| Page Range | 47399-47828 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 47528 - Sunshine Act Meetings; National Science Board | |
| 80 FR 47489 - Farm Credit Administration Board; Sunshine Act; Regular Meeting | |
| 80 FR 47546 - In the Matter of Solar Acquisition Corp., Order of Suspension of Trading | |
| 80 FR 47541 - In the Matter of PDK Energy, Inc.; Order of Suspension of Trading | |
| 80 FR 47453 - Sunshine Act Meeting Notice | |
| 80 FR 47561 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee | |
| 80 FR 47490 - Sunshine Act Meetings | |
| 80 FR 47490 - Sunshine Act Meeting | |
| 80 FR 47529 - Sunshine Act Meeting | |
| 80 FR 47491 - Medicare, Medicaid, and Children's Health Insurance Programs; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests | |
| 80 FR 47514 - Notice of Availability of the Draft Joint Environmental Impact Report and Environmental Impact Statement for the West of Devers Upgrade Project, Riverside and San Bernardino Counties, CA | |
| 80 FR 47517 - United States and State of New York v. Twin America, LLC, et al.; Public Comment and Response on Proposed Final Judgment | |
| 80 FR 47504 - Texas; Amendment No. 9 to Notice of a Major Disaster Declaration | |
| 80 FR 47503 - Texas; Amendment No. 8 to Notice of a Major Disaster Declaration | |
| 80 FR 47557 - Regional Rail Holdings, LLC-Acquisition of Control Exemption-Regional Rail, LLC | |
| 80 FR 47502 - Texas; Amendment No. 10 to Notice of a Major Disaster Declaration | |
| 80 FR 47504 - Texas; Amendment No. 11 to Notice of a Major Disaster Declaration | |
| 80 FR 47503 - New Jersey; Major Disaster and Related Determinations | |
| 80 FR 47504 - Louisiana; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 80 FR 47493 - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction | |
| 80 FR 47462 - Authorization of Production Activity; Foreign-Trade Subzone 167B; Polaris Industries, Inc. (Spark-Ignition Internal Combustion Engines); Osceola, Wisconsin | |
| 80 FR 47469 - Cased Pencils From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review | |
| 80 FR 47463 - Polyethylene Terephthalate Film, Sheet, and Strip From the United Arab Emirates: Negative Final Determination of Circumvention of the Antidumping Duty Order | |
| 80 FR 47464 - Xanthan Gum From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2013-2014 | |
| 80 FR 47467 - Certain Pasta From Italy: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014 | |
| 80 FR 47467 - Chloropicrin From the People's Republic of China: Final Results of the Expedited Sunset Review of the Antidumping Duty Order | |
| 80 FR 47563 - Agency Information Collection-Clarification of a Notice of Disagreement Under OMB Review | |
| 80 FR 47563 - Proposed Information Collection: Income, Net Worth and Employment Statement (in Support of Claim for Total Disability Benefits) and Application for Pension | |
| 80 FR 47554 - Notice of Intent To Release Certain Properties From all Terms, Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement Between the City of Zephyrhills and the Federal Aviation Administration for the Zephyrhills Municipal Airport, Zephyrhills, FL | |
| 80 FR 47515 - Notice of Availability of the Final Environmental Impact Statement and Final Feasibility Report for the Shasta Lake Water Resources Investigation, Shasta and Tehama Counties, California | |
| 80 FR 47493 - Designation of a Class of Employees for Addition to the Special Exposure Cohort | |
| 80 FR 47555 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2006 Ferrari 612 Scagletti Passenger Cars Manufactured Before September 1, 2006 Are Eligible for Importation | |
| 80 FR 47510 - Endangered and Threatened Wildlife and Plants; Enhancement of Survival Permit Application; Greater Sage-Grouse Candidate Conservation Agreement With Assurances for Smith Creek Ranch LTD | |
| 80 FR 47482 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Assessing the Role of Noncognitive and School Environmental Factors in Students' Transitions to High School in New Mexico | |
| 80 FR 47494 - Notice of Service Delivery Area Designation for the Koi Nation of Northern California Formerly Known as the Lower Lake Rancheria | |
| 80 FR 47405 - Liberalization of Certain Documentary Evidence Required as Proof of Exportation on Drawback Claims | |
| 80 FR 47515 - Notice of Public Meetings: Sierra Front-Northwestern Great Basin Resource Advisory Council, Nevada | |
| 80 FR 47513 - Filing of Plats of Survey: California | |
| 80 FR 47450 - Tuolumne and Mariposa Counties Resource Advisory Committee | |
| 80 FR 47451 - Tuolumne and Mariposa Counties Resource Advisory Committee | |
| 80 FR 47553 - Modifications to the Disability Determination Procedures; Extension of Testing of Some Disability Redesign Features | |
| 80 FR 47399 - Special Conditions: Bombardier Inc., Models BD-700-2A12 and BD-700-2A13 Series Airplanes; Side Stick Controllers: Pilot Strength, Pilot Control Authority, and Pilot Control | |
| 80 FR 47400 - Special Conditions: Bombardier Inc., Models BD-700-2A12 and BD-700-2A13 Series Airplanes; Electronic Flight Control System: Control Surface Awareness and Mode Annunciation | |
| 80 FR 47527 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Statement of Recovery Forms | |
| 80 FR 47558 - Importation of Distilled Spirits, Wine, Beer, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes; Availability of Pilot Program and Filing Instructions To Test the Collection of Import Data for Implementation of the International Trade Data System | |
| 80 FR 47452 - Energy Answers Arecibo, LLC: Notice of Availability of a Draft Environmental Impact Statement and Notice of a Public Meeting | |
| 80 FR 47408 - Establishment of the Squaw Valley-Miramonte Viticultural Area | |
| 80 FR 47555 - Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB Review | |
| 80 FR 47454 - Privacy Act of 1974, New System of Records | |
| 80 FR 47457 - Privacy Act of 1974; Amended System of Records | |
| 80 FR 47500 - National Eye Institute; Notice of Meeting | |
| 80 FR 47557 - Nebraska, Kansas & Colorado Railway, L.L.C.-Abandonment Exemption-in Decatur, Norton, and Phillips Counties, Kan., and Harlan County, Neb. | |
| 80 FR 47479 - Agency Information Collection Activities Under OMB Review | |
| 80 FR 47490 - Notice of Agreement Filed | |
| 80 FR 47471 - Marine Mammals; File No. 18903 | |
| 80 FR 47534 - Special Nuclear Material Doorway Monitors | |
| 80 FR 47481 - Agency Information Collection Activities; Comment Request; Student Assistance General Provisions-Student Right-to-Know (SRK) | |
| 80 FR 47481 - International Resource Information System (IRIS); Title; OMB Number; Correction | |
| 80 FR 47489 - Environmental Impact Statements; Notice of Availability | |
| 80 FR 47474 - Procurement List; Additions | |
| 80 FR 47475 - Procurement List Proposed Deletion | |
| 80 FR 47500 - National Cancer Institute: Notice of Closed Meetings | |
| 80 FR 47489 - Federal Advisory Committee Act; Downloadable Security Technology Advisory Committee | |
| 80 FR 47516 - Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedures, 2016 Report | |
| 80 FR 47539 - New Postal Product | |
| 80 FR 47540 - Change in Postal Rates | |
| 80 FR 47538 - New Postal Product | |
| 80 FR 47537 - New Postal Product | |
| 80 FR 47474 - Marine Mammals; File No. 15471-02 | |
| 80 FR 47528 - Arts Advisory Panel Meetings | |
| 80 FR 47429 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; Jest8 Limited, Trading as Riyo, Application for Approval of Parental Consent Method | |
| 80 FR 47552 - South Dakota Disaster #SD-00068 | |
| 80 FR 47486 - Malacha Hydro Limited Partnership and Juniper Ridge Ranches, Inc.; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 80 FR 47485 - Public Utility District No. 2 of Grant County; Notice of Application and Soliciting Comments, Motions To Intervene, and Protests | |
| 80 FR 47482 - Nittany Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 47487 - Comanche Trail Pipeline, LLC; Notice of Intent To Prepare an Environmental Assessment for the Proposed San Elizario Crossing Project; Request for Comments on Environmental Issues | |
| 80 FR 47483 - Combined Notice of Filings #1 | |
| 80 FR 47493 - Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period; Correction | |
| 80 FR 47502 - Advisory Committee for Women's Services (ACWS); Notice of Meeting | |
| 80 FR 47502 - Notice of Meeting | |
| 80 FR 47501 - Center for Substance Abuse Prevention; Notice of Meeting | |
| 80 FR 47562 - Publication of Wait-Times for the Department for the Veterans Choice Program | |
| 80 FR 47554 - Petition for Exemption; Summary of Petition Received; Insitu, Inc. | |
| 80 FR 47552 - Vermont Disaster #VT-00016 | |
| 80 FR 47553 - Louisiana Disaster #LA-00054 | |
| 80 FR 47553 - National Women's Business Council; Quarterly Public Meeting | |
| 80 FR 47529 - Exelon Generation Company, LLC;Three Mile Island Nuclear Station, Unit 1 | |
| 80 FR 47533 - NextEra Energy Seabrook, LLC; Seabrook Station, Unit 1 | |
| 80 FR 47532 - Southern California Edison;San Onofre Nuclear Generating Station, Units 2 and 3 | |
| 80 FR 47450 - Submission for OMB Review; Comment Request | |
| 80 FR 47451 - Inviting Rural Business Development Grant Program Applications for Grants To Provide Technical Assistance for Rural Transportation Systems | |
| 80 FR 47453 - Notice of Public Meeting of the Arizona Advisory Committee To Receive Opinion and Perspective From Members of the Community Regarding Crime Reduction, Police Training, and Police Community Relations | |
| 80 FR 47453 - Notice of Public Meeting of the Arizona Advisory Committee To Receive Information From Police Agencies and Persons Involved in the Administration of Justice Regarding Police Community Relations | |
| 80 FR 47477 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0096, Swap Data Recordkeeping and Reporting Requirements | |
| 80 FR 47476 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0085, Rule 50.50 End-User Notification of Non-Cleared Swaps | |
| 80 FR 47511 - Agency Information Collection Activities: Request for Comments; USA National Phenology Network-The Nature's Notebook Plant and Animal Observing Program | |
| 80 FR 47541 - Product Change-Priority Mail Express Negotiated Service Agreement | |
| 80 FR 47535 - Federal Employees' Group Life Insurance Program; Premium Changes and Open Season | |
| 80 FR 47541 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 47505 - Office for Interoperability and Compatibility Seeks Nominations for the Project 25 Compliance Assessment Program (P25 CAP) Advisory Panel | |
| 80 FR 47470 - Caribbean Fishery Management Council (CFMC); Public Meeting | |
| 80 FR 47475 - Agency Information Collection Activities: Proposed Collection, Comment Request, Foreign Board of Trade Registration | |
| 80 FR 47504 - The Critical Infrastructure Partnership Advisory Council | |
| 80 FR 47509 - Mortgage and Loan Insurance Programs Under the National Housing Act-Debenture Interest Rates | |
| 80 FR 47478 - Agency Information Collection Activities: Notice of Intent to Renew Collection Number 3038-0079, Conflict of Interest Policies and Procedures by Swap Dealers and Major Swap Participants | |
| 80 FR 47525 - Workforce Information Advisory Council | |
| 80 FR 47512 - Agency Information Collection Activities: Request for Comments: National Spatial Data Infrastructure Cooperative Agreements Program (NSDI CAP) | |
| 80 FR 47550 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940 | |
| 80 FR 47541 - Self-Regulatory Organizations; CBOE Futures Exchange, LLC; Notice of Proposed Rule Change Regarding Disruptive Trading Practices | |
| 80 FR 47546 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change to Require an Indicator When a TRACE Report Does Not Reflect a Commission or Mark-Up/Mark-Down | |
| 80 FR 47490 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 80 FR 47501 - Workshop on Alternative Approaches for Identifying Acute Systemic Toxicity: Moving From Research to Regulatory Testing; Notice of Public Meeting; Registration Information | |
| 80 FR 47410 - Drawbridge Operation Regulation; Gulf Intracoastal Waterway, Galveston, TX | |
| 80 FR 47480 - Submission for OMB Review; Comment Request | |
| 80 FR 47448 - Petition for Reconsideration of Action in a Rulemaking Proceeding | |
| 80 FR 47411 - Drawbridge Operation Regulation; Willamette River at Portland, OR | |
| 80 FR 47480 - Information Collection; Submission for OMB Review, Comment Request | |
| 80 FR 47430 - Guidance Under Section 529A: Qualifies ABLE Programs; Correction | |
| 80 FR 47562 - Notice of Establishment of Commission on Care | |
| 80 FR 47562 - Submission for OMB Review; Comment Request | |
| 80 FR 47462 - Carbazole Violet Pigment 23 From India: Final Results of Expedited Second Sunset Review of the Countervailing Duty Order | |
| 80 FR 47430 - Revised Interpretation of Clean Water Act Tribal Provision | |
| 80 FR 47441 - Trichloroethylene (TCE); Significant New Use Rule; TCE in Certain Consumer Products | |
| 80 FR 47418 - Endangered and Threatened Wildlife and Plants; 4(d) Rule for the Georgetown Salamander | |
| 80 FR 47402 - Russian Sanctions: Addition to the Entity List To Prevent Violations of Russian Industry Sector Sanctions | |
| 80 FR 47411 - Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table | |
| 80 FR 47507 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 80 FR 47472 - Notice of Fee Calculations for Special Use Permits | |
| 80 FR 47565 - Occupational Exposure to Beryllium and Beryllium Compounds |
Forest Service
Rural Business-Cooperative Service
Rural Utilities Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
Indian Health Service
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
U.S. Customs and Border Protection
Fish and Wildlife Service
Geological Survey
Land Management Bureau
Reclamation Bureau
Antitrust Division
Employment and Training Administration
Occupational Safety and Health Administration
National Endowment for the Arts
Federal Aviation Administration
National Highway Traffic Safety Administration
Surface Transportation Board
Alcohol and Tobacco Tax and Trade Bureau
Internal Revenue Service
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 LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Bombardier Inc. Models BD-700-2A12 and BD-700-2A13 series airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is side stick controllers for pitch and roll control instead of conventional wheels and columns. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Bombardier Inc. on August 7, 2015. We must receive your comments by September 21, 2015.
Send comments identified by docket number FAA-2015-2567 using any of the following methods:
•
•
•
•
Joe Jacobsen, FAA, Airplane and Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2011; facsimile 425-227-1149.
The substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.
Bombardier Inc. located in Montreal, Canada, applied to Transport Canada Civil Aviation (TCCA) on January 7, 2012, and May 30, 2012, for two amended type certificates in the transport airplane category for two new airplane models designated as the BD-700-2A12 and BD-700-2A13. The BD-700-2A12 and BD-700-2A13 airplanes are 19-passenger, twin-engine, ultra long-range large airplanes targeting the executive interior business jet market. These airplanes share an identical supplier base and significant common design elements.
The BD-700-2A12 and BD-700-2A13 airplanes will use side stick controllers for pitch and roll control. Regulatory requirements pertaining to conventional wheel and column, such as pilot strength and controllability, are not directly applicable for the side stick. In addition, pilot control authority may be uncertain because the side sticks are not mechanically interconnected as with conventional wheel and column controls.
Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Inc. must show that the BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of 14 CFR part 25 as amended by Amendments 25-1 through 25-138 except for Amendment 25-137.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).
The BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design feature: Side stick controllers for pitch and roll control, which are not mechanically interconnected as with conventional wheel and column controls. These airplanes also have a fly-by-wire electronic flight control system. This system provides an electronic interface between the pilot's flight controls and the flight control surfaces for both normal and failure states, and it generates the actual surface commands that provide for stability augmentation and control about all three airplane axes. In addition, pilot control authority may be uncertain, because the side sticks are not mechanically interconnected as with conventional wheel and column controls.
Current FAA regulations do not specifically address the use of side stick controllers for pitch and roll control. The unique features of the side stick must therefore be demonstrated through flight and simulator tests to have suitable handling and control characteristics when considering the following:
1. The handling qualities tasks/requirements of the BD-700-2A12 and BD-700-2A13 airplanes special conditions and other part 25 stability, control, and maneuverability requirements, including the effects of turbulence.
2. General ergonomics: Arm rest comfort and support, local freedom of movement, displacement angle suitability, and axis harmony.
3. Inadvertent input in turbulence.
4. Inadvertent pitch-roll cross talk.
These special conditions elaborate on these requirements and contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
The FAA Handling Qualities Rating Method (HQRM) in appendix 5 of Advisory Circular 25-7C, “Flight Test Guide for Certification of Transport Category Airplanes,” may be used to show compliance.
As discussed above, these special conditions are applicable to the Bombardier Inc. Models BD-700-2A12 and BD-700-2A13 series airplanes. Should Bombardier Inc. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
1.
2.
3.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Bombardier Inc. Models BD-700-2A12 and BD-700-2A13 series airplanes. These airplanes will have
This action is effective on Bombardier Inc. on August 7, 2015. We must receive your comments by September 21, 2015.
Send comments identified by docket number FAA-2015-2566 using any of the following methods:
•
•
•
•
Joe Jacobsen, FAA, Airplane and Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2011; facsimile 425-227-1149.
The substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.
Bombardier Inc. located in Montreal, Canada, applied to Transport Canada Civil Aviation (TCCA) on January 7, 2012, and May 30, 2012, for two amended type certificates in the transport airplane category for two new airplane models designated as the BD-700-2A12 and BD-700-2A13. These airplanes are 19-passenger, twin-engine, ultra long-range large airplanes targeting the executive interior business jet market. They share an identical supplier base and significant common design elements including a fly-by-wire electronic flight control system (EFCS).
Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Inc. must show that the BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of 14 CFR part 25 as amended by Amendments 25-1 through 25-138 except for Amendment 25-137.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design features, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).
The BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design features: A fly-by-wire EFCS and no direct coupling from the flight deck controller to the control surface. As a result, the pilot is not aware of the actual control surface position as envisioned under current airworthiness standards.
These special conditions require that the flightcrew receive a suitable flight control position annunciation when a flight condition exists in which nearly full surface authority (not crew-commanded) is being used. Suitability of such a display must take into account that some pilot-demanded maneuvers (
These special conditions also address flight control system mode annunciation. Suitable mode annunciation must be provided to the flightcrew for events that significantly change the operating mode of the
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Bombardier Models BD-700-2A12 and BD-700-2A13 series airplanes. Should Bombardier Inc. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design features, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
1. In addition to the requirements of §§ 25.143, 25.671, and 25.672, the following requirements apply:
a. The system design must ensure that the flightcrew is made suitably aware whenever the primary control means nears the limit of control authority.
Note: The term “suitably aware” indicates annunciations provided to the flightcrew are appropriately balanced between nuisance and that necessary for crew awareness.
b. If the design of the flight control system has multiple modes of operation, a means must be provided to indicate to the flightcrew any mode that significantly changes or degrades the normal handling or operational characteristics of the airplane.
Bureau of Industry and Security, Commerce.
Final rule.
This final rule amends the Export Administration Regulations (EAR) to further implement U.S. sanctions on certain Russian energy projects. Specifically, in this rule, the Bureau of Industry and Security (BIS) amends the EAR by adding a Russian oil and gas field, the Yuzhno-Kirinskoye Field located in the Sea of Okhotsk, to the Entity List. This Russian field is reported to contain substantial reserves of oil in addition to reserves of gas. The U.S. Government has determined, therefore, that exports, reexports, and transfers (in-country) of all items subject to the EAR to this Russian field by any person without first obtaining a BIS license present an unacceptable risk of use in, or diversion to, the activities specified in the Russian industry sector sanctions. Thus, as part of the BIS “is informed” process, this final rule adds this Russian field to the Entity List to further implement the Russian industry sector sanctions. This Russian field will be listed on the Entity List under the destination of Russia. This final rule clarifies the introductory text of the Entity List to specify that the embargoes and other special controls part of the EAR is also used to add entities to the Entity List. Lastly, this final rule makes a change to the Russian industry sector sanctions by clarifying the additional prohibition on those informed by BIS also includes end-uses that are within the scope of the Russian Industry sector sanctions.
This rule is effective August 7, 2015.
For this Entity List-related change, contact the Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Fax: (202) 482-3911, Email:
This final rule amends the Export Administration Regulations (EAR) to further implement U.S. sanctions on certain Russian energy projects. Specifically, in this rule, the Bureau of Industry and Security (BIS) amends the EAR by adding a Russian oil and gas field, the Yuzhno-Kirinskoye Field located in the Sea of Okhotsk, to the Entity List.
This Russian field is reported to contain substantial reserves of oil in addition to reserves of gas. The U.S. Government has determined, therefore, that exports, reexports, and transfers (in-country) of all items subject to the EAR to this Russian field by any person without first obtaining a BIS license present an unacceptable risk of use in, or diversion to, the activities specified in the Russian industry sector sanctions. Thus, as part of the BIS “is informed” process, this final rule adds this Russian field to the Entity List to further implement the Russian industry sector sanctions. This Russian field will be listed on the Entity List under the destination of Russia.
The Entity List (Supplement No. 4 to Part 744) identifies entities and other persons reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The EAR imposes
The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy, and, where appropriate, the Treasury, rules on additions to, removals from, and other modifications to the Entity List. The ERC makes decisions to add an entry to the Entity List by majority vote and decisions to remove or modify an entry by unanimous vote.
Under § 746.5(a)(2), BIS in this final rule is adding a Russian oil and gas field to the Entity List and informing the public of a license requirement for exports, reexports, or transfers (in-country) of any item subject to the EAR to that location. This Russian field is added based on being the site of activities that are described in Executive Order 13662 (79 FR 16169),
The Yuzhno-Kirinskoye Field is being added to the Entity List because it is reported to contain substantial reserves of oil. Consequently, exports, reexports, and transfers (in-country) of all items subject to the EAR to this Russian oil and gas field by any person without first obtaining a BIS license has been determined by the U.S. Government to present an unacceptable risk of use in, or diversion to, the activities specified in paragraph (a)(1) of § 746.5, namely exploration for, or production of, oil or gas in Russian deepwater (greater than 500 feet) locations. Therefore, a license requirement for all items subject to the EAR is warranted.
License applications for such transactions will be reviewed with a presumption of denial because such exports, reexports, and transfers (in-country) are for use directly or indirectly in exploration or production from a deepwater (greater than 500 feet) project in Russia that has the potential to produce oil. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the field being added to the Entity List in this rule.
This final rule adds the following one Russian gas and oil field to the Entity List to expand the EAR license requirements in § 746.5:
(1)
As noted above, BIS places entities on the Entity List based on certain sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR. This final rule, as a clarification for this existing BIS policy for adding persons to the Entity List, revises the first sentence of the introductory text of the Entity List to add a reference to part 746. This clarification to the introductory text will make it clear that this Supplement lists certain entities subject to license requirements for specified items under this part 744 and part 746 of the EAR.
In § 746.5 (Russian industry sector sanctions), this final rule revises the second sentence of paragraph (a)(2) for the additional prohibition on those informed by BIS to add the term “end-use” after the term “end-user.” This change clarifies that the additional prohibition described in this paragraph (a)(2), as part of the BIS “is informed” process, may be based on an end-user or end-use when BIS determines there is an unacceptable risk of use in, or diversion to, the activities specified in paragraph (a)(1) of this section in Russia. This clarification does not change the scope of § 746.5, but rather clarifies the cases in which BIS will use the “is informed” process to assist exporters, reexporters, and transferors to “know” when an export, reexport, or transfer (in-country) is subject to the license requirements specified in § 746.5.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2014, 79 FR 46959 (August 11, 2014), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
4. For the Entity List changes in this final rule, the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (
5. For the clarification to Russian industry sector sanctions and clarification to the introductory text of the Entity List, the Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because allowing for notice and comment would be contrary to the public interest. The revisions to § 746.5(a)(2) and the introductory text to Supplement No. 4 to Part 744, facilitate public understanding of existing interpretations of current EAR provisions, and therefore prior notice and the opportunity for public comment would prevent BIS promulgating these revisions as soon as possible so that the public will be aware of the correct text and meaning of these current EAR provisions.
BIS finds good cause to waive the 30-day delay in effectiveness under 5 U.S.C. 553(d)(3). As mentioned previously, the revisions described here made by this rule consist of minor clarifications that need to be in place as soon as possible to avoid confusion by the public regarding the intent and meaning of these changes to the EAR.
Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for these amendments by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
Exports, Reporting and recordkeeping requirements, Terrorism.
Exports, Reporting and recordkeeping requirements.
Accordingly, parts 744 and 746 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:
50 U.S.C. app. 2401
The additions read as follows:
This Supplement lists certain entities subject to license requirements for specified items under this part 744 and part 746 of the EAR. License requirements for these entities include exports, reexports, and transfers (in-country) unless otherwise stated. This list of entities is revised and updated on a periodic basis in this Supplement by adding new or amended notifications and deleting notifications no longer in effect.
50 U.S.C. app. 2401
(a) * * *
(2)
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Final rule.
This document amends U.S. Customs and Border Protection (CBP) regulations by removing some of the requirements for documentation used to establish proof of exportation for drawback claims. Currently, claimants must provide originally signed documentary evidence or a certified copy of such documentary evidence to establish the date and fact of exportation of articles for drawback purposes. This document also amends various sections of title 19 of the Code of Federal Regulations (CFR) to reflect that there is no longer a legal requirement that the export invoice for mail shipments be certified. Additionally, this document amends Appendix B to part 191 of title 19 so that the Appendix reflects previous regulatory amendments closing four drawback offices. Finally, this document amends CBP regulations to reflect the change from the legacy agency name of U.S. Customs Service to the current agency name of U.S. Customs and Border Protection and to make other non-substantive editorial changes.
This final rule is effective on August 7, 2015.
For legal aspects, Carrie L. Owens, Chief, Entry Process & Duty Refunds Branch, Regulations and Rulings, Office of International Trade, (202) 325-0266. For operational aspects, Celestine L. Harrell, Chief, Post Release and Trade Processes Branch, Office of International Trade, (202) 863-6937.
This document amends the U.S. Customs and Border Protection (CBP) regulations by: (1) Removing some of the requirements for drawback claimants to establish proof of exportation; (2) conforming Appendix B to part 191 of the CBP regulations to previous regulatory changes reflecting the closing of four drawback offices; (3) updating the regulations to reflect that CBP is now part of the Department of Homeland Security; and (4) making other non-substantive editorial and nomenclature changes.
This document amends title 19 of the Code of Federal Regulations (19 CFR) by making amendments to 19 CFR parts 181 and 191, specifically, sections 19 CFR 181.47, 191.72 and 191.74 to align CBP documentation requirements with current business practices related to the documents used to establish the date and fact of exportation for purposes of drawback. In order to qualify for drawback, claimants must establish that articles are exported or destroyed. When drawback is claimed for exported goods, the claimant must submit documentation that establishes fully the date and fact of exportation and the identity of the exporter.
The documents for establishing exportation include, but are not limited to: a bill of lading, air waybill, freight waybill, Canadian Customs manifest, and/or cargo manifest.
Acquiring pen and ink signatures for the original documentation or certified copies of such documentation is time consuming and often unrealistic for the trade. CBP realizes the difficulty of having to provide a pen and ink signature for documents when these documents are issued electronically and do not contain an actual pen and ink signature. As a consequence, drawback claims are often denied when claimants can produce only documentary evidence that does not contain a signature or copies of such documents that are not certified.
As such, CBP is amending its regulations by removing the requirement that the documentary evidence that establishes the date and fact of exportation for drawback eligibility be originally signed or that any copy of such documentary evidence must be certified. CBP will now allow claimants to provide unsigned originals or copies of documentary evidence as proof of export for drawback eligibility. Therefore, copies of original documentary evidence will no longer need to be certified.
Additionally, pursuant to 19 CFR 191.72(c), CBP currently requires a certified export invoice for mail shipments and references section 191.74. Even though section 191.72(c) cites to section 191.74 as a reference for the “certified export invoice” requirement for mail shipments, the regulatory text of 19 CFR 191.74 does not require a claimant to submit a certified copy of the export invoice, but only requires that the claimant provide the official postal records. There is no reference to “export invoice” in section 191.74. Further, the only reference to “certification” is in the title heading to section 191.74. Accordingly, CBP is removing the phrase “Certification of” from the heading text to section 191.74 as it is misleading as to what that regulation requires. Thus, CBP is clarifying that claimants submitting postal records in support of exportation in accordance with section 191.74 may submit either originals or uncertified copies of official postal records by clearly stating that within the text of section 191.74. Further, CBP is revising section 191.72(c) to accurately reflect the plain language of section 191.74 by requiring evidence of official postal records (originals or copies) that demonstrate exportation by mail.
Other non-substantive editorial changes to reflect the plain English mandate are made to these regulatory sections, 19 CFR 181.47, 191.72 and 191.74.
CBP inadvertently failed to remove from Appendix B to part 191 references to certain drawback offices when the agency previously amended the regulations to close four drawback offices. Three drawback offices were closed in 2003 (Boston, MA; New Orleans, LA; and Miami, FL) and one in 2010 (Long Beach, CA).
On November 25, 2002, the President signed into law the Homeland Security Act of 2002 (Pub. L. 107-296, 116 Stat. 2135). Accordingly, as of March 1, 2003, the former U.S. Customs Service of the Department of the Treasury was transferred to DHS and reorganized to become CBP. Accordingly, this document further amends § 181.47 to reflect the change from the legacy agency name, U.S. Customs Service, to the current name, U.S. Customs and Border Protection or CBP.
Section 181.47 of the CBP regulations (19 CFR 181.47) pertains to the documents required for a NAFTA drawback claim. Paragraph (b)(2)(ii)(G) of § 181.47 is amended by removing the requirement that copies of the exemplar documents in that paragraph be certified.
In addition, section 181.47 contains the legacy agency name of Customs. Accordingly, § 181.47 is amended to remove the outdated information and replace it with the current agency name CBP in §§ 181.47(b)(2), 181.47(b)(2)(i)(A), 181.47(b)(2)(i)(B), 181.47(b)(2)(i)(F), 181.47(b)(2)(ii)(A), 181.47(b)(2)(ii)(B), 181.47(b)(2)(ii)(C), 181.47(b)(2)(ii)(D), 181.47(b)(2)(ii)(E), 181.47(b)(2)(iii)(A), 181.47(b)(2)(iii)(B), and 181.47(b)(2)(iii)(D). Additionally, the word “shall” is replaced with either “must”, “will” or “is”, as appropriate, in paragraphs (a), (b)(1), (b)(2)(i), (b)(2)(i)(E), (b)(2)(ii), (b)(2)(ii)(B), (b)(2)(ii)(G), (b)(2)(ii)(H), (b)(2)(iii), (b)(2)(iv), (b)(2)(v), and (c) of § 181.47 to conform with the plain English mandate.
Section 191.72 of the CBP regulations (19 CFR 191.72) pertains to exportation procedures for drawback. Section 191.72(a) is amended by removing the terms “originally signed” and “certified” from the list of acceptable documentary evidence for establishing the date and fact of exportation for drawback eligibility. Section 191.72(c) is revised to reflect the requirements of section 191.74 and to reflect that the postal records for export shipments no longer have to be certified. Section 191.74 is amended by removing the words “Certification of” from the heading text because the text of 191.74 does not require a claimant to submit a certified copy of the postal record and the title heading cannot impose a legal requirement that is not also reflected in the regulatory text. CBP is also making it clear that claimants may submit either originals or copies of official postal records by adding the parenthetical phrase “(originals or copies)” after the phrase “official postal records” in section 191.74.
This document also makes non-substantive amendments to Appendix B, Sections II through V within part 191 of 19 CFR as discussed above.
Because the amendments in parts 181 and 191 of 19 CFR set forth in this document merely relieve a burden on the public and the amendments to the Appendix of part 191 conform the regulations to previous regulatory changes to reflect the consolidation of drawback offices, CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary under 5 U.S.C. 553(b)(B). For this same reason, pursuant to 5 U.S.C. 553(d)(3), CBP finds good cause for dispensing with the requirement for a delayed effective date.
Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601
These amendments do not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866, as supplemented by Executive Order 13563.
This regulation is being issued in accordance with 19 CFR 0.1(a)(1), pertaining to the authority of the Secretary of the Treasury (or that of his delegate) to approve regulations concerning drawback.
Administrative practice and procedure, Customs duties and inspection, Exports, Imports, Reporting and recordkeeping requirements.
Claims, Customs duties and inspection, Exports, Reporting and recordkeeping requirements.
For the reasons set forth above, parts 181 and 191 of the CBP Regulations (19 CFR parts 181 and 191) and Appendix B to part 191 of 19 CFR are amended as set forth below:
19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624, 3314.
The revision reads as follows:
(b) * * *
(2) * * *
(ii) * * *
(G)
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1313, 1624.
4. In § 191.72:
(a) Documentary evidence of exportation (originals or copies) issued by the exporting carrier, such as a bill of lading, air waybill, freight waybill, Canadian Customs manifest, and/or cargo manifest;”.
(c) Official postal records (originals or copies) which evidence exportation by mail (§ 191.74);
The revision reads as follows:
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Final rule; Treasury decision.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes, through this final rule, the approximately 44,690-acre “Squaw Valley-Miramonte” viticultural area in Fresno County, California. The viticultural area does not overlap any established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
This final rule is effective September 8, 2015.
Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; phone 202-453-1039, ext. 175.
Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013, to the TTB Administrator to perform the functions and duties in the administration and enforcement of this law.
Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.
Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.
Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12(c) of the TTB regulations (27 CFR 9.12(c)) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:
• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;
• An explanation of the basis for defining the boundary of the proposed AVA;
• A narrative description of the features of the proposed AVA affecting viticulture, including climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;
• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and
• A detailed narrative description of the proposed AVA boundary based on USGS map markings.
TTB received a petition from Christine Flannigan, owner of the Sierra Peaks Winery and Purgatory Vineyards, on behalf of the Squaw Valley Grape Growers Group, proposing the establishment of the “Squaw Valley-Miramonte” AVA in Fresno County, California, approximately 40 miles east of the city of Fresno. The proposed AVA is a largely rural region in the foothills of the Sierra Nevada Mountains and does not overlap any established AVAs. To the northwest, west, and south of the proposed AVA is the San Joaquin Valley. The Sequoia National Forest is adjacent to the northern and eastern boundaries of the proposed AVA.
The proposed Squaw Valley-Miramonte AVA contains approximately 44,690 acres and has 3 bonded wineries and 5 commercially producing vineyards, covering a total of 7.5 acres, distributed across the proposed AVA. The petition states that vineyards within the proposed AVA are small due to the region's steep and rugged terrain, which requires most vineyard work to be done by hand rather than by machine.
According to the petition, the distinguishing features of the proposed AVA include its climate, topography, and soils. Daytime temperatures within the proposed AVA are generally cooler than in the neighboring San Joaquin Valley to the south, west, and northwest. However, nighttime temperatures are usually warmer within the proposed AVA than within the San Joaquin Valley because cool air drains off the slopes of the proposed AVA at night and settles in the valley. The cool daytime temperatures and warm nighttime temperatures during the growing season produce higher levels of sugar and anthocyanins (pigments responsible for the color of grape skins) at harvest than occur in grapes grown in the warmer San Joaquin Valley. The temperatures in the proposed AVA also contribute to later harvest dates than in the San Joaquin Valley. The proposed AVA also receives significantly more rainfall than the San Joaquin Valley, but less than the regions to the north and east of the proposed AVA, within the Sequoia National Forest. The high rainfall amounts within the proposed AVA increase the risk of erosion, so vineyard owners plant ground cover between the vineyard rows to help hold the soil in place.
The topography of the proposed AVA consists of steep and rugged hillsides
The majority of the soils within the proposed Squaw Valley-Miramonte AVA are derived from granitic material, mainly quartz diorite. The three most common soil series are the Vista, Sierra, and Auberry series. All three soil series are described as having good drainage, which reduces the risk of root disease. The soils within the proposed AVA have pH levels ranging from a slightly acidic 5.6 to a neutral 7.3, levels which are adequate for viticulture and do not promote overly vigorous vine or canopy growth. The soils within the proposed AVA are severely deficient in nitrogen, a nutrient necessary for vine growth, and therefore require supplementation. Additionally, soils in some of the vineyards within the proposed AVA have an excess of potassium, which interferes with the vines' ability to uptake magnesium. As a result, magnesium must be added to the soil in these vineyards. To the north of the proposed AVA, the soils are primarily of the Coarsegold and Trabuco series, which are derived from weathered schist and igneous rock, respectively. The most common soil series east of the proposed AVA are the Holland series, derived from weathered granitic rock, and the Aiken series, derived from volcanic rocks. These soils are more acidic than the soils within the proposed AVA due to deep mats of decomposing needle litter from conifer trees. South and west of the proposed AVA, within the San Joaquin Valley, alluvial soils such as San Joaquin loam and San Joaquin sandy loam become common, as are soils of the Hanford and Greenfield series. These soils are all less acidic and have finer textures than the soils of the proposed AVA.
TTB published Notice No. 146 in the
After careful review of the petition, TTB finds that the evidence provided by the petitioner supports the establishment of the Squaw Valley-Miramonte AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and part 4 and part 9 of the TTB regulations, TTB establishes the “Squaw Valley-Miramonte” AVA in Fresno County, California, effective 30 days from the publication date of this document.
See the narrative description of the boundary of the AVA in the regulatory text published at the end of this final rule.
The petitioner provided the required maps, and they are listed below in the regulatory text.
Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986.
With the establishment of this AVA, its name, “Squaw Valley-Miramonte,” will be recognized as a name of viticultural significance under 27 CFR 4.39(i)(3). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Squaw Valley-Miramonte” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin. TTB is not designating either “Squaw Valley” or “Miramonte,” standing alone, as terms of viticultural significance because both of these names are also associated with multiple locations within the United States outside the AVA.
TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.
It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.
Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.
Wine.
For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:
27 U.S.C. 205.
(a)
(b)
(1) Orange Cove North, Calif., 1966;
(2) Pine Flat Dam, Calif., 1965; photoinspected 1978;
(3) Luckett Mtn., Calif., provisional edition 1987;
(4) Verplank Ridge, Calif., provisional edition 1987;
(5) Miramonte, Calif., 1966; and
(6) Tucker Mtn., Calif., 1966.
(c)
(1) The beginning point is located on the Orange Cove North map, at the southwest corner of section 21, T14S/R25E. From the beginning point, proceed north-northwesterly in a straight line to the marked 3,355-foot elevation point on Bear Mountain, section 5, T14S/R25E; then
(2) Proceed northeast in a straight line, crossing onto the Pine Flat Dam map and over the marked 3,354-foot elevation point on Bear Mountain, section 32, T13S/R25E, and then continuing northeasterly in a straight line and crossing onto the Luckett Mountain map, proceed to the marked 3,489-foot summit of Dalton Mountain, section 22, T13S/R25E; then
(3) Proceed easterly in a straight line to the Sequoia National Forest boundary line at the northwest corner of section 28, T13S/R26E; then
(4) Proceed east along the Sequoia National Forest boundary line, crossing onto the Verplank Ridge map, and continue south, then east, then south along the national forest boundary line, crossing onto the Miramonte map, and then continue south, then east along the national forest boundary line to the northeast corner of section 5, T14S/R27E; then
(5) Proceed south along the eastern boundary lines of sections 5, 8, and 17, T14S/R27E, to the southeast corner of section 17; then
(6) Proceed east along the northern boundary line of section 21, T14S/R27E, to the northeast corner of that section; then
(7) Proceed south along the eastern boundary lines of sections 21, 28, and 33, T14S/R27E, to the Fresno-Tulare County boundary line at the southeast corner of section 33; then
(8) Proceed west along the Fresno-Tulare County boundary line, crossing onto the Tucker Mountain map, to the southwest corner of section 34, T14S/R26E; then
(9) Proceed north along the western boundary lines of sections 34, 27, 22, and 15, T14S/R26E, to the northwest corner of section 15; then
(10) Proceed west along the southern boundary lines of sections 9, 8, and 7, T14S/R26E, and sections 12 and 11, T14S/R25E, to the southwest corner of section 11; then
(11) Proceed south along the eastern boundary lines of sections 15 and 22, T14S/R25E, to the southeast corner of section 22; then (12) Proceed west along the southern boundary line of section 22, T14S/R25E, and, crossing onto the Orange Cove North map, continue west along the southern boundary line of section 21, T14S/R25E, returning to the beginning point.
Coast Guard, DHS.
Notice of deviation from drawbridge regulations.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Galveston Causeway Railroad Vertical Lift Bridge across the Gulf Intracoastal Waterway, mile 357.2 west of Harvey Locks, at Galveston, Galveston County, Texas. The deviation is necessary in order to conduct maintenance on the bridge. This deviation allows the bridge to remain temporarily closed to navigation for eight hours on consecutive days during day light hours and will operate normally at all other times.
This deviation is effective from August 31 through September 5, 2015. This deviation will be enforced from 7:30 a.m. to 11:30 and then again from 1:30 p.m. to 5:30 p.m., daily, beginning August 31 through September 5, 2015.
The docket for this deviation, [USCG-2015-0741] is available at
If you have questions on this temporary deviation, call or email Jim Wetherington, Bridge Administration Branch, Coast Guard; telephone 504-671-2128, email
The BNSF Railway Company requested a temporary deviation from the operating schedule of the Galveston Causeway Railroad Vertical Lift Bridge across the Gulf Intracoastal Waterway, mile 357.2 west of Harvey Locks, at Galveston, Galveston County, Texas.
The bridge has a vertical clearance of 8.0 feet above mean high water, elevation 3.0 feet (NAVD88), in the closed-to-navigation position and 73 feet above mean high water in the open-to-navigation position. In accordance with 33 CFR 117.5, the draw shall open on signal for the passage of vessels.
This temporary deviation allows the vertical lift bridge to remain closed to navigation from 7:30 a.m. to 11:30 and then again from 1:30 p.m. to 5:30 p.m., daily, beginning August 31 through September 5, 2015. During this time, the bridge owner will complete cable lubing, welding joints and replacing span guide bearings. If the vessel can safely pass without an opening, the vessel may pass at the slowest safe speed. The bridge can open in case of emergency.
Navigation at the site of the bridge consists mainly of tows with barges and some recreational pleasure craft. Based on known waterway users, as well as coordination with those waterway users, it has been determined that this closure will not have a significant effect on these vessels. No alternate routes are available.
In accordance with 33 CFR 117.35, the draw bridge must return to its regular operating schedule immediately
This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs four Multnomah County bridges: the Broadway Bridge, mile 11.7, Burnside Bridge, mile 12.4, Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1, all crossing the Willamette River at Portland, OR. This deviation is necessary to accommodate the annual Portland Providence Bridge Pedal event. This deviation allows the bridges to remain in the closed-to-navigation position to allow safe roadway movement of event participants.
This deviation is effective from 6 a.m. on August 9, 2015, to 12:30 p.m. on August 9, 2015.
The docket for this deviation, [USCG-2015-0624] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Multnomah County has requested a temporary deviation from the operating schedule for the Broadway Bridge, mile 11.7, Burnside Bridge, mile 12.4, Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1, all crossing the Willamette River at Portland, OR. The requested deviation is to accommodate the annual Providence Bridge Pedal event. To facilitate this event, the draws of the bridges will be maintained in the closed-to-navigation positions as follows: The Broadway Bridge, mile 11.7, provides a vertical clearance of 90 feet in the closed position; Burnside Bridge, mile 12.4, provides a vertical clearance of 64 feet in the closed position; Morrison Bridge, mile 12.8, provides a vertical clearance of 69 feet in the closed position; and Hawthorne Bridge, mile 13.1, provides a vertical clearance of 49 feet in the closed position; all clearances are referenced to the vertical clearance above Columbia River Datum 0.0. The normal operating schedule for all four bridges is set in 33 CFR 117.897, and states that the bridges need not open from 7 a.m. to 9 a.m., and from 4 p.m. to 6 p.m. Monday through Friday. These four bridges need not open for vessel traffic from 6 a.m. on August 9, 2015, to 12:30 p.m. on August 9, 2015. This deviation period is from 6 a.m. on August 9, 2015, to 12:30 p.m. August 9, 2015. The deviation allows the Broadway Bridge, Burnside Bridge, Morrison Bridge, and the Hawthorne Bridge all crossing the Willamette River, to remain in the closed-to-navigation position and need not open for maritime traffic from 6 a.m. to 12:30 p.m. on August 9, 2015. The four bridges shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft.
Vessels able to pass through the bridge in the closed-to-navigation positions may do so at any time. The bridges will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Final rule.
HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds regulations for the purpose of creating Covered Countermeasures Injury Tables. The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus (hereafter referred to as the 2009 H1N1 virus) and other potential pandemic strains, such as H5N1 avian influenza.
This rule is effective September 8, 2015.
Dr. Avril M. Houston, Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857, or by telephone (855) 266-2427. This is a toll-free number.
On March 30, 2014, HHS published the Notice of Proposed Rulemaking (NPRM) in the
The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) directs the Secretary to establish, through regulation, a Covered Countermeasures Injury Table (Table) identifying serious physical injuries that are presumed to be directly caused by the administration or use of covered countermeasures identified in PREP Act declarations issued by the Secretary.
The Secretary may only add to a Table injuries that are directly caused by the administration or use of the covered countermeasure based on “compelling, reliable, valid, medical and scientific evidence.”
The PREP Act authorizes both liability protections and compensation based on the terms of the PREP Act declarations, but this final rule concerns only the compensation program, not the liability protections set forth therein.
The Secretary published the interim final rule implementing the Program on October 15, 2010.
Individuals with injuries not meeting the requirements listed on the Table may still pursue their claims as non-Table injuries under the Program. In this instance, the requester does not receive the presumption of causation for a Table injury and must demonstrate that the use or administration of the covered countermeasure directly caused the injury. Proof of a causal association for the non-Table injury must be based on compelling, reliable, valid, medical and scientific evidence.
Through this final rule, the Secretary will be adding subpart K to 42 CFR part 110, which had been reserved for the purpose of creating a Covered Countermeasures Injury Table. The Table established in this final rule is limited to pandemic influenza covered countermeasures. These countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 virus, and other potential pandemic strains, such as H5N1 avian influenza. The Secretary may create and publish Tables in the
Through the Pandemic Influenza Countermeasures Injury Table Final Rule, the Secretary provides, as authorized by statute, a Table for several covered countermeasures listing serious physical injuries. The serious physical injuries included on the Table are injuries that are supported by compelling, reliable, valid, medical and scientific evidence showing that the administration or use of the covered countermeasures directly causes such injuries. The Table lists the serious injuries directly caused by a specific countermeasure, the time interval within which the first symptom or manifestation of onset of injury must appear, and the definition of the injury. Table definitions are included to further explain each covered injury and the level of severity necessary to qualify as a Table injury.
The injuries, time intervals, definitions, and requirements reflect the Secretary's efforts to identify those serious physical injuries causally related to the covered countermeasures. The causal linkages between the covered countermeasures and these associated injuries are based on compelling, reliable, valid, medical and scientific evidence. The Secretary will stay informed of updates in the scientific and medical field concerning new information about causal associations between injuries and covered countermeasures.
In this final rule, the Secretary has made the following changes to the Qualifications and Aids to Interpretation (QAI) of the Table for purposes of clarity.
a. Changed section (b)(4)(i) by adding an accent over the “e” in Guillain-Barre Syndrome (GBS). The revised section term reads, “Guillain-Barré Syndrome.” In the first sentence, added “currently is known to encompass” after “that” and delete “encompasses.” The revised sentence states, “GBS is an acute monophasic peripheral neuropathy that currently is known to encompass a spectrum of four clinicopathological subtypes described below.” In the fourth sentence, changed “nine” to “9.” The revised sentence states, “Treatment related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time frame would not be consistent with GBS.”
b. Changed section (b)(4)(iv) by adding “The results of both . . .” to the beginning of the second sentence. The revised sentence states, “The results of both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS.”
c. Deleted section (b)(4)(v) which states, “For all types of GBS, the onset of symptoms less than three days (72 hours) after exposure to the influenza vaccine excludes vaccine exposure as a cause” because timeframes for serious physical injuries to be Table injuries are listed in the Table, not in the QAI.
d. Changed section (b)(4)(vi) to (b)(4)(v) since (b)(4)(v) has been deleted as stated above and added to the beginning of the first sentence of section (b)(4)(v), “For GBS to qualify as a Table injury.” The revised sentence states, “For GBS to qualify as a Table injury, there must not be a more likely alternative diagnosis for the weakness.”
e. Changed section (b)(5)(i)(A) by adding “or” after “tube;”. The revised statement states, “(A) trauma or necrosis from an endotracheal tube; or.”
f. Changed section (b)(6)(i) by deleting “Definition -” before “VAP” at the beginning of the first sentence. In the fourth sentence, changed the phrase “radiographic infiltrate in the lungs that is consistent with pneumonia” to “radiographic infiltrate that is in the lungs and consistent with pneumonia.”
g. Changed section (b)(7) by adding “To qualify as Table injuries,” before “these” to the beginning of the last sentence. The revised sentence states, “To qualify as Table injuries, these manifestations must occur in patients who are being mechanically ventilated at the time of initial manifestation of the VILI.” VILI is Ventilator-Induced Lung Injury.
h. Changed section (b)(8) by adding “who are” after “patients” and before “under” to the first sentence. The revised sentence states, “Bleeding events are defined as excessive or abnormal bleeding in patients who are under the pharmacologic effects of anticoagulant therapy provided for extracorporeal membrane oxygenation (ECMO) treatment.”
The NPRM set forth a 60-day public comment period, which ended on May 30, 2014. During this comment period, HHS received five sets of comments—one set from a physicians' organization and four sets from individuals. Below is a summary of the comments and HHS's responses.
Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. The axon is a portion of the nerve cell that transmits nerve impulses away from the nerve cell body. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the axons of sensory nerves and roots.
According to the Brighton Collaboration, Fisher Syndrome (FS), also known as Miller-Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and GBS may be seen with limb weakness.
GBS is proposed for inclusion on the Table because it is a serious physical injury, and the fact that it may be directly caused by the use of the monovalent 2009 H1N1 influenza vaccine (hereafter 2009 H1N1 vaccine) is supported by compelling, reliable, valid, medical and scientific evidence. Further, GBS is characterized by various degrees of weakness, sensory abnormality and autonomic dysfunction due to damage to peripheral nerves and nerve roots. These variants or subtypes of GBS were addressed fully in the NPRM and are adopted in the final rule.
Furthermore, as explained above, the description of GBS as stated in the NPRM, and adopted in this final rule, is complete. To the extent that one comment suggested that organ damage should be included as a Table injury, HHS respectfully disagrees. Although demyelination of peripheral nerves or axonal damage can lead to disruption of organ function, they do not lead directly to organ damage. At this time, there is no compelling, reliable, valid, medical and scientific evidence to support including organ damage on the Table.
As stated in the NPRM, multiple studies performed to monitor the safety of 2009 H1N1 vaccine provide evidence that demonstrates a small statistically significant increased risk of GBS in the 6 weeks following administration of the 2009 H1N1 vaccine.
The symptoms of GBS do not develop immediately after exposure to the causative agent. The immune system requires a specified time to complete the steps leading to nerve injury and dysfunction and the early symptoms of GBS. A minimum of 3 days would be necessary from the time of exposure and immune system stimulation to the first symptoms of GBS. Therefore, onset of GBS within less than 72 hours or 3 days of immunization would be strong evidence that the vaccine is not the causative agent.
HHS believes that the
HHS has examined the impact of this rulemaking as required by Executive Order 12866 on Regulatory Planning and Review, Executive Order 13563 on Improving Regulation and Regulatory Review, the Congressional Review Act (5 U.S.C. 804(2)), the Regulatory Flexibility Act (RFA), section 202 of the Unfunded Mandates Reform Act of 1995, section 654(c) of the Treasury and General Government Appropriations Act of 1999, and Executive Order 13132 on Federalism.
Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis. In 2011, President Obama supplemented and reaffirmed Executive Order 12866. This rulemaking is not being treated as a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the final rule has not been reviewed by the Office of Management and Budget.
Executive Order 13563 provides that, to the extent feasible and permitted by law, the public must be given a meaningful opportunity to comment on any proposed regulations, with at least a 60-day comment period. In addition, to the extent feasible and permitted by law, agencies must provide timely on-line access to both proposed and final rules of the rulemaking docket on Regulations.gov, including relevant scientific and technical findings, in an open format that can be searched and downloaded. Federal agencies must consider approaches to maintain the freedom of choice and flexibility, including disclosure of relevant information to the public. Regulations must be guided by objective scientific evidence, easy to understand, consistent, and written in plain language. Furthermore, Federal agencies must attempt to coordinate, simplify, and harmonize regulations to reduce costs and promote certainty for the public.
In this final rule, the Secretary specifies a Table identifying serious physical injuries that shall be presumed to result from the administration or use of the covered countermeasures, and the time interval in which the onset of the first symptom or manifestation of each such serious physical injury must manifest in order for such presumption to apply. The Secretary is also specifying Table definitions and requirements. This final rule would have the effect of affording certain persons a presumption that particular serious physical injuries were sustained as the result of the administration or use of covered pandemic influenza countermeasures. The Table will establish a presumption of causation and relieve requesters of the burden of demonstrating causation for covered injuries listed on the Table. However, this presumption is rebuttable based on the Secretary's review of the evidence. In addition, this Table may afford some requesters a new filing deadline.
Other than showing that a serious physical injury or death directly resulted from an injury included on the Table, individuals may, in the alternative, be eligible for compensation if they otherwise meet the CICP's requirements and can show a causation-in-fact relationship between an injury or death and a covered countermeasure. This rule is based upon legal authority.
Because any resources required to implement the regulatory requirements imposed by the Program are not required by virtue of the establishment of a Table, and because the Secretary conducted an independent analysis concerning any burdens associated with the implementation of the Program when the Secretary published the companion regulation setting forth the Program's administrative implementation,
The Secretary has also determined that this rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. The Secretary has determined that this rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. This final rule comports with the 2011 supplemental requirements.
The Secretary has determined that this final rule will not have effects on State, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.
The Secretary has also reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This final rule will not “have substantial direct effects on the States, or 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 final rule will not adversely affect the following elements of family well-being: family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income, or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999. In fact, this rule may have a positive impact on the disposable
This final rule has no information collection requirements.
Anaphylaxis, Anticoagulation, Antiviral, Avian, Benefits, Biologics, Bleeding, Bursitis, Compensation, Countermeasure, Declaration, Deltoid, Diagnostics, Device, Eligibility, Extra-Corporeal Membrane Oxygenation (ECMO), Fisher Syndrome, Guillain-Barré Syndrome, 2009 H1N1, Influenza, Injury Table, Immunization, Oseltamivir, Pandemic, Peramivir, Public Readiness and Emergency Preparedness Act (PREP Act), Radiation syndrome, Respiratory protection, Relenza, Respirator, Respirator support, Tamiflu, Tracheal Stenosis, Vaccine, Vasovagal Syncope, Ventilator, Ventilator-Associated Pneumonia and Tracheobronchitis, Ventilator-Induced Lung Injury, Zanamivir.
Therefore, for the reasons stated, the Department of Health and Human Services amends 42 CFR part 110 as follows:
42 U.S.C. 247d-6e.
(a)
(b)
(1)
(2)
(3)
(4)
(ii) The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP) which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and AMSAN requires bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs; a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse); and, the absence of an identified more likely alternative diagnosis. Death may occur without a clinical plateau.
(iii) Fisher syndrome (FS), also known as Miller-Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and AIDP may be seen with limb weakness. The diagnosis of FS requires bilateral ophthalmoparesis; bilateral reduced or absent tendon reflexes; ataxia; the absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP); a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse); no alteration in consciousness; no corticospinal track signs; and, the absence of an identified more likely alternative diagnosis. Death may occur without a clinical plateau.
(iv) Evidence that is supportive, but not required, of a diagnosis of all subtypes of GBS includes electrophysiologic findings consistent with GBS or an elevation of cerebral spinal fluid (CSF) protein with a total CSF white blood cell count below 50 cells per microliter. The results of both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS.
(v) For GBS to qualify as a Table injury there must not be a more likely alternative diagnosis for the weakness. Exclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: Chronic immune demyelinating polyradiculopathy (“CIDP”), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive.
(5)
(A) Trauma or necrosis from an endotracheal tube; or
(B) Stomal injury from a tracheostomy; or
(C) A combination of the two.
(ii) Tracheal stenosis or narrowing due to tumors (malignant or benign), infections of the trachea (such as
(6)
(ii) VAT will be considered to be present when the patient demonstrates fever, leukocytosis or leukopenia, purulent tracheal secretions, and a positive tracheal aspirate culture in the absence of a change of antibiotics within the 72 hours prior to culture. Tracheal colonization with microorganisms is common in intubated patients, but in the absence of clinical findings is not a sign of VAT.
(7)
(8)
(c)
(1) Pandemic influenza vaccines;
(2) Tamiflu;
(3) Relenza;
(4) Peramivir;
(5) Personal respiratory protection devices;
(6) Respiratory support devices;
(7) Diagnostic testing devices.
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service, finalize a rule under authority of section 4(d) of the Endangered Species Act of 1973, as amended, that provides measures that are necessary and advisable to provide for the conservation of the Georgetown salamander
This 4(d) rule is necessary and advisable to provide for the conservation of the Georgetown salamander because it strengthens water quality protection measures throughout the species' range, allows for consideration of new information to optimize conservation measures, and furthers conservation partnerships that can be leveraged to improve the status of the Georgetown salamander.
This rule is effective September 8, 2015.
This final rule, the final environmental assessment, and a list of references cited are available on the Internet at
Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Rd., Suite 200, Austin, TX 78758; telephone 512-490-0057; facsimile 512-490-0974. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
On August 22, 2012, we published a proposed rule in the
The Georgetown salamander is entirely aquatic and depends on water from the Edwards Aquifer in sufficient quantity and quality to meet the species' life-history requirements for survival, growth, and reproduction. Degradation of habitat, in the form of reduced water quality and quantity and disturbance of spring sites, is the main threat to this species. For more information on the Georgetown salamander and its habitat, please refer to the February 24, 2014, final listing determination (79 FR 10236).
The Act does not specify particular prohibitions, or exceptions to those prohibitions, for threatened species. Instead, under section 4(d) of the Act, the Secretary of the Interior has the discretion to issue such regulations as she deems necessary and advisable to provide for the conservation of such species. The Secretary also has the discretion to prohibit by regulation, with respect to any threatened wildlife species, any act prohibited under section 9(a)(1) of the Act. Exercising this discretion, the Service developed general prohibitions (50 CFR 17.31) and exceptions to those prohibitions (50 CFR 17.32) under the Act that apply to most threatened wildlife species. Alternately, for other threatened species, under the authority of section 4(d) of the Act, the Service may develop specific prohibitions and exceptions that are tailored to the specific conservation needs of the species. In such cases, some of the prohibitions and authorizations under 50 CFR 17.31 and 17.32 may be appropriate for the species and incorporated into a rule under section 4(d) of the Act. However, these rules, known as 4(d) rules, will also include provisions that are tailored to the specific conservation needs of the threatened species and may be more or less restrictive than the general provisions at 50 CFR 17.31.
Based on information we received in both public comment periods on the proposed 4(d) rule (see Summary of Comments and Recommendations), we revised the provisions of the 4(d) rule to provide greater clarity around the activities that are covered and not covered by this rule.
Under section 4(d) of the Act, the Secretary may publish a rule that modifies the standard protections for threatened species and that contains prohibitions tailored to the conservation of the species and that are determined to be necessary and advisable. Under this 4(d) rule, the Service provides that all of the prohibitions under 50 CFR 17.31 and 17.32 are necessary and advisable and, therefore, apply to the Georgetown salamander, except as noted below. This 4(d) rule will not remove or alter in any way the consultation requirements under section 7 of the Act.
For activities outside of habitat occupied by the Georgetown salamander, the final 4(d) rule provides that take of Georgetown salamanders that is incidental to regulated activities (as defined in title 30, Texas Administrative Code, section 213.3(28)) that are conducted consistent with the water quality regulations contained in chapter 11.07 of the City of Georgetown Unified Development Code (UDC 11.07) (
“Regulated activities” are defined in title 30, Texas Administrative Code, section 213.3(28) as any construction-related or post-construction activities on the Recharge Zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. “Regulated activities” do not include the clearing of vegetation without soil disturbance, agricultural activities, oil and gas activities, routine maintenance of existing structures that does not involve additional site disturbance, and construction of single-family residences on lots larger than 2 hectares (ha) (5 acres (ac)). More specific details on spring and stream buffers can be found in sections 11.07.003A. and B. of the UDC.
When a property owner submits a development application for a regulated activity on a tract of land located over the Edwards Aquifer Recharge Zone, that individual is required to submit a geologic assessment to the City of Georgetown. The geologic assessment identifies and describes all springs and streams on any subject property, and the UDC establishes buffer zones around identified springs and streams. For springs, the buffer encompasses 50 meters (m) (164 feet (ft)) extending from the approximate center of the spring outlet that is identified in a geologic assessment. For streams, the boundaries of the buffer must coincide with either the boundaries of the Federal Emergency Management Agency (FEMA) one percent floodplain or a calculated one percent floodplain, whichever is smaller. In the absence of a FEMA floodplain or calculated one percent floodplain, these stream buffers may be no smaller than 61 m (200 ft) wide with at least 23 m (75 ft) from the centerline of the stream. Section 11.07.003 of the UDC states that no “regulated activities” may be conducted within the spring and stream buffers.
In addition to the establishment of these spring and stream buffers, the UDC outlines water quality best management practices designed to minimize sediment runoff, increase the removal of total suspended solids, prevent an increase in flow rates, and ensure spill containment for new or expanded roadways. These regulations in chapter 11.07 of the UDC are designed to reduce water quality degradation that may occur as a result of development. By reducing further water quality degradation that may result from development, these protective measures are also expected to reduce degradation to Georgetown salamander habitat that may occur.
The UDC 11.07 also outlines exemptions from the requirement to prepare a geologic assessment, the process by which a landowner may request a variance to the spring and
Properties with a site occupied by the Georgetown salamander are exempt from the spring and stream buffer requirements in chapter 11.07. Rather, UDC Appendix A outlines conservation measures (which are voluntary under the UDC) to be implemented when undertaking regulated activities that occur on a tract of land with an occupied site or within 984 ft (300 m) of an occupied site. An “occupied site” is defined in the UDC as any spring identified as a critical habitat unit by the Service for the Georgetown salamander and includes the following sites: Cobb Well, Cobb Springs, Cowen Creek Spring, Bat Well Cave, Walnut Spring, Twin Spring, Hogg Hollow Spring, Cedar Hollow Spring, Knight (Crockett Garden) Spring, Cedar Breaks Hiking Trail Spring, Water Tank Cave, Avant's (Capitol Aggregates), Buford Hollow Springs, Swinbank Spring, Shadow Canyon, San Gabriel Spring, and Garey Ranch Springs. For the purposes of this 4(d) rule, however, we define an occupied site to be any site where Georgetown salamanders have been found in the past or new sites found in the future.
For activities involving habitat occupied by the Georgetown salamander, the final 4(d) rule provides that take of the Georgetown salamander that is incidental to regulated activities that are conducted consistent with the guidelines described in Appendix A of the UDC will not be prohibited under the Act. Similar to chapter 11.07 of the UDC, the guidelines in Appendix A establish stream and spring buffers and allowable activities within those buffers; however, the measures described in Appendix A create larger, more protective buffers than those that appear in chapter 11 for unoccupied sites. First, Appendix A establishes a “No-Disturbance Zone” in the stream or waterway into which a spring drains directly; this zone extends 80 m (264 ft) upstream and downstream from the approximate center of the spring outlet of an occupied site and is bounded by the top of the bank. No regulated activities may occur within the “No-Disturbance Zone.” In addition, Appendix A establishes a “Minimal-Disturbance Zone” for the subsurface area that drains to the spring(s) at an occupied site; this zone consists of the area within 300 m (984 ft) of the approximate center of the spring outlet of an occupied site, except those areas within the “No-Disturbance Zone.” Most regulated activities are also prohibited in the “Minimal-Disturbance Zone,” but single-family developments, limited parks and open space development, and wastewater infrastructure will be allowed. For additional details on the buffers around occupied sites and prohibited actions, please refer to the UDC Appendix A.
In general, this 4(d) rule does not apply to deviations from the water quality measures in UDC 11.07 and Appendix A. Any variance from the measures and guidelines described in UDC 11.07 (non-occupied sites) is not covered by this final 4(d) rule, unless that variance has been granted by the City of Georgetown. In addition, variances from the spring and stream buffer requirements of UDC 11.07 may be granted by the City of Georgetown only if the variance is not contrary to the public interest, if due to special conditions a literal enforcement of the ordinance would result in unnecessary hardship, and if the spirit of the ordinance is observed and substantial justice is done, in accordance with UDC section 2.05.010.A.6. Projects involving habitat occupied by the Georgetown salamander (which are not eligible for variances) where the project proponent chooses not to follow the voluntary guidelines in Appendix A of the UDC, may work with the Service to pursue take coverage by developing a habitat conservation plan (HCP) in accordance with section 10 of the Act.
Section 11.07.008 of the UDC also establishes an Adaptive Management Working Group (Working Group) that is responsible for reviewing data on a regular basis and making recommendations for specific changes in the management directions related to the voluntary conservation measures for occupied sites in Appendix A. Adaptive management for preservation of the Georgetown salamander is one of the duties tasked to the Working Group. The adaptive management described in the UDC specifically applies to the guidelines (
Section 4(d) of the Act states that “the Secretary shall issue such regulations as [s]he deems necessary and advisable to provide for the conservation” of species listed as threatened species. Conservation is defined in the Act to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to [the Act] are no longer necessary.”
The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, the Secretary may find that it is necessary and advisable not to include a taking prohibition, or to include a limited taking prohibition. See
Section 9 prohibitions make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or attempt any of these), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened wildlife in 50 CFR 17.31(a) and (b). For the Georgetown salamander, the Service has determined that a 4(d) rule tailored to its specific conservation needs is necessary and advisable, as discussed below. This final 4(d) rule provides that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except as described below.
Under this final 4(d) rule, incidental take of the Georgetown salamander will not be considered a violation of section 9 of the Act if the take occurs on any non-Federal land and from regulated activities that are conducted consistent with the water quality protection measures contained in chapter 11.07 and Appendix A of the City of Georgetown Unified Development Code. This final 4(d) rule refers to the definition of “regulated activities” in title 30, Texas Administrative Code, section 213.3(28), which is any construction-related or post-construction activities on the recharge zone of the Edwards Aquifer having the potential for polluting the Edwards Aquifer and hydrologically connected surface streams. We have determined that this provision is necessary and advisable for the conservation of the Georgetown salamander, as explained in the paragraphs that follow.
The local community in the City of Georgetown and Williamson County has expressed a desire to design and implement a local solution to conserving the natural resources in their county, including water quality and the Georgetown salamander (City of Georgetown Resolution No. 082812-N). All currently known locations for the Georgetown salamander are within the jurisdiction of the City of Georgetown, making the city an appropriate entity to manage conservation measures that protect Georgetown salamander habitat. Because impervious cover levels within most of the watersheds known to be occupied by the Georgetown salamander are still relatively low, a window of opportunity exists to design and implement measures to protect water quality and, therefore, conserve the salamander. The City and County's approach for accomplishing this conservation goal includes regulatory and non-regulatory actions, as described below. Regulatory actions include passage of the Edwards Aquifer Recharge Zone Water Quality Ordinance (Ordinance No. 2013-59) by the Georgetown City Council on December 20, 2013, and the revisions to their UDC (chapter 11.07) finalized on February 24, 2015. Their approach also includes non-regulatory actions, such as the technical guidance provided in Appendix A of the UDC, which outlines additional conservation measures to protect water quality and to avoid direct destruction of occupied sites.
Habitat modification, in the form of degraded water quality and quantity and disturbance of spring sites, is the primary threat to the Georgetown salamander. The conservation measures in both chapter 11.07 and Appendix A of the UDC provide a variety of water quality protection measures, such as the creation of buffers around springs and streams where regulated activities are prohibited, designed to lessen impacts to the water quality of springs and streams in the Edwards Aquifer Recharge Zone. The UDC is applied throughout the watersheds that contain the Georgetown salamander. Absent this 4(d) rule, the status quo would be to address development impacts through traditional tools (that is, sections 7 and 10 of the Act) that are generally applied at the project-by-project scale. The watershed-level approach in UDC 11.07 and Appendix A works to avoid incremental environmental degradation that may go unnoticed on a small, individual project scale. Through this final 4(d) rule, we can achieve a greater level of conservation for the Georgetown salamander than we could without it because it encourages rangewide implementation of water quality protective measures that are aimed at addressing the primary threat of habitat modification and degradation for Georgetown salamanders. The majority of Georgetown salamanders occur within 164 ft (50 m) of a spring outlet (Pierce
Although the areas that provide recharge and the source water for specific areas occupied by the salamander have not been precisely delineated, the watershed-level approach makes it likely that unknown recharge areas are receiving water quality protection under the UDC. This is because the UDC prohibits regulated activities within buffers around all streams located within the recharge zone and the City of Georgetown jurisdiction. In karst aquifer systems, streams often contain important recharge features called swallow holes or swallets, which allow the stream to continue flowing underground in a conduit and feed the larger aquifer or even small springs directly (White 1998, p. 172). For example, in the Barton Springs Segment of the Edwards Aquifer, hydrologists generally agree that most of the aquifer's recharge comes via these streambed recharge features (Mahler
This watershed-level approach also includes an adaptive management component that will allow the Adaptive Management Working Group (Working Group) to evaluate the response of salamander populations to management actions and quickly respond and recommend adjustments, if necessary, to management strategies to protect water
• Review scientific information to understand the latest science on watershed management practices and the conservation of the Georgetown salamander;
• Recommend support for additional Georgetown salamander scientific studies and oversee a long-term monitoring program to ensure that salamander abundance at monitored locations is stable or improving;
• Conduct and evaluate water quality trend analysis as part of its long-term monitoring program to ensure water quality conditions do not decline and, in turn, result in impacts to salamander abundance; and
• Develop recommendations for changes to the UDC Appendix A for occupied sites if scientific and monitoring information indicates that water quality and salamander protection measures need changes to minimize impacts to salamander populations and to help attain the goal of species conservation.
While a window of opportunity exists to design and implement conservation measures to conserve the Georgetown salamander, human population levels and development are expected to increase rapidly in Williamson County (Texas State Data Center 2012, pp. 166-167). The success of the local community's efforts depends on their robust adaptive management program. The program is designed to monitor and quickly assess the effectiveness of the identified conservation measures and strategies and to be able to respond quickly and adapt the conservation measures and strategies to provide equal or better conservation benefits to the Georgetown salamander. The adaptive management approach will ensure that the water quality protective measures are serving their intended purpose of conserving the Georgetown salamander, thereby providing for the conservation of the species. Changes to UDC Appendix A that are agreed upon by the Working Group through the adaptive management process, provide equal or greater conservation benefits to the Georgetown salamander, and approved by the Service would be covered under this 4(d) rule.
By not prohibiting incidental take resulting from regulated activities conducted in accordance with the UDC 11.07 and Appendix A, the Service is supporting and encouraging a local solution to conservation of the Georgetown salamander. This final 4(d) rule will provide the Service the opportunity to work cooperatively, in partnership with the local community and State agencies, on conservation of the Georgetown salamander and the ecosystems on which it depends. Leveraging our conservation capacity with that of the State, local governments, and the conservation community at large may make it possible to attain biological outcomes larger than those we could attain ourselves due to the watershed-scale protection the UDC requires. Further, our local partners are best able to design solutions that minimize socioeconomic impacts, thereby encouraging participation in measures that will protect water quality and conserve the Georgetown salamander. In addition, by not prohibiting incidental take resulting from regulated activities conducted in accordance with UDC 11.07 and Appendix A, the Service is providing a streamlining mechanism for compliance with the Act for those project proponents who comply with the protective measures in UDC 11.07 and Appendix A and, thus, are considered covered by this final 4(d) rule. Project proponents who comply with these protective measures, as outlined in this final rule, can implement their projects without any potential delay from seeking incidental take coverage from the Service, while also minimizing water quality degradation. This approach provides greater regulatory certainty and streamlines compliance for project proponents and thus is likely to result in increased implementation of water quality protective measures that benefit salamanders.
In summary, this 4(d) rule is necessary and advisable to provide for the conservation of the Georgetown salamander because it strengthens water quality protection measures throughout the species' range, allows for consideration of new information to optimize conservation measures, and furthers conservation partnerships that can be leveraged to improve the status of the Georgetown salamander. Implementation of water quality protection measures throughout the range of the species will provide greater protection for the species than would project-by-project efforts, and provide protections to recharge areas that we may not be able to protect under our traditional tools (
If an activity that may affect the species is not regulated by UDC 11.07 or is not in accordance with UDC 11.07 and Appendix A, or a person or entity is not in compliance with all terms and conditions of UDC 11.07 and Appendix A and the activity would result in an act that would be otherwise prohibited under 50 CFR 17.31, then the general provisions of 50 CFR 17.31 and 17.32 for threatened species apply. In such circumstances, the prohibitions of 50 CFR 17.31 would be in effect, and authorization under 50 CFR 17.32 would be required. In addition, nothing in this 4(d) rule affects in any way other provisions of the Act, such as the designation of critical habitat under section 4, recovery planning provisions of section 4(f), and consultation requirements under section 7.
We requested written comments from the public on the proposed 4(d) rule for the Georgetown salamander during two comment periods: February 24 to April 25, 2014, and April 9 to May 11, 2015. We also contacted appropriate Federal, State, and local agencies; scientific organizations; and other interested parties and invited them to comment on the proposed 4(d) rule, draft environmental assessment, and chapter 11.07 and Appendix A of the UDC during the respective comment periods.
Over the course of the two comment periods, we received 39 comment submissions. All substantive information provided during these comment periods has either been incorporated directly into this final rule or is addressed below. Comments from peer reviewers and State agencies are grouped separately.
In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion
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While it is true that the conservation measures in UDC Appendix A may be revised, those changes would not be covered under this 4(d) rule unless they are agreed upon by the Working Group through the adaptive management process outlined in the UDC, provide
We believe the development of this 4(d) rule has been an open process comparable to that of a section 10 permit process. In addition, the process of amending the UDC is very transparent, involving monthly meetings of the Unified Development Code Advisory Committee that are open to the public with minutes and agendas posted online (
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Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this final 4(d) rule in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
On February 24, 2014 (79 FR 10236), we published the final determination to list the Georgetown salamander as a threatened species. That rule became effective on March 26, 2014. As a result, the Georgetown salamander is currently covered by the full protections of the Act, including the full section 9 prohibitions that make it illegal for any person subject to the jurisdiction of the United States to take (harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct), import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any wildlife species listed as an endangered species, without written authorization. It also is illegal under section 9(a)(1) of the Act to possess, sell, deliver, carry, transport, or ship any such wildlife that is taken illegally. Prohibited actions consistent with section 9 of the Act are outlined for threatened species in 50 CFR 17.31(a) and (b). This final 4(d) rule states that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except regulated activities that are conducted consistent with the water quality protective measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(a) This final rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or [T]ribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and [T]ribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”
(b) This 4(d) rule promulgates that all prohibitions in 50 CFR 17.31(a) and (b) will apply to the Georgetown salamander, except activities that are conducted consistent with the water quality protection measures contained in Chapter 11.07 and Appendix A of the Unified Development Code, which would result in a less restrictive regulation under the Act, as it pertains to the Georgetown salamander, than would otherwise exist. As a result, we do not believe that this rule would significantly or uniquely affect small governments. Therefore, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630, this final rule will not have significant takings implications. We have determined that the rule has no potential takings of private property implications as defined by this Executive Order because this 4(d) rule will result in a less-restrictive regulation under the Endangered Species Act than would otherwise exist. A takings implication assessment is not required.
In accordance with Executive Order 13132, this final 4(d) rule does not have significant Federalism effects. A federalism summary impact statement is not required. This rule will not have substantial direct effects on the State, on the relationship between the Federal Government and the State, or on the distribution of power and responsibilities among the various levels of government.
In accordance with Executive Order 12988, the Office of the Solicitor has determined that this final rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking actions that significantly affect energy supply, distribution, and use. For reasons discussed within this final rule, we believe that the rule will not have any effect on energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.
This rule does not contain collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
We have prepared a final environmental assessment, as defined under the authority of the National Environmental Policy Act of 1969. For information on how to obtain a copy of the final environmental assessment, see
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. We determined that there are no known tribal lands within the range of the Georgetown salamander.
The primary authors of this final rule are the staff members of the Austin Ecological Services Field Office (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; 4201-4245; unless otherwise noted.
(e) Georgetown salamander
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Federal Trade Commission (FTC or Commission).
Request for public comment.
The Federal Trade Commission requests public comment concerning the proposed parental consent method submitted by Jest8 Limited, trading as Riyo (“Riyo”), under the Voluntary Commission Approval Processes provision of the Children's Online Privacy Protection Rule.
Written comments must be received on or before September 3, 2015.
Interested parties may file a comment at
Miry Kim, Attorney, (202) 326-3622, or Peder Magee, Attorney, (202) 326-3538, Division of Privacy and Identity Protection, Federal Trade Commission, Washington, DC 20580.
On October 20, 1999, the Commission issued its final Rule
Pursuant to Section 312.12(a) of the Rule, Riyo has submitted a proposed parental consent method to the Commission for approval. The full text of its application is available on the Commission's Web site at
The Commission is seeking comment on the proposed parental consent method, and is particularly interested in receiving comment on the questions that follow. These questions are designed to assist the Commission's consideration of the petition and should not be construed as a limitation on the issues on which public comment may be submitted. Responses to these questions should cite the number of the question being answered. For all comments submitted, please provide any relevant data, statistics, or any other evidence, upon which those comments are based.
1. Is this method, both with respect to the process for obtaining consent for an initial operator and any subsequent operators, already covered by existing methods enumerated in Section 312.5(b)(2) of the Rule?
2. If this is a new method, provide comments on whether the proposed parental consent method, both with respect to an initial operator and any subsequent operators, meets the requirements for parental consent laid out in 16 CFR 312.5(b)(1). Specifically, the Commission is looking for comments on whether the proposed parental consent method is reasonably calculated, in light of available technology, to ensure that the person providing consent is the child's parent.
3. Does this proposed method pose a risk to consumers' personal information? If so, is that risk outweighed by the benefit to consumers and businesses of using this method?
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 3, 2015. Write “Jest8 Limited (Trading as Riyo”) Application for Parental Consent Method, Project No. P-155405” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, including medical records or other individually identifiable health information. In addition, do not include
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Jest8 Limited (Trading as Riyo) Application for Parental Consent Method, Project No. P-155405” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex E), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex E), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
By direction of the Commission.
Internal Revenue Service (IRS), Treasury.
Correction to a notice of proposed rulemaking and notice of public hearing.
This document contains corrections to a notice of proposed rulemaking and notice of public hearing (REG-102837-15) that was published in the
Written or electronic comments and request for a public hearing for the notice of proposed rulemaking at 80 FR 35602, June 22, 2015, are still being accepted and must be received by September 21, 2015.
Taina Edlund or Terri Harris at (202) 317-4541, or Sean Barnett (202) 317-5800, or Theresa Melchiorre (202) 317-4643 (not a toll-free number).
The notice of proposed rulemaking that is subject of this document is under section 529A of the Internal Revenue Code.
As published, the notice of proposed rulemaking and notice of public hearing (REG-102837-15) contains errors that may prove to be misleading and are in need of clarification.
Accordingly, the notice of proposed rulemaking and notice of public hearing (REG-102837-15) that are subject to FR Doc. 2015-15280 are corrected as follows:
1. On page 35603, in the preamble, second column, twelfth line, the language “Section 529(d)(2) provides that the” is corrected to read “Section 529A(d)(2) provides that the.”
2. On page 35603, in the preamble, second column, nineteenth line, the language “529(d)(3) requires qualified ABLE” is corrected to read “529A(d)(3) requires qualified ABLE.”
3. On page 35606, in the preamble, first column, second line from the bottom of the first paragraph, the language “meaning of § 1.529A-1(b)(9)(A) or” is corrected to read “meaning of § 1.529A-1 (b)(9)(i).”
4. On page 35612, second column, second and third line from the bottom of paragraph (b)(16), the language “within the meaning of § 1.529-1(b)(9)(A) or § 1.529-2(e)(1)(i) are not qualified” is corrected to read “within the meaning of § 1.529A-1(b)(9)(i) or § 1.529A-2(e)(1)(i) are not qualified.”
5. On page 35619, third column, paragraph (a)(5)(iii) the language “furnished though a Web site posting and” is corrected to read “furnished through a Web site posting and.”
Environmental Protection Agency (EPA).
Proposed interpretive rule; request for comments.
Waters on the majority of Indian reservations do not have water quality standards under the Clean Water Act to protect human health and the environment. Only 40 of over 300 federally recognized tribes with
EPA must receive comments on this proposal on or before October 6, 2015. EPA will discuss this proposed rule and answer questions about it in a webinar during the above comment period. If you are interested, see EPA's Web site at
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2014-0461, by one of the following methods:
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• Fax: 202-566-0409
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Fred Leutner, Standards and Health Protection Division, Office of Science and Technology (4305T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 566-0378; fax number: (202) 566-0409; email address:
This supplementary information section is organized as follows:
This action applies to tribal governments that seek eligibility to administer regulatory programs under the Clean Water Act (CWA, or the Act). The table below provides examples of entities that could be affected by this action or have an interest in it.
If you have questions regarding the effect of this proposed action on a particular entity, please consult the person listed in the preceding
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• Identify the proposed action by docket number and other identifying information (subject heading,
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible.
• Submit your comments by the date shown in the
Congress added CWA section 518, 33 U.S.C. 1377, as part of amendments made in 1987. Section 518(e) authorizes EPA to treat eligible Indian tribes in the same manner as it treats states for a variety of purposes, including administering each of the principal CWA regulatory programs and receiving grants under several CWA funding authorities. Section 518(e) is commonly known as the “TAS” provision, for treatment in a similar manner as a state.
Section 518(e) establishes eligibility criteria for TAS, including requirements that the tribe have a governing body carrying out substantial governmental duties and powers; that the functions to be exercised by the tribe pertain to the management and protection of water resources within the borders of an Indian reservation; and that the tribe be reasonably expected to be capable of carrying out the functions to be exercised in a manner consistent with the terms and purposes of the Act and applicable regulations. Section 518(e) also requires EPA to promulgate regulations specifying the TAS process for applicant tribes. See section II.B.
Section 518(h) defines “Indian tribe” to mean any Indian tribe, band, group, or community recognized by the Secretary of the Interior and exercising governmental authority over a federal Indian reservation. It defines “federal Indian reservation” to mean all land within the limits of any reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and including rights-of-way running through the reservation.
Pursuant to section 518(e), EPA promulgated several final regulations establishing TAS criteria and procedures for Indian tribes interested in administering programs under the Act. The relevant regulations addressing TAS requirements for the principal CWA regulatory programs are:
• 40 CFR 131.8 for section 303(c) water quality standards (WQS). Final rule published December 12, 1991 (56 FR 64876); proposed rule published September 22, 1989 (54 FR 39098). Referred to hereafter as the “1991 WQS TAS rule” or “1991 TAS rule”;
• 40 CFR 131.4(c) for section 401 water quality certification, published in the 1991 WQS TAS rule;
• 40 CFR 123.31-34 for section 402 National Pollutant Discharge Elimination System (NPDES) permitting and other provisions, and 40 CFR 501.22-25 for the state sewage sludge management program. Final rule published December 22, 1993 (58 FR 67966); proposed rule published March 10, 1992 (57 FR 8522); and
• 40 CFR 233.60-62 for section 404 dredge or fill permitting. Final rule published February 11, 1993 (58 FR 8172); proposed rule published November 29, 1989 (54 FR 49180).
In 1994, EPA amended the above regulations to simplify the TAS process and eliminate unnecessary and duplicative procedural requirements.
This proposed action would not address or affect the TAS requirements or review process for tribes to receive grants.
In the 1991 WQS TAS rule, which addressed TAS for the WQS and certification programs, EPA explained that tribes must meet four criteria to be approved for TAS eligibility. Specifically, an applicant tribe must: (1) Be federally recognized, (2) carry out substantial governmental duties and powers over a “Federal Indian reservation” as defined in CWA section 518(h)(1), (3) have appropriate authority to regulate the quality of reservation waters, and (4) be reasonably expected to be capable of administering the CWA program. 54 FR at 39101.
The third of the criteria—regulatory authority—is the sole focus of the proposed change in statutory interpretation. This proposal would not affect the other TAS criteria or tribal application requirements relating to those criteria.
With regard to regulatory authority,
EPA specifically noted the import of language in
At the same time EPA recognized that Justice White's opinion was not a majority opinion of the Supreme Court (the other five Justices did not opine on the issue) and that the interpretation of CWA section 518 was not actually before the Court in
Ultimately, EPA took a cautious approach in the 1991 TAS rule and stated it would await further congressional or judicial guidance on the extent to which section 518 is properly interpreted as an express congressional delegation of authority.
EPA's approach required an applicant tribe to demonstrate its inherent tribal authority over the activities of non-tribal members on lands they own in fee within a reservation (“nonmember fee lands”) under the principles of
EPA noted that in applying the second prong of the
EPA adopted an identical approach and reasoning regarding tribal inherent regulatory authority in its subsequent TAS regulations (see list of regulations in section II.B). In these rules, EPA restated that the question of whether section 518 delegated authority to tribes to administer CWA regulatory programs on their reservations was unresolved and remained subject to additional consideration in light of subsequent congressional or judicial guidance.
EPA has taken final action approving TAS for CWA regulatory programs for 50 tribes since the 1991 WQS TAS rule.
As noted in section III's discussion of the 1991 TAS rule, EPA was mindful of the statement in
Since the 1991 TAS rule, there have been significant developments supporting the interpretive change EPA proposes. Notably, the first court to review a challenge to an EPA CWA TAS approval expressed the view that the statutory language of section 518 indicated plainly that Congress intended to delegate authority to Indian tribes to regulate their entire reservations, including regulation of non-Indians on fee lands within a reservation.
The TAS provision of a separate statute—the Clean Air Act (CAA)—provides additional relevant insight into congressional intent. Congress added the CAA TAS provision—section 301(d)—to the statute in 1990, only three years after it enacted CWA section 518. Although CAA section 301(d) pre-dates EPA's 1991 CWA TAS rule, it was
EPA finalized its regulations implementing CAA section 301(d) in 1998. 40 CFR part 49; 63 FR 7254 (February 12, 1998) (the “CAA Tribal Authority Rule”). The CAA TAS provision, combined with the definition of Indian tribe in CAA section 302(r), established the same basic TAS eligibility criteria for CAA purposes that apply under the CWA:
EPA noted at that time important similarities between the CAA and CWA TAS provisions. Most notably, the tribal provisions of both statutes expressly provided eligibility for tribal programs that pertain to the management and protection of environmental resources (
Several parties petitioned for judicial review of the CAA Tribal Authority Rule and challenged whether CAA section 301(d) could be properly interpreted as a delegation of authority by Congress to eligible Indian tribes.
A dissenting judge in the
As the D.C. Circuit stated in
In light of these developments, as well as EPA's experience administratively interpreting and implementing the CAA TAS provision, it is appropriate to revisit and revise EPA's approach to TAS under the CWA. In the preambles to the CWA TAS regulations from the 1990s, EPA discussed the possibility of reinterpreting CWA section 518 as an express congressional delegation of authority to tribes based on subsequent congressional or judicial guidance. The proposed action would accomplish such a reinterpretation.
Based on EPA's experience to date, the TAS application process has become significantly more burdensome than EPA anticipated in 1991. Many authorized tribes have informed EPA that the demonstration of inherent tribal authority, including application of the
In the 1991 TAS rule, EPA expressed its expert view that given the importance of surface water to tribes and their members, the serious nature of water pollution impacts, and the mobility of pollutants in water, applicant Indian tribes would generally be able to demonstrate inherent regulatory authority to set WQS for reservation waters, including as applied to nonmembers on fee lands under federal Indian law principles.
EPA thus anticipated in the early 1990s that applicant tribes would face a relatively simple initial burden of supplying basic facts to demonstrate that they retain requisite inherent authority to regulate under the CWA—including regulation of nonmember activities on fee lands—under established federal Indian law principles.
Unfortunately, EPA's expectations have not, as a general matter, been realized. Although each TAS application has varied according to the particular facts and circumstances of the applicant tribe and its reservation, the general experience confirms that demonstrations of inherent regulatory authority continue to impose unintended administrative hurdles on applicant tribes and to require substantial commitments of limited tribal and federal resources. In particular, the demonstration of inherent authority over nonmember activities on the reservation under the so-called
The elimination of such unintended administrative burdens does not, in itself, provide a legal rationale to alter EPA's interpretation of section 518. However, streamlining a TAS process that has become unnecessarily restrictive and burdensome does offer a strong policy basis for the Agency to take a careful second look at that provision and to consider—as it contemplated as early as 1991—whether intervening events have shed additional light on the appropriate statutory interpretation. Eliminating such unnecessary burdens is consistent with longstanding EPA and Executive policy to support tribal self-determination and promote and streamline tribal involvement in managing and regulating their lands and environments.
As explained in section III, EPA has long interpreted the CWA as expressing Congress' preference for tribal regulation of reservation surface water quality.
In April 2013, the National Tribal Water Council
Based on the analysis in sections III and IV above, EPA proposes to revise its interpretation of CWA section 518 and conclude definitively that Congress expressly delegated authority to Indian tribes to administer CWA regulatory programs over their entire reservations, including over nonmember activities on fee lands within the reservation of the applicant tribe, subject to the eligibility requirements in section 518. In doing so, EPA thus proposes to exercise the
EPA's revised interpretation is, most importantly, expressed in the language of section 518. Section 518(e)(2) requires only that the functions to be exercised by the applicant Indian tribe pertain to the management and protection of water resources “within the borders of an Indian reservation.” Section 518(h)(1) then defines the term “federal Indian reservation” to include all lands within the limits of any Indian reservation notwithstanding the issuance of any patent, and including rights-of-way running through the reservation. That definition is precisely the same language that the dissent in
The effect of this proposal would be to relieve tribes of the need to demonstrate their inherent authority when they apply for TAS to administer CWA regulatory programs. In particular, this proposal would eliminate any need to demonstrate that the applicant tribe retains inherent authority to regulate the conduct of nonmembers of the tribe on fee lands under the test established by the Supreme Court in
EPA's proposal would not affect—either by expanding or contracting—the geographic scope of potential tribal TAS eligibility under the CWA. Under section 518, tribes can only obtain TAS status over waters within the borders of their reservations.
The proposed change in statutory interpretation would not alter the current approach to tribal trust lands. Indian reservations include trust lands validly set aside for Indian tribes even if such lands have not formally been designated as an Indian reservation. Many named Indian reservations were established through federal treaties with tribes, federal statutes, or Executive Orders of the President. Such reservations are often referred to as formal Indian reservations. Many tribes have lands that the United States holds in trust for the tribes, but that have not been formally designated as reservations. As EPA has consistently stated, and consistent with relevant judicial precedent, such tribal trust lands are informal reservations and thus have the same status as formal reservations for purposes of the Agency's programs.
EPA's proposed change in statutory interpretation would not affect any existing limitations on tribal criminal enforcement authority. This proposal relates solely to applicant Indian tribes' civil regulatory authority to administer CWA regulatory programs on their reservations; it does not address or in any way alter the scope of tribal criminal enforcement jurisdiction. EPA has previously established regulations addressing implementation of criminal enforcement authority on Indian reservations for those CWA programs that include potential exercises of such authority.
There could be rare instances where special circumstances limit or preclude a particular tribe's ability to accept or effectuate the congressional delegation of authority over its reservation. For example, there could be a separate federal statute establishing unique jurisdictional arrangements for a specific state or a specific reservation that could affect a tribe's ability to exercise authority under the CWA. It is also possible that provisions in particular treaties or tribal constitutions could limit a tribe's ability to exercise relevant authority.
The application requirements of existing CWA TAS regulations already require tribes to submit a statement of their legal counsel (or equivalent official) describing the basis for their assertion of authority. The statement can include copies of documents such as tribal constitutions, by-laws, charters, executive orders, codes, ordinances, resolutions, etc.
Section 10211(b) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Stat. 1144 (August 10, 2005) established a unique TAS requirement with respect to Indian tribes located in the State of Oklahoma. Under section 10211(b) of SAFETEA, tribes in Oklahoma seeking TAS under a statute administered by the EPA for the purpose of administering an environmental regulatory program must, in addition to meeting applicable TAS requirements under the EPA statute, enter into a cooperative agreement with the state that is subject to EPA approval and that provides for the tribe and state to jointly plan and administer program requirements. This requirement of SAFETEA exists apart from, and in addition to, existing TAS criteria, including the TAS criteria set forth in section 518 of the CWA. EPA's proposal relates solely to the interpretation of an existing CWA TAS requirement; it would thus have no effect on the separate TAS requirement of section 10211(b) of SAFETEA.
EPA's proposed change in statutory interpretation is not intended as any comment on the extent of tribal inherent regulatory authority. As the Agency clearly articulated in the TAS rules identified in section II.B, the importance of water resources to tribes, the serious potential impacts of water pollution on tribes' uses of their waters, and the mobility of pollutants in water all strongly support tribes' ability to demonstrate their inherent authority to regulate surface water quality on their reservations, including the authority to regulate nonmember conduct on fee lands under the Supreme Court's test established in
The proposed change in interpretation would not affect these prior TAS approvals. The proposed change would, however, modify EPA's approach going forward to be consistent with Congress' intent to delegate authority to eligible tribes. It would relieve tribes of the administrative burden associated with demonstrating their inherent regulatory authority in the TAS application process. The change in interpretation does not, however, alter EPA's prior views regarding the extent of tribal inherent regulatory authority.
Because the proposed change in statutory interpretation is consistent with existing CWA TAS regulatory text, EPA's proposal would not revise any regulatory text in the Code of Federal Regulations.
If EPA finalizes its change in interpretation, tribes would be able to rely on the congressional delegation of authority in section 518 as the source of their authority to regulate water quality on their reservations. Aside from any special circumstances (see section V.E.), the main focus in determining the extent of an applicant tribe's jurisdiction for CWA regulatory purposes would then be identifying the geographic boundaries of the Indian reservation area (whether a formal or informal reservation) over which the congressionally delegated authority would apply. EPA's existing CWA TAS regulations already provide for applicant tribes to submit a map or legal description of the reservation area that is the subject of the TAS application.
The existing regulations provide appropriate opportunities for potentially interested entities to provide input to EPA regarding any jurisdictional issues associated with a tribe's TAS application. As mentioned in section II.B. above, EPA's TAS regulations for the CWA section 303(c) WQS program include a process for notice to appropriate governmental entities—states, tribes and other federal entities located contiguous to the reservation of the applicant tribe—and provide an opportunity for such entities to provide comment on the applicant tribe's assertion of authority. EPA makes such notice broad enough that other potentially interested entities can participate in the process. 56 FR at 64884. For example, EPA routinely publishes notice of tribal TAS applications for the WQS program in relevant local newspapers covering the area of the subject reservation and in electronic media.
EPA's TAS regulations for the CWA section 402 and 404 permitting programs require an analysis of regulatory authority as part of the program approval process under 40 CFR parts 123 and 233 that are described in section II.B. As described in the Simplification Rule, EPA makes its decisions to approve or disapprove those programs as part of a public notice and comment process conducted in the
Thus, the regulations would continue to afford appropriate opportunities for interested parties to comment on tribal assertions of authority for all CWA regulatory programs. Because the principal jurisdictional issue under the proposed reinterpretation would be the boundaries of the subject reservation, any comments on an applicant tribe's assertion of authority would likely focus on the reservation boundaries.
Because this proposal merely explains EPA's revised interpretation of existing statutory requirements established in the CWA tribal provision—and does not propose any changes to the existing regulatory language applicable to CWA TAS applications—an interpretive rule is the appropriate vehicle to announce EPA's revised approach. This interpretive rule is not subject to notice and comment requirements of the Administrative Procedure Act. However, EPA decided to provide notice and an opportunity for comment to increase transparency and to allow interested parties to provide their views. EPA intends this process to ensure that the Agency's decision making is well informed by stakeholder views and invites comments on all aspects of this proposal to reinterpret section 518 of the CWA as a congressional delegation of authority to eligible tribes.
As noted in section V.G., EPA's proposal would not revise any regulatory text. However, if EPA finalizes the proposal, the Agency would consider revising and updating some of its existing guidance to tribes and EPA regional offices on implementing the regulations.
For example, a 1998 memorandum to EPA staff (the “Cannon-Perciasepe Memorandum”)
If EPA finalizes this proposal, the memorandum's
There would be no effect on tribes that EPA has previously found eligible for TAS for the purpose of a CWA regulatory program.
If EPA finalizes this proposed interpretive rule, then after the effective date TAS applications for CWA regulatory programs would be able to rely on the delegation from Congress as the relevant source of authority supporting their eligibility. The reinterpretation should thus streamline the TAS process for many tribes seeking eligibility to administer CWA regulatory programs. EPA anticipates that this proposed action, if finalized, could significantly reduce the time and effort for tribes to develop their TAS applications, and could encourage more tribes to apply for TAS for CWA regulatory programs.
EPA advises tribes that have already initiated TAS applications for CWA regulatory programs that the reinterpretation proposed in this action has not yet taken effect. The earliest it could take effect would be 30 days after EPA issues a final interpretive rule after reviewing and considering all comments received during the public comment period (see
EPA's proposal would have no effect on the scope of existing state regulatory programs approved by EPA under the CWA. Generally speaking, civil regulatory jurisdiction in Indian country lies with the federal government and the relevant Indian tribe, not with the states.
The proposal relates solely to the exercise of jurisdiction by Indian tribes on their reservations; it would have no effect on the scope of existing CWA regulatory programs administered by states outside of Indian country. It would neither diminish, nor enlarge, the scope of such approved state programs.
There are uncommon situations where a federal statute other than the CWA grants a state jurisdiction to regulate in areas of Indian country. For example, in a few cases EPA has approved states to operate CWA regulatory programs in areas of Indian country where the states demonstrated jurisdiction based on such a separate federal statute. This proposal is not intended to address or affect such jurisdiction that other federal statutes provide to states.
Regulations already exist to address circumstances where a state or tribe believes that unreasonable consequences could arise or have arisen as a result of differing WQS set by states and eligible Indian tribes on common bodies of water. Section 518(e) of the CWA required EPA to provide a mechanism to address such situations. The Agency did so at 40 CFR 131.7, which establishes a detailed dispute resolution mechanism. This proposal does not affect that process; it would remain available as needed to address potential state/tribal issues.
This rule would entail no significant cost. Its only direct effect would be to reduce the administrative burden for a tribe applying to administer a CWA regulatory program, and to potentially increase the pace at which tribes seek such programs. See the discussion of administrative burden and cost in section IX.B. (Paperwork Reduction Act).
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
EPA has submitted the information collection activities in this proposed interpretive rule to OMB for approval under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2515.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
As discussed in section II.B., EPA's regulations require that a tribe seeking to administer a CWA regulatory program must submit information to EPA demonstrating that the tribe meets the statutory criteria described in section II.A. EPA requires this information in order to determine that the tribe is eligible to administer the program.
This proposed interpretive rule would streamline the application by removing the current requirement for an applicant tribe to demonstrate its inherent regulatory authority, including demonstrating that it meets the
This estimate could overstate actual burden because (a) EPA assumed that all applications are first-time applications for CWA regulatory programs, and thus the tribes submitting them would be unable to rely on materials from previous applications for different regulatory programs; (b) EPA used a liberal estimate of the annual rate of tribal applications to ensure that the ICR does not underestimate tribal burden; and (c) EPA used a simplifying steady-state assumption in estimating annualized costs.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified in the
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 action affects only Indian tribes that seek to administer CWA regulatory programs.
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 would not have federalism implications. It would 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 proposed action would apply only to tribal governments that seek eligibility to administer CWA regulatory programs. Although it could be of interest to some state governments, it would not apply directly to any state government or to any other entity. As discussed in section VII.C., the action would have no effect on the scope of existing state regulatory programs approved by EPA under the CWA.
In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and state and local governments, EPA consulted with representatives of state governments to obtain meaningful and timely input for consideration in this proposal. On June 18, 2014, EPA invited ten national and regional state associations
Some participants expressed concerns, which included: Whether the proposal would affect the geographic scope of TAS under the CWA; whether there is adequate evidence of congressional intent; how the proposal would affect a state's ability to dispute a TAS application; and how the proposal would affect the status of existing TAS applications. Some states also had questions about issues unique to their situations. EPA considered this input in developing the proposed rule, particularly in developing sections IV. and V.
EPA specifically solicits additional comment on this proposed action from state officials.
This action has tribal implications because it would directly affect tribes seeking to administer CWA regulatory programs. However, it would neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. EPA consulted and coordinated with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation and coordination follows.
EPA initiated a tribal consultation and coordination process for this action by sending a “Notification of Consultation and Coordination” letter on April 18, 2014, to all 566 federally recognized tribes. EPA contacted all federally recognized tribes, even though only tribes with reservations can apply for TAS under the CWA, because it is possible that additional tribes could acquire reservation lands in the future. The letter invited tribal leaders and designated consultation representatives to participate in the tribal consultation and coordination process. EPA held two identical webinars concerning this matter for tribal representatives on May 22 and May 28, 2014. A total of 70 tribal representatives participated in the two webinars, and tribes and tribal organizations sent 23 comment letters to EPA.
All tribal comments generally supported EPA's potential reinterpretation of section 518. Some comments expressed concerns about whether there would be adequate funding to help tribes administer CWA regulatory programs after they have TAS. EPA considered the tribal comments in developing this proposal, and will continue to consider tribal resource issues in its budgeting and planning process. However, EPA cannot assure tribes that additional funding will be available for a tribe to develop or implement the CWA regulatory program it seeks. A tribe choosing to administer such programs will need to carefully weigh its priorities and any available EPA assistance.
EPA specifically solicits additional comment on this proposed action from tribal officials.
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 could 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 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.
This proposed interpretive rule would not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. This action would affect the procedures tribes must follow in order to seek TAS for CWA regulatory purposes and would not directly affect the level of environmental protection.
Environmental Protection Agency (EPA).
Proposed rule.
Under the Toxic Substance Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for trichloroethylene (TCE). The proposed significant new use is manufacture or processing for use in a consumer product, with a proposed exception for use of TCE in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing of TCE for a significant new use. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs.
Comments must be received on or before October 6, 2015.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0697, by one of the following methods:
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You may be potentially affected by this action if you manufacture, process, or distribute in commerce chemical substances and mixtures. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Textile Product Mills (NAICS code 314).
• Wood Product Manufacturing (NAICS code 321).
• Printing and Related Support Activities (NAICS code 323).
• Chemical Manufacturing (NAICS code 325).
• Plastics and Rubber Product Manufacturing (NAICS code 326).
• Primary Metal Manufacturing (NAICS code 331).
• Fabricated Metal Product Manufacturing (NAICS code 332).
• Machinery Manufacturing (NAICS code 333).
• Computer and Electronic Product Manufacturing (NAICS code 334).
• Electrical Equipment, Appliance, and Component Manufacturing (NAICS code 335).
• Transportation Equipment Manufacturing (NAICS code 336).
• Furniture and Product Related Manufacturing (NAICS code 337).
• Miscellaneous Manufacturing (NAICS code 339).
• Clothing and Clothing Accessory Stores (NAICS code 488).
• Warehousing and Storage (NAICS code 493).
• Repair and Maintenance (NAICS code 811).
• National Security and International Affairs (NAICS code 928).
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 8, 2015 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contact listed under
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.
EPA is proposing a SNUR for trichloroethylene (TCE). The proposed significant new use is: Manufacturing and processing for any use in a consumer product of TCE except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray.
The proposed significant use EPA has identified in this unit is a use that EPA believes is not ongoing at the time of this proposed rule. EPA is requesting public comment on this proposal, and specifically on the Agency's understanding of ongoing uses for the chemical identified. EPA is particularly interested in whether there are any ongoing uses of this chemical in consumer products of which the Agency is currently unaware. EPA would welcome specific documentation of any such ongoing uses. A consumer product is defined at 40 CFR 721.3 as “a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation.”
This proposed SNUR would require persons that manufacture (including import) or process any of the chemicals for a significant new use, consistent with the requirements at 40 CFR 721.25, to notify EPA at least 90 days before commencing such manufacture or process of the chemical substance for a significant new use.
This SNUR is necessary to ensure that EPA receives timely advance notice of any future manufacturing and processing of TCE for new uses that may produce changes in human and environmental exposures. The rationale and objectives for this SNUR are explained in Unit III.
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substance included in this proposed rule. This analysis, which is available in the docket, is discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is submitted, costs are estimated to be less than $8,900 per SNUN submission for large business submitters and $6,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN and the payment of a user fee. The proposed SNUR would require first-time submitters of any TSCA section 5 notice to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account before they may submit a SNUN, for a cost of $203 per firm. However, these activities are only required of first time submitters of
This proposed SNUR would apply to TCE (Chemical Abstract Services Registry Number (CASRN 79-01-6) manufactured or processed for use in a consumer product except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. TCE is a volatile organic compound (VOC) that is produced and imported into the United States, with use estimated to be around 250 million pounds per year. It is a clear, colorless liquid that has a sweet odor and evaporates quickly (Ref. 1).
To ascertain if TCE is used in consumer products, EPA reviewed published literature, the National Institute of Health's (NIH) Household Product Database (HPD), Safety Data Sheets (SDSs), data submitted under EPA's Chemical Data Reporting (CDR) rule, and data submitted under EPA's Toxics Release Inventory (TRI) and communicated directly with domestic manufacturers and processors (Refs. 1 and 2). From review of these resources it was confirmed that the following consumer products containing TCE are available in retail outlets and e-commerce sites: Cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. Cleaners and solvents can be used to clean automotive parts, fabrics, and carpets. EPA does not believe that there are any other types of consumer products containing TCE(Ref. 1).
Following the release of the final risk assessment, EPA received a letter from PLZ Aeroscience Corporation on March 5, 2015, indicating their intent to reformulate their spray fixative product for consumers. Their letter states that they will no longer manufacture or process spray fixatives with TCE by September 1, 2015 (Ref. 3). EPA's review of the resources indicates this is the only TCE-containing spray fixative that is still used in a consumer product.
The majority (>80%) of TCE is used as an intermediate for manufacturing refrigerant chemicals. Much of the remainder, less than 14 percent, is used as a solvent for metals degreasing, leaving a relatively small percentage to account for all other uses, including its use in consumer products. In 2011, global consumption of TCE was 945 million pounds (lbs) and U.S. consumption was 255 million lbs. Nine companies, including domestic manufacturers and importers, reported a total production of 224.7 million lbs of TCE in 2011 to the CDR database. Based on the TRI data for 2012, 38 companies use TCE as a formulation component, 33 companies process TCE by repackaging the chemical, 28 companies use TCE as a manufacturing aid, and 1,113 companies use TCE for ancillary uses, such as degreasing. Overall, most U.S. consumption is attributable to two specific uses: As an intermediate for manufacturing the refrigerant (closed system) HFC-134a (a major alternative to CFC-12), and as a solvent for metal degreasing (Ref. 1).
A broad set of relevant studies including epidemiologic studies, animal bioassays, metabolism studies and mechanistic studies show that TCE exposure is associated with a wide array of adverse health effects. TCE has the potential to induce neurotoxicity, immunotoxicity, developmental toxicity, liver toxicity, kidney toxicity, endocrine effects, and several forms of cancer (Ref. 1).
TCE is fat soluble (lipophilic) and easily crosses biological membranes. It is readily absorbed into the body following oral, dermal, or inhalation exposure. Following oral ingestion TCE is rapidly absorbed from the gastrointestinal tract into the systemic circulation (
The metabolism of TCE has been extensively studied in humans and experimental rodent models. Both humans and animals metabolize TCE to numerous toxicologically active metabolites to varying degrees. These metabolites are generated from and transported across multiple tissues and play a key role in causing TCE‐associated toxic effects that target the liver and kidney (Ref. 1).
TCE is characterized as carcinogenic to humans by all routes of exposure as documented in EPA's TCE Integrated Risk Information System (IRIS) assessment (Ref. 4). This conclusion is based on strong cancer epidemiological data that reported an association between TCE exposure and the onset of various cancers, primarily in the kidney, liver and the immune system (
EPA's IRIS assessment also concluded that TCE poses a potential human health hazard for non-cancer toxicity including neurotoxicity, liver and kidney effects, immunotoxicity, reproductive, and developmental effects. Also evaluated in the IRIS assessment were TCE's and its metabolites genotoxic effects. As shown through the results of
Neurotoxicity has been demonstrated in animal and human studies under both acute and chronic exposure conditions. Evaluation of the human studies revealed TCE‐induced neurotoxic effects including alterations in trigeminal nerve and vestibular function, auditory effects, changes in vision, alterations in cognitive function, changes in psychomotor effects, and neurodevelopmental outcomes. The strongest neurological evidence of human toxicological hazard is for changes in trigeminal nerve function or morphology and impairment of vestibular function. Multiple epidemiological studies in different populations have reported TCE‐induced abnormalities in trigeminal nerve
Animals and humans exposed to TCE consistently experience liver toxicity. Specific effects include the following structural changes: Increased liver weight, increase in deoxyribonucleic acid (DNA) synthesis (transient), enlarged hepatocytes, enlarged nuclei, and peroxisome proliferation. Several human studies reported an association between TCE exposure and significant changes in serum liver function tests used in diagnosing liver disease, or changes in plasma or serum bile acids. There was also human evidence for hepatitis accompanying immune‐related generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, and liver failure in TCE‐exposed workers. For kidney effects, studies in both humans and animals have shown changes in the proximate tubules of the kidney following exposure to TCE. TCE metabolites also appear to be the causative agents that induce renal toxicity (Ref. 1).
Immune‐related effects following TCE exposures have been observed in both animal and human studies. In general, these effects were associated with inducing enhanced immune responses as opposed to immunosuppressive effects. Human studies have reported a relationship between systemic autoimmune diseases, such as scleroderma with occupational exposure to TCE. There have also been a large number of case reports in TCE‐exposed workers developing a severe hypersensitivity skin disorder, often accompanied by systemic effects to the lymph nodes and other organs, such as hepatitis (Ref. 1).
The toxicological literature provides support for male and female reproductive toxicity following TCE exposure. Both the epidemiological and animal studies provide evidence of adverse outcomes to female reproductive outcomes. However, much more extensive evidence exists in support of an association between TCE exposures and male reproductive toxicity. There is evidence that the metabolism of TCE in male reproductive tract tissues is associated with adverse effects on sperm measures in both humans and animals. Furthermore, human studies support an association between TCE exposure and alterations in sperm density and quality, as well as changes in sexual drive or function and altered serum endocrine levels (Ref. 1).
An evaluation of the overall weight and strength of the evidence of the human and animal developmental toxicity data suggests an association between pre‐ and/or post-natal TCE exposures and potential adverse developmental outcomes. TCE‐induced heart malformations in animals have been identified as the most sensitive developmental toxicity endpoint for TCE. Human studies examined the possible association of TCE with various prenatal effects. These adverse effects of developmental TCE exposure could include death (spontaneous abortion, perinatal death, pre- or post-implantation loss, resorptions), decreased growth (low birth weight, small for gestational age), and congenital malformations, in particular cardiac defects, and postnatal effects such as growth, survival, developmental neurotoxicity, developmental immunotoxicity, and childhood cancers. There have also been some epidemiological studies that have consistently reported an increased incidence of birth defects in TCE‐exposed populations from exposure to contaminated water. As for human developmental neurotoxicity, studies collectively suggest that the developing brain is susceptible to TCE toxicity. These studies have reported an association with TCE exposure and central nervous system birth defects and postnatal effects such as delayed newborn reflexes, impaired learning or memory, aggressive behavior, hearing impairment, speech impairment, encephalopathy, impaired executive and motor function and attention deficit (Ref. 1).
The main route of exposure for TCE is inhalation due to its chemical properties and the nature of the consumer products. However, EPA recognizes that highly volatile compounds such as TCE may also be absorbed through the skin. (Ref. 1).
In EPA's final risk assessment for TCE, EPA examined acute risks for consumer exposures in residential settings. The assessment identified risks to consumers and residential bystanders from use of solvent degreasers and protective spray coatings, also referred to as spray fixatives, because of either their high TCE content or high potential for human exposure. TCE is also present in film cleaners, and mirror edge sealants, but these products were not evaluated because of either their low TCE content, less frequent use, or low exposure potential. The final risk assessment calculated indoor air concentrations using the Exposure and Fast Assessment Screening Tool Version 2 (E-FAST2) Consumer Exposure Model (CEM) for the consumer exposure. EPA used E-FAST2 CEM because of the lack of available emissions and monitoring data for the TCE containing consumer products (Ref. 1).
For the spray fixatives and solvent degreasers used by consumers who experience exposures, there is the potential for acute risks that could result from even one improper use of these products containing TCE. Most consumers would be unaware of the potential toxicity of consumer products containing TCE. Consequently, insufficient and inadequate hazard communication may lead to incorrect use and increased consumer and bystander exposures. Even if consumers are aware of such potential hazards, they may not take appropriate precautions or research the appropriate resources in which these precautions are addressed. Of particular concern is that TCE has harmful effects that occur below the odor threshold, meaning that smelling the chemical in the home environment is not a sufficient approach to avoid hazardous effects (Ref. 1).
EPA is concerned about the adverse health effects of TCE resulting from commercial and consumer uses of the chemical substance identified for a risk assessment as part of EPA's Existing Chemicals Management Program. EPA identified a work plan of 83 chemicals including TCE for further assessment under the TSCA Work Plan for Chemical Assessments in March 2012, to help focus and direct the activities of its Existing Chemicals Management Program. EPA reviewed readily available information on TCE including uses, physical and chemical properties, fate, exposure potential, and associated hazards to humans and the environment. TCE was selected based on concerns for its human health hazard (
EPA believes that any additional use of this chemical substance in consumer
Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency action is based on EPA's determination that if the use begins or resumes, it may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.
Based on the considerations in Unit III.A., EPA wants to achieve the following objectives with regard to the significant new use(s) that are designated in this proposed rule:
1. EPA would receive notice of any person's intent to manufacture or process TCE for the described significant new use before that activity begins.
2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing TCE for the described significant new use.
3. EPA would be able to regulate prospective manufacturers or processors of TCE before the described significant new use of the chemical substance occurs, provided that regulation is warranted pursuant to TSCA section 5(e), 5(f), 6 or 7.
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors including:
1. The projected volume of manufacturing and processing of a chemical substance.
2. The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
3. The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
4. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use of TCE compounds subject to this proposed rule, as discussed in this unit, EPA considered relevant information about the toxicity of the substance, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new use: Manufacture or processing for any use in a consumer product except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. Because TCE is not used in consumer products (with the limited exceptions of use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, pepper spray, and (before September 1, 2015) spray fixatives), EPA believes new use in consumer products could increase the magnitude and duration of human exposure to TCE. Exposure to TCE through inhalation may lead to a wide array of adverse health effects, such as neurotoxicity, immunotoxicity, developmental toxicity, liver toxicity, kidney toxicity, endocrine effects, and several forms of cancer, as further explained in Unit II.C., and because of these adverse effects EPA would like the opportunity to evaluate such potential uses in consumer products for any associated risks or hazards that might exist before those uses would begin.
General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule.
Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the
Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger export notification for articles. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.
As discussed in the
EPA recognizes that TSCA section 5 does not usually require developing any particular test data before submission of a SNUN. There are two exceptions:
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on:
• Human exposure and environmental releases that may result from the significant new uses of the chemical substance;
• Potential benefits of the chemical substance; and
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substance included in this proposed rule (Ref. 2). In the event that a SNUN is submitted, costs are estimated at approximately $8,900 per SNUN submission for large business submitters and $6,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN, and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the public docket for this proposed rule (Ref. 2).
Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 707, subpart D, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications (
Before proposing this SNUR, EPA considered the following alternative regulatory action:
Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the agency when they intend to manufacture or process a listed chemical for a specific use or any use. However, for TCE, the use of TSCA section 8(a) rather than SNUR authority would have several limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human and environmental hazards and exposures associated with the proposed significant new use and, if necessary, take immediate follow-up regulatory action under TSCA section 5(e) or 5(f) to prohibit or limit the activity before it begins. In addition, EPA may not receive important information from small businesses, because such firms generally are exempt from TSCA section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)). In view of the level of health concerns about TCE if used for the proposed significant new use, EPA believes that a
EPA welcomes comment on all aspects of this proposed rule. EPA based its understanding of the use profile of these chemicals on the published literature, the 2012 CDR submissions, market research, discussions with manufacturers, and review of SDSs. To confirm EPA's understanding, the Agency is requesting public comment on the EPA's understanding that cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray contain TCE. The Agency is also requesting public comment if any of the listed uses that contain TCE are no longer available to consumers. EPA believes that other consumer products do not contain TCE, however, EPA is interested in information indicating that there are other ongoing uses of TCE in consumer products. In providing comments on an ongoing use of TCE in a consumer product, it would be helpful if you provide sufficient information for EPA to substantiate any assertions of use.
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
This proposed SNUR is not a “significant regulatory action” under the terms of the Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Order 12866 and 13563, entitled “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011).
This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601
A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new” and based on all information currently available to EPA, it appears
Therefore, EPA believes that the potential economic impact of complying with this proposed SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.
This action will not have a substantial direct effect on 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 Executive Order 13132 (64 FR 43255, August 10, 1999).
This proposed rule does not have Tribal implications because it is not expected to have any effect (
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this action is not intended to address environmental health or safety risks for children.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.
Since this action does not involve any technical standards, section 12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action.
This proposed rule does not invoke special consideration of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment.
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) Manufacture or processing for use in a consumer product except for use in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray.
(b) [Reserved]
Federal Communications Commission.
Petition for reconsideration.
A Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding by Harold Mordkofsky, on behalf of Halstad Telephone Company.
Oppositions to the Petition must be filed on or before August 24, 2015. Replies to an opposition must be filed on or before September 1, 2015.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Alexander Minard, Telecommunications Access Policy Division, Wireline Competition Bureau, (202) 418-7400, email:
This is a summary of Commission's document,
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden 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 the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by September 8, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice of meeting.
The Tuolumne and Mariposa Counties Resource Advisory Committee (RAC) will meet in Sonora, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held September 10, 2015, from 12:00 p.m. to 3:00 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the City of Sonora Fire Department, 201 South Shephard Street, Sonora, California.
Written comments may be submitted as described under
Beth Martinez, RAC Coordinator, by phone at 209-532-3671, extension 321; or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is:
1. To vote on project proposals; and
2. Make recommendations to the Forest Service from the Tuolumne and Mariposa Counties RAC.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by at least a week in advance to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Beth Martinez, RAC Coordinator, Stanislaus National Forest, 19777 Greenley Road, Sonora, California 95370; by email to
Forest Service, USDA.
Notice of meeting.
The Tuolumne and Mariposa Counties Resource Advisory Committee (RAC) will meet in Sonora, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held August 31, 2015, from 12:00 p.m. to 3:00 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the City of Sonora Fire Department, 201 South Shephard Street, Sonora, California.
Written comments may be submitted as described under
Beth Martinez, RAC Coordinator, by phone at 209-532-3671, extension 321; or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is for project proponents to make oral presentations about their projects.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by at least a week in advance to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Beth Martinez, RAC Coordinator, Stanislaus National Forest, 19777 Greenley Road, Sonora, California 95370; by email to
Rural Business—Cooperative Service, USDA.
Initial Notice; Correction.
This document corrects an error in the initial notice that appeared in the
This document is effective August 7, 2015.
Specialty Programs Division, Business Programs, Rural Business-Cooperative Service, United States Department of Agriculture, 1400 Independence Avenue SW., MS 3226, Room 4204-South, Washington, DC 20250-3226, telephone (202) 720-1400.
In FR Doc. 2015-18391 of July 28, 2015 (80 FR 44925), make the following corrections:
1. On page 44928, in the first column, at the fifty-first line, remove “September 28” and add “August 27” in its place.
Rural Utilities Service, USDA.
Notice of availability of a draft environmental impact statement.
The Rural Utilities Service (RUS), an agency within the U.S. Department of Agriculture (USDA), has issued a Draft Environmental Impact Statement (EIS) for Energy Answers Arecibo, LLC's (Energy Answers) proposed Waste to Energy Project (Project) in Arecibo, Puerto Rico. RUS is issuing the Draft EIS to inform interested parties and the general public about the proposed Project and to invite the public to comment on the scope, proposed action, and other issues addressed in the Draft EIS. The Draft EIS addresses the construction, operation, and maintenance of Energy Answers' proposed Project, a waste-to-energy generation and resource recovery facility in the Cambalache Ward of Arecibo, Puerto Rico. RUS prepared the EIS in accordance with the National Environmental Policy Act (NEPA), as amended, the Council on Environmental Quality's Regulation for Implementing the Procedural Provisions of the NEPA (40 CFR parts 1500-1508), and RUS's Environmental Policies and Procedures (7 CFR part 1794). RUS will hold a public hearing to receive oral comments on the Draft EIS.
The public comment period on the Draft EIS will be announced in the U.S. Environmental Protection Agency's (USEPA) EIS receipt notice, which will be published in the
The public hearing will be held at the Arecibo Country Club in Arecibo, Puerto Rico, 00612. Copies of the Draft EIS will be available for public viewing at the Arecibo Public Library (Nicolas Nabal Barreto), located at: 210 Santiago Iglesias Pantin Ave., Arecibo, Puerto Rico 00612. Parties wishing to be placed on the Project mailing list or those wishing to participate more directly with RUS as a “consulting party” in Section 106 review may submit a written request to: Ms. Lauren McGee Rayburn, Environmental Scientist, Rural Utilities Service, 84 Coxe Ave., Suite 1E, Ashville, North Carolina 28801,
For information on the proposed Project and the Draft EIS process, please contact Ms. Lauren McGee Rayburn, Environmental Scientist, Rural Utilities Service, 84 Coxe Ave., Suite 1E, Ashville, North Carolina 28801,
Energy Answers plans to request financial assistance for the proposed Project from RUS. Completing the EIS is one of RUS's requirements in processing Energy Answers' pending application, along with other technical and financial considerations. Energy Answers proposes to a construct a waste to energy generation and resource recovery facility in the Cambalache Ward of Arecibo, Puerto Rico. The proposed facility would process approximately 2100 tons of municipal waste per day and generate a net capacity of 77 megawatts (MW). The Puerto Rico Electric Power Authority will purchase power generated from the facility. The preferred location of the facility is the site of a former paper mill and would cover approximately 79.6 acres of the 90-acre parcel. The proposal would include the following facility components: A municipal solid waste receiving and processing building; processed refuse fuel storage building; boiler and steam turbine; emission control system; ash processing and storage building; and other associated infrastructure and buildings. Two other connected actions, which would be constructed by other utilities, include installation of an approximately 2.0-mile raw water line and construction of a 38 kilovolt (kV) transmission line approximately 0.8 miles in length. The connected actions will be addressed in the proposed Project's EIS.
In accordance with 7 CFR 1794.74 and 40 CFR 1502.21, RUS incorporates by reference the environmental impact analyses and associated documentation prepared by the Puerto Rico Industrial Development Company (PRIDCO) and the USEPA where appropriate. PRIDCO served as a lead agency in preparing an EIS under the Puerto Rico Environmental Public Policy Act, Article 4(B)(3), Law No. 416 (September 22, 2004). The USEPA completed air quality analyses and issued a Prevention of Significant Deterioration (PSD) permit for the proposed Project on June 11, 2013. As applicable, the EIS will document changes in the affected environment and environmental consequences that may have changed since issuance of the PRIDCO-EIS and USEPA PSD permit.
Because the proposed Project may involve action in floodplains or wetlands, this Notice also serves as a notice of proposed floodplain or wetland action. The draft EIS will include a floodplain/wetland assessment and, if required, a floodplain/wetland statement of findings will be issued with the Final EIS.
RUS has determined that its action regarding the proposed Project would be an undertaking subject to review under Section 106 of the National Historic Preservation Act, 16 U.S.C. 470 and its implementing regulations, “Protection of Historic Properties” (36 CFR part 800). As part of its broad environmental review process, RUS must take into account the effect of the proposed Project on historic properties in accordance with Section 106. Pursuant to 36 CFR 800.2(d)(3), RUS is using its procedures for public involvement under NEPA to meet its responsibilities to solicit and consider the views of the public during Section 106 review. Accordingly, comments submitted in response to this Notice will inform RUS decision-making in its Section 106 review process. Any party wishing to participate more directly with RUS as a “consulting party” in Section 106 review may submit a written request to the RUS contact provided in this Notice.
The Draft EIS is available in both Spanish and English for review at the following Web site:
Any final action by RUS related to the proposed Project will be subject to, and contingent upon, compliance with all relevant presidential executive orders and federal, state, and local environmental laws and regulations in addition to the completion of the environmental review requirements as prescribed in RUS's Environmental Policies and Procedures, 7 CFR part 1794, as amended.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Arizona Advisory Committee (Committee) to the Commission will be held on Tuesday, August 25, 2015. The purpose of the meeting is for the Committee to hear from police agencies and persons involved in the administration of justice regarding police community relations. The meeting will be held at the Native American Connections, 4520 N. Central Avenue, Phoenix, AZ 85012. It is scheduled to begin at 1:30 p.m. and adjourn at approximately 5:00 p.m.
Members of the public are entitled to make comments in the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by September 25, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Peter Minarik, Regional Director, Western Regional Office, at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Tuesday, August 25, 2015 from 1:30 p.m. to 5:00 p.m. PST.
Native American Connections, 4520 N. Central Avenue, Phoenix, AZ 85012.
Peter Minarik, DFO, at (213) 894-3437 or
United States Commission on Civil Rights.
Notice of Commission Business Meeting.
Lenore Ostrowsky, Acting Chief, Public Affairs Unit (202) 376-8591.
Hearing-impaired persons who will attend the briefing and require the services of a sign language interpreter should contact Pamela Dunston at (202) 376-8105 or at
This meeting is open to the public.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Arizona Advisory Committee (Committee) to the Commission will be held on Wednesday, August 26, 2015. The purpose of the meeting is for the Committee to receive opinion and
Members of the public are entitled to make comments in the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by September 30, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Peter Minarik, Regional Director, Western Regional Office, at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Wednesday, August 26, 2015 from 1:30 p.m. to 5:30 p.m. PST.
Cholla Public Library, 10050 Metro Parkway E., Phoenix, AZ 85051
Peter Minarik, DFO, at (213) 894-3437 or
U.S. Department of Commerce, National Oceanic and Atmospheric Administration.
Notice of Privacy Act system of records; “COMMERCE/NOAA-23; Economic Data Collection Program for West Coast Groundfish Trawl Catch Share Program off the coast of Washington, Oregon, and California.”
This notice announces the Department of Commerce (Department) proposal for a new system of records under the Privacy Act. NOAA's National Marine Fisheries Service (NMFS), Northwest Fisheries Science Center (NWFSC), is creating a system of records for the mandatory collection of economic data in the West Coast Region consisting of the Economic Data Collection (EDC) for West Coast Groundfish Trawl Catch Share Program. Information will be collected from individuals under the authority of the Magnuson-Stevens Fishery Conservation and Management Act and the American Fisheries Act. This record system is necessary to evaluate information on costs of fishing and processing, revenues for harvesters and processors, and employment information.
To be considered, written comments must be submitted on or before September 8, 2015. Unless comments are received, the system of records will become effective as proposed on the date of publication of a subsequent notice in the
Comments may be mailed to Erin Steiner, NOAA Fisheries, Northwest Fisheries Science Center, FRAM Division, 2725 Montlake Boulevard East, Seattle, WA 98112.
This notice announces the Department of Commerce (Department) proposal for a new system of records under the Privacy Act. NMFS' NWFSC is creating a system of records for the EDC for the West Coast Groundfish Trawl Catch Share Program. This record system is necessary to evaluate information on costs of fishing and processing, revenues for harvesters and processors, and employment information.
Under the EDC, information would be requested from individuals under the authority of the Magnuson-Stevens Fishery Conservation and Management Act and the 50 CFR 660.114. This collection would apply to all owners, lessees, and charterers of a catcher vessel registered to a limited entry trawl endorsed permit, a mothership vessel registered to a mothership permit, or a catcher-processor vessel registered to a catcher-processor-endorsed limited entry trawl permit; owners of a first receiver site license; and owners and lessees of a shorebased processor that received round or headed and gutted individual fishing quota groundfish species or whiting from a first receiver are required to submit an EDC to the NWFSC Economics and Social Science Research Program (ESSR).
The collection of information is necessary to identify participants and their roles in these fisheries and to evaluate the programs in which they participate. NMFS would collect information from individuals in order to evaluate the economic effects of fisheries programs, specifically the effects on the harvesting and processing sectors, and to determine the economic efficiency and distributional effects of the programs.
COMMENRCE/NOAA-23, Economic Data Collection (EDC) Program for West Coast Groundfish Trawl Catch Share Program off the coast of Washington, Oregon, and California.
Moderate.
The EDC system is designed as follows: (1) Participants are required to submit an annual EDC to the NMFS Northwest Fisheries Science Center (NWFSC) Economics and Social Science Research Program (ESSR); (2) Upon request, the NWFSC will provide the EDC information with individual identifiers to NOAA Office for Enforcement and the U.S. Coast Guard; and (3) Upon request, NWFSC ESSR will provide the EDC information with individual identifiers to the Department of Justice (DOJ) and Federal Trade Commission (FTC) to assist in anti-trust analysis of the Program.
NMFS Northwest Fisheries Science Center, 2725 Montlake Blvd. East, Seattle, WA 98112
System would include records for historical, annual, and current EDCs including financial information, harvest activity and cost, product and cost information, labor cost information for crew, and sales information. The EDCs request data on cost, revenue, ownership, and employment and will be used to study the economic impacts of the West Coast Trawl Groundfish Catch Share Program on affected harvesters, processors, and communities, as well as net benefits to the nation.
Each report would include the following: The name, title, telephone number, fax number, and email address of the person completing the EDC; name and address of the owner or lessee of the plant or vessel; Federal fisheries permit number; Federal processor permit number; Coast Guard vessel registration number or state vessel registration number, Federal license number, state buyer number, and an assigned internal individual identifier.
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
This information will allow NMFS to evaluate the economic effects of the West Coast Trawl Groundfish Catch Share Program, specifically the harvesting and processing sectors; the determination of the economic efficiency and distributional effects of the Program.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the PrivacyAct, these records or information contained therein may specifically be disclosed outside the Department of Commerce (Department). The records or information contained therein may specifically be disclosed as a routine use as stated below. The Department will, when so authorized, make the determination as to the relevancy of a record prior to its decision to disclose a document.
1. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature and whether arising by general statute or particular program statute or contract, rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records, may be referred to the appropriate agency, whether Federal, State, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, rule, regulation, or order issued pursuant thereto, or protecting the interest of the Department.
2. A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate, hearing officer or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations, administrative appeals and hearings.
3. A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
4. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether the Freedom of Information Act (5 U.S.C. 552) requires disclosure thereof.
5. A record in this system will be disclosed to the Department of Treasury for the purpose of reporting and recouping delinquent debts owed the United States pursuant to the Debt Collection Improvement Act of 1996.
6. A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
7. A record in this system of records may be disclosed to the applicable Fishery Management Council (Council) staff and contractors tasked with the development of analyses to support Council decisions about Fishery Management Programs.
8. A record in this system of records may be disclosed to appropriate agencies, entities and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or whether systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.
9. A record in this system of records may be disclosed to the Department of Justice and the Federal Trade Commission to assist in anti-trust analysis of the fisheries programs.
10. A record from this system of records may be disclosed, as a routine use, to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the
11. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.
12. A record in this system of records which contains medical information may be disclosed, as a routine use, to the medical advisor of any individual submitting a request for access to the record under the Act and 15 CFR part 4b if, in the sole judgment of the Department, disclosure could have an adverse effect upon the individual, under the provision of 5 U.S.C. 552a(f)(3) and implementing regulations at 15 CFR 4b.6.
13. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.
14. A record in this system may be transferred, as a routine use, to the Office of Personnel Management: for personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.
15. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (
Disclosure to consumer reporting agencies pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) and the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
Computerized data base; CDs; back-up files stored on tape; paper records in file folders in locked metal cabinets and/or locked rooms.
Records are organized and retrieved by NMFS internal identification number, name of owner or lessee, vessel permit number, buyer identification number, vessel name, or plant name. Records can be accessed by any file element or any combination thereof.
The system of records is stored in a building with doors that are locked during and after business hours. Visitors to the facility must register and must be accompanied by Federal personnel at all times. Only those that have the need to know, to carry out the official duties of their job, have access to the information. Paper records are maintained in secured file cabinets in areas that are accessible only to authorized personnel of the Data Collection Agent. Electronic records containing Privacy Act information are protected by a user identification/password. The user identification/password is issued to individuals by authorized personnel.
NMFS, Northwest Fisheries Science Center, contractors, to whom access to this information is granted in accordance with this system of records routine uses provision, are instructed on the confidential nature of this information.
All electronic information disseminated by NOAA adheres to the standards set out in Appendix III, Security of Automated Information Resources, OMB Circular A-130; the Computer Security Act (15 U.S.C. 278g-3 and 278g-4); and the Government Information Security Reform Act, Public Law 106-398; and follows NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems; NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems; and NIST SP 800-53, Recommended Security Controls for Federal Information Systems.
All records are retained and disposed of in accordance with National Archives and Records Administration regulations (36 CFR Subchapter XII, Chapter B—Records Management); Departmental directives and comprehensive records schedules; NOAA Administrative Order 205-01; and the NMFS Records Disposition Schedule, Chapter 1500.
Northwest Fisheries Science Center Economics Program Manager, NMFS Northwest Fisheries Science Center, 2725 Montlake Blvd. East, Seattle, WA 98112.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquires to the national Privacy Act Officer: Privacy Act Officer, NOAA, 1315 East-West Highway, Room 10641, Silver Spring MD 20910. Written requests must be signed by the requesting individual. Requestor must make the request in writing and provide his/her name, address, and date of the request and record sought. All such requests must comply with the inquiry provisions of the Department's Privacy Act rules which appear at 15 CFR part 4, subpart B, Appendix A.
Requests for access to records maintained in this system of records should be addressed to the same address given in the Notification Procedure section above.
The Department's rules for access, for contesting contents, and appealing initial determinations by the individual concerned are provided for in 15 CFR part 4, subpart B, Appendix A.
Information contained in this system will be collected from individuals participating in the EDC data collections.
None.
U.S. Department of Commerce, National Oceanic and Atmospheric Administration.
Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/NOAA-19, Permits and Registrations for United States Federally Regulated Fisheries.
This notice announces the Department of Commerce's (Department) proposal to amend the system of records entitled “COMMERCE/NOAA-19, Permits and Registrations for United States Federally Regulated Fisheries,” under the Privacy Act of 1974, as amended. The National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS) is revising its system of records for permits and non-permit registrations for use with a variety of fisheries management programs. Information will be collected from individuals under the authority of the Magnuson-Stevens Fishery Conservation and Management Act, the High Seas Fishing Compliance Act, the American Fisheries Act, the Tuna Conventions Act of 1950, the Atlantic Coastal Fisheries Cooperative Management Act, the Atlantic Tunas Convention Authorization Act, the Northern Pacific Halibut Act, the Antarctic Marine Living Resources Convention Act, the Western and Central Pacific Fisheries Convention Implementation Act, international fisheries regulations regarding U.S. Vessels Fishing in Colombian Treaty Waters, and the Marine Mammal Protection Act. This revised record system is necessary to identify participants in the fisheries and to evaluate the qualifications of the applicants. We invite public comment on the amended system announced in this publication.
To be considered, written comments must be submitted on or before September 8, 2015. Unless comments are received, the new system of records will become effective as proposed on the date of publication of a subsequent notice in the
Comments may be mailed to Sarah Brabson, NOAA Office of the Chief Information Officer, Room 9856, 1315 East-West Highway, Silver Spring, MD 20910.
Sarah Brabson, NOAA Office of the Chief Information Officer, Room 9856, 1315 East-West Highway, Silver Spring, MD 20910.
NMFS is revising its system of records for permit and non-permit registrations for use with a variety of fisheries management programs. NMFS requires the use of permits or registrations by participants in U.S. Federally regulated fisheries. Information collections would be requested from individuals under the authority of the Magnuson-Stevens Fishery Conservation and Management Act, the High Seas Fishing Compliance Act, the American Fisheries Act, the Atlantic Coastal Fisheries Cooperative Management Act, the Tuna Conventions Act of 1950, the Atlantic Tunas Convention Authorization Act, the Northern Pacific Halibut Act, the Antarctic Marine Living Resources Convention Act, the Western and Central Pacific Fisheries Convention Implementation Act, International Fisheries Regulations regarding U.S. Vessels Fishing in Colombian Treaty Waters, the Marine Mammal Protection Act, the Endangered Species Act and the Fur Seal Act. The collection of information is necessary to identify participants in these fisheries and to evaluate the qualifications of the applicants. NMFS would collect information from individuals in order to issue, renew, or transfer fishing permits, or to make non-permit registrations. NMFS may use lists of permit holders, or registrants as sample frames for the conduct of surveys to collect information necessary to the administration of the statutes cited above. The authority for the mandatory collection of the Tax Identification Number (Employer Identification Number or Social Security Number) is 31 U.S.C. 7701.
COMMERCE/NOAA-19, Permits and Registrations for United States Federally Regulated Fisheries.
None.
a. NMFS Greater Atlantic Region, 55 Great Republic Dr., Gloucester, MA 01930 (includes Atlantic Highly Migratory Species (HMS) Tuna Dealer permits).
b. NMFS Southeast Region, 263 13th Avenue South, St. Petersburg FL 33701 (includes HMS International Trade Permit, Shark and swordfish vessel permits, shark and swordfish dealer permits).
c. NMFS West Coast Region, Sustainable Fisheries Division, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
d. NMFS West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
e. NMFS Southwest Fisheries Science Center, 8604 La Jolla Shores Drive, La Jolla, CA 92037 (Pacific Highly Migratory Species database only).
f. NMFS Office of the Chief Information Officer, 1315 East-West Highway, Silver Spring, MD 20910 (National Permits System).
g. NMFS Pacific Islands Region, 1845 Wasp Boulevard, Building 176, Honolulu, HI 96818.
h. NMFS Alaska Region, 709 West Ninth Street, Juneau, AK 99801.
i. NMFS Office of Science and Technology, 1315 East-West Highway, Silver Spring, MD 20910 (National Saltwater Angler Registry).
j. NMFS Office of International Affairs, 1315 East-West Highway, Silver Spring, MD 20910 (High Seas Fishing Compliance Act and Antarctic Marine Living Resources harvesting and dealer permit data).
k. NMFS Office of Sustainable Fisheries, 3209 Frederic St., Pascagoula, MS 39567 (Antarctic Marine Living Resources preauthorization certification data).
l. NMFS Office of Sustainable Fisheries, 1315 East-West Highway, Room 13130, Silver Spring, MD 20910 (Atlantic HMS Tuna vessel permits, HMS Angling Permit, HMS Charter/headboat permits database).
Owners or holders of a permit or registration as recognized by NMFS, owner agents, vessel owners, and/or operators. Individuals, who apply for any permit, permit exception, permit exemption or regulation exemption, registration, dedicated access privilege or fishing quota share either initially, annually, or by transfer. Applicants seeking permission to fish in a manner that would otherwise be prohibited in order to conduct experimental fishing. Owners of processing facilities and/or fish dealers. Permit qualifiers (persons whose incomes are used for permit qualification). Allocation assignees under a Southeast Region individual fishing quota.
For transferable permits: Current permit number, permit status information, type of application, name and type of applicant, cellular telephone number and/or fax number, hair and eye color, height and weight, ID-sized photograph, medical records for resolution of permit dispute, enforcement actions, court and legal documents, and permit sanction notice files by NOAA General Counsel, checking account numbers, cancelled checks, tax returns, internal permit number specific to each limited entry permit, baseline specifications on limited entry permit, country, captain's license, State and Federal Dealer Numbers (if applicable), name of incorporation, state and date of incorporation of business and articles of incorporation, coast on which dealer does business, processing sector, facilities where fish received, vessel landing receipts and records, dealer purchase receipts, bills of sale, type of vessel registration, NMFS unique vessel ID, year vessel built, hailing port, hailing port state, principal port, principal state, vessel operations type (catching and/or processing: for at-sea processing permit), fish hold capacity, passenger capacity, VMS status, crew size, fishery type, fishery management plan and category, maximum days at sea, quota allocation and shares, regional fishery management organization, species or species code, type of gear, gear code and rank, buoy and trap/pot color, number of tags assigned to vessel, number of traps, and dredge size and number.
Fee payment information, applicant cellular telephone number and/or fax number, email address, Web site, gender, hair and eye color, height and weight, ID-sized photograph, corporation name, Dunn and Bradstreet Corporation Number, state and date of incorporation; for all entities with a business relationship (officer, owner or shareholder) to a wreckfish certificate holder, or with a business relationship (officer, owner or shareholder) to a vessel owner or vessel lessee, position held in the business, percent ownership of the business, and citizenship status; NMFS internal identification number, county, country, marriage certificate, divorce decree, death certificate, trust documents, probated will, enforcement actions, court and legal documents, and permit sanction notices files by General Counsel, name of vessel permit applicant if not owner, and relationship to owner, type of vessel ownership, captain's license, original permit, permit payment information, name of permit transferor and number of permit before transfer, permit and vessel sale price (for permit transfers), date of permit transfer signature, notarized, sale and lease agreement with lease start and end dates if applicable, income or license qualifier for certain fisheries, Income Qualification Affidavit for income qualified fisheries, U.S. importer number, State and Federal dealer numbers (if applicable), plant name and operator, hull identification number, hailing port and hailing port state, year vessel built, location where vessel built, vessel function, vessel characteristics (length, breadth, external markings, hull/or superstructure color), gross and net tonnage, type of construction, fuel capacity and type, horsepower (engine, pump), type of product storage, fish hold capacity, live well capacity, radio call sign, vessel communication types and numbers, crew size, passenger capacity, fishery type, quota shares, vessel landing receipts and records, bills of sale, processing facility where fish are received, gear type, species/gear endorsements, buoy/trap color code, number of traps, trap tag number series, trap dimensions, trap mesh size, designated fishing zone, aquaculture reports: site description, material deposited and harvested, value of material, Highly Migratory Species workshop certificate, informational telephone calls recorded with member of public's knowledge, (or customer service evaluation and constituent statement records); U.S. Citizenship or permanent resident alien status, facility name, address, telephone information (for dealer permits), and permit or license numbers for other Federal or state permit/licenses issued.
Current permit number, permit status information, type of application, name and type of applicant, business email address, cellular telephone and/or fax number, Web site, corporation name and state and date of incorporation, Dunn and Bradstreet Corporation Number, percent/rank of ownership interest, lease start/end date, income or license qualifier for certain fisheries, United States Coast Guard (USCG) Certificate of Documentation number or state vessel registration number, U.S. Importer Number (dealers), State and Federal Dealer Numbers (if applicable), processing facility where fish are received, name of vessel, type of vessel registration, hull identification number, vessel characteristics (length, breadth, external markings, hull/or superstructure color), gross and net tonnage, type of construction, fuel capacity and type, horsepower (engine, pump), type of product storage, passenger capacity; crew size, hailing port, hailing port state, principal port, principal port state, fish hold capacity, year vessel built, fishery type, species or species code, type of fishing gear, gear code; vessel monitoring system (VMS) activation certification, vessel name, and vessel function.
Northwest Permits: NMFS internal identification number, permit/license number, applicant or new permit/license owner name, (current and new) permit/license or vessel owner name, email address, name of authorized representative and title, permit action requested, midseason sablefish tier landed amount, application fee payment information (check/money order date, check/money order number, bank account number or credit card last 4 digits, check amount), copies of checks, divorce decree, marriage certificate, death certificate, probated will, trust documents, medical records of permit owners seeking exemption from certain permit requirements, proof of citizenship, enforcement actions and settlement agreements, power of attorney documents, affidavits, court and legal documents, articles of incorporation, state and date of incorporation, permit sanction notices, period of permit lease, permit sale/lease price, sales/lease agreement. vessel name and registration number, vessel length overall, location of where vessel built, documentation of loss or destruction of vessel, vessel registration documentation (USCG or state), names of entities/individuals having a share(s) in a corporate/business entity, percent of ownership interest in corporate/
Current permit number, permit status information, type of application, name of applicant and of other individuals on application (vessel owner(s), owner's agent, dealer, corporation members), and position in company if applicable, corporation name, state and date of incorporation, cellular telephone number and/or fax number, email address, photograph identification, verification of citizenship or nationality, owner of checking account from which application processing fees made, date and number of check, enforcement actions, court and legal documents, and permit sanction notices filed by General Counsel, name of permit transferor and transferee and number of permit before transfer, letters of authorization or power of attorney, compliance with protected species workshop, USCG Certificate of Documentation number or state vessel registration number, vessel name, permits registered to vessel, international radio call sign, year vessel built, location where vessel built, endorsements, vessel markings and photograph, vessel refrigeration and capacity, fish hold capacity, communication types and addresses, fishery type, percent of ownership interest, ownership and catch history as basis for permit qualification or renewal vessel landing receipts and records, dealer purchase receipts, and bills of sale.
Current permit number, permit status information, type of application, name of applicant and of other individuals on application (vessel owner(s), owner's agent, dealer, corporation members), and position in company if applicable, corporation name, state and date of incorporation and articles of incorporation (if applicable), cellular and/or fax telephone number, business email address, country, citizenship, NMFS internal identification number, USCG Certificate of Documentation number or state vessel registration number, vessel name, reference names, owner beneficiary, death certificate, marriage certificate, divorce decree, trust documents, probated will, medical information for emergency transfer of certain permits only, enforcement actions, court and legal documents, and permit sanction notices files by General Counsel, bank account number, canceled checks, tax returns, name of Alaska Native tribe, community of residence, fishery community organization, community governing body contact person, nonprofit name, community represented by nonprofit, cooperative representative, percent of ownership interest, permit restrictions, quota type, names of other quota holders if affiliated with any, cooperative member receiving quota against cap, names and relationship of permit transferor and transferee, transfer eligibility certificate, sector and region before transfer, reason for transfer, broker's name and fee, lien information (if applicable), quota transfer costs, permit financing source, permit fee, sale/lease agreement, period of lease, agreement to return shares (if applicable), and documentation of military service for certain quota leases; for crab rationalization: Affidavit that right of first refusal contracts were signed, number of units and pounds of fish transferred, applicable dealer license numbers, processing plant name and identification, operation type and operator, type of vessel registration, State of Alaska registration number, NMFS vessel identification number, hull identification number, hailing port and hailing port state, vessel breadth, gross tonnage, fuel capacity and horsepower, numbers of existing permits if applicable to current application, documentation of loss or destruction of a vessel, list of vessels in a vessel cooperative, vessel operations type in terms of catching and/or processing, species/gear endorsements for fisheries requiring vessel monitoring systems, fishery type, species or species code, fishery management plan, days at sea allocations, quota shares, type of fishing gear, gear code, vessel landing receipts and records, bills of sale, delivery receipts, dealer purchase receipts, and processing sector and facility where fish are received.
Name of applicant and of other individuals on application (vessel owner(s), vessel operator(s), owner's agent, dealer, corporation members), citizenship, cellular telephone and/or fax number, email, positions of individuals in company if applicable, corporation name, State and date of incorporation (if applicable), current permit number, permit status information, type of application, internal identification number, percent/rank of ownership interest, hull identification number, vessel photograph, type of vessel registration, USCG Certificate of Documentation number or state vessel registration number, vessel name, year vessel built, where vessel built, fish hold capacity,
Current permit number, permit status information, type of application, name of applicant and of other individuals on application (vessel owner(s), owner's agent, dealer, corporation members), and position in company if applicable, corporation name, state and date of incorporation and articles of incorporation (if applicable), nationality, cellular telephone and/or fax number, type of vessel (commercial fishing, charter), where vessel built, year vessel built, fish hold capacity, USCG Certificate of Documentation number or state vessel registration number, vessel name, International Maritime Organization number (if issued), vessel communication types and serial numbers, details of tamper-proof VMS elements, ice classification, processing equipment, international radio call sign, foreign vessel flag, previous vessel flag, previous vessel name, permit number of supporting foreign vessel, crew size, species code, type of fishing gear, information on the known and anticipated impacts of bottom trawling gear on vulnerable marine ecosystems, species and amount to be imported, and the products to be derived from an anticipated catch of krill.
Email address, business telephone number, designation as owner-operator or for-hire vessel, vessel name and registration/documentation number, and a statement of the region(s) in which the registrant fishes.
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
This information will allow NMFS to identify owners and holders of permits and non-permit registrations; identify vessel owners and operators; evaluate requests by applicants and current participants, or agency actions, related to the issuance, renewal, transfer, revocation, suspension or modification of a permit or registration.
1. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature and whether arising by general statute or particular program statute or contract, rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, State, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, rule, regulation, or order issued pursuant thereto, or protecting the interest of the Department.
2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate or administrative tribunal, including disclosures to opposing counsel representing the requester and/or subject of the records in the course of settlement negotiations.
3. A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
4. A record in this system of records may be disclosed, as a routine use, to the Department of Justice in connection with determining whether disclosure thereof is required by the Freedom of Information Act (5 U.S.C. 552).
5. A record in this system will be disclosed to the Department of Treasury for the purpose of reporting and recouping delinquent debts owed the United States pursuant to the Debt Collection Improvement Act of 1996.
6. A record in this system may be disclosed to the Department of Homeland Security for the purposes of determining the admissibility of certain seafood imports into the United States.
7. A record in this system of records may be disclosed, as a routine use, to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
8. A record in this system of records may be disclosed to approved persons at the state or interstate level within the applicable Marine Fisheries Commission for the purpose of co-managing a fishery or for making determinations about eligibility for permits when state data are all or part of the basis for the permits.
9. A record in this system of records may be disclosed to the applicable Fishery Management Council (Council) staff and contractors tasked with the development of analyses to support Council decisions about Fishery Management Programs.
10. A record in this system of records may be disclosed to the applicable NMFS Observer Program for purposes of identifying current permit owners and vessels and making a random assignment of observers to vessels in a given fishing season.
11. A record in this system of records may be disclosed to the applicable regional or international fisheries management body for the purposes of identifying current permit owners and vessels pursuant to applicable statutes or regulations and/or conservation and management measures adopted by a regional or international fisheries management body, such as: The Food and Agriculture Organization of the United Nations, Commission for the Conservation of Antarctic Marine Living Resources, Inter-American Tropical Tuna Commission, International Pacific Halibut Commission, and International Commission for the Conservation of Atlantic Tunas.
12. A record in this system of records may be disclosed to appropriate agencies, entities, and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identify theft or fraud, or harm to the security or integrity of this system or other systems
Disclosure to consumer reporting agencies pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) and the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
Computerized database; CDs; back-up files stored on tape, paper records stored in file folders in locked metal cabinets and/or locked rooms.
Records are organized and retrieved by NMFS internal identification number, name of entity, permit number, vessel name or identification number, or processing plant name. Records can be accessed by any file element or any combination thereof.
The system of records is stored in a building with doors that are locked during and after business hours. Visitors to the facility must register with security guards and must be accompanied by Federal personnel at all times. Records are stored in a locked room and/or a locked file cabinet. Electronic records containing Privacy Act information are protected by a user identification/password. The user identification/password is issued to individuals as authorized by authorized personnel.
All electronic information disseminated by NOAA adheres to the standards set out in Appendix III, Security of Automated Information Resources, OMB Circular A-130; the Computer Security Act (15 U.S.C. 278g-3 and 278g-4); and the Government Information Security Reform Act, Public Law 106-398; and follows NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems; NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems; and NIST SP 800-53, Recommended Security Controls for Federal Information Systems.
All records are retained and disposed of in accordance with National Archive and Records Administration regulations (36 CFR Chapter XII, Subchapter B—Records Management); Departmental directives and comprehensive records schedules; NOAA Administrative Order 205-01; and the NMFS Records Disposition Schedule, Chapter 1500.
For records at location a.: Division Chief, Fisheries Statistics Office, NMFS Greater Atlantic Region, NMFS Greater Atlantic Region, 55 Great Republic Dr., Gloucester, MA 01930.
For records at location b.: Assistant Regional Administrator for Operations, Management, and Information Services, NMFS Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701.
For records at location c.: Permit Team Leader, NMFS West Coast Region, Sustainable Fisheries Division, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
For records at location d.: Permits Specialist, NMFS West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
For records at location e.: Supervisory IT Specialist, NMFS Southwest Fisheries Science Center, 8604 La Jolla Shores Drive, La Jolla, CA 92037 (Pacific Highly Migratory Species database only).
For records at location f.: Supervisory IT Specialist, NMFS Office of the Chief Information Officer, 1315 East-West Highway, Silver Spring, MD 20910 (National Permits System).
For records at location g.: Information/Permit Specialist, Sustainable Fisheries Division, NMFS Pacific Islands Region, 1845 Wasp Boulevard, Building 176, Honolulu, HI 96818.
For records at location h.: Information/Permit Specialist, Sustainable Fisheries Division, NMFS Alaska Region, 709 West Ninth Street, Juneau, AK 99801.
For records at location i.: Chief, Fisheries Statistics Division, NMFS Office of Science and Technology, 1315 East-West Highway, Silver Spring, MD 20910 (National Saltwater Angler Registry).
For records at location j.: Fishery Management Specialist, Office of International Affairs, 1315 East-West Highway, Silver Spring, MD 20910 (High Seas Fishing Compliance Act and Antarctic Marine Living Resources harvesting and dealer permit data).
For records at location k.: Fishery Biologist, NMFS Office of Sustainable Fisheries, 3209 Frederic St., Pascagoula, MS 39567 (Antarctic Marine Living Resources preauthorization certification data).
For records at location l.: Division Chief, Highly Migratory Species Management (F/SF1), NMFS 1315 East-West Highway, Room 13458, Silver Spring, MD 20910 (Atlantic HMS Tuna vessel permits, HMS Angling Permit, HMS Charter/headboat permits database).
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the national or regional Privacy Act Officer:
Privacy Act Officer, NOAA, 1315 East-West Highway, Room 10641, Silver Spring, MD 20910.
Privacy Act Officer, NMFS Greater Atlantic Region, 55 Great Republic Dr., Gloucester, MA 01930.
Privacy Act Officer, NMFS Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701.
Privacy Act Officer, NMFS West Coast Region, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
Privacy Act Officer, NMFS West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
Privacy Act Officer, NMFS Pacific Islands Region, 1845 Wasp Boulevard, Building 176, Honolulu, HI 96818.
Privacy Act Officer, NMFS Alaska Region, P.O. Box 21668, Juneau, Alaska 99802, or delivered to the Federal Building, 709 West 9th Street, Juneau, Alaska 99801.
Written requests must be signed by the requesting individual. Requestor must make the request in writing and provide his/her name, address, and date of the request and record sought. All such requests must comply with the inquiry provisions of the Department's Privacy Act rules which appear at 15 CFR part 4, Appendix A.
Requests for access to records maintained in this system of records should be addressed to the same address given in the Notification section above.
The Department's rules for access, for contesting contents, and appealing initial determinations by the individual concerned are provided for in 15 CFR part 4, Appendix A.
Information in this system will be collected from individuals applying for a permit or registration or from an entity
None.
On March 30, 2015, Polaris Industries, Inc., operator of Subzone 167B, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility located in Osceola, Wisconsin.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce finds that revocation of the countervailing duty (CVD) order on carbazole violet pigment 23 (CVP-23) from India would be likely to lead to continuation or recurrence of a countervailable subsidy at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Effective Date: August 7, 2015.
Jacqueline Arrowsmith, Office VII, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-5255.
On December 29, 2004, the Department of Commerce (the Department) published the CVD order on CVP-23 from India.
The Department received an adequate substantive response from the domestic industry within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). The Department did not receive a response from the Government of India or any respondent interested party to the proceeding. As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(l)(ii)(B)(2) and (C)(2), the Department conducted an expedited review of this
The merchandise subject to this
The Issues and Decision Memorandum is a public document and is on file electronically
All issues raised in this review are addressed in the Issues and Decision Memorandum. The issues discussed include the likelihood of continuation or recurrence of a countervailable subsidy and the net countervailable subsidy rate likely to prevail if the
Pursuant to sections 752(b)(1) and (3) of the Act, we determine that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
The Department is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On May 7, 2015, the Department of Commerce (the Department) published the negative preliminary determination of circumvention of the antidumping duty order
Effective date: August 7, 2015.
Andrew Huston, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4261.
On July 29, 2014, the Department initiated an anti-circumvention inquiry of the antidumping duty order on PET film from the UAE, pursuant to section 781(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.225(h).
The products covered by the order are all gauges of raw, pre-treated, or primed polyethylene terephthalate film, whether extruded or co-extruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer more than 0.00001 inches thick. Also excluded is roller transport cleaning film which has at least one of its surfaces modified by application of 0.5 micrometers of SBR latex. Tracing and drafting film is also excluded. Polyethylene terephthalate film is classifiable under subheading 3920.62.00.90 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.
This anti-circumvention inquiry covers PET film produced in Bahrain by JBF Bahrain from inputs (PET chips and silica chips) manufactured in the UAE, and that is subsequently exported from Bahrain to the United States.
All issues raised in the comments by parties in this proceeding are addressed in the Issues and Decision Memorandum.
In the
This notice is the only reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to
This negative final circumvention determination is published in accordance with section 781(b) of the Act and 19 CFR 351.225.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) is conducting an administrative review of the antidumping duty order on xanthan gum from the People's Republic of China (“PRC”). The period of review (“POR”) is July 19, 2013, through June 30, 2014.
Effective date: August 7, 2015.
Brandon Farlander or Erin Kearney, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0182 or (202) 482-0167, respectively.
The scope of the order covers dry xanthan gum, whether or not coated or blended with other products. Further, xanthan gum is included in this order regardless of physical form, including, but not limited to, solutions, slurries, dry powders of any particle size, or unground fiber. Merchandise covered by the scope of this order is classified in the Harmonized Tariff Schedule of the United States at subheading 3913.90.20. This tariff classification is provided for convenience and customs purposes; however, the written description of the scope is dispositive.
Based on an analysis of U.S. Customs and Border Protection (“CBP”) information, and questionnaire responses provided by A.H.A. International Co., Ltd. (“AHA”) and Deosen, the Department preliminarily determines that AHA did not have any reviewable transactions during the POR. For additional information regarding this determination,
Consistent with an announced refinement to its assessment practice in non-market economy (“NME”) cases, the Department is not rescinding this review for AHA, but intends to complete the review and issue appropriate instructions to CBP based on the final results of the review.
Based on record evidence, the Department preliminarily finds that Deosen Biochemical Ltd. and Deosen Biochemical (Ordos) Ltd. are affiliated pursuant to section 771(33)(G) of the Tariff Act of 1930, as amended (the “Act”) and should be treated as a single entity for AD purposes pursuant to 19 CFR 351.401(f). Furthermore, based on record evidence, the Department preliminarily finds that Neimenggu Fufeng Biotechnologies Co., Ltd. (aka Inner Mongolia Fufeng Biotechnologies Co., Ltd.), Shandong Fufeng Fermentation Co. Ltd., and Xinjiang Fufeng Biotechnologies Co., Ltd. are affiliated pursuant to section 771(33)(F) of the Act and should be treated as a single entity for AD purposes pursuant to 19 CFR 351.401(f). For additional information,
The Department preliminarily determines that information placed on the record by the mandatory respondents Deosen and Fufeng, as well as by the separate rate applicants CP Kelco (Shandong) Biological Company Limited and Shanghai Smart Chemicals Co. Ltd., demonstrates that these companies are entitled to separate rate status. Hebei Xinhe Biochemical Co. Ltd., which did not claim that it made no shipments of subject merchandise during the POR, failed to submit a separate rate application or separate rate certification. Therefore, this company is not eligible for separate rate status.
The Department's change in policy regarding conditional review of the PRC-wide entity applies to this administrative review.
The statute and the Department's regulations do not address the establishment of a rate to be applied to respondents not selected for individual examination when the Department limits its examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, the Department looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero,
The Department is conducting this review in accordance with section 751(a)(1)(B) of the Act. The Department calculated export prices and constructed export prices in accordance with section 772 of the Act. Given that the PRC is a NME country, within the meaning of section 771(18) of the Act, the Department calculated NV in accordance with section 773(c) of the Act.
For a full description of the methodology underlying the preliminary results of this review,
The Department preliminarily determines that the following weighted-average dumping margins exist for the POR:
The Department intends to disclose to parties the calculations performed for these preliminary results of review not later than ten days after the date of the public announcement of, or, if there is no public announcement, within five days after the date of publication of, the preliminary results of review in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice.
All submissions, with limited exceptions, must be filed electronically using ACCESS.
Unless otherwise extended, the Department intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.
Upon issuance of the final results of this review, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
On October 24, 2011, the Department announced a refinement to its assessment practice in NME antidumping duty cases.
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.
The Department will instruct CBP to require a cash deposit equal to the weighted-average amount by which the normal value exceeds U.S. price. The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is zero or
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On April 1, 2015, the Department of Commerce (“the Department”) initiated a sunset review of the antidumping duty order on chloropicrin from the People's Republic of China (“PRC”)
Howard Smith, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5193.
On April 1, 2015, the Department initiated a sunset review of the order on chloropicrin from the PRC pursuant to section 751(c) of the Act.
The merchandise subject to the antidumping duty order is chloropicrin, also known as trichloronitromethane. A major use of the product is as a pre-plant soil fumigant (pesticide). Such merchandise is currently classifiable under Harmonized Tariff Schedule (“HTS”) item number 2904.90.50.05.
All issues raised in this sunset review are addressed in the “Issues and Decision Memorandum for the Expedited Sunset Review of the Antidumping Duty Order on Chloropicrin from the People's Republic of China” from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, dated concurrently with, and hereby adopted by, this notice (“Decision Memorandum”). The issues discussed in the Decision Memorandum include the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the
Pursuant to Section 752(c)(3) of the Act, the Department determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (“APO”') of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
In response to requests from interested parties, the Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on certain pasta (pasta) from Italy,
Joy Zhang or George McMahon, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1168 or (202) 482-1167, respectively.
Imports covered by the order are shipments of certain non-egg dry pasta. The merchandise subject to review is currently classifiable under items 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.
On October 10, 2014, and November 25, 2014, respectively, Dalla Costa Alimentare srl (Dalla Costa) and Pasta Lensi S.r.l. (Pasta Lensi) timely withdrew their requests for an administrative review.
The Department conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Constructed export price or export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our preliminary results,
As a result of this review, we preliminarily determine the following weighted-average dumping margins
Upon issuance of the final results, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. If the weighted-average dumping margin for La Molisana or the Rummo Group is not zero or
In accordance with the Department's “automatic assessment” practice, for entries of subject merchandise during the POR produced by each respondent for which they did not know that their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. For a full discussion of this clarification,
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 15.45 percent, the all-others rate established in the antidumping investigation as modified by the section 129 determination.
The Department will disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of these preliminary results.
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system within 30 days of publication of this notice.
Unless the deadline is extended pursuant to section 751(a)(2)(B)(iv) of the Act, the Department will issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their case briefs, within 120 days after issuance of these preliminary results.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and increase the subsequent assessment of the antidumping duties by the amount of antidumping duties reimbursed.
These preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On May 29, 2015, the Department of Commerce (the Department) received a timely request for a new shipper review (NSR) from
Mary Kolberg, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; Telephone: (202) 482-1785.
The antidumping duty order on cased pencils from the PRC published in the
Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Wah Yuen certified that it did not export subject merchandise to the United States during the period of investigation (POI).
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2), Wah Yuen submitted documentation establishing the following: (1) The date on which it first shipped subject merchandise for export to the United States; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.
In accordance with 19 CFR 351.214(g)(1)(B), the period of review (POR) for new shipper reviews initiated in the month immediately following the semiannual anniversary month will be the six-month period immediately preceding the semiannual anniversary month. Therefore, based on the
Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(d)(1), the Department finds that the request from Wah Yuen meets threshold requirements for the initiation of a new shipper review of shipments of cased pencils from the PRC produced and exported by Wah Yuen.
The Department intends to issue the preliminary results of this new shipper review no later than 180 days from the date of initiation and the final results of the review no later than 90 days after the date the preliminary results are issued.
We will instruct CBP to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for the entry of the subject merchandise from Wah Yuen, in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Specifically, the bonding privilege will apply only to entries of subject merchandise exported and produced by Wah Yuen, the sales of which are the basis for this NSR request.
Interested parties requiring access to proprietary information in the new shipper review should submit applications for disclosure under administrative protective order, in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Caribbean Fishery Management Council's (Council) Outreach and Education Advisory Panel (OEAP) will meet.
The meeting will be held on August 25, 2015, from 9 a.m. to 5 p.m.
The meeting will be held at CFMC Office, 270 Munoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918.
Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918, telephone: (787) 766-5926.
The OEAP will meet to discuss the items contained in the following agenda:
The OEAP meeting will convene on August 25, 2015, from 9 a.m. until 5 p.m.
The meeting is open to the public, and will be conducted in English. Fishers and other interested persons are invited to attend and participate with oral or written statements regarding agenda issues.
This meeting is physically accessible to people with disabilities. For more information or request for sign language interpretation and/other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918, telephone (787) 766-5926, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Peter Tyack, Ph.D., Senior Scientist Emeritus, Woods Hole Oceanographic Institution, 86 Water Street, Woods Hole, Massachusetts 02543, has applied in due form for a permit to conduct research on several species of cetaceans worldwide.
Written, telefaxed, or email comments must be received on or before September 8, 2015.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Courtney Smith or Amy Sloan, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a permit to take multiple cetacean species during research activities focused on cetacean behavior, sound production and responses to sound in U.S. waters of the North Atlantic and North Pacific Ocean and international waters near the Mediterranean Sea and the Bahamas. See tables in the permit application for annual numbers of takes by species, stock and activity. Researchers would take animals by harassment during close approaches with vessels for behavioral observations and photo-identification; attachment of suction-cup or implantable tags and marking with zinc oxide; biopsy sampling; and playbacks of natural and simulated sound. Playback takes involve conducting sound playback experiments where subjects whose responses are being measured will be exposed to specific sounds in a carefully controlled manner using a source level <197.4 dB re 1 microPa at 1 m. Incidental harassment of other species in the area may occur during playbacks and vessel surveys. Skin samples would be imported from foreign field sites to the United States for genetic analyses. The requested permit would be valid for five years from issuance.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA).
Notice; request for public comments.
In accordance with a requirement of Public Law 106-513 (16 U.S.C. 1441(b)), NOAA hereby gives public notice of the methods, formulas and rationale for the calculations it will use in order to assess fees associated with special use permits (SUPs).
Comments must be received on or before October 6, 2015.
You may submit comments on this document, identified by NOAA-NOS-2015-0066, by any of the following methods:
•
•
Matt Nichols, Office of National Marine Sanctuaries, 1305 East West Highway (N/NMS2), Silver Spring, MD 20910, telephone (301) 713-7262, email
This
Congress first granted NOAA the authority to issue SUPs for conducting specific activities in national marine sanctuaries in the 1988 Amendments to the National Marine Sanctuaries Act (“NMSA”) (16 U.S.C. 1431
(d) Fees—
(1) Assessment and Collection—The Secretary may assess and collect fees for the conduct of any activity under a permit issued under this section.
(2) Amount—The amount of the fee under this subsection shall be the equal to the sum of—
(A) Costs incurred, or expected to be incurred, by the Secretary in issuing the permit;
(B) Costs incurred, or expected to be incurred, by the Secretary as a direct result of the conduct of the activity for which the permit is issued, including costs of monitoring the conduct of the activity; and
(C) An amount which represents the fair market value of the use of the sanctuary resource.
(3) Use of Fees—Amounts collected by the Secretary in the form of fees under this section may be used by the Secretary—
(A) For issuing and administering permits under this section; and
(B) For expenses of managing national marine sanctuaries.
(4) Waiver or Reduction of Fees—The Secretary may accept in-kind contributions in lieu of a fee under paragraph (2)(C), or waive or reduce any fee assessed under this subsection for any activity that does not derive profit from the access to or use of sanctuary resources.
The purpose of this notice is to propose standard procedures for assessing fee components associated with the application for and issuance of an SUP. SUPs are generally a small portion of the total number of permits issued by ONMS. However, with the addition of new SUP categories in 2013 and the current and potential expansion of the National Marine Sanctuary System, ONMS may see a rise in the number of applications submitted annually as well as an increase in the complexity of the proposed projects. Due to this, NOAA is asking for public comment on a set of proposed standard procedures for assessing SUP fees.
When an SUP is applied for by an interested party, and ultimately issued by ONMS, the total fee assessed to the applicant will be the sum of the three categories of fees provided for in section 310(d)(2) of the NMSA: administrative costs, implementation and monitoring costs, and fair market value.
NOAA proposes to assess a non-refundable $50 application fee for each SUP application submitted. Administrative costs spent reviewing the permit for sufficiency and suitability would be calculated by multiplying a regional labor rate, derived from the pay rates of ONMS permitting staff and averaged across ONMS regions, by the time spent by staff reviewing each permit application. NOAA will update the rate every year to account for staff changes as well as inflation. Such administrative costs could also include, but are not necessarily limited to, any environmental analyses and consultations associated with evaluating the permit application and issuing the permit; and equipment used in permit review and issuance (
NOAA may also charge a fee for costs associated with the implementation and monitoring of a permitted activity. Such costs would include staff time (calculated similarly to the labor rate described above), equipment use (including vessels or aircraft to oversee permit implementation), the expenses of monitoring the impacts of a permitted activity, and compliance with the terms and conditions of the permit.
To date, NOAA ONMS has assessed fair market value (FMV) fees assessed for an SUP on a case-by-case basis. The
1. The placement and recovery of objects associated with public or private events on non-living substrate of the submerged lands of any national marine sanctuary. The FMV for this activity would be $200 per event, based on fee values historically applied at national marine sanctuaries for this activity.
2. The placement and recovery of objects related to commercial filming. With this notice, NOAA would adopt the fee structure below from the National Park Service (NPS), which shares a similar mandate with ONMS to protect natural spaces of national importance. ONMS has determined NPS's broad evaluation methods to be sound and within the intent of ONMS SUPs for commercial filming.
The number of people refers to the cast and/or crew on location within the sanctuary for the commercial filming event, including pre- and post-production.
3. The continued presence of commercial submarine cables on or within the submerged lands of any national marine sanctuary. NOAA assesses FMV for submarine cables in national marine sanctuaries based on the findings of its 2002 study entitled “Fair Market Value Analysis for a Fiber Optic Cable Permit in National Marine Sanctuaries”(67 FR 55201). FMV for cables is assessed annually and adjusted according to the consumer price index. NOAA would continue using this methodology for assessing FMV fees for the continued presence of commercial submarine cables.
4. The disposal of cremated human remains (“cremains”)within or into any national marine sanctuary. NOAA would waive all fees, including the FMV fee, for private individuals disposing of cremains, but NOAA would assess a $50 per disposal FMV fee for commercial operators. This value is based on similar practices of state governments, such as the State of Washington, which assesses a $70 flat fee for a Cremated Human Remains Disposition Permit for disposal of cremains by airplane, boat, or other disposal methods for businesses.
5. Recreational diving near the USS
6. Fireworks displays. The FMV for fireworks would be a tiered structure based on the number of fireworks events conducted per calendar year. The fee schedule would be as follows: 1 event per calendar year—$100; 2-5 events per calendar year—$300; 6-10 events per calendar year—$500; 11-20 events per calendar year—$700.
7. The operation of aircraft below the minimum altitude in restricted zones of national marine sanctuaries. The FMV would be $500 per site/per day. This is an existing value that has been applied historically at national marine sanctuaries for this activity.
NOAA may accept in-kind contributions in lieu of a fee, or waive or reduce any fee assessed for any activity that does not derive profit from the access to or use of sanctuary resources. NOAA may consider the benefits of the activity to support the goals and objectives of the sanctuary as an in-kind contribution in lieu of a fee.
NOAA is requesting comments on the proposed methods for assessment of SUP fees.
NOAA has concluded that this action will not have a significant effect, individually or cumulatively, on the human environment. This action is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement in accordance with Section 6.03c3(i) of NOAA Administrative Order 216-6. Specifically, this action is a notice of an administrative and legal nature. Furthermore, individual permit actions by NOAA will be subject to additional case-by-case analysis, as required under NEPA, which will be completed as new permit applications are submitted for specific projects and activities.
NOAA also expects that many of these individual actions will also meet the criteria of one or more of the categorical exclusions described in NOAA Administrative Order 216-6 because SUPs cannot be issued for activities that are expected to result in any destruction of, injury to, or loss of any sanctuary resource. However, the SUP authority may at times be used to allow activities that may meet the Council on Environmental Quality's definition of the term “significant” despite the lack of apparent environmental impacts. In addition, NOAA may, in certain circumstances, combine its SUP authority with other regulatory authorities to allow activities not described above that may result in environmental impacts and thus require the preparation of an environmental assessment or environmental impact statement. In these situations NOAA will ensure that the appropriate NEPA documentation is prepared prior to taking final action on a permit or making any irretrievable or irreversible commitment of agency resources.
Notwithstanding any other provisions of the 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 (PRA), 44 U.S.C. 3501
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that to Michael Adkesson, D.V.M., Chicago Zoological Society, 3300 Golf Rd., Brookfield, IL 60527 has been issued a minor amendment to Scientific Research Permit No. 15471-01.
The amendment and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Jennifer Skidmore, (301) 427-8401.
The requested permit amendment has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
The original permit (No. 15741), issued on August 23, 2010 (75 FR 52721), and subsequent amendment (No. 15741-01; 76 FR 60808) authorizes the importation of biological samples from South American fur seals (
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Effective date September 7, 2015.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 6/12/2015 (80 FR 33485-33489) and 6/26/2015 (80 FR 36773-36774), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to furnish the products and service and impact of the additions on the current or most recent contractors, the Committee has determined that the products and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. The action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service proposed for addition to the Procurement List.
Accordingly, the following products and service are added to the Procurement List:
Committee for Purchase from People Who Are Blind or Severely Disabled.
Proposed Deletion from the Procurement List.
The Committee is proposing to delete a service from the Procurement List previously provided by the nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed action.
The following service is proposed for deletion from the Procurement List:
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before October 6, 2015.
You may submit comments, identified by “FBOT Registration” or PRA collection 3038-0101 by any of the following methods:
• The Agency's Web site, at
•
•
•
Please submit your comments using only one method.
Duane C. Andresen, Associate Director, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5492; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before October 6, 2015.
You may submit comments, identified by “Rule 50.50 End-User Notification of Non-Cleared Swaps,” by any of the following methods:
• The Agency's Web site, at
•
•
•
Please submit your comments using only one method.
Peter A. Kals, Division of Clearing and Risk, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581, (202) 418-5466; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the collection of information, the Commission invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before October 6, 2015.
You may submit comments, identified by “Renewal of Collection Pertaining to Swap Data Recordkeeping and Reporting Requirements,” or Renewal 3038-0096, by any of the following methods:
• The Agency's Web site, at
• Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.
• Hand Delivery/Courier: Same as Mail above.
• Federal eRulemaking Portal:
Please submit your comments using only one method.
Thomas Guerin, Division of Market Oversight, Commodity Futures Trading Commission, 1155 21st Street NW., (202) 734-4194; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
44 U.S.C. 3501
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA), Federal agencies are required to publish notice in the
Comments must be submitted on or before October 6, 2015.
You may submit comments, identified by “Conflict of Interest Policies and Procedures by Swap Dealers and Major Swap Participants,” and Collection Number 3038-0079 by any of the following methods:
• The Agency's Web site, at
• Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.
• Hand Delivery/Courier: Same as Mail above.
• Federal eRulemaking Portal:
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Jacob Chachkin, Special Counsel, Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, (202) 418-5496; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
44 U.S.C. 3501
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before September 8, 2015.
Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (“OIRA”) in OMB, within 30 days of the notice's publication, by email at
Comments may also be mailed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581 or by Hand Deliver/Courier at the same address.
A copy of the supporting statements for the collection of information discussed above may be obtained by visiting
Christopher Hower, Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-6703; email:
Pursuant to these provisions, the Commission adopted § 1.71(d)(1) relating to FCMs and § 23.605(d)(1) relating to swap dealers and major swap participants. These regulations prohibit swap dealers and major swap participants from interfering or attempting to influence the decisions of affiliated FCMs with regard to the provision of clearing services and activities and prohibit FCMs from permitting them to do so. The Commission also adopted § 23.607 to prohibit swap dealers and major swap participants from adopting any process or taking any action that results in any unreasonable restraint on trade or imposes any material anticompetitive burden on trading or clearing, unless necessary or appropriate to achieve the purposes of the Act. The Commission adopted § 39.12(b)(2) requiring that derivatives clearing organization rules provide for the non-discriminatory clearing of swaps executed bilaterally or through an unaffiliated designated contract market or swap execution facility.
As discussed further below, the additional information collection burden arising from the proposed regulations primarily is restricted to the costs associated with the affected registrants' obligation to maintain records related to clearing documentation between the customer and the customer's clearing member.
The information collection obligations imposed by the regulations are necessary to implement certain provisions of the CEA, including ensuring that registrants exercise effective risk management and for the
44 U.S.C. 3501
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled AmeriCorps Child Care Program Information Collection for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Jennifer Veazey, at 202-606-6770 or email to
Comments may be submitted, identified by the title of the information collection activity, within September 8, 2015.
Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in the
(1) By fax to: 202-395-6974, Attention: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service; or
(2) By email to:
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, 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;
• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and
• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
A 60-day Notice requesting public comment was published in the
The information collection is requested of AmeriCorps Members who are applying for the AmeriCorps Child Care benefit (or in some cases, member of their households); information collected is used to determine a member's eligibility based upon statutory, regulatory, and program eligibility requirements. In addition, the information collection is requested of the child care providers to determine a child care provider's eligibility to provide the child care service.
Information is collected via hardcopy and electronically through an online application system.
CNCS seeks to renew the current AmeriCorps Child Care Application and add four new instruments: the AmeriCorps Member Application, Attendance Sheet, Member Update Form, and Statement of Work Activities.
The information collection will otherwise be used in the same manner as the existing application.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by September 8, 2015.
Fred Licari, 571-372-0493.
Written comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Department of Education.
Correction Notice.
On August 4, 2015 the U.S. Department of Education published a 30-day comment period notice in the
The Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management, hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.
Federal Student Aid (FSA), 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 October 6, 2015.
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 Beth Grebeldinger, 202-377-4018.
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
Department of Education (ED), Institute of Education Sciences (IES).
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 September 8, 2015.
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 Christopher Boccanfuso, 202-219-1674.
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.
This is a supplemental notice in the above-referenced proceeding of Nittany Energy, 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
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 August 24, 2015.
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 the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following land acquisition reports:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, and protests: September 1, 2015.
All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
k. Description of Request: Article 409 requires Malacha Hydro Limited Partnership and Juniper Ridge Ranches, Inc. (licensees) to upgrade existing access to adjacent public lands managed by the U.S. Bureau of Land Management (BLM), including the construction of trail-head parking facilities, within five years from license issuance. The project license was issued on December 2, 1986. Since license issuance, the licensees have been unable to fulfill this license condition due to an on-going land exchange matter between the BLM and a private landowner, whose land is necessary to provide access to the trailhead parking facilities. The BLM land to be exchanged for the landowner's property is located within the Pit River Canyon Wilderness Study Area. The BLM cannot implement the land exchange until Congress acts to either designate these lands as wilderness or release the lands. Until Congress acts, BLM cannot complete the land exchange and the licensees cannot construct the required trailhead facilities. For these reasons, the licensees request a stay of five years for article 409 to allow Congress additional time to act on the Pit River Canyon Wilderness Study Area.
l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at
You may also register online at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents: All filings must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or
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 San Elizario Crossing Project involving construction and operation of specific border crossing facilities for the export of natural gas by Comanche Trail Pipeline, LLC (Comanche Trail) in El Paso County, Texas. The Commission will use this EA in its decision-making process to determine whether the project is in the public interest.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. 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. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before September 2, 2015.
If you sent comments on this project to the Commission before the opening of this docket on May 29, 2015, you will need to file those comments in Docket No. CP15-503-000 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 proposed project and encourage them to comment on their areas of concern.
Comanche Trail provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?”. This fact sheet addresses a number of typically-asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also 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 (CP15-503-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Comanche Trail proposes to construct and operate a new border crossing at the international boundary between the United States and Mexico in El Paso County, Texas. The San Elizario Crossing Project would consist of the construction of approximately 1,086 feet of FERC-jurisdictional 42-inch-diameter pipeline, installed using a horizontal directional drill (HDD) beneath the Rio Grande River near the City of San Elizario in El Paso, Texas. The new pipeline would have a maximum design export capacity of approximately 1.1 billion cubic feet per day, in order to transport natural gas to a new delivery interconnect in the vicinity of the City of San Isidro, in the State of Chihuahua, Mexico.
The general location of the project facilities is shown in appendix 1.
The San Elizario Crossing Project has associated facilities that would be constructed in support of the project, but do not fall under the jurisdiction of the FERC. The proposed Comanche Trail intrastate pipeline facilities, consist of 196 miles of new 42-inch-diameter pipeline, multiple receipt and delivery metering stations, and other auxiliary facilities extending from Pecos County, Texas and terminating at the proposed FERC-jurisdictional project facilities in El Paso County. The intrastate facilities would be subject to the jurisdiction of the Texas Railroad Commission and would be non-jurisdictional to the FERC. In the EA, we will provide available descriptions of the non-jurisdictional facilities and include available environmental impact information under our analysis of cumulative impacts.
Construction of the San Elizario Crossing Project pipeline would affect a total of 4.2 acres of land in the United States, which includes temporary workspace for HDD construction, hydrostatic testing of the pipeline, and project access. Following construction, Comanche Trail would retain 1.3 acres as a 50-foot-wide permanent easement for operation of the FERC-jurisdictional pipeline, and the remaining acreage would be restored and revert to former uses.
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 an Authorization. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• land use;
• water resources, fisheries, and wetlands;
• cultural resources;
• vegetation and wildlife;
• air quality and noise;
• endangered and threatened species;
• public safety; and
• cumulative impacts.
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. We will also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making 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 of 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 Office (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.
The environmental mailing list includes: Federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; 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 proposed project.
When 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).
In addition to involvement in the EA scoping process, 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. Instructions for becoming an intervenor are available on the Commission's Web site 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 at
In addition, the Commission now 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
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Farm Credit Administration.
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).
The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on August 13, 2015, from 9:00 a.m. until such time as the Board concludes its business.
Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.
Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to
Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to
• July 8, 2015
• Mergers, Consolidations and Charter Amendments of Banks and Associations—Final Rule
• Office of Secondary Market Oversight Quarterly Report
* Session Closed-Exempt pursuant to 5 U.S.C. Section 552b(c)(8) and (9).
Federal Communications Commission.
Notice.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (“FCC” or “Commission”) Downloadable Security Technology Advisory Committee (“DSTAC”) will hold a meeting on August 28, 2015. At the meeting, the committee will consider and debate a final DSTAC report and discuss any other DSTAC issues that may arise.
August 28, 2015.
Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.
For additional information on this proceeding, contact Brendan Murray,
This meeting will be held on August 28, 2015, from 9:30 a.m. to 4:00 p.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street SW., Washington, DC 20554.
The DSTAC is a Federal Advisory Committee that will “identify, report, and recommend performance objectives, technical capabilities, and technical standards of a not unduly burdensome, uniform, and technology- and platform-neutral software-based downloadable security system.”
The meeting on August 28, 2015, will be the seventh meeting of the DSTAC. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the
Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to
Federal Election Commission.
Tuesday, August 11, 2015 at the conclusion of the open meeting, and Thursday, August 13, 2015 at 10:00 a.m.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Internal personnel rules and internal rules and practices.
Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Federal Election Commission
Tuesday, August 11, 2015 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 Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Signed:
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 24, 2015.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528:
1.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces 15 membership appointments to the Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the first meeting date for the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on issues related to clinical diagnostic laboratory tests. The membership appointments are for 3 years. This notice also announces the first meeting date of the Panel on Wednesday, August 26, 2015.
The public may attend the meeting in-person, view via webcast, or listen via teleconference. Beginning Friday, August 7, 2015 and ending Friday, August 14, 2015 at 5:00 p.m. EDT, registration to attend the meeting in-person may be completed online at
• Name.
• Company name.
• Postal address.
• Email address.
Participants who do not plan to attend the meeting in-person on August 26, 2015, should not register. No registration is required for participants who plan to view the meeting via webcast or listen via teleconference.
We are interested in submitted comments or in presentations at the meeting concerning the issues described in the
For reconsidered and new test codes, presenters should address all of the following items:
• Reconsidered or new test code(s) and descriptor.
• Test purpose and method.
• Costs.
• Charges.
• A recommendation with rationale for one of the two methods (crosswalking or gapfilling) for determining payment for new tests, or a recommendation with rationale for changing the basis or payment amount, as applicable, for reconsidered tests.
Additionally, the presenters should provide the data on which their recommendations are based.
When registering, individuals who want to make a presentation must also specify for which new test codes they will be presenting comments. A confirmation will be sent upon receipt of the registration. Presenters must register by the date specified in the “Meeting Registration” section of this notice.
The meetings will be held in the Auditorium, CMS Central Office, 7500 Security Boulevard, Woodlawn, Maryland 21244-1850. Alternately, the public may either view the meetings via a webcast or listen by teleconference. During the scheduled meeting, webcasting is accessible online at
This meeting is open to the public. The onsite check-in for visitors will be held from 8:30 a.m. to 9:00 a.m. EDT on Wednesday, August 26, 2015, followed by opening remarks. Following the opening remarks, the Panel will hear oral presentations from the public for no more than 1 hour during two sessions. During the first session, registered persons from the public may present recommendations for crosswalks for new laboratory codes for the CY 2016 CLFS. During the second session, registered persons from the public may present recommendations for drugs of abuse testing and crosswalks. Time allotted for each presentation may be limited. If the number of registrants requesting to present is greater than can be reasonably accommodated during the scheduled open public hearing session, we may conduct a lottery to determine the speakers for the scheduled open public hearing session. We will accept written presentations from those who were unable to present due to time constraints.
Glenn C. McGuirk, Designated Federal Official (DFO), Center for Medicare, Division of Ambulatory Services, CMS, 7500 Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, 410-786-5723, email
The Advisory Panel on Clinical Diagnostic Laboratory Tests is
Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (Secretary) to consult with an expert outside advisory panel, established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. Such individuals may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics.
The Panel will provide input and recommendations to the Secretary and the Administrator, Centers for Medicare & Medicaid Services (CMS), on the following:
• The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test;
• The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and
• Other aspects of the new payment system under section 1834A of the Act.
The Panel charter provides that panel meetings will be held up to four times annually. The Panel will consist of up to 15 individuals and a Chair. The Panel Chair will facilitate meetings and the DFO or DFO's designee must be present at all meetings. Meetings will be open to the public except as determined otherwise by the Secretary or other official to whom the authority has been delegated in accordance with the Sunshine Act of 1976 (5 U.S.C. 552b(c)) and FACA. Notice of all meetings will be published in the
In order to conduct the business of the Panel, a quorum is required. A quorum exists when a majority of currently appointed members is present at full Panel or subcommittee meetings or is participating in conference calls.
We published a notice in the
The Panel will consist of the following members and a Chair:
The first meeting (August 26, 2015) is open to the public; however, attendance is limited to space available. Priority will be given to those who pre-register and attendance may be limited based on the number of registrants and the space available.
Persons wishing to attend this meeting, which is located on federal property, must register by following the instructions in the “Meeting Registration” section of this notice. A confirmation email will be sent to the registrants shortly after completing the registration process.
The following are the security, building, and parking guidelines:
• Persons attending the meeting, including presenters, must be pre-registered and on the attendance list by the prescribed date.
• Individuals who are not pre-registered in advance may not be permitted to enter the building and may be unable to attend the meeting.
• Attendees must present a government-issued photo identification to the Federal Protective Service or Guard Service personnel before entering the building. Without a current, valid photo ID, persons may not be permitted entry to the building.
• Security measures include inspection of vehicles, inside and out, at the entrance to the grounds.
• All persons entering the building must pass through a metal detector.
• All items brought into CMS including personal items, for example, laptops and cell phones are subject to physical inspection.
• The public may enter the building 30 to 45 minutes before the meeting convenes each day.
• All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building.
• The main-entrance guards will issue parking permits and instructions upon arrival at the building.
Individuals requiring special accommodations must include the request for these services during registration.
The Panel's recommendations will be posted to our Web site after the meeting.
The Secretary's Charter for the Advisory Panel on Clinical Diagnostic Laboratory Tests is available on the CMS Web site at
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
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
In FR Doc. 2015-18782, appearing in the
On page 45661, in the third column, the first paragraph of the Comments section is corrected to read:
Interested persons may submit either electronic comments regarding this document to
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Please note that your name, contact information, and other information identifying you will be posted on
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
In FR Doc. 2015-18448, appearing on page 44973, in the
On page 44973, in the first column, in the headings section of the document, “[Docket No. FDA-2014-D-2537]” is corrected to read “FDA-2015-D-2537”.
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a decision to designate a class of employees from the Westinghouse Electric Corporation in Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 1-877-222-7570. Information requests can also be submitted by email to
42 U.S.C. 7384q(b). 42 U.S.C. 7384
On July 31, 2015, as provided for under 42 U.S.C. 7384
All Atomic Weapons Employees who worked at the facility owned by Westinghouse Electric Corp., in Bloomfield, New Jersey, during the period from February
This designation will become effective on August 27, 2015, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the
Indian Health Service, HHS.
Notice.
This Notice advises the public that the Indian Health Service (IHS) proposes the geographic boundaries of the Service Delivery Area (SDA) for the reaffirmed Koi Nation of Northern California, formerly known as the Lower Lake Rancheria, California (Indian Entities Recognized and Eligible to Receive Services From the United States Bureau of Indian Affairs, 80
This notice is effective 30 days after date of publication in the
Comments may be mailed to Ms. Betty Gould, Regulations Officer, Indian Health Service, 801 Thompson Avenue, Suite 450, Rockville, Maryland 20852. Comments will be made available for public inspection at this address from 8:30 a.m. to 5:00 p.m. Monday-Friday beginning approximately two weeks after publication of this notice.
Mr. Carl Harper, Director, Office of Resource Access and Partnerships, Indian Health Service, 801 Thompson Avenue, Suite 360, Rockville, Maryland 20852. Telephone 301/443-2694 (This is not a toll free number).
The IHS currently provides services under regulations in effect on September 15, 1987 and IHS republished at 42 CFR part 136, subparts A through C. Many of the newly recognized/restored/reaffirmed Tribes do not have reservations and either Congress has legislatively designated counties to serve as SDAs or the Director, IHS, exercised reasonable administrative discretion to designate SDAs to effectuate the intent of Congress for these Tribes. The Director, IHS, published notice of the establishment of SDAs in the June 21, 2007 FR Notice (72 FR 34262-01). The SDAs function as PRC SDAs for the purposes of operating a PRC program pursuant to the ISDEAA, Pub. L. 93-638. Thus, the PRC SDA list incorporates the SDAs that operate as PRC SDAs for newly recognized/restored/reaffirmed Tribes. At 42 CFR part 136 Subpart C, a PRC SDA is defined as the geographic area within which PRC will be made available by the IHS to members of an identified Indian community who reside in the area. Residence within a PRC SDA by a person who is within the scope of the Indian health program, as set forth in 42 CFR 136.12 creates no legal entitlement to PRC but only potential eligibility for services. Services needed but not available at an IHS/Tribal facility are provided under the PRC program depending on the availability of funds, the person's relative medical priority, and the actual availability and accessibility of alternate resources in accordance with the regulations.
As applicable to the Tribes, these regulations provide that, unless otherwise designated, a PRC SDA shall consist of a county which includes all or part of a reservation and any county or counties which have a common boundary with the reservation (42 CFR 136.22(a)(6) (2014). On December 29, 2000 the Assistant Secretary of Indian Affairs reaffirmed the Federal recognition of the Koi Nation (Tribe), formerly known as the Lower Lake Rancheria, and the government-to-government relationship between the United States and the Tribe. The Koi Nation is located in Lake and Sonoma Counties in the State of California. After consultation with the Tribal governing body, the SDA for the Tribe was agreed upon. The purpose of this FR notice is to notify the public that the IHS now administratively designates Lake and Sonoma Counties as the Koi Nation's SDA.
Under 42 CFR 136.23 those otherwise eligible Indians who do not reside on a reservation but reside within a PRC SDA must be either members of the Tribe or maintain close economic and social ties with the Tribe. In this case, the Tribe estimated the eligible user population to be 72 enrolled Koi Nation members who are actively involved with the Tribe.
The Koi Nation's Tribal office is located in the city of Santa Rosa, Sonoma County, in the State of California. A significant number of the Koi Nation SDA eligible user population also resides in Lake County in the State of California. There are other Federally recognized Tribes in Lake and Sonoma Counties and both counties are currently part of other Tribes' PRC SDA. The Koi Nation only seeks to provide health care services to its members who reside in Lake and Sonoma Counties.
This notice does not contain reporting or recordkeeping requirements subject to prior approval by the Office of Management and Budget under the Paperwork Reduction Act of 1980.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Eye Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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.
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the workshop “Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing.” Workshop attendees will discuss the state of the science of alternative approaches for identifying acute systemic toxicity and explore ways to facilitate their implementation.
Meeting Location: Porter Neuroscience Conference Center, National Institutes of Health, Bethesda, MD 20892.
Meeting Web page: The preliminary agenda, registration, and other meeting materials are at
Dr. Warren S. Casey, Director, NICEATM; email:
Acute systemic toxicity tests, which evaluate the propensity of a substance to produce lethality when administered orally, dermally, or by inhalation, are the most commonly performed type of safety test worldwide. This workshop will explore and discuss alternative approaches that could replace, reduce, or refine the use of animals for identifying chemicals that may cause acute systemic toxicity.
During the workshop, participants will (1) review the regulatory guidelines to define when and how acute systemic toxicity data are used; (2) review the science of alternative approaches for identifying acute systemic toxicity, including mechanism-based models,
A preliminary agenda and additional information are available at
This meeting is open to the public, free of charge, with attendance limited only by available meeting space. Individuals who plan to attend should register at
Visitor and security information for visitors to NIH is available at
NICEATM conducts data analyses, workshops, independent validation studies, and other activities to assess new, revised, and alternative test methods and strategies. NICEATM also provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 (42 U.S.C. 285
Pursuant to Public Law 92-463, notice is hereby given for the meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) on August 26, 2015.
The Council was established to advise the Secretary, Department of Health and Human Services (HHS); the Administrator, SAMHSA; and Center Director, CSAP concerning matters relating to the activities carried out by and through the Center and the policies respecting such activities.
The meeting will be open to the public and will include discussion of the alignment of substance abuse and mental illness prevention within the context of overall healthcare, and CSAP program developments.
The meeting will be held in Rockville, Maryland. Attendance by the public will be limited to the space available. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Written submissions should be forwarded to the contact person on or before one week prior to the meeting. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact on or before one week prior to the meeting. Five minutes will be allotted for each presentation.
To attend onsite, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register at the SAMHSA Committees' Web site,
Substantive program information may be obtained after the meeting by accessing the SAMHSA Committee Web site,
Pursuant to Public Law 92-463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) National Advisory Council will meet on August 12, 2015, 2 p.m.-3 p.m., via teleconference.
The meeting will include the review, discussion, and evaluation of grant applications reviewed by the Initial Review Group, and involve an examination of confidential financial and business information as well as personal information concerning the applicants. Therefore, these meetings will be closed to the public as determined by the SAMHSA Administrator, in accordance with Title 5 U.S.C. 552b(c)(4) and (c)(6) and (c)(9)(B); and 5 U.S.C. App. 2, Section 10(d).
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Advisory Committee for Women's Services (ACWS) on August 26, 2015.
The meeting will include discussions on behavioral health for Pregnant and Postpartum Women (PPW) and their families; disparities in behavioral health services for women; and a conversation with the SAMHSA Administrator.
The meeting is open to the public and will be held at SAMHSA, 1 Choke Cherry Road, Rockville, MD 20857, in the VTC Room. Attendance by the public will be limited to space available. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions should be forwarded to the contact person (below) on or before August 14, 2015. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact person on or before August 14, 2015. Five minutes will be allotted for each presentation.
The meeting may be accesed via telephone. To attend on site, obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at
Substantive meeting information and a roster of Committee members may be obtained either by accessing the SAMHSA Committees' Web site
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 29, 2015.
Red River County for Individual Assistance.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of New Jersey (FEMA-4231-DR), dated July 22, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated July 22, 2015, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of New Jersey resulting from a severe storm on June 23, 2015, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Seamus K. Leary, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of New Jersey have been designated as adversely affected by this major disaster:
Atlantic, Burlington, Camden, Gloucester Counties for Public Assistance.
All areas within the State of New Jersey are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 29, 2015.
Shelby County for Individual Assistance.
Hood, Madison, and Wharton Counties for Individual Assistance (already designated for Public Assistance).
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4228-DR), dated July 13, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of July 13, 2015.
Rapides Parish for Public Assistance.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period is now May 4, 2015, through and including June 22, 2015.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 29, 2015.
Austin, Brown, Delta, DeWitt, Gonzales, Hopkins, Jack, Jones, Orange, Robertson, San Augustine, Starr, Tarrant, Throckmorton, and Waller Counties for Public Assistance.
Ellis, Red River, and Wichita Counties for Public Assistance (already designated for Individual Assistance).
National Protection and Programs Directorate, DHS.
Quarterly Critical Infrastructure Partnership Advisory Council membership update.
The Department of Homeland Security (DHS) announced the establishment of the Critical Infrastructure Partnership Advisory
Larry May, Alternate Designated Federal Officer, Critical Infrastructure Partnership Advisory Council, Sector Outreach and Programs Division, Office of Infrastructure Protection, National Protection and Programs Directorate, U.S. Department of Homeland Security, 245 Murray Lane, Mail Stop 0607, Arlington, VA 20598-0607; telephone: (703) 603-5070; email:
(i) Critical Infrastructure owner and operator members of a DHS-recognized SCC, including their representative trade associations or equivalent organization members of a SCC as determined by the SCC.
(ii) Federal, state, local, and tribal governmental entities comprising the members of the GCC for each sector, including their representative organizations; members of the State, Local, Tribal, and Territorial Government Coordinating Council; and representatives of other federal agencies with responsibility for critical infrastructure activities.
CIPAC membership is organizational. Multiple individuals may participate in CIPAC activities on behalf of a member organization.
Science and Technology Directorate, DHS.
Notice.
The Department of Homeland Security (DHS) is seeking nominations and expressions of interest for membership on the Project 25 Compliance Assessment Program Advisory Panel (P25 CAP AP). The activities of the P25 CAP AP are expected to commence in fall 2015.
P25 is a standard which enables interoperability among digital two-way land mobile radio communications products created by and for public safety professionals. P25 CAP is a formal, independent process, created by DHS and operated in collaboration with the National Institute of Standards and Technology (NIST), for ensuring that communications equipment that is declared by the supplier to be P25 compliant, in fact, is tested against the standards with publicly published results. The P25 CAP AP would provide a resource by which DHS could gain insight into the collective interest of organizations that procure P25-compliant equipment and a resource in DHS's continuing to establish the policies of the P25 CAP along with assisting the DHS Office for Interoperability and Compatibility (OIC) in the administration of the Program.
All responses must be received within 30 days from the date of this notice at the address listed below.
Expressions of interest and nominations should be submitted to
• Instructions: All submissions received must include the words “Department of Homeland Security” and DHS-2015-0041, the docket number for this action.
John Merrill, Director, Office for Interoperability and Compatibility, Science and Technology Directorate, Department of Homeland Security, 202-254-5604 (O),
TIA-102/Project 25 (P25) is a standards development process for the design, manufacture, and evaluation of interoperable digital two-way land mobile radio communications products created by and for public safety professionals. The goal of P25 is to specify formal standards for interfaces and features between the various components of a land mobile radio system commonly used by public safety agencies in portable handheld and mobile vehicle-mounted devices. The P25 standard enables interoperability among different suppliers' products.
P25 CAP was developed by DHS and the National Institute of Standards and Technology (NIST) to test equipment designed to comply with P25 standards. The program provides public safety agencies with evidence that the communications equipment they are purchasing is tested against and complies with the P25 standards for performance, conformance, and interoperability.
P25 CAP is a voluntary system that provides a mechanism for the recognition of testing laboratories based on internationally accepted standards. It identifies competent P25 CAP testing laboratories for DHS-recognition through assessments by DHS-authorized accreditation bodies and promotes the acceptance of compliant test results from these laboratories.
As a voluntary program, P25 CAP allows suppliers to publicly attest to their products' compliance with a selected group of requirements through Summary Test Report (STR) and Supplier's Declaration of Compliance (SDOC) documents based on the Detailed Test Report (DTR) from the DHS-recognized laboratory (ies) that performed the product testing. In turn, P25 CAP makes these documents available to the first response community to inform their purchasing decisions via the
The Science and Technology Directorate (S&T) of the DHS is forming the P25 CAP Advisory Panel to provide S&T with the views of active local, state, tribal, territorial and Federal government officials who use or whose offices use portable handheld and mobile vehicle-mounted radios. Those government officials selected to participate in the P25 CAP AP will be selected based on their experience with the management and procurement of land mobile radio systems or knowledge of conformity assessment programs and methods. OIC will select candidates in light of the desire to balance viewpoints required to effectively address P25 CAP issues under consideration. OIC is particularly interested in receiving nominations and expressions of interest from individuals in the following categories:
• State, tribal, territorial, or local government agencies and organizations with expertise in communications issues and technologies.
• Federal government agencies with expertise in communications or homeland security matters.
While OIC can call for a meeting of the P25 CAP AP as it deems necessary and appropriate, for member commitment and planning purposes, it is anticipated that the P25 CAP AP will meet approximately 3-4 times annually in their role of providing guidance and support to the P25 CAP.
Those selected to serve on the P25 CAP AP will be required to sign a gratuitous services agreement and will not be paid or reimbursed for their participation; however, DHS S&T will reimburse the travel expenses associated with the participation of non-Federal members in accordance with Federal Travel Regulations. OIC reserves the right to select primary and alternate members to the P25 CAP AP for terms appropriate for the accomplishment of the Board's mission. Members serve at the pleasure of the OIC Director.
Registered lobbyists pursuant to the Lobbying Disclosure Act of 1995 are not eligible for membership on the P25 CAP AP and will not be considered.
The duties of the P25 CAP AP will include providing recommendations of its individual members to OIC regarding actions and steps OIC could take to promote the P25 CAP. The duties of the P25 CAP AP may include but are not limited to its members reviewing, commenting on, and advising on:
a. The laboratory component of the P25 CAP under established, documented laboratory recognition guidelines.
b. Proposed Compliance Assessment Bulletins (CABs).
c. Proposed updates to previously approved CABs, as Notices of Proposed CABs, to enable comment and input on the proposed CAB modifications.
d. OIC updates to existing test documents or establishing new test documents for new types of P25 equipment.
e. Best practices associated with improvement of the policies and procedures by which the P25 CAP operates.
f. Existing test documents including but not limited to Supplier Declarations of Compliance (SDOCs) and Summary Test Reports (STRs) posted on the
g. Proposed P25 user input for improving functionality through the standards-making process.
Nominations and expressions of interest shall be received by OIC no later than 30 days from the date of this notice at the address listed above (
• A cover letter that highlights a history of proven leadership within the public safety community including, if applicable, a description of prior experience with law enforcement, fire response, emergency medical services, emergency communications, National Guard, or other first responder roles and how the use of communications in those roles qualifies the nominee to participate on the P25 CAP AP.
• Name, title, and organization of the nominee.
• A resume summarizing the nominee's contact information (including the mailing address, phone number, facsimile number, and email address), qualifications, and expertise to explain why the nominee should be appointed to the P25 CAP AP.
• The resume must demonstrate a minimum of ten years (10) years of experience directly using P25 systems in an operational environment in support of established public safety communications or from a system implementer/administrator perspective; a bachelor's or associate degree with an emphasis in communications and engineering may be substituted for three (3) years, a master's/professional certification for seven (7) years, and a Ph.D. for ten (10) years of the requirement.
• The resume must discuss the nominee's familiarity with the current P25 CAP, including documents that are integral to the process such as the SDOCs, STRs, and CABs referenced in this notice.
• A letter from the nominee's supervisor indicating the nominee's agency's support for the nominee to participate on the P25 CAP AP.
• Disclosure of Federal boards, commissions, committees, task forces, or work groups on which the nominee currently serves or has served within the past 12 months.
• A statement confirming that the nominee is not registered as a lobbyist pursuant to the Lobbying Disclosure Act of 1995.
Additional information can be found as follows:
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
This notice announces changes in the interest rates to be paid on debentures issued with respect to a loan or mortgage insured by the Federal Housing Administration under the provisions of the National Housing Act (the Act). The interest rate for debentures issued under section 221(g)(4) of the Act during the 6-month period beginning July 1, 2015, is 2
Yong Sun, Department of Housing and Urban Development, 451 Seventh Street SW., Room 5148, Washington, DC 20410-8000; telephone (202) 402-4778 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.
Section 224 of the National Housing Act (12 U.S.C. 1715o) provides that debentures issued under the Act with respect to an insured loan or mortgage (except for debentures issued pursuant to section 221(g)(4) of the Act) will bear interest at the rate in effect on the date the commitment to insure the loan or mortgage was issued, or the date the loan or mortgage was endorsed (or initially endorsed if there are two or more endorsements) for insurance, whichever rate is higher. This provision is implemented in HUD's regulations at 24 CFR 203.405, 203.479, 207.259(e)(6), and 220.830. These regulatory provisions state that the applicable rates of interest will be published twice each year as a notice in the
Section 224 further provides that the interest rate on these debentures will be set from time to time by the Secretary of HUD, with the approval of the Secretary of the Treasury, in an amount not in excess of the annual interest rate determined by the Secretary of the Treasury pursuant to a statutory formula based on the average yield of all outstanding marketable Treasury obligations of maturities of 15 or more years.
The Secretary of the Treasury (1) has determined, in accordance with the provisions of section 224, that the statutory maximum interest rate for the period beginning July 1, 2015, is 2
For convenience of reference, HUD is publishing the following chart of debenture interest rates applicable to mortgages committed or endorsed since January 1, 1980:
Section 215 of Division G, Title II of Public Law 108-199, enacted January 23, 2004 (HUD's 2004 Appropriations Act) amended section 224 of the Act, to change the debenture interest rate for purposes of calculating certain insurance claim payments made in cash. Therefore, for all claims paid in cash on mortgages insured under section 203 or 234 of the National Housing Act and endorsed for insurance after January 23, 2004, the debenture interest rate will be the monthly average yield, for the month in which the default on the mortgage occurred, on United States Treasury Securities adjusted to a constant maturity of 10 years, as found in Federal Reserve Statistical Release H-
Section 221(g)(4) of the Act provides that debentures issued pursuant to that paragraph (with respect to the assignment of an insured mortgage to the Secretary) will bear interest at the “going Federal rate” in effect at the time the debentures are issued. The term “going Federal rate” is defined to mean the interest rate that the Secretary of the Treasury determines, pursuant to a statutory formula based on the average yield on all outstanding marketable Treasury obligations of 8- to 12-year maturities, for the 6-month periods of January through June and July through December of each year. Section 221(g)(4) is implemented in the HUD regulations at 24 CFR 221.255 and 24 CFR 221.790.
The Secretary of the Treasury has determined that the interest rate to be borne by debentures issued pursuant to section 221(g)(4) during the 6-month period beginning July 1, 2015, is 2
The subject matter of this notice falls within the categorical exemption from HUD's environmental clearance procedures set forth in 24 CFR 50.19(c)(6). For that reason, no environmental finding has been prepared for this notice.
Sections 211, 221, 224, National Housing Act, 12 U.S.C. 1715b, 1715l, 1715o; Section 7(d), Department of HUD Act, 42 U.S.C. 3535(d).
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received an application for an enhancement of survival permit (EOS) under the Endangered Species Act of 1973, as amended (ESA). The permit application includes a draft candidate conservation agreement with assurances (CCAA) between Smith Creek Ranch LTD and the Service for the greater sage-grouse on private rangelands in Churchill and Lander Counties, Nevada. We invite comments from all interested parties on the application, including the draft CCAA, and a draft environmental action statement (EAS) prepared pursuant to the requirements of the National Environmental Policy Act (NEPA).
To ensure consideration, written comments must be received from interested parties no later than September 8, 2015.
To request further information or submit written comments, please use one of the following methods, and note that your information request or comments are in reference to the Smith Creek Ranch LTD CCAA.
Edward D. Koch, Field Supervisor, Reno Fish and Wildlife Office (see
We have received an application from Smith Creek Ranch LTD for an EOS permit under the ESA. The permit application includes a CCAA between the applicant and the Service for the greater sage-grouse (
Private and other non-Federal property owners are encouraged to enter into CCAAs, in which they voluntarily undertake management activities on their properties to enhance, restore, or maintain habitat benefiting species that are proposed for listing under the ESA, candidates for listing, or species that may become candidates or proposed for listing. Through a CCAA and its associated EOS permit, the Service provides assurances to property owners that they will not be subjected to increased land use restrictions if the covered species become listed under the ESA in the future, provided the CCAA is being properly implemented and the EOS permit conditions are met. Application requirements and issuance criteria for EOS permits for CCAAs are found in the Code of Regulations (CFR) at 50 CFR 17.22(d) and 17.32 (d), respectively. See also our joint policy on CCAAs, which we published in the
On March 23, 2010, the Service published a 12-month finding in the
The Service proposes to approve the CCAA and to issue an EOS permit, both with a term of 20 years, to Smith Creek Ranch LTD for incidental take of greater sage-grouse caused by covered activities, if permit issuance criteria are met. The area to be addressed under this proposed CCAA (
Consistent with our CCAA Policy (64 FR 32726), the conservation goal of the proposed CCAA is to encourage enhancement and protection of greater sage-grouse habitat on non-Federal lands by either maintaining or modifying existing land uses so that they are consistent with the conservation needs of the greater sage-grouse. We can meet this conservation goal with the use of a CCAA by giving non-Federal landowners incentives to implement conservation measures, primarily through regulatory certainty concerning land-use restrictions that might otherwise apply should the greater sage-grouse become listed under the ESA.
We have made a preliminary determination that the proposed CCAA and permit issuance are eligible for categorical exclusion under NEPA. The basis for our preliminary determination is contained in an EAS, which is available for public review (see
We request data, comments, new information, or suggestions from the public, other concerned governmental agencies, the scientific community, Tribes, industry, or any other interested party on this notice. We particularly seek comments on the following: (1) Biological information concerning the greater sage-grouse; (2) relevant data concerning this species; (3) additional information concerning the range, distribution, population size, and population trends of the greater sage-grouse; (4) current or planned activities in the covered area and their possible impacts on the species; (5) identification of any other environmental issues that should be considered with regard to the proposed permit action; and (6) information regarding the adequacy of the CCAA pursuant to the requirements for permits at 50 CFR parts 13 and 17.
All comments and materials we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personal identifiable information (PII) in your comments, you should be aware that your entire comment—including your PII—may be made publically available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee we will be able to do so. Comments and materials we receive, as well as supporting documentation we used in preparing the draft EAS, will be available for public inspection by appointment, during normal business hours, at our Reno Fish and Wildlife Office (see
We will evaluate the permit application, associated documents, and comments we receive to determine whether the permit application meets the requirements of section 10(a)(1)(A) of the ESA and NEPA and their implementing regulations. We will also evaluate whether issuance of an EOS permit would comply with section 7 of the ESA by conducting an intra-Service section 7 consultation on the proposed permit action. If we determine that all requirements are met, we will sign the proposed CCAA and issue an EOS permit under section 10(a)(1)(A) of the ESA to Smith Creek Ranch LTD for incidental take of greater sage-grouse that is likely to occur with implementation of the CCAA. We will not make our final decision until after the end of the 30-day public comment period, and we will fully consider all comments we receive during the public comment period.
We provide this notice in accordance with the requirements of section 10(c) of the ESA (16 U.S.C. 1531
U.S. Geological Survey (USGS), Interior.
Notice of a revision of a currently approved information collection.
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on January 31, 2016.
To ensure that your comments are considered, we must receive them on or before October 6, 2015.
You may submit comments on this information collection to the Information Collection Clearance Officer, U.S. Geological Survey, 12201 Sunrise Valley Drive MS 807, Reston, VA 20192 (mail); (703) 648-7197 (fax); or
Jake Weltzin, U.S. Geological Survey, 1955 East 6th Street, Tucson, AZ 85721 (mail); (520) 626-3821 (phone); or
The USA-NPN is a program sponsored by the USGS that uses
We are soliciting comments as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Please note that the comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public view, we cannot guarantee that we will be able to do so.
U.S. Geological Survey (USGS), Interior.
Notice of a new information collection.
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC.
To ensure that your comments are considered, we must receive them on or before October 6, 2015.
You may submit comments on this information collection to the Information Collection Clearance Officer, U.S. Geological Survey, 12201 Sunrise Valley Drive MS 807, Reston, VA 20192 (mail); (703) 648-7197 (fax); or
Brigitta Urban-Mathieux, Federal Geographic Data Committee Office of the Secretariat, U.S. Geological Survey, 12201 Sunrise Valley Drive, Mail Stop 590, Reston, VA 20192 (mail); 703-648-5175 (phone); or
Respondents are submitting proposals to acquire funding for projects to help build the infrastructure necessary for the geospatial data community to effectively discover, access, share, manage, and use digital geographic data. The National Spatial Data Infrastructure (NSDI) consists of the technologies, policies, organizations, and people necessary to promote cost-effective production, and the ready availability and greater utilization of geospatial data among a variety of sectors, disciplines, and communities. Specific NSDI areas of emphasis include: Metadata
We will issue a request for proposal (RFP) via Grant.gov. The incoming proposals will be reviewed and scored based on the responses to the questions in the RFP. Responses are voluntary. No questions of a “sensitive” nature are asked. We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and it's implementing regulations (43 CFR part 2), and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” We intend to release the project abstracts and primary investigators for awarded/funded projects only.
We are soliciting comments as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology. Please note that the comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public view, we cannot guarantee that we will be able to do so.
Bureau of Land Management, Interior.
Notice.
The plats of survey of lands described below are scheduled to be officially filed in the Bureau of Land Management, California State Office, Sacramento, California.
September 8, 2015.
A copy of the plats may be obtained from the California State Office, Bureau of Land Management, 2800 Cottage Way, Sacramento, California 95825, upon required payment.
Chief, Branch of Geographic Services, Bureau of Land Management, California State Office, 2800 Cottage Way W-1623, Sacramento, California 95825, (916) 978-4310. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-(800)-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
A person or party who wishes to protest a survey must file a notice that they wish to protest with the Chief, Branch of Geographic Services. A statement of reasons for a protest may be filed with the notice of protest and must be filed with the Chief, Branch of Geographic Services within thirty days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
T. 11 N., R. 3 E., supplemental plat of the S
T. 23 N., R. 13 W., metes-and-bounds survey of lots in section 36, accepted July 21, 2015.
T. 17 S., R. 8 E., dependent resurvey and subdivision of section 6, accepted July 28, 2015.
T. 9 N., R. 23 E., supplemental plat of the NW
T. 9 S., R. 14 E., supplemental plat of the SW
T. 2 N., R. 9 E., dependent resurvey and subdivision of section 34, accepted July 21, 2015.
43 U.S.C., Chapter 3.
Bureau of Land Management, Interior.
Notice of Availability.
In accordance with the National Environmental Policy Act of 1969, as amended, the Bureau of Land Management (BLM) has prepared a Draft Environmental Impact Statement (EIS) for the West of Devers Upgrade Project (WOD UP) and by this notice is announcing the opening of the comment period. This document is also an Environmental Impact Report (EIR) prepared by the California Public Utilities Commission (CPUC) under the California Environmental Quality Act (CEQA).
To ensure comments will be considered, the BLM must receive written comments on the West of Devers Upgrade Project Draft Joint EIR/EIS within 45 days following the date the Environmental Protection Agency publishes its Notice of Availability in the
You may submit comments related to the WOD UP by any of the following methods:
• Web site:
• Email:
• Fax: 760-833-7199.
• Mail: WOD Project Manager; BLM Palm Springs-South Coast Field Office, 1201 Bird Center Drive, Palm Springs, CA 92262
Copies of the Draft Joint EIR/EIS for the WOD UP are available in the Palm Springs/South Coast Field Office at the above address and the BLM California Desert District Office, 22835 Calle San Juan De Los Lagos, Moreno Valley, CA 92553.
Frank McMenimen, Project Manager, telephone 760-833-7150; address 1201 Bird Center Drive, Palm Springs, CA 92262; email
Southern California Edison (SCE) proposes to upgrade and adjust the routes of the following existing 220 kV transmission lines within SCE's existing West of Devers right-of-way corridor in incorporated and unincorporated areas of Riverside and San Bernardino Counties, including: Devers-El Casco, El Casco-San Bernardino, Devers-San Bernardino, Devers-Vista No. 1 and No. 2, Etiwanda-San Bernardino, and San Bernardino-Vista.
Of the overall 48-mile length of the transmission corridor, approximately 6 miles would cross Trust Lands (Reservation) of the Morongo Band of Mission Indians and approximately 1 mile is on BLM- administered public lands. The BLM lands are located east of the City of Banning and west of the City of Desert Hot Springs in Riverside County.
In addition to the transmission line improvements, substation equipment at Devers, El Casco, Etiwanda, San Bernardino, Timoteo and Tennessee and Vista Substations would be upgraded to accommodate the project changes to transmission and subtransmission systems. Construction of the WOD UP would facilitate the full deliverability of new renewable energy generation resources now being developed in eastern Riverside County, including the BLM's Riverside East Solar Energy Zone, into the Los Angeles area.
The WOD UP would facilitate progress towards meeting California's Renewable Portfolio Standard goals requiring utilities to produce 33 percent of their electricity sales from renewable energy sources by 2020. Utility-scale solar energy development in eastern Riverside County plays an important role in meeting California's renewable energy goals, allowing for immediate and sizeable deployment, driving costs down and taking advantage of the State's best renewable energy resources. Additionally, these upgrades are required to comply with transmission reliability standards and will support integration of small scale electricity generation.
In addition to the Proposed Project, the WOD UP Draft Joint EIR/EIS considers three project alternatives and a No Action/No Project alternative, as well as connected actions enabled by the project. The first alternative moves towers away from residences. The second alternative would place portions of the line underground. The third alternative would use fewer towers, and would not remove all the old towers and poles, leaving future expansion opportunities. Based on the small amount of BLM lands involved, and because of the lack of apparent resource conflicts for the BLM among the alternatives, the BLM has not identified a preferred alternative. The BLM will identify a preferred alternative for the Final EIS based on feedback on the Draft EIS from the public and cooperating agencies.
During the public scoping process, BLM personnel, Federal, State, local agencies, and other stakeholders identified issues for the EIR/EIS, including aesthetics/visual effects; conflicts with existing land uses; social and economic effects, including property values; fire, electric and magnetic fields, and other hazards; construction-related impacts from dust and traffic; slope stability; effects on biological resources; and possible curtailment of electric generation during construction.
Please note that public comments and information submitted including names, street addresses, and email addresses of persons who submit comments will be available for public review and disclosure at the above address during regular business hours (8 a.m. to 4 p.m.), Monday through Friday, except holidays.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
40 CFR 1506.6, 40 CFR 1506.10.
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Sierra Front-Northwestern Great Basin Resource Advisory Council (RAC), will hold a meeting in Nevada, in September 2015. The meeting is open to the public.
September 17 and 18 at the BLM Winnemucca, Nevada District. A meeting will be held on Thursday, September 17, at the Winnemucca BLM District Office (5100 East Winnemucca Blvd.) in Winnemucca, Nevada. Approximate meeting times are 8 a.m. to 4 p.m. However, meetings could end earlier if discussions and presentations conclude before 4 p.m. The meeting will include a public comment period at approximately 11:30 a.m. A field trip will be held on Friday, September 18 within the Winnemucca BLM District.
Lisa Ross, Public Affairs Specialist, Carson City District Office, 5665 Morgan Mill Road, Carson City, NV 89701, telephone: (775) 885-6107, email:
The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Nevada. Topics for discussion at the meeting will include, but are not limited to:
• September 17-18 (Carson City)—landscape vegetative management, rangeland health assessments, Fire Invasive Assessment Tool (FIAT), sage grouse, drought, and fire restoration.
Managers' reports of district office activities will be distributed at each meeting. The Council may raise other topics at the meetings.
Final agendas will be posted on-line at the BLM Sierra Front-Northwestern Great Basin RAC Web site at
Individuals who need special assistance such as sign language interpretation or other reasonable accommodations, or who wish to receive a copy of each agenda, may contact Lisa Ross no later than 10 days prior to each meeting.
Bureau of Reclamation, Interior.
Notice.
The Bureau of Reclamation has prepared the Final Environmental Impact Statement (FEIS) for the Shasta Lake Water Resources Investigation (SLWRI). The purpose of the proposed action is to improve operational flexibility of the Sacramento-San Joaquin Delta watershed system by modifying the existing Shasta Dam and Reservoir to meet specified objectives. Primary objectives are to increase the survival of anadromous fish populations in the upper Sacramento River and increase water supply and water supply reliability for agricultural, municipal and industrial, and environmental purposes. Secondary planning objectives are to: Conserve, restore, and enhance ecosystem resources in the primary study area; reduce flood damage along the Sacramento River; develop additional hydropower generation capabilities at Shasta Dam; maintain and increase recreation opportunities at Shasta Lake; and maintain or improve water quality conditions in the Sacramento River downstream from Shasta Dam and in the Sacramento-San Joaquin Delta. The companion Final Feasibility Report is also available, and together, these documents are provided to inform the Congress and the public of the technical studies conducted to date.
Ultimately, if the project is authorized by Congress, the Secretary may issue a Record of Decision (ROD) at least 30 days after release of the FEIS. The ROD will state the action that will be implemented, consistent with Congressional authorization, and will discuss all factors leading to the decision.
The FEIS may be viewed at the SLWRI Web site at
Ms. Katrina Chow, Reclamation Project Manager, Bureau of Reclamation, 2800 Cottage Way, Sacramento, CA 95825; 916-978-5067, TDD 916-978-5608; via fax at 916-978-5094; or email to
A Notice of Availability of the Draft Environmental Impact Statement (DEIS) was published in the
Shasta Dam was completed in 1945 to serve multiple purposes, including flood control; water supply for agricultural, municipal and industrial, and environmental purposes; and hydropower generation. In addition, extensive recreational opportunities in and around Shasta Lake significantly contribute to the regional economy.
Authorization for the investigation comes from Public Law (Pub. L.) 96-375, 1980, directing the Secretary of the Interior to engage in feasibility studies related to enlarging Shasta Dam and Reservoir. Related legislation includes Title 34 of Pub. L. 102-575 (the Central Valley Project Improvement Act) and Pub. L. 108-361, the CALFED Bay-Delta Authorization Act. In addition, enlargement of Shasta Dam was identified in the CALFED Programmatic Environmental Impact Report/Statement and Record of Decision.
With the release of the FEIS, the Final Feasibility Report and FEIS will be provided to Congress. The following
• Primary Planning objectives: (1) Increase the survival of anadromous fish populations in the Sacramento River, primarily upstream from the Red Bluff Diversion Dam, and (2) increase water supply and water supply reliability for agricultural, municipal and industrial, and environmental purposes to help meet future water demands, with a focus on enlarging Shasta Dam and Reservoir. Action alternatives were formulated to address these primary planning objectives.
• Secondary Planning Objectives. The following actions, operations, or features are included to the extent possible and consistent with the primary planning objectives: (1) Conserve, restore, and enhance ecosystem resources in the Shasta Lake area and along the upper Sacramento River, (2) reduce flood damage along the Sacramento River, (3) develop additional hydropower generation capabilities at Shasta Dam, (4) maintain and increase recreation opportunities at Shasta Lake, and (5) maintain or improve water quality conditions in the Sacramento River downstream from Shasta Dam and in the Sacramento-San Joaquin Delta.
The FEIS documents a reasonable range of alternatives and evaluates the potential direct, indirect, and cumulative environmental effects of alternative plans. Evaluation of six alternatives is documented in the FEIS, including a No-Action Alternative and five action alternatives. The FEIS displays the potential project-related impacts, including the effects of project construction and operation on the following resource areas: Geology, air quality, hydrology, water quality, noise, hazards and hazardous materials, important agricultural lands, fish, vegetation and wildlife, cultural resources, Indian Trust Assets, socioeconomics, land use, recreation, visual resources, traffic and circulation, utilities, public services, power and energy, environmental justice, and wild and scenic rivers; and identifies the Preferred Alternative, pursuant to the National Environmental Policy Act.
Potential project-related impacts include the construction-related effects of the dam enlargement, reservoir area relocations, and other alternative features; water operations-related effects within the reservoir area (
Copies of the FEIS and Final Feasibility Report are available for public review at the following locations:
• Bureau of Reclamation, Regional Library, 2800 Cottage Way, Sacramento, CA 95825.
• Bureau of Reclamation, Northern California Area Office, 16349 Shasta Dam Boulevard, Shasta Lake, CA 96019.
• Natural Resources Library, Department of the Interior, 1849 C Street NW., Main Interior Building, Washington, DC 20240.
• Shasta County Main Library, 1855 Shasta Street, Redding, CA 96001.
Copies of the FEIS and Final Feasibility Report are available on-line via the SLWRI Web site, at:
Before including your address, phone number, email address, or other personal identifying information in any correspondence, you should be aware that your entire correspondence—including your personal identifying information—may be made publicly available at any time. While you can ask us in your correspondence to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
United States International Trade Commission.
Institution of investigation and scheduling of public hearing.
The Commission has instituted investigation No. 332-555, Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedures, 2016 Report, for the purpose of preparing the first of two reports required by section 105(f)(2) of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (Public Law 114-26). Section 105(f)(2) requires that the Commission submit to the House Committee on Ways and Means and the Senate Committee on Finance two reports, one by June 29, 2016, and a second by June 29, 2020, on the economic impact on the United States of all trade agreements with respect to which Congress has enacted an implementing bill under trade authorities procedures since January 1, 1984.
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW., Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW., Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Project Leaders Tamar Khachaturian (202-205-3299 or
(2) REPORT ON IMPACT OF TRADE PROMOTION AUTHORITY.— Not later than one year after the date of the enactment of this Act, and not later than 5 years thereafter, the United States International Trade Commission shall submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a report on the economic impact on the United States of all trade agreements with respect to which Congress has enacted an implementing bill under trade authorities procedures since January 1, 1984.
The Commission will submit its first report by June 29, 2016, and the second report by June 29, 2020. This notice pertains only to the procedures relating to preparation of the first report.
For purposes of this report the Commission considers the trade agreements covered to include the Uruguay Round Agreements, the North American Free Trade Agreement (NAFTA—Canada and Mexico), and U.S. free trade agreements (FTAs) with Australia, Bahrain, Canada, Chile, Colombia, the Dominican Republic and five Central American countries (Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua), Israel, Jordan, Korea, Morocco, Oman, Panama, Peru, and Singapore.
The Commission has instituted an investigation under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)) for the purpose of preparing this report and also for the purpose of assisting the public in the filing and inspection of documents and also to make the report more readily accessible to the public through the Commission's Web site.
Any submissions that contain confidential business information (CBI) must also conform to the requirements of section 201.6 of the
By order of the Commission.
Pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), the United States hereby publishes below the comment received on the proposed Final Judgment in
Copies of the comment and the United States' Response are available for inspection at the Department of Justice Antitrust Division, 450 Fifth Street NW., Suite 1010, Washington, DC 20530 (telephone: 202-514-2481), on the Department of Justice's Web site at
UNITED STATES OF AMERICA, AND STATE OF NEW YORK,
Pursuant to the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h) (“Tunney Act”), the United States hereby files the single public comment received concerning the proposed Final Judgment in this case and the United States' response to the comment. After careful consideration of the submitted comment, the United States continues to believe that the proposed Final Judgment provides an effective and appropriate remedy for the violations alleged in the Complaint. The United States will move the Court for entry of the proposed Final Judgment after the public comment and this Response have been published in the
On March 17, 2009, Defendants Coach USA, Inc. (through subsidiary International Bus Services, Inc.) and CitySights LLC (through subsidiary City Sights Twin, LLC) formed Twin America, LLC (“Twin America”), a joint venture that combined their hop-on, hop-off bus tour operations in New York City.
Defendants subsequently applied to the federal Surface Transportation Board (“STB”) for approval of the Twin America transaction, which would have conferred antitrust immunity. After more than two years of proceedings, the STB rejected the joint venture as anticompetitive. However, while Defendants ceased operating the nominal interstate service that had formed the basis for the STB's jurisdiction, they continued operating their hop-on, hop-off bus tour operations in New York City.
In December 2012, the United States and the State of New York (collectively, “Plaintiffs”) filed this civil antitrust action, alleging that the formation of Twin America substantially lessened competition in the market for hop-on, hop-off bus tours in New York City in violation of Section 7 of the Clayton Act, 15 U.S.C. 18, and also violated Section 1 of the Sherman Act, 15 U.S.C. 1, Section 340 of the Donnelly Act, N.Y. Gen. Bus. Law § 340, and Section 63(12) of the New York Executive Law, N.Y. Exec. Law § 63(12). The Complaint sought to remedy the harm to competition and disgorge the ill-gotten gains Defendants had obtained from operating Twin America in violation of the antitrust laws.
In December 2014, the parties adjourned a February 2015 trial date to facilitate settlement discussions. These discussions culminated in the proposed Final Judgment, which was filed on March 16, 2015 (Dkt. No. 127-1).
The Complaint alleged that the formation of Twin America had the purpose and effect of creating a monopoly in the hop-on, hop-off bus tour market in New York City. The joint venture eliminated substantial head-to-head competition between Coach and City Sights that had benefitted consumers in the form of discounts, increased product offerings, and service improvements. The joint venture also enabled Defendants to increase hop-on, hop-off bus tour prices by approximately 10%, resulting in immediate and continuing harm to consumers.
The Complaint alleged that entry of new firms into the market or expansion of existing firms was unlikely to counteract the competitive harm caused by the formation and operation of Twin America. According to the Complaint, the primary barrier to entry was the difficulty of obtaining hop-on, hop-off bus stop authorizations from the New York City Department of Transportation (“NYCDOT”). Bus stop authorizations are required by NYCDOT for each location a tour operator wishes to load and unload passengers. Defendants obtained a robust portfolio of bus stop authorizations from NYCDOT several years ago, including authorizations at or very close to virtually all of Manhattan's major tourist attractions. Recent entrants, by contrast, were consistently unable to obtain competitive bus stop authorizations from NYCDOT at top tourist attractions because NYCDOT allocated such authorizations on a “first come, first served” basis and most competitive bus stop locations were already at capacity or otherwise unavailable. As a result, more than five years after Twin America's formation, the joint venture still dominated the market and Defendants had sustained their anticompetitive price increases.
The proposed Final Judgment addresses the harm alleged in the Complaint by requiring Twin America to divest all of City Sights's bus stop authorizations in Manhattan to NYCDOT, the city agency charged with managing bus stop authorizations. The divestiture significantly eases the primary entry barrier alleged in the Complaint by increasing NYCDOT's inventory of bus stops, including for the locations most sought by recent entrants. City Sights's set of approximately 50 bus stops includes highly-coveted stops surrounding key tourist attractions such as Times Square, the Empire State Building, and Battery Park that are critical to operating a competitive hop-on, hop-off bus tour. The proposed Final Judgment also prohibits Defendants from applying for or obtaining any bus stop authorizations for hop-on, hop-off bus tours at the locations of the divested City Sights bus stop authorizations for five years, subject to limited exceptions. In compliance with the proposed Final Judgment, Defendants relinquished the City Sights bus stop authorizations to NYCDOT on April 30, 2015.
The proposed Final Judgment also requires Defendants to pay $7.5 million in disgorgement to the United States and State of New York, which is on top
The Tunney Act requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day public comment period, after which the court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. 16(e)(1);
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
In considering these statutory factors, the court's inquiry is necessarily a limited one.
“The role of the court is not to determine whether the decree results in the array of rights and liabilities `that will
In determining whether a proposed settlement is in the public interest, “the court should be `deferential to the government's predictions as to the effect of the proposed remedies.' ”
A court “is not permitted to reject the proposed remedies merely because the court believes other remedies are preferable.”
The relevant inquiry “is whether the Government has established an ample `factual foundation for [its] decisions such that its conclusions regarding the proposed settlement are reasonable.' ”
In its 2004 amendments to the Tunney Act,
The United States received one public comment, from Taxi Tours, Inc., doing business as BigBus (“Big Bus”). Big Bus entered the New York City hop-on, hop-off bus tour market in 2014 by acquiring an existing player, Big Taxi. The comment makes four principal points: (1) There should be additional remedies to facilitate competitors' ticket sales; (2) there should be a more specific process governing the allocation of bus stop authorizations; (3) the judgment should apply to Defendants' future affiliated
Big Bus's comment asserts that Defendants prevent competitors from selling tickets for hop-on, hop-off bus tours at or near certain key tourist attractions and proposes that the settlement be amended to ensure equal access to vendors to market and sell tickets from Defendants' competitors. Big Bus also expresses concerns regarding the conduct of City Experts, an affiliate of Defendants that offers tourists a variety of tours and attractions from concierge desks it operates at certain New York City hotels. Big Bus contends that because City Experts sells Defendants' hop-on, hop-off bus tours as part of its bundled tourism packages but not the hop-on, hop-off bus tours of Defendants' competitors, it “prevents the Defendants' competitors from effectively competing at the hotel and retail level.” Big Bus also complains that Twin America's employees prevent Big Bus staff from selling tickets by verbally and physically attacking them.
Pursuant to the Tunney Act, review of a proposed Final Judgment is limited to the relationship of the remedy to the violations alleged in the Complaint.
The Complaint did not allege that the conduct of Defendants' street sellers, its City Experts affiliate, or Defendants' sales practices otherwise served as a meaningful barrier to competition in the hop-on, hop-off bus tour market. Nor did the Complaint allege that the formation of the joint venture had an impact on these practices. Thus, the suggested additional provisions are unnecessary to address the competitive harm set forth in the Complaint.
Big Bus argues that the proposed settlement should establish certain rules and processes related to the allocation and use of hop-on, hop-off bus stops. First, Big Bus asserts that the Final Judgment “should define a fair and monitored process of reassignment/reallocation of the divested [City Sights bus stop] authorizations to ensure that all competitors in the relevant market have an equal opportunity to apply for the divested stop authorizations.” Big Bus also claims that the Final Judgment should address how hop-on, hop-off bus stop authorizations would be handled in the event that Defendants acquired an existing hop-on, hop-off bus tour business.
Procedures relating to the assignment and allocation of bus stop authorizations are within the jurisdiction of NYCDOT, the New York City agency charged with regulating and managing bus stops.
Given the established NYCDOT role in bus stop authorizations and allocations, the United States concluded that the facts of this case did not call for the proposed Final Judgment to establish any additional regulations or processes relating to the assignment or allocation of bus stop authorizations.
Big Bus's comment raises a concern that two provisions of the proposed Final Judgment—having to do with notification to the government of certain transactions (Section X) and “reacquisition” of stops (Section XII)—would not apply to affiliated entities that Defendants might form after entry of the Final Judgment. Big Bus is incorrect. The proposed Final Judgment applies to Defendant entities as well as their “
Finally, Big Bus argues that Section XIII of the proposed Final Judgment, which provides that the Court retains jurisdiction for ten years to monitor and enforce the terms of the Final Judgment, should also set forth “a process whereby third parties may directly report violations of the Final Judgment by the Defendants.” The United States does not believe this is necessary. Third parties can already report such violations to the Antitrust Division of the Department of Justice or the Antitrust Bureau of the New York Attorney General's Office. Plaintiffs will take the appropriate steps to respond to any reported violations, including by applying to the Court to enforce compliance or punish violations pursuant to Section XIII of the proposed Final Judgment.
After carefully reviewing the public comment submitted by Big Bus, the United States has determined that the proposed Final Judgment, as drafted, provides an effective and appropriate remedy for the antitrust violation alleged in the Complaint and is therefore in the public interest. The United States will move this Court to enter the proposed Final Judgment after the public comment and this Response have been published in the
Employment and Training Administration, Labor.
Notice of Establishment of the Workforce Information Advisory Council and Solicitation of Nominations for Membership.
The Department of Labor (Department) announces the establishment of the Workforce Information Advisory Council (WIAC), invites interested parties to submit nominations for individuals to serve on the WIAC, and announces the procedures for those nominations.
Nominations for individuals to serve on the WIAC must be submitted (postmarked, if sending by mail; submitted electronically; or received, if hand delivered) by October 6, 2015.
You may submit nominations and supporting materials described in this
Kimberly Vitelli, Division of National Programs, Tools, and Technical Assistance, Office of Workforce Investment (address above); (202) 693-3045; or use email address for the WIAC,
Section 15 of the Wagner-Peyser Act, 29 U.S.C. 49
The statute, as amended, requires the Secretary, acting through the Commissioner of Labor Statistics and the Assistant Secretary for Employment and Training, to formally consult at least twice annually with the WIAC to address: (1) Evaluation and improvement of the nationwide workforce and labor market information system established by the Wagner-Peyser Act, and of the statewide systems that comprise the nationwide system, and (2) how the Department and the States will cooperate in the management of those systems. The Secretary, acting through the Bureau of Labor Statistics (BLS) and the Employment and Training Administration (ETA), and in consultation with the WIAC and appropriate Federal agencies, must also develop a 2-year plan for management of the system, with subsequent updates every two years thereafter. The statute generally prescribes how the plan is to be developed and implemented, outlines the contents of the plan, and requires the Secretary to submit the plan to designated authorizing committees in the House and Senate.
By law, the Secretary must “seek, review, and evaluate” recommendations from the WIAC, and respond to the recommendations in writing to the WIAC. The WIAC must make written recommendations to the Secretary on the evaluation and improvement of the workforce and labor market information system, including recommendations for the 2-year plan. The 2-year plan, in turn, must describe WIAC recommendations and the extent to which the plan incorporates them.
The Department anticipates that the WIAC will accomplish its objectives by, for example: (1) Studying workforce and labor market information issues; (2) seeking and sharing information on innovative approaches, new technologies, and data to inform employment, skills training, and workforce and economic development decision making and policy; and (3) advising the Secretary on how the workforce and labor market information system can best support workforce development, planning, and program development.
The Wagner-Peyser Act at section 15(d)(2)(B), requires the WIAC to have representative 14 members, appointed by the Secretary, consisting of:
(i) Four members who are representatives of lead State agencies with responsibility for workforce investment activities, or State agencies described in Wagner-Peyser Act section 4 (agency designated or authorized by Governor to cooperate with the Secretary), who have been nominated by such agencies or by a national organization that represents such agencies;
(ii) Four members who are representatives of the State workforce and labor market information directors affiliated with the State agencies responsible for the management and oversight of the workforce and labor market information system as described in Wagner-Peyser Act section 15(e)(2), who have been nominated by the directors;
(iii) One member who is a representative of providers of training services under WIOA section 122 (Identification of Eligible Providers of Training Services);
(iv) One member who is a representative of economic development entities;
(v) One member who is a representative of businesses, who has been nominated by national business organizations or trade associations;
(vi) One member who is a representative of labor organizations, who has been nominated by a national labor federation;
(vii) One member who is a representative of local workforce development boards, who has been nominated by a national organization representing such boards; and
(viii) One member who is a representative of research entities that use workforce and labor market information.
The Secretary must ensure that the membership of the WIAC is geographically diverse, and that no two members appointed under clauses (i), (ii), and (vii), above, represent the same State. Each member will be appointed for a term of three years, except that the initial terms for members may be one, two, or three years in order to establish a rotation in which one-third of the members are selected each year. The Secretary will not appoint a member for any more than two consecutive terms. Any member whom the Secretary appoints to fill a vacancy occurring before the expiration of the predecessor's term will be appointed only for the remainder of that term. Members of the WIAC will serve on a voluntary and generally uncompensated basis, but will be reimbursed for travel expenses to attend WIAC meetings, including per diem in lieu of subsistence, as authorized by the Federal travel regulations.
Of the seven types of members listed above and at section 15(d)(2), the Secretary may consider all nominations for three types, but for the other four, the Secretary may only appoint individuals nominated by particular organizations. Type (i) requires nomination from “lead State agencies with responsibility for workforce investment activities” and type (ii) requires nomination from “State workforce and labor market information directors.” Type (v) requires nomination by national business organizations or trade associations and type (vi) requires nomination by a national labor federation. But for types (iii), (iv), and (vii), any interested person or organization may nominate one or more qualified individuals for membership. If you would like to nominate an individual or yourself for appointment to the WIAC, please submit, to one of the addresses listed below, the following information:
• A copy of the nominee's biographical information and resume;
• A cover letter that provides your reason(s) for nominating the individual, the constituency area that they represent (as outlined above in the WIAC membership identification discussion), and their particular expertise for contributing to the national policy discussion on: (1) The evaluation and improvement of the nationwide workforce and labor market information system and statewide systems that comprise the nationwide system, and (2) how the Department and the States will cooperate in the management of those systems, including programs that produce employment-related statistics and State and local workforce and labor market information; and
• Contact information for the nominee (name, title, business address, business phone, fax number, and business email address).
In addition, the cover letter must state that the nomination is being made in response to this
Pursuant to the Wagner-Peyser Act of 1933, as amended, 29 U.S.C. 49
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Statement of Recovery Forms,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before September 8, 2015.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
44 U.S.C. 3507(a)(1)(D).
This ICR seeks approval under the PRA for revisions to the Statement of Recovery Forms information collection (Forms CA-1108 and CA-1122). The forms are used to obtain information about amounts received from a final judgments in litigation, or a settlement of the litigation, brought against a third party who is liable for damages due to a Federal employee comprehensive work-related injury. A Federal employee can sustain a work-related injury, for which he or she is eligible for compensation under the Federal Employees' Compensation Act (FECA), under circumstances that also create a legal liability for some third party to pay damages for the same injury. When this occurs, the FECA authorizes the Secretary of Labor either to require the employee to assign his or her right of action to the United States or to prosecute the action.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• 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;
• Enhance the quality, utility, and clarity of the information to be collected; 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,
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
All meetings are Eastern time and ending times are approximate:
National Endowment for the Arts, Constitution Center, 400 7th St. SW., Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Kathy Plowitz-Worden, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of February 15, 2012, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
The National Science Board, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of meetings for the transaction of National Science Board business, as follows:
August 12, 2015 from 8:00 a.m. to 4:45 p.m. and August 13, 2015 from 8:00 a.m. to 2:00 p.m. (EDT).
These meetings will be held at the National Science Foundation, 4201 Wilson Blvd., Room 1235, Arlington, VA 22230. All visitors must contact the Board Office (call 703-292-7000 or send an email message to
Public meetings and public portions of meetings will be webcast. To view the meetings, go to
Please refer to the National Science Board Web site for additional information. Meeting information and schedule updates (time, place, subject matter or status of meeting) may be found at
Ron Campbell,
Nadine Lymn,
Portions open; portions closed.
2:00 p.m.
9:30 a.m., Tuesday, August 11, 2015.
NTSB Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
The one item is open to the public.
8717—Highway Accident Report: Multivehicle Work Zone Crash on Interstate 95, Cranbury, New Jersey, June 7, 2014.
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314-6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates, including weather-related cancellations, are also available at
Candi Bing at (202) 314-6403 or by email at
Keith Holloway (202) 314-6100 or by email at
Nuclear Regulatory Commission.
License amendment application; opportunity to comment, request a hearing, and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Renewed Facility Operating License No. DPR-50, issued to Exelon Generation Company, LLC, for operation of the Three Mile Island Nuclear Station, Unit 1 (TMI or the licensee). The proposed amendment would modify the technical specifications to allow for the temporary connection of the borated water storage tank (BWST) to non-seismic piping for cleanup and recirculation to support activities associated with the TMI-1 fall 2015 Refueling Outage and Fuel Cycle 21 operation.
Submit comments by September 8, 2015. Requests for a hearing or petition for leave to intervene must be filed by October 6, 2015.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Robert L. Gladney, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-1022, email:
Please refer to Docket ID NRC-2015-0185 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-2015-0185 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 posts 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 submissions into ADAMS.
The NRC is considering issuance of an amendment to Renewed Facility Operating License No. DPR-50, issued to TMI, for operation of Unit 1, located in Dauphin County, Pennsylvania.
This amendment proposes changes to the technical specifications to allow for the temporary connection of the BWST to non-seismic piping for cleanup and recirculation to support activities associated with the TMI-1 Fall 2015 Refueling Outage and Fuel Cycle 21 operation.
Before any issuance of the proposed license amendment, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations.
The NRC has made a proposed determination that the license amendment request (LAR) involves no significant hazards consideration. Under the NRC's regulations in § 50.92 of Title 10 of the
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The use of the Liquid Waste Disposal System (WDL) and the Spent Fuel Pool Cooling System (SF) to re-circulate and cleanup the BWST contents does not involve any physical changes or modifications to the plant, or create any new interfaces with the reactor coolant system. Therefore, the connection of the WDL and SF to the BWST would not affect the probability of Large and Small Break Loss of Coolant Accidents occurring. The WDL and the applicable components of the SF are not credited for safe shutdown of the plant or accident mitigation. A technical evaluation was performed to validate the seismic adequacy of the WDL piping to withstand a Safe Shutdown Earthquake (SSE). The evaluation determined sufficient margin exists in the installed piping and supports such that during an SSE, the WDL system and piping would not lose pressure boundary integrity. In addition, as additional defense-in-depth measure, administrative controls ensure that the BWST can be isolated from seismic Class II WDL piping following an SSE. Since the BWST will continue to perform its safety functions and overall system performance is not affected, the consequences of an accident are not increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The design of the BWST, WDL and SF systems to allow recirculation and filtration/demineralization has not been altered. No new procedures are required to start or end BWST Cleanup or Recirculation operation. Proposed changes to the existing operating procedures will provide a higher priority and quicker response to isolate the BWST from seismic Class II piping paths, if operating in Cleanup or Recirculation modes, as an additional defense-in-depth administrative control during a seismic event. Since the seismic adequacy of the interconnected WDL system and piping has been evaluated for an SSE and validated by calculations to maintain pressure boundary integrity, the BWST safety functions are not affected.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The WDL and applicable components of the SF are not credited for safe shutdown of the plant or accident mitigation. The seismic adequacy of the BWST is maintained. The seismic evaluation determined that sufficient margin exists in the installed piping and supports such that during an SSE, the seismic Class II WDL system and piping would not lose pressure boundary integrity. Maximum piping and piping support stresses are below their respective allowables, are acceptable, and no pipe leakage will occur.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the LAR involves no significant hazards consideration.
The NRC is seeking public comments on this proposed determination that the LAR involves no significant hazards consideration. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-
Within 60 days after the date of publication of this
As required by 10 CFR 2.309, a request for hearing or petition for leave to intervene must set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The hearing request or petition must specifically explain the reasons why intervention should be permitted, with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The hearing request or petition must also include the specific contentions that the requestor/petitioner seeks to have litigated at the proceeding.
For each contention, the requestor/petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the requestor/petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the application. The hearing request or petition must also include a concise statement of the alleged facts or expert opinion that support the contention and on which the requestor/petitioner intends to rely at the hearing, together with references to those specific sources and documents. The hearing request or petition must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact, including references to specific portions of the application for amendment that the petitioner disputes and the supporting reasons for each dispute. If the requestor/petitioner believes that the application for amendment fails to contain information on a relevant matter as required by law, the requestor/petitioner must identify each failure and the supporting reasons for the requestor's/petitioner's belief. Each contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who does not satisfy these requirements for at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies, and procedures. The Atomic Safety and Licensing Board will set the time and place for any prehearing conferences and evidentiary hearings, and the appropriate notices will be provided.
Hearing requests or petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For further details with respect to this action, see the application for license amendment dated July 23, 2015 (ADAMS Accession No. ML15204A843), as supplemented by letter dated July 28, 2015 (ADAMS Accession No. ML15209A960).
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Director's decision under 10 CFR 2.206; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued a final director's decision with regard to a petition dated June 18, 2012, filed by Mr. Richard Ayres, Counsel for Friends of the Earth (the petitioner), requesting that the NRC take action with regard to Southern California Edison (SCE or the licensee) at the San Onofre Nuclear Generating Station (SONGS). The petitioner's requests and the final director's decision are included in the
Please refer to Docket ID NRC-2013-0083 when contacting the
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Thomas Wengert, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-4037, email:
Notice is hereby given that the Director, Office of Nuclear Reactor Regulation, has issued a director's decision (ADAMS Accession No. ML15183A164) on a petition filed by the petitioner on June 18, 2012 (ADAMS Accession No. ML12171A409). The petition was supplemented on November 16, 2012, January 16, 2013, and February 6, 2013 (ADAMS Accession Nos. ML12325A748, ML13029A643, and ML13109A075, respectively).
The petitioner requested that the NRC order SCE to submit a license amendment application for the design and installation of the SONGS, Units 2 and 3, replacement steam generators.
As the basis of the request, the petitioner asserted that the licensee violated section 50.59 of Title 10 of the
On January 16, 2013, the petitioner met with the NRC's Petition Review Board (PRB). The meeting provided the petitioner and the licensee an opportunity to provide additional information and to clarify issues cited in the petition. During the PRB meeting, the petitioner further requested that the NRC suspend SCE's licenses until they are amended. The transcript for that meeting was treated as a supplement to the petition and is available in ADAMS under Accession No. ML13029A643.
The NRC sent a copy of the proposed director's decision to the petitioner and the licensee for comment on February 27, 2015 (ADAMS Accession Nos. ML15020A121 and ML15020A165, respectively). The petitioner and the licensee were asked to provide comments within 30 days on any part of the proposed director's decision that was considered to be erroneous or any issues in the petition that were not addressed. Comments were received from the petitioner and are addressed in an attachment to the final director's decision. The licensee had no comments on the proposed director's decision; however, the licensee did provide a response to the petitioner's comments. The NRC staff reviewed the response from the licensee and determined that, because the licensee's comments are direct rebuttals to the petitioner's comments and raised no concerns with the director's decision, no changes to the director's decision are required as a result of these comments.
The Director of the Office of Nuclear Reactor Regulation has determined that the requests for the NRC to order the licensee to submit a license amendment application for the design and installation of the SONGS, Units 2 and 3, replacement steam generators and to suspend SCE's licenses until they are amended be denied. The reasons for this decision are explained in the director's decision (DD-15-07) pursuant to 10 CFR 2.206, “Requests for action under this subpart,” of the Commission's regulations.
The NRC will file a copy of the director's decision with the Secretary of the Commission for the Commission's review in accordance with 10 CFR 2.206. As provided by this regulation, the director's decision will constitute the final action of the Commission 25 days after the date of the decision unless the Commission, on its own motion, institutes a review of the director's decision in that time.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Supplemental environmental impact statement; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final plant-specific supplement, Supplement 46, to NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants” (GEIS), regarding the renewal of NextEra Energy Seabrook, LLC (NextEra) operating license NPF-86 for an additional 20 years of operation for Seabrook Station, Unit 1 (Seabrook).
The final Supplement 46 to the GEIS is available as of August 7, 2015.
Please refer to Docket ID NRC-2010-0206 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:
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Lois James, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3306; email:
In accordance with § 51.118 of Title 10 of the
As discussed in Section 9.4 of the final Supplement 46 to the GEIS, the NRC determined that the adverse environmental impacts of license renewal for Seabrook are not so great that preserving the option of license renewal for energy-planning decisionmakers would be unreasonable. This recommendation is based on: (1) the analysis and findings in the GEIS; (2) information provided in the environmental report and other documents submitted by NextEra; (3) consultation with Federal, State, local, and Tribal agencies; (4) the NRC staff's independent environmental review; and (5) consideration of public comments received during the scoping process and on the draft Supplemental Environmental Impact Statement.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a revised regulatory guide, (RG) 5.27, Revision 1, “Special Nuclear Material Doorway Monitors.” This guidance addresses NRC requirements that individuals must be searched as they leave a material access area (MAA) for facilities that contain special nuclear material (SNM) of a type and quantity that require an MAA.
Please refer to Docket ID NRC-2014-0062 when contacting the NRC about the availability of information regarding this document. You may access information related to this document, which the NRC possesses and is publicly available, using the following methods:
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Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Al Tardiff, Office of Nuclear Security and Incident Response, telephone: 301-415-7015, email:
The NRC is issuing a new guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information such as methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its review of applications for permits and licenses.
Regulatory Guide 5.27, Revision 1 was issued for comment as Draft Regulatory Guide (DG) 5038. The NRC developed this regulatory guide to describe a method that the NRC staff considers acceptable to implement the search requirement for concealed SNM applied to personnel exiting a material access area MAA. For holders of a reactor license under part 50 of title 10 of the
This RG is being revised because it was out-of-date with current, related
DG-5038 was published in the
This regulatory guide 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 RG applies to applicants for, and current and future holders of special nuclear material licenses under 10 CFR part 70, and operating licenses under part 50, combined licenses under part 52, and certificates of compliance or approvals of a compliance plan for gaseous diffusion plants under part 76 if they are also applicants for, or holders of, special nuclear material licenses under part 70. Issuance of this RG does not constitute backfitting under 10 CFR parts 50, 70, or 76, and is not otherwise inconsistent with the issue finality provisions in 10 CFR part 52. As discussed in the “Implementation” section of the RG, the NRC has no current intention to impose this RG on holders of part 50 operating licenses, part 52 combined licenses, part 70 licensees, or part 76 certificates of compliance. Moreover, the guidance in the RG addresses security issues, which are matters separate from the technical requirements to operate a facility covered by backfitting and issue finality provisions.
The NRC has determined that the backfit provisions in § 50.109 do not apply to non-power reactor licensees because the rulemaking record for § 50.109 indicates that the Commission likely intended to apply this provision to only power reactors, and NRC practice has been consistent with this rulemaking record. The part 52 issue finality provisions do not apply to non-power reactors because part 52 does not apply to non-power reactors.
This RG could be applied to applications for part 50 operating licenses, part 52 combined licenses, part 70 licenses, and part 76 certificates of compliance docketed by the NRC as of the date of issuance of the RG, as well as future such applications submitted after the issuance of the RG. Such action would not constitute backfitting as defined in 10 CFR 50.109, 70.76, or 76.76, or be otherwise inconsistent with the applicable issue finality provision in 10 CFR part 52, inasmuch as such applicants or potential applicants are not within the scope of entities protected by 10 CFR 50.109, 70.76, and 76.76, or the relevant issue finality provisions in part 52. Backfitting restrictions were not intended to apply to every NRC action that substantially changes settled expectations, and applicants have no reasonable expectation that future requirements may change,
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management.
Notice.
The Office of Personnel Management (OPM) is announcing an upcoming FEGLI Open Season and changes in premium rates for certain Federal Employees' Group Life Insurance (FEGLI) categories in accordance with sections 870.401(a)(2) and 870.402(a)(3) of title 5 of the Code of Federal Regulations. These include changes to premium rates for Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after January 1, 2016. The FEGLI Open Season will be held from September 1, 2016 through September 30, 2016.
These rates will be effective the first pay period beginning on or after January 1, 2016.
Delon Pinto,
This notice announces an upcoming FEGLI Open Season between September 1, 2016 and September 30, 2016 and also announces changes to FEGLI Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance.
Open Seasons are one method by which healthy individuals can be attracted to join and reduce the risk profile of the program. Some less healthy individuals may elect coverage during Open Seasons. To mitigate this risk, the effective date for employees in active pay status who make an Open Season election would be delayed one full year to October 1, 2017, subject to FEGLI law and regulation, including applicable pay and duty status requirements.
FEGLI premium rates are assessed based on Program experience in accordance with FEGLI statutes at 8711(b), 8714a(e), 8714b(e), and 8714c(e), and OPM's Annual FEGLI Rate Review Process. The premium rates in the FEGLI program represent estimates of premium income necessary to pay future expected benefits costs. The rates for all coverage categories are specific to the experience of the FEGLI group and are not based on mortality rates within the general population. Actuarial analysis of changing mortality rates makes periodic premium adjustments necessary.
OPM has completed a study of funding and claims experience within the FEGLI Program. Based on this updated actuarial analysis of actual claims experience, OPM has determined that changes are required to Option A, Option B, Option C and Post-Retirement Basic Insurance premiums. These changes reflect updated mortality and claims rates from actual program experience within each FEGLI category.
We will issue guidance to all agencies for the purpose of counseling employees and we will notify affected annuitants directly via OPM's Office of Retirement Services. The FEGLI premium rates will be maintained on the FEGLI Web site
The new FEGLI premium rates for Option A, Option B, Option C and the Post-Retirement Basic Option are as follows:
Premium rates for Basic Employee insurance will not change at this time. These rates will be effective the first pay period beginning on or after January 1, 2016.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On July 31, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015-119 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than August 10, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
1. The Commission establishes Docket No. CP2015-119 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed as the Public Representative in this proceeding.
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 139 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-76 and CP2015-120 to consider the Request pertaining to the
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than August 10, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Katalin K. Clendenin to serve as Public Representative in these dockets.
It is ordered:
1. The Commission establishes Docket Nos. MC2015-76 and CP2015-120 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On July 31, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015-122 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than August 10, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints JP Klingenberg to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015-122 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, JP Klingenberg is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an amendment to the existing Priority Mail Contract 83 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On July 31, 2015, the Postal Service filed notice that it has agreed to an Amendment to the existing Priority Mail Contract 83 negotiated service agreement approved in this docket.
The Postal Service also filed the unredacted Amendment under seal. The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal.
The Amendment changes the volume commitment provision in Section I.E of the contract.
The Postal Service intends for the Amendment to become effective one business day after the date that the Commission completes its review of the Notice.
The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than August 10, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints JP Klingenberg to represent the interests of the general public (Public Representative) in this docket.
It is ordered:
1. The Commission reopens Docket No. CP2014-56 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, the Commission appoints JP Klingenberg to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Express Contract 26 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-77 and CP2015-121 to consider the Request pertaining to the proposed Priority Mail Express Contract 26 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than August 12, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
It is ordered:
1. The Commission establishes Docket Nos. MC2015-77 and CP2015-121 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than August 12, 2015.
4. The Secretary shall arrange for publication of this order in the
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On July 31, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a),
The Commission establishes Docket No. CP2015-118 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than August 10, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015-118 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning change in rates not of general applicability for Inbound EMS 2. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
To accompany its Notice, the Postal Service filed the following attachments:
• Attachment 1—an application for non-public treatment of materials filed under seal;
• Attachment 2A—a redacted copy of Governors' Decision No. 08-20;
• Attachment 2B—a redacted copy of Governors' Decision No. 11-6;
• Attachment 3—a redacted copy of the new rates;
• Attachment 4—a copy of the certification required under 39 CFR 3015.5(c)(2); and
• Attachment 5—the most recent annual EMS Pay-for-Performance Plan available, the most recent annual Report Card, and all available quarterly Report Cards for the calendar year preceding the effective date of the Inbound EMS 2 rates that are the subject of the filing.
Notice at 2-3.
The material filed under seal consists of unredacted copies of Governors' Decision Nos. 08-20 and 11-6, the new rates, and related financial information.
Further, in Docket No. CP2013-77, the Postal Service notified the Commission of a pricing separation of Tier 1 for Pay-for-Performance members into Tiers 1a and 1b.
The Commission establishes Docket No. CP2015-117 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, or 3633, and 39 CFR part 3015. Comments are due no later than August 10, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Katalin K. Clendenin to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015-117 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than August 10, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2015, it filed with the Postal Regulatory Commission a
PDK Energy, Inc. (CIK No. 0001497126) is a Mississippi corporation located in Ann Arbor, Michigan with a class of securities registered with the Securities and Exchange Commission (“Commission”) pursuant to Section 12(g) of the Securities Exchange Act of 1934 (“Exchange Act”). PDK Energy, Inc. is delinquent in its periodic filings with the Commission, having not filed any periodic reports since it filed a Form 10-Q for the period ended April 30, 2013. On January 26, 2015, the Division of Corporation Finance sent PDK Energy, Inc. a delinquency letter requesting compliance with its periodic filing obligations, but the letter was returned because of PDK Energy, Inc.'s failure to maintain a valid address on file with the Commission. As of June 16, 2015, the company's stock (symbol “PDKI”) was quoted on OTC Link (previously, “Pink Sheets”) operated by OTC Markets Group, Inc., had two market makers, and was eligible for the “piggyback” exception of Exchange Act Rule 15c2-11(f)(3).
It appears to the Commission that there is a lack of current and accurate information concerning the securities of PDK Energy, Inc. because it has not filed any periodic reports since its Form 10-Q for the period ended April 30, 2013. The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of PDK Energy, Inc.
Therefore, it is ordered, pursuant to Section 12(k) of the Exchange Act, that trading in the securities of PDK Energy, Inc. is suspended for the period from 9:30 a.m. EDT on August 5, 2015, through 11:59 p.m. EDT on August 18, 2015.
By the Commission.
Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its rules related to disruptive trading practices. The scope of this filing is limited solely to the application of the rule amendments to security futures that are permitted for trading on CFE. The only security futures that previously traded on CFE were traded under Chapter 16 of CFE's Rulebook, which is applicable to Individual Stock Based and Exchange-Traded Fund Based Volatility Index security futures. No security futures are currently listed for trading on CFE. The text of the proposed rule change is attached as Exhibit 4 to the filing but is not attached to the publication of this notice.
In its filing with the Commission, CFE included statements concerning the
The purpose of the proposed CFE rule amendments included as part of this rule change is to amend CFE Rule 620 (Disruptive Practices) and add CFE Policy and Procedure XVIII (Disruptive Trading Practices (Rule 620)) to provide further guidance on prohibited disruptive trading practices. The rule amendments included as part of this rule change are to apply to all products traded on CFE. As previously noted, no security futures are currently listed for trading on the Exchange.
CFE Rule 620 currently prohibits the disruptive practices enumerated in Section 4c(a)(5) of the CEA,
The amendments add new paragraph (b) to Rule 620, which sets forth particular types of disruptive order entry and trading practices that CFE considers to be abusive to the orderly conduct of trading or the fair execution of transactions. Specifically, the amendments add the following language as new subsection (b) to Rule 620:
(b) All Orders must be entered for the purpose of executing bona fide transactions. Additionally, all non-actionable messages must be entered in good faith for legitimate purposes.
(i) No Person shall enter or cause to be entered an Order or quote with the intent, at the time of entry, to cancel the Order or quote before execution or to modify the Order or quote to avoid execution;
(ii) No Person shall enter or cause to be entered an actionable or non-actionable message or messages with intent to mislead other market participants;
(iii) No Person shall enter or cause to be entered an actionable or non-actionable message or messages with intent to overload, delay, or disrupt the systems of the Exchange or other market participants; and
(iv) No Person shall enter or cause to be entered an actionable or non-actionable message with intent to disrupt, or with reckless disregard for the adverse impact on, the orderly conduct of trading or the fair execution of transactions.
The provisions of this Rule apply to all market states, including the pre-opening period, the closing period, and all trading sessions.
These amendments are consistent with similar rules and guidance established and provided by other designated contract markets (“DCMs”) regarding disruptive practices.
The Exchange understands that there is a desire by many market participants for uniformity and consistency among DCMs to have similar rules and interpretations regarding disruptive trading practices. CFE states that this current filing closely tracks the provisions adopted by CME, ICE and NFX and deviates as needed when issues or topics addressed by the other DCMs do not apply to CFE,
The amendments add new CFE Policy and Procedure XVIII, which lists various factors that the Exchange may consider in assessing whether conduct violates CFE Rule 620 and provides a non-exhaustive list of examples of activity considered by CFE to be in violation of Rule 620. Specifically, the amendments provide the following as new Policy and Procedure XVIII:
Rule 620 prohibits disruptive trading practices as described by the Rule. The following are a non-exclusive list of factors that the Exchange may consider in assessing whether conduct violates Rule 620.
The Exchange may consider a variety of factors in assessing whether conduct violates Rule 620, including, but not limited to:
• Whether the market participant's intent was to induce others to trade when they otherwise would not;
• whether the market participant's intent was to affect a price rather than to change the market participant's position;
• whether the market participant's intent was to create misleading market conditions;
• market conditions in the impacted market(s) and related markets;
• the effect on other market participants;
• the market participant's historical pattern of activity;
• the market participant's Order
• the size of the Order(s) relative to market conditions at the time the Order(s) was placed;
• the size of the Order(s) relative to the market participant's position and/or capitalization;
• the number of Orders;
• the ability of the market participant to manage the risk associated with the Order(s) if fully executed;
• the duration for which the Order(s) is exposed to the market;
• the duration between, and frequency of, non-actionable messages;
• the queue position or priority of the Order in the order book;
• the prices of preceding and succeeding bids, offers, and trades;
• the change in the best offer price, best bid price, last sale price, or other price (such as the Expected Opening Price (“EOP”)) that results from the entry of the Order; and
• the market participant's activity in related markets.
The language is intended to be a more specific statement of the general requirement that market participants are not permitted to act in violation of just and equitable principles of trade. This section of the Rule prohibits a market participant from entering Orders or messages with the intent of creating the false impression of market depth or market interest. The Exchange generally will find the requisite intent where the purpose of the participant's conduct was, for example, to induce another market participant to engage in market activity.
Although the amount of time an Order is exposed to the market may be a factor that is considered when determining whether the Order constituted a disruptive trading practice, there is no prescribed safe harbor. The Exchange will consider a variety of factors, including exposure time, to determine whether an Order or Orders constitute a disruptive practice.
An Order, entered with the intent to execute a bona fide transaction, that is subsequently modified or cancelled due to a perceived change in circumstances does not constitute a violation of Rule 620.
An unintentional, accidental, or “fat-finger” Order will not constitute a violation of Rule 620, but such activity may be a violation of other Exchange rules, including, but not limited to, Rule 608 (Acts Detrimental to the Exchange; Acts Inconsistent with Just and Equitable Principles of Trade; Abusive Practices). Market participants are expected to take steps to mitigate the occurrence of errors, and their impact on the market. This is particularly true for entities that run algorithmic trading applications, or otherwise submit large numbers of automated Orders to the market.
While execution of an Order, in part or in full, may be one indication that an Order was entered in good faith, an execution does not automatically cause the Order to be considered compliant with Rule 620. Orders must be entered in an attempt to consummate a trade. A variety of factors may lead to a violative Order ultimately achieving an execution. The Exchange will consider a multitude of factors in assessing whether Rule 620 has been violated.
Market participants are not precluded from making unequal markets as long as the Orders are entered for the purpose of executing bona fide transactions. If either (or both) Order(s) are entered with prohibited intent, including recklessness, such activity will constitute a violation of Rule 620.
Market participants may enter Stop Limit Orders as a means of minimizing potential losses with the hope that the Order will not be triggered. However, it must be the intent of the market participant that the Order will be executed if the specified condition is met. Such an order entry is not prohibited by this Rule.
It is understood that market participants may want to achieve queue position at certain price levels, and given changing market conditions may wish to modify or cancel those Orders. In the absence of other indicia that the Orders were entered for disruptive purposes, they would not constitute a violation of Rule 620.
Actionable messages are messages that can be accepted by another party or otherwise lead to the execution of a trade. An example of an actionable message is an Order message. Non-actionable messages are those messages submitted to the Exchange that relate to a non-actionable event. An example of a non-actionable message is a Request for Quote.
Whether a market participant intends to disrupt the orderly conduct of trading or the fair execution of transactions or demonstrates a reckless disregard for the orderly conduct of trading or the fair execution of transactions may be evaluated only in the context of the specific instrument, market conditions, and other circumstances present at the time in question. Some of the factors that may be considered in determining whether there was orderly conduct or the fair execution of transactions were described by the Commission as follows: “[A]n orderly market may be characterized by, among other things, parameters such as a rational relationship between consecutive prices, a strong correlation between price changes and the volume of trades, levels of volatility that do not dramatically reduce liquidity, accurate relationships between the price of a derivative and the underlying such as a physical commodity or financial instrument, and reasonable spreads between contracts for near months and for remote months.” Antidisruptive Practices Authority, 78 FR at 31,895-96. Volatility alone, however, will not be presumptively interpreted as disorderly or disruptive as market volatility can be consistent with markets performing their price discovery function.
The size of an Order or cumulative Orders may be deemed to violate Rule 620 if the entry results in disorderliness in the markets, including, but not limited to, price or volume aberrations. Market participants should further be aware that the size of an Order may be deemed to violate Rule 620 if that Order distorts the integrity of the settlement prices. Accordingly, market participants should be cognizant of the market characteristics of the products they trade and ensure that their Order entry activity does not result in market disruptions. Exigent circumstances may be considered in determining whether a violation of Rule 620 has occurred and, if so, what the appropriate sanction should be for such violation.
“Closing period” typically refers to the period during which transactions, bids, and offers are reviewed for purposes of informing settlement price determinations.
Proof of intent is not limited to instances in which a market participant admits the market participant's state of mind. Where the conduct was such that it more likely than not was intended to produce a prohibited disruptive consequence, intent may be found. Claims of ignorance, or lack of
A “momentum ignition” strategy occurs when a market participant initiates a series of Orders or trades in an attempt to ignite a price movement in that market or a related market.
This conduct may be deemed to violate Rule 620 if it is determined the intent was to disrupt the orderly conduct of trading or the fair execution of transactions, if the conduct was reckless, or if the conduct distorted the integrity of the determination of settlement prices. Further, this activity may violate Rule 620(b)(i) if the momentum igniting Orders were intended to be canceled before execution, or if the Orders were intended to mislead others. If the conduct was intended to create artificially high or low prices, this may also constitute a violation of Rule 603 (Market Manipulation).
Flipping is defined as the entry of Orders or trades for the purpose of causing turns of the market and the creation of volatility and/or instability.
A “flip” Order typically has two main characteristics. First, it is an aggressor Order (
Flipping activity may, however, be disruptive to the marketplace. For example, repeated instances of a market participant entering flipping Orders that are each large enough to turn the market (
• The impact on other market participants;
• price fluctuations;
• market conditions in the impacted market(s) and related markets;
• the participant's activity in related markets;
• whether the flip involved the cancellation of a large sized Order(s) relative to the existing bid or offer depth; and
• whether repeated flipping turns the market back and forth (
The means by which an Order is cancelled, in and of itself, is not an indicator of whether an Order violates Rule 620. The use of self-trade prevention functionality in a manner that causes a disruption to the market may constitute a violation of Rule 620. Further, if the resting Order that was cancelled was non-bona fide
Orders entered during the pre-opening period and opening rotation period must be entered for the purpose of executing bona fide transactions upon the opening of the market.
The entry and cancellation of Orders during the pre-opening period and opening rotation period for the purpose of either manipulating the EOP or attempting to identify the depth of the order book at different price levels is prohibited and may be deemed a violation of Rule 620 or other rules.
Other activity related to the pre-opening period may also be considered disruptive, including but not limited to the entry of orders prior to the commencement of the pre-opening period in an attempt to “time” the price-time priority queue for Trade at Settlement (“TAS”) transactions, or other similar purposes.
The entering of an Order(s) without the intent to execute a bona fide transaction, including for the purpose of verifying connectivity or checking a data feed, is not permissible. CFE provides a testing environment and test symbols in CBOE Command for TPHs to use for the purpose of testing.
Trading Privilege Holders are not permitted to attempt to create any user-defined spreads (
Market participants are reminded that knowingly creating and/or trading spreads in a manner intended to deceive or unfairly disadvantage other market participants is considered a violation of Rule 620.
The following is a non-exhaustive list of various examples of conduct that may be found to violate Rule 620.
• A market participant enters one or more Orders to generate selling or buying interest in a specific contract. By entering the Orders, often in substantial size relative to the contract's overall pending order volume, the market participant creates a misleading and artificial appearance of buy- or sell-side pressure. The market participant places these large Orders at or near the best bid and offer prevailing in the market at the time. The market participant benefits from the market's reaction by either receiving an execution on an already resting Order on the opposite side of the book from the larger Order(s) or by obtaining an execution by entering an opposing side Order subsequent to the market's reaction. Once the smaller Orders are filled, the market participant cancels the large Orders that had been designed to create the false appearance of market activity. Placing a bona fide Order on one side of the market while entering Order(s) on the other side of the market without intention to trade those Orders violates Rule 620.
• A market participant places buy (or sell) Orders that the market participant
• A market participant enters one or more Orders in a particular market (Market A) to identify algorithmic activity in a related market (Market B). Knowing how the algorithm will react to order activity in Market A, the participant first enters an Order or Orders in Market B that the market participant anticipates would be filled opposite the algorithm when ignited. The participant then enters an Order or Orders in Market A for the purpose of igniting the algorithm and creating momentum in Market B. This results in the market participant's Order(s) in Market B being filled opposite the algorithm. This conduct violates Rule 620(b)(i), as the Orders in Market A were not intended to be executed, and Rule 620(b)(ii), as the Orders in Market A were intended to mislead participants in related markets. If the conduct resulted in a disruption to the orderly execution of transactions, it may also violate Rule 620(b)(iv).
• A market participant enters a large aggressor buy (sell) Order at the best offer (bid) price, trading opposite the resting sell (buy) Orders in the book, which results in the remainder of the original aggressor Order resting first in the queue at the new best bid (offer). As the market participant anticipated and intended, other participants join the market participant's best bid (offer) behind the market participant in the queue. The market participant then enters a large aggressor sell (buy) Order into the market participant's now resting buy (sell) Order at the top of the book. The market participant's use of CFE's Self-Trade Prevention functionality or other wash blocking functionality cancels the market participant's resting buy (sell) Order, such that market participant's aggressor sell (buy) Order then trades opposite the Orders that joined and were behind the market participant's best bid (offer) in the book.
• A market participant places large quantity Orders during the pre-opening period in an effort to artificially increase or decrease the EOP with the intent to attract other market participants. Once others join the market participant's bid or offer, the market participant cancels the market participant's Orders shortly before the opening.
• During the pre-opening period, a market participant enters a large Order priced at a bid higher than the existing best bid or at an offer lower than the existing best offer, and continues to systematically enter successive Orders priced further through the book until it causes a movement in the best bid or best offer. These Orders are subsequently cancelled. The market participant continues to employ this strategy on both sides of the market for the purpose of determining the depth of support at a specific price level for the product before the market opens.
• A market participant enters a large number of messages for the purpose of overloading the quotation systems of other market participants with excessive market data messages to create “information arbitrage.”
• A market participant enters messages for the purpose of creating latencies in the market or in information dissemination by the Exchange for the purpose of disrupting the orderly functioning of the market.
As with the amendments to CFE Rule 620, these amendments are consistent with similar rules and guidance established and provided by other DCMs regarding disruptive practices.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
• To prevent fraudulent and manipulative acts and practices,
• to promote just and equitable principles of trade,
• to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and
• to remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest.
The Exchange believes that the proposed rule change would strengthen its ability to carry out its responsibilities as a self-regulatory organization by providing further guidance regarding the type of activity that is prohibited under CFE Rule 620. CFE Rule 620 currently prohibits the disruptive trading practices that were added to the CEA by the Dodd-Frank Act and are codified under Section 4c(a)(5) of the CEA. The proposed rule change sets forth particular types of disruptive order entry and trading practices that are prohibited under Rule 620, lists various factors that the Exchange may consider in assessing whether conduct violates Rule 620, and provides a non-exhaustive list of examples of activity considered by CFE to be in violation of Rule 620. By providing this further guidance, the proposed rule change not only will provide greater clarity to market participants regarding prohibited disruptive trading practices but also will strengthen the Exchange's disciplinary program for these types of violative behavior. As a result, the Exchange believes that the proposed rule change is equitable and not unfairly discriminatory because the amendments regarding disruptive trading practices will apply equally to all market participants. In addition, the proposed rule change will promote consistency in guidance for market participants regarding disruptive trading practices by paralleling similar guidance provided by other DCMs.
CFE does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, in that the rule change will enhance CFE's ability to carry out its responsibilities as a self-regulatory organization. The proposed rule change is not designed to address any aspect of competition, whether between the Exchange and its competitors, or among market participants. Instead, the proposed rule change is designed to make CFE's disruptive trading practice rules consistent with the existing rules and guidance published by other DCMs.
No written comments were solicited or received with respect to the proposed rule change.
The proposed rule change will become effective on July 30, 2015. At any time within 60 days of the date of effectiveness of the proposed rule change, the Commission, after consultation with the CFTC, may summarily abrogate the proposed rule
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.
Solar Acquisition Corp. (CIK No. 0001375495) is a Florida corporation located in Ann Arbor, Michigan with a class of securities registered with the Securities and Exchange Commission (“Commission”) pursuant to Section 12(g) of the Securities Exchange Act of 1934 (“Exchange Act”). Solar Acquisition Corp. is delinquent in its periodic filings with the Commission, having not filed any periodic reports since it filed a Form 10-K for the period ended December 31, 2012. On November 6, 2014, the Division of Corporation Finance sent Solar Acquisition Corp. a delinquency letter requesting compliance with its periodic filing obligations, but the letter was returned because of Solar Acquisition Corp.'s failure to maintain a valid address on file with the Commission. As of June 16, 2015, the company's stock (symbol “SLRX”) was quoted on OTC Link (previously, “Pink Sheets”) operated by OTC Markets Group, Inc., had eight market makers, and was eligible for the “piggyback” exception of Exchange Act Rule 15c2-11(f)(3).
It appears to the Commission that there is a lack of current and accurate information concerning the securities of Solar Acquisition Corp. because it has not filed any periodic reports since its Form 10-K for the period ended December 31, 2012. The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of Solar Acquisition Corp.
Therefore, it is ordered, pursuant to Section 12(k) of the Exchange Act, that trading in the securities of Solar Acquisition Corp. is suspended for the period from 9:30 a.m. EDT on August 5, 2015, through 11:59 p.m. EDT on August 18, 2015.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend FINRA Rule 6730 (Transaction Reporting) to require an indicator when the TRACE report does not reflect a commission or mark-up/mark-down.
Below is the text of the proposed rule change. Proposed new language is in italics.
(a) through (b) No Change.
(c) Transaction Information To Be Reported.
Each TRACE trade report shall contain the following information:
(1) through (10) No Change.
(11) The commission (total dollar amount)
(12) through (13) No Change.
(d) Procedures for Reporting Price, Capacity, Volume.
(1) Price.
For principal transactions, report the price, which must include the mark-up or mark-down. (However, if a price field is not available, report the contract amount and, if applicable, the accrued interest.) For agency transactions, report the price, which must exclude the commission. (However, if a price field is not available, report the contract amount and, if applicable, the accrued interest.) Report the total dollar amount of the commission
(2) through (3) No Change.
(4) Modifiers; Indicators.
Members shall append the applicable trade report modifiers or indicators as specified by FINRA to all transaction reports.
(A) through (E) No Change.
(F) No Remuneration Indicator.
Where a trade report does not reflect either a commission, mark-up or mark-down, select the No Remuneration indicator.
(e) through (f) No Change.
• • • Supplementary Material:
.01 through .02 No Change.
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FINRA Rule 6730 (Transaction Reporting) sets forth the requirements applicable to members reporting transactions in TRACE-Eligible Securities,
FINRA is proposing that firms identify those transactions for which a commission or mark-up/mark-down is not reflected in a TRACE trade report because the firm does not charge or does not know the amount of the commission or mark-up/mark-down at the time of TRACE reporting. For example, some firms may assess a charge that is not transaction-based, such as in the case of a “fee-based account” where remuneration is based upon assets under management (and individual commissions or mark-ups/mark-downs are not charged).
By way of further example, some firms charge a commission or mark-up/mark-down, but may not know the exact amount of that commission or mark-up/mark-down at the time the TRACE transaction report is required to be submitted because of their remuneration structure (
FINRA therefore proposes to require firms to identify such trades, and FINRA will flag these disseminated transactions as not being inclusive of remuneration.
FINRA also believes that this proposal will enhance its regulatory audit trail
FINRA discussed the proposal with advisory committees in developing its approach. These parties were supportive of the proposal, believing that it would improve the value of information for TRACE-Eligible Securities that is submitted to FINRA, and, by extension, to investors and market participants. With regards to effort involved in affecting the change, committee members did not express any particular concerns with respect to the operational impacts or costs of the proposal. However, as to facilitate planning and scheduling, firms specifically requested that sufficient lead-time be provided when determining the effective date of the rule. Further discussions with firms that would be directly impacted by the proposal also indicated that the proposal would be beneficial to market participants, and that the necessary technological changes would not be unduly burdensome given an adequate implementation timeframe.
If the Commission approves the proposed rule change, the proposed rule change shall be effective upon Commission approval. The implementation date will be May 23, 2016.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA believes that this proposal is consistent with the Act because the additional identifier will enhance its regulatory audit trail and surveillance patterns. With this additional level of detail, surveillance patterns should yield fewer false positives regarding mark-up and best execution surveillance, reduce regulatory inquiries, and provide greater focus for FINRA's regulatory efforts. For example, without this designation, FINRA's surveillance patterns for best execution may generate an alert for transactions whose prices reflect a commission or a mark-up as being outliers compared to transactions whose prices do not reflect a charge. FINRA also believes that the proposal will improve the information value of TRACE reports as investors and other market participants will receive additional information regarding pricing information for TRACE-Eligible Securities. Finally, FINRA believes that this proposal would permit firms additional flexibility in structuring their fee arrangements with investors, which may provide cost benefits to such investors.
FINRA 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. FINRA notes that the proposed rule change is designed to assist FINRA in meeting its regulatory obligations by enhancing its audit trail and surveillance patterns. While this proposal will require members to meet the proposed reporting obligation, ensure that they can properly ascertain transactions that require the new identifier, and update their compliance procedures and reporting protocols accordingly, FINRA notes that this proposal will apply uniformly to firms that report transactions in TRACE-Eligible Securities. FINRA also believes that this proposal will allow firms more flexibility in designing their fee structures.
As set forth above, FINRA has undertaken an economic impact assessment to further analyze, among other things, the need for the proposed rulemaking and the economic impacts of the proposed rulemaking. As discussed above, FINRA does not believe that the compliance costs associated with the proposal would be unduly burdensome given an adequate implementation timeframe.
FINRA has undertaken an economic impact assessment, as set forth below, to further analyze the need for the proposed rulemaking, the regulatory objective of the rulemaking, the economic baseline of analysis, and the economic impacts.
FINRA believes that pricing information disseminated today may be incomplete and, in some cases, misleading given that disseminated prices on transactions that do not include remuneration are not distinguished from transactions that do include a commission or mark-up/mark-down.
FINRA believes that the proposal will provide more meaningful pricing transparency through TRACE by identifying those transactions where no commission or mark-up/mark-down was charged or known at the time of TRACE reporting, while not inhibiting possible firm fee remuneration arrangements, particularly if these fee arrangements benefit customers. FINRA also believes that the additional identifier will enhance its regulatory audit trail and surveillance patterns, because it will require the firm to affirmatively report this information related to the commission or mark-up/mark-down and will enable FINRA to more efficiently separate out no-remuneration trades for purposes of surveillance, analysis, and dissemination.
The staff analyzed corporate bond transactions reported to TRACE in Q3 2013.
Corporate bond transactions represented approximately 73% of all transactions reported to TRACE in 2013.
During Q3 2013, the daily average number of agency-capacity transactions in corporate bonds was 9,100.
During Q3 2013, the daily average number of principal-capacity transactions in corporate bonds was just under 48,000.
FINRA believes that the proposal will enable market participants, including investors relying on TRACE for valuation information, to better understand the prevailing market prices by being able to distinguish between transactions that include remuneration and those that do not. As discussed above, FINRA further believes that the additional identifier will enhance its regulatory audit trail and surveillance patterns. With this additional level of detail, surveillance patterns should yield fewer false positives regarding mark-up and best execution surveillance, reduce regulatory inquiries, and provide greater focus for FINRA's regulatory efforts. For example, without this designation, FINRA's surveillance patterns for best execution may generate an alert for transactions whose prices reflect a commission or a mark-up as being outliers compared to transactions whose prices do not reflect a charge.
The proposal will require member firms to meet the proposed reporting obligation, ensure that they can properly ascertain transactions that require the new identifier, and update their compliance procedures and reporting protocols accordingly. Member firms would also need to make technological changes to their systems to include the identifier. Based on discussions with advisory committees and member firms, FINRA does not believe that the compliance costs associated with the proposal would be unduly burdensome given an adequate implementation timeframe.
Written comments were neither solicited nor received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
• 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.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of July 2015. A copy of each application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
The Commission: Brent J. Fields, Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Diane L. Titus at (202) 551-6810, SEC, Division of Investment Management, Chief Counsel's Office, 100 F Street NE., Washington, DC 20549-8010.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Dakota (FEMA-4233-DR), dated 07/30/2015.
Submit completed loan applications to: U.S. Small Business Administration Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 07/30/2015, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14399B and for economic injury is 14400B.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Vermont (FEMA-4232-DR), dated 07/29/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 07/29/2015, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14397B and for economic injury is 14398B.
National Women's Business Council.
Notice of open Public Meeting.
The U.S. Small Business Administration (SBA) announces the meeting of the National Women's Business Council.
The meeting will be held on September 11th, 2015 from 2:00 p.m. to 4:00 p.m. EST.
The meeting will take place virtually via webconference.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), the U.S. Small Business Administration (SBA) announces the meeting of the National Women's Business Council. The National Women's Business Council is tasked with providing policy recommendations on issues of importance and impact to women entrepreneurs to the SBA, Congress, and the White House.
The business portion will include remarks from the Council Chair, Carla Harris; an update from each of the NWBC committees on recent activities and research on women business owners; and a preview of the policy recommendations that the Council will be making to the SBA, Congress, and the White House for improving the business climate for women entrepreneurs, as well as the new research portfolio. The second half of the program will include a panel discussion related to the Council's Access to Capital body of work. The panel will feature women influencers discussing the lack of women in venture capital generally and the potential policy implications.
The meeting is open to the public however advance notice of attendance is requested. To RSVP and confirm attendance, the general public should email
For more information, please visit the National Women's Business Council Web site at
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Louisiana dated 07/29/2015.
07/29/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14391 6 and for economic injury is 14392 0.
The States which received an EIDL Declaration # are Louisiana, Arkansas, Texas.
Social Security Administration.
Notice of the extension of tests involving modifications to the disability determination procedures.
We are announcing the extension of tests involving modifications to disability determination procedures authorized by 20 CFR 404.906 and 416.1406. These rules authorize us to test several modifications to the disability determination procedures for adjudicating claims for disability insurance benefits under title II of the Social Security Act (Act) and for supplemental security income payments based on disability under title XVI of the Act.
We are extending our selection of cases to be included in these tests from September 25, 2015 until no later than September 23, 2016. If we decide to continue selection of cases for these tests beyond this date, we will publish another notice in the
Kenneth Williams, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, MD
Our current rules authorize us to test, individually or in any combination, certain modifications to the disability determination procedures. 20 CFR 404.906 and 416.1406. We conducted several tests under the authority of these rules. In the “single decisionmaker” test, a disability examiner may make the initial disability determination in most cases without obtaining the signature of a medical or psychological consultant.
We also conducted a separate test, which we call the “prototype,” in 10 States. 64 FR 47218. Currently, the prototype combines the single decisionmaker approach described above with the elimination of the reconsideration level of our administrative review process.
We extended the period for selecting claims for these tests several times. Most recently, we extended the time from September 26, 2014 to September 25, 2015. 79 FR 39453. We are extending case selection for the prototype and the single decisionmaker tests until September 23, 2016. If we decide to continue selection of cases for these tests beyond this date, we will publish another notice in the
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 27, 2015.
Send comments identified by docket number FAA-2015-2904 using any of the following methods:
• Federal eRulemaking Portal: Go to
• Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
• Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Fax: Fax comments to Docket Operations at 202-493-2251.
Thuy H. Cooper (202) 267-4715 Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Request for public comment.
The FAA hereby provides notice of intent to release approximately 3.99 acres at the Zephyrhills Municipal Airport, Zephyrhills, FL from the conditions, reservations, and restrictions as contained in a Quitclaim Deed agreement between the FAA and the City of Zephyrhills, dated May 15, 1947. The release of property will allow the City of Zephyrhills to dispose of the property for other than aeronautical purposes. The property is located on the northeast corner of airport property at 39301 South Avenue, Zephyrhills, FL 33647. The parcel is currently designated as non-aeronautical use. The property will be released of its federal obligations for industrial purposes. The fair market value of this parcel has been determined to be $200,000.
Documents reflecting the Sponsor's request are available, by appointment only, for inspection at the Zephyrhills Municipal Airport and the FAA Airports District Office.
Comments are due on or before September 8, 2015.
Documents are available for review at the Zephyrhills Municipal Airport, and the FAA Airports District Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822. Written comments on the Sponsor's request must be delivered or mailed to: Marisol C. Elliott, Program Manager, Orlando Airports District Office, 5950 Hazeltine
Marisol C. Elliott, Program Manager, Orlando Airports District Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL 32822-5024.
Section 125 of The Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (AIR-21) requires the FAA to provide an opportunity for public notice and comment prior to the “waiver” or “modification” of a sponsor's Federal obligation to use certain airport land for non-aeronautical purposes.
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before September 8, 2015.
Send comments, within 30 days, to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725-17th Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
Dr. Kathy Sifrit, 202-366-0868.
This research effort is focused on determining how much older drivers self-regulate their driving through changes in behaviors or by reducing exposure. The project involves an initial questionnaire collecting information from licensed drivers about their age, driver license status, driving habits, vehicle type and age, and the extent to which they self-limit their driving exposure. The project plans to recruit a total of 60 participants, 20 of whom are 60-69, 20 who are 70-79, and 20 who are 80+ years of age. Staff will attempt to recruit equal numbers of males and females in each age group and to distribute the ages across each interval. Qualifying participants will have a tracking device installed in the vehicle for approximately 30 days. The device will record all trips made by the participant. At the end of the 30-day tracking period, each participant will be asked to take a battery of standard clinical functional measures and complete an on-road driving assessment administered by a certified driving rehabilitation specialist. Researchers will examine the driving behaviors of participants based on age group and other covariates collected during the initial questionnaire and assessments.
The results of this project will assist NHTSA in determining the relative extent to which older drivers appear to be aware of their cognitive and motor skill deterioration, and whether their perception of declining ability was affecting driving behaviors and exposure.
Comments are invited on the following:
(i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(ii) the accuracy of the Department's estimate of the burden of the proposed information collection;
(iii) ways to enhance the quality, utility and clarity of the information to be collected; and
(iv) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
A comment to OMB is most effective if OMB receives it within 30 days of publication of this notice.
44 U.S.C. Section 3506(c)(2)(A).
National Highway Traffic Safety Administration, DOT.
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that nonconforming model year (MY) 2006 Ferrari 612 Scagletti passenger cars (PC) manufactured before September 1, 2006 that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-
The closing date for comments on the petition is September 8, 2015.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
•
•
•
•
George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
Wallace Environmental Testing Laboratories (“WETL”), Inc. of Houston, Texas (Registered Importer R-90-005) has petitioned NHTSA to decide whether nonconforming MY 2006 Ferrari 612 Scagletti PC's manufactured before September 1, 2006 are eligible for importation into the United States. The vehicles which WETL believes are substantially similar are MY 2006 Ferrari 612 Scagletti PC's manufactured before September 1, 2006 for sale in the United States and certified by their manufacturer as conforming to all applicable FMVSS.
The petitioner claims that it compared non-U.S. certified MY 2006 Ferrari 612 Scagletti PC's manufactured before September 1, 2006 to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.
WETL submitted information with its petition intended to demonstrate that non-U.S. certified MY 2006 Ferrari 612 Scagletti PC's manufactured before September 1, 2006, as originally manufactured, conform to many FMVSS in the same manner as their U.S.-certified counterparts, or are capable of being readily altered to conform to those standards. Specifically, the petitioner claims that the non-U.S. certified MY 2006 Ferrari 612 Scagletti PC's manufactured before September 1, 2006 are identical to their U.S.-certified counterparts with respect to compliance with Standard Nos. 102
The petitioner also contends that the subject non-U.S. certified vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
Standard No. 114
Standard No. 225
Standard No. 301
Standard No. 401
The petitioner additionally states that a vehicle identification plate must be affixed to the vehicle near the left windshield pillar to meet the requirements of 49 CFR part 565.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
Regional Rail Holdings, LLC (Regional Holdings), a noncarrier, has filed a verified notice of exemption under 49 CFR 1180.2(d)(2) to acquire control of Regional Rail, LLC (Regional Rail), a holding company for three Class III rail carriers, East Penn Railroad, LLC, Middletown & New Jersey Railroad, LLC, and Tyburn Railroad LLC.
The transaction is expected to be consummated on or after August 22, 2015, the effective date of the exemption.
Applicants state that: (i) The railroads will not connect with each other or any railroad in their corporate family; (ii) the subject acquisition of control is not part of a series of anticipated transactions that would connect the railroads with each other or any railroad in their corporate family; and (iii) the transaction does not involve a Class I carrier. Therefore, the transaction is exempt from the prior approval requirements of 49 U.S.C. 11323.
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under sections 11324 and 11325 that involve only Class III rail carriers. Because this transaction involves Class III rail carriers only, the Board, under the statute, may not impose labor protective conditions for this transaction.
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings referring to Docket No. FD 35945, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Mary Anne Mason, Crowell & Moring LLP, 1001 Pennsylvania Ave. NW., Washington, DC 20004.
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Nebraska, Kansas & Colorado Railway, L.L.C. (NKCR) has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—
NKCR has certified that: (1) No local traffic has moved over the lines for at least two years; (2) any overhead traffic could be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the lines (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the lines either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the two-year period; and (4) the requirements at 49 CFR
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on September 8, 2015, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to NKCR's representative: Karl Morell, Karl Morell & Associates, 655 Fifteenth Street NW., Suite 225, Washington, DC 20005.
If the verified notice contains false or misleading information, the exemption is void
NKCR has filed environmental and historic reports that address the effects, if any, of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by August 14, 2015. Interested persons may obtain a copy of the EA by writing to OEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), NKCR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the lines. If consummation has not been effected by NKCR's filing of a notice of consummation by August 7, 2016, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Notice of availability and request for comments.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is announcing a pilot program in which importers, Customs and Border Protection (CBP), and TTB will test, as part of the International Trade Data System (ITDS) project, the electronic collection of import data required by TTB and the transfer of that data through CBP to TTB. TTB is also announcing the availability of and requesting comment on a draft set of instructions that describes how importers of distilled spirits, wine, beer, tobacco products, processed tobacco, or cigarette papers and tubes may file information electronically to meet TTB requirements at the importation of those commodities. The information gathered through the comments on the draft instructions and pilot program and through an evaluation of the pilot program will allow TTB and CBP to refine their implementation of ITDS.
Comments on the draft Filing Instructions must be received by October 6, 2015.
The pilot program will commence no earlier than August 19, 2015, and will continue until concluded by publication of a notice in the
Please send your comments on the draft Automated Commercial Environment Filing Instructions for TTB-Regulated Commodities and on the pilot program to one of the following addresses:
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See the Public Participation section of this document for specific instructions and requirements for submitting comments.
For information about the filing instructions or the pilot program, contact 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
The Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department
Section 103(a) of the FAA Act (27 U.S.C. 203(a)) requires that a person obtain a permit before engaging in certain activities related to distilled spirits, wine, and malt beverages, including importation. This section of the FAA Act states that it shall be unlawful, except pursuant to a “basic permit” issued by the Secretary of the Treasury (the Secretary), to engage in the business of importing into the United States distilled spirits, wine, or malt beverages. Section 103(a) of the FAA Act also states that it is unlawful, except pursuant to a basic permit, for any person so engaged to sell, offer or deliver for sale, contract to sell, or ship, in interstate or foreign commerce, directly or indirectly or through an affiliate, distilled spirits, wine, or malt beverages so imported. The terms “distilled spirits” and “wine,” when used in the context of the FAA Act, apply only to distilled spirits and wine for nonindustrial use.
Additionally, section 105(e) of the FAA Act (27 U.S.C. 205(e)) authorizes the Secretary to prescribe regulations relating to the labeling of distilled spirits, wine, and malt beverages. With regard to imported commodities, the FAA Act provides that no person shall remove from customs custody, in bottles, for sale or any other commercial purpose, distilled spirits, wine, or malt beverages, without having obtained a certificate of label approval and being in possession of that certificate.
Chapter 51 of the IRC pertains to the taxation and regulation of distilled spirits (including spirits used for both beverage and nonbeverage purposes), wines, and beer (see 26 U.S.C. chapter 51). The IRC imposes a Federal excise tax on all distilled spirits, wine, and beer manufactured in or imported into the United States. See, respectively, 26 U.S.C. 5001, 5041, and 5051. In general, the tax on imported distilled spirits, wine, and beer is collected by CBP, along with any import duties. The IRC at 26 U.S.C. 5232, 5364, and 5418 provides for limited circumstances under which products may be withdrawn from customs custody without payment of tax for transfer to the bonded premises of an industry member regulated by TTB. These provisions cover distilled spirits imported in bulk and released from customs custody for transfer to a distilled spirits plant, natural wine (as defined in 26 U.S.C. 5381) imported in bulk and released from customs custody for transfer to a bonded wine cellar, and beer imported in bulk and released from customs custody for transfer to a brewery. Under these circumstances, the proprietor of the bonded premises becomes liable for the tax on the product withdrawn from customs custody upon its release from customs custody, and the applicable tax is collected by TTB when the product is removed from the distilled spirits plant, bonded wine cellar, or brewery, respectively. The IRC also contains provisions under which imported distilled spirits may be entered free of tax by the United States or any governmental agency of the United States for nonbeverage purposes. See 26 U.S.C. 5313. Furthermore, industrial alcohol may under certain circumstances be imported free of tax from the Virgin Islands to qualified industrial alcohol users. See 26 U.S.C. 5314(b).
Chapter 52 of the IRC contains excise tax and related provisions pertaining to tobacco products and cigarette papers and tubes. Section 5701 of the IRC (26 U.S.C. 5701) imposes Federal excise tax on such commodities manufactured in or imported into the United States. In general, the tax on imported tobacco products and cigarette papers and tubes is collected by CBP, along with any import duties. Under 26 U.S.C. 5704, tobacco products and cigarette papers and tubes may be released from customs custody under certain conditions without payment of tax for delivery to the proprietor of an export warehouse or a manufacturer of tobacco products or cigarette papers and tubes. Upon removal from the manufacturer's premises, the tax on such products is collected by TTB.
Chapter 52 of the IRC also contains provisions pertaining to the manufacture and importation of processed tobacco, which is not subject to tax. Section 5712 of the IRC (26 U.S.C. 5712) requires that importers of tobacco products or processed tobacco, before engaging in such business, apply for and obtain a permit.
TTB administers the FAA Act and chapters 51 and 52 of the IRC pursuant to section 1111(d) of the Homeland Security Act of 2002, as codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013, to the TTB Administrator to perform the functions and duties in the administration and enforcement of these provisions. Responsibility for collecting, accounting for, and depositing as internal revenue the excise taxes due incident to the importation of alcohol and tobacco products is vested by statute with the Secretary of the Treasury (see 6 U.S.C. 212), but has been delegated to the Secretary of Homeland Security and CBP. See Treasury Department Order 100-16, 68 FR 28322 (May 23, 2003), and 6 U.S.C. 212 and 215(1).
The TTB regulations at 27 CFR parts 1, 4, 5, and 7 set forth requirements related to certain FAA Act provisions. Section 1.20 (27 CFR 1.20) repeats the FAA Act basic permit requirement for importers of distilled spirits, wine, and malt beverages. Parts 4, 5, and 7 require that, in order for an imported distilled spirit, wine, or malt beverage to be released from customs custody, a certificate of label approval must be “deposited with the appropriate Customs officer at the port of entry.” See 27 CFR 4.40, 5.51, and 7.31, respectively, regarding wine, distilled spirits, and malt beverages. Parts 4 and 5 also include several requirements related to certification of the origin and, in some cases, method of production of certain alcohol beverages by a foreign government. In general, certificates relating to origin or method of production are required to “accompany” the imported commodities. See 27 CFR 4.27, 4.45, and 5.52.
The TTB regulations at 27 CFR part 27 set forth requirements related to the IRC provisions that apply to importations of distilled spirits, wine, and beer. One example of a requirement for which records must be filed with CBP is the importation of distilled spirits in bulk without payment of tax, which is subject to the requirements in subparts H and I of part 27. For such releases, the person importing the spirits must prepare a record of information that is given to the customs officer upon release of the spirits from customs custody. Part 27 also includes requirements to submit information for transfers of distilled spirits without payment of tax from customs custody to a distilled spirits plant (27 CFR 27.172) and for imports of distilled spirits free of tax for use of a government agency (27 CFR 27.183).
The TTB regulations at 27 CFR part 26 address distilled spirits, wine, and beer brought into the United States from
The TTB regulations at 27 CFR part 41 address the importation of tobacco products, processed tobacco, and cigarette papers and tubes. In that part, § 41.81 requires certain information to be submitted to CBP regarding imported tobacco products or cigarette papers or tubes, and § 41.86 requires information to be submitted using a specified form in order for tobacco products or cigarette papers and tubes imported and released without payment of tax to be delivered to a specified TTB-permitted manufacturer or export warehouse proprietor.
On March 27, 2014, TTB published in the
The International Trade Data System (ITDS) is an interagency program to establish a single electronic access point (or “single window”) through which importers and exporters may submit the data required by Federal government agencies for international trade transactions. The Security and Accountability for Every Port Act of 2006 (SAFE Port Act, Pub L. 109-347) mandated participation in ITDS for all agencies that require documentation for clearing or licensing the importation and exportation of cargo. The purpose of ITDS is to eliminate redundant information requirements, to efficiently regulate the flow of commerce, and to effectively enforce laws and regulations relating to international trade, by establishing a single portal system, operated by CBP, for the collection and distribution of standard electronic import and export data required by all participating Federal agencies. TTB is one of the Partner Government Agencies (PGAs) working with CBP to implement ITDS.
The “single window” utilizes the Automated Commercial Environment (ACE), which is maintained by CBP. ACE allows importers and exporters to enter one set of data for each consignment of imported or exported articles. Currently, importers and exporters that are regulated by multiple agencies or that import or export commodities regulated by multiple agencies must submit data to those agencies through various channels, often in paper form. Through the implementation of ITDS, data will be entered into ACE and then made available to each government agency.
The PGA Message Set defines the agency-specific information that importers will submit directly through the Automated Broker Interface (ABI), which transfers data into ACE as part of the CBP entry process. After the importer submits the data, it will be available to TTB, along with certain other data collected through the ABI filing.
On February 19, 2014, the President issued Executive Order 13659, “Streamlining the Export/Import Process for America's Businesses.”
TTB intends to initiate a pilot program beginning no earlier than August 19, 2015, to test the electronic collection and transfer of data from importers through CBP to TTB. Instead of submitting the paper forms and documents currently required in TTB's regulations, participating U.S. importers and brokers will follow the draft ACE Filing Instructions for TTB-Regulated Commodities (Filing Instructions), described below, and use the PGA Message Set to send TTB-specific data elements and electronic images through ABI to ACE for review by TTB. The specific data elements are outlined in the draft Filing Instructions. TTB anticipates that this pilot program will help TTB and importers prepare for an efficient transition to ACE.
To be eligible to apply for this pilot, importers must have the ability to file ACE entry summaries and ACE cargo release, and must file entries for TTB-regulated commodities. All pilot program participants are required to use a software program that has completed ACE certification testing for the PGA Message Set.
Upon commencement of this test, a limited number of ports of entry will be accepting PGA Message Set data. A list of those ports and the dates they become operational is provided on the following CBP Web site:
As discussed earlier, TTB's import regulations currently require importers to submit to CBP various forms and documents in paper format. Importers who are accepted for participation in the pilot program will be supplying information electronically in accordance with the Filing Instructions. TTB will consider pilot program participants who follow the Filing Instructions to be in compliance with the current requirements to submit paper documents. TTB will provide further details in its approval letters to accepted applicants.
The PGA Message Set that will be used in the pilot program incorporates requirements that will be published in a future issue of the
To apply to participate in the pilot program, please contact John Kyranos, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; telephone (202) 453-2265, extension 001; or email
Please note that acceptance into the pilot program is based on the eligibility of the participant, along with TTB's need to include a broad cross-section of importers of the commodities regulated by TTB in order to evaluate the effectiveness of the system. In addition, participants may have different start dates.
To facilitate implementation of ITDS and ACE for importers of alcohol and tobacco products, TTB is making available for review and comment a draft document containing instructions for importers of TTB-regulated articles on how to use the new system.
The draft ACE Filing Instructions for TTB-Regulated Commodities document made available via this notice is intended to provide a framework for discussion, review, and comment, in order to aid the system development. The draft Filing Instructions document also reflects requirements that TTB may propose through the future publication in the
The draft Filing Instructions are available on Regulations.gov as part of Docket No. TTB-2015-0012 on Regulations.gov. You can also obtain a copy by contacting John Kyranos as described above.
TTB invites comments from interested members of the public on the draft Filing Instructions. TTB is particularly interested in comments related to the usability of the Filing Instructions. TTB will also accept comments regarding the pilot program through the duration of the test.
You may submit comments on the Filing Instructions or on the pilot program by using one of the following three methods:
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Please submit your comments by the closing date shown above in this notice. Your comments must reference Notice No. 156 and include your name and mailing address. Your comments also must be made in English, be legible, and be written in language acceptable for public disclosure. TTB does not acknowledge receipt of comments, and TTB considers all comments as originals.
In your comment, please clearly state if you are commenting for yourself or on behalf of an association, business, or other entity. If you are commenting on behalf of an entity, your comment must include the entity's name as well as your name and position title. In your comment via Regulations.gov, please enter the entity's name in the “Organization” blank of the online comment form. If you comment via postal mail or hand delivery/courier, please submit your entity's comment on letterhead.
All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure.
TTB will post, and you may view, copies of this notice, the Filing Instructions, and any online or mailed comments received about this proposal within Docket No. TTB-2015-0012 on the Federal e-rulemaking portal, Regulations.gov, at
All posted comments will display the commenter's name, organization (if any), city, and State, and, in the case of mailed comments, all address information, including email addresses. TTB may omit voluminous attachments or material that the Bureau considers unsuitable for posting.
You may also view copies of this notice, the Filing Instructions, and any electronic or mailed comments that TTB receives about this proposal by appointment at the TTB Information Resource Center, 1310 G Street NW., Washington, DC 20005. You may also obtain copies at 20 cents per 8.5- x 11-inch page. Contact TTB's information specialist at the above address or by telephone at 202-453-2270 to schedule an appointment or to request copies of comments or other materials.
Andrew Malone of the Regulations and Rulings Division drafted this notice.
Internal Revenue Service (IRS), Treasury.
Notice of Meeting.
An open meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project
The meeting will be held Wednesday, September 9, 2015.
Otis Simpson at 1-888-912-1227 or 202-317-3332.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be held Wednesday, September 9, 2015, at 3:00 p.m. Eastern Time. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Otis Simpson. For more information please contact: Otis Simpson at 1-888-912-1227 or 202-317-3332, TAP Office, 1111 Constitution Avenue NW., Room 1509—National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing various issues related to the Taxpayer Assistance Centers and public input is welcomed.
Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before September 8, 2015 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission(s) may be obtained by email at
The Department of Veterans Affairs (VA) hereby gives notice of the establishment of the Commission on Care (“the Commission”), authorized by section 202 of the Veterans Access, Choice, and Accountability Act of 2014 (VACAA),
The Commission will examine the access of Veterans to health care from VA and strategically examine the access of Veterans how best to organize the Veterans Health Administration, locate health care resources, and deliver health care to Veterans during the 20-year period beginning on the date of the enactment of VACAA, August 7, 2014.
The Commission members will be composed of 15 voting members who are appointed by the President and Congressional leadership for the life of the Commission in accordance with section 202(a)(2) of VACAA.
Any member of the public seeking additional information should contact Ms. Susan Webman, Executive Director (10P1), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC or email at
Department of Veterans Affairs.
Notice.
In keeping with its commitment to improve transparency, the Department of Veterans Affairs' (VA) publishes wait-times for the scheduling of appointments in each VA facility for primary care, specialty care, and mental health services twice each month. VA also publishes a
The wait-time data for all Veterans Health Administration (VHA) medical centers and clinics is available on the following Web site:
Dr. Joe Francis, Director, Clinical Analytics and Reporting, Veterans Health Administration, 810 Vermont Avenue NW., Washington, DC 20420 Telephone: (202) 302-3310. (This is not a toll-free number.)
Section 206 of the Veterans Access, Choice, and Accountability Act of 2014 (Pub. L. 113-146, “the Act”) directed the Department of Veterans Affairs (VA), not later than 90 days after the date of the enactment of the Act, to publish in the
VA publishes wait-times for the scheduling of appointments in each VA facility for primary care, specialty care, and mental health services twice each month. VA also publishes a
The wait-time data report, which also includes data at the Community-Based Outpatient Clinic level for all VA facilities, can be found using the following link:
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, approved this document on August 3, 2015, for publication.
Board of Veterans' Appeals, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Board of Veterans' Appeals (BVA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
Comments must be submitted on or before September 8, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice; comment request.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before October 6, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Occupational Safety and Health Administration (OSHA), Department of Labor.
Proposed rule; request for comments.
The Occupational Safety and Health Administration (OSHA) proposes to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds and promulgate a substance-specific standard for general industry regulating occupational exposure to beryllium and beryllium compounds. This document proposes a new permissible exposure limit (PEL), as well as ancillary provisions for employee protection such as methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. In addition, OSHA seeks comment on a number of alternatives, including a lower PEL, that could affect construction and maritime, as well as general industry.
If you submit scientific or technical studies or other results of scientific research, OSHA requests (but is not requiring) that you also provide the following information where it is available: (1) Identification of the funding source(s) and sponsoring organization(s) of the research; (2) the extent to which the research findings were reviewed by a potentially affected party prior to publication or submission to the docket, and identification of any such parties; and (3) the nature of any financial relationships (
Electronic copies of this
OSHA has not provided the document ID numbers for all submissions in the record for this beryllium proposal. The proposal only contains a reference list for all submissions relied upon. The public can find all document ID numbers in an Excel spreadsheet that is posted on OSHA's rulemaking Web page (see
For general information and press inquiries, contact Frank Meilinger, Director, Office of Communications, Room N-3647,
The preamble to the proposed standard on occupational exposure to beryllium and beryllium compounds follows this outline:
OSHA currently enforces permissible exposure limits (PELs) for beryllium in general industry, construction, and shipyards. These PELs were adopted in 1971, shortly after the Agency was created, and have not been updated since then. The time-weighted average (TWA) PEL for beryllium is 2 micrograms per cubic meter of air (μg/m
OSHA's proposal 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. See Section II of this preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements.
OSHA has conducted an extensive review of the literature on adverse health effects associated with exposure to beryllium. The Agency has also assessed the risk of beryllium-related diseases at the current TWA PEL, the proposed TWA PEL and the alternative TWA PELs. These analyses are presented in this preamble at Section V, Health Effects, Section VI, Preliminary Risk Assessment, and Section VIII, Significance of Risk. As discussed in Section VIII of this preamble, Significance of Risk, the available evidence indicates that worker exposure to beryllium at the current PEL poses a significant risk of chronic beryllium disease (CBD) and lung cancer, and that the proposed standard will substantially reduce this risk.
Section 6(b) of the OSH Act requires OSHA to determine that its standards are technologically and economically feasible. OSHA's examination of the technological and economic feasibility of the proposed rule is presented in the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA) (OSHA, 2014), and is summarized in Section IX of this preamble, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis. OSHA has preliminarily concluded that the proposed PEL of 0.2 μg/m
OSHA developed quantitative estimates of the compliance costs of the proposed rule for each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide a screening analysis of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Industries with unusually high costs as a percentage of revenues or profits were further analyzed for possible economic feasibility issues. After performing these analyses, OSHA has preliminarily concluded that compliance with the requirements of the proposed rule would be economically feasible in every affected industry sector.
The Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires that OSHA either certify that a rule would not have a significant economic impact on a substantial number of small entities or prepare a regulatory flexibility analysis and hold a Small Business Advocacy Review (SBAR) Panel prior to proposing the rule. OSHA has determined that a regulatory flexibility analysis is needed and has provided this analysis in Chapter IX of the PEA (OSHA, 2014). A summary is provided in Section IX of this preamble, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis. OSHA also previously held a SBAR Panel for this rule. The recommendations of the Panel and OSHA's response to them are summarized in Section IX of this preamble.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. Accordingly, this proposed rule has been reviewed by the Office of Management and Budget. The remainder of this section summarizes the key findings of the analysis with respect to costs and benefits of the proposed standard, presents alternatives
Table I-1, which is derived from material presented in the PEA, provides a summary of OSHA's best estimate of the costs and benefits of this proposed rule. As shown, this proposed rule is estimated to prevent 96 fatalities and 50 non-fatal beryllium-related illnesses annually once it is fully effective, and the monetized annualized benefits of the proposed rule are estimated to be $576 million using a 3-percent discount rate and $255 million using a 7-percent discount rate. Also as shown in Table I-1, the estimated annualized cost of the rule is $37.6 million using a 3-percent discount rate and $39.1 million using a 7-percent discount rate. This proposed rule is estimated to generate net benefits of $538 million annually using a 3-percent discount rate and $216 million annually using a 7-percent discount rate. These estimates are for informational purposes only and have not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for this proposed beryllium rule. The courts have ruled that OSHA may not use benefit-cost analysis or a criterion of maximizing net benefits as a basis for setting OSHA health standards.
Both the costs and benefits of Table I-1 reflect the incremental costs and benefits associated with achieving full compliance with the proposed standard. They do not include costs and benefits associated with employers' current exposure control measures or other aspects of the proposed standard they have already implemented. For example, for employers whose exposures are already below the proposed PEL, OSHA's estimated costs and benefits for the proposed standard do not include the costs of their exposure control measures or the benefits of these employers' compliance with the proposed PEL. The costs and benefits of Table I-1 also do not include costs and benefits associated with achieving compliance with existing requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements.
In addition to the proposed standard itself, this preamble discusses more than two dozen regulatory alternatives, including various sub-alternatives, to the proposed standard and requests comments and information on a variety of topics pertinent to the proposed standard. The regulatory alternatives OSHA is considering include alternatives to the proposed scope of the standard, regulatory alternatives to the proposed TWA PEL of 0.2 μg/m
OSHA believes that inclusion of regulatory alternatives serves two important functions. The first is to explore the possibility of less costly ways (than the proposed standard) to provide an adequate level of worker protection from exposure to beryllium. The second is tied to the Agency's statutory requirement, which underlies the proposed standard, to reduce significant risk to the extent feasible. Each regulatory alternative presented here is described and analyzed more fully elsewhere in this preamble or in the PEA. Where appropriate, the alternative is included in this preamble at the end of the relevant section of Section XVIII, Summary and Explanation of the Proposed Standard, to facilitate comparison of the alternative to the proposed standard. For example, alternative PELs under consideration by the Agency are presented in the discussion of paragraph (c) in Section XVIII. In addition, all
The more than two dozen regulatory alternatives, including various sub-alternatives regulatory alternatives under consideration are summarized below, and are organized into the following categories: alternatives to the proposed scope of the standard; alternatives to the proposed PELs; alternatives to the proposed methods of compliance; alternatives to the proposed ancillary provisions; and the timing of the standard.
OSHA has examined three alternatives that would alter the groups of employers and employees covered by this rulemaking. Regulatory Alternative #1a would expand the scope of the proposed standard to include all operations in general industry where beryllium exists only as a trace contaminant; that is, where the materials used contain no more than 0.1% beryllium by weight. Regulatory Alternative #1b is similar to Regulatory Alternative #1a, but exempts operations where the employer can show that employees' exposures will not meet or exceed the action level or exceed the STEL. Where the employer has objective data demonstrating that a material containing beryllium or a specific process, operation, or activity involving beryllium cannot release beryllium in concentrations at or above the proposed action level or above the proposed STEL under any expected conditions of use, that employer would be exempt from the proposed standard except for recordkeeping requirements pertaining to the objective data. Alternative #1a and Alternative #1b, like the proposed rule, would not cover employers or employees in construction or shipyards.
Regulatory Alternative #2a would expand the scope of the proposed standard to also include employers in construction and maritime. For example, this alternative 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. Regulatory Alternative #2b would update §§ 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to all employers and employees in general industry, shipyards, and construction, including occupations where beryllium exists only as a trace contaminant. However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule. More detailed discussion of Regulatory Alternatives #1a, #1b, #2a, and #2b appears in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, Section XVIII of this preamble, Summary and Explanation, includes a discussion of paragraph (a) that describes the scope of the proposed rule, issues with the proposed scope, and Regulatory Alternatives #1a, #1b, #2a, and #2b.
Another regulatory alternative that would impact the scope of affected industries, extending eligibility for medical surveillance to employees in shipyards, construction, and parts of general industry excluded from the scope of the proposed standard, is discussed along with other medical surveillance alternatives later in this section (Regulatory Alternative #21) and in the discussion of paragraph (k) in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard.
OSHA has examined several regulatory alternatives that would modify the TWA PEL or STEL for the proposed rule. Under Regulatory Alternative #3, OSHA would adopt a STEL of 5 times the proposed PEL. Thus, this alternative STEL would be 1.0 μg/m
The proposed standard would require employers to implement engineering and work practice controls to reduce employees' exposures to or below the TWA PEL and STEL. Where engineering and work practice controls are insufficient to reduce exposures to or below the TWA PEL and STEL, employers would still be required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. In addition, for each operation where there is airborne beryllium exposure, the employer must ensure that one or more of the engineering and work practice controls listed in paragraph (f)(2) are in place, unless all of the listed controls are infeasible, or the employer can demonstrate that exposures are below the action level based on two samples taken seven days apart. Regulatory Alternative #6 would eliminate the engineering and work practice controls provision currently specified in paragraph (f)(2). This regulatory alternative does not eliminate the need for engineering controls to lower exposure levels to or below the TWA PEL and STEL; rather, it dispenses with the mandatory use of certain engineering controls that must be installed above the action level but at or below the TWA PEL.
More detailed discussion of Regulatory Alternative #6 appears in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the discussion of paragraph (f) in Section XVIII of this preamble, Summary and Explanation, provides a more detailed explanation of the proposed methods of compliance, issues with the proposed methods of compliance, and Regulatory Alternative #6.
The proposed rule contains several ancillary provisions, including requirements for exposure assessment, personal protective clothing and equipment (PPE), medical surveillance, medical removal, training, and regulated areas or access control. OSHA has examined a variety of regulatory alternatives involving changes to one or more of these ancillary provisions. OSHA has preliminarily determined that several of these ancillary provisions will increase the benefits of the proposed rule, for example, by helping to ensure the TWA PEL is not exceeded
During the Small Business Regulatory Fairness Act (SBREFA) process conducted in 2007, the SBAR Panel recommended that OSHA analyze a PEL-only standard as a regulatory alternative. The Panel also recommended that OSHA consider applying ancillary provisions of the standard so as to minimize costs for small businesses where exposure levels are low (OSHA, 2008b). In response to these recommendations, OSHA analyzed Regulatory Alternative #7, a PEL-only standard, and Regulatory Alternative #8, which would only apply ancillary provisions of the beryllium standard at exposures above the proposed PEL of 0.2 µg/m
As indicated previously, OSHA has preliminarily determined that there is significant risk remaining at the proposed PEL of 0.2 μg/m
Under Regulatory Alternative #8, several ancillary provisions that the current proposal would require under a variety of exposure conditions (
OSHA has examined three regulatory alternatives that would modify the proposed standard's provisions on exposure monitoring, which require periodic monitoring annually where exposures are at or above the action level and at or below the TWA PEL. Under Regulatory Alternative #9, employers would be required to perform periodic exposure monitoring every 180 days where exposures are at or above the action level or above the STEL, and at or below the TWA PEL. Under Regulatory Alternative #10, employers would be required to perform periodic exposure monitoring every 180 days where exposures are at or above the action level or above the STEL, including where exposures exceed the TWA PEL. Under Regulatory Alternative #11, employers would be required to perform periodic exposure monitoring every 180 days where exposures are at or above the action level or above the STEL, and every 90 days where exposures exceed the TWA PEL. More detailed discussions of Regulatory Alternatives #9, #10, and #11 appear in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the discussion of proposed paragraph (d) in Section XVIII of this preamble, Summary and Explanation of the Proposed Standard, provides a more detailed explanation of the proposed requirements for exposure monitoring, issues with exposure monitoring, and the considerations pertinent to Regulatory Alternatives #9, #10, and #11.
The proposed standard would require employers to establish and maintain two types of areas: beryllium work areas, wherever employees are, or can reasonably be expected to be, exposed to any level of airborne beryllium; and regulated areas, wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. Employers are required to demarcate beryllium work areas, but are not required to restrict access to beryllium work areas or provide respiratory protection or other forms of PPE within work areas that are not also regulated areas. Employers must demarcate regulated areas, restrict access to them, post warning signs and provide respiratory protection and other PPE within regulated areas, as well as medical surveillance for employees who work in regulated areas for more than 30 days in a 12-month period. During the SBREFA process conducted in 2007, the SBAR Panel recommended that OSHA consider dropping or limiting the provision for regulated areas (OSHA, 2008b). In response to this recommendation, OSHA analyzed Regulatory Alternative #12, which would not require employers to establish regulated areas. More detailed discussion of Regulatory Alternative #12 appears in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the discussion of
Regulatory Alternative #13 would modify the proposed requirements for PPE, which require PPE where exposure exceeds the TWA PEL or STEL; where employees' clothing or skin may become visibly contaminated with beryllium; and where employees may have skin contact with soluble beryllium compounds. The requirement to use PPE where work clothing or skin may become “visibly contaminated” with beryllium differs from prior standards that do not require contamination to be visible in order for PPE to be required. In the case of beryllium, which OSHA has preliminarily concluded can sensitize through dermal exposure, the exposure levels capable of causing adverse health effects and the PELs in effect are so low that beryllium surface contamination is unlikely to be visible (see this preamble at section V, Health Effects). OSHA is therefore considering Regulatory Alternative #13, which would require appropriate PPE wherever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. More detailed discussion of Regulatory Alternative #13 is provided in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the discussion of paragraph (h) in Section XVIII of this preamble, Summary and Explanation, provides a more detailed explanation of the proposed requirements for PPE, issues with PPE, and the considerations pertinent to Regulatory Alternative #13.
The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium above the proposed PEL for 30 days or more per year, who are exposed to beryllium in an emergency, or who show signs or symptoms of CBD; and (2) low-dose helical tomography (low-dose computed tomography, hereafter referred to as “CT scans”), for employees who were exposed above the proposed PEL for more than 30 days in a 12-month period for 5 years or more. This type of CT scan is a method of detecting tumors, and is commonly used to diagnose lung cancer. The proposed standard would require periodic medical exams to be provided for employees in the medical surveillance program annually, while tests for beryllium sensitization and CT scans would be provided to eligible employees biennially.
OSHA has examined eight regulatory alternatives (#14 through #21) that would modify the proposed rule's requirements for employee eligibility, the types of exam that must be offered, and the frequency of periodic exams. Medical surveillance was a subject of special concern to SERs during the SBREFA process, and the SBREFA Panel offered many comments and recommendations related to medical surveillance for OSHA's consideration. Some of the Panel's concerns have been addressed in this proposal, which was modified since the SBREFA Panel was convened (see this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, for more detailed discussion). Several of the alternatives presented here (#16, #18, and #20) also respond to recommendations by the SBREFA Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements. OSHA also seeks to ensure that the requirements of the final standard offer workers adequate medical surveillance while limiting the costs to employers. Thus, OSHA requests feedback on several additional alternatives and on a variety of issues raised later in this section of the preamble.
Regulatory Alternatives #14, #15, and #21 would expand eligibility for medical surveillance to a broader group of employees than would be eligible in the proposed standard. Under Regulatory Alternative #14, medical surveillance would be available to employees who are exposed to beryllium above the proposed PEL, including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would expand 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. Regulatory Alternative #21 would extend eligibility for medical surveillance as set forth in proposed paragraph (k) to all employees in shipyards, construction, and general industry who meet the criteria of proposed paragraph (k)(1) (or any of the alternative criteria under consideration). However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule.
Regulatory Alternatives #16 and #17 would modify the proposed standard's requirements to offer beryllium sensitization testing to eligible employees. Under Regulatory Alternative #16, employers would not be required to offer employees testing for beryllium sensitization. Regulatory Alternative #17 would increase the frequency of periodic sensitization testing, from the proposed standard's biennial requirement to annual testing. Regulatory Alternatives #18 and #19 would similarly modify the proposed standard's requirements to offer CT scans to eligible employees. Regulatory Alternative #18 would drop the CT scan requirement from the proposed rule, whereas Regulatory Alternative #19 would increase the frequency of periodic CT scans from biennial to annual scans. Finally, under Regulatory Alternative #20, all periodic components of the medical surveillance exams would be available biennially to eligible employees. Instead of requiring employers to offer eligible employees a medical examination every year, employers would be required to offer eligible employees a medical examination every other year. The frequency of testing for beryllium sensitization and CT scans would also be biennial for eligible employees, as in the proposed standard.
More detailed discussions of Regulatory Alternatives #14, #15, #16, #17, #18, #19, #20, and #21 appear in Section IX of this preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, Section XVIII of this preamble, Summary and Explanation, paragraph (k) provides a more detailed explanation of the proposed requirements for medical surveillance, issues with medical surveillance, and the considerations pertinent to Regulatory Alternatives #14 through #21.
The proposed requirements for medical removal protection provide an option for medical removal to an employee who is working in a job with exposure at or above the action level and is diagnosed with CBD or confirmed positive for beryllium sensitization. If the employee chooses removal, the employer must either remove the employee to comparable work in a work environment where exposure is below the action level, or if comparable work is not available, must place the employee on paid leave for 6 months or until such time as comparable work becomes available. In either case, the employer must maintain for 6 months the employee's base earnings, seniority,
The proposed standard would become effective 60 days following publication of the final standard in the
OSHA invites comment and suggestions for phasing in requirements for engineering controls, medical surveillance, and other provisions of the standard. A longer phase-in time would have several advantages, such as reducing initial costs of the standard or allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However, a longer phase-in would also postpone and reduce the benefits of the standard. Suggestions for alternatives may apply to specific industries (
OSHA requests comments on these regulatory alternatives, including the Agency's choice of regulatory alternatives (and whether there are other regulatory alternatives the Agency should consider) and the Agency's analysis of them. In addition, OSHA requests comments and information on a number of specific topics and issues pertinent to the proposed standard. These are summarized below.
In this section, we solicit public feedback on issues associated with the proposed standard and request information that would help the Agency craft the final standard. In addition to the issues specified here, OSHA also raises issues for comment on technical questions and discussions of economic issues in the PEA (OSHA, 2014). OSHA requests comment on all relevant issues, including health effects, risk assessment, significance of risk, technological and economic feasibility, and the provisions of the proposed regulatory text. In addition, OSHA requests comments on all of the issues raised by the Small Business Advocacy Review (SBAR) Panel, as summarized in the SBAR report (OSHA, 2008b)
We present these issues and requests for information in the first chapter of the preamble to assist readers as they review the preamble and consider any comments they may want to submit. The issues are presented here in summary form. However, to fully understand the questions in this section and provide substantive input in response to them, the sections of the preamble relevant to these issues should be reviewed. These include: Section V, Health Effects; Section VI, the Preliminary Risk Assessment; Section VIII, Significance of Risk; Section IX, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis; and Section XVIII, Summary and Explanation of the Proposed Standard.
OSHA requests that comments be organized, to the extent possible, around the following issues and numbered questions. Comment on particular provisions should contain a heading setting forth the section and the paragraph in the proposed standard that the comment addresses. Comments addressing more than one section or paragraph will have correspondingly more headings.
Submitting comments in an organized manner and with clear reference to the issue raised will enable all participants to easily see what issues the commenter addressed and how they were addressed. Many commenters, especially small businesses, are likely to confine their comments to the issues that affect them, and they will benefit from being able to quickly identify comments on these issues in others' submissions. The Agency welcomes comments concerning all aspects of this proposal. However, OSHA is especially interested in responses, supported by evidence and reasons, to the following questions:
1. OSHA has described a variety of studies addressing the major adverse health effects that have been associated with exposure to beryllium. Using currently available epidemiologic and experimental studies, OSHA has made a preliminary determination that beryllium presents risks of lung cancer; sensitization; CBD at 0.1 µg/m
2. Has OSHA adequately identified and documented all critical health impairments associated with occupational exposure to beryllium? If not, what other adverse health effects should be added? Are there additional studies or other data OSHA should consider in evaluating any of these health outcomes?
3. Are there any additional studies, other data, or information that would affect the information discussed or significantly change the determination of material health impairment?
Please submit any relevant information, data, or additional studies (or citations to studies), and explain your reasons for recommending any studies you suggest.
4. OSHA has developed an analysis of health risks associated with occupational beryllium exposure, including an analysis of sensitization and CBD based on a selection of recent
5. OSHA preliminarily concluded that there is significant risk of material health impairment (lung cancer or CBD) from a working lifetime of occupational exposure to beryllium at the current TWA PEL of 2 µg/m
6. Please provide comment on OSHA's analysis of risk for beryllium sensitization, CBD and lung cancer. Are there important gaps or uncertainties in the analysis, such that the Agency's preliminary conclusions regarding significance of risk at the current, proposed, and alternative PELs may be in error? If so, please provide a detailed explanation and suggestions for how OSHA's analysis should be corrected or improved.
7. OSHA has made a preliminary determination that the available data are not sufficient or suitable for risk analysis of effects other than beryllium sensitization, CBD and lung cancer. Do you have, or are you aware of, studies or data that would be suitable for a risk assessment for these adverse health effects? Please provide the studies, citations to studies, or data you suggest.
8. Has OSHA defined the scope of the proposed standard appropriately? Does it currently include employers who should not be covered, or exclude employers who should be covered by a comprehensive beryllium standard? Are you aware of employees in construction or maritime, or in general industry who deal with beryllium only as a trace contaminant, who may be at significant risk from occupational beryllium exposure? Please provide the basis for your response and any applicable supporting information.
9. Has OSHA defined the Beryllium lymphocyte proliferation test appropriately? If not, please provide the definition that you believe is appropriate. Please provide rationale and citations supporting your comments.
10. Has OSHA defined CBD Diagnostic Center appropriately? In particular, should a CBD diagnostic center be required to analyze biological samples on-site, or should diagnostic centers be allowed to send samples off-site for analysis? Is the list of tests and procedures a CBD Diagnostic Center is required to be able to perform appropriate? Should any of the tests or procedures be removed from the definition? Should other tests or procedures be added to the definition? Please provide rationale and information supporting your comments.
11. Do you currently monitor for beryllium exposures in your workplace? If so, how often? Please provide the reasoning for the frequency of your monitoring. If periodic monitoring is performed at your workplace for exposures other than beryllium, with what frequency is it repeated?
12. Is it reasonable to allow discontinuation of monitoring based on one sample below the action level? Should more than one result below the action level be required to discontinue monitoring?
The proposed standard would require employers to establish and maintain two types of areas: beryllium work areas, wherever employees are, or can reasonably be expected to be, exposed to any level of airborne beryllium; and regulated areas, wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. Employers are required to demarcate beryllium work areas, but are not required to restrict access to beryllium work areas or provide respiratory protection or other forms of PPE within work areas with exposures at or below the TWA PEL or STEL. Employers must also demarcate regulated areas, including posting warning signs; restrict access to regulated areas; and provide respiratory protection and other PPE within regulated areas.
13. Does your workplace currently have regulated areas? If so, how are regulated areas demarcated?
14. Please describe work settings where establishing regulated areas could be problematic or infeasible. If establishing regulated areas is problematic, what approaches might be used to warn employees in such work settings of high risk areas?
Paragraph (f)(2) of the proposed standard would require employers to implement engineering and work practice controls to reduce employees' exposures to or below the TWA PEL and STEL. Where engineering and work practice controls are insufficient to reduce exposures to or below the TWA PEL and STEL, employers would still be required to implement them to reduce exposure as much as possible, and to supplement them with a respiratory protection program. In addition, for each operation where there is airborne beryllium exposure, the employer must ensure that at least one of the engineering and work practice controls listed in paragraph (f)(2) is in place, unless all of the listed controls are infeasible, or the employer can demonstrate that exposures are below the action level based on no fewer than two samples taken seven days apart.
15. Do you usually use engineering or work practices controls (local exhaust ventilation, isolation, substitution) to reduce beryllium exposures? If so, which controls do you use?
16. Are the controls and processes listed in paragraph (f)(2)(i)(A) appropriate for controlling beryllium exposures? Are there additional controls or processes that should be added to paragraph (f)(2)(i)(A)?
17. OSHA's asbestos standard (CFR 1910.1001) requires employers to provide each employee with a tight-fitting, powered air-purifying respirator (PAPR) instead of a negative pressure respirator when the employee chooses to use a PAPR and it provides adequate protection to the employee. Should the beryllium standard similarly require employers to provide PAPRs (instead of allowing a negative pressure respirator) when requested by the employee? Are there other circumstances where a PAPR should be specified as the appropriate respiratory protection? Please provide the basis for your response and any applicable supporting information.
18. Do you currently require specific PPE or respirators when employees are working with beryllium? If so, what type?
19. The proposal requires PPE wherever work clothing or skin may become visibly contaminated with beryllium; where employees' skin can reasonably be expected to be exposed to soluble beryllium compounds; or where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL. The requirement to use PPE where work clothing or skin may become “visibly contaminated” with beryllium differs from prior standards which do not require contamination to be visible in order for PPE to be required. Is “visibly contaminated” an appropriate trigger for PPE? Is there reason to require PPE where employees' skin can be exposed to insoluble beryllium compounds? Please provide the basis for your response and any applicable supporting information.
20. The proposal requires employers to provide showers in their facilities if (A) 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. Is this requirement reasonable and adequately protective of beryllium-exposed workers? Should OSHA amend the provision to require showers in facilities where exposures exceed the PEL or STEL, without regard to areas of bodily contamination?
21. The proposed rule prohibits 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 exposure have been tried and were not effective. Please comment on this provision. What methods do you use to clean work surfaces at your facility? Are HEPA-filtered vacuuming or other methods to minimize beryllium exposure used to clean surfaces at your facility? Have they been effective? Are there any circumstances under which dry sweeping or brushing are necessary? Please explain your response.
22. The proposed rule requires that materials designated for recycling that are visibly contaminated with beryllium particulate shall be cleaned to remove visible particulate, or placed in sealed, impermeable enclosures. However, small particles (<10 μg) may not be visible to the naked eye, and there are studies suggesting that small particles may penetrate the skin, beyond which beryllium sensitization can occur (Tinkle et al., 2003). OSHA requests feedback on this provision. Should OSHA require that all material to be recycled be decontaminated regardless of perceived surface cleanliness? Should OSHA require that all material disposed or discarded be in enclosures regardless of perceived surface cleanliness? Please provide explanation or data to support your comments.
The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium above the proposed PEL for 30 days or more per year, who are exposed to beryllium in an emergency, or who show signs or symptoms of CBD; and (2) CT scans for employees who were exposed above the proposed PEL for more than 30 days in a 12-month period for 5 years or more. The proposed standard would require periodic medical exams to be provided for employees in the medical surveillance program annually, while tests for beryllium sensitization and CT scans would be provided to eligible employees biennially.
23. Is medical surveillance being provided for beryllium-exposed employees at your worksite? If so:
a. Do you provide medical surveillance to employees under another OSHA standard or as a matter of company policy? What OSHA standard(s) does the program address?
b. How many employees are included, and how do you determine which employees receive medical surveillance (
c. Who administers and implements the medical surveillance (
d. What examinations, tests, or evaluations are included in the medical surveillance program, and with what frequency are they administered? Does your program include a surveillance program specifically for beryllium-related health effects (
e. If your facility offers the BeLPT, please provide feedback and data on your experience with the BeLPT, including the analytical or interpretive procedure you use and its role in your facility's exposure control program. Has identification of sensitized workers led to interventions to reduce exposures to sensitized individuals, or in the facility generally? If a worker is found to be sensitized, do you track worker health and possible progression of disease beyond sensitization? If so, how is this done?
f. What difficulties and benefits (
g. What are the costs of your medical surveillance program? How do your costs compare with OSHA's estimated unit costs for the physical examination and employee time involved in the medical surveillance program? Are OSHA's baseline assumptions and cost estimates for medical surveillance consistent with your experiences providing medical surveillance to your employees?
24. Please review paragraph (k) of the proposed rule, Medical Surveillance, and comment on the frequency and contents of medical surveillance in the proposed rule. Is 30 days from initial assignment a reasonable time at which to provide a medical exam? Should there be a requirement for beryllium sensitization testing at time of employment? Should there be a requirement for beryllium sensitization testing at an employee's exit exam, regardless of when the employee's most recent sensitization test was administered? Are the tests required and the testing frequencies specified appropriate? Should sensitized employees have the opportunity to be examined at a CBD Diagnostic Center more than once following a confirmed positive BeLPT? Are there additional tests or alternate testing schedules you would suggest? Should the skin be examined for signs and symptoms of beryllium exposure or other medical issues, as well as for breaks and wounds? Please explain the basis for your position and provide data or studies if applicable.
25. Please provide comments on the proposed requirements regarding referral of a sensitized employee to a CBD diagnostic center, which specify referral to a diagnostic center “mutually agreed upon” by the employer and employee. Is this requirement for mutual agreement necessary and appropriate? How should a diagnostic center be chosen if the employee and employer cannot come to agreement? Should OSHA consider alternate language, such as referral for CBD
26. In the proposed rule, OSHA specifies that all medical examinations and procedures required by the standard must be performed by or under the direction of a licensed physician. Are physicians available in your geographic area to provide medical surveillance to workers who are covered by the proposed rule? Are other licensed health care professionals available to provide medical surveillance? Do you have access to other qualified personnel such as qualified X-ray technicians, and pulmonary specialists? Should the proposal be amended to allow examination by, or under the direction of, a physician or other licensed health care professional (PLHCP)? Please explain your position. Please note what you consider your geographic area in responding to this question.
27. The proposed standard requires the employer to obtain the Licensed Physician's Written Medical Opinion from the PLHCP within 30 days of the examination. Should OSHA 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, the employer could instead be required to obtain a certification from the PLCHP within 30 days of the examination stating (1) when the examination took place, (2) that the examination complied with the standard, and (3) that the PLHCP provided the employee a copy of the Licensed Physician's Written Medical Opinion required by the standard. The PLHCP would need the employee's written consent to send the employer the Licensed Physician's Written Medical Opinion or any other medical information about the employee. This approach might lead to corresponding changes in proposed paragraphs (f)(1) (written exposure control program), (l) (medical removal) and (n) (recordkeeping) to reflect that employers will not automatically be receiving any medical information about employees as a result of the medical surveillance required by the proposed standard, but would instead only receive medical information the employee chooses to share with the employer. Please 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, and explain the basis for your position and the potential impact on the benefits of medical surveillance.
28. Appendix A to the proposed standard reviews procedures for conducting and interpreting the results of BeLPT testing for beryllium sensitization. Is there now, or should there be, a standard method for BeLPT laboratory procedure? If yes, please describe the existing or proposed method. Is there now, or should there be, a standard algorithm for interpreting BeLPT results to determine sensitization? Please describe the existing or proposed laboratory method or interpretation algorithm. Should OSHA require that BeLPTs performed to comply with the medical surveillance provisions of this rule adhere to the Department of Energy (DOE) analytical and interpretive specifications issued in 2001? Should interpretation of laboratory results be delegated to the employee's occupational physician or PLHCP?
29. Should OSHA require the clinical laboratories performing the BeLPT to be accredited by the College of American Pathologists or another accreditation organization approved under the Clinical Laboratory Improvement Amendments (CLIA)? What other standards, if any, should be required for clinical laboratories providing the BeLPT?
30. Are there now, or are there being developed, alternative tests to the BeLPT you would suggest? Please explain the reasons for your suggestion. How should alternative tests for beryllium sensitization be evaluated and validated? How should OSHA determine whether a test for beryllium sensitization is more reliable and accurate than the BeLPT? Please see Appendix A to the proposed standard for a discussion of the accuracy of the BeLPT.
31. The proposed rule requires employers to provide OSHA with the results of BeLPTs performed to comply with the medical surveillance provisions upon request, provided that the employer obtains a release from the tested employee. Will this requirement be unduly burdensome for employers? Are there alternative organizations that would be appropriate to send test results to?
The proposed requirements for medical removal protection provide an option for medical removal to an employee who is working in a job with exposure at or above the action level and is diagnosed with CBD or confirmed positive for beryllium sensitization. If the employee chooses removal, the employer must remove the employee to comparable work in a work environment where exposure is below the action level, or if comparable work is not available, must place the employee on paid leave for 6 months or until such time as comparable work becomes available. In either case, the employer must maintain for 6 months the employee's base earnings, seniority, and other rights and benefits that existed at the time of removal.
32. Do you provide MRP at your facility? If so, please comment on the program's benefits, difficulties, and costs, and the extent to which eligible employees make use of MRP.
33. OSHA has included requirements for medical removal protection (MRP) in the proposed rule, which includes provisions for medical removal for employees with beryllium sensitization or CBD, and an extension of removed employees' rights and benefits for six months. Are beryllium sensitization and CBD appropriate triggers for medical removal? Are there other medical conditions or findings that should trigger medical removal? For what amount of time should a removed employee's benefits be extended?
34. Some OSHA health standards include appendices that address topics such as the hazards associated with the regulated substance, health screening considerations, occupational disease questionnaires, and PLHCP obligations. In this proposed rule, OSHA has included a non-mandatory appendix to describe and discuss the BeLPT (Appendix A), and a non-mandatory appendix presenting a non-exhaustive list of engineering controls employers may use to comply with paragraph (f) (Appendix B). What would be the advantages and disadvantages of including each appendix in the final rule? What would be the advantages and disadvantages of providing this information in guidance materials?
35. What additional information, if any, should be included in the appendices? What additional information, if any, should be provided in guidance materials?
36. The current beryllium proposal includes triggers that require employers to initiate certain provisions, programs, and activities to protect workers from beryllium exposure. All employers covered under an OSHA health standard are required to initiate certain activities such as initial monitoring to evaluate the potential hazard to employees. OSHA health standards typically include ancillary provisions with various triggers indicating when an
For the current Proposal, exposures to beryllium above the TWA PEL or STEL trigger the provisions for regulated areas, additional or enhanced engineering or work practice controls to reduce airborne exposures to or below the TWA PEL and STEL, personal protective clothing and equipment, medical surveillance, showers, and respiratory protection if feasible engineering and work practice controls cannot reduce airborne exposures to or below the TWA PEL and STEL. Exposures at or above the action level in turn trigger the provisions for periodic exposure monitoring, and medical removal eligibility (along with a diagnosis of CBD or confirmed positive for beryllium sensitization). Finally, an employer covered under the scope of the proposed standard must establish a beryllium work area where employees are, or can reasonably be expected to be, exposed to airborne beryllium regardless of the level of exposure. In beryllium work areas, employers must implement a written exposure control plan, provide washing facilities and change rooms (change rooms are only necessary if employees are required to remove their personal clothing), and follow housekeeping provisions. The employers must also implement at least one of the engineering and work practice controls listed in paragraph (f)(2) of the proposed standard. An employer is exempt from this requirement if he or she can demonstrate that such controls are not feasible or that exposures are below the action level.
Certain provisions are triggered by one condition and other provisions are triggered only if multiple conditions are present. For example, medical removal is only triggered if an employee has CBD or is confirmed positive AND the employee is exposed at or above the action level.
OSHA is requesting comment on the triggers in the proposed beryllium standard. Are the triggers OSHA has proposed appropriate? OSHA is also requesting comment on these triggers relative to the regulatory alternatives affecting the scope and PELs as described in this preamble in section I, Issues and Alternatives. For example, are the triggers in the proposed standard appropriate for Alternative #1a, which would expand the scope of the proposed standard to include all operations in general industry where beryllium exists only as a trace contaminant (less than 0.1% beryllium by weight)? Are the triggers appropriate for the alternatives that change the TWA PEL, STEL, and action level? Please specify the trigger and the alternative, if applicable, and why you agree or disagree with the trigger.
37. In Section IX—Preliminary Economic Analysis under the
Nevertheless, under 10 CFR 850.22, DOE has included in its CBDPP regulation a requirement for compliance with the current OSHA permissible exposure limit (PEL), and any lower PEL that OSHA establishes in the future. Thus, although DOE has preempted OSHA's standard from applying at DOE facilities and OSHA cannot exercise any authority at those facilities, DOE relies on OSHA's PEL in implementing its own program. However, DOE's decision to tie its own standard to OSHA's PEL has little consequence to this rulemaking because the requirements in DOE's beryllium program (controls, medical surveillance, etc.) are triggered by DOE's action level of 0.2 µg/m
DOE has expressed to OSHA that DOE facilities are already in compliance with 10 CFR 850 and its action level of 0.2 µg/m
DOE also has noted some potential overlap with a separate DOE provision in 10 CFR part 851, which requires its contractors to comply with DOE's CBDPP (10 CFR 851.23(a)(1)) and also with all OSHA standards under 29 CFR part 1910 except “Ionizing Radiation” (§ 1910.1096) (10 CFR 851.23(a)(3)). These requirements, which DOE established in 2006 (71 FR 6858 (February 9, 2006)), make sense in light of OSHA's current regulation because OSHA's only beryllium protection is a PEL, so compliance with 10 CFR 851.23(a)(1) and (3) merely make OSHA's current PEL the relevant level for purposes of the CBDPP. However, its function would be less clear if OSHA adopts a beryllium standard as proposed. OSHA's proposed beryllium standard would establish additional substantive protections beyond the PEL. Consequently, notwithstanding the CBDPP's preemptive effect on the OSHA beryllium standard as a result of 29 U.S.C. 653(b)(1), 10 CFR 851.23(a)(3) could be read to require DOE contractors to comply with all provisions in OSHA's proposal (if finalized), including the ancillary provisions, creating a dual regulatory scheme for beryllium protection at DOE facilities.
DOE officials have indicated that this is not their intent. Instead, their intent is that DOE contractors comply solely with the CBDPP provisions in 10 CFR part 850 for protection from beryllium.
OSHA can envision several potential scenarios developing from its rulemaking, ranging from OSHA retaining the proposed PEL of 0.2 µg/m
OSHA is aware that, in the preamble to its 1999 CBDPP rule, DOE analyzed the costs for implementing the CBDPP for action levels of 0.1 µg/m
Based on the range of potential scenarios and the prior DOE cost estimates, OSHA estimates that the annual cost impact on DOE facilities could range from $0 to $4,065,768 (2010 dollars). The upper end of the cost range would reflect the unlikely scenario in which OSHA promulgates a final PEL of 0.1 µg/m
OSHA requests comment on the potential overlap of DOE's rule with OSHA's proposed rule.
The purpose of the Occupational Safety and Health Act, 29 U.S.C. 651
To achieve this goal Congress authorized the Secretary of Labor (the Secretary) to promulgate and enforce occupational safety and health standards. 29 U.S.C. 654(b) (requiring employers to comply with OSHA standards), 655(a) (authorizing summary adoption of existing consensus and federal standards within two years of the Act's enactment), and 655(b) (authorizing promulgation, modification or revocation of standards pursuant to notice and comment).
The Act provides that in promulgating health standards dealing with toxic materials or harmful physical agents, such as this proposed standard regulating occupational exposure to 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. See 29 U.S.C. 655(b)(5).
The Supreme Court has held that before the Secretary can promulgate any permanent health or safety standard, he must make a threshold finding that significant risk is present and that such risk can be eliminated or lessened by a change in practices.
The Court further observed that what constitutes “significant risk” is “not a mathematical straitjacket” and must be “based largely on policy considerations.”
. . . the odds are one in a billion that a person will die from cancer . . . the risk clearly could not be considered significant. On the other hand, if the odds are one in one thousand that regular inhalation of gasoline vapors that are 2% benzene will be fatal, a reasonable person might well consider the risk significant. [
OSHA standards must be both technologically and economically feasible.
. . . within the limits of the best available evidence . . . 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. [
With respect to economic feasibility, the courts have held that a standard is feasible if it does not threaten massive dislocation to or imperil the existence of the industry.
. . . in relation to the financial health and profitability of the industry and the likely effect of such costs on unit consumer prices . . . [T]he practical question is whether the standard threatens the competitive stability of an industry, . . . or whether any intra-industry or inter-industry discrimination in the standard might wreck such stability or lead to undue concentration. [
Finally, sections 6(b)(7) and 8(c) of the Act authorize OSHA to include among a standard's requirements labeling, monitoring, medical testing, and other information-gathering and -transmittal provisions. 29 U.S.C. 655(b)(7), 657(c).
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, a national consensus standard (ANSI Z37.29-1970) for beryllium and beryllium compounds. The standard set a permissible exposure limit (PEL) for beryllium and beryllium compounds at 2 µg/m
Section 6(a) stipulated 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.
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 that beryllium caused cancer in animal experiments (40 FR 48814 (October 17, 1975)). 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 (DOE, 1999). 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) (OSHA, 2002) and by Dr. Lee Newman and Ms. Margaret Mroz, from the National Jewish Medical Research Center (NJMRC) (OSHA, 2002), 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 (OSHA, 2002). 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)). The burden of proof is on the Department and because of the difficulty of meeting this burden, the Department usually proceeds when appropriate with 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.
On November 26, 2002, OSHA published a Request for Information (RFI) for “Occupational Exposure to Beryllium” (OSHA, 2002). 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 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
The SBREFA Panel issued a report which included the SERs' comments on January 15, 2008. 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.”
The SBREFA Panel issued a number of recommendations, which OSHA carefully considered. In section XVIII of this preamble, Summary and Explanation, OSHA has responded to the Panel's recommendations and clarified the requirements about which SERs expressed confusion. OSHA also examined the regulatory alternatives recommended by the SBREFA Panel. The regulatory alternatives examined by OSHA are listed in section I of this preamble, Issues and Alternatives. The alternatives are discussed in greater detail in section XVIII of this preamble, Summary and Explanation, and in the PEA (OSHA, 2014). In addition, the Agency intends to develop interpretive guidance documents following the publication of a final rule.
In 2010, OSHA hired a contractor to oversee an independent scientific peer review of a draft preliminary beryllium health effects evaluation (OSHA, 2010a) and a draft preliminary beryllium risk assessment (OSHA, 2010b). 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 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 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. 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. 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). This draft proposal 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. The United Steelworkers and Materion 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 for beryllium.
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 (NTP 2014). It occurs naturally in rocks, soil, coal, and volcanic dust (ATSDR, 2002). 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 (NTP, 2014). 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 (IARC, 1993).
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 (IARC, 1993). Imported beryl is also converted into beryllium hydroxide as the United States has very little beryl that can be economically mined (USGS, 2013a).
Materion Corporation, 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 (NTP, 2014). Beryllium oxide is used in components such as ceramics, electrical insulators, microwave oven components, military vehicle armor, laser structural components, and automotive ignition systems (ATSDR, 2002). 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 (OSHA, 2014).
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.
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).
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 (Be; CAS No. 7440-41-7) is a steel-grey, brittle metal with an atomic number of 4 and an atomic weight of 9.01 (Group IIA of the periodic table). Because of its high reactivity, beryllium is not found as a free metal in nature; however, there are approximately 45 mineralized forms of beryllium. Beryllium compounds and alloys include commercially valuable metals and gemstones.
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 or dermal exposure may occur. The 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, 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. Solubility also 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.
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 exposure, the physical characteristics of the particle are important as well since they can influence skin absorption and bioavailability. This section addresses certain physical characteristics (
Solubility may 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; Mandervelt
This section reviews the relevant information regarding solubility, its importance in a biological matrix and its relevance to sensitization and beryllium lung disease. The weight of evidence presented below suggests that both soluble and non-soluble forms of beryllium can induce a sensitization response and result in progression of lung disease.
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, insoluble beryllium, taken up by activated phagocytes, was shown to be ionized by myeloperoxidases (Leonard and Lauwerys, 1987; Lansdown, 1995). 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). 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
The toxicity of beryllium as exemplified by beryllium oxide also is dependent, in part, on the particle size, with smaller particles (<10 μm) 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). 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).
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 and biologically relevant toxicity endpoints of either sensitization or CBD.
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 et al. (2011) evaluated particle size distribution, chemistry and solubility in areas with historically elevated risk of sensitization and CBD at a beryllium metal powder, beryllium oxide, and alloy production facility. The investigators observed that historically, exposure-response relationships have been inconsistent when using mass concentration to identify process-related risk, possibly due to incomplete particle characterization. Two separate exposure surveys were conducted in March 1999 and June-August 1999 using multi-stage personal impactor samplers (to determine particle size distribution) and personal 37 mm closed face cassette (CFC) samplers, both located in workers' breathing zones. One hundred and ninety eight time-weighted-average (TWA) personal impactor samples were analyzed for representative jobs and processes. A total of 4,026 CFC samples were collected over the 5-month collection period and analyzed for mass concentration, particle size, chemical content and solubility and compared to process areas with high risk of sensitization and CBD. The investigators found that total beryllium concentration varied greatly between workers and among process areas. Analysis of chemical form and solubility also revealed wide variability among process areas, but high risk process areas had exposures to both soluble and insoluble forms of beryllium. Analysis of particle size revealed most process areas had particles ranging from 5-14 µm mass median aerodynamic diameter (MMAD). Rank order correlating jobs to particle size showed high overall consistency (Spearman
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; Miller, 1995; Oberdorster
Finch
Several studies have investigated the lung toxicity of beryllium oxide calcined at different temperatures and generally had 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, ingestion, or absorption through the skin. 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. Inhaled beryllium particles are deposited along the respiratory tract in a size dependent manner. In general, particles larger than 10 μm tend to deposit in the upper respiratory tract or nasal region and do not appreciably penetrate lower in the tracheobronchial or pulmonary regions (Figure 1). Particles less than 10 μm increasingly penetrate and deposit in the tracheobronchial and pulmonary regions with peak deposition in the pulmonary region occurring below 5 μm in particle diameter. The CBD pathology of concern is found in the pulmonary region. For particles below 1 μm, regional deposition changes dramatically. Ultrafine particles (generally considered to be 100 nm or lower) have a higher rate of deposition along the entire respiratory system (ICRP model, 1994). Those 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. Sparingly soluble or insoluble beryllium may remain in the lungs for many years after exposure, as has been observed in workers (Schepers, 1962). Clearance mechanisms for sparingly soluble or insoluble beryllium particles include: In the nasal passage, sneezing, mucociliary transport to the throat, or dissolution; in the tracheobronchial region, mucociliary transport, coughing, phagocytosis, or dissolution; in the pulmonary or alveolar region, phagocytosis, movement through the interstitium (translocation), or dissolution (Schlesinger, 1997).
Clearance mechanisms may occur slowly in humans, which is consistent with some animal studies. For example, subjects in the Beryllium Case Registry (BCR), which identifies and tracks cases of acute and chronic beryllium diseases, had elevated concentrations of beryllium in lung tissue (
Clearance rates may depend on the solubility, dose, and size of the beryllium particles inhaled as well as the sex and species of the animal tested. As reviewed in a WHO Report (2001), 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; Hart
Evidence from animal studies suggests that greater amounts of beryllium deposited in the lung may result in slower clearance times. A comparative study of rats and mice using a single dose of inhaled aerosolized beryllium metal demonstrated that an acute inhalation exposure to beryllium metal can slow particle clearance and induce lung damage in rats (Haley
Beryllium absorbed from the respiratory system is mainly distributed to the tracheobronchial lymph nodes via the lymph system, bloodstream, and skeleton, which is the ultimate site of beryllium storage (Stokinger
Systemic distribution of the more soluble compounds appears to be greater than that of the insoluble compounds (Stokinger
Beryllium compounds have been shown to cause skin irritation and sensitization in humans and certain animal models (Van Orstrand
Although its precise role remains to be elucidated, there is evidence to indicate 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
A study by Deubner
A study conducted by Day
The same group of investigators (Armstrong
According to the WHO Report (2001), gastrointestinal absorption of beryllium can occur by both the inhalation and oral routes of exposure. Through inhalation exposure, a fraction of the inhaled material is transported to the gastrointestinal tract by the mucociliary escalator or by the swallowing of the insoluble material deposited in the upper respiratory tract (WHO, 2001). Gastrointestinal absorption of beryllium can occur by both the inhalation and oral routes of exposure. 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 insoluble material deposited in the upper respiratory tract (Schlesinger, 1997). Animal studies have shown oral administration of beryllium compounds to result in very limited absorption and storage (as reviewed by U.S. EPA, 1998). In animal ingestion studies using radio-labeled beryllium chloride in rats, mice, dogs, and monkeys, the vast majority of the ingested dose passed through the gastrointestinal tract unabsorbed and was excreted in the feces. In most studies, <1 percent of the administered radioactivity was absorbed into the bloodstream and subsequently excreted in the urine (Crowley
Urinary excretion of beryllium has been shown to correlate with the amount of occupational exposure (Klemperer
Beryllium and its compounds are not metabolized or biotransformed, but soluble beryllium salts may be converted to less soluble forms in the lung (Reeves and Vorwald, 1967). As stated earlier, solubility is an important factor for persistence of beryllium in the lung. Insoluble beryllium, engulfed by activated phagocytes, can be ionized by an acidic environment and by myeloperoxidases (Leonard and Lauwerys, 1987; Lansdown, 1995; WHO, 2001), and this positive charge could potentially make it more biologically reactive because it may allow the beryllium to bind to a peptide or protein and be presented to the T cell receptor or antigen-presenting cell (Fontenot, 2000).
The forms and concentrations of beryllium across the workplace vary substantially based upon location, process, production and work task. Many factors influence the potency of beryllium including concentration, composition, structure, size 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), 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 (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 insoluble particles or mist) can deposit in the respiratory tract and interact with immune cells located along the entire respiratory tract (Scheslinger, 1997). However, more study is needed to precisely determine the physiochemical characteristics of beryllium that influence toxicity and immunogenicity.
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
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; DeNardi
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. It was proposed as early as 1951 that CBD could be a chronic disease resulting from an immune sensitization to beryllium (Sterner and Eisenbud, 1951; Curtis, 1959; Nishimura, 1966). 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). 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. This includes 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 (Rossman, 1996; NAS, 2008). Besides these listed symptoms from CBD patients, there have been reported cases of CBD that remained asymptomatic (Muller-Querheim, 2005; NAS, 2008).
Unlike ABD, CBD can result from inhalation exposure to beryllium at levels below the current OSHA PEL, can take months to years after initial beryllium exposure before signs and symptoms of CBD occur (Newman 1996, 2005 and 2007; Henneberger, 2001; 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, 2008; NAS, 2008). The management of CBD is based on the hypothesis that suppression of the hypersensitivity reaction (
To date, there have been no controlled studies to determine the optimal treatment for CBD (Rossman, 1996; NAS 2008; Sood, 2009). Management of CBD is generally modeled after sarcoidosis treatment. Oral corticosteroid treatment can be initiated in patients with
Sensitization to beryllium is an essential step for worker development of CBD. Sensitization to beryllium can result from inhalation exposure to beryllium (Newman
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 (
Next in sequence is the beryllium-MHC-APC complex binding to a T-cell receptor (TCR) on a naïve T-cell which stimulates the proliferation and accumulation of beryllium-specific CD4
As CD4
The continued persistence 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.
Over time, the granulomas spread and can lead to lung fibrosis and abnormal pulmonary function, with symptoms including a persistent dry cough and shortness of breath (Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain, clubbing of fingers (due to impaired oxygen exchange), loss of appetite or unexplained weight loss, and cor pulmonale have been experienced in certain patients as the disease progresses (Conradi
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
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). Additional
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, and beryllium sensitization and CBD (McClesky et al., 2009). Specific SNPs have been evaluated as a factor in Glu69 variant from the HLA-DPB1 locus (Richeldi et al., 1993; Cai et al., 2000; Saltini et al., 2001; Silviera et al., 2012; Dai et al., 2013), HLA-DRPheβ47 (Amicosante et al., 2005).
HLA-DPB1 with a glutamic acid at amino position 69 (Glu 69) has been shown to confer increased risk of beryllium sensitization and CBD (Richeldi
In contrast, the HLA-DRB1 allele, which lacks Glu 69, 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 associated with a more severe pulmonary disease in 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). 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 gender may play a role in the development of CBD (NAS, 2008). 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 BeLT (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). 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). In advanced cases of CBD, corticosteroids are the standard treatment (NAS, 2008). No comprehensive studies have been published measuring the overall effect of removal of workers from beryllium exposure on sensitization and CBD (NAS, 2008) although this has been suggested as part of an overall treatment regime for CBD (Mapel
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 Appendix summarizes the prevalence of beryllium sensitization and CBD, range of exposure measurements, and other salient information from the key epidemiological studies.
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 current OSHA PEL of 2 μg/m
Some of the epidemiological studies presented in this review 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). 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). 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). 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):
(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). In a 1969 study, Stoeckle
The criteria for diagnosis of CBD have evolved over time as more advanced
(1) History of beryllium exposure;
(2) Histopathological evidence of noncaseating 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). 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
There has been criticism regarding the reliability and specificity of the BeLPT as a screening tool (Borak
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). 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). Most exposures from mining and extraction come in the form of beryllium ore, beryllium salts, beryllium hydroxide (NAS 2008) 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, with 18.5 percent of samples exceeding OSHA's STEL of 5.0 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 upon initial testing and at least one of two subsequent tests was classified 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 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
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.
Of those workers who underwent bronchoscopy, 32 (5.5 percent) with evidence of granulomas were classified as “definite” CBD cases. 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 the 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.
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 OSHA PEL of 2 μ g/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 μ g/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 et al. (1997) and Rosenman et al. (2005) at a beryllium production and processing facility in eastern Pennsylvania by Schuler et al. (2012), and in a companion study by Virji et al. (2012). Schuler et al. evaluated the worker population employed in 1999 with six years or less work tenure in a cross-sectional study. The investigators evaluated the worker population by administering a work history questionnaire with a follow-up examination for sensitization and CBD. A job-exposure matrix (JEM) was combined with work histories to create individual estimates of average, cumulative, and highest-job-related exposure for total, respirable, and sub-micron beryllium mass concentration. Of the 291 eligible workers, 90.7 percent (264) participated in the study. Sensitization prevalence was 9.8 percent (26/264) with CBD prevalence of 2.3 percent (6/264). The investigators found a general pattern of increasing sensitization prevalence as the exposure quartile increased indicating an exposure-response relationship. The investigators found positive associations with both total and respirable mass concentration with sensitization (average and highest job) and CBD (cumulative). Increased sensitization prevalence was observed with metal oxide production alloy melting and casting, and maintenance. CBD was associated with melting and casting. The investigators summarized that both total and respirable mass concentration were relevant predictors of risk (Schuler
In the companion study by Virji et al. (2012), the investigators reconstructed historical exposure from 1994 to 1999 utilizing the personal sampling data collected in 1999 as baseline exposure estimates (BEE). The study evaluated techniques for reconstructing historical data to evaluate exposure-response relationships for epidemiological studies. The investigators constructed JEMs using the BEE and estimates of annual changes in exposure for 25 different process areas. The investigators concluded these reconstructed JEMs could be used to evaluate a range of exposure parameters from total, respirable and submicron mass concentration including cumulative, average, and highest exposure. These two studies demonstrate that high-quality exposure estimates can be developed both for total mass and respirable mass concentrations.
Newman
Engineering and administrative measures, 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 on BeLPT testing above), and was considered borderline if one of the indices exceeded the normal range. A repeat BeLPT was conducted for workers with abnormal or borderline initial results. Workers were identified as beryllium sensitized and referred for a clinical evaluation, including bronchoalveolar lavage (BAL) and transbronchial lung biopsy, if the repeat test was abnormal. CBD was diagnosed upon evidence of sensititization with granulomas or mononuclear cell infiltrates in the lung tissue (Newman
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 current PEL of 2 μ g/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 (3.7 percent of the screening population) of the nine 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
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 of average exposures—0.39 μg/m
Fifteen cases of sensitization were found, including eight among short-term and seven among long-term workers. Eight of the 15 workers were found to have CBD. Of the workers diagnosed with CBD, seven (88 percent) were long-term workers. One non-sensitized long-term worker and one sensitized long-term worker declined clinical examination.
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
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). 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 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 it 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
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; and at 3-year intervals thereafter. Among 82 workers hired after 1999, three (3.7 percent) cases of sensitization were found. Two (5.4 percent) of 37 workers hired prior to enclosure of the wire annealing and pickling process were found to be sensitized within 3 and 6 months of beginning work at the plant. One (2.2 percent) of 45 workers hired after the enclosure was confirmed as sensitized.
Thomas
Stanton
The authors estimated workers' beryllium exposures using IH data from company records and job history information collected through interviews conducted by a company occupational health nurse. 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, range < 0.02-0.13 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 BLPT 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. 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
Armojandi
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 beryllium levels were believed to be 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 agreed to participate in a medical surveillance program between 2000 and 2006 (60 percent participation rate). The medical surveillance program included serum BeLPT analysis, confirmation of an abnormal BeLPT with a second BeLPT, and follow-up of all confirmed positive responses by a pulmonary physician to evaluate for progression to CBD.
Eight-hour TWAs 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
A study by Nilsen
This section reviews the relevant animal studies supporting the mechanisms outlined above. Researchers have attempted to identify animal models with which to further investigate the mechanisms underlying the development of CBD. A suitable animal model should exhibit major characteristics of CBD, including the demonstration of a beryllium-specific immune response, the formation of immune granulomas following inhalation exposure to beryllium, and mimicking the progressive nature of the 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 formed by foreign-body reactions, which result from persistent irritation and consist predominantly of macrophages and monocytes, and small numbers of lymphocytes. Foreign-body granulomas are distinct from the immune granulomas of CBD, which are caused by antigenic stimulation of the immune system and contain large numbers of lymphocytes. 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. However, the lack of a dependable animal model that mimics all facets of the human response combined with study limitations in terms of single dose experiments, few animals, or abbreviated observation periods have limited the utility of the data. Currently, no single model has completely mimicked the disease process as it progresses in humans. 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 Appendix summarizes species, route, chemical form of beryllium, dose levels, and pathological findings of the key studies.
Harmsen
Cells were collected from the dogs by BAL at 30, 60, 90, 180, and 210 days after exposure, and the percentages of neutrophils and lymphocytes were determined. In addition, the mitogenic responses of blood lymphocytes and lavage cells collected at 210 days were determined with either phytohemagglutinin or beryllium sulfate as mitogen. The percentage of neutrophils in the lavage fluid was significantly elevated only at 30 days with exposure to either dose of 500 °C beryllium oxide. The percentage of lymphocytes in the fluid was significantly elevated in samples across all times with exposure to the high dose of this beryllium oxide form. Beryllium oxide calcined at 1,000° C elevated lavage lymphocytes only in high dose at 30 days. 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. The investigators in this study were able to replicate some of the same findings as those observed in human studies—specifically, that beryllium in soluble and insoluble forms can be mitogenic to immune cells, an important finding for progression of sensitization and proliferation of immune cells to developing full-blown CBD.
In another beagle study Haley
This study also provided an opportunity to compare the effects of beryllium oxide calcination temperature on granulomatous disease in the beagle respiratory system. Haley
The histologic and immunologic responses of canine lungs to aerosolized beryllium oxide were investigated in another 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 for an initial lung burden (ILB) target of 50 μg beryllium oxide/kg body weight (Haley
A 1994 study by Haley
In an experiment similar to the one conducted with dogs, Conradi
As discussed earlier in this Health Effects section, at the cellular level, beryllium dissolution must occur for either a dendritic cell or a macrophage to present beryllium as an antigen to induce the cell-mediated CBD immune reactions (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
It is well-established that skin and inhalation exposure to beryllium may lead to sensitization and that inhalation exposure, or skin exposure coupled with inhalation exposure, may lead to the onset and progression of CBD. This is supported by extensive human studies. 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 previous sections. Sensitization is a necessary first step to the onset of CBD (NAS, 2008). 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 progress to CBD (Rosenman
The epidemiological evidence presented in this section demonstrates that sensitization and CBD are continuing to occur from present-day exposures below OSHA's PEL (Rosenman, 2005 with erratum published 2006). The available literature discussed above shows that disease prevalence can be reduced by reducing inhalation exposure (Thomas
Studies have demonstrated there remains a prevalence of sensitization and CBD in facilities with exposure levels below the current OSHA PEL (Rosenman
Of workers who were found to be sensitized and underwent clinical evaluation, 20-49 percent were diagnosed with CBD (Kreiss
Beryllium exposure has been 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, the International Agency for Research on Cancer (IARC) did an extensive evaluation in 1993 and reevaluation in April 2009 (IARC, 2012). 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), and the National Toxicology Program (NTP) has determined beryllium and its compounds to be known carcinogens (NTP, 2014). OSHA has conducted an independent evaluation of the carcinogenic potential of beryllium and these compounds as well. The following is a summary of the studies used to support the Agency findings 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).
Gene mutations have been observed in mammalian cells cultured with beryllium chloride in a limited number of studies (EPA, 1998; ATSDR, 2002; Gordon and Bowser, 2003). Culturing mammalian cells with beryllium chloride, beryllium sulfate, or beryllium nitrate has resulted in clastogenic alterations. However, most studies have found that beryllium chloride, beryllium nitrate, beryllium sulfate, and beryllium oxide did not induce gene mutations in bacterial assays with or without metabolic activation. In the case of beryllium sulfate, all mutagenicity studies (Ames (Simmon, 1979; Dunkel
Beryllium nitrate was negative in the Ames assay (Tso and Fung, 1981; Kuroda
Gene mutations have been observed in mammalian cells (V79 and CHO) cultured with beryllium chloride (Miyaki
Data on the
This section reviews in greater detail the studies used to support the mechanistic findings for beryllium-induced cancer. Table A.3 in the Appendix summarizes the important features and characteristics of each study.
a. Beryllium Case Registry (BCR).
Two studies evaluated participants in the BCR (Infante
Steenland and Ward (1991) 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. The largest and most comprehensive study investigated the mortality experience of 9,225 workers employed in seven different beryllium processing plants over a 30-year period (Ward
Bayliss
Mancuso (1970, 1979, 1980) and Mancuso and El-Attar (1969) performed a series of occupational cohort studies on a group of over 3,685 workers (primarily white males) employed in the beryllium manufacturing industry during 1937-1948.
Wagoner
Ward
The EPA Integrated Risk Information System (IRIS), IARC, and California EPA Office of Environmental Health Hazard Assessment (OEHHA) have all based their cancer assessment on the Ward
Levy
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 cumulative, average, and maximum beryllium exposure concentration estimates for the 142 known lung cancer cases were 46.06 ± 9.3µg/m
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. There was also a lack of evidence that confounding factors such as smoking affected the results of the regression analysis. The authors noted that there was considerable uncertainty in the estimation of exposure in the 1940's and 1950's and the shape of the dose-response curve for lung cancer. Another analysis of the study data using a different statistical method did not find a significantly greater relative risk of lung cancer with increasing beryllium exposures (Levy
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.
The authors stated that the reanalysis indicated that differences in the hire ages among cases and controls, first noted by Deubner
Hollins
Schubauer-Berigan
Overall mortality in the cohort compared with the US 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). Mortality rates for most diseases of interest increased with time-since-hire. For the category including CBD, rates were substantially elevated compared to the US population across all exposure groups. Workers whose maximum beryllium exposure was ≥ 10 μg/m
The authors concluded 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
This section reviews the animal literature used to support the findings for beryllium-induced lung cancer. 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 possibly in mice. The chronic oral studies did not report increased incidences of tumors in rodents, but these were conducted at doses below the maximum tolerated dose (MTD) (EPA, 1998).
Early animal studies revealed that some beryllium compounds are carcinogenic when inhaled (ATSDR, 2002). Animal experiments have shown consistent increases in lung cancers in rats, mice and rabbits chronically exposed to beryllium and beryllium compounds by inhalation or intratracheal instillation. In addition to lung cancer, osteosarcomas have been produced in mice and rabbits exposed to various beryllium salts by intravenous injection or implantation into the bone (NTP, 1999).
In an inhalation study assessing the potential tumorigenicity of beryllium, Schepers
Schepers (1962) 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) 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
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 “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 only 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
Lung tumors were observed only in rats exposed to beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. Passivation refers to the process of removing iron contamination from the surface of
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. From 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
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
The exact mechanism by which beryllium induces pulmonary neoplasms in animals remains unknown (NAS 2008). Keshava
Keshava
Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph
OSHA has preliminarily determined that the weight of evidence indicates that beryllium compounds should be regarded as potential occupational lung carcinogens. Other scientific organizations, including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (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 a possible indirect mechanism may be responsible for most tumorigenic activity of beryllium in animal models and possibly humans (EPA, 1998). Inflammation has been postulated to be a key contributor to many different forms of cancer (Jackson
In addition to a T-cell mediated response beryllium has been demonstrated to produce an inflammatory response in animal models similar to other particles (Reeves
It has been hypothesized that the recruitment of neutrophils during the inflammatory response and subsequent release of oxidants from these cells have been demonstrated to play an important role in the pathogenesis of rat lung tumors (Borm
Epidemiological studies indicate excess risk of lung cancer mortality from occupational beryllium exposure levels at or below the current OSHA PEL (Schubauer-Berigan
Past studies on other health effects have been thoroughly reviewed by several scientific organizations (NTP, 1999; EPA, 1998; ATSDR, 2002; WHO, 2001; HSDB, 2010). 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, beryllium phosphate had accumulated almost exclusively within sinusoidal (Kupffer) cells of the liver, while the beryllium derived from beryllium sulfate was found mainly in parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes were rapidly excreted (Skillteter and Paine, 1979).
According to a few autopsies, beryllium-laden liver had central necrosis, mild focal necrosis as well as congestion, and occasionally beryllium granuloma.
Residents near a beryllium plant may have been exposed by inhaling trace amounts of beryllium powder, and different beryllium compounds may have induced different toxicant reactions (Yian and Yin, 1982).
There is very limited evidence of cardiovascular effects of beryllium and its compounds in humans. Severe cases of chronic beryllium disease 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). 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 calculi (stones) were unusually prevalent in severe cases that resulted from high levels of beryllium exposure. Renal stones containing beryllium occurred in about 10 percent of patients affected by high exposures (Barnett,
Both the soluble, sparingly soluble, and insoluble beryllium compounds have been shown to cause ocular irritation in humans (Van Orstrand
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
Through careful analysis of the current best available scientific information outlined in this Health Effects Section V, OSHA has preliminarily determined that beryllium and beryllium-containing compounds are able to cause sensitization, chronic beryllium disease (CBD) and lung cancer below the current OSHA PEL of 2 μg/m
Through the biological and immunological processes outlined in section V.B. of the Health Effects, the Agency believes that the scientific evidence supports the following mechanism for the development of sensitization and CBD.
• Inhaled beryllium and beryllium-containing materials able to be retained and solubilized in the lungs initiate sensitization and facilitate CBD development (Section V.B.5).
• 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 been demonstrated to dissolve beryllium compounds in the lung (section V.A.2a).
• Sensitization occurs through a CD4+ T-cell mediated process with both soluble and insoluble beryllium and beryllium-containing compounds through direct antigen presentation or through further antigen processing (section V.D.1) 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).
○ Animal studies have provided supporting evidence for T-cell proliferation in the development of granulomatous lung lesions after beryllium exposure (section 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 (V.D.1). While no clinical symptoms are associated with sensitization, a sensitized worker is at risk of developing CBD upon subsequent inhalation exposure to beryllium.
○ Epidemiological evidence that covers a wide variety of different beryllium compounds and industrial processes demonstrates that sensitization and CBD are continuing to occur at present-day exposures below OSHA's PEL (section V.D.4; V.D.5).
• 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 may 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 has conducted an evaluation of the current available scientific information of the carcinogenic potential of beryllium and beryllium-containing compounds (section V.E). Based on weight of evidence and plausible mechanistic information obtained from
• Lung cancer is an irreversible and frequently fatal disease with an extremely poor 5-year survival rate (NCI, 2009).
• 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 of experimental animals resulted in an increased incidence of lung tumors (Section V.E.3).
• Authoritative scientific organizations, such as the IARC, NTP, and EPA, have classified beryllium as a known or probable human carcinogen.
While OSHA has preliminarily determined there is sufficient evidence of beryllium carcinogenicity, the exact tumorigenic mechanism for beryllium is unclear and a number of mechanisms are plausibly 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 animal models after inhalation exposure to sparingly soluble particles at doses causing marked, chronic inflammation is due to a secondary mechanism unrelated to the genotoxicty of the particle (section V.E.5).
• A review conducted by the NAS (2008) 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 have been summarized 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 1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less relevant today than in the past.
The Occupational Safety and Health (OSH) Act and court cases arising under it have led OSHA to rely on risk assessment to support the risk determinations required to set a permissible exposure limit (PEL) for a toxic substance in standards under the OSH Act. Section 6(b)(5) of the OSH Act states that “The Secretary [of Labor], in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, 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)).
In
OSHA's approach for the risk assessment incorporates both a review of the recent literature on populations of workers exposed to beryllium below the current Permissible Exposure Limit (PEL) of 2 μg/m
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 PEL of 2 μg/m
The Health Effects section also discussed the role of particle characteristics and beryllium compound solubility in the development of sensitization and CBD among beryllium-exposed workers. 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. The weight of evidence indicates that both soluble and insoluble forms of beryllium are able to induce sensitization and CBD. Insoluble 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 these factors potentially influence the toxicity of beryllium, the available data are too limited to reliably account for solubility and particle size in the Agency estimates of risk. The qualitative impact on conclusions and uncertainties with regard to risk are discussed in a later section.
Schuler
Personal lapel samples were collected in production and production support jobs between 1995 and May 2000. These samples showed primarily very low airborne beryllium levels, with a median of 0.073 μg/m
After the BeLPT screening was conducted in 2000, the company began implementing new measures to further reduce workers' exposure to beryllium. Requirements designed to minimize dermal contact with beryllium, including long-sleeve facility uniforms and polymer gloves, were instituted in production areas in 2000. In 2001 the company installed local exhaust ventilation (LEV) in die grinding and polishing. Personal lapel samples collected between June 2000 and December 2001 show reduced exposures plant-wide. Of 2,211 exposure samples collected during this “pre-enclosure program” period, 98 percent were below 0.2 μg/m
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; and at 3-year intervals thereafter. Among 82 workers hired after 1999, three cases of sensitization were found (3.7 percent). Two (5.4 percent) of 37 workers hired prior to enclosure of the wire annealing and pickling process were found to be sensitized within 3 and 6 months of beginning work at the plant. One (2.2 percent) of 45 workers hired after the enclosure was confirmed as sensitized. Among these early results, it appears that the greatest reduction in sensitization risk was achieved after median exposures in all areas of the plant were reduced to below 0.1 μg/m
Kreiss
Kreiss
Following the 1992 screening, the facility reduced exposures in machining areas by enclosing machines and installing HEPA filter exhaust systems. Personal samples collected between 1994 and 1999 had a median of 0.2 μg/m
Following the 1998 screening, the company continued efforts to reduce exposures and risk of sensitization and CBD by implementing additional engineering and administrative controls and PPE. Respirator use was required in production areas beginning in 1999, and latex gloves were required beginning in 2000. The lapping area was enclosed in 2000, and enclosures were installed for all mechanical presses in 2001. Between 2000 and 2003, water-resistant or water-proof garments, shoe covers, and taped gloves were incorporated to keep beryllium-containing fluids from wet machining processes off the skin. The new engineering measures did not appear to substantially reduce airborne beryllium levels in the plant. Personal lapel samples collected in production processes between 2000 and 2003 had a median and geometric mean of 0.18 μg/m
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 (Cummings
Kreiss
Kreiss
In 1996-1999, the company took steps to reduce workers' beryllium exposures: some high-exposure processes were enclosed, special restricted-access zones were set up, HEPA filters were installed in air handlers, and some ventilation systems were updated. In 1997 workers in the pebble plant restricted access zone were required to wear half-face air-purifying respirators, and beginning in 1999 all new employees were required to wear loose-fitting powered air-purifying respirators (PAPR) in manufacturing buildings (Bailey
Beginning in 2000, workers were offered periodic BeLPT testing to evaluate the effectiveness of a new exposure control program implemented by the company. Bailey
In addition, Bailey
Schuler
Exposure estimates were constructed using two exposure surveys conducted in 1999: a survey of total mass exposures (4022 full-shift personal samples) and a survey of size-separated impactor samples (198 samples). The 1999 exposure surveys and work histories were used to estimate long-term lifetime weighted (LTW) average, cumulative, and highest-job-worked exposure for total, respirable, and submicron beryllium mass concentrations.
Newman
After a sentinel case of CBD was diagnosed at the plant in 1995, the company began BeLPT screenings to identify workers at increased risk of CBD and implemented engineering and administrative controls and PPE designed to reduce workers' beryllium exposures in machining operations. Newman
Personal lapel samples collected extensively between 1996 and 1999 in machining jobs have an overall median of 0.16 μg/m
At the time that Newman
Beginning in 2000, exposures in all jobs at the machining facility were reduced to extremely low levels. Personal lapel samples collected in machining processes between 2000 and 2005 had a median of 0.09 μg/m
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 pulmony 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
The published literature on beryllium sensitization and CBD shows that risk of both can be substantial in workplaces in compliance with OSHA's current PEL (Kreiss
Cases of CBD have also continued to develop among workers in facilities and jobs where exposures were below 0.2 µg/m
In contrast, more recent exposure control programs that have used a combination of engineering controls, PPE, and stringent housekeeping measures to reduce workers' airborne and dermal exposures have substantially lowered risk of sensitization among newly-hired workers. Of 97 workers hired between 2000 and 2004 in Tucson, where respiratory and skin protection was instituted for all workers in production areas, only one (1 percent) worker became sensitized, and in that case the worker's dermal protection had failed during wet-machining work (Thomas
Madl
The results of the Reading, Tucson, and Elmore studies show that reducing airborne exposures to below 0.1 μg/m
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 address the question of how frequently workers who become sensitized in environments with extremely low airborne exposures (median <0.1 μg/m
Arjomandi
Five of the 50 sensitized 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. As discussed in the epidemiology section of the Health Effects chapter, the prevalence of CBD among worker populations regularly exposed at higher levels (
The literature on community-acquired chronic beryllium disease (CA-CBD) documents cases of CBD among individuals exposed to airborne beryllium at concentrations below the proposed PEL. OSHA notes that these case studies do not provide information on how frequently individuals exposed to very low airborne levels develop CBD and that reconstructed exposure estimates for CA-CBD cases are less reliable than exposure estimates for working populations reviewed in the previous sections. In addition, the cumulative exposure that an occupationally exposed person would accrue at any given exposure concentration is far less than would typically accrue from long-term environmental exposure. The literature on CA-CBD thus has important limitations and is not used as a basis for quantitative risk assessment for CBD from low-level beryllium exposure. Nevertheless, these case reports and the broader CA-CBD literature indicate that individuals exposed to airborne beryllium below the proposed PEL can develop CBD.
Cases of CA-CBD were first reported among residents of Lorain, OH, and Reading, PA, who lived in the vicinity of beryllium plants. More recently, BeLPT screening has been used to identify additional cases of CA-CBD in Reading.
In 1948, the State of Ohio Department of Public Health conducted an X-ray program surveying more than 6,000 people who lived within 1.5 miles of a Lorain beryllium plant (Eisenbud, 1949; Eisenbud, 1982; Eisenbud, 1998). This survey, together with a later review of all reported cases of CBD in the area, found 13 cases of CBD. All of the residents who developed CBD lived within 0.75 miles of the plant, and none had occupational exposure or lived with beryllium-exposed workers. Among the population of 500 people living within 0.25 miles of the plant, seven residents (1.4 percent) were diagnosed with CBD. Five cases were diagnosed among residents living between 0.25 and 0.5 miles from the plant, one case was diagnosed among residents living between 0.5 and 0.75 miles from the plant, and no cases were found among those living farther than 0.75 miles from the plant (total populations not reported) (Eisenbud, 1998).
Beginning in January 1948, air sampling was conducted using a mobile sampling station to measure
Thirty-two cases of CA-CBD were reported in a series of papers published in 1959-1969 concerning a beryllium refinery in Reading (Lieben and Metzner, 1959; Metzner and Lieben, 1961; Dattoli
The Pennsylvania Department of Health conducted extensive environmental sampling in the area of the plant beginning in 1958. Based on samples collected in 1958, Maier
In the early series of publications, cases of CA-CBD were reported among people living both close to the plant (Maier
At the time of the final follow-up study (1968), 11 residents diagnosed with CA-CBD were alive and 21 were deceased. Among those who had died, berylliosis was listed as the cause of death for three, including a 10-year-old girl and two women in their sixties. Fibrosis, granuloma or granulomatosis, and chronic or fibrous pneumonitis were listed as the cause of death for eight more of those deceased. Histologic evidence of CBD was reported for nine of 12 deceased individuals who had been evaluated for it. In addition to showing radiologic abnormalities associated with CBD, all living cases were dyspneic.
Following the 1969 publication by Liebman and Williams, no additional CA-CBD cases were reported in the Reading area until 1999, when a new case was diagnosed. The individual was a 72-year-old woman who had had abnormal chest x-rays for the previous six years (Maier
Among those referred, eight cases of definite or probable CBD were identified between 1999 and 2002. All eight were women who lived between 0.1 and 1.05 miles from the plant, beginning between 1943-1953 and ending between 1956-2001. Five of the women were considered definite cases of CA-CBD, based on an abnormal blood or lavage cell BeLPT and granulomatous inflammation on lung biopsy. Three probable cases of CA-CBD were identified. One had an abnormal BeLPT and radiography consistent with CBD, but granulomatous disease was not pathologically proven. Two met Beryllium Case Registry epidemiologic criteria for CBD based on radiography, pathology and a clinical course consistent with CBD, but both died before they could be tested for beryllium sensitization. One of the probable cases, who could not be definitively diagnosed with CBD because she died before she could be tested, was the mother of both a definite case and the probable case who had an abnormal BeLPT but did not show granulomatous disease.
The individuals with CA-CBD identified in this study suffered significant health impacts from the disease, including obstructive, restrictive, and gas exchange pulmonary defects in the majority of cases. All but two had abnormal pulmonary physiology. Those two were evaluated at early stages of disease following their mother's diagnosis. Six of the eight women required treatment with prednisone, a step typically reserved for severe cases due to the adverse side effects of steroid treatment. Despite treatment, three had died of respiratory impairment from CBD as of 2002 (Maier
OSHA notes that compared with the occupational studies discussed in the previous section, there is comparatively sparse information on exposure levels of Lorain and Reading residents. There remains the possibility that some individuals with CA-CBD may have had higher exposures than were known and reported in these studies, or have had unreported exposure to beryllium dust via contact with beryllium-exposed workers. Nevertheless, the studies conducted in Lorain and Reading demonstrate that long-term exposure to the apparent low levels of airborne beryllium, with sufficient disease latency, can lead to serious or fatal CBD. Genetic susceptibility may play a role in cases of CBD among individuals with very low or infrequent exposures to beryllium. The role of genetic susceptibility in the CBD disease process is discussed in detail in section V.D.3.
To further examine the relationship between exposure level and risk of both sensitization and disease, we next review exposure-response studies in the CBD literature. Many publications have reported that exposure levels correlate with risk, including a small number of
In 2000, Viet
Workers were considered sensitized if two BeLPT results were positive, either from two blood draws or from a single blood draw analyzed by two different laboratories. All sensitized individuals were offered clinical evaluation, and 51 were diagnosed with CBD based on positive lung LPT and evidence of noncaseating granulomas upon lung biopsy. The number of sensitized individuals who declined clinical evaluation was not reported. Two cases, one with CBD and one who was sensitized but not diagnosed with CBD, were excluded from the case-control analysis due to reported or potential prior beryllium exposure at a ceramics plant. Another sensitized individual who had not been diagnosed with CBD was excluded because she could not be matched by the study's criteria to a non-sensitized control within the BHSP database. Viet
Viet
Exposure estimates for jobs in Building 444 were constructed for the years 1960-1988 from this database. Viet
Viet
The Cullman, AL, precision machining facility discussed previously was the subject of a case-control study published by Kelleher
Detailed work history information gathered from plant data and worker interviews was used in combination with job exposure estimates to characterize cumulative and LTW average beryllium exposures for workers in the surveillance program. In addition to cumulative and LTW exposure estimates based the total mass of beryllium reported in their exposure samples, Kelleher
To analyze the relationship between exposure level and risk of sensitization and CBD, Kelleher
Although the Viet
To better characterize the relationship between exposure level and risk of sensitization and CBD, OSHA developed an independent exposure-response analysis based on a dataset maintained by NJMRC on workers at the Cullman, AL, machining plant. The dataset includes exposure samples collected between 1980 and 2005, and has updated work history and screening information for several hundred workers through 2003. OSHA's analysis of the NJMRC data set is presented in the next section, E. OSHA's Exposure-Response Analysis.
After OSHA completed its analysis of the NJMRC data set, Schuler
Schuler
For beryllium sensitization, logistic models showed elevated odds ratios for average (OR 1.48) and highest job (OR 1.37) exposure for total mass exposure; the OR for cumulative exposure was smaller (OR 1.23) and borderline statistically significant (95 percent CI barely included unity). Relationships between sensitization and respirable exposure estimates were similarly elevated for average (OR 1.37) and highest job (OR 1.32). Among the submicron exposure estimates, only highest job (OR 1.24) had a 95 percent CI that just included unity for sensitization. For CBD, elevated odds ratios were observed only for the cumulative exposure estimates and were similar for total mass and respirable exposure (total mass OR 1.66, respirable (OR 1.68). Cumulative submicron exposure showed an elevated, borderline significant odds ratio (OR 1.58). The odds ratios for average exposure and highest-exposed job were not statistically significantly elevated. Schuler
OSHA evaluated exposure and health outcome data on a population of workers employed at the Cullman machining facility. NJMRC researchers, with consent and information provided by the 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 from (1) two surveys of the Cullman plant conducted by OSHA's contractor (ERG, 2003 and ERG, 2004a), (2) published articles of investigations conducted at the plant by researchers from NJMRC (Kelleher
The Cullman plant is a leading fabricator of precision-machined and processed materials including beryllium and its alloys, titanium, aluminum, quartz, and glass (ERG, 2009b). The plant has approximately 210 machines, primarily mills and lathes, and processes large quantities of beryllium on an annual basis. The plant provides complete fabrication services including ultra-precision machining; ancillary processing (brazing, ion milling, photo etching, precision cleaning, heat treating, stress relief, thermal cycling, mechanical assembly, and chemical
The 120,000 square-foot plant has two main work areas: a front office area and a large, open production shop. Operations in the production shop include inspection of materials, machining, polishing, and quality assurance. The front office is physically separated from the production shop. Office workers enter through the front of the facility and have access to the production shop through a change room where they must don laboratory coats and shoe covers to enter the production area. Production workers enter the shop area at the rear of the facility where a change/locker room is available to change into company uniforms and work shoes. Support operations are located in separate areas adjacent to the production shop and include management and administration, sales, engineering, shipping and receiving, and maintenance. Management and administrative personnel include two groups: those primarily working in the front offices (front office management) and those primarily working on the shop floor (shop management).
In 1974, the company moved its precision machining operations to the plant's current location in Cullman. Workplace exposure controls reportedly did not change much until the diagnosis of an index case of CBD in 1995. Prior to 1995, exposure controls for machining operations primarily included a low volume/high velocity (LVHV) central exhaust system with operator-adjusted exhaust pickups and wet machining methods. Protective clothing, gloves, and respiratory protection were not required. After the diagnosis, the facility established an in-house target exposure level of 0.2 μg/m
In 1996, the company instituted requirements for work uniforms and dedicated work shoes for production workers, eliminated dry sweeping in all departments, and purchased high-efficiency particulate air (HEPA) filter vacuum cleaners for workplace cleanup and decontamination. Major engineering changes were also initiated in 1996, including the purchase of a new local exhaust ventilation (LEV) system to exhaust machining operations producing finer aerosols (
Most exposure controls were reportedly in place by 2000 (ERG, 2009a). In 2004, the plant industrial hygienist reported that all machines had LEV and about 65 percent were also enclosed with either partial or full enclosures to control the escape of machining coolant (ERG, 2004b). Over time, the facility has built enclosures for operations that consistently produce exposures greater than 0.2 μg/m
The NJMRC dataset includes industrial hygiene sampling results collected by the plant (1980-1984 and 1995-2005) and NJMRC researchers (June 1996 to February 1997 and September 1999), including 4,370 breathing zone (personal lapel) samples and 712 area samples (ERG, 2004b). Limited air sampling data is available before 1980 and no exposure data appears to be available for the 10-year time period 1985 through 1994. A review of the NJMRC air sampling database from 1995 through 2005 shows a significant increase in the number of air samples collected beginning in 2000, which the plant industrial hygienist attributes to an increase in the number of air sampling pumps (from 5 to 23) and the purchase of an automated atomic absorption spectrophotometer.
ERG used the personal breathing zone sampling results contained in the sample database to quantify exposure levels for each year and for several-year periods. Separate exposure statistics were calculated for each job included in the job history database. For each job included in the job history database, ERG estimated the arithmetic mean, geometric mean, median, minimum, maximum, and 95th percentile value for the available exposure samples. Prior to generating these statistics ERG made several adjustments. After consultation with researchers at NJMRC, four particularly high exposures were identified as probably erroneous and excluded from calculations. In addition, a 1996 sample for the HS (Health and Safety) process was removed from the sample calculations after ERG determined it was for a non-employee researcher visiting the facility.
Most samples in the sample database for which sampling times were recorded were long-term samples: 2,503 of the 2,557 (97.9 percent) breathing zone samples with sampling time recorded had times greater than or equal to 400 minutes. No adjustments were made for sampling time, except in the case of four samples for the “maintenance” process for 1995. These results show relatively high values and exceptionally short sampling times consistent with the nature of much maintenance work, marked by short-term exposures and periods of no exposure. The four 1995 maintenance samples were adjusted for an eight-hour sampling time assuming that the maintenance workers received no further beryllium exposure over the rest of their work shift.
OSHA examined the database for trends in exposure by reviewing sample statistics for individual years and grouping years into four time periods that correspond to stages in the plant's approach to beryllium exposure control. These were: 1980-1995, a period of relatively minimal control prior to the 1995 discovery of a case of CBD among the plant's workers; 1996-1997, a period during which some major engineering controls were in the process of being installed on machining equipment; 1998-1999, a period during which most engineering controls on the machining equipment had been installed; and 2000-2003, a period when installation of all exposure controls on machining equipment was complete and exposures very low throughout the plant. Table VI-4 below summarized the available data for each time period. As the four probable sampling errors identified in
Reviewing the revised statistics for individual years for different groupings, OSHA noted that exposures in the 1996-1997 period were for some machining jobs equivalent to, or even higher than, exposure levels recording during the 1980-1995 period. During 1996-1997, major engineering controls were being installed, but exposure levels were not yet consistently reduced.
Table VI-5 below summarizes exposures for the four time periods in jobs other than beryllium machining. These include jobs such as administrative work, health and safety, inspection, toolmaking (`Tool' and `Cgrind'), and others. A description of jobs by title is available in the risk assessment background document.
From
Because exposure results from 1996-1997 were not found to be consistently reduced in comparison to the 1985-1995 period in primary machining jobs, these two periods were grouped together in the JEM. Exposure monitoring for jobs other than the primary machining operations were represented by a single mean exposure value for 1980-2003. As respiratory protection was not routinely used at the plant, there was no adjustment for respiratory protection in workers' exposure estimates. The job exposure matrix is presented in full in the background document for the quantitative risk assessment.
The work history database contains job history records for 348 workers, including start years, duration of employment, and percentage of worktime spent in each job. One hundred ninety-eight of the workers had been employed at some point in primary machining jobs, including deburring,
Based on these records and the JEM described previously, ERG calculated cumulative and average exposure estimates for each worker in the database. Cumulative exposure was calculated as, Σ
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. Unfortunately, because it is not possible to continuously monitor individuals' beryllium exposure levels and sensitization status, 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 constructed 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.
In the database provided to OSHA, seven workers were reported as sensitized only. 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-6, VI-7, and VI-8 below present the prevalence of sensitization and CBD cases across several categories of lifetime-weighted (LTW) average, cumulative, and highest-exposed job (HEJ) exposure. Exposure values were grouped by quartile. 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-6 shows increasing prevalence of total sensitization and CBD with increasing LTW average exposure, measured both as average and cumulative 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-7, 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 and total sensitization 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 (Table VI-8). The lowest prevalence is observed in the first quartile (0.0-0.86 μg/m
It is of some value to compare the prevalence analysis of the Cullman (NJMRC) data set with the results of the Reading and Tucson studies discussed previously. An exact comparison is not possible, in part because the Reading and Tucson exposure values are associated with jobs and the NJMRC values are estimates of lifetime weighted average, cumulative, and highest-exposed job (HEJ) exposures for individuals in the data set. Nevertheless, OSHA believes it is possible to very roughly compare the results of the Reading and Tucson studies and the results of the NJMRC prevalence analysis presented above. As discussed in detail below, OSHA found a general consistency between the prevalence of sensitization and CBD in the quartiles of average exposure in the NJMRC data set and the prevalence of sensitization and CBD at the Reading and Tucson plants for similar exposure values.
Personal lapel samples collected at the Reading plant between 1995 and 2000 were relatively low overall (median of 0.073 μg/m
As with Reading, the prevalence of sensitization observed at Tucson and in the NJMRC data set are not exactly comparable due to the different natures of the exposure estimates. Nevertheless, in a rough sense the results of the Tucson study and the NJMRC prevalence analysis appear similar. In Tucson, a 1998 BeLPT screening showed that 9.5 percent of workers hired after 1992 were sensitized (Henneberger
Beginning in 1999, the Tucson facility instituted strict requirements for respiratory protection and other PPE, essentially eliminating airborne and dermal exposure for most workers. After these requirements were put in place, Cummings
While the literature analysis presented here shows a clear reduction in risk with well-controlled airborne exposures (≤ 0.1 μg/m
OSHA's contractor performed a complementary log-log proportional hazards model using the NJMRC data set. The proportional hazards model is a generalization of logistic regression that allows for time-dependent exposures and differential time at risk. The proportional hazards model accounts for the fact that individuals in the dataset are followed for different amounts of time, and that their exposures change over time. The proportional hazards model provides hazards ratios, which estimate the relative risk of disease at a specified time for someone with exposure level 1 compared to exposure level 2. To perform this analysis, OSHA's contractor constructed exposure files with time-dependent cumulative and average exposures for each worker in the data set in each year that a case of sensitization or CBD was identified. Workers were included in only those years after they started working at the plant and continued to be followed. Sensitized cases were not included in analysis of sensitization after the year in which they were identified as being sensitized, and CBD cases were not included in analyses of CBD after the year in which they were diagnosed with CBD. Follow-up is censored after 2002 because work histories were deemed to be less reliable after that date.
The results of the discrete proportional hazards analyses are summarized in Tables VI-9-12 below. All coefficients used in the models are displayed, including the exposure coefficient, the model constant for diagnosis in 1995, and additional exposure-independent coefficients for each succeeding year (1996-1999 for sensitization and 1996-2002 for CBD) of diagnosis that are fit in the discrete time proportional hazards modeling procedure. Model equations and variables are explained more fully in the companion risk assessment background document.
Relative risk of sensitization increased with cumulative exposure (p = 0.05). A positive, but not statistically significant, association was observed with LTW average exposure (p = 0.09). The association was much weaker for exposure duration (p = 0.31), consistent with the expected biological action of an immune hypersensitivity response where onset is believed to be more dependent on the concentration of the sensitizing agent at the target site rather than the number of years of occupational exposure. The association was also much weaker for highest-exposed job (HEJ) exposure (p = 0.3).
The proportional hazards models for the CBD endpoint (Tables VI-13 through 16 below) showed positive relationships with cumulative exposure (p = 0.09) and duration of exposure (p = 0.10). However, the association with the cumulative exposure metric was not as strong as that for sensitization, probably due to the smaller number of CBD cases. LTW average exposure and HEJ exposure were not closely related to relative risk of CBD (p-values > 0.5).
In addition to the models reported above, comparable models were fit to the upper 95 percent confidence interval of the HEJ exposure; log-transformed cumulative exposure; log-transformed LTW average exposure; and log-transformed HEJ exposure. Each of these measures was positively but not significantly associated with sensitization.
OSHA used the proportional hazards models based on cumulative exposure, shown in Tables VI-9 and VI-13, to derive quantitative risk estimates. Of the metrics related to exposure level, the cumulative exposure metric showed the most consistent association with sensitization and CBD in these models. Table VI-17 summarizes these risk estimates for sensitization and the corresponding 95 percent confidence intervals separately for 1995 and 1999, the years with the highest and lowest baseline rates, respectively. The estimated risks for CBD are presented in VI-18. The expected number of cases is based on the estimated conditional probability of being a case in the given year. The models provide time-specific point estimates of risk for a worker with any given exposure level, and the corresponding interval is based on the uncertainty in the exposure coefficient (
Each estimate represents the number of sensitized workers the model predicts in a group of 1000 workers at risk during the given year with an exposure history at the specified level and duration. For example, in the exposure scenario where 1000 workers are occupationally exposed to 2 μg/m
The statistical modeling analysis predicts high risk of both sensitization (96-394 cases per 1000, or 9.6-39.4 percent) and CBD (44-313 cases per 1000, or 4.4-31.3 percent) at the current PEL of 2 μg/m
The model estimates are not directly comparable to prevalence values discussed in previous sections. They assume a group without turnover and are based on a comparison of unexposed and hypothetically exposed workers at specific points in time, whereas the prevalence analysis simply reports the percentage of workers at the Cullman plant with sensitization or CBD in each exposure category. Despite the difficulty of direct comparison, the level of risk seen in the prevalence analysis and predicted in the modeling analysis appear roughly similar at low exposures. In the second quartile of cumulative exposure (0.148-1.467 μg/m
Due to limitations including the 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, and limited follow-up time on many workers, OSHA must interpret the model-based risk estimates presented in Tables VI-17 and VI-18 with caution. The Cullman study population is a relatively small group and can support only limited statistical analysis. For example, its size precludes inclusion of multiple covariates in the exposure-response models or a two-stage exposure-response analysis to model both sensitization and the subsequent development of CBD within the subpopulation of sensitized workers. The limited size of the Cullman dataset is characteristic of studies on beryllium-exposed workers in modern, low-exposure environments, which are typically small-scale processing plants (up to several hundred workers, up to 20-30 cases). However, these recent studies also have important strengths: They include workers hired after the institution of stringent exposure controls, and have extensive exposure sampling using full-shift personal lapel samples. In contrast, older studies of larger populations tend to have higher exposures, less exposure data, and exposure data collected in short-term samples or outside of workers' breathing zones.
Another limitation of the Cullman dataset, which is common to recent low-exposure studies, is the short follow-up time available for many of the workers. While in some cases CBD has been known to develop in short periods (< 2 years), it more typically develops over a longer time period. Sensitization occurs in a typically shorter time frame, but new cases of sensitization have been observed in workers exposed to beryllium for many years. Because the data set is limited to individuals then working at the plant, the Cullman data set cannot capture CBD occurring among workers who retire or leave the plant. OSHA expects that the dataset does not fully represent the risk of sensitization, and is likely to particularly under-represent CBD among workers exposed to beryllium at this facility. The Agency believes the short follow-up time to be a significant source of uncertainty in the statistical analysis, a factor likely to lead to underestimation of risk in this population.
A common source of uncertainty in quantitative risk assessment is the series of choices made in the course of statistical analysis, such as model type, inclusion or exclusion of additional explanatory variables, and the assumption of linearity in exposure-response. Sensitivity analyses and statistical checks were conducted to test the validity of the choices and
OSHA's contractor examined whether smoking and age were confounders in the exposure-response analysis by adding them as variables in the discrete proportional hazards model. Neither smoking status nor age was a statistically significant predictor of sensitization or CBD. The model coefficients, 95 percent confidence intervals, and p values can be found in the background document. A sensitivity analysis was done using the standard Cox model that treats survival time as continuous rather than discrete. The model coefficients with the standard Cox using cumulative exposure were 0.025 and very similar to the 0.03 reported in Tables VI-9 and VI-13 above. The interaction between exposure and follow-up time was not significant in these models, suggesting that the proportional hazard assumption should not be rejected. The proportional hazards model assumes a linear relationship between exposure level and relative risk. The linearity assumption was assessed using a fractional polynomial approach. For both sensitization and CBD, the best-fitting fractional polynomial model did not fit significantly better than the linear model. This result supports OSHA's use of the linear model to estimate risk. The details of these statistical analyses can be found in the background document.
The possibility that the number of times a worker has been tested for sensitization might influence the probability of a positive test was examined (surveillance bias). Surveillance bias could occur if workers were tested because they showed some sign of disease, and not tested otherwise. It is also possible that the original analysis included erroneous assumptions about the dates of testing for sensitization and CBD. OSHA's contractor performed a sensitivity analysis, modifying the original analysis to gauge the effect of different assumptions about testing dates. In the sensitivity analysis, the exposure coefficients increased for all four indices of exposure when the sensitization analysis was restricted to times when cohort members were assumed to be tested. The exposure coefficient was statistically significant for duration of exposure but not for cumulative, LTW average, or HEJ exposure. The increase in exposure coefficients suggests that the original models may have underestimated the exposure-response relationship for sensitization and CBD.
Errors in exposure measurement are a common source of uncertainty in quantitative risk assessments. Because errors in high exposures can heavily influence modeling results, OSHA's contractor performed sensitivity analyses excluding the highest 5 percent of cumulative exposures (those above 25.265 μg/m
Particle size, particle surface area, and beryllium compound solubility are believed to be important factors influencing the risk of sensitization and CBD among beryllium-exposed workers. The workers at the Cullman machining plant were primarily handling insoluble beryllium compounds, such as beryllium metal and beryllium metal/beryllium oxide composites. Particle size distributions from a limited number of airborne beryllium samples collected just after the 1996 installation of engineering controls indicate worker exposure to a substantial proportion of respirable particulates. There was no available particle size data for the 1980 to 1995 period prior to installation of engineering controls when total beryllium mass exposure levels were greatest. Particle size data was also lacking from 1998 to 2003 when additional control measures were in place and total beryllium mass exposures were lowest. For these reasons, OSHA was not able to quantitatively account for the influence of particle size and solubility in developing the risk estimates based on the Cullman data set. However, it is not unreasonable to expect the CBD experienced by this cohort to generally reflect the risk from exposure to beryllium that is relatively insoluble and enriched with respirable particles. As explained previously, the role of particle size and surface area on risk of sensitization is more difficult to predict.
Additional uncertainty is introduced when extrapolating the quantitative estimates presented above to operations that process beryllium compounds that have different solubility and particle characteristics than those encountered at the Cullman machining plant. OSHA does not have sufficient information to quantitatively assess the degree to which risks of beryllium sensitization and CBD based on the NJMRC data may be impacted in workplaces where such beryllium forms and processes are used. However, OSHA does not expect this uncertainty to alter its qualitative conclusions with regard to the risk at the current PEL and at alternate PELs as low as 0.1 μg/m
OSHA considers lung cancer to be an important health endpoint for beryllium-exposed workers. 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. The National Academy of Sciences (NAS), Environmental Protection Agency, the Agency for Toxic Substances and Disease Registry (ATSDR), the National Institute of Occupational Safety and Health (NIOSH), and other reputable scientific organizations have reviewed the scientific evidence demonstrating that beryllium is associated with an increased incidence of cancer. OSHA also has performed an extensive review of the scientific literature regarding beryllium and cancer. This includes an evaluation of human epidemiological, animal cancer, and mechanistic studies described in the Health Effects section of this preamble. Based on the weight of evidence, the Agency has preliminarily determined beryllium to be an occupational carcinogen.
Although epidemiological and animal evidence supports a conclusion of beryllium carcinogenicity, there is considerable uncertainty surrounding the mechanism of carcinogenesis for beryllium. The evidence for direct genotoxicity of beryllium and its compounds has been limited and
OSHA's review of epidemiological studies of lung cancer mortality among beryllium workers found that most did not characterize exposure levels sufficiently for exposure-response analysis. However, one NIOSH study evaluated the association between beryllium exposure and lung cancer mortality based on data from a beryllium processing plant in Reading, PA (Sanderson
Between 1971 and 1992, the plant collected close to 7,000 high volume filter samples consisting of both general area and short-term, task-based breathing zone measurements for production jobs and exclusively area measurements for office, lunch, and laboratory areas (Sanderson
Results of a conditional logistic regression analysis showed an increased risk of lung cancer in workers with higher exposures when dose estimates were lagged by 10 and 20 years (Sanderson
OSHA is interested in lung cancer risk estimates from a 45-year (
In addition, the relatively high exposures of even the least-exposed workers in the NIOSH study may create 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 the NIOSH study workers in the lowest quartile were exposed well above the OSHA PEL (average exposure <11.2 μg/m
In 2010, researchers at NIOSH published a quantitative risk assessment based on an update of the Reading cohort analyzed by Sanderson
The cohort studied by Schubauer-Berigan
Workers' cumulative exposures (μg/m
Schubauer-Berigan
Because smoking information was available for only about 25 percent of the cohort, smoking could not be controlled for directly in the models. The authors reported that within the subset with smoking information, there was little difference in smoking by cumulative or maximum exposure category (p. 6), suggesting that smoking was unlikely to act as a confounder in the cohort. In addition to models based on the full cohort, 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
The NIOSH publication did not discuss the reasons for basing risk estimates on mean exposure rather than cumulative exposure that is more commonly used for lung cancer risk analysis. OSHA believes the decision may involve the nonmonotonic relationship NIOSH observed between cancer risk and cumulative exposure level. As discussed previously, workers from the Reading plant frequently had very short tenures and high exposures yielding lower cumulative exposures compared to cohort workers from other plants with longer employment. Despite the low estimated cumulative exposures among the short-term Reading workers, they may be at high risk of lung cancer due to the tendency of beryllium to persist in the lung for long periods. This exposure misclassification could lead to the appearance of a nonmonotonic relationship between cumulative exposure and lung cancer risk. It is possible that a dose-rate effect may exist for beryllium, such that the risk from a cumulative exposure gained by long-term, low-level exposure is not equivalent to the risk from a cumulative exposure gained by very short-term, high-level exposure. In this case, mean exposure level may better correlate with the risk of lung cancer than cumulative exposure level. For these reasons OSHA considers the NIOSH choice of mean exposure metric to be appropriate and scientifically defensible for this particular dataset.
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 dataset provided by NJRMC. First, the Agency reviewed the scientific literature to ascertain whether there is substantial risk to workers exposed at and below the current PEL and to characterize the expected impact of more stringent controls on workers' risk of sensitization and CBD. This review focused on facilities where exposures were primarily below the current PEL, and where several rounds of BeLPT and CBD screening had been conducted to evaluate the effectiveness of various exposure control measures. Second, OSHA investigated the exposure-response relationship for beryllium sensitization and CBD by analyzing a dataset that NJMRC provided on workers at a prominent, long-established beryllium machining facility. Although exposure-response studies have been published on sensitization and CBD, OSHA believes the nature and quality of their exposure data significantly limits their value for the Agency's risk assessment. Therefore, OSHA developed an independent exposure-response analysis using the NJMRC dataset, which was recently updated, includes workers exposed at low levels, and includes extensive exposure data collected in workers' breathing zones, as is preferred by OSHA.
OSHA's review of the scientific literature found substantial risk of both sensitization and CBD in workplaces in compliance with OSHA's current PEL (
In contrast, industrial hygiene programs that minimized both airborne and dermal exposure substantially lowered workers' risk of sensitization in the first years of employment. Programs that drastically reduced respiratory exposure via a combination of engineering controls and respiratory protection, minimized the potential for skin exposure via dermal PPE, and employed stringent housekeeping methods to keep work areas clean and prevent transfer of beryllium between areas sharply curtailed new cases of sensitization among newly-hired workers. For example, studies conducted at copper-beryllium processing, beryllium production, and beryllia ceramics facilities show that reduction of exposures to below 0.1 μg/m
The most recent epidemiological literature on programs that have been successful in reducing workers' risk of sensitization have had very short follow-up time; therefore, they cannot address the question of how frequently workers sensitized in very low-exposure environments develop CBD. Clinical evaluation for CBD was not reported for workers at the copper-beryllium processing, beryllium production, and ceramics facilities. However, cases of CBD among workers exposed at low levels at a machining plant and cases of CA-CBD demonstrate that individuals exposed to low levels of airborne beryllium can develop CBD, and over time, can progress to severe disease. This conclusion is also supported by case reports within the literature of workers with CBD who may have been minimally exposed to beryllium, such as a worker employed only in administration at a beryllium ceramics facility (Kreiss
The Agency's analysis of the Cullman dataset provided by NJMRC showed strong exposure-response trends using multiple analytical approaches, including examination of sensitization and disease prevalence by exposure categories and a proportional hazards modeling approach. In the prevalence analysis, cases of sensitization and disease were evident at all levels of exposure. The lowest prevalence of sensitization (2.0 percent) and CBD (1.0 percent) was observed among workers with LTW average exposure levels below 0.1 μg/m
OSHA's proportional hazards analysis of the Cullman dataset found increasing risk of sensitization with both cumulative exposure and average exposure. OSHA also found a positive relationship between risk of CBD and cumulative exposure, but not between CBD and average exposure. The Agency used the cumulative exposure model results to estimate hazards ratios and risk of sensitization and CBD at the current PEL of 2 μg/m
OSHA has a high level of confidence in the finding of substantial risk of sensitization and CBD at the current PEL, and the Agency believes that a 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 beryllium-exposed workers' risk of lung cancer will be reduced by more stringent control of airborne beryllium exposures. The risk estimates from NIOSH's recent lung cancer study, described above, range from 33 to 140 excess lung cancers per 1000 workers exposed at the current PEL of 2 μg/m
In 2010, Eastern Research Group, Inc. (ERG), under contract to the Occupational Safety and Health Administration (OSHA) ,
ERG conducted a search for nationally recognized experts in the areas of occupational epidemiology, occupational medicine, toxicology, immunology, industrial hygiene/exposure assessment, and risk assessment/biostatistics as requested by OSHA. ERG sought experts familiar with beryllium health effects research and who had no conflict of interest (COI) or apparent bias in performing the review. Interested candidates submitted evidence of their qualifications and responded to detailed COI questions. ERG also searched the Internet to determine whether qualified candidates had made public statements or declared a particular bias regarding beryllium regulation.
From the pool of qualified candidates, ERG selected five experts to conduct the review, based on:
○ Their qualifications, including their degrees, years of relevant experience, number of related peer-reviewed publications, experience serving as a peer reviewer for OSHA or other government organizations, and committee and association memberships related to the review topic;
○ Lack of any actual, potential, or perceived conflict of interest; and
○ The need to ensure that the panel collectively was sufficiently broad and
OSHA reviewed the qualifications of the candidates proposed by ERG to verify that they collectively represented the technical areas of interest. ERG then contracted the following experts to perform the review.
(1)
(2)
(3)
(4)
(5)
Reviewers were provided with the Technical Charge and Instructions (see ERG, 2010), a Request for Peer Review of NIOSH Manuscripts (see ERG, 2010), the draft Preliminary OSHA Health Effects Evaluation (OSHA, 2010a), the draft Preliminary Beryllium Risk Assessment (OSHA, 2010b), and access to relevant references. Each reviewer independently provided comments on the Health Effects, Risk Assessment, and NIOSH documents. A briefing call was held early in the review to ensure that reviewers understood the peer review process. ERG organized the call and OSHA representatives were available to respond to technical questions of clarification. Reviewers were invited to submit any subsequent questions of clarification.
The written comments from each reviewer were received and organized by ERG by charge questions. The unedited individual and reorganized comments were submitted to OSHA and the reviewers in preparation for a follow-up conference call. The conference call, organized and facilitated by ERG, provided an opportunity for OSHA to clarify individual reviewer's comments. After the call, reviewers were given the opportunity to revise their written comments to include the clarifications or additional information provided on the call. ERG submitted the revised comments to OSHA organized by both individual reviewer and by charge question. A final peer review report is available in the docket (ERG, 2010). Section VII.A of this preamble summarizes the comments received on the draft health effects document and OSHA's responses to those comments. Section VII.B summarizes comments received on the draft Preliminary Risk Assessment and the OSHA response.
The Technical Charge to peer reviewers posed general questions on the draft health effects document as well as specific questions pertaining to particle/chemical properties, kinetics and metabolism, acute beryllium disease, development of beryllium sensitization and CBD, genetic susceptibility, epidemiological studies of sensitization and CBD, animal models of chronic beryllium disease, genotoxicity, lung cancer epidemiological studies, animal cancer studies, other health effects, and preliminary conclusions drawn by OSHA.
OSHA asked the peer reviewers to generally comment on whether the draft health effects evaluation included the important studies, appropriately addressed their strengths and limitations, accurately described the results, and drew scientifically sound conclusions. Overall, the reviewers felt that the studies were described in sufficient detail, the interpretations accurate, and the conclusions reasonable. They agreed that the OSHA document covered the significant health endpoints related to occupational beryllium exposure. However, several reviewers requested that additional studies and other specific information be included in various sections of the document and these are discussed further below.
The reviewers had similar suggestions to improve the section V.A of this preamble on physical/chemical properties and section V.B on kinetics/metabolism. Dr. Balmes requested that physical and chemical characteristics of beryllium more clearly relate to development of sensitization and progression to CBD. Dr. Gordon requested greater consistency in the terminology used to describe particle characteristics, sampling methodologies, and the particle deposition in the respiratory tract. Dr. Breysse agreed and requested that the respiratory deposition discussion be better related to the onset of sensitization and CBD. Dr. Rossman suggested that the discussion of particle/chemical characteristics might be better placed after section V.D on the immunobiology of sensitization and CBD.
OSHA made a number of revisions to sections V.A and V.B to address the peer review comments above. Terminology used to describe particle characteristics in various studies was modified to be more consistent and better reflect the authors' intent in the published research articles. Section V.B.1 on respiratory kinetics of inhaled beryllium was modified to more clearly describe particle deposition in the different regions of the respiratory tract and their influence on CBD. At the recommendation of Dr. Gordon, a confusing figure was removed since it did not portray particle deposition in a clear manner. Rather than relocate the entire discussion of particle/chemical characteristics, a new section V.B.5 was added to specifically address the influence of beryllium particle characteristics and chemical form on the development of sensitization and CBD. Other section areas were shortened to remove information that was not necessarily relevant to the overall disease process. Statements were added on the effect of pre-existing diseases and smoking on beryllium clearance from the lung. It was made clear that the precise role of dermal exposure in beryllium sensitization is not completely understood. These smaller changes were made at the request of individual reviewers.
There were a couple of comments from reviewers pertaining to acute beryllium disease (ABD). Dr. Rossman commented that ABD did not make the development of CBD more likely. He requested that the document include a reference to the Van Ordstrand et al. (1943) article that first reported ABD in the U.S. Dr. Balmes pointed out that pathologists, rather than clinicians, interpret ABD pathology from lung tissue biopsy. Dr. Gordon commented that ABD is of lesser importance than CBD to the risk assessment and suggested that discussion of ABD be moved later in the document.
The Van Ordstrand reference was included in section V.C on acute beryllium diseases and statements were modified to address the peer review comments above. While OSHA agrees that ABD does not have a great impact on the Agency risk findings, the Agency believes the current organization does
Most reviewers found the description of the development and pathogenesis of CBD in section V.D to be accurate and understandable. Dr. Breysse felt the section could better delineate the steps in disease development (
OSHA extensively reorganized section V.D to clearly delineate the disease process in a more linear fashion starting with the formation of beryllium antigen complex, its interaction with naïve T-cells to trigger CD4
While peer reviewers felt genetic susceptibility was adequately characterized, Dr. Rossman, Dr. Gordon, and Dr. Breysse suggested that additional study data be discussed to provide more depth on the subject, particularly the role genetic polymorphisms in providing a negatively charged HLA protein binding site for the positively charged beryllium ion. Section V.D.3 on genetic susceptibility now includes more information on the importance of gene-environment interaction in the development of CBD in low-exposed workers. The section expands on HLA-DPB1 alleles that influence beryllium-hapten binding and its impact on CBD risk.
All reviewers found the definition of CBD to be clear and understandable. However, several reviewers commented on the document discussion of the BeLPT which operationally defines beryllium sensitization. Drs. Balmes and Rossman requested a more clear statement that two abnormal blood BeLPT results were generally necessary to confirm sensitization. Dr. Balmes and Dr. Breysse requested more discussion of historical changes in the BeLPT method that have led to improvement in test performance and reductions in interlaboratory variability. These comments were addressed in an expanded document section V.D.5.b on criteria for sensitization and CBD case definition following development of the BeLPT.
Reviewers made suggestions to improve presentation of the many epidemiological studies of sensitization and CBD in the draft health effects document. Dr. Breysse and Dr. Gordon recommended that common weaknesses that apply to multiple studies be more rigorously discussed. Dr. Gordon requested that the discussion of the Beryllium Case Registry be modified to clarify the case inclusion criteria. Most reviewers called for the addition of tables to assist in summarizing the epidemiological study information.
A paragraph has been added near the beginning of section V.D.5 that identifies the common challenges to interpreting the epidemiological evidence that supports the occurrence of sensitization and CBD at occupational beryllium exposures below the current PEL. These include studies with small numbers of subjects and CBD cases, potential exposure misclassification resulting from lack of personal and short-term exposure data prior to the late 1990s, and uncertain dermal contribution among other issues. Table A.1 summarizing the key sensitization and CBD epidemiological studies was added to this preamble in appendix A of section V. Subsection V.D.5.a on studies conducted prior to the BeLPT has been reorganized to more clearly present the need for the Registry prior to listing the inclusion criteria.
Several reviewers requested that the draft health effects document discuss additional occupational studies on sensitization and CBD. Dr. Balmes suggested including Bailey et al. (2010) on reduction in sensitization at a beryllium production plant and Arjomandi et al. (2010) on CBD among workers in a nuclear weapons facility. Dr. Breysse recommended adding a brief discussion of Taiwo et al. (2008) on sensitization in aluminum smelter workers. Dr. Gordon and Dr. Rossman suggested mention of Curtis, (1951) on cutaneous hypersensitivity to beryllium as important for the role of dermal exposure. Dr. Rossman also provided a reference to a number of other sensitization and CBD articles of historical significance.
The above studies have been incorporated in several subsections of V.D.5 on human epidemiological evidence. The 1951 Curtis study is mentioned in the introduction to section V.D.5 as evidence of sensitization from dermal exposure. The Bailey
Dr. Gordon suggested that the draft health effects document make clear that limitations in study design and lack of an appropriate model limited extrapolation of animal findings to the human immune-based respiratory disease. Dr. Rossman also remarked on the lack of a good animal model that consistently demonstrates a specific cell-mediated immune response to beryllium. Section V.D.6 was modified to include a statement that lack of a dependable animal model combined with studies that used single doses, few animals or abbreviated observation periods have limited the utility of the data. Table A.2 was added that summarizes important information on key animal studies of beryllium-induced immune response and lung inflammation.
In general, peer reviewers considered the preliminary conclusions with regard to sensitization and CBD to be reasonable and well presented in the draft health effects evaluation. All reviewers agreed that the scientific evidence supports sensitization as a necessary condition and an early endpoint in the development of CBD.
There were other suggested improvements to the preliminary conclusion section of the draft document. Dr. Breysse felt that presenting the range of observed prevalence from occupational studies would help support the Agency findings. He also recommended that the preliminary conclusions make clear that CBD is a very complex disease and certain steps involved in the onset and progression are not yet clearly understood. Dr. Rossman pointed out that a report from Mroz
A statement has been added to section V.D.7 on the preliminary sensitization and CBD conclusions to indicate that all facets of development and progression of sensitization and CBD are not fully understood. Study references and prevalence ranges were provided to support the conclusion that epidemiological evidence demonstrates that sensitization and CBD occur from present-day exposures below OSHA's PEL. Statements were modified to indicate animal studies provide important insights into the roles of chemical form, genetic susceptibility, and residual lung burden in the development of beryllium lung disease. Updated information on rate of progression from sensitization to CBD was also included.
Reviewers made suggestions to improve presentation of the epidemiological studies of lung cancer that were similar to their comments on the CBD studies. Dr. Steenland requested that a table summarizing the lung cancer studies be added. He also recommended that more emphasis be placed on the SMR results from the Ward
The recent Schubauer-Berigan
Reviewers were asked two questions regarding the OSHA preliminary conclusions on beryllium-induced lung cancer: was the inflammation mechanism presented in the lung cancer section reasonable; and were there other mechanisms or modes of action to be considered? All reviewers agreed that inflammation was a reasonable mechanistic presentation as outlined in the document. Dr. Gordon requested OSHA clarify that inflammation may not be the sole mechanism for carcinogenicity. OSHA inserted statements in section V.E.5 on the preliminary lung cancer conclusions clarifying that tumorigenesis secondary to inflammation is a reasonable mechanism of action but other plausible mechanisms independent of inflammation may also contribute to the lung cancer associated with beryllium exposure.
There were a few comments from reviewers on health effects other than sensitization/CBD and lung cancer in the draft document. Dr. Balmes requested that the term “beryllium poisoning” not be used when referring to the hepatic effects of beryllium. He also offered language to clarify that the cardiovascular mortality among beryllium production workers in the Ward study cohort was probably due to ischemic heart disease and not the result of impaired lung function. Dr. Gordon requested removal of references to hepatic studies from in vitro and intravenous administration done at very high dose levels of little relevance to the occupational exposures of interest to OSHA. These changes were made to section V.F on other health effects.
The Technical Charge to peer reviewers for review of the draft preliminary risk assessment was to ensure OSHA selected appropriate study data, assessed the data in a scientifically credible manner, and clearly explained its analysis. Specific charge questions were posed regarding choice of data sets, risk models, and exposure metrics; the role of dermal exposure and dermal protection; construction of the job exposure matrix; characterization of the risk estimates and their uncertainties; and whether a quantitative assessment of lung cancer risk, in addition to sensitization and CBD, was warranted.
Overall, the peer reviewers were highly supportive of the Agency's approach and major conclusions. They offered valuable suggestions for revisions and additional analysis to improve the clarity and certain technical aspects of the risk assessment. These suggestions and the steps taken by OSHA to address them are summarized here. A final peer review report (ERG, 2010c) and a risk assessment background document (OSHA, 2014a) are available in the docket.
OSHA asked peer reviewers a series of questions regarding its selection of surveys from a beryllium ceramics facility, a beryllium machining facility, and a beryllium alloy processing facility as the critical studies that form the basis of the preliminary risk assessment. Research showed that these workplaces had well characterized and relatively low beryllium exposures and underwent plant-wide screenings for sensitization and CBD before and after implementation of exposure controls. The reviewers were requested to comment on whether the study discussions were clearly presented, whether the role of dermal exposure and dermal protection were adequately addressed, and whether the preliminary conclusions regarding the observed exposure-related prevalence and reduction in risk were reasonable and scientifically credible. They were also asked to identify other studies that should be reviewed as part of the sensitization/CBD risk assessment.
Every peer reviewer felt the key studies were appropriate and their selection clearly explained in the document. Every peer reviewer regarded the preliminary conclusions from the OSHA review of these studies to be reasonable and scientifically sound. This conclusion stated that substantial risk of sensitization and CBD were observed in facilities where the highest exposed processes had median full-shift beryllium exposures around 0.2 μg/m
The reviewers suggested that three additional studies be added to the risk assessment review of the
A new subsection VI.A.3 was added to the preliminary risk assessment that describes the changes in beryllium exposure measurements, prevalence of sensitization and CBD, and implementation of exposure controls between 1992 and 2006 at the Elmore plant. This subsection includes a discussion of the Bailey
While the majority of reviewers stated that OSHA adequately addressed the role of dermal exposure in sensitization and the importance of dermal protection for workers, a few had additional suggestions for OSHA's discussion. Dr. Breysse and Dr. Gordon pointed out that because the beryllium exposure control programs featured steps to reduce both skin contact and inhalation, it was difficult to distinguish between the effects of reducing airborne and dermal exposure. A statement was added to subsection VI.B that concurrent implementation of respirator use, dermal protection and engineering changes made it difficult to attribute reduced risk to any single control measure. Since the Cullman plant did not require glove use, OSHA believes it to be the best data set available for evaluating the effects of airborne exposure control on risk of sensitization.
Dr. Breysse requested additional discussion of the role of respiratory protection in achieving reduction in risk. Dr. Gordon suggested some additional clarification regarding mean and median exposure measures. Additional information on respiratory programs and exposure measures (
The peer reviewers generally agreed that it was reasonable to conclude that community-acquired CBD (CA-CBD) resulted from low beryllium exposures. Drs. Breysse, Balmes and others noted that higher short-term excursions could not be ruled out. Dr. Gordon suggested that genetic susceptibility may have a role in cases of CA-CBD. Dr. Rossman raised the possibility that some CA-CBD cases could occur from contact with beryllium workers. All these points were added to subsection VI.C.
OSHA asked the peer reviewers to evaluate the choice of the National Jewish Medical and Research Center (NJMRC) data set on the Cullman, AL machinist population as a basis for exposure-response analysis and the reliance on cumulative exposure as the basis for the exposure-response analysis of sensitization and CBD. All peer reviewers indicated that the choice of the NJMRC data set for exposure-response analysis was clearly explained and reasonable and that they knew of no better data set for the analysis. Dr. Rossman commented that the NJMRC data set was an excellent source of exposures to different levels of beryllium and testing and evaluation of the workers. Dr. Steenland and Dr. Gordon suggested that the results from the OSHA analysis of the NJMRC data be compared with the available data from the studies of other beryllium facilities discussed in the epidemiological literature analysis. While a rigorous quantitative comparison (
OSHA asked the peer reviewers to evaluate methods used to construct the job exposure matrix (JEM) and to estimate beryllium exposure for each worker in the NJMRC data set. The JEM procedure was briefly summarized in the review document and described in detail as part of a risk assessment technical background document made available to the reviewers (OSHA, 2014a). Dr. Balmes felt that a more thorough discussion of the JEM would strengthen the preamble document. Dr. Gordon requested information about values assigned exposures below the limit of detection. Dr. Steenland requested that both the preamble and technical background document contain additional information on aspects of the JEM construction such as the job categories, job-specific exposure values, how jobs were grouped, and how non-machining jobs were handled in the JEM. He suggested the entire JEM be included in the technical background document. OSHA greatly expanded subsection VI.E.2 on air sampling and JEM to include more detailed discussion of the JEM construction. Exposure values for machining and non-machining job titles were provided in Tables VI-4 and VI-5. The procedures and rationale for grouping job-specific measurements into four time periods was explained. Jobs were not grouped in the JEM; rather, individual exposure estimates were created for each job in the work history data set. The technical background document further clarifies the JEM construction and the full JEM is included as an appendix to the revised background document (OSHA, 2014a). Subsection VI.E.3 on worker exposure reconstruction contains further detail about the work histories.
Peer reviewers fully supported OSHA's choice of the cumulative exposure metric to estimate risk of CBD from the NJMRC data set. As explained by Dr. Steenland, “cumulative exposure is often the choice for many chronic diseases as opposed to average or highest exposure.” He pointed out that the cumulative exposure metric also fit the CBD data better than other metrics. The reviewers generally felt that short-term peak exposure was probably the measure of airborne exposure most relevant to risk of beryllium sensitization. However, peer reviewers agreed that data required to capture workers' short-term peak exposures and to relate the peak exposure levels to sensitization were not available. Dr. Breysse explained that “short-term (hrs to minutes) peak exposures may be important to sensitization risk, while long term averages are more important for CBD risk. Unfortunately data for short-term peak exposures may not exist.” Dr. Steenland explained that of the available metrics “cumulative exposure fits the sensitization data better than the two alternatives, and hence is the best metric.” Statements were added to subsection VI.E.3 to indicate that while short-term exposures may be highly relevant to risk of sensitization, the individual peak exposures leading up to onset of sensitization was not able to be determined in the NJRMC Cullman study.
Peer reviewers found the methods used in the statistical exposure-response analysis to be clearly described. With the exception of Dr. Steenland, reviewers believed that a detailed critique of the statistical approach was
Many of Dr. Steenland's comments were addressed in subsection VI.F on the statistical modeling. The logistic regression analysis was removed from the section. A sensitivity analysis using the standard Cox model that treats survival time as continuous rather than discrete was added to the risk assessment background document and results were described in subsection VI.F. The interaction between exposure and follow-up time was not significant in the models suggesting that the proportional hazard assumption should not be rejected. The model coefficients using the standard Cox model were similar to model coefficients for the discrete model. Given this, OSHA did not feel it necessary to further estimate risks using the continuous Cox model at specific exposure levels.
A table of the mean number of BeLPT tests across the study population was added to the risk assessment background document. Subsection VI.F describes the table results and its impact on the statistical modeling. Smoking status and age were included in the discrete Cox proportional hazards model and not found to be significant predictors of beryllium sensitization. However, the available study population composition did not allow a confounder analysis of race and gender. OSHA chose not to include a detailed explanation of the model constant for the year of diagnosis in the preamble section. OSHA agrees with Dr. Steenland that the risk assessment background document adequately describes the model terms. For that reason, OSHA prefers that the risk assessment preamble focus on the results and major points of the analysis and refer the reader to the more technical background document for an explanation of model parameters. The linearity assumption was assessed using a fractional polynomial approach. The best fitting polynomials did not fit significantly better than the linear model. The details of the analysis were included in the risk assessment background document. Tables VI-17 and VI-18 now include the upper 95 percent confidence limits on the model-predicted cases of sensitization and CBD for the current and alternative PELs.
Most peer reviewers felt the major uncertainties of the risk assessment were clearly and adequately discussed in the documents they reviewed. Dr. Breysse requested that the risk assessment cover potential underestimation of risk from exposure misclassification bias. He requested further discussion of the degree to which the risk estimates from the Cullman machining plant could be extrapolated to workplaces that use other physical (
Discussion of these uncertainties was added in the final paragraphs of section VI.F. The section was modified to more clearly identify assumptions with regard to the risk modeling such as an assumed linearity in exposure-response and cumulative dose equivalency when extrapolating risks over a 45-year working lifetime. Section VI.F recognizes the uncertainties in risk that can result from reconstructing individual exposures with very limited sampling data prior to 1994. The potential exposure misclassification can limit the strength of exposure-response relationships and result in the underestimation of risk. A more technical discussion of modeling assumptions and exposure measurement error are provided in the risk assessment background document. Section VI.F points out that the NJMRC data set does not capture CBD that occurred among workers who retired or left the Cullman plant. This and the short follow-up time is a source of uncertainty that likely leads to underestimation of risk. The section indicates that it is not unreasonable to expect the risk estimates to generally reflect onset of sensitization and CBD from exposure to beryllium forms that are relatively insoluble and enriched with respirable particles as encountered at the Cullman machining plant. Additional uncertainty is introduced when extrapolating the risk estimates to beryllium compounds of vastly different solubility and particle characteristics. OSHA does not agree with the comment suggesting that the association between CBD and insoluble forms of beryllium is weak. The principle sources of beryllium encountered at the Cullman machining plant, the Reading copper beryllium processing plant and the Tucson ceramics plant where excessive CBD was observed are insoluble forms of beryllium, such as beryllium metal, beryllium alloy, and beryllium oxide.
Finally, OSHA asked the peer reviewers to evaluate its treatment of lung cancer in the earlier draft preliminary risk assessment (OSHA, 2010b). When that document was prepared, OSHA had elected not to conduct a lung cancer risk assessment. The Agency believed that the exposure-response data available to conduct a lung cancer risk assessment from a Sanderson
Just prior to arranging the peer review, a NIOSH study was published by Schubauer-Berigan
The preliminary risk assessment preamble subsection VI.G on lung cancer includes a discussion of the quantitative lung cancer risk assessment published by NIOSH researchers in 2010 (Schubauer-Berigan, 2011). The discussion describes the lower exposure levels, longer tenure, fewer short-term workers and additional years of observation that make the data more suitable for risk assessment. NIOSH relied on several modeling approaches to show that lung cancer risk was significantly related to both mean and cumulative beryllium exposure. Subsection VI.G provides the excess lifetime lung cancer risks predicted from several best-fitting NIOSH models at beryllium exposures of interest to OSHA (Table VI-20). Using the piecewise log-linear proportional hazards model favored by NIOSH, there is a projected drop in excess lifetime lung cancer risks from approximately 61 cases per 1000 exposed workers at the current PEL of 2.0 μg/m
To promulgate a standard that regulates workplace exposure to toxic materials or harmful physical agents, OSHA must first determine that the standard reduces a “significant risk” of “material impairment.” 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.
The Agency's burden to establish significant risk is based on the requirements of the OSH Act (29 U.S.C. 651
“[S]afe” is not the equivalent of “risk-free.” A workplace can hardly be considered “unsafe” unless it threatens the workers with a significant risk of harm. Therefore, before the Secretary can promulgate
As the Court made clear, the Agency has considerable latitude in defining significant risk and in determining the significance of any particular risk. The Court did not specify a means to distinguish significant from insignificant risks, but rather instructed OSHA to develop a reasonable approach to making a significant risk determination. The Court stated that “it is the Agency's responsibility to determine in the first instance what it considers to be a 'significant' risk,” (448 U.S. at 655) and it did not express “any opinion on the . . . difficult question of what factual determinations would warrant a conclusion that significant risks are present which make promulgation of a new standard reasonably necessary or appropriate” (448 U.S. at 659). The Court also stated that, while OSHA's significant risk determination must be supported by substantial evidence, the Agency “is not required to support the finding that a significant risk exists with anything approaching scientific certainty” (448 U.S. at 656). Furthermore:
A reviewing court [is] to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge . . . . [T]he Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking error on the side of overprotection rather than underprotection [so long as such assumptions are based on] a body of reputable scientific thought (448 U.S. at 656).
The OSH Act also requires that the Agency make a finding that the toxic material or harmful physical agent at issue causes material impairment to worker health. In that regard, the Act directs the Secretary of Labor to set standards based on the available evidence where no employee, over his/her working life time, will suffer from material impairment of health or functional capacity, even if such employee has regular exposure to the hazard, to the exent feasible (29 U.S.C. 655(b)(5)).
As with significant risk, what constitutes material impairment in any given case is a policy determination for which OSHA is given substantial leeway. “OSHA is not required to state with scientific certainty or precision the exact point at which each type of [harm] becomes a material impairment” (
In formulating this proposed beryllium standard, OSHA has reviewed the best available evidence pertaining to the adverse health effects of occupational beryllium exposure, including lung cancer and chronic beryllium disease (CBD), and has evaluated the risk of these effects from exposures allowed under the current standard as well as the expected impact of the proposed standard on risk. Based on its review of extensive epidemiological and experimental research, OSHA has preliminarily determined that long-term exposure at the current Permissible Exposure Limit (PEL) would pose a significant risk of material impairment to workers' health, and that adoption of the new PEL and other provisions of the proposed rule will substantially reduce this risk.
In this preamble at section V, Health Effects, OSHA reviewed the scientific evidence linking occupational beryllium exposure to a variety of adverse health effects, including CBD and lung cancer. Based on this review, OSHA preliminarily concludes that beryllium exposure causes these effects. The Agency's preliminary conclusion was strongly supported by a panel of independent peer reviewers, as discussed in section VII.
Here, OSHA discusses its preliminary conclusion that CBD and lung cancer constitute material impairments of health, and briefly reviews other adverse health effects that can result from beryllium exposure. Based on this preliminary conclusion and on the scientific evidence linking beryllium exposure to both CBD and lung cancer, OSHA concludes that occupational exposure to beryllium causes “material impairment of health or functional capacity” within the meaning of the OSH Act.
CBD is a respiratory disease in which 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 (
Over time, the granulomas can spread and lead to lung fibrosis (scarring) and moderate to severe loss of pulmonary function, with symptoms including a persistent dry cough and shortness of breath (Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain, clubbing of fingers (due to impaired oxygen exchange), loss of appetite, and unexplained weight loss may occur as the disease progresses. Corticosteroid therapy, in workers whose beryllium exposure has ceased, has been shown to control inflammation, ease symptoms (
While the use of steroid therapy has mitigated CBD mortality, treatment with corticosteroids has side effects that need to be measured against the possibility of progression of disease (Trikudanathan and McMahon, 2008; Lipworth, 1999; Gibson
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 associated with severe and lasting side effects, and may in some cases be life-threatening. Furthermore, OSHA believes that material impairment begins prior to the development of symptoms of the disease.
Although there are no symptoms associated with early-stage CBD, during which small lesions and inflammation appear in the lungs, the Agency has preliminarily concluded that the earliest stage of CBD is material impairment of health. OSHA bases this conclusion on evidence showing that early-stage CBD is a measurable change in the state of health which, with and sometimes without continued exposure, can progress to symptomatic disease. Thus, prevention of the earliest stages of CBD will prevent development of more serious disease. The OSHA Lead Standard established the Agency's position that a `subclinical' health effect may be regarded as a material impairment of health. In the preamble to that standard, the Agency said:
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 beginnings of illness the standard must be selected to prevent an earlier point
Since the Lead rulemaking, OSHA has also found other non-symptomatic health conditions to be material impairments of health. In the Bloodborne Pathogens (BP) 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 preliminarily 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 standard. Early stage CBD involves lung tissue inflammation without symptomatology 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 argued 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 preliminarily finds all stages of CBD to be material impairments of health.
OSHA considers lung cancer, a frequently fatal disease, to be a material impairment of health. OSHA's finding that inhaled beryllium causes lung cancer 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 (see this preamble at section V, Health Effects). For example, 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 (IARC, 2009).
The Agency's epidemiological evidence comes from multiple studies of U.S. beryllium workers (Sanderson
Supporting evidence of beryllium carcinogenicity comes from various animal studies as well as in vitro genotoxicity and other studies (EPA, 1998; ATSDR, 2002; Gordon and Bowser, 2003; NAS, 2008; Nickell-Brady
While OSHA has relied primarily on the relationship between occupational beryllium exposure and CBD and lung cancer to demonstrate the necessity of the standard, the Agency has also determined that several other adverse health effects can result from exposure to beryllium. Inhalation of high airborne concentrations of beryllium (well above the 2 μg/m
The Agency has also determined that beryllium sensitization, a precursor which occurs before early stage CBD and is an essential step for worker development of the disease, can result from exposure to beryllium. The Agency takes no position at this time on whether sensitization constitutes a material impairment of health, because it was unnecessary to do so as part of this rulemaking. As discussed in Section V, Health Effects, only sensitized individuals can develop CBD (NAS, 2008). OSHA's risk assessment for sensitization informs the Agency's understanding of what exposure control measures have been successful in preventing sensitization, which in turn prevents development of CBD. Therefore sensitization is considered in the next section on significance of risk.
To evaluate the significance of the health risks that result from exposure to hazardous chemical agents, OSHA relies on the best available 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 at levels of exposure reflecting compliance with current standards and compliance with the new standards being proposed.
As discussed above, the Agency's characterization of risk is guided in part by the
It is the Agency's responsibility to determine in the first instance what it considers to be a “significant” risk. Some risks are plainly acceptable and others are plainly unacceptable. If, for example, 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 percent benzene will be fatal, a reasonable person might well consider the risk significant and take the appropriate steps to decrease or eliminate it (
In this preamble at section VI, Preliminary Risk Assessment, OSHA finds that the available epidemiological data are sufficient to evaluate risk for beryllium sensitization, CBD, and lung cancer among beryllium-exposed workers. The preliminary findings from this assessment are summarized below.
OSHA's preliminary risk assessment for CBD and beryllium sensitization relies on studies conducted at a Tucson, AZ beryllium ceramics plant (Kreiss
In the Tucson ceramics plant, 4,133 short-term breathing zone measurements collected between 1981 and 1992 had a median of 0.3 μg/m
Kreiss
Newman
Sensitization and CBD were studied in a population of workers at a Reading, PA copper beryllium plant, where alloys containing a low level of beryllium were processed (Schuler
In summary, the epidemiological literature on beryllium sensitization and CBD that OSHA's risk assessment relied on show sensitization prevalences ranging from 6.5 percent to 11.5 percent and CBD prevalences ranging from 1.3 percent to 9.7 percent among workers who had full-shift exposures well below the current PEL and median full-shift exposures at or below the proposed PEL, and whose follow-up time was less than 45 years. As referenced earlier, OSHA is interested in the risk associated with a 45-year (
The available epidemiological evidence shows that reducing workers' levels of airborne beryllium exposure can substantially reduce risk of beryllium sensitization and CBD. The best available evidence on effective exposure control programs comes partly from studies of programs introduced around 2000 at Reading, Tucson, and Elmore that used a combination of engineering controls, dermal and respiratory PPE, and stringent housekeeping measures to reduce workers' dermal exposures and airborne exposures to levels well below the proposed PEL of 0.2 μg/m
In the Reading, PA copper beryllium plant, full-shift airborne exposures in all jobs were reduced to a median of 0.1 μg/m
In the Tucson beryllium ceramics plant, respiratory and skin protection was instituted for all workers in production areas in 2000. BeLPT testing done in 2000-2004 showed that only 1 (1 percent) worker had been sensitized out of 97 workers hired during that time period (Cummings
The modern Elmore facility provides further evidence that combined reductions in respiratory exposure (via respirator use) and dermal exposure are effective in reducing risk of beryllium sensitization. In Elmore, historical beryllium exposures were higher than in Tucson, Reading, and Cullman. Personal lapel samples collected at Elmore in 1990-1992 had a median of 1.0 µg/m
OSHA's preliminary risk assessment also includes analysis of a data set provided to OSHA by the National Jewish Research and Medical Center (NJMRC). 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 for over three hundred workers 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 (1.0 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 proposed PEL, and extensive exposure data collected in workers' breathing zones, as is preferred by OSHA. Unlike the Tucson, Reading, and Elmore facilities, respirator use was not generally required for workers at the Cullman facility. Thus, analysis of this data set shows the risk associated with varying levels of airborne exposure, rather than the virtual elimination of airborne exposure via respiratory PPE. Also unlike the Tucson, Elmore, and Reading facilities, glove use was not reported to be mandatory in the Cullman facility. Thus, OSHA believes reductions in risk at the Cullman facility to be the result of airborne exposure control, rather than the combination of airborne and dermal exposure controls at the Tucson, Elmore, and Reading facilities.
OSHA analyzed the prevalence of beryllium sensitization and CBD among workers at the Cullman facility who were exposed to airborne beryllium levels at and below the current PEL of 2 µg/m
Tables 1 and 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 dataset, including workers with and without a diagnosis of CBD.
The current PEL of 2 μg/m
The proposed PEL of 0.2 μg/m
Table 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 employment.
A 45-year working lifetime of occupational exposure at the current PEL would result in 90 μg/m
As discussed in the Health Effects section (V.D), CBD often worsens with increased time and level of exposure. In a longitudinal study, workers initially identified as beryllium sensitized through workplace surveillance developed early stage CBD defined by granulomatous inflammation but no apparent physiological abnormalities (Newman
Studies of community-acquired (CA) CBD support the occurrence of advanced clinical CBD from long-term exposure to airborne beryllium (Eisenbud, 1998; Maier
OSHA believes that the literature review, prevalence analysis, and the evidence for time-dependent progression of CBD described above provide sufficient information to draw preliminary conclusions about significance of risk, and that further quantitative analysis of the NJMRC data set is not necessary to support the proposed rule. The studies OSHA used to support its preliminary conclusions regarding risk of beryllium sensitization and CBD were conducted at modern industrial facilities with exposure levels in the range of interest for this rulemaking, so a model is not needed to extrapolate risk estimates from high to low exposures, as has often been the case in previous rules. Nevertheless, the Agency felt further quantitative analysis might provide additional insight into the exposure-response relationship for sensitization and CBD.
Using the NJMRC data set, Dr. Stone ran a complementary log-log proportional hazards model, an extension of logistic regression that allows for time-dependent exposures and differential time at risk. Relative risk of sensitization increased with cumulative exposure (p = 0.05). A positive, but not statistically significant association was observed with LTW average exposure (p = 0.09). There was little association with highest-exposed job (HEJ) exposure (p = 0.3). Similarly, the proportional hazards models for the CBD endpoint showed positive relationships with cumulative exposure (p = 0.09), but LTW average exposure and HEJ exposure were not closely related to relative risk of CBD (p-values > 0.5). Dr. Stone used the cumulative exposure models to generate risk estimates for sensitization and CBD.
Tables 4 and 5 below present risk estimates from these models, assuming 5, 10, 20, and 45 years of beryllium exposure. The tables present sensitization and CBD risk estimates based on year-specific intercepts, as
As shown in Tables 4 and 5, the exposure-response models Dr. Stone developed based on the Cullman data set predict a high risk of both sensitization (about 96-394 cases per 1000 exposed workers) and CBD (about 44-313 cases per 1000) at the current PEL of 2 μg/m
OSHA does not believe the risk estimates generated by these exposure-response models to be highly accurate. Limitations of the analysis include the size of the dataset, relatively sparse exposure data from the plant's early years, study size-related constraints on the statistical analysis of the dataset, and limited follow-up time on many workers. The Cullman study population is a relatively small group and can support only limited statistical analysis. For example, its size precludes inclusion of multiple covariates in the exposure-response models or a two-stage exposure-response analysis to model both sensitization and the subsequent development of CBD within the subpopulation of sensitized workers. The limited size of the Cullman dataset is characteristic of studies on beryllium-exposed workers in modern, low-exposure environments, which are typically small-scale processing plants (up to several hundred workers, up to 20-30 cases).
Despite these issues with the statistical analysis, OSHA believes its main policy determinations are well supported by the best available evidence, including the literature review and careful examination of the prevalence of sensitization and CBD among workers with exposure levels comparable to the current and proposed PELs in the NJMRC data set. The previously described literature analysis and prevalence analysis demonstrate that workers with occupational exposure to airborne beryllium at the current PEL face a risk of becoming sensitized to beryllium and progressing to both early and advanced stages of CBD that far exceeds the value of 1 in 1000 used by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's preliminary risk assessment indicates that risk of beryllium sensitization and CBD can be significantly reduced by reduction of airborne exposure levels, along with respiratory and dermal protection measures, as demonstrated in facilities such as the Tucson ceramics plant, the Elmore beryllium production facility, and the Reading copper beryllium facility described in the literature review.
OSHA's preliminary risk assessment also indicates that despite the reduction in risk expected with the proposed PEL, the risk to workers with average exposure levels of 0.2 μg/m
OSHA's review of epidemiological studies of lung cancer mortality among beryllium workers found that most did not characterize exposure levels sufficiently to characterize risk of lung cancer at the current and proposed PELs. However, as discussed in this preamble at section V, Health Effects and section VI, Preliminary Risk Assessment, NIOSH recently published a quantitative risk assessment based on beryllium exposure and lung cancer mortality among 5436 male workers employed at beryllium processing plants in Reading, PA; Elmore, OH; and Hazleton, PA, prior to 1970 (Schubauer-Berigan
Schubauer-Berigan
The lowest estimate of excess lung cancer deaths from the six final models presented by Schubauer-Berigan
As discussed above, OSHA used the best available scientific evidence to identify adverse health effects of
OSHA's Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA) addresses issues related to the costs, benefits, technological and economic feasibility, and the economic impacts (including impacts on small entities) of this proposed respirable beryllium rule and evaluates regulatory alternatives to the proposed rule. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity), unless a statute requires another regulatory approach. Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The full PEA has been placed in OSHA rulemaking docket OSHA-H005C-2006-0870. This rule is an economically significant regulatory action under Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by executive order.
The purpose of the PEA is to:
• Identify the establishments and industries potentially affected by the proposed rule;
• Estimate current exposures and the technologically feasible methods of controlling these exposures;
• Estimate the benefits resulting from employers coming into compliance with the proposed rule in terms of reductions in cases of lung cancer and chronic beryllium disease;
• Evaluate the costs and economic impacts that establishments in the regulated community will incur to achieve compliance with the proposed rule;
• Assess the economic feasibility of the proposed rule for affected industries; and
• Assess the impact of the proposed rule on small entities through an Initial Regulatory Flexibility Analysis (IRFA), to include an evaluation of significant regulatory alternatives to the proposed rule that OSHA has considered.
The PEA contains the following chapters:
The PEA includes all of the economic analyses OSHA is required to perform, including the findings of technological and economic feasibility and their supporting materials required by the OSH Act as interpreted by the courts (in Chapters III, IV, V, and VI); those required by EO 12866 and EO 13563 (primarily in Chapters III, V, and VII, though these depend on material in other chapters); and those required by the Regulatory Flexibility Act (in Chapters VI, VIII, and IX, though these depend, in part, on materials presented in other chapters).
Key findings of these chapters are summarized below and in sections IX.B through IX.I of this PEA summary.
This proposed rule would affect employers and employees in many different industries across the economy. As described in Section IX.C and reported in Table IX-2 of this preamble, OSHA estimates that a total of 35,051 employees in 4,088 establishments are potentially at risk from exposure to beryllium.
As described in more detail in Section IX.D of this preamble and in Chapter IV of the PEA, OSHA assessed, for all affected sectors, the current exposures and the technological feasibility of the proposed PEL of 0.2 μg/m
Tables IX-5 in section IX.D of this preamble summarizes all nine application groups (industry sectors and production processes) studied in the technological feasibility analysis. The technological feasibility analysis includes information on current exposures, descriptions of engineering controls and other measures to reduce exposures, and a preliminary assessment of the technological feasibility of compliance with the proposed PELs.
The preliminary technological feasibility analysis shows that for the majority of the job groups evaluated, exposures are either already at or below the proposed PEL, or can be adequately controlled with additional engineering and work practice controls. Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2 μg/m
Based on the currently available evidence, it is more difficult to determine whether an alternative PEL of 0.1 μg/m
OSHA also evaluated the feasibility of a STEL of 2.0 μg/m
As described in more detail in Section IX.E and reported, by application group and NAICS code, in Table IX-7 of this preamble, the total annualized cost of compliance with the proposed standard is estimated to be about $37.6 million. The major cost elements associated with the revisions to the standard are housekeeping ($12.6 million), engineering controls ($9.5 million), training ($5.8 million), and medical surveillance ($2.9 million).
The compliance costs are expressed as annualized costs in order to evaluate economic impacts against annual revenue and annual profits, to be able to compare the economic impact of the rulemaking with other OSHA regulatory actions, and to be able to add and track Federal regulatory compliance costs and economic impacts in a consistent manner. Annualized costs also represent a better measure for assessing the longer-term potential impacts of the rulemaking. The annualized costs were calculated by annualizing the one-time costs over a period of 10 years and applying a discount rate of 3 percent (and an alternative discount rate of 7 percent).
The estimated costs for the proposed beryllium standard represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that has already been achieved with regard to the new requirements or costs necessary to achieve compliance with existing beryllium requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements.
To assess the nature and magnitude of the economic impacts associated with compliance with the proposed rule, OSHA developed quantitative estimates of the potential economic impact of the new requirements on entities in each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide an assessment of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts.
As described in greater detail in Section IX.F of this preamble and in Chapter VI of the PEA, the costs of compliance with the proposed rulemaking are not large in relation to the corresponding annual financial flows associated with each of the affected industry sectors. The estimated annualized costs of compliance represent about 0.11 percent of annual revenues and about 1.52 percent of annual profits, on average, across all affected firms. Compliance costs do not represent more than 1 percent of revenues or more than 16.25 percent of profits in any affected industry.
Based on its analysis of the relative inelasticity of demand for beryllium-containing inputs and products and of possible international trade effects, OSHA concluded that most or all costs arising from this proposed beryllium rule would be passed on in higher prices rather than absorbed in lost profits and that any price increases would result in minimal loss of business to foreign competition.
Given the minimal potential impact on prices or profits in the affected industries, OSHA has preliminarily concluded that compliance with the requirements of the proposed rulemaking would be economically feasible in every affected industry sector.
As described in more detail in Section VIII.G of this preamble, OSHA estimated the benefits, net benefits, and incremental benefits of the proposed beryllium rule. That section also contains a sensitivity analysis to show how robust the estimates of net benefits are to changes in various cost and benefit parameters. A full explanation of the derivation of the estimates presented there is provided in Chapter VII of the PEA for the proposed rule.
OSHA estimated the benefits associated with the proposed beryllium PEL of 0.2 μg/m
By applying the dose-response relationship to estimates of current exposure levels across industries, it is possible to project the number of cases of the following diseases expected to occur in the worker population given current exposure levels (the “baseline”):
• fatal cases of lung cancer,
• fatal cases of chronic beryllium disease (CBD), and
• morbidity related to chronic beryllium disease.
Table IX-1 provides a summary of OSHA's best estimate of the costs and benefits of the proposed rule. As shown, the proposed rule, once it is fully effective, is estimated to prevent 96 fatalities and 50 non-fatal beryllium-related illnesses annually, and the monetized annualized benefits of the proposed rule are estimated to be $575.8 million using a 3-percent discount rate and $255.3 million using a 7-percent discount rate. Also as shown in Table IX-1, the estimated annualized cost of the rule is $37.6 million using a 3-percent discount rate and $39.1 million using a 7-percent discount rate. The proposed rule is estimated to generate net benefits of $538.2 million annually using a 3-percent discount rate and $216.2 million annually using a 7-percent discount rate. The estimated costs and benefits of the proposed rule, disaggregated by industry sector, were previously presented in Table I-1 in this preamble.
OSHA has prepared an Initial Regulatory Flexibility Analysis (IRFA) in accordance with the requirements of the Regulatory Flexibility Act, as amended in 1996. Among the contents of the IRFA are an analysis of the potential impact of the proposed rule on small entities and a description and discussion of significant alternatives to the proposed rule that OSHA has considered. The IRFA is presented in its entirety both in Chapter IX of the PEA and in Section IX.I of this preamble.
The remainder of this section (Section IX) of the preamble is organized as follows:
Employees in work environments addressed by the proposed 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 PEA in support of the proposed rule, the risks to employees are excessively large due to the existence of various types of market failure, and existing and alternative methods of overcoming these negative consequences—such as workers' compensation systems, tort liability options, and information dissemination programs—have been shown to provide insufficient worker protection.
After carefully weighing the various potential advantages and disadvantages of using a regulatory approach to improve upon the current situation, OSHA preliminarily concludes that, in the case of beryllium exposure, the proposed mandatory standards represent the best choice for reducing the risks to employees. In addition, rulemaking is necessary in this case in order to replace older existing standards with updated, clear, and consistent health standards.
Chapter III of the PEA presents a profile of industries that use beryllium, beryllium oxide, and/or beryllium alloys. The discussion below summarizes the findings in that chapter. For each industry sector identified, the Agency describes the uses of beryllium and estimates the number of establishments and employees that may be affected by this proposed rulemaking. Employee exposure to beryllium can also occur as a result of certain processes such as welding that are found in many industries. OSHA uses the umbrella term “application group” to refer either to an industrial sector or a cross-industry group with a common process. These groups are all mutually exclusive and are analyzed in separate sections in Chapter III of the PEA. These sections briefly describe each application group and then explain how OSHA estimated the number of establishments working with beryllium and the number of employees exposed to beryllium. Beryllium is rarely used by all establishments in any particular application group because its unique properties and relatively high cost typically result in only very specific and limited usage within a portion of a group.
The information in Chapter III of the PEA is based on reports prepared under task order by Eastern Research Group (ERG), an OSHA contractor; information collected during OSHA's Small Business Advocacy Review Panel (OSHA 2008b); and Agency research and analysis. Technological feasibility reports (summarized in Chapter IV of the PEA) for each beryllium-using application group provide a detailed presentation of processes and occupations with beryllium exposure, including available sampling exposure measurements and estimates of how many employees are affected in each specific occupation.
OSHA has identified nine application groups that would be potentially affected by the proposed beryllium standard:
1. Beryllium Production
2. Beryllium Oxide Ceramics and Composites
3. Nonferrous Foundries
4. Secondary Smelting, Refining, and Alloying
5. Precision Turned Products
6. Copper Rolling, Drawing, and Extruding
7. Fabrication of Beryllium Alloy Products
8. Welding
9. Dental Laboratories
These application groups are broadly defined, and some include establishments in several North
One application group, welding, reflects industrial activities or processes that take place in various industry sectors. All of the industries in which a given activity or process may result in worker exposure to beryllium are identified in the sections on the application group. The section on each application group describes the production processes where occupational contact with beryllium can occur and contains estimates of the total number of firms, employees, affected establishments, and affected employees.
Chapter III of the PEA presents formulas in the text, usually in parentheses, to help explain the derivation of estimates. Because the values used in the formulas shown in the text are sometimes rounded, while the actual spreadsheet formulas used to create final costs are not, the calculation using the presented formula will sometimes differ slightly from the total presented in the text—which is the actual total as shown in the tables.
At the end of Chapter III in the PEA, OSHA discusses other industry sectors that have reportedly used beryllium in the past or for which there are anecdotal or informal reports of beryllium use. The Agency was unable to verify beryllium use in these sectors that would be affected by the proposed standard, and seeks further information in this rulemaking on these or other industries where there may be significant beryllium use and employee exposure.
As shown in Table IX-2, OSHA estimates that a total of 35,051 workers in 4,088 establishments will be affected by the proposed beryllium standard. Also shown are the estimated annual revenues for these entities.
The technological feasibility analyses presented in Chapter IV of the PEA contain data and discussion of worker exposures to beryllium throughout industry. Exposure profiles, by job category, were developed from individual exposure measurements that were judged to be substantive and to contain sufficient accompanying description to allow interpretation of the circumstance of each measurement. The resulting exposure profiles show the job categories with current overexposures to beryllium and, thus, the workers for whom beryllium controls would be implemented under the proposed rule.
Table IX-3 summarizes, from the exposure profiles, the number of workers at risk from beryllium exposure and the distribution of 8-hour TWA respirable beryllium exposures by affected job category and sector. Exposures are grouped into the following ranges: Less than 0.1 μg/m
Table IX-4 presents data by NAICS code on the estimated number of workers currently at risk from beryllium exposure, as well as the estimated number of workers at risk of beryllium exposure above 0 μg/m
This section summarizes the technological feasibility analysis presented in Chapter IV of the PEA (OSHA, 2014). The technological feasibility analysis includes information on current exposures, descriptions of engineering controls and other measures to reduce exposures, and a preliminary assessment of the technological feasibility of compliance with the proposed standard, including a reduction in OSHA's permissible exposure limits (PELs) in nine affected application groups. The current PELs for beryllium are 2.0 μg/m
The technological feasibility analysis includes nine application groups that correspond to specific industries or production processes that OSHA has preliminarily determined fall within the scope of the proposed standard. Within each of these application groups, exposure profiles have been developed
The nine application groups included in this analysis were identified based on information obtained during preliminary rulemaking activities that included a SBRFA panel, a comprehensive review of the published literature, stakeholder input, and an analysis of IMIS data collected during OSHA workplace inspections where detectable airborne beryllium was found. The nine application groups and their corresponding section numbers in Chapter IV of the PEA are:
• Section 3—Beryllium Production,
• Section 4—Beryllium Oxide Ceramics and Composites,
• Section 5—Nonferrous Foundries,
• Section 6—Secondary Smelting, Refining, and Alloying,
• Section 7—Precision Turned Products,
• Section 8—Copper Rolling, Drawing, and Extruding,
• Section 9—Fabrication of Beryllium Alloy Products,
• Section 10—Welding, and
• Section 11—Dental Laboratories.
OSHA developed exposure profiles by job or group of jobs using exposure data at the application, operation or task level to the extent that such data were available. In those instances where there were insufficient exposure data to create a profile, OSHA used analogous operations to characterize the operations. The exposure profiles represent baseline conditions with existing controls for each operation with potential exposure. For job groups where exposures were above the proposed TWA PEL of 0.2 μg/m
For the purposes of this technological feasibility assessment, these nine application groups can be divided into three general categories based on current exposure levels:
(1) application groups in which current exposures for most jobs are already below the proposed PEL of 0.2 μg/m
(2) application groups in which exposures for most jobs are below the current PEL, but exceed the proposed PEL of 0.2 μg/m
(3) application groups in which exposures in one or more jobs routinely exceed the current PEL, and therefore substantial reductions in exposure would be required to achieve the proposed PEL.
The majority of exposure measurements taken in the application groups in the first category are already at or below the proposed PEL of 0.2 μg/m
The two application groups in the second category include: precision turned products and secondary smelting. For these two groups, the median exposures in most jobs are below the current PEL, but the median exposure levels for some job groups currently exceed the proposed PEL. Additional exposure controls and work practices could be implemented that the Agency has preliminarily concluded would reduce exposures to or below the proposed PEL for most jobs most of the time. One exception is furnace operations in secondary smelting, in which the median exposure exceeds the current PEL. Furnace operations involve high temperatures that produce significant amounts of fumes and particulate that can be difficult to contain. Therefore, the proposed PEL may not be feasible for most furnace operations involved with secondary smelting, and in some cases, respiratory protection would be required to adequately protect furnace workers when exposures exceed 0.2 μg/m
Exposures in the third category of application groups routinely exceed the current PEL for several jobs. The three application groups in this category include: Beryllium production, beryllium oxide ceramics production, and nonferrous foundries. The individual job groups for which exposures exceed the current PEL are discussed in the application group specific sections later in this summary, and described in greater detail in the PEA. For the jobs that routinely exceed the current PEL, OSHA identified additional exposure controls and work practices that the Agency preliminarily concludes would reduce exposures to or below the proposed PEL most of the time, with three exceptions: Furnace operations in primary beryllium production and nonferrous foundries, and shakeout operations at nonferrous foundries. For these jobs, OSHA recognizes that even after installation of feasible controls, respiratory protection may be needed to adequately protect workers.
In conclusion, the preliminary technological feasibility analysis shows that for the majority of the job groups evaluated, exposures are either already at or below the proposed PEL, or can be adequately controlled with additional engineering and work practice controls. Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2 μg/m
Based on the currently available evidence, it is more difficult to determine whether an alternative PEL of
OSHA also evaluated the feasibility of a STEL of 2.0 μg/m
OSHA requests available exposure monitoring data and comments regarding the effectiveness of currently implemented control measures and the feasibility of the PELs under consideration, particularly the proposed TWA PEL of 0.2 μg/m
This section summarizes the technological feasibility analysis for each of the nine application groups affected by the proposed standard. Chapter IV of the PEA, Technological Feasibility Analysis, identifies specific jobs or job groups with potential exposure to beryllium, and presents exposure profiles for each of these job groups (OSHA, 2014). Control measures and work practices that OSHA believes can reduce exposures are described along with preliminary conclusions regarding the feasibility of the proposed PEL. Table IX-5, located at the end of this summary, presents summary statistics for the personal breathing zone samples taken to measure full-shift exposures to beryllium in each application group. For the five application groups in which the median exposure level for at least one job group exceeds the proposed PEL, the sampling results are presented by job group. Table IX-5 displays the number of measurements; the range, the mean and the median of the measurement results; and the percentage of measurements less than 0.1 μg/m
Only one primary beryllium production facility is currently in operation in the United States, a plant owned and operated by Materion Corporation,
The Agency developed an exposure profile for each of these eight job groups to analyze the distribution of exposure levels associated with primary beryllium production. The job exposure profiles are based primarily on full-shift personal breathing zone (PBZ) (lapel-type) sample results from air monitoring conducted by Brush Wellman's primary production facility in 1999 (Brush Wellman, 2004). Starting in 2000, the company developed the Materion Worker Protection Program (MWPP), a multi-faceted beryllium exposure control program designed to reduce airborne exposures for the vast majority of workers to less than an internally established exposure limit of 0.2 μg/m
Additional exposure samples were taken by NIOSH at the Elmore facility from 2007 through 2008 (NIOSH, 2011). This dataset, which was made available to OSHA by Materion, contains fewer samples than the 1999 survey. OSHA did not incorporate these samples into the exposure profile due to the limited documentation associated with the sampling data. The lack of detailed information for individual samples has made it difficult for OSHA to correlate job classifications and identify the working conditions associated with the samples. Sampling data provided by Materion for 2007 and 2008 were not incorporated into the exposure profiles because the data lacked specific information on jobs and workplace conditions. In a meeting in May 2012 held between OSHA and Materion Corporation at the Elmore facility, the Agency was able to obtain some general information on the exposure control modifications that Materion Corporation made between 1999 and 2007, but has been unable to determine what specific
In five of the primary production job groups (
For three of the job groups involved with primary beryllium production, (
OSHA identified seven job groups involved with beryllium oxide ceramics production. These include: Material preparation operator, forming operator, machining operator, kiln operator, production support, metallization, and administrative work. Four of these jobs (material preparation, forming operator, machining operator and kiln operator) work directly with beryllium oxides, and therefore these jobs have a high potential for exposure. The other three job groups (production support work, metallization, and administrative work) have primarily indirect exposure that occurs only when workers in these jobs groups enter production areas and are exposed to the same sources to which the material preparation, forming, machining and kiln operators are directly exposed. However, some production support and metallization activities do require workers to handle beryllium directly, and workers performing these tasks may at times be directly exposed to beryllium.
The Agency developed exposure profiles for these jobs based on air sampling data from four sources: (1) Samples taken between 1994 and 2003 at a large beryllium oxide ceramics facility, (2) air sampling data obtained during a site visit to a primary beryllium oxide ceramics producer, (3) a published report that provides information on beryllium oxide ceramics product manufacturing for a slightly earlier time period, and (4) exposure data from OSHA's Integrated Management Information System (OSHA, 2009). The exposure profile indicates that the three job groups with mostly indirect exposure (production support work, metallization, and administrative work) already achieve the proposed PEL of 0.2 μg/m
The four job groups with direct exposure had higher exposures. In forming operations and machining operations, the median exposure levels of 0.18 and 0.15 ug/m
The profile for the directly exposed jobs may overestimate exposures due to the preponderance of data from the mid-1990s, a time period prior to the implementation of a variety of exposure control measures introduced after 2000. In forming operations, 44 percent of sample values in the exposure profile exceeded 0.2 ug/m
In the exposure profile for material preparation, 73 percent of sample values exceeded 0.2 ug/m
OSHA identified eight job groups in aluminum and copper foundries with beryllium exposure: Molding, material handling, furnace operation, pouring, shakeout operation, abrasive blasting, grinding/finishing, and maintenance. The Agency developed exposure profiles based on an air monitoring survey conducted by NIOSH in 2007, a Health Hazard Evaluation (HHE) conducted by NIOSH in 1975, a site visit by ERG in 2003, a site visit report from 1999 by the California Cast Metals Association (CCMA); and two sets of data from air monitoring surveys obtained from Materion in 2004 and 2010.
The exposure profile indicates that in foundries processing beryllium alloys, six of the eight job groups have median exposures that exceed the proposed PEL of 0.2 μg/m
In some of the foundries at which the air samples included in the exposure profile were collected, there are indications that the ventilation systems were not properly used or maintained, and dry sweeping or brushing and the use of compressed air systems for cleaning may have contributed to high dust levels. OSHA believes that exposures in foundries can be substantially reduced by improving and properly using and maintaining the ventilation systems; switching from dry brushing, sweeping and compressed air to wet methods and use of HEPA-filtered vacuums for cleaning molds and work areas; enclosing processes; automation of high-exposure tasks; and modification of processes (
The Agency is less confident that exposure can be reliably reduced to the proposed PEL for furnace and shakeout operators. Beryllium concentrations in the proximity of the furnaces are typically higher than in other areas due to the fumes generated and the difficulty of controlling emissions during furnace operations. The exposure profile for furnace operations shows a median beryllium exposure level of 1.14 μg/m
OSHA identified two job groups in this application group with exposure to beryllium: Mechanical process operators and furnace operations workers. Mechanical operators handle and treat source material, and furnace operators run heating processes for refining, melting, and casting metal alloy. OSHA developed exposure profiles for these jobs based on exposure data from ERG site visits to a precious/base metals recovery facility and a facility that melts and casts beryllium-containing alloys, both conducted in 2003. The available exposure data for this application group are limited, and therefore, the exposure profile is supplemented in part by summary data presented in secondary sources of information on beryllium exposures in this application group.
The exposure profile for mechanical processing operators indicates low exposures (3 samples less than 0.2 μg/m
As with furnace operations examined in other application groups, the exposure profile indicates higher worker exposures for furnace operators in the secondary smelting, refining, and alloying application group (six samples with a median of 2.15 μg/m
OSHA's preliminary feasibility analysis for precision turned products focuses on machinists who work with beryllium-containing alloys. The Agency also examined the available exposure data for non-machinists and has preliminarily concluded that, in most cases, controlling the sources of exposures for machinists will also reduce exposures for other job groups with indirect exposure when working in the vicinity of machining operations.
OSHA developed exposure profiles based on exposure data from four NIOSH surveys conducted between 1976 and 2008; ERG site visits to precision machining facilities in 2002, 2003, and 2004; case study reports from six facilities machining copper-beryllium alloys; and exposure data collected between 1987 and 2001 by the U.S. Navy Environmental Health Center (NEHC). Analysis of the exposure data showed a substantial difference between the median exposure level for workers machining pure beryllium and/or high-beryllium alloys compared to workers machining low-beryllium alloys. Most establishments in the precision turned products application group work only with low-beryllium alloys, such as copper-beryllium. A relatively small number of establishments (estimated at 15) specialize in precision machining of pure beryllium and/or high-beryllium alloys.
The exposure profile indicates that machinists working with low-beryllium alloys have mostly low exposure to airborne beryllium. Approximately 85 percent of the 80 exposure results are less than or equal to 0.2 μg/m
Machinists working with high-beryllium alloys have higher exposure than those working with low-beryllium alloys. This difference is reflected in the exposure profile for this job, where the median of exposure is 0.31 μg/m
OSHA's exposure profile for copper rolling, drawing, and extruding includes four job groups with beryllium exposure: strip metal production, rod and wire production, production support, and administrative work. Exposure profiles for these jobs are based on personal breathing zone lapel sampling conducted at the Brush Wellman Reading, Pennsylvania, rolling and drawing facility from 1977 to 2000.
Prior to 2000, the Reading facility had limited engineering controls in place. Equipment in use included LEV in some operations, HEPA vacuums for general housekeeping, and wet methods to control loose dust in some rod and wire production operations. The exposure profile shows very low exposures for all four job groups. All had median exposure values below 0.1 μg/m
To characterize exposures in extrusion, OSHA examined the results of an industrial hygiene survey of a copper-beryllium extruding process conducted in 2000 at another facility. The survey reported eight PBZ samples, which were not included in the exposure profile because of their short duration (2 hours). Samples for three of the four jobs involved with the extrusion process (press operator, material handler, and billet assembler) were below the limit of detection (LOD) (level not reported). The two samples for the press operator assistant, taken when the assistant was buffing, sanding, and cleaning extrusion tools, were very high (1.6 and 1.9 μg/m
In summary, exposures at or below 0.2 μg/m
This application group includes the fabrication of beryllium alloy springs, stampings, and connectors for use in electronics. The exposure profile is based on a study conducted at four precision stamping companies; a NIOSH report on a spring and stamping company; an ERG site visit to a precision stamping, forming, and plating establishment; and exposure monitoring results from a stamping facility presented at the American Industrial Hygiene Conference and Exposition in 2007. The exposure profiles for this application group include three jobs: chemical processing operators, deburring operators, and assembly operators. Other jobs for which all samples results were below 0.1 μg/m
For the three jobs in the profile, the majority of exposure samples were below 0.1 μg/m
Most of the samples in OSHA's exposure profile for welders in general industry were collected between 1994 and 2001 at two of Brush Wellman's alloy strip distribution centers, and in 1999 at Brush Wellman's Elmore facility. At these facilities, tungsten inert gas (TIG) welding was conducted on beryllium alloy strip. Seven samples in the exposure profile came from a case study conducted at a precision stamping facility, where airborne beryllium levels were very low (see previous summary, Fabrication of Beryllium Alloy Products). At this facility, resistance welding was performed on copper-beryllium parts, and welding processes were automated and enclosed.
Most of the sample results in the welding exposure profile were below 0.2 μg/m
OSHA's exposure profile for dental technicians includes sampling results from a site visit conducted by ERG in 2003; a study of six dental laboratories published by Rom
The exposure profile indicates that 52 percent of samples are less than or equal to 0.2 μg/m
Based on this information, OSHA preliminarily concludes that beryllium exposures for most dental technicians are already below 0.2 μg/m
Chapter V of the PEA in support of the proposed beryllium rule provides a detailed assessment of the costs to 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
As shown in Table IX-7 at the end of this section, OSHA estimates that the proposed standard would have an annualized cost of $37.6 million. All cost estimates are expressed in 2010 dollars and were annualized using a discount rate of 3 percent, which—along with 7 percent—is one of the discount rates recommended by OMB.
The estimated costs for the proposed beryllium rule represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that may already have been achieved with regard to existing beryllium requirements or costs necessary to achieve compliance with existing beryllium requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements.
Throughout this section and in the PEA, OSHA presents cost formulas in the text, usually in parentheses, to help explain the derivation of cost estimates for individual provisions. Because the values used in the formulas shown in the text are shown only to the second decimal place, while the actual spreadsheet formulas used to create final costs are not limited to two decimal places, the calculation using the presented formula will sometimes differ slightly from the presented total in the text, which is the actual and mathematically correct total as shown in the tables.
OSHA's estimate of the costs for affected employers to comply with the proposed PEL of 0.2 μg/m
In the technological feasibility analysis presented in Chapter IV of the PEA, OSHA concluded that implementing all engineering controls and work practices necessary to reach the proposed PEL will, except for a small residual group (accounting for about 6 percent of all exposures above the STEL), also reduce exposures below the STEL. However, based on the nature of the processes this residual group is likely to be engaged in, the Agency expects that employees would already be using respirators to comply with the PEL under the proposed standard. Therefore, with the proposed STEL set at ten times the proposed PEL, the Agency has preliminarily determined that engineering controls, work practices, and (when needed) respiratory protection sufficient to meet the proposed PEL are also sufficient to meet the proposed STEL. For that reason, OSHA has taken no additional costs for affected employers to meet the proposed STEL. The Agency invites comment and requests that the public provide data on this issue.
For this preliminary cost analysis, OSHA estimated the necessary engineering controls and work practices for each affected application group according to the exposure profile of current exposures by occupation presented in Chapter III of the PEA. Under the requirements of the proposed standard, employers would be required to implement engineering or work practice controls whenever beryllium exposures exceed the proposed PEL of 0.2 μg/m
In addition, even if employers are not exposed above the proposed PEL or proposed STEL, paragraph (f)(2) of the proposed standard would require employers at or above the action level to use at least one engineering or work practice control to minimize worker exposure. Based on the technological feasibility analysis presented in Chapter IV of the PEA, OSHA has determined that, for only two job categories in two application groups—chemical process operators in the Stamping, Spring and Connection Manufacture application group and machinists in the Machining application group—do the majority of facilities at or above the proposed action level, but below the proposed PEL, lack the baseline engineering or work controls required by paragraph (f)(2). Therefore, OSHA has estimated costs, where appropriate, for employers in these two application groups to comply with paragraph (f)(2).
By assigning controls based on application group, the Agency is best able to identify those workers with exposures above the proposed PEL and to design a control strategy for, and attribute costs specifically to, these groups of workers. By using this approach, controls are targeting those specific processes, emission points, or procedures that create beryllium exposures. Moreover, this approach allows OSHA to assign costs for technologies that are demonstrated to be the most effective in reducing exposures resulting from a particular process.
In developing cost estimates, OSHA took into account the wide variation in the size or scope of the engineering or work practice changes necessary to minimize beryllium exposures based on technical literature, judgments of knowledgeable consultants, industry observers, and other sources. The resulting cost estimates reflect the representative conditions for the affected workers in each application group and across all work settings. In all but a handful of cases (with the exceptions noted in the PEA), all wage costs come from the 2010 Occupational Employment Statistics (OES) of the Bureau of Labor Statistics (BLS, 2010a) and utilize the median wage for the appropriate occupation. The wages used include a 30.35 percent markup for fringe benefits as a percentage of total
The specific engineering costs for each of the applications groups, and the NAICS industries that contain those application groups, are discussed in Chapter V of the PEA. Like the industry profile and technological feasibility analysis presented in other PEA chapters, Chapter V of the PEA presents engineering control costs for the following application groups:
Dental Laboratories
The costs within these application groups are estimated by occupation and/or operation. One application group could have multiple occupations, operations, or activities where workers are exposed to levels of beryllium above the proposed PEL, and each will need its own set of controls. The major types of engineering controls needed to achieve compliance with the proposed PEL include ventilation equipment, pharmaceutical-quality high-containment isolators, decontainment chambers, equipment with controlled water sprays, closed-circuit remote televisions, enclosed cabs, conveyor enclosures, exhaust hoods, and portable local-exhaust-ventilation (LEV) systems. Capital costs and annual operation and maintenance (O&M) costs, as well as any other annual costs, are estimated for the set of engineering controls estimated to be necessary for limiting beryllium exposures for each occupation or operation within each application group.
Tables V-2 through V-10 in Chapter V of the PEA summarize capital, maintenance, and operating costs for each application group disaggregated by NAICS code. Table IX-7 at the end of this section breaks out the costs of engineering controls/work practices by application group and NAICS code.
Some engineering control costs are estimated on a per-worker basis and then multiplied by the estimated number of affected workers—as identified in Chapter III: Profile of Affected Industries in the PEA—to arrive at a total cost for a particular control within a particular application group. This worker-based method is necessary because—even though OSHA has data on the number of firms in each affected industry, the occupations and industrial activities that result in worker exposure to beryllium, and the exposure profile of at-risk occupations—the Agency does not have a way to match up these data at the firm level. Nor does the Agency have establishment-specific data on worker exposure to beryllium for all establishments, or even establishment-specific data on the level of activity involving worker exposure to beryllium. Thus, OSHA could not always directly estimate per-affected-establishment costs, but instead first had to estimate aggregate compliance costs (using an estimated per-worker cost multiplied by the number of affected workers) and then calculate the average per-affected-establishment costs by dividing those aggregate costs by the number of affected establishments. This method, while correct on average, may under- or over-state costs for certain firms. For other controls that are implemented on a fixed-cost basis per establishment (
In developing cost estimates, the Agency sometimes had to make case-specific judgments about the number of workers affected by each engineering control. Because work environments vary within occupations and across establishments, there are no definitive data on how many workers are likely to have their exposures reduced by a given set of controls. In the smallest establishments, especially those that might operate only one shift per day, some controls would limit exposures for only a single worker in one specific affected occupation. More commonly, however, several workers are likely to benefit from each enhanced engineering control. Many controls were judged to reduce exposure for employees in multi-shift work or where workstations are used by more than one worker per shift.
In general, improving work practices involves operator training, actual work practice modifications, and better enforcement or supervision to minimize potential exposures. The costs of these process improvements consist of the supervisor and worker time involved and would include the time spent by supervisors to develop a training program.
Unless otherwise specified, OSHA viewed the extent to which exposure controls are already in place to be reflected in the distribution of exposures at levels above the proposed PEL among affected workers. Thus, for example, if 50 percent of workers in a given occupation are found to be exposed to beryllium at levels above the proposed PEL, OSHA judged this equivalent to 50 percent of facilities lacking adequate exposure controls. The facilities may have, for example, the correct equipment installed but without adequate ventilation to provide protection to workers exposed to beryllium. In this example, the Agency would expect that the remaining 50 percent of facilities to either have installed the relevant controls to reduce beryllium exposures below the PEL or that they engage in activities that do not require that the exposure controls be in place (for example, they do not perform any work with beryllium-containing materials). To estimate the need for incremental controls on a per-worker basis, OSHA used the exposure profile information as the best available data. OSHA recognizes that a very small percentage of facilities might have all the relevant controls in place but are still unable, for whatever reason, to achieve the proposed PEL through controls alone. ERG's review of the industrial hygiene literature and other source materials (ERG, 2007b), however, suggest that the large majority of workplaces where workers are exposed to high levels of beryllium lack at least some of the relevant controls. Thus, in estimating the costs associated with the proposed standard, OSHA has generally assumed that high levels of exposure to beryllium occur due to the absence of suitable controls. This assumption likely results in an overestimate of costs since, in some cases, employers may not need to install and maintain new controls in order to meet the proposed PEL but merely need to upgrade or better maintain existing controls, or to improve work practices.
Based on the findings of the technological feasibility analysis, a small subset of employees working with a few processes in a handful of application groups will need to use respirators, in addition to required engineering controls and improved work practices, to reduce employee exposures to meet the proposed PEL. Specifically, furnace operators—both in non-ferrous foundries (both sand and non-sand) and in secondary smelting, refining, and alloying—as well as welders in a few other processes, will
There are five primary costs for respiratory protection. First, there is a cost per establishment to set up a written respirator program in accordance with the respiratory protection standard (29 CFR 1910.134). The respiratory protection standard requires written procedures for the proper selection, use, cleaning, storage, and maintenance of respirators. As derived in the PEA, OSHA estimates that, when annualized over 10 years, the annualized per-establishment cost for a written respirator program is $207.
For reasons unrelated to the proposed standard, certain establishments will already have a respirator program in place. Table V-11 in Chapter V of the PEA presents OSHA's estimates, by application group, of current levels of compliance with the respirator program provision of the proposed rule.
The four other major costs of respiratory protection are the per-employee costs for all aspects of respirator use: equipment, training, fit-testing, and cleaning. Table V-12 of Chapter V in the PEA breaks out OSHA's estimate of the unit costs for the two types of respirators needed: A half-mask respirator and a full-face powered air-purifying respirator. As derived in the PEA, the annualized per-employee cost for a half-mask respirator would be $524 and the annualized per-employee cost for a full-face powered air-purifying respirator would be $1,017.
Table V-13 in Chapter V of the PEA presents the number of additional employees, by application group and NAICS code, that would need to wear respirators to comply with the proposed standard and the cost to industry to comply with the respirator protection provisions in the proposed rule. OSHA judges that only workers in Beryllium Production work with processes that would require a full-face respirator and estimates that there are 23 of those workers. Three hundred and eighteen workers in other assorted application groups are estimated to need half-mask respirators. A total of 341 employees would need to wear some type of respirator, resulting in a total annualized cost of $249,684 for affected industries to comply with the respiratory protection requirements of the proposed standard. Table IX-7 at the end of this section breaks out the costs of respiratory protection by application group and NAICS code.
This section presents OSHA's estimated costs for ancillary beryllium control programs required under the proposed rule. Based on the program requirements contained in the proposed standard, OSHA considered the following cost elements in the following employer duties: (a) Assess employees' exposure to airborne beryllium, (b) establish regulated areas, (c) develop a written exposure control plan, (d) provide protective work clothing, (e) establish hygiene areas and practices, (f) implement housekeeping measures, (g) provide medical surveillance, (h) provide medical removal for employees who have developed CBD or been confirmed positive for beryllium sensitization, and (i) provide appropriate training.
The worker population affected by each program element varies by several criteria discussed in detail in each subsection below. In general, some elements would apply to all workers exposed to beryllium at or above the action level. Other elements would apply to a smaller set of workers who are exposed above the PEL. The training requirements would apply to all employees who work in a beryllium work area (
Costs for each program requirement are aggregated by employment and by industry. For the most part, unit costs do not vary by industry, and any variations are specifically noted. The estimated compliance rate for each provision of the proposed standard by application group is presented in Table V-15 of the PEA.
Most establishments wishing to perform exposure monitoring would require the assistance of an outside consulting industrial hygienist (IH) to obtain accurate results. While some firms might already employ or train qualified staff, OSHA judged that the testing protocols are fairly challenging and that few firms have sufficiently skilled staff to eliminate the need for outside consultants.
The proposed standard requires that, after receiving the results of any exposure monitoring where exposures exceed the TWA PEL or STEL, the employer notify each such affected employee in writing of suspected or known sources of exposure, and the corrective action(s) being taken to reduce exposure to or below the PEL. Those workers exposed at or above the action level and at or below the PEL must have their exposure levels monitored annually.
For costing purposes, OSHA estimates that, on average, there are four workers per work area. OSHA interpreted the initial exposure assessment as requiring first-year testing of at least one worker in each distinct job classification and work area who is, or may reasonably be expected to be, exposed to airborne concentrations of beryllium at or above the action level.
The proposed standard requires that whenever there is a change in the production, process, control equipment, personnel, or work practices that may result in new or additional exposures, or when the employer has any reason to suspect that a change may result in new or additional exposures, the employer must conduct additional monitoring. The Agency has estimated that this provision would require an annual sampling of 10 percent of the affected workers.
OSHA estimates that an industrial hygienist (IH) would spend 1 day each year to sample 2 workers, for a per worker IH fee of $257. This exposure monitoring requires that three samples be taken per worker: One TWA and two STEL for an annual IH fee per sample of $86. Based on the 2000 EMSL Laboratory Testing Catalog (ERG, 2007b), OSHA estimated that analysis of each sample would cost $137 in lab fees. When combined with the IH fee, OSHA estimated the annual cost to obtain a TWA sample to be $223 per sampled worker and the annual cost to obtain the two STEL samples to be $445 per sampled worker. The direct exposure monitoring unit costs are
The cost of the sample also incorporates a productivity loss due to the additional time for the worker to participate in the sampling (30 minutes per worker sampled) as well as for the associated recordkeeping time incurred by a manager (15 minutes per worker sampled). The STEL samples are assumed to be taken along with the TWA sample and, thus, labor costs were not added to both unit costs. Including the costs related to lost productivity, OSHA estimates the total annual cost of a TWA sample to be $251, and 2 STEL samples, $445. The total annual cost per worker for all sampling taken is then $696. OSHA estimates the total annualized cost of this provision to be $2,208,950 for all affected industries. The annualized cost of this provision for each affected NAICS industry is shown in Table IX-6.
The proposed beryllium standard requires the employer to establish and maintain a regulated area wherever employees are, or can reasonably expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. Regulated areas require specific provisions that both limit employee exposure within its boundaries and curb the migration of beryllium outside the area. The Agency judged, based on the preliminary findings of the technological feasibility analysis, that companies can reduce establishment-wide exposure by ensuring that only authorized employees wearing proper protective equipment have access to areas of the establishment where such higher concentrations of beryllium exist, or can be reasonably expected to exist. Workers in other parts of the establishment are also likely to see a reduction in beryllium exposures due to these measures since fewer employees would be traveling through regulated areas and subsequently carrying beryllium residue to other work areas on their clothes and shoes.
Requirements in the proposed rule for a regulated area include: Demarcating the boundaries of the regulated area as separate from the rest of the workplace, limiting access to the regulated area, providing an appropriate respirator to each person entering the regulated area and other protective clothing and equipment as required by paragraph (g) and paragraph (h), respectively.
OSHA estimated that the total annualized cost per regulated area, including set-up costs ($76), respirators ($1,768) and protective clothing ($4,500), is $6,344.
When establishments are in full compliance with the standard, regulated areas would be required only for those workers for whom controls could not feasibly reduce their exposures to or below the 0.2 μg/m
The proposed standard requires that all beryllium work areas are adequately established and demarcated. ERG estimated that one work area would need to be established for every 12 at-risk workers. OSHA estimates that the annualized cost would be $33 per work area.
OSHA estimates the total annualized cost of the regulated areas and work areas is $629,031 for all affected industries. The cost for each affected application group and NAICS code is shown in Table IX-6.
The proposed standard requires that employers must establish and maintain a written exposure control plan for beryllium work areas. The written program must contain:
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 minimizing cross-contamination, including but not limited to preventing the transfer of beryllium between surfaces, equipment, clothing, materials and articles within beryllium work areas.
5. Procedures for keeping surfaces in the beryllium work area 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 required by paragraph (f)(2) of this standard.
8. Procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.
The unit cost estimates take into account the judgment that (1) most establishments have an awareness of beryllium risks and, thus, should be able to develop or modify existing safeguards in an expeditious fashion, and (2) many operations have limited beryllium activities and these establishments need to make only modest changes in procedures to create the necessary exposure control plan. ERG's experts estimated that managers would spend eight hours per establishment to develop and implement such a written exposure control plan, yielding a total cost per establishment to develop and implement the written control plan of $563.53 and an annualized cost of $66. In addition, because larger firms with more affected workers will need to develop more complicated written control plans, the development of a plan would require an extra thirty minutes of a manager's time per affected employee, for a cost of $35 per affected employee and an annualized cost of $4 per employee. Managers would also need 12 minutes (0.2 hours) per affected employee per quarter, or 48 minutes per affected employee per year to review and update the plan, for a recurring cost of $56 per affected employee per year to maintain and update the plan. Five minutes of clerical time would also be needed per employee for providing each employee with a copy of the written exposure control plan—yielding an annualized cost of $2 per employee. The total annual per-employee cost for development, implementation, review, and update of a written exposure control plan is then $62. The Agency estimates the total annualized cost of this provision to be $1,769,506 for all affected establishments. The breakdown of these costs by application group and NAICS code is presented in Table IX-6.
The proposed standard requires personal protective clothing and equipment for workers:
1. Whose exposure can reasonably be expected to exceed the TWA PEL or STEL.
2. When work clothing or skin may become visibly contaminated with beryllium, including during maintenance and repair activities or during non-routine tasks.
3. Where employees' skin can reasonably be expected to be exposed to soluble beryllium compounds.
OSHA has determined that it would be necessary for employers to provide reusable overalls and/or lab coats at a
Chemical process operators in the spring and stamping application group would require chemical resistant protective clothing at an annual cost of $849. Gloves and/or shoe covers would be required when performing operations in several different application groups, depending on the process being performed, at an annual cost of $50 and $78, respectively.
The proposed standard requires that all reusable protective clothing and equipment be cleaned, laundered, repaired, and replaced as needed to maintain their effectiveness. This includes such safeguards as transporting contaminated clothing in sealed and labeled impermeable bags and informing any third party businesses coming in contact with such materials of the risks associated with beryllium exposure. OSHA estimates that the lowest cost alternative to satisfy this provision is for an employer to rent and launder reusable protective clothing—at an estimated annual cost per employee of $49. Ten minutes of clerical time would also be needed per establishment with laundry needs to notify the cleaners in writing of the potentially harmful effects of beryllium exposure and how the protective clothing and equipment must be handled in accordance with this standard—at a per establishment cost of $3.
The Agency estimates the total annualized cost of this provision to be $1,407,365 for all affected establishments. The breakdown of these costs by application group and NAICS code is shown in Table IX-6.
The proposed standard requires employers to provide readily accessible washing facilities to remove beryllium from the hands, face, and neck of each employee working in a beryllium work area and also to provide a designated change room in workplaces where employees would have to remove their personal clothing and don the employer-provided protective clothing. The proposed standard also requires that employees shower at the end of the work shift or work activity if the employee reasonably could have been exposed to beryllium at levels above the PEL or STEL, and if those exposures could reasonably be expected to have caused contamination of the employee's hair or body parts other than hands, face, and neck.
In addition to other forms of PPE costed previously, for processes where hair may become contaminated, head coverings can be purchased at an annual cost of $28 per employee. This could satisfy the requirement to avoid contaminated hair. If workers are covered by protective clothing such that no body parts (including their hair where necessary, but not including their hands, face, and neck) could reasonably be expected to have been contaminated by beryllium, and they could not reasonably be expected to be exposed to beryllium while removing their protective clothing, they would not need to shower at the end of a work shift or work activity. OSHA notes that some facilities already have showers, and the Agency judges that all employers either already have showers where needed or will have sufficient measures in place to ensure that employees could not reasonably be expected to be exposed to beryllium while removing protective clothing. Therefore, OSHA has preliminarily determined that employers will not need to provide any new shower facilities to comply with the standard.
The Agency estimated the costs for the addition of a change room and segregated lockers based on the costs for acquisition of portable structures. The change room is presumed to be used in providing a transition zone from general working areas into beryllium-using regulated areas. OSHA estimated that portable building, adequate for 10 workers per establishment can be rented annually for $3,251, and that lockers could be procured for a capital cost of $407—or $48 annualized—per establishment. This results in an annualized cost of $3,299 per facility to rent a portable change room with lockers. OSHA estimates that the 10 percent of affected establishments unable to meet the proposed TWA PEL would require change rooms. The Agency estimated that a worker using a change room would need 2 minutes per day to change clothes. Assuming 250 days per year, this annual time cost for changing clothes is $185 per employee.
The Agency estimates the total annualized cost of the provision on hygiene areas and practices to be $389,241 for all affected establishments. The breakdown of these costs by application group and NAICS code can be seen in Table IX-6.
The proposed rule specifies requirements for cleaning and disposing of beryllium-contaminated wastes. The employer shall maintain all surfaces in beryllium work areas as free as practicable of accumulations of beryllium and shall ensure that all spills and emergency releases of beryllium are cleaned up promptly, in accordance with the employer's written exposure control plan and using a HEPA-filtered vacuum or other methods that minimize the likelihood and level of exposure. The employer shall 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 exposure have been tried and were not effective.
ERG's experts estimated that each facility would need to purchase a single vacuum at a cost of $2,900 for every five affected employees in order to successfully integrate housekeeping into their daily routine. The per-employee cost would be $580, resulting in an annualized cost of $68 per worker. ERG's experts also estimated that all affected workers would require an additional five minutes per work day (.083 hours) to complete vacuuming tasks and to label and dispose of beryllium-contaminated waste. While this allotment is modest, OSHA judged that the steady application of this incremental additional cleaning, when combined with currently conducted cleaning, would be sufficient in average establishments to address dust or surface contamination hazards. Assuming that these affected workers would be working 250 days per year, OSHA estimates that the annual labor cost per employee for additional time spent cleaning in order to comply with this provision is $462.
The proposed standard requires each disposal bag with contaminated materials to be properly labeled. ERG estimated a cost of 10 cents per label with one label needed per day for every five workers. With the disposal of one labeled bag each day and 250 working days, the per-employee annual cost would be $5. The annualized cost of a HEPA-filtered vacuum, combined with the additional time needed to perform housekeeping and the labeling of disposal bags, results in a total annualized cost of $535 per employee.
The Agency estimates the total annualized cost of this provision to be $12,574,921 for all affected establishments. The breakdown of these costs by application group and NAICS code is shown in Table IX-6.
The proposed standard requires the employer to make medical surveillance available at no cost to the employee, and at a reasonable time and place, for the following employees:
1. Employees who have worked in a regulated area for more than 30 days in the last 12 months
2. Employees showing signs or symptoms of chronic beryllium disease (CBD)
3. Employees exposed to beryllium during an emergency; and
4. Employees exposed to airborne beryllium above 0.2 μg/m
As discussed in the regulated areas section of this analysis of program costs, the Agency estimates that approximately 10 percent of affected employees would have exposure in excess of the PEL after the standard goes into effect and would therefore be placed in regulated areas. The Agency further estimates that a very small number of employees will be affected by emergencies in a given year, likely less than 0.1 percent of the affected population, representing a small additional cost. The number of workers who would suffer signs and symptoms of CBD after the rule takes effect is difficult to estimate, but would likely substantially exceed those with actual cases of CBD.
While the symptoms of CBD vary greatly, the first to appear are usually chronic dry cough (generally defined as a nonproductive cough, without phlegm or sputum, lasting two months or more) and shortness of breath during exertion. Ideally, in developing these costs estimates, OSHA would first estimate the percent of affected workers who might be presenting with a chronic cough and/or experiencing shortness of breath.
Studies have found the prevalence of a chronic cough ranging from 10 to 38 percent across various community populations, with smoking accounting for up to 18 percent of cough prevalence (Irwin, 1990; Barbee, 1991). However, these studies are over 20 years old, and the number of smokers has decreased substantially since then. It's also not clear whether the various segments of the U.S. population studied are similar enough to the population of workers exposed to beryllium such that results of these studies could be generalized to the affected worker population.
A more recent study from a plant in Cullman, Alabama that works with beryllium alloy found that about five percent of employees said they were current smokers, with roughly 52 percent saying they were previous smokers and approximately 43 percent stating they had never smoked (Newman et al., 2001). This study does not, however, report on the prevalence of chronic cough in this workplace.
OSHA was unable to identify any studies on the general prevalence of the other common early symptom of CBD, shortness of breath. Lacking any better data to base an estimate on, the Agency used the studies cited above (Irwin, 1990; Barbee, 1991) showing the prevalence of chronic cough in the general population, adjusted to account for the long term decrease in smoking prevalence (and hence, the amount of overall cases of chronic cough), and estimated that 15 percent of the worker population with beryllium exposure would exhibit a chronic cough or other sign or symptom of CBD that would trigger medical surveillance. The Agency welcomes comment and further data on this question.
According to the proposed rule, the initial (baseline) medical examination would consist of the following:
1. A medical and work history, with emphasis on past and present exposure, smoking history and any history of respiratory system dysfunction;
2. A physical examination with emphasis on the respiratory tract;
3. A physical examination for skin breaks and wounds;
4. A pulmonary function test;
5. A standardized beryllium lymphocyte proliferation test (BeLPT) upon the first examination and within every two years from the date of the first examination until the employee is confirmed positive for beryllium sensitization;
6. A CT scan, offered every two years for the duration of the employee's employment, if the employee was exposed to airborne beryllium at levels above 0.2 μg/m
7. Any other test deemed appropriate by the Physician or other Licensed Health Care Professional (PLHCP).
Table V-17 in Chapter V of the PEA lists the direct unit costs for initial medical surveillance activities including: Work and medical history, physical examination, pulmonary function test, BeLPT, CT scan, and costs of additional tests. In OSHA's cost model, all of the activities will take place during an employee's initial visit and on an annual basis thereafter and involve a single set of travel costs, except that: (1) The BeLPT tests will only be performed at two-year intervals after the initial test, but will be conducted in conjunction with the annual general examination (no additional travel costs); and (2) the CT scans will typically involve different specialists and are therefore treated as separate visits not encompassed by the general exams (therefore requiring separate travel costs). Not all employees would require CT scans, and employers would only be required to offer them every other year.
In addition to the fees for the annual medical exam, employers may also incur costs for lost work time when their employees are unavailable to perform their jobs. This includes time for traveling, a health history review, the physical exam, and the pulmonary function test. Each examination would require 15 minutes (or 0.25 hours) of a human resource manager's time for recording the results of the exam and tests and the PLHCP's written opinion for each employee and any necessary post-exam consultation with the employee. There is also a cost of 15 minutes of supervisor time to provide information to the physician, five minutes of supervisor time to process a licensed physician's written medical opinion, and five minutes for an employee to receive a licensed physician's written medical opinion. The total unit annual cost for the medical examinations and tests, excluding the BeLPT test, and the time required for both the employee and the supervisor is $297.
The estimated fee for the BeLPT is $259. With the addition of the time incurred by the worker to undergo the test, the total cost for a BeLPT is $261. The standard requires a biennial BeLPT for each employee covered by the medical surveillance provision, so most workers would receive between two and five BeLPT tests over a ten year period (including the BeLPT performed during the initial examination), depending on whether the results of these tests were positive. OSHA therefore estimates a net present value (NPV) of $1,417 for all five tests. This NPV annualized over a ten year period is $166.
Together, the annualized net present value of the BeLPT and the annualized cost of the remaining medical surveillance produce an annual cost of $436 per employee.
The proposed standard requires that a helical tomography (CT scan) be offered to employees exposed to airborne beryllium above 0.2 μg/m
Based on OSHA's estimates explained earlier in this section, all workers in regulated areas, workers exposed in emergencies, and an estimated 15 percent of workers not in regulated areas who exhibit signs and symptoms of CBD will be eligible for medical surveillance other than CT scans. The estimate for the number of workers eligible to receive CT scans is 25 percent of workers who are exposed above 0.2 in the exposure profile. The estimate of 25 percent is based on the facts that roughly this percentage of workers have 15-plus years of job tenure in the durable manufacturing sector and the estimate that all those with 15-plus years of job tenure and current exposure over 0.2 would have had at least 5 years of such exposure in the past.
The costs estimated for this provision are likely to be significantly overestimated, since not all affected employees offered medical surveillance would necessarily accept the offer. At Department of Energy facilities, only about 50 percent of eligible employees participate in the voluntary medical surveillance tests, and a report on an initial medical surveillance program at four aluminum manufacture facilities found participation rates to be around 57 percent (Taiwo et al., 2008). Where employers already offer equivalent health surveillance screening, no new costs are attributable to the proposed standard.
Within 30 days after an employer learns that an employee has been confirmed positive for beryllium sensitization, the employer's designated licensed physician shall consult with the employee to discuss referral to a CBD diagnostic center that is mutually agreed upon by the employer and the employee. If, after this consultation, the employee wishes to obtain a clinical evaluation at a CBD diagnostic center, the employer must provide the evaluation at no cost to the employee. OSHA estimates this consultation will take 15 minutes, with an estimated total cost of $33.
Table V-18 in Chapter V of the PEA lists the direct unit costs for a clinical evaluation with a specialist at a CBD diagnostic center. To estimate these costs, ERG contacted a healthcare provider who commonly treats patients with beryllium-related disease, and asked them to provide both the typical tests given and associated costs of an initial examination for a patient with a positive BeLPT test, presented in Table V-18 in Chapter V of the PEA. Their typical evaluation includes bronchoscopy with lung biopsy, a pulmonary stress test, and a chest CAT scan. The total cost for the entire suite of tests is $6,305.
In addition, there are costs for lost productivity and travel. The Agency has estimated the clinical evaluation would take three days of paid time for the worker to travel to and from one of two locations: Penn Lung Center at the Cleveland Clinic Foundation in Cleveland, Ohio or National Jewish Medical Center in Denver, Colorado. OSHA estimates lost work time is 24 hours, yielding total cost for the 3 days of $532.
OSHA estimates that roundtrip air-fare would be available for most facilities at $400, and the cost of a hotel room would be approximately $100 per night, for a total cost of $200 for the hotel room. OSHA estimates a per diem cost of $50 for three days, for a total of $150. The total cost per trip for traveling expenses is therefore $750.
The total cost of a clinical evaluation with a specialist at a CBD diagnostic center is equal to the cost of the examination plus the cost of lost work-time and the cost for the employee to travel to the CBD diagnostic center, or $7,620.
Based on the data from the exposure profile and the prevalence of beryllium sensitization observed at various levels of cumulative exposure,
OSHA did not assume that all workers with confirmed sensitization would choose to undergo evaluation at a CBD diagnostic center, which may involve invasive procedures and/or travel. For purposes of this cost analysis, OSHA estimates that approximately two-thirds of workers who are confirmed positive for beryllium sensitization will choose to undergo evaluation for CBD. OSHA requests comment on the CBD evaluation participation rate. OSHA estimates that about 264 of all non-dental lab workers will go to a diagnostic center for CBD evaluation in the first year.
The calculation method described above applies to all workers except dental technicians, who were analyzed with one modification. The rates for dental technicians are calculated differently due to the estimated 75 percent beryllium-substitution rate at dental labs, where the 75 percent of labs that eliminate all beryllium use are those at higher exposure levels. None of the remaining labs affected by this standard had exposures above 0.1 μg/m
In each year after the first year, OSHA relied on a 10 percent worker turnover rate in a steady state (as discussed in Chapter VII of the PEA) to estimate that the annual sensitization incidence rate is 10 percent of the first year's incidence rate. Based on that rate and the number of workers in the medical surveillance program, the CBD evaluation rate for workers other than those in dental labs would drop to 0.63 percent (.063 × .10). The evaluation rate for dental labs technicians is similarly estimated to drop to 0.58 percent (.058 × .10).
Based on these unit costs and the number of employees requiring medical surveillance estimated above, OSHA estimates that the medical surveillance and referral provisions would result in an annualized total cost of $2,882,706. These costs are presented by application group and NAICS code in Table IX-7.
Once a licensed physician diagnoses an employee with CBD or the employee is confirmed positive for sensitization to beryllium, that employee is eligible for medical removal and has two choices:
(a) Removal from current job, or
(b) Remain in a job with exposure above the action level while wearing a respirator pursuant to 29 CFR 1910.134.
To be eligible for removal, the employee must accept comparable work if such is available, but if not available the employer would be required to place the employee on paid leave for six months or until such time as comparable work becomes available, whichever comes first. During that six-month period, whether the employee is re-assigned or placed on paid leave, the employer must continue to maintain the employee's base earnings, seniority and other rights, and benefits that existed at the time of the first test.
For purposes of this analysis, OSHA has conservatively estimated the costs as if all employees will choose removal, rather than remaining in the current job while wearing a respirator. In practice, many workers may prefer to continue working at their current job while wearing a respirator, and the employer would only incur the respirator costs identified earlier in this chapter. The removal costs are significantly higher over the same six-month period, so this analysis likely overestimates the total costs for this provision.
OSHA estimated that the majority of firms would be able to reassign the worker to a job at least at the clerical level. The employer will often incur a cost for re-assigning the worker because this provision requires that, regardless of the comparable work the medically removed worker is performing, the employee must be paid the full base earnings for the previous position for six months. The cost per hour of reassigning a worker to a clerical job is based on the wage difference of a production worker of $22.16 and a clerical worker of $19.97, for a difference of $2.19. Over the six-month period, the incremental cost of reassigning a worker to a clerical position would be $2,190 per employee. This estimate is based on the employee remaining in a clerical position for the entire 6-month period, but the actual cost would be lower if there is turnover or if the employee is placed in any alternative position (for any part of the six-month period) that is compensated at a wage closer to the employee's previous wage.
Some firms may not have the ability to place the worker in an alternate job. If the employee chooses not to remain in the current position, the additional cost to the employer would be at most the cost of equipping that employee with a respirator, which would be required if the employee would continue to face exposures at or above the action level. Based on the earlier discussion of respirator costs, that option would be significantly cheaper than the alternative of providing the employee with six months of paid leave. Therefore, in order to estimate the maximum potential economic cost of the remaining alternatives, the Agency has conservatively estimated the cost per worker based on the cost of 6 months paid leave.
Using the wage rate of a production worker of $22.16 for 6 months (or 8 hours a day for 125 days), the total per-worker cost for this provision when a firm cannot place a worker in an alternate job is $22,161.
OSHA has estimated an average medical removal cost per worker assuming 75 percent of firms are able to find the employee an alternate job, and the remaining 25 percent of firms would not. The weighted average of these costs is $7,183. Based on these unit costs, OSHA estimates that the medical removal provision would result in an annualized total cost of $148,826. The breakdown of these costs by application group and NAICS code is shown in Table IX-6.
As specified in the proposed standard and existing OSHA standard 29 CFR 1910.1200 on hazard communication, training is required for all employees where there is potential exposure to beryllium. In addition, newly hired employees would require training before starting work.
OSHA anticipates that training in accordance with the requirements of the proposed rule, which includes hazard communication training, would be conducted by in-house safety or supervisory staff with the use of training modules or videos. ERG estimated that this training would last, on average, eight hours. (Note that this estimate does not include the time taken for hazard communication training that is already required by 29 CFR 1910.1200.) The Agency judged that establishments could purchase sufficient training materials at an average cost of $2 per worker, encompassing the cost of handouts, video presentations, and training manuals and exercises. For initial and periodic training, ERG estimated an average class size of five workers with one instructor over an eight hour period. The per-worker cost of initial training totals to $239.
Annual retraining of workers is also required by the standard. OSHA estimates the same unit costs as for initial training, so retraining would require the same per-worker cost of $239.
Finally, to calculate training costs, the Agency needs the turnover rate of affected workers to know how many workers are receiving initial training versus retraining. Based on a 26.3 percent new hire rate in manufacturing, OSHA calculated a total net present value (NPV) of ten years of initial and annual retraining of $2,101 per employee. Annualizing this NPV gives a total annual cost for training of $246.
Based on these unit costs, OSHA estimates that the training requirements in the standard would result in an annualized total cost of $5,797,535. The breakdown of these costs by application group and NAICS code is presented in Table IX-6.
As shown in Table IX-7, the total annualized cost of the proposed rule is estimated to be about $37.6 million. As shown, at $27.8 million, the program costs represent about 74 percent of the total annualized costs of the proposed rule. The annualized cost of complying with the PEL accounts for the remaining 26 percent, almost all of which is for engineering controls and work practices. Respiratory protection, at about $237,600, represents only 3 percent of the annualized cost of complying with the PEL and less than 1 percent of the annualized cost of the proposed rule.
Chapter VI of the PEA, summarized here, investigates the economic impacts of the proposed beryllium rule on affected employers. This impact investigation has two overriding objectives: (1) To establish whether the proposed rule is economically feasible for all affected application groups/industries, and (2) to determine if the Agency can certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
In the discussion below, OSHA first presents its approach for achieving these objectives and next applies this approach to industries with affected employers. The Agency invites comment on any aspect of the methods, data, or preliminary findings presented here or in Chapter VI of the PEA.
Section 6(b)(5) of the OSH Act directs the Secretary of Labor to set standards based on the available evidence where no employee, over his/her working life time, will suffer from material impairment of health or functional capacity, even if such employee has regular exposure to the hazard, “to the exent feasible” (29 U.S.C. 655(b)(5)). OSHA interpreted the phrase “to the extent feasible” to encompass economic feasibility and was supported in this view by the U.S. Court of Appeals for the D.C. Circuit, which has long held that OSHA standards would satisfy the economic feasibility criterion even if they imposed significant costs on regulated industries and forced some marginal firms out of business, so long as they did not cause massive economic dislocations within a particular industry or imperil the existence of that industry.
In practice, the economic burden of an OSHA standard on an industry—and whether the standard is economically feasible for that industry—depends on
The price elasticity of demand refers to the relationship between the price charged for a product and the demand for that product: The more elastic the relationship, the less an establishment's compliance costs can be passed through to customers in the form of a price increase and the more the establishment has to absorb compliance costs in the form of reduced profits. When demand is inelastic, establishments can recover most of the costs of compliance by raising the prices they charge; under this scenario, profit rates are largely unchanged and the industry remains largely unaffected. Any impacts are primarily on those customers using the relevant product. On the other hand, when demand is elastic, establishments cannot recover all compliance costs simply by passing the cost increase through in the form of a price increase; instead, they must absorb some of the increase from their profits. Commonly, this will mean reductions both in the quantity of goods and services produced and in total profits, though the profit rate may remain unchanged. In general, “[w]hen an industry is subjected to a higher cost, it does not simply swallow it; it raises its price and reduces its output, and in this way shifts a part of the cost to its consumers and a part to its suppliers,” in the words of the court in
The court's summary is in accord with microeconomic theory. In the long run, firms can remain in business only if their profits are adequate to provide a return on investment that ensures that investment in the industry will continue. Over time, because of rising real incomes and productivity increases, firms in most industries are able to ensure an adequate profit. As technology and costs change, however, the long-run demand for some products naturally increases and the long-run demand for other products naturally decreases. In the face of additional compliance costs (or other external costs), firms that otherwise have a profitable line of business may have to increase prices to stay viable. Increases in prices typically result in reduced quantity demanded, but rarely eliminate all demand for the product. Whether this decrease in the total production of goods and services results in smaller output for each establishment within the industry or the closure of some plants within the industry, or a combination of the two, is dependent on the cost and profit structure of individual firms within the industry.
If demand is perfectly inelastic (
If the demand is perfectly elastic (
A commonly-discussed intermediate case would be a price elasticity of demand of one (in absolute terms). In this situation, if the costs of compliance amount to one percent of revenues, then production would decline by one percent and prices would rise by one percent. As a result, industry revenues would remain the same, with somewhat lower production, but with similar profit rates per unit of output (in most situations where the marginal costs of production net of regulatory costs would fall as well). Customers would, however, receive less of the product for their (same) expenditures, and firms would have lower total profits; this, as the court described in
A decline in output as a result of an increase in price may occur in a variety of ways: individual establishments could each reduce their levels of production; some marginal plants could close; or, in the case of an expanding industry, new entry may be delayed until demand equals supply. In some situations, there could be a combination of these three effects. Which possibility is most likely depends on the form that the costs of the regulation take. If the costs are variable costs (
Most of the costs of this regulation, as estimated in Chapter V of the PEA, are variable costs in the sense that they will tend to vary by production levels and/or employment levels. Almost all of the major costs of program elements, such as medical surveillance and training, will vary in proportion to the number of employees (which is a rough proxy for the amount of production). Exposure monitoring costs will vary with the number of employees, but do have some economies of scale to the extent that a larger firm need only conduct representative sampling rather than sample every employee. Finally, the costs of operating and maintaining engineering controls tend to vary by usage—which typically closely tracks the level of production and are not fixed costs in the strictest sense.
This leaves two kinds of costs that are, in some sense, fixed costs—capital costs of engineering controls and certain initial costs. The capital costs of engineering controls due to the standard—many of which are scaled to production and/or employment levels—constitute a relatively small share of the total costs, representing 10 percent of total annualized costs (or approximately $870 per year per affected establishment).
Some ancillary provisions require initial costs that are fixed in the sense that they do not vary by production activity or the number of employees. Some examples are the costs to develop a training plan for general training not currently required and to develop a written exposure control plan.
As a result of these considerations, OSHA expects it to be quite likely that any reductions in total industry output would be due to reductions in output at each affected facility rather than as a result of plant closures. However, closures of some marginal plants or poorly performing facilities are always possible.
To determine whether a rule is economically feasible, OSHA begins with two screening tests to consider minimum threshold effects of the rule under two extreme cases: (1) All costs are passed through to customers in the form of higher prices (consistent with a price elasticity of demand of zero), and (2) all costs are absorbed by the firm in the form of reduced profits (consistent with an infinite price elasticity of demand).
In the former case, the immediate impact of the rule would be observed in increased industry revenues. While there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of one percent of annual revenues. Retrospective studies of previous OSHA regulations have shown that potential impacts of such a small magnitude are unlikely to eliminate an industry or significantly alter its competitive structure,
In the latter case, the immediate impact of the rule would be observed in reduced industry profits. OSHA uses the ratio of annualized costs to annual profits as a second check on economic feasibility. Again, while there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of ten percent of annual profits. In the context of economic feasibility, the Agency believes this threshold level to be fairly modest, given that normal year-to-year variations in profit rates in an industry can exceed 40 percent or more. OSHA also considered whether this threshold would be adequate to assure that upfront costs would not create major credit problems for affected employers. To do this, OSHA examined a worst case scenario in which annualized costs were ten percent of profits and all of the annualized costs were the result of upfront costs. In this scenario, assuming a three percent discount rate and a ten year life of equipment, total costs would be 85 percent of profits
In general, because it is usually the case that firms would be able to pass on to their customers some or all of the costs of the proposed rule in the form of higher prices, OSHA will tend to give much more weight to the ratio of industry costs to industry revenues than to the ratio of industry costs to industry profits. However, if costs exceed either the threshold percentage of revenue or the threshold percentage of profits for an industry, or if there is other evidence of a threat to the viability of an industry because of the proposed standard, OSHA will examine the effect of the rule on that industry more closely. Such an examination would include market factors specific to the industry, such as normal variations in prices and profits, and any special circumstances, such as close domestic substitutes of equal cost, which might make the industry particularly vulnerable to a regulatory cost increase.
The preceding discussion focused on the economic viability of the affected industries in their entirety. However, even if OSHA found that a proposed standard did not threaten the survival of affected industries, there is still the question of whether the industries' competitive structure would be significantly altered. For example, if the annualized costs of an OSHA standard were equal to 10 percent of an industry's annual profits, and the price elasticity of demand for the products in that industry were equal to one, then OSHA would not expect the industry to go out of business. However, if the increase in costs were such that most or all small firms in that industry would have to close, it might reasonably be concluded that the competitive structure of the industry had been altered. For this reason, OSHA also calculates compliance costs by size of firm and conducts its economic feasibility screening analysis for small and very small entities.
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 proposed rulemaking will have on small entities. The RFA states that whenever a Federal agency is required to publish general notice of proposed rulemaking for any proposed rule, the agency must prepare and make available for public comment an initial regulatory flexibility analysis (IRFA). 5 U.S.C. 603(a). Pursuant to section 605(b), in lieu of an IRFA, the head of an agency may certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. A certification must be supported by a factual basis. If the head of an agency makes a certification, the agency shall publish such certification in the
To determine if the Assistant Secretary of Labor for OSHA can certify that the proposed beryllium rule will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the proposed rule on
There are, however, two differences. First, for each affected industry, the screening tests are applied, not to all establishments, but to small entities (defined as “small business concerns” by SBA) and also to very small entities (as defined by OSHA as businesses with fewer than 20 employees). Second, although OSHA's regulatory flexibility screening test for revenues also uses a minimum threshold level of annualized costs equal to one percent of annual revenues, OSHA has established a minimum threshold level of annualized costs equal to five percent of annual profits for the average small entity or very small entity. The Agency has chosen a lower minimum threshold level for the profitability screening analysis and has applied its screening tests to both small entities and very small entities in order to ensure that certification will be made, and an IRFA will not be prepared, only if OSHA can be highly confident that a proposed rule will not have a significant economic impact on a substantial number of small entities or very small entities in any affected industry.
Furthermore, certification will not be made, and an IRFA will be prepared, if OSHA believes the proposed rule might otherwise have a significant economic impact on a substantial number of small entities, even if the minimum threshold levels are not exceeded for revenues or profitability for small entities or very small entities in all affected industries.
In this section, OSHA applies its screening criteria and other analytic methods, as needed, to determine (1) whether the proposed rule is economically feasible for all affected industries within the scope of this proposed rule, and (2) whether the Agency can certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
To determine whether the proposed rule's projected costs of compliance would threaten the economic viability of affected industries, OSHA first compared, for each affected industry, annualized compliance costs to annual revenues and profits per (average) affected establishment. The results for all affected establishments in all affected industries are presented in Table IX-8. Shown in the table for each affected industry are the total number of establishments, the total number of affected establishments, annualized costs per affected establishment, annual revenues per establishment, the profit rate, annual profits per establishment, annualized compliance costs as a percentage of annual revenues, and annualized compliance costs as a percentage of annual profits.
The annualized costs per affected establishment for each affected industry were calculated by distributing the industry-level (incremental) annualized compliance costs among all affected establishments in the industry, where annualized compliance costs reflect a 3 percent discount rate. The annualized cost of the proposed rule for the average affected establishment is estimated at $9,197 in 2010 dollars. It is clear from Table IX-8 that the estimates of the annualized costs per affected establishment vary widely from industry to industry. These estimates range from $1,257,214 for NAICS 331419 (Beryllium Production) and $120,372 for NAICS 327113a (Porcelain Electrical Supply Manufacturing (primary)) to $1,636 for NAICS 621210 (Offices of Dentists) and $1,632 for NAICS 339116 (Dental Laboratories).
As previously discussed, OSHA has established a minimum threshold level of annualized costs equal to one percent of annual revenues—and, secondarily, annualized costs equal to 10 percent of annual profits—below which the
As Table IX-8 shows, there are no industries in which the annualized costs of the proposed rule exceed one percent of annual revenues. However there are three six-digit NAICS industries where annualized costs exceed ten percent of annual profits.
NAICS 331525 (Copper foundries except die-casting) has the highest cost impact as a percentage of profits. NAICS 331525 is made up of two types of copper foundries: sand casting foundries and non-sand casting foundries, incurring an annualized cost as a percent of profit of 16.25 percent and 14.92 percent, respectively. The other two six-digit NAICS industries where annualized costs exceed ten percent of annual profits are NAICS 331534: Aluminum foundries (except die-casting), 13.65 percent; and NAICS 811310: Commercial and industrial machinery and equipment repair, 10.19 percent.
OSHA believes that the beryllium-containing inputs used by these industries have a relatively inelastic demand for three reasons. First, beryllium has rare and unique characteristics, including low mass, high melting temperature, dimensional stability over a wide temperature range, strength, stiffness, light weight, and high elasticity (“springiness”) that can significantly improve the performance of various alloys. These characteristics cannot easily be replicated by other materials. In economic terms, this means that the elasticity of substitution between beryllium and non-beryllium inputs will be low. Second, products which contain beryllium or beryllium-alloy components typically have high-performance applications (whose performance depends on the use of higher-cost beryllium). The lack of available competing products with these performance characteristics suggests that the price elasticity of demand for products containing beryllium or beryllium-alloy components will be low. Third, components made of beryllium or beryllium-containing alloys typically account for only a small portion of the overall cost of the finished goods that these parts are used to make. For example, the cost of brakes made of a beryllium-alloy used in the production of a jet airplane represents a trivial percentage of the overall cost to produce that airplane. As economic theory indicates, the elasticity of derived demand for a factor of production (such as beryllium) varies directly with the elasticity of substitution between the input in question and other inputs; the price elasticity of demand for the final product that the input is used to produce; and, in general, the share of the cost of the final product that the input accounts for. Applying these three conditions to beryllium points to the relative inelastic derived demand for this factor of production and the likelihood that cost increases resulting from the proposed rule would be passed on to the consumer in the form of higher prices.
A secondary point is that the establishments in an industry that use beryllium may be more profitable than those that don't. This follows from the prior arguments about beryllium's rare and desirable characteristics and its valuable applications. For example, of the 208 establishments that make up NAICS 331525, OSHA estimated that 45 establishments (or 21 percent) work with beryllium. Of the 394 establishments that make up NAICS 331524, OSHA estimated that only 7 establishments (less than 2 percent) work with beryllium. Of the 21,960 establishments that make up NAICS 811310, OSHA estimated that 143 (0.7 percent) work with beryllium. However, when OSHA calculated the cost-to-profit ratio, it used the average profit per firm for the entire NAICs industry, not the average profit per firm for firms working with beryllium.
The United States has a dynamic and constantly changing economy in which an annual percentage increase in industry revenues or prices of one percent or more are common. Examples of year-to-year changes in an industry that could cause such an increase in revenues or prices include increases in fuel, material, real estate, or other costs; tax increases; and shifts in demand.
To demonstrate the normal year-to-year variation in prices for all the manufacturers in general industry affected by the proposed rule, OSHA developed in the PEA year-to-year producer price indices and year-to-year percentage changes in producer prices, by industry, for the years 1999-2010. For all of the industries estimated to be affected by this proposed standard over the 12-year period, the average change in producer prices was 4.4 percent a year—which is over 4 times as high as OSHA's 1 percent cost-to-revenue threshold. For the industries found to have the largest estimated potential annual cost impact as a percentage of revenue shown in Chapter VI of the PEA are—NAICS 331524: Aluminum Foundries (except Die-Casting), (0.71 percent); NAICS 331525(a and b): Copper Foundries (except Die-Casting) (average of 0.81 percent); NAICS 332721a: Precision Turned Product Manufacturing of high content beryllium (0.49 percent);
Based on these data, it is clear that the potential price impacts of the proposed rule in affected industries are all well within normal year-to-year variations in prices in those industries. The maximum cost impact of the proposed rule as a percentage of revenue in any affected industry is 0.84 percent, while, as just noted, the average annual change in producer prices for affected industries was 4.4 percent for the period 1999-2010. In fact, Chapter VI of the PEA shows two of the industries within the secondary smelting, refining, and alloying group, for example, the prices rose over 60 percent in one year without imperiling the existence of those industries. Thus, OSHA preliminarily concludes that the potential price impacts of the proposal would not threaten the economic viability of any industries affected by this proposed standard.
Profit rates are also subject to the dynamics of the U.S. economy. A recession, a downturn in a particular industry, foreign competition, or the increased competitiveness of producers of close domestic substitutes are all easily capable of causing a decline in profit rates in an industry of well in excess of ten percent in one year or for several years in succession.
To demonstrate the normal year-to-year variation in profit rates for all the manufacturers affected by the proposed rule, OSHA presented data in the PEA on year-to-year profit rates and year-to-year percentage changes in profit rates, by industry, for the years 2002-2009. For the industries that OSHA has estimated will be affected by this
A longer-term loss of profits in excess of 10 percent a year could be more problematic for some affected industries and might conceivably, under sufficiently adverse circumstances, threaten an industry's economic viability. However, as previously discussed, OSHA's analysis indicates that affected industries would generally
World production of beryllium is a thin market, with only a handful of countries known to process beryllium ores and concentrates into beryllium products, and characterized by a high degree of variation and uncertainty. The United States accounts for approximately 65 percent of world beryllium deposits and 90 percent of world production, but there is also a significant stockpiling of beryllium materials in Kazakhstan, Russia, China, and possibly other countries (USGS, 2013a). For the individual years 2008-2012, the United States' net import reliance as a percentage of apparent consumption (that is, imports minus exports net of industry and government stock adjustments) ranged from 10 percent to 61 percent (USGS, 2013b). To assure an adequate stockpile of beryllium materials to support national defense interests, the U.S. Department of Defense, in 2005, under the Defense Production Act, Title III, invested in a public-private partnership with the leading U.S. beryllium producer to build a new $90.4 million primary beryllium facility in Elmore, Ohio. Construction of that facility was completed in 2011 (USGS, 2013b).
One factor of importance to firms working with beryllium and beryllium alloys is to have a reliable supply of beryllium materials. U.S. manufacturers can have a relatively high confidence in the availability of beryllium materials relative to manufacturers in many foreign countries, particularly those that do not have economic or national security partnerships with the United States.
Firms using beryllium in production must consider not just the cost of the chemical itself but also the various regulatory costs associated with the use, transport, and disposal of the material. For example, for marine transport, metallic beryllium powder and beryllium compounds are classified by the International Maritime Organization (IMO) as poisonous substances, presenting medical danger. Beryllium is also classified as flammable. The United Nations classification of beryllium and beryllium compounds for the transport of dangerous goods is “poisonous substance” and, for packing, a “substance presenting medium danger” (WHO, 1990). Because of beryllium's toxicity, the material is subject to various workplace restrictions as well as international, national, and State requirements and guidelines regarding beryllium content in environmental media (USGS, 2013a).
As the previous discussion indicates, the production and use of beryllium and beryllium alloys in the United States and foreign markets appears to depend on the availability of production facilities; beryllium stockpiles; national defense and political considerations; regulations limiting the shipping of beryllium and beryllium products; international, national, and State regulations and guidelines regarding beryllium content in environmental media; and, of course, the special performance properties of beryllium and beryllium alloys in various applications. Relatively small changes in the price of beryllium would seem to have a minor effect on the location of beryllium production and use. In particular, as a result of this proposed rule, OSHA would expect that, if all compliance costs were passed through in the form of higher prices, a price increase of 0.11 percent, on average, for firms manufacturing or using beryllium in the United States—and not exceeding 1 percent in any affected industry—would have a negligible effect on foreign competition and would therefore not threaten the economic viability of any affected domestic industries.
The preceding discussion focused on the economic viability of the affected industries in their entirety. Even though OSHA found that the proposed standard did not threaten the survival of these industries, there is still the possibility that the competitive structure of these industries could be significantly altered such as by small entities exiting from the industry as a result of the proposed standard.
To address this possibility, OSHA examined the annualized costs of the proposed standard per affected small entity, and per affected very small entity, for each affected industry. Again, OSHA used a minimum threshold level of annualized compliance costs equal to one percent of annual revenues—and, secondarily, annualized compliance costs equal to ten percent of annual profits—below which the Agency has concluded that the costs are unlikely to threaten the survival of small entities or very small entities or, consequently, to alter the competitive structure of the affected industries.
Based on the results presented in Table IX-9, the annualized cost of compliance with the proposed rule for the average affected small entity is estimated to be $8,108 in 2010 dollars. Based on the results presented in Table IX-10, the annualized cost of compliance with the proposed rule for the average affected very small entity is estimated to be $1,955 in 2010 dollars. These tables also show that there are no industries in which the annualized costs of the proposed rule for small entities or very small entities exceed one percent of annual revenues. NAICS 331525b: Sand Copper Foundries (except die-casting) has the highest estimated cost
Small entities in four industries—NAICS 331525: Sand and non-sand foundries (except die-casting); NAICS 331524(a and b): Aluminum foundries (except die-casting); NAICS 811310: Commercial and Industrial Machinery and Equipment; and NAICS 331522: Nonferrous (except aluminum) die-casting foundries—have annualized costs in excess of 10 percent of annual profits (17.45 percent, 16.12 percent, 11.68 percent, and 10.64 percent, respectively). Very small entities in 7 industries are estimated to have annualized costs in excess of 10 percent of annual profit; NAICS 336322b: Other motor vehicle electrical and electronic equipment (38.49 percent);
In general, cost impacts for affected small entities or very small entities will tend to be somewhat higher, on average, than the cost impacts for the average business in those affected industries. That is to be expected. After all, smaller businesses typically suffer from diseconomies of scale in many aspects of their business, leading to less revenue per dollar of cost and higher unit costs. Small businesses are able to overcome these obstacles by providing specialized products and services, offering local service and better service, or otherwise creating a market niche for themselves. The higher cost impacts for smaller businesses estimated for this rule—other than very small entities in NAICS 336322b: Other motor vehicle electrical and electronic equipment—generally fall within the range observed in other OSHA regulations and, as verified by OSHA's lookback reviews, have not been of such a magnitude to lead to the economic failure of regulated small businesses.
The ratio of annualized costs to annual profit is a sizable 38.49 percent in NAICS 336322b: Other motor vehicle electrical and electronic equipment. However, OSHA believes that the actual ratio is significantly lower. There are 386 very small entities in NAICS 336322, of which only 6, or 1.5 percent, are affected entities using beryllium. When OSHA calculated the cost-to-profit ratio, it used the average profit per firm for the entire NAICs industry, not the average profit rate for firms working with beryllium. The profit rate for all establishments in NAICS 336322b was estimated at 1.83 percent. If, for example, the average profit rate for a very small entity in NAICS 336322b were equal to 5.95 percent, the average profit rate for its application group, Beryllium Oxide Ceramics and Composites, then the ratio of the very small entity's annualized cost of the proposed rule to its annual profit would actually be 11.77 percent. OSHA tentatively concludes the 6 establishments in the NAICS specializing in beryllium production will have a higher than average profit rate and will be able to pass much of the cost onto the consumer for three main reasons: (1) The absence of substitutes containing the rare performance characteristics of beryllium; (2) the relative price insensitivity of (other) motor vehicles containing the special performance characteristics of beryllium and beryllium alloys; and (3) the fact that electrical and electronic components made of beryllium or beryllium-containing alloys typically account for only a small portion of the overall cost of the finished (other) motor vehicles. The annualized compliance cost to annual revenue ratio for NAICS 336332b is 0.70 percent, 0.30 percent below the 1 percent threshold. Based on OSHA's experience, price increases of this magnitude have not historically been associated with the economic failure of small businesses.
To determine if the Assistant Secretary of Labor for OSHA can certify that the proposed beryllium standard will not have a significant economic impact on a substantial number of small entities, the Agency has developed screening tests to consider minimum threshold effects of the proposed standard on small entities. The minimum threshold effects for this purpose are annualized costs equal to one percent of annual revenues, and annualized costs equal to five percent of annual profits, applied to each affected industry. OSHA has applied these screening tests both to small entities and to very small entities. For purposes of certification, the threshold level cannot be exceeded for affected small entities or very small entities in any affected industry.
Tables IX-9 and Table IX-10, presented above, show that the annualized costs of the proposed standard do not exceed one percent of annual revenues for affected small entities or affected very small entities in any affected industry. These tables also show that the annualized costs of the proposed standard exceed five percent of annual profits for affected small entities in 12 industries and for affected very small entities in 30 industries. OSHA is therefore unable to certify that the proposed standard will not have a significant economic impact on a substantial number of small entities and must prepare an Initial Regulatory Flexibility Analysis (IRFA). The IRFA is presented in Chapter IX of the PEA and is reproduced in Section IX.I of this preamble.
In this section, OSHA presents a summary of the estimated benefits and net benefits of the proposed beryllium rule. This section 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 proposed PEL is adopted in a final standard to a world in which employees are exposed at the level of the proposed PEL throughout their working lives. The second step also assumes that the proposed PEL is adopted, but uses the results from the first step to estimate what would happen under a more realistic scenario in which employees have been exposed for varying periods of time to the baseline situation and will thereafter be exposed to the new PEL.
The third step covers the monetization of benefits. Then, in the fourth step, OSHA estimates the net benefits and incremental benefits of the proposed rule by comparing the monetized benefits to the costs presented in Chapter V of the PEA. The models underlying each step inevitably need to make a variety of assumptions based on limited data. 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. A full explanation of the derivation of the estimates presented here is provided in Chapter VII of the PEA for the proposed rule. OSHA invites comments on any aspect of the data and methods used to estimate the benefits and net benefits of this proposed rule. Because dental labs constitute a significant source of both costs and benefits to the rule (over 40 percent), OSHA is particularly interested in comments regarding the appropriateness of the model, assumptions, and data to estimating the benefits to workers in that industry.
OSHA has added to the docket the spreadsheets used to calculate the estimates of benefits outlined below (OSHA, 2015a). Those interested in exploring the details and methodology of OSHA's benefits analysis, such as how the life table referred to below was developed and applied, should consult those spreadsheets.
The first step in OSHA's development of the benefits analysis compares the situation in which employees continue to be at baseline exposure levels for their entire working lives to the situation in which all employees have been exposed at a given PEL for their entire working lives. This is a comparison of two steady-state situations. To do this, OSHA must estimate both the risk associated with the baseline exposure levels and the risk following the promulgation of a new beryllium standard. OSHA's approach assumes for inputs such as the turnover rate and the exposure response function that they are similar across all workers exposed to beryllium, regardless of industry.
An exposure-response model, discussed below, is used to estimate a worker's risk of beryllium-related disease based on the worker's cumulative beryllium exposure. The Agency used a lifetime risk model to estimate the baseline risk and the associated number of cases for the various disease endpoints. A lifetime risk model explicitly follows a worker each year, from work commencement onwards, accumulating the worker's beryllium exposure in the workplace and estimating outcomes each year for the competing risks that can occur. To go from exposure to number of cases, the Agency needs to estimate an exposure-response relationship, and this is discussed below. The possible outcomes are no change, or the various health endpoints OSHA has considered (beryllium sensitization, CBD, lung cancer, and the mortality associated with these endpoints). As part of the estimation discussion, OSHA will mention specific parameters used in some of the estimation methods, but will further discuss how these parameters were derived later in this section.
The baseline lifetime risk model is the most complicated part of the analysis. The Agency only needs to make relatively simple adjustments to this model to reflect changes in activities and conditions due to the standard, which, working through the model, then lead to changes in relevant health outcomes. There are three channels by which the standard generates benefits. First are estimated benefits due to the lowering of the PEL. Second are estimated benefits with further exposure reductions from the substitution of non-beryllium for beryllium-containing materials, ending workers' beryllium exposures entirely. This potential source of benefits is particularly significant with respect to OSHA's assumptions for how dental labs are likely to reduce exposures (see below). Finally, the model estimates benefits due to the ancillary programs that are required by the proposed standard. The last channel affects CBD and sensitization, endpoints which may be mitigated or prevented with the help of ancillary provisions such as dermal protection and medical surveillance for early detection, and for which the Agency has some information on the effects on risk of ancillary provisions. The benefits of ancillary provisions are not estimated for lung cancer because the benefits from reducing lung cancer are considered to be the result of reducing airborne exposure only and thus the ancillary provisions will have no separable effect on airborne exposures. The discussion here will concentrate on CBD as being the most important and complex endpoint, and most illustrative of other endpoints: The structure for other endpoints is the same; only the exposure response functions are different. Here OSHA will
The exposure response model is designed to translate beryllium exposure to risk of adverse health endpoints. In the case of beryllium sensitization and CBD, the Agency uses the cumulative exposure data from a beryllium manufacturing facility. Specifically, OSHA uses the quartile data from the Cullman plant that is presented in Table VI-7 of the Preliminary Risk Assessment in the preamble. The raw data from this study show cases of CBD with cumulative exposures that would represent an average exposure level of less than 0.1 µg/m
Prevalence is defined as the percentage of persons with a condition in a population at a given point in time. The quartile data in Table VI-7 of the Preliminary Risk Assessment are prevalence percentages (the number of cases of illness documented over several years in the 319 person cohort from the Cullman plant) at different cumulative exposure levels. The Cullman data do not cover persons who left the work force or what happened to persons who remained in the workforce after the study was completed. For the lifetime risk model, the prevalence percentages will be translated into incidence percentages—the estimated number of new cases predicted to occur each year. For this purpose OSHA assumed that the incidence for any given cumulative exposure level is constant from year to year and continues after exposure ceases.
To calculate incidence from prevalence, OSHA assumed a steady state in which both the size of the beryllium-exposed affected population, exposure concentrations during employment and prevalence are constant over time. If these conditions are met, and turnover among workers with a condition is equal to turnover for workers without a condition, then the incidence rate will be equal to the turnover rate multiplied by the prevalence rate. If the turnover rate among persons with a condition is higher than the turnover rate for workers without the condition, then this assumption will underestimate incidence. This might happen if, in addition to other reasons for leaving work, persons with a condition leave a place of employment more frequently because their disabilities cause them to have difficulty continuing to do the work. If the turnover rate among persons with a condition is lower than the turnover rate for workers without the condition, then this assumption will overestimate incidence. This could happen if an employer provides special benefits to workers with the condition, and the employer would cease to provide these benefits if the employee left work.
To illustrate, if 10 percent of the work force (including 10 percent of those with the condition) leave each year and if the overall prevalence is at 20 percent, then a 2 percent (10 percent times 20 percent) incidence rate will be needed in order to keep a steady 20 percent group prevalence rate each year. OSHA's model assumes a constant 10 percent turnover rate (see later in this section for the rationale for this particular turnover rate). While turnover rates are not available for the specific set of employees in question, for manufacturing as a whole, the turnover rates are greater than 20 percent, and greater than 30 percent for the economy as a whole (BLS, 2013). For this analysis, OSHA assumed an effective turnover rate of 10 percent. Different turnover rates will result in different incidence rates. The lower the turnover rate the lower the estimated incidence rate. This is a conservative assumption for the industries where turnover rates may be higher. However, some occupations/industries, such as dental lab technicians, may have lower turnover rates than manufacturing workers. Additionally, the typical dental technician even if leaving one workplace, has significant likelihood of continuing to work as a dental technician and going to another workplace that uses beryllium. OSHA welcomes comments on its turnover estimates and on sectors, such as dental laboratories, where turnover may be lower than ten percent.
Using Table VI-7 of the Preliminary Risk Assessment, when a worker's cumulative exposure is below 0.147 (μg/m
The model assumes a maximum 45-year (250 days per year) working life (ages 20 through 65 or age of death or onset of CBD, whichever is earlier) and follows workers after retirement through age 80. The 45-year working life is based on OSHA's legal requirements and is longer than the working lives of most exposed workers. A shorter working life will be examined later in this section. While employed, the worker accumulates beryllium exposure at a rate depending on where the worker is in the empirical exposure profile presented in Chapter IV of the PEA (
OSHA's model follows the population of workers each year, keeping track of cumulative exposure and various health outcomes. Explicitly, each year the model calculates: The increased cumulative exposure level for each worker versus last year, the incidence at the new exposure level, the survival rate for this age bracket, and the percentage of workers who have not previously developed CBD in earlier years.
For any individual year, the equation for predicting new cases of CBD for workers at age t is:
New CBD cases rate(t) = modeled incidence rate(t) * survival rate(t) * (1- currently have CBD rate(t)), where the variables used are:
New CBD cases rate(t) is the output variable to be calculated;
cumulative exposure(t) = cumulative exposure(t-1) + current exposure;
modeled incidence rate(t) is a function of cumulative exposure; and
survival rate(t) is the background survival rate from mortality due to other causes in the national population.
Then for the next year the model updates the survival rate (due to an increase in the worker's age), incidence rate (due to any increased cumulative exposure), and the rate of those currently having CBD, which increases due to the new CBD case rate of the year before. This process then repeats for all 60 years.
It is important to note that this model is based on the assumption that prevalence is explained by an underlying constant incidence, and as a result, prevalence will be different depending on the average number of years of exposure in the population examined and (though a sensitivity analysis is provided later) on the assumption of a maximum of 45 years of exposure. OSHA also examined (OSHA 2015c) a model in which prevalence is constant at the levels shown in Table VI-7 of the preliminary
In the next step, OSHA uses its model to take into account the adoption of the lower proposed PEL. OSHA uses the exposure profile for workers as estimated in Chapter IV of the PEA for each of the various application groups. These exposure profiles estimate the number of workers at various exposure levels, specifically the ranges less than 0.1 μg/m
The model increases the workers' cumulative exposure each year by these midpoints and then plugs these new values into the new case equation. This alters the incidence rate as cumulative exposure crosses a threshold of the quartile data. So then using the exposure profiles by application group from Chapter IV of the PEA, the baseline exposure flows through the life time risk model to give us a baseline number of cases. Next OSHA calculated the number of cases estimated to occur after the implementation of the proposed PEL of 0.2 μg/m
Based on these methods, OSHA's estimate of benefits associated with the proposed rule does not include benefits associated with current compliance that have already been achieved with regard to the new requirements, or benefits obtained from future compliance with existing beryllium requirements. However, available exposure data indicate that few employees are currently exposed above the existing standard's PEL of 2.0 μg/m
There is also a component that applies only to dental labs. OSHA has preliminarily assumed, based on the estimates of higher costs for engineering controls than using substitutes presented in the cost chapter, that rather than incur the costs of compliance with the proposed standard, many dental labs are likely to stop using beryllium-containing materials after the promulgation of the proposed standard.
Estimation results for both dental labs and non-dental workplaces appear in the table below.
In contrast to this PEL component of the benefits, both the ancillary program benefits calculation and the substitution benefits calculation are relatively simple. Both are percentages of the lifetime-risk-model CBD cases that still occur in the post-standard world. OSHA notes that in the context of existing CBD prevention programs, some ancillary-provision programs similar to those included in OSHA's proposal have eliminated a significant percentage of the remaining CBD cases (discussed later in this chapter). If the ancillary provisions reduce remaining CBD cases by 90 percent for example, and if the estimated baseline contains 120 cases of CBD, and post-standard compliance with a lower PEL reduces the total to 100 cases of CBD, then 90 of those remaining 100 cases of CBD would be averted due to the ancillary programs.
OSHA assumed, based on the clinical experience discussed further below, that approximately 65 percent of CBD cases ultimately result in death. Later in this chapter, OSHA provides a sensitivity analysis of the effects of different values for assuming this percentage at 50 percent and 80 percent on the number of CBD deaths prevented. OSHA welcomes comment on this assumption. OSHA's exposure-response model for lung cancer is based on lung cancer mortality data. Thus, all of the estimated cases of lung cancer in the benefits analysis are cases of premature death from beryllium-related lung cancer.
Finally, in recognition of the uncertainty in this aspect of these models, OSHA presents a “high” estimate, a “low” estimate, and uses the midpoint of these two as our “primary” estimate. The low estimate is simply those CBD fatalities prevented due to everything except the ancillary provisions,
CBD is a respiratory disease in which 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. Immunological sensitization to beryllium (BeS) is a precursor that occurs before early-stage CBD. Only sensitized individuals can go on to develop CBD. In early, asymptomatic stages of CBD, small granulomatous lesions and mild inflammation occur in the lungs. As CBD progresses, the capacity and function of the lungs decrease, which eventually affects other organs and bodily functions as well. Over time the spread of lung fibrosis (scarring) and loss of pulmonary function cause symptoms such as: A persistent dry cough, shortness of breath, fatigue, night sweats, chest and join pain, clubbing of fingers due to impaired oxygen exchange, and loss of appetite. In these later stages CBD can also impair the liver, spleen, and kidneys, and cause health effects such as granulomas of the skin and lymph nodes, and
Corticosteroid therapy, in workers whose beryllium exposure has ceased, has been shown to control inflammation, ease symptoms, and in some cases prevent the development of fibrosis. However, corticosteroid use can have adverse effects, including increased risk of infections; accelerated bone loss or osteoporosis; psychiatric effects such as depression, sleep disturbances, and psychosis; adrenal suppression; ocular effects; glucose intolerance; excessive weight gain; increased risk of cardiovascular disease; and poor wound healing. The effects of CBD, and of common treatments for CBD, are discussed in detail in this preamble at Section V, Health Effects, and Section VIII, Significance of Risk.
OSHA's review of the literature on CBD suggests three broad types of CBD progression (see this preamble at Section V, Health Effects). In the first, individuals progress relatively directly toward death related to CBD. They suffer rapidly advancing disability and their death is significantly premature. Medical intervention is not applied, or if it is, does little to slow the progression of disease. In the second type, individuals live with CBD for an extended period of time. The progression of CBD in these individuals is naturally slow, or may be medically stabilized. They may suffer significant disability, in terms of loss of lung function—and quality of life—and require medical oversight their remaining years. They would be expected to lose some years of normal lifespan. As discussed previously, advanced CBD can involve organs and systems beyond the respiratory system; thus, CBD can contribute to premature death from other causes. Finally, individuals with the third type of CBD progression do not die prematurely from causes related to CBD. The disease is stabilized and may never progress to a debilitating state. These individuals nevertheless may experience some disability or loss of lung function, as well as side effects from medical treatment, and may be affected by the disease in many areas of their lives: Work, recreation, family, etc.
In the analysis that follows, OSHA assumes, based on the clinical experience discussed below, that 35 percent of workers who develop CBD experience the third type of progression and do not die prematurely from CBD. The remaining 65 percent were estimated to die prematurely, whether from rapid disease progression (type 1) or slow (type 2). Although the proportion of CBD patients who die prematurely as a result of the disease is not well understood or documented at this time, OSHA believes this assumption is consistent with the information submitted in response to the RFI. Newman et al. (2003) presented a scenario for what they considered to be the “typical” CBD patient:
We have included an example of a life care plan for a typical clinical case of CBD. In this example, the hypothetical case is diagnosed at age 40 and assumed to live an additional 33.7 years (approximately 5% reduced life expectancy in this model). In this hypothetical example, this individual would be considered to have moderate severity of chronic beryllium disease at the time of initial diagnosis. They require treatment with prednisone and treatment for early cor pulmonale secondary to CBD. They have experienced some, but not all, of the side effects of treatment and only the most common CBD-related health effects.
In short,
As mentioned previously, OSHA used the Cullman data set for empirical estimates of beryllium sensitization and CBD prevalence in its exposure response model, which translates beryllium exposure to risk of adverse health endpoints for the purpose of determining the benefits that could be achieved by preventing those adverse health endpoints.
OSHA chose the cumulative exposure quartile data as the basis for this benefits analysis. The choice of cumulative quartiles was based in part on the need to use the cumulative exposure forecast developed in the model, and in part on the fact that in statistically fitted models for CBD, the cumulative exposure tended to fit the CBD data better than other exposure variables. OSHA also chose the quartile model because the outside expert who examined the logistic and proportional hazards models believed statistical modeling of the data set to be unreliable due to its small size. In addition, the proportional hazards model with its dummy variables by year of detection is difficult to interpret for purposes of this section. Of course regression analyses are often useful in empirical analysis. They can be a useful compact representation of a set of data, allow investigations of various variable interactions and possible causal relationships, have added flexibility due to covariate transformations, and under certain conditions can be shown to be statistically “optimal.” However, they are only useful when used in the proper setting. The possibility of misspecification of functional form, endogeneity, or incorrect distributional assumptions are just three reasons to be cautious about using regression analyses.
On the other hand, the use of results produced by a quartile analysis as inputs in a benefits assessment implies that the analytic results are being interpreted as evidence of an exposure-response causal relationship. Regression analysis is a more sophisticated approach to estimating causal relationships (or even correlations) than quartile or other quantile analysis, and any data limitations that may apply to a particular regression-based exposure-response estimation also apply to exposure-response estimation conducted with a quartile analysis using the same data set. In this case, OSHA adopted the quartile analysis because the logistic regression analysis yielded extremely high prevalence rates for higher level of exposure over long time periods that some might not find credible. Use of the quartile analysis serves to show that there are significant benefits even without using an extremely high estimate of prevalence for long periods of exposure at high levels. As a check on the quartile model, the Agency performed the same benefits calculation using the logit model estimated by the Agency's outside expert, and these benefit results are presented in a separate OSHA background document (OSHA, 2015b). The difference in benefits between the two models is slight, and there is no qualitative change in final outcomes. The Agency solicits comment on these issues.
To examine the effect of simply changing the PEL, including the effect of the standard on some dental labs to discontinue their use of beryllium, OSHA compared the number of CBD-related deaths (mortality) and cases of non-fatal CBD (morbidity) that would occur if workers were exposed for a 45-year working life to PELs of 0.1, 0.2, or 0.5 μg/m
As indicated in Table IX-11, the Agency estimates that there would be 16,240 cases of beryllium sensitization, from which there would be 11,017, or about 70 percent, progressing to CBD. The Agency arrived at these estimates by using the CBD and BeS prevalence values from the Agency's preliminary risk analysis, the exposure profile at current exposure levels (under an assumption of full, or fixed, compliance with the existing beryllium PEL), and the model outlined in the previous methods of estimation section after a working lifetime of exposure. Applying the prior midpoint estimate, as explained above, that 65 percent of CBD cases cause or contribute to premature death, the Agency predicts a total of 7,161 cases of mortality and 3,856 cases of morbidity from exposure at current levels; this translates, annually, to 165 cases of mortality and 86 cases of morbidity. At the proposed PEL, OSHA's base model estimates that, due to the airborne factor only, a total of 2,563 CBD cases would be avoided from exposure at current levels, including 1,666 cases of mortality and 897 cases of morbidity—or an average of 37 cases of mortality and 20 cases of morbidity annually. OSHA has not estimated the quantitative benefits of sensitization cases avoided.
OSHA requests comment on this analysis, including feedback on the data relied on and the approach and assumptions used. As discussed earlier, based on information submitted in response to the RFI, the Agency estimates that most of the workers with CBD will progress to an early death, even if it comes after retirement, and has quantified those cases prevented. However, given the evolving nature of science and medicine, the Agency invites public comment on the current state of CBD-related mortality.
The proposed standard also includes provisions for medical surveillance and removal. The Agency believes that to the extent the proposal provides medical surveillance sooner and to more workers than would have been the case in the absence of the proposed standard, workers will be more likely to receive appropriate treatment and, where necessary, removal from beryllium exposure. These interventions may lessen the severity of beryllium-related illnesses, and possibly prevent premature death. The Agency requests public comment on this issue.
The nature of the chronic beryllium disease process should be emphasized. As discussed in this preamble at Section V, Heath Effects, the chronic beryllium disease process involves two steps. First, workers become sensitized to beryllium. In most epidemiological studies of CBD conducted to date, a large percentage of sensitized workers have progressed to CBD. A certain percentage of the population has an elevated risk of this occurring, even at very low exposure levels, and sensitization can occur from dermal as well as inhalation exposure to beryllium. For this reason, the threat of beryllium sensitization and CBD persist to a substantial degree, even at very low levels of airborne beryllium exposure. It is therefore desirable not only to significantly reduce airborne beryllium exposure, but to avoid nearly any source
The analysis presented above accounted only for CBD-prevention benefits associated with the proposed reduction of the PEL, from 2 ug/m
The leading manufacturer of beryllium in the U.S., Materion Corporation (Materion), has implemented programs including these types of provisions in several of its plants and has worked with NIOSH to publish peer-reviewed studies of their effectiveness in reducing workers' risk of sensitization and CBD. The Agency used the results of these studies to estimate the health benefits associated with a comprehensive standard for beryllium.
The best available evidence on comprehensive beryllium programs comes from studies of programs introduced at Materion plants in Reading, PA; Tucson, AZ; and Elmore, OH. These studies are discussed in detail in this preamble at Section VI, Preliminary Risk Assessment, and Section VIII, Significance of Risk. All three facilities were in compliance with the current PEL prior to instituting comprehensive programs, and had taken steps to reduce airborne levels of beryllium below the PEL, but their medical surveillance programs continued to identify cases of sensitization and CBD among their workers. Beginning around 2000, these facilities introduced comprehensive beryllium programs that used a combination of engineering controls, dermal and respiratory PPE, and stringent housekeeping measures to reduce workers' dermal exposures and airborne exposures. These comprehensive beryllium programs have substantially lowered the risk of sensitization among workers. At the times that studies of the programs were published, insufficient follow-up time had elapsed to report directly on the results for CBD. However, since only sensitized workers can develop CBD, reduction of sensitization risk necessarily reduces CBD risk as well.
In the Reading, PA copper beryllium plant, full-shift airborne exposures in all jobs were reduced to a median of 0.1 ug/m
In the Tucson beryllium ceramics plant, respiratory and skin protection was instituted for all workers in production areas in 2000 (Cummings
In the Elmore, OH beryllium production and processing facility, all new workers were required to wear loose-fitting powered air-purifying respirators (PAPRs) in manufacturing buildings, beginning in 1999 (Bailey
In a response to OSHA's 2002 Request for Information (RFI), Lee Newman
A: From experience in [the Tucson, AZ facility discussed above], one can infer that approximately 90 percent of beryllium sensitization can be eliminated. Furthermore, the preliminary data would suggest that potentially 100 percent of CBD can be eliminated with appropriate workplace control measures.
In a study by Kelleher 2001, Martyny 2000, Newman, JOEM 2001) in a plant that previously had rates of sensitization as high as 9.7 percent, the data suggests that when lifetime weighted average exposures were below 0.02 μg per cu meter that the rate of sensitization fell to zero and the rate of CBD fell to zero as well.
In an unpublished study, we have been conducting serial surveillance including testing new hires in a precision machining shop that handles beryllium and beryllium alloys in the Southeast United States. At the time of the first screening with the blood BeLPT of people tested within the first year of hire, we had a rate of 6.7 percent (4/60) sensitization and with 50 percent of these individuals showing CBD at the time of initial clinical evaluation. At that time, the median exposures in the machining areas of the plant was 0.47 μg per cu meter. Subsequently, efforts were made to reduce exposures, further educate the workforce, and increase monitoring of exposure in the plant. Ongoing testing of newly hired workers within the first year of hire demonstrated an incremental decline in the rate of sensitization and in the rate of CBD. For example, at the time of most recent testing when the median airborne exposures in the machining shop were 0.13 μg per cu meter, the percentage of newly hired workers found to have beryllium sensitization or CBD was now 0 percent (0/55). Notably, we also saw an incremental decline in the percentage of longer term workers being detected with sensitization and disease across this time period of exposure reduction and improved hygiene practices.
Thus, in calculating the potential economic benefit, it's reasonable to work with the assumption that with appropriate efforts to control exposures in the work place, rates of sensitization can be reduced by over 90 percent. (NJMRC, RFI Ex. 6-20)
OSHA has reviewed these papers and is in agreement with Dr. Newman's testimony. OSHA judges Dr. Newman's estimate to be an upper bound of the effectiveness of ancillary programs and examined the results of using Dr. Newman's estimate that beryllium ancillary programs can reduce BeS by 90 percent, and potentially eliminate CBD where sensitization is reduced, because CBD can only occur where there is sensitization. OSHA applied this 90 percent reduction factor to all cases of CBD remaining after application of the reductions due to lowering the PEL alone. OSHA applied this reduction broadly because the proposed standard would require housekeeping and PPE related to skin exposure (18,000 of
The Agency recognizes that there are significant differences between the comprehensive programs discussed above and the proposed standard. While the proposed standard includes many of the same elements, it is generally less stringent. For example, the proposed standard's requirements for respiratory protection and PPE are narrower, and many provisions of the standard apply only to workers exposed above the proposed TWA PEL or STEL. However, many provisions, such as housekeeping and beryllium work areas, apply to all employers covered by the proposed standard. To account for these differences, OSHA has provided a range of benefits estimates (shown in Table IX-11), first, assuming that there are no ancillary provisions to the standard, and, second, assuming that the comprehensive standard achieves the full 90-percent reduction in risk documented in existing programs. The Agency is taking the midpoint of these two numbers as its main estimate of the benefits of avoided CBD due to the ancillary provisions of the proposed standard. The results in Table IX-11 suggest that approximately 60 percent of the beryllium sensitization cases and the CBD cases avoided would be attributable to the ancillary provisions of the standard. OSHA solicits comment on all aspects of this approach to analyzing ancillary provisions and solicits additional data that might serve to make more accurate estimates of the effects of ancillary provisions. OSHA is interested in the extent of the effects of ancillary provisions and whether these apply to all exposed employees or only those exposed above or below a given exposure level.
As previously indicated, the Agency does not believe that all CBD cases will ultimately result in premature death. While currently strong empirical data on this are lacking, the Agency estimates that approximately 35 percent of cases would not ultimately be fatal, but would result in some pain and suffering related to having CBD, and possible side effects from steroid treatment, as well as the dread of not knowing whether the disease will ultimately lead to premature death. These would be described as “mild” cases of CBD relative to the others. These are the residual cases of CBD after cases with premature mortality have been counted. As indicated in Table IX-11, the Agency estimates the standard will prevent 2,228 such cases (midpoint) over 45 years, or an estimated 50 cases annually.
In addition to the Agency's determinations with respect to the risk of chronic beryllium disease, the Agency has preliminarily determined that chronic beryllium exposure at the current PEL can lead to a significantly elevated risk of (fatal) lung cancer. OSHA used the estimation methodology outlined at the beginning of this section. However, unlike with chronic beryllium disease, the underlying data were based on incidence of lung cancer and thus there was no need to address the possible limitations of prevalence data. The Agency also used lifetime excess risk estimates of lung cancer mortality, presented in Table VI-20 in Section VI of this preamble, Preliminary Risk Assessment, to estimate the benefits of avoided lung cancer mortality. The lung cancer risk estimates are derived from one of the best-fitting models in a recent, high-quality NIOSH lung cancer study, and are based on average exposure levels. The estimates of excess lifetime risk of lung cancer were taken from the line in Table VI-20 in the risk assessment labeled PWL (piecewise log-linear) not including professional and asbestos workers. This model avoids possible confounding from asbestos exposure and reduces the potential for confounding due to smoking, as smoking rates and beryllium exposures can be correlated via professional worker status. Of the three estimates in the NIOSH study that excluded professional workers and those with asbestos exposure, this model was chosen because it was at the midpoint of risk results.
Table IX-11 shows the number of avoided fatal lung cancers for PELs of 0.2 μg/m
Combining the two major fatal health endpoints—for lung cancer and CBD-related mortality—OSHA estimates that the proposed PEL would prevent between 1,846 and 6,791 premature fatalities over the lifetime of the current worker population, with a midpoint estimate of 4,318 fatalities prevented. This is the equivalent of between 41 and 151 premature fatalities avoided annually, with a midpoint estimate of 96 premature fatalities avoided annually, given a 45-year working life of exposure.
Note that the Agency based its estimates of reductions in the number of beryllium-related diseases over a working life of constant exposure for workers who are employed in a beryllium-exposed occupation for their entire working lives, from ages 20 to 65. In other words, workers are assumed not to enter or exit jobs with beryllium exposure mid-career or to switch to other exposure groups during their working lives. While the Agency is legally obligated to examine the effect of exposures from a working lifetime of exposure and set its standard accordingly,
A comparison of exposures over a maximum of 25 working years versus over a potentially 45-year working life shows variations in the number of estimated prevented cases by health outcome. For chronic beryllium disease, there is a substantial increase in the number of estimated baseline and prevented cases if one assumes that the typical maximum exposure period is 25 years, as opposed to 45. This reflects the
Overall, the 45-year-maximum-working-life assumption yields smaller estimates of the number of cases of avoided fatalities and illnesses than does the maximum-25-years-of-exposure assumption. For example, the midpoint estimates of the number of avoided fatalities and illnesses related to CBD under the proposed PEL of 0.2 μg/m
Risk assessments in the occupational environment are generally designed to estimate the risk of an occupationally related illness over the course of an individual worker's lifetime. As demonstrated previously in this section, the current occupational exposure profile for a particular substance for the current cohort of workers can be matched up against the expected profile after the proposed standard takes effect, creating a “steady state” estimate of benefits. However, in order to annualize the benefits for the period of time after the beryllium rule takes effect, it is necessary to create a timeline of benefits for an entire active workforce over that period.
While there are various approaches that could be taken for modeling the workforce, there seem to be two polar extremes. At one extreme, one could assume that none of the benefits occur until after the worker retires, or at least 45 years in the future. In the case of lung cancer, that period would effectively be at least 55 years, since the 45 years of exposure must be added to a 10-year latency period during which it is assumed that lung cancer does not develop.
At first glance, the simplest intermediate approach would be to follow the pattern of the risk assessments, which are based in part on life tables, and observe that typically the risk of the illness grows gradually over the course of a working life and into retirement. Thus, the older the person exposed to beryllium, the higher the odds that that person will have developed the disease.
However, while this is a good working model for an individual exposed over a working life, it is not very descriptive of the effect of lowering exposures for an entire working population. In the latter case, in order to estimate the benefits of the standard over time, one has to consider that workers currently being exposed to beryllium are going to vary considerably in age. Since the calculated health risks from beryllium exposure depend on a worker's cumulative exposure over a working lifetime, the overall benefits of the proposed standard will phase in over several decades, as the cumulative exposure gradually falls for all age groups, until those now entering the workforce reach retirement and the annual stream of beryllium-related illnesses reaches a new, significantly lowered “steady state.”
In order to characterize the magnitude of benefits before the steady state is reached, OSHA created a linear phase-in model to reflect the potential timing of benefits. Specifically, OSHA estimated that, for all non-cancer cases, while the number of cases of beryllium-related disease would gradually decline as a result of the proposed rule, they would not reach the steady-state level until 45 years had passed. The reduction in cases estimated to occur in any given year in the future was estimated to be equal to the steady-state reduction (the number of cases in the baseline minus the number of cases in the new steady state) times the ratio of the number of years since the standard was implemented and a working life of 45 years. Expressed mathematically:
In the case of lung cancer, the function representing the decline in the number of beryllium-related cases as a result of the proposed rule is similar, but there would be a 10-year lag before any reduction in cancer cases would be achieved. Expressed mathematically, for lung cancer:
This model was extended to 60 years for all the health effects previously discussed in order to incorporate the 10-year lag, in the case of lung cancer, and a maximum-45-year working life, as well as to capture some occupationally-related disease that manifests itself after retirement.
In order to compare costs to benefits, OSHA assumes that economic conditions remain constant and that annualized costs—and the underlying costs—will repeat for the entire 60-year time horizon used for the benefits analysis (as discussed in Chapter V of the PEA). OSHA welcomes comments on the assumption for both the benefit and cost analysis that economic conditions remain constant for sixty years. OSHA is particularly interested in what assumptions and time horizon should be used instead and why.
In previous sections, OSHA modeled the timing and incidence of morbidity. OSHA's benefit estimates are based on an underlying CBD-related mortality rate of 65 percent. However, this mortality is not simultaneous with the onset of morbidity. Although mortality from CBD has not been well studied, OSHA believes, based on discussions with experienced clinicians, that the average lag for a larger population has a range of 10 to 30 years between morbidity and mortality. The Agency's review of Workers Compensation data related to beryllium exposure from the Office of Worker Compensation Programs (OWCP) Division of Energy Employees Occupational Illness Compensation is consistent with this range. Hence, for the purposes of this
The Agency invites comment on each of these elements of the analysis, particularly on the estimates of the expected life expectancy of a patient with CBD.
To estimate the monetary value of the reductions in the number of beryllium-related fatalities, OSHA relied, as OMB recommends, on estimates developed from the willingness of affected individuals to pay to avoid a marginal increase in the risk of fatality. While a willingness-to-pay (WTP) approach clearly has theoretical merit, it should be noted that an
For estimates using the willingness-to-pay concept, OSHA relied on existing studies of the imputed value of fatalities avoided based on the theory of compensating wage differentials in the labor market. These studies rely on certain critical assumptions for their accuracy, particularly that workers understand the risks to which they are exposed and that workers have legitimate choices between high- and low-risk jobs. These assumptions are far from obviously met in actual labor markets.
OSHA has used this approach in many recent proposed and final rules. Although this approach has been criticized for yielding results that are less than statistically robust (see, for example, Hintermann, Alberini and Markandya, 2010), a more recent WTP analysis, by Kniesner
Viscusi & Aldy (2003) conducted a meta-analysis of studies in the economics literature that use a willingness-to-pay methodology to estimate the imputed value of life-saving programs and found that each fatality avoided was valued at approximately $7 million in 2000 dollars. Using the GDP Deflator (U.S. BEA, 2010), this $7 million base number in 2000 dollars yields an estimate of $8.7 million in 2010 dollars for each fatality avoided.
In addition to the benefits that are based on the implicit value of fatalities avoided, workers also place an implicit value on occupational injuries or illnesses avoided, which reflect their willingness to pay to avoid monetary costs (for medical expenses and lost wages) and quality-of-life losses as a result of occupational illness. Chronic beryllium disease and lung cancer can adversely affect individuals for years, or even decades, in non-fatal cases, or before ultimately proving fatal. Because measures of the benefits of avoiding these illnesses are rare and difficult to find, OSHA has included a range based on a variety of estimation methods.
For both CBD and lung cancer, there is typically some permanent loss of lung function and disability, on-going medical treatments, side effects of medicines, and major impacts on one's ability to work, marry, enjoy family life, and quality of life.
While diagnosis with CBD is evidence of material impairment of health, placing a precise monetary value on this condition is difficult, in part because the severity of symptoms may vary significantly among individuals. For that reason, for this preliminary analysis, the Agency employed a broad range of valuation, which should encompass the range of severity these individuals may encounter.
Using the willingness-to-pay approach, discussed in the context of the imputed value of fatalities avoided, OSHA has estimated a range in valuations (updated and reported in 2010 dollars) that runs from approximately $62,000 per case—which reflects estimates developed by Viscusi and Aldy (2003), based on a series of studies primarily describing simple accidents—to upwards of $5 million per case—which reflects work developed by Magat, Viscusi, and Huber (1996) for non-fatal cancer. The latter number is based on an approach that places a willingness-to-pay value to avoid serious illness that is calibrated relative to the value of an avoided fatality. OSHA previously used this approach in the Preliminary Economic Analysis (PEA) supporting its respirable crystalline silica proposal (2013) and in the Final Economic Analysis (FEA) supporting its hexavalent chromium final rule (2006), and EPA (2003) used this approach in its Stage 2 Disinfection and Disinfection Byproducts Rule concerning regulation of primary drinking water. Based on Magat, Viscusi, and Huber (1996), EPA used studies on the willingness to pay to avoid nonfatal lymphoma and chronic bronchitis as a basis for valuing a case of nonfatal cancer at 58.3 percent of the value of a fatal cancer. OSHA's estimate of $5 million for an avoided case of non-fatal cancer is based on this 58.3 percent figure.
The Agency believes this range of estimates, between $62,000 and $5 million, is descriptive of the value of preventing morbidity associated with moderate to severe CBD that ultimately results in premature death.
While the Agency has estimated that 65 percent of CBD cases will result in premature mortality, the Agency has also estimated that approximately 35 percent of CBD cases will not result in premature mortality. However, the Agency acknowledges that it is possible there have been new developments in medicine and industrial hygiene related to the benefits of early detection, medical intervention, and greater control of exposure achieved within the past decade. For that reason, as elsewhere, the Agency requests comment on these issues.
Also not clear are the negative effects of the illness in terms of lost productivity, medical costs, and potential side-effects of a lifetime of immunosuppressive medication. Nonetheless, the Agency is assigning a valuation of $62,000 per case, to reflect the WTP value of a prevented injury not estimated to precede premature mortality. The Agency believes this is conservative, in part because, with any given case of CBD, the outcome is not known in advance, certainly not at the point of discovery; indeed much of the psychic value of preventing the cases may come from removing the threat of premature mortality. In addition, as previously noted, some of these cases could involve relatively severe forms of CBD where the worker died of other causes; however, in those cases, the duration of the disease would be shortened. While beryllium sensitization is a critical precursor of CBD, this preliminary analysis does not attempt to assign a separate value to sensitization itself.
Particularly given the uncertainties in valuation on these questions, the Agency is interested in public input on the issue of valuing the cost to society of morbidity associated with CBD, both in cases preceding mortality, and those that may not result in premature mortality. The Agency is also interested in comments on whether it is appropriate to assign a separate valuation to prevented sensitization cases in their own right, and if so, how such cases should be valued.
Table IX-12 presents the estimated annualized (over 60 years, using a 0 percent discount rate) benefits from each of these components of the valuation, and the range of estimates, based on uncertainty of the prevention factor (
As shown in Table IX-12, the full range of monetized benefits, undiscounted, for the proposed PEL of 0.2 µg/m
Also, the analysis illustrates that most of the morbidity benefits are related to CBD and lung cancer cases that are ultimately fatal. At the valuation and case frequency midpoint, $663 million in benefits are related to mortality, $226 million are related to morbidity preceding mortality, and $4.3 million are related to morbidity not preceding mortality.
OSHA's estimates of the monetized benefits of the proposed rule are based on the imputed value of each avoided fatality and each avoided beryllium-related disease. As previously discussed, these, in turn, are derived from a worker's willingness to pay to avoid a fatality (with an imputed value per fatality avoided of $8.7 million in 2010 dollars) and to avoid a beryllium-related disease (with an imputed value per disease avoided of between $62,000
First, economic theory indicates that the value of reducing life-threatening and health-threatening risks—and correspondingly the willingness of individuals to pay to reduce these risks—will increase as real per capita income increases. With increased income, an individual's health and life becomes more valuable relative to other goods because, unlike other goods, they are without close substitutes and in relatively fixed or limited supply. Expressed differently, as income increases, consumption will increase but the marginal utility of consumption will decrease. In contrast, added years of life (in good health) is not subject to the same type of diminishing returns—implying that an effective way to increase lifetime utility is by extending one's life and maintaining one's good health (Hall and Jones, 2007).
Second, real per capita income has broadly been increasing throughout U.S. history, including recent periods. For example, for the period 1950 through 2000, real per capita income grew at an average rate of 2.31 percent a year (Hall and Jones, 2007),
On the basis of the predicted increase in real per capita income in the United States over time and the expected resulting increase in the value of avoided fatalities and diseases, OSHA has adjusted its estimates of the benefits of the proposed rule to reflect the anticipated increase in their value over time. This type of adjustment has been recognized by OMB (2003), supported by EPA's Science Advisory Board (EPA, 2000), and applied by EPA
What remains is to estimate a value for “k” with which to increase benefits annually in response to annual increases in real per capita income, where “k” is equal to “(1+g) * (η)”, “g” is the expected annual percentage increase in real per capita income, and “η” is the income elasticity of the value of a statistical life. Probably the most direct evidence of the value of “k” comes from the work of Costa and Kahn (2003, 2004). They estimate repeated labor market compensating wage differentials from cross-sectional hedonic regressions using census and fatality data from the Bureau of Labor Statistics for 1940, 1950, 1960, 1970, and 1980. In addition, with the imputed income elasticity of the value of life on per capita GNP of 1.7 derived from the 1940-1980 data, they then predict the value of an avoided fatality in 1900, 1920, and 2000. Given the change in the value of an avoided fatality over time, it is possible to estimate a value of “k” of 3.4 percent a year from 1900-2000; of 4.3 percent a year from 1940-1980; and of 2.5 percent a year from 1980-2000.
Other, more indirect evidence comes from estimates in the economics literature of “η”, the income elasticity of the value of a statistical life. Viscusi and Aldy (2003) performed a meta-analysis on 0.2 wage-risk studies and concluded that the confidence interval upper bound on the income elasticity did not exceed 1.0 and that the point estimates across a variety of model specifications ranged between 0.5 and 0.6. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of “k” of about 1.5 percent a year.
More recently, Kniesner, Viscusi, and Ziliak (2010), using panel data quintile regressions, developed an estimate of the overall income elasticity of the value of a statistical life of 1.44. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of “k” of about 3.9 percent a year.
Based on the preceding discussion of these three approaches for estimating the annual increase in the value of the benefits of the proposed rule and the fact that the projected increase in real per capita income in the United States has flattened in recent years and could flatten in the long run, OSHA suggests a conservative value for “k” of approximately two percent a year. The Agency invites comment on this estimate and on estimates of the income elasticity of the value of a statistical life.
The Agency believes that the rising value, over time, of health benefits is a real phenomenon that should be taken into account in estimating the annualized benefits of the proposed rule. Table IX-13, in the following section on discounting benefits, shows estimates of the monetized benefits of the proposed rule (under alternative discount rates) with this estimated increase in monetized benefits over time. The Agency invites comment on this adjustment to monetized benefits.
As previously noted, the estimated stream of benefits arising from the proposed beryllium rule is not constant from year to year, both because of the 45-year delay after the rule takes effect until all active workers obtain reduced beryllium exposure over their entire working lives and because of, in the case of lung cancer, a 10-year latency period between reduced exposure and a reduction in the probability of disease. An appropriate discount rate
Following OMB (2003) guidelines, OSHA has estimated the annualized benefits of the proposed rule using separate discount rates of 3 percent and 7 percent. Consistent with the Agency's own practices in recent rulemakings, OSHA has also estimated, for benchmarking purposes, undiscounted benefits—that is, benefits using a zero percent discount rate.
The question remains, what is the “appropriate” or “preferred” discount rate to use to monetize health benefits? The choice of discount rate is a controversial topic, one that has been the source of scholarly economic debate for several decades. However, in simplest terms, the basic choices involve a social opportunity cost of capital approach or social rate of time preference approach.
The social opportunity cost of capital approach reflects the fact that private funds spent to comply with government regulations have an opportunity cost in terms of foregone private investments that could otherwise have been made. The relevant discount rate in this case is the pre-tax rate of return on the foregone investments (Lind, 1982, pp. 24-32).
The rate of time preference approach is intended to measure the tradeoff between current consumption and future consumption, or in the context of the proposed rule, between current benefits and future benefits. The
The usual method for estimating the social rate of time preference is to calculate the post-tax real rate of return on long-term, risk-free assets, such as U.S. Treasury securities (OMB, 2003, p. 33). A variety of studies have estimated these rates of return over time and reported them to be in the range of approximately 1-4 percent.
In accordance with OMB Circular A-4 (2003), OSHA presents benefits and net benefits estimates using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach). The Agency is interested in any evidence, theoretical or applied, that would inform the application of discount rates to the costs and benefits of a regulation.
Table IX-13 presents OSHA's estimates of the sum of the annualized benefits of the proposed rule, using alternative discount rates of 0, 3, and 7 percent, with the suggested adjustment for increasing monetized benefits in response to annual increases in per capita income over time.
Given that the stream of benefits extends out 60 years, the value of future benefits is sensitive to the choice of discount rate. The undiscounted benefits in Table IX-13 range from $291 million to $2.1 billion annually. Using a 7 percent discount rate, the annualized benefits range from $60 million to $591 million. As can be seen, going from undiscounted benefits to a 7 percent discount rate has the effect of cutting the annualized benefits of the proposed rule by about 74 percent.
Taken as a whole, the Agency's best preliminary estimate of the total annualized benefits of the proposed rule—using a 3 percent discount rate with an adjustment for the increasing value of health benefits over time—is between $158 million and $1.2 billion, with a mid-point value of $576 million.
OSHA has estimated, in Table IX-14, the monetized and annualized net benefits of the proposed rule (with a PEL of 0.2 μg/m
Table IX-14 is being provided for informational purposes only. As previously noted, the OSH Act requires the Agency to set standards based on eliminating significant risk to the extent feasible. An alternative criterion of maximizing net (monetized) benefits may result in very different regulatory outcomes. Thus, this analysis of net benefits has not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for the proposed beryllium rule.
Table IX-14 shows net benefits using alternative discount rates of 0, 3, and 7 percent for benefits and costs, having previously included an adjustment to monetized benefits to reflect increases in real per capita income over time. OSHA has relied on a uniform discount rate applied to both costs and benefits. The Agency is interested in any evidence, theoretical or applied, that would support or refute the application of differential discount rates to the costs and benefits of a regulation.
As previously noted in this section, the choice of discount rate for annualizing benefits has a significant effect on annualized benefits. The same is true for net benefits. For example, the net benefits using a 7 percent discount rate for benefits are considerably smaller than the net benefits using a 3 percent discount rate, declining by over half under all scenarios. (Conversely, as noted in Chapter V of the PEA, the choice of discount rate for annualizing costs has a relatively minor effect on annualized costs.)
Based on the results presented in Table IX-14, OSHA finds:
• While the net benefits of the proposed rule vary considerably—depending on the choice of discount rate used to annualize benefits and on whether the benefits being used are in the high, midpoint, or low range—benefits exceed costs for the proposed 0.2 μg/m
• The Agency's best estimate of the net annualized benefits of the proposed rule—using a uniform discount rate for both benefits and costs of 3 percent—is between $120 million and $1.2 billion, with a midpoint value of $538 million.
• The alternative of a 0.5 μg/m
Incremental costs and benefits are those that are associated with increasing the stringency of the standard. A comparison of incremental benefits and costs provides an indication of the relative efficiency of the proposed PEL and the alternative PELs. Again, OSHA has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.
OSHA provides, in Table IX-15, estimates of the net benefits of the alternative 0.1 and 0.5 μg/m
Table IX-15 demonstrates that, regardless of discount rate, there are net benefits to be achieved by lowering exposures from the current PEL of 2.0 μg/m
In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard. These regulatory alternatives are discussed Section IX.H of this preamble.
In this section, OSHA presents the results of two different types of sensitivity analysis to demonstrate how robust the estimates of net benefits are to changes in various cost and benefit parameters. In the first type of sensitivity analysis, OSHA made a series of isolated changes to individual cost and benefit input parameters in order to determine their effects on the Agency's estimates of annualized costs, annualized benefits, and annualized net benefits. In the second type of
Again, the Agency has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.
The methodology and calculations underlying the estimation of the costs and benefits associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to isolated variations in a particular input parameter. For example, if the estimated time that employees need to travel to (and from) medical screenings were doubled, the corresponding labor costs would double as well.
OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. OSHA first considered changes to input parameters that affected only costs and then changes to input parameters that affected only benefits. Each of the sensitivity tests on cost parameters had only a very minor effect on total costs or net costs. Much larger effects were observed when the benefits parameters were modified; however, in all cases, net benefits remained significantly positive. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the cost or benefit input parameters still show significant net benefits for the proposed rule. The results of the individual sensitivity tests are summarized in Table IX-16 and are described in more detail below.
In the first of these sensitivity tests, where OSHA doubled the estimated portion of employees in need of protective clothing and equipment (PPE), essentially doubling the estimated baseline non-compliance rate (
In a second sensitivity test, OSHA increased the estimated unit cost of ventilation from $13.18 per cfm for most sectors to $25 per cfm for most sectors. As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $2.0 million annually, or by about 5.3 percent, while net benefits would also decline by $2.0 million annually, from $538.2 million to $536.2 million annually.
In a third sensitivity test, OSHA increased the estimated share of workers showing signs and symptoms of CBD from 15 to 25 percent, thereby adding these workers to the group eligible for medical surveillance and assuming that they would not be otherwise eligible for another reason (working in a regulated area, exposed during an emergency, etc.). As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $1.5 million annually, or by about 4.1 percent, while net benefits would also decline by $1.5 million annually, from $538.2 million to $536.7 million annually.
In a fourth sensitivity test, OSHA increased its estimated incremental time per workers for housekeeping by 50
In a fifth sensitivity test, OSHA increased the estimated number of establishments needing engineering controls. For this sensitivity test, if less than 50 percent of the establishments in an industry needed engineering controls, OSHA doubled the percentage of establishments needing engineering controls. If more than 50 percent of establishments in an industry needed engineering controls, then OSHA increased the percentage of establishment needing engineering control to 100 percent. The purpose of this sensitivity analysis was to check the importance of using a methodology that treated 50 percent of workers in a given occupation exposed above the PEL as equivalent to 50 percent of facilities lacking adequate exposure controls. As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $4.5 million, or by about 11.9 percent, while net benefits would also decline by $4.5 million, from $538.2 million to $533.7 million annually.
The Agency also performed sensitivity tests on several input parameters used to estimate the benefits of the proposed rule. In the first two tests, in an extension of results previously presented in Table IX-12, the Agency examined the effect on annualized net benefits of employing the high-end estimate of the benefits, as well as the low-end estimate, specifically examining the effect on undiscounted benefits of varying the valuation of individual morbidity cases. Table IX-16 presents the effect on annualized net benefits of using the extreme values of these ranges: the high morbidity valuation case and the low morbidity valuation case. For the low estimate of valuation, the benefits decline by 37.7 percent, to $359 million annually, yielding net benefits of $321 million annually. As shown, using the high estimate of morbidity valuation, the benefits rise by 77.0 percent to $1.0 billion annually, yielding net benefits of $982 million annually.
In a third sensitivity test of benefits, the Agency examined the effect of removing the component for the estimated rising value of health and safety over time. This would reduce the benefits by 54.6 percent, or $314 million annually, lowering the net benefits to $224 million annually.
In Chapter VII of the PEA the Agency examined the effect of raising the discount rate for costs and benefits to 7 percent. Raising the discount rate to 7 percent would increase costs by $1.5 million annually and lower benefits by $320.5 million annually, yielding annualized net benefits of $216.2 million.
Also in Chapter VII of the PEA the Agency performed a sensitivity analysis of dental lab substitution. In the PEA, OSHA estimates that 75 percent of the dental laboratory industry will react to a new standard on beryllium by substituting away from using beryllium to the use of other materials. Substitution is not costless, and Chapter V of the PEA estimates the increased cost due to the higher costs of using non-beryllium alloys. These costs are smaller than the avoided costs of the ancillary provisions and engineering controls. Thus, as indicated in Table VII-8 of the PEA, the benefits of the proposal would be lower and the costs higher if there were less substitution out of beryllium in dental labs. The lowest net benefits would occur if labs were unable to substitute out beryllium-containing materials at all, and had to use ventilation to control exposures. In this case, the proposal would yield only $420 million in net benefits. The highest net benefits, larger than assumed for OSHA's primary estimate, would be if all dental labs substituted out of beryllium-containing materials as a result of the proposal; as a result, the proposal would yield $573 million in net benefits. Another possibility is a scenario is which technology and the market move along rapidly away from using beryllium-containing materials, independently of an OSHA rule, and the proposal itself would therefore produce neither costs nor benefits in this sector. If dental labs are removed from the PEA, the net benefits for the proposal—for the remaining industry sectors—decline to $284 million. This analysis demonstrates, however, that regardless of any assumption regarding substitution in dental labs, the proposal would generate substantially more monetized benefits than costs.
Finally, the Agency examined in Chapter VII of the PEA the effects of changes in two important inputs to the benefits analysis: the factor that transforms CBD prevalence rates into incidence rates, needed for the equilibrium lifetime risk model, and the percentage of CBD cases that eventually lead to a fatality.
From the Cullman dataset, the Agency has estimated the prevalence of CBD cases at any point in time as a function of cumulative beryllium exposure. In order to utilize the lifetime risk model, which tracks workers over their working life in a job, OSHA has turned these prevalence rates into an incidence rate, which is the rate of contracting CBD at a point in time. OSHA's baseline estimate of the turnover rate in the model is 10 percent. In Table VII-10 in the PEA, OSHA also presented alternative turnover rates of 5 percent and 20 percent. A higher turnover rate translates into a higher incidence rate, and the table shows that, from a baseline midpoint estimate with 10 percent turnover the number of CBD cases prevented is 6,367, while raising the turnover rate to 20 percent causes this midpoint estimate to rise to 11,751. Conversely, a rate of 5 percent lowers the number of CBD cases prevented to 3,321. Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8 million now ranges from $314.4 million to $1,038 million.
Also in TableVII-10 of the PEA, the Agency looked at the effects of varying the percentage of CBD cases that eventuate in fatality. The Agency's baseline estimate of this outcome is 65 percent, with half of this occurring relatively soon, and the other half after an extended debilitating condition. The Agency judged that a reasonable range to investigate was a low of 50 percent and a high of 80 percent, while maintaining the shares of short-term and long-term endpoint fatality. At a baseline of 65 percent, the midpoint estimate of total CBD cases prevented is 4,139. At the low end of 50 percent mortality this estimate lowers to 3,183 while at the high end of 80 percent mortality this estimate rises to 5,094. Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8 million now ranges from $500.1 million to $651.5 million.
OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the proposed rule. However, for these, the Agency performed a “break-even” analysis, asking how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits. The results are shown in Table IX-17.
In one break-even test on cost estimates, OSHA examined how much total costs would have to increase in order for costs to equal benefits. As shown in Table IX-17, this point would
In a second test, looking specifically at the estimated engineering control costs, the Agency found that these costs would need to increase by $566.7 million, or 6,240 percent, for costs to equal benefits.
In a third sensitivity test, on benefits, OSHA examined how much its estimated monetary valuation of an avoided illness or an avoided fatality would need to be reduced in order for the costs to equal the benefits. Since the total valuation of prevented mortality and morbidity are each estimated to exceed the estimated costs of $38 million, an independent break-even point for each is impossible. In other words, for example, if no value is attached to an avoided illness associated with the rule, but the estimated value of an avoided fatality is held constant, the rule still has substantial net benefits. Only through a reduction in the estimated net value of both components is a break-even point possible.
The Agency, therefore, examined how large an across-the-board reduction in the monetized value of all avoided illnesses and fatalities would be necessary for the benefits to equal the costs. As shown in Table IX-17, a 94 percent reduction in the monetized value of all avoided illnesses and fatalities would be necessary for costs to equal benefits, reducing the estimated value to $733,303 per fatality prevented, and an equivalent percentage reduction to about $4,048 per illness prevented.
In a fourth break-even sensitivity test, OSHA estimated how many fewer beryllium-related fatalities and illnesses would be required for benefits to equal costs. Paralleling the previous discussion, eliminating either the prevented mortality or morbidity cases alone would be insufficient to lower benefits to the break-even point. The Agency therefore examined them as a group. As shown in Table IX-17, a reduction of 96 percent, for both simultaneously, is required to reach the break-even point—90 fewer fatalities prevented annually, and 46 fewer beryllium-related illnesses-only cases prevented annually.
Taking into account both types of sensitivity analysis the Agency performed on its point estimates of the annualized costs and annualized benefits of the proposed rule, the results demonstrate that net benefits would be positive in all plausible cases tested. In particular, this finding would hold even with relatively large variations in individual input parameters. Alternately, one would have to imagine extremely large changes in costs or benefits for the rule to fail to produce net benefits. OSHA concludes that its finding of significant net benefits resulting from the proposed rule is a robust one.
OSHA welcomes input from the public regarding all aspects of this sensitivity analysis, including any data or information regarding the accuracy of the preliminary estimates of compliance costs and benefits and how the estimates of costs and benefits may be affected by varying assumptions and methodological approaches. OSHA also invites comment on the risk analysis and risk estimates from which the benefits estimates were derived.
This section discusses various regulatory alternatives to the proposed OSHA beryllium standard. Executive Order 12866 instructs agencies to “select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.” The OSH Act, as interpreted by the courts, requires health regulations to reduce significant risk to
Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency's preliminary findings of significant risk and feasibility. To facilitate comment, OSHA has organized some two dozen specific regulatory alternatives into five categories: (1) Scope; (2) exposure limits; (3) methods of compliance; (4) ancillary provisions; and (5) timing.
The first set of regulatory alternatives would alter scope of the proposed standard—that is, the groups of employees and employers covered by the proposed standard. The scope of the current beryllium proposal applies only to general industry work, and does not apply to employers when engaged in construction or maritime activities. In addition, the proposed rule provides an exemption for those working with materials that contain beryllium only as a trace contaminant (less than 0.1percent composition by weight).
As discussed in the explanation of paragraph (a) in Section XVIII of this preamble, Summary and Explanation of the Proposed Standard, OSHA is considering alternatives to the proposed scope that would increase the range of employers and employees covered by the standard. OSHA's review of several industries indicates that employees in some construction and maritime industries, as well as some employees who deal with materials containing less than 0.1 percent beryllium, may be at significant risk of CBD and lung cancer as a result of their occupational exposures. Regulatory Alternatives #1a, #1b, #2a, and #2b would increase the scope of the proposed standard to provide additional protection to these workers.
Regulatory Alternative #1a would expand the scope of the proposed standard to also include all operations in general industry where beryllium exists only as a trace contaminant; that is, where the materials used contain less than 0.1 percent beryllium by weight. Regulatory Alternative #1b is similar to Regulatory Alternative #1a, but exempts operations where beryllium exists only as a trace contaminant and the employer can show that employees' exposures will not meet or exceed the action level or exceed the STEL. Where the employer has objective data demonstrating that a material containing beryllium or a specific process, operation, or activity involving beryllium cannot release beryllium in concentrations at or above the proposed action level or above the proposed STEL under any expected conditions of use, that employer would be exempt from the proposed standard except for recordkeeping requirements pertaining to the objective data. Alternative #1a and Alternative #1b, like the proposed rule, would not cover employers or employees in construction or shipyards.
OSHA has identified two industries with workers engaged in general industry work that would be excluded under the proposed rule but would fall within the scope of the standard under Regulatory Alternatives #1a and #1b: Primary aluminum production and coal-fired power generation. Beryllium exists as a trace contaminant in aluminum ore and may result in exposures above the proposed permissible exposure limits (PELs) during aluminum refining and production. Coal fly ash in coal-powered power plants is also known to contain trace amounts of beryllium, which may become airborne during furnace and baghouse operations and might also result in worker exposures. See Appendices VIII-A and VIII-B at the end of Chapter VIII in the PEA for a discussion of beryllium exposures and available controls in these two industries.
As discussed in Appendix IV-B of the PEA, beryllium exposures from fly ash high enough to exceed the proposed PEL would usually be coupled with arsenic exposures exceeding the arsenic PEL. Employers would in that case be required to implement all feasible engineering controls, work practices, and necessary PPE (including respirators) to comply with the OSHA Inorganic Arsenic standard (29 CFR 1910.1018)—which would be sufficient to comply with those aspects of the proposed beryllium standard as well. The degree of overlap between the applicability of the two standards and, hence, the increment of costs attributable to this alternative are difficult to gauge. To account for this uncertainty, the Agency at this time is presenting a range of costs for Regulatory Alternative #1a: From no costs being taken for ancillary provisions under Regulatory Alternative #1a to all such costs being included. At the low end, the only additional costs under Regulatory Alternative #1a are due to the engineering control costs incurred by the aluminum smelters (see Appendix VIII-A).
Similarly, the proposed beryllium standard would not result in additional benefits from a reduction in the beryllium PEL or from ancillary provisions similar to those already in place for the arsenic standard, but OSHA does anticipate some benefits will flow from ancillary provisions unique to the proposed beryllium standard. To account for significant uncertainty in the benefits that would result from the proposed beryllium standard for workers in primary aluminum production and coal-fired power generation, OSHA estimated a range of benefits for Regulatory Alternative #1a. The Agency estimated that the proposed ancillary provisions would avert between 0 and 45 percent
Table IX-18 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 proposed rule. Table IX-18 also breaks out costs by provision, and benefits by type of disease and by morbidity/mortality.
As shown in Table IX-18, Regulatory Alternative #1a would increase the annualized cost of the rule from $37.6 million to between $39.6 and $56.0 million using a 3 percent discount rate and from $39.1 million to between $41.3 and $58.1 million using a 7 percent discount rate. OSHA estimates that regulatory Alternative #1a would prevent as few as an additional 0.3 (
OSHA estimates that the costs and the benefits of Regulatory Alternative #1b will be somewhat lower than the costs of Regulatory Alternative #1a, because most—but not all—of the provisions of the proposed standard are triggered by exposures at the action level, 8-hour time-weighted average (TWA) PEL, or STEL. For example, where exposures exist but are below the action level and at or below the STEL, Alternative #1a would require employers to establish work areas; develop, maintain, and implement a written exposure control plan; provide medical surveillance to employees who show signs or symptoms of CBD; and provide PPE in some instances. Regulatory Alternative #1b would not require employers to take these measures in operations where they can produce objective data demonstrating that exposures are below the action level and at or below the STEL. OSHA only analyzed costs, not benefits, for this alternative, consistent with the Agency's treatment of Regulatory Alternatives in the past. Total costs for Regulatory Alternative #1b versus #1a, assuming full ancillary costs, drop from to $56.0 million to $49.9 million using a 3 percent discount rate, and from $58.1 million to $51.8 million using a 7 percent discount rate.
Regulatory Alternative #2a would expand the scope of the proposed standard to include employers in construction and maritime. For example, this alternative would cover abrasive blasters, pot tenders, and
As discussed in the explanation of proposed paragraph (a) in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, abrasive blasting is the primary application group in construction and maritime industries where workers may be exposed to beryllium. OSHA has judged that abrasive blasters and their helpers in construction and maritime industries have the potential for significant airborne exposure during blasting operations and during cleanup of spent media. Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 μg/m
To address high concentrations of various hazardous chemicals in abrasive blasting material, employers must already be using engineering and work practice controls to limit workers' exposures and must be supplementing these controls with respiratory protection when necessary. For example, abrasive blasters in the construction industry fall under the protection of the Ventilation standard (29 CFR 1926.57). The Ventilation standard includes an abrasive blasting subsection (29 CFR 1926.57(f)), which requires that abrasive blasting respirators be worn by all abrasive blasting operators when working inside blast-cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand in manual blasting operations where the nozzle and blast are not physically separated from the operator in an exhaust-ventilated enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures to hazardous substances in excess of the limits set in § 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971). For maritime, standard 29 CFR 1915.34(c) covers similar requirements for respiratory protection needed in blasting operations. Due to these requirements, OSHA believes that abrasive blasters already have controls in place and wear respiratory protection during blasting operations. Thus, in estimating costs for Regulatory Alternatives #2a and #2b, OSHA judged that the reduction of the TWA PEL would not impose costs for additional engineering controls or respiratory protection in abrasive blasting (see Appendix VIII-C of Chapter VIII in the PEA for details). OSHA requests comment on this issue—in particular, whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE that would be required by Regulatory Alternatives #2a and #2b.
In the estimation of benefits for Regulatory Alternative #2a, OSHA has estimated a range to account for significant uncertainty in the benefits to this population from some of the ancillary provisions of the proposed beryllium standard. It is unclear how many of the workers associated with abrasive blasting work would benefit from dermal protection, as comprehensive dermal protection may already be used by most blasting operators. It is also unclear whether the housekeeping requirements of the proposed standard would be feasible to implement in the context of abrasive blasting work, and to what extent they would benefit blasting helpers, who are themselves exposed while performing cleanup activities. OSHA estimated that the proposed ancillary provisions would avert between 0 and 45 percent of those baseline CBD cases not averted by the proposed PEL.
These considerations also lead the Agency to present a range for the costs of this alternative: From no costs being estimated for ancillary provisions under Regulatory Alternative #2a to including all such costs. Based on the considerations discussed above, the Agency judges that costs and benefits at the low end of this range are more likely to be correct. The Agency invites comment on these issues.
In addition, OSHA believes that a small number of welders in the maritime industry may be exposed to beryllium via arc and gas welding (and none through resistance welding). The number of maritime welders was estimated using the same methodology as was used to estimate the number of general industry welders. Brush Wellman's customer survey estimated 2,000 total welders on beryllium-containing products (Kolanz, 2001). Based on ERG's assumption of 4 welders per establishment, ERG estimated that a total of 500 establishments would be affected. These affected establishments were then distributed among the 26 NAICS industries with the highest number of IMIS samples for welders that were positive for beryllium. To do this, ERG first consulted the BLS OES survey to determine what share of establishments in each of the 26 NAICS employed welders and estimated the total number of establishments that perform welding regardless of beryllium exposure (BLS, 2010a). Then ERG distributed the 500 affected beryllium welding facilities among the 26 NAICS based on the relative share of the total number of establishments performing welding. Finally, to estimate the number of welders, ERG used the assumption of four welders per establishment. Based on the information from ERG, OSHA estimated that 30 welders would be covered in the maritime industry under this regulatory alternative. For these welders, OSHA used the same controls and exposure profile that were used to estimate costs for arc and gas welders in Chapter V of the PEA. ERG judged there to be no construction welders exposed to beryllium due to a lack of any evidence that the construction sector uses beryllium-containing products or electrodes in resistance welding. OSHA solicits comment and any relevant data on beryllium exposures for welders in construction and maritime employment.
Estimated costs and benefits for Regulatory Alternative #2a are shown in Table IX-18a. Regulatory Alternative
Table IX-18b presents, for informational purposes, the estimated costs, benefits, and net benefits, of Regulatory Alternative #2b 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 proposed rule. Table IX-18b also breaks out costs by provision and benefits by type of disease and by morbidity/mortality.
As shown in Table IX-18b, this regulatory alternative would increase the annualized cost of the rule from $37.6 million to $39.6 million, using a 3 percent discount rate, and from $39.1 million to $41.1 million using a 7 percent discount rate. Regulatory Alternative #2b would prevent less than one additional beryllium-related fatalities and less than one beryllium-related illness annually relative to the proposed rule. As a result, annualized benefits would increase from $575.8 million to $578.1 million, using a 3 percent discount rate, and from $255.3 million to $256.3 million using a 7 percent discount rate. Net benefits would increase from $538.2 million to $538.5 million using a 3 percent discount rate and slightly decrease from $216.2 million to $215.2 million using a 7 percent discount rate.
OSHA is proposing a new TWA PEL for beryllium of 0.2 μg/m
Paragraph (c) of the proposed standard establishes two PELs for beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of 0.2 μg/m
As discussed in this preamble explanation of paragraph (c) in Section XVIII, Summary and Explanation of the Proposed Standard, OSHA is considering three regulatory alternatives that would modify the PELs for the proposed standard.
Regulatory Alternative #3 would modify the proposed STEL to be five times the TWA PEL, as is typical for OSHA standards that have STELs. A STEL five times the TWA PEL has more practical effect because a STEL ten times the TWA PEL will rarely be exceeded without also driving exposures above the TWA PEL. For example, assuming a background exposure level of 0.1 μg/m
As discussed in this preamble at Section V, Health Effects, immunological sensitization can be triggered by short-term exposures. OSHA believes a STEL for beryllium will help reduce the risk of sensitization and CBD in beryllium-exposed employees. For instance, without a STEL, workers' exposures could be as high as 6.4 μg/m
OSHA requests comment on the range of short-term exposures in covered industries, the types of operations where these are occurring, and on the proposed and alternative STELs, including any data or information that may help OSHA choose between them.
OSHA identified two job categories where workers would be expected to have short-term exposures in the range between the proposed STEL and the STEL under Regulatory Alternative #3 (that is, between 2.0 and 1.0 μg/m
Under Regulatory Alternative #4, the TWA PEL would be 0.1
While OSHA's preliminary analysis indicates that the proposed TWA PEL of 0.2 μg/m
Regulatory Alternative #5, which would set a TWA PEL at 0.5 μg/m
Table IX-20 below presents, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed TWA PEL of 0.2 μg/m
OSHA has not made a determination that a TWA PEL of 0.1 μg/m
The estimated benefits for Regulatory Alternative #4 were calculated based on the number of workers identified with exposures between 0.1 and 0.2 μg/m
As Table IX-20 shows, going from a TWA PEL of 0.5 μg/m
Table IX-20 also shows the costs and benefits of going from the proposed TWA PEL of 0.2 μg/m
An Informational Analysis: This proposed regulation has the somewhat unusual feature for an OSHA substance-specific health standard that most of the quantified benefits would come from the ancillary provisions rather than from meeting the PEL with engineering controls. OSHA decided to analyze for informational purposes the effect of retaining the existing 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 proposed provisions (including respiratory protection, which OSHA does not consider an ancillary provision) would be required with their triggers remaining the same as in the proposed 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 because the absence of a more protective requirement for engineering controls would not be consistent with section 6(b)(5) of the OSH Act, which 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, and OSHA estimates the costs would be about the same (or slightly lower, depending on certain assumptions) under that approach as under the traditional proposed approach.
On an industry by industry basis, OSHA found that some industries would have lower costs if they could adopt the ancillary-provisions-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 of the employer-by-employer situations in which there exist some employers for whom the ancillary-provisions-only approach might be cheaper. In the majority of affected industries, the Agency estimates there are no costs saving to the ancillary-provisions-only approach. However, OSHA estimates a total of $2,675,828 per year in costs saving 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
The ancillary-provisions-only approach adds uncertainty to the benefits analysis such that the benefits of the rule as proposed may exceed, and perhaps greatly exceed, the benefits of this ancillary-provisions-only approach:
(1) Most exposed individuals would be in respirators, which OSHA considers less effective than engineering controls in preventing employee exposure to beryllium. OSHA last did an extensive review of the evidence on effectiveness of respirators for its APFs rulemaking in 2006 (71 FR 50128-45, August 24, 2006). OSHA has not in the past tried to quantify the size of this effect, but it could partially negate the estimated benefits of 92 CBD deaths prevented per year and 4 lung cancer cases prevented per year by the proposed standard.
(2) As noted above, in the proposal 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.
(3) OSHA believes that there is a strong possibility that the benefits of the ancillary provisions (a midpoint estimate of eliminating 45 percent of all remaining cases of CBD) would be partially or wholly negated in the absence of engineering controls that would reduce both airborne and surface dust levels. The measured reduction in benefits from ancillary provision was in a facility with average exposure levels of less than 0.2 μg/m
Based on these considerations, OSHA believes that the ancillary-provisions-only approach is not one that is likely to maximize net benefits. The costs saving, if any, are estimated to be small, and the difficult-to-measure declines in benefits could be substantial.
Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure: Material and/or process substitution; ventilated enclosures; local exhaust ventilation; or process controls, such as wet methods and automation. Employers are exempt from using engineering and work practice controls only when they can show that such controls are not feasible or where exposures are below the action level based on two exposure samples taken seven days apart.
These requirements, which are based on the stakeholders' recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and United Steelworkers, 2012), address a concern associated with the proposed TWA PEL. OSHA expects that day-to-day changes in workplace conditions, such as workers' positioning or patterns of airflow, may cause frequent exposures above the TWA PEL in workplaces where periodic sampling indicates exposures are between the action level and the TWA PEL. As a result, the default under the standard is that the controls are required until the employer can demonstrate that exposures have not exceeded the action level from at least two separate measurements taken seven days apart.
OSHA believes that substitution or engineering controls such as those 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
The proposed standard contains several ancillary provisions (provisions other than the exposure limits), including requirements for exposure assessment, medical surveillance, medical removal, training, and regulated areas or access control. As reported in Chapter V of the PEA, these ancillary provisions account for $27.8 million (about 72 percent) of the total annualized costs of the rule ($37.6 million) using a 3 percent discount rate, or $28.6 million (about 73 percent) of the total annualized costs of the rule ($39.1 million) using a 7 percent discount rate. The most expensive of the ancillary provisions are the requirements for housekeeping and training, with annualized costs of $12.6 million and $5.8 million, respectively, at a 3 percent discount rate ($12.9 million and $5.8 million, respectively, at a 7 percent discount rate).
OSHA's reasons for including each of the proposed ancillary provisions are explained in Section XVIII of this preamble, Summary and Explanation of the Standards.
In particular, OSHA is proposing the requirements for exposure assessment to provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is especially important because workers exposed above the proposed TWA PEL, as well as many workers exposed below the proposed TWA PEL, are at significant risk of death and illness. Medical surveillance would allow for identification of beryllium-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA is proposing regulated areas and access control because they serve to limit exposure to beryllium to as few employees as possible. OSHA is proposing worker training to ensure that employers inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize their exposure to beryllium. Worker training on beryllium-related work practices is particularly important in controlling beryllium exposures because engineering controls frequently require action on the part of workers to function effectively.
OSHA has examined a variety of regulatory alternatives involving changes to one or more of the proposed ancillary provisions. The incremental cost of each of these regulatory alternatives and its impact on the total costs of the proposed rule is summarized in Table IX-22 at the end of this section. OSHA has preliminarily determined that several of these ancillary provisions will increase the benefits of the proposed 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 proposed 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
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 proposed TWA PEL of 0.2 μg/m
Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1 and Z-2, so that the proposed TWA PEL and STEL would apply to all workers in general industry. This alternative would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical surveillance, medical removal, PPE, housekeeping, training, and regulated areas or access control. Under this regulatory alternative, OSHA estimates that the costs for the proposed ancillary provisions of the rule (estimated at $27.8 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 USW, 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 these costs under Regulatory Alternative #7 would reasonably be attributable to the proposed rule. OSHA welcomes comment on the issue.
OSHA has also estimated the effect of this regulatory alternative on the benefits of the rule. As a result of eliminating all of the ancillary provisions, annualized benefits are estimated to decrease 57 percent, relative to the proposed rule, from $575.8 million to $249.1 million, using a 3 percent discount rate, and from $255.3 million to $110.4 million using a 7 percent discount rate. This estimate follows from OSHA's analysis of benefits in Chapter VII of the PEA, which found that about 57 percent of the benefits of the proposed 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 proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed 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 the primary beryllium manufacturing industry 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 USW, 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 proposed TWA PEL alone could achieve.
Moreover, where there is continuing significant risk at the TWA PEL, the decision in the Asbestos case (
Under Regulatory Alternative #8, several ancillary provisions that the current proposal would require under a variety of exposure conditions (
To estimate the cost savings for this alternative, OSHA re-estimated the group of workers that would fall under the above provisions and the changes to their scope. Combining these various adjustments along with associated unit costs, OSHA estimates that, under this regulatory alternative, the costs for the proposed rule would decline from $37.6 million to $18.9 million using a 3 percent discount rate and from $39.1 million to $20.0 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 proposed 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 proposed TWA PEL and STEL could achieve. OSHA's preliminary conclusion is that the requirements triggered by the action level and other exposures below the proposed PELs will result in very real and necessary, but difficult to quantify, further reduction in risk beyond that provided by the PELs alone.
The remainder of this section discusses additional regulatory alternatives that apply to individual
Paragraph (d) of the proposed standard, Exposure Monitoring, requires annual monitoring where exposures are at or above the action level and at or below the TWA PEL. It does not require periodic monitoring where exposure levels have been determined to be below the action level, or above the TWA PEL. The rationale for this provision is provided in this preamble discussion of paragraph (a) in Section XVIII, Summary and Explanation of the Proposed Standard. Below is a brief summary, followed by a discussion of three alternatives.
Because of the variable nature of employee exposures to airborne concentrations of beryllium, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to beryllium at levels above the TWA PEL on days when no exposure measurements are made. Even when all measurements on a given day fall at or below the TWA PEL, if those measurements are still at or above the action level, there is a smaller safety margin and a greater chance that on another day, when exposures are not measured, the employee's exposure may exceed the TWA PEL. When exposure measurements are at or above the action level, the employer cannot be reasonably confident that employees have not been exposed to beryllium concentrations in excess of the TWA PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is met or exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring. The proposed action level that would trigger the exposure monitoring is one-half of the TWA PEL, which reflects the Agency's typical approach to setting action levels (see,
Certain other aspects of the proposed periodic monitoring requirements, which the Agency based on the stakeholders' recommended standard submitted by Materion and the United Steelworkers (Materion and USW, 2012), depart significantly from OSHA's usual exposure monitoring requirements. The proposed standard only requires annual monitoring, and does not require periodic monitoring when exposures are recorded above the TWA PEL, whereas most OSHA standards require monitoring at least every 6 months when exposure levels exceed the action level, and every 3 months when exposures are above the TWA PEL. For example, the standards for vinyl chloride (29 CFR 1910.1017), inorganic arsenic (29 CFR 1910.1018), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR 1910.1045), ethylene oxide (29 CFR 1910.1047), and formaldehyde (29 CFR 1910.1048), all specify periodic monitoring at least every six months when exposures are at, or above, the action level. Monitoring is required every three months when exposures exceed the TWA PEL in the standards for methylene chloride, ethylene oxide, acrylonitrile, inorganic arsenic, lead, and vinyl chloride. In the standards for cadmium, 1,3-Butadiene, formaldehyde, benzene and asbestos (29 CFR 1910.1001), monitoring is required every six months when exposures exceed the TWA PEL. In these standards, monitoring workers exposed above the TWA PEL ensures that employers know workers' exposure levels in order to select appropriate respirators and other PPE, and that records of their exposures are available if needed for medical, legal, or epidemiological purposes.
OSHA has examined three regulatory alternatives that would modify the requirements of paragraph (d) to be more similar to OSHA's typical periodic monitoring requirements. Under Regulatory Alternative #9, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level or above the STEL, but at or below the TWA PEL. As shown in Table IX-22, Regulatory Alternative #9 would increase the annualized cost of the proposed rule by about $773,000 using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #10, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level or above the STEL, including where exposures exceed the TWA PEL. As shown in Table IX-22, Regulatory Alternative #10 would increase the annualized cost of the proposed rule by about $929,000 using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #11, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level, and every 90 days where exposures exceed the TWA PEL or STEL. This alternative is similar to the periodic monitoring requirements in the draft proposed rule presented to the SERs during the 2007 OSHA beryllium SBAR Panel process. Of the exposure monitoring alternatives, it is also the most similar to the exposure monitoring provisions of most other 6(b)(5) standards. As shown in Table IX-22, Regulatory Alternative #11 would increase the annualized cost of the proposed rule by about $1.07 million using either a 3 percent or 7 percent discount rate.
Proposed paragraph (e) requires employers to establish and maintain beryllium work areas wherever employees are exposed to airborne beryllium, regardless of the level of exposure, and regulated areas wherever airborne concentrations of beryllium exceed the TWA PEL or STEL. Employers are required to demarcate beryllium work areas and regulated areas and limit access to regulated areas to authorized persons.
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. This alternative is meant only to eliminate the requirement to set up and demarcate specific physical areas: All ancillary provisions would be triggered by the same conditions as under the standard's definition of a “regulated area.” For example, under the current proposal, employees who work in regulated areas for at least 30 days annually are eligible for medical surveillance. If OSHA were to remove the requirement to establish regulated areas, the medical surveillance provisions would be altered so that employees who work more than 30 days annually in jobs or areas with exposures that exceed the TWA PEL or STEL are eligible for medical surveillance. This alternative would not eliminate the proposed requirement to establish beryllium work areas. As shown in Table IX-22, Regulatory Alternative #12 would decrease the annualized cost of the proposed rule by about $522,000 using a 3 percent discount rate, and by about $523,000 using a 7 percent discount rate.
Regulatory Alternative #13 would modify the requirements for personal protective equipment (PPE) by requiring appropriate PPE whenever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. This alternative would be broader, and thus more protective, than the PPE requirement in the proposed standard, which requires PPE to be used in three circumstances: (1) Where exposure exceeds the TWA PEL or STEL; (2) where employees' clothing or skin may become visibly contaminated with beryllium; and (3) where employees may have skin contact with soluble beryllium compounds. These PPE requirements were based on the stakeholders' recommended standard that Materion and the United Steelworkers submitted to the Agency (Materion and USW, 2012).
The proposed rule's requirement to use PPE where work clothing or skin may become “visibly contaminated” with beryllium differs from prior standards, which do not require contamination to be visible in order for PPE to be required. While OSHA's language regarding PPE requirements varies somewhat from standard to standard, previous standards tend to emphasize potential for contact with a substance that can trigger health effects via dermal exposure, rather than “visible contamination” with the substance. For example, the standard for chromium (VI) 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) (29 CFR 1910.1026). The lead and cadmium 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. Under the Methylenedianiline (MDA) standard (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.
OSHA requests comment on the proposed PPE requirements in Regulatory Alternative #13, which would modify the proposed PPE requirements to be similar to the chromium (VI), lead, cadmium, and MDA standards. 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. Although solubility may play a role in the level of sensitization risk, the available evidence suggests that contact with insoluble, as well as soluble, beryllium can cause sensitization via dermal contact (see this preamble at Section V, Health Effects). Sensitized workers are at significant risk of developing CBD (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk).
To estimate the cost of Regulatory Alternative #13, OSHA assumed that all at-risk workers, except administrative occupations, would require protective clothing and a pair of work gloves that would need to be replaced annually. The economic analysis of the proposed standard already contained costs for protective clothing for all employees whose clothing might be contaminated by beryllium (the analysis assumed that all clothing contamination would be visible, or the clothing is already provided even if not required by this standard) and gloves for many jobs where workers were expected to be exposed to visible contamination or soluble beryllium; thus OSHA estimated the cost of this alternative as the cost of providing gloves for the remainder of the jobs where workers have potential for skin exposure even in the absence of visible contamination. As shown in Table IX-22, Regulatory Alternative #13 would increase the annualized cost of the proposed rule by about $138,000 using either a 3 percent or 7 percent discount rate.
The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium in a regulated area (
OSHA estimated in Chapter V of the PEA that the medical surveillance requirements would apply to 4,528 workers in general industry, of whom 387 already receive that surveillance.
OSHA has examined eight regulatory alternatives (#14 through #21) that would modify the proposed 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 proposal, which was modified since the SBAR Panel was convened (see this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, for more detailed discussion). Several of the regulatory alternatives presented here (#16, #18, and #20) also respond to recommendations by the SBAR Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements. OSHA is also considering several additional regulatory alternatives that would increase the frequency of surveillance or the range of employees covered by medical surveillance (#14, #15, #17, #19, and #21).
OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exists at exposure levels below the proposed TWA PEL and that there is evidence that beryllium sensitization can occur even from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII,
OSHA is considering three regulatory alternatives that would expand eligibility for medical surveillance to a broader group of employees than those eligible under the proposed standard. Under Regulatory Alternative #14, medical surveillance would be available to employees who are exposed to beryllium above the proposed TWA PEL or STEL, including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would expand 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. Regulatory Alternative #21 would extend eligibility for medical surveillance as set forth in proposed paragraph (k) to all employees in shipyards, construction, and general industry who meet the criteria of proposed paragraph (k)(1). However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule. Each of these alternatives would provide surveillance to fewer workers (and cost less to employers) than the draft proposed rule presented to SERs during the SBAR Panel process, which included skin contact as a trigger and would therefore cover most beryllium-exposed workers in general industry, construction, and maritime. These alternatives would provide more surveillance (and cost more to employers) than the medical surveillance requirements in the current proposal.
To estimate the cost of Regulatory Alternative #14, OSHA assumed that 1 person would enter regulated areas for less than 30 days a year for every 4 people working in regulated areas on a regular basis. Thus, this alternative includes costs for an incremental number of annual medical exams equal to 25 percent of the number of workers estimated to be working in regulated areas after the standard is promulgated. As shown in Table IX-22, Regulatory Alternative #14 would increase the annualized cost of the proposed rule by about $38,000 using either a 3 percent or 7 percent discount rate.
To estimate the cost of Regulatory Alternative #15, OSHA assumed that all workers exposed above the action level before the standard would continue to be exposed after the standard is promulgated. OSHA also assumed that 1 person would enter areas exceeding the action level for fewer than 30 days a year for every 4 people working in an area exceeding the action level on a regular basis. Thus, this alternative includes costs for medical exams for the number of workers exposed between the action level and the TWA PEL as well as an incremental 25 percent of all workers exposed above the action level. As shown in Table IX-22, Regulatory Alternative #15 would increase the annualized cost of the proposed rule by about $3.9 million using a discount rate of 3 percent, and by about $4.0 million using a discount rate of 7 percent.
For Alternative #21, OSHA is considering two different scenarios to estimate costs: One where the TWA PEL for the groups outside the scope of the proposed standard changes from 2 μg/m
For Regulatory Alternative #21a, medical surveillance above the proposed TWA PEL of 0.2, OSHA estimated the cost of extending medical surveillance to workers in aluminum production, abrasive blasting in construction, maritime abrasive blasting, maritime welding, and coal fired power plants, assuming that all feasible controls are in place to reduce exposures to the proposed TWA PEL of 0.2 μg/m
For Alternative #21b, medical surveillance above the current TWA PEL of 2.0 μg/m
In response to concerns raised during the SBAR Panel process about testing requirements, OSHA is considering 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 IX-22, this alternative would decrease the annualized cost of the proposed rule by about $710,000 using a discount rate of 3 percent, and by about $724,000 using a discount rate of 7 percent.
Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule. This alternative would decrease the annualized cost of
OSHA is considering several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. The frequency of periodic medical surveillance is an important factor in the efficacy of the surveillance in protecting worker health. Regular, appropriately frequent medical surveillance promotes awareness of beryllium-related health effects and early intervention in disease processes among workers. In addition, the longer the time interval between when a worker becomes sensitized and when the worker's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to sensitization. Therefore, reducing the frequency of sensitization testing would reduce the usefulness of the surveillance information in identifying problem areas and reducing risks to other workers. These concerns must be weighed against the costs and other burdens of surveillance.
Regulatory alternative #17 would require employers to offer annual testing for beryllium sensitization to eligible employees, as in the draft proposal presented to the SBAR Panel. As shown in Table IX-22, this alternative would increase the annualized cost of the proposed rule by about $392,000 using a discount rate of 3 percent, and by about $381,000 using a discount rate of 7 percent.
Regulatory Alternative #19 would similarly increase the frequency of periodic CT scans from biennial to annual scans, increasing the annualized cost of the proposed rule by about $459,000 using a discount rate of 3 percent, and by about $450,000 using a discount rate of 7 percent.
Finally, under Regulatory Alternative #20, employers would only have to provide all periodic components of the medical surveillance exams biennially to eligible employees. This alternative would decrease the annualized cost of the proposed rule by about $446,000 using a discount rate of 3 percent and by about $433,000 using a discount rate of 7 percent.
Under paragraph (l) of the proposed standard, Medical Removal, employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. When an employee chooses removal, the employer is required to remove the employee to comparable work in an environment where beryllium exposure is below the action level if such work is available and the employee is either already qualified or can be trained within one month. If comparable work is not available, paragraph (l) would require the employer to place the employee on paid leave for six months or until comparable work becomes available (whichever comes first). Or, rather than choosing removal, an eligible employee could choose to remain in a job with exposure at or above the action level and wear a respirator. The proposed medical removal protection (MRP) requirements are based on the stakeholders' recommended beryllium standard that representatives of the beryllium production industry and the United Steelworkers union submitted to OSHA in 2012 (Materion and USW, 2012).
The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are sensitized or have early-stage CBD (see this preamble at Section VIII, Significance of Risk). As CBD progresses, symptoms become serious and debilitating. Steroid treatment is less effective at later stages, once fibrosis has developed (see this preamble at Section VIII, Significance of Risk). Given the progressive nature of the disease, OSHA believes it is reasonable to conclude that removal from exposure to beryllium will benefit sensitized employees and those with CBD. Physicians at National Jewish Health, one of the main CBD research and treatment sites in the US, “consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,” and “recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average” (NJMRC, 2013). However, OSHA is aware that MRP may prove costly and burdensome for some employers and that the scientific literature on the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD is limited.
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 proposed requirement that employers offer MRP. As shown in Table IX-22, this alternative would decrease the annualized cost of the proposed rule by about $149,000 using a discount rate of 3 percent, and by about $166,000 using a discount rate of 7 percent.
As proposed, the new standard would become effective 60 days following publication in the
OSHA invites suggestions for alternative phase-in schedules for engineering controls, medical surveillance, and other provisions of the standard. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), some general outcomes are likely. For example, a longer phase-in time would have several advantages, such as reducing initial costs of the standard or allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However, a longer phase-in would also postpone and reduce the benefits of the standard. Suggestions for alternatives may apply to specific industries (
OSHA requests comments on all these regulatory alternatives, including the Agency's regulatory alternatives presented above, the Agency's analysis of these alternatives, and whether there are other regulatory alternatives the Agency should consider.
The Regulatory Flexibility Act, as amended in 1996, requires the preparation of an Initial Regulatory Flexibility Analysis (IRFA) for proposed rules where there would be a significant economic impact on a substantial number of small entities. (5 U.S.C. 601-612). Under the provisions of the law, each such analysis shall contain:
1. A description of the impact of the proposed rule on small entities;
2. A description of the reasons why action by the agency is being considered;
3. A succinct statement of the objectives of, and legal basis for, the proposed rule;
4. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply;
5. A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record;
6. An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the proposed rule;
7. A description and discussion of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities, such as:
(a) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(b) The clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;
(c) The use of performance rather than design standards; and
(d) An exemption from coverage of the rule, or any part thereof, for such small entities.
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 PEA and its supporting materials, the IRFA summarizes the key aspects of OSHA's analysis as they affect small entities.
Section IX.F of this preamble summarized the impacts of the proposed rule on small entities. Table IX-9 showed costs as a percentage of profits and revenues for small entities, classified as small by the Small Business Administration, and Tables IX-10 showed costs as a percentage of revenues and profits for business entities with fewer than 20 employees. (The costs in these tables were annualized using a discount rate of 3 percent.)
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 initial 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 preliminary risk assessment, presented in Section VI of this 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
For CBD to occur, an employee must first become sensitized (
While CBD primarily affects the lungs, it can also involve other organs such as the liver, skin, spleen, and kidneys. As discussed in more detail in this preamble, some studies demonstrate that sensitization and CBD cases have occurred in workplaces that use a wide range of beryllium compounds, including several beryllium salts, refined beryllium metal, beryllium oxide, and the beryllium alloys. While water-soluble and insoluble beryllium compounds have the potential to cause sensitization, it has been suggested that CBD is the result of occupational exposure to beryllium oxide and other water-insoluble berylliums rather than exposure to water-soluble beryllium or beryllium ores. However, there are inadequate data, at this time, on employees selectively exposed to specific beryllium compounds to eliminate a potential CBD concern for any particular form of this metal. Regardless of the type of beryllium compound, in order to cause respiratory disease the inhaled beryllium must contain particulates that are small enough to reach the bronchoalveolar region of the lung where the disease takes place (OSHA, 2007).
Some research suggests that skin exposure to small beryllium particles or beryllium-containing solutions may also lead to sensitization (Tinkle et al., 2003). These additional risk factors may explain why some individuals with seemingly brief, low level exposure to airborne beryllium become sensitized while others with long-term high exposures do not. Other studies indicate that even though employees sensitized to beryllium do not exhibit clinical symptoms, their immune function is altered such that inhalation to previously safe levels of beryllium can now trigger serious lung disease (Kreiss
In the 1980s, the laboratory blood test known as the BeLPT was developed. The test substantially improved identification of beryllium-sensitized individuals and provides an opportunity to diagnose CBD at an early stage. The BeLPT measures the ability of immune cells (
An employee with an abnormal BeLPT (
The BeLPT/lung biopsy diagnostic approach has been utilized in several occupational surveys and surveillance programs over the last fifteen years. The findings have expanded scientific awareness of sensitization and CBD prevalence among beryllium employees and provided a better understanding of its work-related risk factors. Some of the more informative studies come from nuclear weapons facilities operated by the Department of Energy (Viet
In most of the surveys discussed above, 36-100 percent of those workers who initially tested positive with the BeLPT were diagnosed with CBD upon pathological evaluation. Most of these workers diagnosed with CBD had worked four to10 years on the job, although some were diagnosed within several months of employment. Surveys that found a high proportion (
The greatest prevalence of sensitization and CBD were reported for production processes that involve heating beryllium metal (
The potential importance of respirable and ultrafine beryllium particulates in the onset of CBD is illustrated in studies of employees at a large beryllium metal, alloy, and oxide production plant in Ohio. An initial cross-sectional survey reported that the highest prevalence of sensitization and CBD occurred among workers employed in beryllium metal production, even though the highest airborne total mass concentrations of beryllium were generally among employees operating the beryllium alloy furnaces in a different area of the plant (Kreiss
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. The largest and most comprehensive study investigated the mortality experience of over 9,000 workers employed in seven different beryllium processing plants over a 30 year period (Ward
The weight of evidence indicates that beryllium compounds should be regarded as potential occupational lung carcinogens, and OSHA has regulated it since 1974. Other organizations, such as the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium.
The objective of the proposed 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 to perform their jobs safely. The legal basis for the rule is the responsibility given the U.S.
OSHA has completed a preliminary analysis of the impacts associated with this proposed rule, including an analysis of the type and number of small entities to which the proposed rule would 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.
The proposed standard would impact occupational exposures to beryllium in all forms, compounds, and mixtures in general industry. Based on the definitions of small entities developed by SBA for each industry, the proposal is estimated to potentially affect a total of 3,741 small entities as shown in Table IX-1 in Chapter IX of the PEA.
The Agency also estimated costs and conducted a screening analysis for very small employers (those with fewer than 20 employees). OSHA estimates that approximately 2,875 very small entities would be affected by the proposed standard, as shown in Table III-13 in Chapter III of the PEA.
Tables IX-23 and IX-24 show the average costs of the proposed standard by NAICS code and by compliance requirement (PEL/STEL or ancillary provisions) for, respectively, small entities (classified as small by SBA) and very small entities (those with fewer than 20 employees). Total costs are reported as N/A for NAICS codes with no affected entities in the relevant size classification. The weighted average cost per small entity for the proposed rule would be about $8,638 annually, with PEL/STEL compliance accounting for about 23 percent of the costs and ancillary provisions accounting for about 77 percent of the costs.
The weighted average cost per very small entity for the proposed rule would be about $2,212 annually, with PEL/STEL compliance accounting for about 39 percent of the costs and ancillary provisions accounting for about 61 percent of the costs.
Section 4(b)(1) of the OSH Act exempts the working conditions for certain Federal and non-Federal employees from the provisions of the OSH Act to the extent that other Federal agencies exercise statutory authority to prescribe and enforce occupational safety and health standards. The Department of Energy (DOE) issued a regulation in 1999 entitled Chronic Beryllium Disease Prevention Program (CBDPP) (10 CFR part 850, 64 FR 68854-68914, December 8, 1999). Additionally, DOE issued 10 CFR part
There is also a Federal statute addressing the compensation of some employees with beryllium related illnesses—The Energy Employees Occupational Illness Compensation Program Act (EEOICPA) of 2000 and its subsequent amendments. The EEOICPA creates a Federal employees' compensation program that covers beryllium-related health effects for DOE employees and its contractor employees, including many private companies that work away from DOE sites. Several of the private companies whose employees are covered by the OSH Act, either directly in amendments to the OSH Act or identified in subsequent Department of Labor regulations on that Act, would be covered by an OSHA occupational health standard for beryllium and EEOICPA.
There would be no conflict or duplication, however, between an OSHA standard and the EEOICPA. In general, the OSHA standard would have requirements to protect employee health in the future, and the EEOICPA provides compensation for employees who have developed beryllium-related illness. There is some overlap between the two in that they may both require similar medical examinations, or require employers to provide some compensation to employees, but the proposed OSHA standard specifically contemplates and addresses that overlap to avoid conflict and duplication. The explanation for proposed paragraph (k) in Section XVIII of this preamble, Summary and Explanation, notes that employers may satisfy the both examination requirements with a single examination, and the proposed standard specifies that the amount of an employer's financial obligations will be reduced by the amount of EEOICPA payments received by that employee (see proposed paragraph (l)(4)).
This section first discusses several provisions in the proposed standard that OSHA has adopted or modified based on comments from small entity representatives (SERs) during the SBREFA process or on recommendations made by the SBAR Panel as potentially alleviating impacts on small entities. Then, the Agency presents various regulatory alternatives to the proposed OSHA beryllium standard.
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 proposed rule, the Agency has removed skin contact as a trigger for medical surveillance along with providing four clearly defined trigger mechanisms. The newly defined medical surveillance provision reduces the number of employees requiring a BeLPT, particularly for small businesses with low exposures.
Some of the SERs in low-exposure industries wanted to be “shielded” from “expensive” compliance with a standard they perceive to be unnecessary and suggested a PEL-only standard that triggered provisions on the PEL. The alternative of a PEL-only standard and ancillary provisions triggered only by the PEL are discussed in Chapter 8 of the PEA (and is repeated in the following section).
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 proposed rule, OSHA has preliminarily concluded that all affected employers currently have hand washing facilities. OSHA has also preliminarily concluded that no affected employers will be required to install showers. 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.
For the convenience of those persons interested only in OSHA's regulatory flexibility analysis, this section repeats the discussion of the various regulatory alternatives to the proposed OSHA beryllium standard presented in Chapter VIII of the PEA, but only for the regulatory alternatives to the proposed OSHA beryllium standard that lower costs. OSHA believes that this presentation of specific regulatory alternatives explores the possibility of less costly ways (than the proposed rule) to provide an adequate level of worker protection from exposure to beryllium.
Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency's preliminary findings of significant risk and feasibility. As noted above, for this chapter on the Initial Regulatory Flexibility Analysis, the Agency is only presenting regulatory alternatives that reduce costs for small entities. (See Chapter VIII for the full list of all alternatives analysed.) There are eight regulatory alternatives and an informational alternative that reduce costs for small entities (and for all businesses in total). Using the numbering scheme from Chapter VIII, these are Regulatory Alternatives #5, #6, #7, #8. #12, #16, #18, and #22. To facilitate comment, OSHA has organized these potentially less costly regulatory alternatives (and a general discussion of possible phase-ins of the rule) into four categories: (1) Exposure limits; (2) methods of compliance; (3) ancillary provisions; and (4) timing.
Regulatory Alternative #5, which would set a TWA PEL at 0.5 μg/m
Table IX-25 below presents, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed TWA PEL of 0.2 μg/m
An Informational Analysis: This proposed regulation has the somewhat unusual feature for an OSHA substance-specific health standard that most of the quantified benefits would come from the ancillary provisions rather than from meeting the PEL with engineering controls. OSHA decided to analyze for informational purposes the effect of retaining the existing 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 proposed provisions (including respiratory protection, which OSHA does not consider an ancillary provision) would be required with their triggers remaining the same as in the proposed 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 because the absence of a more protective requirement for engineering controls would not be consistent with section 6(b)(5) of the OSH Act, which 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. EO 12866 and EO 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, and OSHA estimates the costs would be about the same (or slightly lower, depending on certain assumptions) under that approach as under the traditional proposed approach.
On an industry by industry basis, OSHA found that some industries would have lower costs if they could adopt the ancillary-provisions-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 of the employer-by-employer situations in which there exist some employers for whom the ancillary-provisions-only approach might be cheaper. In the majority of affected industries, the Agency estimates there are no costs saving to the ancillary-provisions-only approach. However, OSHA estimates a total of $2,675,828 per year in costs saving 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
The ancillary-provisions-only approach adds uncertainty to the benefits analysis such that the benefits of the rule as proposed may exceed, and perhaps greatly exceed, the benefits of this ancillary-provisions-only approach:
(1) Most exposed individuals would be in respirators, which OSHA considers less effective than engineering controls in preventing employee exposure to beryllium. OSHA last did an extensive review of the evidence on effectiveness of respirators for its APFs rulemaking in 2006 (71 FR 50128-45 Aug 24, 2006). OSHA has not in the past tried to quantify the size of this effect, but it could partially negate the estimated benefits of 92 CBD deaths prevented per year and 4 lung cancer cases prevented per year by the proposed standard.
(2) As noted above, in the proposal 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.
(3) OSHA believes that there is a strong possibility that the benefits of the ancillary provisions (a midpoint estimate of eliminating 45 percent of all remaining cases of CBD) would be partially or wholly negated in the absence of engineering controls that would reduce both airborne and surface dust levels. The measured reduction in benefits from ancillary provision was in a facility with average exposure levels of less than 0.2 µg/m
Based on these considerations, OSHA believes that the ancillary-provisions-only approach is not one that is likely to maximize net benefits. The costs saving, if any, are estimated to be small, and the difficult-to-measure declines in benefits could be substantial.
Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure: Material and/or process substitution; ventilated enclosures; local exhaust ventilation; or process controls, such as wet methods and automation. Employers are exempt from using engineering and work practice controls only when they can show that such controls are not feasible or where exposures are below the action level based on two exposure samples taken seven days apart.
These requirements, which are based on the stakeholders' recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and USW, 2012), address a concern associated with the proposed TWA PEL. OSHA expects that day-to-day changes in workplace conditions, such as workers' positioning or patterns of airflow, may cause frequent exposures above the TWA PEL in workplaces where periodic sampling indicates exposures are between the action level and the TWA PEL. As a result, the default under the standard is that the controls are required until the employer can demonstrate that exposures have not exceeded the action level from at least two separate measurements taken seven days apart.
OSHA believes that substitution or engineering controls such as those 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
The proposed standard contains several ancillary provisions (provisions other than the exposure limits), including requirements for exposure assessment, medical surveillance, medical removal, training, and regulated areas or access control. As reported in Chapter V of the PEA, these ancillary provisions account for $27.8 million (about 72 percent) of the total annualized costs of the rule ($37.6 million) using a 3 percent discount rate, or $28.6 million (about 73 percent) of the total annualized costs of the rule ($39.1 million) using a 7 percent discount rate. The most expensive of the ancillary provisions are the requirements for housekeeping and training, with annualized costs of $12.6 million and $5.8 million, respectively, at a 3 percent discount rate ($12.9 million and $5.8 million, respectively, at a 7 percent discount rate).
OSHA's reasons for including each of the proposed ancillary provisions are explained in Section XVIII of this preamble, Summary and Explanation of the Standards. In particular, OSHA is proposing the requirements for exposure assessment to provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is especially important because workers exposed above the proposed TWA PEL, as well as many workers exposed below the proposed TWA PEL, are at significant risk of death and illness. Medical surveillance would allow for identification of beryllium-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA is proposing regulated areas and access control because they serve to limit exposure to beryllium to as few employees as possible. OSHA is proposing worker training to ensure that employers inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize their exposure to beryllium. Worker training on beryllium-related work practices is particularly important in controlling beryllium exposures because engineering controls frequently require action on the part of workers to function effectively.
OSHA has examined a variety of regulatory alternatives involving changes to one or more of the proposed ancillary provisions. The incremental cost of each of these regulatory alternatives and its impact on the total costs of the proposed rule is summarized in Table IX-27 at the end of this section. OSHA has preliminarily determined that several of these ancillary provisions will increase the benefits of the proposed 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 proposed 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
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 proposed TWA PEL of 0.2 μg/m
Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1 and Z-2, so that the proposed TWA PEL and STEL would apply to all workers in general industry. This alternative would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical surveillance, medical removal, PPE, housekeeping, training, and regulated areas or access control. Under this regulatory alternative, OSHA estimates that the costs for the proposed ancillary provisions of the rule (estimated at $27.8 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 USW, 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 these costs under Regulatory Alternative #7 would reasonably be attributable to the proposed rule. OSHA welcomes comment on the issue.
OSHA has also estimated the effect of this regulatory alternative on the benefits of the rule. As a result of eliminating all of the ancillary provisions, annualized benefits are estimated to decrease 57 percent, relative to the proposed rule, from $575.8 million to $249.1 million, using a 3 percent discount rate, and from $255.3 million to $110.4 million using a 7 percent discount rate. This estimate follows from OSHA's analysis of benefits in Chapter VII of the PEA, which found that about 57 percent of the benefits of the proposed 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 proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed 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 the primary beryllium manufacturing industry 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 USW, 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 proposed TWA PEL alone could achieve.
Moreover, where there is continuing significant risk at the TWA PEL, the decision in the Asbestos case (
Under Regulatory Alternative #8, several ancillary provisions that the current proposal would require under a variety of exposure conditions (
To estimate the cost savings for this alternative, OSHA re-estimated the group of workers that would fall under the above provisions and the changes to their scope. Combining these various adjustments along with associated unit costs, OSHA estimates that, under this regulatory alternative, the costs for the proposed rule would decline from $37.6 million to $18.9 million using a 3 percent discount rate and from $39.1 million to $20.0 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 proposed 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 proposed TWA PEL and STEL could achieve. OSHA's preliminary conclusion is that the requirements triggered by the action level and other exposures below the proposed PELs will result in very real and necessary, but difficult to quantify, further reduction in risk beyond that provided by the PELs alone.
The remainder of this section discusses additional regulatory alternatives that apply to individual
Proposed paragraph (e) requires employers to establish and maintain beryllium work areas wherever employees are exposed to airborne beryllium, regardless of the level of exposure, and regulated areas wherever airborne concentrations of beryllium exceed the TWA PEL or STEL. Employers are required to demarcate beryllium work areas and regulated areas and limit access to regulated areas to authorized persons.
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. This alternative is meant only to eliminate the requirement to set up and demarcate specific physical areas: All ancillary provisions would be triggered by the same conditions as under the standard's definition of a “regulated area.” For example, under the current proposal, employees who work in regulated areas for at least 30 days annually are eligible for medical surveillance. If OSHA were to remove the requirement to establish regulated areas, the medical surveillance provisions would be altered so that employees who work more than 30 days annually in jobs or areas with exposures that exceed the TWA PEL or STEL are eligible for medical surveillance. This alternative would not eliminate the proposed requirement to establish beryllium work areas. As shown in Table IX-27, Regulatory Alternative #12 would decrease the annualized cost of the proposed rule by about $522,000 using a 3 percent discount rate, and by about $523,000 using a 7 percent discount rate.
The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium in a regulated area (
OSHA estimated in Chapter V of the PEA that the medical surveillance requirements would apply to 4,528 workers in general industry, of whom 387 already receive that surveillance.
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 proposal, which was modified since the SBAR Panel was convened (see this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, for more detailed discussion). The regulatory alternatives presented in this sub-section (#16, #18, and #20) also respond to recommendations by the SBAR Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements. OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exists at exposure levels below the proposed TWA PEL and that there is evidence that beryllium sensitization can occur even from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII, 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 this preamble at Section V, Health Effects).
In response to concerns raised during the SBAR Panel process about testing requirements, OSHA is considering 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 IX-27, this alternative would decrease the annualized cost of the proposed rule by about $710,000 using a discount rate of 3 percent, and by about $724,000 using a discount rate of 7 percent.
Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule. This alternative would decrease the annualized cost of the proposed rule by about $472,000 using a discount rate of 3 percent, and by about $481,000 using a discount rate of 7 percent.
OSHA is considering several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. The frequency of periodic medical surveillance is an important factor in the efficacy of the surveillance in protecting worker health. Regular, appropriately frequent medical surveillance promotes awareness of beryllium-related health effects and early intervention in disease processes among workers. In addition, the longer the time interval between when a worker becomes sensitized and when the worker's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to sensitization. Therefore, reducing the frequency of sensitization testing would reduce the usefulness of the surveillance information in identifying problem areas and reducing risks to other workers. These concerns must be weighed against the costs and other burdens of surveillance.
Finally, under Regulatory Alternative #20, employers would only have to provide all periodic components of the medical surveillance exams biennially to eligible employees. This alternative would decrease the annualized cost of the proposed rule by about $446,000 using a discount rate of 3 percent and by about $433,000 using a discount rate of 7 percent.
Under paragraph (l) of the proposed standard, Medical Removal, employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. When an employee chooses removal, the employer is required to remove the employee to comparable work in an environment where beryllium exposure is below the action level if such work is available and the employee is either already qualified or can be trained within one month. If comparable work is not available, paragraph (l) would require the employer to place the employee on paid leave for six months or until comparable work becomes available (whichever comes first). Or, rather than choosing removal, an eligible employee could choose to remain in a job with exposure at or above the action level and wear a respirator. The proposed medical removal protection (MRP) requirements are based on the stakeholders' recommended beryllium standard that representatives of the beryllium production industry and the United Steelworkers union submitted to OSHA in 2012 (Materion and USW, 2012).
The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are sensitized or have early-stage CBD (see this preamble at Section VIII, Significance of Risk). As CBD progresses, symptoms become serious and debilitating. Steroid treatment is less effective at later stages, once fibrosis has developed (see this preamble at Section VIII, Significance of Risk). Given the progressive nature of the disease, OSHA believes it is reasonable to conclude that removal from exposure to beryllium will benefit sensitized employees and those with CBD. Physicians at National Jewish Health, one of the main CBD research and treatment sites in the US, “consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,” and “recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average” (NJMRC, 2013). However, OSHA is aware that MRP may prove costly and burdensome for some employers and that the scientific literature on the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD is limited.
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 proposed requirement that employers offer MRP. As shown in Table IX-27, this alternative would decrease the annualized cost of the proposed rule by about $149,000 using a discount rate of 3 percent, and by about $166,000 using a discount rate of 7 percent.
As proposed, the new standard would become effective 60 days following publication in the
OSHA invites suggestions for alternative phase-in schedules for engineering controls, medical surveillance, and other provisions of the standard. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), some general outcomes are likely. For example, a longer phase-in time would have several advantages, such as reducing initial costs of the standard or allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However, a longer phase-in would also postpone and reduce the benefits of the standard. Suggestions for alternatives may apply to specific industries (
OSHA requests comments on all these regulatory alternatives, including the Agency's regulatory alternatives presented above, the Agency's analysis of these alternatives, and whether there are other regulatory alternatives the Agency should consider.
Table IX-28 lists all of the SBAR Panel recommendations and OSHA's response to those recommendations.
The proposed general industry standard for occupational exposure to beryllium contains 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-95), 44 U.S.C. 3501
Under PRA-95, a Federal agency cannot conduct or sponsor a collection of information unless OMB approves it, and the agency displays a currently valid OMB control number. In addition, the public is not required to respond to a collection of information unless the collection of information displays a currently valid OMB control number. Also, notwithstanding any other provision of law, no person 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.
OSHA prepared and submitted an Information Collection Request (ICR) for the collection of information requirements identified in this NPRM to OMB for review in accordance with 44 U.S.C. 3507(d). The Agency solicits comments on the proposed collection of information requirements and the estimated burden hours and costs associated with these requirements, including comments on the following items:
• Whether the proposed collection of information requirements are necessary for the proper performance of the
• The accuracy of OSHA's estimate of the burden (time and cost) of the information collection requirements, 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.
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(1), the following paragraphs provide information about this ICR.
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Below is a summary of the collection of information requirements identified in the Beryllium proposal. Specific details contained in the following collections of information requirements are discussed in Section XVIII:
Under paragraph (d)(5)(i) of the proposed standard, within 15 working days after receiving the results of any exposure monitoring completed under this standard, employers must notify each employee whose exposure is characterized by the monitoring in writing. Employers must either notify each of these employees individually in writing, or post the exposure monitoring results in an appropriate location accessible to all of these employees. In this proposed standard, the following provisions require exposure monitoring: § 1910.1024(d)(1), General; § 1910.1024(d)(2), Initial Exposure Monitoring; § 1910.1024(d)(3), Periodic Exposure Monitoring; § 1910.1024(d)(4), Additional Monitoring.
Proposed paragraph (d)(5)(ii) details additional information an employer would need to include in the written notification in (d)(5)(i), should beryllium exposure exceed the TWA PEL or STEL: a description of the suspected or known sources of exposure, and the corrective action(s) the employer has taken or will take to reduce the employee's exposure to or below the applicable PEL.
Proposed paragraph (e)(2)(i) would require employers to identify each beryllium work area through signs or any other methods that adequately establish and inform each employee of the boundaries of each beryllium work area. Paragraph (e)(2)(ii) would require employers to identify each regulated area in accordance with paragraph (m)(2).
Proposed paragraph (f)(1)(i) would require employers to establish, implement, and maintain a written exposure control plan for beryllium work areas. The plan must contain: (A) An inventory of operations and job titles reasonably expected to have exposure; (B) an inventory of operations and job titles reasonably expected to have exposure at or above the action level; (C) an inventory of operations and job titles reasonably expected to have exposure above the TWA PEL or STEL; (D) procedures for minimizing cross-contamination, including but not limited to preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas; (E) procedures for keeping surfaces in the beryllium work area 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) an inventory of engineering and work practice controls; and (H) procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.
Proposed paragraph (f)(1)(ii) would require employers to update their exposure control plans whenever 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. Paragraph (f)(1)(ii) also requires employers to update their plans when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows other signs or symptoms related to beryllium exposure. In addition, this paragraph requires employers to update their plans if the employer has any reason to believe that new or additional exposures are occurring or will occur. Proposed paragraph (f)(1)(iii) would require employers 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)).
Proposed paragraph (g)(1) would require employers to provide at no cost and ensure that each employee uses respiratory protection during certain periods or operations. Where the proposed standard requires an employee to use respiratory protection, proposed paragraph (g)(2) requires such use to be in accordance with the Respiratory Protection Standard (29 CFR 1910.134).
The Respiratory Protection Standard's collection of information requirements indicate that employers must: develop a written respirator program; obtain and maintain employee medical evaluation records; provide the physician or other licensed health care professional (PLHCP) with information about the employee's respirator and the conditions under which the employee will use the respirator; administer fit tests for employees who will use negative- or positive-pressure, tight-fitting facepieces; and establish and retain written information regarding medical evaluations, fit testing, and the respirator program.
Proposed paragraph (h)(2)(v) would require employers to ensure that any protective clothing or equipment required by the standard which is removed from the workplace for laundering, cleaning, maintenance, or disposal is labeled in accordance with paragraph (m)(3) of the proposed standard and the Hazard Communication standard at 29 CFR 1910.1200.
Proposed paragraph (h)(3)(iii) would require employers to inform in writing the persons or the business entities who launder, clean or repair the protective clothing or equipment required by this
Proposed paragraph (j)(3)(i) requires waste, debris, and materials visibly contaminated with beryllium and consigned for disposal to be disposed of in sealed, impermeable enclosures. Proposed paragraph (j)(3)(ii) requires these enclosures to be labeled in accordance with proposed paragraph (m)(3) of the standard.
Proposed paragraph (j)(3)(iii) requires materials designated for recycling that are visibly contaminated with beryllium to be cleaned to remove the visible particulate or placed in sealed, impermeable enclosures that are labeled in accordance with proposed paragraph (m)(3) of the standard.
Proposed paragraph (k)(1) details when and under what conditions an employer must make medical surveillance available to its employees. Paragraph (k)(2) of the proposed standard specifies the frequency of medical examinations that are to be offered to those employees covered by the medical surveillance program, and proposed paragraph (k)(3) details the content of the medical examinations.
Proposed paragraph (k)(4) would require employers to provide a copy of this standard and its appendices to the examining PLHCP. In addition, the proposed paragraph would require employers to provide the following information, if known, to the PLHCP: (A) A description of the employee's former and current duties that relate to the employee's occupational exposure; (B) the employee's former and current levels of occupational exposure; (C) a description of any protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that protective clothing and equipment; and (D) information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining a medical release from the employee.
Under proposed paragraph (k)(5)(i), the employer must obtain a written medical opinion from the licensed physician within 30 days of the employee's medical examination. The written medical opinion must contain the following information: (A) 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 exposure; (B) any recommended limitations on the employee's exposure, including the use and limitations of protective clothing or equipment, including respirators; and (C) 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 exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
Proposed paragraph (k)(5)(ii) would require the employer to ensure that neither the licensed physician nor any other PLHCP reveals to the employer findings or diagnoses which are unrelated to beryllium exposure.
Proposed paragraph (k)(5)(iii) would require the employer to provide a copy of the licensed physician's written medical opinion to the employee within two weeks after receiving it.
Proposed paragraph (k)(7) would require employers, upon request by OSHA, to convey employees' beryllium sensitization test results to OSHA for evaluation and analysis.
Proposed paragraph (m)(1)(i) would require chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the Hazard Communication Standard (HCS) for beryllium (29 CFR 1910.1200). Proposed paragraph (m)(1)(ii) requires that when classifying the hazards of beryllium, the employer must address at least the following: cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation.
Proposed paragraph (m)(1)(iii) would require 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.
Proposed paragraph (m)(2)(i) would require employers to post 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) would require these signs to be legible and readily visible, and contains language that would be required to appear on each warning sign.
Proposed paragraph (m)(3) would require employers to label each bag and container of clothing, equipment, and materials visibly contaminated with beryllium consistent with the Hazard Communication standard at 29 CFR 1910.1200. Proposed paragraph (m)(3) also contains language that would be required to appear on every such label.
Proposed paragraph (m)(4)(iv) would require employers to make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative.
Paragraph (m)(4)(iv) requires that employers make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative.
Proposed paragraph (n)(1)(i) would require employers to keep records of all measurements taken to monitor employee exposure to beryllium as required by paragraph (d) of the standard.
Proposed paragraph (n)(1)(ii) would require employers to include at least the following information in the records: (A) The date of measurement for each sample taken; (B) the operation 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.
Proposed paragraph (n)(1)(iii) would require employers to maintain employee exposure monitoring records in
Proposed paragraph (n)(2)(i) would require employers to establish an accurate record of any historical monitoring data used to satisfy the initial monitoring requirements in paragraph (d)(2) of the proposed standard. Paragraph (n)(2)(ii) would require the employer to demonstrate that the data comply with the requirements of paragraph (d)(2) of the standard. Paragraph (n)(2)(iii) would require the employer to maintain historical monitoring data in accordance with 29 CFR 1910.1020.
Proposed paragraph (n)(3)(i) would require employers to establish accurate records of any objective data relied upon to satisfy the requirement for initial monitoring in proposed paragraph (d)(2). Proposed paragraph (n)(3)(ii) would require employers to have at least the following information in such records: (A) The data relied upon; (B) the beryllium-containing material in question; (C) the source of the objective data; (D) a description of the operation exempted from initial monitoring and how the data support the exemption; and (E) other information demonstrating that the data meet the requirements for objective data contained in paragraph (d)(2)(ii) of the proposed standard. Proposed paragraph (n)(3)(iii) would require employers to maintain objective data records in accordance with 29 CFR 1910.1020.
Proposed paragraph (n)(4)(i) would require employers to establish accurate records for each employee covered by the medical surveillance requirements in proposed paragraph (k). Proposed paragraph (n)(4)(ii) would require employers to include in employee medical records the following information about the employee: (A) Name, social security number, and job classification; (B) a copy of all licensed physicians' written opinions; and (C) a copy of the information provided to the PLHCP as required by paragraph (k)(4) of the proposed standard. Proposed paragraph (n)(4)(iii) would require employers to maintain medical records in accordance with 29 CFR 1910.1020.
Proposed paragraph (n)(5)(i) would require employers to prepare an employee training record at the completion of any training required by the proposed standard. The training record must contain the following information: The name, social security number, and job classification of each employee trained; the date the training was completed; and the topic of the training. Proposed paragraph (n)(5)(ii) would require employers to maintain employee training records for three years after the completion of training. This record maintenance requirement would also apply to records of annual retraining or additional training as described in paragraph (m)(4) of the proposed standard.
Under proposed paragraph (n)(6), employers must make all records maintained as a requirement of the standard available for examination and copying to the Assistant Secretary, the Director of NIOSH, each employee, and each employee's designated representative(s) in accordance with the
Paragraph (n)(7) of the proposed standard would require employers to comply with the transfer requirements contained in the
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Members of the public who wish to comment on the paperwork requirements in this proposal must send their written comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, OSHA (RIN-1218-AB76), Office of Management and Budget, Room 10235, Washington, DC 20503, Fax: 202-395-5806 (this is not a toll-free numbers), email:
To access the docket to read or download comments and other materials related to this paperwork determination, including the complete Information Collection Request (ICR) (containing the Supporting Statement with attachments describing the paperwork determinations in detail) use the procedures described under the section of this notice titled ADDRESSES. You also may obtain an electronic copy of the complete ICR by visiting the Web page at
The Agency reviewed the proposed beryllium rule according to the Executive Order (E.O.) on Federalism (E.O. 13132, 64 FR 43255, Aug. 10, 1999), which requires that Federal
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; States that obtain Federal approval for such a plan are referred to 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.
While OSHA drafted this proposed rule to protect employees in every State, Section 18(c)(2) of the OSHA Act permits State-Plan States to develop and enforce their own standards, provided the requirements in these standards are at least as safe and healthful as the requirements specified in this proposed rule if it is promulgated.
In summary, this proposed 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.
When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, the 27 State and U.S. territories with their own OSHA-approved occupational safety and health plans (“State-Plan States”) must revise their standards to reflect the new standard or amendment. The State standard must be at least as effective as the Federal standard or amendment, and must be promulgated within six months of the publication date of the final Federal rule. 29 CFR 1953.5(a).
The State may demonstrate that a standard change is not necessary because, for example, the State standard is already the same as or at least as effective as the Federal standard change. 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 27 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 five states and territories whose OSHA-approved State plans cover only public-sector employees are: Connecticut, Illinois, New Jersey, New York, and the Virgin Islands.
This proposed beryllium rule applies to general industry. If adopted as proposed, all State Plan States would be required to revise their general industry standard appropriately within six months of Federal promulgation.
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” in any one year before issuing a notice of proposed rulemaking. OSHA's proposal 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 (
Based on the analysis presented in the Preliminary Economic Analysis (see Section IX above), OSHA concludes that the proposal would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. The Preliminary Economic Analysis constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits required under Section 202(a) of the UMRA (2 U.S.C. 1532).
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 proposed beryllium rule is economically significant under E.O. 12866 (see Section IX of this preamble). However, after reviewing the proposed beryllium rule, OSHA has determined that the rule would not impose environmental health or safety risks to children as set forth in E.O. 13045. The proposed rule would require employers to limit employee exposure to beryllium and take other precautions to protect employees from adverse health effects
OSHA has reviewed the beryllium proposal according to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
OSHA reviewed this proposed rule in accordance with E.O. 13175 on Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), and determined that it does not have “tribal implications” as defined in that order. The rule, if promulgated, would 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.
OSHA encourages members of the public to participate in this rulemaking by submitting comments on the proposal.
This section of the preamble explains the requirements that OSHA proposes to control occupational exposure to beryllium, including the purpose of these requirements and how they will protect workers from hazardous beryllium exposures.
OSHA believes, based on currently available information, that the proposed requirements are necessary and appropriate to protect workers exposed to beryllium. In developing this proposed rule, OSHA has considered many sources of data and information, including responses to the Request for Information (RFI) for “Occupational Exposure to Beryllium” (OSHA, 2002); the responses from Small Entity Representatives (SERs) who participated in the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601
The provisions in the proposed standard are generally consistent with other recent OSHA health standards, such as chromium (VI)(29 CFR 1910.1026) and cadmium (29 CFR 1910.1027). Using a similar approach across health standards, when possible, makes them more understandable and easier for employers to follow, and helps to facilitate uniformity of interpretation. This approach is also consistent with section 6(b)(5) of the OSH Act, which states that health standards shall consider “experience gained under this and other health and safety laws” (29 U.S.C. 655(b)(5)). However, to the extent that protecting workers from occupational exposure to beryllium requires different or unique approaches, the Agency has formulated proposed requirements to address the specific hazards and working conditions associated with beryllium exposure.
Also pursuant to section 6(b)(5), OSHA has expressed the proposed requirements in performance-based language, where possible, to provide employers with greater flexibility in determining the most effective strategies for controlling beryllium hazards in their workplaces. OSHA believes this approach allows employers to incorporate changes and advancements in control strategy, technology, and industry practice, thereby reducing the need to revise the rule when those changes occur.
In paragraph (a)(1), OSHA proposes to apply this standard to occupational exposure to beryllium in all forms, compounds, and mixtures in general industry.
For the purpose of the proposed rule, OSHA is treating beryllium generally, instead of individually addressing specific compounds, forms, and mixtures. Based on a review of scientific studies, OSHA has preliminarily determined that the toxicological effects of beryllium exposure on the human body are similar regardless of the form of beryllium (see the Health Effects section of this preamble at V.B.5; V.G). OSHA is not aware of any information that would lead the Agency to conclude that exposure to different forms of beryllium necessitates different regulatory approaches or requirements.
OSHA has preliminarily decided to limit the scope of the rulemaking to general industry. This proposal is modeled on a suggested rule that was crafted by two major stakeholders in general industry, Materion Brush and the United Steelworkers Union (Materion and USW, 2012). In the course of developing this proposal, they provided OSHA with data on exposure and control measures and information on their experiences with handling beryllium in general industry settings. At this time, the information available to OSHA on beryllium exposures outside of general industry is limited, but suggests that most operations in other sectors are unlikely to involve beryllium exposure. The Agency hopes to expedite the rulemaking process by limiting the scope of this proposal to general industry and relying on already existing standards to protect workers in those operations outside of general industry where beryllium exposure may exist.
The proposed rule would not apply to marine terminals, longshoring, or agriculture. OSHA has not found evidence indicating that beryllium is used or handled in these sectors in a way that might result in beryllium exposure. The proposed rule also excludes the construction and shipyard sectors. OSHA believes that occupational exposures to beryllium in
Abrasive blasters and ancillary abrasive blasting workers are exposed to beryllium from coal slag and other abrasive blast material that may contain beryllium as a trace contaminant. Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 μg/m
To address high concentrations of various hazardous chemicals in abrasive blasting material, employers must already be using engineering and work practice controls to limit workers' exposures and must be supplementing these controls with respiratory protection when necessary. For example, abrasive blasters in the construction industry fall under the protection of the Ventilation standard (29 CFR 1926.57). The Ventilation standard includes an abrasive blasting subsection (29 CFR 1926.57(f)), which requires that abrasive blasting respirators be worn by all abrasive blasting operators when working inside blast-cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand in manual blasting operations where the nozzle and blast are not physically separated from the operator in an exhaust-ventilated enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures to hazardous substances in excess of the limits set in § 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971)). For maritime, standard 29 CFR 1915.34(c) covers similar requirements for respiratory protection needed in blasting operations. Due to these requirements, OSHA believes that abrasive blasters already have controls in place and wear respiratory protection during blasting operations. Thus, in estimating costs for Regulatory Alternatives #2a and #2b, OSHA judged that the reduction of the TWA PEL would not impose costs for additional engineering controls or respiratory protection in abrasive blasting (see Appendix VIII-C in this chapter for details). OSHA requests comment on this issue—in particular, whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE that would be required by Regulatory Alternatives #2a and #2b.
OSHA requests comment on the limitation of the scope to general industry, as well as information on beryllium exposures in all industry sectors. The Agency requests information on whether employees in the construction, maritime, longshoring, shipyard, and agricultural sectors are exposed to beryllium in any form and, if so, their levels of exposure and what types of exposure controls are currently in place. In particular, OSHA requests comment on whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE. OSHA also requests comment on Regulatory Alternatives #2a and #2b, presented at the end of this section, that would provide protection to workers in sectors outside of general industry. Regulatory Alternative #2a would expand the scope of the proposed standard to include employers in construction and maritime. Regulatory #2b would change the Z tables in 29 CFR 1910.1000 and 29 CFR 1915.1000, and Appendix A of 29 CFR 1926.55, to lower the permissible exposure limits for beryllium for workers in all beryllium-exposed occupations. Another regulatory alternative that would impact the scope of affected industries, extending eligibility for medical surveillance to employees in shipyards, construction, and parts of general industry excluded from the scope of the proposed standard, is discussed along with other medical surveillance alternatives (see this preamble at Section XVIII, paragraph (k), Regulatory Alternative #21). Depending on the nature of the data and comments provided, OSHA envisions possible expansions of its regulation of beryllium either as part of this rulemaking or at a later time.
Paragraph (a)(2) specifies that the proposed rule would 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. The HCS defines an article as “a manufactured item other than a fluid or particle: (i) Which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities
Paragraph (a)(3) specifies that the proposed rule would not apply to materials containing less than 0.1% beryllium by weight. A similar exemption is included in several previously promulgated 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 to limit the regulatory burden on employers who do not use materials containing 0.1 percent or more of the substance in question, on the premise that workers in exempted industries are not exposed at levels of concern. 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, August 10, 1992). The exemption in the BD standard does not apply where airborne concentrations generated by such mixtures can exceed the action level or STEL. 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 belief that the exemption would encourage employers to reduce the concentration of benzene in certain
OSHA is aware of two industries in the general industry sector that would be exempted from the proposed standard under proposed paragraph (a)(3): Coal-fired electric power generation and primary aluminum production. As discussed in the PEA, Chapter IV, Appendices A and B, most employees' TWA exposures in these industries do not exceed the proposed action level of 0.1 μg/m
OSHA requests comment on the exemption proposed for the beryllium standard. Is it appropriate to include an exemption for operations where beryllium exists only as a trace contaminant, but some workers can nevertheless be significantly exposed? Should the Agency consider dropping the exemption, or constraining it to operations where exposures are below the proposed action level and STEL? OSHA requests additional data describing the levels of airborne beryllium in workplaces that fall under this exemption and comments on regulatory alternatives, discussed at the end of this section, that would eliminate or modify the exemption.
A number of stakeholders, including SERs who participated in the SBREFA process, urged OSHA to exempt certain industries or processes and activities from the proposed standard. In support of this request, SERs from the stamping industry argued that their exposures are low, below 0.2 µg/m
The Panel's recommendation is addressed in part in this proposed standard, which has a much more limited scope than the draft standard reviewed by the SBREFA Panel. Whereas the draft reviewed by the Panel covered beryllium in all forms and compounds in general industry, construction, and maritime, the scope of the current beryllium proposal includes general industry only, and does not apply to employers in construction and maritime. In addition, it provides an exemption for those working with materials that contain beryllium only as a trace contaminant (less than 0.1 percent composition by weight).
Although much narrower than the scope in the SBREFA draft, the current proposal's scope includes industries of concern for some SERs. OSHA's preliminary feasibility analysis indicates that worker exposures in both dental laboratories and stamping facilities exceed or have the potential to exceed the proposed TWA PEL where appropriate controls are not in place (see section IX of this preamble, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis). Accordingly, OSHA has not exempted them from the proposed standard. However, if employers in these industries have historical or objective data that meet the requirements set forth in proposed paragraph (d)(2) demonstrating that they have no exposures or that exposures are below the action level and at or below the STEL, these employers may be able to satisfy many of their obligations under this proposed standard by reference to these data.
Some stakeholders, including employers who do stripping operations, urged that OSHA exempt them from the proposed rule because any beryllium exposures generated in their facilities were comprised of larger-sized particles, which they contended were not as harmful as smaller ones (OSHA, 2008b). OSHA has decided not to exempt operations based on particle size. As discussed in this preamble at section V, Health Effects, there is not sufficient evidence to demonstrate that particle size has a significant bearing on health outcomes.
While acknowledging the concerns raised by SERs that the scope of the standard might be too broad, OSHA is concerned that the scope of the current proposal might be too narrow. Exposures have the potential to exceed the proposed PEL in some blasting operations in construction and maritime, and in some general industry operations where beryllium exists as a trace contaminant. Abrasive blasters and ancillary abrasive blasting workers are exposed to beryllium from coal slags and other abrasive blast material, which contain beryllium in amounts less than 0.1 percent. Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 μg/m
OSHA invites comment on the proposed scope of the standard and on Regulatory Alternatives 1 and 2 below, which would increase protection for workers in maritime and construction industries and in occupations dealing with beryllium as a trace contaminant.
Regulatory Alternative #1a would modify the proposed scope to eliminate the exemption for materials containing less than 0.1 percent beryllium by weight. Under this alternative, the scope of the rule would cover employers in general industry, including industries or occupations where beryllium exists as a trace contaminant. Regulatory Alternative #1a would expand the scope of the proposed standard to include all operations in general industry where beryllium exists only as a trace contaminant; that is, where the materials used contain no more than 0.1 percent beryllium by weight. Regulatory
These two alternatives would increase protections for workers in the construction and maritime sectors. Regulatory alternative #2a would expand the scope of the proposed standard to also include employers in construction and maritime. For example, this alternative 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. Regulatory alternative #2b would amend 29 CFR 1910.1000 Table Z-1, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A to replace the current permissible exposure limits for beryllium and beryllium compounds (and the reference in 1910.1000 Table Z-1 to Table Z-2) with the TWA PEL and STEL adopted through this rulemaking. This alternative would also delete the entry for beryllium and beryllium compounds in 29 CFR 1910.1000 Table Z-2 because the entry would instead be listed in Table Z-1 as described above. Note that OSHA is proposing an 8-hour TWA PEL of 0.2 μg/m
The Z Tables and 1926.55 Appendix A do not incorporate ancillary provisions such as exposure monitoring, medical surveillance, medical removal, and PPE. However, many of the occupations excluded from the scope of the proposed beryllium standard receive some ancillary provision protections from other rules, such as Personal Protective Equipment (1910 Subpart I, 1915 Subpart I, 1926.28, also 1926 Subpart E), Ventilation (1926.57), Hazard Communication (1910.1200), and specific provisions for welding (1910 Subpart Q, 1915 Subpart D, 1926 Subpart J) and abrasive blasting (1910.109, 1926 Subpart U).
Proposed paragraph (b) includes definitions of key terms used in the proposed standard. To the extent possible, OSHA uses the same terms and definitions in the proposed 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.
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OSHA's preliminary risk assessment indicates that significant risk remains at the proposed TWA PEL (see this preamble at section VI, Significance of Risk). When there is a continuing exposure risk 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 for proposing an action level involves the variable nature of employee exposures to beryllium. Because of this fact, OSHA believes 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 proposed paragraph (d)(3).
OSHA's decision to propose 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), and methylene chloride (29 CFR 1910.1052).
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The presence of a beryllium work area triggers a number of the requirements in this proposal. Under paragraphs (d)(1)(ii) and (iii), employers must determine exposures for each beryllium work area. Furthermore, 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), employers must establish and maintain a written exposure control plan for beryllium work areas. And paragraph (f)(2)(i) requires employers to implement at least one of the controls listed in (f)(2)(i)(A)(1) through (4) for each operation in a beryllium work area unless one of the exemptions in (f)(2)(i)(B) applies. In addition, paragraph (i)(1) requires employers to provide readily accessible washing facilities to employees working in a beryllium work area, and to instruct employees to use these facilities when necessary. Where employees are allowed to eat or drink in beryllium work areas, employers must ensure that surfaces in these areas are as free as practicable of beryllium, that exposures are below the action level, and 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.
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Proposed paragraph (k)(6) requires employers to offer employees who have been confirmed positive a referral to a CBD diagnostic center for a clinical evaluation.
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Paragraph (f)(1)(ii)(B) requires employers to update the exposure control plan whenever an employee is confirmed positive or is diagnosed with CBD. Under proposed paragraph (k)(3)(ii)(E), employers are required to ensure that a BeLPT is offered to each eligible employee at the employee's first medical examination under this proposed standard, and every two years from the date of the first examination unless the employee receives an abnormal BeLPT result. If the employee's first BeLPT result is abnormal, the employer must provide the employee a second test within one month of the first test. If the employee's second BeLPT result is also abnormal, the employee is considered confirmed positive for purposes of this proposed standard. OSHA requests comment on the methods used to determine when a BeLPT test result is abnormal, and on standardizing the use and interpretation of the BeLPT (see section I of this preamble, Issues and Alternatives).
A confirmed positive result will indicate to the licensed physician that the employee is sensitized to beryllium and is at increased risk of developing CBD (see paragraph (k)(5)(i)(A)). Employees who are confirmed positive are eligible for medical removal under proposed paragraph (l)(1).
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Emergencies trigger several requirements of this proposed 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), employers must train employees in applicable emergency procedures.
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Under paragraph (k)(5) of the proposed standard, the written medical opinion must 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 (see paragraphs (k)(1)(ii), (k)(3)(i), (k)(3)(ii)(G), (k)(5)(i)(C), and (k)(5)(ii)). The proposed standard also identifies what information must be given to the PLHCP providing the services listed in this standard, and requires that employers maintain a record of this information (see paragraphs (k)(4) and (n)(4)(ii)(C)).
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), and methylene chloride (29 CFR 1910.1052).
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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 proposed paragraph (m)). 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. Proposed paragraph (i)(5)(i) prohibits employers from allowing employees to eat, drink, smoke, chew tobacco or gum, or apply cosmetics in regulated areas.
Under proposed paragraph (k)(1)(i)(A), employees who have worked in a regulated area for more than 30 days in the previous 12 months are eligible for medical surveillance. In addition, proposed paragraph (m)(2) requires warning signs associated with regulated areas to meet certain specifications. Proposed paragraph (m)(4) requires employers to train employees in the written exposure control plan required by paragraph (f)(1), including the location of regulated areas.
This proposed definition of regulated areas is consistent with other substance-specific health standards, such as Cadmium (29 CFR 1910.1027), Butadiene (29 CFR 1910.1051), and Methylene Chloride (29 CFR 1910.1052).
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Paragraph (c) of the proposed standard 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
The TWA PEL section of the proposed standard requires employers to ensure that each employee's exposure to beryllium, averaged over the course of an 8-hour work shift, does not exceed 0.2 μg/m
OSHA believes this proposed PEL would be feasible across all affected industry sectors (see section IX.D of this preamble, Technological Feasibility) and that compliance with the proposed PEL would substantially reduce employees' risks of beryllium sensitization, CBD, and lung cancer (see section VI of this preamble, Preliminary Beryllium Risk Assessment). OSHA's confidence in the feasibility of the proposed PEL is high, based both on the preliminary results of the Agency's feasibility analysis and on the recommendation of the proposed PEL by Materion Corporation and the United Steelworkers. 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. As with several other provisions of the proposed standard, OSHA's proposal for the TWA PEL follows the draft recommended standard submitted to the Agency by Materion and the Steelworkers Union (see this preamble at section III, Events Leading to the Proposed Standard).
OSHA's preliminary risk assessment indicates that the risks remaining at the proposed TWA PEL—while much lower than risks at the current PEL—are still significant (see this preamble at section VIII, Significance of Risk). In addition to the proposed PEL, the Agency is considering an alternative PEL of 0.1 μg/m
Because significant risks of sensitization and CBD remain at both 0.1 μg/m
Other federal agencies and organizations have recommended occupational exposure limits for beryllium. As mentioned in this preamble at section III, Events Leading to the Proposed Standard, in 1999 the Department of Energy (DOE) issued its Chronic Beryllium Disease Prevention Program rule (10 CFR part 850). The DOE rule established a beryllium action level of 0.2 μg/m
NIOSH has published a Recommended Exposure Limit (REL) of 0.5 μg/m
The SERs who participated in the SBREFA process had few comments about the proposed PELs (OSHA, 2008b). The major concerns about a reduced TWA PEL were economic impact and belief that beryllium-related health effects did not frequently occur in their industries (OSHA, 2008b). The Panel recommended that OSHA consider to what extent a very low PEL may result in increased costs to small entities. In section V of the Preliminary Economic Analysis (OSHA, 2014), OSHA considers the costs of the proposed PEL and ancillary provisions triggered by the PEL to all affected entities. In addition, the Agency is considering an alternative PEL of 0.5 μg/m
As discussed in section VIII of this preamble, Significance of Risk, significant risk of CBD remains at the proposed 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 that 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 been shown to contribute to the development of lung disease in experimental animals. Beagle dogs that were administered a single short-term perinasal exposure to aerosolized beryllium oxide developed a granulomatous lung inflammation similar to CBD, accompanied by an abnormal BeLPT response (Haley
STEL exposures are typically associated with, and need to be measured during, the highest-exposure operations that an employee performs (see proposed paragraph (d)(1)(iii)). OSHA has preliminarily determined that the proposed STEL of 2.0 μg/m
The current entry for beryllium and beryllium compounds (as Be) in 29 CFR 1910.1000 Table Z-1 directs the reader to the entry for beryllium and beryllium compounds in 29 CFR 1910.1000 Table Z-2. Table Z-2's entry for beryllium and beryllium compounds includes the current TWA PEL of 2 μg/m
As discussed in this Summary and Explanation section of the preamble regarding paragraph (a), the scope of the proposed rule is limited to general industry. In addition, it provides an exemption for those working with materials that contain beryllium only as a trace contaminant (less than 0.1 percent composition by weight). The proposal would amend the entry for beryllium and beryllium compounds (as Be) in 29 CFR 1910.1000 Table Z-1, to add a cross reference to the new standard for operations or sectors that fall within the scope of the proposed standard, and note that industries not covered under the proposed standard would continue to be covered by the entry in 29 CFR 1910.1000 Table Z-2. The TWA, ceiling, and maximum peak exposure limits in 29 CFR 1910.1000 Table Z-2 would still apply to general industry applications and sectors exempted from the proposed standard. Under the proposed standard, the exposure limits in the current 29 CFR 1915.1000 Table Z and 29 CFR 1926.55 Appendix A would continue to apply in construction and maritime industries. As discussed previously in this preamble at Section I, Issues and Alternatives, and Section XVIII, paragraph (a), OSHA is considering Regulatory Alternative #2b, which would update 29 CFR 1915.1000 Tables Z-1 and Z-2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A to the PEL and STEL adopted through this rulemaking to the general industry, construction, and maritime sectors and applications that do not fall within the scope of the proposed rule. Note that OSHA is proposing a TWA PEL of 0.2 μg/m
OSHA invites comment on the proposed TWA PEL and STEL and on Regulatory Alternatives 3, 4, and 5 below, which specify a lower STEL, a lower TWA PEL, and a higher TWA PEL than those proposed, respectively. OSHA also requests comments and data on the range of TWA and short-term exposures in covered industries and the types of operations and engineering or work practice controls in place where these exposures are occurring.
This alternative would modify the proposed STEL to be five times the TWA PEL, rather than ten times the TWA PEL. Thus, if OSHA promulgates the proposed TWA PEL of 0.2 μg/m
As discussed above, OSHA has preliminarily determined that short-term exposures to beryllium can cause beryllium sensitization, and that therefore a STEL in combination with a TWA PEL adds further protection from risk of harm than that afforded by the proposed 0.2 μg/m
When OSHA regulations in the past have included a STEL, it is typically five times the PEL. For example, OSHA's standard for methylene chloride (29 CFR 1910.1052) specifies an 8-hour TWA PEL of 25 ppm, and a short-term limit of 125 ppm averaged over 15 minutes. The standard for acrylonitrile (29 CFR 1910.1045) sets an 8-hour TWA PEL of 2 ppm, and a short-term limit of 10 ppm averaged over 15 minutes. The final standards for benzene (29 CFR 1910.1028), for ethylene oxide (29 CFR 1910.1047) and for 1,3-Butadiene (29 CFR 1910.1051) specify an 8-hour time-weighted average TWA PEL of 1 ppm and short-term limits of 5 ppm averaged over 15 minutes. OSHA has occasionally deviated from its usual practice of setting a STEL at five times the TWA PEL, as in the cases of formaldehyde (29 CFR 1910.1048) (TWA PEL 0.75 ppm, STEL 2 ppm) and methylenedianiline (29 CFR 1910.1050) (TWA PEL 10 ppb, STEL 100 ppb). OSHA requests comment on whether the beryllium standard should set a STEL at ten times the TWA PEL, as suggested by the Materion-USW joint proposed rule and specified in this proposal, or should it maintain its more usual practice of setting a STEL at five times the PEL.
This alternative would modify the proposed TWA PEL to be 0.1 μg/m
This alternative would modify the proposed TWA PEL to be 0.5 μg/m
Paragraph (d) of the proposed standard imposes monitoring requirements pursuant to section 6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), 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.”
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. Exposure assessment enables employers to meet their legal obligation to ensure that their employees are not exposed to beryllium in excess of the permissible exposure limits and to notify employees of their exposure levels, including any overexposures as required by section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)). In addition, the availability of exposure data enables PLHCPs performing medical examinations to be informed of the extent of an employee's occupational exposures.
Paragraph (d)(1) contains proposed general requirements for exposure monitoring. Under paragraph (d)(1)(i), the monitoring requirements apply whenever there is actual exposure to airborne beryllium at any level, or a reasonable expectation of such exposure. As reflected in the definition of “exposure” in paragraph (b) of this standard, exposure monitoring results must reflect the amount of beryllium an employee would be exposed to without the use of a respirator.
Under paragraph (d)(1)(ii), monitoring to determine employee time-weighted average exposures must represent the employee's average exposure to airborne beryllium over an eight-hour workday. Under paragraph (d)(1)(iii), short term exposures must be characterized by sampling periods of 15 minutes for each operation likely to produce exposures above the STEL.
Employers must accurately characterize the exposure of each employee. In some cases, this will entail monitoring all exposed employees. In other cases, monitoring of “representative” employees is sufficient. Under paragraph (d)(1)(iv), representative exposure sampling is permitted when a number of employees perform essentially the same job under the same conditions. For such situations, it may be sufficient to monitor a fraction of these employees in order to obtain data that are representative of the remaining employees. Representative personal sampling for employees engaged in similar work with beryllium exposure of similar frequency and duration can be achieved by monitoring the employee(s) reasonably expected to have the highest exposures. For example, this may involve monitoring the beryllium exposure of the employee closest to an exposure source. This exposure result may then be attributed to the remaining employees in the group.
Representative exposure monitoring must at a minimum include one full-shift sample taken for each job classification, in each beryllium work area, for each shift. These samples must consist of at least one sample characteristic of the entire shift or consecutive representative samples taken over the length of the shift. Where employees are not performing the same job tasks under the same conditions, representative sampling will not adequately characterize actual exposures, and employers must monitor each employee individually.
Under paragraph (d)(1)(v), the employer would be required to use monitoring and analytical methods that can measure airborne levels of beryllium to an accuracy of plus or minus 25 percent (+/−25 percent and can produce accurate measurements at a statistical confidence level of 95 percent for airborne concentrations at or above the action level. OSHA believes the following methods could 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. It should be noted that most of these analytical methods were validated using soluble beryllium compounds and hence the efficacy of the sample preparation (specifically digestion of particulate beryllium in mineral acids) step must be verified prior to use (Stefaniak et al., 2008). Verification can be aided, in part, through use of an appropriate reference material. However, not all of these methods are appropriate for measuring beryllium oxide, so employers must verify that the analytical methods they use are appropriate for measuring the form(s) of beryllium present in the workplace. A certified reference material consisting of high-fired beryllium oxide is available from the National Institute of Standards and Technology as Standard Reference Material 1877: Beryllium oxide powder. This reference material carries a certified value for beryllium content and was developed to meet the need to demonstrate analytical method efficacy for poorly soluble forms of beryllium (Winchester et al., 2009). OSHA requests comment on whether these methods would satisfy the requirements of proposed paragraph (d)(1)(v), and whether other methods would also meet these criteria.
Rather than specifying a particular method that must be used, OSHA proposes to take a performance-oriented approach and instead allow the employer to use the method of its choosing as long as that method meets the accuracy specifications in paragraph (d)(1)(v), and the reported results represent the total airborne concentration of beryllium for the operation and worker being characterized. For example, a respirable fraction sample or size selective sample would not be directly comparable to either PEL, and therefore would not be considered valid.
Paragraph (d)(2) contains proposed requirements for initial monitoring. OSHA proposes that employers characterize the 8-hour TWA exposure and 15-minute short-term exposure for each employee who is known to be exposed to airborne beryllium at any level or whose exposure is reasonably expected. Further obligations under the standard would be based on the results of this assessment. These obligations may include periodic monitoring, establishment of regulated areas, and implementation of control measures.
Initial monitoring need not be conducted in two circumstances. First, under paragraph (d)(2)(i), initial monitoring is not required where the employer has previously monitored for beryllium exposure and the data were obtained during work operations and under workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations. In addition, the characteristics of the beryllium-containing material being handled when the employer previously monitored must closely resemble the characteristics of the beryllium-containing material used in the employer's current operations. Such historical monitoring must satisfy all other requirements of this section, including the accuracy and confidence requirements in paragraph (d)(1)(v). If these requirements are satisfied, the employer may rely on such earlier monitoring results to satisfy the initial monitoring requirements of this section. This provision is designed to make it clear that OSHA does not intend to require employers who have recently performed appropriate employee monitoring to conduct initial monitoring. For historical data to satisfy the employer's obligation to monitor for 8-hour TWA exposures under paragraph (d)(1)(ii), these data must characterize 8-hour TWA exposures that satisfy the requirements of paragraph (d)(2)(i). For historical monitoring to satisfy an employer's obligation to monitor for 15-minute short-term exposures under paragraph (d)(1)(iii), these data must reflect 15-minute short-term exposures. OSHA anticipates that paragraph (d)(2)(i) will reduce the compliance burden on employers, since redundant monitoring would not be required.
Second, under paragraph (d)(2)(ii), where the employer has objective data demonstrating that a particular product or material containing beryllium or a specific process, operation, or activity involving beryllium cannot release dust, fumes, or mist in concentrations at or above the action level or STEL under any reasonably expected conditions of use, the employer may rely upon such data to satisfy initial monitoring requirements. The data must reflect workplace conditions closely resembling the processes, types of material, control methods, work practices, and environmental conditions in the employer's current operations.
Objective data used in place of initial monitoring under paragraph (d)(2) must demonstrate that the work operation or the product cannot reasonably be foreseen to release beryllium in airborne concentrations at or above the action level or above the STEL under the expected conditions of use that will cause the greatest possible release. The data must demonstrate that exposures cannot meet or exceed the action level
Paragraph (d)(3) contains requirements for periodic monitoring. The requirement for this continued monitoring depends on the results of initial monitoring. If the initial monitoring indicates that employee exposures are below the action level, no further monitoring would be required unless, under paragraph (d)(4), changes in the workplace could result in new or additional exposures. If the initial determination reveals employee exposures to be at or above the action level and at or below the TWA PEL, the employer must perform periodic monitoring at least annually. In stating “at least annually,” OSHA intends that employers must monitor at least once during the 12-month period after initial monitoring is performed, and then at least once in every subsequent 12-month period. Of course, the proposed requirement for annual monitoring does not preclude employers from monitoring more frequently.
OSHA recognizes that exposures in the workplace can vary from day to day, between shifts, and even within the same operation. Beryllium exposures for many operations have been shown to be highly variable, with some exposures exceeding the current TWA PEL. When airborne concentrations fluctuate in this way, the probability of exceeding the PELs increases. Periodic monitoring provides the employer with additional and up-to-date information to use to make informed decisions on whether additional control measures are necessary.
Periodic monitoring provides the employer with exposure information for additional use beyond that of determining compliance with the PELs. Periodic monitoring will provide data to determine whether or not engineering controls are working properly and work practices are effective in preventing exposure. Selection of appropriate respiratory protection also depends on adequate knowledge of employee exposures obtained through periodic monitoring.
This proposal does not require periodic monitoring where exposures are above the TWA PEL, which represents a departure from past OSHA standards such as Chromium (29 CFR 1910.1026) and Cadmium (29 CFR 1910.1027). OSHA has eliminated the requirement for periodic monitoring where exposures are above the PEL in response to a multi-stakeholder proposal to this effect (Materion and Steelworkers, 2012). OSHA anticipates this could be an appropriate way to reduce costs for employers where exposures are above the TWA PEL after the employer has implemented all feasible engineering and work practice controls. However, the employer must continue to assess the status of available
Under paragraph (d)(4), employers are to perform additional monitoring when there is a change in production processes, materials, equipment, personnel, work practices, or control methods, that may result in new or additional exposures to beryllium. 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 requires the employer to perform additional monitoring whenever the employer has any reason to believe that a change has occurred that may result in new or additional exposures. For example, an employer would be required to perform additional monitoring 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 additional monitoring to ascertain if airborne exposures contributed to the positive results of the medical testing. Another example of a situation requiring additional monitoring would be a process modification that would increase the amount of beryllium-containing material used thereby possibly increasing employee exposure. Once additional monitoring has been performed and exposures characterized, the employer can take appropriate action to protect exposed employees.
Under paragraph (d)(5) employers must notify each employee of his or her monitoring results within 15 working days after receiving the results. Employees who must be notified include both the employees whose exposures were monitored directly and those whose exposures are represented by the monitoring. The employer must either notify each employee individually in writing, or post the monitoring results in an appropriate location accessible to all employees required to be notified. This proposed requirement is consistent with other OSHA standards, such as those for methylenedianiline (29 CFR 1910.1050), 1,3-butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052). In addition, whenever the TWA PEL or STEL has been exceeded, the written notification required by paragraph (d)(5)(i) must contain a description of the suspected or known sources of exposure as well as the corrective action(s) being taken by the employer to reduce the employee's exposure to or below the applicable PEL. This requirement is necessary to assure employees that the employer is making efforts to furnish them with a safe and healthful work environment, and is required under section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)).
Paragraph (d)(6) requires the employer to provide employees and their designated representatives an opportunity to observe any monitoring of employee exposure to beryllium. Employees who must be allowed to observe monitoring include both the employees whose exposures are being monitored and those whose exposures are represented by the monitoring. When observation of monitoring requires entry into an area where the use of protective clothing or equipment is required, the employer must provide the observer with that protective clothing or equipment, at no cost. The employer must also assure that the observer uses such clothing or equipment appropriately and complies with all other applicable safety and health requirements and procedures.
The requirement for employers to provide employees and their representatives the opportunity to observe monitoring is consistent with the OSH Act. Section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)) mandates that regulations requiring employers to keep records of employee exposures to toxic materials or harmful physical agents provide employees or their representatives with the opportunity to observe monitoring or measurements. Also, Section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)) states that, where appropriate, OSHA standards are to prescribe suitable protective equipment to be used in dealing with hazards. The provision for observation of monitoring and protection of the observers is also consistent with OSHA's other substance-specific health standards, such as those for cadmium (29 CFR 1910.1027) and methylene chloride (29 CFR 1910.1052).
After reviewing commenter responses to the SBREFA inquiry and the Agency's RFI on beryllium, OSHA has learned that the amount of employer effort and diligence in assessing exposure levels is proportional to the presumed degree of exposure (OSHA, 2008b). Commenters whose companies make products with high-content beryllium are much more likely to have incorporated considerable sampling into their exposure assessment protocol. (Brush Wellman, 2003, Honeywell, 2003). In other instances, where manufacturers use less beryllium or low-content beryllium alloys, such as in specialty or precision products, sampling occurs less frequently. (OSHA, 2007a).
Representatives of various stamping firms who are currently experiencing low levels of exposure felt that their industry as a whole should be exempt from the initial exposure assessment provision of this standard and any additional requirements related to exposure monitoring. (OSHA, 2007a). However, available information demonstrates that initial exposure assessment needs to be applied to all industries where beryllium is processed or otherwise handled (see this preamble at section V, Health Effects). For example, OSHA's technological feasibility analysis for fabrication of beryllium alloy products summarizes exposures for workers in the stamped and formed metal products sector (see this preamble at Section IX.D, Technological Feasibility). Exposure monitoring data indicate that while for most production tasks, the median baseline exposure is less than the proposed action level of 0.1 μg/m
To address many of these comments, OSHA has established performance-oriented language for the exposure assessment provisions of this standard, allowing employers to choose any method of exposure monitoring that meets the accuracy specifications in paragraph (d)(1)(v) of this standard, and that measures the total airborne concentration of beryllium for the operation and worker exposures being characterized. In addition, employers may use historical or objective data in accordance with proposed paragraph (d)(2) of this standard to satisfy their initial monitoring obligations. OSHA
SERs also commented that exposure monitoring is costly and that OSHA should consider alternatives that allow employers with very low exposures to be exempt from monitoring. As a possible means of alleviating costs, the Panel recommended that OSHA encourage the use of objective data and explain more clearly the requirements for its use. (OSHA, 2008b). OSHA has clarified in this preamble the circumstances under which an employer may use historical and objective data in lieu of initial monitoring. OSHA is also considering whether to create a guidance product on the use of objective data. The Agency requests comments on whether a guidance product on the use of objective data would be helpful to businesses seeking to comply with the beryllium standard, and what questions or areas of information it should address.
In addition, OSHA has reduced to annually the frequency of periodic monitoring where exposures are at or above the action level and at or below the TWA PEL, rather than the six-month frequency proposed during the SBREFA process. OSHA has also removed the requirement for periodic monitoring every three months where exposures exceed the PEL. The new provisions were suggested in the Materion-USW recommended standard submitted to OSHA in 2012 (Materion and USW, 2012). While these changes to the proposed standard reduce the cost burden of exposure monitoring for employers, they also may reduce employees' protection from overexposure to beryllium.
OSHA notes that the frequency and performance of exposure monitoring in the draft proposal presented to the SBREFA Panel are similar to OSHA's typical approach to periodic exposure monitoring. Most OSHA standards require monitoring at least every six months where exposure levels meet or exceed the action level, and every three months where exposures are above the TWA PEL. For example, the standards for vinyl chloride (29 CFR 1910.1017), inorganic arsenic (29 CFR 1910.1018), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR 1910.1045), ethylene oxide (29 CFR 1910.1047), formaldehyde (29 CFR 1910.1048), all specify periodic monitoring at least every six months where exposures are above the action level. Periodic exposure monitoring is also required where exposures exceed the PEL in most health standards issued since OSHA began specifying frequency for periodic monitoring. In many cases monitoring is required every three months where exposures exceed the PEL (methylene chloride (29 CFR 1910.1052), ethylene oxide (29 CFR 1910.1047), acrylonitrile (29 CFR 1910.1045), inorganic arsenic (29 CFR 1910.1018), lead (29 CFR 1910.1025), and vinyl chloride (29 CFR 1910.1017)); in other cases, it is required at least every six months (cadmium (29 CFR 1910.1027), 1,3-Butadiene (29 CFR 1910.1051), formaldehyde (29 CFR 1910.1048), benzene (29 CFR 1910.1028) and asbestos (29 CFR 1910.1001)). Thus, the periodic monitoring requirements outlined in this proposal and in the Materion-USW recommended standard depart significantly from OSHA's usual requirements.
OSHA requests comment on the proposed schedule for periodic monitoring. Are the proposed requirements both practical for employers and protective for employees? OSHA also requests comment on Regulatory Alternatives 9, 10, and 11 below, which would modify the frequency and performance of exposure monitoring to be more similar to previous standards and to the draft proposal presented to the SBREFA Panel.
This alternative would require employers to perform exposure monitoring at least every 180 days where exposures are at or above the action level or above the STEL, and at or below the TWA PEL. If the initial monitoring required by paragraph (d)(2) of this section reveals employee 8-hour TWA exposure at or above the action level, the employer shall repeat such monitoring for each such employee at least every 180 days to evaluate the employee's TWA exposures. If the initial 15-minute short-term exposure monitoring reveals employee exposure above the STEL, the employer shall repeat such monitoring for each such employee at least every 180 days to evaluate the employee's 15-minute short-term exposures. Where 8-hour TWA exposures are above the TWA PEL, no monitoring would be required.
This alternative would require employers to perform monitoring at least every 180 days where exposures are at or above the action level or above the STEL. Unlike the periodic monitoring requirement in the current proposal, this alternative would include periodic monitoring where exposures are above the TWA PEL. If the initial 8-hour TWA exposure monitoring required by paragraph (d)(2) of this section reveals employee exposure at or above the action level, the employer shall repeat such monitoring for each such employee at least every 180 days to evaluate the employee's TWA exposures. If the initial 15-minute short-term exposure monitoring reveals employee exposure above the STEL, the employer shall repeat such monitoring for each such employee at least every 180 days to evaluate the employee's short-term exposures.
This alternative would require employers to perform monitoring at least every 180 days where exposures are at or above the action level and at or below the TWA PEL. It would require employers to perform monitoring at least every 90 days where exposures are above the TWA PEL or STEL.
If the initial 8-hour TWA exposure monitoring required by paragraph (d)(2) of this section reveals employee TWA exposure at or above the action level and at or below the TWA PEL, the employer shall repeat such monitoring for each such employee at least every 180 days to evaluate the employee's TWA exposures. If this initial monitoring reveals employee exposure above the TWA PEL or STEL, the employer shall repeat such monitoring for each such employee at least every 90 days to evaluate the employee's 8-hour TWA and 15-minute short-term exposures.
Proposed paragraph (e) requires employers to establish and maintain beryllium work areas wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium, regardless of the level of exposure, and regulated areas wherever employees are, or can reasonably be expected to be, exposed to airborne concentrations of beryllium in excess of the TWA PEL or STEL. Paragraph (e) would also require employers to demarcate beryllium work areas and regulated areas, and limit access to regulated areas to authorized persons.
The proposed requirements for these areas serve several important purposes. First, requiring employers to establish and demarcate beryllium work areas and regulated areas ensures that workers and other persons are aware of the potential presence of airborne beryllium. Second, the demarcation of regulated areas must include warning signs describing the dangers of
Proposed paragraph (e)(1)(i) would require employers to establish beryllium work areas where employees are, or can reasonably be expected to be, exposed to airborne beryllium. OSHA intends this provision to apply to all areas and situations where employees are actually exposed to airborne beryllium and to areas and situations where the employer has reason to anticipate or believe that airborne exposures may occur. The requirements for beryllium work areas under proposed paragraph (e)(1)(i) are not tied to a particular level of exposure, but rather are triggered by the presence of airborne beryllium at any exposure level.
Proposed paragraph (e)(1)(ii) would require employers to establish regulated areas wherever employees are actually exposed to airborne beryllium above either the TWA PEL or STEL, and wherever such exposure can reasonably be expected. This requirement would apply if any exposure monitoring or historical or objective data indicate that airborne exposures are in excess of either the TWA PEL or STEL, or if the employer has reason to anticipate or believe that airborne exposures may be above the TWA PEL or STEL, even if the employer has not yet characterized or monitored those exposures. For example, if newly introduced processes involving beryllium appear to be creating dust and have not yet been monitored, the employer should reasonably anticipate that airborne exposures could exceed the TWA PEL or STEL. In this situation the employer must designate and demarcate the area as a regulated area to protect workers and other persons until monitoring results establish that exposures are at or below the TWA PEL and STEL. The employer may then remove the regulated area designation.
Proposed paragraph (e)(2)(i) requires employers to demarcate each beryllium work area to distinguish it from the rest of the workplace. The proposal specifies that employers must identify beryllium work areas “through signs or any other methods that adequately establish and inform each employee of the boundaries of each beryllium work area.” This means that the demarcation must effectively alert workers and other persons that airborne beryllium may be present. Proposed paragraph (e)(2)(ii) requires employers to identify regulated areas and post warning signs at each approach to the regulated area in accordance with proposed paragraph (m)(2) of this standard.
This proposed rule gives employers flexibility in determining the best means to demarcate beryllium work areas and regulated areas (with the exception of paragraph (m), which sets forth specific requirements for warning signs at entry points to regulated areas). OSHA is aware that employers use various methods to demarcate certain areas in the workplace, including barricades, textured flooring, roped-off areas, “No entry”/“No access” signs, and painted boundary lines (AIA, 2003, Honeywell, 2003, DOD, 2003). Allowing employers to choose the methods that best demarcate beryllium work areas and regulated areas is consistent with OSHA's belief that employers are in the best position to make such determinations, based on the specific conditions in their workplaces. Whatever demarcation methods the employer selects must be clear and understandable enough to alert workers to the boundaries of the beryllium work area or regulated area. This may mean, for example, including more than one language on a sign, if the inclusion of a second language would make the sign understandable to workers with limited English reading skills.
In determining what demarcation might be necessary and effective, employers should consider factors including:
• The configuration of the beryllium work area or regulated area;
• Whether the beryllium work area or regulated area is permanent or temporary;
• 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 requests comment on the proposed requirement to demarcate beryllium work areas and regulated areas. OSHA also requests comment on whether the standard should allow the performance-based approach indicated in the proposal or whether the rule should specify what types of demarcation employers must use.
Proposed paragraph (e)(3) requires employers to limit access to regulated areas. Because of the potentially serious health effects of exposure to beryllium and the need for persons entering the regulated area to be properly protected, OSHA believes that the number of persons allowed to access regulated areas should be limited to those individuals listed in proposed paragraph (e)(3). Specifically, this provision would require employers 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.
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 is made up of persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring under paragraph (d)(6). As explained in this section of the preamble regarding paragraph (d), 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 cadmium (29 CFR 1910.1027) and methylene chloride (29 CFR 1910.1052).
The third 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.
Proposed paragraph (e)(4) requires 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 this standard.
In general, commenters did not oppose the concept of regulated areas. Stakeholders responding to the RFI supported the need for regulated areas
Most small entity representatives (SERs) who participated in the SBREFA process were not concerned about the impact of tying the regulated area requirements to one of the PEL options presented in the SBREFA draft proposed standard (OSHA, 2007b). Only one of the SERs indicated that it may have a process where typical or average exposures are above the lowest PEL option of 0.1 μg/m
SERs were divided on the issue of whether it was possible to isolate or segregate operations to meet the conditions of a regulated area. Most of the SERs did not currently isolate or segregate their beryllium processes, and several expressed concern about the difficulty and costs associated with isolating or segregating their beryllium processes (OSHA, 2008b). Some SERs said they have large, open plant floors making it difficult to isolated specific beryllium operations (OSHA, 2008b). Other SERs said the proposed requirement for a regulated area would be difficult and costly because they move machinery and equipment for production purposes. They said that segregating or restricting processes or machines and equipment to certain areas would affect productivity to some extent (OSHA, 2008b). SERs who use beryllium-containing materials only occasionally, frequently as part of a larger order, said that it would be impractical to isolate specific areas or machines for beryllium work (OSHA, 2008b). SERs in the precision metal products industry indicated their beryllium operations already were well controlled with machine enclosures (
The proposed rule presented during the SBREFA process did not contain any requirements for beryllium work areas. These requirements were added by OSHA after the SBREFA process in response to a proposal OSHA received from a stakeholder group (Materion and USW, 2012). However, because the proposal presented during the SBREFA process included a range of proposed TWA PELs down to 0.1 μg/m
This alternative would eliminate the requirement to establish and demarcate regulated areas within facilities where there is beryllium exposure. It does not eliminate the proposal's requirement to establish and demarcate beryllium work areas.
OSHA is aware that eliminating the requirement for regulated areas may ease the costs and burdens of compliance for some employers. However, this potential benefit of Alternative #12 must be considered in light of the reasons regulated areas were included in the proposal, and are a feature of most OSHA health regulations. As discussed previously, the proposed requirements for regulated areas serve to ensure that access to areas where beryllium exposures exceed the TWA PEL or STEL is restricted, reducing the number of people exposed to beryllium at levels that create a high risk of adverse health effects. Second, the requirement for warning signs ensures that persons who enter areas where exposures exceed the TWA PEL or STEL will be aware of the hazards present and take appropriate precautions such as the proper use of personal protective equipment.
OSHA believes the proposed requirements for beryllium work areas and regulated areas balance commenters' concerns with the need to reduce the number of employees exposed to beryllium and notify those exposed of the risks involved. The proposed standard does not require employers to establish and demarcate beryllium work areas or regulated areas by permanently segregating and isolating processes generating airborne beryllium. Instead, the standard allows employers to use temporary or flexible methods to demarcate beryllium work areas and regulated areas.
OSHA believes that these flexible, performance-based requirements could accommodate open work spaces, changeable plant layouts, and sporadic or occasional beryllium use without imposing undue costs or burdens. For example, the standard does not prohibit employers from moving machinery or equipment for production purposes as occurs in the beryllium-copper alloy industry (OSHA, 2008b). Where employers need to move machinery and equipment, the proposed rule allows employers to use methods such as temporary designations and flexible demarcations. OSHA also notes that some employers have enclosed machines (
Paragraph (f) of the proposed rule establishes methods for reducing employee exposure to beryllium through the use of a written exposure control plan and engineering and work practice controls.
Under proposed paragraph (f)(1)(i), employers must establish, implement, and maintain a written exposure control plan for beryllium work areas. OSHA believes 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. Because skin contact and airborne exposure can occur in any workplace within the scope of the standard, OSHA has made the preliminary determination to require a written exposure control plan for all employers within the scope of the standard. In addition, requiring employers to establish and maintain a written exposure control plan is consistent with other OSHA health standards, including 1,3 butadiene (29 CFR 1910.1051) and bloodborne pathogens (29 CFR 1910.1030).
OSHA's proposal to require a written exposure control plan is based in part on the recommendation of two stakeholders, Materion Corporation and the Steelworkers Union. Materion and the Steelworkers submitted a joint proposal for a standard to the Agency (Materion and Steelworkers, 2012) that includes a requirement for a written
Under proposed paragraphs (f)(1)(i)(A), (B), and (C), the written exposure control plan must contain inventories of operations and job titles reasonably expected to have any exposure to airborne beryllium, exposure at or above the action level, and exposure above the TWA PEL or STEL. And, under proposed paragraph (f)(1)(i)(G), the plan must include an inventory of engineering and work practice controls required by paragraph (f)(2) of this standard.
A record of which operations and job titles are likely to have exposures at certain levels and which engineering and work practice controls the company has selected to control exposures will make it easier for employers to implement monitoring, hygiene practices, housekeeping, engineering and work practice controls, and other measures. These inventories will also help to assure employees' awareness of the exposures associated with their jobs, their eligibility for medical surveillance, and the controls that should be in use throughout the workplace. This will enable employees to work together with employers to ensure that the appropriate engineering controls and work practices are in use and functioning and that provisions such as medical surveillance, housekeeping, and PPE are properly implemented. In addition, these inventories, like all of the items required to be included in the written exposure control plan, will help safety and health personnel, including OSHA Compliance Officers, carry out their duties. A written plan provides detailed information to interested parties including employees, employee representatives, supervisors, and safety consultants of the employer's determination of the jobs and operations that may place employees at risk of exposure and the measures the employer has selected to control exposure.
Under proposed paragraph (f)(1)(D) through (F) and (H), the exposure control plan must contain procedures for: minimizing cross-contamination, including preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas; 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. Each of these procedures serves to minimize the spread of beryllium throughout and outside the workplace. They also work to reduce the likelihood of skin contact and re-entrainment of beryllium particulate into the workplace atmosphere. 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.
The requirement to document these procedures in writing, as part of the exposure control plan, will help to ensure that employees are advised of their responsibilities and can easily review the procedures if they have questions. Because employees play an important part in exposure control through compliance with the rules regarding hygiene practices, housekeeping, and other measures, employees should have easy access to documentation detailing the procedures in place in their workplace. A review of the written exposure control plan should be part of the hazard communication training for employees as required by 1910.1200 and proposed paragraph (m). Additionally, the documentation of the procedures will help OSHA Compliance Officers assess employers' procedures.
Proposed paragraph (f)(1)(ii) requires that employers update their exposure control plans whenever 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. Paragraph (f)(1)(ii) also requires employers to update their plans when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows other signs and symptoms related to beryllium exposure. In addition, the paragraph requires employers to update their plans if the employer has any reason to believe that new or additional exposures are occurring or will occur.
The requirements to update the exposure control plan if changes in the workplace result in or can be expected to result in new or additional exposures, or where the employer has any reason to believe that such exposures are occurring or will occur, ensure that an employer's plan reflects the current conditions in the workplace. If an employee becomes sensitized or develops CBD, the employer should investigate the source(s) of exposure responsible, and must make any necessary changes to address the source(s) of exposure, and update the written exposure control plan as necessary to reflect any new information or corrective action resulting from the employer's investigation. For example, the employer may find that housekeeping procedures in the employee's area need improvement, or that more appropriate PPE could be used. In some cases, the employer may find that additional engineering or work practice controls are appropriate to the processes in use. When the employer discovers new sources of exposure or makes changes in its control strategy, the employer must update its written exposure control plan to reflect current conditions in the workplace. 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 (Bailey
Proposed paragraph (f)(1)(iii) requires employers 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 Standard (29 CFR 1910.1020). As mentioned above, access to the exposure control plan will enable employees to partner with their employers in keeping the workplace safe.
Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. The proposed rule relies on engineering and work practice controls as the primary means to reduce
OSHA requires adherence to this hierarchy of controls in a number of standards, including the Air Contaminants (29 CFR 1910.1000) and Respiratory Protection (29 CFR 1910.134) standards, as well as other substance-specific standards. The Agency's adherence to the hierarchy of controls has been successfully upheld by the courts (see
The Agency understands 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. For these reasons, engineering controls are preferred by OSHA and the safety and health professional community in general.
The provisions related to engineering and work practice controls begin in paragraph (f)(2)(i)(A). For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure:
(1) Material and/or process substitution;
(2) Ventilated partial or full enclosures;
(3) Local exhaust ventilation at the points of operation, material handling, and transfer; or
(4) Process control, such as wet methods and automation. OSHA has included a non-mandatory appendix presenting a non-exhaustive list of engineering controls employers may use to comply with paragraph (f)(2)(i) (Appendix B).
Proposed paragraph (f)(2)(i)(B) offers two exemptions from the engineering and work practice controls requirements. First, under paragraph (f)(2)(i)(B)(1), an employer is exempt from using engineering and work practice controls where the employer can establish that the controls are not feasible.
Second, under paragraph (f)(2)(i)(B)(2), an employer is exempt from using the controls where the employer can 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.
The engineering work practice control requirement in paragraph (f)(2)(i)(A), like the written exposure control plan requirement, was proposed by the United Steelworkers and Materion as part of their joint submission to OSHA (Materion and United Steelworkers, 2012). The inclusion of the engineering work practice control provision in paragraph (f)(2)(i)(A) addresses a concern regarding the proposed PEL. OSHA expects that day-to-day changes in workplace conditions may 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. OSHA believes that substitution or engineering controls such as those outlined in paragraph (f)(2)(i)(A) provide the most reliable means to control variability in exposure levels. OSHA therefore included this requirement in the proposal. The Agency included the exemption in paragraph (f)(2)(i)(B)(2) to reduce the cost burden to employers with operations where measured exposures are below the action level, and therefore less likely to exceed the PEL in the course of typical exposure fluctuations. This exemption is similar to a provision in 1,3 Butadiene (29 CFR 1910.1051), which requires an exposure goal program where exposures exceed the action level.
OSHA recognizes that the requirements of paragraph (f)(2)(i) are not typical of OSHA standards, which usually require engineering controls only where exposures exceed the PEL(s). The Agency is therefore considering Regulatory Alternative #6, which would drop the provisions of paragraph (f)(2)(i) from the proposed standard. OSHA requests comments on the potential benefits of including such a provision in the beryllium standard, the potential costs and burdens associated with it, and whether OSHA should include or exclude this provision in the final standard.
Proposed paragraph (f)(2)(ii) applies when exposures exceed the TWA PEL or STEL after employers have implemented the control(s) required by paragraph (f)(2)(i). It requires employers 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 ventilation system to more effectively capture airborne beryllium at the source.
However, under proposed paragraph (f)(2)(iii), wherever the employer demonstrates that it is not feasible to reduce exposures to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(ii), the employer shall 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.
Paragraph (f)(3) of the proposed rule would prohibit the employer from rotating workers to different jobs to achieve compliance with the PELs. Worker rotation can potentially reduce exposures to individual employees, but increases the number of employees exposed. Because OSHA has made a preliminary determination 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 is prudent to limit the number of workers exposed at any concentration.
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 proposed PEL; worker rotation may be used as deemed appropriate by the employer in
The SERs who participated in the SBREFA process did not voice opposition to a requirement for a written exposure control program or challenge the utility of a written program in helping to control exposures (OSHA, 2008b). Several indicated that they already had a beryllium exposure control program in place. Some SERs suggested that OSHA should tie the written exposure control program requirement to exposures exceeding a revised PEL (OSHA, 2008b). The SERs' request to tie the written exposure control program requirement to the PEL appears to emerge from their belief that employees exposed below the proposed PEL are not at risk from beryllium exposure (OSHA, 2008b).
As stated earlier, OSHA's proposed standard would require a written exposure control plan for all beryllium work areas;
Several SERs expressed doubt that material substitution could be an effective means of reducing beryllium exposures in their facilities. One SER stated that substitutes for beryllium alloys are not presently viable for industrial uses that require certain high-performance electrical characteristics, or wear resistance (OSHA, 2007a). Another SER commented that substitutes for beryllium alloys in the dental appliance industry have also been associated with occupational disease (OSHA, 2007a).
OSHA recognizes that the use of substitutes for beryllium may not be feasible or appropriate for some employers. The Agency's intent is to offer material substitution as one possible means of compliance with the proposed standard. Employers must determine whether material substitution is an effective and appropriate means of exposure control for their facilities. In addition, it is employers' responsibility to check the toxicity of any material they may use in their facilities, including potential substitutes for beryllium.
OSHA anticipates that most small businesses will be able to comply with the proposed standard regardless of whether they choose to substitute other materials for beryllium in their facilities.
Paragraph (g) of the proposed standard lays out the situations in which employers are required to protect employees' health through the use of respiratory protection. Specifically, this paragraph would require that employers provide respiratory protection at no cost and ensure that employees utilize the protection during the situations listed in paragraph (g)(1). As detailed in proposed paragraph (g)(2), the required respiratory protection must comply with the Respiratory Protection standard (29 CFR 1910.134).
Proposed 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 proposed paragraph (g)(1) unless the employer also ensures that its employees wear the respirators when required. Proposed paragraph (g)(1) would also require employers to provide required respirators at no cost to employees. This requirement is consistent 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. Proposed paragraph (g)(1)(i) requires respiratory protection during the installation and implementation of engineering and/or work practice controls where exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL. The Agency realizes that changing workplace conditions may require employers to install new engineering controls, modify existing controls, or make other workplace changes to reduce employee exposure to beryllium to at or below the TWA PEL and STEL. In these cases, the proposed standard recognizes that installing appropriate engineering controls and implementing proper work practices may take time. During this time, employers must demonstrate that they are making prompt, good faith efforts to purchase and install appropriate engineering controls and implement effective work practices, and to evaluate their effectiveness for reducing exposure to beryllium to at or below the TWA PEL and STEL.
Proposed paragraph (g)(1)(ii) requires the provision 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 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 controlling exposures to at or below the TWA PEL and STEL. For 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.
Proposed paragraph (g)(1)(iii) requires the provision 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 very few situations where feasible engineering and work practice controls are incapable of lowering employee exposure to beryllium to at or below the TWA PEL
Proposed paragraph (g)(1)(iv) requires the provision of respiratory protection in emergencies. At such times, 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 proposed 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 beryllium.
The situations in which respiratory protection is required 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 proposed 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 proposed paragraph (f) earlier in this section of the preamble).
Whenever respirators are used to comply with the requirements of this proposed 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 workers. 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;
• Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;
• Procedures and schedules for 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 the Agency's policy to avoid duplication and to establish regulatory consistency, proposed paragraph (g)(2) incorporates by reference the requirements of 29 CFR 1910.134 rather than reprinting those requirements in this proposed standard. OSHA notes that the respirator selection provisions in 1910.134 include requirements for Assigned Protection Factors (APFs) and Maximum Use Concentrations (MUCs) that OSHA adopted in 2006 (71 FR 50122-50192, August 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.
OSHA believes that the proposed respiratory protection requirements are feasible even for small employers. Although none of the SERs who participated in the SBREFA process made specific recommendations about respiratory protection, some said that they currently have existing respiratory protection programs in place as supplemental support to engineering and work practice controls (OSHA, 2008b).
OSHA requests comment on the proposed requirement to establish and maintain a respiratory protection program that complies with 29 CFR 1910.134. OSHA would like to hear from companies of all sizes regarding whether they have respiratory protection programs to protect employees from beryllium exposures. If so, please explain the parameters of your program including types of respirators used, when and where respirators are required, program evaluation, and annual costs.
Paragraph (h) of the proposed standard 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; 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 are exposed to soluble beryllium compounds. These PPE requirements are intended to prevent adverse health effects associated with dermal exposure to beryllium, and accumulation of beryllium on clothing, shoes, and equipment that can result in additional inhalation exposure. The requirements also protect employees in other work areas from exposures that could occur if contaminated clothing carried beryllium to those areas, as well as employees and other individuals outside the workplace. The proposed standard requires the employer to provide PPE at no cost to employees, and to ensure that employees use the provided PPE in accordance with the written exposure control plan as described in paragraph (f)(1) of this proposed standard and OSHA'S Personal Protective Equipment standards (29 CFR part 1910 subpart I).
Proposed paragraph (h)(1)(i) requires the provision and use of PPE for employees exposed to airborne beryllium in any form exceeding 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. And, OSHA believes that regardless of the level of exposure, the use of PPE further reduces exposure where employees' clothing or skin could become visibly contaminated with beryllium (paragraph (h)(1)(ii)).
The term “visibly contaminated with beryllium” means visibly contaminated with any material that contains beryllium. The proposed standard does not specify criteria for determining whether work clothing or skin may become visibly contaminated with beryllium. When evaluating whether this definition is satisfied, OSHA expects that the employer will assess the workplace in a manner consistent with the Agency's general requirements for the use of personal protective equipment in general industry (29 CFR part 1910 subpart I). These standards require the employer to assess the workplace to determine if hazards associated with dermal or inhalation exposure to a substance such as beryllium are, or are likely to be, present.
The proposed standard also requires the provision and use of PPE where employees are exposed to soluble
Requiring PPE is consistent with section 6(b)(7) of the OSH Act which states that, where appropriate, standards shall prescribe suitable protective equipment to be used in connection with hazards. The proposed requirements for PPE are based upon widely accepted principles and conventional practices of industrial hygiene, and in some respects are similar to other OSHA health standards such as those for chromium (VI) (29 CFR 1910.1026), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), and methylenedianiline (MDA; 29 CFR 1910.1050). However, the requirement to use PPE where work clothing or skin may become “visibly contaminated” with beryllium differs from prior health standards, which do not require contamination to be visible in order for PPE to be required. For example, the standard for chromium (VI) 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) (29 CFR 1910.1026). 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, 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 (29 CFR 1910.1050). While OSHA's language regarding PPE requirements varies somewhat from standard to standard, previous standards tend to emphasize potential for contact with a substance that can trigger health effects via dermal exposure, rather than “visible contamination” with the substance.
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). 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 expects individuals conducting hazard assessments to be familiar the employer's work processes, materials, and work environment. A thorough hazard assessment should include a walk-through survey 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 they are exposed. Information obtained in this manner provides a basis for the identification and evaluation of potential hazards. OSHA believes that the implementation of a comprehensive and thorough program to determine areas of potential exposure, consistent with the employer's written exposure control plan, is a sound safety and health practice and a necessary element of ensuring overall worker protection.
Based on the hazard assessment results, the employer must determine what PPE is necessary to protect employees. The proposed requirement is performance-oriented, and is designed to allow the employer flexibility in selecting the PPE most suitable for each particular workplace. The type of PPE needed will depend on the potential for exposure, the physical properties of the beryllium-containing material used, and the conditions of use in the workplace. For example, shipping and receiving activities may necessitate only work uniforms and gloves. In other situations such as when a worker is performing facility maintenance, gloves, work uniforms, coveralls, and respiratory protection may be appropriate. Beryllium compounds can exist in acidic or alkaline form, and these characteristics may influence the choice of PPE. Face shields may be appropriate in situations where there is a danger of being splashed in the face with soluble beryllium or a liquid containing beryllium. Coveralls with a head covering may be appropriate when a sudden release of airborne beryllium could result in beryllium contamination of clothing, hair, or skin. Respirators are addressed separately in the explanation of proposed paragraph (g) earlier in this section of the preamble.
Note that paragraph (i)(2) of this proposed standard requires change rooms only where employees are required to remove their personal clothing. 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, the employer must select and ensure the use of protective clothing that is worn in lieu of (rather than over) street clothing.
Paragraph (h)(2) contains proposed 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. A National Jewish Medical and Research Center 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 (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 (
Under proposed paragraph (h)(2)(i)(A), beryllium-contaminated PPE must be removed at the end of the work shift or at the completion of tasks involving beryllium exposure, whichever comes first. This language 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
Paragraph (h)(2)(i)(B) would require employers to ensure that employees remove PPE that has become visibly contaminated with beryllium. This language is intended to convey that PPE that is visibly contaminated with beryllium should be changed at the earliest reasonable opportunity, for example, at the end of the task during which it became visibly contaminated. This language 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.
Proposed paragraph (h)(2)(ii) requires employees to remove PPE consistent with the written exposure control plan required by proposed 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 (see (f)(1)(i)(D) & (H)). Paragraph (h)(2)(iii) would require employers to ensure that protective clothing is stored separately from employees' street clothing. OSHA believes these provisions are necessary to prevent the spread of beryllium throughout and outside the workplace.
To further limit exposures outside the workplace, OSHA proposes in paragraph (h)(2)(iv) that the employer ensure that beryllium-contaminated PPE is only removed 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 this proposed standard. The standard would further require in paragraph (h)(2)(v) that PPE removed from the workplace for laundering, cleaning, maintenance, or discarding 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 would alert those handling the contaminated PPE of the potential hazards of exposure to beryllium. Such labels must conform with the HCS (29 CFR 1910.1200) and paragraph (m)(3) of this proposed standard. These warning requirements are meant to reduce confusion and ambiguity regarding critical information communicated in the workplace by requiring that this information be presented in a clear and uniform manner.
Proposed paragraph (h)(3)(i) would require the employer to ensure that reusable PPE is cleaned, laundered, repaired, and replaced as needed to maintain its effectiveness. These requirements must be completed at a frequency, and in a manner, necessary to ensure that PPE continues to serve its intended purpose of protecting workers from beryllium exposure.
In keeping with the performance-orientation of the proposed standard, OSHA does not specify how often PPE should be cleaned, repaired or replaced. The Agency believes that appropriate time intervals 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, the employer is still obligated to keep the PPE in the condition necessary to perform its protective function. A number of Small Entity Representatives (SERS) from OSHA's SBREFA panel noted they now use low maintenance Tyvek disposable protective suits for some high exposure areas to address potential contamination situations (OSHA, 2007a).
Under paragraph (h)(3)(ii), removal of beryllium from PPE by blowing, shaking, or any other means which disperses beryllium in the air would be prohibited as this practice could result in unnecessary exposure to airborne beryllium.
Paragraph (h)(3)(iii) would require 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 soluble beryllium compounds, and of the need to handle the PPE in accordance with this standard. This provision is intended to limit dermal or inhalation exposure to beryllium, and to emphasize the need for hazard awareness and protective measures consistent with the proposed standard among persons who clean, launder, or repair beryllium-contaminated items.
Comments from SERs indicate that a number of beryllium-related businesses already have comprehensive protocols in place for the use and maintenance of PPE (OSHA, 2007a). One commenter indicated that it has effectively reduced sensitization and CBD through the use of respirators, other PPE, and engineering controls (OSHA, 2007a). Another commenter stated that it utilizes PPE to reduce skin exposure (OSHA, 2007a). These existing PPE programs achieve many of the Agency's goals and incorporate many of the requirements of this proposed standard.
The primary objections from SERs came from companies that raised concerns regarding the “trigger” (
However, OSHA is concerned that the requirement to use PPE where work clothing or skin may become “visibly contaminated” with beryllium or where
Paragraph (i) of the proposed standard requires that, when certain conditions are met, employers must provide employees with readily accessible washing facilities, change rooms, and showers. Proposed paragraph (i) also requires employers to take certain steps to minimize exposure in eating and drinking areas, and prohibits certain practices that may contribute to beryllium exposure. OSHA believes that strict compliance with these provisions would substantially reduce employee exposure to beryllium.
The proposed standard requires certain hygiene facilities and procedures in beryllium work areas, and additional hygiene facilities and procedures when airborne exposures exceed the TWA PEL or STEL. OSHA believes that skin contact with beryllium can occur even at low airborne exposures. Skin wipe sample analysis of dental laboratory technicians performing grinding operations demonstrated that beryllium was present on the hands of workers even when airborne exposures were well below the PEL (ERG, 2006).
As discussed in the Health Effects section of this preamble, section V, respiratory tract, skin, eye, or mucosal contact with beryllium can result in 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 the National Jewish Medical and Research Center of Denver, Colorado, measured the levels of beryllium on workers' skin and vehicle surfaces at a machining plant where many workers did not change out of their clothes and shoes at the end of their shifts. The study showed elevated surface levels of beryllium were present on workers' skin and in their vehicles, demonstrating that workers carried residual beryllium on their hands and shoes when leaving work (Sanderson
Paragraph (i)(1) would require the employer to provide readily accessible washing facilities capable of removing beryllium from the hands, face, and neck, and to ensure that employees working in beryllium work areas use these facilities when necessary. This requirement is performance-oriented, and does not specify any particular frequency. At a minimum, employees working in a beryllium work area must wash their hands, faces, and necks at the end of the shift to remove any residual beryllium. Likewise, washing prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet would also protect employees against beryllium ingestion and inhalation.
Typically, washing facilities would 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 or cleaning agent. 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.
Under proposed paragraph (i)(2), where employees are required to remove their personal clothing in order to use personal protective clothing, the employer must provide designated change rooms with separate storage facilities for street and work clothing to prevent cross contamination. Change rooms must be in accordance with the Sanitation standard (29 CFR 1910.141). OSHA intends the change rooms requirement to apply to all covered workplaces where employees must change their clothing (
Change rooms must be designed in accordance with the written exposure control plan required by paragraph (f)(1) of this proposed standard, and with the Sanitation standard (29 CFR 1910.141). These provisions require change rooms to be equipped with storage facilities (
Because of the risk of beryllium sensitization via the skin as described in section V of this preamble, Health Effects, OSHA has determined that employers must provide showers if their employees could 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. Other OSHA health standards, such as the standards for cadmium (29 CFR
Paragraph (i)(3)(ii) 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. This language is intended to convey that showers are required for employees who satisfy both paragraphs (i)(3)(ii)(A) and (B) when work activities involving beryllium exposure have been completed for the day. For example, if employees perform work activities involving beryllium exposure 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 not intended to require them to shower before the completion of the last task involving exposure.
To minimize the possibility of food contamination and the likelihood of additional exposure to beryllium through inhalation or ingestion, paragraph (i)(4) would require that employers provide employees with a place to eat and drink where beryllium exposure is below the action level, and where the surfaces are maintained as free as practicable of beryllium. Eating and drinking areas must further comply with the Sanitation standard (29 CFR 1910.141(g)), which prohibits consuming food or beverages in a toilet area or in any area with exposures above an OSHA PEL.
The requirement to maintain surfaces as free as practicable of beryllium 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). 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 (29 CFR 1926.62), 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). 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 Chromium (IV) Standards provides additional detail on how OSHA interprets “as free as practicable” for enforcement purposes (OSHA, 2008a). As explained in the directive, if a wipe sample reveals a toxic substance on a surface, and the employer has not taken practicable measures to keep the surface clean, the employer has not kept the surface as free as practicable of the toxic substance.
The proposed standard does 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 would be required to maintain the area in accordance with paragraph (i)(4) of this proposed standard.
Paragraph (i)(5)(i) would prohibit eating, drinking, smoking, chewing tobacco or gum, or applying cosmetics in regulated areas. Where exposures can reasonably be expected at levels above the proposed TWA PEL or STEL, there is a greater risk of beryllium contaminating the food, drink, tobacco, gum, or cosmetics. Prohibiting these activities would reduce the potential for this manner of exposure.
Under paragraph (i)(5)(ii), employers would also be required to ensure that employees do not enter eating or drinking areas wearing contaminated protective clothing or equipment. This is to further minimize the likelihood that employees will be exposed to beryllium in eating and drinking areas through inhalation, dermal contact, and ingestion.
The draft regulatory text presented during the SBREFA process would have required handwashing facilities and certain other hygiene provisions when exposures exceeded the TWA PEL, or when there was “anticipated skin exposure.” Small Entity Representatives (SERs) from OSHA's SBREFA panel expressed concern that the phrase “anticipated skin exposure” was vague and lacked definition (OSHA, 2007a). Commenters suggested that this could require employers at workplaces with low exposures to make significant modifications to the workplace, such as installing showers and change rooms. OSHA has evaluated the hygiene triggers and clarified that change rooms are only required when employees must remove their street clothes in order to wear protective clothing. Showers are only required when exposures exceed the TWA PEL or STEL, and beryllium could reasonably contaminate employees' hair or body parts other than hands, face, and neck. OSHA has removed the phrase “anticipated skin exposure” from the proposed standard. OSHA believes these changes address the commenters' concerns.
Paragraph (j) of the proposed standard requires employers to maintain surfaces in beryllium work areas as free as practicable of accumulations of beryllium; promptly clean spills and emergency releases; use appropriate cleaning methods; and properly dispose of beryllium-contaminated waste, debris, and materials. These provisions are especially important because they minimize additional sources of exposure that engineering controls are not designed to address. Good housekeeping measures are a cost-effective way to control employee 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. Contact with contaminated surfaces may also 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. The proposed provisions in this paragraph are consistent with housekeeping requirements in other OSHA standards for toxic metals including cadmium (29 CFR 1910.1027), chromium (VI)(29 CFR 1910.1026), and lead (29 CFR 1910.1025).
Paragraph (j)(1) requires the employer to ensure that all surfaces in beryllium work areas are maintained as free as practicable of accumulations of beryllium, and that spills and emergency releases are cleaned up promptly. Employers must follow the procedures that they have listed under their exposure control plan required by paragraph (f)(1) to clean beryllium-
Paragraph (j)(1) directs the employer to maintain surfaces where beryllium may accumulate “as free as practicable” of beryllium. In this context, the phrase “as free as practicable” sets 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 of proposed paragraph (i) earlier in this section of the preamble.
Employers must regularly clean surfaces in beryllium work areas to minimize re-entrainment of dust into the work environment, and to ensure that accumulations of beryllium do not become sources of exposure. Although OSHA does not define “surface” in the proposed standard, the term would include surfaces workers come into contact with such as working surfaces, floors, and storage facilities, as well as surfaces workers do not directly contact such as rafters. Because all surfaces in beryllium work areas could potentially accumulate beryllium 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 preliminarily decided not to require employers to measure beryllium contamination on surfaces, because the Agency does not have the necessary data to understand the relationship between surface level of beryllium and risk of absorption through the skin. The use of wipe samples, however, remains a useful qualitative tool to detect the presence of beryllium on surfaces.
As mentioned above, when beryllium is released into the workplace as a result of a spill or emergency release, paragraph (j)(1)(ii) would require the employer to ensure prompt and proper cleanup in accordance with the written exposure control plan required by paragraph (f)(1) and to use the cleaning methods required by paragraph (j)(2) of this proposed standard. Spills or emergency releases not attended to promptly are likely to result in additional employee exposure or skin contact.
Paragraph (j)(2) provides that clean-up procedures for beryllium-containing material must minimize employee exposure. OSHA recognizes that each work environment is unique, so OSHA has established performance-oriented requirements for housekeeping to allow employers to determine how best to clean beryllium work areas while minimizing employee exposure. Paragraph (j)(2)(i) of the proposed standard would require that surfaces contaminated with beryllium be cleaned by high efficiency particulate air filter (HEPA) vacuuming or other methods that minimize the likelihood of beryllium exposure. OSHA believes HEPA vacuuming is a highly effective method of cleaning beryllium-contaminated surfaces. However, other cleaning methods equally effective at minimizing the likelihood of beryllium exposure may be used.
Paragraph (j)(2)(ii) would permit dry sweeping or brushing in certain cases only. The employer must demonstrate that it has tried cleaning with a HEPA-filter vacuum or another method that minimizes the likelihood of exposure, and that those methods were not effective under the particular circumstances found in the workplace. OSHA has included this provision in an attempt to provide employers flexibility when exposure-minimizing cleaning methods would not be effective, but OSHA is not aware of any circumstances in which dry sweeping or brushing would be necessary. OSHA requests comment on whether dry sweeping or brushing would ever be necessary, and if so, under what circumstances (see section I of this preamble, Issues and Alternatives).
Paragraph (j)(2)(iii) would prohibit the use of compressed air in cleaning beryllium-contaminated surfaces unless it is used in conjunction with a ventilation system designed to capture any resulting airborne beryllium. This provision is also intended to prevent the dispersal of beryllium into the air.
Proposed paragraph (j)(2)(iv) details further protections for those employees who are using certain cleaning methods. Under this provision, where employees use dry sweeping, brushing, or compressed air to clean beryllium-contaminated surfaces, the employer must provide respiratory protection and protective clothing and equipment and ensure that each employee uses this protection in accordance with paragraphs (g) and (h) of this standard. 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.
Paragraph (j)(2)(v) would require employers to ensure that equipment used to clean beryllium from surfaces is handled in a manner that minimizes employee exposure and the re-entrainment of beryllium into the workplace environment. For example, cleaning and maintenance of HEPA-filtered vacuum equipment must be done carefully to avoid exposure to beryllium. Similarly, filter changes and bag and waste disposal must be performed in a manner that minimizes the risk of employee exposure to airborne beryllium. This provision is consistent with the requirement in proposed paragraph (f)(1)(i)(F) for the written exposure control plan, under which employers must establish and implement procedures for minimizing the migration of beryllium. And of course, employees handling and maintaining cleaning equipment must be protected in accordance with the other paragraphs of this proposed standard as well, including the requirements for respiratory protection and PPE in paragraphs (g) and (h).
Proposed paragraph (j)(3)(i) would require that items visibly contaminated with beryllium and consigned for disposal be disposed of in sealed, impermeable bags or other closed impermeable containers. Proposed paragraph (j)(3)(ii) requires these containers to be marked with warning labels to inform individuals who handle these items of the potential hazards associated with beryllium exposure, and the labels must contain specific language in accordance with paragraph (m)(3) of the proposed standard. Alerting employers and employees who are involved in disposal to the potential hazards of beryllium exposure will better enable them to implement protective measures.
Proposed paragraph (j)(3)(iii) gives employers two options for materials designated for recycling that are visibly contaminated with beryllium: Sealing them in impermeable enclosures and labeling them in accordance with proposed paragraph (m)(3), or cleaning them to remove visible particulate. Proposed paragraph (j)(3)(iii) allows employers this flexibility to facilitate the recycling process, and ensures that employees handling these items for recycling purposes will not be exposed to visible particulate if the items are not sealed in impermeable enclosures and labeled with warnings about the dangers of beryllium exposure.
OSHA believes that the concept and importance of housekeeping programs in protecting workers from beryllium
Those companies that did have comprehensive housekeeping policies provided the Agency with a number of useful practices and examples in response to the RFI as well as during the SBREFA process. One company offered its 8-step housekeeping and control strategy into the record as a comprehensive model (Brush Wellman, 2003). Another company presented its facility housekeeping program specifying a number of containment measures such as tack mats, absorbent carpet, and damp disposable towels to collect any contamination from beryllium operations. Certain practices were expressly prohibited such as dry sweeping, brushing, wiping, and the use of compressed air systems to clean machinery (Honeywell, 2003). Researchers with the National Jewish Hospital and Research Center found that most of the beryllium facilities that they visited prohibited the use of compressed air in beryllium areas (NJMRC, 2003).
Several commenters also questioned the vagueness of the term “contaminated surfaces” (OSHA, 2008b). The proposed standard no longer uses this term. Rather, proposed paragraph (j) would require employers to maintain surfaces in beryllium work areas “as free as practicable of accumulations of beryllium,” which is explained earlier in this section.
Under paragraph (k)(1) of the proposed standard, OSHA would require employers to make medical surveillance available at no cost, and at a reasonable time and place, for all employees who have worked in a regulated area for more than 30 days in the past 12 months; show signs and symptoms of CBD; are exposed to beryllium during an emergency; or were exposed to beryllium in concentrations above 0.2 μg/m
Under paragraph (k)(1)(ii), the required medical surveillance must be performed by or under the direction of a licensed physician. OSHA chose to require licensed physicians, as opposed to PLHCPs, to oversee medical surveillance in this standard, and to provide certain services required by this standard (see,
The purpose of medical surveillance for beryllium is, where reasonably possible, to identify beryllium-related adverse health effects so that appropriate intervention measures can be taken, and to determine the employee's fitness to use personal protective equipment such as respirators. The proposed standard 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 toxic substances. Other OSHA health standards, such as Chromium (VI) (29 CFR 1910.1026), Methylene Chloride (29 CFR 1910.1052), and Cadmium (29 CFR 1910.1027), also include medical surveillance requirements.
The proposed standard is intended to encourage participation in medical surveillance by requiring at paragraph (k)(1)(i) that the employer provide medical examinations without cost to employees (also required by section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)), and at a reasonable time and place. If participation requires travel away from the worksite, the employer would be required to bear all travel costs. Employees must be paid for time away from work spent attending medical examinations, including travel time.
Paragraph (k)(1)(i)(A) proposes to require employers to make medical surveillance available to all employees who worked in a regulated area for more than 30 days in the past 12 months. This requirement attempts to ensure that those employees who are at most risk for developing beryllium-related adverse health effects have access to medical services so that such adverse health effects can be detected early.
In addition, paragraph (k)(1)(i)(B) would require that employers provide medical surveillance to any employee who shows signs or symptoms of CBD. It is expected that employees experiencing signs and symptoms of exposure will report them to their employers. If an employer becomes aware that an employee shows signs and symptoms of CBD either through employee self-reporting or from observation of the employee, the employer is required to provide medical surveillance to the employee. However, this provision is not intended to force employers to survey their workforce, make diagnoses, or determine causality.
Proposed paragraph (k)(1)(i)(B) recognizes that some employees may exhibit signs and symptoms of the adverse health effects associated with beryllium exposure even when not exposed above the TWA PEL or the STEL for more than 30 days per year. OSHA's preliminary risk assessment concludes that there is significant risk of adverse health effects from beryllium exposure below the proposed PEL (see this preamble at section VI, Preliminary Risk Assessment). 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.
Self-reporting by employees will be supported by the training required under proposed paragraph (m)(4)(ii) on the health hazards of beryllium exposure and the signs and symptoms of CBD, and the medical surveillance and medical removal requirements of the proposed standard in paragraphs (k) and (l). Employees have a right under section 11(c) of the OSH Act to report suspected work-related health effects to their employers without retaliation. Any employer program or practice that
As discussed in this preamble at section V, Health Effects, CBD causes fatigue, weakness, difficulty breathing, and a persistent dry cough, among other symptoms. In more advanced cases, CBD may also result in anorexia and weight loss, as well as right side heart enlargement (cor pulmonale) and heart disease. By requiring covered employers to make a medical exam available when an employee exhibits these types of symptoms, the proposed standard would protect all employees who may have developed CBD, whether or not these employees have been exposed to beryllium in an emergency or for more than 30 days in a regulated area.
Paragraph (k)(1)(i)(C) would require that appropriate surveillance also be made available for employees exposed to beryllium during an emergency, regardless of the airborne concentrations of beryllium to which these employees are routinely exposed in the workplace. Emergency situations involve uncontrolled releases of airborne beryllium, and the significant exposures that can occur in these situations justify a requirement for medical surveillance. The proposed requirement for medical examinations after 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), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052).
Paragraph (k)(1)(i)(D) would require medical surveillance to be provided to employees who have been exposed to beryllium above 0.2 μg/m
Paragraph (k)(2) of the proposed standard specifies how frequently medical examinations are to be offered to those employees covered by the medical surveillance program. Under paragraph (k)(2)(i)(A), employers would be required to provide each employee with a medical examination within 30 days after the employee has worked in a regulated area for more than 30 days in the past 12 months, unless the employee has received a medical examination provided in accordance with this standard within the previous 12 months. Paragraph (k)(2)(i)(B) requires 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 paragraph (k)(1)(i)(B) or (C). Paragraph (k)(2)(i)(B) requires an examination without regard to whether these employees received an exam in the previous 12 months.
Paragraph (k)(2)(ii) of the proposed standard requires that employers provide an examination annually (after the first examination is made available) to employees who continue to meet the criteria of paragraph (k)(1)(i)(A) or (B). This includes employees who have worked in a regulated area for more than 30 days in the past 12 months and employees who continue to exhibit signs and symptoms of CBD. The requirement for annual examinations in paragraph (k)(2)(ii) means that an examination must be made available at least once every 12 months.
Employees exposed in an emergency, who are covered by paragraph (k)(1)(i)(C), are not included in the annual examination requirement unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B), because OSHA expects that most effects of exposure will be detected during the medical examination provided within 30 days of the emergency, pursuant to paragraph (k)(2)(i)(A). An exception to this is beryllium sensitization, which OSHA believes may result from exposure in an emergency, but may not be detected within 30 days of the emergency. Thus, proposed paragraph (k)(3)(ii)(E) requires biennial testing for beryllium sensitization for employees exposed in emergencies. This paragraph is discussed in more detail later in this section of the preamble. Employees covered by paragraph (k)(1)(i)(D) are also not required to receive exams annually unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B).
OSHA believes that the annual provision of medical surveillance, and the biennial provision of beryllium sensitization testing and CT scans for certain employees, are appropriate frequencies for screening employees for beryllium-related diseases. The main goals of medical surveillance for employees are to detect beryllium sensitization before employees develop CBD, and to detect CBD, lung cancer, and other adverse health effects at an early stage. The proposed requirement for annual examinations is consistent with other OSHA health standards, including those for chromium (VI) (29 CFR 1910.1026) and formaldehyde (29 CFR 1910.1048). Based on the Agency's experience, OSHA believes that annual surveillance and biennial tests for beryllium sensitization and CT scans would strike a reasonable balance between the need to diagnose health effects at an early stage, while being sufficiently affordable for employers.
Finally, proposed paragraph (k)(2)(iii) would require the employer to offer a medical examination at the termination of employment, if the departing employee meets the criteria of paragraph (k)(1)(i)(A), (B), or (C) at the time the employee's employment is terminated. This would apply to employees who worked in a regulated area for more than 30 days during the previous 12 months, employees showing signs or symptoms of CBD, and employees who were exposed to beryllium in an emergency at any time during their employment. This proposed requirement is waived if the employer provided the departing employee with an exam during the six months prior to the date of termination. The provision of an exam at termination is intended to ensure that no employee terminates employment while carrying a detectable, but undiagnosed, health condition related to beryllium exposure.
Proposed paragraph (k)(3) details the contents of the examination. Paragraph (k)(3)(i) would require the employer to ensure that the PLHCP advises the employee of the risks and benefits of participating in the medical surveillance program and the employee's right to opt out of any or all parts of the medical examination. Benefits of participating in medical surveillance may include early detection of adverse health effects, and aiding intervention efforts to prevent or treat disease. However, there may also be risks associated with medical testing for some conditions, which the PLHCP should communicate to the employee.
Paragraph (k)(3)(ii) then specifies that the medical examination must consist of a medical and work history; a physical examination with emphasis on the respiratory tract, skin breaks, and wounds; and pulmonary function tests.
The physical exam focuses on organs and systems known to be susceptible to beryllium toxicity. For example, proposed paragraph (k)(3)(ii)(C) focuses on the skin, and paragraph (k)(3)(ii)(D) focuses on the lungs. The information obtained will allow the PLHCP and supervising physician to assess the employee's health status, identify adverse health effects related to beryllium exposure, and determine if limitations should be placed on the employee's exposure to beryllium. The proposed standard does not include a comprehensive list of specific tests that must be part of the medical examination. OSHA does not believe that any particular test—beyond those listed in paragraph (k)(3)(ii)(D)-(F)—is necessarily applicable to all employees covered by the medical surveillance requirements. The Agency proposes to give the PLCHP the flexibility to determine any other appropriate tests to be selected for a given employee, as provided in paragraph (k)(3)(ii)(G).
Under paragraph (k)(3)(ii)(E), an employee must be offered a BeLPT (or a more reliable and accurate test for identifying beryllium sensitization) at the employee's first examination, and then every two years after the first examination unless the employee is confirmed positive. The requirement to test for beryllium sensitization applies whether or not an employee is otherwise entitled to a medical examination in a given year. For example, for an employee exposed during an emergency who would normally be entitled to 1 exam within 30 days of the emergency but not annual exams thereafter, the employer must still provide this employee with a test for beryllium sensitization every 2 years. This biennial requirement applies until the employee is confirmed positive. OSHA believes that 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.
OSHA considers the BeLPT to be a reliable medical surveillance tool for the purposes of a medical surveillance program. However, OSHA considers two abnormal test results necessary to confirm a finding of beryllium sensitization when using the BeLPT (“confirmed positive”). Therefore, a BeLPT must also be offered within one month of an employee receiving a single abnormal result. However, this requirement is waived if a more reliable and accurate test becomes available that could confirm beryllium sensitization based on one test result. OSHA requests comment on how to determine whether a test is more reliable and accurate than the BeLPT for identifying beryllium sensitization. OSHA has included a non-mandatory appendix that describes the BeLPT, discusses several studies of the BeLPT's validity and reliability, and states criteria OSHA believes are important to judge a new test's validity and reliability (Appendix A).
Under paragraph (k)(3)(ii)(F), a CT scan must be offered to employees who have been exposed to beryllium at concentrations above 0.2 μg/m
The CT scan requirement may be triggered by exposures that occurred before or after the effective date of this standard, or a combination of exposures before and after the effective date. This requirement may also be triggered by exposures that occurred when the employee was working for a different employer. An employer is required to offer a CT scan to employees who meet the criteria of paragraph (k)(1)(i)(D) if the employer has exposure records demonstrating that the employee meets the criteria, regardless of whether the exposure records were generated by the employer or given to the employer by the employee or a third party.
In a recent systematic review of CT screening trials for lung cancer, Bach
OSHA seeks comment on the proposed requirement and whether it is likely to benefit the beryllium-exposed employee population. As appropriate, please submit information, studies and data to support your comments.
OSHA notes that another form of CT scanning, High Resolution Computed Tomography (HRCT), is available and may be useful in screening for CBD. In patients with CBD, HRCT scanning of the chest is more sensitive than plain chest radiography in identifying abnormalities (NAS, 2008). However, HRCT scans showing no signs consistent with CBD have been reported in 25 percent of patients with biopsy-proven noncaseating granulomas (Newman
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. In addition, medical examinations that include more invasive testing, such as bronchoscopy, alveolar lavage, and transbronchial biopsy, have been demonstrated to provide additional valuable medical information. OSHA believes that the PLHCP is in the best position to decide which medical tests are necessary for each individual examined. Where specific tests are deemed appropriate by the PLHCP, the proposed standard, at paragraph (k)(3)(ii)(G), would require that they be provided.
Proposed paragraph (k)(4) details which information must be provided to the PHLCP. Specifically, the proposed standard would require the employer to ensure the examining PLHCP has a copy of the standard and all the appendices, and to provide to the examining PLHCP the following information, if known or reasonably available to the employer: a
Providing the PLHCP with exposure monitoring results, as required under paragraph (k)(4)(ii), will assist the physician completing the written medical opinion in determining if an employee is likely to be at risk of adverse effects from beryllium exposure at work. A well-documented exposure history would also assist the PLCHP in determining if a condition (
Proposed paragraph (k)(5) would require employers to obtain a written medical opinion from the licensed physician who performed or directed the exam within 30 days of the examination. The purpose of requiring the physician to supply a written opinion to the employer is to provide the employer with a documented medical basis for the employee's eligibility for medical removal, and to assess the employee's ability to use protective clothing and equipment, including respirators. In addition, provision of the written opinion to the employer may alert the employer to sources of beryllium exposure or problems with exposure controls at its worksite. OSHA believes the 30-day period will allow the licensed physician sufficient time to receive and consider the results of any tests included in the examination, and allow the employer to take any necessary protective measures in a timely manner. The proposed requirement that the opinion be in written form is intended to ensure that employers and employees have the benefit of the same information and that no information gets lost in oral communications. OSHA requests 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 (see this preamble at Section 1, Issues and Alternatives, Issue #26).
Paragraphs (k)(5)(i)(A)-(C) of the proposed standard specify what must be included in the licensed physician's written opinion. The first item for inclusion is 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 exposure. The standard also proposes that the medical opinion include any recommended limitations on the employee's exposure, including recommended use of, and limitations on the use of, personal protective clothing or equipment such as respirators.
The licensed physician would also need to state in the written opinion that the PLHCP has explained the results of the medical examination to the employee, including the results of any tests conducted, any medical conditions related to exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment, including respirators. Under proposed paragraph (k)(5)(i)(C), OSHA anticipates that the employee will be informed directly by the PLCHP of all results of his or her medical examination, including conditions of non-occupational origin. Direct consultation between the PLHCP and employee ensures that the employee will receive all information about the employee's health status, including non-occupationally related conditions that are not communicated to the employer.
Proposed paragraph (k)(5)(ii) would require the employer to ensure that neither the licensed physician nor any other PLHCP reveals to the employer findings or diagnoses which are unrelated to beryllium exposure. OSHA has proposed this provision to reassure employees participating in medical surveillance that they will not be penalized or embarrassed as a result of the employer obtaining information about them not directly pertinent to beryllium exposure. Paragraph (k)(5)(iii) would also require the employer to provide a copy of the licensed physician's written opinion to the employee within two weeks after receiving it to ensure that the employee has been informed of the results of the examination in a timely manner.
Proposed paragraph (k)(6)(i) provides for the referral to a CBD diagnostic center of any employee who is confirmed positive for beryllium sensitization. Within 30 days after the employer learns of the confirmed positive result, the employer must ensure that a licensed physician designated by the employer consults with the employee about referral to a CBD diagnostic center for further testing, to determine whether a sensitized employee has CBD. If the employee chooses to obtain a clinical evaluation at a CBD diagnostic center, the diagnostic center must be agreed upon by the employer and the employee. The employer and employee must make a good faith effort to agree on a CBD diagnostic center that is acceptable to them both. Under paragraph (k)(6)(ii), the employer is responsible for all costs associated with testing performed at the center. The term CBD diagnostic center is defined in proposed paragraph (b), and discussed in this section of the preamble regarding proposed paragraph (b).
Finally, under paragraph (k)(7), the employer would be required to convey the results of the medical tests to OSHA for evaluation and analysis at the request of the Assistant Secretary. The results of the tests may be used to evaluate the nature, variability, reliability, and relevance of the beryllium sensitization test results, to evaluate the effectiveness of the beryllium standard in reducing beryllium-related occupational disease, or for other scientific purposes. Results conveyed to OSHA must first be stripped of employees' names, social security numbers, and other identifying information.
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 proposed standard. Covered medical surveillance provided to eligible persons under the EEOICPA program is paid for by the federal government.
Employees covered by both the EEOICPA program and this proposed standard would not be required to attend separate medical examinations for the separate programs. Rather, these dual-coverage employees could attend consolidated medical examinations at which they would receive the services
As stated in the SBREFA Report, the medical surveillance section “was the most controversial part of the draft standard for most SERs and received the most comment” (OSHA, 2008b). SERs generally were concerned about the cost of medical surveillance, commenting that surveillance is unnecessary for employees with low beryllium exposures (OSHA, 2008b). The requirement of dermal triggers for medical surveillance was confusing for SERs and led to a number of comments (OSHA, 2008b). One SER suggested that the medical surveillance requirements should be performance-based, which would allow employers to determine which tests were appropriate for their employees (OSHA, 2008b). Use of the BeLPT was also controversial, given SERs' concerns about its accuracy and costs (OSHA, 2008b). OSHA requests comment on the proposed requirements for beryllium sensitization testing, including issues raised in this preamble at section I, Issues and Alternatives, and on the regulatory alternatives presented later in this section.
In response to these concerns, OSHA notes several changes made to the regulatory text since the SBREFA panel was convened. In the proposed standard, medical surveillance is limited to those employees who have worked in a regulated area for more than 30 days per year in the previous 12-month period, employees showing signs and symptoms of CBD, employees exposed during emergencies, and employees who have been exposed above 0.2 μg/m
These changes will result in fewer employees being eligible for medical surveillance than were covered in the draft standard presented to the SBREFA panel. The changes will thereby reduce costs to employers. However, OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exist at exposure levels below the proposed PEL, and there is evidence that beryllium sensitization can occur from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk). The Agency therefore anticipates that some employees will develop adverse health effects and may not receive the benefits of early intervention in the disease process because they are not eligible for medical surveillance (see this preamble at Section V, Health Effects). Thus, OSHA is considering three regulatory alternatives that would expand eligibility for medical surveillance to a broader group of employees than those eligible in the proposed standard. Under Regulatory Alternative #14, medical surveillance would be available to employees who are exposed to beryllium above the proposed PEL, including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would expand 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. Regulatory Alternative #21 would extend eligibility for medical surveillance as set forth in proposed paragraph (k) to all employees in shipyards, construction, and general industry who meet the criteria of proposed paragraph (k)(1). However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule. Most of these alternatives would provide surveillance to fewer employees (and cost less to employers) than the draft regulation presented to the SBREFA Panel, but would provide more surveillance (and cost more to employers) than the medical surveillance requirements in the current proposal.
The SER who suggested allowing performance-based surveillance stated that this would permit employers “to design and determine what tests were appropriate” (OSHA, 2008b). OSHA is considering 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. Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule.
OSHA is evaluating these alternatives and has also included some performance-based elements in its medical surveillance requirements (
Finally, at least one SER commented that providing annual BeLPTs would result in high costs with no added benefit to employees (OSHA, 2008b). As discussed previously, OSHA would also allow substitution of a more accurate and reliable test for the BeLPT should such a test become available. When this occurs, employers can choose to use whichever test is less expensive. OSHA has also, in its proposed standard, reduced the frequency of required BeLPTs (or other test substituted for the BeLPT) to every two years, with follow-up tests for employees who receive abnormal test results. This change would significantly reduce the cost of testing, but would also delay early detection of beryllium-related health effects and intervention to prevent disease progression among employees in medical surveillance. In addition, the longer the time interval between when an employee becomes sensitized and when the employee's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to the employee's sensitization. Therefore, lengthening the time between
The benefits of regular medical surveillance for beryllium-related health effects and the costs of surveillance to employers are important and complex factors in the proposed standard, and OSHA requests feedback from the regulated and medical communities to help determine the most appropriate schedule for periodic testing. In particular, the Agency requests comments on several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. Regulatory alternative #17 would require employers to offer annual testing for beryllium sensitization to eligible employees, as in the draft proposal presented to the SBREFA panel. Regulatory Alternative #19 would similarly increase the frequency of periodic CT scans from biennial to annual scans. Finally, under Regulatory Alternative #20, all periodic components of the medical surveillance exams would be available biennially to eligible employees. Instead of requiring employers to offer eligible employees a medical examination every year, employers would be required to offer eligible employees a medical examination every other year. The frequency of testing for beryllium sensitization and CT scans would also be biennial for eligible employees, as in the proposed standard. For all comments on the medical surveillance provisions of the proposed standard, please provide an explanation of your position, and supporting data or studies as appropriate.
Paragraph (l) of the proposed rule contains the provisions related to medical removal protection (MRP). Proposed paragraph (l)(1) explains that employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. These medical findings may be made pursuant to the surveillance requirements of proposed paragraph (k). The terms “CBD” and “confirmed positive” are defined in proposed paragraph (b).
Proposed paragraph (l)(1) is in keeping with OSHA's provisions for MRP in past standards, where the Agency has specified objective removal criteria. For example, the Lead standard (29 CFR 1910.1025) requires that an employee be removed from exposure at or above the action level when an employee's blood lead concentration exceeds a certain value. Similarly, the Cadmium standard (29 CFR 1910.1027) includes objective biological monitoring criteria that trigger removal.
Paragraph (l)(2) lays out the options for employees who are eligible for MRP. Specifically, paragraph (l)(2)(i) would permit eligible employees to choose removal as described under proposed paragraph (l)(3), and proposed paragraph (l)(2)(ii) would permit them to remain in a job with exposure at or above the action level and wear a respirator in accordance with the Respiratory Protection standard (29 CFR 1910.134). Eligible employees must choose one of these two options. OSHA requests comment on whether the standard should establish a timeframe in which eligible employees must choose one of the options in paragraph (l)(3) (such as within 7 days, 14 days, or 30 days), and whether the standard should require the employee to wear a respirator if the employee fails to choose one of the options within the specified timeframe.
Proposed paragraph (l)(3) describes eligible employees' removal options. When an employee chooses removal, the employer is required to remove the employee to comparable work if such work is available. Comparable work is a position for which the employee is already qualified or can be trained within one month, in an environment where beryllium exposure is below the action level. Comparable work would not require the employee to use a respirator, although the employee may choose to use a respirator to minimize beryllium exposure. An employer is not required to place an employee on paid leave if the employee refuses comparable work offered under paragraph (l)(3)(i). An employee must be transferred to comparable work, trained for comparable work, or placed on paid leave immediately after choosing removal.
If comparable work is not immediately available, paragraph (l)(3)(ii) would require the employer to place the employee on paid leave for six months or until comparable work becomes available, whichever occurs first. If comparable work becomes available before the end of the six month paid leave period, the employer is obligated to offer the open position to the employee. Should the employee decline, the employer has no further obligation to continue the paid leave.
Proposed paragraph (l)(3)(iii) would continue a removed employee's rights and benefits for six months, regardless of whether the employee is removed to comparable work or placed on paid leave. The six month period would begin when the employee is removed, which means either the day the employer transfers the employee to comparable work, or the day the employer places the employee on paid leave. For this period, the provision would require 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. This provision is typical of medical removal provisions in other OSHA standards, such as Cadmium (29 CFR 1910.1027) and Benzene (29 CFR 1910.1028).
Paragraph (l)(4) would reduce an employer's obligation to provide MRP benefits to a removed employee 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. Benefits received under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) do not constitute wage replacement, and therefore would not offset the employee's medical removal benefits under this proposed standard.
By protecting an employee's rights and benefits during the first six months of removal, and by reducing in certain circumstances an employer's obligation to compensate employees for earnings lost, OSHA emphasizes that MRP is not intended to serve as a workers' compensation system. The primary reason MRP has been included in this standard is to provide eligible employees a six-month period to adjust to the comparable work arrangement or seek alternative employment, without any further exposure at or above the action level.
The prospect of a medical removal provision concerned some SERS. Some stated that there is no evidence that removing sensitized employees will change their health outcomes (OSHA 2008b). Others commented that they did not believe medical removal was appropriate because neither sensitization nor CBD is reversible (OSHA 2008b).
OSHA believes 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. The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are
There is widespread support for removal of individuals with sensitization or CBD from further beryllium exposure in the medical community and among other experts in beryllium disease prevention and treatment. Physicians at National Jewish, one of the main CBD research and treatment sites in the US, “consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,” and “recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average” (National Jewish site on Chronic Beryllium Disease: Work Environment Management, accessed May 2013). The Department of Energy included MRP in its Chronic Beryllium Disease Prevention Program (10 CFR part 850), stating that without MRP, employers would be “free to maintain high-risk workers in their current jobs, which would not be sufficiently protective of their health” (64 FR 68894, December 8, 1999). MRP is included in the recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and United Steelworkers, 2012).
OSHA believes that MRP also improves the medical surveillance program described in proposed paragraph (k). Paragraph (k)(1)(i)(B) requires medical examinations for 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 paid leave or comparable work can help allay an employee's fear that a CBD diagnosis will negatively affect earnings or career prospects. MRP encourages employees to report their symptoms and seek treatment, as OSHA has previously recognized when including medical removal in regulations governing the exposure to lead (43 FR 52973, November 14, 1978), benzene (52 FR 34557, September 11, 1987), and cadmium (57 FR 42367-68, September 14, 1992). This reasoning was also cited by the Department of Energy in support of the medical removal provisions of its Chronic Beryllium Disease Prevention Program, stating that the availability of medical removal benefits encourages worker participation and cooperation in medical surveillance (64 FR 68893, December 8, 1999).
MRP also provides an incentive for employers to keep employee exposures low. The risk of developing CBD or beryllium sensitization decreases at lower exposures (see this preamble at section VI, Preliminary Risk Assessment), meaning that employers can improve their chances of avoiding MRP costs by lowering employee exposure levels. OSHA previously noted this incentive when describing MRP provisions in the Lead standard (43 FR 52973, November 14, 1978) and the Cadmium standard (57 FR 42368, September 14, 1992).
Finally, OSHA's preliminary risk assessment indicates that significant risk remains at the proposed TWA PEL (see this preamble at section VI, Preliminary Risk Assessment). MRP offers additional protection for situations in which workers develop CBD or beryllium sensitization despite exposures at or below the PEL. As discussed above regarding the definition of “action level” in paragraph (b), if OSHA finds a continuing exposure risk at the PEL, it has the authority to impose additional feasible requirements on employers to further reduce risk when those requirements will result in a greater than minimal incremental benefit to workers' health (
During the SBREFA process, SERs commented that small entities may lack the flexibility and resources to provide comparable positions for MRP-eligible employees (OSHA 2008b). The SBREFA Panel recommended that OSHA give careful consideration to the impacts that an MRP requirement could have on small businesses (OSHA, 2008b). In response to this recommendation, the Agency has provided flexibility in how employers may comply with MRP requirements. Where employers have no comparable positions in environments with exposures below the action level, the proposed standard permits an employer to place eligible employees on paid leave for six months, or until comparable work becomes available. Under proposed paragraph (l)(4), if an employee is placed on paid leave and receives government or employer-provided compensation, or such paid leave allows the employee to secure other work, the original employer's compensation obligations would be offset. Also in response to the Panel's recommendations, OSHA analyzed Regulatory Alternative #22, which would eliminate the proposed requirement to offer MRP to employees with beryllium sensitization or CBD.
Finally, OSHA notes that there is considerable scientific uncertainty about the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD. Members of the medical community support removal from beryllium exposure as a prudent step in the management of beryllium sensitization and disease. For example, physicians at National Jewish Medical Center, a leading organization in CBD research and treatment, recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour TWA (
OSHA proposes to include MRP in the beryllium standard, providing workers with sensitization or CBD the opportunity and means to minimize their further exposure to beryllium via MRP in keeping with the recommendation of beryllium specialists in the medical community and with the draft recommended standard provided by union and industry stakeholders (Materion and Steelworkers, 2012).
OSHA solicits comments on the health effects of MRP and the proposed provisions for MRP. Is MRP an appropriate means of intervention in the disease process for workers with beryllium sensitization or CBD? Do the proposed MRP provisions appropriately balance SBREFA commenters' concerns with the need to reduce beryllium exposure for employees with
Paragraph (m) of this proposal sets forth the employer's obligations to comply with OSHA's Hazard Communication standard (HCS)(29 CFR 1910.1200), and to take additional steps to warn and train employees about the hazards of beryllium.
Paragraph (m)(1)(i) of this proposal requires chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the HCS for beryllium. As described in this preamble at section V, Health Effects, and section VI, Preliminary Beryllium Risk Assessment, OSHA considers beryllium a hazardous chemical.
In classifying the hazards of beryllium, the employer must address at least the following: Cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation (paragraph (m)(1)(ii)). 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)).
Paragraph (m)(1)(iii) requires that employers 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 proposal.
According to paragraph (e)(1)(ii) of this proposal, employers must establish and maintain regulated areas wherever employees are or can reasonably be expected to be exposed to beryllium at levels above the TWA PEL or STEL, and each employee entering a regulated area must wear a respirator and protective clothing and equipment in accordance with paragraphs (g) and (h) of this standard. Under paragraph (m)(2) of this proposal, employers must 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. Employers must ensure that warning signs required by paragraph (m)(2) are legible and readily visible, and that they bear the following legend:
Danger; Beryllium; May Cause Cancer; Causes Damage to Lungs; Authorized Personnel Only; Wear respiratory protection and protective clothing and equipment in this area.
Some SERs objected to having cancer warnings displayed on the legends for warning signs and labels. They expressed the opinion that cancer warnings would unnecessarily scare customers and employees. Further, they alleged evidence for beryllium causation of cancer was not sufficient (OSHA, 2008b). OSHA disagrees with these comments. OSHA has thoroughly reviewed the literature for beryllium carcinogenicity, and has preliminarily concluded that beryllium is carcinogenic. OSHA's finding that inhaled beryllium causes lung cancer 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 (see this preamble at section V, Health Effects). For example, 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 (IARC, 2009). OSHA believes that the weight of evidence is sufficient to support the requirement for cancer warnings on signs and labels.
The signs required by paragraph (m)(2) of this proposal 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 proposal and 29 CFR 1910.1200(h) for training requirements).
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 have access to regulated areas to avoid the area. 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 that may require medical surveillance or be subject to the other requirements in this proposal associated with working in a regulated area.
Paragraph (m)(2) specifies the wording of the warning signs for regulated areas in order to ensure that the proper warning is consistently given to employees, and to notify employees that respirators and personal protective clothing and equipment are required in the regulated area. OSHA believes that the use of the word “Danger” is appropriate, based on the evidence of the toxicity of beryllium. “Danger” is used to attract the attention of employees to alert them to the fact that they are entering an area where the TWA PEL or STEL may be exceeded, and to emphasize the importance of the message that follows. The use of the word “Danger” is also consistent with other OSHA health standards dealing with toxins such as cadmium (29 CFR 1910.1027), methylenedianiline (29 CFR 1910.1050), asbestos (29 CFR 1910.1001), and benzene (29 CFR 1910.1028). In addition, use of the word “Danger” for this chemical is consistent with the Globally Harmonized System of Classification and Labeling of Chemical guidelines (GHS) (77 FR 17740-48, March 26, 2012). In the
Paragraph (m)(3) requires that labels be affixed to all bags and containers of clothing, equipment, and materials visibly contaminated with beryllium. The term “materials” includes waste, scrap, debris, and any other items visibly contaminated with beryllium that are consigned for disposal or recycling (see paragraphs (h)(2)(iv) and (v) and (j)(3)(i) through (iii)). The labels must state:
Danger; Contains Beryllium; May Cause Cancer; Causes Damage to Lungs; Avoid Creating Dust; Do Not Get on Skin.
The purpose of this labeling requirement is to 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
As discussed previously, these labeling requirements are consistent with the HCS, which requires classification of hazardous chemicals and labeling appropriate for the classification (see 77 FR 17740-48, March 26, 2012). In addition, these requirements for labeling are consistent with the mandate of section (6)(b)(7) of the OSH Act, which requires that OSHA health standards prescribe the use of labels or other appropriate forms of warning to apprise employees of the hazards to which they are exposed.
Paragraph (m)(4) contains requirements for employee information and training, and applies to all employees who are or can reasonably be expected to be exposed to airborne beryllium. Employers must ensure that employees receive 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. 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)).
Under paragraph (m)(4)(i)(B), training must be provided to each employee 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. This training must be repeated at least annually thereafter ((m)(4)(i)(C)). OSHA believes that annual retraining is necessary due to the hazards of beryllium exposure, and for reinforcement of employees' knowledge of those hazards. The annual training requirement is 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 butadiene (29 CFR 1910.1051).
Paragraph (m)(4)(ii) requires 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 (see paragraph (m)(4)(ii)(A)—(I)). Providing information and training on these topics is essential to informing employees of current hazards and explaining how to minimize potential health hazards associated with beryllium exposure. As part of an overall hazard communication program, training serves to explain and reinforce the information presented on labels and safety data sheets. 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. Training should lead to better work practices and hazard avoidance.
The training requirements in paragraph (m)(4)(ii) are performance-oriented. This paragraph lists the topics that training must address, but does not prescribe specific training methods. OSHA believes that the employer is in the best position to determine how to conduct training that imparts knowledge and promotes retention. Appropriate training may include video, DVD or slide presentations; classroom instruction; hands-on training; informal discussions during safety meetings; written materials; or a combination of these methods. This performance-oriented approach is intended to encourage employers to tailor training to the needs of their workplaces, thereby resulting in the most effective training program in each individual workplace.
For training to be effective, the employer must ensure that it is provided in a manner that each employee is able to understand. OSHA recognizes that employees have varying education levels, literacy levels, and language skills, and is requiring that they receive training in a language and at a level of complexity that accounts for these differences. This may require, for example, providing materials, instruction, or assistance in Spanish rather than English if the employees being trained are Spanish-speaking and do not understand English well. The employer would not be required to provide training in the employee's preferred language if the employee understands both languages; as long as the employee is able to understand the language used, the intent of the proposed standard would be met.
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 video presentations or computer-based programs are used, employers may meet this requirement 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.
In addition to being performance-oriented, these training requirements are also results-oriented. Paragraph (m)(4)(ii) requires employers to ensure that affected employees can demonstrate knowledge of the nine topics enumerated in paragraph (m)(4)(ii)(A) through (I). Accordingly, employers must ensure that employees participate in and comprehend the training, and are able to demonstrate knowledge of the specified topics. Some examples of methods to ensure knowledge are discussions of the required training subjects, written tests, or oral quizzes. Although the standard only requires annual retraining, employers must ensure that employees can demonstrate up-to-date knowledge of the listed topics at all times.
Paragraph (m)(4)(iii) requires employers to provide additional training, even if a year has not passed since the previous 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. Some examples of changes in work conditions triggering the requirement for additional training include changes in work production operations or personnel that affect the way employees operate equipment. Additional training would also be required if employers introduce new production or personal protective equipment where employees 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. As another example, 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 believes the additional training requirement in this proposal 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.
Paragraph (m)(5) requires that employers make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative. This requirement ensures that employees and their representatives have direct access to regulations affecting them, and knowledge of the protective measures employers must take on employees' behalf.
Commenters to both the RFI and SBREFA recognized the importance of educating and training their employees about the hazards of beryllium exposure. In commenting on an earlier OSHA draft standard for beryllium during the SBREFA process, several companies (
Paragraph (n) of the proposed standard requires employers to maintain records of exposure measurements, historical monitoring data, objective data, medical surveillance, and training. The recordkeeping requirements are proposed 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 proposed recordkeeping provisions are also consistent with OSHA's standard addressing access to employee exposure and medical records (29 CFR 1910.1020).
Proposed paragraph (n)(1)(i) requires employers to keep records of all measurements taken to monitor employee exposure to beryllium as required by paragraph (d) of this standard. Paragraph (n)(1)(ii) would require that such records include the following information: The date of measurement for each sample taken; the operation involving exposure to beryllium that was monitored; the sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of samples taken; the types of respiratory protection and other personal protective equipment used; and the name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
These requirements are consistent with those found in other OSHA standards, such as those for methylene chloride (29 CFR 1910.1052) and chromium (VI) (29 CFR 1910.1026). These standards, like most of OSHA's substance-specific standards, require that exposure monitoring and medical surveillance records include the employee's social security number. OSHA has included this requirement in the past because social security numbers are particularly useful in identifying employees, since each number is unique to an individual for a lifetime and does not change when an employee changes employers. When employees have identical or similar names, identifying employees solely by name makes it difficult to determine to which employee a particular record pertains. However, based on privacy concerns, OSHA examined alternatives to requiring social security numbers for employee identification as part of its Standards Improvement Project-Phase II (“SIPs”) Final Rule. The Agency analyzed public comment on the necessity, usefulness, and effectiveness of social security numbers as a means of identifying employee records. OSHA also analyzed comments regarding privacy concerns raised by this requirement, as well as the availability of other effective methods of identifying employees for OSHA recordkeeping purposes. Comments were divided regarding whether social security information should be retained for exposure and medical records. The Agency examined the comments and decided not to take any action in the SIPs final rule regarding the use of social security numbers because the conflicting comments all raised significant concerns, and OSHA wished to study the issue further. (See 70 FR 1112, 1126-27, March 7, 2005).
In this rulemaking, OSHA proposes to continue to require the use of social security numbers. OSHA emphatically recommends against distributing or posting employees' social security numbers with monitoring results. OSHA welcomes comment on this issue.
Proposed paragraph (n)(2) addresses historical monitoring data. Paragraph (n)(2)(i) would require employers to establish and maintain an accurate record of any historical monitoring data used to satisfy the initial monitoring requirements in paragraph (d)(2) of this standard. As explained earlier in this preamble, paragraph (d)(2) permits employers to substitute beryllium monitoring results obtained at an earlier time for the initial monitoring requirements, as long as employers abide by the criteria specified. Paragraph (n)(2)(ii) requires the employer to establish and maintain records or documents showing that the criteria discussed in paragraph (d)(2) are met. This would mean documenting the workplace conditions present when the historical data were collected, for purposes of showing that those conditions closely resemble the conditions present in the employer's current operations. Employers should also document the dates of reliance on the historical data as well as the dates on which the historical data were collected.
Proposed paragraph (n)(3) addresses objective data. Proposed paragraph (n)(3)(i) requires 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 must contain 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 support the exemption; and other information demonstrating that the data meet the requirements for objective data in accordance with paragraph (d)(2). Such other information may include reports of engineering controls, work area layout and dimensions, and natural air movements pertaining to the data and current conditions.
Since historical and 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. Historical and objective data are intended to provide the same degree of assurance that employee exposures have been correctly characterized as would exposure monitoring. The records must demonstrate a reasonable basis for conclusions drawn from the data.
Under proposed paragraph (n)(4)(i) employers must establish and maintain accurate medical surveillance records for each employee covered by the
OSHA believes that medical records, like exposure records, are necessary and appropriate. Medical records document the results of medical surveillance and the screening of employees. Employers can use the information contained in the records to identify and adjust hazardous workplace conditions and mitigate exposures. Employees can use these records to make informed decisions regarding medical surveillance and medical removal. PLHCPs would have the records to use in any further employee consultations or in making recommendations at a later time. In sum, medical records play an important part in properly evaluating the effects of beryllium exposure on employees' health.
Paragraph (n)(5)(i) would require that employers prepare and maintain records of any training required by this standard. At the completion of training, the employer would be required to prepare a record that indicates 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 would also apply to records of annual retraining or additional training as described in paragraph (m)(4).
Proposed paragraphs (n)(1) through (4) require employers to maintain exposure measurements, historical monitoring data, and medical surveillance records, respectively, in accordance with OSHA's Records Access standard (29 CFR 1910.1020). That standard, specifically 29 CFR 1910.1020(d), requires employers to ensure the preservation and retention of exposure and medical records. Exposure measurements and historical monitoring data are considered employee exposure records that must be maintained for at least 30 years in accordance with 29 CFR 1910.1020(d)(1)(ii). Medical surveillance records must be maintained for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.1020(d)(1)(i).
Proposed paragraph (n)(5)(ii) requires employers to retain training records, including records of annual retraining or additional training required under this standard, for a period of three years after the completion of the training. OSHA believes that the retention period for training records is reasonable for documentation purposes. The three year period for the maintenance of training records is consistent with the Bloodborne Pathogens standard (29 CFR 1910.1030). Other OSHA standards require training records to be kept for one year beyond the last date of employment (
These maintenance provisions, as well as the access requirements discussed below, ensure that records are available to employees so that they may examine the employer's exposure measurements, historical monitoring data, and objective data, as well as medical surveillance and training records, and evaluate whether employees are being adequately protected. Moreover, compliance with the requirement to maintain records of exposure data will enable the employer to show, at least for the duration of the retention-of-records period, that the requirements of this standard were carried out appropriately. For example, maintenance of these types of data could protect employers from allegations of violating paragraph (d)(2). The lengthy record retention period is necessitated by the long latency period commonly associated with diseases such as chronic beryllium disease and cancer (see this preamble at section V, Health Effects).
Paragraph (n)(6) requires that all records mandated by this standard must be made 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).
Paragraph (n)(7) requires that employers comply with the Records Access standard regarding the transfer of records. Specifically, 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.
Commenters to the RFI fully endorsed the need for the collection and maintenance of health-related records dealing with beryllium exposure, as well as those for employee hazard training (Brush Wellman, 2003). No comments were received in opposition to the need for such recordkeeping. However, one commenter suggested that most dental labs will not have any incentive to comply with the recordkeeping requirements because they have fewer than ten employees and therefore would not be subject to OSHA audits of their records. The commenter noted that OSHA will have difficulty measuring the effectiveness of the standard if small businesses do not keep accurate records (OSHA, 2007a). OSHA does not intend to exempt small businesses from the recordkeeping requirements in this proposal because the Agency believes the severity of disease resulting from beryllium exposure is great enough to justify requiring small businesses to maintain employee health records in accordance with this proposal. Also, recordkeeping for fewer employees should be less resource-intensive than for a larger organization. OSHA requests comment on the appropriateness of the proposed recordkeeping requirements.
According to paragraph (o), this standard will become effective 60 days after the publication of the final rule in the
There are two exceptions to the normal start-up intervals—establishing change rooms and implementing engineering controls—that provide additional time for employers to comply. Change rooms are required no later than one year after the effective date of the standard, and engineering controls need to be in place within two years after the effective date. The delayed start-up dates allow affected employers sufficient time to design and construct change rooms where necessary, and to design, obtain, and install any required control equipment. In addition, the longer intervals for change rooms and engineering controls are consistent with other OSHA
Cancer, Chemicals, Hazardous substances, Health, Occupational safety and health, Reporting and recordkeeping requirements.
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, directed the preparation of this notice. OSHA is issuing this notice under Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); section 41 of the Longshore and Harbor Worker's Compensation Act (33 U.S.C. 941); section 107 of the Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3704); Secretary of Labor's Order 1-2012 (77 FR 3912, January 25, 2012); and 29 CFR part 1911.
Chapter XVII of Title 29 of the Code of Federal Regulations is proposed to be amended as follows:
Sections 4, 6, 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act of 1970, except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under section 6(a) (29 U.S.C. 655(a)).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under 29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under 29 U.S.C. 653. Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
The revisions and additions read as follows:
(a)
(2) This section 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 section does not apply to materials containing less than 0.1% beryllium by weight.
(b)
(c)
(2)
(d)
(ii) Except as provided in paragraphs (d)(2)(i) and (ii) of this section, the employer shall determine the 8-hour TWA exposure for each employee based on one or more breathing zone samples that reflect the exposure of employees on each work shift, for each job classification, in each beryllium work area.
(iii) Except as provided in paragraph (d)(2)(i) and (ii) of this section, the employer shall determine short-term exposure from 15-minute breathing zone samples measured in operations that are likely to produce exposures above the STEL for each work shift, for each job classification, and in each beryllium work area.
(iv) The employer may perform representative sampling to characterize exposure, provided that the employer:
(A) Performs representative sampling where several employees perform the same job tasks, in the same job classification, on the same work shift, and in the same work area, and have similar duration and frequency of exposure;
(B) Takes sufficient personal breathing zone air samples to accurately characterize exposure on each work shift, for each job classification, in each work area; and
(C) Samples those employee(s) who are expected to have the highest exposure.
(v)
(2)
(i) Where the employer has conducted exposure monitoring for beryllium and relies on these historical data, provided that:
(A) The work operations and workplace conditions that were in place when the historical monitoring data were obtained reflect workplace conditions closely resembling the processes, material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations;
(B) The characteristics of the beryllium-containing material being handled when the historical monitoring data were obtained closely resemble the characteristics of the beryllium-containing material used during the job for which initial monitoring will not be performed; and
(C) The exposure monitoring satisfied all other requirements of this section, including Accuracy of Measurement in paragraph (d)(1)(v).
(ii) Where the employer relies on objective data to satisfy initial monitoring requirements, provided that such data:
(A) Demonstrate that any material containing beryllium or any specific process, operation, or activity involving beryllium cannot release beryllium dust, fumes, or mist in concentrations at or above the action level or above the STEL under any expected conditions of use; and
(B) Reflect workplace conditions closely resembling the processes, material, control methods, work practices, and environmental conditions used and prevailing in the employer's current operations.
(3)
(4)
(i) Any change in production processes, equipment, materials, personnel, work practices, or control methods that can reasonably be expected to result in new or additional exposure; or
(ii) The employer has any other reason to believe that new or additional exposure is occurring.
(5)
(ii) Where exposures exceed the TWA PEL or STEL, the written notification required by paragraph (d)(5)(i) of this section shall include 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.
(6)
(ii) When observation of monitoring requires entry into an area where the use of protective clothing or equipment (which may include respirators) is required, the employer shall provide each observer with appropriate protective clothing and equipment at no
(iii) The employer shall ensure that each observer complies with all applicable OSHA requirements and the employer's workplace safety and health procedures.
(e)
(ii) The employer shall 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 shall identify each regulated area in accordance with paragraph (m)(2) of this section.
(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)(6) of this section; and
(iii) Persons authorized by law to be in a regulated area.
(4)
(i) Respiratory protection in accordance with paragraph (g) of this section; and
(ii) Personal protective clothing and equipment in accordance with paragraph (h) of this section.
(f)
(i) The employer shall establish, implement, and maintain a written exposure control plan for beryllium work areas, which shall contain:
(A) An inventory of operations and job titles reasonably expected to have exposure;
(B) An inventory of operations and job titles reasonably expected to have exposure at or above the action level;
(C) An inventory of operations and job titles reasonably expected to have exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination, including but not limited to preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas;
(E) Procedures for keeping surfaces in the beryllium work area 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) An inventory of engineering and work practice controls required by paragraph (f)(2) of this standard; and
(H) Procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.
(ii) The employer shall 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.
(iii) The employer shall 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)).
(2)
(1) Material and/or process substitution;
(
(
(
(B) An employer is exempt from using the above controls to the extent that:
(
(
(ii) If after implementing the control(s) required by (f)(2)(i)(A) exposures exceed the TWA PEL or STEL, the employer shall implement additional or enhanced engineering and work practice controls to reduce exposures to or below the PELs.
(iii) Wherever the employer demonstrates that it is not feasible to reduce exposures to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (ii) of this section, the employer shall 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 section.
(3)
(g)
(i) Periods necessary to install or implement feasible engineering and work practice controls where exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL;
(ii) Operations, including maintenance and repair activities and non-routine tasks, when engineering and work practice controls are not feasible and exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL;
(iii) Work operations for which an employer has implemented all feasible engineering and work practice controls when such controls are not sufficient to reduce exposure to or below the TWA PEL or STEL;
(iv) Emergencies.
(2)
(h)
(i) Where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL;
(ii) Where employees' clothing or skin may become visibly contaminated with
(iii) Where employees' skin can reasonably be expected to be exposed to soluble beryllium compounds.
(2)
(A) At the end of the work shift or at the completion of tasks involving beryllium, whichever comes first, or
(B) When protective clothing or equipment becomes visibly contaminated with beryllium.
(ii) The employer shall ensure that each employee removes protective clothing visibly contaminated with beryllium as specified in the exposure control plan required by paragraph (f)(1) of this section.
(iii) The employer shall ensure that each employee stores and keeps required protective clothing separate from street clothing.
(iv) The employer shall ensure that no employee removes beryllium-contaminated 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 protective clothing and equipment at an appropriate location or facility away from the workplace.
(v) When protective clothing or equipment required by this standard is removed from the workplace for laundering, cleaning, maintenance or disposal, the employer shall ensure that 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 section and the HCS (29 CFR 1910.1200).
(3)
(ii) The employer shall ensure that beryllium is not removed from protective clothing and equipment by blowing, shaking or any other means that disperses beryllium into the air.
(iii) The employer shall 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 that the protective clothing and equipment must be handled in accordance with this standard.
(i)
(i) Provide readily accessible washing facilities to remove beryllium from the hands, face, and neck; and
(ii) Ensure each employee exposed to beryllium to use these facilities when necessary.
(2)
(3)
(A) 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 section shall ensure that each employee showers at the end of the work shift or work activity if:
(A) The employee reasonably could have been exposed 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 employee in eating and drinking areas is exposed to airborne beryllium at or above the action level; and
(iii) Eating and drinking facilities provided by the employer are in accordance with the Sanitation standard (29 CFR 1910.141).
(5)
(ii) The employer shall ensure that no employees enter any eating or drinking area with protective work clothing or equipment unless 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.
(j)
(ii) The employer shall ensure that all spills and emergency releases of beryllium are cleaned up promptly and in accordance with the exposure control plan required under paragraph (f)(1) of this section and the cleaning methods required under paragraph (j)(2) of this section.
(2)
(ii) The employer shall 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 exposure have been tried and were not effective.
(iii) The employer shall 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 shall provide and ensure that each employee uses respiratory protection and protective clothing and equipment in accordance with paragraphs (g) and (h) of this section.
(v) The employer shall ensure that cleaning equipment is handled and maintained in a manner that minimizes the likelihood and level of employee exposure and the re-entrainment of airborne beryllium in the workplace.
(3)
(i) Waste, debris, and materials visibly contaminated with beryllium and consigned for disposal are disposed of in sealed, impermeable enclosures, such as bags or containers;
(ii) Bags or containers of waste, debris, and materials required by (j)(3)(i) of this section are labeled in accordance with paragraph (m)(3) of this section; and
(iii) Materials designated for recycling that are visibly contaminated with beryllium shall be 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 this section.
(k)
(A) For each employee who has worked in a regulated area for more than 30 days in the last 12 months;
(B) For each employee 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;
(C) For each employee exposed to beryllium during an emergency; and
(D) For each employee who was exposed to airborne beryllium above .2 μg/m
(ii) The employer shall 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 section, unless the employee has received a medical examination, provided in accordance with this standard, within the last 12 months; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C) of this section.
(ii) Annually thereafter for each employee who continues to meet the criteria of paragraph (k)(1)(i)(A) or (B) of this section; and
(iii) At the termination of employment for each employee who meets the criteria of paragraph (k)(1)(i)(A), (B), or (C) of this section at the time the employee's employment is terminated, unless an examination has been provided in accordance with this standard during the 6 months prior to the date of termination.
(3)
(ii) The employer shall ensure that the employee is offered a medical examination that includes:
(A) A medical and work history, with emphasis on past and present exposure, smoking history, and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory tract;
(C) A physical examination for skin breaks and wounds;
(D) Pulmonary function tests, performed in accordance with the guidelines established by the American Thoracic Society including forced vital capacity and forced expiratory volume at one (1) second (FEV1);
(E) (
(
(F) Each employee who meets the criteria of paragraph (k)(1)(i)(D) shall be offered a low dose helical tomography (CT Scan). The CT Scan shall be offered every 2 years for the duration of the employee's employment. This obligation begins on the [EFFECTIVE DATE OF FINAL RULE], or on the 15th year after the employee's first exposure above .2 μg/m
(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 occupational exposure;
(ii) The employee's former and current levels of occupational exposure;
(iii) A description of any protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that 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 a medical release from the employee.
(5)
(A) 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 exposure;
(B) Any recommended limitations on the employee's exposure, including the use and limitations of protective clothing or equipment, including respirators; and
(C) 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 exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.
(ii) The employer shall ensure that neither the licensed physician nor any other PLHCP reveals to the employer specific findings or diagnoses unrelated to exposure to airborne beryllium or contact with soluble beryllium compounds.
(iii) The employer shall provide a copy of the licensed physician's written medical opinion to the employee within 2 weeks after receiving it.
(6)
(ii) If, after this consultation, the employee wishes to obtain a clinical evaluation at a CBD diagnostic center, the employer shall provide the evaluation at no cost to the employee.
(7)
(l)
(2) If an employee is eligible for medical removal, the employee must choose:
(i) Removal as described in paragraph (l)(3) of this section; or
(ii) To remain in a job with exposure at or above the action level, provided that the employee wears a respirator in accordance with the Respiratory Protection standard (29 CFR 1910.134).
(3) If the employee chooses removal:
(i) The employer shall remove the employee to comparable work for which the employee is qualified or can be trained within 1 month. In this standard, comparable work must be in a work environment where the exposure is below the action level. The employee must accept comparable work if such work is available;
(ii) If comparable work is not available, the employer shall place the employee on paid leave for 6 months or until such time as comparable work becomes available, whichever comes first; and
(iii) 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.
(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, the employer shall address at least the following hazards: Cancer; lung effects (CBD and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation.
(iii) Employers shall include beryllium in the hazard communication program established to comply with the HCS. Employers shall 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 section.
(2)
(ii)
(B) The employer shall ensure each warning sign required by paragraph (m)(2)(i) of this section bears the following legend:
(3)
(4)
(A) The employer shall provide information and training in accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer shall provide initial training to each employee by the time of initial assignment; and
(C) The employer shall repeat the training required under this section annually for each employee.
(ii) The employer shall ensure that each employee who is or can reasonably be expected to be exposed to airborne beryllium can demonstrate knowledge of the following:
(A) The health hazards associated with exposure to beryllium and contact with soluble beryllium compounds, 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 employee exposure, especially employee 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 exposure to beryllium and contact with soluble beryllium compounds, including personal hygiene practices;
(F) The purpose and a description of the medical surveillance program required by paragraph (k) of this section 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 section;
(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 employee exposure that exceeds, or can reasonably be expected to exceed, either the TWA PEL or the STEL, the employer shall provide additional training to those employees affected by the change in exposure.
(iv)
(n) Recordkeeping—(1)
(ii) This record shall include at least the following information:
(A) The date of measurement for each sample taken;
(B) The operation 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 shall maintain this record as required by the Records
(2)
(ii) The record shall demonstrate that the data comply with the requirements of paragraph (d)(2) of this section.
(iii) The employer shall maintain this record as required by the Records Access standard (29 CFR 1910.1020).
(3)
(ii) This record shall 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 operation exempted from initial monitoring and how the data support the exemption; and
(E) Other information demonstrating that the data meet the requirements for objective data contained in paragraph (d)(2)(ii) of this section.
(iii) The employer shall maintain this record as required by the Records Access standard (29 CFR 1910.1020).
(4)
(ii) The record shall include the following information about the employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written opinions; and
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this section.
(iii) The employer shall ensure that medical records are maintained in accordance with the Records Access standard (29 CFR 1910.1020).
(5)
(ii) This record shall be maintained for 3 years after the completion of training.
(6)
(7)
(o)
(2)
(i) Change rooms required by paragraph (i) of this section shall be provided no later than 1 year after [EFFECTIVE DATE OF FINAL RULE]; and
(ii) Engineering controls required by paragraph (f) of this standard shall be implemented no later than 2 years after [EFFECTIVE DATE OF FINAL RULE].
(p)
Exposure to beryllium via inhalation or dermal contact has been determined to cause an immunological reaction (sensitization) in some individuals. Beryllium sensitization can progress to chronic beryllium disease (CBD). Identifying sensitized workers through an immunological screening program is an essential element in any monitoring and surveillance program designed to reduce the risk of developing CBD in the workplace (Kreiss, 1993b, Newman, 2005). Immunological testing for sensitization to beryllium serves to identify workers at risk for progression to CBD. The medical surveillance and medical removal provisions of the proposed standard provide for clinical evaluation of sensitized workers for early-stage CBD and intervention before progression to more debilitating health effects occurs.
2. This appendix provides an overview of the test currently used to detect beryllium sensitization, the peripheral blood Beryllium Lymphocyte Proliferation Test (BeLPT) as well as a description of the test procedure, the best available information on the accuracy of the test, and several repeat-testing algorithms designed to improve the predictive value of the test. It is important that this information be made available to employers, employees, physicians and other medical personnel to ensure their understanding of the test and the meaning of test results, and to provide a basis to compare the reliability and validity (utility) of any other sensitization tests that may be developed with the utility of the BeLPT.
1. The BeLPT is an in-vitro blood test that measures the beryllium antigen-specific T-cell mediated immune response. Currently, the BeLPT is the most commonly available diagnostic tool for identifying beryllium sensitization.
2. To perform the BeLPT, venous blood is collected in heparinized tubes. Lymphocytes are isolated from the blood using centrifugation and washed in salt solution. The lymphocytes are counted and evaluated for cell viability. These cells are then cultured in quadruplicate in the presence or absence of beryllium sulfate at 1, 10, and 100 μM concentrations for 3-7 days. During the last 4 hours of the culture, cells are pulsed with a radiolabeled DNA precursor (tritiated thymidine deoxyriboside), harvested onto filters and counted in a liquid scintillation counter. The counts per minute (cpm) from each set of quadruplicates are averaged and expressed as a ratio of the cpm of the beryllium stimulated cells to the unstimulated cells. This ratio is called the stimulation index (SI) (Maier, 2003).
3. The BeLPT is interpreted based on the proportion of SIs that exceeds a cut-off value, the expected SI for non-sensitized individuals. Each laboratory sets its own cut-off for the test (Newman 1996). Traditionally, this cut-off value is determined by testing cells from control/non-exposed individuals, and must be determined with each new serum lot that will be used for culturing the peripheral blood lymphocytes. The cut-off is based on the mean value of the peak stimulation index among controls plus 2 or 3 standard deviations. This methodology was modeled into a statistical method known as the “least absolute values” (an adaptation of the “statistical-biological positive” method) and relies on natural log modeling of the median stimulation index values (DOE 2001, Frome 2003). This methodology is recommended by the Department of Energy in guidance (DOE-SPEC-1142-2001) developed by DOE to optimize and standardize beryllium sensitivity testing. It is recommended, but not mandated, to be used in all DOE contracts with laboratories for the purchase of BeLPT services. Other labs have used a standard ratio of 3.0 (stimulated to unstimulated) as the cut-off for an abnormal result (Stange 2004, Deubner 2001).
4. BeLPT results are reported as “normal,” “abnormal,” or “borderline abnormal.” According to the DOE a BeLPT result is considered “abnormal” if at least two of the six stimulation indices are elevated (DOE 2001). If only one of the six stimulation indices is elevated, the test is considered “borderline abnormal” (DOE 2001). If no stimulation index is elevated, the test is normal. A BeLPT may be considered uninterpretable if there are problems with the viability of the cells or lack of response to mitogen, or other problems with the test procedure. (DOE 2001).
5. Due to the nature of the test, issues with variability and reproducibility of a test can
6.
7. Stange et al. (2004) investigated the utility of BeLPT testing in a population of employees of 18 United States Department of Energy (DOE) sites. At these sites, 12,194 current and former employees were tested for beryllium sensitization at four laboratories with BeLPT expertise. Stange
8. Middleton
9. In April 2006, the Agency for Toxic Substances and Disease Registry (ATSDR) convened an expert panel of seven physicians and scientists to discuss the BeLPT and to consider what algorithm should be used to interpret BeLPT results to establish beryllium sensitization (Middleton
10. Using the single-test outcome probabilities developed by Stange
11. The study demonstrated that confirmation of BeLPT results, whether as one abnormal and one borderline abnormal or as two abnormals, enhances the test's PPV and protects the persons tested from unnecessary and invasive medical procedures. In populations with a high prevalence of beryllium sensitization (
12. In a later analysis, Middleton
1. In the medical surveillance provisions of this standard, OSHA requires the use of a standardized BeLPT, but states that a “more reliable and accurate diagnostic test” for beryllium sensitization may be used in lieu of the BeLPT if such a test is developed. The Agency considers the following criteria to be important in judging a new test's validity and reliability:
a. A test report prepared by an independent
b. An article that has been published in a peer-reviewed journal describing the protocol and explaining how test data support the protocol's validity and reliability.
c. Sensitivity and specificity that meet or exceed those reported for the BeLPT in peer-reviewed publications.
Paragraph (f)(2)(i) of § 1910.1024 requires employers to use one or more of the control methods listed in paragraph (f)(2)(i)(A) of § 1910.1024 to minimize worker exposure in each operation in a beryllium work area, unless the operation is exempt under paragraph (f)(2)(i)(B) of § 1910.1024. This appendix sets forth a non-exhaustive list of control options that employers could use to comply with paragraph (f)(2)(i)(A) of § 1910.1024 for a number of specific beryllium operations.
| 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 |