazardous substances where a release is either on, or the sole source of the release is from, any facility or vessel under the jurisdiction, custody, or control of the federal agency. Federal agencies are required to exercise this authority consistent with the requirements of CERCLA section 120, as amended, and implement regulations under the NCP, for both NPL and non-NPL sites. Therefore, federal agencies are in a position to proactively identify and respond to risks posed by subsurface intrusion of hazardous substances into regularly occupied structures for all populations who live and work in areas where the subsurface environment may create exposures. If it is determined that releases of hazardous substances pose immediate threats to public health and the environment, EPA fully expects that the appropriate federal agency will continue to undertake response actions to address such threats. Many federal agencies, including EPA, have developed or are developing new or updated agency-specific policy and guidance documents to address subsurface intrusion threats.
As a result of federal agency existing environmental programs and authorities, this rulemaking is not anticipated to have a significant impact to the resources and costs to federal cleanup programs.
Since EPA's overall appropriated Superfund budget as well EPA's cooperative agreement budget for performing site assessments will continue to remain relatively steady, EPA anticipates that this final rule will not result in additional site assessments nor the placement of more sites on the NPL during any particular interval, but rather a shift in the make-up of the type of sites included on the NPL. EPA will continue to review sites as part of Superfund remedial site assessment to determine whether sites are eligible for further remedial evaluation under CERCLA authorities and prioritize sites that pose the highest risk. This is not a change to how EPA currently evaluates and prioritizes sites for the NPL. Because the level of effort required to evaluate a site, regardless of pathway, varies on a site-by-site basis, depending on the size and extent of contamination at the site, it cannot be predicted with any certainly that there will be an increase in cost or level of effort for any particular site due to this rulemaking.
This rulemaking, which could lead to the inclusion of a site on the NPL that did not qualify for the NPL previously, does not itself impose any costs on outside parties; it does not establish that EPA will necessarily undertake response actions, nor does it require any action by a private party or determine liability for site response costs. Costs are limited to screening relevant sites for subsurface intrusion contamination during site inspections and the resulting HRS evaluation and documentation record preparation. Costs that arise from site remedial responses are the result of site-specific decisions made post-listing, not directly from the act of listing itself. These costs are a result of a release of hazardous substances and would not be incurred if hazardous substances had not been released.
Later Superfund-related decisions that consider information collected under the HRS SsI Addition could separately have specific economic costs and benefits (
This rulemaking does not impose any requirements on small entities, and therefore can be certified as no Significant Economic Impact on a Substantial Number of Small Entities (SISNOSE). With the exception of other federal agencies, site assessments are performed by EPA and on behalf of EPA by states and tribes in cooperative agreement partnerships with EPA. Under section 601 of the Regulatory Flexibility Act, federal agencies do not fit under the definition of small business, small entity, small organization or small governmental jurisdiction.
This final rule, with the addition of a subsurface intrusion component, does not change the purpose of the HRS, its fundamental structure or its application. It does not change the balance between the pathways or calculation of the overall HRS site score and the same cutoff score to qualify a site for the NPL is maintained. The current approach for scoring the ground water, surface water, and air migration pathways is not being altered by the addition of a subsurface intrusion component. EPA added the subsurface intrusion threat as a component to the present soil exposure pathway because its structure already focuses on populations actually or potentially coming into direct contact with hazardous substances. The re-structured pathway is called the “Soil Exposure and Subsurface Intrusion” pathway and now allows for the consideration of the threat posed by subsurface contaminant intrusion. The Soil Exposure and Subsurface Intrusion pathway retains the existing two soil exposure threats (resident population and nearby population) in the pathway as one component, with subsurface intrusion as the second component.
The narrow technical modifications resulting from this Final Rule reflect the agency's actions to encompass additional risks posed by releases of hazardous substances and to address the SARA statutory requirement that EPA amend the HRS to assure “to the maximum extent feasible, that the HRS accurately assesses the relative degree of risk to human health and the environment posed by sites subject to review.” Thus, the fundamental purpose and structure of the HRS approach has not changed with this amendment to the HRS to include the consideration of subsurface intrusion.
This final rule revises the 1990 HRS to include a component for evaluating the threats posed from subsurface intrusion. The following sections discuss the structure of the HRS, the subsurface intrusion component within the HRS, the major factors of the subsurface intrusion addition, and how the evaluation will be performed using a structure consistent with the other threats, components, and pathways in the HRS, but taking into account the unique parameters impacting the probability of exposure to subsurface intrusion. All sites that qualified for the NPL under the 1990 HRS, would still qualify for the NPL under this revised HRS. For a more comprehensive description and rationale of changes, see the February 29, 2016 Proposed Rule [81 FR 10372, February 29, 2016].
EPA added the evaluation of the relative risk posed by subsurface intrusion of hazardous substances into regularly occupied structures by restructuring the soil exposure pathway from the 1990 HRS to include subsurface intrusion. The soil exposure pathway has been renamed the soil exposure and subsurface intrusion pathway to reflect both components of
As explained in the preamble to the proposed HRS SsI addition, the subsurface intrusion component is added as a new component of the soil exposure and subsurface intrusion pathway. The soil exposure pathway included in the 1990 HRS is retained as one component of the Soil Exposure and Subsurface Intrusion pathway. The scoring of the soil exposure component remains unaltered, but the score is assigned as the soil exposure component score, not the pathway score. (See section 5.1 of the HRS). As discussed in greater detail below, the SsI component has the same basic structure, scoring, and weighting as other parts of the HRS.
The score for the soil exposure and subsurface intrusion pathway is based on a combination of the two component scores—soil exposure and subsurface intrusion but the pathway score is capped at the same value as other HRS pathways. The soil exposure component score is added to the subsurface intrusion component score to determine the pathway score. The two component scores are additive to reflect that populations may be exposed via both routes: The soil exposure component reflects exposures to people when outside a structure and focuses on ingestion, and the subsurface intrusion component reflects exposures inside a structure and focuses on inhalation. Hence, the addition of the two component scores reflects the potential cumulative risk of multiple exposure routes and is not double counting the same relative risk.
A maximum pathway score is not contingent on scoring both the soil exposure and subsurface intrusion components. It is possible for a site to have only one component evaluated and still reach the maximum pathway score. Because the scoring of the soil exposure component is not being altered, this component would contribute the same score to the overall site score absent the addition of subsurface intrusion.
The structure of the HRS is fundamentally the same for all individual pathways, components, and/or threats. The design of the HRS reflects a conceptual understanding of how hazardous substance releases from CERCLA sites can result in risks to public health and welfare and the environment. The risk scenario at these sites is a function of:
• The probability of exposure to (or releases to a medium in a migration pathway of) hazardous substances,
• The expected magnitude and duration of the releases or exposures,
• The toxicity or other potential adverse effects to a receptor associated with a target from the releases,
• For the three migration pathways, the probability that the release will reach a target and the expected change in the concentration of hazardous substances during the movement from the location of the contamination to the targets. For the exposure pathway, the probability a receptor will be exposed at the target location,
• The expected dose to the receptor, and
• The expected number and type of the receptors.
The above considerations are addressed in three factor categories: Likelihood of exposure (or release), waste characteristics, and targets.
The following subsections describe the structure of the subsurface intrusion component and how this structure is consistent conceptually with the existing structure of the other HRS pathways and components: (1) New definitions, (2) delineation of areas of subsurface intrusion, (3) likelihood of exposure, (4) waste characteristics, (5) targets, and (6) calculating and incorporating the subsurface intrusion component score into the HRS site score.
EPA has added 15 new definitions to the HRS, section 1.1, along with updated nomenclature to existing definitions. EPA received no comments on the 14 proposed new definitions to the rule; therefore, EPA is finalizing the new definitions as proposed with the following change: The term surficial ground water has been changed to shallow ground water for clarity. In addition, EPA has added the term non-aqueous phase liquid (NAPL) to the definition section because EPA added consideration of NAPLs to the assignment of degradation factor values and the weighting of targets in the area of subsurface contamination (ASC).
EPA has included in the subsurface intrusion component evaluation two areas in which exposure due to subsurface intrusion contamination exists or is likely to exist: (1) Areas of observed exposure—areas in which contaminant intrusion into regularly occupied structures has been documented, and (2) areas of subsurface contamination—areas in which subsurface contamination underlying regularly occupied structures (such as in shallow ground water or soil vapor) has been documented, but at which either sampling of indoor air has not documented that subsurface contamination has entered a regularly occupied structure or no sampling of indoor air has been undertaken.
An area (or areas) of observed exposure at a site is identified based on the location of regularly occupied structures with a documented significant increase in hazardous substance concentrations above background levels resulting at least in part from subsurface intrusion attributable to the site being evaluated. The area encompassed by such structures constitutes the area of observed exposure (AOE). Other regularly occupied structures within this encompassed area (or areas) are also inferred to be in the AOE unless available information indicates otherwise.
An area (or areas) of subsurface contamination is identified as an area outside that of the AOE, at which subsurface contamination has been documented at levels meeting observed release criteria (contamination at levels significantly above background and the significant increase can be attributed at least in part to the site). The contamination would be present in subslab or semi-enclosed or enclosed crawl space samples or in a subsurface sample. (See section 2.3 of the HRS for observed exposure criteria.) In addition, EPA is limiting the delineation of an ASC to be based on the location of subsurface contamination meeting the criteria for observed exposure or observed release and has a vapor pressure greater than or equal to one torr or a Henry's constant greater than or equal to 10
A key factor considered in the HRS relative risk ranking is whether any exposure to a hazardous substance via subsurface intrusion has occurred, or if not, whether there is a probability that exposure could occur in a regularly occupied structure. This is termed the likelihood of exposure for the subsurface intrusion component.
For HRS purposes, an observed exposure is established if it can be documented that a hazardous substance from the site being evaluated has moved through the subsurface and has entered at least one regularly occupied structure.
When an observed exposure has not been established, the potential for exposure can be determined for any regularly occupied structure located in an ASC.
The evaluation of the potential for exposure for the subsurface intrusion component uses the same concept and framework used to estimate the potential to release in other pathways. This involves predicting the probability of exposure in an area of subsurface contamination based on structural containment features of the regularly occupied structure and a hazardous substance's physical and chemical properties and the physical subsurface properties that influence the probability that intrusion is occurring. These factor values include:
Consistent with potential to release determinations in the HRS, the potential for exposure for this component is calculated by summing depth to contamination, vertical migration and vapor migration potential factor values and multiplying the sum by the containment factor value to determine a potential for exposure factor value.
As in all HRS pathways and components, the likelihood of exposure factor category value is assigned based on the higher of the observed exposure (or release) value or the potential for exposure (or release) value. The maximum value assigned for the likelihood of exposure factor category is 550 and is assigned if observed exposure is documented. If observed exposure is not documented, the value assigned when evaluating potential for exposure ranges between 0 and 500.
The waste characteristics factor category is based on factors that are related to the relative risk considerations included in the basic HRS structure. The factors considered in determining the waste characteristics factor category value are the toxicity of the hazardous substances, the ability of the hazardous substance to degrade, and an estimate of the quantity of the hazardous substances to which occupants could be exposed.
The combined toxicity/degradation factor includes consideration of both the toxicity and the possibility for degradation of hazardous substances being evaluated for HRS purposes. The toxicity factor in the overall HRS structure reflects the toxicity of a hazardous substance associated with a source, release or exposure at a site, and is assigned the same factor value for all the pathways and components in the HRS. Any hazardous substance identified in an observed exposure within the AOE or meeting the observed release criteria in either the AOE or ASC will be assigned a toxicity factor value.
The degradation factor represents the possibility for a substance to degrade in the subsurface prior to intruding into a regularly occupied structure. The subsurface intrusion component evaluates degradation based on the substance being evaluated, the depth to contamination, and the presence of a NAPL. It also assumes the presence of biologically active soil unless information indicates otherwise. If it has been documented that a hazardous substance has been found to have entered a regularly occupied structure, regardless of the substance or the site conditions, the degradation value is assigned to reflect the likelihood that the substance is not significantly degrading in the subsurface. Additionally, any eligible hazardous substance present in the subsurface below an AOE or ASC as a NAPL at depth less than 30 feet is assigned a degradation value to reflect the likelihood that the substance will not significantly degrade in the subsurface environment.
The toxicity and degradation factors are multiplied together to assign a combined factor value. If multiple substances are present, the highest combined factor value is selected for use in determining the waste characteristics factor category value, as discussed below.
The waste quantity factor value for this component reflects only the amount of hazardous substances that people are exposed to, that is, the amount in regularly occupied structures. EPA has retained a four-tiered hierarchical approach consistent with the HRS as well as minimum waste quantity factors. The estimation of waste quantity for the subsurface intrusion component considers the regularly occupied structures located within the AOE and ASC. For sites at which the component waste quantity (the sum waste quantities for all regularly occupied structures in the AOE and ASC) is below 10, a minimum factor of 10 would apply, the same as in other pathways and components. The minimum waste quantity factors are included because of insufficient information at many sites to adequately estimate waste quantity with confidence.
As in all HRS pathways and components, the waste characteristics category value is the product of the waste characteristics factor values (
The targets factor is based upon estimates of the expected dose to each receptor associated with a target and the number and type of receptors present at each target. In assessing human risk, it is critical to understand the nature and extent of exposure to individuals, populations, and resources.
The soil exposure and subsurface intrusion pathway uses the same target categories used in the HRS soil exposure pathway, including exposed individual, resident populations, workers, and resources. However, unlike the HRS soil exposure pathway, workers are to be evaluated as exposed individuals and as part of the population within an area of subsurface contamination instead of being evaluated under a separate worker factor value.
In the SsI component, targets in the AOE are considered actually contaminated, whereas, those in the ASC are considered potentially contaminated. The targets in an AOE are further divided into Level I and II, based on whether the hazardous substance concentrations are at or above identified health-based benchmarks.
The targets within an ASC are categorized based on the type of sample (
The evaluation of exposed individuals in the SsI component includes individuals living, attending school or day care, or working in a regularly occupied structure. Individuals in the eligible target population are expected to be exposed to the highest concentration of the hazardous substance in question for a significant time.
The population factor for the SsI component includes all populations qualifying as exposed individuals, including residents, students, workers, and those attending day care. Workers are weighted slightly differently than other exposed individuals to reflect that a worker's exposure is limited to the time present in a workplace. The number of workers present in a structure or subunit is adjusted by an appropriate factor reflecting whether or not they are a full-time or part-time worker.
Consistent with the weighting of populations throughout the HRS, the subsurface intrusion component will weight targets in an AOE subject to Level I contaminant concentrations by a factor of 10 and weight targets subject to Level II contaminant concentrations by a factor of 1. Eligible populations include individuals living, working, and
Within the AOE, those populations in regularly occupied structures for which observed exposures have not been established but the structures are surrounded by regularly occupied structures in which observed exposures have been identified, are also considered as actually contaminated unless evidence indicates otherwise. Targets inferred to be exposed to this contamination will be weighted as Level II as there are no actual sample results to compare against benchmarks.
In the case of multi-story/multi-subunit structures, all regularly occupied subunits on a level with an observed exposure and all levels below are considered to be within an AOE, unless available information indicates otherwise. For multi-story/multi-subunit structures located within an AOE, but where an observed exposure has not been documented, only those regularly occupied spaces on the lowest level are considered to be within an AOE, unless available information indicates otherwise.
Due to the variability in subsurface intrusion rates, the potential weighting factor values for targets within an ASC range from 0.1 to 0.9 and depend on where the subsurface contamination has been found and whether a NAPL is present.
Potential targets are weighted to reflect the distance to or the depth at which contamination is found and whether a NAPL is present. The weighting factors applied to populations being evaluated based on the presence of subsurface contamination containing a NAPL reflects greater subsurface source concentrations and an increased probability that contaminant intrusion into a regularly occupied structure from the subsurface will result in a concentration significantly above background levels for the site. In the case of multi-story/multi-subunit structures, all regularly occupied subunits on a level above one where an observed exposure has been documented or inferred, or where a gaseous indoor air sample meeting observed release criteria is present, are considered to be located within an ASC, unless available information indicates otherwise. For multi-story/multi-subunit structures located only within an ASC, only those regularly occupied subunits within the lowest level are considered in an HRS evaluation.
Eligible populations in an ASC include individuals living in, attending school or day care, and working in regularly occupied structures. However, the number of workers is adjusted to reflect that their exposure is limited to the time they are in a workplace.
Resources for this component include regularly occupied structures that are located within a defined AOE or ASC and in which populations may be exposed to contamination due to subsurface intrusion. Libraries, recreational facilities, and religious or tribal structures used by individuals may qualify as eligible resources.
The Target Factor Category Value is the sum of all the Target Factor values.
The following subsections summarize the calculation of the subsurface intrusion component score, how the component score is used in the calculation of the soil exposure and subsurface intrusion pathway score, and how, in turn, the pathway score is subsequently incorporated into the HRS site score.
The SsI Component score is the product of the likelihood of exposure factor category value, the waste characteristics factor category value, and the targets factor category value; that value is divided by a weighting factor so that it has equal magnitude to other component scores (subject to a maximum value).
The Soil Exposure and Subsurface Intrusion pathway score is a combination of the two component scores.
EPA did not change the methodology used to assign an overall site score due to the addition of the subsurface intrusion component to the soil exposure pathway and renaming that pathway the soil exposure and subsurface intrusion pathway. The overall site score remains a function of four pathway scores and the same weighting is given to each pathway score as in the 1990 HRS.
The SsI component was tested extensively throughout the development of this rule, using multiple methods. The main goals of testing the component included:
• Ensuring the addition of the SsI component to the soil exposure pathway did not change relative contribution to the site score as the other HRS pathways and maintained the same relative risk of a site with a similar threshold for qualifying for the NPL.
• Ensuring the number of targets subject to actual contamination needed to achieve a site score sufficient for NPL proposal remained consistent across pathways.
• Ensuring that applying the SsI component as part of an HRS evaluation would not result in identification of sites with a low level of risk or would not identify sites with a high level of risk.
These goals were met by using conceptual simulations to project the effectiveness and appropriateness for factor values, by developing and testing numerous example site scenarios to refine the model and by applying the model to test sites to determine its efficacy. The following information provides details on the approaches used to test the SsI component.
Sensitivity analyses were performed during development of the rule to test the SsI component and identify and assign the relative magnitude of the factors having the greatest impact on the HRS site score. The analyses illustrated the types of sites that would qualify for the NPL considering subsurface intrusion contamination, and sites that would qualify for the NPL considering the contribution of subsurface intrusion contamination to other pathways. The scenarios illustrate different site characteristics and different factor value weightings. An initial conceptual site scenario evaluation was developed with varying likelihood of intrusion levels, zone of contamination, waste characteristics and levels of contamination. The conceptual site scenario evaluation was varied to reflect possible ranges in the factors considered in the HRS evaluation.
The first phase of testing estimated site scores based on options considered
To support the final rulemaking, EPA conducted a screening-level assessment of sites with identified subsurface intrusion threats. As a first step in collecting the list of sites potentially affected by the final rule, EPA consulted with site assessment experts that work in Superfund to identify potential site candidates. EPA also reached out to state counterparts, in particular to state programs that were known to have taken a more thorough investigation of the subsurface intrusion pathway at sites. Through this process, EPA identified approximately 1,073 sites. These sites are not currently on the NPL, and all have a potential or identified SsI threat. Within the group of sites potentially affected by the HRS SsI Addition, EPA defined four categories:
1. Tier 4: Sites identified as having a suspected SsI threat based on EPA's Superfund database and Agency for Toxic Substances and Disease Registry keyword searches, as well as EPA or state self-identification, but for which no sampling data were obtained;
2. Tier 3: Sites identified as having characteristics or evidence that indicate SsI may have occurred or will occur;
3. Tier 2: Sites identified as having an SsI threat documented by subslab, crawl space, or indoor air samples, but insufficient HRS-required evaluation factors to qualify for the NPL; and
4. Tier 1: Sites identified as having an SsI threat with documented actual exposure of a sufficient number of targets with enough other HRS-required evaluation factors to suggest the site may qualify for the NPL.
EPA selected the Tier 1 sites for use in testing the SsI component evaluation process. The 11 Test Sites had documentation of indoor contamination due to subsurface intrusion based on actual sampling data and other typically HRS-required data. Of the 11 sites scored, 9 were projected to score 28.50 or higher using only the SsI component. 1 site was projected to score 28.50 or higher only by including both the scores from the SsI component evaluation and the ground water migration pathway evaluation in the site score. It was unknown whether these sites would qualify for the NPL when they were chosen as Test Sites, as the SsI scoring process had not been developed. The Test Site with a projected score below 28.50 did not qualify for the NPL even though the site was located in a mixed-used residential and industrial area, illustrating that not all sites in an urban area will qualify for the NPL.
That 10 of the 11 Test Sites have a projected HRS site score of 28.50 or greater using the SsI component is not an indication that the addition of the SsI component will result in a large number of SsI sites qualifying for the NPL; this would be a possible projection if the Test Sites were chosen randomly so as to represent a typical SsI site. The Test Sites were not randomly chosen, but instead were specifically chosen because they have a documented subsurface intrusion threats at the sites and sufficient available data to test all parts of the SsI component. The Test Sites all had areas of observed exposure; most had more than 38 structures at the site (some with hundreds of structures), and all but two Test Sites had at least 50 targets (more than half had over 100 targets). Each site was also associated with volatile hazardous substances that are considered hazardous to human health at low concentrations. Appendix B of the Technical Support Document (TSD) for this final rulemaking provides a summary of these scoring evaluations.
The main purpose of the Pilot Study was to identify sites currently being evaluated for SsI by the EPA regions with a suspected subsurface intrusion threat and determine whether an SI would provide enough information to score a site under the new component. Additional goals of the Pilot Study were to gather data and determine if design of the SsI model is practical and gives expected results; identify a range for the cost of a projected SsI site assessment; and assist in developing future guidelines for SsI assessments. A total of 10 sites were identified across 5 of the 10 EPA Regions. The pilot studies were not intended to identify sites for placement on the NPL, and not all sites considered for the pilot studies achieved an HRS score greater than (or equal to) 28.50. However, collecting actual data for the purposes of generating an SsI component score, ensured the HRS was considering subsurface intrusion threats appropriately. Ultimately, the pilot studies were used to proof the concept and validate the SsI component in terms of the application of selected weighting factor values and the efficacy for accurately identifying sites with significant relative risk.
Comments on the Proposed Rule were received from 15 organizations/individuals. The commenters included state and federal agencies, industry associations, community groups, consultants, and private citizens. No major conceptual or structural changes were necessary based on comments received during the public comment period. While many of the comments focused on the structure of the SsI component, there was not sufficient rationale for making major changes to the basic structure of the SsI component. There were minor revisions made based on comments, which help refine the mechanics of assigning an HRS site score. As a result, the SsI component better reflects current science and better aligns with underlying concepts in the
Section 5.2 was revised to clarify that areas of subsurface contamination are only delineated based on the presence of hazardous substances meeting the criteria for observed exposure or observed release and have a vapor pressure greater than or equal to one torr or a Henry's constant greater than or equal to 10
Table 5-21, Weighting Factor Values for Populations within an Area of Subsurface Contamination, of the HRS was revised to include consideration of the presence of NAPLs identified in an area of subsurface contamination. These additions increase the weighting of the population in an area of subsurface contamination to the SsI component score. These revisions were in response to comments that the proposed addition did not reflect the magnitude of contaminant concentrations in the evaluation of targets in the area of subsurface contamination. While EPA considers it unlikely that the actual aerial distribution and magnitude of contaminant concentrations can be determined in an area of observed contamination during a site inspection, if NAPLs are identified as present, EPA agrees that there is a greater risk to receptors than if no NAPL is present.
Section 5.2.1.2.1.2 of the HRS was revised to make it easier for the reader to determine degradation factor values and to add consideration of the presence of NAPLs. Commenters asserted that the text was difficult to follow and that the presence of NAPLs was a major factor in the impact of degradation. A new table, Table 5-18 of the HRS, simplifying the assignment of degradation factor values based on the depth to contamination and a substance's half-life was inserted to replace proposed text. Additionally, if no half-life information is available for a hazardous substance and the substance is not already assigned a degradation factor value of 1, a value of 1 will be assigned. This modification further simplifies the degradation evaluation and is also protective of human health, for if no half-life information is available for a hazardous substance, EPA cannot assume that degradation will occur. In addition, parent-daughter relationships between substances are no longer considered in the assignment of the degradation factor value, in part to simplify the assignment and in part to reflect the variation in rates of degradation due to site-specific subsurface conditions. Even if degradation occurs, if a contaminant is at high enough concentration to exist as a NAPL at depths less than or equal to 30 feet, it is more likely to pose a threat to populations in overlying structure.
Section 5.2.1.1.2.1 and Table 5-12 of the HRS were revised in response to comments on the rationale for assigning containment values to individual structures. The assignment of a structure containment factor value assigned to structures in Table 5-12 with vapor mitigation systems or other response actions was revised. These revisions were made in response to a comment questioning why response actions taken by federal, state, and tribal authorities are treated differently than those taken by private entities in determining containment for a structure. The language regarding treatment of removals by federal, state, and tribal authorities has been removed from Table 5-12 and the corresponding containment value was assigned a 1. This change allows a consideration of public and private removal actions to be evaluated in a consistent manner.
Section 5.2.1.1.2.1 and Table 5-12 of the HRS was also revised to remove from the table the direction of the assignment of a structure containment value for a regularly occupied structure with unknown containment features. This direction, which assigns a value of “greater than zero” to this situation, was moved to the text in section 5.2.1.1.2.1 of the HRS. This revision was made in response to a comment questioning the rationale for the various containment values and was made to improve the continuity of the table, which directs the assignment of values when containment features of the structure are known. A structure with a containment factor value of greater than zero cannot be used in assigning a potential for exposure factor value. EPA considers it appropriate that the potential for exposure factor value should be based on actual field observations. However a structure with a structure containment value of greater than zero allows the structure to be evaluated for assigning waste characteristics values (
Table 5-14 of the HRS was revised to allow assignment of an effective porosity/permeability factor value based on site-specific measurements of hydraulic conductivity, if known. This addition was made in response to a comment suggesting the rule be modified to allow use of site-specific information for this purpose when available.
The term surficial ground water was re-named shallow ground water and was changed to be consistent with current EPA usage.
EPA has added the term non-aqueous phase liquid (NAPL) to the definition section. EPA added consideration of the identification of concentrations of hazardous substances high enough to indicate the presence of NAPLs in the subsurface during a site inspection to the assignment of degradation factor values and the weighting of targets in the ASC. The presence of NAPLs in the subsurface demonstrates the hazardous substances will be present at high concentrations for a significant time period at that location and the high concentration is not a transient situation.
a. The addition of a subsurface intrusion component is added to the 1990 Soil Exposure pathway as section 5.2 in Chapter 5 of the 2016 Revised HRS. The new pathway name is the soil exposure and subsurface intrusion pathway. The existing method for evaluating the soil exposure threat will remain unchanged.
b. Chapter 2: Evaluations Common to All Pathways is updated to reflect the
c. Chapter 7: Sites Containing Radioactive Substances is updated to reflect how radioactive substances are evaluated using the added subsurface intrusion component.
The following terms are updated to reflect current terminology and procedures used by EPA in performing risk assessments.
a. Ambient Water Quality Criteria: Ambient Water Quality Criteria (AWQC) are now identified also as National Recommended Water Quality Criteria (NRWQC). In addition, the acute AWQC are now identified as the Criterion Maximum Concentration (CMC) and the chronic criteria are referred to as the Criterion Continuous Concentration (CCC). (See section 1.1 of the HRS.) These criteria are used to determine the level of threat to environmental targets.
b. Reference Concentrations: For inhalation exposures, EPA is adopting the use of Reference Concentrations (RfCs) instead of Reference Doses (RfDs) when determining non-cancer-related risk levels. RfCs are used in determining the level of threat to human targets due to possible inhalation and when determining the toxicity of the substances.
c. Cancer Unit Risk: For inhalation exposures, EPA is adopting the use of Inhalation Unit Risk (IUR) instead of cancer slope factors in determining cancer-related risk levels. IURs are used in determining the level of threat to human targets due to possible inhalation and when determining the toxicity of the substances.
d. Weight-of-Evidence Groupings: The 2005 EPA weight-of-evidence groupings supporting the designation of a substance as a human carcinogen have been incorporated into the HRS algorithm for assigning the toxicity factor value. (The former EPA weight-of-evidence categories included as part of the 1990 HRS have been retained as EPA has not yet completed assigning all substances to the revised categories and are doing so at the time the EPA substance literature reviews are updated.)
Comments on the Proposed Rule were received from 15 organizations/individuals. The commenters included state and federal agencies, industry associations, community groups, consultants, and private citizens. This section discusses the major issues raised by commenters, which are summarized, and EPA's summary of responses. In addition, EPA solicited and received input from commenters on three technical questions posed in the Preamble to the Proposed Rule.
A support document, Response to Comments on the 2016 Revisions to the Hazard Ranking System (HRS), that includes all issues raised during the public comment period, comments received on the questions posed in the preamble to the proposed rule and EPA's more comprehensive response to each issue, is available in the docket for this rulemaking.
Question 1: Is there a way to determine the presence and extent of biologically active soil at a site during a limited site investigation? If so, what soil characteristics should EPA consider to determine whether biologically active soil is documented to be present?
EPA received multiple comments in response to this question. One commenter suggested that this activity is beyond the scope of the site assessment process, while another commenter suggested that EPA consider measuring specific compounds or other factors reflecting biological activity when conducting soil vapor analysis. A third commenter remarked that half-lives faster than 100 days are presumably due to aerobic biodegradation and that most vadose zone soils that are not grossly impacted are considered biologically active. A commenter also suggested using soil characteristics reflected in soil surveys to reflect the possibility that biologically active soil could be present. No commenter suggested practical methods to determine site-specific biological activity throughout a site or over time.
The HRS SsI addition was revised to clarify the assumption of the presence of biologically soil in evaluating the degradation factor unless evidence indicates otherwise (see section 5.2.1.2.1.2 of the HRS).
Question 2: How could EPA further take into account the difference in dilution and air exchange rates in large industrial buildings as compared to smaller residential and commercial structures when calculating the hazardous waste quantity for the HRS SsI Addition?
EPA received multiple comments in response to this question. One commenter suggested developing intrusion screening values based on exposure scenarios for “most sensitive individual” and “industrial” models. One commenter indicated that there is not a dependable way to account for the differences between large commercial/industrial structures and smaller residential/commercial structures. Another commenter noted that there are several parameters (
EPA did not make any changes to the final rule based on the comments received as the type of information requested in these responses is generally not available during a typical site inspection. The HRS has also been designed so that it can be applied consistently to a wide variety of sites. The HRS is not a tool for conducting quantitative risk assessment and was designed to be a measure of relative risk among sites rather than absolute site-specific risk.
Question 3: The HRS SsI addition considers source strength in delineating ASCs and AOEs, in scoring in likelihood of exposure, in assigning waste quantity specifically when estimating hazardous constituent quantity and in weighting targets in an ASC. The HRS algorithm for all pathways incorporates the consideration of source strength in determining an HRS site score. Could EPA further take into account source strength in performing an HRS evaluation?
EPA received multiple comments in response to this question. One commenter suggested that EPA assign a higher score when the contaminant concentration is high (
The assignment of a degradation factor value (see section 5.2.1.2.1.2 of the HRS) and the weighting factors for targets in an area of subsurface contamination (see Table 5-21 of the HRS) were revised to include consideration of source strength; specifically in the situation where NAPLs are present.
EPA received comments suggesting that sufficient justification or rationale for the need to revise the HRS has not been provided and that a revision to the HRS is unnecessary because the 1990 HRS adequately evaluates the relative risk posed by a site and identifies those priority sites for further investigation.
The rationale for revising the HRS to add a subsurface intrusion component is EPA's statutory authority. Specifically, CERCLA 105(a)(8)(A), requires EPA to amend the HRS “to assure to the maximum extent feasible, that the HRS accurately assess the relative degree of risk to human health and the environment posed by sites and facilities subject to review.” Contamination due to subsurface intrusion is a known risk to human health and the ability to evaluate those risks is consistent with the CERCLA 105 mandate. The 1990 HRS did not evaluate the risk posed by subsurface intrusion when evaluating sites for the NPL. As part of the development of this rule, EPA identified high priority sites with significant contamination due to SsI that could not be evaluated using the 1990 HRS for possible placement on the NPL. With the addition of the SsI component to the HRS, sites can now be evaluated more comprehensively to consider the relative risk posed by a site.
EPA received comments suggesting that the proposed HRS SsI addition conflicts with CERCLA's statutory mandate regarding prioritizing drinking water sites.
The revision to the HRS to add a subsurface intrusion component is not in conflict with the CERCLA 105 mandate to prioritize drinking water sites. The priority given by EPA under CERCLA to sites with a high risk of populations exposed to hazardous substances in drinking water has not decreased with the addition of a subsurface intrusion component to the HRS. In fact, the score for some sites with contaminated drinking water supplies may increase because sites with contaminated drinking water may also be associated with subsurface intrusion contamination and the combination of the ground water migration pathway score and the SsI component score may increase the overall site score. Furthermore, EPA notes that drinking water is a priority identified by CERCLA, but it is not the only priority identified in CERCLA 105, which also mandates the prioritization of dangers of direct human contact, for which SsI is one example.
The addition of the SsI component does not change the priority given to drinking water sites. It does not change the scoring of contaminated drinking water supplies under the HRS, reduce in anyway the overall HRS score for any site based on drinking water contamination (or any other threat due to exposure to released hazardous substances in the HRS), or change the site score of 28.50 being the HRS score that qualifies sites for placement on the NPL. If a site qualifies for placement on the NPL based on its HRS score reflecting drinking water contamination prior to the addition of the SsI component, it will continue to do so. Adding an evaluation of the SsI component can only increase an overall site score. The algorithm used to combine pathways scores to obtain an overall site score results in an increase in the overall site score with the evaluation of additional pathways, components and threats scored. In fact, the SsI addition may raise the overall site score at some sites with ground water drinking water contamination from below the 28.50 cut-off score to above it. This may occur because, as stated above, a site's HRS score can increase with the scoring of additional threats. Sites with ground water contaminated by volatile substances and used for drinking water are also sites at which the ground water contamination may volatilize and intrude into overlying regularly occupied structures. Thus, a site at which ground water contamination has occurred but does not have an HRS score above 28.50 based only on the ground water threat, may have an overall HRS site score above 28.50 based on the combination of the scores for the contaminated drinking water and SsI threats.
Furthermore, EPA notes that CERCLA 118 refers to CERCLA sections104 and 108, which address activities that occur pre- or post-NPL-listing, and not to the section of CERCLA that addresses site ranking using the HRS, which is addressed in CERCLA section 105. CERCLA Section 105 and specifically 105(a)(8)(A) requires EPA to prioritize sites based on “the population at risk, the hazard potential of hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact [and] the potential for destruction of sensitive ecosystems.” Since subsurface intrusion contamination is a direct human contact threat, the addition of a subsurface intrusion component, which addresses this threat, is mandated by CERCLA.
EPA received comments suggesting that contrary to EPA's suggestion that the HRS SsI addition may not result in more site assessments per year and only minimal cost increases, commenters claimed that there will be substantial increases in cost and level of effort for states and federal agencies, due to the complexity in assessing subsurface intrusion sites.
EPA acknowledges that in some cases the scope of a typical site inspection (SI) may need to be expanded to collect the information necessary to evaluate the SsI threat present at a site. EPA also acknowledges that sites that did not qualify previously for the NPL, may now do so. The number of samples and level of effort required to evaluate a site using the 1990 HRS pathways or components already varies on a site-by-site basis depending on the size and extent of contamination at the site. Therefore, it cannot be predicted with certainty that there will be an overall increase in cost or level of effort for any particular site due to the HRS SsI addition. However, the overall budget for performing site assessments per year is not expected to change significantly. EPA's budget for site assessment is dependent on Congressional appropriation and EPA does not expect the rulemaking to impact the appropriation. EPA's budget for site assessment has remained relatively constant for the last several years. Hence, EPA expects that the allocation of available resources may be changed to reflect this rulemaking but will continue to be optimized by EPA, its state and tribal partners, and with other federal agencies to evaluate priority sites. However, the number of site assessments or NPL proposals conducted each year will not significantly increase.
EPA received comments stating that the type and amount of information available for collection during a time-limited site inspection would be insufficient to properly evaluate a site using the HRS SsI addition and would be beyond the scope of site evaluations typically conducted at the preliminary assessment or site inspection stage.
During development of the HRS SsI addition EPA considered the type of information that could be collected during a time-limited site inspection when selecting the factors to include in an evaluation of the subsurface intrusion component. The purpose of the site inspection (NCP 300.420(c)) is to determine if a release of a hazardous substance poses an actual or potential threat to human health or the environment, to determine if there is an immediate threat to people or the environment, and to collect sufficient data to enable the site to be scored using the HRS. EPA also notes that neither the NCP nor the HRS requires a certain number of samples be collected during an SI, because the number of samples required to evaluate a site varies on a site-by-site basis and the possible risk pathways being evaluated. However, to properly evaluate the subsurface intrusion component, additional information may be required beyond that collected during a typical current site inspection may be required; this is consistent with the need to collect data on the threat posed by a different pathway. In these instances, as stated in EPA's Guidance for Performing Site Inspections under CERCLA (September 1992), an expanded site inspection (ESI) may be required. The objective of the ESI is to collect data that was not collected during an initial site inspection. Furthermore, EPA found that information required for an SsI evaluation was available based on a pilot study which included several candidate NPL sites. The pilot study was performed in part to demonstrate the availability of the necessary data from screening level investigations. Therefore, EPA considers that the information required to properly evaluate the subsurface intrusion component can be obtained during the site assessment process.
EPA received comments questioning or requesting additional information or guidance regarding the type and amount of data to collect, data collection methods, and how to apply the subsurface intrusion component to a site. Commenters also suggested it was difficult to properly evaluate and comment on the proposed HRS SsI addition without a thorough understanding of how the SsI component would be implemented and that promulgation should be delayed until guidance is developed.
The HRS does not provide prescriptive methods for performing site investigations for any HRS pathway evaluation because the methods used during the collection and analysis of environmental samples depend on site conditions and could not be written to cover all possible situations and could also become outdated in the future. Additionally, it is outside the scope of the HRS to identify and describe methods for conducting a subsurface intrusion screening for HRS purposes. The sampling and data collection information in the EPA OSWER VI Guide, (particularly in section 6 of the guide) are an appropriate resource for gathering data for HRS purposes. For example, Section 6.4 of the guide identifies basic principles, methods and procedures for indoor air sampling. In addition, states, federal agencies, and private contractors have considerable experience in VI investigations and collecting VI-related data. Guidance on implementation of the proposed SsI addition is not necessary for evaluating the SsI component, which is a scoring mechanism not procedures for data collection. Any guidance developed will provide details on collecting data to support an HRS SsI evaluation. EPA also notes that to delay addressing sites that may pose a significant human health risk until all necessary guidance documents have been developed would not be consistent with EPA's mandate to protect human health. Therefore, EPA does not agree that promulgation of the HRS SsI addition needs to be delayed until guidance documents related to its implementation have been developed.
EPA received comments suggesting that the HRS SsI addition is not consistent with the VI Guide, published in June 2015 and will create confusion when evaluating sites for SsI.
The VI Guide and HRS SsI rule work in concert to establish national consistency in the evaluation of SsI threats. The HRS SsI addition and the OSWER VI Guide both address the threat posed by vapor intrusion and use the same principles, sampling procedures and concepts to characterize the threat posed by vapor intrusion as the sites. However, the HRS SsI addition and the OSWER VI Guide serve different purposes and support different phases of EPA's site remediation process with different data quality requirements and different enabling legislations.
The purpose of the OSWER VI Guide is to guide the investigation and assessment of the threat posed by vapor intrusion into structures from all sources under all Office of Land and Emergency Management (OLEM, formerly OSWER) programs, particularly actions taken under CERCLA and RCRA. This guidance is used to support decisions by EPA on whether vapor intrusion is posing an unacceptable risk to human health based on sufficient site specific data. It contains principles for making such a decision, as well as procedures and guidance for collecting the information necessary to make these decisions.
The HRS and the SsI addition is part of the NCP, (the regulations implementing CERCLA) required by CERCLA to identify priority sites for further investigation based on screening level information (Such sites are identified for the public by placing the sites on the NPL, a separate rulemaking process). This prioritization is based on the possible cumulative relative risk amongst all candidate sites posed by releases of hazardous substances to human health and the environment by either migration to receptors or by direct contact with the contamination, such as by subsurface intrusion. The HRS is only a method for assigning a relative score to candidate sites. It is not a method for determining site specific risk. The HRS SsI addition is not guidance. The HRS SsI addition does not address such subjects as data collection and sampling procedures: Many of the procedures and many of the guidelines in the OSWER VI Guide are also applicable for HRS purposes if they can be implemented as part of a screening level assessment.
Given that the purposes for the two documents are considerably different and based on different levels of information, it is not an issue that decision criteria are different in the two documents. It is certainly possible that, based on an HRS evaluation, EPA may determine a site warrants further investigation, and that after further investigation is performed EPA may decide no remediation is necessary. However until further information is collected during a remedial investigation, such an outcome cannot be predicted. Furthermore, such a situation is not an indication the results of the HRS evaluation was incorrect.
EPA received comments suggesting that by inferring contamination between sampling locations, the extent of the risk is overstated. The commenters considered identifying targets as actually or potentially exposed based on inference to inflate the HRS site score. It was also suggested that this method conflicts with the other HRS pathways.
The HRS is not a quantitative risk assessment. Instead, the HRS SsI addition score reflects the possible threat posed by subsurface intrusion at one site relative to other sites. By inferring contamination in an AOE or an ASC between sampling locations, it is not assumed that all populations within the two areas are exposed to contamination from the subsurface. Inferring contamination also allows sites with large populations within the two areas to be ranked higher than sites with smaller populations. If the HRS scoring required sampling every structure a sufficient number of times to assure that all exposed targets were accounted for, the scope of the sampling effort would be beyond that of a screening tool and more consistent with the scope of a remedial investigation.
Inference of contamination between sampling locations is also assumed in other HRS pathways. The other pathways allow the inference of contamination based on the location of samples documenting the presence of contamination attributable to the site being investigated. For example, in the soil exposure component, inference of contamination is done by drawing AOC boundaries based on sample locations and inferring that those targets associated with the properties within the boundaries are actually exposed.
In the SsI component, unless site-specific information indicates otherwise, when delineating an AOE or an ASC, populations in occupied structures within an AOE are inferred to be actually exposed, and, populations in occupied structures within an ASC are inferred to likely be exposed to contamination.
Commenters noted that as explained in the TSD for the proposed HRS SsI Addition, the hazardous waste quantity factor serves as a surrogate for the contaminant dose that populations may be exposed to. Commenters asserted that the hazardous waste quantity factor is not adequately reflective of this dose to be used as a surrogate.
The commenters appear to be confusing consideration of waste quantity as a surrogate for dose in an HRS evaluation with the calculation of a site-specific risk level based on the ratio of waste quantity to receptors. EPA is not projecting a specific risk level based on the waste quantity alone when it performs an HRS evaluation. Other HRS factors such as the population associated with the structures, the probability of a release into the occupied structures, the possibility of degradation, and the toxicity of the substances are also considered,
The decision to include waste quantity as a surrogate for dose in all pathways and components in the HRS algorithm was made when the HRS was last revised in 1990 (see Section V.3 of the proposed 1988 HRS, 53 FR 51692, December 23, 1988; Section III.C of the 1990 HRS, 55 FR 51542, December 14, 1990). The decision was based on the concept that determining an accurate dose that receptors would be exposed to was beyond the scope of information available after a site inspection. It is not possible to accurately predict the hazardous substance concentration that receptors would be exposed to over a representative exposure period based on information collected during a site inspection due to the variability in exposure levels over time and space. Instead, hazardous waste quantity is used as a surrogate for dose in the sense that the quantity of the hazardous substances is at least qualitatively correlated to the magnitude of the exposure. If there is no waste quantity, there will be no exposure; as the waste quantity increases, the greater the possibility of exposure to hazardous substances that a receptor may come in contact with. EPA agrees this is not a perfect correlation, and has built into the HRS four order of magnitude ranges for assigning factor values that reflect the imperfection of this correlation.
In addition, the inclusion of hazardous waste quantity in the subsurface intrusion component is consistent with its inclusion in all the other existing HRS pathway evaluations and is consistent with the goal that the scoring of the new component not impact the balance built into overall HRS site scoring algorithm among the HRS pathways.
Furthermore, for determining waste quantity for the SsI component, EPA made a specific alteration to how waste quantity is calculated as compared to other HRS pathway. EPA decided to only include the amount of hazardous substance that actually enters into or that could enter into occupied structures, not the total amount in the release to the environment, based on the rationale that at least some of the original release in the subsurface would vent directly to the atmosphere. Therefore only the amount of hazardous substances that has entered into occupied structures or the amount located under structures is reflected in the estimate. This was achieved by not estimating the waste quantity based on the area or the volume of the contaminated media in the subsurface, but instead on the volume of the structures, or the basal area if the volume cannot be determined.
Finally, no comments were received that provided a viable alternative to the proposed method of estimating hazardous waste quantity. Commenters stated the amount of exposure was overestimated for large buildings because in general larger buildings have lower air exchange rates and suggested that this consideration be built into the estimation methods for all structures. However, the commenters did not present data to document this generality nor suggest how to determine the air exchange rate for all structures if it is not provided by the building owner. EPA notes that if air exchange rates are available, the present estimation method (which has not changed since proposal) allows for a hazardous waste quantity estimate using that information (see, HRS section 5.2.1.2.2 Tier B, hazardous wastestream quantity).
While some commenters suggested procedures for determining a more accurate hazardous waste quantity for specific situations they did not suggest how the hazardous waste quantity calculated for these situations could be relatively ranked against sites where equivalent information was not available. When developing a hazardous waste quantity factor in 1988, EPA performed studies that showed this level of information was not available at all sites, and was not likely to be collectible during a limited screening assessment. Therefore, EPA considers it inappropriate to incorporate the suggested procedures into the HRS.
In addition, EPA proposed the present hazardous waste quantity estimation process as part of the revision of the HRS in 1988. At that time EPA requested the Science Advisory Board's (SAB's) assistance on the use of concentration data in determining the hazardous waste quantity factor as part of the overall SAB peer review of the HRS changes. The current method for use of concentration data in determining the hazardous waste quantity factor is based on the SAB's recommendation.
Commenters noted that establishing that indoor air contamination is
The HRS SsI addition, just as in other HRS pathways and components, does not require absolute proof that the significant increase in indoor contaminant concentrations is due to subsurface intrusion. It only requires at least part of the significant increase be attributable to subsurface intrusion. EPA expects to use multiple lines-of-evidence in meeting the attribution requirement as discussed in various comments. The VI Guide outlines use of multiple lines-of-evidence and provides guidance on how to distinguish subsurface intrusion from other sources of vapor intrusion. As is done for other HRS pathways and components, the HRS standard for establishing attribution is to establish a reasoned explanation that is not shown to be incorrect during public review of placement of a proposed site on the NPL.
EPA received comments suggesting that the criteria for establishing background for the SsI component is too complex given the variability in sampling for SsI and that a significant difference between the background level and release concentration is not an adequate measure for establishing an observed exposure in a regularly occupied structure.
EPA agrees that establishing a background level for indoor air can be difficult. However, it does not mean that the HRS criteria for establishing actual exposure should not be used. Methods for establishing background levels are too site-specific to be discussed in the HRS regulation, which is a scoring methodology. Instead, as occurred after the 1990 HRS was promulgated, criteria for establishing background was refined based on actual experience gained as sites were being scored. EPA expects the same to occur for the HRS SsI component.
Comparison of background levels and indoor air concentrations are used only to establish that the contaminant level in a structure is elevated (
The argument that vapor intrusion rates are too variable to justify the use of the same procedure for establishing observed releases or exposures as in other parts of the HRS is invalid. Hazardous substance concentrations are unpredictably variable temporally and spatially for all HRS pathways and SsI variability is no different in that regard. For example, in the surface water migration pathway overland flow threat, the hazardous substance may only be entering surface water via runoff due to rain events. No runoff occurs if it is not raining. The amount entering surface water in this situation has been shown to vary with the length of time between rains, which impacts the amount of material deposited and available for entrainment into the runoff. Runoff also varies with the portion of each rain cycle whether the sample is collected at the beginning, middle or end of a rain event. At the beginning of a rain event all erodible materials are present and available. During the middle or during a high intensity period of rain, the force of the rain drops can dislodge and entrain hazardous substances at greater rates that during low intensity periods. At the end of a rain event, it may be that much of the hazardous substances have already been washed away. In continuous air releases, the contaminant concentration can vary by order of magnitudes with distance from the source, with wind direction and wind speed all of which can cause differences in concentrations spatially due to the three dimensionality of the atmosphere, and cannot be predicted or accounted for based on a screening assessment. Even in ground water contamination, the contaminant plume's concentration can vary spatially depending on the rate of ground water movement from the original spill concentrations. It is not possible to account for these factors that can drastically impact the contaminant concentration at a sampling location, based on screening level information.
For example, variation in the occurrence of releases is no greater in the SsI component than would be expected in point-source air releases or spills to surface water.
Commenters suggested changes in how the degradation factor value for the subsurface intrusion component is assigned. Other comments dealt with conditions associated with assigning different degradation factor values based on the depth of biologically active soil and the half-lives of individual hazardous substances. In addition, commenters suggested moving the consideration of degradation from the waste characteristics factor category value calculations to the likelihood of exposure factor category value calculations.
After evaluation of the comments, EPA modified the assignment of the degradation factor to simplify the evaluation and to consider the presence of non-aqueous phase liquids (NAPLs); other changes suggested by commenters were not implemented. Some changes were not made because a sufficient rationale was not provided to justify a change. Regarding the placement of the degradation factor in the HRS equation, the consideration of an individual substance's characteristics in the waste characteristics factor category is consistent with other HRS pathways and components. Furthermore, whether the degradation factor is put in the likelihood of release or waste characteristic factor category, the impact of the factor on the score would be similar.
EPA received comments on the weightings assigned to targets in both the AOE and ASC. Commenters suggested that the weightings reflect the strength of the attribution argument that the significant increase in indoor air concentrations is due to subsurface intrusion and also reflect the concentration of the contaminants in the subsurface.
After consideration of these comments, EPA has changed the weightings of targets in the ASC to reflect the presence of NAPLs (
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. This action may raise novel
EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis, Addition of a Subsurface Intrusion (SsI) Component to the Hazard Ranking System (HRS): Regulatory Impact Analysis is available in the docket for this action.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2050-0095.
This regulatory change will only affect how EPA and organizations performing work on behalf of EPA (state or tribal partners) conduct site assessments and HRS scoring at sites where certain environmental conditions exist. This regulatory change will result in data collection at these types of sites to allow evaluation under the HRS. EPA expects that the total number of site assessments performed and the number of sites added to the NPL per year will not increase, but rather expects that there will be a realignment and reprioritization of its internal resources and state cooperative agreement funding.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This regulatory change enables the HRS evaluation to directly consider human exposure to hazardous substances that enter building structures through subsurface intrusion. This addition to the HRS would not impose direct impacts on any other entities. For additional discussion on this subject, see section 4.9 of the Regulatory Impact Analysis (see the docket for this action).
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects 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.
This action does not have tribal implications, as specified in Executive Order 13175. EPA's evaluation of a site using the HRS does not impose any costs on a tribe (except those already in a cooperative agreement relationship with EPA). Thus, Executive Order 13175 does not apply to this action.
Although Executive Order 13175 does not apply to this action, EPA consulted with tribal officials through meetings and correspondence, including a letter sent to all federally recognized tribes asking for comment on the “Notice of Opportunity for Public Input” that was published in the
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The site assessment activities affected by this rule are limited in scope and number and rely on existing energy distribution systems. Further, we have concluded that this rule would not significantly expand the energy demand for site assessments, and would not require an entity to conduct any action that would require significant energy use, that would significantly affect energy supply, distribution, or usage. Thus, Executive Order 13211 does not apply to this action.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on, low-income or indigenous populations. The results of this evaluation are contained in section 4.3 (and all subsections) of the Regulatory Impact Analysis for this rulemaking. A copy of the Addition of a Subsurface Intrusion (SsI) Component to the Hazard Ranking System (HRS): Regulatory Impact Analysis is available in the docket for this action.
Executive Order 12580, section 1(d), states that revisions to the NCP shall be made in consultation with members of the National Response Team (NRT) prior to publication for notice and comment. Revisions shall also be made in consultation with the Director of the Federal Emergency Management Agency (FEMA) and the Nuclear Regulatory Commission (NRC) to avoid inconsistent or duplicative requirements in the emergency planning responsibilities of those agencies. Executive Order 12580 delegates responsibility for revision of the NCP to EPA.
The agency has complied with Executive Order 12580 to the extent that it is related to the addition of a new component to the HRS, through consultation with members of the NRT.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Oil pollution, Penalties, Reporting and recordkeeping
For the reasons set out in the preamble, Title 40, Chapter 1 of the Code of Federal Regulations is amended as follows:
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
The revisions and additions read as follows:
• Group A: Human carcinogen—sufficient evidence of carcinogenicity in humans.
• Group B1: Probable human carcinogen—limited evidence of carcinogenicity in humans.
• Group B2: Probable human carcinogen—sufficient evidence of carcinogenicity in animals.
• Group C: Possible human carcinogen—limited evidence of carcinogenicity in animals.
• Group D: Not classifiable as to human carcinogenicity—applicable when there is no animal evidence, or when human or animal evidence is inadequate.
• Group E: Evidence of noncarcinogenicity for humans.
Or the descriptors:
• Carcinogenic to humans.
• Likely to be carcinogenic to humans.
• Suggestive evidence of carcinogenic potential.
• Inadequate information to assess carcinogenic potential.
• Not likely to be carcinogenic to humans.
2.1
• Ground Water Migration (S
• Surface Water Migration (S
• Soil Exposure and Subsurface Intrusion (S
• Air Migration (S
The ground water and air migration pathways use single threat evaluations, while the surface water migration and soil exposure and subsurface intrusion pathways use multiple threat evaluations. Three threats are evaluated for the surface water migration pathway: Drinking water, human food chain, and environmental. These threats are evaluated for two separate migration components—overland/flood migration and ground water to surface water migration. Two components are evaluated for the soil exposure and subsurface intrusion pathway: Soil exposure and subsurface intrusion. The soil exposure component evaluates two threats: Resident population and nearby population, and the subsurface intrusion component is a single threat evaluation.
The HRS is structured to provide a parallel evaluation for each of these pathways, components, and threats. This section focuses on these parallel evaluations, starting with the calculation of the HRS site score and the individual pathway scores.
2.1.1
2.1.2
2.1.3
These evaluations are essentially identical for the three migration pathways (ground water, surface water, and air). However, the evaluations differ in certain respects for the soil exposure and subsurface intrusion pathway.
Section 7 specifies modifications that apply to each pathway when evaluating sites containing radioactive substances.
Section 2 focuses on evaluations common at the pathway, component, and threat levels. Note that for the ground water and surface water migration pathways, separate scores are calculated for each aquifer (see section 3.0) and each watershed (see sections 4.1.1.3 and 4.2.1.5) when determining the pathway scores for a site. Although the evaluations in section 2 do not vary when different aquifers or watersheds are scored at a site, the specific factor values (for example, observed release, hazardous waste quantity, toxicity/mobility) that result from these evaluations can vary by aquifer and by watershed at the site. This can occur through differences both in the specific sources and targets eligible to be evaluated for each aquifer and watershed and in whether observed releases can be established for each aquifer and watershed. Such differences in scoring at the aquifer and watershed level are addressed in sections 3 and 4, not section 2.
2.2
• Sources (and areas of observed contamination, areas of observed exposure, or areas of subsurface contamination) at the site.
• Hazardous substances associated with these sources (or areas of observed contamination, areas of observed exposure, or areas of subsurface contamination).
• Pathways potentially threatened by these hazardous substances.
Table 2-2 presents a sample worksheet for source characterization.
2.2.1
2.2.2
For an area of observed contamination in the soil exposure component of the soil exposure and subsurface intrusion pathway, consider only those hazardous substances that meet the criteria for observed contamination for that area (see section 5.1.0) to be associated with that area when evaluating the pathway.
For an area of observed exposure or area of subsurface contamination (see section 5.2.0) in the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, consider only those hazardous substances that:
• Meet the criteria for observed exposure, or
• Meet the criteria for observed release in an area of subsurface contamination and have a vapor pressure greater than or equal to one torr or a Henry's constant greater than or equal to 10
• Meet the criteria for an observed release in a structure within, or in a sample from below, an area of observed exposure and have a vapor pressure greater than or equal to one torr or a Henry's constant greater than or equal to 10
2.2.3
In evaluating the soil exposure and subsurface intrusion pathway, consider the following hazardous substances available to the pathway:
2.3
Establish an observed release either by direct observation of the release of a hazardous substance into the media being evaluated (for example, surface water) or by chemical analysis of samples appropriate to the pathway being evaluated (see sections 3, 4 and 6). The minimum standard to establish an observed release by chemical analysis is analytical evidence of a hazardous substance in the media significantly above the background level. Further, some portion of the release must be attributable to the site. Use the criteria in Table 2-3 as the standard for determining analytical significance. (The criteria in Table 2-3 are also used in establishing observed contamination for the soil exposure component and for establishing areas of observed exposure and areas of subsurface contamination in the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, see section 5.1.0 and section 5.2.0). Separate criteria apply to radionuclides (see section 7.1.1).
2.4
2.4.1
2.4.1.1
Establish human toxicity factor values based on quantitative dose-response parameters for the following three types of toxicity:
• Cancer—Use slope factors (also referred to as cancer potency factors) combined with weight-of-evidence ratings for carcinogenicity for all exposure routes except inhalation. Use inhalation unit risk (IUR) for inhalation exposure. If an inhalation unit risk or a slope factor is not available for a substance, use its ED
• Noncancer toxicological responses of chronic exposure—use reference dose (RfD) or reference concentration (RfC) values as applicable.
• Noncancer toxicological responses of acute exposure—use acute toxicity parameters, such as the LD
Assign human toxicity factor values to a hazardous substance using Table 2-4, as follows:
• If RfD/RfC and slope factor/inhalation unit risk values are available for the hazardous substance, assign the substance a value from Table 2-4 for each. Select the higher of the two values assigned and use it as the overall toxicity factor value for the hazardous substance.
• If either an RfD/RfC or slope factor/inhalation unit risk value is available, but not both, assign the hazardous substance an overall toxicity factor value from Table 2-4 based solely on the available value (RfD/RfC or slope factor/inhalation unit risk).
• If neither an RfD/RfC nor slope factor/inhalation unit risk value is available, assign the hazardous substance an overall toxicity factor value from Table 2-4 based solely on acute toxicity. That is, consider acute toxicity in Table 2-4 only when both RfD/RfC and slope factor/IUR values are not available.
• If neither an RfD/RfC, nor slope factor/inhalation unit risk, nor acute toxicity value is available, assign the hazardous substance an overall toxicity factor value of 0 and use other hazardous substances for which information is available in evaluating the pathway.
If a toxicity factor value of 0 is assigned to all hazardous substances available to a particular pathway (that is, insufficient toxicity data are available for evaluating all the substances), use a default value of 100 as the overall human toxicity factor value for all hazardous substances available to the pathway. For hazardous substances having usable toxicity data for multiple exposure routes (for example, inhalation and ingestion), consider all exposure routes and use the highest assigned value, regardless of exposure route, as the toxicity factor value. For HRS purposes, assign both asbestos and lead (and its compounds) a human toxicity factor value of 10,000.
Separate criteria apply for assigning factor values for human toxicity and ecosystem toxicity for radionuclides (see sections 7.2.1 and 7.2.2).
2.4.1.2
Determine each combined factor value for a hazardous substance by multiplying the individual factor values appropriate to the pathway (or threat). For each migration pathway (or threat) being evaluated, select the hazardous substance with the highest combined factor value and use that substance in evaluating the waste characteristics factor category of the pathway (or threat).
For the soil exposure and subsurface intrusion pathway, determine toxicity and toxicity/degradation factor values as follows:
2.4.2
In evaluating the hazardous waste quantity factor for the three migration pathways, allocate hazardous substances and hazardous wastestreams to specific sources in the manner specified in section 2.2.2, except: Consider hazardous substances and hazardous wastestreams that cannot be allocated to any specific source to constitute a separate “unallocated source” for purposes of evaluating only this factor for the three migration pathways. Do not, however, include a hazardous substance or hazardous wastestream in the unallocated source for a migration pathway if there is definitive information indicating that the substance or wastestream could only have been placed in sources with a containment factor value of 0 for that migration pathway.
In evaluating the hazardous waste quantity factor for the soil exposure component of the soil exposure and subsurface intrusion pathway, allocate to each area of observed contamination only those hazardous substances that meet the criteria for observed contamination for that area of observed contamination and only those hazardous wastestreams that contain hazardous substances that meet the criteria for observed contamination for that area of observed contamination. Do not consider other hazardous substances or hazardous wastestreams at the site in evaluating this factor for the soil exposure component of the soil exposure and subsurface intrusion pathway.
In evaluating the hazardous waste quantity factor for the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, allocate to each area of observed exposure or area of subsurface contamination only those hazardous substances and hazardous wastestreams that contain hazardous substances that:
Do not consider other hazardous substances or hazardous wastestreams at the site in evaluating this factor for the subsurface intrusion component of the soil exposure and subsurface intrusion pathway. When determining the hazardous waste quantity for multi-subunit structures, use the procedures identified in section 5.2.1.2.2.
2.4.2.1
For the soil exposure component of the soil exposure and subsurface intrusion pathway, assign a source hazardous waste quantity value to each area of observed contamination, as applicable to the threat being evaluated.
For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, assign a source hazardous waste quantity value to each regularly occupied structure within an area of observed exposure or an area of subsurface contamination that has a structure containment factor value greater than 0. If sufficient data is available and state of the science shows there is no unacceptable risk due to subsurface intrusion into a regularly occupied structure located within an area of subsurface contamination, that structure can be excluded from the area of subsurface contamination.
For determining all hazardous waste quantity calculations except for an unallocated source or an area of subsurface contamination, evaluate using the following four measures in the following hierarchy:
• Hazardous constituent quantity.
• Hazardous wastestream quantity.
• Volume.
• Area.
For the unallocated source, use only the first two measures. For an area of subsurface contamination, evaluate non-radioactive hazardous substances using only the last two measures and evaluate radioactive hazardous substances using hazardous wastestream quantity only. See also section 7.0 regarding the evaluation of radioactive substances.
Separate criteria apply for assigning a source hazardous waste quantity value for radionuclides (see section 7.2.5).
2.4.2.1.1
• For a hazardous waste listed pursuant to section 3001 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA), 42 U.S.C. 6901
• For a RCRA hazardous waste that exhibits the characteristics identified under section 3001 of RCRA, as amended, determine its mass for the evaluation of this measure as follows:
Based on this mass, designated as C, assign a value for hazardous constituent quantity as follows:
• For the migration pathways, assign the source a value for hazardous constituent quantity using the Tier A equation of Table 2-5.
• For the soil exposure and subsurface intrusion pathway—soil exposure component, assign the area of observed contamination a value using the Tier A equation of Table 5-2 (section 5.1.1.2.2).
• For the soil exposure and subsurface intrusion pathway—subsurface intrusion component, assign the area of observed exposure a value using the Tier A equation of Table 5-19 (section 5.2.1.2.2).
If the hazardous constituent quantity for the source (or area of observed contamination or area of observed exposure) is adequately determined (that is, the total mass of all CERCLA hazardous substances in the source and releases from the source [or in the area of observed contamination or area of observed exposure] is known or is estimated with reasonable confidence), do not evaluate the other three measures discussed below. Instead assign these other three measures a value of 0 for the source (or area of observed contamination or area of observed exposure) and proceed to section 2.4.2.1.5.
If the hazardous constituent quantity is not adequately determined, assign the source (or area of observed contamination or area of observed exposure) a value for hazardous constituent quantity based on the available data and proceed to section 2.4.2.1.2.
2.4.2.1.2
Based on this mass, designated as W, assign a value for hazardous wastestream quantity as follows:
• For the migration pathways, assign the source a value for hazardous wastestream quantity using the Tier B equation of Table 2-5.
• For the soil exposure and subsurface intrusion pathway—soil exposure component, assign the area of observed contamination a value using the Tier B equation of Table 5-2 (section 5.1.1.2.2).
• For the soil exposure and subsurface intrusion pathway—subsurface intrusion component, assign the area of observed exposure a value using the Tier B equation of Table 5-19 (section 5.2.1.2.2).
Do not evaluate the volume and area measures described below if the source is the unallocated source or if the following condition applies:
• The hazardous wastestream quantity for the source (or area of observed contamination or area of observed exposure) is adequately determined—that is, total mass of all hazardous wastestreams and CERCLA pollutants and contaminants for the source and releases from the source (or for the area of observed contamination) is known or is estimated with reasonable confidence.
If the source is the unallocated source or if this condition applies, assign the volume and area measures a value of 0 for the source (or area of observed contamination) and proceed to section 2.4.2.1.5. Otherwise, assign the source (or area of observed contamination) a value for hazardous wastestream quantity based on the available data and proceed to section 2.4.2.1.3.
2.4.2.1.3
Based on the volume, designated as V, assign a value to the volume measure as follows:
• For the migration pathways, assign the source a value for volume using the appropriate Tier C equation of Table 2-5.
• For the soil exposure and subsurface intrusion pathway—soil exposure component, assign the area of observed contamination a value for volume using the appropriate Tier C equation of Table 5-2 (section 5.1.1.2.2).
• For the soil exposure and subsurface intrusion pathway—subsurface intrusion component, assign the value based on the volume of the regularly occupied structures within the area of observed exposure or area of subsurface contamination using the Tier C equation of Table 5-19 (section 5.2.1.2.2).
If the volume of the source (or volume of the area of observed contamination, area of observed exposure, or area of subsurface contamination, if applicable) can be determined, do not evaluate the area measure. Instead, assign the area measure a value of 0 and proceed to section 2.4.2.1.5. If the volume cannot be determined (or is not applicable for the soil exposure and subsurface intrusion pathway), assign the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination) a value of 0 for the volume measure and proceed to section 2.4.2.1.4.
2.4.2.1.4
• For the migration pathways, assign the source a value for area using the appropriate Tier D equation of Table 2-5.
• For the soil exposure and subsurface intrusion pathway—soil exposure component, assign the area of observed contamination a value for area using the appropriate Tier D equation of Table 5-2 (section 5.1.1.2.2).
• For the soil exposure and subsurface intrusion pathway—subsurface intrusion component, assign a value based on the area of regularly occupied structures within the area of observed exposure or area of subsurface contamination using the Tier D equation of Table 5-19 (section 5.2.1.2.2).
2.4.2.1.5
2.4.2.2
For a migration pathway, if the hazardous constituent quantity is adequately determined (see section 2.4.2.1.1) for all sources (or all portions of sources and releases remaining after a removal action), assign the value from Table 2-6 as the hazardous waste quantity factor value for the pathway. If the hazardous constituent quantity is not adequately determined for one or more sources (or one or more portions of sources or releases remaining after a removal action) assign a factor value as follows:
• If any target for that migration pathway is subject to Level I or Level II concentrations (see section 2.5), assign either the value from Table 2-6 or a value of 100, whichever is greater, as the hazardous waste quantity factor value for that pathway.
• If none of the targets for that pathway is subject to Level I or Level II concentrations, assign a factor value as follows:
For the soil exposure component of the soil exposure and subsurface intrusion pathway, if the hazardous constituent quantity is adequately determined for all areas of observed contamination, assign the value from Table 2-6 as the hazardous waste quantity factor value. If the hazardous constituent quantity is not adequately determined for one or more areas of observed contamination, assign either the value from Table 2-6 or a value of 10, whichever is greater, as the hazardous waste quantity factor value.
For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, if the hazardous constituent
• If any target for the subsurface intrusion component is subject to Level I or Level II concentrations (see section 2.5), assign either the value from Table 2-6 or a value of 100, whichever is greater, as the hazardous waste quantity factor value for this component.
• If none of the targets for the subsurface intrusion component is subject to Level I or Level II concentrations and if there has been a removal or other temporary response action that does not permanently interrupt target exposure form subsurface intrusion, assign a factor value as follows:
• Otherwise, if none of the targets for the subsurface intrusion component is subject to Level I or Level II concentrations and there has not been a removal action, assign a value from Table 2-6 or a value of 10, whichever is greater.
2.4.3
2.4.3.1
2.4.3.2
• A maximum product of 1x10
• A maximum product exclusive of the bioaccumulation (or ecosystem bioaccumulation) potential factor of 1x10
Based on the total waste characteristics product, assign a waste characteristics factor category value to these threats from Table 2-7.
2.5
• Individual (factor name varies by pathway, component, and threat).
• Human population.
• Resources (these vary by pathway, component, and threat).
• Sensitive environments (included for the surface water migration pathway, air migration pathway, and soil exposure component of the soil exposure and subsurface intrusion pathway).
The factor values that may be assigned to each type of target have the same range for each pathway for which that type of target is evaluated. The factor value for most types of targets depends on whether the target is subject to actual or potential contamination for the pathway and whether the actual contamination is Level I or Level II:
• Actual contamination: Target is associated either with a sampling location that meets the criteria for an observed release (or observed contamination or observed exposure) for the pathway or with an observed release based on direct observation for the pathway (additional criteria apply for establishing actual contamination for the human food chain threat in the surface water migration pathway, see sections 4.1.3.3 and 4.2.3.3). Sections 3 through 6 specify how to determine the targets associated with a sampling location or with an observed release based on direct observation. Determine whether the actual contamination is Level I or Level II as follows:
• Potential contamination: Target is subject to a potential release (that is, target is not associated with actual contamination for that pathway or threat).
Assign a factor value for individual risk as follows (select the highest value that applies to the pathway, component or threat):
• 50 points if any individual is exposed to Level I concentrations.
• 45 points if any individual is exposed to Level II concentrations.
• Maximum of 20 points if any individual is subject to potential contamination. The value assigned is 20 unless reduced by a distance or dilution weight appropriate to the pathway. Assign factor values for population and sensitive environments as follows:
• Sum Level I targets and multiply by 10. (Level I is not used for sensitive environments in the soil exposure component of the soil exposure and subsurface intrusion and air migration pathways.)
• Sum Level II targets.
• Multiply potential targets in all but the soil exposure and subsurface intrusion pathway by distance or dilution weights appropriate to the pathway, sum, and divide by 10. Distance or dilution weighting accounts for diminishing exposure with increasing distance or dilution within the different pathways. For targets within an area
• Sum the values for the three levels.
In addition, resource value points are assigned within all pathways for welfare-related impacts (for example, impacts to agricultural land), but do not depend on whether there is actual or potential contamination.
2.5.1
• Select the benchmarks applicable to the pathway (component or threat) being evaluated.
• Compare the concentrations of hazardous substances in the sample (or comparable samples) to their benchmark concentrations for the pathway (component or threat), as specified in section 2.5.2.
• Determine which level applies based on this comparison.
• If none of the hazardous substances eligible to be evaluated for the sampling location has an applicable benchmark, assign Level II to the actual contamination at that sampling location for the pathway (component or threat).
In making the comparison, consider only those samples, and only those hazardous substances in the sample, that meet the criteria for an observed release (or observed contamination or observed exposure) for the pathway, except: Tissue samples from aquatic human food chain organisms may also be used as specified in sections 4.1.3.3 and 4.2.3.3 of the surface water-human food chain threat. If any hazardous substance is present in more than one comparable sample for the sampling location, use the highest concentration of that hazardous substance from any of the comparable samples in making the comparisons.
Treat sets of samples that are not comparable separately and make a separate comparison for each such set.
2.5.2
• Maximum Contaminant Level Goals (MCLGs)—ground water migration pathway and drinking water threat in surface water migration pathway. Use only MCLG values greater than 0.
• Maximum Contaminant Levels (MCLs)—ground water migration pathway and drinking water threat in surface water migration pathway.
• Food and Drug Administration Action Level (FDAAL) for fish or shellfish—human food chain threat in surface water migration pathway.
• EPA Ambient Water Quality Criteria (AWQC/National Recommended Water Quality Criteria) for protection of aquatic life—environmental threat in surface water migration pathway.
• EPA Ambient Aquatic Life Advisory Concentrations (AALAC)—environmental threat in surface water migration pathway.
• National Ambient Air Quality Standards (NAAQS)—air migration pathway.
• National Emission Standards for Hazardous Air Pollutants (NESHAPs)—air migration pathway. Use only those NESHAPs promulgated in ambient concentration units.
• Screening concentration for cancer corresponding to that concentration that corresponds to the 10
• Screening concentration for noncancer toxicological responses corresponding to the RfC for inhalation exposures (air migration pathway and subsurface intrusion component of the soil exposure and subsurface intrusion pathway) or RfD for oral exposures (ground water migration pathway; drinking water and human food chain threats in surface water migration pathway; and soil exposure and subsurface intrusion pathway).
Select the benchmark(s) applicable to the pathway (component or threat) being evaluated as specified in sections 3 through 6. Compare the concentration of each hazardous substance from the sampling location to its benchmark concentration(s) for that pathway (component or threat). Use only those samples and only those hazardous substances in the sample that meet the criteria for an observed release (or observed contamination or observed exposure) for the pathway, except: Tissue samples from aquatic human food chain organisms may be used as specified in sections 4.1.3.3 and 4.2.3.3. If the concentration of any applicable hazardous substance from any sample equals or exceeds its benchmark concentration, consider the sampling location to be subject to Level I concentrations for that pathway (or threat). If more than one benchmark applies to the hazardous substance, assign Level I if the concentration of the hazardous substance equals or exceeds the lowest applicable benchmark concentration.
If no hazardous substance individually equals or exceeds its benchmark concentration, but more than one hazardous substance either meets the criteria for an observed release (or observed contamination or observed exposure) for the sample (or comparable samples) or is eligible to be evaluated for a tissue sample (see sections 4.1.3.3 and 4.2.3.3), calculate the indices I and J specified below based on these hazardous substances.
For those hazardous substances that are carcinogens (that is, those having either a carcinogen weight-of-evidence classification of A, B, or C or a weight-of-evidence classification of carcinogenic to humans, likely to be carcinogenic to humans, or suggestive evidence of carcinogenic potential), calculate an index I for the sample location as follows:
For those hazardous substances for which an RfD or RfC is available, calculate an index J for the sample location as follows:
If either I or J equals or exceeds 1, consider the sampling location to be subject to Level I concentrations for that pathway (component or threat). If both I and J are less than 1, consider the sampling location to be subject to Level II concentrations for that pathway (component or threat). If, for the sampling location, there are sets of samples that are not comparable, calculate I and J separately for each such set, and use the highest calculated values of I and J to assign Level I and Level II.
See sections 7.3.1 and 7.3.2 for criteria for determining the level of contamination for radioactive substances.
5.0.1
• Soil exposure component (see section 5.1).
• Subsurface intrusion component (see section 5.2).
Score one or both components considering their relative importance. If only one component is scored, assign its score as the soil exposure and subsurface intrusion pathway score. If both components are scored, sum the two scores and assign it as the soil exposure and subsurface intrusion pathway score, subject to a maximum of 100.
5.1
Determine the soil exposure component score (S
Table 5-1 outlines the specific calculation procedure.
5.1.0
• Consider observed contamination to be present at sampling locations where analytic evidence indicates that:
• Establish areas of observed contamination based on sampling locations at which there is observed contamination as follows:
• If an area of observed contamination (or portion of such an area) is covered by a permanent, or otherwise maintained, essentially impenetrable material (for example, asphalt) that is not more than 2 feet thick, exclude that area (or portion of the area) in evaluating the soil exposure component.
• For an area of observed contamination, consider only those hazardous substances that meet the criteria for observed contamination for that area to be associated with that area in evaluating the soil exposure component (see section 2.2.2).
If there is observed contamination, assign scores for the resident population threat and the nearby population threat, as specified in sections 5.1.1 and 5.1.2. If there is no observed contamination, assign the soil exposure component of the soil exposure and subsurface intrusion pathway a score of 0.
5.1.1
• Within the property boundary of a residence, school, or day care center
• Within a workplace property boundary
• Within the boundaries of a resource specified in section 5.1.1.3.4, or
• Within the boundaries of a terrestrial sensitive environment specified in section 5.1.1.3.5.
If not, assign the resident population threat a value of 0, enter this value in Table 5-1, and proceed to the nearby population threat (section 5.1.2).
5.1.1.1
5.1.1.2
5.1.1.2.1
5.1.1.2.2
• Consider only the first 2 feet of depth of an area of observed contamination, except as specified for the volume measure.
• Use the volume measure (see section 2.4.2.1.3) only for those types of areas of observed contamination listed in Tier C of Table 5-2. In evaluating the volume measure for these listed areas of observed contamination, use the full volume, not just the volume within the top 2 feet.
• Use the area measure (see section 2.4.2.1.4), not the volume measure, for all other types of areas of observed contamination, even if their volume is known.
Enter the value assigned in Table 5-1.
5.1.1.2.3
5.1.1.3
In evaluating the targets factor category for the resident population threat, count only the following as targets:
• Resident individual—a person living or attending school or day care on a property with an area of observed contamination
• Worker—a person working on a property with an area of observed contamination
• Resources located on an area of observed contamination, as specified in section 5.1.1.
• Terrestrial sensitive environments located on an area of observed contamination, as specified in section 5.1.1.
5.1.1.3.1
First, determine those areas of observed contamination subject to Level I concentrations and those subject to Level II concentrations as specified in sections 2.5.1 and 2.5.2. Use the health-based benchmarks from Table 5-3 in determining the level of contamination. Then assign a value to the resident individual factor as follows:
• Assign a value of 50 if there is at least one resident individual for one or more areas subject to Level I concentrations.
• Assign a value of 45 if there is no such resident individuals, but there is at least one resident individual for one or more areas subject to Level II concentrations.
• Assign a value of 0 if there is no resident individual.
5.1.1.3.2
Count only those persons meeting the criteria for resident individual as specified in section 5.1.1.3. In estimating the number of people living on property with an area of observed contamination, when the estimate is based on the number of residences, multiply each residence by the average number of persons per residence for the county in which the residence is located.
5.1.1.3.2.1
5.1.1.3.2.2
5.1.1.3.2.3
5.1.1.3.3
5.1.1.3.4
• Assign a value of 5 to the resources factor if one or more of the following is present on an area of observed contamination at the site:
• Assign a value of 0 if none of the above are present.
Enter the value assigned in Table 5-1.
5.1.1.3.5
Calculate a value (ES) for terrestrial sensitive environments as follows:
Because the pathway score based solely on terrestrial sensitive environments is limited to a maximum of 60, determine the value for the terrestrial sensitive environments factor as follows:
• Multiply the values assigned to the resident population threat for likelihood of exposure (LE), waste characteristics (WC), and ES. Divide the product by 82,500.
Assign the value EC as the terrestrial sensitive environments factor value. Do not round this value to the nearest integer.
Enter the value assigned for the terrestrial sensitive environments factor in Table 5-1.
5.1.1.3.6
5.1.1.4
5.1.2
Do not consider areas of observed contamination that have an attractiveness/accessibility factor value of 0 (see section
5.1.2.1
5.1.2.1.1
5.1.2.1.2
5.1.2.1.3
5.1.2.2
5.1.2.2.1
5.1.2.2.2
5.1.2.2.3
5.1.2.3
5.1.2.3.1
If no person meets the criteria for a resident individual, determine the shortest travel distance from the site to any residence or school. In determining the travel distance, measure the shortest overland distance an individual would travel from a residence or school to the nearest area of observed contamination for the site with an attractiveness/accessibility factor value greater than 0. If there are no natural barriers to travel, measure the travel distance as the shortest straight-line distance from the residence or school to the area of observed contamination. If natural barriers exist (for example, a river), measure the travel distance as the shortest straight-line distance from the residence or school to the nearest crossing point and from there as the shortest straight-
5.1.2.3.2
In estimating residential population, when the estimate is based on the number of residences, multiply each residence by the average number of persons per residence for the county in which the residence is located.
Based on the number of people included within a travel distance category, assign a distance-weighted population value for that travel distance from Table 5-10.
Calculate the value for the population within 1 mile factor (PN) as follows:
If PN is less than 1, do not round it to the nearest integer; if PN is 1 or more, round to the nearest integer. Enter this value in Table 5-1.
5.1.2.3.3
5.1.2.4
5.1.3
5.2
Determine the component score (S
Table 5-11 outlines the specific calculation procedure.
5.2.0
In evaluating the subsurface intrusion component, consider the following:
• Area(s) of observed exposure: An area of observed exposure is delineated by regularly occupied structures with documented contamination meeting observed exposure criteria; an area of observed exposure includes regularly occupied structures with samples meeting observed exposure criteria or inferred to be within an area of observed exposure based on samples meeting observed exposure criteria (see section 5.2.1.1.1
• Area(s) of subsurface contamination: An area of subsurface contamination is delineated by sampling locations meeting observed release criteria for subsurface intrusion, excluding areas of observed exposure (see Table 2-3 in section 2.3). The area within an area of subsurface contamination includes potentially exposed populations. If the significant increase in hazardous substance levels cannot be attributed at least in part to the site, and cannot be attributed to other sites, attribution can be established based on the presence of hazardous substances in the area of subsurface contamination. Establish areas of subsurface contamination as follows:
See Section 7.0 for establishing an area of subsurface contamination based on the
If there is no area of observed exposure and no area of subsurface contamination, assign a score of 0 for the subsurface intrusion component.
5.2.1
• Within or underlying a residence, school, day care center, workplace, or
• Within or underlying a resource specified in section 5.2.1.3.3.
5.2.1.1
5.2.1.1.1
• Direct observation:
• Chemical analysis:
If observed exposure can be established in a regularly occupied structure, assign an observed exposure factor value of 550, enter this value in Table 5-11, and proceed to section 5.2.1.1.3. If no observed exposure can be established, assign an observed exposure factor value of 0, enter this value in Table 5-11, and proceed to section 5.2.1.1.2.
5.2.1.1.2
5.2.1.1.2.1
5.2.1.1.2.2
Based on this calculated depth, assign a factor value from Table 5-13. If the necessary information is available at multiple locations, calculate the depth to contamination at each location. Use the location having the least depth to contamination to assign the factor value. Enter this value in Table 5-11.
5.2.1.1.2.3
• If the depth to contamination (see section 5.2.1.1.2.2) is 10 feet or less, assign a value of 15.
• If the depth to contamination is greater than 10 feet, do not consider layers or portions of layers within the first 10 feet of the depth to contamination (as assigned in section 5.2.1.1.2.2).
• If, for the interval between the lowest point of a regularly occupied structure and the highest point of hazardous substances in the subsurface, all layers that underlie a portion of a regularly occupied structure at the site are karst or otherwise allow channelized flow, assign a value of 15.
• Otherwise:
Determine vertical migration only at locations within an area of subsurface contamination at the site. If the necessary subsurface geologic information is available at multiple locations, evaluate the vertical migration factor at each location. Use the location having the highest vertical migration factor value to assign the factor value. Enter this value in Table 5-11.
5.2.1.1.2.4
• If the depth to contamination (see section 5.2.1.1.2.2) is 10 feet or less, assign a value of 25.
• Assign a value for vapor migration potential to each of the gaseous hazardous substances associated with the area of subsurface contamination (see section 2.2.2) as follows:
• Assign a value for vapor migration potential to each area of subsurface contamination as follows:
Enter this value in Table 5-11.
5.2.1.1.2.5
5.2.1.1.3
5.2.1.2
5.2.1.2.1
5.2.1.2.1.1
5.2.1.2.1.2
• For any hazardous substance that meets the criteria for an observed exposure, or if a NAPL is present in the subsurface below an area of observed exposure or area of subsurface contamination at a depth less than or equal to 30 feet, assign that substance a degradation factor value of 1.
• For all other situations, assign a degradation factor value using Table 5-18. Assign the depth to contamination as directed in section 5.2.1.1.2.2, except if evidence indicates that biologically active soil is not present throughout the depth beneath any regularly occupied structure. In this situation, subtract any thickness of non-biologically active soil from the estimated depth to contamination.
The half-life of a substance in the subsurface is defined for HRS purposes as the time required to reduce the initial concentration of the substance in the subsurface by one-half as a result of the combined decay processes of two components: Biodegradation and hydrolysis.
Estimate the half-life (t
If either of these component half-lives cannot be estimated for the hazardous substance from available data, delete that component half-life from the above equation.
If no half-life information is available for a hazardous substance and the substance is not already assigned a value of 1, unless information indicates otherwise, assign a value of 1.
5.2.1.2.1.3
5.2.1.2.2
• For Tier A, hazardous constituent quantity, use the mass of constituents found in the regularly occupied structure(s) where the observed exposure has been identified.
• For Tier B, hazardous wastestream quantity, use the flow-through volume of the regularly occupied structures where the observed exposure has been identified.
• For Tier C, volume, use the volume divisor listed in Tier C of Table 5-19. Volume is calculated for those regularly occupied structures located within areas of observed exposure with observed or inferred
• For Tier D, area, if volume is unknown, use the area divisor listed in Tier D of Table 5-19 for those regularly occupied structures within areas of observed exposure with observed or inferred intrusion and within areas of subsurface contamination.
For the subsurface intrusion component, if the hazardous constituent quantity is adequately determined for all areas of observed exposure, assign the value from Table 2-6 as the hazardous waste quantity factor value. If the hazardous constituent quantity is not adequately determined for one or more areas of observed exposure or if one or more areas of subsurface contamination are present, assign either the value from Table 2-6 or assign a factor value as follows:
• If any target for the subsurface intrusion component is subject to Level I or Level II concentrations (see section 2.5), assign either the value from Table 2-6 or a value of 100, whichever is greater, as the hazardous waste quantity factor value for this component.
• If none of the targets for the subsurface intrusion component is subject to Level I or Level II concentrations and if there has been a removal action that does not permanently interrupt target exposure from subsurface intrusion, and if an area of subsurface contamination exists, assign a factor value as follows:
• Otherwise, if none of the targets for the subsurface intrusion component is subject to Level I or Level II concentrations and there has not been a removal action, assign a value from Table 2-6 or a value of 10, whichever is greater.
Enter the value assigned in Table 5-11.
5.2.1.2.3
5.2.1.3
In evaluating the targets factor category for the subsurface intrusion threat, count only the following as targets:
• Exposed individual—a person living, attending school or day care, or working in a regularly occupied structure with observed exposure or in a structure within an area of observed exposure or within an area of subsurface contamination.
• Population—exposed individuals in a regularly occupied structure within an area of observed exposure or within an area of subsurface contamination.
• Resources—located within an area of observed exposure or within an area of subsurface contamination as specified in section 5.2.1.3.3.
If a formerly occupied structure has been vacated due to subsurface intrusion attributable to the site, count the initial targets as if they were still residing in the structure. In addition, if a removal or temporary response action has occurred that has not completely mitigated the release, count the initial targets as if the removal or temporary response action has not permanently interrupted target exposure from subsurface intrusion. Evaluate those targets based on conditions at the time of removal of temporary response action.
For populations residing in or working in a multi-subunit structure with multiple stories in an area of observed exposure or area of subsurface contamination, count these targets as follows:
• If there is no observed exposure within the structure, include in the evaluation only those targets, if any, in the lowest occupied level. If sufficient structure-specific concentration data is available and state of the science shows there is no unacceptable risk of exposure to targets in the lowest level, those targets are not included in the evaluation.
• If there is an observed exposure in any level, include in the evaluation those targets in that level, the level above and all levels below. (The weighting of these targets is specified in Section 5.2.1.3.2.) If sufficient structure-specific concentration data is available and state of the science shows there is no unacceptable risk of exposure to targets in the level above where the observed exposure has been documented, those targets are not included in the evaluation.
5.2.1.3.1
First, determine those regularly occupied structures or partitioned subunit(s) within structures in an area of observed exposure subject to Level I concentrations and those subject to Level II concentrations as specified as follows (see section 5.2.0):
• Level I Concentrations: For contamination resulting from subsurface intrusion, compare the hazardous substance concentrations in any sample meeting the observed exposure by chemical analysis criteria to the appropriate benchmark. Use the health-based benchmarks from Table 5-20 to determine the level of contamination.
• Level II Concentrations: Structures, or subunits within structures, with one or more samples that meet observed exposure by chemical analysis criteria but do not equal or exceed the appropriate benchmark; structures, or subunits, that have an observed exposure by direct observation; and structures inferred to be in an area of observed exposure based on samples meeting observed exposure, are assigned Level II concentrations.
Then assign a value to the exposed individual factor as follows:
• Assign a value of 50 if there is at least one exposed individual in one or more regularly occupied structures subject to Level I concentrations.
• Assign a value of 45 if there are no Level I exposed individuals, but there is at least one exposed individual in one or more regularly occupied structures subject to Level II concentrations.
• Assign a value of 20 if there is no Level I or Level II exposed individual but there is at least one individual in a regularly occupied structure within an area of subsurface contamination. Enter the value assigned in Table 5-11.
5.2.1.3.2
Count only those persons meeting the criteria for population as specified in section 5.2.1.3. In estimating the number of individuals in structures in an area of observed exposure or area of subsurface contamination if the actual number of residents is not known, multiply each residence by the average number of persons per residence for the county in which the residence is located.
5.2.1.3.2.1
1. Identify all exposed individuals regularly present in an eligible structure with a structure containment value greater than zero, or if the structure has subunits, identify those regularly present in each subunit, located in an area of observed exposure subject to Level I concentrations as described in sections 5.2.0 and 5.2.1.3.1. Identify only once per structure those exposed individuals that are using more than one eligible subunit of the same structure (
2. For each structure or subunit count the number of individuals residing in or attending school or day care in the structure or subunit.
3. Count the number of full-time and part-time workers in the structure or subunit(s) subject to Level I concentrations. If information is unavailable to classify a worker as full- or part-time, evaluate that worker as being full-time. Divide the number of full-time workers by 3 and the number of part-time workers by 6, and then sum these products with the number of other individuals for each structure or subunit.
4. Sum this combined value for all structures, or subunits, within areas of observed exposure and multiply this sum by 10.
Assign the resulting product as the combined population factor value subject to Level I concentrations for the site. Enter this value in line 9a of Table 5-11.
5.2.1.3.2.2
1. Identify all exposed individuals regularly present in an eligible structure with a structure containment value greater than zero, or if the structure has subunits, identify those regularly present in each subunit, located in an area of observed exposure subject to Level II concentrations as described in sections 5.2.0 and 5.2.1.3.1. Identify only once per structure those exposed individuals that are using more than one eligible subunit of the same structure (
2. Do not include exposed individuals already counted under the Level I concentrations factor.
3. For each structure or subunit(s), count the number of individuals residing in or attending school or day care in the structure, or subunit, subject to Level II concentrations.
4. Count the number of full-time and part-time workers in the structure or subunit(s) subject to Level II concentrations. If information is unavailable to classify a worker as full- or part-time, evaluate that worker as being full-time. Divide the number of full-time workers by 3 and the number of part-time workers by 6, and then sum these products with the number of other individuals for each structure or subunit.
5. Sum the combined population value for all structures within the areas of observed exposure for the site.
Assign this sum as the combined population factor value subject to Level II concentrations for this site. Enter this value in line 9b of Table 5-11.
5.2.1.3.2.3
1. Identify the regularly occupied structures with a structure containment value greater than zero and the eligible population associated with the structures or portions of structures in each area of subsurface contamination:
• For each regularly occupied structure or portion of a structure in an area of subsurface contamination, sum the number of all individuals residing in or attending school or day care, in the structure or portion of the structure in the area of subsurface contamination.
• Count the number of full-time and part-time workers regularly present in each
• Use this sum as the population for the structure.
2. Estimate the depth or distance to contamination at each regularly occupied structure within an area of subsurface contamination based on available sampling data, and categorize each eligible structure based on the depth or distance to contamination and sample media as presented in Table 5-21. Weight the population in each structure using the appropriate weighting factors in Table 5-21. If samples from multiple media are available, use the sample that results in the highest weighting factor.
3. Sum the weighted population in all structures within the area(s) of subsurface contamination and assign this sum as the population within an area of subsurface contamination factor value. Enter this value in line 9c of Table 5-11.
5.2.1.3.2.4
5.2.1.3.3
• Assign a value of 5 if a resource structure (
• Assign a value of 0 if there is no resource structure within an area of observed exposure or area of subsurface contamination.
Enter the value assigned in Table 5-11.
5.2.1.3.4
5.2.2
5.3
* * * These differences apply largely to the soil exposure and subsurface intrusion pathway and to sites containing mixed radioactive and other hazardous substances. * * *
7.1
7.1.1
• Direct observation:
• Analysis of radionuclide concentrations in samples appropriate to the pathway (that is, ground water, soil, air, indoor air, soil gas, surface water, benthic, or sediment samples):
• Gamma radiation measurements (applies only to observed contamination or observed exposure in the soil exposure and subsurface intrusion pathway):
For the three migration pathways and for the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, if an observed release or observed exposure can be established for the pathway (or component, threat, aquifer, or watershed, as appropriate), assign the pathway (or component, threat, aquifer, or watershed) an observed release or observed exposure factor value of 550 and proceed to section 7.2. If an observed release or observed exposure cannot be established, assign an observed release or observed exposure factor value of 0 and proceed to section 7.1.2.
For the soil exposure component of the soil exposure and subsurface intrusion pathway, if observed contamination can be established, assign the likelihood of exposure factor for resident population a value of 550 if there is an area of observed contamination in one or more locations listed in section 5.1.1; evaluate the likelihood of exposure factor for nearby population as specified in section 5.1.2.1; and proceed to section 7.2. If observed contamination cannot be established, do not evaluate the soil exposure component of the soil exposure and subsurface intrusion pathway.
At sites containing mixed radioactive and other hazardous substances, evaluate observed release (or component, observed contamination or observed exposure) separately for radionuclides as described in this section and for other hazardous substances as described in sections 2 through 6.
For the three migration pathways and the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, if an observed release or observed exposure can be established based on either radionuclides or other hazardous substances, or both, assign the pathway (or threat, aquifer, or watershed) an observed release or observed exposure factor value of 550 and proceed to section 7.2. If an observed release or observed exposure cannot be established based on either radionuclides or other hazardous substances, assign an observed release or observed exposure factor value of 0 and proceed to section 7.1.2.
For the soil exposure component of the soil exposure and subsurface intrusion pathway, if observed contamination can be established based on either radionuclides or other hazardous substances, or both, assign the likelihood of exposure factor for resident population a value of 550 if there is an area of observed contamination in one or more locations listed in section 5.1.1; evaluate the likelihood of exposure factor for nearby population as specified in section 5.1.2.1; and proceed to section 7.2. If observed contamination cannot be established based on either radionuclides or other hazardous substances, do not evaluate the soil exposure component of the soil exposure and subsurface intrusion pathway.
7.1.2 Potential to release/potential for exposure. For the three migration pathways and the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, evaluate potential to release or potential for exposure for sites containing radionuclides in the same manner as specified for sites containing other hazardous substances. Base the evaluation on the physical and chemical properties of the radionuclides, not on their level of radioactivity. For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, if the potential for exposure is based on the presence of gamma emitting radioactive substances, assign a potential for exposure factor value of 500 only if the contamination is found within 2 feet beneath a regularly occupied structure, otherwise assign a potential for exposure factor value of 0.
For sites containing mixed radioactive and other hazardous substances, evaluate potential to release or potential for exposure considering radionuclides and other hazardous substances together. Evaluate potential to release for each migration pathway and the potential for exposure for the subsurface intrusion component of the soil exposure and subsurface intrusion pathway as specified in sections 3 through 6, as appropriate.
7.2.1 Human Toxicity. For radioactive substances, evaluate the human toxicity factor as specified below, not as specified in section 2.4.1.1.
Assign human toxicity factor values to those radionuclides available to the pathway based on quantitative dose-response parameters for cancer risks as follows:
• Evaluate radionuclides only on the basis of carcinogenicity and assign all radionuclides to weight-of-evidence category A, or weight-of-evidence category “Carcinogenic to Humans”.
• Assign a human toxicity factor value from Table 7-2 to each radionuclide based on its slope factor (also referred to as a cancer potency factor).
• If all radionuclides available to a particular pathway are assigned a human toxicity factor value of 0 (that is, no slope factor is available for all the radionuclides), use a default human toxicity factor value of 1,000 as the human toxicity factor value for all radionuclides available to the pathway.
At sites containing mixed radioactive and other hazardous substances, evaluate the toxicity factor separately for the radioactive and other hazardous substances and assign each a separate toxicity factor value. This applies regardless of whether the radioactive and other hazardous substances are physically separated, combined chemically, or simply mixed together. Assign toxicity factor values to the radionuclides as specified above and to the other hazardous substances as specified in section 2.4.1.1.
At sites containing mixed radioactive and other hazardous substances, if all radionuclides available to a particular pathway are assigned a human toxicity factor value of 0, use a default human toxicity factor value of 1,000 for all those radionuclides even if nonradioactive hazardous substances available to the pathway are assigned human toxicity factor values greater than 0. Similarly, if all nonradioactive hazardous substances available to the pathway are assigned a human toxicity factor value of 0, use a default human toxicity factor value of 100 for all these nonradioactive hazardous substances even if radionuclides available to the pathway are assigned human toxicity factor values greater than 0.
7.2.3
If the volatilization half-life cannot be estimated for a radionuclide from available data, delete it from the equation. Select the portion of Table 4-10 to use in assigning the persistence factor value as specified in section 4.1.2.2.1.2.
At sites containing mixed radioactive and other hazardous substances, evaluate the persistence factor separately for each radionuclide and for each nonradioactive hazardous substance, even if the available data indicate that they are combined chemically. Assign a persistence factor value to each radionuclide as specified in this section and to each nonradioactive hazardous substance as specified in section 4.1.2.2.1.2. When combined chemically, assign a single persistence factor value based on the higher of the two values assigned (individually) to the radioactive and nonradioactive components.
In determining the subsurface intrusion degradation factor for radionuclides, when evaluating this factor based solely on half-life, assign a degradation factor value from section 5.2.1.2.1.2 to each radionuclide based on half-life (t
If no radioactive half-life information is available for a radionuclide and the substance is not already assigned a value of 1, unless information indicates otherwise, assign a value of 1.
At sites containing mixed radioactive and other hazardous substances, evaluate the degradation factor separately for each radionuclide and for each nonradioactive hazardous substance, even if the available data indicate that they are combined chemically. Assign a degradation factor value to each radionuclide as specified in this section and to each nonradioactive hazardous substance as specified in section 5.2.1.2.1.2. If no radioactive half-life information is available for a radionuclide and the substance is not already assigned a value of 1, unless information indicates otherwise, assign a value of 1. Similarly, if no half-life information is available for a nonradioactive substance, and the substance is not already assigned a value of 1, unless information indicates otherwise, assign a value of 1. When combined chemically, assign a single persistence or degradation factor value based on the higher of the two values assigned (individually) to the radioactive and nonradioactive components.
7.2.4
7.2.5.1
7.2.5.1.1
• Estimate the net activity content (in curies) for the source (or area of observed contamination or area of observed exposure) based on:
• Convert from curies of radionuclides to equivalent pounds of nonradioactive hazardous substances by multiplying the activity estimate for the source (or area of observed contamination or area of observed exposure) by 1,000.
• Assign this resulting product as the radionuclide constituent quantity value for the source (or area of observed contamination or area of observed exposure).
If the radionuclide constituent quantity for the source (or area of observed contamination or area of observed exposure) is adequately determined (that is, the total activity of all radionuclides in the source and releases from the source [or in the area of observed contamination or area of observed exposure] is known or is estimated with reasonable confidence), do not evaluate the radionuclide wastestream quantity measure in section 7.2.5.1.2. Instead, assign radionuclide wastestream quantity a value of 0 and proceed to section 7.2.5.1.3. If the radionuclide constituent quantity is not adequately determined, assign the source (or area of observed contamination or area of observed exposure) a value for radionuclide constituent quantity based on the available data and proceed to section 7.2.5.1.2.
7.2.5.1.2 Radionuclide wastestream quantity (Tier B). Evaluate radionuclide wastestream quantity for the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination) based on the activity content of radionuclide wastestreams allocated to the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination) as follows:
• Estimate the total volume (in cubic yards or in gallons) of wastestreams containing radionuclides allocated to the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination).
• Divide the volume in cubic yards by 0.55 (or the volume in gallons by 110) to convert to the activity content expressed in terms of equivalent pounds of nonradioactive hazardous substances.
• Assign the resulting value as the radionuclide wastestream quantity value for the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination).
• For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, estimate the total wastestream volume for all regularly occupied structures that have a containment value >0 and that are located within areas of observed exposure with observed or inferred intrusion, and
7.2.5.1.3 Calculation of source hazardous waste quantity value for radionuclides. Select the higher of the values assigned to the source (or area of observed contamination, area of observed exposure, and/or area of subsurface contamination) for radionuclide constituent quantity and radionuclide wastestream quantity. Assign this value as the source hazardous waste quantity value for the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination). Do not round to the nearest integer.
7.2.5.2 Calculation of hazardous waste quantity factor value for radionuclides. Sum the source hazardous waste quantity values assigned to all sources (or areas of observed contamination, areas of observed exposure, or areas of subsurface contamination) for the pathway being evaluated and round this sum to the nearest integer, except: if the sum is greater than 0, but less than 1, round it to 1. Based on this value, select a hazardous waste quantity factor value for this pathway from Table 2-6 (section 2.4.2.2).
For a migration pathway, if the radionuclide constituent quantity is adequately determined (see section 7.2.5.1.1) for all sources (or all portions of sources and releases remaining after a removal action), assign the value from Table 2-6 as the hazardous waste quantity factor value for the pathway. If the radionuclide constituent quantity is not adequately determined for one or more sources (or one or more portions of sources or releases remaining after a removal action), assign a factor value as follows:
• If any target for that migration pathway is subject to Level I or Level II concentrations (see section 7.3), assign either the value from Table 2-6 or a value of 100, whichever is greater, as the hazardous waste quantity factor value for that pathway.
• If none of the targets for that pathway is subject to Level I or Level II concentrations, assign a factor value as follows:
For the soil exposure component of the soil exposure and subsurface intrusion pathway, if the radionuclide constituent quantity is adequately determined for all areas of observed contamination, assign the value from Table 2-6 as the hazardous waste quantity factor value. If the radionuclide constituent quantity is not adequately determined for one or more areas of observed contamination, assign either the value from Table 2-6 or a value of 10, whichever is greater, as the hazardous waste quantity factor value.
For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, if the radionuclide constituent quantity is adequately determined for all areas of observed exposure, assign the value from Table 2-6 as the hazardous waste quantity factor value. If the radionuclide constituent quantity is not adequately determined for one or more areas of observed exposure, assign either the value from Table 2-6 or a value of 10, whichever is greater, as the hazardous waste quantity factor value.
7.2.5.3 Calculation of hazardous waste quantity factor value for sites containing mixed radioactive and other hazardous substances. For each source (or area of observed contamination, area of observed exposure, or area of subsurface contamination) containing mixed radioactive and other hazardous substances, calculate two source hazardous waste quantity values—one based on radionuclides as specified in sections 7.2.5.1 through 7.2.5.1.3 and the other based on the nonradioactive hazardous substances as specified in sections 2.4.2.1 through 2.4.2.1.5, and sections 5.1.1.2.2, 5.1.2.2.2 and 5.2.1.2.2 (that is, determine each value as if the other type of substance was not present). Sum the two values to determine a combined source hazardous waste quantity value for the source (or area of observed contamination, area of observed exposure, or area of subsurface contamination). Do not round this value to the nearest integer.
Use this combined source hazardous waste quantity value to calculate the hazardous waste quantity factor value for the pathway as specified in section 2.4.2.2, except: if either the hazardous constituent quantity or the radionuclide constituent quantity, or both, are not adequately determined for one or more sources (or one or more portions of sources or releases remaining after a removal action) or for one or more areas of observed contamination or areas of observed exposure, as applicable, assign the value from Table 2-6 or the default value applicable for the pathway, whichever is greater, as the hazardous waste quantity factor value for the pathway.
7.3 Targets. For radioactive substances, evaluate the targets factor category as specified in section 2.5 and sections 3 through 6, except: Establish Level I and Level II concentrations at sampling locations as specified in sections 7.3.1 and 7.3.2 and establish weighting factors for populations associated with an area of subsurface contamination in the subsurface intrusion component of the soil exposure and subsurface intrusion pathway as specified in section 7.3.3.
For all pathways (components and threats), use the same target distance limits for sites containing radioactive substances as is specified in sections 3 through 6 for sites containing nonradioactive hazardous substances. At sites containing mixed radioactive and other hazardous substances, include all sources (or areas of observed contamination, areas of observed exposure, or areas of subsurface contamination) at the site in identifying the applicable targets for the pathway.
7.3.1
• Select the benchmarks from section 7.3.2 applicable to the pathway (or component or threat) being evaluated.
• Compare the concentrations of radionuclides in the sample (or comparable samples) to their benchmark concentrations for the pathway (or component or threat) as specified in section 7.3.2. Treat comparable samples as specified in section 2.5.1.
• Determine which level applies based on this comparison.
• If none of the radionuclides eligible to be evaluated for the sampling location have an applicable benchmark, assign Level II to the actual contamination at that sampling location for the pathway (or component or threat).
• In making the comparison, consider only those samples, and only those radionuclides in the sample, that meet the criteria for an observed release (or observed contamination or observed exposure) for the pathway, except: Tissue samples from aquatic human food chain organisms may also be used for the human food chain threat of the surface water pathway as specified in sections 4.1.3.3 and 4.2.3.3.
7.3.2
• Maximum Contaminant Levels (MCLs)—ground water migration pathway and drinking water threat in surface water migration pathway.
• Uranium Mill Tailings Radiation Control Act (UMTRCA) standards—soil exposure component of the soil exposure and subsurface intrusion pathway only.
• Screening concentration for cancer corresponding to that concentration that corresponds to the 10
Select the benchmark(s) applicable to the pathway (component or threat) being
If no radionuclide individually equals or exceeds its benchmark concentration, but more than one radionuclide either meets the criteria for an observed release (or observed contamination or observed exposure) for the sample or is eligible to be evaluated for a tissue sample (see sections 4.1.3.3 and 4.2.3.3), calculate a value for index I for these radionuclides as specified in section 2.5.2. If I equals or exceeds 1, assign Level I to the sampling location. If I is less than 1, assign Level II.
At sites containing mixed radioactive and other hazardous substances, establish the level of contamination for each sampling location considering radioactive substances and nonradioactive hazardous substances separately. Compare the concentration of each radionuclide and each nonradioactive hazardous substance from the sampling location to its respective benchmark concentration(s). Use only those samples and only those substances in the sample that meet the criteria for an observed release (or observed contamination or observed exposure) for the pathway except: Tissue samples from aquatic human food chain organisms may be used as specified in sections 4.1.3.3 and 4.2.3.3. If the concentration of one or more applicable radionuclides or other hazardous substances from any sample equals or exceeds its benchmark concentration, consider the sampling location to be subject to Level I concentrations. If more than one benchmark applies to a radionuclide or other hazardous substance, assign Level I if the concentration of the radionuclide or other hazardous substance equals or exceeds its lowest applicable benchmark concentration.
If no radionuclide or other hazardous substance individually exceed a benchmark concentration, but more than one radionuclide or other hazardous substance either meets the criteria for an observed release (or observed contamination or observed exposure) for the sample or is eligible to be evaluated for a tissue sample, calculate an index I for both types of substances as specified in section 2.5.2. Sum the index I values for the two types of substances. If the value, individually or combined, equals or exceeds 1, assign Level I to the sample location. If it is less than 1, calculate an index J for the nonradioactive hazardous substances as specified in section 2.5.2. If J equals or exceeds 1, assign Level I to the sampling location. If J is less than 1, assign Level II.
7.3.3 Weighting of targets within an area of subsurface contamination. For the subsurface intrusion component of the soil exposure and subsurface intrusion pathway, assign a weighting factor as specified in section 5.2.1.3.2.3 except when a structure in an area of subsurface contamination is delineated or inferred to be delineated by gamma radiation exposure rates meeting observed release criteria with a depth to contamination of 2 feet or less. For those populations residing, working, or attending school or day care in a structure delineated or inferred to be delineated by gamma radiation exposure rates meeting observed release criteria with a depth to contamination of 2 feet or less, assign a weighting factor of 0.9.
Architectural and Transportation Barriers Compliance Board.
Final rule.
The Architectural and Transportation Barriers Compliance Board (Access Board or Board) is issuing accessibility standards for medical diagnostic equipment. The standards for medical diagnostic equipment (MDE Standards) contain minimum technical criteria to ensure that medical diagnostic equipment, including but not limited to, examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to, and usable by, individuals with disabilities. The MDE Standards will allow independent entry to, use of, and exit from the equipment by individuals with disabilities to the maximum extent possible. The MDE Standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However, other agencies, referred to as enforcing authorities in the MDE Standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that complies with the MDE Standards.
The final rule is effective February 8, 2017.
Earlene Sesker, U.S. Access Board, 1331 F Street NW., Suite 1000, Washington, DC 20004-1111. Telephone numbers: 202-272-0022 (voice) or 202-272-0091 (TTY). Email address:
The Access Board is an independent federal agency established by Section 502 of the Rehabilitation Act (29 U.S.C. 792). The Access Board is responsible for developing accessibility guidelines and standards under various laws to ensure that individuals with disabilities have access to and use of buildings and facilities, transportation vehicles, and information and communication technology. Pursuant to these laws, other federal agencies have adopted the Access Board's guidelines and standards as mandatory requirements for entities subject to their jurisdiction.
On March 23, 2010, Section 4203 of the Patient Protection and Affordable Care Act (ACA) amended Title V of the Rehabilitation Act, which established the rights and protections for individuals with disabilities, by adding Section 510. Public Law 111-148, 124 Stat. 570). Section 510 of the Rehabilitation Act charges the Access Board, in consultation with the Commissioner of the Food and Drug Administration, with issuing standards that set forth the minimum technical criteria to ensure that medical diagnostic equipment (diagnostic equipment) used in (or in conjunction with) “physician's offices, clinics, emergency rooms, hospitals, and other medical settings, is accessible to, and usable by, individuals with accessibility needs, and shall allow independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible.” 29 U.S.C. 794f.
The statute gives examples of diagnostic equipment, including “examination tables, examination chairs (including chairs used for eye examinations or procedures, and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals.” 29 U.S.C. 794f. This list is not considered exhaustive, but is illustrative of types of medical diagnostic equipment.
Section 510 of the Rehabilitation Act instructs the Access Board to promulgate technical standards regarding accessibility of medical diagnostic equipment, but does not give the Access Board authority to enforce these standards. Compliance with the MDE Standards becomes mandatory only when an enforcing authority adopts the MDE Standards as mandatory for entities subject to its jurisdiction. Additionally, the enforcing agencies will determine the application and scope of these standards, such as who must comply and the extent to which medical diagnostic equipment used by covered entities must comply with these MDE Standards. As discussed below, the U.S. Department of Justice (DOJ) may adopt the MDE Standards as mandatory requirements for health care providers pursuant to its authority under Titles II and III of the Americans with Disabilities Act. Other federal agencies may adopt the standards as mandatory requirements for health care providers pursuant to their authority under Section 504 of the Rehabilitation Act.
Private parties, including individuals with disabilities, have also entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.
The Commissioner of the Food and Drug Administration designated the Director of the Center for Devices and Radiological Health (FDA-CDRH) to consult with the Access Board on the development of the MDE Standards. The Access Board has worked throughout the process with the FDA-CDRH in developing these Standards.
The Access Board has divided the MDE Standards into separate technical criteria based on how the diagnostic equipment is used by the patient: (1) Supine, prone, or side lying position (M301); (2) seated position (M302); (3) while seated in a wheelchair (M303); and (4) standing position (M304). For each category the Access Board has provided technical criteria to allow independent access to and ensure the diagnostic equipment was usable by patients with disabilities to the maximum extent possible. The technical requirements for diagnostic equipment used by patients in the supine, prone, or side-lying position and diagnostic equipment used by patients in the seated position focus on ensuring the patient can transfer from a mobility device onto the diagnostic equipment. The other two categories, M303 and M304, focus on the necessary technical requirements to allow the patient to use the diagnostic equipment while seated in their wheeled mobility device, or while standing, respectively.
The MDE Standards also include technical criteria for supports (M305), for instructions or other information communicated to patients through the equipment (M306), and for operable parts used by patients (M307).
The MDE Standards are advisory and are not binding until adopted by an enforcing authority. The Access Board's mandate was to establish only the minimum technical criteria, however enforcing authorities may establish scoping requirements in the future. As
Nevertheless, the Board is able to characterize qualitatively some of the potential impacts of these Standards. If enforcing agencies adopt the MDE Standards as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers, medical device manufacturers, and individuals with disabilities. Once health care providers and facilities are required to acquire accessible medical equipment, they could incur compliance costs, to the extent that their equipment is not already accessible. Medical device manufacturers would then decide whether to incur incremental costs to meet the demand for accessible equipment, and some or many manufacturers may have an economic incentive to produce accessible equipment. Finally, given the many barriers to health care that patients with mobility and communication disabilities encounter due to inaccessible medical diagnostic equipment, individuals with disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. Consequently, they may be able to receive health care comparable to that received by their non-disabled counterparts.
In addition, the Standards could yield some immediate benefits, even before any adoption by implementing agencies in formal rulemaking. First, the technical specifications for accessible MDE incorporated in the Standards will benefit enforcing agencies that are considering similar accessibility requirements for entities under their jurisdiction. Although enforcing agencies have full authority over whether to adopt the Access Board's final rule (in whole or in part), the technical specifications in the MDE Standards reflect the input from a diverse set of stakeholders and provide solid groundwork for any future rulemaking pertaining to the accessibility of medical diagnostic equipment. Second, the Standards will serve as a best-practice document for the medical device industry and for health care providers and facilities. While the MDE Standards are non-binding, health care providers can use this final rule as guidance on how to provide equitable access to medical diagnostic equipment for people with mobility and communication disabilities. Manufacturers can also use the MDE Standards as they target their research and development efforts at producing diagnostic equipment that can be used by a larger segment of population—one that includes more people with disability and older adults.
The Board thus concludes that the potential benefits of the MDE Standards justify its potential costs; that the MDE Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits.
Section 510 of the Rehabilitation Act requires the Access Board to issue standards for medical diagnostic equipment to ensure such equipment is accessible to, and usable by, individuals with disabilities no later than 24 months after the date of the enactment of the ACA. 29 U.S.C 794f.
On February 9, 2012, the Access Board formally commenced the rulemaking process and issued a notice of proposed rulemaking proposing accessibility standards for medical diagnostic equipment. Notice of Proposed Rulemaking—Medical Diagnostic Equipment Accessibility Standards, 77 FR 6916 (February 9, 2012) (hereinafter MDE NPRM). The proposed standards contained minimum technical criteria to ensure that medical diagnostic equipment, including, but not limited to, examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purpose is accessible to, and usable by, individuals with disabilities.
The public comment period for the proposed rule ended on June 6, 2012. Comments were submitted by persons with disabilities, governmental agencies, disability rights organizations, and representatives of the medical diagnostic equipment industry and the medical community. In all, 59 comments were received; twenty-four from individuals, thirteen from the medical diagnostic equipment industry and the medical community, nine from disability rights organizations, four from accessibility consultants, three from academics, two from state and federal organizations, and four duplicate submissions. The public comments are available at
On March 13, 2012, the Access Board published a notice of intent to establish an advisory committee to advise the Board on matters addressed in the MDE NPRM and issues raised in the public comments. Notice of Intent to Establish Advisory Committee—Medical Diagnostic Equipment Accessibility Standards, 77 FR 14706 (March 13, 2012). On July 5, 2012, the Access Board established the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (MDE Advisory Committee). Notice of Establishment; Appointment of Members—Medical Diagnostic Equipment Accessibility Standards Advisory Committee, 77 FR 39656 (July 5, 2012). The MDE Advisory Committee was comprised of individuals from 24 organizations representing a range of stakeholders and ex officio members from the FDA, Department of Justice, and the
In all 60 comments were received; the comments are available at:
In the preamble to the MDE NPRM, the Access Board identified the following barriers to accessibility, as documented in the Rehabilitation Engineering Research Center on Accessible Medical Instrument National Survey,
The technical criteria in the final rule addresses most of the barriers that were identified in the study as affecting the accessibility and usability of medical diagnostic equipment. However, at this time it is not possible for the MDE Standards to address every barrier. The Access Board is very interested in the additional barriers raised by public commenters and believes that further research is needed on some of the recommendations; such as equipment characteristics of stiffness, comfort, and color contrast of contact surfaces, and ensuring the accessibility of people with sensory and cognitive disabilities, and pediatric and bariatric patients. Section 510 of the Rehabilitation Act requires the Access Board to periodically review and amend the standards, as appropriate. The Access Board will address other barriers in future updates to the MDE Standards.
Additionally, commenters noted other areas of medical diagnostic equipment and issues of patient accessibility and recommended multiple changes or additions to the final rule. Specifically, commenters recommended adding weight capacity or patient load requirements, ensuring that the room is accessible, developing a manner to evaluate and measure the accessibility of equipment to give to patients, requiring staff training on how to use accessible equipment and how to provide assistance to people with disabilities, and requiring patient support surfaces. Based on the Access Board's review of these issues, many of the commenters concerns are outside the scope of this rulemaking but are issues that may be addressed by enforcing authorities when they provide scoping and application requirements in adopting the MDE Standards. Additionally, the Board may elect to address the accessibility of examination rooms and other spaces containing diagnostic equipment under its authority to develop guidelines for buildings and facilities subject to the ADA and ABA. The other issues of weight capacity and patient support surfaces will be added to the additional barriers list above, and considered for inclusion when the MDE Standards are updated.
The Access Board received nine comments asserting that figures help the reader to better understand the technical
This section of the preamble addresses significant changes made from the MDE NPRM to the final rule in response to the comments received, recommendations from the MDE Advisory Committee, and other information that has come to the Access Board's attention during the rulemaking process. Individual provisions of the rule are discussed in detail under the Section-by-Section Analysis below.
In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply. There was only one significant change to this section, which added a general exception for diagnostic equipment that is unable to meet one or more of the requirements in the final rule.
The MDE NPRM proposed several limited exceptions to certain provisions addressing the limitations of current technology and design. Through testimony at the public hearings, comments, and MDE Advisory Committee discussions, the manufacturers of imaging equipment consistently raised concerns about inherent barriers to compliance with the proposed MDE Standards due to the location of imaging and mechanical components necessary to achieve the diagnostic aims. Some specific examples include: Dual Energy X-Ray Absorptiometry (DXA) machines, with a mechanism that moves imaging components along a track beneath the patient surface precluding height adjustability for the transfer surface; prone biopsy tables that must be of a sufficient height to permit health care providers access beneath the patient surface to perform procedures, precluding the equipment from meeting the minimum transfer surface height; and mammography machines with low dose radiation detectors that are larger in size than conventional configurations and required to be in locations that partially obstruct clearances for knee and toe space beneath the breast platform. While the MDE NPRM proposed several specific technical exceptions in Chapter 3, the exceptions did not address the manufacturers' overall concerns regarding imaging equipment. Section 510 of the Rehabilitation Act requires the MDE Standards to provide independent access “to the maximum extent possible.” The Access Board interprets this language as recognizing that, in some situations, current technology may preclude diagnostic equipment from meeting all of the technical requirements in the MDE Standards. Therefore, the Access Board has added a general exception to Chapter 2 allowing compliance to the maximum extent practicable for the rare circumstance where full compliance would alter diagnostically required structural or operational characteristics of the equipment, and would prevent the use of the equipment for its intended diagnostic purpose. Any equipment utilizing this exception is still required to meet all other applicable provisions of the MDE Standards. We anticipate that this exception will be employed on a very limited basis for a few specialized equipment types, primarily imaging equipment. This provision is not intended to exempt a piece of diagnostic equipment from the MDE Standards as a whole. Limitations resulting from existing equipment designs or manufacturing practices that could be altered to meet the requirements are not a basis for invoking this exception; only diagnostically required structural or operational characteristics that cannot be made to comply with the technical requirements without preventing the use of the equipment for its intended diagnostic purpose are covered by this provision.
In the final rule M301 and M302 provide the technical requirements for diagnostic equipment used in the supine, prone, or side-lying position, and diagnostic equipment used by patients in the seated position. Sections M301 and M302, which ensure that patients can transfer from their mobility devices onto the diagnostic equipment, share many technical requirements. Therefore, the Significant Changes Section addresses the transfer surface and lift compatibility requirements for M301 and M302 together. New exceptions pertaining to weight scales and to the type of equipment that must comply with M301 and the decision to remove the armrest requirements from M302, are also discussed below.
The MDE NPRM proposed that the same transfer surface height range of 17 inches minimum to 19 inches maximum be applied to both diagnostic equipment used in the supine, prone, or side-lying position and diagnostic equipment used in the seated position (proposed M301.2.1 and M302.2.1, respectively). The Board considered it likely that diagnostic equipment would be adjustable in height to serve practitioners' needs however, the transfer surface could be fixed within the proposed height range. The Access Board sought public comment in the MDE NPRM preamble on whether the final standards should require the height of the transfer surface to be adjustable from 17 inches minimum to 25 inches maximum. NPRM, 77 FR at 6922-6933, questions 13 and 14. The majority of commenters, including manufacturers and disability advocates, supported both an adjustability requirement and the proposed high transfer height, but disagreed on what should be the low transfer height.
The MDE Advisory Committee recommended a high transfer height of at least 25 inches and recommended that the transfer surface be adjustable in small, virtually continuous increments. MDE Advisory Committee Report, 67-71, available at
After considering the public comments and the recommendations from the MDE Advisory Committee, the Access Board has decided to include in the final rule the following requirements for diagnostic equipment used in the supine, prone or side-lying position, and for diagnostic equipment used in the seated position: An adjustable transfer height range with a minimum high and low height; four intermediate transfer heights within the adjustable range; and a specific method to measure the transfer heights. These new
In the preamble to the MDE NPRM, the Access Board sought comment in question 14 on whether the final rule should require an adjustable height range of 17 inches to 25 inches; whether equipment currently met this proposed requirement and, if not, what would the cost be to achieve that range; and whether intermediate heights should also be required within the adjustable height range. NPRM, 77 FR at 6923. While 20 commenters responded to question 14, only four commenters explicitly addressed the proposed minimum high height of 25 inches. Of these, two commenters (an accessibility consultant and a state agency concerned with accessibility) concurred with a minimum high height of 25 inches. One commenter, a manufacturer, recommended increasing the minimum high height to 28 inches for all diagnostic equipment except magnetic resonance imaging (MRI) equipment, which has limitations that may prevent it from reaching 28 inches. Another manufacturer gave examples of the height ranges of its beds and stretchers, each of which met the 25-inch minimum high height.
After reviewing the comments and other evidence before it, the MDE Advisory Committee recommended a high transfer height requirement of 25 inches noting that:
The Access Board was persuaded by the arguments of commenters and the MDE Advisory Committee in favor of requiring a minimum high transfer surface height of 25 inches. A 25-inch minimum high height will ensure that the transfer surface can be raised up to the height of the vast majority of wheelchair seat heights, which are 25 inches high or lower. The final rule requires a minimum high transfer surface height of 25 inches for both diagnostic equipment used in the supine, prone or side-lying position (M301.2.1), as well as diagnostic equipment used in the seated position (M302.2.1). Nothing in the rule prohibits a manufacturer from providing a high transfer height above 25 inches as long as transfer is provided within the range specified up to 25 inches.
The Access Board received many comments from disability rights organizations, individuals, accessibility consultants, and a health care provider supporting the need for lower height adjustable tables. Specifically, these commenters explained the need for adjustable height tables to facilitate and promote independent or semi-independent transfer. These commenters explained the delay in diagnosis and treatment when patients are unable to transfer from their wheeled mobility device to the examination surface and are inadequately examined while remaining in their wheelchair. These commenters also explained that adjustable tables would enhance both the safety of patients, by reducing the risk of falls and injury incurred from assisted transfer, as well as reducing injury to medical staff and caregivers by lessening the likelihood of back and other lifting injuries. One individual commenter recalled being bruised when she was dragged onto medical equipment that was too high, while another commenter noted that the risk to healthcare workers increases when access to medical diagnostic equipment is not optimized.
In addressing what the low transfer height should be, 12 commenters responded to question 14 specifically addressing the proposed minimum low transfer surface height. Six commenters (an individual, a state agency concerned with accessibility, two accessibility consultants and two disability rights advocates, one whose comment was supported by 50 disability rights organizations) supported requiring a low transfer height of 17 inches. These commenters asserted that the lower height would provide more accessibility, safety for both patients and healthcare providers, and allow more patients to transfer independently or semi-independently. One commenter, a medical association, supported allowing a minimum low height range of 17 to 19 inches recommending as much latitude for manufacturers as possible. The remaining six commenters (manufacturers and a medical association) voiced strong concerns about the cost of complying with a minimum low height of 17 inches, the potential consequences of being unable to raise the equipment up to a height comfortable for practitioners, and whether current technology and designs would allow diagnostic equipment to reach such a low height. Additionally, some of the manufacturers and medical associations voicing support for a minimum low height of 19 inches, indicated that either their equipment currently meets or would be capable of meeting a 19-inch low height requirement.
Like the public commenters, the MDE Advisory Committee was divided on this issue and was unable to reach consensus regarding a minimum low transfer surface height. MDE Advisory Committee Report, 70, available at
After careful consideration of the available information, the MDE Advisory Committee was unable to agree upon a recommendation for a transfer surface height, and Committee members were invited to submit minority reports supporting their view of the issue.
The minority reports submitted by the disability advocates and academics supported a minimum low height of 17 inches.
Most manufacturers on the Committee had a 19 to 21-inch surface available currently, with at least one having a product at 18. Their argument has always been that providing the lowest transfer heights would be an extraordinary expense and burden on the business community (their consumer), not based on how it benefitted a patient with a disability. This effort was never supposed to be about the manufacturers or the doctors. It is the charge of this committee to answer questions and come up with recommendations for accessibility, based by some members on engineering and others by experience. NCIL's 30-plus years of experience as advocates for people with disabilities dictates that we continue to strongly insist that the U.S. Access Board maintain the low accessible height at 17 inches above the floor in order for medical and diagnostic equipment to be accessed by the greatest number of people.
The minority reports submitted by manufacturers supported a minimum low height of 19 inches.
Brewer has been manufacturing adjustable height examination tables since 2002. These tables were designed specifically for wheelchair accessibility by meeting the 19-inch height referenced in the ADA/ABA Accessibility Guidelines. Brewer is ISO 13485 certified. ISO requires a robust method for recording customer, end user, and clinician feedback. In the 11 years we have been selling adjustable height examination tables we do not have a single complaint on record regarding the accessibility of our 19″ low height tables. There have been no
In their joint minority report, examination table manufacturers asserted, “Based on our analysis, we determined that transfer surface height requirements lower than 19 inches would increase the cost of designing and manufacturing examination tables, reduce the rate of adoption of accessible equipment, and increase the health provider's cost of purchasing accessible equipment.”
With respect to the cost of compliance for the tables on imaging equipment, some manufacturers noted the inherent difficulty of redesign, the potential cascading impacts of adopting a low height of 17 inches, and the difficulty in that imaging equipment undergoes many years of work before they become commercially available.
Moreover, the most significant of these design changes can result in cascading alterations to the scanner, potentially leading to unacceptable heating in the case of MR, impacts on image signal/quality, and changes in dose levels to ensure the same, effective, high quality images and increased examination times, that is, additional workflow steps.
After carefully considering the totality of comments received and the MDE Advisory Committee materials, the Access Board has concluded that there is insufficient information to designate a single minimum low height requirement at this time. Specifically, there is insufficient data on the extent to which and how many individuals would benefit from a transfer height lower than 19 inches. Due to this lack of sufficient information, coupled with the lack of consensus among the MDE Advisory Committee and the commenters, the Access Board has decided to establish, for five years only, a range for the minimum low height requirement of 17 inches to 19 inches. During the five-year period following issuance of the final rule, any low transfer height between 17 and 19 inches will meet the MDE Standards. The Access Board acknowledges that this is a temporary solution, and has commissioned a study to quantify the portion of the population that would benefit from a low transfer height below 19 inches. A pilot study was completed prior to the publication of this final rule. A sunset provision has been included in the final rule that will repeal this low height range five years after the date of publication in the
In the MDE NPRM there was no requirement for the transfer surface to have intermediate transfer heights. Under the proposed rule, diagnostic equipment would be in compliance if it provided a low transfer height anywhere within the range of 17 inches minimum and 19 inches maximum. In addition to the matter of low transfer height, the Access Board sought public comment in question 14(c) on whether the final rule should require intermediate heights between a minimum low transfer height and a minimum high transfer height. NPRM, 77 FR at 6923. Three commenters responded (two accessibility consultants and a disability rights advocate) and supported the idea of requiring intermediate heights within a minimum low height and minimum high height of the transfer surface. One commenter, an accessibility consultant, recommended intervals of
The Access Board has decided to require that the height of the transfer surface be adjustable within the range for the minimum low and high heights in at least four unspecified intermediate heights, but has determined that the intermediate heights should be set a minimum of one inch apart. While the Access Board agrees that continuous adjustment is preferable, requiring such adjustability could preclude the use of certain types of lifting devices such as hydraulic systems that work in increments. The intent is to permit manufacturers flexibility in setting intermediate heights and not prohibitively restrict designs to those of particular manufacturers or equipment.
The MDE NPRM proposed that the measurement of the height of the transfer surface for both diagnostic equipment used in the supine, prone, or side-lying position and diagnostic equipment used in the seated position, be taken from the floor to the top of the transfer surface (proposed M301.2.1 and M302.2.1, respectively). The Access
The MDE NPRM proposed the same location and transfer sides of the transfer surface for diagnostic equipment used by patients in the supine, prone, or side-lying position (M301) and diagnostic equipment used by patients in the seated position (M302). This transfer surface was located at the end of the diagnostic equipment and provided options to transfer from a mobility device onto one short side and one long side of the transfer surface. (proposed M301.2.3 and M302.2.3, respectively). Numerous commenters objected on the basis that this type of transfer is not always possible for certain types of medical diagnostic equipment; the MDE Advisory Committee agreed with commenter concerns. The Access Board is persuaded by many of the concerns raised by commenters and the MDE Advisory Committee. In the final rule the structure and content of the transfer surface provision has been revised for diagnostic equipment used by patients in the supine, prone, or side-lying positions to provide two types of transfer surfaces; end transfer surfaces and side transfer surfaces. For diagnostic equipment used by patients in the seated position, the Access Board has decided to retain the proposed rule requirements for transfer surface location and transfer sides, but has added an exception to the transfer sides provision in the final rule to address the concerns raised by commenters and the MDE Advisory Committee.
Multiple commenters expressed concerns that transfer cannot always occur at the end of the diagnostic equipment as contemplated by the requirements in the proposed rule. One commenter elaborated that stretchers and hospital beds are always entered from one or the other long side of the bed, not the foot end, due to obstructions at the head and foot ends that cannot be removed. Another commenter recommended allowing transfer space at both the center and the end of the transfer surface.
Evidence presented to the MDE Advisory Committee during its deliberations revealed that it is not always possible to transfer from adjoining sides at the end of the diagnostic equipment in the prone, supine, or side-lying position on certain types of equipment such as stretchers and imaging equipment with scanning beds. MDE Advisory Committee Report, 75-82, available at
Based on the comments received and the MDE Advisory Committee recommendations, the Access Board has concluded that for diagnostic equipment used by patients in supine, prone, or side-lying positions two transfer surface orientations are possible depending on the intended location from which the transfer is to be made. These orientations are now identified as an end transfer surface and side transfer surface. This necessitated adding the definition of “end transfer surface” and “side transfer surface” to the defined terms (M102.1) in the final rule and resulted in the removal of the proposed M301.2.3 Transfer Sides, as that is now described within the two types of transfer surfaces provided. The end transfer surface accommodates the transfer method conceived of in the proposed rule; where the transfer occurs at one end of the examination surface and allows the patient the option to transfer at the end and on one adjoining side of the examination surface. The side transfer surface responds to the concerns raised by commenters and the MDE Advisory Committee to accommodate diagnostic equipment where transfer occurs within the length of the examination surface and allows patient transfer at the sides of the examination surface. Side transfer surfaces most typically will be imaging equipment, stretchers, hospital beds, and other equipment where the end is obstructed and cannot be used for transfer. Accordingly, the Access Board has reorganized the requirements regarding the transfer surface for M301 into two types based on where the transfer is to occur: “End Transfer” or “Side Transfer.” This revision to provide options for two types of transfer surfaces necessitated adding additional technical criteria addressing transfer surface size (M301.2.3) and transfer supports (M305.2), as well as adding the
Commenters also raised concerns with the provisions in the MDE NPRM related to transferring to medical diagnostic equipment used by patients in the seated position. Commenters stated that there is certain diagnostic equipment used by patients in the seated position where transfer at the end of the seat by two adjoining sides is not feasible. Specifically, commenters raised concerns about diagnostic equipment with fixed footrests, such as podiatry and dentistry chairs. Transfer onto these types of diagnostic equipment must be made from either long side, similar to the side transfer surface described above. One commenter explained that fixed footrest chairs are meant to treat patients with their legs extended parallel to the ground. If entered as suggested in the proposed rule the patient would have to enter the chair by positioning themselves onto this fixed footrest section that is at a downward angle and would require the patient to slide up an inclined surface to be properly positioned on the diagnostic equipment.
The MDE Advisory Committee agreed with a majority of the commenters that some examination chairs which have fixed footrests prevent transfer as conceived of in the proposed rule. The Committee noted that:
The Access Board agrees that diagnostic equipment used by patients in the seated position with fixed footrests requires a different transfer approach than those without fixed footrests. Therefore, the Access Board has added an exception to the transfer sides provision (M302.2.4) in the final rule to permit diagnostic equipment with fixed footrests to provide options to transfer from opposing sides of the transfer surface.
The American Dental Association proposed a complete exemption of dental chairs from the MDE Standards, asserting that the Access Board has not provided any evidence that dental offices are inaccessible, citing to the national survey in MDE NPRM “that collected information on the types of medical equipment that are most difficult for individuals with disabilities to access and use. The American Dental Association urge[d] the Access Board to refrain from proposing costly new requirements based on examination chairs that are only `moderately difficult' for disabled patients to use.” The American Dental Association explains that “dental chairs already have many accessibility features built in and manufacturers as well as health care providers have an economic incentive to produce and procure accessible medical diagnostic equipment and therefore, the American Dental Association does not believe that additional regulations are necessary, particularly with respect to dental examination chairs.” Comment of American Dental Association, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (Apr. 4, 2012), available at
The Access Board does not concur with the comment urging that dental chairs should receive a blanket exemption. The record is replete with evidence that individuals with disabilities do encounter barriers to dental care as a result of inaccessible dental chairs. For example, one commenter, a disability rights organization representing 37,000 members, explained that it asked its members “and others with disabilities about the barriers they encounter when seeking medical care and treatment. The most frequent responses involved access to examination chairs, dentist chairs, scales and mammography and colonoscopy equipment.” Comment of United Spinal Association, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (June 4, 2012), available at
The MDE NPRM proposed a transfer surface size for diagnostic equipment used in the supine, prone, or side-lying position of 30 inches wide and 15 inches deep minimum (proposed M301.2.2). These dimensions were based on the dimensions specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers (36 CFR part 1191, App. D 610.3.1) and the ANSI/AAMI HE 75 which notes that a standard examination table is 27 inches wide and a bariatric table is approximately 30 to 32 inches wide and recommends wider surfaces to make repositioning easier. ANSI/AAMI HE 75, section 16.4.7, available at
The MDE Advisory Committee discussions mirrored the comments to the MDE NPRM with recommendations ranging from 24 inches to 36 inches for the width of the transfer surface. The MDE Advisory Committee reviewed evidence about transfer surface size to include: Numerous video clips showing various transfers (both assisted and unassisted); industry exhibited tables to show current table and chair widths; and the findings of the Wheeled Mobility Anthropometry Project presented by Dr. Edward Steinfeld of the IDeA Center at the University of Buffalo. MDE Advisory Committee Report, 72-76, available at
The MDE Advisory Committee made multiple recommendations for the transfer surface depth of diagnostic equipment used by patients in the supine, prone, or side-lying position.
As discussed above in Section IV.B.1.b (Significant Changes—Transfer Surface Location) the restructure of the transfer surface to include two types of transfer surfaces; end transfer surface and side transfer surface, necessitates new technical requirements for the new side transfer surface. Accordingly, based on the comments received and the recommendations from the MDE Advisory Committee, the final rule establishes different sizes for each of the end and side transfer surfaces. The final rule requires that diagnostic equipment with an end transfer surface be a minimum size of 28 inches wide and 17 inches long. The Access Board has decreased the minimum width of the transfer surface from 30 inches to 28 inches based on the evidence presented to the advisory committee that 28 inches is sufficient to accommodate 95 percent of the users and will ensure that patients are able to utilize the transfer supports on the opposite side of the transfer surface. The Access Board has increased the length of the end transfer surface from 15 inches to 17 inches based on the evidence that diagnostic equipment currently on the market is already built to this dimension. In the final rule, the Access Board does not see a reason to prohibit an adjustable feature, such as a table with extendable sides, from meeting the size requirements of the transfer surface but believes it is unlikely that any diagnostic equipment would contain such a feature.
For diagnostic equipment with side transfer surfaces, the Access Board has decided to require a transfer surface size of 28 inches wide by 28 inches long, minimum. While the MDE Advisory Committee recommended only increasing the transfer surface size for imaging equipment to 28 inches deep by 28 inches wide minimum, the Access Board has concluded that diagnostic equipment used by patients in the supine, prone, or side-lying position with side transfer surfaces involve the same transfer dynamics whether they are imaging equipment, hospital beds, or stretchers and therefore should be subject to the same transfer surface size requirement.
Additionally, the Access Board concurs with the MDE Advisory Committee recommendation to provide an exception for the transfer surface size of imaging equipment in the final rule given the physical limitations affecting surface depth for imaging equipment with bores and the fact that it is unclear when technological advances in bore size may permit larger patient examination surfaces. However, the Access Board has narrowed the application of this exception only to imaging equipment with bores. The Access Board has determined that this exception, as recommended, was intended to account for the space constraints of imaging equipment with bores and wants to ensure the exception stays as narrow as possible. Therefore, in the final rule, the Access Board has provided an exception which permits the imaging bed of imaging equipment with bores' to be a minimum of 21 inches wide but requires the transfer surface to be the full width of the examination surface. As this exception applies regardless of whether the
The MDE NPRM proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer (proposed M301.2.3 and M302.2.3). As explained in the MDE NPRM preamble, the unobstructed access requirement was to ensure that armrests, side rails, stirrups, or other equipment parts attached to the diagnostic equipment did not impede the patient's ability to transfer. NPRM, 77 FR at 6923. The final rule retains the proposed requirements for unobstructed transfer for diagnostic equipment used in a supine, prone, or side-lying position, as well as diagnostic equipment used in the seated position, and has added a new exception described below.
In the preamble to the MDE NPRM the Access Board noted that it was considering permitting equipment parts to extend a maximum of three inches horizontally beyond the edge of the transfer side. The Access Board explained that “[t]he 2004 ADA and ABA Accessibility Guidelines provide a gap of 3 inches between the edge of the shower seat and the shower compartment entry, and the gap does not appear to interfere with transferring onto and off of the shower seat.” NPRM, 77 FR at 6924. The Access Board sought input from the public in the MDE NPRM preamble question 17, on whether equipment parts should be permitted to extend a maximum of three inches horizontally beyond the edge of the transfer sides, provided that they did not extend above the top of the transfer surface.
The MDE Advisory Committee reviewed the comments. The Committee observed that transfer supports provide handholds that facilitate transfers onto and off of the equipment, and that some types of diagnostic equipment have components that create a gap between the transfer surface and the outer edge of the equipment on the side used for transfer. MDE Advisory Committee Report, 78-82, available at
Based on the comments received and the MDE Advisory Committee recommendations, the Access Board is persuaded that a gap of up to three inches between the transfer side and the wheeled mobility device will not impede transfer given that accessible diagnostic equipment will be required to be adjustable. In addition, the Access Board is not persuaded that special consideration for stretchers is necessary in order to accommodate the IEC 60601-2-52 prohibition against vertical obstructions within one inch of the top of the patient surface. The final rule would not permit obstruction above the patient surface; consequently, by meeting the IEC requirements manufacturers will meet the MDE Standards.
Accordingly, the final rule includes an exception permitting obstructions of no more than three inches deep beyond the transfer side of the transfer surface provided that such obstructions do not protrude above the top of the transfer surface. A common example of this type of obstruction is articulating side rails on stretchers that move out of the way during transfer, but create a gap between the transfer surface and the mobility device. The exception allowing obstructions of up to three inches is included in each of the new provisions for unobstructed transfer for diagnostic equipment used in the supine, prone, or side-lying position (M301.2.4), and diagnostic equipment used in the seated position (M302.2.5), as Exception 1.
As noted above, the Access Board has retained the original exception from the MDE NPRM, permitting temporary obstructions provided that they can be repositioned out of the way during transfer. In the final rule, the Board moved this provision to Exception 2 to accommodate the new exception discussed above, and added language to specify that this exception may also apply to obstructions that qualify for Exception 1. For example, side rails that create a gap of three inches from the transfer side of the diagnostic equipment to the mobility device when moved out of the way for transfer, but also protrude above the top of the transfer surface when in place as a side rail.
In the MDE NPRM, the Access Board required diagnostic equipment used by patients in the seated position to
After review of the comment and the recommendations of the MDE Advisory Committee, the Access Board is persuaded that requiring armrests as well as transfer supports is redundant and has the potential to cause conflict between the two devices. Therefore, the Access Board has removed the provision requiring armrests from the final rule.
The MDE NPRM proposed that diagnostic equipment used by patients in the supine, prone or side-lying position and diagnostic equipment used by patients in the seated position be usable with portable patient lifts. The proposed rule specified base clearance requirements to ensure lift compatibility (M301.4 and M302.4, respectively). The preamble to the MDE NPRM sought comment on whether the final rule should exempt certain diagnostic equipment from these requirements if the equipment was specifically designed to be used with a fixed overhead lift. NPRM, 77 FR at 6927, question 27.
Eleven commenters responded to question 27. Six of the ten commenters (one manufacturer, three medical associations, and two government entities) concurred with the proposed scenario that if equipment was designed for use with overhead lifts then that equipment should be exempted from the proposed base clearance requirements. One commenter, a manufacturer, agreed that equipment designed for use with an overhead lift should be excepted, and also stated that portable floor lifts should be designed to be compatible with exam and procedure tables, not that the tables be redesigned to be compatible with floor lifts. Four of the commenters (three disability rights organizations and an accessibility consultant) were opposed to this exemption and expressed concern that the overhead lift would not be available when needed if the diagnostic equipment was moved to another room or the lift was not functioning. The final commenter, a manufacturer, opposed the exemption unless the overhead lift was included as part of the equipment when sold.
The MDE Advisory Committee reviewed this issue and recommended the use of overhead lifts as an alternative for imaging equipment where portable floor lifts are not feasible. Specifically, the MDE Advisory Committee explained:
Overhead lifts can provide an alternate means of access instead of clearances around the bases of imaging equipment required for portable lifts. Table structural design and/or room layout may be such that providing the clearances in and around the base may be either technically difficult or impractical. In these cases, a ceiling-mounted lift may be a better method for some types of imaging equipment because the portable lift would need to access the diagnostic imaging table from the side or far end. Some imaging systems already use overhead lifts to assist patients . . . [Overhead lifts] may offer flexibility over a portable lift because it can transfer the patient from either side placing the patient in the desired imaging orientation, and the ability to move completely out of the way when not needed. MDE Advisory Committee Report, 107, available at
After review of the comments received and the recommendations from the MDE Advisory Committee, the Access Board has concluded that fixed overhead lifts may be appropriate and even preferred in certain circumstances. However, the Access Board believes that the determination of the circumstances where an exception is warranted and the types of diagnostic equipment that should be excepted from the portable floor lift requirement is more appropriately left to the enforcing authority. Accordingly, the final rule provides a limited exception to the lift compatibility requirements for fixed overhead lifts in situations where: (1) A fixed overhead lift is provided; (2) the diagnostic equipment is clearly labeled as not compatible with portable floor lifts; and (3) the use of the overhead lift with that diagnostic equipment is specifically permitted by the enforcing authority. The exception applies only if all three conditions are met.
The Access Board proposed in M101.2 in the MDE NPRM to require diagnostic equipment to meet the standards for each patient position supported, meaning that if diagnostic equipment was designed to support a patient in multiple positions then the equipment would have to meet the technical criteria for each of those positions. The Access Board sought public input in question three in the preamble in the MDE NPRM, on whether organizing the technical criteria functionally by patient position was clear. 77 FR at 6919.
Fifteen commenters responded, with only two disability advocates and one medical association agreeing that the division of the MDE Standards was clear. The manufacturers raised concerns about applying the MDE Standards for multiple patient positions to a single piece of equipment. Multiple commenters recommended that when diagnostic equipment that fits in multiple categories, one category should take precedence. Medical Association and Accessibility Consultants recommended reorganizing the standards by types of facilities or by feature and one manufacturer recommended harmonizing M301 and M302 into one requirement. Additionally, commenters raised concerns about diagnostic chairs which could be reclined into a supine position after transfer; such as podiatry and dental chairs. These commenters argued that requiring the equipment to be designed to accommodate transfer in both positions would not achieve any objective benefit and would impose transfer surface width requirements that would not be appropriate and would be overly burdensome. The MDE Advisory Committee did not make a recommendation on this provision. However, the subcommittee for tables and chairs did explain that while the primary function of examination chairs is to support patients in a seated position, they are also capable of being reclined. The ability to recline is a secondary, rather than a primary purpose. The subcommittee asserted that these types of chairs should be covered by M302.
In response to the comments and Advisory Committee discussions, the Access Board acknowledges that one of the most important features of making diagnostic equipment used by patients in either the supine, prone, or side-lying position or the seated position accessible, is to ensure the patient has the opportunity to transfer independently to the maximum extent possible. The Access Board concurs with the commenters that there are certain examination chairs, such as dentistry and podiatry chairs, where the patient is only intended to transfer while the chair is in a seated position but is then reclined into a supine position while the diagnostic procedure is being performed. The Access Board concurs with commenters that in this limited situation it is unnecessary for the examination chair, which complies with the technical requirements in M302, to also have to comply with the technical requirements in M301. Therefore, in the final rule the Access Board has added an exception to M301.1 which states that examination chairs that comply with M302 and, after the patient transfers into the seat, reclines to facilitate diagnosis, do not have to comply with M301. Additionally, the Board has added a new definition for examination chair in M102.1 in the final rule to assist with the application of this exception. The other commenter concerns regarding the proposed application provision, M101.2, are addressed below in the Section-by-Section Analysis.
The MDE NPRM proposed that diagnostic equipment which could be used by patients in multiple positions must comply with the technical criteria for all positions in which it could be used (proposed M101.2). In the preamble in the MDE NPRM the Access Board proposed an exception to this requirement for folding seats on diagnostic equipment used by patients seated in a wheelchair. The MDE NPRM proposed that this type of diagnostic equipment would have to meet the technical requirements of M302 (diagnostic equipment used by patients in the seated position) and M303 (diagnostic equipment used by patients seated in a wheelchair), with the exception of the lift compatibility requirements in M302.4. NPRM, 77 FR at 6927. The Board explained that because the patients can use the equipment while seated in their wheelchairs, the seat does not have to provide the clearance necessary to be usable with a portable floor lift.
In the MDE NPRM preamble the Access Board sought comment with two questions, 28 and 37. Question 37 asked whether a folding or removable seat should be required on weight scales for use in the standing position. NPRM, 77 FR at 6930. Four commenters responded: Three concurred (an accessibility consultant, disability rights organization, and a state agency concerned with accessibility); and one commenter (a manufacturer) agreed it should be an option, but not a requirement. Six commenters responded to question 28, which asked whether a folding seat provided on diagnostic equipment with a wheelchair space should be required to comply with the technical criteria in proposed M302 for transfer surfaces and supports. NPRM, 77 FR at 6927. Five of the commenters (three disability rights organizations, a state agency concerned with accessibility, and an accessibility consultant) asserted that if a seat is provided it should have to comply with the technical provisions for diagnostic equipment used by a patient in the seated position. One of these commenters explained that not all people with disabilities who need to transfer are wheelchair users and some wheelchair users may choose to transfer, even if the device is designed for use in a wheelchair. The remaining commenter, a medical association, noted that it was unaware of any diagnostic equipment with a folding seat, but asserted that if patients can use the equipment in wheelchairs, then they should not be transferred onto the folding seat, and the chair should not have to meet the requirements in proposed M302.
The MDE Advisory Committee discussed weight scales, noting the importance of obtaining a patient's weight for medical treatment and the difficulty patients in wheelchairs confront with obtaining an accurate weight.
After reviewing the comments and the Subcommittee on Weight Scales Report, the Access Board has determined that weight scales that are designed to be used by patients seated in a wheelchair, but also provides a seat integral to the equipment, present a unique situation which warrants an exception to the general provision of M302.1 in the final rule. The primary purpose of the technical requirements for diagnostic equipment used by patients in the seated position is to facilitate independent transfer from a mobility device onto the diagnostic equipment. Some wheelchair accessible scales also provide a seat for patients who ambulate onto the scale, but due to stability or fatigue issues, may need to sit in order to be weighed. On many of these scales the seat folds down into the wheelchair space to accommodate the ambulatory patient who needs to sit. The MDE Advisory Committee notes that space is already at a premium for weight scales. To require a seat integral to the weight scale to meet the provisions of M302, when it already meets the requirements of M303 would require the weight scale platform to be significantly larger than a weight scale which just provides a wheelchairs space. To accommodate both a wheelchair space and seat permitting transfer from a mobility device, the platform would have to be large enough to accommodate individuals in their mobility devices and also provide enough space to allow for a side or perpendicular transfer from the mobility device onto the seat. Because weight scales with wheelchair spaces and seats are intended to be used by patients remaining in their wheelchairs or ambulating onto the scale, the Access Board has concluded that it is not necessary to require the weight scale to provide the wheelchair space for the patient to use the weight scale in a wheelchair and also provide the space for the patient to wheel onto the weight scale and then transfer onto the seat. Accordingly, the Access Board has excepted integral seats on weight scales that also contain wheelchair spaces meeting all the requirements of M303 from complying with M302. Due
The Access Board acknowledges the comments recommending that accessible diagnostic equipment used in the standing position also provide a seat. However, the Access Board has declined to include such a provision in the final rule because of the potential space impact and because, it will ultimately be up to the enforcing authority to determine what types of diagnostic equipment and how many of each type must be provided in medical settings. However, if diagnostic equipment used in a standing position does provide a seat, but does not provide a wheelchair space, then it would have to comply with the requirements of M302 and M304 in the final rule.
M303 contains the technical requirements for diagnostic equipment used by patients seated in wheelchairs. In the final rule the Access Board made four significant changes to this section: Two significant changes to accommodate the unique challenges of mammography equipment; one significant change to the ramped running slope requirement; and a final significant change to the width and depth of wheelchair spaces.
The MDE NPRM proposed to require diagnostic equipment to have a wheelchair space that is at least 36 inches wide (proposed M303.2.2). The MDE NPRM further proposed two alternative depth requirements: 48 inches for wheelchair spaces that are entered from the front or rear, and 60 inches for wheelchair spaces entered from the side (proposed 303.2.3). The MDE NPRM preamble also noted that the Access Board was considering adding exceptions in the final rule to the width and depth requirements for wheelchair spaces on raised platforms. NPRM, 77 FR at 6928-6929. The Access Board sought input in questions 31, 32, and 33, regarding the required size of wheelchair spaces on raised platforms, the use of scooters on raised platforms, and the associated costs.
No commenters responded to questions 31 and 33; four commenters responded to question 32. Question 32 asked whether equipment with wheelchair spaces on raised platforms, such as weight scales, can accommodate patients who use scooters, and if they currently cannot, should the width and depth be changed so the equipment is usable by patients who use scooters. One commenter (a disability rights organization) asserted that if diagnostic equipment is accessible for wheelchairs it should also be accessible to scooters and recommended enlarging the space beyond 36 inches. Another disability rights organization opined that most weight scales in healthcare settings are inaccessible to wheelchair users, asserting that even the “accessible” weight scales are only 24 inches wide by 30 inches deep and are too small to accommodate manual wheelchairs and definitely would not accommodate the longer wheelbases of many power wheelchairs and scooters. This commenter recommended taking a “universal design” approach with a requirement of 34 inches wide by 58 inches deep for raised platforms on weight scales. The other two commenters (an academic and state agency concerned with accessibility) agreed that diagnostic equipment with wheelchair spaces on raised platforms should be usable by scooters, but did not provide any suggested dimensions.
The MDE Advisory Committee recommended a minimum platform size of 32 inches clear width and 40 inches clear length (depth). The Committee noted that their proposed recommendation sought to address the unique considerations of weight scales with raised platforms. The Committee stated that this size “accommodates both manual and power wheeled mobility devices including small and mid-size scooters.” MDE Advisory Committee Report, 109, available at
In order to reconcile the public comments and the MDE Advisory Committee recommendations, the final rule retains the proposed M303.2.2 requirement for minimum width of 36 inches for wheelchair spaces, but provides an exception to permit wheelchair spaces on raised platforms to be a minimum of 32 inches wide. This width restriction assumes that the elbows and hands of persons using mobility devices would overhang the width of the platform and they would still be able to propel themselves. Because the final rule also requires raised platforms over 1
For the depth of the wheelchair space, the final rule has retained both alternative depth requirements in proposed M303.2.3: 60 inches for wheelchair spaces entered from the side, and 48 inches for wheelchair spaces entered from the front or rear, discussed below in Section VI.10.c (Section-by-Section Analysis—M303.2.3). However, the Access Board has included an additional requirement for wheelchair spaces that are entered from the front or rear and permit pass-through from one end to the other. This provision requires wheelchair spaces that permit pass-through to have a minimum depth of 40 inches. Less space is required in these circumstances because the wheelchair user does not have to turn around or back out to exit the diagnostic equipment, but can enter and exit continuing on in one direction. Due to the addition of the new requirement, the Board reorganized this provision in the final rule to M303.2.3.1 (front or rear entry depth), M303.2.3.2 (Pass Through Entry), and M303.2.3.3 (side entry depth).
The MDE NPRM proposed knee and toe clearance requirements for diagnostic equipment used by patients seated in wheelchairs that paralleled the knee and toe clearance requirements from the 2004 ADA and ABA Accessibility Guidelines. NPRM, 77 FR at 6929. The proposed rule included a requirement that 17 inches minimum and 25 inches maximum of the 48-inch
Two commenters, one manufacturer and one disability rights organization, commented on the knee and toe clearance under breast platforms. The disability rights organization raised concerns that existing machines do not provide deep enough clearance and that during the examination the breast platform will hit the patient's knees. The manufacturer also raised concerns with the size of the knee and toe clearance and recommended basing the requirements in relation to the height of the breast platform. Additionally, this commenter raised concerns that mammography equipment must have a stabilizing flange or foot at its base to prevent the equipment from tipping when the gantry is extended. This flange protrudes into the knee and toe clearance. Specifically, this commenter explained that the flange can be designed for optimal accessibility, but is necessary for the safety of the equipment.
The MDE Advisory Committee reviewed this provision and gave multiple recommendations regarding the necessary clearances for breast platforms. The Advisory Committee noted that mammography equipment presents a unique challenge for individuals seated in wheelchairs because the mammography exam requires the patient's breasts to be placed on top of the breast platform thereby requiring the knees and toes to go deeper beneath the equipment. The MDE Advisory Committee recommended changes to the proposed requirements for knee and toe clearance to create a deeper knee space under breast platforms. The MDE Advisory Committee did not suggest revisions to the proposed knee and toe clearances for diagnostic equipment used by patients seated in wheelchairs, other than for mammography equipment.
The knee and toe clearance requirements were adopted from the 2004 ADA and ABA Accessibility Guidelines and typically will allow a person seated in a wheelchair to pull underneath a work surface or equipment component or permit forward access to a control located above equipment overhanging the knee and toe space. We are persuaded by the MDE Advisory Committee report that mammography equipment presents a unique use and requires different specifications for the knee and toe clearance to ensure that the patient's breast can rest on top of the platform. The knee and toe clearance underneath mammography equipment must provide sufficient space to allow the patient to get close enough for their breast to be placed on the breast platform in order for the diagnostic procedure to be performed. Thus, the Access Board has reorganized the equipment clearances provision in the final rule into two separate requirements; breast platforms and other equipment. The requirements for breast platforms (M303.2.4.2 in the final rule) account for obstructions in the knee and toe clearance necessary to stabilize the mammography equipment and the location of the patient's body within the depth of the wheelchair space, such that more of the overall space is allocated to knees and toes. As discussed above, these factors result in an exception to allow equipment components of a low profile to extend into the toe end of the wheelchair space. The requirements for other equipment (M303.2.4.2 in the final rule) are substantively unchanged from the NPRM, and are discussed below in the Section VI.C.10.d (Section-by-Section Analysis—M303.2.4).
The proposed rule recommended a knee and toe clearance depth for breast platforms of 25 inches. There were no comments received on this requirement. The MDE Advisory Committee recommended increasing the overall knee and toe space to a minimum 28 inches deep. MDE Advisory Committee Report, 115-116, available at
The Access Board concurs with the MDE Advisory Committee's conclusion that an increase in the overall knee and toe clearance under breast platforms is warranted. However, the Board is concerned that if the Advisory Committee's recommendation is adopted without change, it would significantly impact the requirement in the final rule for a 48-inch deep wheelchair space. Because at least 25 inches of the space must accommodate knees and toes, only 23 inches remains to accommodate that portion of the occupied wheelchair not including knees and toes. If the Access Board were to require 28 inches minimum knee and toe clearance, only 20 inches would remain. After reviewing all the evidence before the MDE Advisory Committee, the Access Board has decided to make a number of changes to the requirements for the knee and toe clearances for breast platforms. These new requirements are described in the Section VI.C.10.d (Section-by-Section Analysis—M303.2.4). The requirements are intended to ensure that there is adequate space for a patient seated in a wheelchair to position underneath the equipment and align themselves against the breast platform so that the diagnostic procedures can be performed.
In the proposed rule, obstructions were not permitted within the knee and toe clearance space. This is consistent with the requirement in the existing accessibility guidelines and standards. One manufacturer commented on this provision, asserting that mammography equipment poses unique challenges and requires separate consideration. The commenter explained that the gantry of a mammography machine includes a base lip which is required for structural and seismic stability, and protrudes into the knee and toe clearance. This commenter recommended revisions to allow for a base lip on mammography equipment.
The MDE Advisory Committee recommended allowing obstructions into the knee and toe clear space, up to a height and depth that still permits the footrests of wheelchairs to pass over it. Specifically, the Committee recommended allowing base supports to be a maximum of 1
The base support is of fundamental importance to mammography equipment and provides structural support, seismic stability, and installation safety. It does obstruct the floor space in front of the gantry and, thus, may limit how close a wheelchair can get to the equipment. To respond to this issue, industry proposed a configuration that would cause minimal obstruction to the floor space in front of the gantry and would allow footrests to ride over it.
To discuss the maximum base support height, the sub-committee looked at anthropomorphic data regarding footrest
The Access Board concurs with the need for permitting base components in the knee and toe clear space for mammography equipment. While the Access Board recognizes that this is a deviation from existing accessibility guidelines and standards, the Board believes that mammography equipment presents special challenges due to the diagnostic, structural, and seismic requirements of the diagnostic equipment. In the final rule, the Access Board has created an exception to the height requirement for breast platforms. This exception permits the profile of base components to extend into the wheelchair space at a height of 1
The MDE NPRM proposed that where there is a change in level at the entry of a wheelchair space that is greater than 1
[It] considered the needs of a ramped surface to access the platform on the accessible scale. Because there are different types of scales with different platform heights, the Committee developed a three tiered ramp slope proposal to fit different situations. The Committee reviewed and discussed the provisions on slopes for ramps as they apply to architectural elements in the built environment. The maximum slope for a ramp in the 2010 Standards is a rise of 1 vertical inch for each 12 inches of horizontal distance slope. Under very limited conditions in the built environment, the 2010 Standards allow a steeper ramp for a limited rise. A ramp in the built environment to which this exception applies may use a 1:2 grade slope on a short rise ramp.
Industry experts spoke to the concern for facility space often expressed by healthcare entities. The space constraints affect the desirability of accessible scales since space is often expensive and tight in many medical facilities. Scales that can be wall mounted or portable enhance the flexibility of scales and allow use in tight environments. Currently, these types of accessible scales use the short rise ramp to facilitate easy storage or mounting.
Existing technology for weight cell load allows for a platform profile to go as low as
The MDE Advisory Committee recommended a three tiered approach for allowable ramp runs on raised platforms: Allowing a slope of 1:2 at 0 to 1
The Access Board agrees with the MDE Advisory Committee that additional allowances in the slope of ramp runs of diagnostic equipment used by patients seated in a wheelchair with raised platforms, primarily weight scales, is appropriate. However, for usability and safety reasons, the Access Board has determined that slopes of such ramp runs should not exceed the long standing maximum slope for accessible ramps of 1:8 that is allowable in certain circumstances in the 2004 ADA and ABA Accessibility Guidelines. The Board also notes that the Guidelines only permit changes in level up to
Therefore, the Access Board has decided to add an exception in the final rule to the requirement that ramped entry wheelchair spaces have ramp runs with a running slope no steeper than 1:12 (M303.3.3.1). This exception permits a running slope not steeper than 1:8 for ramp runs with a maximum height of 2
The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair that have components which are used to examine specific body parts to be capable of examining the body parts of a patient while seated in a wheelchair (proposed M303.4). Additionally, the Access Board proposed specific technical requirements for breast platforms of mammography equipment. The MDE NPRM proposed a height range for breast platforms of 30 inches minimum and 42 inches maximum above the floor (proposed M303.4.1). In the preamble to the MDE NPRM, the Access Board sought input in question 36, on whether the breast platform height range proposed was sufficient to accommodate a patient seated in a wheelchair. NPRM, 77 FR at 6930.
Three commenters responded to this question. One commenter, a medical association, concurred with the proposed provisions. Two other commenters, a disability rights organization and a manufacturer disagreed. The disability rights organization recommended adopting a minimum height range of 24 to 26 inches. The manufacturer indicated that the proposed height range of 30 inches to 42 inches is sufficient, but also noted that several manufacturers lower the breast platform to 25 to 28 inches due to requests for accessibility. This manufacturer also recommended requiring a minimum range of travel for the breast platform instead of a specific minimum and maximum height.
The MDE Advisory Committee recommended changing the breast platform height requirement from a specified height range to a required minimum range bounded by a required high height of 42 inches and a required low height of 26 inches which
The MDE Advisory Committee recommended, by strong majority, a minimum low height of 26 inches and a minimum high height of 42 inches. After review of the comments and the MDE Advisory Committee recommendations, the Access Board has accepted the MDE Advisory Committee's recommendation of low and high minimum heights. The Access Board believes that this requirement will ensure that the breast platform can be lowered or raised to the proper height for a patient seated in a wheelchair and is also within the range requested from manufacturers for patient accessibility. Therefore, the final rule requires at M303.4.1 that breast platforms have a minimum low height of 26 inches, a minimum high height of 42 inches, and be continually adjustable between the minimum low and high heights.
The MDE NPRM proposed edge protection on the ramps leading up to the raised platform (proposed M303.3.3.4), but did not require edge protection on the raised platforms themselves. The Access Board sought public input with question 30 in the MDE NPRM preamble, on whether there is diagnostic equipment with wheelchair spaces on raised platforms that does not provide edge protection.
The Access Board received two comments from disability rights organizations. These commenters recommended requiring edge protection on platforms and one commenter suggested that the edge protection should not encroach into the wheelchair space on the platform and should be designed according to the edge protection requirements from the 2010 ADA Standards.
The Advisory Committee made two recommendations for requiring edge protection on raised platforms; for single ramped entry platforms, the Committee recommended requiring a minimum two-inch high edge protection on the back of the platform opposite the entry ramp and on the two sides of the platform, and for double ramped entry platforms, the Committee recommended a minimum two-inch high edge protection on both sides of the platform. The Advisory Committee explained that edge protection “provides an additional safety feature and guides users of wheeled mobility devices onto the platform.” The edge protection prevents the patient from over-shooting the platform, driving off either side, tipping, or falling. MDE Advisory Committee Report, 112-113, available at
The Access Board concurs with the Advisory Committee that edge protection is necessary on raised platforms to provide a mechanism to ensure that wheelchair users do not fall off the platform. Therefore, the final rule requires in M303.2.6 that platforms with wheelchair spaces that are raised more than 1
M304 provides the technical requirements for diagnostic equipment used by patients in a standing position. There was only one significant change made to the requirement of standing supports on the diagnostic equipment.
The proposed rule included a provision requiring standing supports on each side of the standing surface and compliance with the technical requirements for standing supports in proposed M305.3 (proposed M304.3). Question 38 in the MDE NPRM preamble requested input on the standing support configurations currently provided, their effectiveness for patients with disabilities, whether alternative criteria would be appropriate, whether angled standing supports are effective, and whether there are any industry standards for structural strength requirements. NPRM, 77 FR at 6931.
Two commenters responded to this question. One commenter, a medical association, indicated that standing supports for imaging equipment vary widely based on the type of environment and specific imaging equipment being used. For example, the standing support on a chest x-ray machine and mammography equipment is much different than a support on a fluoroscopic room table that can be moved from a recumbent to standing position. The second commenter, a manufacturer, expressed concerns that the proposed rule was treating supports on breast platforms as standing supports, explaining that this was not the supports' intended purpose. This commenter argued that these supports are actually arm supports intended to ensure proper patient positioning during the diagnostic exam, and were not intended as an accessibility feature to assist the patient in standing.
The MDE Advisory Committee addressed the issue of standing supports for mammography equipment as well as that of standing supports for wheelchair spaces with raised platforms. For mammography equipment, the MDE Advisory Committee came to a consensus agreeing with the commenter that the “standing supports” on mammography equipment were actually positioning supports and the “primary use of these supports is for positioning of the arms during the imaging process to keep them out of the field of view of the image.” MDE Advisory Committee Report, 135, available at
The MDE Advisory Committee made two recommendations for standing supports on raised platforms with wheelchair spaces: One for single-ramped entry raised platforms, and a second for dual-ramped entry raised platforms. These recommendations would apply when the diagnostic equipment is designed to accommodate both persons seated in wheelchairs and standing persons. For single-ramped entry raised platforms, the MDE Advisory Committee recommended maintaining the requirement for standing supports on both sides of the diagnostic equipment. To address concerns raised by industry representative on the MDE Advisory Committee regarding the space on the platform needed to attach two sets of standing supports which must be outside the minimum clear space required for a wheelchair, the Committee recommended that dual-ramped entry raised platforms require only one standing support on one side of the platform. The MDE Advisory Committee explained that patients may have a stronger side, right or left, and therefore with only one standing support provided, they would need to be able to use their preferred side to hold onto the standing support. With a single entry ramp, supports on both sides are necessary to allow patients to choose to use the right or left side of their body, but on a dual entry ramp the patient can enter or exit on opposing sides to allow them to use their preferred side of their body with only one support.
The Access Board concurs with the commenters and the MDE Advisory Committee that the supports on mammography equipment were intended as positioning supports, not standing supports. However, the Board has determined that an exception is not necessary due to the restructuring of this requirement in the final rule. In the final rule, standing supports are only required on diagnostic equipment used by patients in a standing position that provide a surface on which a patient would stand. This is discussed in greater detail below in Section V.C. (Section-by-Section Analysis—M304.2). Additionally, as discussed below in Section IV.E.1. (Significant Changes—Positioning Supports), the Access Board has elected not to include positioning supports for mammography equipment in the final rule.
With regard to the MDE Advisory Committee recommendations regarding standing supports on diagnostic equipment with raised platforms, the Access Board has decided to include an exception in the final rule for diagnostic equipment with entry and exit that permit pass-through from one end to the other to provide a standing support on only one side of the standing surface, provided that the standing support complies with the requirements in M305.3 for standing supports in a horizontal position. This exception would not just apply to diagnostic equipment on a raised platform designed both for people seated in wheelchairs and in standing positions, it would also apply to equipment designed solely for patients in a standing position and would apply regardless of whether the standing surface is raised on a platform or combined with a wheelchair space. For all other standing surfaces, the Access Board has retained the original requirement of standing supports on two sides of the standing surface from the proposed rule. While the MDE Advisory Committee spoke in terms of raised platforms, the Access Board believes the exception should be permitted where entry and exit permits pass-through from one end to the other, regardless of whether the standing surface is raised. Accordingly, the Access Board has decided to apply this exception to all diagnostic equipment which permits this type of entry and exit in final rule (M304.2.2).
M305 provides the technical requirements for supports on medical diagnostic equipment. There were multiple significant changes made to the transfer supports section, including the addition of new requirements as well as the removal of structural strength requirements from the final rule. Additionally, changes were made to the vertical and horizontal standing supports requirements.
The MDE NPRM proposed requirements for transfer supports that applied to all transfer surfaces (proposed M305.2). The requirements were the same for transfer surfaces on diagnostic equipment used by patients in the supine, prone, or side-lying position, as well as diagnostic equipment used by patients in the seated position. The proposed standards required transfer supports to be located within reach of the transfer surface and not obstruct transfer, be capable of resisting vertical and horizontal forces of 250 pounds applied to all points, and not rotate in their fittings. The latter two requirements were taken from the 2004 ADA and ABA Accessibility Guidelines for grab bars. 36 CFR part 1191, App. D. In the preamble to the MDE NPRM, the Access Board posed multiple questions about whether the final rule should include more specific requirements regarding location, length, size, height, and angle for transfer supports; and whether transfer supports should be allowed to rotate in their fittings. The Access Board received 31 comments to these questions and the MDE Advisory Committee made 10 recommendations regarding the transfer support section.
In response to the comments and the recommendations of the MDE Advisory Committee, and in consideration of the changes to the final rule regarding types of transfer surfaces, the Access Board has made multiple changes and additions to the transfer support requirements, located at M305.2. Specifically, the Access Board has added technical specifications to the requirements for location (M305.2.1) and length (M305.2.2) based on the type of transfer support required; has added new technical requirements for height (M305.2.3), cross section (M305.2.4), absence of surface hazards (M305.2.5), gripping surfaces (M305.2.6), and clearance (M305.2.7); and has made changes to the fittings provision (M305.2.8). These new and revised provisions are based on the 2004 ADA and ABA Accessibility Guidelines for grab bars and handrails, 36 CFR part 1191, App. D. Finally, the Access Board has removed the requirement for structural strength for transfer supports and has decided not to add any positioning support requirements in the final rule. Each requirement is discussed in detail in the Section-by-Section Analysis below.
The MDE NPRM proposed to require transfer supports to be capable of resisting vertical and horizontal forces of 250 pounds at all points (proposed M305.2.2). The Access Board sought input in question 18, on whether current transfer supports are capable of
The MDE Advisory Committee recommended revising the language proposed in the MDE NPRM to require transfer supports to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment. The Committee indicated that “during committee discussions manufacturers stated that industry is required to test the most vulnerable spots on the transfer support. Industry must follow testing parameters found in other standards.” MDE Advisory Committee Report, 103, available at
After reviewing the comments received and the recommendations from the MDE Advisory Committee, the Access Board has decided to remove this section in the final rule. The prevailing standard used by industry, IEC 60601 adopted under the ANSI/AAMI ES 60601 series in the U.S., contains provisions that address the structural strength of supports. ANSI/AAMI ES60601-1:2005/(R)2012, available at
The Access Board noted in the MDE NPRM preamble that it was considering adding positioning supports to the final rule and sought public input with question 24 on whether positioning supports should be required in the final rule. NPRM, 77 FR at 6927. Six commenters responded: Two commenters (disability rights organizations) recommended adding positioning supports; two commenters (manufacturers) recommended providing positioning supports within reach of the patient; one commenter (an accessibility consultant) recommended flexibility to allow for design based on use; and the final commenter (a manufacturer) raised concerns about the technical impact for MRI machines. Additionally, as discussed above in Section IV.D.1 (Significant Changes—Standing Supports) and below in Section V.C.17 (Section-by-Section Analysis—M305.2), the MDE Advisory Committee made recommendations to add requirements for positioning supports on mammography equipment and imaging equipment with transfer surfaces having depths greater than 24 inches.
After review of the comments and the MDE Advisory Committee's recommendations, the Access Board has decided not to require positioning supports in the final rule. Although the Access Board considers positioning supports to be helpful, even necessary in some instances, given the wide range of diagnostic equipment addressed by the final rule, we have insufficient information on which to base a meaningful requirement that could apply to all types of equipment. Additionally, where transfer supports are provided, they can also serve to assist patients to position themselves.
The proposed rule provided technical criteria for vertical and horizontal standing supports. For horizontal standing supports, the Access Board proposed a gripping surface of 4 inches long minimum, the top of which would be required to be located 34 inches minimum and 38 inches maximum above the standing surface (proposed M305.3.1). For vertical standing supports, the Access Board proposed a gripping surface of 18 inches long minimum, the bottom of which would be required to be located 34 inches minimum and 37 inches maximum above the standing surface (proposed M305.3.2). In the preamble to the MDE NPRM the Access Board sought input with question 38 on: (a) The current configurations of standing supports, and their effectiveness for persons with disabilities; (b) if there were any alternative technical criteria that would be appropriate; (c) whether angled supports are effective; and (d) whether there are industry standards for the structural strength of standing supports. NPRM, 77 FR at 6931. The Access Board received two comments, one of which addressed standing supports on mammography equipment (discussed above in Section IV.D.1 (Significant Changes—Standing Supports)) and one commenter (medical association) who noted that angled standing supports would be effective and that they are unaware of any industry standards regarding structural strength.
The MDE Advisory Committee reviewed the standing supports provision and while it supported the technical criteria in the proposed rule, the MDE Advisory Committee recommended adding additional criteria for standing supports on raised platforms with wheelchair spaces based on the recommended changes in requirements for standing supports for such diagnostic equipment (discussed above in Section IV.D.1 (Significant Changes—Standing Supports)). The Committee recommended that for single-ramped entry raised platforms with wheelchair spaces, the standing supports located on two sides of the platform have a minimum of 34 inches between supports, be integrated into the platform, and be a minimum of 32 inches in length (at least 80 percent of the platform length) at the platform entry edge. MDE Advisory Committee Report, 136-137, available at
The Access Board concurs with most of the MDE Advisory Committee's recommendations; however, although the Committee's recommendations pertained to diagnostic equipment with wheelchair spaces and standing spaces on raised platforms, the Access Board has decided to apply the recommended criteria to all diagnostic equipment for patients in a standing position that also contains a wheelchair space, regardless of whether the equipment standing surface is raised. In addition, the exception permitting only one standing support is conditioned on that support being positioned horizontally in relation to the standing surface, not vertically. Additionally, the Access Board has adopted the Committee's recommendation regarding the length of
In the final rule Chapter 1 establishes the purpose and the general requirements for the application of the MDE Standards. This chapter received 21 comments and no recommendations from the MDE Advisory Committee. The Access Board made a few editorial changes to some of the provisions, and added one provision M101.3 Existing Diagnostic Equipment, which is discussed below.
This is an introductory section.
The MDE NPRM proposed that the purpose of the MDE Standards was to establish technical criteria for diagnostic equipment that is accessible to and usable by patients with disabilities and to provide patients with disabilities independent access to and use of diagnostic equipment to the maximum extent possible. One commenter, a manufacturer, responded to the proposed provision. The commenter asserted that this provision was unclear without a list of applicable disabilities and an explanation on how the maximum extent possible would be determined.
In response to the commenter, the Access Board notes that the term “disability” is defined in the Americans with Disabilities Act (ADA), 42 U.S.C. 12102. None of the Standards and Guidelines promulgated by the Access Board include a list of applicable disabilities. Rather, they rely on the definition of disability provided in the ADA. As for determining whether diagnostic equipment provides independent access and egress to the maximum extent possible, that is a decision left to the enforcing authorities that adopt and implement this standard. The Access Board, therefore, declines to implement the commenter's suggested changes. The Access Board has, however, made two editorial changes to this provision clarifying that “medical diagnostic equipment” is referred to as “diagnostic equipment,” and that these standards are referred to as “MDE Standards” throughout the rule text.
In the NPRM the Access Board proposed that the MDE Standards would be applied to diagnostic equipment based on the patient position the equipment is designed to support. Additionally, this provision stated that where the equipment was designed to support more than one patient position, the MDE Standards for each patient position supported would be applied to the equipment. Fifteen commenters responded to this provision asserting that some diagnostic equipment should not have to comply with more than one patient position requirement. These concerns have resulted in two added exceptions to the final rule. The first is to exempt examination chairs which comply with M302 and can be reclined to facilitate diagnosis after the patient transfers onto the seat from complying with M301. (M301.1, Exception). This exception is discussed above in Section IV.B.4 (Significant Changes—Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302). Additionally, the final rule also exempts weight scales which contain a wheelchair space complying with M303 and that have a seat integral to the equipment from complying with M302 (M302.1, Exception). This exception is discussed above in Section IV.B.5. (Significant Changes—Exception from the Requirements of M302 for Weight Scales with Integral Seats). In the final rule, the application provision was revised due to the addition of the exceptions and a few editorial changes were made for clarity. This provision now requires that sections M301 through M304 of the MDE Standards be applied to diagnostic equipment based on the patient position that the equipment supports during patient transfer and diagnostic use and sections M306 and M307 will be applied to diagnostic equipment that contains communication features or operable parts that are provided for patient use.
The MDE NPRM did not address when or how the MDE Standards would be applied to existing medical diagnostic equipment. Commenters raised concerns about the cost of immediate compliance for the more expensive imaging equipment, noting the high cost and the concern that rooms are designed specifically for such equipment. Specifically, at the public hearing on March 14, 2012, two commenters recommended phasing in these requirements for imaging equipment based on when it is replaced. The public hearing transcript is available at
The MDE Standards are advisory and are not binding until adopted by an enforcing authority. The Access Board's mandate was to establish only the minimum technical criteria, however enforcing authorities may establish scoping requirements in the future. In response to the commenters' concerns regarding existing equipment, the Access Board has decided to add a new provision which clarifies that the MDE Standards do not address the accessibility of existing diagnostic equipment and that the enforcing authority will determine whether and how diagnostic equipment will be regulated.
The MDE NPRM proposed to permit the use of alternative designs or technologies that are substantially equivalent to or provide greater accessibility and usability than strict compliance with provisions in the MDE Standards. One commenter, a manufacturer, requested that the Access Board include examples of acceptable methods for providing equivalent facilitation.
The Access Board is unable to provide examples of acceptable methods of equivalent facilitation, as this section is intended to encompass those design solutions which the Access Board is unaware at the time that this rule is published. Additionally, the final determination of whether a particular design or technology meets this provision will be determined by the enforcing authorities. Therefore, the only change to this provision was to adjust the section number to allow for the addition of the new provision, M101.3 Existing Diagnostic Equipment.
The MDE NPRM proposed that the MDE Standards be based on adult dimensions and anthropometrics. One commenter and the MDE Advisory Committee raised concerns about providing standards for obese patients and pediatric patients. While the Access Board acknowledges that these are additional issues of accessibility, the
The MDE NPRM proposed that dimensions were to be subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. In the preamble of the MDE NPRM, the Access Board sought public input in question five on available information or resources concerning conventional industry tolerances for medical diagnostic equipment. NPRM, 77 FR at 6920. Six commenters responded to the question. Three commenters (two manufacturers and one medical association) indicated that tolerances vary based on the manufacturer, product design, and manufacturing process and that they are unaware of any industry standard. One commenter, a manufacturer, referenced ASME Y14.5-1994 for dimensional tolerances. Another commenter, a medical association, asserted that tolerances are in operator manuals. The final commenter, a manufacturer, recommended providing tolerances when dimensions are specified and recommended defining a specific tolerance, such as +/− 0.5 inch for linear dimensions.
After considering the comments received, the Access Board has decided to retain the original provision. The Access Board was persuaded by arguments from the commenters that there is not one industry-wide standard that can be applied to all MDE and concurs that the Access Board should not attempt to establish manufacturing tolerances. Where available, tolerances are best addressed by industry standards for the specific materials and methods employed in the manufacturing process. The only change to this provision was to adjust the section number to allow for the addition of a new section, M101.3 Existing Diagnostic Equipment.
In the MDE NPRM there was no explanation of the units of measurement used throughout the rule text. In order to avoid confusion and to align this final rule with the other accessibility guidelines and standards promulgated by the Access Board; this provision has been added to explain that the values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system must be used independently of the other.
This is an introductory section.
The MDE NPRM proposed definitions for enforcing authority, medical diagnostic equipment, operable parts, and transfer surface. The Access Board sought input in question six in the preamble of the MDE NPRM, on whether there were other terms in the proposed standards that should be defined. NPRM, 77 FR at 6920. Ten commenters responded to this question. One commenter, a medical association, did not offer other terms that should be defined, but stated that there were many instances where the Board used acronyms without a definition. However, this commenter failed to provide any examples. Another commenter, a disability rights organization, suggested modifying the definition of medical diagnostic equipment to clarify that the standard is intended for all medical equipment in which any part of the equipment is used for diagnostic purposes for any amount of time. Another commenter, a manufacturer, recommended changing the term “operable part” to “applied part” and adding a new definition of operable part as “caregiver operated parts,” asserting that this aligns with IEC 60601. Other commenters (manufacturers, medical associations, disability rights organizations, and an individual) suggested the following terms be defined: health care provider, breast platform, patient support surface, transfer supports, positioning supports, prone position, supine position, examination tables, diagnostic purposes, maximum extent possible, landing area, exam table, procedure table, and procedure chair.
After review of the comments, the Access Board declines to add any of the suggested terms to the defined terms section. The definition of medical diagnostic equipment was taken directly from Section 510 of the Rehabilitation Act and thus for consistency has not been altered. 29 U.S.C. 794f. Some of the definitions proposed by commenters are not terms used in the MDE final rule and, therefore, providing the requested definitions would serve no purpose. The definitions for other proposed terms used in the final rule are the same as the ordinarily accepted meanings in the context that applies, and the Access Board does not believe that the reader would be significantly aided in understanding the final rule by adding the requested definitions. However, the Access Board has decided to add six additional terms to this section; end transfer surface, examination chair, imagining equipment with bores, imagining bed, side transfer surface, and wheelchair space. As described above in Section IV.B.1.b. (Significant Changes—Transfer Surface Location), the Access Board has added definitions for “end transfer surface” and “side transfer surface” to this provision to describe the two types of transfer surfaces for diagnostic equipment used by patients in the supine, prone, or side-lying position. The “wheelchair space” definition was taken from the 2004 ADA and ABA Accessibility Guidelines and adopted in the MDE final rule to provide consistency across Access Board rulemakings. Examination chair, imagining equipment with bores, and imagining bed were added to help clarify application of exceptions added in the final rule. (
The MDE NPRM proposed that the meaning of terms not defined in proposed M102.1 or in regulations or policies issued by an enforcing authority, be defined by collegiate dictionaries in the sense that the context implies. There were no comments and no MDE Advisory Committee recommendations on this provision. In the final rule, the Access Board has changed this provision to indicate that the meaning of terms not defined in M102.1 will be given their ordinarily accepted meaning in the context that applies.
The MDE NPRM proposed that singular and plural words, terms, and phrases are used interchangeably. There were no comments on this requirement and no changes have been made.
In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply. The Access Board did not receive any comments regarding Chapter 2 as written; however, several commenters expressed concern
This is an introductory section.
The MDE NPRM proposed to explain that the enforcing authority would specify the minimum number of types of accessible diagnostic equipment that would be required to comply with the MDE Standards. There were no public comments regarding this provision. The Access Board has decided to make an editorial change to this section to clarify that the enforcing authority will specify the minimum number and types of accessible diagnostic equipment that will be required to comply with the MDE Standards.
The MDE NPRM did not propose a general exception for diagnostic equipment that was not capable of meeting the MDE Standards. As described in Section IV.A.1. (Significant Changes—General Exception), the Access Board received public comments and MDE Advisory Committee recommendations regarding certain types of diagnostic equipment that are unable to meet all of the requirements in the MDE Standards. In response, the Access Board has added a new provision excepting diagnostic equipment from compliance with an applicable requirement in the MDE Standards in the rare circumstance where compliance would alter diagnostically required structural or operational characteristics of the equipment, and would prevent the use of the equipment for its intended diagnostic purpose. Any equipment falling under this exception must comply with the provision(s) in question to the maximum extent practicable, and must fully comply with all other provisions not utilizing this exception.
In the final rule, Chapter 3 establishes the technical requirements for accessible medical diagnostic equipment based on how the diagnostic equipment is used by the patients, including: Diagnostic equipment used by patients in a supine prone, or side-lying position (M301); diagnostic equipment used by patients in a seated position (M302); diagnostic equipment used by patients seated in a wheelchair (M303); and diagnostic equipment used by patients in a standing position (M304). Chapter 3 also provides technical criteria for supports (M305), communication (M306), and operable parts (M307). This chapter underwent significant reorganization and changes as described in Section IV.B through IV.E (Significant Changes—M301 through M305). Additionally, the Access Board made editorial changes which are described below in the applicable Section-by-Section Analysis.
M301 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a supine, prone, or side-lying position such as, examination tables, imaging tables, hospital beds, and stretchers.
The MDE NPRM proposed that all diagnostic equipment used by patients in a supine, prone, or side-lying position must comply with the technical requirements of proposed section M301. As discussed in Section IV.B.4. (Significant Changes—Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302), in response to public comment and recommendations from the MDE Advisory Committee, in the final rule the Access Board has added an exception to this requirement for examination chairs that can be reclined to facilitate diagnosis after the patient transfers. This new exception exempts these diagnostic chairs from compliance with M301's requirements, as long as the examination chairs comply with the requirements in M302.
This is an introductory section.
The MDE NPRM proposed a transfer surface height range for diagnostic equipment used by patients in the supine, prone, or side-lying position of 17 inches minimum and 19 inches maximum. The Access Board received multiple comments on this provision and the MDE Advisory Committee provided four recommendations. As discussed in Section IV.B.1.a. (Significant Changes—Transfer Surface Adjustability), in the final rule the Access Board has renamed this provision and now requires the transfer surface height to be adjustable to: (1) A low transfer height of 17 inches minimum and 19 inches maximum; (2) a high transfer height of 25 inches; (3) at least four additional transfer heights located between the low and high transfer heights, separated by one inch minimum increments; and (4) the transfer surface height will be measured from the floor to the top of the uncompressed transfer surface.
As discussed in Section IV.B.1.a. (Significant Changes—Transfer Surface Adjustability), this is a new provision that was added to the final rule in conjunction with the new requirement of a low height range in M301.2.1. It provides a sunset for the low transfer height provision of five years from the date of publication of this rule in the
The MDE NPRM proposed a transfer surface size for diagnostic equipment used in the supine, prone, or side-lying position of 30 inches wide and 15 inches deep minimum. (proposed M301.2.2). The Access Board received multiple comments on this provision as well as multiple recommendations from the MDE Advisory Committee. As discussed in Section IV.B.1.c (Significant Changes—Transfer Surface Size), in the final rule the Access Board has revised this provision to account for the two types of transfer surfaces (end and side), requiring end transfer surfaces to be a minimum of 28 inches wide and 17 inches long and side transfer surfaces to be a minimum of 28 inches wide and 28 inches long and has added an exception for transfer surfaces for imagining equipment with bores.
In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer. Examples of temporary obstructions include folding armrests, removable side rails, retractable footrests, and stirrups. NPRM, 77 FR at 6924. There were no comments received on the proposed provision and the MDE Advisory Committee did not make any recommendations. The final rule retains the requirement for unobstructed
Additionally, the Access Board sought public input on whether an additional exception to the requirement of unobstructed transfer should be added. NPRM, 77 FR at 6924. Specifically, the Access Board asked whether equipment parts should be permitted to extend a maximum of three inches horizontally beyond the edge of the transfer sides, provided they do not extend above the top of the transfer surface. The Access Board received multiple comments and recommendations from the MDE Advisory Committee on this topic. As discussed above in the Section IV.B.1.d. (Significant Changes—Unobstructed Transfer), the final rule includes a second exception to the unobstructed transfer provision which permits obstructions of no more than three inches to extend beyond the transfer side of the transfer surface, provided that such obstructions do not protrude above the top of the transfer surface.
This is an introductory section. An editorial change was made to this section as a result of the change in M301.3.2, described below, to replace the word “stirrups” with the term “leg supports.”
The MDE NPRM proposed to require transfer supports to be provided for use with transfer sides on diagnostic equipment used by patients in the supine, prone, or side-lying position, and that these transfer supports comply with the technical requirements for transfer support in M305.2. There were no public comments and no recommendations by the MDE Advisory Committee on this provision. The only change in the final rule was to update the cross reference to applicable transfer surfaces to accommodate the changes made to transfer surfaces, described above in Section IV.B.1. (Significant Changes—Transfer Surface).
In the MDE NPRM, the Access Board proposed to place the requirements for stirrups on diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule the Access Board has decided to move the technical requirements for stirrups to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that when stirrups are provided on diagnostic equipment used in the supine, prone, or side-lying position leg supports must also be provided and comply with the technical requirements in M305.4. Additionally, in the final rule, the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to an MDE Advisory Committee recommendation to draw a distinction between stirrups which often only support the feet and leg supports which would support the legs when the patient's feet are in the stirrups and to provide consistency with the headings of other support provisions which are based on the body part supported.
In the MDE NPRM the Access Board proposed to place the requirements for head and back support for diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule, the Access Board has decided to move the technical requirements for head and back support to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that where diagnostic equipment is used in a reclined position it must provide head and back support that complies with the technical requirements in M305.5.
The MDE NPRM proposed to require that diagnostic equipment used by patients in the supine, prone, or side-lying position be usable with a patient lift and comply with either the proposed clearance in base (proposed M301.4.1) or clearance around base (proposed M301.4.2) technical requirements. One manufacturer commented on this provision, asserting that the proposed requirement was unclear and should clearly state that the diagnostic equipment only has to be compatible with either the clearance around base or the clearance in base provisions. The Access Board considered this comment, but finds that the language is clear as written. This provision clearly states that diagnostic equipment shall comply with clearance in base or clearance around base. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, and a change to clarify that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift.
Additionally, question 27 in the MDE NPRM preamble requested input on whether the final rule should provide an exception from the lift compatibility requirements where the diagnostic equipment is designed for use with overhead lifts. As discussed above in Section IV.B.3. (Significant Changes—Lift Compatibility Exception), the Access Board has decided to add this exception for diagnostic equipment that meets the following three criteria: Fixed overhead patient lifts are provided for use with the diagnostic equipment; the use with the fixed overhead patient lift with the diagnostic equipment is permitted by an enforcing authority; and the diagnostic equipment is clearly labeled as not compatible with portable patient lifts.
The MDE NPRM proposed certain clearance requirements beneath the diagnostic equipment to allow sufficient space for the legs of a portable patient lift to fit underneath the equipment so that the patient could be raised out of their mobility device, moved over to the medical diagnostic equipment, and then be lowered onto the transfer surface. The proposed requirement could be met by providing an open area beneath the equipment, or by configuring the equipment with a wide slot recessed into the base enclosure. NPRM, 77 FR at 6927. The MDE NPRM proposed a clearance in the base of 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the equipment is less than 36 inches wide, the proposed rule required the clearance to extend the full width of the equipment.
Six commenters responded to the question. One commenter, a manufacturer, concurred with the proposed provision. Another commenter, a medical association, explained that portable lifts are a problem in older outpatient facilities due to limited space. Another commenter, a manufacturer, raised concerns about requiring floor based patient lifts with MRI systems, explaining the concern about the significant structural support required in the patient bed which makes the under bed clearance impractical and the concern about requiring non-ferrous materials in the MRI room. This commenter explained a preference for
The MDE Advisory Committee recommended reducing the equipment base clearance for stretchers from 44 inches wide minimum to 39 inches wide minimum. The Committee noted that this was to harmonize the MDE Standards with IEC 60601-2-52, which provides requirements for stretchers and includes lift clearance at the 39-inch width. MDE Advisory Committee Report, 106-107, available at
The Access Board has reviewed the comments and the recommendations from the MDE Advisory Committee and is persuaded by the arguments in favor of harmonizing the lift clearance requirements with the IEC 60601-2-52. Accordingly, the Access Board has adopted the recommendation from the MDE Advisory Committee, but has decided to apply the reduction in lift clearance width to all medical diagnostic equipment that complies with the clearance in base provision because a lift that deploys effectively under a stretcher should also function properly under other less constrained diagnostic equipment. Secondly, the Access Board has decided to retain the six-inch height clearance requirement but agrees with the commenters that the diagnostic equipment should not have to meet the six-inch height clearance requirement when in position for independent transfer. Therefore, the final rule clarifies that the lift compatibility requirements only apply when the diagnostic equipment is being used with the portable lift, as a lift will only be used when independent transfer is not possible.
The MDE NPRM proposed certain requirements to provide clearance around the base of the diagnostic equipment to allow the legs of the portable floor lift to straddle the base of the diagnostic equipment with a solid base that sits on or close to the floor. The proposed rule required a minimum clearance of 6 inches high measured from the floor and 36 inches deep measured from the edge of the examination surface. NPRM, 77 FR at 6927. The width of the base permitted within this clearance would be 26 inches maximum at the edge of the examination surface and was permitted to increase at a rate of 1 inch in width for every 3 inches in depth.
Two commenters, both manufacturers, responded to this question. One commenter recommended clarifying that the exam table must be compatible with a patient lift and meet the six-inch clearance, but not when the table is at its lowest level for independent transfer. This manufacturer indicated that its adjustable table does not have a six-inch minimum clearance when at its lowest position, but does meet the standard when the table is raised. The other commenter asserted that the proposed dimensions are not sufficient to accommodate the various portable floor lifts and recommended that the Access Board instead provide technical criteria for the portable patient lift to be usable with diagnostic equipment since it is more cost effective to change the floor lift, than to change the diagnostic equipment. Additionally, this manufacturer reported that all but one of its examination and procedure tables currently meet the clearance around base provision, but opined that if the proposed increase in width of the transfer surface of examination tables and chairs to 30 inches by 15 inches is adopted then it would be required to redesign the examination tables and chairs to have a larger base which would interfere with the ability to meet this clearance around base provision. The MDE Advisory Committee did not address this provision, and thus provided no recommendations on the clearance around the base requirements.
The Access Board has reviewed the comments and has decided to retain the provision from the proposed rule. In the final rule, the Access Board has decided to decrease the size of the transfer surface (See final M301.2.3) and thus the commenter's concern regarding an increase in base size is not applicable. As described above, M301.4 does not require the 6-inch height clearance to be maintained when the equipment is lowered to the minimum low height for independent transfer as required by M301.2.1, because portable patient lifts will only be used when independent transfer is not possible. Finally, a portable patient lift is not medical diagnostic equipment and, therefore, not within the purview of the Access Board's regulatory jurisdiction. However, portable patient lifts are integral to ensuring that patients with disabilities who are unable to independently transfer are otherwise able to use the medical diagnostic equipment. Therefore, the Access Board has provided the technical criteria necessary for the portable floor lift to be usable with medical diagnostic equipment.
M302 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a seated position such as examination chairs.
The MDE NPRM proposed that all diagnostic equipment used by patients in a seated position must comply with the technical requirements of proposed section M302. As discussed in Section IV.B.5. (Significant Changes—Exception from the Requirements of M302 for Weight Scales with Integral Seats), in response to public comment and evidence presented to the MDE Advisory Committee, in the final rule the Access Board has added an exception to this requirement for weight
This is an introductory section.
The MDE NPRM proposed a transfer surface height range for diagnostic equipment used by patients in a seated position of 17 inches minimum and 19 inches maximum. The Access Board received multiple comments on this provision and the MDE Advisory Committee provided four recommendations. As discussed in Section IV.B.1.a. (Significant Changes—Transfer Surface Adjustability) in the final rule the Access Board has renamed this provision and now requires the transfer surface to be adjustable to: (1) A low transfer position height at or between 17 inches and 19 inches; (2) a high transfer position of 25 inches; (3) at least four additional transfer positions located between the low and high transfer positions and separated by one inch minimum increments; (4) measured from the floor to the top of the uncompressed transfer surface.
As discussed in Section IV.B.1.a. (Significant Changes—Transfer Surface Adjustability), this is a new provision added to the final rule in conjunction with the new requirement of a low height range in M302.2.1. It provides a sunset for the low transfer height provision of five years from the date of publication of this rule in the
The MDE NPRM proposed a transfer surface size for diagnostic equipment used by patients in the seated position of 21 inches wide and 15 inches deep (proposed M302.2.2). The Access Board also solicited comment in question 16 on whether the transfer surface size proposed for seated position diagnostic equipment was sufficient to facilitate independent transfer. NPRM, 77 FR at 6924. Two of the seven commenters who responded supported the proposed requirements. One commenter, a manufacturer, although in agreement with the 21-inch width, stated that the 15 inches deep requirement should be increased to 17 inches, a disability advocate recommended increasing the width to 23 inches, two of the commenters, accessibility consultant and disability advocate, stated that the proposed dimensions were insufficient citing concerns for persons of larger stature or who are obese and may be unable to safely transfer to a surface of that size. One commenter, a manufacturer, recommended harmonizing with the requirements for the seated position with those of the supine, prone, or side-lying position transfer surface size.
The MDE Advisory Committee considered the dimensions for rectangular seats in roll-in showers from the 2010 ADA Standards for Accessible Design and the “ideal” chair width recommended in Architectural Graphic Standards for auditorium seating. MDE Advisory Committee Report, 77, available at
Based on the commenters' responses and the MDE Advisory Committee recommendations, the Access Board has decided to increase the transfer surface size for equipment used by patients in a seated position to 17 inches deep and retain the 21-inch-wide requirement from the proposed rule.
In the MDE NPRM, the transfer side provision for diagnostic equipment used by patients in the seated position required transfer surfaces to have the option to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface, and provide unobstructed transfer to the surface. The Access Board received multiple comments and recommendations from the MDE Advisory Committee, which are discussed above in Section IV.B.1.b. (Significant Changes—Transfer Surface Location). In the final rule, the Access Board retained this provision, but made editorial changes to clarify the location of the transfer sides and to relocate the language concerning unobstructed transfer into a new section M302.2.5. The transfer sides are still intended to allow a patient to choose to transfer onto either of two adjoining sides of the transfer surface. Additionally, based on comments and recommendations from the MDE Advisory Committee, the Access Board has decided to add an exception to this provision to accommodate chairs with fixed footrests which prevent transfer onto the adjoining sides. This is discussed in Section IV.B.1.b. (Significant Changes—Transfer Surface Location). As explained above, in order to provide patients with the ability to choose what side of their body they use to transfer, chairs with fixed footrests will provide the ability to transfer from either opposing side of the transfer surface. This allows the patient to choose to transfer from their right or left side and prevents the patient from having to transfer onto a fixed footrest.
In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer. This requirement is identical to the unobstructed transfer requirement in M301.2.4, and this provision is discussed in the Section V.C.2.d. (Section-by-Section Analysis—M301.2.4). The final rule retains the requirement for unobstructed transfer, but has been reworded to specify that each transfer surface must provide two unobstructed sides for the patient to transfer.
Additionally, as discussed above in the Section IV.B.1.d. (Significant Changes—Unobstructed Transfer), the final rule includes a second exception to the unobstructed transfer provision which permits obstructions of no more than three inches to extend beyond the transfer side of the transfer surface, provided that such obstructions do not protrude above the top of the transfer surface.
This is an introductory section. An editorial change was made to this section as a result of the change in M302.3.2, described below, to replace the word “stirrups” with the term “leg supports.”
In the MDE NPRM the Access Board proposed that transfer supports must be provided for use with transfer sides on
The MDE NPRM did not propose to require stirrups to provide a method of supporting, positioning, and securing the patient's legs for diagnostic equipment used by patients in the seated position. However, in response to question 23, on whether diagnostic equipment used by patients in a seated position that provide stirrups should have to provide such support, the Board received six comments. NPRM, 77 FR at 6926. All six commenters concurred that when stirrups are provided for use with diagnostic equipment used by patients in the seated position, a method must be provided for supporting, positioning, and securing the patient's legs. The MDE Advisory Committee did not address this provision.
The Access Board concurs with the commenters, and the final rule requires that where stirrups are provided on seated diagnostic equipment, leg supports must also be provided and must comply with the technical requirements for leg supports in M305.4. This will ensure that patients with limited leg strength and control will be able to keep their legs in the appropriate position for examination.
In the MDE NPRM the Access Board proposed to place the requirements for head and back support for diagnostic equipment used by patients in the seated position in M302. In the final rule the Access Board has decided to move the technical requirements for head and back support to M305 which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that where diagnostic equipment is used in a reclined position it must provide head and back support that complies with the technical requirements in M305.5.
The MDE NPRM proposed to require that diagnostic equipment used by patients in the seated position be usable with a patient lift and comply with either the proposed clearance in base (proposed M302.4.1) or clearance around base (proposed M302.4.2) technical requirements. This requirement is identical to the lift compatibility requirement for diagnostic equipment used by patients in the supine, prone, or side-lying position, and is discussed in the Section-by Section Analysis for M301.4. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, reduced the lift clearance to 39 inches and clarified that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift.
M303 in the final rule establishes the technical requirements for diagnostic equipment used by patients seated in a wheelchair, such as weight scales with wheelchair spaces and mammography equipment.
This is an introductory section.
This is an introductory section.
The MDE NPRM proposed to require wheelchair spaces to be designed so that a patient in a wheelchair using diagnostic equipment would be oriented in the same direction that other non-wheelchair using patients using the equipment are typically oriented. NPRM, 77 FR at 6927. The Access Board received one comment about this requirement. The commenter, an accessibility consultant, recommended that patient positioning be addressed along with orientation of the wheelchair, noting that there are many cases where it is insufficient to simply position the user facing the same direction as a non-wheelchair user. The commenter asserted that body positioning is key for obtaining accurate results when using diagnostic devices, such as x-ray equipment, and recommends amending the rule text to require wheelchair spaces to be designed so that the patient orients and positions their body in the same position as someone who is not in a wheelchair. There was no recommendation from the MDE Advisory Committee on this requirement. The Access Board has retained the original requirement in the final rule. The Board did not include requirements for patient body positioning because the diagnostic equipment cannot override the position in which an individual is seated in his or her wheelchair. Wheelchairs often are contoured to fit the specific and unique needs of the user and to provide support where it is needed. However, the design of a wheelchair space often influences whether a wheelchair user can orient with respect to diagnostic components. For example, without knee and toe space beneath an optometrist diopter, the patient cannot look into the lens.
The MDE NPRM proposed to require that diagnostic equipment used by patients seated in a wheelchair provide a wheelchair space that was at least 36 inches wide. There were no public comments and no MDE Advisory Committee recommendations regarding this requirement. Thus, the final rule retains the 36-inch wheelchair space width requirement. However, the Board added a new exception for wheelchair spaces on raised platforms, as discussed in Section IV.C.1. (Significant Changes—Width and Depth of Wheelchair Spaces), and discussed briefly below.
In the preamble to the MDE NPRM, the Access Board sought input on whether an exception to the width requirement was needed for wheelchair spaces on raised platforms. Multiple commenters responded to this provision and the MDE Advisory Committee recommended reducing the width requirement for wheelchair spaces on raised platforms. The Access Board has added an exception in the final rule that permits wheelchair spaces on raised platforms to be 32 inches wide minimum with edge protection no higher than 4 inches, measured from the platform surface.
The MDE NPRM proposed two wheelchair space depth requirements based on how the wheelchair user enters the space: For spaces entered from the front or rear, 48 inches deep minimum; and for spaces that can only be entered from the side, 60 inches deep minimum. In the preamble in the MDE NPRM, the Access Board noted it was considering increasing the minimum depth for wheelchair spaces entered from the front or rear to 58 inches and sought input in question 29 on whether the Access Board should increase this minimum depth requirement. NPRM, 77 FR at 6928.
The Access Board received eight comments in response to this question. Three commenters (two disability rights organizations and a state agency concerned with accessibility) recommended increasing the depth of front or rear entered spaces to 58 inches. The other five commenters (manufacturers, medical associations and accessibility consultants) recommended retaining the proposed requirement in the MDE NPRM of 48 inches minimum, raising concerns that the size of the rooms in which the diagnostic equipment are located are insufficient to provide additional space. The MDE Advisory Committee did not make recommendations regarding the general requirement for depth for wheelchair spaces, but did make recommendations regarding the depth of wheelchair spaces on raised platforms, which is discussed in above in Section IV.C.1. (Significant Changes—Width and Depth of Wheelchair Spaces).
First, the Access Board clarifies that this provision is not a clear space requirement for wheelchair approach, but is instead the wheelchair space integral to diagnostic equipment for a patient seated in a wheelchair, such as mammography equipment or wheelchair accessible scales. Second, based on the comments received and the absence of recommendations from the MDE Advisory Committee to change the proposed requirement, the Access Board has retained the MDE NPRM's requirements for a minimum depth of 48 inches for wheelchair spaces entered from the front or rear, and a minimum depth of 60 inches for wheelchair spaces entered from the side. However, the Access Board has reorganized this provision into three separate requirements based on how the wheelchair space is entered, made an editorial change to clarify that front or rear entry is where the wheelchair space entry and exit is provided at only one end, and as discussed in Section IV.C.1. (Significant Changes—Width and Depth of Wheelchair Spaces), added an additional requirement to the depth provision for wheelchair spaces entered from the front or rear to permit a minimum of 40 inches if the wheelchair space provides pass-through from one end to the other.
The MDE NPRM proposed knee and toe clearance for diagnostic equipment used by patients seated in wheelchairs to allow for components in the wheelchair space which the patient could approach successfully to use for its intended diagnostic purpose. The proposed requirements for equipment clearances paralleled the knee and toe clearance requirements from the 2004 ADA and ABA Accessibility Guidelines. The proposed rule provided one additional requirement for breast platforms on mammography equipment, proposing the knee and toe clearance under a breast platform to be 25 inches deep (proposed M303.2.4). The MDE NPRM preamble sought input with question 34 on whether the dimensions recommended by the Wheeled Mobility Anthropometry Project should be adopted.
The Access Board has determined that mammography equipment presents a unique challenge. Mammography equipment contains breast platforms which patients seated in wheelchairs must approach, and successfully maneuver their lower body under the platform enough to allow their chest to be flush with the leading edge of the platform. A separate set of equipment clearance requirements is necessary to address the unique positioning at mammography equipment. Therefore, in the final rule the Access Board has separated out the knee and toe clearance requirements into two provisions; breast platforms and other equipment. Breast platform requirements address the knee and toe clearance requirements for mammography equipment which is usable by patients seated in a wheelchair and is discussed in Section IV.C.2. (Significant Changes—Equipment Clearances for Breast Platforms). All other diagnostic equipment used by patients seated in a wheelchair must comply with the other equipment clearances requirements.
For all other equipment, the Access Board has decided to retain the original requirements in the proposed rule for knee and toe clearance. The Access Board is not persuaded to adopt the Wheeled Mobility Anthropometry Project recommendations for knee and toe clearances at this time. These recommendations represent a significant departure from the 2004 ADA and ABA Accessibility Guidelines. Therefore, the Board has elected in the final rule to retain the proposed provisions in the NPRM for knee and toe clearance for other equipment (M303.2.4.2). Due to the reorganization of the equipment clearances provision in the final rule, the knee and toe clearance requirements for the other equipment section have been renamed depth and height and relocated to M303.2.4.2. In addition, the Access Board has made an editorial change to the toe height requirement to clarify that the measurement is taken from the toe end of the wheelchair space.
The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair to provide a wheelchair space with a surface that does not slope more than 1:48 in any direction. This provision is consistent with the 2004 ADA and ABA Accessibility Guidelines. There were no comments on this section and it was not addressed by the MDE Advisory
The MDE NPRM proposed edge protection on the ramps leading up to the raised platform (proposed M303.3.3.4), but did not require edge protection on the raised platforms themselves. The Access Board received two comments and two recommendations from the MDE Advisory Committee regarding edge protection on raised platforms. As discussed in Section IV.C.5. (Significant Changes—Edge Protection), the final rule requires platforms with wheelchair spaces that are raised more than 1
This is an introductory section.
The MDE NPRM proposed that for equipment with a change in level at the entry to the wheelchair space, level changes of up to
The MDE NPRM proposed that for equipment with a change in level at the entry to the wheelchair space, level changes greater than
The MDE NPRM proposed that for equipment with a change in level at the entry of a wheelchair space, level changes greater than
Regarding running slope, the MDE NPRM proposed that ramp runs have a running slope not steeper than 1:12. There were no comments on this section; however, as discussed in Section IV.C.3. (Significant Changes—Exception to Ramp Running Slope), the MDE Advisory Committee made a three-tiered recommendation for the allowable running slope. After careful consideration of the Advisory Committee's recommendations, the Access Board has retained in the final rule the original requirement for running slope, but has added an exception that permits a running slope not steeper than 1:8 for ramp runs with a maximum height of 2
The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair which has components that are used to examine specific body parts, be capable of examining those body parts of the patient while the patient is seated in a wheelchair. For example, an x-ray platform on which a patient places an arm or hand would have to be capable of examining the arm or hand of the patient while seated in a wheelchair. NPRM, 77 FR at 6930. There were no comments on this requirement and it was not addressed by the MDE Advisory Committee. There have been no changes made to this requirement.
The MDE NPRM proposed a mammography breast platform height range of 30 inches high minimum and 42 inches high maximum above the floor. The Access Board received three comments on this provision, and the MDE Advisory Committee made several recommendations for changes. As discussed above in the Section IV.C.4. (Significant Changes—Breast Platform Adjustability), the Access Board has revised this provision to require the breast platform to be continually adjustable from a low height of 26 inches to a high height of 42 inches above the floor and made an editorial change to the provision title changing it from height to adjustability.
M304 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a standing position such as a weight scale or x-ray equipment that is used in a standing position for certain diagnostic procedures.
This is an introductory section.
The MDE NPRM proposed to require that the standing surface on which patients stand be slip resistant. In preparing the final rule, the Board has determined that as previously drafted this provision unintentionally placed requirements on the facility floor, as opposed to restricting the requirements to the diagnostic equipment itself. While the Access Board may choose to promulgate requirements for the building under its other rulemaking authority at a later date, this type of requirement is outside the scope of the MDE Standards and therefore M304 in the final rule has been restructured. The requirement for slip resistant and standing supports has been moved under this new requirement applying to standing surfaces. This reorganization ensures that only diagnostic equipment used by patients in a standing position that provides a surface for the patient to stand on must be slip resistant (M304.2.1) and provide standing supports (M304.2.2) in the final rule. Both of these requirements are discussed below.
The MDE NPRM proposed to require that the standing surface on which patients stand be slip resistant. One manufacturer commented on this requirement, requesting that the rule provide clarification on how to define or measure a standing surface as “slip resistant.” This provision was not addressed by the MDE Advisory Committee. The Access Board has decided to retain the original requirement in the final rule as it is the Board's understanding that various industries employ different testing methods, there is no universally adopted or specified test for slip resistance, and the assessed level varies according to the measuring method used. Other than the change to clarify that the provision applies only to standing surfaces that are part of the
The MDE NPRM proposed requiring standing supports on each side of the standing surface of diagnostic equipment used by patients in the standing position, and compliance with the technical requirements for standing supports in proposed M305.3. The Access Board received multiple comments and two recommendations from the MDE Advisory Committee. As discussed above in the Section IV.D.1. (Significant Changes—Standing Supports) and IV.E.2. (Significant Changes—Standing Supports), the final rule retains the general requirement that standing supports be provided on two sides of the standing surface. In addition, the Access Board has added a new exception for diagnostic equipment with entry and exit that permits pass-through from one end to another to provide one standing support provided it complies with the requirements for standing supports in the horizontal position in M305.3 in the final rule.
M305 in the final rule provides the technical requirements for transfer supports, standing supports, leg supports, and head and back supports. Transfer supports are required for diagnostic equipment complying with M301 and M302 and standing supports are required for diagnostic equipment complying with M304. Leg supports and head and back supports apply, where provided, to diagnostic equipment complying with M301 and M302.
This is an introductory section.
This is an introductory section. As discussed above in Section IV.E.1. (Significant Changes—Transfer Supports), the Access Board strengthened the transfer support requirements and added additional requirements in the final rule to ensure that supports are capable of assisting with independent transfer onto and off of the diagnostic equipment. With the changes to the final rule, the Board sought to harmonize as much as possible, these requirements with the 2004 ADA and ABA Accessibility Guidelines for grab bars.
The MDE NPRM proposed that transfer supports be located within reach of the transfer surface and not obstruct transfer onto or off of the surface when in position (proposed M305.2.1). In the preamble to the MDE NPRM, the Access Board noted it was considering requiring transfer supports to be located no further than 1
Eight commenters responded to question 19, but only six of the commenters addressed the location of transfer supports. Two commenters, a manufacturer and a state agency concerned with accessibility, concurred with the technical requirements proposed in question 19 for the transfer support location. Another commenter, a disability rights organization, stated that transfer supports should be required on both sides of the equipment. A manufacturer noted that if the proposed transfer surface size of 30 inches wide is adopted, then a transfer support opposite the transfer side would be useless as the patient would be unable to reach the support until nearly fully on the diagnostic equipment. This commenter noted that an adjacent transfer support would be more effective, but would conflict with the provider expectations of bed and stretcher side rails. The final two commenters, a manufacturer and a medical association, raised concerns about requiring any transfer supports on imaging equipment, specifically MRI and CT machines, asserting that the supports may interfere with the image quality.
The MDE Advisory Committee made three separate recommendations for the location of transfer supports: A general requirement, a requirement for stretchers, and a requirement for imaging equipment. For the general provision, the MDE Advisory Committee recommended requiring transfer supports on both sides of the transfer surface that can be removed or repositioned during transfer and are located at a maximum distance of 1
For stretchers, the MDE Advisory Committee noted that patients enter from either of the long sides, rather than on one long side and one short side, and this change in orientation necessitated a different location for the transfer supports so that the support would be reachable during transfer. The MDE Advisory Committee recommended locating the transfer support “along the long side of the transfer surface on the opposite side of the transfer.” MDE Advisory Committee Report, 87-88, available at
For imaging equipment, the MDE Advisory Committee recommended requiring transfer supports when the transfer surface was 24 inches deep or less, and requiring positioning supports for transfer surface depths of greater than 24 inches.
After review of the public comments and the MDE Advisory Committee recommendations, the Access Board has determined that there is a need for two types of transfer supports, based on the orientation of the transfer surface. As
In the final rule the Access Board has decided for end transfer supports to require at least one support located on the long side of the transfer surface, opposite the transfer side. For side transfer supports, the Access Board has decided to require a transfer support which is capable of supporting transfer on each side of the transfer surface. A side transfer surface could contain one transfer support which is capable of being repositioned from one side to the other side depending on which side the patient chooses to transfer or it is acceptable to have two transfer supports, one on each long side, which are both capable of being removed or repositioned on the side the patient chooses to transfer. Additionally, the final rule requires both end and side transfer supports to be located a maximum of 1
In the MDE NPRM there was no requirement for length of the transfer support; however, the MDE NPRM preamble noted that the Access Board was considering requiring the transfer supports to extend the entire depth of the transfer surface and be a minimum of 15 inches in length. NPRM, 77 FR at 6925. The Access Board specifically sought public input with question 19, asking if the proposed length of the transfer supports would be sufficient to facilitate transfer and maintain position on the diagnostic equipment.
Three commenters responded to this issue, two manufacturers and a state agency concerned with accessibility. The state agency concurred with the 15-inch requirement. One commenter did not support a 15-inch length transfer support. This commenter (a manufacturer) stated that a transfer support that is a minimum of 15 inches in length would make it even more difficult to comply with load bearing requirements and recommended that this length requirement be reduced. The second commenter, a manufacturer, recommended revising the proposed provision from requiring the transfer support to extend horizontally the entire depth of the transfer surface, to extend horizontally along the transfer surface to within three inches, to allow for manufacturing tolerances.
The MDE Advisory Committee made three transfer support length recommendations, one for each type of transfer support recommended by the Committee, described above. For the general provision, the MDE Advisory Committee recommended a transfer support with a length of 15 inches minimum, that overlaps the minimum depth of the transfer surface by 80 percent. The Committee explained that the transfer support length provides the gripping surface for the patient to grasp or maintain balance while transferring. MDE Advisory Committee Report, 90, available at
The Access Board agrees with the MDE Advisory Committee that the addition of a requirement for a transfer support length provision is necessary and has adopted many of the MDE Advisory Committee's recommendations for transfer support length in the final rule. The Board restructured the Committee's recommendations to fit within the end and side transfer supports discussed above. For end transfer supports the Access Board has adopted the general provision recommended by the MDE Advisory Committee and determined that the required length will be 15 inches minimum. Additionally, the Access Board acknowledges that manufacturers need some flexibility with respect to the location of the support to account for clearances with other equipment components that may articulate or move. Therefore, the final rule requires that the 15-inch minimum length transfer support be positioned along 13
For side transfer supports the Access Board adopted the MDE Advisory Committee recommendation for imaging equipment, that this support be a minimum of 28 inches long positioned along the width of the transfer surface. In addition, the Board has added two exceptions to the requirements for side transfer supports to address the concerns raised by the MDE Advisory Committee. The first exception addresses articulating patient surfaces, primarily stretchers, where a continuous 28‐inch transfer support may conflict with other supports or railings as the
In question 19 part (e) the Access Board sought input on whether angled or vertical transfer supports should be permitted. 77 FR at 6925. Three commenters, a manufacturer, an accessibility consultant, and a disability rights organization, responded and all concurred with the proposal. The MDE Advisory Committee did not specifically address this proposal, however, in its recommendations for the length of transfer supports on imaging equipment, it did recommend that the transfer support should extend horizontally along the side of the patient table. MDE Advisory Committee Report, 90-91, available at
In the MDE NPRM there was no specific requirement regarding the height of the transfer support, only that it be “within reach” of the patient (proposed M305.2.1). The Access Board sought input from the public in question 20 of the MDE NPRM preamble, on whether a transfer support height requirement of 6 inches minimum and 19 inches maximum above the transfer surface would be usable by patients with disabilities. NPRM, 77 FR at 6925. Six commenters responded to question 20. Four commenters (two manufacturers, one disability rights organization, and a state agency concerned with accessibility) supported the proposed height range. Three commenters (a manufacturer, a medical association, and a disability rights organization) did not support the proposal. The manufacturer opposing the proposed range raised concerns with its ability to attain a 19-inch height on its diagnostic equipment. The medical association asserted that radiography exam tables are not equipped with transfer bars, and if required should retract fully into the surface of the table and the disability rights organization expressed concern that 19 inches was too high to facilitate safe transfer.
The MDE Advisory Committee supported adding a requirement setting the height of transfer supports within the range described in question 20 in the MDE NPRM preamble, of 6 inches minimum and 19 inches maximum. The MDE Advisory Committee explained that the manufacturers on the Committee determined that this recommendation did not conflict with the IEC 60601-2-52, which provides requirements for side rails to prevent entrapment hazards, and would allow the equipment to be designed to provide accessibility and safety from entrapment hazards. MDE Advisory Committee Report, 94, available at
The Access Board considered the public comments and the MDE Advisory Committee's recommendations, and has decided to include a new provision, M305.2.3 in the final rule, that requires the tops of transfer support gripping surfaces to be located 6 inches minimum and 19 inches maximum higher than the top of the associated uncompressed transfer surface during use. This range allows the manufacturer to choose a height between 6 inches and 19 inches to place their transfer supports; it does not require that the transfer supports be 19 inches high. The transfer support is permitted to be horizontal, angled, curved, or a combination of these as long as the top of any point along the gripping surface is located at or between 6 inches and 19 inches. Thus, the commenter's concern about reaching the 19-inch height is not warranted. Secondly, as discussed above in Section IV.E.1.b (Significant Changes —Positioning Supports), the Access Board has declined to include the MDE Advisory Committee's recommended positioning supports in the final rule; however, the Access Board does concur with the MDE Advisory Committee that for imaging equipment with transfer surfaces that exceed 24 inches in width, a lower transfer support is warranted. Therefore, in the final rule, the Access Board has provided an exception that permits transfer supports to be located three inches minimum and six inches maximum higher than the tops of the transfer surfaces for imagining beds that are greater than 24 inches wide.
The proposed rule did not provide specific requirements for the cross section of transfer supports. However, in the MDE NPRM preamble, the Access Board noted that it was considering adopting the cross sectional dimensions for grab bars from the 2004 ADA and ABA Accessibility Guidelines for transfer supports. NPRM, 77 FR at 6925-6926. Specifically, the Access Board indicated it was considering requiring circular cross sections to have an outside diameter of 1
Five commenters responded to question 21. Two commenters (one manufacturer and one accessibility consultant) were opposed to permitting non-rounded cross sections, noting concern that harsh edges or angles may not allow users to comfortably and adequately grasp the support. One commenter (a manufacturer) asserted that because currently there are no standards, existing products would likely not meet the proposed provision. Another commenter (a manufacturer) was concerned that the requirement could preclude the use of cushioned arm pads.
The MDE Advisory Committee expressed confidence “in reliance on the cross section dimensions in the 2010 Standards.” MDE Advisory Committee Report, 99, available at
Allowing both noncircular cross sections and circular cross sections gives manufacturers flexibility to employ the best configuration for use of the equipment, hand, grip strength, and power grab functions. While a majority of the Committee members supported a recommendation allowing both noncircular and circular cross sections, some members noted ergonomic considerations support the better functionality of circular cross section gripping surface.
After review of the comments and the MDE Advisory Committee's recommendations, the Access Board has decided to apply the 2004 ADA and ABA Accessibility Guidelines for grab bar cross sections to transfer supports in the final rule. Accordingly, the final rule includes a new provision, M305.2.4, requiring transfer supports to have one of two cross sections: circular cross sections, with an outside diameter of 1
The proposed rule did not provide any specific restrictions regarding surface hazards around the transfer supports. No public comments were submitted on this issue, but the MDE Advisory Committee voiced concern about surface hazards stating, “gripping surface configurations must provide an effective and safe surface for patients to hold onto. Sharp edges or abrasive elements may injure and cause the patient to lose their grip during positioning or transfer.” The MDE Advisory Committee recommended that a provision be added to the final rule requiring “gripping surfaces to be free of sharp or abrasive elements and have rounded edges.” The Committee based this recommendation on related provisions in the 2004 ADA and ABA Accessibility Guidelines for handrails and grab bars. MDE Advisory Committee Report, 101, available at
The Access Board concurs with the MDE Advisory Committee's recommendation and views the proposed provision as beneficial and consistent with the cross section requirements of M305.2.4, above. Therefore, the Access Board has added a new provision to the final rule, M305.2.5 Surface Hazards, to ensure that transfer supports and surfaces adjacent to transfer supports are free of sharp or abrasive components and have eased edges.
The proposed rule did not provide any specific requirements regarding gripping surfaces on transfer supports. However, in the MDE NPRM preamble the Access Board repeatedly noted that it was considering applying many of the provisions from the 2004 ABA and ADA Accessibility Guidelines for grab bars and handrails to transfer supports. NPRM, 77 FR at 6924-6926. The MDE Advisory Committee explained that:
The Access Board concurs with the recommendation of the MDE Advisory Committee and views the proposed provision as beneficial and consistent with the existing accessibility guidelines. Therefore, the Access Board has added this new provision to the final rule, M305.2.6, which ensures that an adequate surface area for gripping is provided to the patient.
In the MDE NPRM, the Access Board did not provide any specific requirements for clearances around the transfer support. However, in the preamble to the MDE NPRM the Access Board noted that it was considering applying the 2004 ADA and ABA Accessibility Guidelines for clearance around grab bars to the transfer support provision in the final rule. NPRM, 77 FR at 6926. Specifically, the Access Board sought input from the public in question 22, on whether transfer supports on diagnostic equipment could provide 1
Based on public commenter responses and MDE Advisory Committee recommendations, the Access Board has added a new provision to the final rule, M305.2.7, requiring a 1
The MDE NPRM proposed to require that transfer supports not rotate in their fittings (proposed M305.2.3). Five commenters addressed this provision. Four of the commenters disagreed with this requirement and explained the need for transfer supports to be able to rotate in their fittings. Specifically, one commenter (manufacturer) asserted that the technical criteria from the 2004 ADA and ABA Accessibility Guidelines for grab bars in bathrooms should not be applied to exam tables as they would restrict the ability for the transfer supports to be moved out of the way after transfer. Further, this commenter noted that the requirement conflicts with proposed M302.2.3, which allows for temporary obstructions such as armrests, footrests, and side rails that can be repositioned to allow for transfer. Another commenter (manufacturer) pointed out that bed rails, which are common on hospital beds, require a latched position and an unlatched position, which allows them to rotate in their fittings when not latched. A different manufacturer stated that its seated diagnostic equipment uses armrests as transfer supports, which can be pushed back toward the rear of the equipment to allow entry. An accessibility consultant recommended swing-away or removable armrests for chairs to allow for transfer on either side. The only commenter (accessibility consultant) opposed to allowing transfer supports to rotate in their fittings, expressed concern for the potential for injury if transfer supports rotated unexpectedly during transfer.
The MDE Advisory Committee recommended amending this provision to allow transfer supports to rotate in their fittings, but to require that they not rotate when they are locked into place for transfer. The Committee noted that it is advantageous to allow supports to perform the needed movement, but they should not do so when locked. MDE Advisory Committee Report, 102-103, available at
The Access Board concurs with the majority of the commenters and the MDE Advisory Committee. As noted in proposed M302.2.3, the Access Board intended to allow manufacturers to provide temporary obstructions such as armrests and bedrails that can be repositioned, or rotate in their fittings, and then be locked into place when needed as a transfer support. Therefore, the Access Board has revised this provision in the final rule to require that transfer supports do not rotate in their fittings when in place for transfer (M305.2.8).
M305.3 provides the technical requirements for standing supports which are required on diagnostic equipment covered by M304. This provision has been reorganized in the final rule into requirements for length and height, as opposed to vertical and horizontal.
In the MDE NPRM preamble, the Access Board noted that it was considering adopting the cross section dimensions for grab bars from the 2004 ADA and ABA Accessibility Guidelines and applying them to standing supports. The Access Board sought public input in questions 39 and 40 in the MDE NPRM preamble on whether the cross section dimensions for gripping surfaces should be applied to standing supports and whether standing supports can provide a 1
Additionally, one commenter (manufacturer) requested that requirements for structural strength be added to the standing support provision. For the same reasons the Access Board has removed the requirement of structural strength for transfer supports (See Section IV.E.1.a. (Significant Changes—Structural Strength) the Access Board declines to adopt such a requirement for standing supports in the final rule.
In the MDE NPRM, the Access Board proposed a gripping surface length of four inches minimum for horizontal standing supports. No public comments were submitted on this requirement. The MDE Advisory Committee supported the proposed technical provisions, but recommended adding additional criteria for standing supports on raised platforms with wheelchair spaces. As discussed above in the Section IV.E.2. (Significant Changes—Standing Supports), the final rule requires that horizontal standing supports be positioned horizontally in relation to standing surfaces and retains the proposed requirement of four inches minimum length. The Access Board added a new provision applying to diagnostic equipment containing a wheelchair space that also requires standing supports. This provision, M305.3.1.2 in the final rule, has added two new requirements for this type of equipment. First, for diagnostic equipment containing wheelchair spaces with one entry that also serves as the exit, the length of the gripping surface for horizontal standing supports must be equal to or greater than 80 percent of the overall length of the platform. Second, for diagnostic equipment with wheelchair spaces that permit pass-through from one end to the other, the length of the gripping surface for the horizontal standing support must be at least equal to the length of the platform. In the final rule these requirements are located in M305.3.1.1 Horizontal Position and M305.3.1.2 Diagnostic Equipment Containing a Wheelchair Space.
For vertical standing supports, the MDE NPRM proposed a gripping surface length of 18 inches minimum. There were no public comments submitted on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule, the Access Board retained the original requirement for gripping surface length and clarified that the vertical standing supports must be positioned vertically in relation to the standing surface. Both requirements are included in the new M305.3.1.3 Vertical Position provision in the final rule.
For horizontal supports, the MDE NPRM proposed a gripping surface height of 34 inches minimum and 38 inches maximum above the standing surface. There were no public comments on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule the Access Board retains the original requirement. This requirement has been relocated to M305.3.2.1 in the final rule.
For vertical supports, the MDE NPRM proposed that the bottom end of the support be 34 inches high minimum and 37 inches high maximum above the standing surface. There were no public comments on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule the Access Board retains the original requirement, but made a few minor editorial changes to the text. This requirement has been relocated to M305.3.2.2 in the final rule.
The MDE NPRM proposed to prohibit standing supports from rotating in their fittings. There were no comments on this section and it was not addressed by the MDE Advisory Committee. The Access Board made no changes to this provision.
As discussed above in Section V.C.3.b (Section-by-Section Analysis—M301.3.2) and Section V.C.7.b (Section-by-Section Analysis—M302.3.2), the technical requirements for leg supports from M301 and M302 have been relocated to M305 Supports. The MDE NPRM proposed that where stirrups are provided, they must provide a method to support, position, and secure the patients legs. Four commenters (medical association, accessibility consultant, disability rights organization, and a state agency) agreed with requiring leg supports when stirrups are provided.
The MDE Advisory Committee agreed that, for procedures that use stirrups and require the leg to be stable, there must be a method to support the patient's legs. The Committee referenced ANSI/AAMI HE75 which recommends that “[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in the appropriate position.” MDE Advisory Committee
After reviewing the MDE Advisory Committee recommendations, the Access Board has decided that the proposed provision is sufficient to require the leg support advocated by the MDE Advisory Committee and has therefore not adopted the MDE Advisory Committee recommendation to require an alternate method of leg supports. However, in the final rule the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to the MDE Advisory Committee recommendation and to provide consistency with the headings of other support provisions that are based on the body part supported.
As discussed above in Section V.C.3.c (Section-by-Section Analysis—M301.3.3) and Section V.C.7.c. (Section-by-Section Analysis—M302.3.3), the technical requirements for head and back supports from M301 and M302 have been relocated to M305 Supports. The MDE NPRM proposed to require diagnostic equipment used by patients in the supine, prone, or side-lying position and the seated position that can be adjusted to a reclined position to provide head and back support throughout the entire range of the incline. Three manufacturers commented on this provision. One manufacturer asserted that this requirement was ambiguous and that he had to read it multiple times to understand it; however, this commenter also indicated that the tables it currently manufactures meet the proposed requirement. Another manufacturer noted that existing MRI equipment meets this requirement. The final manufacturer asserted that a reclining backrest necessarily provides head and back support, unless the Access Board intended a different meaning for “support.” The MDE Advisory Committee did not review the proposed requirement for head and back support, and thus provided no recommendations on this requirement.
After review of the comments, the Access Board has decided not to make any changes to this provision in the final rule. All of the commenters on this topic agree that current diagnostic equipment meets the proposed requirement and the Access Board believes that this requirement is clearly articulated. Therefore, the final rule requires that where diagnostic equipment can be adjusted to a reclined position, head and back support must be provided.
M306 in the final rule provides the technical criteria for communication from the diagnostic equipment to the patient.
The MDE NPRM proposed that, where diagnostic equipment communicates instructions or other information to the patient, the instructions or information must be provided in at least two of the following methods: Audible, visible, or tactile (proposed M306.1). The Access Board sought public input in question 41 in the preamble to the MDE NPRM, on whether diagnostic equipment that communicates instructions or other information to the patient should provide information in all three methods of communication, and what the cost to provide all three methods would be. NPRM, 77 FR at 6931. Seven commenters responded. Three commenters (a manufacturer, a medical association, and a state agency concerned with accessibility) concurred with the proposed requirement to provide two methods of communication. Three commenters (two disability rights organizations and one medical association) supported requiring all three modes of communication, and the final commenter (a manufacturer) recommended requiring one mode of communication if the medical provider is present and three modes of communication for home use devices. The MDE Advisory Committee did not address this provision.
The Access Board carefully considered the public comments; however, it has decided to retain the provision from the proposed rule, requiring diagnostic equipment that communicates instructions or other information to the patient to provide the communication in two methods. The commenters were split in their support of two or three methods of communication and the commenters supporting the increase to three methods of communication provided no additional information to warrant the increase. The commenter that recommended different requirements for home-use equipment is not dispositive as this rule does not cover any home use equipment. The Access Board has concluded that providing two means of communication will serve the majority of people and that there was not enough information provided to warrant an increase in this requirement in the final rule.
M307 in the final rule provides the technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment. For example, equipment used for an auditory examination may require the patient to press a button when sounds are heard. M307 does not apply to controls used only by health care personnel or others who are not patients. There were no comments received on the proposed provisions, and as discussed below, the provisions from the proposed rule have been retained in the final rule.
The Access Board did receive comments in response to question 43, which sought public input on whether the final rule should include reach range requirements such as those in the 2004 ADA and ABA Accessibility Guidelines for an unobstructed forward reach or side reach for the operable parts provision. Five commenters responded, one commenter (state agency concerned with accessibility) recommended adopting the reach ranges and four commenters (one medical association, one academic, and two disability rights organizations) recommended against adding reach ranges for operable parts to the final rule. One of these commenters (disability rights organization) explained that the 2004 ADA and ABA requirements are not appropriate for application to operable parts of medical diagnostic equipment. The MDE Advisory Committee did not address this provision. Based on the majority of the commenters response, the Access Board has decided not to add reach ranges to the operable parts section at this time.
This is an introductory section.
The MDE NPRM proposed that operable parts intended for patient use be tactilely discernible without activation. Patients who are blind or have low vision have difficulty
The MDE NPRM proposed to require operable parts to be operable with one hand and not require tight grasping, pinching, or twisting of the wrist. There were no public comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.
The MDE NPRM proposed to restrict the force required to activate operable parts to 5 pounds. The Access Board sought public input on this provision in question 42 on whether the operating force should be reduced to 2 pounds. NPRM, 77 FR at 6932. One commenter, a state agency concerned with accessibility, responded and concurred with the suggested reduction. The MDE Advisory Committee did not address this requirement. Although the Access Board initially considered a reduction in the force required to activate operable parts, upon further consideration, the Board found no reason to deviate from the long-established maximum of 5 pounds in the 2004 ADA and ABA Accessibility Guidelines. 36 CFR part 1191, App. D 309.4. Therefore, there have been no changes made to this provision.
Executive Orders 13563 and 12866 direct agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Important goals of regulatory analysis are to (1) establish whether federal regulation is necessary and justified to achieve a market failure or other social goal and (2) demonstrate that a range of reasonably feasible regulatory alternatives have been considered and that the most efficient and effective alternative has been selected. Executive Order 13563 also recognizes that some benefits are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively those values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
The final rule, which sets forth the MDE Standards, is a significant regulatory action within the meaning of Executive Order 12866.
Section 510 of the Rehabilitation Act, as amended by the Patient Protection and Affordable Care Act, requires the Access Board, in coordination with the Food and Drug Administration, to issue accessibility standards that contain minimum technical criteria to ensure that medical diagnostic equipment is accessible to and usable by patients with disabilities. Examples of such diagnostic equipment include examination tables and chairs, weight scales, mammography equipment, and other imaging equipment. The Access Board is now issuing the final rule pursuant to this authority.
The MDE Standards set forth minimum technical criteria for medical diagnostic equipment to facilitate access and use of medical diagnostic equipment by persons with disabilities, most particularly those with mobility- or communication-related impairments. However, under Section 510, the Access Board is statutorily tasked only with promulgation (and revision) of these Standards. Although the MDE Standards do not have legal effect until adopted (in whole or in part) by an enforcing authority, they can advance accessibility to medical services for persons with disabilities by providing specific guidance concerning accessible medical diagnostic equipment that can be used by service providers in a voluntary manner.
At this point, the Board does not know whether enforcing authorities will adopt the MDE Standards, nor (if they do) to what extent health care practices or particular types of medical diagnostic equipment will be required to comply with the Standards' technical requirements. For this reason, the Board cannot estimate the incremental monetary or quantitative impacts of the final rule.
Nevertheless, the Board is able to characterize qualitatively some of the potential impacts of these Standards. If enforcing agencies adopt the MDE Standards as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers, medical device manufacturers, and individuals with disabilities. Once health care providers and facilities are required to acquire accessible medical equipment, they could incur compliance costs, to the extent that their equipment is not already accessible. Medical device manufacturers would then decide whether to incur incremental costs to meet the demand for accessible equipment, and some or many manufacturers may have an economic incentive to produce accessible equipment. Finally, given the many barriers to health care that patients with disabilities encounter due to inaccessible medical diagnostic equipment, individuals with mobility and communication disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. Consequently, they may be able to receive health care comparable to that received by their non-disabled counterparts.
In addition, the Standards could yield some immediate benefits, even before any adoption by implementing agencies in formal rulemaking. First, the technical specifications for accessible MDE incorporated in the Standards will benefit enforcing agencies that are considering similar accessibility requirements for entities under their jurisdiction. Although enforcing agencies have full authority over whether to adopt the Access Board's final rule (in whole or in part), the technical specifications in the MDE Standards reflects the input from a diverse set of stakeholders and provide solid groundwork for any future rulemaking pertaining to the accessibility of medical diagnostic equipment. Second, the Standards will serve as a best-practice document for the medical device industry and for health care providers and facilities. While the MDE Standards are non-binding, health care providers can use this final rule as
The Board thus concludes that the potential benefits of the MDE Standards justify the potential costs; that the MDE Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits.
The Regulatory Flexibility Act (RFA) requires federal agencies to analyze the impact of regulatory actions on small entities, unless an agency certifies that the rule will not have a significant impact on a substantial number of small entities. 5 U.S.C. 604, 605(b). The MDE Standards do not impose any mandatory requirements on any entity, including small entities. Therefore, we did not prepare a final regulatory flexibility analysis for the final rule.
The MDE Standards do not impose any mandatory requirements on state and local governments. The MDE Standards do not have any direct effects on the state governments, the relationship between the national government and state governments, or the distribution of power and responsibilities among the various levels of government. The MDE Standards do not preempt state law. Therefore, the consultation and other requirements of Executive Order 13132 (Federalism) do not apply.
The proposed standards do not impose any mandatory requirements on state, local, or tribal governments or the private sector. Therefore, the Unfunded Mandates Reform Act does not apply.
Under the Paperwork Reduction Act (PRA), federal agencies are generally prohibited from conducting or sponsoring a “collection of information” as defined by the PRA, absent OMB approval.
Health care, Individuals with disabilities, Medical devices.
29 U.S.C. 794f.
The standards for accessible medical diagnostic equipment are set forth in the appendix to this part. Other agencies, referred to as an enforcing authority in the standards, may adopt the standards as mandatory requirements for entities subject to their jurisdiction. Advisory sections and figures that illustrate the technical requirements in the appendix to part 1195 are available on the Internet at:
A. A low transfer position at a height of 17 inches (430 mm) minimum and 19 inches (485 mm) maximum;
B. A high transfer position at 25 inches (635 mm); and
C. At least 4 additional transfer positions located between the low and high transfer positions and separated by 1 inch (25 mm) minimum.
2. Temporary obstructions shall be permitted provided that they can be repositioned during transfer to comply with M301.2.4, including Exception 1.
A. A low transfer position at a height of 17 inches (430 mm) minimum and 19 inches (485 mm) maximum;
B. A high transfer position at 25 inches (635 mm); and
C. At least 4 additional transfer positions located between the low and high transfer positions and separated by 1 inch (25 mm) minimum.
2. Temporary obstructions shall be permitted provided that they can be repositioned during transfer to comply with M302.2.5, including Exception 1.
2. Where the width of an imaging bed is more than 24 inches (533 mm), transfer supports shall be permitted to be 12 inches (305 mm) long minimum.
| 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 |