Federal Register Vol. 80, No.222,

Federal Register Volume 80, Issue 222 (November 18, 2015)

Page Range71927-72326
FR Document

80_FR_222
Current View
Page and SubjectPDF
80 FR 72325 - America Recycles Day, 2015PDF
80 FR 72323 - Get Smart About Antibiotics Week, 2015PDF
80 FR 72321 - American Education Week, 2015PDF
80 FR 72043 - Notice of Amendment to Agenda for November 23, 2015, Sunshine Act Meeting, Previously Announced in the Board's Notice of November 6, 2015PDF
80 FR 71927 - Distribution of Department of Defense Funded Humanitarian Assistance in SyriaPDF
80 FR 72057 - Sunshine Act Meeting NoticePDF
80 FR 72125 - Sunshine Act MeetingPDF
80 FR 72126 - Sunshine Act MeetingPDF
80 FR 72052 - Sunshine Act NoticePDF
80 FR 72046 - President's Export Council Subcommittee on Export Administration; Notice of Partially Closed MeetingPDF
80 FR 72136 - Commercial Space Transportation Advisory Committee-Public TeleconferencePDF
80 FR 72102 - Guidance, Waivers, and Alternative Requirements for Grantees in Receipt of Community Development Block Grant Disaster Recovery Funds Under Public Law 113-2: “Buyout” and “Acquisition” Activities; Assistance to Agricultural Enterprises; and State of Colorado Waiver for Tourism PromotionPDF
80 FR 72094 - Notice of Single Family Loan Sales (SFLS 2016-1)PDF
80 FR 72100 - 10-Day Extension to 60-Day Notice of Proposed Information Collection: Core Performance Reporting Requirements for Competitively-Funded GrantsPDF
80 FR 71936 - Changes to Accounting Requirements for the Community Development Block Grants (CDBG) Program; CorrectionPDF
80 FR 72098 - 30-Day Notice of Proposed Information Collection: Accountability in the Provision of HUD Assistance Applicant/Recipient Disclosure/Update Report-HUD 2880PDF
80 FR 72046 - Reorganization of Foreign-Trade Zone 8 (Expansion of Service Area) Under Alternative Site Framework Toledo, OhioPDF
80 FR 71973 - Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic; 2015-2016 Accountability Measure and Closure for King Mackerel in Western Zone of the Gulf of MexicoPDF
80 FR 72106 - Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing ProgramsPDF
80 FR 72096 - 60-Day Notice of Proposed Information Collection: Manufactured Home Construction and Safety Standards ProgramPDF
80 FR 72095 - 60-Day Notice of Proposed Information Collection: Public Housing Capital Fund ProgramPDF
80 FR 71944 - 2-Propenoic Acid, Polymer With Ethenylbenzene and (1-Methylethenyl)benzene; Tolerance ExemptionPDF
80 FR 72097 - 60-Day Notice of Proposed Information Collection: Public Housing Agency (PHA) 5-Year and Annual PlanPDF
80 FR 72099 - 60-Day Notice of Proposed Information Collection: Renewable Energy Commitment FormPDF
80 FR 71947 - Flutriafol; Pesticide TolerancesPDF
80 FR 72105 - 60-Day Notice of Proposed Information Collection: Indian Community Capital InitiativePDF
80 FR 72045 - Approval of Expansion of Subzone 50H Tesoro Refining and Marketing Company, LLC, Long Beach, CaliforniaPDF
80 FR 72076 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment RequestPDF
80 FR 72086 - Chemical Security Assessment Tool (CSAT)PDF
80 FR 72069 - Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; AvailabilityPDF
80 FR 72059 - Notice of Agreements FiledPDF
80 FR 72113 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
80 FR 72049 - Fisheries of the Exclusive Economic Zone Off Alaska; Application for an Exempted Fishing PermitPDF
80 FR 72067 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsPDF
80 FR 71940 - Safety Zone; Turritella FPSO, Walker Ridge 551, Outer Continental Shelf on the Gulf of MexicoPDF
80 FR 71942 - Safety Zone; Titan SPAR, Mississippi Canyon 941, Outer Continental Shelf on the Gulf of MexicoPDF
80 FR 72108 - Proposed Habitat Conservation Plan/Natural Community Conservation Plan for Western Butte County, California: Environmental Impact StatementPDF
80 FR 72130 - In the Matter of the Designation of Maghomed Maghomedzakirovich Abdurakhmanov, Also Known as Abu Banat, Also Known as Abu al Banat, as a Specially Designated Global Terrorist Pursuant to Section 1(b) of Executive Order 13224, as AmendedPDF
80 FR 72081 - Privacy Act of 1974; Department of Homeland Security/U.S. Customs and Border Protection-021 Arrival and Departure Information SystemPDF
80 FR 72063 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
80 FR 72060 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
80 FR 72052 - Notice Expanding an Experiment Under the Experimental Sites Initiative; Federal Student Financial Assistance Programs Under Title IV of the Higher Education Act of 1965, as AmendedPDF
80 FR 72114 - Records Schedules; Availability and Request for CommentsPDF
80 FR 72055 - Nuclear Energy Advisory CommitteePDF
80 FR 72028 - Refuge Alternatives for Underground Coal MinesPDF
80 FR 72146 - Unblocking of a Specially Designated National and Blocked Person Pursuant to Executive Order 13566PDF
80 FR 72147 - Sanctions Actions Pursuant to Executive Order 13687PDF
80 FR 72057 - Defense Programs Advisory CommitteePDF
80 FR 72056 - Advanced Scientific Computing Advisory CommitteePDF
80 FR 71936 - Interpretive Bulletin Relating to State Savings Programs That Sponsor or Facilitate Plans Covered by the Employee Retirement Income Security Act of 1974PDF
80 FR 72006 - Savings Arrangements Established by States for Non-Governmental EmployeesPDF
80 FR 72115 - Northwest Medical Isotopes, LLCPDF
80 FR 71929 - List of Approved Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR® Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1PDF
80 FR 71982 - List of Approved Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR ® Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1PDF
80 FR 72114 - Notice of Intent To Grant Exclusive LicensePDF
80 FR 72143 - National Emergency Medical Services Advisory Council (NEMSAC) and Federal Interagency Committee on Emergency Medical Services (FICEMS); Notice of Federal Advisory Committee MeetingPDF
80 FR 72131 - Petition for Exemption; Summary of Petition Received; HUVRData, LLCPDF
80 FR 72141 - Environmental Impact Statement for the Green Line to the Airport Project, Sacramento County, CaliforniaPDF
80 FR 72044 - Submission for OMB Review; Comment RequestPDF
80 FR 72045 - Submission for OMB Review; Comment RequestPDF
80 FR 72035 - Federal Acquisition Regulation; Unique Identification of Entities Receiving Federal AwardsPDF
80 FR 72107 - Trinity River Adaptive Management Working Group; Public MeetingPDF
80 FR 72144 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment RequestPDF
80 FR 72047 - Endangered and Threatened Species; Take of Anadromous FishPDF
80 FR 72071 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting; Electronic SubmissionsPDF
80 FR 72068 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review VouchersPDF
80 FR 72049 - Proposed Information Collection; Comment Request; Application for Appointment in the NOAA Commissioned Officer CorpsPDF
80 FR 72052 - Submission for OMB Review; Comment RequestPDF
80 FR 71974 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
80 FR 72117 - New Postal ProductPDF
80 FR 72118 - New Postal ProductPDF
80 FR 72047 - Export Trade Certificate of ReviewPDF
80 FR 72060 - General Services Administration Acquisition Regulation; Information Collection; Federal Supply Schedule Pricing DisclosuresPDF
80 FR 72126 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To Adopt a New Policy Relating to Trade Reports for Exchange Traded ProductsPDF
80 FR 72118 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change To Adopt FINRA Rule 3210 (Accounts at Other Broker-Dealers and Financial Institutions), as Modified by Partial Amendment No. 1, in the Consolidated FINRA RulebookPDF
80 FR 72129 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Discontinue the NYSE Arca Realtime Reference Price Market Data Product OfferingPDF
80 FR 72124 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Discontinue the NYSE MKT Realtime Reference Price Market Data Product OfferingPDF
80 FR 72041 - Agency Information Collection Activities: Proposed Collection; Comments Request-Erroneous Payments in Child Care Centers Study (EPICCS)PDF
80 FR 72040 - Agency Information Collection Activities: Proposed Collection; Comment Request-Information Collection for the National School Lunch ProgramPDF
80 FR 72132 - Thirty-Seventh Meeting: RTCA Special Committee (224) Airport Security Access Control SystemsPDF
80 FR 72132 - Third Meeting: RTCA Special Committee (234) Portable Electronic Devices (PEDs) and EUROCAE WG-99 Plenary #6PDF
80 FR 72136 - Forty-Second Meeting: RTCA Special Committee (206) Aeronautical Information and Meteorological Data Link ServicesPDF
80 FR 72131 - Twenty-First Meeting: RTCA Special Committee (225) Rechargeable Lithium Battery and Battery SystemsPDF
80 FR 72133 - Notice of Opportunity to Participate; Criteria and Application Procedures for Participation in the Military Airport Program (MAP)PDF
80 FR 72137 - Supplemental Notice and Response to Comments on National Transit DatabasePDF
80 FR 72147 - Sanctions Actions Pursuant to Executive Order 13581PDF
80 FR 72077 - Proposed Collection; 60-Day Comment Request; The National Physician Survey of Precision Medicine in Cancer Treatment (NCI)PDF
80 FR 72077 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 72078 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
80 FR 72078 - National Institute on Drug Abuse Amended; Notice of MeetingPDF
80 FR 72079 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of MeetingPDF
80 FR 72076 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingPDF
80 FR 72077 - Eunice Kennedy Shriver National Institute of Child Health And Human Development; Notice of Closed MeetingPDF
80 FR 72079 - Eunice Kennedy Shriver National Institute of Child Health And Human Development; Notice of Closed MeetingPDF
80 FR 72079 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingPDF
80 FR 72079 - Identification of Foreign Countries Whose Nationals Are Eligible to Participate in the H-2A and H-2B Nonimmigrant Worker ProgramsPDF
80 FR 72085 - National Infrastructure Advisory CouncilPDF
80 FR 72029 - Structure and Practices of the Video Relay Service Program; Telecommunications Relay Services and Speech-to-Speech Services for Individuals With Hearing and Speech DisabilitiesPDF
80 FR 72029 - Pesticides; Certification of Pesticide Applicators; Extension of Comment PeriodPDF
80 FR 72117 - Information Collection: Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material; CorrectionPDF
80 FR 72066 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food EstablishmentsPDF
80 FR 71984 - Energy Conservation Program: Exempt External Power Supplies Under the EPS Service Parts Act of 2014PDF
80 FR 72014 - Claims Procedure for Plans Providing Disability BenefitsPDF
80 FR 72192 - Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care ActPDF
80 FR 71990 - Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed FoodsPDF
80 FR 71975 - Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Seabird Avoidance MeasuresPDF
80 FR 71952 - Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable TrainsPDF
80 FR 72150 - Health and Human Services Acquisition RegulationsPDF
80 FR 72296 - Claims for Compensation Under the Energy Employees Occupational Illness Compensation Program ActPDF

Issue

80 222 Wednesday, November 18, 2015 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72063-72066 2015-29440 Agriculture Agriculture Department See

Food and Nutrition Service

Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72052 2015-29401 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72066-72067 2015-29343 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 72043-72044 2015-29593 Coast Guard Coast Guard RULES Safety Zones: Titan SPAR, Mississippi Canyon 941, Outer Continental Shelf on the Gulf of Mexico, 71942-71944 2015-29448 Turritella FPSO, Walker Ridge 551, Outer Continental Shelf on the Gulf of Mexico, 71940-71942 2015-29449 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72044-72045 2015-29415 2015-29416 2015-29417
Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72144-72146 2015-29410 Defense Department Defense Department See

Army Department

PROPOSED RULES Federal Acquisition Regulation: Unique Identification of Entities Receiving Federal Awards, 72035-72039 2015-29414
Defense Nuclear Defense Nuclear Facilities Safety Board NOTICES Meetings; Sunshine Act, 72052 2015-29497 Education Department Education Department NOTICES Expanding an Experiment under the Experimental Sites Initiative: Federal Student Financial Assistance Programs under Title IV of the Higher Education Act of 1965, as, 72052-72055 2015-29437 Employee Benefits Employee Benefits Security Administration RULES Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections, 72192-72294 2015-29294 Interpretive Bulletin Relating to State Savings Programs that Sponsor or Facilitate Plans Covered by the Employee Retirement Income Security Act, 71936-71940 2015-29427 PROPOSED RULES Claims Procedure for Plans Providing Disability Benefits, 72014-72028 2015-29295 Savings Arrangements Established by States for Non-Governmental Employees, 72006-72014 2015-29426 Energy Department Energy Department See

Federal Energy Regulatory Commission

See

National Nuclear Security Administration

PROPOSED RULES Energy Conservation Program: Exempt Power Supplies under the 2014 EPS Service Parts Act, 71984-71990 2015-29303 NOTICES Meetings: Advanced Scientific Computing Advisory Committee, 72056 2015-29429 Nuclear Energy Advisory Committee, 72055-72056 2015-29434
Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Flutriafol, 71947-71952 2015-29462 Pesticide Tolerances; Exemptions: 2-Propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene, 71944-71947 2015-29466 PROPOSED RULES Pesticides; Certification of Pesticide Applicators, 72029 2015-29370 Federal Aviation Federal Aviation Administration NOTICES Criteria and Application Procedures for Participation in the Military Airport Program, 72133-72136 2015-29385 Meetings: Commercial Space Transportation Advisory Committee; Public Teleconference, 72136-72137 2015-29493 RTCA Special Committee 206 Aeronautical Information and Meteorological Data Link Services, 72136 2015-29387 RTCA Special Committee 224 Airport Security Access Control Systems, 72132 2015-29389 RTCA Special Committee 225 Rechargeable Lithium Battery and Battery Systems, 72131-72132 2015-29386 RTCA Special Committee 234 Portable Electronic Devices (PEDs) and EUROCAE WG-99 Plenary #6, 72132 2015-29388 Petitions for Exemptions; Summaries: HUVRData, LLC, 72131 2015-29419 Federal Communications Federal Communications Commission PROPOSED RULES Structure and Practices of the Video Relay Service Program: Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, 72029-72035 2015-29371 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72144-72146 2015-29410 Federal Energy Federal Energy Regulatory Commission NOTICES Meetings; Sunshine Act, 72057-72059 2015-29509 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 72059-72060 2015-29454 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72144-72146 2015-29410 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 72060 2015-29439 Federal Transit Federal Transit Administration NOTICES Environmental Impact Statements; Availability, etc.: Green Line to the Airport Project Sacramento County, CA, 72141-72143 2015-29418 Response to Comments on National Transit Database, 72137-72141 2015-29384 Fish Fish and Wildlife Service NOTICES Environmental Impact Statements; Availability, etc.: Conservation Plan/Natural Community Conservation Plan for Western Butte County, CA, 72108-72113 2015-29447 Meetings: Trinity River Adaptive Management Working Group, 72107-72108 2015-29411 Food and Drug Food and Drug Administration RULES Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments, 71934-71936 2015-29340 PROPOSED RULES Food Labeling: Gluten-Free Labeling of Fermented or Hydrolyzed Foods, 71990-72006 2015-29292 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Reporting; Electronic Submissions, 72071-72075 2015-29407 Guidance for Industry on Tropical Disease Priority Review Vouchers, 72068-72069 2015-29406 Guidance: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants, 72069-72071 2015-29455 Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 72067-72068 2015-29450 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Erroneous Payments in Child Care Centers Study, 72041-72043 2015-29391 National School Lunch Program, 72040-72041 2015-29390 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 2015-29383 2015-29431 72146-72147 2015-29432 Foreign Trade Foreign-Trade Zones Board NOTICES Approvals of Expansion: Tesoro Refining and Marketing Company, LLC, Subzone 50H, Long Beach, CA, 72045-72046 2015-29459 Reorganizations under Alternative Site Framework: Foreign-Trade Zone 8, Toledo, OH, 72046 2015-29476 General Services General Services Administration PROPOSED RULES Federal Acquisition Regulation: Unique Identification of Entities Receiving Federal Awards, 72035-72039 2015-29414 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Supply Schedule Pricing Disclosures, 72060-72063 2015-29396 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

RULES Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections, 72192-72294 2015-29294 Health and Human Services Acquisition Regulations, 72150-72189 2015-28214 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 72076 2015-29458
Homeland Homeland Security Department See

Coast Guard

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Chemical Security Assessment Tool, 72086-72094 2015-29457 Foreign Countries Whose Nationals Are Eligible to Participate in the H-2A and H-2B Nonimmigrant Worker Programs, 72079-72081 2015-29373 Meetings: National Infrastructure Advisory Council, 72085-72086 2015-29372 Privacy Act; Systems of Records, 72081-72085 2015-29445
Housing Housing and Urban Development Department RULES Changes to Accounting Requirements for the Community Development Block Grants Program; Correction, 71936 2015-29478 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accountability in the Provision of HUD Assistance Applicant/Recipient Disclosure/Update Report, 72098-72099 2015-29477 Core Performance Reporting Requirements for Competitively-Funded Grants; Extension, 72100-72102 2015-29484 Indian Community Capital Initiative, 72105-72106 2015-29461 Manufactured Home Construction and Safety Standards Program, 72096-72097 2015-29468 Public Housing Agency 5-Year and Annual Plan, 72097-72098 2015-29465 Public Housing Capital Fund Program, 72095-72096 2015-29467 Renewable Energy Commitment Form, 72099-72100 2015-29463 Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing Programs, 72106-72107 2015-29469 Guidance, Waivers, and Alternative Requirements: Grantees in Receipt of Community Development Block Grant Disaster Recovery Funds, etc., 72102-72105 2015-29487 Single Family Loan Sales, 72094-72095 2015-29486 Industry Industry and Security Bureau NOTICES Meetings: President's Export Council Subcommittee On Export Administration, 72046 2015-29495 Interior Interior Department See

Fish and Wildlife Service

Internal Revenue Internal Revenue Service RULES Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections, 72192-72294 2015-29294 International Trade Adm International Trade Administration NOTICES Export Trade CertificateS of Review, 72047 2015-29397 International Trade Com International Trade Commission NOTICES Complaints: Certain Computer Cables, Chargers, Adapters, Peripheral Devices and Packaging Containing the Same, 72113 2015-29453 Labor Department Labor Department See

Employee Benefits Security Administration

See

Mine Safety and Health Administration

See

Workers Compensation Programs Office

Mine Mine Safety and Health Administration PROPOSED RULES Refuge Alternatives for Underground Coal Mines, 72028 2015-29433 NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulation: Unique Identification of Entities Receiving Federal Awards, 72035-72039 2015-29414 NOTICES Intents to Grant Exclusive Licenses, 72114 2015-29422 National Archives National Archives and Records Administration NOTICES Records Schedules; Availability, 72114-72115 2015-29436 National Highway National Highway Traffic Safety Administration NOTICES Meetings: National Emergency Medical Services Advisory Council and Federal Interagency Committee on Emergency Medical Services, 72143-72144 2015-29421 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: The National Physician Survey of Precision Medicine in Cancer Treatment, 72077-72078 2015-29382 Meetings: Center for Scientific Review, 72077 2015-29381 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 2015-29374 2015-29375 2015-29376 72076-72077, 72079 2015-29377 2015-29378 National Institute of Allergy and Infectious Diseases, 72078 2015-29380 National Institute on Drug Abuse; Amendments, 72078 2015-29379 Energy National Nuclear National Nuclear Security Administration NOTICES Meetings: Defense Programs Advisory Committee, 72057 2015-29430 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries, 71974-71975 2015-29400 Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic: 2015-2016 Accountability Measure and Closure for King Mackerel in Western Zone of the Gulf of Mexico, 71973-71974 2015-29475 Fisheries off West Coast States: Pacific Coast Groundfish Fishery; Seabird Avoidance Measures, 71975-71981 2015-29249 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Appointment in the NOAA Commissioned Officer Corps, 72049 2015-29405 Endangered and Threatened Species: Takes of Anadromous Fish, 72047-72048 2015-29409 Environmental Impact Statements; Availability, etc.: Conservation Plan/Natural Community Conservation Plan for Western Butte County, CA, 72108-72113 2015-29447 Fisheries of the Exclusive Economic Zone off Alaska: Exempted Fishing Permit Applicationa, 72049-72052 2015-29451 Nuclear Regulatory Nuclear Regulatory Commission RULES Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1, 71929-71934 2015-29424 PROPOSED RULES Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1, 71982-71984 2015-29423 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material; Correction, 72117 2015-29353 Environmental Impact Statements; Availability, etc.: Northwest Medical Isotopes, LLC, 72115-72117 2015-29425 Pipeline Pipeline and Hazardous Materials Safety Administration RULES Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains, 71952-71973 2015-28774 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 2015-29398 72117-72118 2015-29399 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: America Recycles Day (Proc. 9368), 72325-72326 2015-29629 American Education Week (Proc. 9366), 72319-72322 2015-29627 Get Smart About Antibiotics Week (Proc. 9367), 72323-72324 2015-29628 ADMINISTRATIVE ORDERS Syria; Department of Defense-Funded Humanitarian Assistance, Distribution (Presidential Determination No. 2016-02 of November 13, 2015), 71927 2015-29569 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 2015-29501 72125-72126 2015-29502 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 72118-72124 2015-29394 NYSE Arca, Inc., 2015-29393 72126-72130 2015-29395 NYSE MKT LLC, 72124-72125 2015-29392 State Department State Department NOTICES Designations as a Global Terrorist: Maghomed Maghomedzakirovich Abdurakhmanov also known as Abu Banat also known as Abu al Banat, 72130-72131 2015-29446 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

Workers' Workers Compensation Programs Office PROPOSED RULES Claims for Compensation Under the Energy Employees Occupational Illness Compensation Program Act, 72296-72318 2015-27121 Separate Parts In This Issue Part II Health and Human Services Department, 72150-72189 2015-28214 Part III Health and Human Services Department, 72192-72294 2015-29294 Labor Department, Employee Benefits Security Administration, 72192-72294 2015-29294 Treasury Department, Internal Revenue Service, 72192-72294 2015-29294 Part IV Labor Department, Workers Compensation Programs Office, 72296-72318 2015-27121 Part V Presidential Documents, 2015-29629 72319-72326 2015-29627 2015-29628 Reader Aids

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.

80 222 Wednesday, November 18, 2015 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0186] RIN 3150-AJ65 List of Approved Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR® Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1 AGENCY:

Nuclear Regulatory Commission.

ACTION:

Direct final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the NAC International, Inc. (NAC), MAGNASTOR® Cask System listing within the “List of approved spent fuel storage casks” to include Revision 1 to Amendment Nos. 0 (the initial Certificate), 1, 2, and 3 to Certificate of Compliance (CoC) No. 1031. Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 makes changes to the Technical Specifications (TSs), including correcting a typographical error in two actual boron loadings in TS 4.1.1(a), and revising the decay times in Tables B2-4 (for Amendment Nos. 0 and 1) and B2-5 (for Amendment Nos. 2 and 3) in Appendix B of the TSs for minimum additional decay time required for spent fuel assemblies that contain nonfuel hardware.

DATES:

The direct final rule is effective February 1, 2016, unless significant adverse comments are received by December 18, 2015. If the direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

ADDRESSES:

You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0186. Address questions about NRC dockets to Carol Gallagher, telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

• Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

• Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-3781; email: [email protected]

SUPPLEMENTARY INFORMATION: Table of Contents I. Obtaining Information and Submitting Comments II. Procedural Background III. Background IV. Discussion of Changes V. Voluntary Consensus Standards VI. Agreement State Compatibility VII. Plain Writing VIII. Environmental Assessment and Finding of No Significant Environmental Impact IX. Paperwork Reduction Act Statement X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality XIII. Congressional Review Act XIV. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2015-0186 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:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0186.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

Please include Docket ID NRC-2015-0186 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Procedural Background

This rule is limited to the changes contained in Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 and does not include other aspects of the MAGNASTOR® Cask System design. The NRC is using the “direct final rule” procedure to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on February 1, 2016. However, if the NRC receives significant adverse comments on this direct final rule by December 18, 2015, the NRC will publish a document that withdraws this action, and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rule section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or TSs.

For detailed instructions on submitting comments, please see the ADDRESSES section of this document.

III. Background

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs.

The NRC issued a final rule on November 21, 2008 (73 FR 70587), that approved the NAC MAGNASTOR® Cask System design to add Amendment No. 0 to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No.1031. Subsequently on June 15, 2010 (75 FR 33678), the NRC issued a final rule adding Amendment No. 1 to CoC No. 1031 to the list of NRC-approved cask designs in 10 CFR 72.214. Similar final rules were issued on November 14, 2011 (76 FR 70331), and June 25, 2013 (78 FR 37927), to add Amendment Nos. 2 and 3 to CoC No. 1031, respectively, to the list of NRC-approved cask designs in 10 CFR 72.214.

By letter dated June 5, 2014 (ADAMS Accession No. ML14160A856), NAC submitted a technical deficiency report for the calculation error associated with the additional cooling time required for fuel assemblies that contain nonfuel hardware—one issue sought to be addressed by this revision. In its letter, NAC stated that Duke Energy Carolinas, LLC (Duke Energy), hold the only two general licenses (Catawba Nuclear Station and McGuire Nuclear Station) that are loading and storing casks using Amendment No. 2 to CoC No. 1031; and that ZionSolutions is the only general licensee currently loading and storing casks using Amendment No. 3 to CoC No. 1031. According to NAC, no casks manufactured under CoC No. 1031, Amendment Nos. 0 and 1, have been purchased by a general licensee. Subsequently, NAC contacted the licensees loading and storing casks Amendment Nos. 2 and 3 to CoC No. 1031 to notify them of the errors and to determine whether any loaded casks did not meet or planned loading would not meet the correct additional cool times.

In its revision request dated January 14, 2015, NAC provided letters from both Duke Energy and ZionSolutions discussing the actions Duke Energy and ZionSolutions took after being notified of the errors. Duke Energy established administrative controls to ensure that all loaded storage casks will meet the proposed cooling time limits in Table B2-5, which are more conservative than the additional cooling time limits in Table B2-5 of the TSs for Amendment No. 2. Duke Energy evaluated the five already-loaded storage systems to ensure compliance with NAC's proposed Table B2-5 (correct additional cooling times for spent fuel assemblies that contain control components). Duke Energy determined that all five already-loaded systems meet NAC's proposed Table B2-5. Additionally, Duke Energy stated that the five storage casks loaded since Duke Energy implemented administrative controls to ensure compliance with NAC's proposed Table B2-5 also meet both the TSs and NAC's proposed Table B2-5. Duke Energy documented these results within the Duke Energy corrective action program.

ZionSolutions initiated a condition report to review the loading records of the 20 already-loaded storage systems and those storage systems that ZionSolutions planned to continue loading using this amendment. ZionSolutions also established administrative controls to ensure that all loaded storage casks will meet the proposed cooling time limits in NAC's proposed Table B2-5, which are more conservative than the additional cooling time limits in Table B2-5 of the TSs for Amendment No. 3.

IV. Discussion of Changes

By application dated June 20, 2014 (ADAMS Accession No. ML14174B095), as supplemented January 14, 2015 (ADAMS Accession No. ML15016A047), NAC submitted an application for revision to Amendment Nos. 0 (the initial certificate), 1, 2, and 3 to CoC No. 1031, MAGNASTOR® Cask System. Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 makes changes to the TSs, including correcting a typographical error in two actual boron loadings in TS 4.1.1(a), and revising the decay times in Tables B2-4 (for Amendment Nos. 0 and 1) and B2-5 (for Amendment Nos. 2 and 3) in Appendix B of the TSs for minimum additional decay time required for spent fuel assemblies that contain nonfuel hardware.

As documented in the Safety Evaluation Reports (SERs) (ADAMS Accession Nos. ML15180A092, ML15180A141, ML15180A220, and ML15180A281), for Revision 1 to Amendment Nos. 0-3 to CoC No. 1031, the NRC staff performed detailed safety evaluations of the proposed CoC revision request. There are no significant changes to cask design requirements in the proposed CoC revision. Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control. If there is no loss of containment, shielding, or criticality control, the environmental impacts would be insignificant. This amendment does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 would remain well within the 10 CFR part 20 limits. Therefore, the proposed CoC changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents.

This direct final rule revises the MAGNASTOR® Cask System listing in 10 CFR 72.214 by adding Revision 1 to Amendment Nos. 0-3 to CoC No. 1031. The amendment consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified in the SER.

The revised MAGNASTOR® cask design, when used under the conditions specified in the CoC, the TS, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into MAGNASTOR® Cask Systems that meet the criteria of Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 under 10 CFR 72.212.

V. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the MAGNASTOR® Cask System design listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

VI. Agreement State Compatibility

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this direct final rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State.

VII. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

VIII. Environmental Assessment and Finding of No Significant Environmental Impact A. The Action

The action is to amend 10 CFR 72.214 to revise the MAGNASTOR® Cask System listing within the “List of approved spent fuel storage casks” to include Revision 1 to Amendment Nos. 0-3 to CoC No. 1031. Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

B. The Need for the Action

This direct final rule amends the CoC for the MAGNASTOR® Cask System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Revision 1 to Amendment Nos. 0-3 to CoC No. 1031, corrects a typographical error in two actual boron loadings in TS 4.1.1(a), and revises the decay times in Tables B2-4 (for Amendment Nos. 0 and 1) and B2-5 (for Amendment Nos. 2 and 3) in Appendix B of the TSs for minimum additional decay time required for spent fuel assemblies that contain nonfuel hardware.

C. Environmental Impacts of the Action

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this amendment tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act.

The NAC MAGNASTOR® Cask System is designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an Independent Spent Fuel Storage Installation (ISFSI), the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control. If there is no loss of confinement, shielding, or criticality control, the environmental impacts would be insignificant. This amendment does not reflect a significant change in design or fabrication of the cask. There are no significant changes to cask design requirements in the proposed CoC amendment. In addition, because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Revision 1 to Amendments Nos. 0-3 to CoC No. 1031 would remain well within the 10 CFR part 20 limits. Therefore, the proposed CoC revision will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents. The NRC staff documented its safety findings in the SERs for these revisions.

D. Alternative to the Action

The alternative to this action is to deny approval of Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 and end the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into MAGNASTOR® Cask Systems in accordance with the changes described in proposed Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 would have to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts would be the same or less than the action.

E. Alternative Use of Resources

Approval of Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 would result in no irreversible commitments of resources.

F. Agencies and Persons Contacted

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

G. Finding of No Significant Impact

The environmental impacts of the action have been reviewed under the requirements in 10 CFR part 51. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR® Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

IX. Paperwork Reduction Act Statement

This direct final rule does not contain any information collection requirements and, therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number.

X. Regulatory Flexibility Certification

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and NAC. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

XI. Regulatory Analysis

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214. The NRC issued a final rule on November 21, 2008 (73 FR 70587), that approved the NAC MAGNASTOR® Cask System design to add Amendment No. 0 to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1031. Subsequently on June 15, 2010 (75 FR 33678), the NRC issued a final rule adding Amendment No. 1 to CoC No. 1031 to the list of NRC-approved cask designs in 10 CFR 72.214. Similar final rules were issued on November 14, 2011 (76FR 70331), and June 25, 2013 (78 FR 37927), to add Amendment Nos. 2 and 3 to CoC No. 1031, respectively, to the list of NRC-approved cask designs in 10 CFR 72.214.

On June 20, 2014, as supplemented January 14, 2015, NAC submitted an application to revise the MAGNASTOR® Cask Systems as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into the MAGNASTOR® Cask System under the changes described in Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the SERs and the environmental assessment, the direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

XII. Backfitting and Issue Finality

The NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Amendment Nos. 0-3 for CoC No. 1031 for the MAGNASTOR® Cask System, as currently listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 corrects a typographical error in two actual boron loadings in TS 4.1.1(a), and revises the decay times in Tables B2-4 (for Amendment Nos. 0 and 1) and B2-5 (for Amendment Nos. 2 and 3) in Appendix B of the TSs for minimum additional decay time required for spent fuel assemblies that contain nonfuel hardware.

Although NAC has manufactured casks under existing CoC No. 1031, Amendment Nos. 0-3, that are being revised by this final rule, NAC, as the vendor, is not subject to backfitting protection under 10 CFR 72.62. Moreover, NAC requested these changes and has requested to apply it to the existing casks manufactured under Amendment Nos. 0-3. Therefore, even if the vendor were deemed to be an entity protected from backfitting, this request represents a voluntary change and is not backfitting for the vendor.

Under 10 CFR 72.62, general licensees are entities that are protected from backfitting. However, according to NAC, no general licensees have purchased the systems under CoC No. 1031, Amendment Nos. 0 and 1, which are, in part, the subject of this revision. Therefore, the changes in CoC No. 1031, Amendment Nos. 0 and 1, which are approved in this direct final rule do not fall within the definition of backfitting under 10 CFR 72.62 or 10 CFR 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52 for general licensees.

According to NAC, casks under CoC No. 1031, Amendment Nos. 2 and 3, have been provided to two general licensees (Duke Energy Carolinas, LLC, loaded under CoC No. 1031, Amendment No. 2; and ZionSolutions loaded under CoC No. 1031, Amendment No. 3). General licensees are required, pursuant to 10 CFR 72.212, to ensure that each cask conforms to the terms, conditions, and specifications of a CoC, and that each cask can be safely used at the specific site in question. Because the casks delivered under CoC No. 1031, Amendment Nos. 2 and 3, now must be evaluated under 10 CFR 72.212 consistent with Revision 1 to Amendment Nos. 2 and 3 to CoC No. 1031, this change in the evaluation method and criteria constitutes a change in a procedure required to operate an ISFSI and, therefore, would constitute backfitting under 10 CFR 72.62(a)(2).

However, in this instance, NAC has provided documentation from the general licensees voluntarily indicating their lack of objection to Revision 1 to, Amendment Nos. 2 and 3 to CoC No. 1031. Specifically, in this instance, both licensees indicated their intention to upgrade their existing CoC No. 1031, Amendment Nos. 2 and 3, storage fleet to Amendment Nos. 4 or 5 of CoC No. 1031. These later amendments to CoC No. 1031 are consistent with the corrections being made in this revision. Therefore, although the general licensees are entities protected from backfitting, this request represents a voluntary change and is not backfitting. In order to provide general licensees adequate time to implement the revised CoC in the event that they have not upgraded to Amendment Nos. 4 or 5 by the time these revisions become effective, the revised CoC also incorporates a condition that provides general licensees 180 days from the effective date of Revision 1, for each revised certificate, to implement the changes authorized by this revision and to perform the required evaluation.

In addition, the changes in Revision 1 to CoC No. 1031, Amendment Nos. 0-3to CoC No. 1031, do not apply to casks which were manufactured to other amendments of CoC No. 1031, and, therefore, have no effect on current ISFSI licensees using casks which were manufactured to other amendments of CoC No. 1031. For these reasons, NRC approval of Revision 1 to, Amendment Nos. 0-3 to CoC No. 1031, does not constitute backfitting for users of the MAGNASTOR® Cask System which were manufactured to other amendments of CoC No. 1031, under 10 CFR 72.62, 10 CFR 50.109(a)(1), or the issue finality provisions applicable to combined licenses in 10 CFR part 52.

Accordingly, no backfit analysis or additional documentation addressing the issue finality criteria in 10 CFR part 52 has been prepared by the staff.

XIII. Congressional Review Act

This action is not a major rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

XIV. Availability of Documents

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

Document ADAMS Accession No. Proposed CoC No. 1031, Amendment No. 0, Revision 1 ML15180A230. Proposed CoC No. 1031 Amendment No. 0, Revision 1, TS Appendix A ML15180A238. Proposed CoC No. 1031 Amendment No. 0, Revision 1, TS Appendix B ML15180A270. Proposed SER for CoC No. 1031 Amendment No. 0, Revision 1 ML15180A281. Proposed CoC No. 1031, Amendment No. 1, Revision 1 ML15180A161. Proposed CoC No. 1031 Amendment No. 1, Revision 1, TS Appendix A ML15180A164. Proposed CoC No. 1031 Amendment No. 1, Revision 1, TS Appendix B ML15180A192. Proposed SER for CoC No. 1031 Amendment No. 1, Revision 1 ML15180A220. Proposed CoC No. 1031, Amendment No. 2, Revision 1 ML15180A114. Proposed CoC No. 1031, Amendment No. 2, Revision 1, TS Appendix A ML15180A119. Proposed TS Amendment No. 2, Revision 1, TS Appendix B ML15180A128. Proposed SER for CoC No. 1031 Amendment No. 2, Revision 1 ML15180A141. Proposed CoC No. 1031, Amendment No. 3, Revision 1 ML15180A033. Proposed CoC No. 1031 Amendment No. 3, Revision 1, TS Appendix A ML15180A077. Proposed CoC No. 1031 Amendment No. 3, Revision 1, TS Appendix B ML15180A087. Proposed SER for CoC No. 1031 Amendment No. 3, Revision 1 ML15180A092

The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0186. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2015-0186); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

List of Subjects in 10 CFR Part 72

Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

2. In § 72.214, Certificate of Compliance No. 1031 is revised to read as follows:
§ 72.214 List of approved spent fuel storage casks.

Certificate Number: 1031.

Initial Certificate Effective Date: February 4, 2009, superseded by Initial Certificate, Revision 1, on February 1, 2016.

Initial Certificate, Revision 1, Effective Date: February 1, 2016.

Amendment Number 1 Effective Date: August 30, 2010, superseded by Amendment Number 1, Revision 1, on February 1, 2016.

Amendment Number 1, Revision 1, Effective Date: February 1, 2016.

Amendment Number 2 Effective Date: January 30, 2012, superseded by Amendment Number 2, Revision 1, on February 1, 2016.

Amendment Number 2, Revision 1, Effective Date: February 1, 2016.

Amendment Number 3 Effective Date: July 25, 2013, superseded by Amendment Number 3, Revision 1, on February 1, 2016.

Amendment Number 3 Revision 1, Effective Date: February 1, 2016.

Amendment Number 4 Effective Date: April 14, 2015.

Amendment Number 5 Effective Date: June 29, 2015.

SAR Submitted by: NAC International, Inc.

SAR Title: Final Safety Analysis Report for the MAGNASTOR® System.

Docket Number: 72-1031.

Certificate Expiration Date: February 4, 2029.

Model Number: MAGNASTOR®.

Dated at Rockville, Maryland, this 5th day of November, 2015. For the Nuclear Regulatory Commission. Glenn M. Tracy, Acting, Executive Director for Operations.
[FR Doc. 2015-29424 Filed 11-17-15; 8:45 am] BILLING CODE 7590-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] RIN 0910-AG36 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; clarification of compliance date for certain food establishments.

SUMMARY:

The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade “A” milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.

DATES:

The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade “A” milk and milk products covered by NCIMS under the PMO is September 17, 2018.

FOR FURTHER INFORMATION CONTACT:

Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September 17, 2015 (80 FR 55908), we published a final rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (the final human preventive controls rule). Among other things, the final human preventive controls rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under section 415 of the FD&C Act (21 U.S.C. 350d) to establish and implement hazard analysis and risk-based preventive controls for human food. In the preamble to the final human preventive controls rule (80 FR 55908), we stated that the rule is effective November 16, 2015, and provided for compliance dates of 1 to 3 years in most cases.

In Comment 214 in the final human preventive controls final rule (80 FR 55908 at 55986 to 55987), we described comments that discuss facilities that comply with the Grade “A” PMO and are regulated under the NCIMS system, and we used the term “PMO facilities” as an abbreviation for these facilities. As previously discussed (78 FR 3646 at 3662; January 16, 2013), the PMO is a model regulation published and recommended by the U.S. Public Health Service/FDA for voluntary adoption by State dairy regulatory agencies to regulate the production, processing, storage and distribution of Grade “A” milk and milk products to help prevent milk-borne disease. Some comments recommended that we make full use of the existing milk safety system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. Some comments asked us to exempt PMO-regulated facilities (or the PMO-regulated part of a PMO facility that also produces food products not covered by the PMO) from the requirements of the rule for hazard analysis and risk-based preventive controls, or to otherwise determine that facilities operating in compliance with the PMO are also in compliance with those requirements. These comments suggested we could, as an interim step if we find it necessary, stay the application of these requirements to PMO-regulated facilities and work with the NCIMS cooperative program to enact any modifications to the PMO as may be needed to warrant an exemption or comparability determination. In response to these comments, we established a compliance date of September 17, 2018, for “PMO facilities” (see Response 214, 80 FR 55908 at 55987 to 55988).

II. Clarification of the Compliance Date for Facilities Regulated Under the NCIMS System

On September 10, 2015, the Office of the Federal Register made a pre-publication copy of the final human preventive controls rule available to the public through its procedures for advance display (Ref. 1). Since September 10, 2015, we have provided opportunities for stakeholders to ask questions about the rule, through webinars and through a Web portal for submission of questions (Refs. 2 and 3). Some PMO facilities, in addition to manufacturing, processing, packing, or holding grade “A” milk or milk products, manufacture, process, pack, or hold other food subject to the final human preventive controls rule. Some of these facilities have asked us to clarify whether the extended compliance date for “PMO facilities” applies only to grade “A” milk and milk products covered by NCIMS under the PMO, or whether the extended compliance date applies broadly to all activities conducted by the facility (e.g., activities related to other food produced at the facility).

In this document, we are clarifying that the extended compliance date of September 17, 2018, for “PMO facilities” applies only to grade “A” milk and milk products covered by NCIMS under the PMO, and not to the manufacturing, processing, packing, or holding of other food. As we discussed in Response 214 (80 FR 55908 at 55987 to 55988), we agreed that we should make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. We described our reasons for deciding to extend the compliance date for “PMO-regulated facilities” to comply with the requirements of subparts C and G to September 17, 2018. Those reasons related to the current provisions of the PMO, the work already begun by NCIMS to modify the PMO to include all of the requirements established in the final human preventive controls rule, and complex implementation issues concerning the interstate movement of milk and milk products and imported milk. We explained that in establishing a compliance date of September 17, 2018, for PMO facilities, we considered: (1) The extent of revisions that must be made to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO; (2) the process to revise the PMO; and (3) the date at which the necessary revisions to the PMO could begin to be made. All of these discussions in the human preventive controls final rule related to the activities regulated by NCIMS under the PMO.

III. Economic Analysis of Impacts

We have examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of this final rule (Ref. 4). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule is making no change to the compliance date announced for facilities regulated under the NCIMS system in the human preventive controls rule published on September 17, 2105, we have determined that this final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

IV. Environmental Impact, No Significant Impact

We have determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VI. References

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

1. Office of the Federal Register, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” September 10, 2015. Available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21920.pdf.

2. FDA, “FSMA Webinar Series: Preventive Controls for Human and Animal Food Final Rules,” 2015. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461512.htm.

3. FDA, “Contact FDA About FSMA,” 2015. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.

4. FDA, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments,” 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

Dated: November 10, 2015. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2015-29340 Filed 11-17-15; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 570 [Docket Nos. FR 5797-I-01 and FR 5797-C-02] RIN 2506-AC39 Changes to Accounting Requirements for the Community Development Block Grants (CDBG) Program; Correction AGENCY:

Office of the General Counsel, HUD.

ACTION:

Interim final rule; correction.

SUMMARY:

This document corrects a technical error in HUD's interim final rule on CDBG accounting requirements, published November 12, 2015.

DATES:

Effective date: December 14, 2015.

FOR FURTHER INFORMATION CONTACT:

Stanley Gimont, Director, Office of Block Grant Assistance, Department of Housing and Urban Development, Office of Community Planning and Development, 451 7th Street SW., Suite 7286, Washington, DC 20410 at 202-708-3587, (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll-free, at 800-877-8339.

SUPPLEMENTARY INFORMATION:

HUD published a document in the Federal Register on November 12, 2015, at 80 FR 69864, amending the accounting requirements for the CDBG program, including 24 CFR 570.489. The amendments included clarification of how HUD determines compliance with planning and administration cost limits. In the preamble to the rule, at page 69867, first column, HUD stated that the regulations revised by rule modify the limits on administrative and planning expenses by adding to the existing compliance test a new test for grants with an origin year of 2015and subsequent years, which would continue to remain in place for all grants. However, language was inadvertently included in the regulatory text that limited the existing test to CDBG grants with an origin year prior to 2015. This document corrects that limiting language.

Correction

In interim final rule FR Doc. 2015-28700, published on November 12, 2015 (80 FR 69864), make the following correction:

On page 69872, in the first column, in § 570.489, correct paragraph (a)(3)(ii) to read as follows:

§ 570.489 Program administrative requirements.

(a) * * *

(3) * * *

(ii) The combined expenditures by the State and its funded units of general local government for planning, management, and administrative costs shall not exceed 20 percent of the aggregate amount of the origin year grant, any origin year grant funds reallocated by HUD to the State, and the amount of any program income received during the program year.

Dated: November 13, 2015. Camille Acevedo, Associate General Counsel for Legislation and Regulations.
[FR Doc. 2015-29478 Filed 11-17-15; 8:45 am] BILLING CODE 4210-67-P
DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2509 RIN 1210-AB74 Interpretive Bulletin Relating to State Savings Programs That Sponsor or Facilitate Plans Covered by the Employee Retirement Income Security Act of 1974 AGENCY:

Employee Benefits Security Administration, Labor.

ACTION:

Interpretive bulletin.

SUMMARY:

This document sets forth the views of the Department of Labor (Department) concerning the application of the Employee Retirement Income Security Act of 1974 (ERISA) to certain state laws designed to expand the retirement savings options available to private sector workers through ERISA-covered retirement plans. Concern over adverse social and economic consequences of inadequate retirement savings levels has prompted several states to adopt or consider legislation to address this problem. The Department separately released a proposed regulation describing safe-harbor conditions for states and employers to avoid creation of ERISA-covered plans as a result of state laws that require private sector employers to implement in their workplaces state-administered payroll deduction IRA programs (auto-IRA laws). This Interpretive Bulletin does not address such state auto-IRA laws.

DATES:

This interpretive bulletin is effective on November 18, 2015.

FOR FURTHER INFORMATION CONTACT:

Office of Regulations and Interpretations, Employee Benefits Security Administration, (202) 693-8500. This is not a toll-free number.

SUPPLEMENTARY INFORMATION:

In order to provide a concise and ready reference to its interpretations of ERISA, the Department publishes its interpretive bulletins in the Rules and Regulations section of the Federal Register. The Department is publishing in this issue of the Federal Register, ERISA Interpretive Bulletin 2015-02, which interprets ERISA section 3(2)(A), 29 U.S.C. 1002(2)(A), section 3(5), 29 U.S.C. 1002(5), and section 514, 29 U.S.C. 1144, as they apply to state laws designed to expand workers' access to retirement savings programs. Some states have adopted laws or are exploring approaches designed to expand the retirement savings options available to their private sector workers through ERISA-covered retirement plans. One of the challenges the states face in expanding retirement savings opportunities for private sector employees is uncertainty about ERISA preemption of such efforts. ERISA generally would preempt a state law that required employers to establish and maintain ERISA-covered employee benefit pension plans. The Department also has a strong interest in promoting retirement savings by employees. The Department recognizes that some employers currently do not provide pension plans for their employees. The Department believes that it is important that employees of such employers be encouraged to save for retirement, and it is in the interest of the public that employers be encouraged to provide opportunities for their employee retirement savings. The Department therefore believes that states, employers, other plan sponsors, workers, and other stakeholders would benefit from guidance on the application of ERISA to these state initiatives.

List of Subjects in 29 CFR Part 2509

Employee benefit plans, Pensions.

For the reasons set forth in the preamble, the Department is amending Subchapter A, Part 2509 of Title 29 of the Code of Federal Regulations as follows:

Subchapter A—General PART 2509—INTERPRETIVE BULLETINS RELATING TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974 1. The authority citation for part 2509 continues to read as follows: Authority:

29 U.S.C. 1135. Secretary of Labor's Order No. 1-2011, 77 FR 1088 (Jan. 9, 2012). Sections 2509.75-10 and 2509.75-2 issued under 29 U.S.C. 1052, 1053, 1054. Sec. 2509.75-5 also issued under 29 U.S.C. 1002. Sec. 2509.95-1 also issued under sec. 625, Public Law 109-280, 120 Stat. 780.

2. Add § 2509.2015-02 to read as follows:
§ 2509.2015-02 Interpretive bulletin relating to state savings programs that sponsor or facilitate plans covered by the Employee Retirement Income Security Act of 1974.

(a) Scope. This document sets forth the views of the Department of Labor (Department) concerning the application of the Employee Retirement Income Security Act of 1974 (ERISA) to certain state laws designed to expand the retirement savings options available to private sector workers through ERISA-covered retirement plans. Concern over adverse social and economic consequences of inadequate retirement savings levels has prompted several states to adopt or consider legislation to address this problem.1 An impediment to state adoption of such measures is uncertainty about the effect of ERISA's broad preemption of state laws that “relate to” private sector employee benefit plans. In the Department's view, ERISA preemption principles leave room for states to sponsor or facilitate ERISA-based retirement savings options for private sector employees, provided employers participate voluntarily and ERISA's requirements, liability provisions, and remedies fully apply to the state programs.

1 For information on the problem of inadequate retirement savings, see the May 2015 Report of the United States Government Accountability Office (GAO), RETIREMENT SECURITY—Most Households Approaching Retirement Have Low Savings (GAO Report-15-419) (available at www.gao.gov/assets/680/670153.pdf). Also see GAO's September 2015 Report-15-566, RETIREMENT SECURITY—Federal Action Could Help State Efforts to Expand Private Sector Coverage (available at www.gao.gov/assets/680/672419.pdf).

(b) In General. There are advantages to utilizing an ERISA plan approach. Employers as well as employees can make contributions to ERISA plans, contribution limits are higher than for other state approaches that involve individual retirement plans (IRAs) that are not intended to be ERISA-covered plans,2 and ERISA plan accounts have stronger protection from creditors. Tax credits may also allow small employers to offset part of the costs of starting certain types of retirement plans.3 Utilizing ERISA plans also provides a well-established uniform regulatory structure with important consumer protections, including fiduciary obligations, automatic enrollment rules, recordkeeping and disclosure requirements, legal accountability provisions, and spousal protections.

2 Some states are developing programs to encourage employees to establish tax-favored IRAs funded by payroll deductions rather than encouraging employers to adopt ERISA plans. Oregon, Illinois, and California, for example, have adopted laws along these lines. Oregon 2015 Session Laws, Ch. 557 (H.B. 2960) (June 2015); Illinois Secure Choice Savings Program Act, 2014 Ill. Legis. Serv. P.A. 98-1150 (S.B. 2758) (West); California Secure Choice Retirement Savings Act, 2012 Cal. Legis. Serv. Ch. 734 (S.B. 1234) (West). These IRA-based initiatives generally require specified employers to deduct amounts from their employees' paychecks, unless the employee affirmatively elects not to participate, in order that those amounts may be remitted to state-administered IRAs for the employees. The Department is addressing these state “payroll deduction IRA” initiatives separately through a proposed regulation that describes safe-harbor conditions for employers to avoid creation of ERISA-covered plans when they comply with state laws that require payroll deduction IRA programs. This Interpretive Bulletin does not address those laws.

3 For more information, see Choosing a Retirement Solution for Your Small Business, a joint project of the U.S. Department of Labor's Employee Benefits Security Administration (EBSA) and the Internal Revenue Service. Available at www.irs.gov/pub/irs-pdf/p3998.pdf.

The Department is not aware of judicial decisions or other ERISA guidance directly addressing the application of ERISA to state programs that facilitate or sponsor ERISA plans, and, therefore, believes that the states, employers, other plan sponsors, workers, and other stakeholders would benefit from guidance setting forth the general views of the Department on the application of ERISA to these state initiatives. The application of ERISA in an individual case would present novel preemption questions and, if decided by a court, would turn on the particular features of the state-sponsored program at issue, but, as discussed below, the Department believes that neither ERISA section 514 specifically, nor federal preemption generally, are insurmountable obstacles to all state programs that promote retirement saving among private sector workers through the use of ERISA-covered plans.

Marketplace Approach

One state approach is reflected in the 2015 Washington State Small Business Retirement Savings Marketplace Act.4 This law requires the state to contract with a private sector entity to establish a program that connects eligible employers with qualifying savings plans available in the private sector market. Only products that the state determines are suited to small employers, provide good quality, and charge low fees would be included in the state's “marketplace.” Washington State employers would be free to use the marketplace or not and would not be required to establish any savings plans for their employees. Washington would merely set standards for arrangements marketed through the marketplace. The marketplace arrangement would not itself be an ERISA-covered plan, and the arrangements available to employers through the marketplace could include ERISA-covered plans and other non-ERISA savings arrangements. The state would not itself establish or sponsor any savings arrangement. Rather, the employer using the state marketplace would establish the savings arrangement, whether it is an ERISA-covered employee pension benefit plan or a non-ERISA savings program. ERISA's reporting and disclosure requirements, protective standards and remedies would apply to the ERISA plans established by employers using the marketplace. On the other hand, if the plan or arrangement is of a type that would otherwise be exempt from ERISA (such as a payroll deduction IRA arrangement that satisfies the conditions of the existing safe harbor at 29 CFR 2510.3-2(d)), the state's involvement as organizer or facilitator of the marketplace would not by itself cause that arrangement to be covered by ERISA. Similarly, if, as in Washington State, a marketplace includes a type of plan that is subject to special rules under ERISA, such as the SIMPLE-IRA under section 101(h) of ERISA, the state's involvement as organizer or facilitator of the marketplace would not by itself affect the application of the special rules.

4 2015 Wash. Sess. Laws chap. 296 (SB 5826) (available at http://app.leg.wa.gov/billinfo/summary.aspx?bill=5826&year=2015).

Prototype Plan Approach

Another potential approach is a state sponsored “prototype plan.” At least one state, Massachusetts, has enacted a law to allow nonprofit organizations with fewer than 20 employees to adopt a contributory retirement plan developed and administered by the state.5 Banks, insurance companies and other regulated financial institutions commonly market prototype plans to employers as simple means for them to establish and administer employee pension benefit plans.6 The financial institutions develop standard form 401(k) or other tax-favored retirement plans (such as SIMPLE-IRA plans) and secure IRS approval. Typically, employers may choose features such as contribution rates to meet their specific needs. Each employer that adopts the prototype sponsors an ERISA plan for its employees. The individual employers would assume the same fiduciary obligations associated with sponsorship of any ERISA-covered plans. For example, the prototype plan documents often specify that the employer is the plan's “named fiduciary” and “plan administrator” responsible for complying with ERISA, but they may allow the employer to delegate these responsibilities to others. The plan documents for a state-administered prototype plan could designate the state or a state designee to perform these functions. Thus, the state or a designated third-party could assume responsibility for most administrative and asset management functions of an employer's prototype plan. The state could also designate low-cost investment options and a third-party administrative service provider for its prototype plans.

5 The retirement plan will be overseen by the Massachusetts State Treasurer's Office. Mass. Gen. Laws ch.29, § 64E (2012). In June 2014, the Massachusetts Treasurer's Office announced that the IRS had issued a favorable ruling on the proposal, but noted that additional approval from the IRS is still needed (see www.massnonprofitnet.org/blog/nonprofitretirement/). See also GAO's Report 2015 Report-15-566, RETIREMENT SECURITY—Federal Action Could Help State Efforts to Expand Private Sector Coverage, which included the following statement at footnote 93 regarding the Massachusetts program: “The Massachusetts official told us that each participating employer would be considered to have created its own plan, characterizing the state's effort as development of a volume submitter 401(k) plan, which is a type of employee benefit plan that is typically pre-approved by the Internal Revenue Service.” (GAO report is available at www.gao.gov/assets/680/672419.pdf).

6See IRS Online Publication, Types of Pre-Approved Retirement Plans at www.irs.gov/Retirement-Plans/Types-of-Pre-Approved-Retirement-Plans.

Multiple Employer Plan (MEP) Approach

A third approach, (referenced, for example, in the “Report of the Governor's Task Force to Ensure Retirement Security for All Marylanders”),7 involves a state establishing and obtaining IRS tax qualification for a “multiple employer” 401(k)-type plan, defined benefit plan, or other tax-favored retirement savings program. The Department anticipates that such an approach would generally involve permitting employers that meet specified eligibility criteria to join the state multiple employer plan. The plan documents would provide that the plan is subject to Title I of ERISA and is intended to comply with Internal Revenue Code tax qualification requirements. The plan would have a separate trust holding contributions made by the participating employers, the employer's employees, or both. The state, or a designated governmental agency or instrumentality, would be the plan sponsor under ERISA section 3(16)(B) and the named fiduciary and plan administrator responsible (either directly or through one or more contract agents, which could be private-sector providers) for administering the plan, selecting service providers, communicating with employees, paying benefits, and providing other plan services. A state could take advantage of economies of scale to lower administrative and other costs.

7 Governor's Task Force to Ensure Retirement Security for All Marylanders, 1,000,000 of Our Neighbors at Risk: Improving Retirement Security for Marylanders (February 2015) (available at www.dllr.state.md.us/retsecurity/).

As a state-sponsored multiple employer plan (“state MEP”), this type of arrangement could also reduce overall administrative costs for participating employers in large part because the Department would consider this arrangement as a single ERISA plan. Consequently, only a single Form 5500 Annual Return/Report would be filed for the whole arrangement. In order to participate in the plan, employers simply would be required to execute a participation agreement. Under a state MEP, each employer that chose to participate would not be considered to have established its own ERISA plan, and the state could design its defined contribution MEP so that the participating employers could have limited fiduciary responsibilities (the duty to prudently select the arrangement and to monitor its operation would continue to apply). The continuing involvement by participating employers in the ongoing operation and administration of a 401(k)-type individual account MEP, however, generally could be limited to enrolling employees in the state plan and forwarding voluntary employee and employer contributions to the plan. When an employer joins a carefully structured MEP, the employer is not the “sponsor” of the plan under ERISA, and also would not act as a plan administrator or named fiduciary. Those fiduciary roles, and attendant fiduciary responsibilities, would be assigned to other parties responsible for administration and management of the state MEP.8 Adoption of a defined benefit plan structure would involve additional funding and other employer obligations.9

8 A state developing a state sponsored MEP could submit an advisory opinion request to the Department under ERISA Procedure 76-1 to confirm that the MEP at least in form has assigned those fiduciary functions to persons other than the participating employers. ERISA Procedure 76-1 is available at www.dol.gov/ebsa/regs/aos/ao_requests.html.

9 State laws authorizing defined benefit plans for private sector employers (as prototypes or as multiple employer plans) might create plans covered by Title IV of ERISA and subject to the jurisdiction of the Pension Benefit Guaranty Corporation (PBGC). Subject to some exceptions, the PBGC protects the retirement incomes of workers in private-sector defined benefit pension plans. A defined benefit plan provides a specified monthly benefit at retirement, often based on a combination of salary and years of service. PBGC was created by ERISA to encourage the continuation and maintenance of private-sector defined benefit pension plans, provide timely and uninterrupted payment of pension benefits, and keep pension insurance premiums at a minimum. More information is available on the PBGC's Web site at www.pbgc.gov.

For a person (other than an employee organization) to sponsor an employee benefit plan under Title I of ERISA, such person must either act directly as the employer of the covered employees or “indirectly in the interest of an employer” in relation to a plan.10 ERISA sections 3(2), 3(5). A person will be considered to act “indirectly in the interest of an employer, in relation to a plan,” if such person is tied to the contributing employers or their employees by genuine economic or representational interests unrelated to the provision of benefits.11 In the Department's view, a state has a unique representational interest in the health and welfare of its citizens that connects it to the in-state employers that choose to participate in the state MEP and their employees, such that the state should be considered to act indirectly in the interest of the participating employers.12 Having this unique nexus distinguishes the state MEP from other business enterprises that underwrite benefits or provide administrative services to several unrelated employers.13

10 Different rules may apply under the Internal Revenue Code for purposes of determining the plan sponsor of a tax-qualified retirement plan.

11See, e.g., Advisory Opinion 2012-04A. See also MDPhysicians & Associates, Inc. v. State Bd. Ins., 957 F.2d 178,185 (5th Cir.), cert. denied, 506 U.S. 861 (1992) (“the entity that maintains the plan and the individuals that benefit from the plan [must be] tied by a common economic or representation interest, unrelated to the provision of benefits.” (quoting Wisconsin Educ. Assoc. Ins. Trust v. Iowa State Bd., 804 F.2d 1059, 1063 (8th Cir. 1986)).

12 The Department has also recognized other circumstances when a person sponsoring a plan is acting as an “employer” indirectly rather than as an entity that underwrites benefits or provides administrative services. See Advisory Opinion 89-06A (Department would consider a member of a controlled group which establishes a benefit plan for its employees and/or the employees of other members of the controlled group to be an employer within the meaning of section 3(5) of ERISA); Advisory Opinion 95-29A (employee leasing company may act either directly or indirectly in the interest of an employer in establishing and maintaining employee benefit plan).

13See Advisory Opinion 2012-04A (holding that a group of employers can collectively act as the “employer” in sponsoring a multiple employer plan only if the employers group was formed for purposes other than the provision of benefits, the employers have a basic level of commonality (such as the participating employers all being in the same industry), and the employers participating in the plan in fact act as the “employer” by controlling the plan).

(c) ERISA Preemption. The Department is aware that a concern for states adopting an ERISA plan approach is whether or not those state laws will be held preempted. ERISA preemption analysis begins with the “presumption that Congress does not intend to supplant state law.” New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 654 (1995). The question turns on Congress's intent “to avoid a multiplicity of regulation in order to permit nationally uniform administration of employee benefit plans.” Id. at 654, 657. See also Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 11 (1987) (goal of ERISA preemption is to “ensure . . . that the administrative practices of a benefit plan will be governed by only a single set of regulations.”).

Section 514 of ERISA provides that Title I “shall supersede any and all State laws insofar as they . . . relate to any employee benefit plan” covered by the statute. The U.S. Supreme Court has held that “[a] law `relates to' an employee benefit plan, in the normal sense of the phrase, if it has a connection with or reference to such a plan.” Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 96-97 (1983) (footnote omitted); see, e.g., Travelers, 514 U.S. at 656. A law has a “reference to” ERISA plans if the law “acts immediately and exclusively upon ERISA plans” or “the existence of ERISA plans is essential to the law's operation.” California Div. of Labor Standards Enforcement v. Dillingham Constr., N.A., 519 U.S. 316, 325-326 (1997). In determining whether a state law has a “connection with ERISA plans,” the U.S. Supreme Court “look[s] both to `the objectives of the ERISA statute as a guide to the scope of the state laws that Congress understood would survive,' as well as to the nature of the effect of the state law on ERISA plans,” to “determine whether [the] state law has the forbidden connection” with ERISA plans. Egelhoff v. Egelhoff, 532 U.S. 141, 147 (2001) (quoting Dillingham, 519 U.S. at 325). In various decisions, the Court has concluded that ERISA preempts state laws that: (1) Mandate employee benefit structures or their administration; (2) provide alternative enforcement mechanisms; or (3) bind employers or plan fiduciaries to particular choices or preclude uniform administrative practice, thereby functioning as a regulation of an ERISA plan itself.14

14Travelers, 514 U.S. at 658 (1995); Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 142 (1990); Egelhoff v. Egelhoff, 532 U.S. 141, 148 (2001); Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 14 (1987).

In the Department's view, state laws of the sort outlined above interact with ERISA in such a way that section 514 preemption principles and purposes would not appear to come into play in the way they have in past preemption cases. Although the approaches described above involve ERISA plans, they do not appear to undermine ERISA's exclusive regulation of ERISA-covered plans. The approaches do not mandate employee benefit structures or their administration, provide alternative regulatory or enforcement mechanisms, bind employers or plan fiduciaries to particular choices, or preclude uniform administrative practice in any way that would regulate ERISA plans.

Moreover, the approaches appear to contemplate a state acting as a participant in a market rather than as a regulator. The U.S. Supreme Court has found that, when a state or municipality acts as a participant in the market and does so in a narrow and focused manner consistent with the behavior of other market participants, such action does not constitute state regulation. Compare Building and Construction Trades Council v. Associated Builders and Contractors of Massachusetts/Rhode Island, Inc., 507 U.S. 218 (1993); Wisconsin Department of Industry, Labor and Human Relations v. Gould, 475 U.S. 282 (1986); see also American Trucking Associations, Inc. v. City of Los Angeles, 133 S. Ct. 2096, 2102 (2013) (Section 14501(c)(1) of the Federal Aviation Administration Authorization Act, which preempts a state “law, regulation, or other provision having the force and effect of law related to a price, route, or service of any motor carrier,” 49 U.S.C. 14501(c)(1), “draws a rough line between a government's exercise of regulatory authority and its own contract-based participation in a market”); Associated General Contractors of America v. Metropolitan Water District of Southern California, 159 F.3d 1178, 1182-84 (9th Cir. 1998) (recognizing a similar distinction between state regulation and state market participation). By merely offering employers particular ERISA-covered plan options 15 (or non-ERISA plan options), these approaches (whether used separately or together as part of a multi-faceted state initiative) do not dictate how an employer's plan is designed or operated or make offering a plan more costly for employers or employees. Nor do they make it impossible for employers operating across state lines to offer uniform benefits to their employees.16 Rather than impair federal regulation of employee benefit plans, the state laws would leave the plans wholly subject to ERISA's regulatory requirements and protections.

15 In the Department's view, a state law that required employers to participate in a state prototype plan or state sponsored multiple employer plan unless they affirmatively opted out would effectively compel the employer to decide whether to sponsor an ERISA plan in a way that would be preempted by ERISA.

16 The Court in Travelers approved a New York statute that gave employers a strong incentive to provide health care benefits through Blue Cross and Blue Shield as opposed to other providers. The Court noted that the law did not “mandate” employee benefit plans or their administration, or produce such acute economic effects, either directly or indirectly, by intent or otherwise “as to force an ERISA plan to adopt a certain scheme of substantive coverage or effectively restrict its choice of insurers.” Travelers, 514 U.S. at 668. See also De Buono v. NYSA-ILA Medical and Clinical Services Fund, 520 U.S. 806, 816 (1997).

Of course, a state must implement these approaches without establishing standards inconsistent with ERISA or providing its own regulatory or judicial remedies for conduct governed exclusively by ERISA. ERISA's system of rules and remedies would apply to these arrangements. A contractor retained by a state using the marketplace approach would be subject to the same ERISA standards and remedies that apply to any company offering the same services to employers. Similarly, a prototype plan or multiple employer plan program that a state offers to employers would have to comply with the same ERISA requirements and would have to be subject to the same remedies as any private party offering such products and services.17

17 State laws relating to sovereign immunity for state governments and their employees would have to be evaluated carefully to ensure they do not conflict with ERISA's remedial provisions.

Even if the state laws enacted to establish programs of the sort described above “reference” employee benefit plans in a literal sense, they should not be seen as laws that “relate to” ERISA plans in the sense ERISA section 514(a) uses that statutory term because they are completely voluntary from the employer's perspective, the state program would be entirely subject to ERISA, and state law would not impose any outside regulatory requirements beyond ERISA. They do not require employers to establish ERISA-covered plans, forbid any type of plan or restrict employers' choices with respect to benefit structures or their administration. These laws would merely offer a program that employers could accept or reject. See Dillingham, 519 U.S. at 325-28.

In addition, none of the state approaches described above resemble the state laws that the Court held preempted in its pre-Travelers “reference to” cases. Those laws targeted ERISA plans as a class with affirmative requirements or special exemptions. See, e.g., District of Columbia v. Greater Wash. Bd. of Trade, 506 U.S. 125, 128, 129-133 (1992) (workers' compensation law that required employee benefits “set by reference to [ERISA] plans”) (citation omitted); Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 135-136, 140 (1990) (common law claim for wrongful discharge to prevent attainment of ERISA benefits); Mackey v. Lanier Collection Agency & Serv., Inc., 486 U.S. 825, 828 & n.2, 829-830 (1988) (exemption from garnishment statute for ERISA plans). In the case of the state actions outlined above, any restriction on private economic activity arises, not from state regulatory actions, but from the application of ERISA requirements to the plans, service providers, and investment products, that the state, as any other private sector participant in the market, selects in deciding what it is willing to offer.

Finally, it is worth noting that even if the state laws implementing these approaches “relate to” ERISA plans in some sense of that term, it is only because they create or authorize arrangements that are fully governed by ERISA's requirements. By embracing ERISA in this way, the state would not on that basis be running afoul of section 514(a) because ERISA fully applies to the arrangement and there is nothing in the state law for ERISA to “supersede.” In this regard, section 514(a) of ERISA, in relevant part, provides that Title I of ERISA “shall supersede any and all state laws insofar as they may now or hereafter relate to any employee benefit plan . . . .” To the extent that the state makes plan design decisions in fashioning its prototype plan or state sponsored plan, or otherwise adopts rules necessary to run the plan, those actions would be the same as any other prototype plan provider or employer sponsor of any ERISA-covered plan, and the arrangement would be fully and equally subject to ERISA.

This conclusion is supported by the Department's position regarding state governmental participation in ERISA plans in another context. Pursuant to section 4(b)(1) of ERISA, the provisions of Title I of ERISA do not apply to a plan that a state government establishes for its own employees, which ERISA section 3(32) defines as a “governmental plan.” The Department has long held the view, however, that if a plan covering governmental employees fails to qualify as a governmental plan, it would still be subject to Title I of ERISA.18 In these circumstances, the failure to qualify as a governmental plan does not prohibit a governmental employer from providing benefits through, and making contributions to, an ERISA-covered employee benefit plan.19 Thus, the effect of ERISA is not to prohibit the state from offering benefits, but rather to make those benefits subject to ERISA. Here too, ERISA does not supersede state law to the extent it merely creates an arrangement that is fully governed by ERISA.

18See, e.g., Advisory Opinion 2004-04A.

19See Information Letter to Michael T. Scaraggi and James M. Steinberg from John J. Canary (April 12, 2004).

Phyllis C. Borzi, Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor.
[FR Doc. 2015-29427 Filed 11-16-15; 4:15 pm] BILLING CODE 4510-29-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 147 [Docket No. USCG-2015-0318] RIN 1625-AA00 Safety Zone; Turritella FPSO, Walker Ridge 551, Outer Continental Shelf on the Gulf of Mexico AGENCY:

Coast Guard, DHS.

ACTION:

Final rule.

SUMMARY:

The Coast Guard is establishing a safety zone around the Turritella FPSO system, Walker Ridge 551 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. The purpose of the safety zone is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Placing a safety zone around the facility will significantly reduce the threat of allisions, collisions, security breaches, oil spills, releases of natural gas, and thereby protect the safety of life, property, and the environment.

DATES:

This rule is effective December 18, 2015.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-0318 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email Mr. Rusty Wright, U.S. Coast Guard, District Eight Waterways Management Branch; telephone 504-671-2138, [email protected].

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations DHS Department of Homeland Security FR Federal Register FPSO Floating Production Storage Offloading Vessel NPRM Notice of Proposed Rulemaking OCS Outer Continental Shelf USCG United States Coast Guard II. Background Information and Regulatory History

Shell Exploration & Production Company requested that the Coast Guard establish a safety zone around the Turritella FPSO, which is a ship-shaped offshore production facility that stores crude oil in tanks located in its hull. It will attach to a moored turret buoy and move in a 360 degree arc around the position 26°25′38.74″ N., 90°48′45.34″ W. The purpose of the safety zone is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Therefore, on July 28, 2015 we published a NPRM with a request for comments entitled, “Safety Zones: Turritella FPSO system, Walker Ridge 551, Outer Continental Shelf on the Gulf of Mexico” in the Federal Register (80 FR 44910). We received no comments on the NPRM.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under the authority in 14 U.S.C. 85, 43 U.S.C. 1333, Department of Homeland Security Delegation No. 0170.1, and 33 CFR part 147, which collectively permit the establishment of safety zones for facilities located on the OCS for the purpose of protecting life, property and the marine environment.

The Coast Guard has determined that a safety zone is necessary to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. The purpose of the rule is to significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the environment.

For the purpose of safety zones established under 33 CFR part 147, the deepwater area is considered to be waters of 304.8 meters (1,000 feet) or greater depth extending to the limits of the Exclusive Economic Zone (EEZ) contiguous to the territorial sea of the United States and extending to a distance up to 200 nautical miles from the baseline from which the breadth of the sea is measured. Navigation in the vicinity of the safety zone consists of large commercial shipping vessels, fishing vessels, cruise ships, tugs with tows and the occasional recreational vessel. The deepwater area also includes an extensive system of fairways.

IV. Discussion of Comments, Changes and the Final Rule

As noted above, we received no comments on our NPRM published July 28, 2015. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone extending 500 meters (1640.4 feet) around the stern of the FPSO when it is moored to the turret buoy. If the FPSO detaches from the turret buoy, the safety zone of 500 meters (1640.4) will be measured from the center point of the turret buoy. No vessel, except those attending the facility, or those less than 100 feet in length and not engaged in towing will be permitted to enter the safety zone without obtaining permission from Commander, Eighth Coast Guard District or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes and executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This rule is not a significant regulatory action due to the location of the Turritella FPSO—on the Outer Continental Shelf—and its distance from both land and safety fairways. Vessel traffic can pass safely around the safety zone using alternate routes. Exceptions to this rule include vessels measuring less than 100 feet in length overall and not engaged in towing. Deviation to transit through the safety zone may be requested. Such requests will be considered on a case-by-case basis and may be authorized by the Commander, Eighth Coast Guard District or a designated representative.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 0 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone around an OCS Facility to protect life, property and the marine environment. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. The environmental analysis checklist supporting this determination and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 147

Continental shelf, Marine safety, Navigation (water).

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 147 as follows:

PART 147—SAFETY ZONES 1. The authority citation for part 147 continues to read as follows: Authority:

14 U.S.C. 85; 43 U.S.C. 1333; and Department of Homeland Security Delegation No. 0170.1.

2. Add § 147.863 to read as follows:
§ 147.863 Turritella FPSO System Safety Zone.

(a) Description. The Turritella, a Floating Production, Storage and Offloading (FPSO) system is to be installed in the deepwater area of the Gulf of Mexico at Walker Ridge 551. The FPSO can swing in a 360 degree arc around the center point of the turret buoy's swing circle at 26°25′38.74″ N., 90°48′45.34″ W., and the area within 500 meters (1640.4 feet) around the stern of the FPSO when it is moored to the turret buoy is a safety zone. If the FPSO detaches from the turret buoy, the area within 500 meters (1640.4 feet) around the center point at 26°25′38.74″ N., 90°48′45.34″ W. is a safety zone.

(b) Regulation. No vessel may enter or remain in this safety zone except the following:

(1) An attending vessel;

(2) A vessel under 100 feet in length overall not engaged in towing; or

(3) A vessel authorized by the Commander, Eighth Coast Guard District.

Dated: October 27, 2015. David R. Callahan, Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2015-29449 Filed 11-17-15; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 147 [Docket No. USCG-2015-0320] RIN 1625-AA00 Safety Zone; Titan SPAR, Mississippi Canyon 941, Outer Continental Shelf on the Gulf of Mexico AGENCY:

Coast Guard, DHS.

ACTION:

Final rule.

SUMMARY:

The Coast Guard is establishing a safety zone around the Titan SPAR system, located in Mississippi Canyon Block 941 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. The purpose of the safety zone is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Placing a safety zone around the facility will significantly reduce the threat of allisions, collisions, security breaches, oil spills, releases of natural gas, and thereby protect the safety of life, property, and the environment.

DATES:

This rule is effective December 18, 2015.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-0320 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email Mr. Rusty Wright, U.S. Coast Guard, District Eight Waterways Management Branch; telephone 504-671-2138, [email protected]

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking OCS Outer Continental Shelf SPAR A large diameter, vertical cylinder supporting a deck USCG United States Coast Guard II. Background Information and Regulatory History

Bennu Oil and Gas requested that the Coast Guard establish a safety zone extending 500 meters (1640.4 feet) from each point on the Titan SPAR facility structure's outermost edge located in the deepwater area of the Gulf of Mexico on the OCS. The purpose of the safety zone is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Therefore, on July 24, 2015 we published a NPRM with a request for comments entitled, “Safety Zones: Titan SPAR, Mississippi Canyon 941, Outer Continental Shelf on the Gulf of Mexico” in the Federal Register (80 FR 43998). We received no comments on the NPRM.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 14 U.S.C. 85, 43 U.S.C. 1333, Department of Homeland Security Delegation No. 0170.1, and Title 33, CFR part 147, which collectively permit the establishment of safety zones for facilities located on the OCS for the purpose of protecting life, property and the marine environment. The Coast Guard has determined that a safety zone is necessary to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. The purpose of the rule is to significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the environment.

For the purpose of safety zones established under 33 CFR part 147, the deepwater area is considered to be waters of 304.8 meters (1,000 feet) or greater depth extending to the limits of the Exclusive Economic Zone (EEZ) contiguous to the territorial sea of the United States and extending to a distance up to 200 nautical miles from the baseline from which the breadth of the sea is measured. Navigation in the vicinity of the safety zone consists of large commercial shipping vessels, fishing vessels, cruise ships, tugs with tows and the occasional recreational vessel. The deepwater area also includes an extensive system of fairways.

IV. Discussion of Comments, Changes and the Final Rule

As noted above, we received no comments on our NPRM published July 24, 2015. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone extending 500 meters (1640.4 feet) from each point on the Titan SPAR facility structure's outermost edge. No vessel, except those attending the facility, or those less than 100 feet in length and not engaged in towing will be permitted to enter the safety zone without obtaining permission from Commander, Eighth Coast Guard District or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes and executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This rule is not a significant regulatory action due to the location of the Titan SPAR—on the Outer Continental Shelf—and its distance from both land and safety fairways. Vessel traffic can pass safely around the safety zone using alternate routes. Exceptions to this rule include vessels measuring less than 100 feet in length overall and not engaged in towing. Deviation to transit through the safety zone may be requested. Such requests will be considered on a case-by-case basis and may be authorized by the Commander, Eighth Coast Guard District or a designated representative.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 0 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone around an OCS Facility to protect life, property and the marine environment. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. The environmental analysis checklist supporting this determination and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the For Further Information Contact section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 147

Continental shelf, Marine safety, Navigation (water).

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 147 as follows:

PART 147—SAFETY ZONES 1. The authority citation for part 147 continues to read as follows: Authority:

14 U.S.C. 85; 43 U.S.C. 1333; and Department of Homeland Security Delegation No. 0170.1.

2. Add § 147.865 to read as follows:
§ 147.865 Titan SPAR Facility Safety Zone.

(a) Description. The Titan SPAR system is in the deepwater area of the Gulf of Mexico at Mississippi Canyon 941. The facility is located at 28°02′02″ N. 89°06′04″ W. and the area within 500 meters (1640.4 feet) from each point on the facility structure's outer edge is a safety zone.

(b) Regulation. No vessel may enter or remain in this safety zone except the following:

(1) An attending vessel;

(2) A vessel under 100 feet in length overall not engaged in towing; or

(3) A vessel authorized by the Commander, Eighth Coast Guard District.

Dated: October 27, 2015. David R. Callahan, Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2015-29448 Filed 11-17-15; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0376; FRL-9936-48] 2-Propenoic Acid, Polymer With Ethenylbenzene and (1-Methylethenyl)benzene; Tolerance Exemption AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene with a minimum average molecular weight (in amu) of 2,000 (CAS Reg. No. 52831-04-6) when used as an inert ingredient in a pesticide chemical formulation. BASF Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene on food or feed commodities.

DATES:

This regulation is effective November 18, 2015. Objections and requests for hearings must be received on or before January 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0376, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0376 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0376, by one of the following methods.

Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP) IN-10814 filed by BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene (CAS Reg. No. 52831-04-6). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . ” and specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d).

2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6).

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

8. The polymer's minimum number average MW is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene.

IV. Aggregate Exposures

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene is 2,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that -2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene.

VIII. Other Considerations A. Existing Exemptions From a Tolerance

There are no existing tolerance exemptions for 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene.

B. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

C. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for 2-propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene.

IX. Conclusion

Accordingly, EPA finds that exempting residues of polymers of tamarind seed gum, 2-hydroxypropyl ether from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: November 9, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

21 U.S.C. 321(q), 346a and 371.

2. In § 180.960, add alphabetically the following polymer to the table to read as follows:
§  180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. *    *    *    *    * 2-Propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene, minimum number average molecular weight (in amu), 2,000 52831-04-6. *    *    *    *    *    
[FR Doc. 2015-29466 Filed 11-17-15; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0179; FRL-9933-61] Flutriafol; Pesticide Tolerances AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a tolerances for residues of flutriafol in or on hop, dried cones. Cheminova A/S, c/o Cheminova, Inc. requested this tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, tolerances are being removed that were inadvertently returned from an earlier Final rule.

DATES:

This regulation is effective November 18, 2015. Objections and requests for hearings must be received on or before January 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0179, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0179 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0179, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance and This Action

In the Federal Register of April 22, 2015 (80 FR 22466) (FRL-9925-79), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8294) by Cheminova Inc., c/o Cheminova A/S, 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petition requested that 40 CFR 180.629 be amended by establishing tolerances for residues of the fungicide flutriafol, ((±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on hops, dried cones at 20 parts per million (ppm). That document referenced a summary of the petition prepared by Cheminova Inc., c/o Cheminova A/S, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. For purposes of accuracy, the Agency notes that a harmless error was made in the notice of filing publication and is correcting that misstatement here: The petition was actually filed by Cheminova A/S, c/o Cheminova, Inc.

Additionally, in the Federal Register of February 4, 2015 (80 FR 5946) (FRL-9922-06) EPA established tolerances for residues of flutriafol, in or on several commodities, including cotton, gin byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm. When establishing the general tolerances in paragraph (a) for cotton, gin byproducts at 6.0 ppm and cotton, undelinted seed at 0.50 ppm, EPA inadvertently forgot to remove the existing tolerances for cotton, gin byproducts at 0.02 ppm and cotton, undelinted seed at 0.01 ppm from the table in paragraph (d) for Indirect or inadvertent residues. These indirect tolerances were made redundant by the establishment of the tolerances in the General section at a higher level for the same commodities. Therefore, EPA is removing the cotton, gin byproducts and cotton, undelinted seed tolerances established in § 180.629(d).

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flutriafol including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutriafol follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Consistent with the mammalian toxicity profiles of the other triazole fungicides, the prevalent adverse effects following oral exposure to flutriafol were in the liver. Effects consisted of increases in liver enzyme release (alkaline phosphatase), liver weights, and histopathology findings (hepatocyte vacuolization to centrilobular hypertrophy and slight increases in hemosiderin-laden Kupffer cells, minimal to severe fatty changes, and bile duct proliferation/cholangiolar fibrosis). Progression of toxicity occurred with time as some effects were only observed at chronic durations.

Slight indications of effects in the hematopoietic system were sporadically seen in all species consisting of slight anemia, increased platelets, white blood cells, neutrophils, and lymphocytes. The effects in the neurotoxicity screening batteries were observed only at higher doses and were considered secondary effects (decreased motor activity and hindlimb grip strength, ptosis, lost righting reflex, hunched posture, and ataxia). Flutriafol showed no evidence of dermal toxicity, or immunotoxicity. Flutriafol showed no evidence of carcinogenicity in rodents or in vitro.

There is evidence of increased quantitative and qualitative pre- and postnatal susceptibility for flutriafol in rats and rabbits. In the first of two rat developmental toxicity studies, developmental effects (delayed ossification or non-ossification of the skeleton in the fetuses) were observed at a lower dose than that where maternal effects were observed. In the second rat developmental study, developmental effects (external, visceral, and skeletal malformations; embryo lethality; skeletal variations; a generalized delay in fetal development; and fewer live fetuses) were more severe than the decreased food consumption and body-weight gains observed in the dams at the same dose. For rabbits, intrauterine deaths occurred at a dose level that also caused adverse effects in maternal animals. In the 2-generation reproduction studies, effects in the offspring decreased litter size and percentage of live births (increased pup mortality) and liver toxicity can be attributed to the systemic toxicity of the parental animals (decreased body weight and food consumption and liver toxicity) observed at the same dose.

Flutriafol is categorized as having high oral acute toxicity in the mouse. It is categorized as having low acute toxicity via the oral, dermal and inhalation routes in rats. Flutriafol is minimally irritating to the eyes and is not a dermal irritant. Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs.

Flutriafol is considered to be “Not likely to be Carcinogenic to Humans” based on the results of the carcinogenicity studies in rats and mice. The results of the rat chronic toxicity/carcinogenicity study and the mouse carcinogenicity study are negative for carcinogenicity. All genotoxicity studies on flutriafol showed no evidence of clastogenicity or mutagenicity.

Specific information on the studies received and the nature of the adverse effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of June 6, 2014 (79 FR 32666) (FRL-9910-38).

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for flutriafol used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 6, 2014.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flutriafol, EPA considered exposure under the petitioned-for tolerances as well as all existing flutriafol tolerances in 40 CFR 180.629. EPA assessed dietary exposures from flutriafol in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for flutriafol. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, EPA made the following assumptions for the acute exposure assessment: Tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment and 100 percent crop treated (PCT). Since adequate processing studies have been submitted which indicate that tolerances for residues in/on apple juice, grape juice, dried prunes, and tomato puree are unnecessary and since tolerances for residues in/on raisin and tomato paste tolerances are established, the DEEM (ver. 7.81) default processing factors for these commodities were reduced to 1. The DEEM (ver. 7.81) default processing factors were retained for the remaining relevant commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA conducted from 2003-2008. As to residue levels in food, EPA made the following assumptions for the chronic exposure assessment: Tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment and 100 PCT. Since adequate processing studies have been submitted which indicate that tolerances for residues in/on apple juice, grape juice, dried prunes, and tomato puree are unnecessary and since tolerances for residues in/on raisin and tomato paste tolerances are established, the DEEM (ver. 7.81) default processing factors for these commodities were reduced to 1. The DEEM (ver. 7.81) default processing factors were retained for the remaining relevant commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that flutriafol does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flutriafol. Tolerance-level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flutriafol in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flutriafol. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the First Index Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of flutriafol for acute exposures are estimated to be 15.9 parts per billion (ppb) for surface water and 193 ppb for ground water.

For chronic exposures assessments the EDWC's are estimated to be 5.39 ppb for surface water and 165 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 193 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 165 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flutriafol is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Flutriafol is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

Triazole-derived pesticides can form the metabolite 1,2,4-triazole (T) and two triazole conjugates triazolylalanine (TA) and triazolylacetic acid (TAA). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, EPA conducted an initial human-health risk assessment for exposure to T, TA, and TAA resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment was a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X Food Quality Protection Act (FQPA) safety factor (SF) for the protection of infants and children. The assessment included evaluations of risk for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment can be found in the propiconazole reregistration docket at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2005-0497.

The most recent update to that aggregate human health risk assessment for free traizoles and its conjugates was conducted on April 9, 2015. This assessment considered all proposed/registered triazole derived pesticides uses with the resulting risk less than the Agency's level of concern. An update to the aggregate human health risk assessment for free triazoles and its conjugates may be found in this current docket, docket ID number EPA-HQ-OPP-2015-0179-0014 entitled, “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address The New Section 3 Registrations for Use of Propiconazole on Tea, Dill, Mustard Greens, Radish, and Watercress; Use of Difenoconazole on Globe Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversation of the Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.; and Use of Flutriafol on Hops.”

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The potential impact of in utero and perinatal flutriafol exposure was investigated in three developmental toxicity studies (two in rats, one in rabbits) and 2 multi-generation reproduction toxicity studies in rats. In the first of two rat developmental toxicity studies, increased quantitative susceptibility was observed with developmental effects (delayed ossification or non-ossification of the skeleton in the fetuses) seen at a lower dose than maternal effects. In the second rat developmental study, a qualitative susceptibility was noted. Although developmental toxicity occurred at the same dose level that elicited maternal toxicity, the developmental effects (external, visceral, and skeletal malformations; embryo lethality; skeletal variations; a generalized delay in fetal development; and fewer live fetuses) were more severe than the decreased food consumption and body-weight gains observed in the dams. For rabbits, there was in increased qualitative fetal susceptibly. Intrauterine deaths occurred at a dose level that also caused adverse effects in maternal animals. In the 2-generation reproduction studies, a qualitative susceptibility was also seen. Effects in the offspring decreased litter size and percentage of live births (increased pup mortality) and liver toxicity can be attributed to the systemic toxicity of the parental animals (decreased body weight and food consumption and liver toxicity).

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for flutriafol is complete.

ii. There is no indication that flutriafol is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Signs of neurotoxicity were reported in the acute and subchronic neurotoxicity studies at the highest dose only; however, these effects were primarily seen in animals that were agonal (at the point of death) and, thus, are not indicative of neurotoxicity. In addition, there was no evidence of neurotoxicity in any additional short-term or long-term toxicity studies in rats, mice, and dogs.

iii. There are no concerns or residual uncertainties for prenatal and/or postnatal toxicity. Although there is evidence for increased quantitative and qualitative susceptibility in the prenatal study in rats and rabbits and the 2-generation reproduction study rats, there are no concerns for the offspring toxicity observed in the developmental and reproductive toxicity studies for the following reasons: (1) clear NOAELs and LOAELs were established in the fetuses/offspring for each of these studies; (2) the dose-response for these effects are well-defined and characterized; (3) developmental endpoints are used for assessing acute dietary risks to the most sensitive population (females 13-49 years old) as well as all other short and intermediate-term exposure scenarios; (4) the acute reference dose for females 13-49 is 1,000 fold lower than the dose at which quantitative susceptibility in the first developmental rat study was observed; and (5) the chronic reference dose is greater than 300-fold lower than the dose at which the offspring effects were observed in the 2-generation reproduction studies.

iv. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to flutriafol in drinking water. These assessments will not underestimate the exposure and risks posed by flutriafol.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flutriafol will occupy 39% of the aPAD for females 13-49 years, the population group receiving the greatest % aPAD.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flutriafol from food and water will utilize 96% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for flutriafol.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no short-term residential exposure, and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for flutriafol.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no intermediate-term residential exposure, and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for flutriafol.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, flutriafol is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to flutriafol residues.

IV. Other Considerations A. Analytical Enforcement Methodology

Adequate enforcement methodology gas chromotography/nitrogen-phosphorus detector (GC/NPD) for the proposed tolerances is available to enforce the tolerances recommended herein is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for flutriafol.

V. Conclusion

Therefore, tolerances are established for residues of flutriafol, ((±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on hop, dried cones at 20 ppm. Additionally, the tolerances for cotton, gin byproducts, and cotton, undelinted seed established in 180.629(d) are being removed.

VI. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: November 10, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

21 U.S.C. 321(q), 346a and 371.

2. In § 180.629: a. Add alphabetically the commodity “Hop, dried cones” to the table in paragraph (a). b. Remove the commodities “Cotton, gin byproducts,” and “Cotton, undelinted seed” from the table in paragraph (d).

The addition reads as follows:

§ 180.629 Flutriafol; tolerances for residues.

(a) * * *

Commodity Parts per
  • million
  • *    *    *    *    * Hop, dried cones 20 *    *    *    *    *
    [FR Doc. 2015-29462 Filed 11-17-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 172, 173, 174, and 179 [Docket No. PHMSA-2012-0082 (HM-251)] RIN 2137-AE91 Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains AGENCY:

    Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).

    ACTION:

    Response to appeals.

    SUMMARY:

    On May 8, 2015, the Pipeline and Hazardous Materials Safety Administration, in coordination with the Federal Railroad Administration (FRA), published a final rule entitled “Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains,” which adopted requirements designed to reduce the consequences and, in some instances, reduce the probability of accidents involving trains transporting large quantities of Class 3 flammable liquids. The Hazardous Materials Regulations provide a person the opportunity to appeal a PHMSA action, including a final rule. PHMSA received six appeals regarding the final rule, one of which was withdrawn. This document responds to the five remaining appeals submitted by the Dangerous Goods Advisory Council (DGAC), American Chemistry Council (ACC), Association of American Railroads (AAR), American Fuel & Petrochemical Manufacturers (AFPM), and jointly the Umatilla, Yakama, Warm Springs, and Nez Perce tribes (Columbia River Treaty Tribes) and the Quinault Indian Nation (Northwest Treaty Tribes).

    DATES:

    November 18, 2015.

    ADDRESSES:

    You may find information on this rulemaking and the associated appeals (Docket No. PHMSA-2012-0082) at the Federal eRulemaking Portal: http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Ben Supko, (202) 366-8553, Standards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration or Karl Alexy, (202) 493-6245, Office of Safety Assurance and Compliance, Federal Railroad Administration, 1200 New Jersey Ave. SE., Washington, DC 20590.

    SUPPLEMENTARY INFORMATION:

    Table of Contents of Supplementary Information I. Background II. Response to Appeals A. Scope of Rulemaking Dangerous Goods Advisory Council American Chemistry Council Association of American Railroads PHMSA and FRA Response B. Tribal Impacts and Consultation Columbia River Treaty Tribes and Northwest Treaty Tribes PHMSA and FRA Response C. Information Sharing/Notification Columbia River Treaty Tribes and Northwest Treaty Tribes PHMSA and FRA Response D. Testing and Sampling Program Dangerous Goods Advisory Council PHMSA and FRA Response E. Retrofit Timeline and Tank Car Reporting Requirements American Fuel & Petrochemical Manufacturers PHMSA and FRA Response F. Thermal Protection for Tank Cars Association of American Railroads PHMSA and FRA Response G. Advanced Brake Signal Propagation Systems Dangerous Goods Advisory Council PHMSA and FRA Response Association of American Railroads PHMSA and FRA Response III. Summary I. Background

    Under 49 CFR 106.110-106.130,1 a person may appeal a PHMSA action, including a final rule. Appeals must reach PHMSA no later than 30 days after the date PHMSA published the regulation. On May 8, 2015, PHMSA, in coordination with FRA, published a final rule entitled “Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains” (HM-251, 80 FR 26644) (the final rule). The final rule adopted requirements designed to reduce the consequences and, in some instances, reduce the probability of, accidents involving trains transporting large quantities of flammable liquids. The final rule defines certain trains transporting large volumes of flammable liquids as “high-hazard flammable trains” (HHFT) 2 and regulates their operation in terms of enhanced tank car designs, speed restrictions, braking systems, and routing. In response to the final rule, PHMSA received six appeals, one of which was withdrawn. The five active appeals were submitted by the DGAC, ACC, AAR, AFPM, and jointly the Columbia River Treaty Tribes and the Northwest Treaty Tribes.

    1 All references to sections of the regulations in this document refer to title 49 CFR.

    2 HHFT “means a single train transporting 20 or more loaded tank cars of a Class 3 flammable liquid in a continuous block or a single train carrying 35 or more loaded tank cars of a Class 3 flammable liquid throughout the train consist.” § 171.8.

    Section 106.130 requires PHMSA to notify those who appeal, in writing, of the action on the appeal, within 90 days after the date that PHMSA published the action being appealed. Based on the final rule's publication date of May 8, 2015, PHMSA was required to provide a response or notice of delay by August 6, 2015. On August 6, 2015, PHMSA posted a notice of delay on its Web site and subsequently published that notice in the Federal Register on August 10, 2015 (Notice 15-14; 80 FR 47987).3

    3http://www.phmsa.dot.gov/pv_obj_cache/pv_obj_id_79961459E55D0ADB8FF510CF4A93EC93E3A00000/filename/Notice_No_15_14_Delay_in_Appeals.pdf

    This document summarizes and responds to the appeals of the DGAC, ACC, AAR, AFPM, and jointly the Columbia River Treaty Tribes and the Northwest Treaty Tribes. PHMSA has consolidated the appeals and structured this document to address the content of the appeals by topic area. The topic areas include (1) Scope of Rulemaking; (2) Tribal Impacts and Consultation; (3) Information Sharing/Notification; (4) Testing and Sampling Programs; (5) Retrofit Timeline and Tank Car Reporting Requirements; (6) Thermal Protection for Tank Cars; and (7) Advanced Brake Signal Propagation Systems. In each section, PHMSA summarizes the pertinent appeals on the topic area, by appellant, and then provides PHMSA and FRA's response to the appeals on that topic area. The document concludes with a summary of further actions in response to the appeals.

    II. Response to Appeals A. Scope of Rulemaking Dangerous Goods Advisory Council

    DGAC expresses concern that the definition of “HHFT” as adopted in the final rule would subject manifest trains 4 to the applicable additional requirements for HHFTs. DGAC contends that shippers cannot know if tank cars they offer to a carrier will be assembled into a manifest train that meets the definition of HHFT, triggering requirements for those tank cars to meet the enhanced standards the final rule establishes. Additionally, DGAC states that at the time of pick-up, railroads cannot make this determination either. DGAC expects that the inability of both shippers and carriers to determine if a future manifest train will be an HHFT will necessitate approximately 40,000 additional DOT Specification 111 (DOT-111) tank cars to be retrofitted to the DOT Specification 117R (DOT-117R) requirements or replaced with the new DOT Specification 117 (DOT-117) tank cars under the final rule. DGAC believes that the definition of HHFT in the final rule is harmfully broad and should be revised to limit its applicability to railroad operations only and not to determine a tank car specification.

    4 A “manifest train” means a freight train with a mixture of car types and cargoes.

    DGAC also states that both the term and definition for a “high-hazard flammable unit train” (HHFUT) 5 were not proposed in the NPRM. DGAC believes the addition of a new definition for HHFUT is unnecessary and requests that the definition be eliminated.

    5 HHFUT “means a single train transporting 70 or more loaded tank cars containing Class 3 flammable liquid.” § 171.8.

    DGAC also believes that speed restrictions in the final rule should apply only to crude oil and ethanol trains. It states speed restrictions on all flammable liquids may cause delays in rail service for other rail operations, which could cause significant safety impacts. DGAC opines that more time in transit, more or longer trains, and more overall congestion could cause more incidents.

    DGAC also states that the scope of the final rule is not harmonized with applicable Canadian regulations. While it believes Canada has taken a “commodity-based approach” to the phase-out of legacy DOT-111 tank cars and corresponding retrofit timeline, it states that the U.S. approach is based on classification and packing group. DGAC believes that a commodity-based approach, addressing crude oil and ethanol, makes the most sense because it would address the material being transported in unit trains from a reasonable risk approach. DGAC also continues to encourage PHMSA, FRA, and Transport Canada (TC) to better identify the root causes of crashes and derailments involving these flammable liquids.

    In summary, DGAC contends that the applicability of the final rule should be limited to the transportation of crude oil and ethanol trains, which, it says, was the stated intention of the rule. DGAC argues that, if the Department wishes to pursue enhanced tank car standards and operational requirements for other Class 3 (flammable liquid) materials, it should do so in a separate rulemaking.

    American Chemistry Council

    ACC requests that PHMSA revise the final rule to ensure that the requirement to retrofit existing tank cars applies only to cars carrying crude oil and ethanol. Other than tank cars transporting crude oil or ethanol, ACC states that the preamble and the Regulatory Impact Analysis (RIA) show that PHMSA's final rule did not intend to require retrofits of most tank cars transporting other flammable liquids.

    ACC requests “that the HHFT definition be reserved for regulations that apply to railroad train operations, not to tank car design.” They assert that the HHFT definition should not trigger design standards that would apply to most tank cars intended to contain Class 3 flammable liquids. ACC does not contest the application of the HHFT concept to operational controls, such as establishing speed limits or braking requirements.

    Furthermore, like DGAC, ACC contends that the final rule will necessitate that approximately 40,000 6 additional DOT-111 tank cars either be retrofitted to meet the DOT-117R requirements or be replaced with the new DOT-117 tank cars. ACC suggests that this is in contrast to the stated focus on crude oil and ethanol. ACC echoes DGAC, stating that the shipper has no control over how railroads pick up cars and assemble manifest trains. While chemical shippers can, and often do, tender fewer than 20 tank cars loaded with flammable liquids at a time, there is no certainty that those chemicals will always be on a manifest train with fewer than 35 tank cars loaded with a flammable liquid. ACC asserts that the final rule does not align with the increased risk of derailment associated with unit trains and notes that flammable liquid chemicals are not shipped in unit trains. For that reason, ACC considers the HHFT definition to be overly broad and not aligned with the increased risk of derailment associated with unit trains. ACC urges that the scope be clarified so that the final rule will apply to crude oil unit trains, citing the relevant discussion in the Notice of Proposed Rulemaking. See 79 FR 45040. ACC indicates that because even a single tank car loaded with a Class 3 (flammable liquid) material tendered by one of its members may be placed in an HHFT, all tank cars intended to contain Class 3 (flammable liquid) materials will have to meet the design criteria set forth in the final rule. Furthermore, ACC explains that after publication of the final rule, railroads explicitly told ACC members that they will not manage manifest train operations to avoid triggering the regulatory requirements of the HHFT definition.

    6 The members of “the [Railway Supply Institute] RSI Committee on Tank Cars . . . collectively build more than ninety-five percent (95%) of all new railroad tank cars and own and provide for lease over seventy percent (70%) of railroad tank cars operating in North America.” On page 56 of those comments, in Table C-3, RSI estimated that at the end of 2015 tank car fleets will contain the following:

    • 87,507 tank cars (of all types) used for the movement of crude oil;

    • 27,899 tank cars (of all types) in ethanol service; and

    • 39,122 tank cars that carry flammable liquids other than crude oil or ethanol.

    ACC contends that removing the retrofitting requirements for Class 3 flammable liquids that are not crude oil or ethanol would alleviate shop capacity problems and provide greater harmonization with TC's analogous retrofit schedule. ACC contends that PHMSA's adherence to using packing group, rather than to using risk, severely complicates the implementation of the rules in the two countries. ACC states that some of the Class 3 flammable liquid materials that will be affected by the final rule are classified in Packing Group (PG) I, so those tank cars will reach PHMSA's deadlines for retrofit or replacement before the tank cars that carry either ethanol or PG II crude oil. ACC states that the different prioritizations chosen by TC and by PHMSA will exacerbate conflicts over tank car shop space.

    In sum, ACC believes that the scope of the final rule will inadvertently affect nearly 40,000 legacy DOT-111 tank cars that transport Class 3 flammable liquids that were not accounted for in the accompanying RIA. ACC states that because a shipper cannot know how a carrier will assemble a train, the possibility that a shipper's tank car will be placed into an HHFT will force all shippers of Class 3 materials to retrofit or purchase tank cars to meet the DOT-117R or DOT-117 specification. ACC believes that, coupled with a retrofit timeline that does not match the Canadian timeline, the final rule will fail to properly address the risks associated with hazardous materials offered and transported in unit trains.

    Association of American Railroads

    AAR contests the scope of the final rule because it permits shippers to continue to package Class 3 flammable liquid materials in tank cars that do not meet the new DOT-117 tank car standard. AAR states that PHMSA has created two pools of tank cars, those that meet the heightened standard for HHFTs and those that do not. As a result, AAR asserts, shippers may continue to offer Class 3 flammable liquid materials in DOT-111 tank cars as long as the DOT-111 is not placed in an HHFT. According to AAR, this places an unjustified burden on the railroads to continuously analyze the composition of each train transporting Class 3 flammable liquid materials in DOT-111 tank cars. AAR claims that PHMSA's argument, that through fleet management the railroads can avoid this issue, is baseless. AAR believes that PHMSA should harmonize with Canada by banning the use of DOT-111 tank cars for transporting any Class 3 flammable liquid materials. By failing to harmonize with Canada in this respect, AAR contends that the U.S. market will become flooded with legacy DOT-111 tank cars, which will further exacerbate the fleet management challenges U.S. railroads will face to construct trains to avoid meeting the definition of an HHFT.

    To support its appeal, AAR submitted waybill data from its subsidiary Railinc showing numbers of flammable liquid shipments tendered in smaller groups of cars that do not by themselves meet the definition of an HHFT. Data from the first quarter of 2015 illustrate that 37,000 cars of flammable liquids (other than crude oil and ethanol) were tendered in blocks of 20 cars or fewer. During the same period, 37,576 tank cars of other flammable liquids (other than the 25,009 tank cars of crude oil or 39,956 tank cars of ethanol) were tendered in groups of fewer than 35 cars. According to AAR, had the final rule been in effect, a total of 102,541 cars of flammable liquids could have moved in existing DOT-111s.7 AAR contends that PHMSA should specify a sunset date for discontinuing the use of DOT-111 tank cars for hazardous materials not in an HHFT.

    7 The detailed figures AAR provided can be found in its appeal under Docket No. PHMSA-2012-0082.

    PHMSA and FRA Response

    In regards to DGAC's, ACC's, and AAR's appeals on the scope of the final rule, we disagree with those appellants' assertions and maintain that the method we determined to apply the new regulatory requirements and the regulatory analysis to support those decisions were conducted through careful consideration of the risks flammable liquids pose and the comments received during the rulemaking process. The position these appellants are taking in the appeals is based on anecdotal evidence and an interpretation of tank car fleet numbers that exaggerates the scope of the rulemaking. While we respect the argument that both shippers and carriers of Class 3 flammable liquids by rail will face new challenges in the wake of these regulations, we maintain that they are capable of working together to comply with the requirements established by the final rule.

    DGAC, AAR, and ACC contend that both shippers and carriers cannot predict whether tank cars offered for transportation will be placed in a train set meeting the definition of an HHFT. By relying on this rationale, DGAC and ACC contend that the final rule will require nearly 40,000 tank cars to be replaced with the new DOT-117 tank car or be retrofitted to the DOT-117R requirements because a tank car possibly placed in an HHFT. These numbers are based on the 2015 Railway Supply Institute (RSI) fleet forecast predicting the number of DOT-111 tank cars transporting Class 3 flammable liquids (other than crude oil and ethanol). The solution they urge is limiting the scope of the rule to crude oil and ethanol.

    We disagree. We believe that limiting the scope of the rulemaking to crude oil and ethanol would not align with the intent and applicability of the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180). The HMR are risk based and focus on the hazards presented during transportation. Focusing only on a subset of flammable liquids is a short-sighted regulatory approach and has the potential to lead to inconsistencies and safety concerns in the future. PHMSA's goal is to provide regulatory certainty that addresses the risks posed by all HHFTs.

    In the NPRM, PHMSA proposed a definition of an HHFT with a threshold of 20 cars in a train. This aligned with AAR's “Key Train” definition in its circular OT-55-N, indicating the railroads currently recognize that trains of this make-up represent a high risk.8 Additionally, the NPRM tied the applicability of the new tank car specification to the HHFT definition. In response to the NPRM, PHMSA received numerous comments suggesting that both shippers and carriers would be placed in an untenable position because it is impossible to determine when tank cars would be in an HHFT. To address commenters' concerns, we revised the definition of HHFT to 20 cars in a block or 35 throughout the train. The risk-based equivalency of 20 cars in a block and 35 cars throughout the train is calculated in the RIA on page 323.9 PHMSA based this change on calculations finding that 20 cars in a block is roughly equivalent to 35 cars placed throughout a train, as well as AAR's comments noting that such a change would alleviate concerns about manifest trains operating in High Threat Urban Areas (HTUAs).

    8http://www.boe.aar.com/CPC-1258%20OT-55-N%208-5-13.pdf. Note that the current circular is OT-55-O: http://www.boe.aar.com/CPC-1312%20OT-55-O%201.27.2015.pdf.

    9 PHMSA-2012-0082-3442

    Similarly, PHMSA denies DGAC's request to remove the definition of HHFUT. Again, PHMSA developed the definition based on an analysis of comments received on the NPRM and careful cost analysis. While the definition of HHFUT was not expressly proposed in the NPRM, the NPRM did propose requirements for enhanced brake signal propagation systems for all trains meeting the definition of HHFT. PHMSA believes that the HHFUT definition captures the subset of HHFTs that represent the highest risk and where the most benefits from ECP braking will be gained and that the definition is within the scope of the NPRM proposals.

    Regarding the appellants' concerns that the tank car specification is linked to the number of cars in the train, PHMSA understands that railroads have significant fleet management programs in place. On page 221 of the RIA, PHMSA details the agency's understanding of railroads' capability to conduct fleet management. We are aware that both shippers and carriers have fleet managers to predict or control whether a given tank car will be used in manifest train service or unit train service. Despite these fleet management capabilities and programs, the appellants indicate they have little control over the number of cars loaded with Class 3 (flammable liquid) materials in a train. To argue that neither party can predict a train's composition—particularly when transporting hazardous materials—implies an alarming lack of awareness in appellants' own operations. Indeed, train crews are actually required to maintain a document that reflects the current position in the train of each rail car containing a hazardous material. See § 174.26.

    AAR contends that all cars transporting flammable liquids should be retrofitted to the DOT-117R requirements. On the other hand, the shippers contend no cars, other than those transporting crude oil and ethanol, should be retrofitted. PHMSA believes the final rule strikes the correct balance by requiring retrofits of all tank cars in crude oil and ethanol service plus the 354 tank cars in PG III service by estimating roughly 10 percent of trains transporting PG III commodities might meet the HHFT definition, and thus, that 10 percent of the cars would require retrofitting.10 Further, PHMSA expects that the railroads will manage the assembly of loaded tank cars and manage the classification of trains to exclude tank cars from HHFTs that do not meet the new DOT-117 and DOT-117R tank car specifications.

    10 PHMSA-2012-0082-3442 at p. 15.

    Therefore, as previously stated, the estimated number of tank cars in PG III flammable liquid service that would be used to make up HHFTs, and hence have to meet the new requirements, is 354 tank cars, not the nearly 40,000 DGAC and ACC allege. The costs presented in the RIA were based on an analysis of public waybill data and include the costs of retrofitting the 354 tank cars mentioned above. The analysis showed that no other flammable liquid commodities of any packing group—other than crude oil or ethanol—were shipped in quantities that would trigger the HHFT requirements.

    Further, our analysis of the waybill data indicated that far fewer than 10 percent of PG III cars would be affected by the HHFT definition. Nevertheless, to be conservative, we assumed roughly 10 percent of trains transporting PG III commodities might meet the HHFT definition, therefore 10 percent of the cars would require retrofitting. After adjusting for retirement of some cars and accounting for Canada's fleet share, we calculated that 10 percent of the remaining cars equaled the 354 cars that we incorporated into the cost analysis.

    ACC's assertion that nearly 40,000 tank cars would have to be retrofitted or replaced to meet the enhanced tank car standards due to their possible placement in an HHFT is grossly exacerbated by the railroads advising ACC that they will not manage fleets to avoid their shipments becoming subject to the new regulations. PHMSA does not agree that this is a valid basis for revising the scope of the final rule's requirements. We explicitly limited the reach of the final rule to trains transporting large quantities of flammable liquids, and defined HHFT to exclude typical manifest trains that do not transport the large quantities of flammable liquids. For railroads to state that they will not manage train sets undermines the risk-based goal of the final rule to exclude commodities not typically shipped in large quantities.

    DGAC, ACC, and AAR also contend that the U.S. packing group approach is not harmonized with Canada's commodity-based approach to the phase out of DOT-111 tank cars and corresponding retrofit timeline. Again, we disagree. By designating DOT-111 tank cars for phase out by packing group, we are aligned with Canada. While the Canadian approach expressly states crude oil and ethanol, we chose to use PG I, which encapsulates crude oil, and PG II, which encapsulates ethanol. DOT and TC were in constant communication while developing the respective rulemaking actions.

    AAR also appealed the rule for not specifying a sunset date for the continued use of DOT-111 tank cars for all Class 3 flammable liquids. AAR contends that this will cause the non-retrofitted Canadian fleet to flood the U.S. market, making it increasingly difficult to manage the operational complexities of two pools of tank cars. Even if AAR's contention is true, we chose to authorize the continued use of DOT-111 tank cars for the transportation of hazardous materials not in an HHFT because it would have been cost prohibitive to prohibit all Class 3 flammable liquids in DOT-111 tank cars. As stated in the RIA and final rule preamble, we believe that we appropriately addressed the risk of continued use of such cars by prohibiting the use of legacy DOT-111 tank cars for HHFT service. For these reasons, the DGAC, ACC, and AAR appeals on the scope of the final rule are denied.

    B. Tribal Impacts and Consultation Columbia River Treaty Tribes and Northwest Treaty Tribes

    The Columbia River Treaty Tribes and the Northwest Treaty Tribes (“Treaty Tribes”) submitted an appeal to the Secretary on June 5, 2015. The Treaty Tribes' arguments suggest that by omitting formal tribal consultation, DOT did not follow Executive Order (E.O.) 13175 and DOT guidance. By way of remedy, the Treaty Tribes urge PHMSA to “reopen a notice and comment period for the Tank Car Rule [and] carry out tribal consultations on all aspects of the Tank Car Rule.”

    The Treaty Tribes' appeal lays out various arguments for tribal consultation under E.O. 13175 and DOT guidance. First, the appeal argues that PHMSA erred in concluding that the rulemaking “does not significantly or uniquely affect tribes.” Second, the Treaty Tribes' appeal argues that the final rule “impose[s] substantial direct effects or compliance costs” on Indian tribal governments. Third, the Treaty Tribes' appeal finds fault with PHMSA's discussion of its “superseding preemption” authority for hazardous materials regulations in the final rule's discussion of tribal consultation.

    PHMSA and FRA Response

    We appreciate the comments the Treaty Tribes and other Tribes provided to the NPRM, which are addressed in the final rule. However, PHMSA respectfully disagrees with the Treaty Tribes appellants and maintains that the appellants' concerns were addressed during the rulemaking process. Overall, the comments from Indian tribal governments to the NPRM expressed concerns about the potential environmental, economic, and safety impacts of crude oil train derailments on tribal lands. PHMSA responded to those concerns by adopting a final rule designed to reduce the severity of and/or prevent derailments in an effort to improve public safety and protection of the environment. PHMSA and FRA conducted an extensive and thorough review of all comments received, and considered the concerns of all stakeholders, including Indian tribal governments. In the final rule, PHMSA summarized and discussed the comments of our stakeholders, including in-depth discussions of the comments of Indian tribal governments, and provided justifications for our adopted proposals and for those proposals we did not adopt.

    Executive Order 13175

    E.O. 13175 establishes processes for when a Federal agency is “formulating and implementing policies that have tribal implications.” 11 This E.O., re-affirmed by President Obama in a November 5, 2009, “Tribal Consultation” memorandum, 12 states that “[p]olicies that have tribal implications” refers to “regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” In addition, under DOT Order 5301.1 and other DOT tribal policies, components of DOT must consult with Indian tribal governments before taking any actions that “significantly or uniquely” affect them.13 In the final rule, PHMSA discussed E.O. 13175, and reasonably concluded that the rulemaking did not: (1) Have tribal implications; (2) significantly or uniquely affect tribes; or (3) impose substantial direct effects or compliance costs on tribal governments.14

    11 “Consultation and Coordination with Indian Tribal Governments,” 65 FR 67249 (Nov. 9, 2000).

    12 “Memorandum on Tribal Consultation,” 74 FR 57881.

    13 “U.S. Dept. of Transportation, Office of the Secretary of Transportation, Department of Transportation Programs, Policies, and Procedures Affecting American Indians, Alaska Natives, and Tribes,” Order No. DOT 5303.1 (Nov. 16, 1999).

    14 Although PHMSA did not explicitly invoke DOT Order 5303.1, PHMSA analyzed the applicability of tribal consultation using the Order's applicability to actions that “significantly or uniquely” affect Indian tribal governments.

    Significant or Unique Tribal Effects

    The Treaty Tribes argue that consultation was required because of alleged unique and substantial effects of the final rule on the Treaty Tribes and their interests. Specifically, the Treaty Tribes' appeal discusses the unique history of their fishing rights and states, “[h]ad PHMSA consulted with the Northwest treaty tribes, it would have learned of the tribal and federal interests in their collective usual and accustomed fishing areas and potential impacts resulting from the proposed Tank Car Rule.” The Treaty Tribes discussed their concerns with the rail routing analysis discussion of environmentally sensitive areas. Though the Treaty Tribes' fishing rights may be unique, the trigger for the consultation requirement is a federal action that has a significant or unique effect upon tribes. Here, no such federal action exists. The enhanced safety provisions in the final rule, are designed to decrease the likelihood and severity of derailments and resulting spills, in an effort to improve public safety and protect the environment. The requirements adopted in the final rule do not apply directly to tribes. They apply to railroads and hazardous materials shippers. Any potential effect on tribes would take place several stages removed from the federal action of the final rule.

    PHMSA believes that these regulations work to the benefit of all communities and areas affected by the rail transportation of flammable liquids. For this reason, PHMSA affirms that the impact of the final rule is not “significant” or “unique” to communities or resources under the jurisdiction of tribal governments.

    Relationship Between Tribes and United States

    The Treaty Tribes argue that the rule affects the relationship between tribes and the U.S., triggering the consultation provisions of E.O. 13175. The NPRM requested comments on whether the railroad's notification requirements should proceed through tribal emergency response commissions. This proposal was not adopted in the final rule. The tribes argue that this impacted the relationship between the tribes and the federal government. However, the information-sharing provisions would have directed the railroads to share information with the tribes. Although this may or may not affect the tribes' relationships with the railroads, it would not affect the relationship between tribes and the federal government.

    As further discussed in the Notification Section of this document, the Treaty Tribes asked that PHMSA reinstitute the notice provisions of the Secretary's May 7, 2014 Emergency Order. DOT has kept in place the May 2014 Emergency Order that requires railroads to provide Bakken crude oil information directly to State Emergency Response Commissions (SERCs). PHMSA plans to revisit these provisions in an upcoming rulemaking and has pledged to maintain the Emergency Order until such a rulemaking codifying these provisions is published. Accordingly, for the reasons previously stated, this rulemaking has not affected the relationship between tribes and the federal government.

    Preemption/Distribution of Power and Responsibilities

    Finally, the Treaty Tribes argue that “PHMSA asserts the preemption provisions of 49 U.S.C. 5126 and 20106 supersede” the need for tribal consultation. This is an inaccurate characterization of PHMSA's position. In the final rule, we state that “PHMSA has determined that this rulemaking does not significantly or uniquely affect tribes, and does not impose substantial direct effects or compliance costs on such governments.” Although the rule referenced the preemption authorities of PHMSA and FRA, the basis for the decision to forgo tribal consultation was the lack of direct tribal impacts. In this case, PHMSA reasonably determined that a consultation with tribal officials was not necessary under the guidelines of E.O. 13175 and DOT policies.

    Remedy

    Moreover, the Treaty Tribes' appeal asked that PHMSA “reopen a notice and comment period for the Tank Car Rule [and] carry out tribal consultations on all aspects of the Tank Car Rule.” Independent of the arguments discussed above, PHMSA and FRA suggest that granting this aspect of the Treaty Tribes' appeal would result in further rulemaking proceedings that would frustrate implementation of the final rule's safety advancements and potentially delay safety improvements due to regulatory uncertainty.

    Outreach

    While PHMSA does not believe E.O. 13175 required a consultation for the HHFT rulemaking, PHMSA recognizes the importance of government-to-government relationships with tribes. To this end, PHMSA has expanded its tribal outreach efforts. For example, in March 2015, DOT representatives met with representatives from the Prairie Island Tribe to discuss tribal concerns with the movement of Bakken crude oil through their community. In August 2015, PHMSA representatives attended the Northwest Tribal Emergency Management Council's annual meeting in Spokane, Washington. This provided an opportunity to speak directly with tribal emergency management leaders and emphasize the importance of effective tribal and federal cooperation. In addition, PHMSA provides hazardous materials emergency preparedness grant funding to tribes to carry out planning and training activities to ensure that State, local, and tribal emergency responders are properly prepared and trained to respond to hazardous materials transportation incidents. For these reasons, the Treaty Tribes appeal to reopen a notice and comment period for the final rule and carry out tribal consultations on all aspects of the rule is denied.

    C. Information Sharing/Notification Columbia River Treaty Tribes and Northwest Treaty Tribes

    The Treaty Tribes also appealed the notification provisions of the final rule. They have stated, “On its face, the Tank Car Rule could be read to abandon the Emergency Order and cut back on both emergency responder and tribal access to train route and emergency response information.” According to the Treaty Tribes, the notification provisions adopted in the final Rule “weaken the notification scheme in a number of ways” since the information provided is “far less informative” and its dissemination is limited to “those with a need-to-know in an anti-terrorism context.” For these reasons, the Treaty Tribes asked that PHMSA reinstitute the notice provisions of the Secretary's May 7, 2014 Emergency Order.

    PHMSA and FRA Response

    We agree with the Treaty Tribes. As discussed in the Treaty Tribes' petition, on May 7, 2014, the Secretary issued an Emergency Order in Docket No. DOT-OST-2014-0067 (“May 2014 Emergency Order” or “Order”). That Order requires each railroad transporting in commerce within the U.S. 1,000,000 gallons or more of Bakken crude oil in a single train to provide certain information in writing to the SERCs for each State in which it operates such a train. The Order requires railroads to provide: (1) The expected volume and frequency of affected trains transporting Bakken crude oil through each county in a State; (2) the routes over which the identified trains are expected to operate; (3) a description of the petroleum crude oil and applicable emergency response information; and (4) contact information for at least one responsible party at the railroad. In addition, the Order requires that railroads provide copies of notifications made to each SERC to FRA upon request and to provide SERCs updated notifications when there is a “material change” in the volume of affected trains. Subsequent to issuing the Order, in August 2014, PHMSA published the HHFT NPRM, which, in part, proposed to codify and clarify the requirements of the Order, and requested public comment on the proposal.

    Based on the comments received to the NPRM, along with PHMSA and FRA's analysis of the issues involved in the HHFT final rule, PHMSA did not adopt the notification requirements of the proposed rule. PHMSA determined expansion of the existing route analysis and consultation requirements of § 172.820 to include HHFTs was the best approach to ensure emergency responders and others involved with emergency response planning and preparedness would have access to sufficient information regarding crude oil shipments moving through their jurisdictions to adequately plan and prepare from an emergency response perspective. Thus, the final rule expanded the applicability of § 172.820 to HHFTs. As part of these additional safety and security planning requirements, the final rule requires rail carriers operating HHFTs to comply with § 172.820(g), which requires that railroads “identify a point of contact on routing issues and provide that contact's information (including his or her name, title, phone number and email address):

    (1) State and/or regional Fusion Centers that have been established to coordinate with state, local and tribal officials on security issues which are located within the area encompassed by the rail carrier's rail system; and (2) State, local, and tribal officials in jurisdictions that may be affected by a rail carrier's routing decisions and who directly contact the railroad to discuss routing decisions.

    Thus, these notification provisions require railroads to proactively provide this contact information to “State and/or regional Fusion Centers” and ensure that “state, local, and tribal officials . . . who directly contact the railroad to discuss routing decisions” are provided the same information. Tribal officials can also coordinate with Fusion Centers to obtain this information. At the time of the final rule's publication, the notification provisions discussed above were set to supersede the May 2014 Emergency Order, once codified notification provisions are fully implemented (i.e., March 31, 2016).

    Subsequent to publication of the final rule, PHMSA received feedback from stakeholders (including tribal authorities) expressing intense concern about the Department's decision to forgo the proactive notification requirements of the Order and in the NPRM. Generally, these stakeholders expressed the view that given the unique risks posed by the frequent rail transportation of large volumes of flammable liquids, including Bakken crude oil, PHMSA should not eliminate the proactive information sharing provisions of the Order and rely solely on the consultation and communication requirements in existing § 172.820. These stakeholders expressed concern that the final rule may limit the availability of emergency response information by superseding the May 2014 Emergency Order.

    In response to these concerns and after further evaluating the issue within the Department, in a May 28, 2015 notice (Notice), PHMSA announced that it would extend the Order indefinitely, while it considered options for codifying the disclosure requirement permanently.15 Furthermore, on July 22, 2015, FRA issued a public letter instructing railroads transporting crude oil that they must continue to notify SERCs of the expected movement of Bakken crude oil trains through individual states.16

    15http://www.phmsa.dot.gov/hazmat/phmsa-notice-regarding-emergency-response-notifications-for-shipments-of-petroleum-crude-oil-by-rail.

    16http://hazmatship.com/images/stories/pdf2/2015_07_22_Notification+FINAL.pdf?mc_cid=f88dda2d67&mc_eid=1fbd28d3ea.

    The Treaty Tribes' appeal reiterates these concerns about the codified notification provisions, stating that they “cut back on both emergency responder and tribal access to train route and emergency response information.” In light of the May 28, 2015 PHMSA Notice and other DOT communications, PHMSA believes that we have adequately addressed the Treaty Tribes' concerns about the information sharing provisions of the final rule and the Treaty Tribes' explicit support for the notification procedures in the May 2014 Emergency Order. Since DOT has already re-examined the decision to allow the final rule to supersede the May 2014 Emergency Order and determined that the Order will remain in full force and effect until the agency considers options for codifying it on a permanent basis, PHMSA believes we have been responsive to this aspect of the Treaty Tribes' appeal. In accordance with the Notice, PHMSA continues to consider options for codifying the central aspects of the Order permanently in a future rulemaking action. The treaty tribes will have the opportunity to comment on these future regulatory proposals in the course of that rulemaking proceeding. In addition, PHMSA is seeking opportunities similar to attending the Northwest Tribal Emergency Management Council's meeting held in Spokane, Washington, to engage further with the tribal communities affected by our regulations. Continued opportunities to reach out directly to tribal emergency management leaders will improve the cooperation between PHMSA and the tribes.

    D. Testing and Sampling Program Dangerous Goods Advisory Council

    DGAC does not believe the sampling and testing program adopted in § 173.41 is justified or warranted and requests that we eliminate this provision. DGAC asserts that the classification sampling and testing program would not change the tank car selection or emergency response guidebook responses. DGAC also expresses concern that sampling during transportation could create a safety risk as closed packages are re-opened.

    If PHMSA does not repeal the program, DGAC requests additional clarification. Specifically, DGAC requests that we revise the final rule to include a definition for “unrefined petroleum-based products,” consistent with the discussion in the preamble. See 80 FR 26704. DGAC further requests additional guidance on the provision in § 173.41(a)(2), which states “and when changes that may affect the properties of the material may occur . . . ,” and additional guidance on the recordkeeping requirements.

    Finally, DGAC requests that we provide a delayed compliance date of March 31, 2016 for implementation of the requirements in § 173.41 if the requirement is maintained. This date aligns with the delayed compliance date of March 31, 2016, provided for a rail carrier to complete the initial planning process required in § 172.820. DGAC believes that a delayed compliance date is necessary because “affected parties have certain testing procedures in place, the development, distribution and training of affected hazardous materials employees in a more `formal' program by July 7, 2015 is not reasonable.”

    PHMSA and FRA Response

    In regards to DGAC's appeal on the sampling and testing program, PHMSA maintains that that sampling and testing program is justified and necessary. In its safety recommendation, R-14-6, the National Transportation Safety Board (NTSB) recognized the importance of requiring “shippers to sufficiently test and document the physical and chemical characteristics of hazardous materials to ensure the proper classification, packaging, and record-keeping of products offered in transportation.” The entire premise of the HMR is built around the shipper's responsibility to properly classify a hazardous material. Under § 171.2(e), “No person may offer or accept a hazardous material for transportation in commerce unless the hazardous material is properly classed, described, packaged, marked, labeled, and in condition for shipment as required or authorized by applicable requirements of this subchapter.” Proper classification ensures the correct regulatory provisions are being followed both when the material is initially offered and during downstream shipments. The HMR requires correct classification and communication, even when the shipper has the option to use a more stringent packaging. Classification also includes ensuring that all correct hazard classes are identified. Many provisions in the HMR also require the shipper to have knowledge about the material that exceeds the information provided by the shipping papers or Emergency Response Guidebook (ERG). For example, it is forbidden to offer “a material in the same packaging, freight container, or overpack with another material, the mixing of which is likely to cause a dangerous evolution of heat, or flammable or poisonous gases or vapors, or to produce corrosive materials” under § 173.21(e). For petroleum crude oil, the shipper may additionally need to identify properties such as corrosivity, vapor pressure, specific gravity at loading and reference temperatures, and the presence and concentration of specific compounds (e.g., sulfur), depending on the different packaging options selected and the conditions under which the material is being offered. Considering the challenges posed by materials with variable composition and potentially variable properties, such as crude oil, providing criteria for sampling and testing of unrefined petroleum-based products is a critical first step in safe transportation of these materials. Proper classification and the assignment of a packing group for a hazardous material determines what packaging is appropriate for that material.

    Industry also recognizes the importance and unique challenges of properly classifying petroleum crude oil. The American Petroleum Institute spearheaded efforts to develop an industry standard for the classification of petroleum crude oil, resulting in the development of American National Standards Institute (ANSI)/American Petroleum Institute (API) Recommend Practices (RP) 3000, “Classifying and Loading of Crude Oil into Rail Tank Cars.” This API standard went through a public comment period during its development in order to be designated as an American National Standard.

    We also disagree that providing more specificity or guidance to the program is necessary. The term “unrefined petroleum-based products” is clear as written. “Petroleum” is used throughout the HMR. The term “unrefined” is sufficiently clear in the context of the petroleum industry. Therefore, the term “unrefined petroleum-based products” would be any material that is petroleum based, and has not undergone refinement. For example, heat treating to reduce vapor pressure or to remove the dissolved gases in crude oil so that it may be transported for refinement would not meet the American Fuel & Petrochemical Manufacturers (AFPM) or other industry definitions of “refining.” 17

    17http://www.afpm.org/The-Refinery-Process/

    We disagree that additional guidance is necessary, as the requirement in § 173.41(e) to document and maintain records of the sampling and testing program is clear. In both the NPRM and final rule, we stated respectively that we are not proposing or adopting a requirement for the retention of test results. Therefore, the documentation in paragraph (e) must describe the program itself.

    We also disagree that the requirements of when to sample are unclear or present a safety risk. The sampling and testing program is only required prior to the offering of the material for transportation. This is further clarified in § 173.41(a) (2), which states, “Sampling prior to the initial offering of the material for transportation and when changes that may affect the properties of the material occur (i.e., mixing of the material from multiple sources, or further processing and then subsequent transportation).” Therefore, sampling would be required before the initial offering for transportation, and in some situations when the material is re-offered for transportation. The examples in the description provide flexibility to accommodate changing industry practices, and should not be replaced with a prescriptive list. Overall, API RP 3000 provides a more specific example of how the sampling requirements of § 173.41 may be met. As we stated in the final rule,

    Shippers must continue to use the testing methods for classification of flammable liquids outlined in § 173.120 and flammable gases in § 173.115. However, API RP 3000 is otherwise consistent with the sampling program requirements in § 173.41(a)(1)-(6) and may be used to satisfy these adopted sampling provisions. Furthermore, voluntary use of API RP 3000 provides guidance for compliance with these provisions, but still allows flexibility for meeting requirements through other methods.

    See 80 FR 26706.

    Finally, we disagree that a delayed compliance date of March 31, 2016 should be provided for implementation of the requirements in § 173.41 to provide shippers adequate time to implement changes for training and documentation. The date established for rail routing requirements allows for the collection of six months of data and completion of a risk assessment. The sampling and testing requirements are simply a mechanism to document existing regulatory requirements for proper classification of energy products. In addition, the Department issued Emergency Order DOT-OST-2014-0025 on February 25, 2014 (EO 25), which was subsequently revised and amended on March 6, 2014.18 EO 25 required those who offer crude oil for transportation by rail to ensure that the product is properly tested and classified in accordance with federal safety regulations. Further, EO 25 required that all rail shipments of crude oil that are properly classed as a flammable liquid in PG III material be treated as a PG I or II material. The Amended EO 25 also authorized PG III materials to be described as PG III for the purposes of hazard communication. The Amended EO 25 differs from the original in that it prohibits persons who ordinarily offer petroleum crude oil for shipment as UN 1267, petroleum crude oil, Class 3, PG I, II, or III from reclassifying such crude oil with the intent to circumvent the requirements of this Amended Order. As discussed in the final rule, the sampling and testing program requirements superseded EO 25 and made it no longer necessary. By extending the compliance date, PHMSA would create a safety gap which was previously covered under EO 25 as amended. For these reasons, the appeal submitted by DGAC on the sampling and testing program is denied.

    18 The March 6, 2014 “Amended and Restated Emergency Restriction and Prohibition Order (Amended Order)” sought to clarify the original February 25, 2014 Order and superseded and replaced it in its entirety. See http://www.phmsa.dot.gov/pv_obj_cache/pv_obj_id_D03C7A1E859361738D791378144472BF368F0200/filename/Amended_Emergency_Order_030614.pdf.

    E. Retrofit Timeline and Tank Car Reporting Requirements American Fuel and Petrochemical Manufacturers

    AFPM supports PHMSA and FRA's plan to establish a reporting obligation on retrofit progress and shop capacity. However, it asserts that the final rule's reporting requirement is insufficient to accomplish its intended purpose. In its appeal, AFPM recommends a substantial expansion of reporting timelines and requested data to ensure all types of tank car retrofits are evaluated and not just non-jacketed DOT-111 legacy tank cars in Packing Group I service.

    PHMSA and FRA Response

    In regards to AFPM's appeal, PHMSA believes that the final rule's established industry reporting obligation on retrofit progress and shop capacity will achieve the stated goals. The first phase of the retrofit timeline includes a January 1, 2017, deadline for retrofitting non-jacketed DOT-111 tank cars in PG I service. Owners of non-jacketed DOT-111 tank cars in PG I service for use in an HHFT who are unable to meet the January 1, 2017, retrofit deadline specified in § 173.243 (a)(1), are required to submit a report by March 1, 2017, to the Department. Groups representing tank car owners may submit a consolidated report to the Department in lieu of individual reports from each tank car owner. The report must include the following information regarding retrofitting progress:

    • The total number of tank cars retrofitted to meet the DOT-117R standard;

    • The total number of tank cars built or retrofitted to meet the DOT-117P standard;

    • The total number of DOT-111 tank cars (including those built to CPC-1232 industry standard) that have not been modified;

    • The total number of tank cars built to meet the DOT-117 standard; and

    • The total number of tank cars built or retrofitted to a DOT-117, 117R or 117P that are electronically controlled pneumatic (ECP) brake ready or ECP brake equipped.

    In developing the retrofit schedule, PHMSA and FRA examined the available shop capacity, the comments received, historical performance of the rail industry dealing with retrofit requirements, and the potential impacts associated with the retrofit schedule. The final rule also stated the Department could request additional reports with reasonable notice if necessary to facilitate the timely retrofits of those tank cars posing the highest risk. PHMSA and FRA are confident that the adopted reporting requirements are sufficient in that they will achieve the Department's stated goals. In addition, the Department may request additional reports as needed to verify industry progress toward retrofitting requirements. For the reasons stated, the appeal submitted by AFPM on the retrofit and tank car reporting of the final rule is denied.

    F. Thermal Protection for Tank Cars Association of American Railroads

    In its appeal, AAR requests that we require enhanced thermal protection when new or retrofitted tank cars are built with jackets. That thermal protection would be beyond what is required in the final rule and allow further tank car survivability in a pool fire scenario. AAR asserts that PHMSA should require an enhanced thermal blanket with thermal conductivity no greater than 2.65 BTU per inch, per hour, per square foot, and per degree Fahrenheit at a temperature of 2000 F, ± 100F.

    PHMSA and FRA Response

    In regards to AAR's appeal, PHMSA believes AAR has not presented a compelling basis for amending this aspect of the final rule. The final rule requires tank cars in HHFTs to have thermal protection that meets the requirements of § 179.18, while also having a pressure relief device that complies with § 173.31. Section 179.18 establishes a performance standard that requires a tank to be able to withstand a pool fire for at least 100 minutes and a torch fire for at least 30 minutes. The 100-minute standard is intended to provide time for emergency response and accident assessment. Section 173.31 requires a reclosing pressure relief device for any tank car transporting a Class 3 (flammable liquid). Further, the pressure relief device “must be made of materials compatible with the lading, having sufficient flow capacity to prevent pressure build-up in the tank to no more than the flow rating pressure of the pressure relief device in fire conditions as defined in Appendix A of the AAR Specifications for Tank Cars.” See § 179.15. AAR contends that PHMSA should adopt a different standard. Specifically, AAR argues that PHMSA should require that all tank cars transporting flammable liquids be equipped with a thermal blanket that allows for thermal conductivity not to exceed 2.65 BTU per inch, per hour, per square foot, and per degree Fahrenheit at a temperature of 2,000 °F, ± 100 °F. Using the standard AAR proposes would potentially provide 800 minutes of protection in a pool fire. Further, it contends that PHMSA should require that all tank cars transporting flammable liquids be equipped with a pressure relief device that will allow the release of only enough quantity to prevent a thermal tear.

    AAR's suggestion that its thermal blanket proposal would provide greater protection than that currently HMR requirements, raises a number of concerns. First, the units for thermal conductivity are incorrect. Although it may seem counter-intuitive, increasing the thickness of the thermal blanket using the method provided by AAR, would actually increase the thermal conductivity and decrease the performance of the thermal protection system. Additionally, there is no experiential or experimental basis for AAR's use of a 2,000 °F fire temperature. The current requirement of a 1,600 °F pool fire temperature is based on experimental data from a pool fire test involving liquefied petroleum gas (LPG). The experimental data, including the heat flux, were normalized over the entire surface of the car to represent total engulfment in a pool fire.

    Furthermore, it is unclear whether existing thermal blankets would meet AAR's proposed standard or even whether AAR's proposed standard requiring thermal blankets would provide an added benefit compared to that prescribed by PHMSA. AAR provided no evidence that requiring a thermal blanket and specifying the properties of the material will enhance safety. AAR asserts that, based on AFFTAC modeling, a tank car equipped with a thermal blanket can withstand a pool fire for hours, or in some circumstances, a tank car could indefinitely withstand a pool fire without failure and loss of lading. PHMSA and FRA have two concerns with this assertion. As an initial matter, while thermal conductivity is an input to the AFFTAC model, the model does not account for degradation of the material in a pool fire, and therefore it assumes the thermal conductivity is constant for the duration of a pool fire. However, if the thermal protection begins to degrade soon after 100 minutes (assuming constant properties) the results AFFTAC would be overly optimistic. Additionally, AFFTAC is not capable of analyzing a lading comprised of more than two components, such as crude oil. It has been suggested that two component materials can be used as a surrogate for crude oil. Before the design of the AAR proposed thermal protection system meeting the DOT-117 standard can be approved, the accuracy of using a two-component system as a surrogate for crude oil must be demonstrated.

    Assuming that AAR's proposal would add time—an assumption that, at this point, is unsupported by any objective data—AAR has not provided any evidence that there is a practical benefit to extending the time period before the lading is released from a location other than from the pressure relief device. The primary intent of the 100-minute requirement in the HMR is to provide first responders time to assess the accident and initiate remedial actions such as evacuating an area. There has not been any evidence presented that the current requirement is insufficient for achieving these goals.

    Finally, AAR's proposal sets up a technical standard, but it does not necessarily establish a minimum time requirement for survivability of the tank car. The potential for variability under the AAR proposal would present added uncertainty. In developing a first response strategy, a minimum level of certainty is needed, and controlling the anticipated variables is vital. This information is vital for first responders, who need to have a reasonable understanding of the expected time frame after an event to establish an effective plan that can be executed within the baseline time that is available.

    PHMSA addressed its rationale for choosing a minimum standard that requires a DOT-117/DOT-117R tank car to withstand a pool fire for at least 100 minutes and torch fire for at least 30 minutes in the preamble to the final rule. See 80 FR at 26670-26671. It noted that AAR's T87.6 Task Force agreed that a survivability time of 100 minutes in a pool fire should be used as a benchmark for adequate performance. Additionally, the 100-minute pool fire baseline is consistent with the current federal regulations for pressure cars transporting Class 2 materials, and serves as the existing performance standard for pressure tank cars equipped with a thermal protection system. PHMSA also noted that the 100-minute pool fire baseline had been “established to provide emergency responders with adequate time to assess a derailment, establish perimeters, and evacuate the public as needed, while also giving time to vent the hazardous material from the tank and prevent an energetic failure of the tank car.” See 80 FR 26671.

    With respect to pressure relief devices, which are designed to work in conjunction with the thermal protection system, PHMSA noted that there was widespread concurrence among commenters for a redesigned pressure relief device for DOT-117 cars. See 80 FR at 26670-26671. The simulations performed by PHMSA indicated that a reclosing pressure relief valve was of primary importance, because when a tank car is exposed to a pool fire the PRD will maintain a low pressure in the tank and potentially extend the time before a tank car will thermally rupture. PHMSA also determined that high-flow capacity, reclosing pressure relief devices can be acquired reasonably in the market and they can be installed on new or retrofitted tank cars. These factors support the performance standard chosen by PHMSA for pressure relief devices. For the reasons stated, the appeal submitted by AAR on thermal protection in the final rule is denied.

    G. Advanced Brake Signal Propagation Systems Dangerous Goods Advisory Council

    DGAC appeals to PHMSA requesting the elimination of the electronically controlled pneumatic (ECP) brake requirement from the final rule. The DGAC appeal rests on three main arguments. First, DGAC agrees with the comments AAR and API submitted in response to the NPRM. Second, DGAC argues that the timeline for implementing the ECP brake requirement is inconsistent with the retrofit schedule adopted in the final rule and will require ECP brakes to be installed before retrofitting. Third, DGAC alleges there will be difficulties moving HHFUTs from Canada to the U.S. because Canada has not adopted similar ECP brake requirements.

    PHMSA and FRA Response

    In regards to DGAC's appeal to eliminate the ECP brake requirement, PHMSA maintains that the retrofit schedule is consistent, and that the final rule will not lead to the unspecified difficulties that concern DGAC. Further, we respectfully disagree with DGAC's first argument agreeing with AAR and API regarding this issue. PHMSA considered the comments submitted by AAR and API in drafting the final rule, and as part of its appeal, DGAC provides no new information to support the AAR and API comments. Rather than restating its previous analysis here, PHMSA directs DGAC to the discussion of the ECP brake requirement in the final rule and the RIA. See 80 FR 26692-26703; and RIA, p. 33-36, 207-278.

    The timeline for implementing ECP brakes on HHFUTs will allow the rail industry to orderly schedule retrofits to comply with both requirements. PHMSA expects that in most instances ECP brakes will be installed when a tank car is sent to the service shop for retrofitting. This will avoid taking the car out of service more than is absolutely necessary. There should be no need to install ECP brakes on a tank car prior to retrofitting the car. The RIA to the final rule estimates that about 60,000 tank cars will need to have ECP brakes installed. Approximately one-third of these cars will be new construction, and the remaining cars, retrofits. See RIA, pp. 218-219.

    Currently, crude oil and ethanol are the only Class 3 (flammable liquids) transported in trains that fall within the HHFUT definition. These hazardous materials are assigned to a packing group based on their flash point and initial boiling point. Crude oil may be classified as PG I (high danger), PG II (medium danger), or PG III (low danger).

    The final rule requires all DOT-111 and non-jacketed CPC-1232 tank cars used in PG I service to be retrofitted no later than April 1, 2020.19 PHMSA anticipates that the industry will apply a vast majority of those retrofitted cars to unit train service because it makes financial sense to put the first retrofitted cars to use in the highest priority service. The ECP brake requirement for an HHFUT transporting at least one tank car loaded with PG I material does not go into effect until January 1, 2021. Therefore, PHMSA and FRA believe that the combination of new cars and retrofits completed prior to January 1, 2021, should be sufficient to supply the tank cars needed to operate in ECP brake mode. See RIA, p. 146.

    19 Non-jacketed DOT-111 tank cars used in PG I service must be retrofitted by January 1, 2017 (or, under a schedule, not later than January 1, 2018). Jacketed DOT-111 tank cars used in PG I service must be retrofitted by March 1, 2018. Non-jacketed CPC-1232 tank cars used in PG I service must be retrofitted by April 1, 2020.

    The same is true with respect to those HHFUTs transporting loaded tank cars of ethanol or crude oil not in PG I service. These trains must operate in ECP brake mode as of May 1, 2023, when traveling in excess of 30 mph. The final rule requires retrofitting all DOT-111 tank cars used in PG II service no later than May 1, 2023. Non-jacketed CPC-1232 tank cars used in PG II follow closely behind with a retrofit deadline of July 1, 2023. For the reasons stated above, PHMSA reaffirms its position and disagrees that the timeline for implementing the ECP brake requirement is inconsistent with the retrofit schedule adopted in the final rule. See RIA, p. 146.

    Lastly, PHMSA discussed U.S./Canada harmonization efforts in the final rule. See 80 FR 26662. PHMSA recognizes that the transportation of flammable liquids by rail is a cross-border issue. In developing the final rule, U.S. DOT and TC worked closely to ensure that the new tank car standards for HHFTs do not create barriers to movement, but harmonization is not required in every instance. PHMSA and FRA strongly believe that the ECP brake requirement for HHFUTs is an important measure to help protect public safety and the environment in the U.S. That said, PHMSA and FRA carefully considered cross-border issues with respect to ECP braking, particularly when a train is crossing from Canada into the U.S., and provided authorization in the final rule for continued transportation. If an HHFUT without ECP brakes arrives in the U.S. from Canada, that train may continue in transportation at a speed that does not exceed 30 mph. This solution eliminates cross-border barriers to transportation and should alleviate any of the unspecified difficulties that concern DGAC. For these reasons, DGAC's appeal to eliminate the ECP brake requirement of the final rule is denied.

    Association of American Railroads

    AAR also asks us to eliminate the new ECP brake standard for HHFUTs traveling in excess of 30 mph. AAR contends that PHMSA should remove the ECP brake requirement from the final rule, and provides 10 arguments that purportedly support its position.

    PHMSA and FRA Response

    In regards to AAR's appeal with respect to ECP braking, AAR's arguments do not present a compelling basis for repealing the ECP brake requirement in the final rule. PHMSA stands by the Final Rule's established two-tiered approach to braking systems that focuses on increasing safety for trains transporting large quantities of flammable liquids. All HHFTs traveling in excess of 30 mph must operate using a two-way end-of-train (EOT) device or a distributed power system. All HHFUTs traveling in excess of 30 mph must operate using ECP brakes. The ECP brake requirement begins on January 1, 2021, for any HHFUT transporting at least one loaded tank car of PG I material. For all other HHFUTs, the ECP brake requirement is mandatory beginning May 1, 2023.

    The basis for the ECP brake requirement was thoroughly researched prior to publication of the final rule. ECP brakes allow for shorter stopping distances and reduced in-train forces. In the ECP brake mode of operation, all cars brake simultaneously by way of an electronic signal. ECP brake systems simultaneously apply and release freight car air brakes through a hardwired electronic pathway down the length of the train, and allow the engineer to “back off” or reduce the braking effort to match the track grade and curvature, without having to completely release the brakes and having to recharge the main reservoirs before another brake application can be made. These differences in the operation of the two braking systems give ECP brakes several business benefits. Operationally, ECP brakes have the potential to save fuel and reduce emissions, reduce wear and stress on wheels and brake shoes, and provide train engineers greater control on the braking characteristics of trains. From a safety perspective, ECP brakes greatly reduce the risk of runaway trains due to a diminished reservoir air supply, and reduce the probability of an incident by providing 40 to 60 percent shorter stopping distances. ECP brake wiring also provides the train a platform for the gradual addition of other train-performance monitoring devices using sensor-based technology to maintain a continuous feedback loop on the train's condition for the train crew. PHMSA is highly confident that this requirement will minimize the effects of derailments involving HHFUTs by limiting the number of cars involved in the derailment and decreasing the probability of tank car punctures. Indeed, an NTSB study published after PHMSA published the final rule supports the safety basis for ECP brakes, finding that ECP brakes provide better stopping performance than conventional air brakes and distributed power (DP) units in full service and emergency braking applications.20

    20 NTSB recently published the results of its simulation study of train braking as part of its investigation into the December 30, 2013, incident in Casselton, ND, where a crude oil unit train collided with a derailed car resulting in the derailment of 21 tank cars. See Train Braking Simulation Study, Renze, K.J., July 20, 2015, at http://dms.ntsb.gov/public/55500-55999/55926/577439.pdf.

    1. North American Experience With ECP Brakes

    AAR's initial assertion is that PHMSA ignores the actual experience of North American railroads in operating trains equipped with ECP brakes. It contends that the experience of these railroads demonstrates that ECP brakes are unreliable. Additionally, AAR states that ECP brakes do not function materially better than trains with conventional air brakes that make use of DP and dynamic braking. Finally, AAR claims that neither PHMSA nor FRA made any effort to collect information from railroads about their experiences with ECP brakes and that PHMSA failed to incorporate the data that was gathered into its analysis.

    We disagree. In coordination with FRA, PHMSA did consider the experience of North American railroads when we developed the requirement for ECP brakes on HHFUTs that operate in excess of 30 mph. Both the final rule and the RIA discuss at length the North American experience with ECP brakes. See RIA, pp. 216-236; 80 FR 26997-26998. The information relied upon by PHMSA and FRA included comments from the railroads and suppliers, reports and papers presented by railroad officials discussing ECP brake effectiveness, and testimony at previous public hearings held by FRA. Examples of comments that PHMSA and FRA relied upon include AAR's comments on dynamic braking and RSI's comments on the costs of installing ECP brakes on newly constructed and retrofitted tank cars. See RIA, pp. 216-217, 218, 239, and 262-263.

    Examples of reports and presentations from railroad personnel include the following:

    • “Electronically-Controlled Pneumatic (ECP) Brake Experience at Canadian Pacific,” Wachs, K., et al., which was presented at the 2011 International Heavy Haul Association (IHHA) Conference, in Calgary, AB, Canada. See RIA, pp. 216-217, 263, and 267.

    • “Norfolk Southern ECP Brake Pilot Project Update,” Forrester, J., presented at the 2010 National Coal Transportation Association O & M Committee Meeting in Coeur d'Alene ID. See RIA, pp. 236-237.

    • “ECP Perspectives,” Maryott, D. presented at the 2008 Air Brake Association Proceedings of the 100th Annual Convention and Technical Conference in Chicago, IL. See RIA, pp. 236.

    Much of the value of these reports, which were initiated and completed outside this rulemaking, was that PHMSA and FRA received hard numbers and data resulting from the direct testing of North American railroad operations using ECP brakes. The data from these reports included information on fleet reductions, rail wear, wheel wear, stop time, restart time, and stopping distances. Additionally, PHMSA and FRA relied on statements at two FRA public hearings held on October 4, 2007, and October 19, 2007, that were held during FRA's rulemaking process establishing ECP brake system standards. The public hearing included comments from Mr. Michael Iden, an official of Union Pacific Railroad Company (UP), who described an example of how regulatory relief from brake inspections on trains with ECP brakes would help to save fuel while also reducing congestion (by allowing an ECP-equipped train to overtake slower trains that require more frequent brake inspections).21 Based on the totality of the evidence available, PHMSA and FRA unanimously concluded that applying an ECP braking requirement to a limited subset of trains, HHFUTs, is warranted when transporting extremely large quantities of Class 3 (flammable liquids).22

    21 PHMSA recognizes that Mr. Iden also provided a statement as part of UP's comment to the docket for this rulemaking. See PHMSA-2012-0082-2558. In that statement, he restated his caution that “ECP braking should begin with high-mileage high-utilization cars.” PHMSA agrees, which is why it has limited ECP braking to the highest use type trains. However, Mr. Iden now maintains that distributed power delivers comparable benefits to ECP brakes. In making this determination, Mr. Iden states that UP came to this conclusion through in-depth examination of event recorders of test trains. UP has not published the data or the analysis upon which this report was based. It did not provide this information to Booz Allen, which was actively collecting ECP brake information at the time of UP's tests, and it did not produce the information to PHMSA or FRA during this rulemaking.

    22 PHMSA's view also is supported by a 2014 presentation prepared by AAR's transportation research and testing organization, the Transportation Technology Center Inc. (TTCI). This presentation has been added to the docket. The TTCI ECP Brakes presentation is informative on the issue of the North American ECP braking experience and provides a distinct counterpoint to AAR's own arguments in this forum against the ECP braking provisions in the final rule. The presentation is broadly consistent with PHMSA's analysis in the RIA, confirming the many of the benefits of ECP brakes while also noting some of the difficulties acknowledged by PHMSA.

    AAR relies on a report titled “Assessment of the Enhanced Braking Requirements in the Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains Final Rule of May 1, 2015” (hereinafter referred to as the “Oliver Wyman Report”), which lists a number of purported quotes from interviews with unnamed railroad officials in support of the contention that PHMSA and FRA did not incorporate the railroads' negative comments about ECP brakes into its analysis. These anecdotes (from UP, Canadian Pacific Railway (CP), and CSX Transportation, Inc.) essentially suggest that ECP brakes were tried and abandoned a number of years ago. These statements are not persuasive, as PHMSA and FRA acknowledged in the RIA at pages 223-225 that there may be problems at the outset with using ECP brakes, just as there are with any newer technology. There is evidence that ECP brake technology has advanced since these railroads stopped operating trains using ECP brakes, see RIA, pp. 225-226, but there is no discussion in the Oliver Wyman Report about whether these railroads have considered re-adopting ECP brakes in limited circumstances, such as with captive unit train fleets.

    The purported quotes in the Oliver Wyman Report from officials of BNSF Railway Company (BNSF) and Norfolk Southern Railway Company (NS), while current, provide conclusions rather than analysis. In the rare instances where the Oliver Wyman Report does provide tangible numbers, there are no references that would allow PHMSA and FRA to research and verify the information and assess its applicability. See e.g., pp. 8, concerning the rate of failures on BNSF. If these railroads have actual data reflecting the real-world effectiveness of ECP brakes in North America, they have not provided it in the course of this appeal or the rulemaking process.23 Similarly, FRA has not received a written status report from BNSF on the progress of the testing for the 5,000 Mile ECP test train that has been due to the agency since April 2015.24 Therefore, AAR's unsupported contentions concerning the North American experience with ECP brakes do not present a compelling reason to revisit PHMSA and FRA's ECP brake requirement for HHFUTs on trains traveling in excess of 30 mph.

    23 The Oliver Wyman Report contends that FRA committed to collect data from ECP brake testing during the past eight years. This statement mischaracterizes FRA's statements. FRA's ECP brake rulemaking contains no such statements. See 73 FR 61512. FRA did contract with Booz Allen to collect and analyze ECP brake data, but that contract closed in 2010, and was not renewed largely because the railroads failed to provide data for analysis. Of course, the railroads have been free to provide data to FRA or publish papers expanding and reflecting upon their understanding of the effectiveness of ECP braking since 2010, but—except for the 2011 CP paper referenced earlier—the record is devoid of such documents.

    24 On August 18, 2015, BNSF and NS did make an oral presentation to FRA concerning the 5,000-mile pilot train. However, no written or electronic reports have been provided to the agency for review (the railroads cited the need for legal review) . This oral presentation identified concerns related to unanticipated penalty brake applications and repair times. FRA has not received written documentation to support the oral presentation or assess the integrity of the results and determine the underlying cause of these alleged events (for example, it may be helpful to compare the results to normal ECP-equipped trains that operate 3,500 miles between brake tests or how the pilot train compared to lines where there is more experience handling ECP-equipped trains). But, at least some of the problems BNSF presented orally appear to be “teething” issues that should be resolved as railroad personnel servicing the 5,000-mile pilot train along its route become more familiar with ECP brake technology and as equipment to service the train becomes more available.

    2. Foreign Experience With ECP Brakes

    AAR raises two issues about PHMSA's reliance on international experiences with ECP brakes. First, AAR contends that it was inappropriate for PHMSA to rely on the experiences of Australian and other foreign railroads with ECP brakes. AAR believes the ECP brake operations in these other countries are dissimilar to operations in the U.S. AAR states this is because the international systems discussed tend to be closed-loop mining railroads that do not interchange with other railroads and rarely break apart the trainsets. Second, AAR claims that PHMSA and FRA mischaracterize the conclusions of the Sismey and Day Report, published in 2014, that conducted a survey of Australian railroads using ECP brakes to gauge their experiences with ECP brakes. See “The ECP Brake—Now it's Arrived, What's the Consensus?,” Sismey, B. and Day, L., presented to the Conference on Railway Excellence, 2014, Adelaide, Australia. Neither of these issues supports eliminating the ECP brake requirement from the final rule.

    PHMSA and FRA believe that AAR's argument overstates the differences between the international ECP brake model and unit trains in the U.S., particularly HHFUTs. As noted on page 220 of the RIA, PHMSA and FRA expect that the limited number of HHFUTs will stay together for an extended period of time to meet the demand for service. The tank cars in an HHFUT are not regularly being switched to different destinations. These types of trains are not acting like a typical manifest train that commonly enters a yard to be broken up and have its cars reclassified and redirected into other trains. Instead, they are making continuous loops to and from the loading and unloading facilities. This is how these trains are currently marketed. See RIA, pp. 220, 232-233. The final rule builds off of that model. Of course, there may be facilities that cannot take an entire unit train at once. This may necessitate breaking the train apart for the limited purpose of serving the facility. PHMSA and FRA account for this circumstance by recognizing that U.S. railroads will likely use overlay ECP brake systems. This would allow operations at a facility without using ECP brakes, ensuring a measure of flexibility. Once that service is completed, PHMSA reasonably expects that the cut of tank cars will retake its place in the HHFUT to make its return trip. These similarities make the Australian (and other international experiences) relevant.

    The claim that PHMSA mischaracterizes the Sismey and Day Report is surprising in light of PHMSA and FRA's reading of the Oliver Wyman Report. The Oliver Wyman Report cites to selective information from the Sismey and Day Report, which mischaracterizes its findings. To be clear, PHMSA and FRA accurately cite to the Sismey and Day Report in the RIA. See pp. 34-36. On page 34 of the RIA, PHMSA and FRA note that the report details how ECP brakes have performed in practice since Australian railroads began using the technology. PHMSA and FRA fully recognize in the RIA that the report highlights the benefits of ECP brakes and the associated challenges experienced by Australian railroads. In summarizing the conclusion of the Sismey and Day report, PHMSA and FRA note that “[t]he report concludes that the challenges experienced in practice are largely resolved and that there is a business case to expand the use of ECP brakes into intermodal service.” PHMSA and FRA do not see the basis for AAR's claims given the “Conclusion” of the Sismey and Day Report, which is as follows:

    ECP is here to stay and is becoming more widely accepted and understood. There have been issues in the introduction and implementation of ECP brakes which can be categorized as manufacturing/teething issues and unexpected surprises.

    These have not been experienced by all operators of ECP brakes. Solutions have now largely been identified to allow them to be managed to the point where their impact on operations is reduced or eliminated.

    There is as yet untapped potential for ECP brakes to improve train operations on Australia's rail networks.

    Watershed events for the future of ECP brakes and the rail industry:

    • Introduction of ECP brakes on unit mineral trains which happened from 2005 onwards.

    • Retrofit of ECP brakes on unit mineral trains which are underway in the Pilbara from 2012 onwards.

    • The emergence of viable business cases for Introduction of ECP brakes onto intermodal unit trains and onto the wider wagon fleet used in general service.

    See p. 30, “The ECP Brake—Now it's Arrived, What's the Consensus?”.

    There is one additional issue raised by AAR through the Oliver Wyman Report that merits discussion. This is the highlighting of purported difficulties experienced by international users who commingled trains using ECP brakes with trains using conventional air brakes. The Oliver Wyman Report claims, based on an anecdotal report of a single unnamed employee, that the former Quebec Cartier Mining Railroad or QCM (now AccelorMittal) has experienced difficulties with operations where three of the company's eight trains are equipped with ECP brakes while the other five trains have conventional brakes. The report claims that severe problems have occurred when trying to pick up bad order cars when some cars are equipped with ECP brakes while others are equipped with conventional air brakes. The Oliver Wyman Report then attributes to the unnamed employee a statement that the railroad is considering standardizing braking using just ECP brakes or just conventional air brakes.

    To be clear, the Oliver Wyman Report provides no hard evidence that QCM has instituted a plan to eliminate its fleet of trains equipped with ECP brakes or its trains equipped with conventional air brakes.25 However, the situation described above with bad ordered cars would not present the same problem for an HHFUT equipped with ECP brakes in the U.S. The QCM uses a stand-alone ECP brake system on its trains. The stand-alone ECP brake system eliminates the ability to revert to conventional air brake mode. PHMSA expects that U.S. railroads will use an overlay ECP brake system, which allows a car to be transported in ECP brake or conventional air brake mode. This was discussed extensively in the RIA. See pp. 219-220, 225, and 230.

    25 The Oliver Wyman Report does not state whether QCM would convert to all ECP brakes or all conventional air brakes.

    PHMSA also notes that QCM made a business decision to introduce trains equipped with ECP brakes onto its line in 1998. This means that QCM has voluntarily operated with a mixed allotment of ECP brake trains and conventional air brake trains for about 17 years. If the purported difficulties of maintaining ECP trains along with conventional air brake trains were as severe as the Oliver Wyman Report suggests, then PHMSA and FRA expect that QCM would have abandoned either ECP brakes or conventional air brakes long before June 12, 2015, which is the date of the Oliver Wyman Report.

    3. Business Benefits of ECP Brakes

    AAR argues that “PHMSA relied on the purported business benefits of ECP braking as predicted in a 2006 report by Booz Allen Hamilton,” and did not make an effort to verify whether real-world experience with ECP brakes validated the Booz Allen predictions. It is AAR's view “that the benefits predicted by Booz Allen nine years ago did not materialize in subsequent field tests in North America and operations in foreign countries.” Therefore, it states that PHMSA and FRA erred by calculating business benefits based on the Booz Allen analysis. AAR relies on the Oliver Wyman Report to support its contentions, see pp. 24-48, but its contentions simply are not supported by the facts. PHMSA and FRA considered a number of sources in addition to the Booz Allen Report to develop the final rule, including comments to the NPRM, reports and presentations analyzing ECP brake operations in North America and abroad, and testimony during two FRA public hearings on ECP brakes.

    Fuel Savings: The Oliver Wyman Report states that there are likely some fuel savings, but they are not “validated.” The Oliver Wyman Report states that the 5.4 percent fuel savings on CP occurred, but that the actual savings over an entire system would be less, because the terrain over which it realized the 5.4 percent savings was advantageous. The Oliver Wyman Report then states that PHMSA's 2.5 percent estimate of fuel savings, less than half that realized by CP, and half of that predicted by the Booz Allen Report, was arbitrary, with no basis.

    As explained in the RIA on pages 216-217, 262-263, and 267, PHMSA and FRA assumed a reduction of more than 50 percent from the real-world CP experience because PHMSA recognized that the terrain where the testing occurred maximized fuel benefits. This was very conservative, and a larger estimate of fuel savings could have been justified. At no point does the Oliver Wyman Report present hard evidence that railroads would experience less fuel savings than the 2.5 percent PHMSA and FRA estimate. Instead, the Oliver Wyman Report offers something from the Sismey and Day Report that stated “the general feeling was that there may be some fuel savings with ECP braked trains but no one would hazard a guess on the magnitude.” The Oliver Wyman Report also quotes an unnamed employee from the QCM to support its position. This employee purportedly commented to Oliver Wyman that there had been no fuel consumption benefits from ECP brakes compared to conventional systems. This anecdotal evidence from an unnamed source is directly contradicted by independent published reports that we cited in the final rule about QCM, noting that its ECP-equipped trains had led to a decrease in fuel use of 5.7 percent. See 80 FR 26697. This evidence supports the reasonableness of PHMSA and FRA's fuel savings estimate, with the likelihood that any errors were to the conservative side. Even if we accepted the Oliver Wyman Report's unsubstantiated statement that ECP brakes would result in “some fuel savings,” the 2.5 percent we used for fuel savings in the final rule is a reasonable estimate of “some savings.” Therefore, we decline to reduce that estimate to zero as AAR urges.

    Wheel Savings:

    The Oliver Wyman Report states at p. 96:

    [w]heel impact load detectors (WILD) have found wheels on ECP brake-equipped trains with defects such as tread build up, flat spots, and wheel shelling. In the current ECP brake operation, these trains are handled as unit trains and are less subject to switching operations, therefore it appears, from BNSF's ECP experience, that higher brake usage is leading to increased wear and stress on wheels than might otherwise be seen on conventional air brake equivalent trains.

    The Oliver Wyman Report merely makes the statement above but does not present evidence to support that ECP-equipped trains have experienced more of these types of defects than equivalent unit trains with conventional air brakes operating under the same conditions on the same track. Notwithstanding, some initial increase in wheel wear, such as thermal mechanical shelling, is explainable—and, possibly, expected—during the familiarization phase when new train crews gather knowledge about the braking capabilities of ECP braking. PHMSA and FRA addressed this issue in the RIA on page 217. However, the Oliver Wyman Report does not provide the necessary context for the information to allow PHMSA and FRA to draw any judgments about its statements. To adequately evaluate such reports, it is important to untangle the potential causes so that we can determine whether the reported wheel wear was caused by issues related to ECP braking. The Oliver Wyman Report does not do that. As a result, it is impossible to conclude that the reported wheel wear is caused by ECP braking as opposed to factors related to track conditions or usage.

    PHMSA and FRA do note that the phrase “higher brake usage” possibly could explain the greater wheel wear found by some ECP brake operations. The wheel wear per unit time per car is higher because the cars tend to operate more miles. The savings in wheel wear, detailed on pages 263-266 of the RIA, are based on car-miles, as explained in the flow assumptions on pages 252-254 of the RIA. There is no evidence to suggest the cars with ECP brakes have more wheel wear per car-mile. As an example, if the cars have more wheel wear per unit of time and are experiencing a 50 percent reduction in wheel wear, that implies the cars are used for more than twice as many miles per car-year as cars not equipped with ECP brakes. PHMSA and FRA believe this is a reasonable inference to draw from the data and notes that it further contradicts other AAR assertions that more ECP-equipped tank cars will be needed. Evidence that ECP-equipped wheel temperatures are more even, as offered in the Oliver Wyman Report, makes it likely that savings per car mile are being realized in ECP-equipped trains. Neither AAR, nor the Oliver Wyman Report, offers any evidence of less wheel savings per car-mile than estimated in the RIA.

    The Oliver Wyman Report also states that rail renewal will not be coordinated with wheel maintenance because the tank car maintenance will be the responsibility of the tank car owners, not the railroad. FRA staff, including inspectors with recent employment experience on railroads, are not aware of any efforts to coordinate wheel maintenance with rail renewal on any operating railroads. This seems doubly irrelevant, as the RIA does not estimate rail savings as a quantifiable business benefit, while the Oliver Wyman Report describes a failure to coordinate maintenance in a way that is not current railroad practice.

    Brake Inspections: The Oliver Wyman Report contends that North American operations have produced no data to support PHMSA's claim that the overall tank car fleet size can be reduced because cycle times will improve due to longer intervals between brake inspection stops with ECP brake equipment.

    The Oliver Wyman Report contention does not comport with reality. Railroads do see advantages from increasing the current 1,000-mile brake inspection distance to 3,500 miles.26 FRA allowed the longer distance between inspections in its 2008 ECP Brake rule at the request of railroads as an incentive to the railroads to test ECP brake equipment and because of the safety features inherent in ECP brake systems. See 73 FR 61512 (Oct. 16, 2008). FRA has recently granted a request from BNSF and NS allowing these railroads to move forward with a pilot program that increases the distance between brake inspections to 5,000 miles on certain ECP-equipped trains. This pilot program allows BNSF and NS to conduct test operations using an ECP-equipped train from the Powder River Basin to Macon, Georgia with only one brake inspection per trip compared to four inspections (one Class I and three Class IA inspections) for the same train operated using conventional brakes. It follows that if the railroads did not envision a benefit to the decreased frequency of brake inspections, they would not be pursuing the 5,000-mile waiver.

    26 The recent TTCI ECP Brakes presentation notes that permitting 3,500 miles between brake inspections results in about 50 fewer inspections per year for high-mileage cars. TTCI concluded that the current regulatory relief on brake inspections for trains with ECP brakes is a “ `reliable' benefit for high mileage cars ($220/car/year),” with a potential peak of $300/car/year. These estimates are comparable—although slightly less—to the $330/car/year benefits PHMSA estimated.

    Cycle Times: The Oliver Wyman Report argues that PHMSA's assumptions regarding reduced cycle times and reductions in car fleet size are overstated because trains must still regularly stop for servicing events and crew changes. Additionally, the Oliver Wyman Report contends that the speed of a single train will be influenced by other trains on the system, and skipping inspections does not exempt a train from network congestion. These arguments, which are addressed in part above, do not present a compelling rationale for eliminating the ECP brake requirement for HHFUTs.

    Class IA brake tests can take several hours, and are usually performed in yards. If the ECP-equipped train is ready for departure eight hours earlier than usual, the train may be dispatched ahead of other trains that would have been dispatched before it in that eight-hour window, and, it will, on average, arrive at the next yard eight hours earlier, as congestion effects are likely to be random. Also, there is no reason to revise the estimated reduction in tank car fleet size assumed by PHMSA and FRA. Train crew changes do not require Class IA brake tests, and are not relevant to this issue. Further, the Oliver Wyman Report's suggestion that wheel wear is increased because of increased usage would indicate that unit trains are experiencing shorter cycle times.

    Brake Shoe Savings: The Oliver Wyman Report contends based on a singular statement from an unnamed BNSF employee that it is unlikely that any brake shoe savings would be possible for ECP brakes compared to conventionally braked trains.

    While PHMSA and FRA did not calculate any savings for brake shoes in its analysis of business benefits, it appears that there might be a benefit, based on the comment in the Sismey and Day Report, cited in the Oliver Wyman Report, that shoe wear was very even on ECP-equipped trains when compared to trains with conventional air brakes. Thus, the concerns raised by the Oliver Wyman Report in this area are not relevant to PHMSA and FRA's determinations about ECP brakes.

    Network Capacity Benefits: The Oliver Wyman Report questions the RIA to the extent that it includes a statement that “FRA found that ECP brakes offered major benefits in train handling, car maintenance, fuel savings, and increased capacity under the operating conditions present.” The Oliver Wyman Report is unclear about the basis for this claim because it contends that “FRA has not publically reported on any data collection and analysis from North American railroad test operations using ECP brakes.”

    The increased capacity discussed in the RIA comes from a statement in the Booz Allen Report. However, those benefits were based on ECP brakes being installed on a large proportion of the trains on a line. PHMSA and FRA do not expect the same situation with respect to HHFUTs. As a result, PHMSA and FRA did not include capacity benefits in the quantified business benefits.

    4. Reliance on Business Benefits Compared to Safety Benefits of ECP Brakes

    AAR contends that PHMSA must rely on theoretical business benefits, even if not supported by actual experience, because AAR believes the costs far exceed the potential safety benefits of the final rule. We disagree. The safety benefits of ECP brakes are integral to the final rule. As such, PHMSA and FRA relied on both the business benefits and safety benefits to support the ECP brake requirement adopted in the final rule.

    PHMSA and FRA consider the safety benefits to be a fundamental element of the overall benefits and believe that the safety benefits estimated in the RIA are reasonable based on the evidence. The safety benefits of ECP brakes are thoroughly described in detail in the RIA on pages 78-120 discussing both low consequence events and high consequence events. This discussion examines the probability of these events occurring and includes a range of benefits. Furthermore, the RIA thoroughly examines the effectiveness rate for ECP brakes on pages 246-251 in the context of accident mitigation and avoidance, finding that ECP brakes reduce the probability of tank car punctures in the event of derailment by about 20 percent.

    With respect to AAR's argument that PHMSA overly relied on theoretical business benefits, PHMSA and FRA requested comments from the industry in the NPRM. Industry did not submit any data to contradict our findings.27 Moreover, between the NPRM and final rule, PHMSA and FRA continued to conduct research to determine benefits that would be most accurate looking at real world experiences. The business benefits relied upon by PHMSA came from documented sources, including testimony and reports from Class I railroads. These sources include reports addressing operations on CP, BNSF, Quebec Cartier Mining, UP, and NS, as well as operations on international railroads. PHMSA and FRA's views were also informed by review of the Booz Allen report prepared for FRA in 2006. All these reports are cited in the RIA on pages 34, 217, 235, 236, and 263.

    27 Even in the appeal process, the Oliver Wyman Report provides little verifiable data to support its findings. Instead, the report relies almost exclusively on interviews conducted with various unnamed railroad employees.

    These sources discuss the actual effects of ECP brake usage on multiple railroads. Indeed, long before PHMSA began the rulemaking process for the final rule, BNSF reported fleet reductions on trains equipped with ECP brakes. Similarly, NS reported that ECP-equipped trains experienced a reduction in dwell time, operated at track speed for longer periods of time, were able to better control their speed, and had faster loading processes and better car loading performances than trains with conventional braking. This information is consistent with the recent TTCI ECP Brakes presentation noted above, which found among other things that ECP brakes could increase equipment utilization, allow for longer trains, and permit higher train speeds. While this presentation was not used in the development of the final rule, it is helpful in informing the current discussion on ECP brakes. However, even without the TTCI ECP Brakes presentation, PHMSA is confident the information cited in the RIA supports its analysis.

    5. Cost Related to Implementation of ECP Brakes

    AAR argues that PHMSA underestimated the cost of implementing ECP braking in the final rule, and that the actual cost to implement ECP brakes on HHFUTs is more than six times PHMSA's estimate. This argument is based on AAR's contention that ECP brake-equipped tank cars and locomotives will not run in dedicated sets, segregated from the rest of the fleet. AAR contends that segregated fleets are not operationally possible. As a result, it suggests that 10 times as many locomotives will need to be equipped with ECP brakes as we estimated and that PHMSA underestimated the number of tank cars needed for ECP brake service on HHFUTs by more than 25 percent. See Oliver Wyman Report, pp. 49-70.

    These arguments are not new. PHMSA and FRA considered AAR's comments to the NPRM on this subject. We expect that railroads will be able to manage HHFUT fleets, which can be kept as captive fleet unit trains. Similar to unit coal trains that currently operate with ECP brakes, HHFUTs are expected to stay together, including the locomotive. See RIA, p. 220. While railroads may regularly shift locomotives under current operations, PHMSA and FRA are confident that, like coal unit trains, railroads can manage a specialized fleet of ECP-equipped locomotives to handle HHFUTs. See RIA, p. 221. In this sense, managing locomotives for HHFUTs likely is similar to managing distributed power locomotives, which is already a common practice. Not all trains have distributed power, but the railroads have a history of being able to manage these assets efficiently.

    PHMSA and FRA do recognize there are costs associated with keeping a fleet of HHFUT locomotives. As a result, PHMSA and FRA estimated that it would cost around $80 million (undiscounted) to equip all the necessary locomotives with ECP brakes. This included equipping four locomotives for every train, even though we expect that railroads will only need an average of three locomotives for operations. We also included the cost of wrap-around cables to provide a backup preventing the lack of locomotives from becoming a bottleneck. Wrap-around cables allow a train to operate in ECP brake mode even when one or more locomotives or cars are not equipped with ECP brakes. Additionally, PHMSA and FRA accounted for fleet management costs.

    The Oliver Wyman Report assumes that all locomotives will be equipped with ECP brakes, with a total cost of about $1.8 billion. This appears to overestimate the costs, as it assumes that railroads cannot manage their locomotive fleets. Given the railroads' history of effectively managing their equipment, it is unlikely that railroads will equip all locomotives. However, if a railroad chooses to equip all locomotives, it will be an operating practices decision and not due to the regulation.

    The costs that PHMSA and FRA used are well documented in the RIA. They incorporate the comments PHMSA received to the NPRM. Many of these comments came from the rail industry, including AAR, RSI, and car manufacturers. For example, we estimated that it would cost $7,800 to retrofit a tank car with ECP brakes and $7,300 to equip a new car with ECP brakes. This was based on comments from RSI. The average cost—based on the estimated number of new construction tank cars needed compared to the number of retrofit tank cars needed—was $7,633. AAR in its “Supplemental Comments,” which were posted to the docket on January 30, 2015, stated that the cost of ECP brakes per tank car is $7,665. The Oliver Wyman Report states that the cost per tank car for ECP brakes is $9,665. See p. 58. Based on the evidence available, PHMSA made a reasonable estimate of the cost of equipping each required tank car with ECP brakes.

    With respect to the cost of locomotives, the Oliver Wyman Report estimates the cost of equipping a current locomotive to be $88,300 and provides no estimate for equipping new locomotives. PHMSA and FRA anticipate that 2,532 locomotives would be needed to operate all HHFUTs in ECP brake mode. As discussed, this number is based on an average of three locomotives per HHFUT plus an additional locomotive for each HHFUT to act as a buffer when another locomotive is shopped. Therefore, based on current production, PHMSA and FRA expect that the railroads will be able to operate HHFUTs using new locomotives. We estimate the incremental cost of equipping a new locomotive with ECP brakes over current technology electronic brakes (i.e. Wabtec Fastbrake or New York Air Brake CCB-2) to be about $40,000. This information was provided by FRA's Motive Power and Equipment Division, and was based on the Division's background knowledge resulting from information from the manufacturers. As a result, PHMSA and FRA are confident that the estimate is reasonable.

    The Oliver Wyman Report also assumes that every employee must be trained on ECP brake systems. PHMSA and FRA believe the ECP brake requirements in the final rule can reasonably be accomplished without training every employee. Indeed, we significantly increased the number of employees we estimated would need to be trained from the NPRM to the final rule. This was because PHMSA and FRA reassessed their initial position from the NPRM based on the public comments. Using the waybill sample, we determined that approximately 68 percent of the total ton-miles were on routes that had crude oil or ethanol unit trains. As a result, PHMSA and FRA adjusted the number of employees to include 68 percent of the total crews. According to these estimates, around 51,500 employees would need to be trained, as described on page 242 of the RIA.

    The Oliver Wyman Report also states that it takes significantly more time to make repairs on trains equipped with ECP brakes. We acknowledged that the lack of training and unfamiliarity with the ECP brake components likely contribute to such delays.28 See RIA, pp. 223-224. However, once all employees who work at locations with ECP-equipped HHFUTs are adequately trained, PHMSA and FRA expect the repair time will be reduced to match that of conventional brakes.

    28 The current lack of availability of the necessary ECP brake system components can also contribute to delays.

    6. Potential for Network Disruption

    AAR contends that mandating ECP brakes will cause significant collateral damage because ECP brakes are unreliable. AAR similarly believes that deployment of ECP brakes will disrupt major arteries in the national railroad network, thereby degrading the performance and capacity of the network. Further, AAR argues that the ECP brake requirement could delay Positive Train Control (PTC) implementation, which has been deemed safety-critical.

    PHMSA and FRA addressed these arguments in the RIA in our discussion on the reliability of ECP brakes. See RIA, pp. 222-226. PHMSA and FRA conducted substantial research into the implementation of ECP brakes and found no examples of damage to the network where ECP brakes were properly integrated. As a result, we expect that with the correct infrastructure in place—such as sufficient training of railroad personnel and proper deployment of equipment and ECP brake components to ensure that they are readily available when needed—railroads can manage the ECP brake implementation without a disruption to the network. As noted in the RIA, at least one manufacturer has stated that the issue with ECP brake systems “is not reliability, but rather, availability of power and shops.” “The Science of Train Handling”, William C. Vantuono, Railway Age, June 2012, at 25-26. Because of these issues, PHMSA recognized that there may be delays associated with ECP brake implementation at the initial stages, as there would be during the roll-out of any newer technology. However, given that the ECP brake operations are not required on HHFUTs until January 1, 2021, for trains transporting a loaded tank car of Class 3, PG I, flammable liquid, and May 1, 2023, for all other HHFUTs transporting Class 3 flammable liquids, PHMSA believes there is sufficient time built into the implementation to ensure the network is not significantly disrupted by delays attributable to ECP braking technology.

    AAR's reliance on the Oliver Wyman Report does not alter PHMSA and FRA's position. The Oliver Wyman Report claims that “[a]dding a second braking technology to a large portion of the North American rolling stock fleet will materially increase the operational complexity of the railroad industry, and will reverse gains in productivity achieved over the past 35 years.” See Oliver Wyman Report, p. 79. We analyzed the size of the fleet that would be required to be equipped with ECP brakes in the RIA. The number of cars and locomotives required to operate an HHFUT fleet equipped with ECP brakes likely would be relatively small and captive (a maximum of 633 unit trains on the network at any given time, see RIA, p. 219) when compared to the total universe of train movements.

    The Oliver Wyman Report also raises a number of issues, including concerns about ECP cables, ECP brake-equipped locomotives, ECP brake car components, crosstalk, and unexpected stopping. None of these purported issues support eliminating the ECP brake requirement in the final rule. Much of what is presented is anecdotal evidence based on reports from unnamed railroad personnel that are lacking in data or analysis. Further, some of the railroads cited as providing information on their ECP braking experience have no experience with the current version of ECP brakes that is compliant with July 2014 update to the AAR Standard S-4200 series. For example, CP has not used ECP braking since removing it from limited operations in 2012, while UP has not operated ECP-equipped trains in approximately six years.

    AAR raised the ECP brake cable issue in its comments to the NPRM and PHMSA and FRA addressed those comments in the final rule. See 80 FR 26702. AAR commented that the cables and batteries for ECP brakes would need to be replaced every five years. PHMSA and FRA accounted for this cost in the RIA on page 228.

    We also addressed the crosstalk issue in the RIA at page 225. Crosstalk occurs when there is an interruption in the signal, usually caused when two ECP brake trains pass in close proximity, which results in an ECP-equipped train going into emergency brake mode. PHMSA and FRA acknowledged that this was an issue in earlier iterations of ECP brake systems, but software updates to the ECP brake programming had resolved the problem. See “The ECP Brake—Now it's Arrived, What's the Consensus?” Indeed, AAR acknowledged this by incorporating the software update into the AAR Standard S-4200 series in July 2014.

    The Oliver Wyman Report further contends that PHMSA and FRA incorrectly assessed the effect of ECP brakes on wheel wear. The basis for this contention appears to be some recent “test operations” on BNSF where wheel defects such as tread build up, flat spots, and wheel shelling have been found. See Oliver Wyman Report, p. 94. PHMSA and FRA note that the quoted “BNSF 14 Run Overview 2014” has not been provided for reference, and, as discussed above, the report does not present any evidence that ECP-equipped trains actually experience more of these types of defects than equivalent trains with conventional air brakes operating under the same conditions over the same track. Although some initial increase in wheel wear, such as thermal mechanical shelling, would be explainable during the familiarization phase when new train crews gather knowledge about the braking capabilities of ECP brakes, see RIA, p. 217, the Oliver Wyman Report does not put its information in a context that allows PHMSA and FRA to draw any judgments about that information. The same is true with respect to the reporting of a recent situation where a single train had 14 separate wheel exceptions taken. The Oliver Wyman Report merely concludes the wheel exceptions were due to ECP braking without examining the potential causes to determine whether the reported wheel wear was actually caused by issues related to ECP braking or something else. Therefore, as presented, there is no evidence that the reported wheel wear is caused by ECP braking as opposed to factors related to usage or other track conditions. This is important because wheel wear is a function of use. Further, as noted above, the phrase “higher brake usage” possibly explains the greater wheel wear found in some operations. The wheel wear per unit time per car is higher because the cars operate more miles. PHMSA and FRA calculated the savings in wheel wear, detailed on pages 263-266 of the RIA, based on car-miles, as explained in the flow assumptions on pages 252-254 of the RIA. There is no evidence to suggest these cars have more wheel wear per car-mile.

    The Oliver Wyman Report also argues that PHMSA and FRA did not address potential problems with buffer cars for HHFUTs. In the RIA, p. 238, we address the costs associated with equipping the buffer cars with wrap around cables. This was considered the lowest cost option. PHMSA and FRA recognized that there are other options, as the Oliver Wyman Report details. The Oliver Wyman Report option of equipping a fleet of buffer cars with ECP brakes is significantly more expensive than the reasonable alternative we provided. If railroads chose to use a permanent fleet of ECP-equipped buffer cars, that would be a business decision, not a regulatory requirement.

    Finally, AAR contends that the ECP brake requirements in the final rule may delay implementation of PTC. Railroads are currently required by statute to implement PTC by the end of the year 2015. The ECP brake requirement for HHFUTs does not become effective until January 1, 2021, or May 1, 2023, depending on the commodity being transported. This means that railroads should have PTC implemented well in advance of the ECP brake requirement. Thus, we do not foresee a situation where the ECP brake requirements will delay PTC implementation.

    7. Reliance on the Sharma Report

    AAR contends that PHMSA and FRA erred in using the new Sharma & Associates report (Sharma Report) to calculate the benefits due to the reduced probability of punctures on HHFUTs operating in ECP brake mode. It argues that the assumptions used in the Sharma Report are flawed in numerous ways. AAR provides the “Summary Report Review of Analysis Supporting `Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains' Final Rule” (TTCI Summary Report), which TTCI personnel prepared, as a supporting document. We disagree with AAR's contentions. For the reasons discussed below, PHMSA and FRA find that AAR's arguments do not support eliminating the ECP brake requirement in the final rule.

    Statistical approach: The statistical approach used in the Sharma Report to analyze the potential benefits of ECP brakes in the final RIA is not flawed. The confidence band suggested by the TTCI Summary Report is applicable to situations where a minimum value is being specified. The confidence band is needed to understand the range of values and the potential for values to fall below the specified value. For example, when specifying tensile strength of a material (based on average test values) it is important to know the potential variability, in the form of a confidence band, of the strength. In the case of the RIA, PHMSA and FRA's analysis determined the effectiveness of ECP brakes based on the average of the calculated number of punctures. Implicit in a comparison of averages is that in some cases the effectiveness will be less than the average and in others greater than the average.

    Consider the notion of “test” versus “simulation.” As an example, if one were conducting a physical test to determine the effect of a change in thickness on the impact energy of a specimen, one might have to conduct several tests and then apply statistical techniques to the measured values to arrive at the results. On the other hand, if one were using a finite element simulation to measure the same condition, one set of simulations would be sufficient. In fact, every simulation with the same set of input parameters would produce the same output. The variability that is associated with “testing” is not there.

    Another problem with using the conventional statistical methods, such as confidence intervals and margins of error, is that the cases PHMSA is “sampling” are not random. In fact, they were deliberately chosen to represent a range of input conditions. Additionally, the methods suggested in the TTCI Summary Report would not be appropriate because there is no variance in the “measured” results of our trials. Each trial (a simulation with a specific set of inputs) always produces the exact same set of outputs. Hence, our “variation” is not produced by the random variation of factors beyond our control; it is essentially the result of specific input conditions, though the outputs are not predictable from the outset.

    The Sharma Report considers all different combinations of initial speed and number of cars behind the point of derailment (POD). The sample size for the conventional and ECP brake systems consists of 162 cases (separate derailment simulations) each. For the two-way EOT brake configuration, 90 cases were considered. As indicated above, these cases were used to simulate average derailment conditions using each brake configuration. The methodology is not trying to predict the outcome of a specific derailment within some margin of error, nor is it being used to assure that all outcomes meet some minimum requirement within some confidence interval (such as how a set of tensile tests would be used to establish a design stress for a material). For these reasons, the TTCI Summary Report analogy of an election is, again, flawed, as the system is not trying to predict the results of one particular event.

    Inconsistent values in tables: The TTCI Summary Report also points to number of inconsistencies in the values reported for the most likely number of punctures and the analyses in which they are used throughout the RIA. PHMSA recognizes that there was a transcription error in Table BR4 of the RIA, see p. 210, and corrects those errors here. Table BR4 should read as follows:

    Table BR4—Risk Improvement Due to Braking, With POD Distributed Throughout the Train Tank type Speed, mph Most-Likely number of punctures Conventional brakes Two-way EOT
  • (DP: lead + rear)
  • ECP Brakes Percent
  • improvement
  • due to ECP
  • brakes only
  • compared to
  • two-way EOT
  • 7/16″ TC128, 11 gauge jacket, 1/2″ full‐height head shield 30 3.75 3.25 2.91 10.5 40 6.80 6.14 4.64 24.4 50 9.31 7.86 7.23 8.0 9/16″ TC128, 11 gauge jacket, 1/2″ full‐height head shield 30 3.03 2.66 2.12 20.3 40 5.64 5.09 3.78 25.7 50 7.82 6.57 6.01 8.5
    The TTCI Summary Report suggested that the effectiveness rate calculated in Table BR7 would change as a result of the transcription error in Table BR4. However, this is incorrect because Table BR7 calculates the effectiveness of ECP brakes after the effectiveness of the tank car upgrades is calculated. In other words, the ECP brake effectiveness values reported in Table BR7 reflect the effectiveness of ECP brakes in derailments involving DOT-117 and DOT-117R specification tank cars. As a result, Table BR7 continues to read as follows: Table BR7—Effectiveness Rate of ECP Brakes Weighted by Volume of Product Spilled in a Derailment Number of
  • incidents
  • Total spill
  • volume
  • Share of total volume ECP
  • effectiveness
  • rate at 30,
  • 40, 50 mph
  • Cumulative
  • effectiveness
  • rate
  • (%)
  • Below 34 mph 33 798,433 22.8 20.10 4.6 35-44 mph 8 1,488,350 49.2 25.80 12.7 45 mph and above 5 980,180 28 8.60 2.4 Total 46 3,499,656 100 19.7

    Modeling used in the final rule: The TTCI Summary Report contends the modeling and analytical approach used in the final rule is sufficiently different from the modeling and analytical approach used in the NPRM, suggesting that reliance on the final Sharma report for the final rule warranted additional notice and comment. Yet AAR discussed this very work in detail in its comments to the NPRM review. AAR's comments to the NPRM appended a 13-page critique of the LS-Dyna methodology authored by Dr. Steven Kirkpatrick of Applied Research Associates. In addition, the main body of AAR's comments to the NPRM contained several references to both Dr. Kirkpatrick's critique as well as Sharma's reliance on the LS-Dyna work. In developing the final rule, we refined the modeling and analytical approach used in the NPRM to account for and take into consideration many elements of AAR's comments and Dr. Kirkpatrick's critique. For example, the modeling conducted during preparation of the NPRM was limited to modeling the results of a derailment of a 100-car train, assuming the derailment occurred at the first car behind a train's locomotive. In response to AAR's comments and Dr. Kirkpatrick's critique, in developing the final rule, we conducted additional modeling again using a 100-car train model, but this time to more accurately represent real life derailment scenarios, we modeled and analyzed the effects of cars derailing throughout the train consist (i.e., assuming the 20th, 50th, and 80th cars in a consist derail), not just the first car. Similarly, to address AAR and Dr. Kirkpatrick's concerns regarding the impactor size used in the modeling, we conducted a sensitivity analysis using both smaller and larger-sized impactors than used in the NPRM modeling. This sensitivity analysis demonstrated that impactor size affected the number of tank cars punctured and the velocity at which those cars punctured only negligibly.

    One element of the analysis that was introduced for the final rule was the mechanism for calculating overall effectiveness based on the distribution of PODs along the train. This addition to the analysis was in response to the critique of the technique by AAR/TTCI in comments to the NPRM suggesting that this distribution be accounted for in the analysis. This element was added to the analysis in the final rule stage in response to AAR's comments critiquing the NPRM.

    The Sharma Report model was validated in both the number of cars derailed and number of punctures in real life derailments such as Aliceville. Indeed, the rear car distance traveled in one set of Dyna simulations matched the Aliceville locomotive's event recorder data with a difference of less than four percent. This indicates that, in spite of all the potential variations, the derailment simulations closely matched what actually occurred in the Aliceville accident as evidenced by the event recorder download. See RIA, p. 214.

    On the issue of impactor size distribution, the TTCI Summary Report notes that “the distribution of impactor size was very similar.” PHMSA and FRA disagree. The average impactor size variation between the three distributions was 58 percent. We would not characterize that as “similar.” Past work on tank car puncture resistance—including substantial work conducted by Dr. Kirkpatrick (and funded by the industry/AAR)—shows that the effect of a 58 percent variation in impactor size is quite significant.

    Furthermore, the review of Sharma's modeling in AAR's comment to the NPRM suggested that the distribution presented above might be skewed towards smaller impactors. However, as noted by Dr. Kirkpatrick in his earlier work, when the combinations of complex impactor shapes (such as couplers and broken rail) and off-axis impactor orientations are considered, many objects will have the puncture potential of an impactor with a characteristic size that is less than 6 inches. See “Detailed Puncture Analysis of Tank Cars: Analyses of Different Impactor Threats and Impact Conditions,” Kirkpatrick, SW., DOT/FRA/ORD-13/17, March 2013.29 The impactor distributions considered in PHMSA and FRA's analysis in the final rule are consistent with this notion.

    29https://www.fra.dot.gov/eLib/details/L04420.

    Need for additional study: The TTCI Summary Report contends that the modeling and analysis utilize a number of assumptions and simplifications, the effects of which need further study. AAR made a similar comment in its comments on the NPRM, and the extended analysis in the final rule addressed these issues by studying/reviewing several additional elements of the methodology. PHMSA and FRA addressed several prior criticisms submitted in connection with the NPRM, including:

    • The effect of varying the POD along the length of the train • The effect of alternate train lengths • The effect of varying internal pressures • The effect of varying impactor sizing, etc.

    In addition, the RIA for the final rule includes justification for many of the assumptions made in the analysis, including the friction coefficients used, the coupler model, and the lateral derailment load values. See RIA, pp. 63-72, 207-212, 213-216, and 246-247. In other words, this is similar to AAR's earlier critique on the topic and we addressed most elements of that critique in the RIA.

    Derailment location: The TTCI Summary report states that “the probability distribution for derailment location within the train does not appear to take train length into account,” thus exaggerating the benefit of operating in ECP brake mode. The Sharma Report estimated the distribution of PODs using the best available data, which included all reasonable derailments. Any “exaggeration” of benefits towards ECP brakes due to the PODs being skewed towards the front of the train would tend to exaggerate the benefit of DP trains even more. Thus, even if the distribution was skewed towards the front, the Sharma Report does not exaggerate the relative benefits of ECP brakes compared to DP trains.

    Use of derailment data from all train types: The TTCI Summary Report asserts that the analysis performed on the probability of derailments occurring throughout the train seems to use data from all train types to derive a distribution of derailment locations. This is true. The locations of train derailments are more uniformly spread under mixed traffic conditions compared to unit trains. This tends to push the average location of POD further towards the rear of the train. In fact, the POD, as a percent of the length of train for unit trains, is about half that of freight trains (21% compared to 41%). As a result, PHMSA and FRA expect that the use of derailment data of all train types (as opposed to unit trains only), results in a prediction of lower benefits for ECP braking. Using PODs from unit trains only would have led to ECP brake benefits being higher. We considered this during development of the final rule and determined our assumptions were conservative.

    Analyzing the number of cars trailing POD: The TTCI Summary Report notes that “[t]he critical parameter is not the first car in the train that was derailed, but rather the number of cars trailing the first car derailed.” PHMSA and FRA agree. This is exactly how all the LS-Dyna modeling was done. We modeled 100 cars, 80 cars, 50 cars, and 20 cars behind the POD, and interpolated the results for the other cases.

    Net braking ratios: The TTCI Summary report notes that PHMSA and FRA make multiple references in the RIA to the use of higher net braking ratios (NBR) with ECP brakes. While the RIA does make reference to a higher NBR, the LS-Dyna simulations were all performed with the same braking ratio. The results presented in the RIA are based on ECP brakes with 12 percent NBR, the same used for the other brake systems considered. See RIA, pp. 324. So, the benefits attributed to ECP brakes regarding the reduced number of cars punctured do not include any contribution from increased braking ratio.

    However, it is important to note that even though the NBR allowed for the different brake systems are theoretically the same, the use of ECP brakes does, as a practical matter, allow a train to better approach the high end of the limit. This is because features inherent to ECP brake design allow a more uniform and consistent effective brake cylinder pressure to be maintained as compared to conventional pneumatic brakes.30 Closed loop feedback control of the cylinder pressure is an inherently more reliable method of obtaining the commanded pressure than the open loop, volume displacement method used in conventional brake systems. Furthermore, trains equipped with ECP brakes can detect and report low brake cylinder pressure malfunctions on individual cars, which can then be addressed. In contrast, a malfunctioning pneumatic control valve generating lower than commanded pressure may go unnoticed indefinitely. Additionally, the overall braking ratio of a train equipped with ECP brakes can be much closer to the allowable upper limit than a conventionally-braked train because the cars in an ECP-equipped train are all braking at the same effective brake ratio (to the extent that the physical capacity of their individual construction allows). The brake ratios of cars in a conventionally-braked train can vary over the allowable range (8.5 percent to 14 percent loaded NBR), so the train average brake ratio is limited by this variation already built into the existing fleet. For these reasons, PHMSA and FRA expect that DOT-117/DOT-117R cars (with ECP brakes) can be built (or converted from existing cars) with an NBR close to 14 percent and operated (in ECP trains) with a train average brake ratio also very close to 14 percent. In contrast, the train average brake ratio of a train with conventional air brakes is likely to be significantly lower, even if some of the cars have close to a 14 percent NBR.

    30 The NTSB's recent study notes that ECP brake systems can provide the same target NBR for each car in the consist and apply a consistent braking force to each car nearly simultaneously, which allows all cars to decelerate at a similar rate. This minimizes run-in forces, and therefore reduces the likelihood of a wheel derailment and the sliding of braked wheels. All of these factors potentially allow ECP brakes to operate nearer to AAR's upper limit for NBR. See “Train Braking Simulation Study,” pp. 10-11.

    Control of unit trains: The TTCI report takes issue with a statement in the RIA to the final rule concerning unit train operations being more difficult to control than other types of trains. The excerpts, and TTCI's comments, are qualitative characterizations of unit train operations. However, the excerpt from the RIA did not influence the objective analysis we performed in support of this rule.

    Peak ECP brake benefits: TTCI takes issue with the modeling that shows ECP brake effectiveness peaking at 40 mph. The TTCI Summary reports states, ” [i]ntuitively, it would seem that the benefit of ECP brakes would either increase or decrease as speed increases.” Derailment performance is the result of several physical phenomena. Consider a derailment that happens at a very slow speed. Given the physical strength of the tanks and the energy levels involved, there would be no punctures for either a conventionally braked train or an ECP-equipped train. As a result, there would be no perceived derailment benefit to ECP brakes at very low speeds when the benefit is measured by puncture probability. As the speeds increase, and one starts seeing multiple punctures as a result of the derailment, the benefits of ECP braking become more apparent. However, at higher speeds, the percentage of braking time spent in the “propagation mode” (where ECP brakes offer the most benefit) is a smaller portion of the overall time spent braking. Consequently, the relative benefits of ECP braking start to diminish at speeds over 40 mph.

    Derailment rates: The derailment rate we used was based on the most recent five complete years of data: 2009-2013. Using the most recent years to construct this rate largely incorporates the factor of 10 decrease in the observed derailment rate cited by TTCI into our estimate of future derailments. It is not realistic to expect tenfold decreases in the derailment rate to continue indefinitely. In our judgement, the rate decrease may have bottomed out, so we used a constant rate based on the most recent data, which reduces the rate to the fewest derailments per carload observed in the available data, to forecast future derailments.

    Criticism of Train Operation and Energy Simulator (TOES) modeling: The TTCI Summary Report attempts to respond to perceived criticism of the TOES modeling TTCI used to evaluate emergency braking scenarios involving ECP brakes. As an example, the TTCI Summary Report takes issue with the statement in the RIA that TTCI's modeling “only captures a part of the benefit of ECP.” See RIA, p. 70. TTCI contends that

    [t]his statement implies that the ECP braking system has an effect on other aspects of the derailment dynamics that were included in the DOT analysis, such as impactor size distributions and tank car puncture resistance. In fact, the amount of energy is the only thing that ECP brakes (or any brake system, for that matter) can directly affect.

    The TTCI Summary Report's contention, however, ignores the reduced coupler force benefits of ECP braking. The lower coupler forces inherent to an ECP brake application reduce the chaos/energy input into the simulation. The TTCI Summary Report did not consider or even acknowledge the benefits associated with this aspect of ECP braking.

    The TTCI Summary Report also takes issue with statements in the RIA discussing PHMSA and FRA's conclusion that AAR's predictions of two-way EOT or DP performance are overestimated. See RIA, pp. 68 and 70. This is because AAR's comments, which rely on a TTCI Summary Report, expect that DP and two-way EOT devices offer a benefit if the derailment occurs in the rear half of the train. This is incorrect. There is no benefit to DP if the POD is in the second half of the train. Under derailment conditions (where trains break in two), DP offers no benefit over conventional brakes. By keeping the train together in their simulations, AAR attributed benefits to DP and two-way EOT devices where none exist. Indeed, this issue is addressed in NTSB's Train Brake Simulation Study, published on July 20, 2015. See p. 12. While this newly issued study was not used in the development of the final rule, it is informative on ECP brake performance in emergency braking compared to DP emergency braking. Indeed, the NTSB specifically looked at derailments with air hose separation and train separation occurring in the second half of the train and found “there is no benefit to DP if the emergency is initiated in the second half of the train.” 31 Thus, the NTSB study determined that trains operating in ECP brake mode “[are] not substantially affected by the location of the emergency initiation.”

    31 NTSB also notes that this scenario is more consistent with recent tank car derailments than a derailment where there is no train separation.

    Finally, The TTCI Summary Report argues that “there is no analysis produced that shows that reducing the number of cars in the Aliceville derailment from 26 to 24.5 (or even 24) cars would have resulted in a significant—or any—benefit in terms of reduced severity of the accident.” We disagree. The reduction of the number of cars punctured is fundamental to improving tank car safety. All the comments from AAR and the industry, whether it is adding head shields, jackets, or thickness, have aimed exactly for this result: reducing the number of cars punctured. One way to reduce the number of cars punctured is to stop them from entering the pile-up in the first place. By TTCI's own analysis, which is skewed towards overestimating the benefits of DP, ECP braking provides an eight percent reduction in the number of cars entering the pile-up, and a further twelve percent reduction in kinetic energy, a combined benefit of about 20 percent due to ECP braking. If one then combines this benefit with the structural benefit such as jackets and head shields, one starts seeing cumulative significant reductions in damage severity, which is the intent of the final rule.

    8. Integration of ECP Brakes With Positive Train Control (PTC)

    Relying on the Oliver Wyman Report, AAR asserts that requiring ECP brakes on HHFUTs will present integration challenges with PTC for two reasons. First, implementation of the ECP brake requirement will require new braking algorithms. Second, there will be difficulties associated with installing two complex technologies on locomotives simultaneously. PHMSA and FRA addressed both of these arguments in the final rule and do not find either argument compelling.

    The Oliver Wyman Report states that braking algorithms will need to be modified and that there will be great difficulty and expense creating algorithms for PTC for ECP trains. PHMSA and FRA previously addressed this argument in the preamble to the final rule. See 80 FR 26702-26703. We recognize that PTC coupled with ECP brakes may result in significant business benefits—such as increased fluidity and higher throughputs—but there is simply no regulatory requirement directing that ECP brake systems be integrated with PTC. Further, the Oliver Wyman Report assertion that integration is necessary for safety reasons is not supported by data or analysis. PTC operates on a block system with forced braking to ensure that a single block is not occupied by two trains at once. In other words, if one train is occupying the block, then a trailing train cannot enter the block. An algorithm based on a conventionally braked train will provide a conservative cushion for the stopping distance for a train operating in ECP brake mode, but it does not change the fact that under PTC only one train will occupy the block at a time. Operations during this time could be used to safely collect the data needed to develop the algorithm to apply to trains operating in ECP brake mode. Of course, once developed, the benefits of shorter stopping distances can then be safely integrated into the system, but such actions would be voluntary business decisions by a railroad based on a belief that integration between ECP brakes and PTC will provide efficiencies not otherwise available.

    The Oliver Wyman Report further contends that there will be costs associated with placing locomotives in the shop to install ECP brake systems in addition to PTC programming. PHMSA and FRA accounted for the costs of installing ECP brakes on locomotives on page 219-220 of the RIA, assigning a cost of $40,000 per locomotive.32 This is for new locomotives, because PHMSA and FRA expect that the allotment of locomotives needed to operate HHFUTs will come from new builds. As a result, shop time likely will be reserved for regular inspections (e.g., 92-day and 368-day inspections), at which time the railroads may take the opportunity, to the extent necessary, to focus on PTC installation issues.

    32 PHMSA notes that its $40,000 estimate is consistent with a recent TTCI ECP Brakes presentation. In that presentation, TTCI estimated the cost of equipping a locomotive with ECP brakes at $40,000 based on a 2011 study. That is less than half the cost estimated in the Oliver Wyman Report. PHMSA recognizes that costs can change over time, but the presentation is instructive on the issue of costs.

    The Oliver Wyman Report attempts to buttress its argument on costs by stating that there will be hidden costs due to the complexity of integrating PTC and ECP brakes on the same locomotive. Such comments are purely anecdotal and not supported by any data or analysis. The purported costs are unquantified in the Oliver Wyman Report and appear to be based solely on the comments of an unnamed UP mechanical officer. PHMSA notes that UP has minimal experience with ECP brakes, using the technology for about eight months over six years ago.

    Finally, PHMSA and FRA note that the Oliver Wyman Report states ECP braking is not a mature technology and, therefore, “will increase operational disruption and failures that compromise safety.” PHMSA and FRA addressed contentions about technological readiness in the RIA at page 222-225. It is unclear why the Oliver Wyman Report insists on characterizing ECP brake technology as “immature.” Such statements are unsupported and, indeed, contradicted by various other sources. In the RIA, we cited an independent report calling ECP a “mature” technology. To place the quote in context, PHMSA and FRA now cite to the entire paragraph:

    Application of ECP-brakes in freight trains is a technology that can reduce derailment frequency. The technology for ECP-brakes is mature and such brakes are applied in passenger trains and in block trains for freight in Spoornet, South Africa and by Burlington Northern Santa Fe (BNSF) and Norfolk Southern (NS) in the USA. ECP-brakes in freight trains would reduce the longitudinal forces in the train during braking and brake release, and in particular for low speed braking it would significantly reduce the risk of derailment.33

    33See “Assessment of freight train derailment risk reduction measures: A4—New Technologies and Approaches,””, Report for European Railway Agency, Report No. BA 000777/05, April 19, 2011, at 9, http://www.era.europa.eu/Document-Register/Documents/DNV%20Study%20-%20Final%20A4%20Report%20-%2020110419%20-%20Public.pdf.

    PHMSA and FRA recognize that ECP brakes are not in widespread use in the U.S., but that is not a proxy for maturity of the technology. AAR first began developing interchange standards for ECP brake systems in 1993. As noted in the RIA, North American railroads have used ECP brakes in some form since at least 1998. Australian railroads began widespread use of ECP brakes in 2005. The technology has grown and improved over that time as the industry has worked to resolve “crosstalk” and “interoperability” issues. Even TTCI, in its recent ECP Brakes presentation, notes that AAR “agrees that ECP is a mature technology.” Of course, this is not to suggest that no issues will arise with ECP brakes as railroads implement the braking system on HHFUTs. However, PHMSA and FRA account for such issues in the RIA, recognizing there will need to be significant investment in training and to ensure sufficient equipment is on hand to address normal operational issues. Therefore the accumulation of business benefits was assumed to be demonstrated one year after ECP trains are put into service, recognizing that this change in operating culture will take time. See RIA pg. 218.

    9. Impact on Small Business

    AAR contends that the final rule fails to address or mitigate the harmful impact on small business, including Class III railroads, commuter railroads, smaller contractors, and hazardous materials shippers. The basis for this contention is that federal law requires PHMSA and FRA to assess the impact of the final rule on small business and consider less burdensome alternatives. We did assess the impact of the final rule on small business and considered less burdensome alternatives to develop the final rule.

    PHMSA and FRA conducted a Regulatory Flexibility Analysis (RFA), which looked at the costs associated with small businesses for the entire final rule. See 80 FR 26725-26735. The RFA included a focused analysis of braking requirements. See 80 FR 26732-26733. As stated in the RFA, about 22 percent of short lines (160 of 738 small railroads) transport flammable liquids in HHFTs and most small railroads the final rule affects do not operate at speeds higher than the restricted speeds. Indeed, before we issued the NPRM and the final rule, the American Short Line and Regional Railroad Association (ASLRRA) recommended to their members that they voluntarily operate unit trains of crude oil at a top speed of no more than 25 mph on all routes. ASLRRA issued this letter in response to the Secretary's Call to Action on February 12, 2014, and it has been added to the docket.

    PHMSA and FRA did acknowledge that some small railroads may be affected by the ECP brake mandate because they accept unit trains of crude oil (and other trains that trigger the mandate) from Class I railroads. However, we accounted for this impact in two ways in the final rule. First, as discussed on page 220 of the RIA, PHMSA and FRA assumed an overlay ECP brake system. This will allow the tank cars to work both with ECP brakes and conventional air brakes. While the initial cost to the car owner is slightly higher than a stand-alone ECP brake system, we expect that the added flexibility of an overlay system makes it the most likely alternative to be chosen by car owners. Aa a result, any small railroad that accepts a unit train of crude oil would be able to use their own power (locomotives) because the trains would travel at a maximum speed of 30 mph and would be able to use conventional air brakes. Second, PHMSA and FRA also anticipate that Class I and smaller railroads will make use of alternatives, such as trackage rights or interchange agreements, which will allow smaller railroads to avoid equipping their locomotives with ECP brakes. Under this type of scenario, Class I railroad crews operating an HHFUT in ECP brake mode could continue operating over the smaller railroad's line, and the HHFUT would pass through the interchange with the train intact.

    AAR also raised the concern that short line railroads would be assuming the responsibility for troubleshooting ECP brake-related problems by accepting HHFUTs from Class I railroads. AAR states that this type of troubleshooting requires expertise beyond that of most small railroads because they do not have the resources to hire trained electronic engineers with the necessary expertise to identify the source of ECP system failures. PHMSA and FRA addressed the need for training on small railroads in the RIA on page 220. Because the final rule includes the less burdensome alternatives discussed above, PHMSA and FRA believe that there are effective methods for avoiding the type of training described.

    Finally, AAR states that where an interchange agreement requires the small railroads to use existing power, there would be an enormous expense for the small railroad because that railroad would need to equip locomotives with ECP brakes for handling interchanged unit trains. AAR asserts that this is a particularly large problem because most small railroads have older locomotives that are not processor-based and that lack the required space to install an ECP brake system. It estimates it would cost approximately $250,000 to equip a non-processor based locomotive with ECP brakes. For the reasons discussed above, PHMSA and FRA do not anticipate that older locomotives would need to be equipped.

    10. Conflict With the Statute Requiring Two-Way EOT Devices

    AAR argues that the ECP brake requirement in the final rule is prohibited by 49 U.S.C. 20141. This statute provides that “[t]he Secretary shall require two-way end-of-train devices (or devices able to perform the same function) on road trains, except locals, road switchers, or work trains, to enable the initiation of emergency braking from the rear of a train.” The statute further requires the Secretary to establish performance based regulations to govern the use of two-way EOT devices and allows the Secretary “to allow for the use of alternative technologies that meet the same basic performance requirements.” See 49 U.S.C. 20141(b)(2). AAR contends that PHMSA and FRA's ECP braking requirement is defective because it directs freight railroads to use ECP brake systems instead of two-way EOT devices. This argument is without merit because any HHFUT operating in ECP brake mode must comply with the ECP-EOT requirements in part 232, subpart G. See § 174.310(a)(3); 80 FR 26748.

    FRA initially issued regulations governing the use of conventional two-way EOT devices in 1997. See 62 FR 278 (Jan. 2, 1997). These regulations are in part 232, subpart E, and are targeted at trains with conventional air brakes. Subpart E requires a conventionally braked train to have a two-way EOT device or an alternative technology unless it meets one of the explicit exceptions identified in § 232.407(e). For example, under § 232.407(e), a conventionally braked train is not required to operate with a two-way EOT device if a locomotive or locomotive consist is located at the rear of the train that is capable of making an emergency brake from the rear—as would occur with a lined and operative DP locomotive located at the rear of the train—or when the train does not operate over heavy grade and the speed of the train is limited to 30 mph.34

    34See 49 CFR 232.407(e), identifying additional exceptions to the two-way EOT requirement for trains with conventional air brakes.

    AAR appears to be under the misconception that the final rule fails to comply with 49 U.S.C. 20141 because it foregoes the requirements in part 232, subpart E, for HHFUTs operating in excess of 30 mph. However, the final rule pertaining to ECP brakes does comply with 49 U.S.C. 20141. It mandates compliance with part 232, subpart G, for any HHFUT operating in ECP brake mode. Indeed, subpart G contains EOT device requirements that are specific to trains operating in ECP brake mode. See § 232.613.

    The ECP-EOT device requirements in section 232.613 were promulgated as part of FRA's ECP regulations in 2008. See 73 FR 60512 (Oct. 16, 2008). These regulations were issued, in part, under 49 U.S.C. 20141.35 See 73 FR at 61552. While ECP-EOT devices perform many of the same functions as conventional two-way EOT devices, FRA recognized that ECP-EOT devices also have different features than those required for trains operated using conventional air brakes:

    35 It is worth noting that FRA's ECP regulations were also issued under 49 U.S.C. 20306. This provision allows the Secretary to waive the statutory provisions in 49 U.S.C. ch. 203 “when those requirements preclude the development or implementation of more efficient railroad transportation equipment or other transportation innovations under existing law.” FRA held public hearings on October 4, 2007, and October 19, 2007, which included comments and discussion about ECP-EOT devices. Based on the comments received during these public hearings and a related public hearing on January 16, 2007, FRA determined it was appropriate to exercise the Secretary's authority under 49 U.S.C. 20306 to promulgate its ECP regulations.

    In addition to serving as the final node on the ECP brake system's train line cable termination circuit and as the system's `heart beat' monitoring and confirming train, brake pipe, power supply line, and digital communications cable continuity, the ECP-EOT device transmits to the [head end unit or] HEU a status message that includes the brake pipe pressure, the train line cable's voltage, and the ECP-EOT device's battery power level.

    See 73 FR 61545. Although FRA noted that the ECP-EOT device operates differently than a conventional two-way EOT device, the ECP-EOT device does ensure that an automatic emergency brake application occurs in the event of a communication breakdown:

    Since the ECP-EOT device—unlike a conventional EOT device—will communicate with the HEU exclusively through the digital communications cable and not via a radio signal, it does not need to perform the function of venting the brake pipe to atmospheric pressure to engage an emergency brake application. However, ECP-EOT devices do verify the integrity of the train line cable and provide a means of monitoring the brake pipe pressure and gradient, providing the basis for an automatic—rather than engineer commanded—response if the system is not adequately charged. In the case of ECP brakes, the brake pipe becomes a redundant—rather than primary—path for sending emergency brake application commands. Under certain communication break downs between the ECP-EOT device, the HEU, and any number of CCDs, the system will self-initiate an emergency brake application.

    Id. Section 232.613 requires the ECP-EOT device to send a beacon every second from the rear unit of the train to the controlling locomotive. The EOT beacon works as a kind of fail-safe. It functions virtually identically to the radio signal of a conventional two-way EOT device with one important exception: if the EOT Beacon is lost for six seconds on a train operated in ECP brake mode, then the train goes into penalty brake application, which will brake all cars in the train simultaneously. In contrast, a two-way EOT device may lose communication for up to 16 minutes, 30 seconds, at which point the train speed must be reduced to 30 mph.

    Based on these factors, PHMSA and FRA conclude that the ECP brake component of the final rule complies with the requirements of 49 U.S.C. 20141. AAR should be aware that HHFUTs operating in ECP brake mode must have an ECP-EOT or an appropriate alternative, such as an ECP-equipped locomotive, at the rear of the train. This requirement is consistent with FRA's ECP brake regulations at part 232, subpart G.

    For the above reasons, AAR's appeal to eliminate the new ECP brake standard of the final rule is denied.

    III. Summary

    PHMSA denies the appellants' (DGAC, ACC, AAR, AFPM, and Treaty Tribes) appeals on Scope of Rulemaking, Tribal Impacts and Consultation, Retrofit Timeline and Tank Car Reporting Requirements, Thermal Protection for Tank Cars, and Advanced Brake Signal Propagation Systems. We conclude we reasonably determined how to apply new regulations and provided the regulatory analysis to support those decisions. While we understand that shippers, carriers, and tank car manufacturers for Class 3 flammable liquids will face new challenges in the wake of these regulations, we maintain that they are capable of complying with the final rule.

    We also deny DGAC's appeal to eliminate or provide further guidance for the Sampling and Testing program. The sampling and testing program is reasonable, justified, necessary, and clear as written. Additionally, we disagree that a delayed compliance date of March 31, 2016 should be provided for implementation of the requirements in § 173.41 for shippers to implement changes for training and documentation.

    With respect to Information Sharing/Notification, PHMSA announced in a May 28, 2015, notice that it would extend the Emergency Order applicable to the topic of Information Sharing/Notification indefinitely, while it considered options for codifying the disclosure requirement permanently. Furthermore, on July 22, 2015, FRA issued a public letter instructing railroads transporting crude oil that they must continue to notify SERCs of the expected movement of Bakken crude oil trains through individual States. While the treaty tribes and other stakeholders will have the opportunity to comment on these future regulatory proposals in the course of that rulemaking proceeding, PHMSA will continue to seek opportunities to reach out to the tribes and consultation from tribal leaders.

    Issued in Washington, DC on November 5, 2015. Marie Therese Dominguez, Administrator, Pipeline and Hazardous Materials Safety Administration.
    [FR Doc. 2015-28774 Filed 11-17-15; 8:45 am] BILLING CODE 4910-60-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 101206604-1758-02] RIN 0648-XE290 Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic; 2015-2016 Accountability Measure and Closure for King Mackerel in Western Zone of the Gulf of Mexico AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS implements an accountability measure (AM) for commercial king mackerel in the western zone of the Gulf of Mexico (Gulf) exclusive economic zone (EEZ) through this temporary final rule. NMFS has determined that the commercial quota for king mackerel in the western zone of the Gulf EEZ will be reached by November 17, 2015. Therefore, NMFS closes the western zone of the Gulf EEZ to commercial king mackerel fishing on November 17, 2015. This closure is necessary to protect the Gulf king mackerel resource.

    DATES:

    The closure is effective at noon, local time, November 17, 2015, until 12:01 a.m., local time, on July 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Susan Gerhart, NMFS Southeast Regional Office, telephone: 727-824-5305, email: su[email protected]

    SUPPLEMENTARY INFORMATION:

    The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, and cobia) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

    The commercial quota for the Gulf migratory group king mackerel in the western zone is 1,071,360 lb (485,961 kg) (76 FR 82058, December 29, 2011), for the current fishing year, July 1, 2015, through June 30, 2016.

    Regulations at 50 CFR 622.388(a)(1) require NMFS to close the commercial sector for Gulf migratory group king mackerel in the western zone when the quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. Based on the best scientific information available, NMFS has determined the commercial quota of 1,071,360 lb (485,961 kg) for Gulf migratory group king mackerel in the western zone will be reached by November 17, 2015. Accordingly, the western zone is closed to commercial fishing for Gulf migratory group king mackerel effective at noon, local time, November 17, 2015, through June 30, 2016, the end of the current fishing year. The western zone of Gulf migratory group king mackerel is that part of the EEZ between a line extending east from the border of the United States and Mexico and 87°31.1' W. longitude, which is a line directly south from the state boundary of Alabama and Florida.

    Except for a person aboard a charter vessel or headboat, during the closure no person aboard a vessel that has been issued a commercial permit for king mackerel may fish for or retain Gulf migratory group king mackerel in the EEZ in the closed zone (50 CFR 622.384(e)(1)). A person aboard a vessel that has a valid charter vessel/headboat permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed zone under the bag and possession limits set forth in 50 CFR 622.382(a)(1)(ii) and (a)(2), provided the vessel is operating as a charter vessel or headboat (50 CFR 622.384(e)(2)). A charter vessel or headboat that also has a commercial king mackerel permit is considered to be operating as a charter vessel or headboat when it carries a passenger who pays a fee or when there are more than three persons aboard, including operator and crew.

    During the closure, king mackerel from the closed zone, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to king mackerel from the closed zone that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor (50 CFR 622.384(e)(3)).

    Classification

    The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of Gulf migratory group king mackerel and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.388(a)(1) and 622.384(e), and is exempt from review under Executive Order 12866.

    These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

    This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial quota and the associated requirement for closure of the commercial harvest when the quota is reached or is projected to be reached has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Additionally, allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the king mackerel stock, because the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established quota.

    For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 13, 2015. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-29475 Filed 11-13-15; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 RIN 0648-XE316 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notification that Northeast Distant gear restricted area (NED) quota is filled.

    SUMMARY:

    NMFS announces that the 25-mt quota available for Atlantic bluefin tuna bycatch (including landings and dead discards) by the Longline category in the Northeast Distant gear restricted area (NED) was filled on November 12, 2015. NMFS reminds vessels fishing in the NED that they now must account for any bluefin bycatch retained or discarded dead using IBQ allocation available to the vessel and that any quota debt remaining at the end of 2015 will carry over to 2016.

    DATES:

    Effective November 18, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Tom Warren or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

    Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of bluefin tuna by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. bluefin tuna quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014).

    The U.S. bluefin tuna annual quota from the International Commission for the Conservation of Atlantic Tunas (ICCAT) includes, as in previous years, a 25-mt set-aside for bluefin tuna bycatch related to longline fisheries operating in the vicinity of the ICCAT management area boundary. See ICCAT Recommendation 14-05; and 80 FR 52198, (August 28, 2015) (implementing the quota domestically). For management and monitoring purposes, NMFS implements this set-aside in the NED gear restricted area as quota available to Atlantic Longline category permitted vessels. Longline is not a permitted gear for directed fishing on bluefin tuna; any catch must be incidental to fishing for other species. Accounting for this bycatch includes all catch (landings and dead discards). The NED is the Atlantic Ocean area bounded by straight lines connecting the following coordinates in the order stated: 35°00′ N. lat., 60°00′ W. long.; 55°00′ N. lat., 60°00′ W. long.; 55°00′ N. lat., 20°00′ W. long.; 35°00′ N. lat., 20°00′ W. long.; 35°00′ N. lat., 60°00′ W. long.

    The IBQ Program and the Northeast Distant Area (NED)

    Under Amendment 7 (79 FR 71510, December 2, 2014), new rules were implemented for Longline category vessels fishing in the NED. See 50 CFR 635.15(b)(8). Any bluefin tuna bycatch by permitted vessels fishing with pelagic longline gear in the NED counts toward the ICCAT-allocated separate NED quota (25 mt), until that quota has been filled. During that period, the bluefin tuna accounting requirements of the IBQ Program do not apply to those vessels. Once the NED quota is filled, Longline category permitted vessels may fish or continue to fish in the NED, but the permitted vessels must then abide by the applicable requirements of the IBQ program, which requires individual vessel accounting for bluefin tuna bycatch using quota allocation available to the vessel (either through its own quota share or leasing allocation from another vessel). Bluefin tuna must be accounted for as described at § 635.15(b)(4) and (5).

    Based on Atlantic bluefin tuna dealer data and IBQ system data, as of November 10, 2015, 33,484 lb (15.2 mt) of bluefin tuna has been landed, and 90 lb (<0.1 mt) of bluefin tuna has been discarded dead in the NED; an additional 36 bluefin tuna have been reported as retained through Vessel Monitoring System (VMS) bluefin tuna catch reports. These 36 retained bluefin tuna reported via VMS equate to approximately 17,460 lb (7.9 mt) of additional catch, which brings the total estimated bluefin tuna catch from the NED to 51,034 lb (23.2 mt). Based on this data, NMFS has determined that the 25 mt set-aside will be filled on November 12, 2015.

    Because the NED the quota has been reached, vessels are notified that they must account for any bycatch of bluefin tuna (landings and/or dead discards) in the NED using IBQ allocation as specified in the regulations at § 635.15(b)(8). Vessel owners will have to account retroactively for their bluefin tuna bycatch with IBQ to the date that the separate quota was reached. NMFS currently anticipates that date will be November 12, 2015, but will notify relevant vessel owners of the precise date when we have complete NED catch data.

    With respect to quota accounting for the fishery as whole, bluefin bycatch (landings and dead discards) from the NED beyond the 25 mt set-aside will count toward the Longline category annual baseline subquota. For 2015, NMFS delayed certain regulatory requirements requiring vessels with pelagic longline gear to have a minimum amount of IBQ quota before departing on fishing trips, thus allowing such vessels to fish with pelagic longline gear even if they have quota debt. However, we specified that quota debt will accrue throughout the 2015 fishing year, and vessels will be responsible for accounting for all of their bluefin bycatch at the end of the year. If, by the end of 2015, a permit holder does not have adequate IBQ allocation to settle their vessel's quota debt, the vessel's allocation will be reduced in the amount equal to the quota debt in the subsequent year or years until the quota debt is fully accounted for. Vessels with a negative balance will have to satisfy the quota debt before departing on any trips in 2016.

    NMFS will continue to monitor bluefin tuna bycatch by vessels fishing with pelagic longline gear using VMS and dealer data, as well as monitor the accounting for such catch in the IBQ system, to ensure that vessels are accountable for their bluefin bycatch and that quotas are managed consistent with the 2006 Consolidated HMS FMP and our international quota obligations. For fishery updates, fishermen may call the Atlantic Tunas Information Line at (888) 872-8862 or (978) 281-9260, access the following internet address: www.hmspermits.gov.

    Authority:

    16 U.S.C. 971 et seq. and 1801 et seq.

    Dated: November 12, 2015. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-29400 Filed 11-13-15; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 140214140-5999-01] RIN 0648-BD92 Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Seabird Avoidance Measures AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule implements a Seabird Avoidance Program in the Pacific Coast Groundfish Fishery. The rule was recommended by the Pacific Fishery Management Council (Council) in November 2013 to minimize the take of ESA-listed short-tailed albatross (Phoebastria albatrus). A 2012 U.S. Fish and Wildlife Service (USFWS) Biological Opinion (Opinion) required NMFS to initiate implementation of regulations within 2 years that mandate the use of seabird avoidance measures by vessels greater than or equal to 55 feet length overall (LOA) using bottom longline gear to harvest groundfish. The seabird avoidance measures, including streamer lines that deter birds from ingesting baited hooks, are modeled after a similar regulatory program in effect for the Alaskan groundfish fishery.

    DATES:

    Effective on December 18, 2015.

    ADDRESSES:

    Information relevant to this final rule, which includes a final environmental assessment (EA), are available from William W. Stelle, Jr., Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070. Electronic copies of this final rule are also available at the NMFS West Coast Region Web site: http://www.westcoast.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Williams, 206-526-4646; (fax) 206-526-6736; [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The purpose of this rule is to reduce interactions between ESA-listed seabirds and groundfish longline gear. This final rule amends the regulations governing the Pacific Coast Groundfish Fishery (fishery) to require seabird avoidance measures—specifically, the use of streamer lines and related provisions similar to those currently mandated in the Alaskan groundfish fishery—by vessels 55 ft LOA or greater in the bottom longline fishery.

    This rule is needed to minimize takes of endangered short-tailed albatross and comply with a 2012 Biological Opinion (Opinion) issued by the U.S. Fish and Wildlife Service.

    In sum, the rule:

    • Requires the use of streamer lines in the commercial longline fishery of the Pacific Coast Groundfish Fishery for non-tribal vessels 55 feet in length or greater;

    • Requires vessels to deploy one or two streamer lines depending on the type of longline gear being set;

    • Requires that streamer lines meet technical specifications and be available for inspection; and

    • Allows for a rough weather exemption from using streamer lines for safety purposes. The threshold for the rough weather exemption is a Gale Warning as issued by the National Weather Service.

    The rule is designed to be consistent with the requirements of the Opinion and responsive to issues raised through the public process and consultation with experts.

    Comments and Responses

    NMFS solicited public comment on the proposed seabird avoidance measures (79 FR 53401, September 9, 2014). The comment period ended October 9, 2014. NMFS received seven comment letters from individuals or organizations. The letters are available in their entirety from NMFS (see ADDRESSES) or at the following web address: http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=NOAA-NMFS-2014-0099. For clarity in responding, comments have been organized into the following categories, which are addressed in turn below: Monitoring, Gear Specification and Performance, Scope, Environmental Assessment, and Other.

    Monitoring

    Comment 1: Observers or Electronic Monitoring should be used to monitor compliance with performance and materials standards in order for the seabird avoidance regulations to be effective.

    Response: NMFS agrees. The West Coast Groundfish Observer Program (WCGOP) developed and implemented a sampling protocol in 2009 and 2010 to characterize the longline fleet and its use of seabird avoidance gear. The protocol was designed to provide data on the types of streamer lines being deployed and the performance of the streamers insofar as it can be determined visually. For example, observers recorded the number of streamer lines deployed; where the streamer lines were deployed relative to sinking hooks; the deployment of towed objects on the end of streamer lines; the extent of streamer lines relative to the water surface; the number of streamers on each line; the color and material of the streamers; the distance between streamers; the distance from the stern to the first streamer; and a range of measurements associated with the design and performance of streamer lines. The information can be used by managers to assess the performance of streamer lines at sea. Observers currently record the type of seabird avoidance gear being used. In 2015, this will include a distinction between single and double streamer lines. Observers also record the catch of seabirds which is the ultimate determinant of the performance of seabird avoidance measures. In response to this comment and the ongoing need to characterize the use of seabird avoidance gear, WCGOP will refine the sampling protocol for implementation in 2016 or earlier as opportunity allows.

    Comment 2: NMFS should use either human observers or electronic means to monitor seabird interactions in the at-sea hake fishery because there is a high overlap of fishing areas with albatross occurrence; and, the fleet's practice of continuous offal discharge may attract birds. It is known that bird strikes with trawl cables cause high mortality of albatross in other regions.

    Response: As described in the BiOp, seabirds are attracted to offal plumes and can strike trawl cables, sonar cables, or become entangled on nets at or near the surface. Such interactions are unlikely to be detected as they do not show up on the deck to be sampled under normal observer protocols. NMFS agrees with the need to characterize seabird mortality in the at-sea hake fishery and is committed to developing a monitoring plan; however, there are significant issues associated with both the observer program and electronic monitoring that make it premature to choose a specific course of action at this time.

    Regarding the observer program, observer duties are carefully prescribed according to priorities developed to support fishery management decisions. The main priority is to monitor catch composition—including seabirds that come up with the trawl. Each processing vessel carries two observers. Observers subsample the catch to collect data used to estimate catch composition. In addition, the observers collect biological data from groundfish, protected species including seabirds, and prohibited species. Observers are required to be in the factory, below deck, for the majority of their sampling. Observation of trawl and sonar cables would occur on deck and take a significant amount of time away from catch composition sampling.

    Electronic monitoring is in a developmental stage for West Coast groundfish fisheries and significant research is necessary before it is practicable to apply to seabird monitoring in the at-sea hake fishery. Similar to observers, electronic monitoring is being developed to monitor catch composition. There have not been formal investigations into the effectiveness and practicability of training cameras away from the deck to monitor trawl and sonar cables.

    NMFS will pursue a monitoring plan by working through the Council and its appropriate committees, such as the Council's ESA Working Group that was established specifically to implement the Opinion; and, ad hoc committees composed to advise the Council on the development of electronic monitoring. Such committees offer a formal opportunity to engage the Council in monitoring and conservation issues and is the most appropriate opportunity to develop an effective and practicable monitoring plan.

    Comment 3: Observers should record wind speed to associate weather data with seabird interactions in order to assess impacts associated with the rough weather exemption.

    Response: NMFS agrees. Observers currently record weather conditions using the Beaufort scale for any sighting or take of an ESA-listed species, including short-tailed albatross. Weather observations are currently made at the time the observer encounters the animal which, in longline fisheries, is usually during the retrieval of gear. The weather conditions during retrieval may be different from when the mortality event occurred, which is typically as gear is being set. For this reason, and in response to this comment, NMFS will modify WCGOP sampling protocols so that observers record weather conditions as longlines are being set for at least a subset of hauls. The modified protocol may not be fully effective until 2016 due to program logistics.

    Comment 4: NMFS should monitor the free streamer line program to determine if lines are being used properly, ensure plastic components of the streamer lines are not illegally discarded at sea, and to avoid wasteful spending of U.S. tax dollars that are funding the program.

    Response: NMFS agrees. Consistent with the response to Comment 1 above, observers are monitoring the performance of streamer lines at sea. Observers also monitor for violations of the International Convention for the Prevention of Pollution from Ships (MARPOL) that prohibits the at-sea disposal of all plastics. Observers document compliance infractions and suspected violations in their logbook and complete a written statement during debriefing.

    Gear Specification and Performance

    Comment 5: NMFS should exempt the requirement to use streamer lines during longline sets that take place at night. Based on 20 years of personal experience, I have never encountered a seabird on a night set. Requiring streamer lines during night sets imposes a safety risk and inconvenience without reducing seabird mortality.

    Response: To address this comment, NMFS conducted an analysis to determine if seabird catch rates differ when the longline gear is set in the dark versus the light. The analysis shows a reduction in the seabird bycatch when the gear is set at night and could provide an option for fishermen to not use streamer lines at night in the future. At this time, NMFS has determined that providing a night-setting exemption is outside the scope of the proposed rule. NMFS received comments from the Council on including an exemption for night setting, including comments from the U.S. Coast Guard representative, which supported the exemption but requested further investigation into an exemption rather than inclusion in the regulations at this time.

    Comment 6: The proposed rule is inadequate and ineffective as a seabird bycatch mitigation measure. Best practices, as adopted by the Agreement on the Conservation of Albatrosses and Petrels (ACAP), do not support only using streamer lines to deter seabirds. Streamer lines should be used in conjunction with other measures such as weighting the line to maximize sink rates; actively deterring birds from baited hooks by using bird scaring lines; and, setting at night.

    Response: NMFS disagrees that the proposed rule is inadequate; however, NMFS agrees that the full range of best practices described by ACAP is an important component of effective seabird conservation. NMFS and the Council considered alternatives that would have implemented the full suite of ACAP best practices in the EA (see ADDRESSES). The measures described in the comment (other than streamer lines) are being pursued by non-regulatory means. NMFS and partner organizations are working with fishermen to encourage voluntary implementation of measures consistent with ACAP best practices, including sinking hooks quickly, night setting, and managing discharge of offal and bait. Fishermen on the West Coast have a significant incentive to avoid seabirds in order to ensure baited hooks are available to catch fish. A hook with a seabird on it precludes that opportunity and impacts the profitability of fishing operations. For this reason and as analyzed in the EA, NMFS and the Council determined that a non-regulatory approach to the full suite of best practices was the most appropriate at this time. This does not preclude regulatory approaches in the future should monitoring indicate that voluntary efforts are not sufficient. To that end, NMFS has worked to establish the ESA Working Group to consider new information and formulate advice on adaptive management to the Council.

    Comment 7: The proposed streamer line specifications are inadequate and ineffective. The specifications used under the Convention on the Conservation of Antarctic Marine Living Resources (CCAMLR) should be adopted, including: (1) Minimum of height at stern of 7 m; (2) minimum streamer line length of 150 m and the use of a drogue; (3) no rough weather exemption; and, (4) the aerial extent of streamer lines should be stipulated as a performance standard (100 m is suggested).

    Response: NMFS disagrees that the proposed streamer line specifications are inadequate and ineffective. The CCAMLR regulations reflect the development of seabird avoidance measures designed for the specific fisheries and seabird assemblages. The sub-Antarctic fisheries governed under CCAMLR include primarily Patagonia toothfish (Dissostichus eleginoides), which is fished with the Spanish method of bottom longlining, where the gear is more buoyant than that used on the West Coast. The majority of the vessels are large (30-50 m) and deploy gear from the stern at speeds of 10-13 knots. The prevalent seabirds incidentally taken are albatrosses and petrels species, many of which dive to foraging depths that are substantially deeper than the North Pacific albatross and other species that occur off the West Coast.

    In contrast, West Coast groundfish fisheries target primarily sablefish, which is a demersal species fished with bottom gear consisting of groundlines to which relatively short gangions are attached. In general, vessels deploy gear from the stern. The prevalent seabird species incidentally taken are fulmars, gulls, and albatrosses.

    The CCAMLR streamer line specifications are designed to provide more aerial coverage than is necessary or appropriate for West Coast groundfish fisheries. The minimum stern height, line length, and aerial extent specifications cover a greater area because longlines used in those fisheries are more buoyant and extend further behind the vessel than occurs in fisheries covered under this rule, and because the seabird species taken in CCAMLR fisheries dive to deeper depths than those on the West Coast. The specifications in this rule were recommended based on extensive research that demonstrated them to be effective in Alaskan groundfish fisheries, where the targeted fish species, vessels, and seabirds are similar and, in some cases, identical. More information on this research and the effectiveness of the streamer line specification in this final rule is available in the Opinion or EA (see ADDRESSES).

    NMFS notes however that preliminary research by Washington Sea Grant indicates that some vessels in West Coast groundfish fisheries are using floats on gangions to avoid predation by non-marketable bottom fish (i.e., hagfish). The floats may reduce the effectiveness of these streamer line specifications by keeping baited hooks in the water column past the extent of streamer lines. It is unclear at this time how widespread the use of floats is, how much it influences seabird catch rates, and what alternatives are appropriate if floats are determined to be a significant issue affecting seabird catch rates. Because the research is preliminary, and because the streamer line specifications in this final rule have been demonstrated to be effective in reducing seabird mortality and are required by the Opinion, NMFS is finalizing this rule and will continue to monitor its effectiveness to determine if future changes are warranted. NMFS is also continuing to support Washington Sea Grant in conducting this research and has worked to establish the ESA Working Group to consider new information and formulate advice on adaptive management to the Council.

    Comment 8: Vessels should not be permitted to take excessive numbers of seabirds. Vessels should be required to move to night setting for the remainder of the fishing season if seabird bycatch exceeds 0.01 seabirds per 1000 hooks in a set, or until the vessel is able to demonstrate a line sink rate of a minimum of 0.3 m/second to 15 m depth. Applying a performance standard quickly halts lax and ineffective fishing practices.

    Response: A system does not currently exist within NMFS to hold individual vessels accountable for seabird mortality in real time. Similarly, it is not feasible for NMFS to monitor and enforce sink rates of longline gear on individual vessels. More importantly, NMFS does not believe such a system is necessary given that the final regulations are designed to effectively reduce seabird bycatch in the fleet where most of the seabirds are taken.

    Scope of the Regulations

    Comment 9: Vessels smaller than 55 ft should be required to use seabird avoidance measures to minimize the chance that such vessels will take ESA-listed short-tailed albatross and other seabirds.

    Response: NMFS agrees that there may be a risk to short-tailed albatross from longline vessels under 55 ft; however, it would be premature to require that they use seabird avoidance gear at this time. The Opinion specifies that this rule apply to larger vessels for the following reasons: (1) Vessels under 55 ft have not been observed to interact with short-tailed albatross; (2) vessels under 55 ft are being encouraged through formal outreach described in the EA (see ADDRESSES) to deploy seabird avoidance measures on a voluntary basis; and, (3) NMFS does not have an appropriate technical specification for streamer lines proven to be safe for smaller vessels. To address the latter, Washington Sea Grant is conducting research to determine safe and effective seabird avoidance measures for vessels under 55 ft. In limiting the requirement specified in the Opinion to vessels 55 ft and over, USFWS further required NMFS to adapt management as appropriate in response to that research and ongoing monitoring. NMFS is committed to review new information as it becomes available to determine if these regulations should be adapted to cover smaller vessels. To that end, NMFS has worked to establish the ESA Working Group to consider new information and formulate advice on adaptive management to the Council.

    Comment 10: NMFS should require that seabird avoidance measures be deployed in the at-sea hake fishery because there is a high overlap of fishing areas with albatross occurrence and the fleet's practice of continuous offal discharge that may attract birds. It is known that bird strikes with trawl cables cause high mortality of albatross in other regions.

    Response: NMFS agrees that there is a potential threat to seabirds associated with the at-sea hake fishery; however, it is premature to regulate that fishery at this time. As described in the response to Comment 2 above, NMFS will pursue a monitoring plan to assess the level of threat and appropriate responses. Regulating the at-sea hake fishery is outside the scope of this rule, which is focused on implementing requirements stipulated by USFWS in the Opinion. USFWS recognized the potential for interaction between seabirds and the at-sea hake fishery but determined that the focus of seabird avoidance measures should be the longline fleet. In doing so, USFWS further required NMFS to adapt management as appropriate in response to new information. NMFS is committed to reviewing new information as it becomes available to determine if these regulations should be adapted to other fisheries such as the at-sea hake fishery. To that end, NMFS has worked to establish the ESA Working Group to consider new information and formulate advice on adaptive management to the Council.

    Environmental Assessment

    Comment 11: The EA must analyze whether short-tailed albatross are at higher risk of entanglement during high wind events.

    Response: NMFS agrees. The EA, in Section 4.1.1, acknowledges the uncertainty regarding seabird behavior during rough weather and concludes the exemption is not expected to significantly influence the overall reduction in seabird bycatch. NMFS is not aware of additional information pertinent to assessing the effects of rough weather on seabird encounters by longline vessels but will continue to monitor observer data and adapt management as new information becomes available. To that end, NMFS has worked to establish the ESA Working Group to consider new information and formulate advice on adaptive management to the Council.

    Comment 12: The EA does not adequately assess the effects of vessels under 55 ft on short-tailed albatross.

    Response: NMFS disagrees. Consistent with the response to Comment 9, the EA acknowledges there may be a risk to short-tailed albatross from vessels under 55 ft and incorporates voluntary conservation and ongoing research into analysis of the status quo alternative (See ADDRESSES).

    Other

    Comment 13: The groundfish fishery operates in important seabird foraging habitat as well as critical habitat of leatherback sea turtles and green sturgeon. Streamer lines may have unintended consequences if they are lost overboard. Streamers should be made of plant-based materials in order to minimize the biological risks associated with ingestion by marine animals.

    Response: In response to this comment, NMFS consulted with NOAA's Marine Debris Program to determine if there is evidence for streamer lines as marine debris in areas such as Alaska and Hawaii, where there are existing requirements for longline vessels to use them. Streamers (the plastic component of streamer lines) have been observed during shoreline clean-ups in Alaska; however, the quantity relative to other marine debris is very low. Reports from shoreline cleanups in Hawaii have not noted the presence of streamers. Given the low incidence of observed streamers, it would not be reasonable to change design specifications at this time. Streamer lines are constructed of materials, including plastics, sufficient to withstand at-sea conditions. A change in the material specifications would require significant research to ensure streamer lines would continue to function by reducing seabird entanglement. Such research is not practicable at this time. NMFS notes that intentional disposal at sea is unlikely because fishermen are subject to MARPOL, which prohibits the at-sea disposal of plastics.

    Comment 14: NMFS should ensure authorization of fisheries complies with the Migratory Bird Treaty Act (MBTA).

    Response: NMFS agrees. The final regulations are consistent with the MBTA.

    Comment 15: NMFS should provide, and crewmembers should be required to attend, workshops to identify and distinguish short-tailed albatross from other albatrosses and also to safely release live short-tailed albatrosses.

    Response: NMFS agrees that education and outreach is an important component of seabird conservation; however, NMFS disagrees that it should be required. NMFS has provided funding for Washington Sea Grant to conduct outreach that has included mailings to all fixed-gear permit holders, port meetings with fishermen, an internet site, and educational exhibits at trade shows. The material includes information on seabird avoidance, species identification, and how to handle hooked albatross. NMFS believes that these efforts have been successful in educating fishermen on issues related to seabird bycatch.

    Comment 16: A number of commenters were in support of the proposed regulations.

    Response: NMFS acknowledges this comment.

    Changes from the Proposed Rule

    There are no substantial changes from the proposed rule. NMFS made one modification to re-locate the regulatory text so that it is grouped with other groundfish regulations. The goal of this change is to locate the seabird avoidance program regulations near other programs that apply to multiple sectors of the groundfish fishery.

    Classification

    Pursuant to section 304(b)(1)(A) of the MSA, the NMFS Assistant Administrator has determined that this final rule is consistent with the Pacific Coast Groundfish FMP, other provisions of the MSA, and other applicable law.

    NMFS and the Council prepared a final Environmental Assessment (EA) for this regulation and concluded that there would not be a significant impact on the human environment as a result of this rule. A copy of the EA is available from NMFS (see ADDRESSES).

    This final rule has been determined to be not significant for purposes of Executive Order 12866.

    The Regulatory Flexibility Act requires Federal agencies to conduct a full RFAA unless the agency can certify that the proposed and/or final rule would not have a significant economic impact on a substantial number of small entities.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

    Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a public notice that also serves as small entity compliance guide (the guide) was prepared. Copies of this final rule are available from the West Coast Regional Office, and the guide will be posted on the NMFS West Coast Region Web site and emailed to the groundfish fishery listserve. The guide and this final rule will be available upon request.

    NMFS issued Biological Opinions under the Endangered Species Act (ESA) on August 10, 1990, November 26, 1991, August 28, 1992, September 27, 1993, May 14, 1996, and December 15, 1999, pertaining to the effects of the Groundfish FMP fisheries on Chinook salmon (Puget Sound, Snake River spring/summer, Snake River fall, upper Columbia River spring, lower Columbia River, upper Willamette River, Sacramento River winter, Central Valley spring, California coastal), coho salmon (Central California coastal, southern Oregon/northern California coastal), chum salmon (Hood Canal summer, Columbia River), sockeye salmon (Snake River, Ozette Lake), and steelhead (upper, middle and lower Columbia River, Snake River Basin, upper Willamette River, central California coast, California Central Valley, south/central California, northern California, southern California). These biological opinions have concluded that implementation of the FMP is not expected to jeopardize the continued existence of any endangered or threatened species under the jurisdiction of NMFS, or result in the destruction or adverse modification of critical habitat.

    NMFS issued a Supplemental Biological Opinion on March 11, 2006, concluding that neither the higher observed bycatch of Chinook in the 2005 whiting fishery nor new data regarding salmon bycatch in the groundfish bottom trawl fishery required a reconsideration of its prior “no jeopardy” conclusion. NMFS also reaffirmed its prior determination that implementation of the FMP is not likely to jeopardize the continued existence of any of the affected ESUs. Lower Columbia River coho (70 FR 37160, June 28, 2005) and Oregon Coastal coho (73 FR 7816, February 11, 2008) were relisted as threatened under the ESA. The 1999 biological opinion concluded that the bycatch of salmonids in the Pacific whiting fishery were almost entirely Chinook salmon, with little or no bycatch of coho, chum, sockeye, and steelhead.

    On December 7, 2012, NMFS completed a biological opinion concluding that the groundfish fishery is not likely to jeopardize non-salmonid marine species including listed eulachon, green sturgeon, humpback whales, Steller sea lions, and leatherback sea turtles. The opinion also concluded that the fishery is not likely to adversely modify critical habitat for green sturgeon and leatherback sea turtles. An analysis included in the same document as the opinion concluded that the fishery is not likely to adversely affect green sea turtles, olive ridley sea turtles, loggerhead sea turtles, sei whales, North Pacific right whales, blue whales, fin whales, sperm whales, Southern Resident killer whales, Guadalupe fur seals, or the critical habitat for Steller sea lions.

    West Coast pot fisheries for sablefish are considered Category II fisheries under the Marine Mammal Protection Act (MMPA), indicating occasional interactions. All other West Coast groundfish fisheries, including the trawl fishery, are considered Category III fisheries under the MMPA, indicating a remote likelihood of or no known serious injuries or mortalities to marine mammals. MMPA section 101(a)(5)(E) requires that NMFS authorize the taking of ESA-listed marine mammals incidental to U.S. commercial fisheries if it makes the requisite findings, including a finding that the incidental mortality and serious injury from commercial fisheries will have a negligible impact on the affected species or stock. As noted above, NMFS concluded in its biological opinion for the 2012 groundfish fisheries that these fisheries were not likely to jeopardize Steller sea lions or humpback whales. The eastern distinct population segment of Steller sea lions was delisted under the ESA on November 4, 2013 (78 FR 66140). On September 4, 2013, based on its negligible impact determination dated August 28, 2013, NMFS issued a permit for a period of 3 years to authorize the incidental taking of humpback whales by the sablefish pot fishery (78 FR 54553).

    NMFS has reinitiated section 7 consultation on the Pacific Coast Groundfish FMP with respect to its effects on listed salmonids. In the event the consultation identifies either reasonable and prudent alternatives to address jeopardy concerns, or reasonable and prudent measures to minimize incidental take, NMFS would coordinate with the Council to put additional alternatives or measures into place, as required. After reviewing the available information, NMFS has concluded that, consistent with sections 7(a)(2) and 7(d) of the ESA, this action will not jeopardize any listed species, would not adversely modify any designated critical habitat, and will not result in any irreversible or irretrievable commitment of resources that would have the effect of foreclosing the formulation or implementation of any reasonable and prudent alternative measures.

    On November 21, 2012, the U.S. Fish and Wildlife Service (FWS) issued a biological opinion concluding that the groundfish fishery will not jeopardize the continued existence of the short-tailed albatross. The 2012 Opinion evaluated the risks of continued operation of the Pacific Coast groundfish fishery on ESA-listed seabirds, including short-tailed albatross. The 2012 Opinion included a Term and Condition requiring NMFS to promulgate regulations mandating the use of streamer lines by longline vessels 55 feet LOA or greater, patterned on the Alaska streamer line regulations. Accordingly, for the fishery to be exempt from the ESA section 9 prohibition regarding take of a listed species, NMFS must initiate implementation of streamer line regulations by November 21, 2014. The 2012 Opinion anticipates the yearly average take of one short-tailed albatross killed from longline hooks or trawl cables. As the short-tailed albatross population is expanding, it is expected to result in more interactions with the Pacific Coast Groundfish Fisheries. This action would implement one of the Terms and Conditions of the 2012 Opinion and reduce the risk of exceeding the take limits of short-tailed albatross, which in turn would reduce the risk of economic harm to the fishing industry that could result from the incidental take limit being exceeded. The FWS also concurred that the fishery is not likely to adversely affect the marbled murrelet, California least tern, southern sea otter, bull trout, or bull trout critical habitat.

    This final rule does not contain a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA).

    This final rule was developed after meaningful collaboration, through the Council process, with the tribal representative on the Council. The regulations have no direct effect on the tribes and were deemed by the Council as “necessary or appropriate” to implement the FMP as amended.

    List of Subjects in 50 CFR Part 660

    Administrative practice and procedure, American Samoa, Fisheries, Fishing, Guam, Hawaiian natives, Indians, Northern Mariana Islands, Reporting and recordkeeping requirements.

    Dated: November 10, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons stated in the preamble, 50 CFR part 660 is amended as follows:

    PART 660—FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

    2. In § 660.11, add paragraph (6)(i)(A) and reserved paragraph (6)(i)(B) to the definition of “Fishing gear” and add the definition for “Seabird” in alphabetical order to read as follows:
    § 660.11 General definitions.

    Fishing gear * * *

    (6) * * *

    (i) * * *

    (A) Snap gear means a type of bottom longline gear where the hook and gangion are attached to the groundline using a mechanical fastener or snap.

    (B) [Reserved]

    Seabird means those bird species that habitually obtain their food from the sea below the low water mark.

    3. In § 660.12, add paragraph (a)(15) to read as follows:
    § 660.12 General groundfish prohibitions.

    (a) * * *

    (15) Fail to comply with the requirements of the Seabird Avoidance Program described in § 660.21 when commercial fishing for groundfish using bottom longline gear.

    4. Add § 660.21 to read as follows:
    § 660.21 Seabird Avoidance Program.

    This section contains the requirements of the Seabird Avoidance Program.

    (a) Purpose. The purpose of the Seabird Avoidance Program is to minimize interactions between fishing gear and seabird species, including short-tailed albatross (Phoebastria albatrus).

    (b) Applicability. The requirements specified in paragraph (c) of this section apply to the following fishing vessels:

    (1) Vessels greater than or equal to 55 ft (16.8 m) LOA engaged in commercial fishing for groundfish with bottom longline gear as defined in § 660.11 pursuant to the gear switching provisions of the Limited Entry Trawl Fishery, Shorebased IFQ Program as specified in § 660.140(k), or pursuant to Subparts E or F of this Part, except as provided in paragraph (b)(2) of this section.

    (2) Exemptions. The requirements specified in paragraph (c) of this section do not apply to Pacific Coast treaty Indian fisheries, as described at § 660.50, or to anglers engaged in recreational fishing for groundfish, as described in Subpart G of this Part.

    (c) Seabird Avoidance Requirements—(1) General Requirements. The operator of a vessel described in paragraph (b)(1) of this section must:

    (i) Gear onboard. Have onboard the vessel seabird avoidance gear as specified in paragraph (c)(2) of this section.

    (ii) Gear inspection. Upon request by an authorized officer or observer, make the seabird avoidance gear available for inspection.

    (iii) Gear use. Use seabird avoidance gear as specified in paragraph (c)(2) of this section that meets the standards specified in paragraph (c)(3) of this section while bottom longline and snap gears are being deployed.

    (iv) Handling of hooked short-tailed albatross.

    (A) Safe release of live short-tailed albatross. Make every reasonable effort to ensure short-tailed albatross brought on board alive are released alive and that, whenever possible, hooks are removed without jeopardizing the life of the bird(s). If the vessel operator determines, based on personal judgment, that an injured bird is likely to die upon release, the vessel operator is encouraged to seek veterinary care in port. Final disposition of an injured bird will be with a Wildlife Rehabilitator. If needed, phone the U.S. Fish and Wildlife Service at 503-231-6179 to assist in locating a qualified Wildlife Rehabilitator to care for the short-tailed albatross.

    (B) Dead short-tailed albatross must be kept as cold as practicable while the vessel is at sea and frozen as soon as practicable upon return to port. Carcasses must be labeled with the name of vessel, location of hooking in latitude and longitude, and the number and color of any leg band if present on the bird. Leg bands must be left attached to the bird. Phone the U.S. Fish and Wildlife Service at 503-231-6179 to arrange for the disposition of dead short-tailed albatross.

    (C) All hooked short-tailed albatross must be reported to U.S. Fish and Wildlife Service Law Enforcement by the vessel operator by phoning 360-753-7764 (WA); 503-682-6131 (OR); or 916-414-6660 (CA) as soon as practicable upon the vessel's return to port.

    (D) If a NMFS observer is on board at the time of a hooking event, the observer shall be responsible for the disposition of any captured short-tailed albatross and for reporting to U.S. Fish and Wildlife Service Law Enforcement Otherwise, the vessel operator shall be responsible.

    (2) Gear Requirements. The operator of a vessel identified in paragraph (b)(1) of this section must comply with the following gear requirements:

    (i) Snap gear. Vessels using snap gear as defined at § 660.11 must deploy a minimum of a single streamer line in accordance with the requirements of paragraphs (c)(3)(i) through (ii) of this section, except as provided in paragraph (c)(2)(iii) of this section.

    (ii) Bottom longline. Vessels using bottom longline gear must deploy streamer lines in accordance with the requirements of paragraphs (c)(3)(i) and (iii) of this section, except as provided in paragraph (c)(2)(iii) of this section.

    (iii) Weather Safety Exemption. Vessels are exempted from the requirements of paragraph (c)(1)(iii) of this section when a National Weather Service Gale Warning is in effect. This exemption applies only during the time and within the area indicated in the National Weather Service Gale Warning.

    (3) Gear performance and material standards. (i) Material standards for all streamer lines. All streamer lines must:

    (A) Have streamers spaced a maximum of every 16 ft 5 in (5 m).

    (B) Have individual streamers that hang attached to the mainline to 10 in (0.25 m) above the waterline in the absence of wind.

    (C) Have streamers constructed of material that is brightly colored, UV-protected plastic tubing or 3/8 inch polyester line or material of an equivalent density.

    (ii) Snap gear streamer line standards. For vessels using snap gear, a streamer line must:

    (A) Be a minimum length of 147 ft 7 in (45 m).

    (B) Be deployed so that streamers are in the air a minimum of 65 ft 7 in (20 m) aft of the stern and within 6 ft 7 in (2 m) horizontally of the point where the main groundline enters the water before the first hook is set.

    (iii) Bottom longline streamer line standards. Vessels using bottom longline gear but not snap gear must use paired streamer lines meeting the following requirements:

    (A) Streamer lines must be a minimum length of 300 feet (91.4 m).

    (B) Streamer lines must be deployed so that streamers are in the air a minimum of 131 ft (40m) aft of the stern for vessels under 100 ft (30.5 m) LOA and 197 ft (60m) aft of the stern for vessels 100 ft (30.5 m) or over.

    (C) At least one streamer line must be deployed in accordance with paragraph (c)(3)(iii)(B) before the first hook is set and a second streamer line must be deployed within 90 seconds thereafter.

    (D) For vessels deploying bottom longline gear from the stern, the streamer lines must be deployed from the stern, one on each side of the main groundline.

    (E) For vessels deploying bottom longline gear from the side, the streamer lines must be deployed from the stern, one over the main groundline and the other on one side of the main groundline.

    5. In § 660.140, revise paragraph (k)(1)(iv) to read as follows:
    § 660.140 Shorebased IFQ Program.

    (k) * * *

    (1) * * *

    (iv) The vessel must comply with prohibitions applicable to the limited entry fixed gear fishery as specified at § 660.212, gear restrictions applicable to limited entry fixed gear as specified in §§ 660.219 and 660.230(b), and management measures specified in § 660.230(d), including restrictions on the fixed gear allowed onboard, its usage, and applicable fixed gear groundfish conservation area restrictions, except that the vessel will not be subject to limited entry fixed gear trip limits when fishing in the Shorebased IFQ Program. Vessels using bottom longline and snap gears as defined at § 660.11 are subject to the requirements of the Seabird Avoidance Program described in § 660.21.

    6. In § 660.230, add paragraph (b)(5) to read as follows:
    § 660.230 Fixed gear fishery-management measures.

    (b) * * *

    (5) Vessels fishing with bottom longline and snap gears as defined at § 660.11 are subject to the requirements of the Seabird Avoidance Program described in § 660.21.

    7. In § 660.330, revise paragraph (b)(2)(i) to read as follows:
    § 660.330 Open access fishery-management measures.

    (b) * * *

    (2) * * *

    (i) Fixed gear (longline, trap or pot, set net and stationary hook-and-line gear, including commercial vertical hook-and-line gear) must be attended at least once every 7 days. Vessels fishing with bottom longline and snap gears as defined at § 660.11 are subject to the requirements of the Seabird Avoidance Program described in § 660.21.

    [FR Doc. 2015-29249 Filed 11-17-15; 8:45 am] BILLING CODE 3510-22-P
    80 222 Wednesday, November 18, 2015 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0186] RIN 3150-AJ65 List of Approved Spent Fuel Storage Casks: NAC International, Inc., MAGNASTOR ® Cask System; Certificate of Compliance No. 1031, Amendment Nos. 0-3, Revision 1 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the NAC International, Inc. (NAC), MAGNASTOR® Cask System listing within the “List of approved spent fuel storage casks” to include Revision 1 to Amendment Nos. 0 (the initial Certificate), 1, 2 and 3 to Certificate of Compliance (CoC) No. 1031. Revision 1 to Amendment Nos. 0-3 to CoC No. 1031 makes changes to the Technical Specifications (TSs), including correcting a typographical error in two actual boron loadings in TS 4.1.1(a), and revising the decay times in Tables B2-4 (for Amendment Nos. 0 and 1) and B2-5 (for Amendment Nos. 2 and 3) in Appendix B of the TSs for minimum additional decay time required for spent fuel assemblies that contain nonfuel hardware.

    DATES:

    Submit comments by December 18, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0186. Address questions about NRC dockets to Carol Gallagher, telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at (301) 415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-3781; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0186 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:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0186.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2015-0186 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Procedural Background

    This proposed rule is limited to the changes contained in Revision 1 to Amendment Nos. 0-3, to CoC No. 1031 and does not include other aspects of the NAC MAGNASTOR® Cask System. Because the NRC considers this action noncontroversial and routine, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register. Adequate protection of public health and safety continues to be ensured. The direct final rule will become effective on February 1, 2016. However, if the NRC receives significant adverse comments on this proposed rule by December 18, 2015, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to these proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or TSs.

    For additional procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the Federal Register.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs.

    The NRC issued a final rule on November 21, 2008 (73 FR 70587), that approved the NAC MAGNASTOR® Cask System design to add Amendment No. 0 to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No.1031. Subsequently on June 15, 2010 (75 FR 33678), the NRC issued a final rule adding Amendment No. 1 to CoC No. 1031 to the list of NRC-approved cask designs in 10 CFR 72.214. Similar final rules were issued on November 14, 2011 (76 FR 70331), and June 25, 2013 (78 FR 37927), to add Amendment Nos. 2 and 3 to CoC No. 1031, respectively, to the list of NRC-approved cask designs in 10 CFR 72.214.

    IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.

    V. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document ADAMS Accession No. Proposed CoC No. 1031, Amendment No. 0, Revision 1 ML15180A230. Proposed CoC No. 1031 Amendment No. 0, Revision 1, TS Appendix A ML15180A238. Proposed CoC No. 1031 Amendment No. 0, Revision 1, TS Appendix B ML15180A270. Proposed SER for CoC No. 1031 Amendment No. 0, Revision 1 ML15180A281. Proposed CoC No. 1031, Amendment No. 1, Revision 1 ML15180A161. Proposed CoC No. 1031 Amendment No. 1, Revision 1, TS Appendix A ML15180A164. Proposed CoC No. 1031 Amendment No. 1, Revision 1, TS Appendix B ML15180A192. Proposed SER for CoC No. 1031 Amendment No. 1, Revision 1 ML15180A220. Proposed CoC No. 1031, Amendment No. 2, Revision 1 ML15180A114. Proposed CoC No. 1031, Amendment No. 2, Revision 1, TS Appendix A ML15180A119. Proposed TS Amendment No. 2, Revision 1, TS Appendix B ML15180A128. Proposed SER for CoC No. 1031 Amendment No. 2, Revision 1 ML15180A141. Proposed CoC No. 1031, Amendment No. 3, Revision 1 ML15180A033. Proposed CoC No. 1031 Amendment No. 3, Revision 1, TS Appendix A ML15180A077. Proposed CoC No. 1031 Amendment No. 3, Revision 1, TS Appendix B ML15180A087. Proposed SER for CoC No. 1031 Amendment No. 3, Revision 1 ML15180A092.

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0186. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2015-0186); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is proposing to adopt the following amendments to 10 CFR part 72:

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

    2. In § 72.214, Certificate of Compliance No. 1032 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1031.

    Initial Certificate Effective Date: February 4, 2009, superseded by Initial Certificate, Revision 1, on February 1, 2016.

    Initial Certificate, Revision 1, Effective Date: February 1, 2016.

    Amendment Number 1 Effective Date: August 30, 2010, superseded by Amendment Number 1, Revision 1, on February 1, 2016.

    Amendment Number 1, Revision 1, Effective Date: February 1, 2016.

    Amendment Number 2 Effective Date: January 30, 2012, superseded by Amendment Number 2, Revision 1, on February 1, 2016.

    Amendment Number 2, Revision 1, Effective Date: February 1, 2016.

    Amendment Number 3 Effective Date: July 25, 2013, superseded by Amendment Number 3, Revision 1, on February 1, 2016.

    Amendment Number 3, Revision 1, Effective Date: February 1, 2016.

    Amendment Number 4 Effective Date: April 14, 2015.

    Amendment Number 5 Effective Date: June 29, 2015.

    SAR Submitted by: NAC International, Inc.

    SAR Title: Final Safety Analysis Report for the MAGNASTOR® System.

    Docket Number: 72-1031.

    Certificate Expiration Date: February 4, 2029.

    Model Number: MAGNASTOR®.

    Dated at Rockville, Maryland, this 5th day of November, 2015.

    For the Nuclear Regulatory Commission.

    Glenn M. Tracy, Acting Executive Director for Operations.
    [FR Doc. 2015-29423 Filed 11-17-15; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF ENERGY 10 CFR Parts 429 and 430 [Docket No. EERE-2015-BT-CRT-0013] RIN 1904-AD53 Energy Conservation Program: Exempt External Power Supplies Under the EPS Service Parts Act of 2014 AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The U.S. Department of Energy (DOE) is proposing to codify provisions of the EPS Service Parts Act of 2014 that exempt from energy conservation standards certain external power supplies (EPSs) made available by a manufacturer as a service or spare part. Consistent with that Act, DOE is proposing to require annual reports of the total number of exempt EPS units sold as service and spare parts that do not meet the relevant energy conservation standards.

    DATES:

    DOE will accept comments, data, and information regarding this notice of proposed rulemaking no later than December 18, 2015. See section V, “Public Participation,” for details.

    ADDRESSES:

    Any comments submitted must identify the NOPR for Exempt External Power Supplies Under the EPS Service Parts Act of 2014, and provide docket number EERE-2015-BT-CRT-0013 and/or regulatory information number (RIN) number 1904-AD53. Comments may be submitted using any of the following methods:

    1. Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

    2. Email: [email protected]. Include the docket number and/or RIN in the subject line of the message.

    3. Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC, 20585-0121. If possible, please submit all items on a CD. It is not necessary to include printed copies.

    4. Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., Suite 600, Washington, DC, 20024. Telephone: (202) 586-2945. If possible, please submit all items on a CD. It is not necessary to include printed copies.

    For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).

    Docket: The docket, which includes Federal Register notices, public meeting attendee lists and transcripts, comments, and other supporting documents/materials, is available for review at regulations.gov. All documents in the docket are listed in the regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available.

    A link to the docket Web page can be found at: http://www1.eere.energy.gov/buildings/appliance_standards/product.aspx?productid=23. This Web page will contain a link to the docket for this notice on the regulations.gov site. The regulations.gov Web page will contain simple instructions on how to access all documents, including public comments, in the docket. See section V for information on how to submit comments through regulations.gov.

    For further information on how to submit a comment, review other public comments and the docket, or to request a public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Direct requests for additional information may be sent to Mr. Jeremy Dommu, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-2J, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9870. Email: [email protected]

    For legal issues, please contact Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-8145. Email: [email protected]

    Table of Contents I. Authority and Background II. Summary of the Notice of Proposed Rulemaking III. Discussion A. Codifying the Exemption in the CFR B. Service or Spare Part EPS C. Sales Reporting Requirements IV. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act, 1999 I. Review Under Executive Order 12630 J. Review Under Treasury and General Government Appropriations Act, 2001 K. Review Under Executive Order 13211 L. Review Under Section 32 of the Federal Energy Administration Act of 1974 V. Public Participation VI. Approval of the Office of the Secretary I. Authority and Background Authority

    Title III of the Energy Policy and Conservation Act of 1975 (42 U.S.C. 6291, et seq.; “EPCA” or, in context, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. (All references to EPCA refer to the statute as amended through the Energy Efficiency Improvement Act of 2015, Pub. L. 114-11 (April 30, 2015).) Part B of title III, which for editorial reasons was re-designated as Part A upon incorporation into the U.S. Code (42 U.S.C. 6291-6309, as codified), establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles.” External power supplies are among the products affected by these provisions.

    Background

    Section 301 of EISA 2007 established minimum energy conservation standards for Class A external power supplies (EPSs) manufactured on or after July 1, 2008. (42 U.S.C. 6295(u)(3)(A)). See 42 U.S.C. 6291(36)(C)(i)-(ii). EISA 2007 exempts Class A EPSs from meeting these statutorily-prescribed standards if the devices are manufactured before July 1, 2015, and made available by the manufacturer as service parts or spare parts for end-use consumer products that were manufactured prior to July 1, 2008. (42 U.S.C. 6295(u)(3)(B)) Congress created this limited (and temporary) exemption as part of a broad range of amendments to EPCA under EISA 2007. The provision did not grant DOE with the authority to expand or extend the length of this exemption and Congress did not grant DOE with the general authority to exempt any already covered product from the requirements set by Congress.

    After releasing a preliminary analysis and issuing a proposed set of energy conservation standards, DOE published a final rule prescribing new standards for non-Class A EPSs and amended standards for some Class A EPSs—namely, those EPSs that met what DOE has termed as “direct operation” EPSs. See 79 FR 7846 (Feb. 10, 2014). (A direct operation EPS is an external power supply that can operate a consumer product that is not a battery charger without the assistance of a battery. See 10 CFR 430.2.) These new standards apply to products manufactured on or after February 10, 2016. At that time, DOE did not have the authority to provide manufacturers with an exemption for EPSs that were made available as service or spare parts to end-use consumer products that were manufactured prior to the compliance date of these new standards. Accordingly, despite requests from some commenters who responded to DOE's proposed standards by asking for such an exemption, no such relief was provided as part of the final rule.

    On December 18, 2014, the EPS Service Parts Act of 2014, Public Law 113-263 (Dec. 18, 2014) (“Service Parts Act”) was enacted. That law provided manufacturers with an exemption for EPSs that are made available as service and spare parts for end-use products manufactured before February 10, 2016. To be exempt from the new standards under the Service Parts Act, an EPS must meet four separate criteria. Specifically, the EPS must be: (i) Manufactured during the period beginning on February 10, 2016, and ending on February 10, 2020; (ii) marked in accordance with the External Power Supply International Efficiency Marking Protocol; (iii) compliant, where applicable, with the standards for Class A EPSs and certified to DOE as meeting at least International Efficiency Level IV; and (iv) made available by the manufacturer as a service part or spare part for an end-use product manufactured before February 10, 2016.

    Additionally, the Service Parts Act permits DOE to require manufacturers of an EPS that is exempt from the 2016 standards to report to DOE the total number of EPS units shipped annually that are made available as service and spare parts and do not meet those standards. See 42 U.S.C. 6295(u)(5)(A)(ii). DOE may also limit the applicability of the exemption if the Secretary determines that the exemption is resulting in a significant reduction of the energy savings that would result were there no exemption to the new standards. See 42 U.S.C. 6295(u)(5)(A)(iii). Finally, the statute authorizes DOE to provide a similar exemption from future EPS conservation standards.

    II. Summary of the Notice of Proposed Rulemaking

    DOE is proposing to incorporate the statutory provisions described above into its regulations. DOE is also providing some clarification on the circumstances under which EPSs would be considered spare or service parts. DOE also proposes to require that importers and domestic manufacturers annually report to DOE the total units of exempt EPSs sold as service and spare parts that do not meet the 2016 standards.

    III. Discussion A. Codifying the Exemption in the CFR

    DOE is proposing to incorporate the provisions of the Service Parts Act into 10 CFR 430.32. This would help ensure that the regulations reflect the statutory exemption and that interested parties are able to readily access the content of this new statutory provision. It also ensures consistency with the similar exemption to the Class A EPS standards provided by Congress within EISA 2007, which was codified in the CFR.

    B. Service or Spare Part EPSs

    The Service Parts Act provides an exemption for certain EPSs that are made available by manufacturers as service or spare parts. Most end-use products that use EPSs are sold with the EPS that is necessary to operate that product. In such a case, the EPS that is sold with the end-use product would not be considered to be an EPS made available as a spare or service part. However, any EPS that is sold separately from an end-use product, including an EPS made available as a replacement for, or in addition to, the EPS originally sold with an end-use product would be considered an EPS made available as a service or spare part.

    Further, to clarify the application of this statutory exemption, only those EPSs that are made available as service or spare parts for end-use products that were manufactured before February 10, 2016 (the date that manufacturers must comply with the new and amended standards for direct operation EPSs) qualify for the Service Parts Act's exemption. If an EPS is made available as a service part or spare part for any end-use product that continues to be manufactured after February 10, 2016, or is sold with any end-use product manufactured after that date, that EPS would not be eligible for this exemption. Congress specifically limited the application of the exemption to those EPSs that the manufacturer makes available for an end-use product that constitutes the primary load of that end-use product so long as it was manufactured prior to February 10, 2016. See 42 U.S.C. 6295(u)(5)(A).

    Furthermore, DOE recognizes that many EPSs, like those that use an industry standard communication protocol such as the universal serial bus (USB), may be capable of operating many different end-use products. If the EPS is capable of operating multiple end-use products, some of which were manufactured before February 10, 2016, and some of which were manufactured after February 10, 2016, then that EPS would also not be eligible for the service and spare part exemption since the EPS can operate an end-use product manufactured after February 10, 2016. In order to clarify which EPSs are eligible for the exemption, DOE is proposing to clarify that this exemption would apply to an EPS basic model that a manufacturer makes available only as a service part or a spare part for an end-use product that was manufactured before February 10, 2016, and would not apply to an EPS basic model that a manufacturer makes available as a service part or spare part for end-use products that continue to be manufactured after February 10, 2016. Specifically, an EPS would be exempt from the 2016 Level VI standard if, among other criteria, it is made available by the manufacturer only as a service part or a spare part for an end-use product, and only if the end-use product was manufactured before February 10, 2016.

    DOE seeks comment regarding how manufacturers produce spare or service parts as compared to how manufacturers produce EPS units provided with a new product. For example, do manufacturers typically produce a single EPS basic model that is both sold independently as a service/spare part for a given end-use product and packaged with a new end-use product? If a manufacturer typically produces a single EPS basic model, are those EPSs produced as a spare or service part labelled differently from those packaged with a new product?

    C. Sales Reporting Requirements

    Additionally, the Service Parts Act permits DOE to require manufacturers of an EPS that is exempt from the 2016 standards to report to DOE the total number of EPS units shipped annually that are made available as service and spare parts and do not meet those standards. See 42 U.S.C. 6295(u)(5)(A)(ii). Consistent with that authority, DOE is proposing that importers and domestic manufacturers of EPSs that are exempt under the Service Parts Act report to DOE annually the total number of exempt EPS units sold that do not meet the amended standard. DOE considers the “shipments” referred to in the statute to be the units sold by either the importer or the domestic manufacturer. Because importers would have both incoming and outgoing shipments, DOE considers the “units sold” to be clearer than “units shipped.” DOE requests comment on this phrasing.

    Many of the EPSs involved are Class A EPSs and continue to be subject to the current Class A EPS standards (i.e. Level IV) set forth in 10 CFR 430.32(w)(1)(i) and associated certification requirements. Manufacturers of any basic model of such a Class A EPS must, therefore, submit an annual certification report to DOE as required under 10 CFR part 429. For these EPSs, submission of an annual certification report to DOE is required to qualify for the exemption. In addition to the annual certification report requirement for these EPSs, DOE is proposing to require each importer or domestic manufacturer to include in its annual certification report information the number of units of each individual model of exempt EPS it sold in the preceding year that do not meet the 2016 standards. The Service Parts Act authorizes DOE to limit the applicability of the service and spare part exemption if DOE determines that the exemption is resulting in a significant reduction of the energy savings that would otherwise result from the final rule. In assessing whether such a change would be needed, DOE plans to use the reported information to evaluate the exemption's impacts on energy savings.

    Similarly, DOE is proposing to require each importer or domestic manufacturer of non-Class A EPSs that are exempted by the Service Parts Act and do not meet the 2016 standards to submit an annual report of the corresponding number of units of each individual model of such EPS that the importer or domestic manufacturer sold in the prior year. Examples of these kinds of non-Class A EPSs include multiple-voltage EPSs, high-power EPSs, and some EPSs used to operate end-use products that are motor-driven. Under DOE's February 2014 final rule, these EPSs, unless exempt, are required to meet the Level VI standards starting in 2016. These non-class A EPSs would not be certified under the provisions of 10 CFR 429.12 (General requirements applicable to certification reports), if they are exempt. Therefore, consistent with the Service Parts Act, DOE is proposing to require that importers and domestic manufacturers report the total number of units sold in the year preceding the report. Specifically, DOE is proposing to add this reporting requirement to 10 CFR 429.37, with the product-specific certification requirements.

    DOE proposes that the reporting period for the sales information be from August 1 through July 31 of each year. This would allow importers and domestic manufacturers time to compile sales information and report the number of units sold and to align the submittal date with the annual certification report deadline of September 1 for Class-A EPSs. DOE seeks comment on this proposed reporting requirement.

    IV. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866

    This rulemaking is not significant for purposes of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget.

    B. Review Under the Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires preparation of an initial regulatory flexibility analysis (IFRA) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site: http://energy.gov/gc/office-general-counsel.

    For manufacturers of EPSs, the Small Business Administration (SBA) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. 65 FR 30836, 30848 (May 15, 2000), as amended at 65 FR 53533, 53544 (Sept. 5, 2000) and codified at 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at http://www.sba.gov/content/summary-size-standards-industry. EPS manufacturing is classified under NAICS 335999, “All Other Miscellaneous Electrical Equipment and Component Manufacturing.” The SBA sets a threshold of 500 employees or less for an entity to be considered as a small business for this category.

    As a preliminary matter, DOE notes that there are no domestic manufacturers of EPSs. Consequently, there are no small business impacts to evaluate for purposes of the Regulatory Flexibility Act.

    Notwithstanding the absence of domestic EPS manufacturers, DOE reviewed this proposed rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. This proposed rule would incorporate into DOE's regulations a statutorily-prescribed exemption affecting EPSs that manufacturers make available as service or spare parts. The exemption allows manufacturers to maintain and distribute supplies of replacement parts for older equipment without needing to meet the EPS energy conservation standards that will apply starting in 2016. This exemption provides manufacturers flexibility in meeting their warranty and contract obligations in cases where service or spare parts require an EPS. It also relieves manufacturers of the burdens of redesigning and certifying EPSs used for end-use products that are no longer manufactured starting in 2016, which DOE anticipates will save these manufacturers from any significant expenses that would otherwise be used to solely support products that are no longer in production.

    Consistent with its prior incorporation of the previous statutory exemption added by Congress for Class A EPSs made available as service and spare parts, see 10 CFR 430.32(w)(2) (2015), DOE expects any potential impact from its proposal to be minimal.

    For these reasons, DOE certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b).

    C. Review Under the Paperwork Reduction Act of 1995

    This rule proposes to revise an existing information collection. This information collection request contains:

    (1) OMB Control Number: 1910-1400.

    (2) Information Collection Request Title: Certification Reports, Compliance Statements, Application for a Test Procedure Waiver, and Recordkeeping for Consumer Products and Commercial/Industrial Equipment Subject to Energy or Water Conservation Standards.

    (3) Type of Request: Revision of a Currently Approved Collection.

    (4) Purpose: Today's notice would require external power supply manufacturers to report the number of exempt EPS units sold as part of the annual certification report, which is already required. The annual certification report must be submitted via CCMS, an electronic system for recording and processing certification submissions.

    Manufacturers of EPSs must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for EPSs including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including external power supplies. See 10 CFR part 429, subpart B. The collection-of-information requirement for certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB Control Number 1910-1400. Public reporting burden for the proposed certification requirement is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    In today's notice, DOE is proposing to require external power supply manufacturers to provide the total number of exempt EPS units sold as service and spare parts for each basic model for which the manufacturer is claiming exemption from the current standards. The following are DOE estimates of the increased time (over the existing approved information collection) for manufacturers to collect, organize and store the data required by today's notice of proposed rulemaking.

    Affected Public: Manufacturers of external power supplies that are claiming the spare parts exemption.

    Estimated Number of Impacted Manufacturers: 1028.

    Estimated Time per Record: 4 minutes.

    Estimated Total Annual Burden Hours: 69 hours.

    Estimated Total Annual Cost to the Manufacturers: $500.

    This revision would yield the following totals for the information collection:

    (5) Annual Estimated Number of Respondents: 3028 (6) Annual Estimated Number of Total Responses: 20,000 (7) Annual Estimated Number of Burden Hours: 68,069 hours (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $6,800,500

    Notwithstanding any other provision 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 PRA, unless that collection of information displays a currently valid OMB Control Number.

    D. Review Under the National Environmental Policy Act of 1969

    DOE has determined that this proposal, which would incorporate a recently-enacted exemption into the CFR for EPSs sold as spare or service parts, falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321, et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this proposed rule would adopt changes to the manner in which certain covered equipment would be certified and/or reported, which would not affect the amount, quality or distribution of energy usage, and, therefore, would not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A6 (Procedural Rulemaking) under 10 CFR part 1021, subpart D. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

    E. Review Under Executive Order 13132

    Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of today's proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

    F. Review Under Executive Order 12988

    Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.

    G. Review Under the Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a)-(b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at http://energy.gov/gc/office-general-counsel. DOE examined this proposed rule according to UMRA and its statement of policy and determined that the proposed rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply.

    H. Review Under the Treasury and General Government Appropriations Act, 1999

    Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This proposed rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

    I. Review Under Executive Order 12630

    DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this proposed regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

    J. Review Under Treasury and General Government Appropriations Act, 2001

    Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

    K. Review Under Executive Order 13211

    Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

    This proposed regulatory action to amend the existing certification requirements for EPSs sold as spare parts is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

    L. Review Under Section 32 of the Federal Energy Administration Act of 1974

    Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition. This proposal to amend the certification requirements for all covered consumer products does not propose the use of any commercial standards.

    V. Public Participation

    DOE will accept comments, data, and information regarding this proposed rule no later than the date provided in the DATES section at the beginning of this proposed rule. Interested parties may submit comments using any of the methods described in the ADDRESSES section at the beginning of this proposed rule.

    Submitting comments via regulations.gov. The regulations.gov Web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

    However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

    Do not submit to regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through regulations.gov cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

    DOE processes submissions made through regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that regulations.gov provides after you have successfully uploaded your comment.

    Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

    Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.

    Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

    Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

    Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked non-confidential with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

    It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

    VI. Approval of the Office of the Secretary

    The Secretary of Energy has approved publication of this proposed rule.

    List of Subjects 10 CFR Part 429

    Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.

    10 CFR Part 430

    Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Small businesses.

    Issued in Washington, DC, on November 10, 2015. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.

    For the reasons stated in the preamble, DOE is proposing to amend parts 429 and 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:

    PART 429—CERTIFICATION, COMPLIANCE, AND ENFORCEMENT FOR CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT 1. The authority citation for part 429 continues to read as follows: Authority:

    42 U.S.C. 6291-6317.

    2. Section 429.37 is amended by adding paragraphs (b)(3) and (c) to read as follows:
    § 429.37 External power supplies.

    (b) * * *

    (3) Pursuant to § 429.12(b)(13), a certification report for external power supplies that are exempt from the energy conservation standards at § 430.32(w)(1)(ii) pursuant to § 430.32(w)(2) must include the following additional product-specific information: The number of units of each individual model of exempt external power supplies sold during the most recent 12-calendar-month period ending on July 31.

    (c) Exempt External Power Supplies. For each individual model of external power supply that is exempt from energy conservation standards pursuant to § 430.32(w)(2) and has not been certified pursuant to § 429.12(a) as compliant with an applicable standard, the importer or domestic manufacturer must, no later than September 1, 2017, and annually thereafter, submit a report providing the following information:

    (1) The importer or domestic manufacturer's name and address;

    (2) The brand name;

    (3) The model number;

    (4) The average active mode efficiency as a percentage (%);

    (5) No-load mode power consumption in watts (W);

    (6) The nameplate output power in watts (W);

    (7) The nameplate output current in aperes (A); and

    (8) The number of units sold during the most recent 12-calendar-month period ending on July 31. The report must be submitted to DOE in accordance with the submission procedures set forth in § 429.12(h).

    PART 430—ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS 3. The authority citation for part 430 continues to read as follows: Authority:

    42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.

    4. Section 430.32 is amended by revising paragraph (w)(2) to read as follows:
    § 430.32 Energy and water conservation standards and their compliance dates.

    (w) * * *

    (2) A basic model of external power supply is not subject to the energy conservation standards of paragraph (w)(1)(ii) of this section if the external power supply—

    (i) Is manufactured during the period beginning on February 10, 2016, and ending on February 10, 2020;

    (ii) Is marked in accordance with the External Power Supply International Efficiency Marking Protocol, as in effect on February 10, 2016;

    (iii) Meets, where applicable, the standards under paragraph (w)(1)(i) of this section, and has been certified to the Secretary as meeting those standards; and

    (iv) Is made available by the manufacturer only as a service part or a spare part for an end-use product that—

    (A) Constitutes the primary load; and

    (B) Was manufactured before February 10, 2016.

    [FR Doc. 2015-29303 Filed 11-17-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2014-N-1021] RIN 0910-AH00 Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the “gluten-free” labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as “gluten-free.” There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a “gluten-free” claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the “gluten-free” claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is “gluten-free” in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the “gluten-free” claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the “gluten-free” claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are “gluten-free” in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

    DATES:

    Submit either electronic or written comments on the proposed rule by February 16, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 18, 2015.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-N-1021 for Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Submit comments on information collection issues to the Office of Management and Budget in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.

    FOR FURTHER INFORMATION CONTACT:

    With regard to the proposed rule: Carol D'Lima, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, FAX: 301-436-2636.

    With regard to the information collection issues: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    Executive Summary Purpose of the Rule

    Need for the rule: Celiac disease, a hereditary, chronic inflammatory disorder of the small intestine, has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease. In the Federal Register of August 5, 2013 (78 FR 47154), we published a final rule that defines the term “gluten-free” and establishes requirements for the voluntary use of that term in food labeling. The final rule (now codified at § 101.91 (21 CFR 101.91)) is intended to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. The regulation provides that “[w]hen compliance with [the rule] is based on an analysis of the food, the FDA will use a scientifically valid method that can reliably detect the presence of 20 parts per million (ppm) gluten in a variety of food matrices, including both raw and cooked or baked products” (§ 101.91(c)). We established this 20 ppm limit for intact gluten considering multiple factors, including currently available analytical methods and the needs of individuals with celiac disease, as well as factors such as ease of compliance and enforcement, stakeholder concerns, economics, trade issues, and legal authorities. Although test methods for the detection of gluten fragments in fermented and hydrolyzed foods have advanced, there is still uncertainty in interpreting the results of these test methods on a quantitative basis that equates the test results to an equivalent amount of intact gluten. Thus, alternative means are necessary to verify compliance with the provisions of the rule for fermented and hydrolyzed foods, such as cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine, or hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

    Legal authority: Consistent with section 206 of the Food Allergen Labeling and Consumer Protection Act (FALCPA) and sections 403(a)(1), 201(n), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(a)(1), 321(n), and 371(a)), we are proposing requirements to permit the voluntary use of the term “gluten free” in the labeling of foods that are fermented, hydrolyzed, or distilled, or that contain fermented, hydrolyzed, or distilled ingredients.

    Major provisions of the rule: The proposed rule would amend § 101.91(c) to provide alternative means for us to verify compliance based on records that are maintained by the manufacturer of the food bearing the “gluten-free” claim and made available to us for inspection and copying. We propose that, for foods fermented or hydrolyzed by the manufacturer and bearing the “gluten-free” claim, the records must demonstrate adequate assurance that the food is “gluten-free” in compliance with § 101.91(a)(3) before fermentation or hydrolysis. Such adequate assurance can include test results, certificates of analysis (CoAs), or other appropriate verification documentation for each of the ingredients used in the food. Alternatively, adequate assurance can include test results of the food before fermentation or hydrolysis of the food.

    In addition, the proposed rule would require the manufacturer to document that any potential for gluten cross-contact has been adequately assessed, and where such a potential has been identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

    Further, for foods containing one or more fermented or hydrolyzed ingredients and bearing the “gluten-free” claim, manufacturers would have to make and keep records demonstrating with adequate assurance that the fermented or hydrolyzed ingredients are “gluten-free” in compliance with § 101.91(a)(3) including, but not limited to, CoAs or other appropriate verification documentation from the ingredient suppliers and/or results of testing conducted by the ingredient suppliers.

    The proposed rule also would require the manufacturer to retain the records for at least 2 years after introduction or delivery for introduction of the food into interstate commerce. The proposed rule would allow these records to be kept as original records, as true copies or as electronic records, and manufacturers would have to make the records available to us for inspection and copying, upon request, during an inspection. The records would need to be reasonably accessible to FDA during an inspection at each manufacturing facility (even if not stored on site) to determine whether the food has been manufactured and labeled in compliance with § 101.91. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible. The proposed rule would provide that we would evaluate compliance of distilled foods, such as distilled vinegar, by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the food.

    Costs and benefits: Full compliance with the proposed rule, if finalized, would have annualized costs of about $9 million per year and annual health benefits of about $41 million per year, for net benefits of $32 million a year:

    Annual Cost and Benefit Overview Costs Testing of Foods $3,000,000 Standard Operating Procedure Development 1,500,000 Labeling (changes for non-compliant products) 300,000 Paperwork 3,900,000 Benefits Health Gains for Individuals with Celiac Disease 41,000,000 Net Benefits 32,000,000 Table of Contents I. Background A. Why do we need this Proposed Rule? B. What are fermented or hydrolyzed foods? C. Why are there no appropriate analytical methods to quantify intact gluten in fermented or hydrolyzed foods? D. Is it feasible, and under what circumstances, can foods be processed to remove gluten? E. Can beer be labeled “gluten-free”? F. Can a distilled food be labeled “gluten-free”? G. How do I evaluate gluten cross-contact? H. Can a fermented or hydrolyzed food be concentrated or dried? II. What does the proposed rule say? A. For foods fermented or hydrolyzed by the manufacturer, what records must be kept? What must the records demonstrate? (Proposed § 101.91(c)(2)) B. For foods that contain one or more fermented or hydrolyzed ingredients, what records must be kept? What must the records demonstrate? (Proposed § 101.91(c)(3)) C. How must records be maintained and made available? (§ 101.91(c)(4)) D. What are the requirements for distilled products? (§ 101.91(c)(5)) E. What are the conforming changes? (§ 101.91(b)(1) and (2)) F. Compliance Date III. What is our legal authority for this proposed rule? IV. What is the analysis of impacts—preliminary regulatory impact analysis A. Overview B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act of 1996 D. Unfunded Mandates Reform Act of 1995 E. Public Access to the Analyses V. The Paperwork Reduction Act of 1995 VI. What is the environmental impact of this rule? VII. What are the federalism impacts of this rule? VIII. References I. Background A. Why do we need this proposed rule?

    Celiac disease is a hereditary, chronic inflammatory disorder of the small intestine triggered by the ingestion of certain proteins referred to as gluten occurring in wheat, rye, barley, and crossbreeds of these grains. The main protein of wheat gluten is gliadin; the similar proteins of rye and barley are termed secalin and hordein, respectively. Both of the major protein fractions of gluten, gliadins and glutenins, are active in celiac disease. All the gliadins and glutenins subunits are reported to be harmful for individuals with celiac disease (Ref. 1). Celiac disease has no cure, and individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease.

    Under section 206 of FALCPA, in the Federal Register of August 5, 2013, we published a final rule that defines the term “gluten-free” and establishes requirements as to the voluntary use of that term in food labeling. The final rule (now codified at 21 CFR 101.91) is intended to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to foods labeled as “gluten-free.” The final rule does not require manufacturers who label their foods as “gluten-free” to test those foods for the presence of gluten although they may choose to do so to ensure that the food does not contain 20 ppm or more gluten. The regulation provides that “[w]hen compliance with [the rule] is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products” (§ 101.91(c)). We may conduct such testing to verify that foods labeled “gluten free” meet the criteria for “gluten-free” labeling, including the part of the “gluten-free” definition that states that “[a]ny unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food)” (§ 101.91(a)(3)(ii)).

    In comments we received in response to the proposed rule that appeared in the Federal Register of January 23, 2007 (72 FR 2795), and to a related notice we published in the Federal Register of August 3, 2011 (76 FR 46671), we became aware that fermented or hydrolyzed foods, some of which are labeled as “gluten-free,” cannot be tested for a quantitative measure of intact gluten using currently available analytical methods. In the notice that we published in the Federal Register of August 3, 2011 (76 FR 46671 at 46673), we stated that FDA recognized that for some food matrices (e.g., fermented or hydrolyzed foods) there were no currently available validated methods that could be used to accurately determine if they contained <20 ppm gluten. FDA also stated that we were considering whether to require manufacturers of such foods to have a scientifically valid method that would reliably and consistently detect gluten at 20 ppm or less before including a “gluten-free” claim in the labeling of their foods. FDA requested comments on this proposed approach as well as on whether FDA also should require these manufacturers to maintain records on test methods, protocols, and results and to make these records available to FDA upon inspection.

    The notice explained that we interpret the term “scientifically valid method” to mean a method that is “accurate, precise, and specific for its intended purpose and where the results of the method evaluation are published in the peer-reviewed scientific literature. In other words, a scientifically valid test is one that consistently and reliably does what it is intended to do” (id.).

    As of November 18, 2015, we know of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented and hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Without reference standards associated with the production of fermented and hydrolyzed products, such quantification is uncertain and potentially inaccurate (Ref. 2). Thus, we need other means to verify compliance for these foods.

    B. What are fermented or hydrolyzed foods?

    A fermented food is one that has undergone fermentation—a process that typically involves the conversion of complex organic compounds, especially sugars and other carbohydrates, to simpler compounds such as lactic acid and ethyl alcohol. Fermentation has long been used to preserve or produce foods with characteristic flavors or textures. During fermentation, proteins such as gluten break apart into smaller groups of amino acids known as peptides. Examples of foods that are subject to fermentation during manufacturing are cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine.

    A hydrolyzed food is one in which a food's chemical components—such as proteins—are broken into smaller organic compounds by reaction with water. These reactions are often accelerated by enzymes. One common application of hydrolysis in food manufacturing is the hydrolysis of plant proteins—such as soy protein. Hydrolyzed soy proteins are often used as an ingredient to increase digestibility of the protein, to enhance flavor, or to improve texture in processed foods such as soups, sauces, and seasonings. There are many different types of fermented or hydrolyzed foods as well as food products that contain fermented or hydrolyzed ingredients (Ref. 3). Examples of foods that use hydrolyzed plant proteins as flavor enhancers include soups, chili, sauces, gravies, stews, dips, and some snacks like potato chips and pretzels.

    C. Why are there no appropriate analytical methods to quantify intact gluten in fermented or hydrolyzed foods? 1. Background on Analytical Methods for Gluten

    As discussed in the preamble to our final rule (78 FR 47154 at 47165), we routinely rely upon scientifically valid methods in our enforcement programs on food labeling. When we established the requirement that foods bearing the “gluten-free” claim contain less than 20 ppm of intact gluten, we were referring to intact gluten as measured by sandwich ELISA-based methods. (ELISA stands for an enzyme-linked immunosorbent assay.) The sandwich ELISA-based methods can both detect and quantify specific amino acid sequences, known as epitopes, with the requirement that at least two epitopes be present in a single strand of amino acids in order to mediate the binding of two antibodies (hence, the concept of a sandwich). Advantages of sandwich ELISA-based methods are an increased specificity associated with the requirement that two antibodies bind the antigen (especially if the two antibodies recognize different epitopes) and a high sensitivity. As a result, the sample does not have to be extensively purified before analysis (Ref. 4).

    Sandwich ELISA-based methods are appropriate for foods in which the gluten is not subject to fermentation or hydrolysis and remains intact. However, as we discuss in the next section, sandwich ELISA-based methods are not effective in detecting and quantifying gluten proteins that are no longer intact as a result of fermentation or hydrolysis.

    2. Challenges in Quantifying Gluten in Fermented and Hydrolyzed Foods

    Proteins can be broken into smaller fragments called peptides. Unless the proteins are sufficiently broken down so as to eliminate all immunopathogenic elements (e.g., strands of amino acids that cause a celiac response), the fermented or hydrolyzed gluten can be harmful to people with celiac disease (Ref. 5). Compared to other processing methods that physically remove the gluten to produce non-protein containing ingredients (e.g., wheat starch), fermentation, hydrolysis, or enzymatic processing methods that chemically break down gluten peptides may not completely remove the immunotoxic potential of these peptides. Small gluten peptides resulting from these processes and remaining in the finished food could still contain sequences of amino acids which potentially cause adverse reactions in people with celiac disease. We invite comments, including scientific data, on any studies that have been conducted to demonstrate whether any fermentation or hydrolytic processes sufficiently break down gluten into peptides that are harmless to persons with celiac disease.

    The principal limitation of the sandwich ELISA-based methods is that they need at least two epitopes recognized by the antibodies used in the assay to be present in the same continuous amino acid strand. However, in fermented or hydrolyzed foods, gluten proteins are typically fragmented into peptides. Although these peptides may remain immunologically active and be of potential concern to people with celiac disease, the antibodies used in the ELISA-based methods may be unable to recognize the peptides. This affects how one might detect and quantify gluten, such that the quantity of gluten reported may be incorrect (Ref. 6). Thus, sandwich ELISA-based methods are not appropriate analytical methods for detecting and quantifying gluten content in fermented or hydrolyzed products.

    Competitive ELISA-based methods that recognize a single epitope have been developed and may overcome the detection problems encountered with the sandwich ELISA-based assays in hydrolyzed or fermented food. Although some studies have validated the reproducibility of competitive ELISA-based test methods (Ref. 7), there is uncertainty about whether these methods can quantify the amount of protein from which those fragments were generated by hydrolysis (Ref. 2). This uncertainty creates problems in equating these test results to an equivalent amount of intact gluten in the fermented or hydrolyzed product. Further, without an appropriate reference standard to gauge the response, one cannot interpret the results on a quantitative basis that equates the response to a specific amount of intact gluten. As of November 18, 2015, we are not aware of any methods for which there is an appropriate reference standard to gauge the response for detection and quantification, with precision, of the gluten content in terms of intact gluten in fermented and hydrolyzed foods.

    In addition to ELISA-based methods, mass spectrometry (MS) holds significant potential for analysis of hydrolyzed gluten because of its unique capabilities for protein and peptide analysis. In general, MS can provide accurate measurement of peptide molecular weights and identification of peptide primary amino acid sequences. Qualitative methods can be used to determine the identity of the peptides, with quantitative methods able to determine peptide concentrations. As applied to hydrolyzed gluten analysis, MS analysis may be able to identify and quantify the gluten protein fragment peptides that result from food processing. Therefore, for hydrolyzed food, MS could identify gluten and measure gluten fragment concentrations with high sensitivity and molecular specificity. However, without an appropriate hydrolyzed gluten reference standard that would enable interpretation of the test results in terms of intact gluten, as well as the ability to analyze for all potential peptides, MS analysis would not be able to provide a quantitative measure of intact gluten. Therefore, methods are needed that can not only detect gluten protein hydrolysis fragments, but also quantify the source gluten proteins. We invite comment on any additional research into methods that can be used to quantify the gluten protein content in fermented or hydrolyzed foods in terms of intact gluten, including the use of ELISA-based methods and MS testing, as well as any data and information on appropriate reference standards for such test methods.

    D. Is it feasible, and under what circumstances, can foods be processed to remove gluten?

    In some cases, it is possible to remove or separate the gluten protein portion of an ingredient derived from a gluten-containing grain. For example, in processing food starch from various grain sources including wheat, the starch is extracted and refined from the grains by wet grinding, washing, and sieving to separate the protein components from the starch. This starch material can be dried or used in further processing. However, some gluten may remain in these ingredients even after they have been processed to remove gluten. Variations in the processing could result in different trace amounts of gluten remaining in the starch. Therefore, § 101.91(a)(3)(i)(A)(3) provides that the use of such ingredients must not result in the presence of 20 ppm or more gluten in the finished food (i.e., 20 mg or more gluten per kg of food).

    Our regulations do not allow for processing a food (as opposed to the food's ingredients) to remove gluten. Section 101.91(a)(3)(i)(A)(1) requires that the food bearing the claim in its labeling not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat). The intent behind § 101.91(a)(3)(i)(A)(1) was to ensure that the food, as consumed, contains as little gluten as possible. This approach is consistent with other international standards (see Codex Standard 118-1979, section 2.1.1 (Ref. 8)).

    Nevertheless, we have heard arguments that we should allow the use of a “gluten-free” label on foods where the food, rather than the food's ingredients, has been processed to remove gluten. We have not received sufficient information regarding any specific processes to remove gluten to determine whether any processes identified would impact our rationale. Thus, we invite comment and data on the feasibility and circumstances under which a food can be processed to remove gluten and the methods by which the absence of gluten can be determined.

    E. Can beer be labeled “gluten-free”?

    Some comments submitted in response to the 2007 proposed rule and the 2011 notice wanted us to allow beers subject to FDA labeling regulations to be labeled “gluten-free” if the beers contained less than 20 ppm gluten, regardless of whether the beer was made from a gluten-containing grain. Other comments favored prohibiting the use of a “gluten-free” claim on the label of beers made from gluten-containing ingredients but whose manufacturers claim were later “reduced” in gluten by the processing methods.

    The comments favoring the use of “gluten-free” labeling on beers made from gluten-containing grains argued that the beers can be processed to remove gluten. As with other foods, beers that have been made using a gluten-containing grain do not meet the gluten-free definition. Thus, beers made from gluten-containing grains cannot bear a “gluten-free” claim. However, as with other foods, if the gluten-containing grain has been processed to remove gluten in accordance with the provisions in the “gluten-free” definition prior to making beer, the beer may be eligible to make the claim under the provisions of this proposed rule. Regarding the commenters' assertion that beers made from gluten containing grains can be processed to remove gluten, we are not aware of any scientifically valid way to evaluate such a claim, and there is inadequate evidence concerning the effectiveness of the commenters' gluten removal process.

    Gluten can be at least partially broken down by several processes, including fermentation. However, as we explained in section I.C.1., the presence or absence of gluten broken down in this way cannot be reliably detected with sandwich ELISA-based methods. We are interested in learning more about the efficacy of competitive ELISA-based methods (e.g., the R5 or G12 competitive ELISA-based methods), given the beer industry's practice of adding enzymes to the beer to prevent the problem of cloudiness or “haze,” which can occur as a result of residual protein substances extracted from grain during the brewing and fermentation process. The enzyme hydrolyzes or breaks down gluten proteins at proline residues. As a result, adding these haze control enzymes may generate peptides that are not detectable using the commercially available competitive ELISA-based methods that rely on the presence of proline in the epitopes (Refs. 9 and 10). However, it is uncertain that cleavage at proline residues totally eliminates the concern for people with celiac disease because there may be immunopathogenic protein fragments still present.

    FDA recently completed a study on the effectiveness of proline endopeptidase (PEP), an enzyme that the beer industry uses to remove cloudiness in beer, using sorghum beer spiked with gluten as a model system. The study examined the hydrolysis of gluten and some of the protein fragments reported to affect people with celiac disease. The results indicated that fermentation of beer resulted in a gradual reduction in detectable gluten concentration, and addition of PEP increased the reduction in the detectable gluten concentration. However, differences in peptide profiles between the beer and the calibration standards may lead to inaccurate quantitation of gluten in the final product (Ref. 11). Due to the lack of clinical data and a comprehensive understanding of celiac disease, it is not known if immunopathogenic compounds remain after the use of the enzyme. Hydrolyzed gluten may contain protein fragments that can trigger reactions in people with celiac disease which are not recognized by the ELISA methods used or identified by the MS analysis. For example, Western Blot testing showed that high molecular weight glutenins were less susceptible than the low molecular weight fraction of gluten to the action of PEP during the fermentation of beer. Additional data on the effect of PEP, and possibly clinical evidence, are needed before conclusions can be drawn regarding the effectiveness of PEP in breaking down gluten in a manner that renders the beer, or other foods containing gluten, safe for consumption by people with celiac disease.

    We are interested in receiving comment, including scientific research regarding whether beer derived from gluten-containing grains that may still contain protein fragments from gluten can be shown by scientifically valid analytic methods to equate to intact gluten on a quantitative basis. We are also interested in scientific research regarding how we can use such test methods to determine that beer derived from gluten-containing grains contains the equivalent of less than 20 ppm intact gluten proteins, including any data and information regarding quantification of gluten fragments and determining appropriate calibration or reference standards. We also invite comment, including data and any information, on scientific research and methods to determine if a specific enzymatic treatment (or other treatments, if known) of beer derived from gluten-containing grains can modify proteins or protein fragments such that they are present at levels equivalent to less than 20 ppm intact gluten protein.

    We note that the labeling of beer is subject to oversight by two separate Federal Agencies. As we explained in the preamble to the final rule (78 FR 47154 at 47165), the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau (TTB) is responsible for the issuance and enforcement of regulations with respect to the labeling of beers that are malt beverages under the Federal Alcohol Administration Act (FAA Act). Certain other beers do not meet the definition of a malt beverage under the FAA Act (27 U.S.C. 211(a)(7)); those beers are subject to FDA's labeling requirements. We are working with TTB on the issues associated with “gluten-free” labeling of beer to promote consistency in our approach, while taking into consideration the differences in the statutes administered by FDA and TTB, respectively.

    As we noted in the preamble to the final rule (78 FR 47154 at 47166) beer manufacturers whose beers are subject to FDA's labeling requirements that make beer from a gluten-containing grain or from non-gluten-containing grains are not precluded from using other statements on the label, such as a gluten statement consistent with the TTB Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages, about processing of beers to reduce gluten. However, such statements must be truthful and not misleading. Beers bearing statements related to the gluten processing or content other than “gluten free” are still subject to sections 403(a)(1) and 201(n) of the FD&C Act.

    F. Can a distilled food be labeled “gluten-free”?

    The preamble to the final rule (78 FR 47154 at 47174) noted that we had received comments expressing concern that distilled vinegar, as a food product or ingredient, could contain gluten and wanted us to not allow distilled vinegar to be labeled as “gluten-free.” We indicated that we would consider the comments received on distilled foods, including distilled vinegar, in this proposed rule.

    The process of distillation involves heating a liquid such that components with lower boiling points are vaporized and recovered separate from components with higher boiling points. The remaining compounds, whose boiling points were too high to undergo vaporization, are left behind (Ref. 12). We are aware of two commonly used distilled foods subject to FDA labeling regulations; distilled vinegar and distilled water. Of these, distilled water is inherently gluten-free.

    There are several different types of vinegars, and not all of them are distilled, as discussed in the Food and Drug Administration, Compliance Policy Guide Sec. 525.825, “Vinegar Definitions—Adulteration With Vinegar Eels” (Ref. 13). Some examples of these include cider vinegar (also known as apple vinegar or simply “vinegar”), wine vinegar (also known as grape vinegar), malt vinegar, sugar vinegar, and glucose vinegar. All vinegars are made by alcoholic and subsequent acetous fermentation, but can be derived from different substances. Cider vinegar is made from the juice of apples; whereas, wine vinegar is made from the juice of grapes. In addition, some vinegars may be made from gluten-containing grains, such as malt vinegar, which is the product made by the alcoholic and subsequent acetous fermentation, without distillation, of an infusion of barley malt or cereals whose starch has been converted by malt.

    Distilled vinegar is commonly made from ethanol derived from corn or sugar cane, but, to a lesser extent, other raw materials can be used to derive the ethanol used to make distilled vinegar. Distilled vinegar (also known as spirit vinegar or grain vinegar) is made by the acetous fermentation of dilute distilled alcohol. The alcohol derived from the initial alcohol fermentation undergoes distillation followed by acetous fermentation. Because distillation is a purification process, separating volatile components like alcohol and flavors from non-volatile materials like proteins and sugars, it is unlikely that gluten (or any other protein or protein fragments) is present in distilled vinegar if the distillation process is conducted following good manufacturing practices specific to distillation. Although we are not aware of any analytical methods that can be used to reliably detect and accurately quantify the presence of gluten in distilled vinegar, we are aware of analytical methods that could be used to detect the presence of protein and protein fragments as a means for manufacturers to ensure the absence of protein (and thus gluten). We discuss how the proposed rule addresses these methods in section II.D.

    Vinegars that are made from gluten-containing grains but are not further processed by distillation may not bear the gluten-free claim under § 101.91(b). For example, some malt vinegars are the product of fermentation, without distillation, of an infusion of barley malt or cereals whose starch has been converted to malt (Ref. 14). Because these types of malt vinegar are derived from gluten-containing grains that have not been distilled or otherwise processed to remove gluten, they may not be used as ingredients in a food bearing a “gluten-free” claim or bear such a claim themselves as provided in § 101.91(a)(3)(i)(A)(2). Distilled vinegars that are made from gluten-containing grains are first subjected to an alcohol fermentation process followed by distillation and finally an acetous fermentation process of the distilled, diluted alcohol. Distillation in this case is considered as the “process to remove gluten” from the ingredient alcohol, which has been derived from the fermentation of the sugars in the grains, and which is then further fermented to produce vinegar. Distilled vinegars that meet the definition of gluten-free may bear the “gluten-free” claim under § 101.91(b). Thus, when a food or ingredient bearing the “gluten-free” claim is distilled, we will evaluate compliance by verifying the absence of protein in the food or ingredient using a scientifically valid method that can reliably detect the presence or absence of protein or protein fragments in the food. When choosing a method that will verify the absence of protein, among the factors that need to be considered is the sensitivity of the test method for this purpose, such as a limit of detection as close to zero as possible.

    G. How do I evaluate gluten cross-contact?

    As we noted in the preamble to the final rule, “[i]n the context of this rule, [gluten] cross-contact occurs when a food without gluten comes in contact with a gluten-containing food or ingredient, resulting in the presence of gluten in the food not intended to contain gluten” (78 FR 47154 at 47173). We recognize that the supply chain for raw materials, ingredients, and intermediate products used in the food industry can be complex and involve many suppliers outside the manufacturer's immediate control. Thus, for raw materials, ingredients, and intermediate products, the potential for cross-contact with gluten-containing sources may exist.

    For example, official regulatory standards, notably the U.S. Department of Agriculture's Grain Inspection, Packers and Stockyards Administration's (GIPSA's) Federal Grain Inspection Service (FGIS), allow for the adventitious presence of other grains. The FGIS is intended to provide farmers, grain handlers, processors, exporters, and international buyers with information that accurately and consistently describes the quality and quantity of grain being bought and sold (Ref. 15). However, the GIPSA definitions for soybeans, canola, flaxseed, sunflower seeds, corn, and oats, by virtue of their allowance of “other grains,” do not prohibit the presence of gluten-containing grains.

    The “other grains” for which standards exist under the United States Grain Standards Act (Pub. L. 64-90) include barley, rye, triticale, and wheat (see 7 CFR 810.201 (definition of barley), 810.1201 (definition of rye), 810.2001 (definition of triticale), and 810.2201 (definition of wheat)), and these are gluten-containing grains. Therefore, records demonstrating assurance for raw materials such as grains, legumes, and seeds may include certificates of analysis or test results drawn from more frequent sampling or more lots of these source materials.

    Conversely, there are certain fermented or hydrolyzed foods, such as those fermented or hydrolyzed from vegetable, meat, and dairy ingredients, that have a low probability of cross contact with gluten-containing grains because the source ingredients for these foods are inherently free of gluten and are less likely to come into contact with gluten-containing grains before being processed. Examples of such foods include cheese, yogurt, some vinegars, sauerkraut, pickles, green olives, meats, and wine. Through the use of manufacturing practices that can prevent gluten cross-contact situations, these fermented or hydrolyzed foods made from source ingredients that are inherently free of gluten may present less potential for the presence of gluten.

    Given the variety of fermented or hydrolyzed foods and different manufacturing processes for foods fermented or hydrolyzed by the manufacturer and bearing the “gluten-free” claim, we believe that decisions as to how to adequately evaluate any potential for gluten cross-contact during the manufacturing process are best left to manufacturers and their manufacturing operations. Likewise, the manufacturer must determine what measures they should take to prevent the introduction of gluten into the food during the manufacturing process. Manufacturers must keep records adequately evaluating the potential for gluten cross-contact and documenting the measures used to prevent the introduction of gluten into the food during the manufacturing process.

    We invite comment on the potential for source ingredients used in fermentation (i.e., milk in yogurt) to come in contact with gluten-containing grains, and on manufacturing practices that can prevent risk of gluten cross contact.

    H. Can a fermented or hydrolyzed food be concentrated or dried?

    As we explained in the preamble to the final rule (78 FR 47154 at 47159), 20 ppm gluten is a concentration level rather than an absolute quantity of gluten in a food. If a food's ingredients are all below 20 ppm gluten, the food containing those ingredients will have a gluten concentration less than 20 ppm.

    When water or other liquid is removed from a food, for example a soup or sauce, or the product is dried, the relative concentration of the material dissolved or suspended in the product increases as the water or dissolving material is removed. In the case of gluten in a product, we are aware that the relative concentration of gluten could increase if water or other liquid is removed. Given the limitations of gluten testing and the variety of processes involved in concentration or drying of fermented or hydrolyzed ingredients, there could be uncertainty in the determination of the amount of gluten contained in these materials. For this reason, and because methods that can reliably detect the presence of 20 ppm intact gluten in fermented or hydrolyzed foods are not currently available, we are considering several regulatory options regarding records for fermented or hydrolyzed foods or ingredients that are concentrated or dried.

    One option would be to require the manufacturer of a food bearing the “gluten-free” claim to document that the food or ingredient is not concentrated or dried after fermentation or hydrolysis. This would preclude fermented or hydrolyzed foods or ingredients that are concentrated or dried from being in foods bearing the “gluten-free” claim and reduce the number of such foods labeled as “gluten-free” in the marketplace.

    Another option would require the manufacturer of a food bearing the “gluten-free” claim to make and keep records documenting that the concentrated or dried fermented or hydrolyzed ingredients used in a food bearing the “gluten-free” claim comply with § 101.91(a)(3). This, in turn, could cause manufacturers to request records from the ingredient supplier indicating the gluten content of the materials used in the ingredient prior to fermentation or hydrolysis, and specific information as to how the final gluten concentration of the ingredient is determined after concentration or drying.

    We invite comment on these two possible options, how the options could be modified, whether another option exists, or whether it is necessary to address concentrated or dried ingredients in this regulation. We also invite comment on the potential for fermented or hydrolyzed foods made from ingredients that are concentrated or dried to contain less than 20 ppm gluten in their concentrated or dried form, how this gluten content could be verified and the potential costs associated with a new option.

    II. What does the proposed rule say?

    Currently, § 101.91(c) states that when compliance with § 101.91(b) (which pertains to requirements for “gluten-free” labeling) is based on an analysis of the food, we will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices.

    The proposed rule would amend § 101.91(c) to provide alternative means for us to verify compliance for fermented or hydrolyzed foods for which appropriate scientifically valid methods that can reliably detect and quantify the presence of 20 ppm intact gluten are not currently available. If the food or the ingredients used in a food fermented or hydrolyzed by the manufacturer contained less than 20 ppm of intact gluten before fermentation or hydrolysis, then the resulting fermented or hydrolyzed food also would contain less than 20 ppm intact gluten as long as gluten was not introduced during the fermentation or hydrolysis process. For these reasons, the proposed rule would require that the manufacturer of fermented or hydrolyzed foods bearing the “gluten-free” claim make and keep records regarding the food demonstrating adequate assurances that the food is “gluten-free” in compliance with § 101.91(a)(3) before fermentation or hydrolysis and that gluten has not been introduced during the manufacturing process. Likewise, for foods containing one or more fermented or hydrolyzed ingredients and bearing the “gluten-free” claim, the manufacturer would be required to make and keep records demonstrating with adequate assurance that the fermented or hydrolyzed ingredients are “gluten-free” in compliance with § 101.91(a)(3).

    We would expect that, in some cases, this adequate assurance would include test results or a certificate of analysis for the food or ingredients before fermentation or hydrolysis. Other verification procedures may be appropriate in some circumstances. We expect that the accuracy and reliability of any certificate of analysis would be verified based on initial qualification and periodic requalification of the supplier through testing of the ingredient with sufficient frequency to ensure the material contains less than 20 ppm gluten. Likewise we expect that the ingredients used would be tested with sufficient frequency to ensure the material contains less than 20 ppm gluten.

    The content of the records demonstrating adequate assurance that source materials are in compliance with § 101.91(a)(3) before fermentation or hydrolysis may depend on the potential for gluten cross-contact. For example, as discussed in section I.G., a manufacturer of a grain product, such as corn breakfast cereal, may keep different records than a manufacturer of a fruit-flavored yogurt product.

    Specifically, the proposed rule would renumber § 101.91(c) as § 101.91(c)(1) and would create new paragraphs (c)(2), (c)(3), and (c)(4) to explain that, when an appropriate method to verify compliance with the gluten-free regulation is not available because the food is fermented or hydrolyzed or contains one or more ingredients that are fermented or hydrolyzed, the manufacturer of the food bearing the “gluten-free” claim must make and keep certain records. Proposed § 101.91(c)(5) would describe how FDA would evaluate compliance for distilled foods.

    A. For foods fermented or hydrolyzed by the manufacturer, what records must be kept? What must the records demonstrate? (Proposed § 101.91(c)(2))

    Due to the unavoidable presence of gluten that may occur through gluten cross-contact in food ingredients or during manufacturing, the proposed rule would require that the manufacturer of foods fermented or hydrolyzed by the manufacturer and bearing the “gluten-free” claim make and keep records. The records are to provide adequate assurance that the food or its ingredients are “gluten-free” in compliance with § 101.91(a)(3) before fermentation or hydrolysis and that gluten is not introduced during the manufacturing process. If the food or its ingredients comply with § 101.91(a)(3) before fermentation or hydrolysis, and gluten is not introduced during the manufacturing process, the resulting fermented or hydrolyzed food should meet the definition of “gluten-free.”

    1. What records must be kept regarding food before fermentation or hydrolysis? (Proposed § 101.91(c)(2)(i))

    The records described in proposed § 101.91(c)(2)(i) must provide adequate assurance that the food or its ingredients comply with § 101.91(a)(3) before fermentation or hydrolysis. Thus, the records must provide adequate assurance that the ingredients are not gluten-containing grains (e.g., spelt wheat), and are not derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour) or not derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food. Further, the records must provide adequate assurance that any unavoidable presence of gluten in the food is below 20 ppm gluten.

    The assurances could include records of test results conducted by the manufacturer or an ingredient supplier, CoAs, or other appropriate verification documentation for the food itself or each of the ingredients used in the food. We would expect manufacturers of fermented or hydrolyzed foods that bear the “gluten-free” claim, as part of their routine operations, to test their food or ingredients with sufficient frequency to ensure that the gluten level in the food or in each ingredient is below 20 ppm before fermentation or hydrolysis. This testing could include a single record from testing the food before fermentation or hydrolysis (i.e. testing milk before fermentation into yogurt), or could include separate test result records regarding each ingredient, depending on the type of food being produced.

    Alternatively, as we noted in the preamble to the final rule (78 FR 47154 at 47167), manufacturers, as part of routine operations, may rely on records, such as CoAs, from their suppliers to determine that each ingredient is below 20 ppm gluten. A CoA is a document indicating specified test results performed on product(s) by a qualified laboratory that has certified these test results. A CoA should be based on initial qualification and periodic requalification of the supplier with sufficient frequency through review of the supplier's documentation and practices.

    Similarly, other appropriate verification documentation could provide adequate assurance that a manufacturer has adequately ensured the food or ingredients comply with § 101.91(a)(3). We tentatively conclude that it is appropriate to allow a manufacturer to use any means of verification that it can develop, as long as the manufacturer can document that such verification provides adequate assurance that the ingredients comply with § 101.91(a)(3). We anticipate that most manufacturers will receive at least some ingredients from outside suppliers. For ingredients that they receive from outside suppliers, manufacturers may document a visit to a supplier's facility, review a supplier's records, and review written documentation from a supplier to verify the compliance of the ingredients they receive. We invite comment on other ingredient verification methods that may be appropriate.

    The proposed rule would not specify the types of records to be kept, so the manufacturer could, for example, create the records itself regarding the ingredients that it uses or, if it obtains ingredients from a supplier, maintain records or CoAs it obtains from a supplier. The types of records may also vary based on the type of food or ingredients used. For example, a manufacturer of fermented or hydrolyzed foods from non-gluten-containing grains, legumes, or seeds that are susceptible to cross-contact with gluten-containing grains bearing the “gluten-free” claim may be more likely to choose to obtain a CoA from the ingredient suppliers or test the ingredients before fermentation and maintain records of the test results. A manufacturer of products bearing the “gluten-free” claim made from inherently gluten-free ingredients, such as milk, or fruit, that have a low probability of cross-contact with gluten-containing grains, may be more likely to use other appropriate verification documentation.

    2. What records must be kept to address gluten cross-contact? (Proposed § 101.91(c)(2)(ii) and (iii))

    As we discussed in the preamble to the final rule (78 FR 47154 at 47173), we expect foods bearing the “gluten-free” claim to be manufactured using whatever controls are necessary to prevent cross-contact with all gluten sources and to ensure that any amount of gluten that may be present in the food from gluten cross-contact is as low as possible and that the food has less than 20 ppm gluten.

    To help address potential gluten cross-contact during the manufacturing process, proposed § 101.91(c)(2)(ii) and (iii) would require that a manufacturer wishing to use a “gluten-free” claim on a product that they ferment or hydrolyze make and keep records that provide adequate assurance that:

    • The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact during the manufacturing process; and

    • where the potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

    We expect manufacturers of foods bearing the “gluten-free” claim to take proper precautions to reduce the potential for gluten cross-contact of food, food ingredients, or food-contact surfaces. This may include careful examination of all phases of their operations, including, for example, transportation and storage of ingredients and finished products and the use of additional manufacturing controls that can prevent gluten cross-contact situations. For example, manufacturers may use physical barriers (such as walls, curtains, or distance) or air handling as a means of isolating the production line and by cleaning and sanitizing equipment between production runs.

    In order to provide adequate assurance that they have evaluated their processing for the potential for gluten cross-contact, we expect manufacturers to document their determination regarding the potential for gluten cross-contact as well as the reasoning and/or support for their determination. In order to provide adequate assurance that they have implemented measures to prevent the introduction of gluten during the manufacturing process, we expect manufacturers to document the measures they are using as well as how they determined what measures to use and how those measures prevent gluten cross-contact. Again, the types of records that would provide adequate assurance for ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.

    B. For foods that contain one or more fermented or hydrolyzed ingredients, what records must be kept? What must the records demonstrate? (Proposed § 101.91(c)(3))

    When a scientifically valid method is not available that equates the test results in terms of intact gluten because the food contains one or more ingredients that are fermented or hydrolyzed, proposed § 101.91(c)(3) would require the manufacturer of such foods bearing the claim to make and keep records providing adequate assurance that that the fermented or hydrolyzed ingredients are “gluten-free.” When the entire food is not hydrolyzed or fermented, the analytical methods discussed in the current “gluten-free” regulation at § 101.91(c) would be able to detect intact gluten that had been introduced through the manufacturing process or through ingredients that were not hydrolyzed or fermented. Therefore, we are only proposing to require records regarding the specific ingredients that have been fermented or hydrolyzed.

    For an ingredient that was fermented or hydrolyzed by a supplier, one way for the manufacturer of a food bearing the “gluten-free” claim to provide adequate assurance that the ingredient is “gluten-free” would be to obtain records from that supplier supporting that the ingredient meets the definition of “gluten-free,” including that the ingredient was manufactured or processed to avoid gluten cross-contact and to contain less than 20 ppm gluten. Adequate assurance regarding the ingredients fermented or hydrolyzed by an ingredient supplier can include documentation regarding the supplier's manufacturing procedures, records of test results from tests conducted by the ingredient supplier on the components of the ingredient before fermentation or hydrolysis, CoAs, or other appropriate documentation provided by the ingredient supplier for the fermented or hydrolyzed ingredient. As discussed previously in section II.A.1, the types of records that would provide adequate assurance for ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.

    Manufacturers may wish to verify the accuracy and reliability of these records by checking whether and how the supplier of the ingredient documents that the components used in the fermented or hydrolyzed ingredient each meet the definition of “gluten-free,” including that the supplier manufactured or processed the ingredient to avoid gluten cross-contact and contain less than 20 ppm gluten before fermentation or hydrolysis. In addition, manufacturers may wish to verify records documenting the supplier's manufacturing or processing with regard to concentration.

    C. How must records be maintained and made available? (Proposed § 101.91(c)(4))

    Proposed § 101.91(c)(4) would establish the timeframe for keeping records and making them available to FDA. In brief, the proposed rule would:

    • Require the records be retained for 2 years after introduction or delivery for introduction of the food into interstate commerce;

    • allow records to be kept as original records, true copies, or as electronic records; and

    • state that the records must be available to FDA for examination and copying during an inspection upon our request.

    Proposed § 101.91(c)(4) would establish a minimum 2-year recordkeeping period because we consider 2 years to be a reasonable period of time for most foods to be available for purchase in the marketplace. Such a time period is consistent with other FDA regulations, but we invite comment on whether we should use a different recordkeeping period. In addition, the records may be kept in any format, paper or electronic, provided they contain all the necessary information. Paper records can include true copies such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records. All electronic records maintained under § 101.91 would need to comply with part 11 (21 CFR part 11). The use of electronic records is voluntary and thus, a paper record system could be used to comply with the proposed recordkeeping requirements. The proposed requirements for electronic records extend to electronic signatures. We issued final guidance for industry on this topic. The guidance, entitled “Part 11, Electronic Records; Electronic Signatures Scope and Application,” sets out our enforcement policies with respect to certain aspects of part 11. The guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm. This guidance would apply to any electronic record, including electronic signatures, established or maintained to meet a proposed requirement in this rule, if finalized as proposed. This would give manufacturers the maximum flexibility to use whatever recordkeeping system they find most appropriate. We request comment on the proposed requirements for the types of records that must be made and kept and the length of time that the records must be kept.

    The proposal also would state that the records must be made available to us for examination or copying during an inspection upon request; this is consistent with our other recordkeeping regulations (see, e.g., 21 CFR 111.605 and 111.610). The records would need to be reasonably accessible to FDA during an inspection at each manufacturing facility (even if not stored onsite) to determine whether the food has been manufactured and labeled in compliance with § 101.91. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible. We anticipate that manufacturers may have questions about the confidentiality of the information inspected by us under this proposal. We would protect confidential information from disclosure, consistent with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR part 20.

    D. What are the requirements for distilled products? (Proposed § 101.91(c)(5))

    If good manufacturing practices are followed, the process of distillation itself removes all protein. Scientifically valid methods to measure the protein content should find no detectable protein present and thus no gluten in distilled ingredients or distilled foods. The detection of any protein indicates poor manufacturing practices or controls and could point to the potential presence of gluten in the distilled ingredient or product. Likewise, the absence of protein or protein fragments in the distilled product should mean that the product's gluten level is below 20 ppm.

    Consequently, proposed § 101.91(c)(5) would provide that, when a food or ingredient bearing the “gluten-free” claim is distilled, we will evaluate compliance by verifying the absence of protein in the food or ingredient using a scientifically valid method that can reliably detect the presence or absence of protein or protein fragments in the food. When choosing a method that will verify the absence of protein, among the factors that need to be considered is the sensitivity of the test method for this purpose, such as a limit of detection as close to zero as possible.

    The detection of any protein or protein fragments in the food or ingredient may indicate poor manufacturing controls and indicate the presence of gluten in the distilled ingredient or product. We invite comment, especially including data, concerning the effectiveness of good manufacturing practices on distillation. We also invite comment, especially including data, concerning the effectiveness of other processes that can be used to remove gluten from food ingredients or food products. We also invite comment on measures food manufacturers of distilled products or products containing distilled ingredients can take to ensure that the distilled product or distilled ingredients do not contain protein or protein fragments.

    E. What are the conforming changes? (Proposed § 101.91(b)(1) and (2))

    The proposed rule would make two conforming changes to § 101.91(b)(1) and (2). In brief, § 101.91(b)(1) states that a food that bears the claim “gluten-free” in its labeling and fails to meet § 101.91(a)(3) (the definition for the term “gluten-free”) will be deemed misbranded. Section 101.91(b)(2) creates a similar requirement if the food bears the claim “no gluten,” “free of gluten,” or “without gluten” and fails to meet § 101.91(a)(3). Because proposed § 101.91(c)(2) through (4) would establish requirements by which we would determine whether fermented foods, hydrolyzed foods, or foods containing a fermented or hydrolyzed ingredient are “gluten-free” within § 101.91, the proposed rule would amend § 101.91(b)(1) and (2) to add, “if applicable, paragraphs (c)(2) through (4) of this section” to the requirements that must be met if the food is not to be deemed misbranded.

    F. Effective and Compliance Dates

    We are proposing that the compliance date for any final rule resulting from this rulemaking be 1 year from the date of its publication. We recognize that we usually establish a uniform compliance date for food labeling changes that occur between specific dates. For example, January 1, 2016, is the next uniform compliance date for food labeling changes for food labeling regulations issued between January 1, 2013, and December 31, 2014 (77 FR 70885, November 28, 2012). In this case, however, we believe there is sufficient justification for establishing the compliance date of 1 year after the date of publication of a final rule, rather than use the next uniform compliance date for other food labeling changes that we periodically establish for such changes.

    We believe that 12 months from the date of publication of the final rule for gluten-free labeling of fermented or hydrolyzed foods is sufficient time for manufacturers of fermented or hydrolyzed foods to review their products to ensure that these foods comply with that final rule or to remove “gluten-free” or similar claims from the label if their foods do not comply. This period of 12 months is consistent with what we have used in the past for compliance with the requirements of voluntary food labeling claims. We believe that waiting until FDA's next uniform compliance date would create an unnecessary delay in the enforcement of a final rule because fermented or hydrolyzed foods bearing the voluntary label claim “gluten-free” that do not comply with FDA's requirements for use of the term “gluten-free” could have an adverse public health impact on persons with celiac disease who may be consuming those foods.

    Therefore, we propose to establish the compliance date to enforce the provisions of a final rule for the gluten-free labeling of fermented or hydrolyzed foods as 1 year after the date of publication of the final rule in the Federal Register. By that time, manufacturers of fermented or hydrolyzed foods labeled with the “gluten-free” claim would have to comply with the final rule. We also propose an effective date of 30 days after publication in the Federal Register.

    III. What is our legal authority for this proposed rule?

    Section 206 of FALCPA directs the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, to issue a proposed rule to define, and permit use of, the term “gluten-free” on the labeling of foods. Section 403(a)(1) of the FD&C Act states that, “A food shall be deemed to be misbranded if its labeling is false or misleading in any particular.” In determining whether food labeling is misleading, section 201(n) of the FD&C Act explicitly provides for consideration of the extent to which the labeling fails to reveal facts “material with respect to the consequences which may result from the use of the [food] to which the labeling * * * relates under * * * such conditions of use as are customary or usual.” Section 701(a) of the FD&C Act vests the Secretary (and by delegation, FDA) with authority to issue regulations for the efficient enforcement of the FD&C Act. Consistent with section 206 of FALCPA and sections 403(a)(1), 201(n), and 701(a) of the FD&C Act, we are proposing requirements for the use of the term “gluten-free” for hydrolyzed and fermented foods.

    The proposed rule would establish requirements concerning records necessary to ensure compliance with our “gluten-free” labeling regulation for fermented or hydrolyzed food or that which contains a fermented or hydrolyzed ingredient. For these foods, there is no scientifically valid analytical method available that can reliably detect and accurately quantify the equivalent of 20 ppm intact gluten in the food. In enacting FALCPA, Congress recognized the importance to individuals with celiac disease of avoiding gluten (section 202(6)(B) of FALCPA). Therefore, defining the requirements for using the term “gluten-free” in the labeling of fermented or hydrolyzed foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled.

    We are proposing requirements for manufacturers to make and keep records containing information that provides adequate assurance that their food complies with the definition of “gluten-free,” including information that they gather or produce about their ingredients and the details of their manufacturing practices. These proposed record requirements would help ensure that the use of the term “gluten-free” is accurate, truthful, and not misleading based on information known to the manufacturer that FDA would not otherwise be able to access and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where we have found such records to be necessary (National Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir. 1978)). The records we propose to require are only for foods for which an adequate analytical method is not available. The records would allow us to verify that the “gluten-free” claim on foods that are hydrolyzed or fermented or contain hydrolyzed or fermented ingredients is truthful and complies with the requirements of the definition. Thus, the proposed records requirements would help in the efficient enforcement of the FD&C Act.

    The authority granted to us under sections 701(a), 403(a)(1), and 201(n) of the FD&C Act not only includes authority to establish records requirements, but also includes access to such records. Without such authority, we would not know whether the use of the term “gluten-free” on the label or in the labeling of these foods is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine whether the food is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring be made and kept under sections 403(a)(1), 201(n), and 701(a) of the FD&C Act. Failure to make and keep records and provide the records to FDA, as described in proposed § 101.91(c)(4), would result in the food being misbranded under sections 403(a)(1) and 201(n) of the FD&C Act.

    IV. What is the analysis of impacts—Preliminary Regulatory Impact Analysis A. Overview

    FDA has examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a preliminary regulatory impact analysis (PRIA) that presents the benefits and costs of this proposed rule (Ref. 16). FDA believes that the proposed rule will not be an economically significant regulatory action as defined by Executive Order 12866. FDA requests comments on the PRIA.

    The summary analysis of benefits and costs included in this document is drawn from the detailed PRIA (Ref. 16), which is available to the public in the docket for this proposed rule at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021), and is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because many small businesses may need to implement a number of new testing and recordkeeping activities, FDA acknowledges that the proposed rule, if finalized, will have a significant economic impact on a substantial number of small entities.

    C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, OMB has determined that this proposed rule, if finalized, is not a major rule for the purpose of congressional review.

    D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA expects that the proposed rule, if finalized, will not result in a 1-year expenditure that would exceed this amount.

    E. Public Access to the Analyses

    The analyses that FDA has performed in order to examine the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) are available to the public in the docket for this proposed rule (Ref. 16) at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021).

    V. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in this section of the document with an estimate of the annual recordkeeping burden. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

    We invite comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Recordkeeping Requirements for Gluten-Free Labeling of Fermented or Hydrolyzed Foods.

    Description of Respondents: Manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.”

    Description: If the rule is finalized as proposed, we would require manufacturers of food products covered by the rule to make and keep records providing adequate assurance that: (1) The food is gluten-free before fermentation or hydrolysis; (2) the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and (3) if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process.

    Manufacturers using an ingredient that is a hydrolyzed or fermented food only would be required to make and keep these records for the hydrolyzed or fermented ingredient. We estimate that the manufacturers would satisfy the recordkeeping requirements of this proposed rule, if finalized, by maintaining records of their tests or other appropriate verification procedures, their evaluation of the potential for gluten cross contact, and their standard operating procedures (SOPs) for preventing gluten cross-contact. It is also possible that manufacturers would instead comply with this proposed rule by obtaining and maintaining records of Certificates of Analysis, test results, or other appropriate verification procedures from their suppliers.

    Written SOPs and records of testing and other activities are essential for FDA to be able to determine compliance with § 101.91 (the gluten-free regulation) for these products. Records would need to be reasonably accessible at each manufacturing facility and could be examined periodically by FDA inspectors during an inspection to determine whether the food has been manufactured and labeled in compliance with § 101.91 Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible.

    We estimate the burden of this collection of information as follows: We base our estimates of the average burden per recordkeeping on our experience with good manufacturing practices used to control the identity and composition of food and to limit contaminants and prevent adulteration. The hour estimates for the recordkeeping burdens presented here are averages. We anticipate that the records kept would vary based on the type of ingredients used. Some manufacturers, such as those producing fermented dairy products, would likely maintain fewer records overall. Other manufacturers, such as those producing foods with fermented or hydrolyzed grains, legumes, or seeds, would likely maintain more extensive records.

    Our estimates of the numbers of manufacturers/recordkeepers reported in column 2 of tables 1 and 2 are based on the number of food products that would be covered by the proposed rule. We searched the FoodEssentials database (Ref. 3) for foods that are hydrolyzed, fermented, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten,” and found about 2,500 products that would be affected by the proposed rule. We estimate that this database has at least half of all products that would be covered by the proposed rule, so that there would be, at most, 5,000 products affected by the proposed rule.

    We do not have any data about how many products are produced in each facility, so we assume that each product and its production line would be tested separately and would require a separate evaluation and SOP. Thus, we estimate the number of food production facilities and, accordingly, the number of manufacturers/recordkeepers to be 5,000. If multiple products are produced in the same facility and can share testing, evaluation, and SOPs, then the recordkeeping burden would be less than these estimates.

    We do not know how many of these products are already being manufactured using gluten-free ingredients and/or with a process designed to prevent gluten introduction. A survey of food industry practices (Ref. 17) shows that about 45 percent of all food production facilities have a written allergen control plan, and about 39 percent require certificates of analysis for ingredients. Given that producers of foods labeled “gluten-free” are marketing to customers who care more about gluten cross-contact, we estimate that about 75 percent of the 5,000 foods with a “gluten-free” labeling claim already have a written plan for preventing the introduction of gluten into the food product that includes the testing of ingredients and also procedures for evaluating and preventing gluten cross-contact. Therefore, we estimate that 1,250 facilities would incur new SOP development and ingredient testing burdens and all 5,000 facilities would incur certain new recordkeeping burdens.

    Recordkeeping Burden Related to Standard Operating Procedures

    We estimate that 1,250 facilities do not have a written SOP for preventing the introduction of gluten into the food product. For these facilities, developing an SOP would be a first year burden of the proposed rule. We estimate that it would take a facility an average of 7 hours to develop an SOP for gluten control. Thus, we estimate that in the first year of compliance with the proposed rule if finalized, 1,250 facilities would develop an SOP for a burden of 8,750 hours (1,250 × 7 = 8,750), as reported in table 1, row 1.

    Updating the facility's SOP for gluten control would be a recurring burden of the proposed rule for the 1,250 facilities that do not currently have an SOP. We estimate that it would take a facility about 0.7 hours (42 minutes) annually to update its SOP for gluten control, for a burden of 875 hours (1,250 × 0.7 = 875), as reported in table 2, row 1.

    We estimate that maintaining records of their updated SOPs would be a recurring burden of the proposed rule for all 5,000 facilities. We estimate that it would take each facility 1 hour annually to maintain records of its updated SOPs for gluten control, for a burden of 5,000 hours (5,000 × 1 = 5,000), as reported in table 2, row 2.

    Recordkeeping Burden Related to Testing

    In order to demonstrate that the food is gluten-free before fermentation or hydrolysis, we expect that most manufacturers would test their incoming ingredients or obtain Certificates of Analysis from their ingredient suppliers. A manufacturer may test their ingredients for gluten by sending ingredient samples to a testing company or by using test kits to test ingredient samples on site at their facility. Test kits would first undergo method validation for the testing situation in which they are to be used (Ref. 18). We assume that a manufacturer that begins a program of testing the gluten content of an ingredient will start by sending several samples to a lab and obtaining method extension for a test kit for the ingredient. Obtaining a validation for a test kit is a first-year burden only.

    After the first year of testing, we assume the manufacturers would then use test kits to test the ingredient on a regular basis, and may also send one or two samples a year to an outside lab for testing. These are recurring testing burdens. We estimate that an average of two ingredients per product would be tested in this manner. Most foods affected by this proposed rule are those that contain a single hydrolyzed or fermented ingredient, so any testing would have been done by the ingredient supplier before that supplier performed hydrolysis or fermentation. Other products contain several ingredients that would be tested before fermentation or hydrolysis.

    In the first year of compliance, we estimate that the 1,250 manufacturers not currently testing their ingredients and production facilities for gluten and would incur additional testing burdens as a result of the proposed rule. For these manufacturers, obtaining a method extension for a test kit would be a first year burden of the proposed rule. We estimate that 1,250 manufacturers would conduct seven tests for method extension, for each of two ingredients, for a total of 14 samples. We estimate that it would take a manufacturer 5 minutes to collect each sample, for a total of 1,453 hours (1,250 × 14 × (5 ÷ 60) = 1,453) as reported in table 1, row 2. We estimate that this proposed rule would result in manufacturers conducting 17,500 laboratory tests in the first year (1,250 × 14 = 17,500). These tests have an average cost of $84.33, which means that the estimated capital costs related to this first year paperwork burden is about $1.5 million (17,500 × $84.33 = $1,475,833) as reported in table 1, row 2.

    We estimate that, as a first year burden of the proposed rule if finalized, all 5,000 manufacturers would begin retaining records of the method extension tests. We estimate that it would take a manufacturer 30 minutes per record, for a total of 35,000 hours (5,000 × 14 × 0.5 = 35,000), as reported in table 1, row 3.

    We estimate that testing ingredients on a regular basis would be a recurring burden of the proposed rule, if finalized, for the 1,250 manufacturers not currently testing their ingredients and production facilities for gluten. We estimate that 1,250 manufacturers will use 21 test kits annually on average per ingredient, for a total of 42 kits, and that each test will require 5 minutes to collect a sample and 30 minutes to process and file the test results. We estimate that the burden of collecting samples for these tests would be 4,358 hours (1,250 × 21 × (5 ÷ 60) = 4,358), as reported in table 2, row 3. We estimate that this proposed rule, if finalized, would result in manufacturers using 52,500 test kits each year (1,250 × 42 = 52,500). These test kits have an average cost of $11, which means that the estimated capital costs related to this recurring paperwork burden is about $0.6 million (52,500 × $11 = $577,500), as reported in table 2, row 3. We estimate the burden to process and maintain records of the test results would be 105,000 hours (5,000 × 42 × 0.5 = 105,000), as reported in table 2, row 4.

    We estimate that a recurring burden of the proposed rule, if finalized, for all 5,000 manufacturers would be to send one or two samples a year to an outside lab for testing. We estimate that 5,000 manufacturers will conduct one outside test annually on average per ingredient, for a total of 2 tests, and that each test will require 5 minutes to collect a sample and 30 minutes to process and file the test results. We estimate that the burden of collecting samples for these tests would be 208 hours (1,250 × 2 × (5 ÷ 60) = 208), as reported in table 2, row 5. We estimate that this proposed rule would result in manufacturers conducting 2,500 laboratory tests in the first year (1,250 × 2 = 2,500). These tests have an average cost of $84.33, which means that the estimated capital costs related to this recurring paperwork burden is about $0.2 million (2,500 × $84.33 = $210,833), as reported in table 3, row 5. We estimate the burden to process and maintain records of the test results would be 5,000 hours (5,000 × 2 × 0.5 = 5,000), as reported in table 2, row 6.

    Table 1—Estimated First Year Recordkeeping Burden Activity/Proposed 21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Capital costs
  • (USD Millions)
  • Developing an SOP for gluten control; proposed 101.91(c)(2) and (3) 1,250 1 1,250 7 8,750 0 Collecting samples for testing; proposed 101.91(c)(2) and (3) 1,250 14 17,500 0.083 (5 minutes) 1,453 $1.5 Maintaining records of method extension tests; proposed 101.91(c)(2) and (3) 5,000 14 70,000 0.5 (30 minutes) 35,000 0 Total 45,203 $1.5 There are no operating or maintenance cost associated with this collection information.
    Table 2—Estimated Recurring Recordkeeping Burden Activity/Proposed 21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Capital costs
  • (USD Millions)
  • Updating SOP for gluten control; proposed 101.91(c)(2) and (3) 1,250 1 1,250 0.7 (42 minutes) 875 0 Maintaining records of the updated SOP for gluten control; proposed 101.91(c)(2) and (3) 5,000 1 5,000 1 5,000 0 Collecting samples for test kit testing; proposed 101.91(c)(2) and (3) 1,250 42 52,500 0.083 (5 minutes) 4,358 $0.6 Maintaining records of test kit test results; proposed 101.91(c)(2) and (3) 5,000 42 210,000 0.5 (30 minutes) 105,000 0 Collecting samples for testing by an outside lab; proposed 101.91(c)(2) and (3) 1,250 2 2,500 0.083 (5 minutes) 208 $0.2 Maintaining records of testing by an outside lab; proposed 101.91(c)(2) and (3) 5,000 2 10,000 0.5 (30 minutes) 5,000 0 Total 120,441 $0.8 1 There are no operating or maintenance costs associated with this collection of information.

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), we have submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to send comments regarding information collection by January 19, 2016, to the Office of Information and Regulatory Affairs, OMB.

    To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the title “Recordkeeping Requirements for Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods.” These requirements will not be effective until we obtain OMB approval. We will publish a notice concerning OMB approval of these requirements in the Federal Register.

    VI. What is the environmental impact of this rule?

    We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VII. What are the federalism impacts of this rule?

    We have analyzed the proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of Executive Order 13132 requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Here, as in the final rule published in the August 5, 2013, issue of the Federal Register (78 FR 47154 at 47175), we have determined that certain narrow exercises of State authority would conflict with the exercise of Federal authority under the FD&C Act.

    In section 206 of FALCPA, Congress directed us to issue a proposed rule to define and permit use of the term “gluten-free” on the labeling of foods, in consultation with appropriate experts and stakeholders, to be followed by a proposed rule for the use of such term in labeling. In the preamble to the proposed rule regarding the “gluten-free” labeling of foods (72 FR 2795 at 2813 through 2814), we indicated that we had consulted with numerous experts and stakeholders in the proposed rule's development and in the final rule we determined that certain narrow exercises of State authority would conflict with the exercise of Federal authority under the FD&C Act. Different and inconsistent amounts of gluten in foods with “gluten-free” labeling result in the inability of those individuals with celiac disease who adhere to a gluten-free diet to avoid exposure to gluten at levels that may result in adverse health effects. “Gluten-free” labeling, for purposes of this discussion, also includes the use of the terms “no gluten,” “free of gluten,” and without gluten,” as indicated in § 101.91(b)(2). There is a need for national uniformity in the meaning of the term “gluten-free,” which includes the manner in which the definition is enforced, so that most individuals with celiac disease can make informed purchasing decisions that will enable them to adhere to a diet they can tolerate without causing adverse health effects and can select from a variety of available gluten-free foods.

    This proposed rule would establish additional requirements for manufacturers of hydrolyzed and fermented foods or foods that contain hydrolyzed and fermented ingredients wishing to use the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” on their products, thus these requirements are a component of how we permit the use of the “gluten-free” claim. If States were able to establish different requirements regarding what manufacturers of hydrolyzed and fermented foods would need to demonstrate in order to use the term “gluten-free,” then individuals with celiac disease would not be able to rely on a consistent meaning for that term and thereby use the term to identify appropriate dietary selections. As a result, individuals with celiac disease may unnecessarily limit their food choices, or conversely, select foods with levels of gluten that are not tolerated and that may cause adverse health effects. Food manufacturers, if confronted by a State or various State requirements that adopted different requirements for hydrolyzed and fermented foods than this proposed rule, might decide to remove the “gluten-free” label, and such a result would make it more difficult for individuals with celiac disease to identify foods that they can tolerate and achieve a dietary intake from a variety of foods to meet an individual's nutrient needs. Moreover, consistent requirements regarding the way compliance with the final rule is determined, including the records that would need to be maintained in order for a hydrolyzed or fermented food manufacturer to use the “gluten-free” claim and the use of a scientifically valid method to detect the absence of protein to determine compliance for distilled products, enables us to more efficiently enforce the use of the “gluten-free” claim across all hydrolyzed and fermented foods to ensure labels bearing a “gluten-free” claim are truthful and not misleading.

    Therefore, the objective of this proposed rule is standardizing use of the term “gluten-free” in the labeling of hydrolyzed and fermented foods so that foods with this claim in labeling, and foods with a claim of “no,” “free of,” and “without” gluten, which connote a similar meaning to that of “gluten free,” are used in a consistent way and will therefore prevent consumer confusion and assist individuals with celiac disease to make purchasing decisions.

    Section 4(c) of Executive Order 13132 instructs us to restrict any Federal preemption of State law to the “minimum level necessary to achieve the objectives of the statute pursuant to which the regulations are promulgated.” The proposed rule meets the preceding requirement because it would preempt State law narrowly, only to the extent required to achieve uniform national labeling with respect to the requirements related to the use of the term “gluten-free,” as well as the terms “no gluten,” “free of gluten,” or “without gluten” on hydrolyzed and fermented foods. As we explain later in this section, we are proposing to preempt State or local requirements only to the extent that they are different from the requirements in this section related to the use of the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” for hydrolyzed and fermented foods. In addition, we cannot foresee every potential State requirement and preemption that may arise if a State requirement is found to obstruct the federal purpose articulated in this proposed rule. This proposed rule, like the final rule, is not intended to preempt other State or local labeling requirements with respect to other statements or warnings about gluten. For example, a State would still not be preempted from requiring a statement about the health effects of gluten consumption from hydrolyzed and fermented foods on persons with celiac disease or information about how the food was processed.

    Section 4(d) of Executive Order 13132 states that when an Agency foresees the possibility of a conflict between State law and federally protected interests within the Agency's area of regulatory responsibility, the Agency “shall consult, to the extent practicable, with appropriate State and local officials in an effort to avoid such a conflict.” Section 4(e) of Executive Order 13132 provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA's Division of Federal and State Relations will invite the States' participation in this rulemaking by providing notice via fax and email transmission to State health commissioners, State agriculture commissioners, and State food program directors as well as FDA field personnel of the publication of the proposed rule.

    In 2009, the President issued a memorandum entitled “Preemption” (74 FR 24693, May 22, 2009). The memorandum, among other things, instructs Agencies to “not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation” and “not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132”. Because of the May 22, 2009, memorandum we explain in detail the principles underlying our conclusion that this proposed rule may result in preemption of State and local laws under a narrow set of circumstances and describe how the final rule's codified provision regarding preemption, which is now § 101.91(d), would apply to hydrolyzed and fermented foods.

    Under the Supremacy Clause of the Constitution (U.S. Constitution; Art. VI, clause 2), State laws that interfere with or are contrary to Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824).) Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. For example, Federal preemption may be found where Federal law conflicts with State law. Such conflict may be demonstrated either when “compliance with both federal and state [law] is a physical impossibility” (Florida Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963)), or when State law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74 (2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals. (See Int'l Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v. Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984).)

    Additionally, ” 'a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation' and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law” (City of New York v. FCC, 486 U.S. 57, 63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 355, 369 (1986)). “Federal regulations have no less preemptive effect than federal statutes” (Fidelity Federal Savings and Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982)).

    When an Agency's intent to preempt is clearly and unambiguously stated, a court's inquiry will be whether the preemptive action is within the scope of that Agency's delegated authority (Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal Savings, 458 U.S. at 154). If the Agency's choice to preempt “represents a reasonable accommodation of conflicting policies that were committed to the agency's care by the statute [the regulation will stand] unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned” (United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough County, the Supreme Court stated that FDA possessed the authority to issue regulations preempting local laws that compromise the supply of plasma and could do so (Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have similar authority to preempt State and local laws and regulations to the limited extent that they permit use of “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” for hydrolyzed and fermented foods differently from our proposed rule because different State or local requirements would be contrary to the Congressional directive for us to define and permit use of the term “gluten-free.”

    State or local laws or regulations that permit use of “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” differently from our proposed rule could frustrate the ability of most consumers to identify gluten-free foods and avoid adverse health effects and deter manufacturers from applying a “gluten-free” label to their foods. With the proposed rule, consumers throughout the United States can understand what is required to use the term “gluten-free” on a hydrolyzed or fermented packaged food. The proposed rule will also allow us to enforce more efficiently the definition on product labels of hydrolyzed and fermented foods, and manufacturers will be able to comply with a single set of requirements, which may lead to greater use of this voluntary labeling.

    Therefore, we intend to preempt State or local requirements only to the extent that they are different from the proposed requirements related to the use of the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” on fermented or hydrolyzed foods, including the requirement to make and keep certain records and the use of a scientifically valid method to detect the absence of protein for distilled foods. There is no proposed change to § 101.91(d) regarding preemption, but these new proposed requirements in § 101.91(c) would become part of the requirements covered by § 101.91(d).

    VIII. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. Ciclitira, P. J., D. Evans, and N. Fagg, “Clinical Testing of Gliadin Fractions in Coeliac Patients,” Clinical Science, 66: 357-364, 1984.

    2. Garber, E. A. E., Memorandum to the Administrative Record, “Standards Used to Detect and Quantify Fermented and Hydrolyzed Gluten in Foods,” August 25, 2015.

    3. FoodEssentials. Product Label Database. Online version available at: http://labelbase.foodessentials.com/index.jsp.

    4. Belitz, H.-D., W. Grosch, and P. Schieberle, Food Chemistry, Berlin: Springer, pp. 141-142, 2009.

    5. Ciccocioppo, R., A. Di Sabatino, and G. R. Corazza, “The Immune Recognition of Gluten in Coeliac Disease,” Clinical and Experimental Immunology, 140(3):408-416, 2005.

    6. Mena, M. C., M. Lombardia, A. Hernando, et al., “Comprehensive Analysis of Gluten in Processed Foods Using a New Extraction Method and a Competitive ELISA Based on the R5 Antibody,” Talanta, 91(15):33-40, 2012, available at http://dx.doi.org/10.1016/j.talanta.2011.12.073.

    7. Kohler, P., T. Schwalb, U. Immer, et al., “AACCI Approved Methods Technical Committee Report: Collaborative Study on the Immunochemical Determination of Partially Hydrolyzed Gluten Using an R5 Competitive ELISA,” Cereal Foods World, 58(3):154-158, 2013.

    8. Codex Alimentarius Commission, “Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Standard 118-1979),” Rome, Italy, pp. 1-3, 2008; available at http://www.codexalimentarius.org/download/standards/291/CXS_118e_2015.pdf.

    9. Garber, E. A. E., Memorandum to the Administrative Record, “ELISA Methods Used to Detect Gluten in Foods,” August 25, 2015.

    10. Garber, E. A. E., Memorandum to the Administrative Record, “Use of Proline Endopeptidases to Make Gluten Containing Products Safe for Consumption by Individuals With Celiac Disease,” August 25, 2015.

    11. Panda, R., et al. “Effects of a Proline Endopeptidase on the Detection and Quantification of Gluten by Antibody-based Methods During the Fermentation of a Model Sorghum Beer.” Journal of Agriculture and Food Chemistry, November 7, 2015 (web), accessed at http://pubs.acs.org/doi/abs/10.1021/acs.jafc.5b04205.

    12. Fellows, P.J., “Chapter 4-Evaporation and Distillation,” Food Processing and Technology—Principles and Practice (3d Edition). Woodhead Publishing, 2009. Online version available at http://app.knovel.com/hotlink/toc/id:kpFPTPPE14/food-processing-technology/food-processing-technology.

    13. Food and Drug Administration, Compliance Policy Guide Sec. 525.825, “Vinegar Definitions—Adulteration With Vinegar Eels,” available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074471.htm.

    14. Merriam-Webster.com, Merriam-Webster, n.d. Web, available on January 30, 2014, available at http://www.merriam-webster.com/dictionary/malt vinegar.

    15. United States Department of Agriculture, “Federal Grain Inspection Service,” dated September 1997 and revised April 2004, available at http://www.gipsa.usda.gov/Publications/fgis/broch/fgisbrochure.pdf.

    16. FDA, “Preliminary Regulatory Impact Analysis of Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, July 2014, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    17. Eastern Research Group, 2010 Nationwide Survey of Food Industry Safety Practices, Draft final report, January 10, 2011, ERG for FDA under Contract No. 223-01-2461, task order 7.

    18. Thompson, Tricia, “Should Manufacturers & Consumers Use Lateral Flow Devices (EZ Gluten) to Test Food for Gluten?” Online version available at http://www.glutenfreedietitian.com/should-manufacturers-consumers-use-lateral-flow-devices-ez-gluten-to-test-food-for-gluten/.

    List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is proposed to be amended as follows:

    PART 101—FOOD LABELING 1. The authority citation for 21 CFR part 101 continues to read as follows: Authority:

    15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

    2. In § 101.91, revise paragraphs (b)(1), (b)(2), and (c) to read as follows:
    § 101.91 Gluten-free labeling of food.

    (b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded.

    (2) A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded.

    (c) Compliance. (1) When compliance with paragraph (b) of this section is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.

    (2) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food is fermented or hydrolyzed, the manufacturer of such foods bearing the claim must make and keep records regarding the fermented or hydrolyzed food demonstrating adequate assurance that:

    (i) The food is “gluten-free” in compliance with paragraph (a)(3) of this section before fermentation or hydrolysis;

    (ii) The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact; and

    (iii) Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

    (3) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food contains one or more ingredients that are fermented or hydrolyzed, the manufacturer of such foods bearing the claim must make and keep records demonstrating adequate assurance that that the fermented or hydrolyzed ingredients are “gluten-free” as described in paragraph (c)(2) of this section.

    (4) Records necessary to verify compliance with paragraphs (c)(2) and (3) of this section must be retained for at least 2 years after introduction or delivery for introduction of the food into interstate commerce and may be kept as original records, as true copies, or as electronic records. Manufacturers must provide those records to us for examination and copying during an inspection upon request.

    (5) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food is distilled, FDA will evaluate compliance with paragraph (b) of this section by verifying the absence of protein in the distilled component using scientifically valid analytical methods that can reliably detect the presence or absence of protein or protein fragments in the food.

    Dated: November 10, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-29292 Filed 11-17-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2510 RIN 1210-AB71 Savings Arrangements Established by States for Non-Governmental Employees AGENCY:

    Employee Benefits Security Administration, Department of Labor.

    ACTION:

    Proposed rule.

    SUMMARY:

    This document contains a proposed regulation under the Employee Retirement Income Security Act of 1974 (ERISA) setting forth a safe harbor describing circumstances in which a payroll deduction savings program, including one with automatic enrollment, would not give rise to an employee pension benefit plan under ERISA. A program described in this proposal would be established and maintained by a state government, and state law would require certain private-sector employers to make the program available to their employees. Several states are considering or have adopted measures to increase access to payroll deduction savings for individuals employed or residing in their jurisdictions. By making clear that state payroll deduction savings programs with automatic enrollment that conform to the safe harbor in this proposal do not establish ERISA plans, the objective of the safe harbor is to reduce the risk of such state programs being preempted if they were ever challenged. If adopted, this rule would affect individuals and employers subject to such laws.

    DATES:

    Written comments should be received by the Department of Labor on or before January 19, 2016.

    ADDRESSES:

    You may submit comments, identified by RIN 1210-AB71, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Email: [email protected] Include RIN 1210-AB71 in the subject line of the message.

    Mail: Office of Regulations and Interpretations, Employee Benefits Security Administration, Room N-5655, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Attention: State Savings Arrangements Safe Harbor.

    Instructions: All submissions must include the agency name and Regulatory Identification Number (RIN) for this rulemaking. Persons submitting comments electronically are encouraged to submit only by one electronic method and not to submit paper copies. Comments will be available to the public, without charge, online at www.regulations.gov and www.dol.gov/ebsa and at the Public Disclosure Room, Employee Benefits Security Administration, U.S. Department of Labor, Suite N-1513, 200 Constitution Avenue NW., Washington, DC 20210. WARNING: Do not include any personally identifiable or confidential business information that you do not want publicly disclosed. Comments are public records and are posted on the Internet as received, and can be retrieved by most internet search engines.

    FOR FURTHER INFORMATION CONTACT:

    Janet Song, Office of Regulations and Interpretations, Employee Benefits Security Administration, (202) 693-8500; or Jim Craig, Office of the Solicitor, Plan Benefits Security Division, (202) 693-5600. These are not toll-free numbers.

    SUPPLEMENTARY INFORMATION: A. Background

    Approximately 68 million US employees do not have access to a retirement savings plan through their employers.1 For older Americans, inadequate retirement savings can mean sacrificing or skimping on food, housing, health care, transportation, and other necessities. Inadequate retirement savings place greater stress on state and federal social welfare programs as guaranteed sources of income and economic security for older Americans. Accordingly, states have a substantial governmental interest in taking steps to address the problem and protect the economic security of their residents.2 Concerned over the low rate of saving among American workers, some state governments have already sought to expand access to savings programs for their residents and other individuals employed in their jurisdictions by creating their own programs and requiring employer participation.3

    1 Copeland, Craig, Employment-Based Retirement Plan Participation: Geographic Differences and Trends, 2013, Employee Benefit Research Institute, Issue Brief No. 405 (October 2014) (available at www.ebri.org).

    2See Christian E. Weller, Ph.D., Nari Rhee, Ph.D., and Carolyn Arcand, Financial Security Scorecard: A State-by-State Analysis of Economic Pressures Facing Future Retirees, National Institute on Retirement Security (March 2014) (www.nirsonline.org/index.php?option=com_content&task=view&id=830&Itemid=48).

    3See, for example, Report of the Governor's Task Force to Ensure Retirement Security for All Marylanders, Kathleen Kennedy Townsend, Chair, 1,000,000 of Our Neighbors at Risk: Improving Retirement Security for Marylanders (2015). The Georgetown University Center for Retirement Initiatives (CRI) of the McCourt School of Public Policy has compiled a “50 state survey” providing information on state legislation that would establish state-sponsored retirement savings plans at http://cri.georgetown.edu/states/. The stated mission of the CRI is “[to] strengthen the retirement security of American families by developing and promoting the bipartisan adoption of innovative state policies, legislation and administrative models, such as pooled and professionally managed funds, which will expand the availability and effectiveness of retirement solutions.”

    1. State Payroll Deduction Savings Initiatives

    One approach some states have taken is to establish state payroll deduction savings initiatives. Such programs encourage employees to establish tax-favored individual retirement plans (IRAs) funded by payroll deductions. Oregon, Illinois, and California, for example, have adopted laws along these lines.4 These initiatives generally require specified employers that do not offer workplace savings arrangements to deduct amounts from their employees' paychecks in order that those amounts may be remitted to state-administered IRAs for the employees. Typically, with automatic enrollment, the states would require that the employer deduct specified amounts on behalf of the employee, unless the employee affirmatively elects not to participate. As a rule, employees can stop the payroll deductions at any time. The programs, as currently designed, do not require, provide for or permit employers to make matching or other contributions of their own into the employees' accounts. In addition, the state initiatives typically require that employers act as a conduit for information regarding the program, including disclosure of employees' rights and various program features, often based on state-prepared materials.

    4 Illinois Secure Choice Savings Program Act, 2014 Ill. Legis. Serv. P.A. 98-1150 (S.B. 2758) (West); California Secure Choice Retirement Savings Act, 2012 Cal. Legis. Serv. Ch. 734 (S.B. 1234) (West); Oregon 2015 Session Laws, Ch. 557 (H.B. 2960) (June 2015).

    2. ERISA's Regulation of Employee Benefit Plans

    ERISA defines the terms “employee pension benefit plan” and “pension plan” broadly to mean, in relevant part:

    • Any plan, fund, or program which was heretofore or is hereafter established or maintained by an employer or by an employee organization, or by both, to the extent that by its express terms or as a result of surrounding circumstances such plan, fund, or program—

    ○ provides retirement income to employees, or

    ○ results in a deferral of income by employees for periods extending to the termination of covered employment or beyond, regardless of the method of calculating the contributions made to the plan, the method of calculating the benefits under the plan or the method of distributing benefits from the plan.

    29 U.S.C. 1002(2)(A). The provisions of Title I of ERISA, “shall apply to any employee benefit plan if it is established or maintained . . . by any employer engaged in commerce or in any industry or activity affecting commerce.” 5 29 U.S.C. 1003(a).

    5 ERISA includes several express exemptions in section 4(b) from coverage under Title I, for example, for pension plans established or maintained by governmental entities or churches for their employees, certain foreign plans, unfunded excess benefit plans, and plans maintained solely to comply with applicable state laws regarding workers compensation, unemployment, or disability. 29 U.S.C. 1003(b).

    Despite the express intent of the drafters of those state statutes not to have such a result, some have expressed concern that payroll deduction programs, such as those enacted in Oregon, California and Illinois, may cause employers to establish ERISA-covered plans inadvertently. The Department and the courts have interpreted the term “established or maintained” as requiring minimal involvement by the employer or employee organization to trigger the protections of ERISA coverage. For example, an employer may establish a benefit plan by purchasing insurance products for individual employees.6 Moreover, retirement savings programs involving IRAs also fall within the broad definition of pension plan when those programs are established or maintained by an employer or employee organization.7

    6Donovan v. Dillingham, 688 F.2d 1367 (11th Cir. 1982); Harding v. Provident Life and Accident Ins. Co., 809 F. Supp. 2d 403, 415-419 (W.D. Pa. 2011); DOL Adv. Op. 94-22A (July 1, 1994).

    7 ERISA section 404(c)(2) (simple retirement accounts); 29 CFR 2510.3-2(d) (safe harbor for certain payroll deduction individual retirement accounts); 29 CFR 2509-99-1 (interpretive bulletin on payroll deduction IRAs); Cline v. The Industrial Maintenance Engineering & Contracting Co., 200 F.3d 1223, 1230-31 (9th Cir. 2000).

    Pension plans covered by ERISA are subject to various statutory and regulatory requirements to protect the interests of the plan participants. These include reporting and disclosure rules and stringent conduct standards derived from trust law for plan fiduciaries. In addition, ERISA expressly prohibits certain transactions involving plans unless a statutory or administrative exemption applies.

    Moreover, in order to assure nationwide uniformity of treatment, ERISA places the regulation of private-sector employee benefit plans (including employment-based pension plans) under federal jurisdiction. Section 514(a) of ERISA, 29 U.S.C. 1144(a), provides that the Act “shall supersede any and all State laws insofar as they . . . relate to any employee benefit plan” covered by the statute. The U.S. Supreme Court has long held that “[a] law `relates to' an employee benefit plan, in the normal sense of the phrase, if it has a connection with or reference to such a plan.” Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 96-97 (1983) (footnote omitted). In various decisions, the Court has concluded that ERISA preempts state laws that: (1) mandate employee benefit structures or their administration; (2) provide alternative enforcement mechanisms; or (3) bind employers or plan fiduciaries to particular choices or preclude uniform administrative practice, thereby functioning as a regulation of an ERISA plan itself.8

    8New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 658 (1995); Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 142 (1990); Egelhoff v. Egelhoff, 532 U.S. 141, 148 (2001); Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 14 (1987).

    IRAs generally are not established or maintained by employers or employee organizations, and ERISA coverage is contingent on an employer (or employee organization) establishing or maintaining the arrangement. 29 U.S.C. 1002(1)-(2). The Internal Revenue Code is the principal federal law that governs such IRAs. The Code includes prohibited transaction provisions (very similar to those in ERISA), which are primarily enforced through imposition of excise taxes against IRA fiduciaries by the Internal Revenue Service. 26 U.S.C. 4975.

    In other contexts, the Department has provided guidance to help employers determine whether their involvement in voluntary payroll deduction arrangements for sending employee retirement savings contributions to IRAs would amount to establishing or maintaining ERISA-covered plans. For example, in 1975, the Department promulgated a safe harbor regulation to clarify the circumstances under which IRAs funded by payroll deductions would not be treated as ERISA plans. 29 CFR 2510.3-2(d); 40 FR 34,526 (Aug. 15, 1975). This safe harbor is part of a more general regulation that “clarifies the limits of the defined terms `employee pension benefit plan' and `pension plan' for purposes of title I of the Act . . . by identifying specific plans, funds and programs which do not constitute employee pension benefit plans for those purposes.” 29 CFR 2510.3-2(a). Other similar safe harbors were published in the same Federal Register notice.9

    9 29 CFR 2510.3-1(j), Certain group or group-type insurance arrangements; 29 CFR 2510.3-2(f), Tax sheltered annuities. 40 FR 34530 (Aug. 15, 1975).

    The 1975 regulation provides that ERISA does not cover a payroll deduction IRA arrangement so long as four conditions are met: the employer makes no contributions, employee participation is “completely voluntary,” the employer does not endorse the program and acts as a mere facilitator of a relationship between the IRA vendor and employees, and the employer receives no consideration except for its own expenses.10 In essence, if the employer merely allows a vendor to provide employees with information about an IRA product and then facilitates payroll deduction for employees who voluntarily initiate action to sign up for the vendor's IRA, the arrangement is not an ERISA pension plan.

    10 The payroll deduction IRA safe harbor regulation, 29 CFR 2510.3-2(d), Individual Retirement Accounts.

    In 1999, the Department published additional guidance on this safe harbor in the form of Interpretive Bulletin 99-1. 29 CFR 2509.99-1. This guidance explains that employers may, consistent with the third condition in the regulation, furnish materials from IRA vendors to the employees, answer employee inquiries about the program, and encourage retirement savings through IRAs generally, as long as the employer makes clear to employees its neutrality concerning the program and that its involvement is limited to collecting the deducted amounts and remitting them promptly to the IRA sponsor, just as it remits other payroll deductions to taxing authorities and other third parties. 29 CFR 2510.99-1(c).11

    11 The Department has also issued advisory opinions discussing the application of the safe harbor regulation to particular facts. See, e.g., Advisory Opinion 82-67A (Dec. 21, 1982), 1982 WL 21250; DOL Adv. Op. 84-25A (June 18, 1984), 1984 WL 23439.

    The Department's publication of the 1975 payroll deduction IRA safe harbor was prompted by comments on an earlier proposal indicating “considerable uncertainty concerning Title I coverage of individual retirement programs . . . .” 40 FR 34528. When it promulgated the safe harbor regulation, the Department did not consider payroll deduction savings arrangements for private-sector employees with terms required by state laws. Instead, the payroll deduction IRA safe harbor and the group insurance safe harbor published that day focused on employers acting in coordination with IRA and other vendors, without state involvement. Under those circumstances, it was important for both safe harbors to contain conditions to limit employer involvement, both to avoid establishing or maintaining an employee benefit plan and to prevent undue employer influence in arrangements that would not be subject to ERISA's protective provisions. When a program meets the conditions of the safe harbor, employer involvement in the arrangement is minimal and employees' control of their participation in the program is nearly complete. In such circumstances, it is fair to say that each employee, rather than the employer, individually establishes and maintains the program.

    One of the 1975 payroll deduction IRA safe harbor's conditions is that an employee's participation must be “completely voluntary.” The Department intended this term to mean considerably more than that employees are free to opt out of participation in the program. Instead, the employee's enrollment must be self-initiated. In various contexts, courts have held that opt-out arrangements are not consistent with a requirement for a “completely voluntary” arrangement.12 This condition is important because where the employer is acting on his or her own volition to provide the benefit program, the employer's actions—e.g., requiring an automatic enrollment arrangement—would constitute its “establishment” of a plan within the meaning of ERISA's text, and trigger ERISA's protections for the employees whose money is deposited into an IRA. As a result, state payroll deduction savings initiatives with automatic enrollment do not meet the 1975 safe harbor's “completely voluntary” requirement.

    12See Doe v. Wood Co. Bd. Of Educ., 888 F.Supp.2d 771, 775-77 (S.D. W. Va. 2012) (Education Department regulations requiring “completely voluntary” choice of single-gender education not satisfied by opt-out provision); Schear v. Food Scope America, Inc., 297 F.R.D. 114, 125 (S.D.N.Y. 2014) (“For a voluntary `tip pooling' arrangement to exist, it must be `undertaken by employees on a completely voluntary basis and may not be mandated or initiated by employers' and an employer can take `no part in the organization or the conduct of [the] tip-pool.' ”) (quoting N.Y. Dept. of Labor Opinion Letter RO-08-0049). See also Carter v. Guardian Life Ins. Co., Civil No. 11-3-ART, 2011 WL 1884625, *1 (W.D. Ky. May 18, 2011) (“Courts have held that employees' participation is not `completely voluntary' if their enrollment in the plan is `automatic.' ”); Thompson v. Unum Life Ins. Co., No. Civ.A. 3:03-CV-0277-B, 2005 WL 722717, *6 (N.D. Tex. Mar. 29, 2005) (analyzing group welfare plan safe harbor, “Thompson's participation in the plan was automatic rather than voluntary”); cf. The Meadows v. Employers Health Ins., 826 F. Supp. 1225, 1229 (D. Ariz. 1993) (enrollment not “completely voluntary” where health insurance contract required 75 percent of employees to participate); Davis v. Liberty Mut. Ins. Co., Civ. A. No. 87-2851, 1987 WL 16837, *2 (D.D.C. Aug. 31, 1987) (health insurance enrollment not completely voluntary because employee would receive no alternative compensation for refusing coverage, therefore making refusal comparable to a cut in pay). See generally Advisory Council On Employee Welfare And Pension Benefit Plans, Current Challenges And Best Practices For ERISA Compliance For 403(b) Plan Sponsors (2011) (available at www.dol.gov/ebsa/publications/2011ACreport1.html) (“The Council also considered, but is not recommending, that DOL permit the inclusion of an automatic enrollment feature within the context of an ERISA safe harbor 403(b) plan. The majority of Council members concluded that automatic enrollment would require actions typically performed by a plan sponsor/fiduciary (e.g., designation of a default investment alternative), and consequently, an automatic enrollment option in the plan may not be viewed as voluntary even in light of the participant's right to opt out of the automatic contributions.”). DOL Field Assistance Bulletin (FAB) 2004-1 stated that an employer could open a health savings account (HSA) and deposit employer funds into it without the employee's affirmative consent so long as, among other things, the arrangement was “completely voluntary on the part of the employees” and also that employees exercised control over the account with the power to withdraw or transfer the employer money. FAB 2004-1 was focused on the effect of employer contributions, so there was no specific discussion of what was meant by “completely voluntary” in the context of an HSA. Field Assistance Bulletin 2006-2 clarified that the completely voluntary requirement in FAB 2004-1 related to employee contributions to an HSA and confirms that completely voluntary employee contributions to the HSA must be self-initiated. The only “opt out” considered in FAB 2004-1 was the employees' power to move employer contributions out of the HSA. Neither FAB suggested that employee contributions to an HSA could be completely voluntary under an opt out arrangement.

    However, when a state government sets the terms for and administers a payroll deduction savings arrangement, the situation is far different than when the employer sets the terms and administers the program—the 1975 safe harbor was not written with such state laws in mind. Therefore, the Department is promulgating this new safe harbor that does permit automatic enrollment in such state payroll deduction savings arrangements. Where states require employers to offer savings arrangements, undue employer influence or pressure to enroll is far less of a concern. Moreover, the state's active involvement and the limitations on the employers' role removes the employer from the equation such that the payroll deduction arrangements are not established or maintained by an employer or employee organization within the meaning of ERISA section 3(2). Accordingly, the safe harbor proposed today permits automatic enrollment with an opt-out provision in the context of state required and administered programs that meet the terms of the proposal. The safe harbor should remove uncertainty about Title I coverage of such state payroll deduction savings arrangements by promulgating a “voluntary” standard that permits automatic enrollment arrangements with employee opt-out features. By removing this uncertainty, the objective of the proposed safe harbor is to diminish the chances that, if the issue were ultimately litigated, the courts would conclude that state payroll deduction savings arrangements are preempted by ERISA.

    3. Purpose and Scope of Proposed Regulation

    Section 505 of ERISA gives the Secretary of Labor broad authority to prescribe such regulations as he finds necessary and appropriate to carry out the provisions of Title I of the Act. The Department believes that regulatory guidance in this area is necessary to ensure that governmental bodies, employers, and others in the regulated community have guidelines concerning whether state efforts to encourage savings implicate Title I of ERISA by requiring the establishment or maintenance of ERISA-covered employee pension benefit plans.

    The 1975 payroll deduction IRA safe harbor sets forth standards for judging whether employer conduct crosses the line between permitted ministerial activities with respect to non-plan IRAs and activities that involve the establishment or maintenance of an ERISA-covered plan. State payroll deduction savings initiatives are similar to arrangements covered under the 1975 safe harbor if the employer's involvement is limited to withholding and forwarding payroll deductions and performing other related ministerial duties and the state has sole authority to determine the terms and administration of the state savings arrangement. The 1975 safe harbor, however, does not envision state involvement in the IRA programs nor does it envision use of automatic enrollment and related provisions.

    The proposed regulation thus would provide a new and additional “safe harbor” for state savings arrangements that conform to the proposed regulation's provisions. The proposed regulation departs from the 1975 safe harbor for payroll deduction IRA programs by adopting a standard that enrollment be “voluntary” rather than “completely voluntary.” The new safe harbor's voluntary standard will allow employees' participation in state required programs to be initiated by automatic enrollment with an opt-out provision. The Department is also proposing to add other provisions to assure that employer involvement remains minimal.

    The proposed regulation, however, as a “safe harbor,” does not purport to define every possible program that could fall outside of Title I of ERISA because it was not “established or maintained” by an employer. The Department also is not expressing any view regarding the application of provisions of the Internal Revenue Code (Code).

    B. Description of the Proposed Regulation

    The proposed regulation § 2510.3-2(h) provides that for purposes of Title I of ERISA, the terms “employee pension benefit plan” and “pension plan” do not include an individual retirement plan (as defined in 26 U.S.C. 7701(a)(37)) established and maintained pursuant to a state payroll deduction savings program if the program satisfies all of the conditions set forth in paragraphs (h)(1)(i) through (xii) of the proposed regulation. In the Department's view, compliance with these conditions will assure that the employer's involvement in the state program is limited to the ministerial acts necessary to implement the payroll deduction program as required by state law. In addition, the proposed conditions would give employees sufficient freedom not to enroll or to discontinue their enrollment, as well as meaningful control over their IRAs.

    The term “individual retirement plan” means an individual retirement account described in section 408(a) and an individual retirement annuity described in section 408(b) of the Code.13 Thus, by limiting the safe harbor to programs that use such individual retirement plans (which would include both traditional and Roth IRAs), the proposal incorporates the applicable protections under the Code, including the prohibited transaction provisions.

    13 Whether a state program meets the statutory requirements under the Code is a question within the jurisdiction of the Internal Revenue Service.

    The safe harbor conditions under the proposed regulations require that the program be established by a state government pursuant to state law. As discussed above, if an employer's activities are limited to those ministerial functions required by the state law, the arrangement is not established or maintained by the employer. The term “State” in the proposed regulation has the same meaning as in Title I of ERISA generally. As in section 3(10) of ERISA, a “State” includes any “State of the United States, the District of Columbia,” and certain territories.14 29 U.S.C. 1002(10). The state must also administer the program either directly or through a governmental agency or other instrumentality. The safe harbor also contemplates that a state or the governmental agency or instrumentality could contract with commercial service providers, such as investment managers and recordkeepers, to operate and administer its program.

    14 The term “State” in the proposed regulation has the same meaning as in section 3(10) of ERISA. This would not include Indian tribes, tribal subdivisions, or agencies or instrumentalities of either in coverage under the regulation. To date, the Department is unaware of any tribal initiatives similar to the state initiatives described elsewhere in this preamble. Comments are welcome on whether, on what basis, and under what circumstances, payroll deduction programs required by Indian tribes might be covered under the safe harbor.

    The proposal does not address whether the employees that participate in the program must be employed within the state that establishes the program, or alternatively whether the covered employees must be residents of the state or employed by employers doing business within the state. The extent to which a state can regulate employers is already established under existing legal principles. The proposal simply requires that the program be established by a state pursuant to state law. The Department solicits comments on whether the safe harbor should be limited to require some connection between the employers and employees covered by the program and the state that establishes the program, and if so, what kind of connection.

    The proposed regulation requires that participation in the program be voluntary for employees. As discussed above, this requirement is different from the current payroll deduction IRA safe harbor in 29 CFR 2510.3-2(d), which requires that participation be “completely voluntary.” The proposed regulation expressly permits opt-out programs and, accordingly, does not require that participation be “completely voluntary.” By using only the term “voluntary,” the Department intends to make clear that the proposed regulation, unlike the existing safe harbor, would allow the state to require employers to automatically enroll employees, unless they affirmatively elect not to participate in the program.15

    15 If a program requires automatic enrollment, adequate notice of their right to opt out must be furnished to employees in order for the program to meet the safe harbor's voluntariness condition. The proposal does not define the manner and content of “adequate notice” for this purpose. The Department expects that states and their vendors would look to analogous notice requirements contained in federal laws pertaining to automatic enrollment provisions. See, e.g., 26 U.S.C. 401(k)(13)(E) and 414(w); 29 U.S.C. 1144(e)(3); and 29 CFR 2550.404c-5(d). The Department solicits comments on this issue.

    The proposed regulation also includes conditions to assure that control of the payroll deduction program and the savings accounts lies with the state and the employees, and not the employer. These include requirements that (1) the program does not require that an employee or beneficiary retain any portion of contributions or earnings in his or her IRA and does not otherwise impose any restrictions on withdrawals or impose any cost or penalty on transfers or rollovers permitted under the Internal Revenue Code; (2) all rights of the employee, former employee, or beneficiary under the program are enforceable only by the employee, former employee, or beneficiary, an authorized representative of such person, or by the state (or the designated agency or instrumentality); and (3) the state adopts measures to ensure that employees are notified of their rights under the program and creates a mechanism for enforcement of those rights. In addition, the proposal requires the state to assume responsibility for the security of payroll deductions and employee savings. These conditions assure that the employees will have meaningful control over their retirement savings, that the state will enforce the employer's payroll deduction obligations and oversee the security of retirement savings, and that the employer will have no role in enforcing employee rights under the program.

    Limited employer involvement in the program is the key to a determination that a state savings program is not an employee pension benefit program. Thus, the employer's facilitation must be required by state law—if it is voluntary, the safe harbor does not apply. Further, the proposal does not permit the employer to contribute to the program.16 All contributions under the program must be made voluntarily by the employees. When employers make contributions to fund benefits of the type enumerated in Section 3(2) of ERISA, they effectively sponsor an ERISA-covered plan. Similarly, the employer may not have discretionary authority, control, or responsibility under the program and may not receive any direct or indirect compensation in the form of cash or otherwise in connection with the program, other than the reimbursement of the actual costs of the program to the employer. Finally, the proposal specifies that employer involvement must be limited to all or some of the following: (1) Collecting employee contributions through payroll deductions and remitting them to the program; (2) providing notice to the employees and maintaining records regarding the employer's collection and remittance of payments under the program; (3) providing information to the state necessary to facilitate the operation of the program; and (4) distributing program information to employees from the state and permitting the state to publicize the program to employees.

    16 This provision, of course, would not prohibit an employer from allowing employees to review program materials on company time or to use an employer's computer to make elections under the program.

    A program could fit within the safe harbor and include terms that require employers to certify facts within the employer's knowledge as employer, such as employee census information (e.g., status of a full time employee, employee addresses, attendance records, compensation levels, etc.). The employer could also conduct reviews to ensure it was complying with program eligibility requirements and limitations established by the state. The Department requests comments on whether the final regulation should provide more clarity and specificity on the types of functions that could be permitted consistent with the requirements of the safe harbor.17

    17 In previous guidance issued by the Department under other safe harbors involving private parties, the Department concluded that employers could take certain corrective actions to stay within the safe harbor and that such actions, in and of themselves, did not lead to the establishment of an employee benefit plan. See DOL Information Letter to Siegel Benefit Consultants (Feb. 27, 1996) and Field Assistance Bulletin 2007-02 on the safe harbor for tax sheltered annuity programs under 29 CFR 2510.3-2(f).

    A state program that meets all of the foregoing conditions will not fail to qualify for the safe harbor merely because the program is directed toward employees who are not already eligible for some other workplace savings arrangement. Nor will it fail merely because it requires automatic enrollment subject to employees having a right to opt out. Similarly, if the state program offers employees a choice of multiple IRA sponsors to which employees may make payroll deduction contributions, the state program can create a default option, i.e., designate the IRA provider to which the employer must remit the payroll withholding contributions in the absence of an affirmative election by the employee.

    ERISA's expansive plan definition is critical to its protective purposes. When employers establish or maintain ERISA-covered plans, the plan's participants are protected by trust-law obligations of fiduciary conduct, reporting requirements, and a regulatory regime designed to ensure the security of promised benefits. In the circumstances specified by the proposed regulation, however, the employer does not “establish or maintain” the plan. Instead, the program is created and administered by the state for the benefit of those employees who voluntarily participate with minimal employer involvement. State administration of the voluntary program does not give rise to ERISA coverage, and presumably ensures that the program will be administered in accordance with the interests of the state's citizens.18

    18 To the extent that the state program allows employees not subject to the automatic enrollment requirement to voluntarily choose to participate, the employee's voluntarily participation would not result in the employer establishing an ERISA-covered plan or the state program including an ERISA-covered plan if the employer and the state program satisfy the conditions in the Department's existing safe harbor for payroll deduction IRAs at 29 CFR 2510.3-2(d). Of course, as described above, automatic enrollment of employees is not permitted under the existing payroll deduction IRA safe harbor.

    As noted above, ERISA generally preempts state laws that relate to employee benefit plans. The U.S. Supreme Court has long held that “[a] law `relates to' an employee benefit plan, in the normal sense of the phrase, if it has a connection with or reference to such a plan.” Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 96-97 (1983) (footnote omitted); see, e.g., New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 656 (1995). This proposed regulation would provide that certain state savings programs would not create employee benefit plans. However, the fact that state programs do not create ERISA covered plans does not necessarily mean that, if the issue were litigated, the state laws would not be preempted by ERISA. The courts' determinations would depend on the precise details of the statute at issue, including whether that state's program successfully met the requirements of the safe harbor.

    Moreover, states should be advised that a program may be preempted by other Federal laws apart from ERISA. A state law that alters, amends, modifies, invalidates, impairs or supersedes a Federal law would risk being preempted by the Federal law so affected. Such preemption issues are beyond the scope of this proposed rule, however, which addresses only the question of whether particular programs involve the establishment of one or more ERISA covered employee benefit plans.

    Finally, some states are considering approaches that differ from state payroll deduction savings initiatives. In 2012, Massachusetts, for example, enacted a law providing for a state-sponsored plan for non-profit employers with 20 or fewer employees.19 Washington enacted a law to establish a small business retirement market place to assist small employers by making available a number of approved savings plans, some of which may be covered by ERISA, even though the marketplace arrangement itself is not.20 This proposal does not address such state initiatives.

    19 Mass. Gen. Laws ch. 29, sec. 64E (2014)

    20 2015 Wash. Sess. Laws chap. 296 (SB 5826).

    C. Effective Date

    The Department proposes to make this regulation effective 60 days after the date of publication of the final rule in the Federal Register.

    D. Regulatory Impact Analysis 1. Executive Order 12866 Statement

    Under Executive Order 12866, the Office of Management and Budget (OMB) must determine whether a regulatory action is “significant” and therefore subject to the requirements of the Executive Order and subject to review by the OMB. Section 3(f) of the Executive Order defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as an “economically significant” action); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

    OMB has tentatively determined that this regulatory action is not economically significant within the meaning of section 3(f)(1) of the Executive Order. However, it has been determined that the action is significant within the meaning of section 3(f)(4) of the Executive Order and the Department accordingly provides the following assessment of its potential benefits and costs.

    a. Direct Benefits

    As stated earlier in this preamble, some state governments have passed laws designed to expand workers' access to workplace savings programs. Some states are looking at ways to encourage employers to provide coverage under state-administered 401(k)-type plans, while others have adopted or are considering approaches that combine several retirement alternatives including IRAs, ERISA-covered plans and the Department of the Treasury's new starter savings program, myRA.

    One of the challenges states face in expanding retirement savings opportunities for private sector employees is uncertainty about ERISA preemption of such efforts. ERISA generally would preempt a state law that required employers to establish and maintain ERISA-covered employee benefit pension plans. The Department therefore believes that states and other stakeholders would benefit from clear guidelines to determine whether state saving initiatives would effectively require employers to create ERISA-covered plans. The proposed rule would provide a new “safe harbor” from coverage under Title I of ERISA for state savings arrangements that conform to certain requirements. State initiatives within the safe harbor would not result in the establishment of employee benefit plans under ERISA. The Department expects that the proposed rule would reduce legal costs, including litigation costs, by (1) removing uncertainty about whether such state savings arrangements are covered by title I of ERISA, and (2) creating efficiencies by eliminating the need for multiple states to incur the same costs to determine their non-plan status.

    The Department notes that the proposal would not prevent states from identifying and pursuing alternative policies, outside the safe harbor, that also would not require employers to establish or maintain ERISA-covered plans. Thus, while the proposal would reduce uncertainty about state activity within the safe harbor, it would not impair state activity outside it.

    b. Direct Costs

    The proposed rule does not require any new action by employers or the states. It merely clarifies that certain state initiatives that encourage workplace savings would not result in the creation of employee benefit plans covered by Title I of ERISA.

    States may incur legal costs to analyze the rule and determine whether their laws fall within the proposed rule's safe harbor. However, the Department expects that these costs will be less than the savings that will be generated. Moreover, states will avoid incurring the greater costs that might be incurred to determine their programs' non-plan status without benefit of this proposed rule.

    States that design their payroll deduction programs to conform to the safe harbor may incur costs to develop notices to be provided to participants and beneficiaries covered by the program and enter into contracts with investment managers and other service providers to operationalize and administer the programs. The Department's review of existing state payroll deduction legislation indicates that these requirements are customarily part of most state programs, and the initiatives generally could not operate without such requirements. Therefore, to the extent that state programs would exist even in the absence of this rule, only the relatively minor costs of revisions for conformity to the safe harbor are attributable to the rule, because other cost-generating activities are necessary and essential to operate and administer the programs. On the other hand, if state programs are adopted more widely in the rule's presence than in its absence, there would be more general state operational and administrative costs that are attributable to the rule. The Department does not have sufficient data to estimate the number of systems that would need to be updated; therefore, the Department invites comments and any relevant data that would allow it to make a more thorough assessment.

    c. Uncertainty

    The Department is confident that the proposed regulation, by clarifying that certain state programs do not require employers to establish ERISA-covered plans, will benefit states and many other stakeholders otherwise beset by greater uncertainty. However, the Department is unsure as to the magnitude of these benefits. The magnitude of the proposed regulation's benefits, costs and transfer impacts will depend on the states' independent decisions on whether and how best to take advantage of the safe harbor, and on the cost that otherwise would have attached to uncertainty about the legal status of the states' actions. The Department cannot predict what actions states will take, stakeholders' propensity to challenge such actions' legal status, either absent or pursuant to the proposed regulation, or courts' resultant decisions, and therefore the Department invites data submission or other comment that would allow for more thorough assessment of these issues.

    d. Impact of State Initiatives

    There are a number of cases in which this rulemaking could increase the prevalence of state workplace savings initiatives, thus bringing the effects of these initiatives within the scope of this regulatory impact analysis. For instance, if this issue were ultimately resolved in the courts, the courts could make a different preemption decision in the rule's presence than in its absence. Furthermore, even if a potential court decision would be the same with or without the rulemaking, the potential reduction in states' uncertainty-related costs could induce more states to pursue these workplace savings initiatives. An additional possibility is that the rule would not change the prevalence of state retirement savings programs, but would accelerate the implementation of programs that would exist anyway. With any of these possibilities, there would be benefits, costs and transfer impacts that are indirectly attributable to this rule, via the increased or accelerated creation of state-level workplace savings programs.

    Employers may incur costs to update their payroll systems to transmit payroll deductions to the state or its agent and develop recordkeeping systems to document their collection and remittance of payments under the program. As with states' operational and administrative costs (discussed in section D.1.b, above), some portion of these employer costs would be attributable to the rule if more state workplace savings programs are implemented in the rule's presence than in its absence. Because employers' role in the programs must be minimal in order to satisfy the safe harbor, they will incur little cost beyond the costs associated with updating payroll systems. However, the costs that are incurred could fall most heavily on small and start-up companies, which tend to be least likely to offer pensions. Most state payroll deduction programs do exempt the smallest companies, which could significantly mitigate such costs. The Department does not have sufficient data to estimate the number of payroll systems that would have to be updated. Therefore, the Department invites the public to provide comments and relevant data that would allow it to make a more thorough assessment.

    The Department believes that well-designed state-level initiatives have the potential to effectively reduce gaps in retirement security. Relevant variables such as pension coverage,21 labor market conditions,22 population demographics,23 and elderly poverty,24 vary widely across the states, suggesting a potential opportunity for progress at the state level. For example, payroll deduction savings statutes in California and Illinois could extend savings opportunities for 7.8 million workers in California and 1.7 million workers in Illinois who currently do not have access to employment-based savings arrangements.25 The Department offers the following policy discussion for consideration, and invites public input on the issues raised, on the potential for state initiatives to foster retirement security, and on the potential for this proposal or other Departmental action to facilitate effective state activity.

    21See for example Craig Copeland, “Employment-Based Retirement Plan Participation: Geographic Differences and Trends, 2013,” Employee Benefit Research Institute, Issue Brief No. 405 (October 2014) (available at www.ebri.org).

    22See for example US Bureau of Labor Statistics, “Regional and State Employment and Unemployment—JUNE 2015,” USDL-15-1430, July 21, 2015.

    23See for example Lindsay M. Howden and Julie A. Meyer, “Age and Sex Composition: 2010,” US Bureau of the Census, 2010 Census Briefs C2010BR-03, May 2011.

    24 Constantijn W. A. Panis & Michael Brien, August 28, 2015, “Target Populations of State-Level Automatic IRA Initiatives.”

    25Id.

    Effective state initiatives will advance retirement security. Some workers currently may save less than would be optimal because of behavioral biases (such as myopia or inertia) or labor market frictions that prevent them from accessing plans at work. Effective state initiatives would help such workers save more. Such workers will have traded some consumption today for more in retirement, potentially reaping some net gain in overall lifetime well-being. Their additional saving may also reduce fiscal pressure on publicly financed retirement programs and other public assistance programs, such as the Supplemental Nutritional Assistance Program, that support low-income Americans, including older Americans.

    The Department believes that well-designed state initiatives can achieve their intended, positive effects of fostering retirement security. However, the initiatives might have some unintended consequences as well. Those workers least equipped to make good retirement savings decisions arguably stand to benefit most from state initiatives, but also arguably are most at risk of suffering adverse unintended effects. Workers who would not benefit from increased retirement savings could opt out, but some might fail to do so. Such workers might increase their savings too much, unduly sacrificing current economic needs. Consequently they might be more likely to cash out early and suffer tax losses, and/or to take on more expensive debt. Similarly, state initiatives directed at workers who do not currently participate in workplace savings arrangements may be imperfectly targeted to address gaps in retirement security. For example, a college student might be better advised to take less in student loans rather than open an IRA, and a young family might do well to save more first for their children's education and later for their own retirement.

    Employers that wish to provide retirement benefits are likely to find that ERISA-covered programs, such as 401(k) plans, have advantages for them and their employees over participation in state programs. Potential advantages include: Greater tax preferences, greater flexibility in plan selection and design, opportunity for employers to contribute, ERISA protections, and larger positive recruitment and retention effects. Therefore it seems unlikely that state initiatives will “crowd-out” many ERISA-covered plans. However, if they do, some workers might lose ERISA-protected benefits that would have been more generous and more secure than state-based (or IRA) benefits, unless states adopt consumer protections similar to those Congress provided under ERISA. Some workers who would otherwise have saved more might reduce their savings to the low, default levels associated with some state programs. States can address this last concern by incorporating into their programs “auto-escalation” features that increase default contribution rates over time and/or as pay increases.

    2. Paperwork Reduction Act

    As part of its continuing effort to reduce paperwork and respondent burden, the Department of Labor conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps to ensure that the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

    The Department has determined this proposed rule is not subject to the requirements of the PRA, because it does not contain a collection of information as defined in 44 U.S.C. 3502(3). The rule does not require any action by or impose any requirements on employers or the states. It merely clarifies that certain state payroll deduction programs that encourage retirement savings would not result in the creation of employee benefit plans covered by Title I of ERISA.

    Moreover, the PRA definition of burden excludes time, effort, and financial resources necessary to comply with a collection of information that would be incurred by respondents in the normal course of their activities. See 5 CFR 1320.3(b)(2). The definition of burden also excludes burdens imposed by a state, local, or tribal government independent of a Federal requirement. See 5 CFR 1320.3(b)(3). The Department's review of existing state payroll deduction programs indicates that they customarily have notification and recordkeeping requirements and that the initiatives could not operate without such requirements, especially programs that include automatic enrollment. Therefore, the proposed rule imposes no burden, because states customarily include notice and recordkeeping requirements that are an essential and routine part of administering state payroll deduction programs. In addition, employers are responding to state, not Federal, requirements when providing notices to individuals covered under state payroll deduction programs and maintaining records regarding the employers' collection and remittance of payments under the program.

    Although the Department has determined that the proposed rule does not contain a collection of information, when rules contain information collections the Department invites comments that:

    • Evaluate 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;

    • Evaluate the burden of the 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, e.g., permitting electronic submission of responses.

    In addition to having an opportunity to file comments with the Department, comments may also be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Attention: Desk Officer for the Employee Benefits Security Administration. OMB requests that comments be received within 30 days of publication of the proposed rule to ensure their consideration.

    3. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq.) and which are likely to have a significant economic impact on a substantial number of small entities. Unless an agency certifies that a rule will not have a significant economic impact on a substantial number of small entities, section 603 of the RFA requires the agency to present an initial regulatory flexibility analysis at the time of the publication of the notice of proposed rulemaking describing the impact of the rule on small entities. Small entities include small businesses, organizations and governmental jurisdictions.

    Because the proposed rule imposes no requirements or costs on employers, the Department believes that it would not have a significant economic impact on a substantial number of small entities. Accordingly, pursuant to section 605(b) of the RFA, the Assistant Secretary of the Employee Benefits Security Administration hereby certifies that the proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.

    4. Unfunded Mandates Reform Act

    For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.), as well as Executive Order 12875, this rule does not include any federal mandate that may result in expenditures by state, local, or tribal governments, or the private sector, which may impose an annual burden of $100 million.

    5. Congressional Review Act

    The proposed rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and, if finalized, would be transmitted to Congress and the Comptroller General for review.

    6. Federalism Statement

    Executive Order 13132 outlines fundamental principles of federalism. It also requires adherence to specific criteria by federal agencies in formulating and implementing policies that have “substantial direct effects” on the states, the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with state and local officials, and describe the extent of their consultation and the nature of the concerns of state and local officials in the preamble to the final regulation.

    In the Department's view, the proposed regulations, by clarifying that certain workplace savings arrangements under consideration or adopted by certain states will not result in the establishment or maintenance by employers or employee organizations of employee benefit plans under ERISA, would provide more latitude and certainty to state governments and employers regarding the treatment of such arrangements under ERISA. The Department will affirmatively engage in outreach with officials of states, and with employers and other stakeholders, regarding the proposed rule and seek their input on the proposed rule and any federalism implications that they believe may be presented by it.

    List of Subjects in 29 CFR Part 2510

    Accounting, Employee benefit plans, Employee Retirement Income Security Act, Pensions, Reporting, Coverage.

    For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR 2510 as set forth below:

    PART 2510—DEFINITIONS OF TERMS USED IN SUBCHAPTERS C, D, E, F, AND G OF THIS CHAPTER 1. The authority citation for part 2510 is revised to read as follows: Authority:

    29 U.S.C. 1002(2), 1002(21), 1002(37), 1002(38), 1002(40), 1031, and 1135; Secretary of Labor's Order No. 1-2011, 77 FR 1088 (Jan. 9, 2012); Sec. 2510.3-101 also issued under sec. 102 of Reorganization Plan No. 4 of 1978, 43 FR 47713 (Oct. 17, 1978), E.O. 12108, 44 FR 1065 (Jan. 3, 1979) and 29 U.S.C. 1135 note. Sec. 2510.3-38 is also issued under sec. 1, Pub. L. 105-72, 111 Stat. 1457 (1997).

    2. Section 2510.3-2 is amended by adding paragraph (h) to read as follows:
    § 2510.3-2 Employee pension benefit plans.

    (h) Certain State Savings Programs. (1) For the purpose of Title I of the Act and this chapter, the terms “employee pension benefit plan” and “pension plan” shall not include an individual retirement plan (as defined in 26 U.S.C. 7701(a)(37)) established and maintained pursuant to a State payroll deduction savings program, provided that:

    (i) The program is established by a State pursuant to State law;

    (ii) The program is administered by the State establishing the program, or by a governmental agency or instrumentality of the State, which is responsible for investing the employee savings or for selecting investment alternatives for employees to choose;

    (iii) The State assumes responsibility for the security of payroll deductions and employee savings;

    (iv) The State adopts measures to ensure that employees are notified of their rights under the program, and creates a mechanism for enforcement of those rights;

    (v) Participation in the program is voluntary for employees;

    (vi) The program does not require that an employee or beneficiary retain any portion of contributions or earnings in his or her IRA and does not otherwise impose any restrictions on withdrawals or impose any cost or penalty on transfers or rollovers permitted under the Internal Revenue Code;

    (vii) All rights of the employee, former employee, or beneficiary under the program are enforceable only by the employee, former employee, or beneficiary, an authorized representative of such a person, or by the State (or the designated governmental agency or instrumentality described in paragraph (h)(1)(ii) of this section);

    (viii) The involvement of the employer is limited to the following:

    (A) Collecting employee contributions through payroll deductions and remitting them to the program;

    (B) Providing notice to the employees and maintaining records regarding the employer's collection and remittance of payments under the program;

    (C) Providing information to the State (or the designated governmental agency or instrumentality described in paragraph (h)(1)(ii) of this section) necessary to facilitate the operation of the program; and

    (D) Distributing program information to employees from the State (or the designated governmental agency or instrumentality described in paragraph (h)(1)(ii) of this section) and permitting the State or such entity to publicize the program to employees;

    (ix) The employer contributes no funds to the program and provides no bonus or other monetary incentive to employees to participate in the program;

    (x) The employer's participation in the program is required by State law;

    (xi) The employer has no discretionary authority, control, or responsibility under the program; and

    (xii) The employer receives no direct or indirect consideration in the form of cash or otherwise, other than the reimbursement of the actual costs of the program to the employer of the activities referred to in paragraph (h)(1)(viii) of this section.

    (2) A State savings program will not fail to satisfy the provisions of paragraph (h)(1) of this section merely because the program—

    (i) Is directed toward those employees who are not already eligible for some other workplace savings arrangement;

    (ii) Utilizes one or more service or investment providers to operate and administer the program, provided that the State (or the designated governmental agency or instrumentality described in paragraph (h)(1)(ii) of this section) retains full responsibility for the operation and administration of the program; or

    (iii) Treats employees as having automatically elected payroll deductions in an amount or percentage of compensation, including any automatic increases in such amount or percentage, specified under State law until the employee specifically elects not to have such deductions made (or specifically elects to have the deductions made in a different amount or percentage of compensation allowed by the program), provided that the employee is given adequate notice of the right to make such elections; provided, further, that a program may also satisfy this paragraph (h) without requiring or otherwise providing for the automatic elections described in this paragraph (h)(2)(iii).

    (3) For purposes of this section, the term State shall have the same meaning as defined in section 3(10) of ERISA.

    Phyllis C. Borzi, Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor.
    [FR Doc. 2015-29426 Filed 11-16-15; 4:15 pm] BILLING CODE 4510-29-P
    DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2560 RIN 1210-AB39 Claims Procedure for Plans Providing Disability Benefits AGENCY:

    Employee Benefits Security Administration, Department of Labor.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    This document contains proposed amendments to claims procedure regulations for plans providing disability benefits under the Employee Retirement Income Security Act of 1974 (ERISA). The amendments would revise and strengthen the current rules primarily by adopting certain of the new procedural protections and safeguards made applicable to group health plans by the Affordable Care Act. If adopted as final, the proposed regulation would affect plan administrators and participants and beneficiaries of plans providing disability benefits, and others who assist in the provision of these benefits, such as third-party benefits administrators and other service providers that provide benefits to participants and beneficiaries of these plans.

    DATES:

    Written comments should be received by the Department of Labor on or before January 19, 2016.

    ADDRESSES:

    You may submit written comments, identified by RIN 1210-AB39, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Email: [email protected] Include RIN 1210-AB39 in the subject line of the message.

    Mail: Office of Regulations and Interpretations, Employee Benefits Security Administration, Room N-5655, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Attention: Claims Procedure Regulation Amendment for Plans Providing Disability Benefits.

    Instructions: All submissions received must include the agency name and Regulatory Identifier Number (RIN) for this rulemaking. All comments will be available to the public, without charge, online at http://www.regulations.gov and http://www.dol.gov/ebsa, and at the Public Disclosure Room, Employee Benefits Security Administration, Suite N-1513, 200 Constitution Avenue NW, Washington, DC 20210.

    Warning: Do not include any personally identifiable or confidential business information that you do not want publicly disclosed. All comments are posted on the Internet exactly as received, and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records.

    FOR FURTHER INFORMATION CONTACT:

    Frances P. Steen, Office of Regulations and Interpretations, Employee Benefits Security Administration, (202) 693-8500. This is not a toll free number.

    SUPPLEMENTARY INFORMATION: A. Executive Summary

    In accordance with Executive Order 13563, this section of the preamble contains an executive summary of the proposed rulemaking in order to promote public understanding and to ensure an open exchange of information and perspectives. Sections B through E of this preamble, below, contain a more detailed description of the regulatory provisions and need for the rulemaking, as well as its costs and benefits.

    1. Purpose of Regulatory Action

    The purpose of this action is to improve the current procedural protections for workers who become disabled and make claims for disability benefits from an employee benefit plan. ERISA requires that plans provide claimants with written notice of benefit denials and an opportunity for a full and fair review of the denial by an appropriate plan fiduciary. The current regulations governing the processing of claims and appeals were published 15 years ago. Because of the volume and constancy of litigation in this area, and in light of advancements in claims processing technology, the Department recognizes a need to revisit, reexamine, and revise the current regulations in order to ensure that disability benefit claimants receive a fair review of denied claims as provided by law. To this end, the Department has determined to start by proposing to uplift the current standards applicable to the processing of claims and appeals for disability benefits so that they better align with the requirements regarding internal claims and appeals for group health plans under the regulations implementing the requirements of the Affordable Care Act.1 Inasmuch as disability and lost earnings can be sources of severe hardship for many individuals, the Department thinks that disability benefit claimants deserve protections equally as stringent as those that Congress and the President have put into place for health care claimants under the Affordable Care Act.

    1 The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, was enacted on March 30, 2010. (These statutes are collectively known as the “Affordable Care Act.”)

    2. Summary of Major Provisions

    The major provisions in the proposal largely adopt the procedural protections for health care claimants in the Affordable Care Act, including provisions that seek to ensure that: (1) Claims and appeals are adjudicated in manner designed to ensure independence and impartiality of the persons involved in making the decision; (2) benefit denial notices contain a full discussion of why the plan denied the claim and the standards behind the decision; (3) claimants have access to their entire claim file and are allowed to present evidence and testimony during the review process; (4) claimants are notified of and have an opportunity to respond to any new evidence reasonably in advance of an appeal decision; (5) final denials at the appeals stage are not based on new or additional rationales unless claimants first are given notice and a fair opportunity to respond; (6) if plans do not adhere to all claims processing rules, the claimant is deemed to have exhausted the administrative remedies available under the plan, unless the violation was the result of a minor error and other specified conditions are met; (7) certain rescissions of coverage are treated as adverse benefit determinations, thereby triggering the plan's appeals procedures; and (8) notices are written in a culturally and linguistically appropriate manner.

    3. Costs and Benefits

    The Department expects that these proposed regulations would improve the procedural protections for workers who become disabled and make claims for disability benefits from employee benefit plans. This would cause some participants to receive benefits they might otherwise have been incorrectly denied absent the fuller protections provided by the proposed regulations. In other circumstances, expenditures by plans may be reduced as a fuller and fairer system of disability claims and appeals processing helps facilitate participant acceptance of cost management efforts. Greater certainty and consistency in the handling of disability benefit claims and appeals and improved access to information about the manner in which claims and appeals are adjudicated may lead to efficiency gains in the system, both in terms of the allocation of spending at a macro-economic level as well as operational efficiencies among individual plans.

    The Department expects the proposed regulations would impose modest costs on disability benefit plans, because many plans already are familiar with the rules that would apply to disability benefit claims due to their current application to group health plans. As discussed in detail in the cost section below, the Department quantified the costs associated with two provisions of the proposed regulations: the requirement to provide additional information to claimants in the appeals process ($1.9 million annually) and the requirement to provide information in a culturally and linguistically appropriate manner ($1.1 million annually).

    B. Background 1. Section 503 of ERISA and the Section 503 Regulations

    Section 503 of ERISA requires every employee benefit plan, in accordance with regulations of the Department, to “provide adequate notice in writing to any participant or beneficiary whose claim for benefits under the plan has been denied, setting forth the specific reasons for such denial, written in a manner calculated to be understood by the participant” and to “afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim.”

    In 1977, the Department published a regulation pursuant to section 503, at 29 CFR 2560.503-1, establishing minimum requirements for benefit claims procedures for employee benefit plans covered by title I of ERISA (hereinafter “Section 503 Regulation”).2 The Department revised and updated the Section 503 Regulation in 2000 by improving and strengthening the minimum requirements for employee benefit plan claims procedures under section 503 of ERISA.3 As revised in 2000, the Section 503 Regulation provided new time frames and enhanced requirements for notices and disclosure with respect to decisions at both the initial claims decision stage and on review. Although the Section 503 Regulation applies to all covered employee benefit plans, including pension plans, group health plans, and plans that provide disability benefits, the more stringent procedural protections apply to group health plans and to claims with respect to disability benefits.4

    2 42 FR 27426 (May 27, 1977).

    3 65 FR 70246 (Nov. 21, 2000), amended at 66 FR 35887 (July 9, 2001).

    4 A benefit is a disability benefit, subject to the special rules for disability claims under the Section 503 Regulation, if the plan conditions its availability to the claimant upon a showing of disability. It does not matter how the benefit is characterized by the plan or whether the plan as a whole is a pension plan or a welfare plan. If the claims adjudicator must make a determination of disability in order to decide a claim, the claim must be treated as a disability claim for purposes of the Section 503 Regulation. See FAQs About The Benefit Claims Procedure Regulation, A-9 (http://www.dol.gov/ebsa/faqs/faq_claims_proc_reg.html).

    2. The Affordable Care Act Additions to the Section 503 Regulations

    Section 715(a)(1) of ERISA, added by the Affordable Care Act, provides that certain provisions of the Public Health Service Act (PHS Act) apply to group health plans and health insurance issuers in connection with providing health insurance coverage as if the provisions were included ERISA . Such provisions include section 2719 of the PHS Act which addresses among other items internal claims and appeals and processes for group health plans and health insurance issuers. Section 2719 of the PHS Act provides that group health plans must have in effect an internal claims and appeals process and that such plans must initially incorporate the claims and appeals processes set forth in the Section 503 Regulation and update such processes in accordance with standards established by the Secretary of Labor.

    On July 23, 2010, the Departments of Health and Human Services, Labor, and the Treasury (collectively the Departments) issued interim final regulations implementing PHS Act section 2719 and issued amendments to the IFR on June 24, 2011 (hereinafter “the 2719 IFR”).5 The 2719 IFR updated the Section 503 Regulation to ensure that non-grandfathered group health plans implement an effective internal claims and appeal process, in compliance with the Affordable Care Act.6

    5See 75 FR 37188 (June 28, 2010), 75 FR 43330 (July 23, 2010) and 76 FR 37208 (June 24, 2011).

    6 The requirements of the Affordable Care Act and the 2719 IFR do not apply to grandfathered health plans under section 1251 of the Affordable Care Act. The Department in conjunction with the Department of Health and Human Services and the Department of the Treasury published interim final regulations implementing section 1251 of the Affordable Care Act. See 75 FR 34538 (June 17, 2010) and 75 FR 70114 (Nov. 17, 2010). Elsewhere in today's version of the Federal Register, the Departments published final regulations implementing section 1251 of the Affordable Care Act.

    Elsewhere in today's version of the Federal Register, the Departments published final regulations implementing section PHS Act section 2719 (regarding internal claims and appeals and external review processes) and PHS Act 2712 (regarding restrictions on rescissions) (collectively “the 2719 Final Rule”). The 2719 Final Rule implements the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under the Affordable Care Act.

    The 2719 Final Rule adopts and clarifies the new requirements in the 2719 IFR that apply to internal claims and appeals processes for non-grandfathered group health plans.

    3. Substantial Litigation

    Even though fewer private-sector employees participate in disability plans than in other types of plans,7 disability cases dominate the ERISA litigation landscape today.8 An aging American workforce may likely be a contributing factor to the significant volume of disability cases. Aging workers initiate more disability claims, as the prevalence of disability increases with age.9 And as a result, insurers and plans looking to contain disability benefit costs are often motivated to aggressively dispute disability claims. This aggressive posture coupled with the inherently factual nature of disability claims highlight for the Department the need to review and strengthen the procedural rules governing the adjudication of disability benefit claims.

    7 BLS National Compensation Survey, March 2014, at http://www.bls.gov/ncs/ebs/benefits/2014/ebbl0055.pdf.

    8See Sean M. Anderson, ERISA Benefits Litigation: An Empirical Picture, 28 ABA J. Lab. & Emp. L. 1 (2012).

    9See Francine M. Tishman, Sara Van Looy, & Susanne M. Bruyere, Employer Strategies for Responding to an Aging Workforce, NTAR Leadership Center (2012).

    4. ERISA Advisory Council Recommendations

    In 2012, the ERISA Advisory Council undertook a study on issues relating to managing disability in an environment of individual responsibility. The Advisory Council issued a report containing, in relevant part, recommendations for review of the Section 503 Regulation to determine updates and modifications for disability benefit claims, drawing upon analogous processes described in the 2719 IFR where appropriate, to address (1) what is an adequate opportunity to develop the record; and (2) content for denials of such claims.10

    10 The report may be accessed at http://www.dol.gov/ebsa/publications/2012ACreport2.html.

    Based on the foregoing, the Department believes that in order to afford claimants of disability benefits a reasonable opportunity to pursue a full and fair review, as required by ERISA section 503, modifications to the Section 503 Regulation, that align with the updated standards required by the Affordable Care Act and extended to non-grandfathered group health plans in paragraph (b) of the 2719 Final Rule at 29 CFR 2590.715-2719, are necessary.

    C. Overview of Proposed Regulation 1. Independence and Impartiality—Avoiding Conflicts of Interest

    In order to ensure a full and fair review of claims and appeals, the Section 503 Regulation already contains certain standards of independence for persons making claims decisions, and the proposal would build on these standards by providing new criteria for avoiding conflicts of interest. In alignment with criteria in the 2719 Final Rule, paragraph (b)(7) of the proposal explicitly provides that plans providing disability benefits would have to “ensure that all disability benefit claims and appeals are adjudicated in a manner designed to ensure the independence and impartiality of the persons involved in making the decision.” The proposal also would require that decisions regarding hiring, compensation, termination, promotion, or similar matters with respect to any individual (such as a claims adjudicator or medical expert) must not be made based upon the likelihood that the individual will support the denial of disability benefits. For example, a plan would not be permitted to provide bonuses based on the number of denials made by a claims adjudicator. Similarly, a plan would not be permitted to contract with a medical expert based on the expert's reputation for outcomes in contested cases, rather than based on the expert's professional qualifications. These added criteria address practices and behavior which, in the context of disability benefits, the Department finds difficult to reconcile with the “full and fair review” guarantee in section 503 of ERISA and which are questionable under ERISA's basic fiduciary standards.

    2. Improvements to Basic Disclosure Requirements

    The proposal would amend the current disclosure requirements in three significant respects. First, adverse benefit determinations on disability benefit claims would have to contain a discussion of the decision, including the basis for disagreeing with any disability determination by the Social Security Administration (SSA), by a treating physician, or other third party disability payor, to the extent that the plan did not follow those determinations presented by the claimant. This provision would address the confusion often experienced by claimants when there is little or no explanation provided for their plan's determination and/or their plan's determination is contrary to their doctor's opinion or their SSA award of disability benefits.11

    11See, e.g. , McDonough v. Aetna Life Ins. Co., 783 F.3d 374, 382 (1st Cir. 2015) (holding that “Aetna's failure to articulate the contours of the own occupation standard, apply that standard in a meaningful way, and reason from that standard to an appropriate conclusion regarding the appellant's putative disability renders its benefits-termination decision arbitrary and capricious.”). See also Montour v. Hartford Life and Accident Ins. Co., 588 F.3d 623, 637 (9th Cir. 2009) (“Hartford's failure to explain why it reached a different conclusion than the SSA is yet another factor to consider in reviewing the administrator's decision for abuse of discretion, particularly where, as here, a plan administrator operating with a conflict of interest requires a claimant to apply and then benefits financially from the SSA's disability finding.”).

    Second, adverse benefit determinations would have to contain the internal rules, guidelines, protocols, standards or other similar criteria of the plan that were used in denying the claim (or a statement that these do not exist). Third, a notice of adverse benefit determination at the claim stage would have to contain a statement that the claimant is entitled to receive, upon request, relevant documents. Under the current Section 503 Regulation, such statement is required only in notices of an adverse benefit determination denied on appeal.

    These provisions would serve the purpose of ensuring that claimants fully understand why their disability benefit claim was denied so they are able to meaningfully evaluate the merits of pursuing an appeal.12 As described below, paragraph (p) of the proposal incorporates the provision from the 2719 Final Rule that requires notices to be written in a culturally and linguistically appropriate manner.

    12See, e.g. , Bard v. Boston Shipping Ass'n., 471 F.3d 229, 240 (1st Cir. 2006) (“in relying on the McLaughlin arbitration to reject Bard's claim, the Board relied on a rule, guideline, protocol, or other similar criterion[,] [y]et Bard was not notified of even a condensed version of this rule, nor does it appear that he was timely notified that the McLaughlin arbitrator's opinion existed at all.”) (internal quotation and citation omitted); Salomaa v. Honda Long Term Disability Plan, 642 F.3d 666, 679 (9th Cir. 2011) (“The review was not `fair,' as the statute requires, because the plan did not give Salomaa and his attorney and physicians access to the two medical reports of its own physicians upon which it relied, among other reasons. In addition, the plan administrator denied the claim largely on account of absence of objective medical evidence, yet failed to tell Salomaa what medical evidence it wanted.”).

    3. Right To Review and Respond to New Information Before Final Decision

    The proposal would add criteria to ensure a full and fair review of denied disability claims by explicitly providing that claimants have a right to review and respond to new evidence or rationales developed by the plan during the pendency of the appeal, as opposed merely to having a right to such information on request only after the claim has already been denied on appeal, as some courts have held under the Section 503 Regulation. Specifically, the proposal provides that prior to a plan's decision on appeal, a disability benefit claimant must be provided, free of charge, with any new or additional evidence considered, relied upon, or generated by (or at the direction of) the plan in connection with the claim, as well as any new or additional rationale for a denial, and a reasonable opportunity for the claimant to respond to such new or additional evidence or rationale. See paragraph (h)(4)(i)-(iii) of the proposal. Although these important protections are direct imports from the 2719 Final Rule, they would correct procedural problems evidenced in the litigation even predating the ACA.13 It is the view of the Department that claimants are deprived of a full and fair review, as required by section 503 of ERISA, when they are prevented from responding at the administrative stage level to evidence and rationales.14 Accordingly, adding these provisions to the Section 503 Regulation would explicitly address this problem and redress the procedural wrongs evidenced in the litigation under the current regulation.

    13See, e.g. , Metzger v. Unum Life Ins. Co. of America, 476 F.3d 1161, 1165-67 (10th Cir. 2007) (holding that “subsection (h)(2)(iii) does not require a plan administrator to provide a claimant with access to the medical opinion reports of appeal-level reviewers prior to a final decision on appeal.”). Accord Glazer v. Reliance Standard Life Ins. Co., 524 F.3d 1241 (11th Cir. 2008); Midgett v. Washington Group Int'l Long Term Disability Plan, 561 F.3d 887 (8th Cir. 2009).

    14 Brief of the Secretary of Labor, Hilda L. Solis, as Amicus Curiae in Support of Plaintiff-Appellant's Petition for Rehearing, Midgett v. Washington Group Int'l Long Term Disability Plan, 561 F.3d 887 (8th Cir. 2009) (No. 08-2523).

    As an example of how these new provisions would work, assume the plan denies a claim at the initial stage based on a medical report generated by the plan administrator. Also assume the claimant appeals the adverse benefit determination and, during the 45-day period the plan has to make its decision on appeal, the plan administrator causes a new medical report to be generated by a medical specialist who was not involved with developing the first medical report. The proposal would require the plan to automatically furnish to the claimant any new evidence in the second report. The plan would have to furnish the new evidence to the claimant before the expiration of the 45-day period. The evidence would have to be furnished as soon as possible and sufficiently in advance of the applicable deadline (including an extension if available) in order to give the claimant a reasonable opportunity to respond to the new evidence. The plan would be required to consider any response from the claimant. If the claimant's response happened to cause the plan to generate a third medical report containing new evidence, the plan would have to automatically furnish to the claimant any new evidence in the third report. The new evidence would have to be furnished as soon as possible and sufficiently in advance of the applicable deadline to allow the claimant a reasonable opportunity to respond to the new evidence in the third report.

    The right of disability benefit claimants to review new evidence or new rationales is a less meaningful right standing by itself than if accompanied by a right to respond to the new information. Consequently, the proposal would also grant the claimant a right to respond to the new information by explicitly providing claimants the right to present evidence and written testimony as part of the claims and appeals process. See paragraph (h)(4)(i) of the proposal.15

    15 Consistent with paragraph (h)(2)(ii) of the Section 503 Regulation (granting claimants the right to “submit written comments, documents, records, and other information relating to the claim for benefits”), paragraph (h)(4)(i) of the proposal contemplates written evidence and testimony and therefore, in the Department's view, does not entitle the claimant to an oral hearing.

    These new rights (i.e., review and response rights) are being proposed as an overlay to the detailed timing rules already in the Section 503 Regulation. In particular, the Section 503 Regulation already contains timing rules for disability claims that allow plan administrators extensions “for special circumstances” at the appeals stage, with a related tolling provision if the reason for an extension is “due to a claimant's failure to submit information necessary to decide a claim.” See 29 CFR 2560.503-1(i)(3)(i) and (i)(4). Comments are requested on whether, and to what extent, modifications to the existing timing rules are needed to ensure that disability benefit claimants and plans will have ample time to engage in the back-and-forth dialog that is contemplated by the new review and response rights.

    For instance, is a special tolling rule like the one adopted today for group health plans under the 2719 Final Rule also needed for disability benefit appeals? The 2719 Final Rule, in relevant part, provides “if the new or additional evidence is received so late that it would be impossible to provide it to the claimant in time for the claimant to have a reasonable opportunity to respond, the period for providing a notice of final internal adverse benefit determination is tolled until such time as the claimant has a reasonable opportunity to respond. After the claimant responds, or has a reasonable opportunity to respond but fails to do so, the plan or issuer must notify the claimant of the benefit determination as soon as a plan or issuer acting in a reasonable and prompt fashion can provide the notice, taking into account the medical exigencies.” See 29 CFR 2590.715-2719(b)(2)(ii)(C)(2). The proposal does not adopt this tolling provision from the 2719 Final Rule because, as noted above, the existing Section 503 Regulation already permits plans providing disability benefits to take extensions at the appeals stage. This special tolling provision under the 2719 Final Rule was needed for group health plans because the Section 503 Regulation generally does not permit them to take extensions at the appeals stage.

    4. Deemed Exhaustion of Claims and Appeals Processes

    The proposal would strengthen the deemed exhaustion provision in the Section 503 Regulation in three important respects. First, the more stringent standards in the 2719 Final Rule would replace existing standards for disability benefit claims in cases where the plan fails to adhere to all the requirements of the Section 503 Regulation. Thus, in this respect, the proposal would adopt the 2719 Final Rule's approach, including an exception in paragraph (l)(2)(ii) for errors that are minor and meet certain other specified conditions. Second, in those situations when the minor errors exception does not apply, the proposal clarifies that the reviewing tribunal should not give special deference to the plan's decision, but rather should review the dispute de novo. Third, protection would be given to claimants whose attempts to pursue remedies in court under section 502(a) of ERISA based on deemed exhaustion are rejected by a reviewing tribunal.16

    16 The deemed exhaustion provision in the proposal, if adopted in a final regulation, would supersede any and all prior Departmental guidance with respect to disability benefit claims to the extent such guidance is contrary to the final regulation, including but not limited to FAQ F-2 in Frequently Asked Questions About The Benefit Claims Procedure Regulation (http://www.dol.gov/ebsa/faqs/faq_claims_proc_reg.html).

    The minor errors exception would operate as follows. The proposal would provide that any violation of the procedural rules in the Section 503 Regulation would permit a claimant to seek immediate court action, unless the violation was: (i) de minimis; (ii) non-prejudicial; (iii) attributable to good cause or matters beyond the plan's control; (iv) in the context of an ongoing good-faith exchange of information; and (v) not reflective of a pattern or practice of non-compliance. In addition, the claimant would be entitled upon request, to an explanation of the plan's basis for asserting that it meets this standard, so that claimant could make an informed judgment about whether to seek immediate review.

    Too often claimants find themselves without any forum to resolve their disputes if they prematurely pursued their claims in court before exhausting the plan's administrative remedies. To prevent this from happening to disability benefit claimants even more frequently due to the interplay between the strict compliance standard and the minor errors exception, the proposal contains a special safeguard for claimants who erroneously concluded their plan's violation of the Section 503 Regulation entitled them to take their claim directly to court. The safeguard provides that if a court rejects the claimant's request for immediate review on the basis that the plan met the standards for the minor errors exception, the claim would be considered as re-filed on appeal upon the plan's receipt of the decision of the court. In addition, within a reasonable time after the receipt of the decision, the plan would be required to provide the claimant with notice of the resubmission. At this point, the claimant would have the right to pursue the claim in accordance with the plan's provisions governing appeals, including the right to present evidence and testimony.

    The proposed standards set forth the Department's view of the consequences that ensue when a plan fails to provide procedures for disability benefit claims that meet the requirements of section 503 of ERISA as set forth in regulations. They reflect the Department's view that if the plan fails to provide processes that meet the regulatory minimum standards, and does not otherwise qualify for the minor errors exception, the disability benefit claimant should be free to pursue the remedies available under section 502(a) of ERISA on the basis that the plan has failed to provide a reasonable claims procedure that would yield a decision on the merits of the claim. The Department's intentions in including this provision in the proposal are to clarify that the procedural minimums of the Section 503 Regulation are essential to procedural fairness and that a decision made in the absence of the mandated procedural protections should not be entitled to any judicial deference. In this regard, the proposal provides that if a claimant chooses to pursue remedies under section 502(a) of ERISA under such circumstances, the claim or appeal is deemed denied on review without the exercise of discretion by an appropriate fiduciary. Consequently, rather than giving special deference to the plan, the reviewing court should review the dispute de novo.

    5. Coverage Rescissions—Adverse Benefit Determinations

    The proposal would add a new provision to address coverage rescissions not already covered under the Section 503 Regulation. For this purpose, a rescission generally is a cancellation or discontinuance of disability coverage that has retroactive effect. The Section 503 Regulation already covers a rescission if the rescission is the basis, in whole or in part, of an adverse benefit determination. For instance, if a plan were to deny a claim based on a conclusion that the claimant is ineligible for benefits due to a rescission of coverage, the claimant would have a right to appeal the adverse benefit determination under the plan's procedures for reviewing denied claims. Other rescissions (those made in the absence of a claim, such as resulting from an internal audit), however, may not be covered by the Section 503 Regulation and, consequently, would not trigger the procedural protections of section 503 of ERISA. Although many rescissions may be proper under the terms of the plan, some rescissions may be improper or erroneous. In the latter case, participants and beneficiaries may face dangerous and unwanted lapses in disability coverage without their knowledge, and without knowing how to challenge the rescission.

    Accordingly, the proposed rule would amend the definition of an adverse benefit determination to include, for plans providing disability benefits, a rescission of disability benefit coverage that has a retroactive effect, whether or not, in connection with the rescission, there is an adverse effect on any particular benefit at that time. Thus, for example, a rescission of disability benefit coverage would be an adverse benefit determination even if the affected participant or beneficiary was not receiving disability benefits at the time of the rescission. The specific amendment would expand the scope of the current definition by expressly providing that an “adverse benefit determination” includes a rescission of disability coverage with respect to a participant or beneficiary, and define the term “rescission” to mean “a cancellation or discontinuance of coverage that has retroactive effect, except to the extent it is attributable to a failure to timely pay required premiums or contributions towards the cost of coverage.” This new definition is modeled on the definition of rescission in the 2719 Final Rule, but would not be limited to rescissions based upon fraud or intentional misrepresentation of material fact.17 Consequently, if a plan provides for a rescission of coverage for disability benefits if an individual makes a misrepresentation of material fact, even if the misrepresentation was not intentional or made knowingly, the rescission would be an adverse benefit determination under this proposal. This proposed change would not prohibit rescissions; rather, it would require plans to treat certain rescissions as adverse benefit determinations, thereby triggering the applicable procedural rights under the Section 503 Regulation.

    17 The Affordable Care Act prohibits group health plans from rescinding coverage with respect to an individual once the individual is covered, except in the case of fraud or intentional misrepresentation of material fact. Consequently, the definition of adverse benefit determination in the 2719 Final Rule effectively is limited to these situations. See 75 FR 37188 and 75 FR 43330.

    6. Culturally & Linguistically Appropriate Notices

    The proposal contains safeguards for individuals who are not fluent in English. The safeguards would require that adverse benefit determinations with respect to disability benefits be provided in a culturally and linguistically appropriate manner in certain situations. The safeguards include standards that illustrate what would be considered “culturally and linguistically appropriate” in these situations. The safeguards and standards are incorporated directly from the 2719 Final Rule and reflect public comment on that rule. The relevant standards are contained in paragraph (p) of the proposal.

    Under the proposed safeguards, if a claimant's address is in a county where 10 percent or more of the population residing in that county, as determined based on American Community Survey (ACS) data published by the United States Census Bureau, are literate only in the same non-English language, notices of adverse benefit determinations to the claimant would have to include a prominent one-sentence statement in the relevant non-English language about the availability of language services.18 In addition, the plan would be required to provide a customer assistance process (such as a telephone hotline) with oral language services in the non-English language and provide written notices in the non-English language upon request. Oral language services includes answering questions in any applicable non-English language and providing assistance with filing claims and appeals in any applicable non-English language.

    18 The Department provides sample sentences in Model Notices at www.dol.gov/ebsa/healthreform/regulations/internalclaimsandappeals.html.

    Two hundred and fifty-five (255) U.S. counties (78 of which are in Puerto Rico) meet the 10 percent threshold at the time of this proposal. The overwhelming majority of these are Spanish; however, Chinese, Tagalog, and Navajo are present in a few counties, affecting five states (specifically, Alaska, Arizona, California, New Mexico, and Utah). A full list of the affected U.S. counties is available on the Department's Web site and updated annually.19

    19https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/2009-13-CLAS-County-Data.pdf.

    D. Miscellaneous 1. Technical Correction

    The Department has determined that a minor technical fix to the Section 503 Regulation is required with respect to disability claims. The Department proposes to clarify that the extended time frames for deciding disability claims, provided by the quarterly meeting rule found in the current regulation at 29 CFR 2560.503-1(i)(1)(ii), are applicable only to multiemployer plans. Accordingly, the proposal would amend paragraph (i)(3) to correctly refer to the appropriate subparagraph in (i)(1) of the Section 503 Regulation.

    2. Request for Comments—Statute of Limitations

    ERISA does not specify the period after a final adverse benefit determination within which a civil action must be filed under section 502(a)(1)(B) of ERISA. Instead, the federal courts have generally looked to analogous state laws to determine an appropriate limitations period. Analogous state law limitations periods vary, but they generally start with the same event, the plan's final benefit determination. Plan documents and insurance contracts sometimes have limitations periods which may override analogous state laws. These contractual limitations periods are not uniform and the events that trigger their running vary. In addition, claimants may not have read the relevant plan documents or the documents may be difficult for claimants to understand. The Supreme Court recently upheld the use of contractual limitations periods so long as they are reasonable.20

    20Heimeshoff v. Hartford Life & Accident Ins. Co., 134 S.Ct. 604, 611 (2013).

    A separate issue, not before the Supreme Court in Heimeshoff v. Hartford Life & Accident Ins. Co., is whether plans should provide participants with notice with respect to contractual limitations periods in adverse benefit determinations on review. The courts of appeals are currently in disagreement on whether plans should provide such notice under the Section 503 Regulation.21 Inasmuch as plans are responsible for implementing contractual limitations provisions, plans may be in a better position than claimants to understand and to explain what those provisions mean.22 In addition, it could prove costly to a participant to hire a lawyer to provide an interpretation that should be readily available to the plan at little or no cost. Accordingly, the Department solicits comments on whether the final regulation should require plans to provide claimants with a clear and prominent statement of any applicable contractual limitations period and its expiration date for the claim at issue in the final notice of adverse benefit determination on appeal and with an updated notice of that expiration date if tolling or some other event causes that date to change.

    21Compare Moyer v. Metropolitan Life Ins. Co., 762 F.3d 503, 505 (6th Cir. 2014) (“The claimant's right to bring a civil action is expressly included as a part of those procedures for which applicable time limits must be provided” in the notice of adverse benefit determination on review) with Wilson v. Standard Ins. Co., 613 F. App'x 841, 844 n.3 (11th Cir. 2015) (per curiam) (“We are not persuaded by the Sixth Circuit's conclusion that a claims administrator's interpretation of the ambiguous § 2560.503-1(g)(1)(iv) not to require notice in the claim denial letter of the contractual time limit for judicial review necessarily amounts to a failure to comply with § 1133 that renders the contractual limitations provision unenforceable.”).

    22Cf. Moyer, 762 F.3d at 507 (“The exclusion of the judicial review time limits from the adverse benefit determination letter was inconsistent with ensuring a fair opportunity for review and rendered the letter not in substantial compliance.”)

    E. Effective Date

    The Department proposes to make this regulation effective 60 days after the date of publication of the final rule in the Federal Register.

    F. Economic Impact and Paperwork Burden 1. Background and Need for Regulatory Action

    As discussed in Section B of this preamble, the proposed amendments would revise and strengthen the current rules regarding claims and appeals applicable to ERISA-covered plans providing disability benefits primarily by adopting several of the new procedural protections and safeguards made applicable to ERISA-covered group health plans by the Affordable Care Act. Before the enactment of the Affordable Care Act, group health plan sponsors and sponsors of ERISA-covered plans providing disability benefits were required to implement claims and appeal processes that complied with the Section 503 Regulation. The enactment of the ACA and the issuance of the implementing interim final regulations resulted in disability benefit claimants receiving fewer procedural protections than group health plan participants even though litigation regarding disability benefit claims is prevalent today.

    The Department believes this action is necessary to ensure that disability claimants receive the more stringent procedural protections that Congress and the President established for group health care claimants under the Affordable Care Act. This will result in some participants receiving benefits they might otherwise have been incorrectly denied in the absence of the fuller protections provided by the proposed regulation. This will help alleviate the financial and emotional hardship suffered by many individuals when they lose earnings due to their becoming disabled. The proposed rule also should help limit the volume and constancy of disability benefits litigation.

    The Department has crafted these proposed regulations to secure the protections of those submitting disability benefit claims. In accordance with OMB Circular A-4, the Department has quantified the costs where possible and provided a qualitative discussion of the benefits that are associated with these proposed regulations.

    2. Executive Order 12866 and 13563—Department of Labor

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

    Under Executive Order 12866 (58 FR 51735), “significant” regulatory actions are subject to review by the Office of Management and Budget (OMB). Section 3(f) of the Executive Order defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. It has been determined that this rule is significant within the meaning of section 3(f) (4) of the Executive Order. Therefore, OMB has reviewed these proposed rules pursuant to the Executive Order. The Department provides an assessment of the potential costs and benefits of proposed rule below, as summarized in Table 1, below.

    Table 1—Accounting Table Category Estimate Year dollar Discount rate Period
  • covered
  • Benefits—Qualitative The Department expects that these proposed regulations would improve the procedural protections for workers who become disabled and make claims for disability benefits from employee benefit plans. This would cause some participants to receive benefits they might otherwise have been incorrectly denied absent the fuller protections provided by the proposed regulations. In other circumstances, expenditures by plans may be reduced as a fuller and fairer system of disability claims and appeals processing helps facilitate participant acceptance of cost management efforts. Greater certainty and consistency in the handling of disability benefit claims and appeals and improved access to information about the manner in which claims and appeals are adjudicated may lead to efficiency gains in the system, both in terms of the allocation of spending at a macro-economic level as well as operational efficiencies among individual plans. Costs Annualized $3,019,000 2015 7% 2016-2025 Monetized $3,019,000 2015 3% 2016-2025 Qualitative These requirements would impose modest costs on plan, because many plans already are familiar with the rules that would apply to disability benefit claims due to their current application to group health plans. As discussed in detail in the cost section below, the Department quantified the costs associated with two provisions of the proposed regulations: the requirement to provide additional information to claimants in the appeals process and the requirement to provide information in a culturally and linguistically appropriate manner.
    3. Estimated Number of Affected Entities

    The Department does not have complete data on the number of plans providing disability benefits or the total number of participants covered by such plans. All ERISA-covered welfare benefit plans with more than 100 participants are required to file a Form 5500. Only some ERISA-covered welfare benefit plans with less than 100 participants are required to file for various reasons, but this number is very small. Based on current trends in the establishment of pension and health plans, there are many more small plans than large plans, but the majority of participants are covered by the large plans.

    Data from the 2013 Form 5500 indicates that there are 34,300 plans covering 52.2 million participants reporting a code indicating they provide temporary disability benefits, and 26,400 plans covering 46.9 million participants reporting a code indicating they provide long-term disability benefits. To put these numbers in perspective, using the CPS and the MEPS-IC, the Department estimates that there are 140,000 large group health plans and 2.2 million small group health plans.

    4. Benefits

    In developing these proposed regulations, the Department closely considered their potential economic effects, including both benefits and costs. The Department does not have sufficient data to quantify the benefits associated with these proposed regulations due to data limitations and a lack of effective measures. Therefore, the Department provides a qualitative discussion of the benefits below.

    These proposed regulations would implement a more uniform and rigorous system of disability claims and appeals processing that conforms to the rules applicable to group health plans. In general, the Department expects that these proposed regulations would improve the procedural protections for workers who become disabled and make claims for disability benefits from employee benefit plans. This will cause some participants to receive benefits that, absent the fuller protections of the regulation, they might otherwise have been incorrectly denied. In other circumstances, expenditures by plans may be reduced as a fuller and fairer system of claims and appeals processing helps facilitate participant acceptance of cost management efforts. Greater certainty and consistency in the handling of disability benefit claims and appeals and improved access to information about the manner in which claims and appeals are adjudicated may lead to efficiency gains in the system, both in terms of the allocation of spending at a macro-economic level as well as operational efficiencies among individual plans. This certainty and consistency can also be expected to benefit, to varying degrees, all parties within the system and to lead to broader social welfare gains, particularly for participants.

    The Department expects that these proposed regulations also will improve the efficiency of plans providing disability benefits by enhancing their transparency and fostering participants' confidence in their fairness. The enhanced disclosure and notice requirements of these proposed regulations would benefit participants and beneficiaries better understand the reasons underlying adverse benefit determinations and their appeal rights.

    For example, the proposed regulations would require adverse benefit determinations to contain a discussion of the decision, including the basis for disagreeing with any disability determination by the Social Security Administration (SSA), a treating physician, or other third party disability determinations, to the extent that the plan did not follow those determinations presented by the claimant. This provision would address the confusion often experienced by claimants when there is little or no explanation provided for their plan's determination and/or their plan's determination is contrary to their doctor's opinion or their SSA award of disability benefits.

    Under the proposal, adverse benefit determinations would have to contain the internal rules, guidelines, protocols, standards or other similar criteria of the plan that were used in denying the claim (or a statement that these do not exist), and a notice of adverse benefit determination at the claim stage would have to contain a statement that the claimant is entitled to receive, upon request, relevant documents. These provisions would benefit claimants by ensuring that they fully understand why their claim was denied so they are able to meaningfully evaluate the merits of pursuing an appeal.

    The proposal also would require adverse benefit determinations for certain participants and beneficiaries that are not fluent in English to be provided in a culturally and linguistically appropriate manner in certain situations. Specifically, if a claimant's address is in a county where 10 percent or more of the population residing in that county, as determined based on American Community Survey (ACS) data published by the United States Census Bureau, are literate only in the same non-English language, notices of adverse benefit determinations to the claimant would have to include a prominent one-sentence statement in the relevant non-English language about the availability of language services. This provision would ensure that certain disability claimants that are not fluent in English understand the notices received from the plan regarding their disability claims and their right to appeal denied claims. The proposal also would provide claimants with the right to review and respond to new evidence or rationales developed by the plan during the pendency of the appeal, as opposed merely to having a right to such information on request only after the claim has already been denied on appeal, as some courts have held under the current regulation. Specifically, the proposal provides that prior to a plan's decision on appeal, a disability benefit claimant must be provided, free of charge, with new or additional evidence considered, relied upon, or generated by (or at the direction of) the plan in connection with the claim, as well as any new or additional rationale for a denial, and a reasonable opportunity for the claimant to respond to such new or additional evidence or rationale. These important protections would benefit participants and beneficiaries by correcting procedural wrongs evidenced in the litigation even predating the ACA.

    The voluntary nature of the employment-based benefit system in conjunction with the open and dynamic character of labor markets make explicit as well as implicit negotiations on compensation a key determinant of the prevalence of employee benefits coverage. The prevalence of benefits is therefore largely dependent on the efficacy of this exchange. If workers perceive that there is the potential for inappropriate denial of benefits or handling of appeals, they will discount the value of such benefits to adjust for this risk. This discount drives a wedge in compensation negotiation, limiting its efficiency. With workers unwilling to bear the full cost of the benefit, fewer benefits will be provided. To the extent that workers perceive that these proposed regulations, supported by enforcement authority, reduces the risk of inappropriate denials of disability benefits, the differential between the employers' costs and workers' willingness to accept wage offsets is minimized.

    These proposed regulations would reduce the likelihood of inappropriate benefit denials by requiring all disability claims and appeals to be adjudicated by persons that are independent and impartial. Specifically, the proposal would prohibit hiring, compensation, termination, promotion, or other similar decisions with respect to any individual (such as a claims adjudicator or medical expert) to be made based upon the likelihood that the individual will support the plan's benefits denial. This would enhance participants' perception that their disability plan's claims and appeals processes are operated in a fair manner.

    The proposal would add criteria to ensure a full and fair review of denied claims by making it explicitly clear that claimants have a right to review and respond to new evidence or rationales developed by the plan during the pendency of the appeal rather than only after the claim has already been denied on appeal, as some courts have held under the current regulation. Specifically, the proposal would require a disability benefit claimant to be provided, free of charge, with new or additional evidence considered, relied upon, or generated by (or at the direction of) the plan in connection with the claim, as well as any new or additional rationale for a denial, and a reasonable opportunity for the claimant to respond to such new or additional evidence or rationale before issuing an adverse benefit determination on review.

    Providing a more formally sanctioned framework for adjudicating disability claims and appeals facilitates the adoption of cost containment programs by employers who, in the absence of a regulation providing some guidance, may have opted to pay questionable claims rather than risk alienating participants or being deemed to have breached their fiduciary duty.

    In summary, the proposed rules provide more uniform standards for handling disability benefit claims and appeals that are comparable to the rules applicable to group health plans. These rules would reduce the incidence of inappropriate denials, averting serious financial hardship and emotional distress for participants and beneficiaries that are impacted by a disability. They also would enhance participants' confidence in the fairness of their plans' claims and appeals processes. Finally, by improving the transparency and flow of information between plans and claimants, the proposed regulations would enhance the efficiency of labor and insurance markets. The Department therefore concludes that the economic benefits of these proposed regulations will justify their costs.

    5. Costs and Transfers

    The Department has quantified the primary costs associated with these proposed regulations' requirements to (1) provide the claimant free of charge with any new or additional evidence considered, and (2) to providing notices of adverse benefit determinations in a culturally and linguistically appropriate manger. These requirements and their associated costs are discussed below.

    Provision of new or additional evidence or rationale: As stated earlier in this preamble, before a plan providing disability benefits can issue a notice of adverse benefit determination on review on a disability benefit claim, these proposed regulations would require such plans to provide the claimant, free of charge, with any new or additional evidence considered, relied upon, or generated by (or at the direction of) the plan as soon as possible and sufficiently in advance of the date the notice of adverse benefit determination on review is required to be provided and any new or additional rationale sufficiently in advance of the due date of the response to an adverse benefit determination on review. This requirement increases the administrative burden on plans to prepare and deliver the enhanced information to claimants. The Department is not aware of data suggesting how often plans rely on new or additional evidence or rationale during the appeals process or the volume of materials that are received.

    For purposes of this regulatory impact analysis, the Department assumes, as an upper bound, that all appealed claims will involve a reliance on additional evidence or rationale. The Department assumes that this requirement will impose an annual aggregate cost of $1.9 million. The Department estimated this cost by assuming that compliance will require medical office staff, or other similar staff in other service setting with a labor rate of $30, five minutes 23 to collect and distribute the additional evidence considered, relied upon, or generated by (or at the direction of) the plan during the appeals process. The Department estimates that on average, material, printing and postage costs will total $2.50 per mailing. The Department further assumes that 75 percent of all mailings will be distributed electronically with no associated material, printing or postage costs.24

    23 The Department's estimated 2015 hourly labor rates include wages, other benefits, and overhead are calculated as follows: mean wage from the 2013 National Occupational Employment Survey (April 2014, Bureau of Labor Statistics http://www.bls.gov/news.release/archives/ocwage_04012014.pdf); wages as a percent of total compensation from the Employer Cost for Employee Compensation (June 2014, Bureau of Labor Statistics http://www.bls.gov/news.release/archives/ecec_09102014.pdf); overhead as a multiple of compensation is assumed to be 25 percent of total compensation for paraprofessionals, 20 percent of compensation for clerical, and 35 percent of compensation for professional; annual inflation assumed to be 2.3 percent annual growth of total labor cost since 2013 (Employment Costs Index data for private industry, September 2014 http://www.bls.gov/news.release/archives/eci_10312014.pdf).

    24 This estimate is based on the methodology used to analyze the cost burden for the Section 503 Regulation (OMB Control Number 1210-0053).

    The Department lacks data on the number of disability claims that are filed or denied. Therefore, the Department estimates the number of short- and long-term disability claims based on the percentage of private sector employees (119 million) 25 that participate in short- and long-term disability programs (approximately 39 and 33 percent respectively).26 The Department estimates the number of claims per covered life for long-term disability benefits based on the percentage of covered individuals that file claims under the Social Security Disability Insurance Program (two percent of covered individuals). The Department does not have sufficient data to estimate the percentage of covered individuals that file short-term disability claims. Therefore, for purposes of this analysis, the Department estimates of six percent of covered lives file such claims, because it believes that short-term disability claims rates are higher than long-term disability claim rates.

    25 BLS Employment, Hours, and Earnings from the Current Employment Statistics survey (National) Table B-1.

    26 “Beyond the Numbers: Disability Insurance Plans Trends in Employee Access and Employer Cost,” February 2015 Vol. 4 No. 4. http://www.bls.gov/opub/btn/volume-4/disability-insurance-plans.htm.

    The Department estimates the number of denied claims that would be covered by the rule in the following manner: For long-term disability, the percent of claims denied is estimated using the percent of denied claims for the Social Security Disability Insurance Program (75 percent). For short-term disability, the estimate of denied claims (three percent) is from the 2012 National Compensation Survey: Employee Benefits in Private Industry in the United States. The estimates are provided in the table below.

    Table 2—Fair and Full Review Burden [in thousands] Short-Term Electronic Paper Long-Term Electronic Paper Total Electronic Paper All Denied Claims and lost Appeals with Additional Information 63 21 463 154 526 175 701 Mailing cost per event $0.00 $0.99 $0.00 $0.99 $0.00 $0.99 Total Mailing Cost $0.00 $21 $0.00 $153 $0.00 $173 $173 Preparation Cost per event $2.50 $2.50 $2.50 $2.50 $2.50 $2.50 $2.50 Total Preparation cost $157 $52 $1,156 $385 $1,313 $438 $1,751 Total $157 $73 $1,156 $538 $1,313 $611 $1,925

    Providing Notices in a Culturally and Linguistically Appropriate Manner: The proposed regulations would require notices of adverse benefit determinations with respect to disability benefits to be provided in a culturally and linguistically appropriate manner in certain situations. This requirement is satisfied if plans provide oral language services including answering questions and providing assistance with filing claims and appeals in any applicable non-English language. These proposed regulations also require each notice sent by a plan to which the requirement applies to include a one-sentence statement in the relevant non-English that translation services are available. Plans also must provide, upon request, a notice in any applicable non-English language.

    The Department expects that the largest cost associated with the requirement for culturally and linguistically appropriate notices will be for plans to provide notices in the applicable non-English language upon request. Based on the 2013 ACS data, the Department estimates that there are about 11.4 million individuals living in covered counties that are literate in a non-English Language.27 To estimate the number of the 11.4 million individuals that might make a request, the Department estimates the number of workers in each state with access to short-term and long-term disability insurance (total population in county* state labor force participation rate* state employment rate).28 29 The number of employed workers then was multiplied by an estimate of the share of workers participating in disability benefits, 39 percent for short-term and 33 percent for long term disability.30

    27http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/2009-13-CLAS-County-Data.pdf. http://www.dol.gov/ebsa/pdf/coveragebulletin2014.pdf Table 1C.

    28 Labor force Participation rate: http://www.bls.gov/lau/staadata.txt Unemployment rate: http://www.bls.gov/lau/lastrk14.htm.

    29 Please note that using state estimates of labor participation rates and unemployment rates could lead to an over estimate as those reporting in the ACS survey that they speak English less than “very well” are less likely to be employed.

    30 “Beyond the Numbers: Disability Insurance Plans Trends in Employee Access and Employer Cost,” February 2015 Vol. 4 No. 4. http://www.bls.gov/opub/btn/volume-4/disability-insurance-plans.htm.

    In discussions with the regulated community, the Department found that experience in California, which has a State law requirement for providing translation services, indicates that requests for translations of written documents averages 0.098 requests per 1,000 members for health claims. While the California law is not identical to these proposed regulations, and the demographics for California do not match other counties, for purposes of this analysis, the Department uses this percentage to estimate of the number of translation service requests that plans could expect to receive. As there are fewer disability claims than health claims, the Department believes that this estimate significantly overstates the cost. Industry experts also told the Department that while the cost of translation services varies, $500 per document is a reasonable approximation of translation cost.

    Based on the foregoing, the Department estimates that the cost to provide translation services will be approximately $1.1 million annually (23,206,000 lives * 0.098/1000 * $500).

    6. Regulatory Flexibility Act—Department of Labor and Department of Health and Human Services

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq.) and which are likely to have a significant economic impact on a substantial number of small entities. Unless an agency determines that a proposal is not likely to have a significant economic impact on a substantial number of small entities, section 603 of the RFA requires the agency to present an initial regulatory flexibility analysis (IRFA) of the proposed rule. The Department's IRFA of the proposed rule is provided below.

    Need for and Objectives of the Rule: As discussed in section B of this preamble, the proposed amendments would revise and strengthen the current rules regarding claims and appeals applicable to ERISA-covered plans providing disability benefits primarily by adopting several of the new procedural protections and safeguards made applicable to ERISA-covered group health plans by the Affordable Care Act. Before the enactment of the Affordable Care Act, group health plan sponsors and sponsors of ERISA-covered plans providing disability benefits were required to implement internal claims and appeal processes that complied with the Section 503 Regulation. The enactment of the Affordable Care Act and the issuance of the implementing interim final regulations resulted in disability plan claimants receiving fewer procedural protections than group health plan participants even though litigation regarding disability benefit claims is prevalent today.

    The Department believes this action is necessary to ensure that disability claimants receive the same protections that Congress and the President established for group health care claimants under the Affordable Care Act. This will result in some participants receiving benefits they might otherwise have been incorrectly denied in the absence of the fuller protections provided by the proposed regulation. This will help alleviate the financial and emotional hardship suffered by many individuals when they lose earnings due to their becoming disabled. The proposed rule also should help limit the volume and constancy of disability benefits litigation.

    Affected Small Entities: The Department does not have complete data on the number of plans providing disability benefits or the total number of participants covered by such plans. All ERISA-covered welfare benefit plans with more than 100 participants are required to file a Form 5500. Only some ERISA-covered welfare benefit plans with less than 100 participants are required to file for various reasons, but this number is very small. Based on current trends in the establishment of pension and health plans, there are many more small plans than large plans, but the majority of participants are covered by the large plans.

    Data from the 2013 Form 5500 indicates that there are 34,300 plans covering 52.2 million participants reporting a code indicating they provide temporary disability benefits, and 26,400 plans covering 46.9 million participants reporting a code indicating they provide long-term disability benefits. To put these numbers in perspective, using the CPS and the MEPS-IC, the Department estimates that there are 140,000 large group health plans and 2.2 million small group health plans.

    Impact of the Rule: The Department has quantified the primary costs associated with these proposed regulations' requirements to (1) provide the claimant free of charge with any new or additional evidence considered, and (2) to providing notices of adverse benefit determinations in a culturally and linguistically appropriate manger. These requirements and their associated costs are discussed in the Costs and Transfers section above.

    Provision of new or additional evidence or rationale: As stated earlier in this preamble, before a plan can issue a notice of adverse benefit determination on review, these proposed regulations would require plans to provide disability benefit claimants, free of charge, with any new or additional evidence considered, relied upon, or generated by (or at the direction of) the plan as soon as possible and sufficiently in advance of the date the notice of adverse benefit determination on review is required to be provided and any new or additional rationale sufficiently in advance of the due date of the response to an adverse benefit determination on review.

    The Department is not aware of data suggesting how often plans rely on new or additional evidence or rationale during the appeals process or the volume of materials that are received. The Department estimated the cost per claim by assuming that compliance will require medical office staff, or other similar staff in other service setting with a labor rate of $30, five minutes 31 to collect and distribute the additional evidence considered, relied upon, or generated by (or at the direction of) the plan during the appeals process. The Department estimates that on average, material, printing and postage costs will total $2.50 per mailing. The Department further assumes that 75 percent of all mailings will be distributed electronically with no associated material, printing or postage costs.

    31 The Department's estimated 2015 hourly labor rates include wages, other benefits, and overhead are calculated as follows: mean wage from the 2013 National Occupational Employment Survey (April 2014, Bureau of Labor Statistics http://www.bls.gov/news.release/archives/ocwage_04012014.pdf); wages as a percent of total compensation from the Employer Cost for Employee Compensation (June 2014, Bureau of Labor Statistics http://www.bls.gov/news.release/archives/ecec_09102014.pdf); overhead as a multiple of compensation is assumed to be 25 percent of total compensation for paraprofessionals, 20 percent of compensation for clerical, and 35 percent of compensation for professional; annual inflation assumed to be 2.3 percent annual growth of total labor cost since 2013 (Employment Costs Index data for private industry, September 2014 http://www.bls.gov/news.release/archives/eci_10312014.pdf).

    Providing Notices in a Culturally and Linguistically Appropriate Manner: The proposed regulations would require that notices of adverse benefit determinations with respect to disability benefits be provided in a culturally and linguistically appropriate manner in certain situations. This requirement is satisfied if plans provide oral language services including answering questions and providing assistance with filing claims and appeals in any applicable non-English language. These proposed regulations also require such notices of adverse benefit determinations sent by a plan to which the requirement applies to include a one-sentence statement in the relevant non-English language about the availability of language services. Plans also must provide, upon request, such notices of adverse benefit determinations in the applicable non-English language.

    The Department expects that the largest cost associated with the requirement for culturally and linguistically appropriate notices will be for plans to provide notices in the applicable non-English language upon request. Industry experts also told the Department that while the cost of translation services varies, $500 per document is a reasonable approximation of translation cost.

    In discussions with the regulated community, the Department found that experience in California, which has a State law requirement for providing translation services, indicates that requests for translations of written documents averages 0.098 requests per 1,000 members for health claims. While the California law is not identical to these proposed regulations, and the demographics for California do not match other counties, for purposes of this analysis, the Department used this percentage to estimate of the number of translation service requests plans could expect to receive. Based on the low number of requests per claim, the Department expects that translation costs would be included as part of a package of services offered to a plan, and that the costs of actual requests will be spread across multiple plans.

    Duplication, Overlap, and Conflict with Other Rules and Regulations: The Department does not believe that the proposed actions would conflict with any relevant regulations, federal or other.

    Based on the foregoing, the Department hereby certifies that these final regulations will not have a significant economic impact on a substantial number of small entities.

    7. Paperwork Reduction Act

    As part of its continuing effort to reduce paperwork and respondent burden, the Department conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps to ensure that the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) in minimized, collection instructions are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

    As discussed above, these proposed regulations would require plans providing disability benefits to meet additional requirements when complying with the Department's claims procedure regulation. Some of these requirements would require disclosures covered by the PRA. These requirements include disclosing information to ensure a full and fair review of a claim or appeal, and the content of notices of benefit determinations.

    Currently, the Department is soliciting 60 days of public comments concerning these disclosures. The Department has submitted a copy of these proposed regulations to OMB in accordance with 44 U.S.C. 3507(d) for review of the information collections. The Department and OMB are particularly interested in comments that:

    • Evaluate 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;

    • Evaluate the accuracy of the agency's estimate of the burden of the 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, for example, by permitting electronic submission of responses.

    Comments should be sent to the Office of Information and Regulatory Affairs, Attention: Desk Officer for the Employee Benefits Security Administration either by fax to (202) 395-7285 or by email to [email protected] A copy of the ICR may be obtained by contacting the PRA addressee: G. Christopher Cosby, Office of Policy and Research, U.S. Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue NW., Room N-5718, Washington, DC 20210. Telephone: (202) 693-8410; Fax: (202) 219-4745. These are not toll-free numbers. Email: [email protected] ICRs submitted to OMB also are available at reginfo.gov (http://www.reginfo.gov/public/do/ PRAMain).

    ERISA-covered group health plans already are required to comply with the requirements of the Section 503 Regulation. The Section 503 Regulation requires, among other things, plans to provide a claimant who is denied a claim with a written or electronic notice that contains the specific reasons for denial, a reference to the relevant plan provisions on which the denial is based, a description of any additional information necessary to perfect the claim, and a description of steps to be taken if the participant or beneficiary wishes to appeal the denial. The regulation also requires that any adverse decision upon review be in writing (including electronic means) and include specific reasons for the decision, as well as references to relevant plan provisions.

    With the implementation of the ACA claims regulations, participants of disability plans receive fewer procedural protections than participants in group health plan participants, while they experience similar if not significantly more issues with the claims review process. These proposed regulations would reduce the inconsistent procedural rules applied to health and disability benefit plan claims and provide similar procedural protections to both groups of plan participants.

    The burdens associated with this proposed regulatory requirements are summarized below.

    Type of Review: Revised collection.

    Agencies: Employee Benefits Security Administration, Department of Labor.

    Title: ERISA Claims Procedures.

    OMB Number: 1210-0053.

    Affected Public: Business or other for-profit; not-for-profit institutions.

    Total Respondents: 5,961,000.

    Total Responses: 311,867,000.

    Frequency of Response: Occasionally.

    Estimated Total Annual Burden Hours: 515,000.

    Estimated Total Annual Burden Cost: $654,579,000.

    8. Congressional Review Act

    These proposed regulations are subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and, if finalized, would be transmitted to Congress and the Comptroller General for review. The proposed rule is not a “major rule” as that term is defined in 5 U.S.C. 804, because it is not likely to result in an annual effect on the economy of $100 million or more.

    9. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statements assessing the effects of any Federal Mandate in a proposed or final agency rule that may result in annual expenditures of $100 million (as adjusted for inflation) in any one year by State, local and tribal governments, in the aggregate, or the private sector. Such a mandate is deemed to be a “significant regulatory action.” These proposed regulations are not a “significant regulatory action.” Therefore the Department concludes that these proposed regulations would not impose an unfunded mandate on State, local and tribal governments, in the aggregate, or the private sector.

    10. Federalism Statement

    Executive Order 13132 outlines fundamental principles of federalism, and requires the adherence to specific criteria by Federal agencies in the process of their formulation and implementation of policies that have “substantial direct effects” on the States, the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have federalism implications must consult with State and local officials and describe the extent of their consultation and the nature of the concerns of State and local officials in the preamble to the final regulation.

    In the Departments of Labor's view, these proposed regulations have federalism implications because they would have direct effects on the States, the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government to the extent states have enacted laws affecting disability plan claims and appeals that contain similar requirements to the proposal. The Department believes these effects are limited, because although section 514 of ERISA supersedes State laws to the extent they relate to any covered employee benefit plan, it preserves State laws that regulate insurance, banking, or securities. In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the States, the Department welcomes input from affected States, including the National Association of Insurance Commissioners and State insurance officials, regarding this assessment.

    List of Subjects in 29 CFR Part 2560

    Claims, Employee benefit plans, Pensions.

    For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR part 2560 as set forth below:

    PART 2560—RULES AND REGULATIONS FOR ADMINISTRATION AND ENFORCEMENT 1. The authority citation for part 2560 is revised to read as follows: Authority:

    29 U.S.C. 1132, 1135, and Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012). Section 2560.503-1 also issued under 29 U.S.C. 1133. Section 2560.502c-7 also issued under 29 U.S.C. 1132(c) (7). Section 2560.502c-4 also issued under 29 U.S.C. 1132(c)(4). Section 2560.502c-8 also issued under 29 U.S.C. 1132(c)(8).

    2. Section 2560.503-1 is amended by: a. Adding paragraph (b)(7). b. Revising paragraph (g)(1)(v) introductory text. c. Adding paragraphs (g)(1)(vii) and (viii). d. Revising paragraphs (h)(4), (i)(3)(i), and (j)(5) introductory text. e. Adding paragraphs (j)(6) and (7). f. Revising paragraphs (l) and (m)(4). g. Adding paragraphs (m)(9) and (p).

    The revisions and additions read as follows:

    § 2560.503-1 Claims procedure.

    (b) * * *

    (7) In the case of a plan providing disability benefits, the plan must ensure that all claims and appeals for disability benefits are adjudicated in a manner designed to ensure the independence and impartiality of the persons involved in making the decision. Accordingly, decisions regarding hiring, compensation, termination, promotion, or other similar matters with respect to any individual (such as a claims adjudicator or medical expert) must not be made based upon the likelihood that the individual will support the denial of benefits.

    (g)* * * (1) * * *

    (v) In the case of an adverse benefit determination by a group health plan—

    (vii) In the case of an adverse benefit determination with respect to disability benefits—

    (A) A discussion of the decision, including, to the extent that the plan did not follow or agree with the views presented by the claimant to the plan of health care professionals treating a claimant or the decisions presented by the claimant to the plan of other payers of benefits who granted a claimant's similar claims (including disability benefit determinations by the Social Security Administration), the basis for disagreeing with their views or decisions;

    (B) Either the specific internal rules, guidelines, protocols, standards or other similar criteria of the plan relied upon in making the adverse determination or, alternatively, a statement that such rules, guidelines, protocols, standards or other similar criteria of the plan do not exist; and

    (C) A statement that the claimant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records, and other information relevant to the claimant's claim for benefits. Whether a document, record, or other information is relevant to a claim for benefits shall be determined by reference to paragraph (m)(8) of this section.

    (viii) In the case of an adverse benefit determination with respect to disability benefits, the notification shall be provided in a culturally and linguistically appropriate manner (as described in paragraph (p) of this section).

    (h) * * *

    (4) Plans providing disability benefits. The claims procedures of a plan providing disability benefits will not, with respect to claims for such benefits, be deemed to provide a claimant with a reasonable opportunity for a full and fair review of a claim and adverse benefit determination unless, in addition to complying with the requirements of paragraphs (h)(2)(ii) through (iv) and (h)(3)(i) through (v) of this section, the claims procedures—

    (i) Allow a claimant to review the claim file and to present evidence and testimony as part of the disability benefit claims and appeals process;

    (ii) Provide that, before the plan can issue an adverse benefit determination on review on a disability benefit claim, the plan administrator shall provide the claimant, free of charge, with any new or additional evidence considered, relied upon, or generated by the plan (or at the direction of the plan) in connection with the claim; such evidence must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided under paragraph (i) of this section to give the claimant a reasonable opportunity to respond prior to that date; and

    (iii) Provide that, before the plan can issue an adverse benefit determination on review on a disability benefit claim based on a new or additional rationale, the plan administrator shall provide the claimant, free of charge, with the rationale; the rationale must be provided as soon as possible and sufficiently in advance of the date on which the notice of adverse benefit determination on review is required to be provided under paragraph (i) of this section to give the claimant a reasonable opportunity to respond prior to that date.

    (i) * * *

    (3) Disability claims. (i) Except as provided in paragraph (i)(3)(ii) of this section, claims involving disability benefits (whether the plan provides for one or two appeals) shall be governed by paragraph (i)(1)(i) of this section, except that a period of 45 days shall apply instead of 60 days for purposes of that paragraph.

    (j) * * *

    (5) In the case of a group health plan—

    * * *

    (6) In the case of an adverse benefit decision with respect to disability benefits—

    (i) A discussion of the decision, including, to the extent that the plan did not follow or agree with the views presented by the claimant to the plan of health care professionals treating a claimant or the decisions presented by the claimant to the plan of other payers of benefits who granted a claimant's similar claims (including disability benefit determinations by the Social Security Administration), the basis for disagreeing with their views or decisions; and

    (ii) Either the specific internal rules, guidelines, protocols, standards or other similar criteria of the plan relied upon in making the adverse determination or, alternatively, a statement that such rules, guidelines, protocols, standards or other similar criteria of the plan do not exist.

    (7) In the case of an adverse benefit determination on review with respect to a claim for disability benefits, the notification shall be provided in a culturally and linguistically appropriate manner (as described in paragraph (p) of this section).

    (l) Failure to establish and follow reasonable claims procedures. (1) In general. Except as provided in paragraph (l)(2) of this section, in the case of the failure of a plan to establish or follow claims procedures consistent with the requirements of this section, a claimant shall be deemed to have exhausted the administrative remedies available under the plan and shall be entitled to pursue any available remedies under section 502(a) of the Act on the basis that the plan has failed to provide a reasonable claims procedure that would yield a decision on the merits of the claim.

    (2) Plans providing disability benefits. (i) In the case of a claim for disability benefits, if the plan fails to strictly adhere to all the requirements of this section with respect to a claim, the claimant is deemed to have exhausted the administrative remedies available under the plan, except as provided in paragraph (l)(2)(ii) of this section. Accordingly, the claimant is entitled to pursue any available remedies under section 502(a) of ERISA on the basis that the plan has failed to provide a reasonable claims procedure that would yield a decision on the merits of the claim. If a claimant chooses to pursue remedies under section 502(a) of ERISA under such circumstances, the claim or appeal is deemed denied on review without the exercise of discretion by an appropriate fiduciary.

    (ii) Notwithstanding paragraph (l)(2)(i) of this section, the administrative remedies available under a plan with respect to claims for disability benefits will not be deemed exhausted based on de minimis violations that do not cause, and are not likely to cause, prejudice or harm to the claimant so long as the plan demonstrates that the violation was for good cause or due to matters beyond the control of the plan and that the violation occurred in the context of an ongoing, good faith exchange of information between the plan and the claimant. This exception is not available if the violation is part of a pattern or practice of violations by the plan. The claimant may request a written explanation of the violation from the plan, and the plan must provide such explanation within 10 days, including a specific description of its bases, if any, for asserting that the violation should not cause the administrative remedies available under the plan to be deemed exhausted. If a court rejects the claimant's request for immediate review under paragraph (l)(2)(i) of this section on the basis that the plan met the standards for the exception under this paragraph (l)(2)(ii), the claim shall be considered as re-filed on appeal upon the plan's receipt of the decision of the court. Within a reasonable time after the receipt of the decision, the plan shall provide the claimant with notice of the resubmission.

    (m) * * *

    (4) The term “adverse benefit determination” means:

    (i) Any of the following: a denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit, including any such denial, reduction, termination, or failure to provide or make payment that is based on a determination of a participant's or beneficiary's eligibility to participate in a plan, and including, with respect to group health plans, a denial, reduction, or termination of, or a failure to provide or make payment (in whole or in part) for, a benefit resulting from the application of any utilization review, as well as a failure to cover an item or service for which benefits are otherwise provided because it is determined to be experimental or investigational or not medically necessary or appropriate; and

    (ii) In the case of a plan providing disability benefits, the term “adverse benefit determination” also means any rescission of disability coverage with respect to a participant or beneficiary (whether or not, in connection with the rescission, there is an adverse effect on any particular benefit at that time). For this purpose, the term “rescission” means a cancellation or discontinuance of coverage that has retroactive effect, except to the extent it is attributable to a failure to timely pay required premiums or contributions towards the cost of coverage.

    (9) The term “claim file” means the file or other compilation of relevant information, as described in paragraph (m)(8) of this section, to be considered in the full and fair review of a disability benefit claim.

    (p) Standards for culturally and linguistically appropriate notices. A plan is considered to provide relevant notices in a “culturally and linguistically appropriate manner” if the plan meets all the requirements of paragraph (p)(1) of this section with respect to the applicable non-English languages described in paragraph (p)(2) of this section.

    (1) Requirements. (i) The plan must provide oral language services (such as a telephone customer assistance hotline) that include answering questions in any applicable non-English language and providing assistance with filing claims and appeals in any applicable non-English language;

    (ii) The plan must provide, upon request, a notice in any applicable non-English language; and

    (iii) The plan must include in the English versions of all notices, a statement prominently displayed in any applicable non-English language clearly indicating how to access the language services provided by the plan.

    (2) Applicable non-English language. With respect to an address in any United States county to which a notice is sent, a non-English language is an applicable non-English language if ten percent or more of the population residing in the county is literate only in the same non-English language, as determined in guidance published by the Secretary.

    Signed at Washington, DC, this 6th day of November, 2015. Phyllis C. Borzi, Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor.
    [FR Doc. 2015-29295 Filed 11-13-15; 4:15 pm] BILLING CODE 4510-29-P
    DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Parts 7 and 75 [Docket No. MSHA-2013-0033] RIN 1219-AB79 Refuge Alternatives for Underground Coal Mines AGENCY:

    Mine Safety and Health Administration, Labor.

    ACTION:

    Request for Information; extension of comment period.

    SUMMARY:

    In response to requests from interested parties, the Mine Safety and Health Administration (MSHA) is extending the comment period on the Request for Information on Refuge Alternatives for Underground Coal Mines. This extension gives stakeholders additional time to provide input on the current state of refuges in use and recent research and new technology that may lead to the development of a new generation of refuges.

    DATES:

    Comments must be received or postmarked by midnight Eastern Standard Time on January 15, 2016.

    ADDRESSES:

    Submit comments and informational materials, identified by RIN 1219-AB79 or Docket No. MSHA-2013-0033, by one of the following methods:

    Federal E-Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    E-Mail: [email protected] Include RIN 1219-AB79 or Docket No. MSHA-2014-0033 in the subject line of the message.

    Mail: MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.

    Fax: 202-693-9441.

    Hand Delivery or Courier: MSHA, 201 12th Street South, Suite 4E401, Arlington, Virginia, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal holidays. Sign in at the receptionist's desk on the 4th floor.

    Instructions: All submissions must include RIN 1219-AB79 or Docket No. MSHA-2013-0033. Do not include personal information that you do not want publicly disclosed; MSHA will post all comments without change to http://www.regulations.gov and http://www.msha.gov/currentcomments.asp, including any personal information provided.

    Docket: For access to the docket to read comments received, go to http://www.regulations.gov or http://www.msha.gov/currentcomments.asp. To read background documents, go to http://www.regulations.gov. Review the docket in person at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452, between 9:00 a.m. and 5:00 p.m. Monday through Friday, except Federal Holidays. Sign in at the receptionist's desk on the 4th floor.

    E-Mail Notification: To subscribe to receive an email notification when MSHA publishes rules in the Federal Register, and program information, instructions, and policy, go to http://www.msha.gov/subscriptions/subscribe.aspx.

    FOR FURTHER INFORMATION CONTACT:

    Sheila A. McConnell, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at [email protected] (email); 202-693-9440 (voice); or 202-693-9441 (facsimile).

    SUPPLEMENTARY INFORMATION:

    On October 19, 2015, MSHA held a public meeting to gather information on issues and options relevant to coal miners' escape and refuge. The meeting was announced in the Federal Register on September 18, 2015 (80 FR 56416). Coal mine operators, coal miners, equipment manufacturers, academia, and the public were invited to provide information on the current state of refuge alternatives in underground coal mines, particularly on the challenges related to the use of built-in-place refuges and enhancing voice communication when using escape breathing devices. In response to stakeholders, MSHA is providing additional time for interested parties to comment. MSHA is extending the comment period from November 16, 2015, to January 15, 2016.

    Joseph A. Main, Assistant Secretary of Labor for Mine Safety and Health.
    [FR Doc. 2015-29433 Filed 11-16-15; 11:15 am] BILLING CODE 4510-43-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 171 [EPA-HQ-OPP-2011-0183; FRL-9936-82] RIN 2070-AJ20 Pesticides; Certification of Pesticide Applicators; Extension of Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    EPA issued a proposed rule in the Federal Register of August 24, 2015, concerning certification of applicators of restricted use pesticides. This document extends the comment period for 30 days, from November 23, 2015 to December 23, 2015. The comment period is being extended to provide additional time for commenters to prepare their responses.

    DATES:

    Comments, identified by docket identification (ID) number EPA-HQ-OPP-2011-0183, must be received on or before December 23, 2015.

    ADDRESSES:

    Follow the detailed instructions provided under ADDRESSES in the Federal Register document of August 24, 2015 (80 FR 51356) (FRL-9931-83).

    FOR FURTHER INFORMATION CONTACT:

    Michelle Arling, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (703) 308-5891; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    This document extends the public comment period established in the Federal Register document of August 24, 2015. In that document, comments were required to be submitted by November 23, 2015. EPA is hereby extending the comment period to December 23, 2015.

    To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of August 24, 2015. If you have questions, consult the person listed under FOR FURTHER INFORMATION CONTACT.

    List of Subjects in 40 CFR Part 171

    Environmental protection, Administrative practice and procedure, Certified applicator, Commercial applicator, Indian Country, Indian Tribes, Noncertified applicator, Pesticides and pests, Private applicator, Reporting and recordkeeping requirements, Restricted use pesticides.

    Dated: November 10, 2015. James Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
    [FR Doc. 2015-29370 Filed 11-17-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [CG Docket Nos. 10-51 and 03-123; FCC 15-143] Structure and Practices of the Video Relay Service Program; Telecommunications Relay Services and Speech-to-Speech Services for Individuals With Hearing and Speech Disabilities AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Commission proposes to amend its rules to modify its current four-year compensation rate plan for Video Relay Service (VRS), adopted in 2013, by adopting a limited-duration compensation rate freeze applicable to VRS providers with 500,000 or fewer monthly minutes, and solicits comment on whether to adopt a number of service quality measures that could enhance the functional equivalence of VRS.

    DATES:

    Comments on the section entitled VRS Compensation Rates (paragraphs 1-9) are due on or before December 9, 2015, and reply comments are due on or before December 24, 2015. Comments on the section entitled VRS Improvements (paragraphs 10-25) are due on or before January 4, 2016, and reply comments are due on or before February 1, 2016.

    ADDRESSES:

    You may submit comments, identified by CG Docket Nos. 10-51 and 03-123, by any of the following methods:

    Electronic Filers: Comments may be filed electronically using the Internet by accessing the Commission's Electronic Comment Filing System (ECFS), through the Commission's Web site http://fjallfoss.fcc.gov/ecfs2/. Filers should follow the instructions provided on the Commission's Web site for submitting comments. For ECFS filers, in completing the transmittal screen, filers should include their full name, U.S. Postal service mailing address, and CG Docket Nos. 10-51 and 03-123.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although the Commission continues to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Eliot Greenwald, Consumer and Governmental Affairs Bureau, Disability Rights Office, at 202-418-2235 or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW., Room TW-A325, Washington, DC 20554. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.

    • Commercial Mail sent by overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    • U.S. Postal Service first-class, Express, and Priority mail should be addressed to 445 12th Street SW., Washington, DC 20554.

    This is a summary of the Commission's document FCC 15-143, Structure and Practices of the Video Relay Service Program and Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, Further Notice of Proposed Rulemaking, adopted on October 21, 2015, and released on November 3, 2015, in CG Docket Nos. 10-51 and 03-123. The full text of document FCC 15-143 will be available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. Document FCC 15-143 can also be downloaded in Word or Portable Document Format (PDF) at: https://www.fcc.gov/encyclopedia/disability-rights-office-headlines. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the Commission's rules. In proceedings governed by § 1.49(f) of the Commission's rules or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Initial Paperwork Reduction Act of 1995 Analysis

    Document FCC 15-143 seeks comment on proposed rule amendments that may result in modified information collection requirements. If the Commission adopts any modified information collection requirements, the Commission will publish another notice in the Federal Register inviting the public to comment on the requirements, as required by the Paperwork Reduction Act. Public Law 104-13, 109 Stat. 163; 44 U.S.C. 3501-3520. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, the Commission seeks comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees. Public Law 107-198, 116 Stat. 729; 44 U.S.C. 3506(c)(4).

    Synopsis

    1. VRS Compensation Rates. In 2013, the Commission adopted a report and order amending its telecommunications relay service (TRS) rules to improve the structure, efficiency, and quality of the VRS program, reduce the risk of waste, fraud, and abuse, and ensure that the program makes full use of advances in commercially-available technology. Structure and Practices of the Video Relay Services Program, Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CG Docket Nos. 10-51, 03-123, Report and Order and Further Notice of Proposed Rulemaking, published at 78 FR 40407, July 5, 2013, and 78 FR 40582, July 5, 2013 (VRS Reform Order), aff'd in part and vacated in part sub nom. Sorenson Communications, Inc. v. FCC, 765 F.3d 37 (D.C. Cir. 2014) (Sorenson). The VRS Reform Order established the rates at which VRS providers are compensated from the Interstate Telecommunications Relay Service Fund (TRS Fund) for a four-year period beginning July 1, 2013, and adopted structural reforms designed to establish a more level playing field for all VRS providers.

    2. Under the current compensation methodology for VRS, providers submit the number of minutes of service they provide to the TRS Fund administrator on a monthly basis and are compensated for these minutes based on rates set annually by the Commission. The Commission currently uses a three-tier compensation rate structure that allows smaller providers to receive a higher average per-minute rate than larger providers. In the VRS Reform Order, the Commission found that, for many years, VRS compensation rates had exceeded providers' average allowable costs, causing overcompensation of VRS providers. To address this issue, the Commission proposed basing VRS compensation rates largely on competitively established pricing—i.e., prices that would be set through a competitive bidding process, and which would be instituted after the completion of structural reforms to the VRS program in the FNPRM accompanying the VRS Reform Order. Pending the resolution of these matters, however, in the VRS Reform Order, the Commission adopted a four-year schedule for gradually adjusting VRS compensation rates downward towards cost based levels.

    3. On March 30, 2015, the six currently certified VRS providers jointly filed a petition (Joint VRS Providers Proposal) in which they urged the Commission to freeze the currently applicable VRS compensation rates of $5.29, $4.82, and $4.25 per minute. They also indicated that they would support the following measures to improve the service quality of VRS: (1) A faster speed-of-answer standard, under which 80 percent of calls must be answered within 45 seconds, measured monthly; (2) a limited trial of “skills-based routing” in order to assess the cost and feasibility of offering that service feature; and (3) authorization for providers to use deaf sign language interpreters, to supplement hearing interpreters who are communications assistants (CAs), for the purpose of achieving functionally equivalent relay calls to or from certain categories of deaf users.

    4. Generally, the Commission believes the four-year compensation rate plan continues to be justified. For the three smallest providers, however, the record does indicate that their average per-minute costs are higher than the applicable rates in effect as of July 1, 2015. According to recent filings by the smallest providers, while these companies generally have achieved significant reductions in their per-minute costs over the last two years, and while they have begun to increase market share to some extent, they have yet to approach the size or efficiency levels of their larger rivals.

    5. The Commission continues to believe that, as stated in the VRS Reform Order, “it is worth tolerating some degree of additional inefficiency in the short term, in order to maximize the opportunity for successful participation of multiple efficient providers in the future, in the more competition-friendly environment that the Commission expect to result from our structural reforms.” The Commission proposes a limited modification of the VRS Reform Order, to allow small providers a reasonable measure of temporary relief from rate reductions that, according to the TRS Fund administrator, are potentially jeopardizing their continuation of service. Specifically, the Commission proposes to freeze for a maximum of 16 months the rate of compensation paid to “small” VRS providers, defined as providers whose monthly compensable minutes do not exceed 500,000 minutes. The Tier I rate of $5.29 per minute that was in effect prior to June 30, 2015, would be frozen only for those providers whose monthly minutes fall entirely within Tier I. Larger providers would be subject to the Tier I rate established in the VRS Reform Order, as well as the established Tier II and III rates. The Commission invites comment on whether a different dividing line is appropriate for purposes of a rate freeze and also seeks comment generally on this proposal and its costs and benefits.

    6. The Commission next seeks comment on how the proposed partial rate freeze should be implemented. The partial rate freeze proposed herein would extend, for qualifying providers and for a maximum of 16 months, beginning July 1, 2015, the Tier I rate of $5.29 per minute that was in effect prior to June 30, 2015. The Commission seeks comment on this approach, including the precise duration of the proposed rate freeze. The Commission seeks additional comment regarding these providers' actual expectations regarding their progress in closing the gap between rates and costs, what specific structural reform milestones are most critical to their ability to compete effectively, what criteria should be used in determining when such milestones were or will be achieved, and what specific dates for the end of a rate freeze result from that analysis. In addition, the Commission seeks comment on how rate adjustments should be resumed upon the termination of a rate freeze period, regardless of its duration. The Commission also seeks comment on whether it is the case that some small providers may not be likely in the foreseeable future to achieve “minimum efficient scale” but may nevertheless provide significant value to certain consumer groups. The Commission seeks comment on the extent to which some providers offer types of specialized features or services to specific segments of consumers, the nature of such specialized features or services, and the costs of providing them. The Commission also seeks comment on the extent to which larger companies are able to efficiently provide comparable features or services to the specific market segments served by smaller providers and whether they have an adequate incentive to do so notwithstanding the applicability of higher-tier compensation rates.

    7. Generally, the Commission seeks comment on whether the Commission should apply different rates to well-defined categories of specialized service, and how such rate categories could appropriately be defined consistently with the objectives of section 225 of the Act and the need to prevent fraud, abuse, and waste of the TRS Fund. For example, what specific features or services are necessary to ensure the provision of functionally equivalent VRS to deaf-blind individuals, what would be the additional per-minute cost for a company to provide such a service “in the most efficient manner,” and how could such a service be defined and an applicable VRS compensation rate be structured to best meet the statutory objectives? Are there any other specialized features or services that are or could be provided to specific segments of VRS consumers and that are necessary for such consumers to receive functionally equivalent VRS? If so, what is the per-minute cost for a company to provide such features or services “in the most efficient manner,” and how could such services or features be defined and an applicable VRS compensation rate be structured to best meet the statutory objectives?

    8. The Commission tentatively concludes that it would not advance the objectives of section 225 of the Act to freeze VRS compensation rates in all rate tiers, for all providers, at the Jan. 1-June 30, 2015 levels, as proposed by the VRS providers, or to freeze the Tier I rate for all providers. However, the Commission invites comment on the merits, including the costs and benefits, of these alternatives and others that may be suggested by commenting parties. The Commission also seeks comment on the appropriate duration and other parameters of such alternatives.

    9. The Commission invites any party advocating a more broadly applicable rate freeze to provide a detailed, fact-based showing as to why such a rate freeze is necessary to prevent service degradation rather than to provide debt service far in excess of the amounts for which recovery from the TRS Fund is allowed by the Commission's rules and orders. The Commission also invites commenters to suggest how any proposed alternative rate freeze could be structured to ensure that TRS Fund monies are no longer used to subsidize excessive levels of debt.

    10. VRS Improvements. The Commission is charged with ensuring that TRS is made available to the extent possible, and in the most efficient manner, and that it provides the ability for individuals with hearing or speech disabilities to engage in communication by telephone in a manner that is functionally equivalent to the ability of individuals who do not have such disabilities. (47 U.S.C. 225(a)(3), (b)(1).) The Commission seeks comment on whether to: (1) Impose a faster speed-of-answer standard; (2) adopt a limited trial of “skills-based routing”; (3) authorize providers to use qualified deaf sign language interpreters, in addition to the hearing interpreters, as CAs; (4) authorize the use of at-home interpreters under certain conditions; and (5) permit the assignment of ten-digit numbers for telephones used by hearing individuals. In general, the Commission seeks comment on the costs and benefits of these proposals and alternatives discussed in document FCC 15-143 or submitted by the parties, and on whether and how such proposals and alternatives comport with section 225 of the Act and any other relevant legal authorities.

    11. In the VRS Reform Order, the Commission amended the VRS speed-of-answer standard, requiring that (1) effective January 1, 2014, VRS providers must answer 85 percent of all VRS calls within 60 seconds, measured on a daily basis, and (2) effective July 1, 2014, VRS providers must answer 85 percent of all VRS calls within 30 seconds, measured on a daily basis. The U.S. Court of Appeals for the District of Columbia Circuit vacated the amended requirements, ruling that the Commission had failed to consider the cost impact of the strengthened requirements. In the Joint VRS Providers Proposal, the providers endorse strengthening the speed-of-answer rule to require that 80 percent of all VRS calls be answered within 45 seconds, measured on a monthly basis. On June 23, 2015, the Disability Advisory Committee (DAC) submitted to the Commission the same recommendation as was made in the Joint VRS Providers Proposal.

    12. The Commission proposes to amend the speed-of-answer rule to require that 80 percent of all VRS calls be answered within 45 seconds, measured on a monthly basis, and invites parties to comment on the costs and benefits of this proposal. The Commission tentatively concludes that there are factors besides functional equivalence—including the availability of sign language interpreters, the need to ensure adequate working conditions for CAs who handle VRS calls, and the need to ensure a high quality of interpreting—that merit consideration in setting the speed-of-answer standard.

    13. The Commission proposes to continue to measure compliance with the speed-of-answer requirement for VRS on a monthly rather than a daily basis. The Commission seeks comment on this proposal and on whether, as the VRS providers assert, a daily measurement requirement, under which a provider must meet the requirement every day or lose compensation for that day, can be counterproductive because providers are subject to random variation in demand that cannot reasonably be anticipated. To what extent will such standard enable the Commission to meet its obligation to ensure functionally equivalent service? Will a daily measurement have value because it would encourage providers to maintain sufficient staffing to ensure a consistent level of service over time? Is it likely that competitive forces will prompt providers to exceed the level of service the Commission sets by this rulemaking?

    14. The Commission seeks comment on its tentative conclusion that compliance with the proposed standard could be achieved without any provider incurring additional costs in excess of those incurred over the past year.

    15. The Commission seeks comment on the providers' proposal that, in lieu of the “all-or-nothing” compensation withholding policy, under which a provider that misses the speed-of-answer requirement on a particular day or month loses all compensation from the TRS Fund for that period, the Commission adopt a “sliding scale” approach, whereby the consequence for missing the speed-of-answer requirement in a given period is limited to withholding that percentage of the provider's total VRS billing that corresponds to the percentage by which the provider fell short of the applicable standard during that period.

    16. The Commission also seeks comment on (1) whether to adopt an incentive-based system in which providers who meet stricter speed of answer thresholds receive additional compensation, (2) whether the Commission should publish summaries of each provider's speed-of-answer performance data, so that consumers can compare the performance of various providers, and the amount of detail that would be useful for consumers to know, and (3) whether to adopt a self-executing exemption from the speed-of-answer standard for calls occurring as a result of specific extraordinary events beyond a provider's control and a streamlined waiver procedure to address other events that may justify a waiver of the speed-of-answer standard.

    17. Finally, the Commission seeks comment on whether the existing speed-of-answer rule for VRS, which states that the speed of answer for VRS is measured beginning from the time a VRS call reaches facilities operated by the VRS CA service provider, adequately defines when the speed-of-answer “clock” starts. The Commission proposes to amend the speed-of-answer rule for VRS so that it expressly incorporates the same language applicable to other TRS calls, i.e., that the call must be “answered . . . by any method which results in the caller's call immediately being placed, not put in a queue or on hold.”

    18. In the VRS Reform Order, the Commission considered comments advocating the authorization of “skills-based routing,” a practice whereby VRS callers could request that calls be routed to VRS CAs with particular skill sets—such as particular spoken-language abilities, interpreting, transliteration, and signing styles and skills, or knowledge of specific subject matters (e.g., medicine, law, or technology). As suggested in the Joint VRS Providers Proposal, the Commission now seeks comment on whether to authorize “skills-based routing” on a trial basis.

    19. The Commission seeks additional comment on the merits of skills-based routing generally. To what extent is skills-based routing necessary to achieve a telephone service that is functionally equivalent to the service provided to voice telephone users? Is skills-based routing consistent with the fundamental nature of TRS, which is currently subject to requirements that TRS calls must be answered in the order received, that providers must not unreasonably discriminate in the handling of calls, and that CAs must not refuse calls? If skills-based routing is authorized on a permanent basis, how should the types of calls appropriate for skills-based routing be defined? Would it be appropriate to provide compensation for the cost of such interpreters from the TRS Fund as a cost of providing service that meets minimum TRS standards? Generally, what additional costs would be incurred by providers for the provision of skills-based routing? What indirect impact might its provision have on the TRS Fund? For example, we seek comment on whether providers expect that they would need to pay higher wages to interpreters employed in the provision of skills-based routing. Should such additional labor costs be recoverable in VRS compensation rates, and if so, in what manner? To what extent could the provision of skills-based routing using higher-paid interpreters cause a migration of the most qualified interpreters to those positions, lowering the average quality of interpretation available on non-specialized calls?

    20. If the Commission were to authorize a trial of skills-based routing, how should it be structured? Should skills-based routed calls during a trial period be exempt from all speed-of-answer compliance but subject to collection and reporting of speed-of-answer data, as the providers suggest? What types of skills-based routing (e.g., medical, legal, other call categories) should be included in the trial? Should the Commission limit the percentage of calls that can be subject to skills-based routing? Should the Commission waive the “sequential call rule” for successive calls not requiring specialized interpretation, so that such calls can be routed to a generalist interpreter? Should the Commission impose a requirement that a caller requesting a specialist interpreter be given an estimate of the expected wait time and the option of waiting for a skills-based CA or proceeding with a regular interpreter?

    21. If the Commission were to authorize a trial of skills-based routing, how long should that trial last? What types of data should be collected during the trial to assess the costs and benefits of skills-based routing? What standards should be applied in assessing whether the interpreters to whom calls are routed actually have the relevant specialized skills and whether specialized interpreting is actually provided on such calls? The Commission also seeks comment on its assumption that any provider's participation in a trial of skills-based routing should be voluntary and thus that any costs incurred by providers to participate in such a trial would not be billable to the TRS Fund as exogenous costs or otherwise.

    22. The Commission seeks comment on whether to amend its rules to permit compensation for the use of deaf interpreters where needed to achieve functionally equivalent service on VRS calls for consumers of VRS where the provision of a hearing video interpreter in a VRS call is not sufficient for effective communications. The Commission seeks comment on the types and estimated percentage of VRS users who would benefit from the availability of deaf interpreters and on the costs of providing deaf interpreters. How many additional interpreter-hours would be needed and at what hourly rate? In the event that the Commission decides to adopt a rule that supports the provision of deaf interpreters, how should the Commission define the necessary qualifications for a deaf interpreter? What recordkeeping and reporting requirements are appropriate? Should the Commission treat deaf interpreters as a form of skills-based routing, exempting calls requiring a deaf interpreter from the speed-of-answer calculations? The Commission also seeks comment on whether, before authorizing the use of deaf interpreters on a permanent basis, the Commission should first conduct a trial of this practice, similar to the trial of skills-based routing discussed previously.

    23. To prevent fraud and abuse, the Commission previously adopted a rule prohibiting VRS interpreters from working from their homes. (47 CFR 64.604 (b)(4)(iii).) In the VRS Reform Order, the Commission sought comment on whether to permit VRS CAs to work from home during the overnight hours when the safety and security of CAs may be endangered from travelling to or from VRS call centers. The Commission now seeks comment on whether circumstances have changed sufficiently so that CAs should be permitted to work from home at any time, subject to appropriate safeguards. The Commission asks what specific safeguards are needed to ensure protection against fraud and abuse of the VRS program were such rule change to take place. The Commission further notes that home interpreting arrangements might fall short of achieving full compliance with the Commission's mandatory minimum standards for TRS, including standards protecting call privacy, requiring the handling of 911 calls, mandating service redundancy, and assuring certain call quality. The Commission asks commenters to address the costs and benefits of permitting CAs to work from home and how such costs and benefits would differ, based on whether CAs are permitted to work from home at any time or only during overnight hours.

    24. The Commission proposes to allow VRS providers to assign ten-digit Internet-based TRS numbers to hearing individuals so that they are able to place and receive direct (point-to-point) video calls to and from other VRS users. In the VRS Reform Order, the Commission previously sought comment on whether to allow such use. The Commission seeks comment on whether the Commission has statutory authority to allow such use of VRS facilities. The Commission seeks comment on whether permitting eligible VRS users to communicate directly with hearing people who can use American Sign Language (ASL) will increase the functional equivalence of TRS by facilitating telephone communication between members of the deaf and hearing communities, conserve the resources of the TRS Fund, and allow more natural, efficient, and effective communication between the parties, and whether to require or merely authorize providers to register hearing individuals for this service.

    25. The Commission seeks comment on its tentative conclusion that assigning hearing individuals their own numbers would cause no significant increase in the costs incurred by VRS providers and on who should bear such costs as will be incurred to provide this service. The Commission also proposes to adopt measures to prevent fraud, abuse, and waste in connection with ten-digit numbers assigned to hearing individuals, including requiring the default provider to transmit a hearing person's registration information, as well as the assigned ten-digit number, to the TRS User Registration Database (TRS-URD) and to notify both the TRS Numbering Directory and the TRS-URD that the registrant is a hearing person who is not entitled to place or receive VRS calls. The Commission seeks comment on what additional registration information, if any, beyond that collected for eligible VRS users, the Commission should require the default provider to collect and provide to the TRS-URD for hearing users.

    Initial Regulatory Flexibility Act Analysis

    26. As required by the Regulatory Flexibility Act (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in document FCC 15-143. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments as indicated in the Dates section. The Commission will send a copy of document FCC 15-143, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). (See 5 U.S.C. 603(a).)

    A. Need For, and Objectives of, the Proposed Rules

    27. The Commission proposes to modify in part the four-year compensation rate plan for video relay service (VRS) adopted in 2013 and also seeks comment on whether to adopt a number of measures that could enhance the functional equivalence of VRS.

    28. Although the Commission believes that the four-year schedule of VRS compensation rate reductions continues to be justified in order to gradually move compensation rates close to a level close to average allowable provider costs, the Commission proposes to modify the schedule as applied to the smallest VRS providers, i.e., those providing 500,000 or fewer compensable minutes of use of VRS per month. Spreading rate reductions over a four-year period was largely intended to provide a reasonable opportunity for the smallest providers to reach minimum efficient scale while benefitting from the VRS Reform Order initiatives which were intended to address many of the issues that have made it difficult for small providers to operate efficiently.

    29. The smallest providers have achieved significant reductions in their per-minute costs but have yet to approach the size or efficiency levels of their larger rivals. Further, some relevant VRS Reform Order initiatives, such as the open source video access platform, will soon be implemented, and the Commission believes all existing providers should have a fair opportunity to participate in this important reform. Finally, some small providers offer service features that may be helpful in advancing the goal of functionally equivalent service for certain subsets of VRS consumers, such as Spanish language speakers, deaf-blind consumers, and deaf-owned businesses.

    30. Therefore, the Commission proposes to temporarily “freeze” the rate applicable to providers with monthly call volumes that do not exceed 500,000 compensable minutes per month, effective July 1, 2015, at the level of the Tier I rate ($5.29 per minute) in effect on June 30, 2015. The Commission proposes that this rate remain in effect for a maximum of 16 months and seeks comment on the specific duration of the rate freeze and the rate that should apply upon its expiration. The Commission also seeks comment on whether there are unique types of VRS that are inherently more expensive to provide and to which an alternative rate level should apply. Finally, the Commission invites comment on alternatives to its rate freeze proposal, such as freezing rates in all tiers, for all providers, or freezing rates for all providers for their first 500,000 minutes.

    31. In addition to the proposed VRS compensation rate freeze, the FNPRM seeks comment on a number of rule changes that may improve the functional equivalence of VRS. Specifically, the FNPRM seeks comment on whether to: (1) Impose a faster speed-of-answer standard, e.g., requiring VRS providers to answer 80 percent of all VRS calls within 45 seconds, as measured on a monthly basis, in lieu of the current requirement to answer 80 percent of all VRS calls within 120 seconds, as measured on a monthly basis; (2) adopt a limited trial of “skills-based routing,” allowing VRS callers to request that calls be routed to VRS communications assistants (CAs) with particular skill sets, such as particular spoken-language abilities, interpreting, transliteration, and signing styles and skills, or knowledge of specific subject matters (e.g., medicine, law, or technology); (3) authorize providers to use qualified deaf sign language interpreters, in addition to the hearing interpreters, as CAs for those consumers who need such additional assistance for effective communication; (4) authorize the use of at-home interpreters under certain conditions; and (5) permit the assignment of ten-digit numbers for video phones used by hearing individuals who know American Sign Language (ASL) to communicate directly with deaf consumers. The Commission seeks comment on the costs and benefits of each of these measures.

    B. Legal Basis

    32. The authority for this proposed rulemaking is contained in sections 4(i), 201(b), 225, and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 201(b), 225, 303(r).

    C. Description and Estimate of the Number of Small Entities Impacted

    33. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. (5 U.S.C. 603(b)(3).) The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” (5 U.S.C. 601(6).) In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. (5 U.S.C. 601(3).) Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.”) A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. (15 U.S.C. 632.)

    34. VRS Providers. These services can be included within the broad economic category of All Other Telecommunications. Six providers currently receive compensation from the TRS Fund for providing VRS: ASL Services Holdings, LLC (ASL Services); CSDVRS, LLC (CSDVRS); Convo Communications, LLC (Convo); Hancock, Jahn, Lee and Puckett, LLCd/b/a “Communications Axess Ability Group” (CAAG); Purple Communications, Inc. (Purple); and Sorenson Communications, Inc. (Sorenson) (VRS and IP CTS).

    35. All Other Telecommunications. “All Other Telecommunications” is defined as follows: “This U.S. industry comprises establishments primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or voice over Internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry.” (U.S. Census Bureau, North American Industry Classification System, Definition of NAICS Code 517919. See http://www.census.gov/cgi-bin/sssd/naics/naicsrch.)

    36. The SBA has developed a small business size standard for All Other Telecommunications, which consists of all such firms with gross annual receipts of $32.5 million or less. (See 13 CFR 121.201, NAICS Code 517919.) All the authorized VRS providers can be included within the broad economic census category of All Other Telecommunications. Under this category and the associated small business size standard, approximately half of the VRS providers can be considered small.

    D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

    37. No additional compliance requirements would be imposed by the VRS compensation rate freeze proposed in document FCC 15-143. If the Commission were to adopt some or all of the service improvement measures on which comments are sought in document FCC 15-143, the adoption of such measures could result in additional reporting, recordkeeping, and other compliance requirements. Specifically, in seeking comments on whether to authorize a limited trial of “skills-based routing,” provide for the use of qualified deaf sign language interpreters to provide additional communications assistance for VRS users who need such additional assistance for effective communication, or permit the assignment of ten-digit numbers for video phones used by hearing individuals to communicate directly with deaf consumers, the Commission has also sought comment on whether additional reporting and recordkeeping requirements would be needed to document the use of such features in order to prevent fraud, abuse, and waste. There may also be associated recordkeeping, reporting, or compliance requirements if the Commission were to allow the use of at-home interpreters, but such compliance requirements would apply only if a provider chooses to permit its interpreters to work from home. If the Commission were to increase the required speed of answer for VRS calls, no additional reporting and recordkeeping requirements are contemplated, and the cost of compliance would increase only to the extent that the new standard exceeded providers' current performance.

    E. Steps Taken To Minimize Significant Impact on Small Entities, and Significant Alternatives Considered

    38. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. (5 U.S.C. 603(b).)

    39. The temporary compensation rate freeze proposed in document FCC 15-143 would not impose additional compliance burdens and would temporarily ease the impact of existing VRS regulations on small entities by temporarily increasing the VRS compensation rate for small entities above the rate currently in effect. Similarly, if the Commission were to amend its rules to authorize at-home interpreting for VRS, the impact of existing VRS regulations on small entities could be reduced because providers would have additional flexibility to structure their VRS operations so as to minimize cost and maximize efficiency.

    40. Regarding the possible additional record-keeping and reporting requirements that could be adopted if the Commission were to authorize skills-based routing, deaf interpreters, or assignment of ten-digit numbers to hearing individuals using video phones, the Commission is seeking comment on the alternative of allowing providers to choose whether to provide such features and incur the associated compliance requirements.

    F. Federal Rules Which Duplicate, Overlap, or Conflict With, the Commission's Proposals

    41. None.

    Federal Communications Commission.

    Marlene H. Dortch, Secretary.
    [FR Doc. 2015-29371 Filed 11-17-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 2, 4, 9, 12, 19 and 52 [FAR Case 2015-022; Docket No. 2015-0022; Sequence No. 1] RIN 9000-AN00 Federal Acquisition Regulation; Unique Identification of Entities Receiving Federal Awards AGENCY:

    Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to re-designate the terminology for unique identification of entities receiving Federal awards. The change to the FAR will remove the proprietary standard or number.

    DATES:

    Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before January 19, 2016 to be considered in the formulation of a final rule.

    ADDRESSES:

    Submit comments in response to FAR Case 2015-022 by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for “FAR Case 2015-022”. Select the link “Comment Now” that corresponds with FAR Case 2015-022. Follow the instructions provided at the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2015-022” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat (MVCB), ATTN: Ms. Flowers, 1800 F Street NW., 2nd Floor, Washington, DC 20405.

    Instructions: Please submit comments only and cite FAR Case 2015-022, in all correspondence related to this case. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Edward Loeb, Procurement Analyst, at 202-501-0650, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FAR Case 2015-022.

    SUPPLEMENTARY INFORMATION: I. Background

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to re-designate the terminology for unique identification of entities receiving Federal awards. The change to the FAR will remove the proprietary standard or number. Unique identification of such entities is critical to ensure Federal dollars are awarded to responsible parties, awardees are paid in a timely manner, and awards are appropriately recorded and reported. This is currently accomplished through regulation (i.e., the FAR) using the proprietary Data Universal Numbering System (DUNS®) number from Dun and Bradstreet. This rule proposes to eliminate references to the proprietary standard or number and to provide appropriate references to the Web site where information on the unique entity identifier used for Federal contractors will be located. In addition, the proposed rule establishes definitions of “unique entity identifier”, and “electronic funds transfer (EFT) indicator”.

    In recent years, legislation has been enacted (e.g., the Federal Funding Accountability and Transparency Act and the Digital Accountability and Transparency Act) that requires expanded identification of entities working with the Government and the development of standards, processes, and policies to better trace Federal dollars from appropriation to final outcomes or results. Creation and maintenance of data standards will facilitate collection and display of essential information. A data standard for identification of entities receiving Federal awards has been developed as part of the implementation for the Digital Accountability and Transparency Act and is available at http://fedspendingtransparency.github.io/whitepapers/unique-id-business-name/.

    Going forward, the Federal Government will establish a transparent process for exploring potential alternatives to existing entity identifiers. Office of Management and Budget (OMB) and Treasury, in collaboration with the General Services Administration and the Award Committee for E-Government will establish a process for considering options, including soliciting information about viable alternatives from and reaching out about nonproprietary alternatives to all sectors, including private companies, nonprofits, and Federal government providers. This process will result in an analysis of alternatives for the unique identification of entities working with the Federal government while maintaining the statutory and regulatory integrity protections for the needs of the various awarding communities (loans, financial assistance, procurement, etc.) as well as transparency communities. The analysis of alternatives will include consideration of costs, implementation considerations, and protections for Federal taxpayers. The analysis of alternatives is anticipated to be completed in Fiscal Year (FY) 2017.

    Although the Government is not currently in a position to move away from use of the DUNS number in the short term, elimination of regulatory references to a proprietary entity identifier will provide opportunities for future competition that can reduce costs to taxpayers. The current requirement limits competition by using a proprietary number and organization to meet the identification need as well as the need for other business information associated with that number.

    II. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    III. Regulatory Flexibility Act

    DoD, GSA, and NASA do not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. However, an Initial Regulatory Flexibility Analysis (IRFA) has been prepared consistent with 5 U.S.C. 605. The IRFA is summarized as follows:

    The rule is being proposed to remove a proprietary standard or number for the unique identification of entities receiving Federal awards. The current requirement limits competition by using a proprietary number and organization to meet the identification needs.

    Unique identification of such entities is critical to ensure Federal dollars are awarded to responsible parties, awardees are paid in a timely manner, and awards are appropriately recorded and reported. This is currently accomplished through regulation in the FAR using the proprietary Data Universal Numbering System (DUNS®) number from Dun and Bradstreet. This rule proposes to eliminate references to the proprietary standard or number, and to provide appropriate references to the Web site where information on the unique entity identifier used for Federal contractors will be designated.

    Although the Government does not intend to move away from use of the DUNS number in the short term, elimination of regulatory references to a proprietary entity identifier will provide opportunities for future competition that can reduce costs to taxpayers.

    The proposed rule is internal to the Government and does not directly impose any requirements on the vendor community. However, the rule may affect certain entities if those entities have arranged certain of their business systems to utilize, accept, or otherwise recognize the existing unique identifier (DUNS Number) and should that unique identifier be changed at some point to another identifier. As of June 2015, there were 380,092 unique and active DUNS numbers designated in the System for Award Management and attributed to Government contracting.

    There is no change to recordkeeping as a result of this rule.

    The rule does not duplicate, overlap, or conflict with any other Federal rules.

    There are no known significant alternative approaches to the rule that would meet the requirements.

    The Regulatory Secretariat has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

    DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2015-022), in correspondence.

    IV. Paperwork Reduction Act

    The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 48 CFR Parts 2, 4, 9, 12, 19 and 52

    Government procurement.

    William Clark, Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.

    Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 2, 4, 9, 12, 19 and 52 as set forth below:

    1. The authority citation for 48 CFR parts 2, 4, 9, 12, 19 and 52 continues to read as follows: Authority:

    40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.

    PART 2—DEFINITIONS OF WORDS AND TERMS 2. Amend section 2.101, in paragraph (b)(2) by— a. Removing the definitions “Data Universal Numbering System (DUNS) number” and “Data Universal Numbering System +4 (DUNS+4) number”; b. Adding, in alphabetical order the definition “Electronic Funds Transfer (EFT) indicator”; c. Revising paragraph (1) of the definition “Registered in the System for Award Management (SAM) database”; and d. Adding, in alphabetical order, the definition, “Unique entity identifier”.

    The added and revised text reads as follows:

    2.101 Definitions.

    (b) * * *

    (2) * * *

    Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, non-profit, or Government entity to establish additional System for Award Management records for identifying alternative Electronic Funds Transfer (EFT) accounts (see subpart 32.11) for the same entity.

    Registered in the System for Award Management (SAM) database * * *

    (1) The Contractor has entered all mandatory information, including the unique entity identifier and the Electronic Funds Transfer indicator, (if applicable), the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (see subpart 4.14), into the SAM database;

    Unique entity identifier means a number or other identifier used to identify a specific commercial, non-profit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

    PART 4—ADMINISTRATIVE MATTERS 3. Amend section 4.601 by removing the definition “Generic DUNS number” and adding in alphabetical order a definition “Generic entity identifier” to read as follows:
    4.601 Definitions.

    Generic entity identifier means a number or other identifier assigned to a category of vendors and not specific to any individual or entity.

    4. Amend section 4.605 by revising paragraph (b), the heading of paragraph (c), and paragraphs (c)(1), and (c)(2) introductory text; and removing from paragraph (c)(2)(i)(C) “DUNS number” and adding “unique entity identifier” in its place.

    The revised text reads as follows.

    4.605 Procedures.

    (b) Unique entity identifier. The contracting officer shall identify and report a unique entity identifier for the successful offeror on a contract action. The unique entity identifier shall correspond to the successful offeror's name and address as stated in the offer and resultant contract, and as registered in the System for Award Management database in accordance with the provision at 52.204-7, System for Award Management. The contracting officer shall ask the offeror to provide its unique entity identifier by using either the provision at 52.204-6, Unique Entity Identifier, the provision at 52.204-7, System for Award Management, or the provision at 52.212-1, Instructions to Offerors—Commercial Items. (For a discussion of the Commercial and Government Entity (CAGE) Code, which is a different identifier, see subpart 4.18.)

    (c) Generic entity identifier. (1) The use of a generic entity identifier should be limited, and only used in the situations described in paragraph (c)(2) of this section. Use of a generic entity identifier does not supersede the requirements of either provisions 52.204-6, Unique Entity Identifier or 52.204-7, System for Award Management (if present in the solicitation) for the contractor to have a unique entity identifier assigned.

    (2) Authorized generic entity identifiers, maintained by the Integrated Award Environment (IAE) program office (http://www.gsa.gov/portal/content/105036), may be used to report contracts in lieu of the contractor's actual unique entity identifier only for—

    5. Amend section 4.607 by— a. Removing from paragraph (b) “Data Universal Numbering System Number” and adding “Unique Entity Identifier” in its place; and b. Revising paragraph (c) to read as follows.
    4.607 Solicitation provisions and contract clause.

    (c) Insert the clause at 52.204-12, Unique Entity Identifier Maintenance, in solicitations and resulting contracts that contain the provision at 52.204-6, Unique Entity Identifier.

    6. Amend section 4.1103 by— a. Removing from paragraph (a)(1) “must register;” and adding “shall register;” in its place; b. Removing from paragraph (a)(2) introductory text “DUNS number or, if applicable, the DUNS+4 number” and adding “unique entity identifier” in its place; and c. Revising paragraphs (a)(3) and (d) to read as follows:
    4.1103 Procedures.

    (a) * * *

    (3) Need not verify registration before placing an order or call if the contract or agreement includes the provision at 52.204-7, System for Award Management, or the clause at 52.212-4, Contract Terms and Conditions-Commercial Items, or a similar agency clause, except when use of the Governmentwide commercial purchase card is contemplated as a method of payment. (See 32.1108(b)(2)).

    (d) The contracting officer shall, on contractual documents transmitted to the payment office, provide the unique entity identifier and, if applicable, the Electronic Funds Transfer indicator, in accordance with agency procedures.

    4.1402 [Amended]
    7. Amend section 4.1402 by removing from paragraph (b), last sentence, “DUNS number” and adding “entity identifier” in its place.
    4.1705 [Amended]
    8. Amend section 4.1705 by removing from paragraphs (a) and (b) “DUNS number” and adding “entity identifier” in their places. 9. Amend section 4.1800 by revising paragraph (b) to read as follows.
    4.1800 Scope of subpart.

    (b) For information on the unique entity identifier, which is a different identifier, see 4.605 and the provisions at 52.204-6, Unique Entity Identifier, and 52.204-7, System for Award Management.

    10. Amend section 4.1802 by: a. Revising paragraph (a)(1); and b. Removing from paragraph (b) “DUNS Number” and adding “unique entity identifier” in its place.

    The revised text reads as follows:

    4.1802 Policy.

    (a) * * * (1) Offerors shall provide the contracting officer the CAGE code assigned to that offeror's location prior to the award of a contract action above the micro-purchase threshold, when there is a requirement to be registered in the System for Award Management (SAM) or a requirement to have a unique entity identifier in the solicitation.

    4.1804 [Amended]
    11. Amend section 4.1804 by removing from paragraph (a)(1) “Data Universal Numbering System Number” and adding “Unique Entity Identifier” in its place. PART 9—CONTRACTOR QUALIFICATIONS 12. Amend section 9.404 by revising paragraph (b)(6) to read as follows:
    9.404 System for Award Management Exclusions.

    (b) * * *

    (6) Unique Entity Identifier;

    PART 12—ACQUISITION OF COMMERCIAL ITEMS
    12.301 [Amended]
    13. Amend section 12.301 by removing from paragraphs (d)(1) and (2) “DUNS Number” and adding “unique entity identifier” in their places. PART 19—SMALL BUSINESS PROGRAMS
    19.704 [Amended]
    14. Amend section 19.704 by removing from the introductory text of paragraph (a) “must include” and adding “shall include” in its place; and removing from paragraphs (a)(10)(v) and (vi) “DUNS number” and adding “unique entity identifier” in their places. PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 15. Revise section 52.204-6 to read as follows.
    52.204-6 Unique Entity Identifier.

    As prescribed in 4.607(b), insert the following provision:

    Unique Entity Identifier (Date)

    (a) Definitions.

    Electronic Funds Transfer (EFT) indicator, as used in this provision, means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, non-profit, or Government entity to establish additional System for Award Management records for identifying alternative EFT accounts (see subpart 32.11) for the same entity.

    Unique entity identifier, as used in this provision, means a number or other identifier used to identify a specific commercial, non-profit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

    (b) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “Unique Entity Identifier” followed by the unique entity identifier that identifies the Offeror's name and address exactly as stated in the offer. The Offeror also shall enter its EFT indicator, if applicable.

    (c) If the Offeror does not have a unique entity identifier, it should contact the entity designated at SAM for establishment of the unique entity identifier directly to obtain one. The Offeror should be prepared to provide the following information:

    (1) Company legal business name.

    (2) Tradestyle, doing business, or other name by which your entity is commonly recognized.

    (3) Company physical street address, city, state and Zip Code.

    (4) Company mailing address, city, state and Zip Code (if separate from physical).

    (5) Company telephone number.

    (6) Date the company was started.

    (7) Number of employees at your location.

    (8) Chief executive officer/key manager.

    (9) Line of business (industry).

    (10) Company Headquarters name and address (reporting relationship within your entity).

    (End of provision)
    16. Amend section 52.204-7 by— a. Revising the date of the provision; b. Amending paragraph (a) by— i. Removing the definitions “Data Universal Numbering System (DUNS) number” and “Data Universal Numbering System +4 (DUNS+4)”; ii. Adding, in alphabetical order, the definition “Electronic Funds Transfer (EFT) indicator”; iii. Revising paragraph (1) of the definition “Registered in the System for Award Management (SAM) database”; and iv. Adding, in alphabetical order, the definition “Unique entity identifier”; c. Removing from paragraph (b)(1) “the offeror” and adding “the Offeror” in its place; and d. Revising paragraphs (b)(2) and (c).

    The revised and added text reads as follows:

    52.204-7 System for Award Management. System for Award Management (DATE)

    (a) Definitions. As used in this provision—

    Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier, the suffix is assigned at the discretion of the commercial, non-profit, or Government entity to establish additional System for Award Management records for identifying alternative EFT accounts (see the FAR at subpart 32.11) for the same entity.

    Registered in the System for Award Management (SAM) database means that—

    (1) The Offeror has entered all mandatory information, including the unique entity identifier and the EFT indicator, if applicable, the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (see subpart 4.14) into the SAM database;

    Unique entity identifier means a number or other identifier used to identify a specific commercial, non-profit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

    (b) * * *

    (2) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation Unique Entity Identifier followed by the unique entity identifier that identifies the Offeror's name and address exactly as stated in the offer. The Offeror also shall enter its EFT indicator, if applicable. The unique entity identifier will be used by the Contracting Officer to verify that the Offeror is registered in the SAM database.

    (c) If the Offeror does not have a unique entity identifier, it should contact the entity designated at SAM for establishment of the unique entity identifier directly to obtain one. The Offeror should be prepared to provide the following information:

    (1) Company legal business.

    (2) Tradestyle, doing business, or other name by which your entity is commonly recognized.

    (3) Company Physical Street Address, City, State, and Zip Code.

    (4) Company Mailing Address, City, State and Zip Code (if separate from physical).

    (5) Company Telephone Number.

    (6) Date the company was started.

    (7) Number of employees at your location.

    (8) Chief executive officer/key manager.

    (9) Line of business (industry).

    (10) Company Headquarters name and address (reporting relationship within your entity).

    17. Amend section 52.204-10 by— a. Revising the date of the clause; and b. Removing from paragraph (d)(2)(i) “identifier (DUNS Number)” and adding “entity identifier” in its place.

    The revised text reads as follows:

    52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards. Reporting Executive Compensation and First-Tier Subcontract Awards (DATE)
    18. Revise section 52.204-12 to read as follows.
    52.204-12 Unique Entity Identifier.

    As prescribed in 4.607(c), insert the following clause:

    Unique Entity Identifier (DATE)

    (a) Definition. Unique entity identifier, as used in this clause, means a number or other identifier used to identify a specific commercial, non-profit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

    (b) The Contractor shall ensure that the unique entity identifier is maintained with the entity designated at the System for Award Management (SAM) for establishment of the unique entity identifier throughout the life of the contract. The Contractor shall communicate any change to the unique entity identifier to the Contracting Officer within 30 days after the change, so an appropriate modification can be issued to update the data on the contract. A change in the unique entity identifier does not necessarily require a novation be accomplished.

    (End of clause)
    19. Amend section 52.204-13 by— a. Revising the date of the clause; b. Amending paragraph (a) by— i. Removing the definitions “Data Universal Numbering System (DUNS) number” and “Data Universal Numbering System +4 (DUNS+4)”; ii. Adding, in alphabetical order, the definition “Electronic Funds Transfer (EFT) indicator”; iii. Revising paragraph (1) of the definition “Registered in the System for Award Management (SAM) database”; and iv. Adding, in alphabetical order, the definition “Unique entity identifier”; and c. Revising paragraph (c)(3).

    The revised and added text reads as follows:

    52.204-13 System for Award Management Maintenance. System for Award Management Maintenance (DATE)

    (a) * * *

    Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, non-profit, or Government entity to establish additional System for Award Management (SAM) records for identifying alternative EFT accounts (see the FAR at subpart 32.11) for the same entity.

    Registered in the System for Award Management (SAM) database means that—

    (1) The Contractor has entered all mandatory information, including the unique entity identifier (if applicable) or the EFT indicator, the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (see subpart 4.14), into the SAM database;

    Unique entity identifier means a number or other identifier used to identify a specific commercial, non-profit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

    (c) * * *

    (3) The Contractor shall ensure that the unique entity identifier is maintained with the entity designated at SAM for establishment of the unique entity identifier throughout the life of the contract. The Contractor shall communicate any change to the unique entity identifier to the Contracting Officer within 30 days after the change, so an appropriate modification can be issued to update the data on the contract. A change in the unique entity identifier does not necessarily require a novation be accomplished.

    20. Amend section 52.204-14 by— a. Revising the date of the clause; and b. Removing from paragraph (f)(1)(i), “DUNS number” and adding “unique entity identifier” in its place.

    The revised text reads as follows:

    52.204-14 Service Contract Reporting Requirements. Service Contract Reporting Requirements (DATE)
    21. Amend section 52.204-15 by— a. Revising the date of the clause; and b. Removing from paragraph (f)(1)(i) “DUNS number” and adding “unique entity identifier” in its place.

    The revised text reads as follows:

    52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts. Service Contract Reporting Requirements for Indefinite-Delivery Contracts (DATE)
    22. Amend section 52.212-1 by revising the date of the provision and paragraph (j) to read as follows:
    52.212-1 Instructions to Offerors—Commercial Items. Instructions to Offerors-Commercial Items (DATE)

    (j) Unique entity identifier. (Applies to all offers exceeding $3,500, and offers of $3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database.) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “unique entity identifier”. The suffix is followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier assigned at the discretion of the offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at SAM for unique entity identifier establishment directly to obtain one. The offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at SAM for establishing the unique entity identifier.

    23. Amend section 52.212-3 by— a. Revising the date of the provision; and b. Removing from paragraph (p) introductory text “DUNS Number” and adding “unique entity identifier” in its place.

    The revised text reads as follows:

    52.212-3 Offeror Representations and Certifications-Commercial Items. Offeror Representations and Certifications-Commercial Items (DATE)
    24. Amend section 52.212-5 by revising the date of the clause and paragraphs (b)(4), (b)(6), (b)(7), and (b)(17)(i) to read as follows:
    52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (DATE)

    (b) * * *

    _ (4)52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (DATE) (Pub. L. 109-282) (31 U.S.C. 6101 note).

    _ (6)52.204-14, Service Contract Reporting Requirements (DATE) (Pub. L. 111-117, section 743 of Div. C).

    _ (7)52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (DATE) (Pub. L. 111-117, section 743 of Div. C).

    _ (17)(i)52.219-9, Small Business Subcontracting Plan (DATE) (15 U.S.C. 637(d)(4)).

    25. Amend section 52.213-4 by revising the date of the clause and paragraph (b)(1)(i) to read as follows:
    52.213-4 Terms and Conditions—Simplified Acquisitions (Other Than Commercial Items). Terms and Conditions-Simplified Acquisitions (Other Than Commercial Items) (DATE)

    (b) * * *

    (1) * * *

    (i) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (DATE) (Pub. L. 109-282) (31 U.S.C. 6101 note) (Applies to contracts valued at $25,000 or more).

    26. Amend section 52.219-9 by— a. Revising the date of the clause; b. Removing from the introductory text of paragraph (d) “offeror's” and adding “Offeror's” in its place; c. Removing from paragraph (d)(10) introductory text “offeror” and adding “Offeror” in its place; d. Removing from paragraph (d)(10)(v) “DUNS number,” and “the offeror's” and adding “unique entity identifier,” and “the Offeror's” in their places, respectively; and e. Removing from paragraph (d)(10)(vi) “DUNS number,” and adding “unique entity identifier,” in its place.

    The revised text reads as follows:

    52.219-9 Small Business Subcontracting Plan. Small Business Subcontracting Plan (DATE)
    [FR Doc. 2015-29414 Filed 11-17-15; 8:45 am] BILLING CODE 6820-EP-P
    80 222 Wednesday, November 18, 2015 Notices DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Information Collection for the National School Lunch Program AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this information collection. This is a revision of a currently approved collection which FNS employs to determine public participation in the National School Lunch Program.

    DATES:

    Written comments must be received on or before January 19, 2016.

    ADDRESSES:

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments may be sent to: Lynn Rodgers-Kuperman, Branch Chief, Program Monitoring, Child Nutrition Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Alexandria, VA 22302-1594. Comments may also be submitted via fax to the attention of Lynn Rodgers-Kuperman at 703-305-2879 or via email to [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically.

    All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5 p.m., Monday through Friday) at 3101 Park Center Drive, Alexandria, Virginia 22302.

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of this information collection should be directed to Lynn Rodgers-Kuperman at the address indicated above or by phone at 703-305-2595.

    SUPPLEMENTARY INFORMATION:

    Title: 7 CFR part 210, National School Lunch Program.

    Forms: FNS-640, FNS-66, FNS-66A, and FNS-828.

    OMB Control Number: 0584-0006.

    Expiration Date: February 29, 2016.

    Type of Request: Revision of a currently approved collection.

    Abstract: The Richard B. Russell National School Lunch Act (NSLA), as amended, authorizes the National School Lunch Program (NSLP) to safeguard the health and well-being of the nation's children and provide free or reduced price school lunches to qualified students through subsidies to schools. The United States Department of Agriculture (USDA) provides States with general and special cash assistance and donations of foods to assist schools in serving nutritious lunches to children each school day. Participating schools must serve lunches that are nutritionally adequate and maintain menu and food production records and the latest nutritional analysis to demonstrate compliance with the meal requirements.

    Section 10 of the Child Nutrition Act of 1966 (42 U.S.C. 1779) requires the Secretary of Agriculture to prescribe such regulations as deemed necessary to carry out this Act and the NSLA (42 U.S.C. 1751 et seq.). Pursuant to that provision, the Secretary has issued 7 CFR part 210, which sets forth policies and procedures for the administration and operation of the NSLP. The Program is administered at the State and school food authority (SFA) levels and operations include the submission of applications and agreements, submission of the number of meals served and payment of claims, submission of data from required monitoring reviews conducted by the State agency, and maintenance of records. State and local operators of the NSLP are required to meet Federal reporting and accountability requirements and are also required to maintain records that include school food service accounts of revenues and expenditures.

    In addition, FNS collects program data from the State agencies on Forms FNS-10, Report of School Operations; FNS-13, Annual Report of State Revenue Matching; and FNS-777, Financial Status Report. These forms are approved under OMB Control # 0584-0594, Food Program Reporting System (FPRS), which expires June 30, 2017. The reporting burden associated with these reports is covered under #0584-0594 and is not associated with this information collection. However, the recordkeeping burden is still maintained in this collection.

    The reporting and recordkeeping burden associated with this revision is decreased from 11,337,788 to 9,871,395 hours. This change is mainly due to adjustments, the majority of which is the removal of duplicate burden, removal of burden that occurs only once, burden changes for an increase in schools participating in the Program and a decrease in number of School Food Authorities operating the Program, and other program changes.

    This information collection is required to administer and operate this program in accordance with the NSLA. All of the reporting and recordkeeping requirements associated with the NSLP are currently approved by the Office of Management and Budget and are in force. This is a revision of the currently approved information collection.

    Affected Public: (1) State agencies; (2) School Food Authorities; and (3) schools.

    Number of Respondents: 121,210 (56 State agencies (SAs), 19,822 school food authorities (SFAs), and 101,332 schools).

    Number of Responses per Respondent: 4.14573.

    Total Annual Responses: 502,504.

    Reporting Time per Response: 0.703875.

    Estimated Annual Reporting Burden: 353,700.

    Number of Recordkeepers: 121,210 (56 SAs, 19,822 SFAs, 101,332 schools).

    Number of Records per Record Keeper: 406.294827.

    Estimated Total Number of Records: 49,246,996.

    Recordkeeping Time per Response: 0.19326446.

    Total Estimated Recordkeeping Burden: 9,517,694.

    Annual Recordkeeping and Reporting Burden: 9,871,395.

    Current OMB Inventory for Part 210: 11,337,788.

    Difference (change in burden with this renewal): (1,466,393).

    Refer to the table below for estimated total annual burden for each type of respondent.

    Affected public Estimated number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Estimated
  • average hours per response
  • Estimated total burden (hours)
    Reporting State Agencies 56 122 6,832 7.7762 53,127 School Food Authorities 19,822 15 293,008 0.956653 280,307 Schools 101,332 2 202,664 0.1 20,266 Total Estimated Reporting Burden 121,210 502,504 353,700 Recordkeeping State Agencies 56 1419 79,464 1.5913 126,451 School Food Authorities 19,822 20 396,440 4.5380 1,799,045 Schools 101,332 481 48,771,092 0.15567 7,592,199 Total Estimated Recordkeeping Burden 121,210 49,246,996 9,517,694 Total of Reporting and Recordkeeping Reporting 121,210 4.14573 502,504 0.703875 353,700 Recordkeeping 121,210 406.294827 49,246,996 0.19326446 9,517,694 Total 49,749,500 9,871,395
    Dated: November 9, 2015. Audrey Rowe, Administrator, Food and Nutrition Service.
    [FR Doc. 2015-29390 Filed 11-17-15; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comments Request—Erroneous Payments in Child Care Centers Study (EPICCS) AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a new collection for the Erroneous Payments in Child Care Centers Study (EPICCS).

    DATES:

    Written comments must be received on or before January 19, 2016.

    ADDRESSES:

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Written comments may be sent to: Chan Chanhatasilpa, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 1000, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Chan Chanhatasilpa at 703-305-2576 or via email to [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically.

    All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5:00 p.m. EST, Monday through Friday) at 3101 Park Center Drive, Room 1100, Alexandria, Virginia 22302.

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Chan Chanhatasilpa at 703-305-2115.

    SUPPLEMENTARY INFORMATION:

    Title: Erroneous Payments in Child Care Centers Study (EPICCS).

    Form Number: Not applicable.

    OMB Number: 0584—NEW.

    Expiration Date: Not Yet Determined.

    Type of Request: New collection.

    Abstract: The Improper Payments Information Act of 2002, Public Law 107-300, requires the United States Department of Agriculture (USDA) to identify and reduce erroneous payments in various programs, including the Child and Adult Care Food Program (CACFP). The passage of the Improper Payments Elimination and Recovery Act (IPERA) in 2010, Public Law 111-204 amended and enhanced requirements for not only addressing improper payments but also prompting efforts at recovery by requiring annual risk assessments and measurement of improper payments. To comply with IPERA 2010, USDA needs a reliable measure to estimate erroneous payments for CACFP. The program's benefits are provided in various programs that serve both children and adults in both child care centers and private homes. EPICCS will gather information specific to participating child care centers, both sponsored and independent, and including Head Start centers. EPICCS is planned to leverage the procedures and methodologies used to conduct the Access, Participation, Eligibility and Certification (APEC) Study series to develop reliable estimation models to estimate erroneous payment.

    Affected Public: Respondent groups identified include: (1) State CN agencies, (2) CACFP sponsoring organizations, (3) child care centers, and (4) parents/guardians of enrolled children.

    Estimated Number of Respondents: The total estimated number of respondents for data collection is 6,325. This includes: 25 administrators at State CN agencies, 450 directors at sponsoring organizations, 450 child care center directors, and 5,400 parents or guardians of enrolled children at CACFP participating child care centers. The number of sponsors, centers, and parents/guardians recruited will be slightly higher to account for non-respondents. The sample will include 150 independent child care centers who act as their own sponsor for the CACFP. As such, they are included in counts of both sponsors and child care centers.

    Estimated Number of Responses per Respondent: Administrators at State CN agencies will be expected to provide responses on three occasions. The sponsoring organizations may be contacted up to seven times while the child care centers can be contacted up to eleven times. Parents or guardians of sampled households will be contacted on four occasions. The burden for non-respondents is outlined in the table that follows, and includes the time to complete the review of introductory materials and respond to the recruitment call.

    Estimated Total Annual Responses: The total number of responses expected across all respondent categories is 32,272. This includes a total of 16,480 responses for recruitment and review of study information and/or requests, and a total of 15,792 responses for actual data collection (i.e. responses survey/interview questions or compiling data for the study).

    Estimated Time per Respondent: The estimated time will vary depending on the respondent category. The table that follows outlines the estimated total annual burden for each type of respondent.

    Estimated Total Annual Burden on Respondents: The total estimated response time is 12,844 hours.

    EN18NO15.000 Dated: November 10, 2015. Audrey Rowe, Administrator, Food and Nutrition Service.
    [FR Doc. 2015-29391 Filed 11-17-15; 8:45 am] BILLING CODE 3410-30-P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Notice of Amendment to Agenda for November 23, 2015, Sunshine Act Meeting, Previously Announced in the Board's Notice of November 6, 2015

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on November 23, 2015, starting at 1:00 p.m. EST in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW., Suite 910. The agenda for this meeting is amended to include discussion about future public meetings about worker fatigue and Process Safety Management. It is also amended to include a staff presentation and Board vote on a recommendation to the BP Global Executive Board of Directors to implement an incident reporting program. In 2012, a CSB staff evaluation of BP's actions taken in response to that recommendation was calendared for discussion in a public setting. The recommendation was issued as part of the investigation report of the BP America Refinery explosion in Texas City, Texas, in March 2005, and a vote on the status of that recommendation was tabled at the Board's July 22, 2015, public meeting. An opportunity for public comment will be provided prior to Board vote on the status of this recommendation.

    Dated: November 16, 2015. Kara Wenzel, Acting General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2015-29593 Filed 11-16-15; 4:15 pm] BILLING CODE 6350-01-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: Bureau of Economic Analysis (BEA), Department of Commerce.

    Title: Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of U.S. Carriers (BE-30) and the Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses (BE-37).

    OMB Control Number: 0608-0011.

    Form Number: BE-30 and BE-37.

    Type of Request: Regular submission.

    Number of Responses: BE-30 responses: 280 annually (70 filed each quarter; 62 reporting mandatory data and 8 that would file exemption claims). BE-37 responses: 120 annually (30 filed each quarter; 29 reporting mandatory data, and 1 that would file an exemption claim).

    Average Hours per Response: 4 hours is the average for those reporting data and 1 hour is the average for those not reporting data, but hours may vary considerably among respondents because of differences in company size and complexity.

    Estimated Total Annual Burden Hours: 1,492 (BE-30 burden hours of 1,024 and BE-37 burden hours of 468).

    Needs and Uses: The Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of United States Carriers (BE-30) is a survey that collects data from U.S. ocean freight carriers (owners and operators) whose total covered revenues or total covered expenses incurred outside the United States were $500,000 or more in the previous year or are expected to be $500,000 or more during the current year. The covered revenues are: (1) Revenue on cargo outbound from U.S. ports and the associated shipping weight; (2) revenue on cargo inbound into the United States and the associated shipping weight; (3) revenue on cross-trade cargoes; and (4) charter hire (with crew) and space leasing revenues from foreign residents. The covered expenses are: (1) Fuel expenses in foreign countries; (2) expenses in foreign countries (other than fuel expenses); and (3) charter hire (with crew) and space leasing payments to foreign residents.

    The Quarterly Survey of U.S. Airline Operators' Foreign Revenues and Expenses (BE-37) is a survey that collects data from U.S. airline operators engaged in the international transportation of goods and/or passengers and whose total covered revenues or total covered expenses incurred outside the United States were $500,000 or more in the previous year or are expected to be $500,000 or more during the current year. The covered revenues are: (1) Revenue derived from carriage of export freight and express from the United States to points outside the United States; (2) revenue derived from carriage of freight and express originating from, and destined to, points outside the United States; (3) revenue derived from transporting passengers originating from, and destined to, points outside the United States; (4) revenue from transporting passengers to and from the United States and the associated number of passengers; and (5) interline settlement receipts from foreign airline operators. The covered expenses are: (1) Expenses incurred outside the United States for fuel and oil, station and maintenance bases, wages, and other goods and services purchased abroad (except aircraft leasing expenses); (2) aircraft (with crew) leasing expenses; and (3) interline settlement payments to foreign airline operators.

    The data are needed to monitor U.S. trade in transport services, to analyze the impact on the U.S. and foreign economies, to compile and improve the U.S. economic accounts, to support U.S. commercial policy on trade in transport services, to conduct trade promotion, and to improve the ability of U.S. businesses to identify and evaluate market opportunities. The data are used in estimating the transport component of the U.S. international transactions accounts (ITAs) and national income and product accounts (NIPAs).

    The Bureau of Economic Analysis (BEA) is proposing no additions or modifications to the current BE-30 and BE-37 surveys. The effort to keep current reporting requirements unchanged is intended to minimize respondent burden while considering the needs of data users. Existing language in the instructions and definitions will be reviewed and adjusted as necessary to clarify survey requirements.

    Affected Public: Businesses or other for-profit organizations.

    Frequency: Quarterly.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: November 13, 2015. Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2015-29417 Filed 11-17-15; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: Bureau of Economic Analysis (BEA), Department of Commerce.

    Title: Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States.

    OMB Control Number: 0608-0068.

    Form Number: BE-9.

    Type of Request: Regular submission.

    Number of Responses: 180 annually (45 filed each quarter; 44 reporting mandatory data, and 1 that would file an exemption claim).

    Average Hours per Response: 6 hours is the average for those reporting data and 1 hour is the average for those not reporting data, but hours may vary considerably among respondents because of differences in company size and complexity.

    Estimated Total Annual Burden Hours: 1,060.

    Needs and Uses: The Quarterly Survey of Foreign Airline Operators' Revenues and Expenses in the United States (BE-9) is a survey that collects data from U.S. offices, agents, or other representatives of foreign airline operators that transport freight and express to or from the United States and whose total covered revenues or total covered expenses were $5 million or more in the previous year or are expected to be $5 million or more during the current year. The covered revenues are freight revenue on merchandise exported from, or imported into, the United States. The covered expenses are expenses incurred in the United States for: (1) Fuel and oil; (2) wages and salaries paid to employees in the United States; (3) agents' and brokers' fees and commissions for arrangement of freight and passenger transportation; (4) aircraft handling and terminal services, aircraft (with crew) leasing expenses, and (5) all other expenses incurred in the United States except aircraft leasing (without crew) expenses.

    Respondents are also asked to report: (1) Shipping weights on which freight revenues were earned; (2) the number of passengers transported to/from the United States; and (3) revenues associated with these passengers.

    The data are needed to monitor U.S. trade in transport services, to analyze the impact on the U.S. and foreign economies, to compile and improve the U.S. economic accounts, to support U.S. commercial policy on trade in transport services, to conduct trade promotion, and to improve the ability of U.S. businesses to identify and evaluate market opportunities. The data are used in estimating the transport component of the U.S. international transactions accounts (ITAs) and national income and product accounts (NIPAs).

    The Bureau of Economic Analysis (BEA) is proposing no additions or modifications to the current BE-9 survey. The effort to keep current reporting requirements unchanged is intended to minimize respondent burden while considering the needs of data users. Existing language in the instructions and definitions will be reviewed and adjusted as necessary to clarify survey requirements.

    Affected Public: Businesses or other for-profit organizations.

    Frequency: Quarterly.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-806.

    Dated: November 13, 2015. Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2015-29415 Filed 11-17-15; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: Bureau of Economic Analysis (BEA), Department of Commerce.

    Title: Annual Survey of Foreign Ocean Carriers' Expenses in the United States.

    OMB Control Number: 0608-0012.

    Form Number: BE-29.

    Type of Request: Regular submission.

    Number of Responses: 80 annually (70 reporting mandatory data, and 10 that would file exemption claims).

    Average Hours per Response: 3 hours is the average for those reporting data and 1 hour is the average for those not reporting data, but hours may vary considerably among respondents because of differences in company size and complexity.

    Estimated Total Annual Burden Hours: 220.

    Needs and Uses: The Annual Survey of Foreign Ocean Carriers' Expenses in the United States (BE-29) is a survey that collects data from U.S. agents of foreign ocean carriers who handle 40 or more port calls in the reporting period by foreign ocean vessels, or have total covered expenses in the reporting period for all foreign ocean vessels handled by the U.S. agent of $250,000 or more. The covered expenses are: (1) Port call services such as pilotage, towing and tugboat services, harbor fees, and berth fees; (2) cargo-related services such as loading, unloading, and storing cargo at U.S. ports; (3) fuels and oils (bunkers) purchased in U.S. ports; (4) other vessel operating expenses such as stores and supplies, vessel repairs, and personnel expenses in the United States; and (5) other expenses such as U.S. agents' and brokers' fees and commissions and expenses related to maintaining U.S. offices, such as rent, advertising, and wages.

    The data are needed to monitor U.S. trade in transport services, to analyze the impact on the U.S. and foreign economies, to compile and improve the U.S. economic accounts, to support U.S. commercial policy on trade in transport services, to conduct trade promotion, and to improve the ability of U.S. businesses to identify and evaluate market opportunities. The data are used in estimating the transport component of the U.S. international transactions accounts (ITAs) and national income and product accounts (NIPAs).

    The Bureau of Economic Analysis (BEA) is proposing no additions or modifications to the current BE-29 survey. The effort to keep current reporting requirements unchanged is intended to minimize respondent burden while considering the needs of data users. Existing language in the instructions and definitions will be reviewed and adjusted as necessary to clarify survey requirements.

    Affected Public: Businesses or other for-profit organizations.

    Frequency: Annual.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202)395-5806.

    Dated: November 13, 2015. Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2015-29416 Filed 11-17-15; 8:45 am] BILLING CODE 3510-06-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1985] Approval of Expansion of Subzone 50H Tesoro Refining and Marketing Company, LLC, Long Beach, California

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Foreign-Trade Zones Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;

    Whereas, the Board's regulations (15 CFR part 400) provide for the establishment of subzones for specific uses;

    Whereas, the Port of Long Beach, California, grantee of Foreign-Trade Zone 50, has made application to the Board to expand Subzone 50H at the facilities of Tesoro Refining and Marketing Company, LLC, located in Long Beach, California, (FTZ Docket B-55-2015, docketed August 18, 2015);

    Whereas, notice inviting public comment has been given in the Federal Register (80 FR 5198, August 24, 2015) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's memorandum, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby approves the expansion of subzone status at the facilities of Tesoro Refining and Marketing Company, LLC, located in Long Beach, California (Subzone 50H), as described in the application and Federal Register notice, subject to the FTZ Act and the Board's regulations, including Section 400.13.

    Signed at Washington, DC, this 10th day of November 2015. Paul Piquado, Assistant Secretary of Commerce for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.

    ATTEST:

    Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2015-29459 Filed 11-17-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1986] Reorganization of Foreign-Trade Zone 8 (Expansion of Service Area) Under Alternative Site Framework Toledo, Ohio

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Toledo-Lucas County Port Authority, grantee of Foreign-Trade Zone 8, submitted an application to the Board (FTZ Docket B-38-2015, docketed June 9, 2015) for authority to expand the service area of the zone to include Erie, Fulton, Ottawa, Paulding and Williams Counties, as described in the application, adjacent to the Toledo, Ohio Customs and Border Protection port of entry;

    Whereas, notice inviting public comment was given in the Federal Register (80 FR 33479-33480, June 12, 2015) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize FTZ 8 to expand the service area under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and to the Board's standard 2,000-acre activation limit for the zone.

    Signed at Washington, DC, this 10th day of November 2015. Paul Piquado, Assistant Secretary of Commerce for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.

    Attest:

    Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2015-29476 Filed 11-17-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security President's Export Council Subcommittee on Export Administration; Notice of Partially Closed Meeting

    The President's Export Council Subcommittee on Export Administration (PECSEA) will meet on December 2, 2015, 10 a.m., at the U.S. Department of Commerce, Herbert C. Hoover Building, Room 3884, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The PECSEA provides advice on matters pertinent to those portions of the Export Administration Act, as amended, that deal with United States policies of encouraging trade with all countries with which the United States has diplomatic or trading relations and of controlling trade for national security and foreign policy reasons.

    Agenda Open Session

    1. Opening remarks by the Chairman and Vice Chairman.

    2. Opening remarks by the Bureau of Industry and Security.

    3. Export Control Reform Update.

    4. Presentation of papers or comments by the Public.

    Closed Session

    5. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).

    The open session will be accessible via teleconference to 25 participants on a first come, first served basis. To join the conference, submit inquiries to Ms. Yvette Springer at [email protected] no later than November 25, 2015.

    A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.

    The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on February 25, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

    For more information, call Yvette Springer at (202) 482-2813.

    Dated: November 13, 2015. Kevin J. Wolf, Assistant Secretary for Export Administration.
    [FR Doc. 2015-29495 Filed 11-17-15; 8:45 am] BILLING CODE 3510-JT-P
    DEPARTMENT OF COMMERCE International Trade Administration [Application No. 03-1A008] Export Trade Certificate of Review ACTION:

    Notice of Application for an Amended Export Trade Certificate of Review by California Pistachio Export Council (“CPEC”), Application No. 03-1A008.

    SUMMARY:

    The Secretary of Commerce, through the International Trade Administration, Office of Trade and Economic Analysis (OTEA), has received an application for an amended Export Trade Certificate of Review (“Certificate”) from CPEC. This notice summarizes the proposed amendment and seeks public comments on whether the amended Certificate should be issued.

    FOR FURTHER INFORMATION CONTACT:

    Joseph E. Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2015). Section 302(b)(1) of the Export Trade Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the Federal Register identifying the applicant and summarizing its application. Under 15 CFR 325.6(a), interested parties may, within twenty days after the date of this notice, submit written comments to the Secretary on the application.

    Request for Public Comments: Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.

    An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.

    Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 03-1A008.”

    Summary of the Application

    Applicant: California Pistachio Export Council, 512 C Street NE., Washington DC 20002.

    Contact: Robert I. Schramm, Senior Associate at Schramm, Williams & Associates, Inc., (202)-543-4455.

    Application No.: 03-1A008.

    Date Deemed Submitted: November 3, 2015.

    Proposed Amendment:

    1. Remove the following company as Member of the Certificate: Gold Coast Pistachios, Inc.

    2. Change the name of the following existing Member: A&P Growers Cooperative, Inc. is now Horizon Marketing Agency in Common Cooperative Inc.

    CPEC's proposed amendment of its Export Trade Certificate of Review would result in the following entities as Members under the Certificate:

    (a) Keenan Farms, Inc. (b) Monarch Nut Company (c) Nichols Pistachio (d) Primex Farms, LLC (e) Setton Pistachio of Terra Bella, Inc. (f) Horizon Marketing Agency in Common Cooperative Inc. Dated: November 13, 2015. Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration.
    [FR Doc. 2015-29397 Filed 11-17-15; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE221 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Application for one new enhancement of survival permit.

    SUMMARY:

    Notice is hereby given that NMFS has received an application for a new enhancement of survival permit and a request for entry into an associated proposed Programmatic Safe Harbor Agreement (Agreement) between the applicant and NMFS. The proposed Enhancement of Survival Permit and Agreement are intended to promote the survival and recovery of species listed under the Endangered Species Act (ESA). Information NMFS received as a part of the application is available to the public as a matter of public record and is available upon request by contacting the NMFS California Coastal Office in Santa Rosa, California.

    DATES:

    Comments or requests for a public hearing on the action proposed in the application or related matters must be received at the appropriate address or fax number (see ADDRESSES) no later than 5 p.m. Pacific standard time on December 18, 2015.

    ADDRESSES:

    You may submit comments on this document and requests for a public hearing, identified by NOAA-NMFS-2015-0149, by either of the following methods:

    Electronic Submission: Submit electronic public comments via the Federal eRulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0149. Click the “Comment Now!” icon, complete the required fields. Enter or attach your comments.

    —OR—

    Mail, Email, Fax: Submit written comments and requests for a public hearing to California Coastal Office, NMFS, 777 Sonoma Avenue, Room 325, Santa Rosa, CA 95404. Comments and requests may also be submitted via fax to 707-578-3435 or by email to [email protected] (include permit number 20032 in the subject line of the fax or email).

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Dan Wilson, Santa Rosa, CA (ph.: 707-578-8555), Fax: 707-578-3435, email: [email protected]).

    SUPPLEMENTARY INFORMATION:

    Species Covered in This Notice

    The following listed species are covered in this notice:

    Chinook salmon (Oncorhynchus tshawytscha): Threatened California Coastal (CC). Coho salmon (O. kisutch): Endangered Central California Coast (CCC). Steelhead (O. mykiss): Threatened Central California Coast (CCC). Authority

    Enhancement of Survival Permits are issued in accordance with section 10(a)(1)(A) of the ESA (16 U.S.C. 1531 et seq.) and regulations governing listed fish and wildlife permits (50 CFR parts 222-227). NMFS issues permits based on findings that such permits: (1) Are applied for in good faith; (2) if granted and exercised, would not operate to the disadvantage of the listed species that are the subject of the permit; and (3) are consistent with the purposes and policy of section 2 of the ESA. The authority to take listed species is subject to conditions set forth in the permits.

    Under a Safe Harbor Agreement, participating landowners voluntarily undertake management activities on their property to enhance, restore, or maintain habitat benefiting species listed under the Act (16 U.S.C. 1531 et seq.). Safe Harbor Agreements, and the subsequent Enhancement of Survival Permits that are issued pursuant to section 10(a)(1)(A) of the Act, encourage private and other non-Federal property owners to implement conservation efforts for listed species by assuring property owners that they will not be subjected to increased property use restrictions as a result of their efforts to attract listed species to their property or to increase the numbers or distribution of listed species already on their property. Application requirements and issuance criteria for Enhancement of Survival Permits through Safe Harbor Agreements are found in 50 CFR 222.308(b), 222.308(c) and June 17, 1999 (64 FR 32717). These permits allow any necessary future incidental take of covered species above the mutually agreed-upon baseline conditions for those species in accordance with the terms and conditions of the permits and accompanying agreements.

    An interested party may submit written data, views, arguments, or a request for a hearing with respect to the action proposed in the application or related matters. Anyone requesting a hearing on a matter pursuant to this notice should set out the specific reasons why a hearing on that matter would be appropriate (see ADDRESSES). Such hearings are held at the discretion of the Assistant Administrator for Fisheries, NMFS.

    Application Received Permit 20032

    The Sonoma County Water Agency (Applicant) is requesting an Enhancement of Survival Permit and approval of the associated proposed Agreement that was developed by NMFS and the Applicant. The Enhancement of Survival Permit will facilitate implementation of the Agreement that is expected to promote the recovery of the Covered Species on non-federal properties within Dry Creek below Warm Springs Dam, a tributary to the Russian River in Sonoma County, California. The proposed duration of the Agreement and the associated Enhancement of Survival Permit is 35 years. The proposed Enhancement of Survival Permit would authorize the incidental taking of the Covered Species associated with routine viticulture activities and the potential future return of any property included in the Agreement to the Elevated Baseline Conditions. Under this Agreement, individual landowners (Cooperators) may include their properties by entering into a Cooperative Agreement with the Applicant. Each Cooperative Agreement will specify the restoration and/or enhancement, and management activities to be carried out on that specific property and a timetable for implementing those activities. All Cooperative Agreements will be reviewed by NMFS to determine whether the proposed activities will result in a net conservation benefit for the Covered Species and meet all required standards of the Safe Harbor Policy (64 FR 32717). Upon NMFS approval, the Applicant will issue a Certificate of Inclusion to the Cooperator. Each Certificate of Inclusion will extend the incidental take coverage conferred by the Enhancement of Survival permit to the Cooperator. Certificates of Inclusion will be valid for a minimum of 10 years, but no longer than term of the Enhancement of Survival permit.

    The Agreement requires that each enrolled property adopt an Elevated Baseline Condition. Elevated Baseline levels for the Covered Species will be determined by completing the Elevated Baseline Habitat Worksheet (Table 1 in Attachment 3 of the Agreement), which will be completed by the Applicant. NMFS will review each Elevated Baseline determination prior to the Applicant issuing a Certificate of Inclusion to the Cooperator. The Agreement also contains a monitoring component that requires the Applicant to ensure that the Cooperators are in compliance with the terms and conditions of the Agreement and that the Elevated Baseline levels of habitat for the Covered Species occurs on the Enrolled Property. Results of these monitoring efforts will be provided to NMFS by the Applicant in annual reports for the duration of the 35-year permit term.

    Upon approval of this Agreement, and consistent with the NMFS's Safe Harbor Policy (64 FR 32717), NMFS would issue an Enhancement of Survival Permit to the Applicant. The Enhancement of Survival Permit will authorize those Cooperators who have been issued a Certificate of Inclusion to take Covered Species incidental to the implementation of the management activities specified in the Agreement, incidental to other lawful uses of the property including Routine Viticulture Activities, and to return to baseline conditions if desired. In addition to meeting other criteria, actions to be performed under an Enhancement of Survival Permit must not jeopardize the existence of federally listed species.

    This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the application, associated documents, and comments submitted to determine whether the application meets the requirements of section 10(a) of the ESA and Federal regulations. The final permit decisions will not be made until after the end of the 30-day comment period. NMFS will publish notice of its final action in the Federal Register.

    Dated: November 12, 2015. Perry Gayaldo, Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-29409 Filed 11-17-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Application for Appointment in the NOAA Commissioned Officer Corps AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before January 19, 2016.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to LCDR Madeleine Adler—Chief, NOAA Corps Recruiting, or LT Jeffrey Pereira—NOAA Corps Recruiting Officer; OMAO-CPC-OCMD, 8402 Colesville Road, Suite 500, Silver Spring, MD 20910, ((800)-299-6622), [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for extension of a currently approved information collection. The NOAA Commissioned Corps is the uniformed component of the National Oceanic and Atmospheric Administration (NOAA), a bureau of the Department of Commerce. Officers serve under Senate-confirmed appointments and Presidential commissions (33 U.S.C. chapter 17, subchapter 1, sections 853 and 854). The NOAA Corps provides a cadre of professionals trained in engineering, earth sciences, oceanography, meteorology, fisheries science, and other related disciplines, who are dedicated to the service of their country and optimization of NOAA's missions to ensure the economic and physical well-being of the Nation.

    NOAA Corps officers serve in assignments throughout NOAA, as well as in each of NOAA's Line Offices (National Environmental Satellite, Data, and Information Service, National Ocean Service, National Weather Service, Office of Oceanic and Atmospheric Research and Office of Planning, Programming and Integration).

    Persons wishing to be considered for a NOAA Corps Commission must submit a complete application package, including NOAA Form 56-42, at least three letters of recommendation, and official transcripts. A personal interview must also be conducted. Eligibility requirements include a bachelor's degree with at least 48 credit hours of science, engineering or other disciplines related to NOAA's missions (including either calculus or physics), excellent health, normal color vision with uncorrected visual acuity no worse than 20/400 in each eye (correctable to 20/20) and ability to complete 20 years of active duty commissioned service prior to their 62nd birthday.

    II. Method of Collection

    Applicants must utilize the E-recruit electronic application process (https://cpc.omao.noaa.gov/erecruit/login.jsp) and then submit paper forms via mail. An in-person interview is also required.

    III. Data

    OMB Control Number: 0648-0047.

    Form Number(s): NOAA 56-42 and NOAA 56-42A.

    Type of Review: Regular submission (extension of a currently approved information collection).

    Affected Public: Individuals or households.

    Estimated Number of Respondents: 150.

    Estimated Time per Response: Written applications, 5 hours; interviews, 90 minures; references, 15 minutes.

    Estimated Total Annual Burden Hours: 1,088.

    Estimated Total Annual Cost to Public: $10,875 in recordkeeping, recording and travel costs.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: November 13, 2015. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2015-29405 Filed 11-17-15; 8:45 am] BILLING CODE 3510-12-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD294 Fisheries of the Exclusive Economic Zone Off Alaska; Application for an Exempted Fishing Permit AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; receipt of application for exempted fishing permit.

    SUMMARY:

    This notice announces receipt of an exempted fishing permit (EFP) application from the Alaska Seafood Cooperative (AKSC). If granted, this permit would allow up to five AKSC-member Amendment 80 vessels to conduct experimental fishing in two subareas of the Bering Sea that are closed to fishing with trawl gear. Under the permit, experimental fishing with non-pelagic trawl gear would be authorized in Reporting Area 516 of Zone 1 that is otherwise closed to all trawl gear and the Red King Crab Savings Area (RKCSA) that is otherwise closed to non-pelagic trawl gear. The AKSC would collect data on crab prohibited species catch (PSC) rates during commercial groundfish fishing operations inside the Area 516 seasonal closure, the RKCSA, and adjacent areas that are currently open to non-pelagic trawling. The objective of the EFP is to evaluate PSC rates and overall catch of target species in the above-mentioned closed areas compared with the areas currently open to fishing with trawl gear. This experiment has the potential to promote the objectives of the Magnuson-Stevens Fishery Conservation and Management Act.

    DATES:

    Submit comments on this EFP application on or before December 15, 2015.

    The North Pacific Fishery Management Council (Council) will consider the EFP application at its meeting to be held December 9, 2015, through December 15, 2015, in Anchorage, AK.

    ADDRESSES:

    The Council meeting will be held at the Anchorage Hilton Hotel, 500 W. 3rd Avenue, Anchorage, AK, 99501. The agenda for the Council meeting is available at http://legistar2.granicus.com/npfmc/meetings/2015/12/932_A_North_Pacific_Council_15-12-07_Meeting_Agenda.pdf.

    You may submit comments on this document, identified by NOAA-NMFS-2015-0138, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0138, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Address written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Electronic copies of the EFP application and the categorical exclusion under the National Environmental Policy Act are available from the Alaska Region, NMFS Web site at http://alaskafisheries.noaa.gov/.

    FOR FURTHER INFORMATION CONTACT:

    Jeff Hartman, 907-586-7442.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the domestic groundfish fisheries in the Bering Sea and Aleutian Islands management area (BSAI) under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP), which the Council prepared under the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing the BSAI groundfish fisheries appear at 50 CFR parts 600 and 679. The FMP and the implementing regulations, § 600.745(b) and § 679.6, allow the NMFS Regional Administrator to authorize, for limited experimental purposes, fishing that would otherwise be prohibited. Procedures for issuing EFPs are contained in the implementing regulations.

    Background

    BSAI groundfish harvests are managed subject to annual limits on groundfish and PSC. Pacific halibut, Pacific herring, Pacific salmon and steelhead, king crab (including red king crab), and Tanner crab are prohibited species under the FMP. Participants in the BSAI non-pelagic trawl fisheries catch PSC incidentally—primarily crab and halibut.

    The directed red king crab pot fishery is one of the most important shellfish fisheries in the Bering Sea. Current regulations for harvesting red king crab in the crab pot fishery may be found in 50 CFR part 680. Red king crab is also caught incidentally as PSC in Bering Sea groundfish non-pelagic trawl fisheries. PSC (including red king crab) in the non-pelagic trawl fisheries must be minimized to the extent practicable and if caught, immediately returned to the ocean with a minimum of injury.

    The Council and NMFS have implemented FMP amendments, dating back to the 1980s and 1990s to reduce the amount of red king crab PSC in trawl fisheries, including the BSAI non-pelagic trawl fishery. For example, the Area 516 red king crab seasonal closure for all trawl gear (FMP Amendment 10) was implemented in 1987 (52 FR 8592, March 19, 1987). FMP amendment 37, (61 FR 65985, December 16, 1996) was implemented in 1997, to create the red king crab savings area (RKCSA) along with other measures to conserve concentrations of Bristol Bay red king crab. The management and structure of the non-pelagic trawl fisheries in the Bering Sea have changed since these red king crab closure areas were implemented. In 2007, NMFS implemented Amendment 80 to the FMP (72 FR 52668, September 14, 2007). Amendment 80 established a catch share program to allocate specific non-pelagic groundfish species among specific defined participants (the Amendment 80 sector) and facilitate the formation of Amendment 80 cooperatives among those participants. The Amendment 80 sector is comprised of 19 active vessels in 2015, and is the largest component of the non-pelagic trawl fishery. With the implementation of Amendment 80 to the FMP in 2008, vessels operating in Amendment 80 cooperatives were able to develop tools to reduce incidental catch of crab PSC.

    Since the implementation of Amendment 80, participants in Amendment 80 cooperatives have reduced the amount of red king crab bycatch through improved fishing practices that are possible now that participants in the Amendment 80 cooperative receive an allocation of specific groundfish species. These exclusive allocations provide opportunities for Amendment 80 cooperative participants to slow or otherwise change their fishing operations to avoid red king crab bycatch. These modified fishing practices are not practicable when vessels are not provided an exclusive harvest allocation and are racing with other vessels to harvest their groundfish as soon as possible.

    Although Amendment 80 cooperatives have undoubtedly helped to reduce red king crab PSC in the sector's target fisheries, a combination of closed areas and PSC limits currently regulate red king crab PSC in trawl fisheries, including the Amendment 80 sector. For example, the Area 516 of Zone 1 in the Bering Sea sub area closes annually to all trawl gear, including Amendment 80 vessels from March 15 through June 15, § 679.22(a)(2).

    Regulations for groundfish fishing in the RKCSA, § 679.22(a)(3), close directed fishing for non-pelagic trawl gear in a portion of the Bering sea subarea defined in Figure 11 to 50 CFR part 679. Non-pelagic trawl gear is used by all Amendment 80 vessels in the Bering Sea.

    PSC limits for red king crab (§ 679.21(e)(1)(i)) specify the annual PSC allowance of red king crab for all trawl vessels while engaged in directed fishing for groundfish in Zone 1. Approximately 50 percent of the Zone 1 red king crab PSC limit is apportioned to the Amendment 80 sector, and distributed as an allowance of crab to each Amendment 80 cooperative. In 2015, the Zone 1 red king crab PSC allowance for the AKSC is 30,834 animals.

    The Zone 1 red king crab PSC allowance, allowed the Amendment 80 cooperatives to assign voluntary, vessel-level apportionments of PSC to vessels fishing in Zone 1. With these voluntary apportionments, vessel owners and operators in the sector began to share information about individual vessel PSC rates and avoid areas with high PSC rates for red king crab. The primary result of the improved crab avoidance and management tools is that AKSC and the remaining Amendment 80 sector vessels have consistently stayed well under the Zone 1 red king crab PSC allowance. While the potential exists for crab PSC allowances and closure areas to constrain allocated catch in some Amendment 80 target fisheries, the Amendment 80 sector continues to actively explore how to further reduce crab PSC while preserving target fishery harvest opportunities.

    Exempted Fishing Permit Application

    On October 2, 2015, the AKSC, an Amendment 80 cooperative, submitted an application for an EFP. The EFP would allow up to five AKSC-member Amendment 80 vessels to conduct field tests in two subareas of the Bering Sea that are closed to trawl directed fisheries. Those two subareas are Reporting Area 516 of Zone 1, which is closed to all trawl gear § 679.22(a)(2), and the RKCSA, which is closed to non-pelagic trawl gear under § 679.22(a)(3). If granted, this EFP would allow AKSC to collect data on crab bycatch rates during commercial fishing operations on five groundfish fishing vessels (targeting mostly flatfish) inside the Area 516 seasonal closure, the RKCSA, and adjacent areas that are currently open to non-pelagic trawl gear. The principle objective of the EFP is to evaluate whether flatfish and other groundfish trawling in the above-mentioned closed areas under the existing PSC allowance for crab would result in reduced PSC rates for crab or other species, or a change in overall catch of target species compared with the status quo. This data will inform assessment of the effectiveness of these two crab closures.

    The applicant proposes to begin EFP fishing in early February 2016 and end by mid-May 2016. EFP fishing would begin again in late January 2017 and end by mid-May 2017. The EFP would be in place over two winter/spring seasons to increase the chance that data collections will occur in different environmental conditions that are expected to affect crab and flatfish abundance and location.

    To ensure data are available for valid comparisons of catch rates inside and outside the closed areas, participating vessels would fish both inside the closed areas and in adjacent areas outside the closed areas (as proportionally as possible) over the course of their Zone 1 rock sole and yellowfin sole fishing each year of the EFP. Adjacent areas against which rates inside the closed areas will be assessed will be selected based on similarities in the general depth and type of substrates that were test trawled in the RKCSA and Area 516 closures. To help ensure differences in bycatch rates reflect differences in relative abundance rather than the attributes of trawl gear used, the vessels participating in the EFP will keep their ground gear configuration (e.g. size of trawl net and width of footropes) as consistent as possible inside and outside of the closed areas.

    Under the EFP, sea samplers would be required for monitoring and data collection. Sea samplers are NMFS-certified observers that conduct activities under an EFP rather than normal observer activities on an Amendment 80 vessel.

    The sea samplers will conduct a census of all crab for all EFP tows inside the red king crab closed areas and in adjacent areas outside the red king crab closed areas. The census data will include a record of size and sex of each individual. Temperature and depth data will be collected by sea samplers for each tow. Sea samplers will also collect fishing operational information such as tow speed and tow length. AKSC will compare catch rates on different EFP vessels when fishing in similar areas to evaluate the degree to which individual differences in a specific vessel are impacting catch rates.

    To ensure observer sampling duties are undisturbed, expanded crab data collection under the census will be conducted in a manner that is completely separate from current observer sampling protocols. To accomplish this, the crab census will occur after all the catch passes over the vessel's flow scale and the observer has completed all sampling of unsorted catch for all Bering Sea EFP hauls.

    The five vessels authorized to participate in this EFP would be required to comply with all the aggregate target species allocations that apply to the rest of the Amendment 80 sector, and would operate under the Amendment 80 crab and halibut PSC allowances available through membership in the AKSC. These allowances will apply to all EFP and non-EFP fishing during the year.

    Under the EFP, the AKSC and the member EFP vessels would be limited to the amount of aggregate groundfish allocations currently in regulation at 50 CFR part 679. Further, the amount of red king crab PSC accrued by the AKSC and under the EFP would not exceed the AKSC's 2016 or 2017 red king crab allowance. All other crab limits and halibut mortality limits will continue to apply to the EFP activities, and are subject to review and approval by NMFS.

    At the end of EFP fishing in 2016, AKSC would be required to submit to NMFS a preliminary report of the EFP results on PSC use inside and outside of the closed areas and by target fishery. At the end of EFP fishing in 2017, a final, comprehensive EFP report would be submitted.

    The proposed action would exempt participating AKSC vessels from selected 50 CFR part 679 closed areas and PSC handling requirements. Should the Regional Administrator issue a permit based on this EFP application, the conditions of the permit will be designed to minimize PSC, and any potential for biasing estimates of groundfish or PSC. Vessels participating in EFP fishing would be exempt from, at minimum, the following regulations:

    1. Closure to directed fishing by trawl gear in Reporting Area 516 of Zone 1 in the Bering Sea Subarea from March 15 through June 15, at § 679.22(a)(2).

    2. closure to directed fishing by non-pelagic trawl gear in the RKCSA at § 679.22(a)(3).

    3. that the operator of each vessel, after allowing for sampling by an observer, return all prohibited species, or parts thereof, to the sea immediately, with a minimum of injury, regardless of its condition at § 679.21(b)(2)(ii).

    The EFP would be valid upon issuance in 2016 until either the end of designated EFP fishing in 2017 or until the AKSC Zone 1 red king crab PSC allowance is reached in areas of the BSAI open to directed fishing by the Amendment 80 cooperatives. EFP-authorized fishing activities would not be expected to change the nature or duration of the groundfish fishery, gear used, or the amount or species of fish caught by the Amendment 80 cooperatives.

    The fieldwork that would be conducted under this EFP is not expected to have a significant impact on the human environment as detailed in the categorical exclusion prepared for this action (see ADDRESSES).

    In accordance with § 679.6, NMFS has determined that the application warrants further consideration and has forwarded the application to the Council to initiate consultation. The Council is scheduled to consider the EFP application during its December 2015 meeting, which will be held at the Anchorage Hilton Hotel, Anchorage, AK. The EFP application will also be provided to the Council's Scientific and Statistical Committee for review at the December Council meeting. The applicant has been invited to appear in support of the application.

    Public Comments

    Interested persons may comment on the EFP application at the December 2015 Council meeting during public testimony. Information regarding the meeting is available at the Council's Web site at http://alaskafisheries.noaa.gov/npfmc/council.htm. Comments also may be submitted directly to NMFS (see ADDRESSES) by the end of the comment period (see DATES). Copies of the application and categorical exclusion are available for review from NMFS (see ADDRESSES).

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 13, 2015. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-29451 Filed 11-17-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA-2015-0004] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    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.

    DATES:

    Consideration will be given to all comments received by December 18, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and Omb Number: Exchange Official Personnel Folder; Exchange Form 1100-106 “Identification & Privilege Card Application”; OMB Control Number: 0702-XXXX.

    Type of Request: Existing collection in use without an OMB Control Number.

    Number of Respondents: 2,500.

    Responses per Respondent: 1.

    Annual Responses: 2,500.

    Average Burden per Response: 15 minutes.

    Annual Burden Hours: 625.

    Needs and Uses: The information collection requirement is necessary to provide a repository of the records, reports of personnel actions, and the documents and papers required in connection with these actions effected during an employee's service with the Army and Air Force Exchange Service (Exchange). Records provide the basic source of factual data about a person's employment with the agency and have various uses by the Exchange personnel office, including screening qualifications of employees, determining status, eligibility, and employee's rights and benefits, computing length of service and other information needed to provide personnel services.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Instructions: All submissions received must include the agency name, Docket ID number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    DOD Clearance Officer: Mr. Frederick Licari.

    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.

    Dated: November 12, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-29401 Filed 11-17-15; 8:45 am] BILLING CODE 5001-06-P
    DEFENSE NUCLEAR FACILITIES SAFETY BOARD Sunshine Act Notice AGENCY:

    Defense Nuclear Facilities Safety Board.

    ACTION:

    Notice of closed meeting.

    SUMMARY:

    Pursuant to the provisions of the Government in the Sunshine Act (5 U.S.C. 552b), and the Defense Nuclear Facilities Safety Board's (Board) regulations implementing the Government in the Sunshine Act, notice is hereby given of the Board's closed meeting described below.

    DATES:

    1:00 p.m.-3:00 p.m., December 1, 2015.

    ADDRESSES:

    Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Room 425, Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    Mark Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.

    SUPPLEMENTARY INFORMATION:

    The meeting will be closed to the public. No participation from the public will be considered during the meeting.

    Status

    Closed. During the closed meeting, the Board Members will discuss issues dealing with potential Recommendations to the Secretary of Energy. The Board is invoking the exemption to close a meeting described in 5 U.S.C. 552b(c)(3) and 10 CFR 1704.4(c). The Board has determined that it is necessary to close the meeting since conducting an open meeting is likely to disclose matters that are specifically exempted from disclosure by statute. In this case, the deliberations will pertain to potential Board Recommendations which, under 42 U.S.C. 2286d(b) and (h)(3), may not be made publicly available until after they have been received by the Secretary of Energy or the President, respectively.

    Matters To Be Considered:

    The meeting will proceed in accordance with the closed meeting agenda which is posted on the Board's public Web site at www.dnfsb.gov. Technical staff may present information to the Board. The Board Members are expected to conduct deliberations regarding potential Recommendations to the Secretary of Energy.

    Dated: November 13, 2015. Joyce L. Connery, Chairman.
    [FR Doc. 2015-29497 Filed 11-16-15; 11:15 am] BILLING CODE 3670-01-P
    DEPARTMENT OF EDUCATION Notice Expanding an Experiment Under the Experimental Sites Initiative; Federal Student Financial Assistance Programs Under Title IV of the Higher Education Act of 1965, as Amended AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    SUMMARY:

    The Secretary is expanding the Competency-Based Education experiment, which was announced in a previous Federal Register notice, to provide additional flexibility in how institutions provide Federal student aid to students who are enrolled in competency-based education programs, including providing waivers and modifications to statutory and regulatory requirements designed to support competency-based education programs that charge a flat fee for a period of time rather than charging by course or by competency. The expansion of the Competency-Based Education experiment provides two additional sets of waivers that are available to both institutions currently approved for the experiment and institutions that may be approved based on their submission of a letter of interest. These sets of waivers are described in this notice below, under “The Experiment.”

    In a Federal Register notice published on July 31, 2014, the Secretary invited postsecondary educational institutions (institutions) that participate in the student financial assistance programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), to apply to participate in institutionally-based experiments, including the Competency-Based Education experiment, under the Experimental Sites Initiative (ESI).

    DATES:

    Institutions that have not already received approval to participate in the Competency-Based Education experiment must submit a letter of interest following the instructions included in this notice. Letters of interest must be received by the Department no later than January 19, 2016 in order for an institution to receive priority to be considered for participation in the experiment. Letters received after January 19, 2016 may still, at the discretion of the Secretary, be considered for participation.

    The Department will contact those institutions that have already received approval to participate in the Competency-Based Education experiment to determine which of the three sets of waivers, discussed below in the “The Experiment” section of this notice, the institution wishes to apply to their competency-based education programs. Based upon each institution's response, the Department will amend the institution's Program Participation Agreement (PPA) to reflect the specific waivers and modifications to statutory or regulatory provisions included in the set of waivers chosen by the institution.

    ADDRESSES:

    Letters of interest must be submitted by electronic mail to the following email address: [email protected] The subject line of the email should read “ESI 2015—Competency-Based Education.” For formats and other required information, see “Instructions for Submitting Letters of Interest” under SUPPLEMENTARY INFORMATION.

    FOR FURTHER INFORMATION CONTACT:

    Warren Farr, U.S. Department of Education, Federal Student Aid, 830 First Street NE., Washington, DC 20002. Telephone: (202) 377-4380 or by email at: [email protected].

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Instructions for Submitting Letters of Interest

    Letters of interest for the Competency-Based Education experiment should take the form of a PDF attachment to an email message as described in the ADDRESSES section of this notice. The letter of interest should be on institutional letterhead and be signed by at least two officials of the institution—one of these officials should be the institution's financial aid administrator, and the other should be an academic official of the institution who is familiar with the institution's competency-based educational programs. The letter of interest must include the institution's official name and Department of Education Office of Postsecondary Education Identification (OPEID), as well as a mailing address, email address, FAX number, and telephone number of a contact person at the institution. The letter should indicate which of the three sets of waivers, discussed below in the “The Experiment” section of this notice, the institution wishes to apply to their competency-based education programs.

    Background

    The Secretary, under the Experimental Sites Initiative (ESI) authority of section 487A(b) of the HEA, published a Federal Register notice (79 FR 44429) dated July 31, 2014 (July 31, 2014, notice), inviting institutions to participate in four experiments that would waive certain statutory and regulatory requirements related to the title IV, HEA programs. One of those experiments was the Competency-Based Education experiment.

    Under the Competency-Based Education experiment, the Secretary provided limited waivers of certain statutory and regulatory requirements to remove some of the time-based restrictions to the disbursement of student assistance under title IV of the HEA (title IV aid) so that funds are available to a student to pay institutional charges as the student progresses through a program at the student's own pace. Specifically, the Secretary allowed for the disbursement of title IV aid for direct costs as soon as the student completed a required number of competencies, regardless of how many weeks of instructional time have elapsed, and for disbursement of title IV aid for indirect costs at regular calendar intervals, regardless of how many competencies the student had completed, all within award maximums. The Secretary also modified the requirements for monitoring satisfactory academic progress to permit institutions to evaluate a student's pace in a competency-based education program by calculating competencies completed over calendar time, rather than by dividing the hours the student completed by the hours the student attempted. Detailed information regarding these requirements is provided in the Competency-Based Education Experiment Reference Guide, which is available at: https://experimentalsites.ed.gov/exp/guidance.html.

    In the July 31, 2014, notice, the Secretary described the application, selection, reporting, and evaluation requirements for the Competency-Based Education experiment. All of those requirements remain in effect regardless of which set of waivers, as described in this notice, is chosen by an institution.

    Since the publication of the July 31, 2014, notice, the Department has learned that there are challenges associated with the waivers discussed in that notice for institutions that charge students who are enrolled in competency-based programs a set amount for a defined period of time, as opposed to charging an amount for each competency. This is often referred to as a “subscription period model.” Some institutions have suggested that financial aid for programs that charge using subscription periods rather than by competency can be administered more effectively by using term-based disbursements, with flexibilities to allow students to begin and complete their competencies outside of the start and end dates of terms, rather than using a nonterm model as described in the July 31, 2014, notice.

    Other institutions stated that they were primarily interested in the satisfactory academic progress waivers noted in the July 31, 2014, notice and did not need the full set of waivers included in that notice.

    Selection

    For institutions that, in response to this notice, submit letters of interest for the Competency-Based Education experiment, the Secretary's process for selecting participating institutions will remain the same as was described in the July 31, 2014, notice.

    The Experiment Background

    The Department's regulations at 34 CFR 668.4(a) and (b) describe requirements for payment periods for eligible programs that measure progress in credit hours and use standard or nonstandard terms. A term is a period during which all classes are scheduled to begin and end within a set timeframe.

    The Department's regulations for satisfactory academic progress at 34 CFR 668.34 require institutions to measure a student's progress at least once annually, though an institution is permitted to check more often. Those regulations also require an institution to determine a student's academic progress pace by dividing the cumulative number of hours the student has successfully completed by the cumulative number of hours the student has attempted.

    Some institutions offering competency-based programs charge students using “subscription periods,” in which the institution charges the student a single fee for all of the student's competency-based instruction during each subscription period. In some instances, students begin and complete a subscription period within the dates of the term. However, because competency-based programs are generally self-paced, the requirement under a term-based program that coursework must begin and end within the timeframe of the term is often a significant impediment to the students enrolled in such programs.

    Description

    In response to the above, the Secretary is expanding the current Competency-Based Education experiment to provide two additional sets of statutory and regulatory waivers. Institutions must choose a single set of waivers from among the three sets available that will apply to all of the competency-based education programs that it includes under the experiment. The sets of waivers are as follows:

    (1) Split Disbursement: This set of waivers includes all of the disbursement, satisfactory academic progress, and Return of Title IV Funds waivers described in the July 31, 2014, notice and explained in the Competency-Based Education Experiment Reference Guide.

    (2) Satisfactory Academic Progress Only: A second set of waivers will include only the waivers to the satisfactory academic progress requirements described in the July 31, 2014, notice and explained in the Competency-Based Education Experiment Reference Guide.

    (3) Subscription Period Disbursement: The third set of waivers is intended for institutions offering competency-based programs using subscription periods and is described below.

    Under the Subscription Period Disbursement set of waivers, the institution may include in its determination of a student's enrollment status competencies that begin prior to the start of the subscription period, as long as it does not include those competencies in enrollment status for two different payment periods. Institutions will disburse title IV aid based on the student's anticipated enrollment for a subscription period (which is equivalent to a payment period) rather than requiring completion of a specific number of competencies prior to making subsequent disbursements of title IV aid. While an institution will determine a student's title IV aid amounts based on the student's anticipated enrollment status, the institution will be required to perform a satisfactory academic progress evaluation for the student at the end of each subscription period (payment period) to ensure that the student has completed the appropriate number of competencies in that payment period, given the student's enrollment status.

    Program Eligibility: An institution participating in the Competency-Based Education experiment could choose to use the Subscription Period Disbursement set of waivers only if it charges students in a competency-based education program using subscription periods, as described above.

    Payment Periods: Subscription periods under this set of waivers will be considered to be term-based payment periods, as payment periods are defined under 34 CFR 668.4(a) and (b). Institutions disbursing under this set of waivers will generally follow existing rules for standard and nonstandard terms, as appropriate, except that nonstandard terms that are not substantially equal will have the same payment periods for Direct Loans as they do for Pell Grants, with similar proration based on the length of the payment period.

    Enrollment Status: For each payment period, students will be assigned by the institution an enrollment status (full-time, half-time, three-quarter time, less than half-time) based on the student's expected enrollment in and completion of competencies for the payment period. After consulting with the student, the institution will determine the student's enrollment status based on a realistic assessment by the institution of the number of competencies that the student will complete during the payment period. However, unlike under existing regulations for standard and nonstandard term programs, an institution will not be permitted to count a unique competency or course toward a student's enrollment status for more than one payment period.

    In addition, under this set of waivers, a student's enrollment status may not be changed for title IV purposes once it has been established for the payment period, except that an institution must increase a student's enrollment status to reflect any competencies completed by the student during the payment period that were not originally assigned to that payment period or to a previous payment period. If the additional competencies that were completed in the payment period were expected to be completed in a subsequent payment period(s), an adjustment to the student's enrollment status for that subsequent payment period(s) is required.

    For Pell Grant purposes, students will still be required to begin working on at least the number of competencies used in the determination of the student's enrollment status for each payment period. Therefore, to use this set of waivers, an institution must have a mechanism for determining that a student has been participating in a competency during a payment period.

    Satisfactory Academic Progress: As in the Split Disbursement set of waivers, the Subscription Period Disbursement set of waivers will modify the statutory and regulatory requirements for monitoring satisfactory academic progress so that an institution will be required to evaluate a student's pace by using competencies completed over calendar time, rather than by dividing a student's completed credit hours by attempted credit hours. However, two additional requirements will be added for institutions using Subscription Period Disbursement.

    First, the institution must evaluate a student's satisfactory academic progress after every subscription period (payment period), rather than at least once annually, even if the program is more than one academic year in length.

    Second, the institution must evaluate a student's pace using two separate measures:

    (1) The student's progress for the payment period immediately prior to the evaluation, calculated using the number of credit hours or equivalents completed over the number of credit hours or equivalents included in the student's enrollment status for that payment period; and

    (2) The student's cumulative rate of progress, calculated by dividing the aggregate number of credit hours or equivalents completed as of the end of the payment period by the total number of credit hours or equivalents expected to be completed as of the end of that payment period in order for the student to complete the program within the maximum timeframe. The maximum timeframe is based on the published length of the program, expressed in calendar time (i.e., weeks, months, years).

    To make satisfactory academic progress under the payment period measure, a student must complete the minimum number of credit hours or equivalents associated with the enrollment status that was assigned to the student for the payment period under review. For example, if an institution's definition of a “full-time academic workload” in a competency-based education program is 12 semester hours and a student enrolled in that program is assigned a full-time enrollment status in a payment period, the student would need to complete competencies with an equivalent of at least 12 semester hours in that payment period to make satisfactory academic progress. Similarly, if a student in the same program is assigned a half-time enrollment status in a payment period, the student would need to complete at least 6 semester hours in that payment period in order to make satisfactory academic progress.

    For its evaluation of a student's cumulative rate of progress, the institution could use different standards for students on different enrollment tracks—for example, there could be a different maximum timeframe for a student on a half-time enrollment track, for whom the normal time for completion of the program is longer than for a student on a full-time enrollment track.

    If a student fails either of the two satisfactory academic progress evaluations, the student will have failed to make satisfactory academic progress and will, based on the institution's satisfactory academic progress policies, either be assigned to a financial aid warning period or immediately lose eligibility for title IV funds. Institutions will have the same flexibility to establish options for appeals, probation periods, and academic plans as they do under the current regulations.

    Return of title IV Funds (R2T4): Under the Subscription Period Disbursement set of waivers, R2T4 calculations will be required, and will follow the normal requirements under 34 CFR 668.22 when a student withdraws.

    Waivers

    For all of the competency-based education programs that it offers under the experiment, the institution must select one of the following sets of waivers.

    (1) Split Disbursement:

    • This set of waivers was described in the July 31, 2014, notice and explained in the Competency-Based Education Experiment Reference Guide.

    (2) Satisfactory Academic Progress Only:

    • This set of waivers includes only the waivers to the satisfactory academic progress requirements described in the July 31, 2014, notice and explained in the Competency-Based Education Experiment Reference Guide.

    (3) Subscription Period Disbursement:

    • 34 CFR 668.4(a), to the extent that the regulation requires the coursework undertaken within a standard term or a nonstandard term to begin within the term start and end dates.

    • 34 CFR 668.4(b), to the extent that the regulation requires the coursework undertaken within a nonstandard term to begin within the term start and end dates.

    • HEA section 484(c) and 34 CFR 668.34(a)(3)(ii), (a)(5)(ii), and (b), related to the timeframe when the institution must determine whether a student is making satisfactory academic progress and the method by which an institution must calculate the pace of a student's academic progression.

    • 34 CFR 685.303(d)(5), to the extent that the regulations provide that Direct Loan proceeds must be disbursed in substantially equal installments. The modification will require the institution to make disbursements of Direct Loan funds in accordance with the provisions of the Pell Grant program under the same rules used in the calculation of disbursement amounts in the Pell Grant program under 34 CFR 690.63.

    • 34 CFR 690.80(b)(2)(i), which permits an institution to recalculate a student's enrollment status during a payment period after the student has begun all of the coursework for the payment period.

    All other provisions and regulations of the title IV student assistance programs will remain in effect.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g. braille, large print, audiotape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Delegation of Authority: The Secretary of Education has delegated authority to Jamienne S. Studley, Deputy Under Secretary, to perform the functions and duties of the Assistant Secretary for Postsecondary Education.

    Program Authority:

    HEA, section 487A(b); 20 U.S.C. 1094a(b).

    Dated: November 13, 2015. Jamienne S. Studley, Deputy Under Secretary.
    [FR Doc. 2015-29437 Filed 11-17-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY:

    Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Nuclear Energy Advisory Committee (NEAC). The Federal Advisory Committee Act (Pub. L. 94-463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Friday, December 11, 2015, 8:30 a.m.-4:00 p.m.

    ADDRESSES:

    Westin Crystal City, 1800 Jefferson Davis Highway, Arlington, VA 22202.

    FOR FURTHER INFORMATION CONTACT:

    Bob Rova, Designated Federal Officer, U.S. Department of Energy, 19901 Germantown Rd., Germantown, MD 20874; telephone (301) 903-9096; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Nuclear Energy Advisory Committee (NEAC), formerly the Nuclear Energy Research Advisory Committee (NERAC), was established in 1998 by the U.S. Department of Energy (DOE) to provide advice on complex scientific, technical, and policy issues that arise in the planning, managing, and implementation of DOE's civilian nuclear energy research programs. The committee is composed of 17 individuals of diverse backgrounds selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues that pertain to nuclear energy.

    Purpose of the Meeting: To inform the committee of recent developments and current status of research programs and projects pursued by the Department of Energy's Office of Nuclear Energy and receive advice and comments in return from the committee.

    Tentative Agenda: The meeting is expected to include presentations that cover such topics as an update on activities for the Office of Nuclear Energy. In addition, there will be presentations by Nuclear Energy Advisory Committee subcommittees. The agenda may change to accommodate committee business. For updates, one is directed the NEAC Web site: http://energy.gov/ne/services/nuclear-energy-advisory-committee.

    Public Participation: Individuals and representatives of organizations who would like to offer comments and suggestions may do so on the day of the meeting, Friday, December 11, 2015. Approximately thirty minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but is not expected to exceed 5 minutes. Anyone who is not able to make the meeting or has had insufficient time to address the committee is invited to send a written statement to Bob Rova, U.S. Department of Energy 1000 Independence Avenue SW., Washington, DC 20585, or email: [email protected]

    Minutes: The minutes of the meeting will be available by contacting Mr. Rova at the address above or on the Department of Energy, Office of Nuclear Energy Web site at http://energy.gov/ne/services/nuclear-energy-advisory-committee.

    Issued in Washington, DC, on November 12, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-29434 Filed 11-17-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Advanced Scientific Computing Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Advanced Scientific Computing Advisory Committee (ASCAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Wednesday, December 9, 2015 8:30 a.m.-5:30 p.m.; Thursday, December 10, 2015 8:30 a.m.-12:00 p.m. ADDRESSES:

    American Geophysical Union (AGU), 2000 Florida Avenue NW., Washington, DC 20009-1277.

    FOR FURTHER INFORMATION CONTACT:

    Christine Chalk, Office of Advanced Scientific Computing Research; SC-21/Germantown Building; U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-1290; Telephone (301) 903-7486.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Committee: To provide advice and guidance on a continuing basis to the Office of Scientific Computing Research and to the Department of Energy on scientific priorities within the field of advanced scientific computing research.

    Purpose of the Meeting: This meeting is the semi-annual meeting of the Committee.

    Tentative Agenda Topics:

    • View from Germantown • Report from the Next Generation Networking for Science Committee of Visitors • Information on the National Strategic Computing Initiative • Update on Exascale project activities • Summary of workshops on technologies “beyond exascale” • Program response to report from Subcommittee on the Office of Scientific and Technical Information (OSTI) • Technical presentations • Public Comment (10-minute rule) The meeting agenda includes a report from the Committee of Visitors on the Next Generation Networking for Science program; an update on the budget, accomplishments and planned activities of the Advanced Scientific Computing Research program; a program response to the report from the Subcommittee on the Office of Scientific and Technical Information; an update on exascale computing project activities; information on recent workshops exploring potential technologies “beyond exascale”—such as quantum computing and neom orphic computing; a technical presentation from an exascale researcher in Computer Science; and an opportunity for comments from the public. The meeting will conclude at noon on December 10, 2015. Agenda updates and presentations will be posted on the ASCAC Web site prior to the meeting: http://science.energy.gov/ascr/ascac/.

    Public Participation: The meeting is open to the public. Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the meeting. Approximately 30 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but will not exceed 10 minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

    Those wishing to speak should submit your request at least five days before the meeting. Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Christine Chalk, U.S. Department of Energy, 1000 Independence Avenue SW., Washington DC 20585, email to [email protected]

    Minutes: The minutes of this meeting will be available within 90 days on the Office of Advanced Scientific Computing Web site at http://science.energy.gov/ascr/ascac/.

    Issued at Washington, DC, on November 12, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-29429 Filed 11-17-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY National Nuclear Security Administration Defense Programs Advisory Committee AGENCY:

    Office of Defense Programs, National Nuclear Security Administration, Department of Energy.

    ACTION:

    Notice of closed meeting.

    SUMMARY:

    This notice announces a closed meeting of the Defense Programs Advisory Committee (DPAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of meetings be announced in the Federal Register. Due to national security considerations, under section 10(d) of the Act and 5 U.S.C. 552b(c), the meeting will be closed to the public and matters to be discussed are exempt from public disclosure under Executive Order 13526 and the Atomic Energy Act of 1954, 42 U.S.C. 2161 and 2162, as amended.

    DATES:

    December 3, 2015, 8:30 a.m. to 5:00 p.m. and December 23, 2015, 8:30 a.m. to 5:00 p.m.

    ADDRESSES:

    U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Loretta Martin, Office of RDT&E (NA-113), National Nuclear Security Administration, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585, (202) 586-7996.

    SUPPLEMENTARY INFORMATION:

    Background: The DPAC provides advice and recommendations to the Deputy Administrator for Defense Programs on the stewardship and maintenance of the Nation's nuclear deterrent.

    Purpose of the Meeting: The purpose of this meeting of the DPAC is to discuss the final draft of the classified report to be provided to the National Nuclear Security Administration in response to the charge to the Committee. This meeting corresponds to the one previously announced for October 22-23, 2015, in Washington, DC, which had to be postponed.

    Type of Meeting: In the interest of national security, the meeting will be closed to the public. The Federal Advisory Committee Act, 5 U.S.C., App. 2, section 10(d), and the Federal Advisory Committee Management Regulation, 41 CFR 102-3.155, incorporate by reference the Government in the Sunshine Act, 5 U.S.C. 552b, which, at 552b(c)(1) and (c)(3) permits closure of meetings where restricted data or other classified matters will be discussed. Such data and matters will be discussed at this meeting.

    Tentative Agenda: Day 1—Welcome, discussion and editing of draft report; Day 2—Discussion and editing of draft report, reconciliation of input, (tentative) acceptance of report; conclusion.

    Public Participation: There will be no public participation in this closed meeting. Those wishing to provide written comments or statements to the Committee are invited to send them to Loretta Martin at the address listed above.

    Minutes: The minutes of the meeting will not be available.

    Issued in Washington, DC, on November 12, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-29430 Filed 11-17-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:

    AGENCY HOLDING MEETING:

    Federal Energy Regulatory Commission.

    DATE AND TIME:

    November 19, 2015, 10:00 a.m.

    PLACE:

    Room 2C, 888 First Street NE., Washington, DC 20426.

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    Agenda * Note—Items listed on the agenda may be deleted without further notice.

    CONTACT PERSON FOR MORE INFORMATION:

    Kimberly D. Bose, Secretary, Telephone (202) 502-8400. For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.

    This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's Web site at http://www.ferc.gov using the eLibrary link, or may be examined in the Commission's Public Reference Room.

    1021ST—Meeting, Regular Meeting, November 19, 2015, 10:00 a.m. Item No. Docket No. Company