Federal Register Vol. 82, No.8,

Federal Register Volume 82, Issue 8 (January 12, 2017)

Page Range3601-4147
FR Document

82_FR_8
Current View
Page and SubjectPDF
82 FR 3809 - Sunshine Act MeetingPDF
82 FR 3819 - Sunshine Act: OPIC Annual Public HearingPDF
82 FR 3677 - Prevailing Rate Systems; Redefinition of Certain Nonappropriated Fund Federal Wage System Wage AreasPDF
82 FR 3820 - Excepted ServicePDF
82 FR 3759 - Early Engagement Opportunity: Implementation of National Defense Authorization Act for Fiscal Year 2017PDF
82 FR 3797 - Proposed Information Collection Activity; Comment RequestPDF
82 FR 3759 - Information Collection; Submission for OMB Review, Comment RequestPDF
82 FR 3758 - Request for Comments Regarding the Continuation of the Accelerated Examination ProgramPDF
82 FR 3766 - Grand River Dam Authority; Notice of Availability of Draft Environmental AssessmentPDF
82 FR 3790 - Advanced Energy Management Alliance v. PJM Interconnection, L.L.C.; Notice of ComplaintPDF
82 FR 3766 - Combined Notice of Filings #2PDF
82 FR 3789 - Combined Notice of Filings #1PDF
82 FR 3766 - Birch Power Company; Notice of Technical MeetingPDF
82 FR 3789 - PacifiCorp Energy; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final AmendmentsPDF
82 FR 3765 - QEP Field Services, LLC; Notice of Request for Temporary WaiverPDF
82 FR 3725 - Council Coordination Committee MeetingPDF
82 FR 3726 - Proposed Information Collection; Comment Request; Alaska Region Crab PermitsPDF
82 FR 3606 - Hazardous Materials: Amended Emergency Restriction/Prohibition OrderPDF
82 FR 3841 - Office of Commercial Space Transportation; Notice of Availability, Notice of Public Comment Period, and Request for Comment on the Draft Environmental Assessment for Issuing a License to LauncherOne, LLC for LauncherOne Launches at the Mojave Air and Space Port, Kern County, CaliforniaPDF
82 FR 3796 - Agency for Healthcare Research and QualityPDF
82 FR 3790 - Notice of Meeting of the EPA Children's Health Protection Advisory Committee (CHPAC)PDF
82 FR 3841 - E.O. 13224 Designation of Alexanda Amon Kotey, aka Alexanda Kotey, aka Allexanda Kotey, aka Alexander Kotey, aka Alexe Kotey, aka Alex Kotey, aka Abu Salih, aka Abu-Salih al-Baritani as a Specially Designated Global TerroristPDF
82 FR 3840 - E.O. 13224 Designation of Mustafa Mughniyeh, aka Mustafa Mughniyah as a Specially Designated Global TerroristPDF
82 FR 3793 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 3716 - Notice of Public Meeting of the Virginia Advisory Committee To Discuss Potential Projects of Study Including a Proposal on Hate CrimesPDF
82 FR 3738 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Seabird and Shorebird Monitoring and Research at the Eastern Massachusetts National Wildlife Refuge Complex, MassachusettsPDF
82 FR 3724 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment AssistancePDF
82 FR 3760 - Driftwood LNG, LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement NationsPDF
82 FR 3717 - Notice of Public Meeting of the Nevada State Advisory CommitteePDF
82 FR 3812 - Tennessee Valley Authority; Clinch River Nuclear SitePDF
82 FR 3762 - Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, and Vacating Authority During November 2016PDF
82 FR 3811 - Rhode Island Atomic Energy CommissionPDF
82 FR 3816 - Department of the Army, U.S. Army Research, Development and Engineering Command, Armament Research, Development and Engineering Center, Picatinny Arsenal; Picatinny, New JerseyPDF
82 FR 3717 - Proposed Information Collection; Comment Request; Monthly Retail SurveysPDF
82 FR 3760 - Board of Regents, Uniformed Services University of the Health Sciences; Notice of Federal Advisory Committee MeetingPDF
82 FR 3814 - University of Missouri-Columbia Research ReactorPDF
82 FR 3601 - Civil Penalty Inflation AdjustmentsPDF
82 FR 3800 - Advisory Committee for Women's Services (ACWS); Notice of MeetingPDF
82 FR 3845 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
82 FR 3842 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure DisordersPDF
82 FR 3843 - Qualification of Drivers; Exemption Applications; DiabetesPDF
82 FR 3751 - Notice and Request for Comment on Two New Categories of Special Use Permits Related to the Operation of Desalination Facilities Producing Potable Water for ConsumptionPDF
82 FR 3806 - Notice of Intent To Repatriate Cultural Items: Denver Museum of Nature & Science, Denver, COPDF
82 FR 3804 - Notice of Inventory Completion: U.S. Department of Defense, Defense Health Agency, National Museum of Health and Medicine, Silver Spring, MDPDF
82 FR 3805 - Notice of Intent To Repatriate Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZPDF
82 FR 3807 - Notice of Inventory Completion: Metroparks of the Toledo Area, Toledo, OHPDF
82 FR 3802 - Notice of Inventory Completion: International Boundary and Water Commission, U.S. Section, El Paso, TX, and the Texas Archeological Research Laboratory, Austin, TXPDF
82 FR 3805 - Notice To Rescind a Notice of Inventory Completion: Texas Archeological Research Laboratory, Austin, TXPDF
82 FR 3851 - Submission for OMB Review; Comment RequestPDF
82 FR 3810 - Smart Cities and Communities Federal Strategic Plan: Exploring Innovation TogetherPDF
82 FR 3838 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
82 FR 3798 - Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of MeetingPDF
82 FR 3719 - Privacy Act of 1974, Amended System of RecordsPDF
82 FR 3721 - Privacy Act of 1974, Amended System of RecordsPDF
82 FR 3824 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Expiration Date of FINRA Rule 0180 (Application of Rules to Security-Based Swaps)PDF
82 FR 3826 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Options Regulatory FeePDF
82 FR 3831 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing Amendment No. 1 and Order Granting Accelerated Approval of Proposed Rule Change To Amend the ICE Clear Credit Clearing Rules, as Modified by Amendment No. 1, Relating to Default Management, Clearing House Recovery and Wind-DownPDF
82 FR 3828 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Its Price ListPDF
82 FR 3809 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability ActPDF
82 FR 3809 - Notice of Permits Issued under the Antarctic Conservation Act of 1978PDF
82 FR 3737 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
82 FR 3716 - National Urban and Community Forestry Advisory CouncilPDF
82 FR 3676 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure and Possession Prohibition for the Common Pool FisheryPDF
82 FR 3794 - Submission for OMB Review; Alliant2 Greenhouse Gas DisclosurePDF
82 FR 3794 - Submission for OMB Review; USA.gov and All Related SubdomainsPDF
82 FR 3791 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
82 FR 3799 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
82 FR 3799 - Vaccines and Related Biological Products Advisory Committee; Notice of MeetingPDF
82 FR 3727 - Marine Mammals; File Nos. 18059 and 19655PDF
82 FR 3793 - Notice of Agreements FiledPDF
82 FR 3725 - Proposed Information Collection; Comment Request; Request for Duty-Free Entry of Scientific Instrument or ApparatusPDF
82 FR 3837 - Proposed Collection; Comment RequestPDF
82 FR 4064 - Establishing a Deductible for FEMA's Public Assistance ProgramPDF
82 FR 3678 - Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated OrthoticsPDF
82 FR 3727 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Rocky Intertidal Monitoring Surveys Along the Oregon and California CoastsPDF
82 FR 4022 - Endangered and Threatened Wildlife and Plants: Notice of 12-Month Finding on a Petition To List Alabama Shad as Threatened or Endangered Under the Endangered Species ActPDF
82 FR 3694 - 12-Month Finding on a Petition To List Giant and Reef Manta Rays as Threatened or Endangered Under the Endangered Species ActPDF
82 FR 3852 - Debt Management Advisory Committee MeetingPDF
82 FR 3800 - Plum Tree Island National Wildlife Refuge, Poquoson, VA; Comprehensive Conservation Plan and Environmental AssessmentPDF
82 FR 3605 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF
82 FR 3603 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous AmendmentsPDF
82 FR 3625 - Security Zone; Potomac River and Anacostia River, and Adjacent Waters; Washington, DCPDF
82 FR 3655 - List of Fisheries for 2017PDF
82 FR 3609 - Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical SpecimensPDF
82 FR 3619 - Revision of Freedom of Information Act RegulationPDF
82 FR 3623 - Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD-Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing; CorrectionPDF
82 FR 3639 - Air Plan Approval; TN Infrastructure Requirements for the 2010 NO2PDF
82 FR 3633 - Civil Monetary Penalty Inflation Adjustment RulePDF
82 FR 3637 - Approval and Promulgation of Implementation Plans; Alabama; Infrastructure Requirements or the 2010 Sulfur Dioxide National Ambient Air Quality StandardPDF
82 FR 4120 - Exchange Visitor Program-Summer Work TravelPDF
82 FR 3641 - Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping RequirementsPDF
82 FR 3796 - Request for Medicaid and CHIP Payment and Access Commission NominationsPDF
82 FR 3626 - Alaska; Subsistence CollectionsPDF
82 FR 3764 - CIPSEA Confidentiality Pledge Revision NoticePDF
82 FR 3623 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
82 FR 4100 - Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion AuthoritiesPDF
82 FR 3854 - Federal Motor Vehicle Safety Standards; V2V CommunicationsPDF

Issue

82 8 Thursday, January 12, 2017 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Requests for Information: Healthcare Delivery Organizations, 3796-3797 2017-00548 Agriculture Agriculture Department See

Forest Service

Consumer Financial Protection Bureau of Consumer Financial Protection RULES Civil Penalty Inflation Adjustments, 3601-3603 2017-00521 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Monthly Retail Surveys, 3717-3719 2017-00525 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare Program: Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom Fabricated Orthotics, 3678-3694 2017-00425 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Health Profession Opportunity Grant Program, 3797-3798 2017-00570 Civil Rights Civil Rights Commission NOTICES Meetings: Nevada State Advisory Committee, 3717 2017-00530 Virginia Advisory Committee, 3716-3717 2017-00542 Coast Guard Coast Guard RULES Security Zones: Potomac River and Anacostia River, and Adjacent Waters; Washington, DC, 3625-3626 2017-00251 Commerce Commerce Department See

Census Bureau

See

Economic Development Administration

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

NOTICES Privacy Act; Systems of Records, 3719-3724 2017-00495 2017-00494
Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3759 2017-00569 Defense Acquisition Defense Acquisition Regulations System NOTICES Early Engagement Opportunity: Implementation of National Defense Authorization Act for FY 2017, 3759-3760 2017-00571 Defense Department Defense Department See

Defense Acquisition Regulations System

See

Navy Department

NOTICES Meetings: Board of Regents, Uniformed Services University of the Health Sciences, 3760 2017-00524
Economic Development Economic Development Administration NOTICES Trade Adjustment Assistance Eligibility; Petitions, 3724-3725 2017-00535 Energy Department Energy Department See

Energy Information Administration

See

Federal Energy Regulatory Commission

NOTICES Export and Import Liquefied Natural Gas; Authorizations: Constellation Energy Services, Inc., et al., 3762-3764 2017-00528 Export Liquefied Natural Gas; Applications: Driftwood LNG, LLC, 3760-3762 2017-00531
Energy Information Energy Information Administration NOTICES CIPSEA Confidentiality Pledge Revision, 3764-3765 2016-31974 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Alabama; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard, 3637-3639 2017-00159 Tennessee; Infrastructure Requirements for the 2010 NO2 NAAQS, 3639-3641 2017-00161 Chemical Substances When Manufactured or Processed as Nanoscale Materials: TSCA Reporting and Recordkeeping Requirements, 3641-3655 2017-00052 Civil Monetary Penalty Inflation Adjustment Rule, 3633-3637 2017-00160 NOTICES Meetings: Children's Health Protection Advisory Committee, 3790-3791 2017-00547 Federal Aviation Federal Aviation Administration RULES Hazardous Materials: Amended Emergency Restriction/Prohibition Order, 3606-3609 2017-00555 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures: Miscellaneous Amendments, 3603-3606 2017-00293 2017-00295 NOTICES Environmental Assessments; Availability, etc.: Issuing a License to LauncherOne, LLC for LauncherOne Launches at the Mojave Air and Space Port, Kern County, CA, 3841-3842 2017-00549 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3791-3793 2017-00478 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Establishing a Deductible for Public Assistance Program, 4064-4097 2017-00467 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 3766, 3789 2017-00563 2017-00564 Complaints: Advanced Energy Management Alliance v. PJM Interconnection, L.L.C., 3790 2017-00565 Environmental Assessments; Availability, etc.: Grand River Dam Authority, 3766-3788 2017-00566 Hydroelectric Applications: PacifiCorp Energy, 3789-3790 2017-00561 Meetings: Birch Power Co., 3766 2017-00562 Petitions for Waivers: QEP Field Services, LLC, 3765-3766 2017-00560 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 3793 2017-00471 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Diabetes, 3843-3845 2017-00516 Diabetes Mellitus, 3845-3851 2017-00519 Epilepsy and Seizure Disorders, 3842-3843 2017-00518 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 3793-3794 2017-00543 Fish Fish and Wildlife Service NOTICES Environmental Assessments; Availability, etc.: Comprehensive Conservation Plan, Plum Tree Island National Wildlife Refuge, Poquoson, VA, 3800-3802 2017-00314 Food and Drug Food and Drug Administration RULES Microbiology Devices: Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens, 3609-3619 2017-00199 NOTICES Meetings: Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee, 3798-3799 2017-00496 Vaccines and Related Biological Products Advisory Committee, 3799 2017-00476 Foreign Claims Foreign Claims Settlement Commission NOTICES Meetings; Sunshine Act, 3809 2017-00717 Forest Forest Service NOTICES Meetings: National Urban and Community Forestry Advisory Council, 3716 2017-00485 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alliant2 Greenhouse Gas Disclosure, 3794-3796 2017-00483 USA.gov and All Related Subdomains, 3794 2017-00482 Government Accountability Government Accountability Office NOTICES Requests for Nominations: Medicaid and CHIP Payment and Access Commission, 3796 2017-00044 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Inspector General Office, Health and Human Services Department

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Housing Housing and Urban Development Department RULES Freedom of Information Act; Revisions, 3619-3623 2017-00178 Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD-Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing; Correction, 3623 2017-00167 Inspector General Health Inspector General Office, Health and Human Services Department RULES Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities, 4100-4118 2016-31390 Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

International Trade Adm International Trade Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Duty-Free Entry of Scientific Instrument or Apparatus, 3725 2017-00470 Justice Department Justice Department See

Foreign Claims Settlement Commission

NOTICES Proposed Consent Decrees: CERCLA, 3809 2017-00489
National Highway National Highway Traffic Safety Administration PROPOSED RULES Federal Motor Vehicle Safety Standards: V2V Communications, 3854-4019 2016-31059 National Institute National Institutes of Health NOTICES Meetings: National Institute of Allergy and Infectious Diseases, 3799-3800 2017-00477 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure and Possession Prohibition for the Common Pool Fishery, 3676 2017-00484 List of Fisheries for 2017, 3655-3676 2017-00250 PROPOSED RULES Endangered and Threatened Species: 12-Month Finding on a Petition to List Giant and Reef Manta Rays as Threatened or Endangered Under the Endangered Species Act, 3694-3715 2017-00370 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alaska Region Crab Permits, 3726-3727 2017-00557 Endangered and Threatened Wildlife and Plants: Alabama Shad; 12-Month Finding on Petition to List, 4022-4061 2017-00372 Meetings: Council Coordination Committee, 3725-3726 2017-00558 Gulf of Mexico Fishery Management Council, 3737-3738 2017-00486 Permit Applications: Marine Mammals; File Nos. 18059 and 19655, 3727 2017-00472 Special Use Permits: Two New Categories Related to the Operation of Desalination Facilities Producing Potable Water for Consumption, 3751-3758 2017-00515 Takes of Marine Mammals Incidental to Specified Activities: Rocky Intertidal Monitoring Surveys along the Oregon and California Coasts, 3727-3737 2017-00397 Takes of Marine Mammals: Seabird and Shorebird Monitoring and Research at the Eastern Massachusetts National Wildlife Refuge Complex, MA, 3738-3751 2017-00540 National Park National Park Service RULES Subsistence Collections: Alaska, 3626-3633 2016-32045 NOTICES Inventory Completions: Department of Defense, Defense Health Agency, National Museum of Health and Medicine, Silver Spring, MD, 3804-3805 2017-00511 International Boundary and Water Commission, U.S. Section, El Paso, TX, and the Texas Archeological Research Laboratory, Austin, TX, 3802-3804 2017-00508 Metroparks of the Toledo Area, Toledo, OH, 3807-3809 2017-00509 Texas Archeological Research Laboratory, Austin, TX; Withdrawal, 3805 2017-00507 Repatriation of Cultural Items: Arizona State Museum, University of Arizona, Tucson, AZ, 3805-3806 2017-00510 Denver Museum of Nature & Science, Denver, CO, 3806-3807 2017-00512 National Science National Science Foundation NOTICES Antarctic Conservation Act Permit Applications, 3809-3810 2017-00487 Draft Smart Cities and Communities Federal Strategic Plan—Exploring Innovation Together, 3810-3811 2017-00501 Navy Navy Department RULES International Regulations for Preventing Collisions at Sea; Certifications and Exemptions, 3623-3625 2016-31873 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: Department of the Army, U.S. Army Research, Development and Engineering Command, Armament Research, Development and Engineering Center, Picatinny Arsenal; Picatinny, NJ, 3816-3819 2017-00526 License Renewals: Rhode Island Atomic Energy Commission, 3811-3812 2017-00527 University of Missouri—Columbia Research Reactor, 3814-3816 2017-00523 Permit Application: Tennessee Valley Authority; Clinch River Nuclear Site, 3812-3814 2017-00529 Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 3819-3820 2017-00600 Patent Patent and Trademark Office NOTICES Continuation of the Accelerated Examination Program, 3758-3759 2017-00568 Personnel Personnel Management Office PROPOSED RULES Prevailing Rate Systems: Redefinition of Certain Nonappropriated Fund Federal Wage System Wage Areas, 3677-3678 2017-00577 NOTICES Excepted Service, 3820-3824 2017-00576 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3837-3838 2017-00469 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 3824-3825 2017-00493 ICE Clear Credit, LLC, 3831-3837 2017-00491 NASDAQ PHLX, LLC, 3826-3828 2017-00492 New York Stock Exchange, LLC, 3828-3831 2017-00490 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3838-3840 2017-00500 State Department State Department PROPOSED RULES Exchange Visitor Program—Summer Work Travel, 4120-4147 2017-00107 NOTICES Designations as Global Terrorists: Alexanda Amon Kotey, aka Alexanda Kotey, aka Allexanda Kotey, aka Alexander Kotey, aka Alexe Kotey, aka Alex Kotey, aka Abu Salih, aka Abu-Salih al-Baritani, 3841 2017-00545 Mustafa Mughniyeh, aka Mustafa Mughniyah, 3840-3841 2017-00544 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Advisory Committee for Women's Services, 3800 2017-00520 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3851-3852 2017-00504 Meetings: Debt Management Advisory Committee, 3852 2017-00318 Separate Parts In This Issue Part II Transportation Department, National Highway Traffic Safety Administration, 3854-4019 2016-31059 Part III Commerce Department, National Oceanic and Atmospheric Administration, 4022-4061 2017-00372 Part IV Homeland Security Department, Federal Emergency Management Agency, 4064-4097 2017-00467 Part V Health and Human Services Department, Inspector General Office, Health and Human Services Department, 4100-4118 2016-31390 Part VI State Department, 4120-4147 2017-00107 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.

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82 8 Thursday, January 12, 2017 Rules and Regulations BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1083 Civil Penalty Inflation Adjustments AGENCY:

Bureau of Consumer Financial Protection.

ACTION:

Final rule.

SUMMARY:

The Bureau of Consumer Financial Protection (Bureau) is adjusting for inflation the maximum amount of each civil penalty within the Bureau's jurisdiction. These adjustments are required by the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Debt Collection Improvement Act of 1996 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The inflation adjustments mandated by the Inflation Adjustment Act serve to maintain the deterrent effect of civil penalties and to promote compliance with the law.

DATES:

This final rule is effective January 15, 2017.

FOR FURTHER INFORMATION CONTACT:

Jaclyn Maier, Counsel, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552, at (202) 435-7700.

SUPPLEMENTARY INFORMATION:

I. Background

The Inflation Adjustment Act,1 as amended by the Debt Collection Improvement Act of 1996 2 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,3 directs Federal agencies to adjust for inflation the civil penalty amounts within their jurisdiction not later than July 1, 2016, and then not later than January 15 every year thereafter.4 28 U.S.C. 2461 note. Each agency was required to make the 2016 one-time catch-up adjustments through an interim final rule published in the Federal Register. On June 14, 2016, the Bureau published its interim final rule to make the initial catch-up adjustments to civil penalties within the Bureau's jurisdiction.5 The June 2016 interim final rule created a new part 1083 and in § 1083.1 established the inflation-adjusted maximum amounts for each civil penalty within the Bureau's jurisdiction.6 The Inflation Adjustment Act also requires subsequent adjustments to be made annually, not later than January 15, and notwithstanding section 553 of the Administrative Procedure Act (APA).7

1 Public Law 101-410, 104 Stat. 890.

2 Public Law 104-134, section 31001(s)(1), 110 Stat. 1321, 1321-373.

3 Public Law 114-74, section 701, 129 Stat. 584, 599.

4 Section 1301(a) of the Federal Reports Elimination Act of 1998, Public Law 105-362, 112 Stat. 3293, also amended the Inflation Adjustment Act by striking section 6, which contained annual reporting requirements, and redesignating section 7 as section 6, but did not alter the civil penalty adjustment requirements.

5 81 FR 38569 (June 14, 2016). Although the Bureau was not obligated to solicit comments for the interim final rule, the Bureau invited public comment and received none.

6See 12 CFR 1083.1.

7 Inflation Adjustment Act section 4, codified at 28 U.S.C. 2461 note.

Specifically, Federal agencies are directed to adjust annually each civil penalty provided by law within the jurisdiction of the agency by the “cost-of-living adjustment.” 8 For annual adjustments after the initial catch up adjustments, the “cost-of-living adjustment” is defined as the percentage (if any) by which the Consumer Price Index for All Urban Consumers (CPI-U) for the month of October preceding the date of the adjustment, exceeds the CPI-U for October of the prior year.9 The Director of the Office of Management and Budget (OMB) is required to issue guidance (OMB Guidance) to agencies on implementing the annual civil penalty inflation adjustments by December 15, 2016, and December 15 every subsequent year.10 Pursuant to the Inflation Adjustment Act and OMB Guidance, agencies must apply the multiplier reflecting the “cost-of-living adjustment” to the current penalty amount and then round that amount to the nearest dollar to determine the annual adjustments.11

8 Inflation Adjustment Act sections 4 and 5, codified at 28 U.S.C. 2461 note.

9 Inflation Adjustment Act sections 3 and 5, codified at 28 U.S.C. 2461 note.

10 Memorandum from Shaun Donovan, Director, Office of Management and Budget, to the Heads of Executive Departments and Agencies (Dec. 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf.

11 Inflation Adjustment Act section 5, codified at 28 U.S.C. 2461 note; Memorandum from Shaun Donovan, Director, Office of Management and Budget, to the Heads of Executive Departments and Agencies (Dec. 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf.

For the 2017 annual adjustment, the multiplier reflecting the “cost-of-living adjustment” is 1.01636.12 Pursuant to the Inflation Adjustment Act and OMB Guidance, the Bureau multiplied each of its civil penalty amounts by the “cost-of-living adjustment” multiplier and rounded to the nearest dollar.13

12 Memorandum from Shaun Donovan, Director, Office of Management and Budget, to the Heads of Executive Departments and Agencies (Dec. 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf. The multiplier reflecting the “cost-of-living adjustment” that OMB provides is rounded to five decimal places.

13 In rounding to the nearest dollar, the Bureau has rounded down where the digit immediately following the decimal point is less than 5 and has rounded up where the digit immediately following the decimal point is 5 or greater.

The new penalty amounts that apply to civil penalties assessed after January 15, 2017 are as follows:

Law Penalty description Penalty amounts established under June 2016 interim final rule OMB
  • “Cost-of-living
  • adjustment”
  • multiplier
  • New penalty amount
    Consumer Financial Protection Act, 12 U.S.C. 5565(c)(2)(A) Tier 1 penalty $5,437 1.01636 $5,526 Consumer Financial Protection Act, 12 U.S.C. 5565(c)(2)(B) Tier 2 penalty 27,186 1.01636 27,631 Consumer Financial Protection Act, 12 U.S.C. 5565(c)(2)(C) Tier 3 penalty 1,087,450 1.01636 1,105,241 Interstate Land Sales Full Disclosure Act, 15 U.S.C. 1717a(a)(2) Per violation 1,894 1.01636 1,925 Interstate Land Sales Full Disclosure Act, 15 U.S.C. 1717a(a)(2) Annual cap 1,893,610 1.01636 1,924,589 Real Estate Settlement Procedures Act, 12 U.S.C. 2609(d)(1) Per failure 89 1.01636 90 Real Estate Settlement Procedures Act, 12 U.S.C. 2609(d)(1) Annual cap 178,156 1.01636 181,071 Real Estate Settlement Procedures Act, 12 U.S.C. 2609(d)(2)(A) Per failure, where intentional 178 1.01636 181 SAFE Act, 12 U.S.C. 5113(d)(2) Per violation 27,455 1.01636 27,904 Truth in Lending Act, 15 U.S.C. 1639e(k)(1) First violation 10,875 1.01636 11,053 Truth in Lending Act, 15 U.S.C. 1639e(k)(2) Subsequent violations 21,749 1.01636 22,105
    II. Legal Authority

    The Bureau issues this final rule under the Inflation Adjustment Act,14 as amended by the Debt Collection Improvement Act of 1996 15 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,16 which requires the Bureau to adjust for inflation the civil penalties within its jurisdiction according to a statutorily prescribed formula.

    14 Public Law 101-410, 104 Stat. 890.

    15 Public Law 104-134, section 31001(s)(1), 110 Stat. 1321, 1321-373.

    16 Public Law 114-74, section 701, 129 Stat. 584, 599.

    III. Procedural Requirements A. Administrative Procedure Act

    Under the APA, notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest.17 Pursuant to this final rule, § 1083.1 is amended to update the civil penalty amounts. The 2017 adjustments to the civil penalty amounts are technical and non-discretionary, and they merely apply the statutory method for adjusting civil penalty amounts. These adjustments are required by the Inflation Adjustment Act. Moreover, the Inflation Adjustment Act directs agencies to adjust the civil penalties annually notwithstanding section 553 of the APA,18 and OMB Guidance reaffirms that agencies need not complete a notice-and-comment process before making the annual adjustments for inflation.19 For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

    17 5 U.S.C. 553(b)(B).

    18 Inflation Adjustment Act section 4, codified at 28 U.S.C. 2461 note.

    19 Memorandum from Shaun Donovan, Director, Office of Management and Budget, to the Heads of Executive Departments and Agencies (Dec. 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf.

    Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.20 At a minimum, the Bureau believes the annual adjustments to the civil penalty amounts in § 1083.1 fall under the third exception to section 553(d). The Bureau finds that there is good cause to make the amendments effective on January 15, 2017. The amendments to § 1083.1 in this final rule are technical and non-discretionary, and they merely apply the statutory method for adjusting civil penalty amounts and follow the statutory directive to make annual adjustments by January 15 of each year. Moreover, the Inflation Adjustment Act directs agencies to adjust the civil penalties annually notwithstanding section 553 of the APA,21 and OMB Guidance reaffirms that agencies need not provide a delay in effective date for the annual adjustments for inflation.22

    20 5 U.S.C. 553(d).

    21 Inflation Adjustment Act section 4, codified at 28 U.S.C. 2461 note.

    22 Memorandum from Shaun Donovan, Director, Office of Management and Budget, to the Heads of Executive Departments and Agencies (Dec. 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf.

    B. Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.23

    23 5 U.S.C. 603(a), 604(a).

    C. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995,24 the Bureau reviewed this final rule. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.

    24 44 U.S.C. 3506; 5 CFR 1320.

    List of Subjects in 12 CFR Part 1083

    Administrative practice and procedure, Consumer protection, Penalties.

    Authority and Issuance For the reasons set forth above, the Bureau amends 12 CFR part 1083, as set forth below: PART 1083—CIVIL PENALTY ADJUSTMENTS 1. The authority citation for part 1083 continues to read as follows: Authority:

    12 U.S.C. 2609(d); 12 U.S.C. 5113(d)(2); 12 U.S.C. 5565(c); 15 U.S.C. 1639e(k); 15 U.S.C. 1717a(a); 28 U.S.C. 2461 note.

    2. Section 1083.1 is revised to read as follows:
    § 1083.1 Adjustments of civil penalty amounts.

    (a) The maximum amount of each civil penalty within the jurisdiction of the Consumer Financial Protection Bureau to impose is adjusted in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (28 U.S.C. 2461 note) as follows:

    U.S. Code citation Civil penalty description Adjusted
  • maximum civil
  • penalty amount
  • 12 U.S.C. 5565(c)(2)(A) Tier 1 penalty $5,526 12 U.S.C. 5565(c)(2)(B) Tier 2 penalty 27,631 12 U.S.C. 5565(c)(2)(C) Tier 3 penalty 1,105,241 15 U.S.C. 1717a(a)(2) Per violation 1,925 15 U.S.C. 1717a(a)(2) Annual cap 1,924,589 12 U.S.C. 2609(d)(1) Per failure 90 12 U.S.C. 2609(d)(1) Annual cap 181,071 12 U.S.C. 2609(d)(2)(A) Per failure, where intentional 181 12 U.S.C. 5113(d)(2) Per violation 27,904 15 U.S.C. 1639e(k)(1) First violation 11,053 15 U.S.C. 1639e(k)(2) Subsequent violations 22,105

    (b) The adjustments in paragraph (a) of this section shall apply to civil penalties assessed after January 15, 2017, regardless of when the violation for which the penalty is assessed occurred.

    Dated: January 4, 2017. Richard Cordray, Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-00521 Filed 1-9-17; 4:15 pm] BILLING CODE 4810-AM-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31112; Amdt. No. 3727] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective January 12, 2017. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of January 12, 2017.

    ADDRESSES:

    Availability of matters incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

    The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

    Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC, on December 16, 2016. John S. Duncan, Director, Flight Standards Service. Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows: Effective 2 February 2017 Auburn, AL, Auburn University Rgnl, RNAV (GPS) RWY 11, Amdt 2A Geneva, AL, Geneva Muni, RNAV (GPS) RWY 11, Orig-A Geneva, AL, Geneva Muni, RNAV (GPS) RWY 29, Orig-A Sebastian, FL, Sebastian Muni, RNAV (GPS) RWY 5, Orig-C Sebastian, FL, Sebastian Muni, RNAV (GPS) RWY 23, Orig-C Madison, GA, Madison Muni, RNAV (GPS) RWY 14, Orig-A St Joseph, MO, Rosecrans Memorial, RADAR 1, Amdt 2 Medford, WI, Taylor County, NDB RWY 34, Amdt 7, CANCELED Effective 2 March 2017 Healy, AK, Healy River, RNAV (GPS) RWY 15, Orig Healy, AK, Healy River, RNAV (GPS)-A, Orig Nondalton, AK, Nondalton, RNAV (GPS) RWY 2, Orig-A Flippin, AR, Marion County Rgnl, RNAV (GPS) RWY 4, Amdt 1 Flippin, AR, Marion County Rgnl, RNAV (GPS) RWY 22, Amdt 1 Flippin, AR, Marion County Rgnl, Takeoff Minimums and Obstacle DP, Amdt 1 Flippin, AR, Marion County Rgnl, VOR-A, Amdt 15 Clifton/Morenci, AZ, Greenlee County, RNAV (GPS)-A, Orig-A Stockton, CA, Stockton Metropolitan, ILS OR LOC RWY 29R, Amdt 21 Stockton, CA, Stockton Metropolitan, RNAV (GPS) RWY 11L, Amdt 1 Stockton, CA, Stockton Metropolitan, RNAV (GPS) RWY 29R, Amdt 1 Rota Island, CQ, Benjamin Taisacan Manglona Intl, NDB RWY 27, Amdt 4A Rota Island, CQ, Benjamin Taisacan Manglona Intl, RNAV (GPS) RWY 27, Amdt 1A Macon, GA, Macon Downtown, Takeoff Minimums and Obstacle DP, Amdt 8 Clarinda, IA, Schenck Field, NDB-A, Amdt 5B, CANCELED Evansville, IN, Evansville Rgnl, ILS OR LOC RWY 4, Amdt 4 Evansville, IN, Evansville Rgnl, ILS OR LOC RWY 22, Amdt 23 Madison, IN, Madison Muni, RNAV (GPS) RWY 3, Amdt 1C Fort Scott, KS, Fort Scott Muni, NDB RWY 18, Amdt 12, CANCELED Larned, KS, Larned-Pawnee County, NDB RWY 17, Amdt 4A, CANCELED Mayfield, KY, Mayfield Graves County, VOR/DME-A, Amdt 8A Tompkinsville, KY, Tompkinsville-Monroe County, RNAV (GPS) RWY 4, Amdt 1C Vivian, LA, Vivian, NDB RWY 9, Amdt 2B, CANCELED Lansing, MI, Capital Region Intl, ILS OR LOC RWY 10R, Amdt 11A Lansing, MI, Capital Region Intl, ILS OR LOC RWY 28L, Amdt 27B Perryville, MO, Perryville Rgnl, RNAV (GPS) RWY 2, Orig-A Perryville, MO, Perryville Rgnl, RNAV (GPS) RWY 20, Orig-A Perryville, MO, Perryville Rgnl, Takeoff Minimums and Obstacle DP, Orig-A Perryville, MO, Perryville Rgnl, VOR-A, Amdt 5A Shelby, MT, Shelby, NDB RWY 23, Amdt 7A Shelby, MT, Shelby, RNAV (GPS) RWY 5, Orig-B Shelby, MT, Shelby, RNAV (GPS) RWY 23, Amdt 2B Omaha, NE., Eppley Airfield, Takeoff Minimums and Obstacle DP, Amdt 6 Claremont, NH, Claremont Muni, NDB-A, Amdt 1B Nashua, NH, Boire Field, RNAV (GPS) RWY 14, Amdt 1C Ashland, OH, Ashland County, VOR-A, Amdt 9C Batavia, OH, Clermont County, RNAV (GPS) RWY 4, Amdt 1C Batavia, OH, Clermont County, RNAV (GPS) RWY 22, Amdt 1D Batavia, OH, Clermont County, VOR-B, Amdt 7C Pittsburgh, PA, Allegheny County, RNAV (GPS) RWY 10, Amdt 4C Marion, SC, Marion County, NDB RWY 4, Amdt 5, CANCELED Pageland, SC, Pageland, NDB RWY 24, Amdt 1 Pageland, SC, Pageland, Takeoff Minimums and Obstacle DP, Amdt 1 Dayton, TN, Mark Anton, NDB RWY 3, Amdt 2A Littlefield, TX, Littlefield Muni, NDB RWY 1, Amdt 1A, CANCELED Seminole, TX, Gaines County, NDB RWY 35, Amdt 1, CANCELED Provo, UT, Provo Muni, ILS OR LOC RWY 13, Amdt 3
    [FR Doc. 2017-00293 Filed 1-11-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 31114; Amdt. No. 3729] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

    DATES:

    This rule is effective January 12, 2017. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

    The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of January 12, 2017.

    ADDRESSES:

    Availability of matters incorporated by reference in the amendment is as follows:

    For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.

    2. The FAA Air Traffic Organization Service Area in which the affected airport is located;

    3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,

    4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.

    FOR FURTHER INFORMATION CONTACT:

    Thomas J. Nichols, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.

    SUPPLEMENTARY INFORMATION:

    This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

    The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

    Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

    The Rule

    This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

    The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

    Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, Navigation (air).

    Issued in Washington, DC, on December 30, 2016. John S. Duncan, Director, Flight Standards Service. Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

    PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

    2. Part 97 is amended to read as follows: Effective 2 February 2017 Rutland, VT, Rutland-Southern Vermont Rgnl, RNAV (GPS) RWY 1, Amdt 1 Effective 2 March 2017 Birmingham, AL, Birmingham-Shuttlesworth Intl, LOC RWY 18, Amdt 2C Birmingham, AL, Birmingham-Shuttlesworth Intl, RNAV (GPS) RWY 18, Amdt 1B Gadsden, AL, Northeast Alabama Rgnl, ILS OR LOC RWY 24, Orig-B Bullhead City, AZ, Laughlin/Bullhead Intl, RNAV (GPS) RWY 34, Amdt 3 Bullhead City, AZ, Laughlin/Bullhead Intl, Takeoff Minimums and Obstacle DP, Amdt 2 Bullhead City, AZ, Laughlin/Bullhead Intl, VOR RWY 34, Amdt 2 Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, ILS OR LOC RWY 10R, Amdt 1 Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, ILS OR LOC RWY 28L, Amdt 1 Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, RNAV (GPS) RWY 10R, Amdt 1 Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, RNAV (GPS) RWY 28L, Amdt 1 Albany, GA, Southwest Georgia Rgnl, RNAV (GPS) RWY 4, Amdt 1B Lawrenceville, GA, Gwinnett County—Briscoe Field, ILS OR LOC RWY 25, Amdt 2C Crawfordsville, IN, Crawfordsville Muni, RNAV (GPS) RWY 4, Amdt 1A Indianapolis, IN, Indianapolis Downtown, COPTER RNAV (GPS) 291, Orig-A Indianapolis, IN, Indianapolis Downtown, COPTER VOR/DME 287, Amdt 2A Gaithersburg, MD, Montgomery County Airpark, RNAV (GPS)-A, Orig-B Portland, ME, Portland Intl Jetport, ILS OR LOC RWY 11, ILS RWY 11 (SA CAT I), ILS RWY 11 (CAT II), ILS RWY 11 (CAT III), Amdt 4A Jaffrey, NH, Jaffrey Airport-Silver Ranch, RNAV (GPS)-C, Orig-A Buffalo, OK, Buffalo Muni, NDB-A, Amdt 3, CANCELED Hazleton, PA, Hazleton Rgnl, LOC RWY 28, Amdt 8 Hazleton, PA, Hazleton Rgnl, VOR RWY 10, Amdt 11B, CANCELED Hazleton, PA, Hazleton Rgnl, VOR RWY 28, Amdt 9B, CANCELED Quakertown, PA, Quakertown, RNAV (GPS) RWY 11, Orig-B Quakertown, PA, Quakertown, RNAV (GPS) RWY 29, Amdt 1B Aberdeen, SD, Aberdeen Rgnl, RNAV (GPS) RWY 17, Orig Aberdeen, SD, Aberdeen Rgnl, RNAV (GPS) RWY 35, Amdt 1 Aberdeen, SD, Aberdeen Rgnl, Takeoff Minimums and Obstacle DP, Amdt 1 Knoxville, TN, Mc Ghee Tyson, ILS OR LOC RWY 5L, Amdt 9A Gladewater, TX, Gladewater Muni, RNAV (GPS) RWY 14, Orig-B Gladewater, TX, Gladewater Muni, RNAV (GPS) RWY 32, Orig-B Gladewater, TX, Gladewater Muni, VOR RWY 14, Amdt 3B San Antonio, TX, San Antonio Intl, Takeoff Minimums and Obstacle DP, Amdt 1A RESCINDED: On December 19, 2016 (81 FR 91698), the FAA published an Amendment in Docket No. 31107, Amdt No. 3723 to Part 97 of the Federal Aviation Regulations under section 97.33. The following entry for Suffolk, VA, effective January 5, 2017, is hereby rescinded in its entirety: Suffolk, VA, Suffolk Executive, RNAV (GPS) RWY 22, Amdt 2
    [FR Doc. 2017-00295 Filed 1-11-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Chapter I [Docket No. FAA-2016-9288] Hazardous Materials: Amended Emergency Restriction/Prohibition Order AGENCY:

    Federal Aviation Administration (FAA), DOT

    ACTION:

    Notice of amended emergency restriction/prohibition order.

    SUMMARY:

    This document provides notice of the Amended Emergency Restriction/Prohibition Order No. FAA-2016-9288, issued by the Secretary of the Department of Transportation on January 9, 2017, and effective on January 10, 2017, to Samsung Galaxy Note 7 Users and air carriers. The Amended Emergency Restriction/Prohibition Order continues to prohibit persons from offering for air transportation or transporting via air any Samsung Galaxy Note 7 device on their person, in carry-on baggage, in checked baggage, or as cargo; requires individuals who inadvertently bring a Samsung Galaxy Note 7 device onto an aircraft immediately power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight; requires air carriers to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and their baggage of the Samsung Galaxy Note 7 device; and requires that if an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device and not to use or charge the device onboard the aircraft and protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight. The Amended Emergency Restriction/Prohibition Order only removes the requirement for air carriers to alert passengers to the prohibition against air transport of a Samsung Galaxy Note 7 device, in particular, immediately prior to boarding.

    DATES:

    The Amended Emergency Restriction/Prohibition Order issued on January 9, 2017, by the Secretary of the Department of Transportation and provided in this document is effective on January 10, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Landers, Office of the Chief Counsel, Federal Aviation Administration, 1701 Columbia Ave., College Park, GA 30337; telephone: (404)-305-5200; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The full text of the Amended Emergency Restriction/Prohibition Order No. FAA-2016-9288 issued January 9, 2017, is as follows:

    The Emergency Restriction/Prohibition Order (Order) issued by the United States Department of Transportation (DOT) on October 14, 2016, is hereby amended to remove the requirement for air carriers to alert passengers to the prohibition against air transport of a Samsung Galaxy Note 7 device, in particular, immediately prior to boarding. As discussed herein, DOT is removing this requirement due to the extensive efforts by Samsung and U.S. wireless providers to recall all Samsung Galaxy Note 7 devices and to make users aware the Samsung Galaxy Note 7 device is forbidden from transportation by air, as well as the deployment by major U.S. wireless providers of a software update that will ultimately render the phones inoperable as mobile devices. In addition, the hazardous materials regulations (HMR; 49 CFR parts 171-180) provide a systematic framework to protect the safe transportation of hazardous materials that includes procedures for notification, handling, and reporting of discrepancies and incidents at air passenger facilities and cargo facilities. All other requirements of the Order issued on October 14, 2016, remain in effect and are not impacted by this Amendment. The Order, as amended, reads in full as follows:

    This Amended Emergency Restriction/Prohibition Order (Amended Order) is issued by the DOT pursuant to 49 U.S.C. 5121(d) and will be effective on January 9, 2017. This Amended Order is issued to all persons who transport or offer a Samsung Galaxy Note 7 device for air transportation in commerce within the United States. Individuals who own or possess a Samsung Galaxy Note 7 device may not transport the device on their person, in carry-on baggage, in checked baggage, nor offer the device for air cargo shipment. This prohibition includes all Samsung Galaxy Note 7 devices. Samsung Galaxy Note 7 devices are properly classified as lithium ion batteries contained in equipment, UN3481, Class 9 (49 CFR 172.101).

    By this Amended Order, DOT is:

    * Continuing to prohibit persons from transporting or offering for air transportation a Samsung Galaxy Note 7 device, by either carrying it on their person or in carry-on baggage when boarding an aircraft, placing the Samsung Galaxy Note 7 device in checked baggage, or shipping it via air as cargo;

    * continuing to require air carriers to handle Samsung Galaxy Note 7 devices consistently with other forbidden hazardous materials under title 49 of the Code of Federal Regulations, and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and their baggage, including carry-on and checked, of the Samsung Galaxy Note 7 device;

    * continuing to require that persons who inadvertently bring a Samsung Galaxy Note 7 device onto an aircraft immediately power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight; and

    * continuing to require that if an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

    Upon information derived from the Samsung Galaxy Note 7 device recall under Order issued September 15, 2016, recent incidents of a dangerous evolution of heat with Samsung Galaxy Note 7 replacement devices, Samsung's October 11, 2016, decision to stop manufacturing and selling Samsung Galaxy Note 7 devices due to the inability to identify the root cause of the incidents, and the U.S. Consumer Product Safety Commission (CPSC) recall of all Samsung Galaxy Note 7 devices issued October 13, 2016, the Secretary of Transportation (Secretary) has found an unsafe condition and that an unsafe practice exists and constitutes an imminent hazard to the safety of air transportation. For more detailed information, see “Background/Basis for Order” below.

    Effective January 10, 2017, any Person Identified by This Amended Order

    (1) Shall not transport, nor offer for transportation, via air a Samsung Galaxy Note 7 device. By virtue of the Order issued October 14, 2016, and the CPSC recalls, the Samsung Galaxy Note 7 devices are forbidden for transportation by air. For purposes of this Amended Order, transporting or offering for transportation includes bringing a Samsung Galaxy Note 7 device aboard an aircraft on your person (e.g., in your pocket), bringing a Samsung Galaxy Note 7 device aboard an aircraft in carry-on baggage, offering a Samsung Galaxy Note 7 device in checked baggage, and offering a Samsung Galaxy Note 7 device for air cargo shipment (e.g., FedEx or United Parcel Service).

    (2) Shall ensure that a prohibited Samsung Galaxy Note 7 device inadvertently brought aboard an aircraft is immediately powered off, not used or charged while aboard the aircraft, protected from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and kept on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

    Air Carrier Requirements

    By virtue of the Order issued October 14, 2016, this Amended Order, and the CPSC recalls, the Samsung Galaxy Note 7 device is a forbidden hazardous material. In accordance with 49 CFR part 175, air carriers must not accept these devices for air transportation by knowingly permitting a passenger to board an aircraft with a Samsung Galaxy Note 7 device. Damaged or recalled lithium ion batteries, including those contained in equipment, are not permitted to be transported by air, and a Samsung Galaxy Note 7 device is categorized as “forbidden.” 49 CFR 173.21(c). Upon inquiry from a passenger, air carriers are required to make passengers aware of the continuing prohibition against the transportation of Samsung Galaxy Note 7 devices aboard aircraft on their person, in carry on or checked baggage, and in cargo. If an air carrier representative identifies that a passenger is in possession of a Samsung Galaxy Note 7 device prior to boarding the aircraft, the air carrier must deny boarding to the passenger unless and until the passenger divests themselves, including on their person and in checked and carry-on baggage, of the Samsung Galaxy Note 7 device. If an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

    This Amended Order applies to all persons who transport Samsung Galaxy Note 7 devices, or offer them for transportation, by air in commerce (as defined by 49 U.S.C. 5102(1)) to, from, and within the United States, and their officers, directors, employees, subcontractors, and agents. This Amended Order is effective January 10, 2017, and remains in effect unless rescinded in writing by the Secretary, or until it otherwise expires by operation of regulation and/or law.

    Jurisdiction

    The Secretary has the authority to regulate the transportation of lithium ion batteries contained in equipment in commerce. 49 U.S.C. 5103(b). The Secretary has designated lithium ion batteries contained in equipment, UN 3481, as a hazardous material subject to the requirements of the HMR. 49 U.S.C. 5103(a); 49 CFR 172.101. Persons who offer for transportation, or transport, lithium ion batteries contained in equipment by air in commerce to, from, and within the United States are a “person,” as defined by 49 U.S.C. 5102(9), in addition to being a “person” under 1 U.S.C. 1 and a “person who offers” as defined by 49 CFR 171.8. “Commerce” is as defined by 49 U.S.C. 5102(1) and 49 CFR 171.8, and “transportation” or “transport” are as defined by 49 U.S.C. 5102(13) and 49 CFR 171.8. Accordingly, persons who transport or offer for transportation lithium ion batteries contained in equipment in commerce, including by air, are subject to the authority and jurisdiction of the Secretary including the authority to impose emergency restrictions, prohibitions, recalls, or out-of-service orders, without notice or an opportunity for hearing, to the extent necessary to abate the imminent hazard. 49 U.S.C. 5121(d).

    Background/Basis for Order

    An imminent hazard, as defined by 49 U.S.C. 5102(5), constitutes the existence of a condition relating to hazardous materials that presents a substantial likelihood that death, serious illness, severe personal injury, or a substantial endangerment to health, property, or the environment may occur before the reasonably foreseeable completion date of a formal proceeding begun to lessen the risk that death, illness, injury or endangerment may occur.

    A Samsung Galaxy Note 7 device may cause an ignition or a dangerous evolution of heat or become a fuel source for fire. Samsung and CPSC acknowledged this fact with the September 15, 2016 recall, Samsung's October 11, 2016 announcement that it was suspending the manufacture and sale of the Samsung Galaxy Note 7 device, and the October 13, 2016 Samsung and CPSC expanded recall covering all Samsung Galaxy Note 7 devices. Furthermore, persons have experienced incidents of dangerous evolution of heat with the recalled Samsung Galaxy Note 7 devices. Just one fire incident poses a high risk of death, serious illness, severe personal injury, and danger to property and the environment. This risk is magnified when the fire or evolution of heat occurs aboard an aircraft during flight. Therefore, each offering and transportation of a Samsung Galaxy Note 7 device constitutes an imminent hazard.

    A. Samsung Galaxy Note 7 Recall and Incidents

    On September 15, 2016, Samsung and the CPSC recalled certain Samsung Galaxy Note 7 devices sold prior to September 15, 2016. The recall was based on a finding that the lithium ion battery in a Samsung Galaxy Note 7 device “can overheat and catch fire.” Samsung offered either a refund or replacement Samsung Galaxy Note 7 device. Subsequently, there were reported incidents of the replacement Samsung Galaxy Note 7 devices overheating and/or catching fire. In a decision announced on October 11, 2016, Samsung stopped production and sale of Samsung Galaxy Note 7 devices. On October 13, 2016, Samsung and the CPSC expanded the recall to include all Samsung Galaxy Note 7 devices because they “can overheat and catch fire.” On December 9, 2016, Samsung reported that it would release a software update starting on December 19, 2016 that would prevent U.S. Samsung Galaxy Note 7 devices from charging and eliminate their ability to work as mobile devices.

    B. DOT Actions To Mitigate the Safety Risk of Samsung Galaxy Note 7 Devices in Air Transportation

    In the wake of Samsung Galaxy Note 7 device incidents, the Federal Aviation Administration (FAA) and Pipeline and Hazardous Materials Safety Administration (PHMSA) have taken a number of steps to mitigate the safety risk of Samsung Galaxy Note 7 devices in air transportation. On September 8, 2016, the FAA issued a statement strongly advising passengers not to turn on or charge a Samsung Galaxy Note 7 device aboard an aircraft, nor stow a Samsung Galaxy Note 7 device in any checked baggage. On September 15, 2016, PHMSA issued a Safety Advisory Notice to inform the public about the risks associated with transporting damaged, defective, or recalled lithium batteries or portable electronic devices, including the Samsung Galaxy Note 7 device recalled by the CPSC. The Safety Advisory Notice required that persons who wish to carry the recalled Samsung Galaxy Note 7 device aboard an aircraft must (1) turn off the device; (2) disconnect the device from charging equipment; (3) disable all applications that could inadvertently activate the phone; protect the power switch to prevent its unintentional activation; and (4) keep the device in carry-on baggage or on your person.

    On September 16, 2016, the FAA issued general guidance to airlines about the rules for carrying recalled or defective lithium batteries and lithium battery-powered devices aboard an aircraft. Specifically, the FAA noted that (1) U.S. hazardous materials regulations prohibit air cargo shipments of recalled or defective lithium batteries and lithium battery-powered devices; (2) passengers may not turn on or charge the devices when they carry them aboard the aircraft; (3) passengers must protect the devices from accidental activation; and (4) passengers must not pack them in checked baggage. On September 16, 2016, the FAA issued a Safety Alert for Operators (SAFO), recommending the following action by air operators: (1) Ensure that operator personnel responsible for cargo processing know and understand that damaged or recalled lithium batteries—including those installed in equipment and devices—are forbidden on aircraft as air cargo; and (2) ensure that operator personnel responsible for passenger processing and cabin safety know and understand that damaged or recalled lithium batteries—including those installed in devices—may be restricted from carriage or use on the aircraft. On October 10, 2016, the FAA issued updated guidance on the Samsung Galaxy Note 7 device, urging passengers aboard an aircraft to power down and not use, charge, or stow in checked baggage, any Samsung Galaxy Note 7 device.

    Notwithstanding the above DOT actions, and in light of continued risks identified by Samsung and CPSC associated with Samsung Galaxy Note 7 devices, on October 14, 2016, DOT issued the Order to forbid transport of Samsung Galaxy Note 7 devices by air transportation in commerce within the United States. The Order outlined remedial action required, which remains unchanged in this Amended Order except for the requirement for air carriers to alert passengers to the prohibition against air transport of the Samsung Galaxy Note 7 device, in particular, immediately prior to boarding. Since the issuance of the Order, DOT has determined that the remedial action of air carriers alerting passengers to the prohibition against air transport of the Samsung Galaxy Note 7 device, in particular, immediately prior to boarding is no longer warranted, due to the extensive efforts by Samsung and U.S. wireless providers to recall all Samsung Galaxy Note 7 devices and to make users aware the Samsung Galaxy Note 7 device is forbidden from transportation by air. Moreover, on December 9, 2016, Samsung reported on its Web site that more than 93 percent of all recalled Samsung Galaxy Note 7 devices had been returned to Samsung and that it would release a software update starting on December 19, 2016 that would prevent U.S. Samsung Galaxy Note 7 devices from charging and eliminate their ability to work as mobile devices.1 We understand that major U.S. wireless providers will push out this update on or before January 8, 2017. T Mobile reported that it would push the software update on December 27, 2016.2 Verizon Wireless and AT&T both reported that they would push the software update on January 5, 2017,3 and Sprint reported that it would push the update on January 8, 2017.4 We think that these efforts to render U.S. Samsung Galaxy Note 7 devices inoperable, in addition to the ongoing recall and notification efforts, will decrease the likelihood that Samsung Galaxy Note 7 devices will be brought on board aircraft. In addition, the hazardous materials regulations (HMR; 49 CFR parts 171-180) provide a systematic framework to protect the safe transportation of hazardous materials that includes procedures for notification, handling, and reporting of discrepancies and incidents at air passenger facilities and cargo facilities.

    1https://news.samsung.com/us/2016/12/09/samsung-taking-bold-steps-to-increase-galaxy-note7-device-returns/; see also http://www.samsung.com/us/note7recall/.

    2https://explore.t-mobile.com/samsung-galaxy-note7-recall.

    3https://www.verizonwireless.com/support/samsung-galaxy-note7-recall-faqs/; https://www.att.com/esupport/article.html#!/wireless/KM1122948.

    4https://support.sprint.com/support/article/FAQs-about-the-Samsung-Galaxy-Note7-recall/817d4190-b2e2-43c8-b549-97b3553d5c24.

    Remedial Action

    To eliminate or abate the imminent hazard:

    (1) Persons covered by this Amended Order shall not transport, nor offer for transportation, via air any Samsung Galaxy Note 7 device.

    (2) Air carriers are required to handle Samsung Galaxy Note 7 devices consistently with other forbidden hazardous materials under 49 CFR parts 173 and 175, and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and carry-on or checked baggage of the Samsung Galaxy Note 7 device.

    (3) Persons covered by this Amended Order who inadvertently bring a prohibited Samsung Galaxy Note 7 device aboard an aircraft must immediately power off the device, leave it powered off until no longer aboard the aircraft, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

    (4) When a flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

    Rescission of This Amended Order

    This Amended Order remains in effect until the Secretary determines that an imminent hazard no longer exists or a change in applicable statute or federal regulation occurs that supersedes the requirements of this Amended Order, in which case the Secretary will issue a Rescission Order.

    Failure To Comply

    Any person failing to comply with this Amended Order is subject to civil penalties of up to $179,933 for each violation for each day they are found to be in violation (49 U.S.C. 5123). A person violating this Order may also be subject to criminal prosecution, which may result in fines under title 18, imprisonment of up to ten years, or both (49 U.S.C. 5124).

    Right To Review

    Pursuant to 49 U.S.C. 5121(d)(3) and in accordance with section 554 of the Administrative Procedure Act (APA), 5 U.S.C. 500 et seq., a review of this action may be filed. Any petition seeking relief must be filed within 20 calendar days of the date of this order (49 U.S.C. 5121(d)(3)), and addressed to U.S. DOT Dockets, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590 (http://Regulations.gov). Furthermore, a petition for review must state the material facts at issue which the petitioner believes dispute the existence of an imminent hazard and must include all evidence and exhibits to be considered. The petition must also state the relief sought. Within 30 days from the date the petition for review is filed, the Secretary must approve or deny the relief in writing; or find that the imminent hazard continues to exist, and extend the original Emergency Order. In response to a petition for review, the Secretary may grant the requested relief in whole or in part; or may order other relief as justice may require (including the immediate assignment the case to the Office of Hearings for a formal hearing on the record).

    Emergency Contact Official

    If you have any questions concerning this Amended Emergency Restriction/Prohibition Order, you should call PHMSA Hazardous Materials Information Center at 1-800-467-4922 or email at [email protected]

    Issued in Washington, DC, on January 9, 2017. Reginald C. Govan, Chief Counsel, Federal Aviation Administration.
    [FR Doc. 2017-00555 Filed 1-9-17; 4:15 pm] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2014-N-0440] Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

    DATES:

    This order is effective February 13, 2017. See further discussion in section IV, “Implementation Strategy.”

    FOR FURTHER INFORMATION CONTACT:

    Stefanie Akselrod, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5438, Silver Spring, MD 20993-0002, 301-796-6188.

    SUPPLEMENTARY INFORMATION:

    I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments on May 28, 1976 (generally referred to as preamendments devices) are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

    Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as “postamendments devices”), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval.

    Under section 513(i) of the FD&C Act, a device is substantially equivalent if it has the same intended use and technological characteristics as a predicate device, or has the same intended use as the predicate device and has different technological characteristics, but data demonstrate that the new device is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness than the predicate device. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification (510(k)) procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device.

    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order. Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify an eligible device type. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. See, e.g., Holland-Rantos Co. v. U.S. Dep't of Health, Educ., and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).

    Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority. See Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-91 (D.D.C. 1991), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) of the FD&C Act must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). See, e.g., Gen. Med. Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Ass'n. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1986).

    Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device under that section. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. FDA published a proposed order to reclassify this device type in the Federal Register of May 22, 2014 (79 FR 29387). FDA has held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to antigen based rapid influenza diagnostic test (RIDT) systems and has also received and considered comments on the proposed order, as discussed in section II. Therefore, FDA has met the requirements under section 513(e)(1) of the FD&C Act.

    II. Public Comments in Response to the Proposed Order

    On May 22, 2014, FDA published a proposed order to reclassify antigen based RIDTs intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents under § 866.3330 (21 CFR 866.3330) from class I into class II with special controls and into a new device classification regulation (79 FR 29387).

    The Agency received comments on the proposed order from several entities. Comments were received from device industry manufacturers, a consumer group, professional organizations, a health care organization, a device manufacturers association, and an individual consumer.

    To make it easier to identify comments and our responses, the word “Comment” and a comment number appear in parentheses before each comment's description, and the word “Response” in parentheses precedes each response. Similar comments are grouped together under the same number. Specific issues raised by the comments and the Agency's responses follow.

    A. General Comments

    (Comment 1) Commenters expressed support for the proposed order to reclassify antigen based RIDTs from class I to class II with special controls, noting that there is evidence that the currently available antigen based RIDTs, which are widely used in non-clinical laboratory settings such as physician office laboratories, are performing poorly, resulting in many misdiagnosed cases of influenza. Commenters noted that a misdiagnosis of influenza may have serious consequences, including: Inappropriate use of antibiotics and failure to use antiviral therapy, which may be critical for some patients, following false negative results; the unnecessary or inappropriate prescribing of antiviral drugs following false positive results; ineffective infection control measures; and an overall increased public health burden, such as increased rate of hospitalization and return doctor visits. Several commenters expressed a concern regarding frequent antigenic changes in the circulating strains as the influenza virus evolves and agreed with the new requirement that manufacturers conduct annual analytical testing of circulating strains in an effort to monitor the performance of these tests over time. Overall, there was a general consensus among the commenters that the proposed special controls address and mitigate the risks to health.

    (Response) FDA agrees that reclassification of antigen based RIDTs into class II as outlined in this order will help to improve the overall quality of testing for influenza. The new minimum performance requirements for these tests detecting influenza virus antigens are expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus. In addition, the special controls requiring annual and emergency analytical reactivity testing provide a process for continued monitoring of the performance of antigen based RIDTs. As part of that process, the Centers for Disease Control and Prevention (CDC) and FDA will collaborate in efforts to ensure that there is an influenza virus analytical reactivity test panel available to all manufacturers of antigen based RIDTs for evaluation of the analytical reactivity of their assays with circulating viruses on an annual basis.

    (Comment 2) One commenter noted that under the FD&C Act, as amended by FDASIA, FDA is able to reclassify a device via an “order rather than rulemaking,” but the commenter expressed a concern that FDA seems to consider holding a panel meeting after the issuance of a proposed order as “discretionary rather than mandatory.” The commenter urged FDA to hold panel meetings after the issuance of proposed reclassification orders in order to allow the panel to discuss the proposal after it has been issued. The commenter stated that holding a panel meeting following issuance of a proposed reclassification order is a critical element of the process reforms enacted by Congress. In addition, the commenter expressed a concern that the Agency has not obtained sufficient feedback from physicians who commonly use the rapid influenza tests in their practice. Therefore, the commenter suggested that FDA should convene another panel meeting and include these physicians to provide critical expertise and perspective on the overall evaluation of FDA's proposed plans on test reclassification, including the analytical reactivity testing protocol, specifications, and qualification of specimens.

    (Response) The June 13, 2013, Microbiology Advisory Panel (“Panel”) meeting considered all relevant scientific issues associated with the proposed order for the antigen based RIDTs and recommended reclassifying these devices into class II (special controls). The Panel included six physicians and seven researchers who provided input that FDA considered for purposes of the proposed order, including the proposed special controls. Each of the Panel members is considered an authority on matters of influenza infection, treatment, epidemiology, and/or biology. Representatives from CDC and the Association of Public Health Laboratories presented extensive data on the use of the currently available antigen based RIDTs and the outcomes related to patients that support the conclusion that there has been poor performance of antigen based RIDTs in the medical practice. The Panel recommended the reclassification of antigen based RIDTs. FDA is not aware of any significant changes in benefits or risks relating to the antigen based RIDTs that have been identified since the June 13, 2013, Panel meeting. Stakeholders had an opportunity to provide feedback to the proposed order in their comments, and that feedback has been largely positive. The public comments are addressed here and are also available to view by request or on https://www.regulations.gov.

    The process followed by FDA in reclassifying antigen based RIDTs is in accordance with the applicable statutory provisions, which were amended by FDASIA. Section 608 of FDASIA amended section 513(e) of the FD&C Act by changing the reclassification process from rulemaking to an administrative order process. The amendments to section 513(e) of the FD&C Act made by FDASIA require, in relevant part, that issuance of an administrative order reclassifying a device be preceded by a proposed order and a meeting of a device classification panel.

    As amended, section 513(e) of the FD&C Act does not prescribe when these two events (the panel meeting and proposed order) must occur in relation to each other. Therefore, under this provision, the Agency may hold a panel meeting either before or after the issuance of a proposed reclassification order. This approach is consistent with the prior panel provision in section 513(e) of the FD&C Act, which provided for FDA, at its discretion, to secure a panel recommendation prior to the promulgation of a reclassification rule. Generally, for future reclassifications under section 513(e) of the FD&C Act for which a meeting of a device classification panel has not yet occurred, FDA expects a proposed reclassification order will be issued prior to the panel meeting required under section 513(e).

    B. Transition Period

    (Comment 3) While one commenter expressed agreement that the proposed 1 year timeframe should be sufficient for manufacturers to bring devices already on the market into compliance with the special controls, another commenter suggested that FDA consider providing additional transition time for the implementation of the final order. The commenter suggested that this would assist manufacturers who are working in good faith to meet the new requirements to prepare submissions in advance of the influenza season and would provide for product continuity among health care providers. The commenter did not identify why 1 year would be an insufficient period of transition time.

    (Response) The Panel recommended and FDA made the determination that special controls, including the new minimum performance requirements, are needed, in addition to general controls, to provide reasonable assurance of safety and effectiveness for antigen based RIDTs. We, therefore, do not believe, given the risk that poor performance of antigen based RIDTs pose to public health, a delay in implementation of more than 1 year is appropriate. FDA also understands the need for a balanced approach that takes into account the time it will take for manufacturers to come into compliance with the special controls and seeks to avoid disruption of access to these devices. With these considerations in mind, FDA believes that a period of 1 year from the publication date of this final order is appropriate for manufacturers to come into compliance with the special controls and for those manufacturers whose currently legally marketed devices do not meet the minimum performance criteria to prepare and submit a 510(k) for a new or significantly changed or modified device. Therefore, FDA does not intend to enforce compliance with the special controls with respect to currently legally marketed antigen based RIDT devices until 1 year after the date of publication of this final order. FDA believes this approach will help ensure the efficient and effective implementation of the final order.

    C. Clinical Performance Standards and Comparator Methods

    (Comment 4) One comment recommended a transition to one common reference method comparator: A molecular nucleic acid-based method. The reasons cited for this recommendation included: (1) A level playing field for all manufacturers and (2) better clarity for users, industry, and the Agency. Another comment raised concerns about the unreliability of the culture results due to non-standardized culture practices. In addition, a commenter cautioned that providing two minimum performance standards, one when compared to viral culture and another when compared to a nucleic acid-based method, may have unintended consequences: (1) Users may make false assumptions and choose a method based strictly on the presented estimates of sensitivity and specificity without noting the comparator reference method that was used to derive the performance measures and (2) manufacturers may elect to conduct the method comparison using both types of reference methods and submit the results in support of a 510(k) even if only one of the comparisons meets the minimum performance bar.

    (Response) FDA appreciates the concern over the potential consequences of allowing for the two performance levels based on different comparator methods. The Agency carefully considered the public feedback as well as the implications of eliminating the viral culture comparator method as an acceptable comparator method used in the evaluation of clinical performance of antigen based RIDTs. Some important considerations were: (1) A lack of standardization of viral culture methods among various laboratories, (2) an increasing difficulty in procuring the services of a laboratory that is equipped to perform viral culture procedures, (3) the wide availability of FDA-cleared nucleic acid-based comparator methods among laboratories, (4) the demonstrated high sensitivity of the nucleic acid-based methods when compared to viral culture method (when properly performed) for the detection of the influenza viruses, and (5) the reliability of the viral culture method when performed properly.

    In addition, we recognize that performance evaluation based on two different comparators where each detects a different analyte (viral culture methods detect viable virus particles while nucleic acid-based methods detect the viral ribonucleic acids) requires two sets of performance criteria resulting in performance measures that may not allow for direct comparison between some devices. However, viral culture method, when performed correctly, has been shown historically to be accurate and remains a valid reference method for the detection of influenza viruses. There are many influenza detecting devices currently on the market that have been evaluated based on comparison with viral culture comparator methods and met the performance criteria set forth in § 866.3328(b)(1)(ii) (21 CFR 866.3328). FDA has also stated expressly in the special controls that a viral culture comparator method used to demonstrate that a device meets the minimum performance criteria at § 866.3328(b)(1)(ii) must be correctly performed.

    At this time, the only currently appropriate and FDA accepted comparator methods are: (1) An FDA-cleared nucleic acid-based test or (2) a correctly performed viral culture method. However, FDA recognizes that a comparator method at least as accurate as FDA-cleared nucleic acid-based tests in the detection of the influenza viruses may be established in the future. Based on that recognition and the available information, the final order clarifies that other comparator methods, if currently appropriate and FDA accepted, could be used to demonstrate that the performance criteria requirements in § 866.3328(b)(1)(i) have been met. Therefore, if FDA determines at some point in the future that another comparator method at least as accurate as FDA-cleared nucleic acid-based tests has been established as a currently appropriate comparator method, sponsors of premarket submissions for antigen based RIDTs would have the option of demonstrating that their devices meet the minimum performance criteria at § 866.3328(b)(1)(i) based on a comparison to that additional currently appropriate and FDA-accepted comparator method.

    (Comment 5) Another commenter cautioned that the performance estimates shown in the package inserts for these tests may be biased due to the fact that the data have been generated under closely controlled clinical trial procedures that use optimal sample types, a time of sample collection post onset of symptoms, proper sample storage, and time to testing. Because these conditions are often not maintained in daily clinical use, the true performance of these assays in “real life” settings may be different.

    (Response) FDA acknowledges that the performance data in the device labeling are estimates. All assays are subject to variation under real-life circumstances when the assays are used in clinical practice. However, FDA believes that premarket studies demonstrating performance for these devices should include a variety of testing sites representative of the settings in which the device will be used and that a sufficient number of clinical specimens should be tested to arrive at reasonable measures of confidence in the calculated performance estimates (i.e., the lower bound of the two-sided 95 percent confidence interval (calculated by the Score method)), as outlined in the guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm079171.htm) (“2011 Influenza Guidance document”).

    (Comment 6) One commenter suggested that the proposed sensitivity criteria for influenza A for antigen based RIDTs, when using a molecular method as a comparator method, are less stringent than those recorded in the 2011 Influenza Guidance document. The commenter stated that it:

    [I]s not clear . . . why the Special Controls for comparison to a molecular method has become less stringent (sensitivity/PPA estimate for Influenza A reduced from a point estimate of 90 percent with a 95 percent CI lower bound of 80 percent, to a point estimate of 80 percent with a 95 percent CI lower bound of 70 percent) when the intention of a Special Controls document would presumably be thought to make comparative criteria tighter overall.

    The commenter made a reference to the statement in section 9.B.iii, pages 26-27 of the 2011 Influenza Guidance document (3d bullet), that states: “Nucleic acid-based tests should demonstrate at least 90% sensitivity for each analyte and each specimen type with a lower bound of the two-sided 95% CI greater than 80%.” The commenter also questioned whether this determination was discussed and used to scientifically justify the different criteria for sensitive molecular methods, including polymerase chain reaction, which detect inactive virus in the absence of viable viral particles in a sample, and for viral detection in general when using a molecular comparative method.

    (Response) The quoted statement from the 2011 Influenza Guidance document refers to the performance of nucleic acid-based devices, while the performance criteria stated in the May 22, 2014, proposed order (79 FR 29387 at 29390) (Section VIII. Special Controls: . . . If the manufacturer chooses to compare the device to an appropriate molecular comparator method: The positive percent agreement for the device when testing for Influenza A and Influenza B must be at least at the 80 percent point estimate with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent) refer to RIDTs based on antigen detection, which are historically known to have a more limited sensitivity due to the properties of the enzyme immunoassay (EIA) technology. The relevant citation pertaining to the performance of the rapid devices detecting influenza virus antigens may be found in section 9.B.iii, pages 26-27 (1st and 2d bullet) of the 2011 Influenza Guidance document, which states:

    For rapid devices detecting influenza A virus antigen, we recommend that you include a sufficient number of prospectively collected samples for each specimen type claimed to generate a sensitivity result with a lower bound of the two-sided 95% CI greater than 60%. . . . For rapid devices detecting influenza B virus antigen, we recommend that you include a sufficient number of samples for each claimed specimen type to generate a result for sensitivity with a lower bound of the two-sided 95% CI greater than 55%.

    Nucleic acid-based assays that test for influenza are regulated under § 866.3980, Respiratory viral panel multiplex nucleic acid assay, and have been held to higher performance criteria than antigen based RIDTs because of their demonstrated ability to reach higher sensitivity for viral detection. By establishing special controls with minimum performance criteria for antigen based RIDTs, this final order raises the required minimum performance criteria for viral detection by the EIA based tests beyond the recommendations set forth in the 2011 Influenza Guidance Document. Nucleic acid-based tests continue to be subject to the document entitled “Class II Special Controls Guidance: Respiratory Viral Panel Multiplex Nucleic Acid Assay” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm180307.htm), except when the device detects and differentiates Influenza A subtype H1 and subtype H3, in which case they are also subject to the document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays” (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm180310.pdf).

    (Comment 7) One commenter criticized FDA for providing no specifications for how to design a clinical performance study for antigen based RIDT systems in terms of the proportion of samples that should be presented for each age group. In addition, the comment suggested that the performance estimates of different devices presented in their package inserts may be biased due to the actual proportions of age groups in the study (i.e., children vs. adults) and may not be truly reflective of the performance in the population overall. The commenter further suggested that the number of positive samples as well as sensitivity and specificity (or positive percent agreement (PPA)/negative percent agreement (NPA)) for each age group be presented in each device's Instructions for Use to ensure transparency.

    (Response) FDA's current recommendations for appropriate study design can be found in the 2011 Influenza Guidance document, where section 9.B.ii mentions that there should be a representative number of positive samples (determined by the reference method) from each age group and [the data should be presented] stratified by age (e.g., pediatric populations aged birth to 5 years, 6 to 21 years, . . . adults aged 22-59, and greater than 60 years old) in addition to the overall data summary table.

    In addition, the 2011 Influenza Guidance document recommends diversifying the location of the selected clinical sites and the anticipated prevalence of influenza at the time of the study. Depending on the site selection, the age composition of the subjects will vary, but it is difficult to predict the different age groups at the outset of a study. FDA evaluates assay performance estimates stratified by age groups and determines whether the performance among different age groups is similar before making the final decision regarding 510(k) clearance. FDA encourages sponsors to use the pre-submission program to discuss the premarket submission strategy and study design for their specific devices. The pre-submission program is described in the guidance document titled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” found on FDA's Web site at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

    (Comment 8) A commenter also suggested that the proposed special controls do not clearly state that data demonstrating that a device meets the clinical performance criteria be obtained using prospective, fresh samples and that this may be easily remedied by adding a statement in the final special controls document indicating that “clinical performance studies should be carried out on fresh, prospective samples.”

    (Response) The 2011 Influenza Guidance Document, in section 9.B.iii Specimens, on p. 27, states that: “[w]e recommend that you assess the ability of your device to detect influenza viruses in fresh specimens collected from patients suspected of having an influenza infection who have been sequentially enrolled in the study (all-comers study)”. The guidance further states that “[f]rozen archived specimens may be useful for analytical performance evaluations, but are not recommended for studies to calculate clinical sensitivity or specificity”.

    As the incidence of influenza varies from year to year and also from region to region, testing of archived specimens may be acceptable where fresh positive specimens are difficult to obtain. Performance data obtained from testing retrospective archived samples are generally evaluated and presented separately from data obtained with prospectively collected specimens in the final device labeling.

    (Comment 9) A further recommendation was made that the proposed special controls include explicit wording to clarify that clinical performance criteria must be met for each sample type claimed in the proposed labeling submitted for clearance.

    (Response) FDA agrees with this recommendation. The proposed special controls have been modified to clarify that clinical performance criteria must be met for each specimen type claimed in the intended use of the device.

    (Comment 10) One commenter asserted that the proposed acceptance criteria for devices choosing to use viral culture as a comparator have been determined using certain generalizations that can confound the data. Referring to the Executive Summary document prepared for the Panel meeting (Ref. 1), the commenter states that, for example, all sample types and age ranges were included in the overall presentation of sensitivity for various devices. The commenter objected that the performance criteria, as presented in the Executive Summary document, appear to have been subjectively defined. The commenter further suggested that the purpose of tables 1 and 2 in the Executive Summary was to imply that any device cleared prior to 2008 is assumed to have variable and unacceptable performance, and that the performance criteria for antigen based RIDTs were chosen specifically with the intention of removing those devices from use. Additionally, the commenter stated that the information, as presented in the publicly available Executive Summary, did not make it clear that the data were confounded and created an unfair marketing advantage for some manufacturers.

    (Response) The summary data tables presented in the Executive Summary document submitted to the Panel in June 2013 were compiled to illustrate the range in clinical performance among the antigen based RIDTs available on the market in support of the reclassification effort and were not aimed to remove devices cleared before 2008 from the market, as the commenter suggests. The data for each assay presented in table 1 in the Executive Summary document were based on the information provided to FDA in support of the 510(k) submissions for those devices and included results from all prospectively collected samples during the clinical study conducted by the manufacturer, regardless of the specimen type or the age of the patient (Ref. 1). The information in this table shows a wide range of assay performances.

    The data presented in table 2 in the Executive Summary document were intended to illustrate the even broader range in sensitivity of these assays as reported in the scientific literature and derived from postmarket studies conducted in the field. The data in table 2 were also based on combined results, regardless of sample type, patient age and even influenza virus type. Although the commenter may consider the data “confounded,” they were not meant to demonstrate statistical validity but rather to illustrate that some of the currently available antigen based RIDTs have clinically poor sensitivity even under the controlled conditions of a clinical study conducted in support of a regulatory submission. More importantly, the clinical performance of these assays in the field, as reported in peer reviewed publications, is considerably worse for some of these assays than was demonstrated in the studies submitted to FDA to support their clearance. Overall, the data contained in the two tables were intended to help illustrate the sensitivity of the antigen based RIDTs available on the market, taking into consideration the limitations of the available technology. The data presented in both tables in the Executive Summary document support that improved influenza detection devices are needed to benefit public health in detection, treatment, and infection control with regard to the influenza viruses.

    (Comment 11) Some commenters inquired about the process for notifying manufacturers that their assays do not meet the new performance criteria and expressed concern that manufacturers should be allowed sufficient transition time to develop new or modified influenza detection devices and to submit new 510(k)s for those products.

    (Response) A manufacturer will not be individually notified that its product does not comply with the new special controls; each manufacturer of an antigen based RIDT is responsible for compliance with these special controls, including the minimum performance criteria. If an antigen based RIDT device does not meet the new performance criteria set forth in this final order, the device may be considered adulterated under section 501(f)(1)(B) of the FD&C Act (21 U.S.C. 351(f)(1)(B)), and manufacturers must cease marketing of the device. However, as outlined in section IV, “Implementation Strategy,” FDA does not intend to enforce compliance with the special controls with respect to currently legally marketed antigen based RIDT devices until 1 year after the date of publication of this final order. A manufacturer may contact the Center for Devices and Radiological Health's (CDRH) Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) with any specific questions.

    (Comment 12) One commenter inquired whether there will be an appeals mechanism for manufacturers and what specific steps would be available for manufacturers.

    (Response) No new appeals mechanisms will be implemented for those manufacturers whose assays do not comply with the new special controls. However, there are processes available to outside stakeholders to request additional review of decisions or actions by the CDRH. For more information, see the FDA guidance document entitled “Center for Devices and Radiological Health Appeals Processes—Guidance for Industry and Food and Drug Administration Staff” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm284651.htm).

    D. Annual Analytical Reactivity Testing 1. Access to Strains

    (Comment 13) Commenters expressed concerns about whether all manufacturers, regardless of their size or resources, will have equal access to the samples needed to conduct the annual analytical reactivity testing in compliance with the new special controls. One of the commenters noted that there may be challenges to specimen access for some manufacturers under the World Health Organization (WHO) Pandemic Influenza Preparedness (PIP) Framework as well as potential impact on accessing the influenza strains sourced by the WHO Global Influenza Surveillance and Response System (GISRS). The commenter asked if manufacturers required to perform the annual testing would need to participate in the PIP framework to access GISRS specimens. The commenter further stated that unless all companies are able to access specimens in a fair, timely and non-cost restrictive manner to comply with the new postmarket requirements, some innovators may be unable to continue to develop new influenza diagnostics.

    (Response) CDC intends to make available an annual analytical reactivity test panel, which is an annual standardized seasonal influenza virus test panel, so that manufacturers can comply with the annual analytical reactivity testing requirement. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains. The selection of viruses in the CDC annual analytical reactivity test panels is expected to be largely based on the strains selected by WHO for the annual vaccine and will be distributed for annual analytical reactivity testing or analytical validation in support of new 510(k) submissions for antigen based RIDT devices. We expect that the panel will primarily consist of human viruses that circulated in the recent influenza seasons. FDA and CDC do not believe that manufacturers will need to enter agreements under the PIP Framework to access influenza viral strains in the manner described in this final order for the sole purpose of conducting testing to comply with the special controls at § 866.3328(b)(3) and (4). The annual analytical reactivity test panel will be made available to manufacturers at the same time, including those that require it for the annual analytical reactivity testing as well as those who are developing new or modified influenza assays. CDC and FDA are committed to facilitating equal access for manufacturers to the annual analytical reactivity test panel and are prepared to consider any unforeseen circumstances in an equitable manner.

    (Comment 14) Another commenter expressed a concern regarding whether the requisite strain(s) will be made available in sufficient time to allow manufacturers to conduct the studies and have the data available in the labeling or on the manufacturer's Web site within the timeframe specified for both annual and emergency analytical reactivity testing. The comment stated that for most manufacturers, the process of testing and making a change in labeling would take a minimum of 90 days from receipt of samples.

    (Response) Under the new special controls, the results of the last 3 years of annual analytical reactivity testing conducted from the date that the device was given marketing authorization by FDA must be incorporated into the device's labeling in the manner discussed in § 866.3328(b)(3)(iii) by July 31 of each calendar year. CDC and FDA are committed to making available or designating an alternative source for the annual analytical reactivity test panel with sufficient time for all manufacturers to conduct the testing and include the results in their device's labeling within the required timeframe.

    Similarly, in the case of emergency analytical reactivity testing, as described in the special controls at § 866.3328(b)(4), after CDC makes the viral samples available for testing, FDA will notify the manufacturers of the availability of the samples. The manufacturers will have 60 days to perform the testing of the viral samples and to incorporate the results into the device's labeling in the manner discussed in § 866.3328(b)(4)(ii). If a manufacturer is concerned about meeting these timelines due to time needed to amend device labeling that physically accompanies the device, the manufacturer may pursue the § 866.3328(b)(3)(iii)(B) and (b)(4)(ii)(B) alternatives, which allow manufacturers to provide the results as electronic labeling via the manufacturer's public Web site that can be reached via a hyperlink found in the device's label or in other labeling that physically accompanies the device. If a manufacturer chooses the option to post analytical reactivity testing results on its Web site, it would be subject to the requirements of section 502(f) of the FD&C Act (21 U.S.C. 352(f)) that provides that required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means as long as the labeling complies with the law, and that the manufacturer affords users the opportunity to request the labeling in paper form, and that after a request, promptly provides the requested information without additional cost.

    If a manufacturer provides the hyperlink to a public Web site at which annual analytical reactivity and emergency testing data may be viewed, generally no updates would be needed to the labeling that physically accompanies the device when meeting the annual analytical reactivity testing requirements under § 866.3328(b)(3) or the emergency analytical reactivity testing requirements under § 866.3328(b)(4). If annual or emergency analytical reactivity testing reveals that the device is unable to detect one or more strains, the manufacturer would need to include a limitation in the device labeling, as further discussed in our response to Comment 21.

    2. Acquisition of the Annual Analytical Reactivity Test Panel and Reporting of Results

    (Comment 15) Commenters expressed concern about the logistics of the implementation of the new requirement for the annual analytical reactivity testing. One commenter stated that a clear mechanism was not outlined in the proposed order for activities leading to the reporting of results.

    (Response) The activities leading to the reporting of results will include acquisition of the annual analytical reactivity test panel and analytical reactivity testing following the standardized protocol included with the test panel, which will be a standardized protocol considered and determined by FDA to be acceptable and appropriate. Results must be reported by updating the device's labeling in accordance with § 866.3328(b)(3)(iii). As previously stated, CDC and FDA are committed to working with the manufacturers of the influenza tests to facilitate timely and equitable access to the influenza virus annual analytical reactivity test panel. CDC has developed a Web site (http://www.cdc.gov/flu/dxfluviruspanel/index.htm) where the manufacturers can affirm their need for the annual analytical reactivity test panel, referred to by CDC as the “CDC Influenza Virus Panel,” to comply with the annual analytical reactivity testing requirement. The CDC panel will be distributed along with certificates of analyses for the viruses and a standardized testing protocol, considered and determined by FDA to be acceptable and appropriate, instructing the user on handling and testing of the provided virus stocks in the test panel. There are currently no plans to post the analytical reactivity testing data generated by the manufacturers on the CDC Web site. For any questions related to the test procedure, manufacturers may contact CDC or FDA as specified in the information included with the influenza virus analytical reactivity test panel. CDC will serve as the contact for questions pertaining to viruses, and FDA will serve as the contact for all regulatory and reporting issues.

    (Comment 16) Commenters expressed concern about the continued availability of the test panel from CDC due to the future potential for limited resources at CDC or FDA.

    (Response) In a case where the influenza virus analytical reactivity test panel is not available from CDC due to unforeseen limitations in resources, an alternate source of influenza strains for use in conducting the annual analytical reactivity testing will be identified by FDA, in consultation with CDC. An example of an alternate source could be a commercial vendor that specializes in acquisition, authentication, production, and preservation of microorganisms.

    (Comment 17) Commenters suggested that the industry should be engaged for feedback in the development of the standardized testing protocol.

    (Response) A standardized protocol has been developed by CDC in consultation with FDA and will be provided to manufacturers with the annual analytical reactivity test panel. The protocol uses basic principles for working with virus stocks and is general enough to allow for use with various devices. For any questions related to the testing procedure, manufacturers can contact CDC or FDA. CDC will serve as the contact for questions pertaining to viruses, and FDA will serve as the contact for all regulatory and reporting issues.

    (Comment 18) One commenter inquired whether the analytical reactivity testing could be conducted using a modified limit of detection (LoD) protocol, where 60 replicates are tested over 3 dilutions with positivity rates between 80 and 99 percent followed by linear regression to calculate the specific concentration that corresponds to a positivity rate of 95 percent.

    (Response) This approach is acceptable to use in the determination of a LoD of an antigen based RIDT assay. However, manufacturers must follow the protocol included with the influenza virus analytical reactivity test panel, which will be a standardized protocol considered and determined by FDA to be acceptable and appropriate. We believe the standardized protocol will be less burdensome than this commenter's proposal and will help ensure that the results generated allow for comparability between different devices, as all devices will have followed a common standardized testing protocol.

    (Comment 19) One commenter asked whether interested manufacturers would have an option to have the testing conducted by an independent laboratory, such as a laboratory at a university.

    (Response) Yes, a manufacturer may contract an outside laboratory to conduct the testing on its behalf.

    (Comment 20) One commenter raised a concern that customers without access to a manufacturer's Web site may not be able to access the annual and/or emergency analytical reactivity testing information; therefore, the commenter suggested that an alternate method of contact should be provided in the product labeling.

    (Response) All in vitro diagnostic devices are required by regulation to state on the label and in the product labeling the name and place of business of the manufacturer, packer, or distributor § 809.10(a)(8) and (b)(14) (21 CFR 809.10(a)(8) and (b)(14)), except where such information is not applicable, or as otherwise specified in a standard for a particular product class.

    In addition, in accordance with § 866.3328(b)(3)(iii) the results of the annual analytical reactivity testing must either be in the § 809.10(b) compliant labeling that physically accompanies the device or be provided as electronic labeling via the manufacturer's public Web site that can be reached via a hyperlink prominently found in the device's label or in other labeling that physically accompanies the device. If the manufacturer chooses the Web site option, it would be subject to the requirements of section 502(f) of the FD&C Act, which provides that required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, as long as the labeling complies with the law, and that the manufacturer affords users the opportunity to request the labeling in paper form, and that after a request, promptly provides the requested information without additional cost. Therefore, a manufacturer is already required to provide an opportunity for a health care professional to request the annual analytical reactivity test results in paper form.

    (Comment 21) One commenter raised a question about notifying the public when a test is non-reactive with any of the strains included in the influenza virus analytical reactivity test panel provided by CDC and whether the product labeling will be updated annually. In particular, the commenter questioned how labeling changes to reflect absence of reactivity would be communicated to users who have already purchased the test.

    (Response) This final order requires that the results of the last 3 years of annual analytical reactivity testing conducted from the date that the device was given marketing authorization by FDA be included as part of the device's labeling by July 31 of each calendar year. Modification of the labeling solely to incorporate analytical reactivity testing results required under § 866.3328(b)(3)(iii) or (b)(4)(ii) can be made without an official submission to FDA. In a case where one or more strains are shown not to be detected by the device during annual analytical reactivity testing under § 866.3328(b)(3) or emergency analytical reactivity testing under § 866.3328(b)(4), the manufacturer will need to include a limitation in the device labeling regarding reactivity with the specific strain(s) that were not detected by the device. Without such a limitation, the device would not meet the labeling requirements of § 809.10(b).

    (Comment 22) One commenter raised a question about whether there will be a guidance document issued on a yearly basis to interpret the results of the analytical reactivity testing for that year.

    (Response) FDA does not intend to issue a guidance document on how to interpret the results of the analytical reactivity testing each year, as the result interpretations are stated in the CDC information sheet that will be distributed with the CDC annual analytical reactivity test panel. The annual analytical reactivity testing is intended to evaluate whether the assay detects each strain included in the annual analytical reactivity test panel; however, that testing does not provide direct information about how the assay performs when used with clinical specimens that are collected directly from patients. Any positive result obtained during analytical reactivity testing performed with the annual influenza virus analytical reactivity test panel, at any viral concentration/dilution, indicates that the assay is reactive with that virus; however, the minimal concentration of the virus that is needed for the detection (assay sensitivity) may vary. Since the difference in analytical reactivity does not necessarily translate into an appreciable difference in performance when testing clinical specimens, it is important to emphasize that the results should not be over-interpreted for clinical purposes.

    (Comment 23) One commenter suggested further collaboration between the Agency and influenza test manufacturers in establishing the regulatory process for implementing the labeling change before a final “Notice to Industry” or other document is published. The commenter further recommended that FDA specify an interactive process, whereby individual manufacturers can seek guidance, particularly if they encounter issues that may impede timely publication of annual and emergency analytical reactivity testing data (e.g., if the matrix used in the preparation of the virus strains in the test panel causes invalid results with a particular device).

    (Response) Interactive communication with manufacturers is common practice among the reviewers and the managers in CDRH. Manufacturers are encouraged to contact CDRH's OIR with questions or about issues related to the new requirements. In addition, the CDRH pre-submission program is designed to allow sponsors the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols, or data requirements prior to making a submission to the Agency.

    E. Timely Testing of Newly Emergent Strains

    (Comment 24) Similar concerns to those surrounding the annual reactivity testing requirement were raised in regard to the emergency testing of emergent strains. In addition, one comment expressed support for specifying a timeline for reporting the results after the samples become available.

    (Response) Section 866.3328(b)(4)(ii) requires that, in certain emergency or potential emergency situations involving an influenza viral strain, the results of analytical reactivity testing with the emerging virus(es) must be made available within 60 days from the date that FDA notifies antigen based RIDT manufacturers that characterized viral samples are available. The results of the influenza emergency analytical reactivity testing must be disclosed in a tabular format in a similar manner as the results of the annual analytical reactivity testing (i.e., either by placing the table directly in the device's § 809.10(b) compliant labeling that physically accompanies the device in the section of the labeling devoted to analytical reactivity testing, or in a section of the device's label or in labeling that physically accompanies the device, by prominently providing a hyperlink to a part of the manufacturer's Web site where the analytical reactivity testing data can be found). As previously discussed, modification of the labeling solely to incorporate annual analytical reactivity testing results under § 866.3328(b)(3)(iii) or emergency analytical reactivity testing results under § 866.3328(b)(4)(ii) can be made without an official submission to FDA. In a case where one or more strains are shown not to be detected by the device during annual analytical reactivity testing under § 866.3328(b)(3) or emergency analytical reactivity testing under § 866.3328(b)(4), the manufacturer will need to include a limitation in the device labeling regarding reactivity with the specific strain(s) that were not detected by the device. Without such a limitation the device would not meet the labeling requirements of § 809.10(b).

    FDA is also clarifying the special controls to be more precise regarding the situations in which emergency analytical reactivity testing is required. Under section 564(a)-(b) of the FD&C Act (21 U.S.C. 360bbb-3(a)-(b)), the Secretary of Health and Human Services (HHS) may authorize the introduction into interstate commerce of a drug, device, or biologic product intended for use in an actual or potential emergency (referred to as “emergency use”) after making a declaration, under section 564(b)(1) of the FD&C Act, that circumstances exist justifying the authorization. Such a declaration must be based on one of the following actions listed at section 564(b)(1)(A)-(D) of the FD&C Act:

    • A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (CBRN) agent or agents;

    • A determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a CBRN agent or agents;

    • A determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents; or

    • The identification of a material threat, by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act, that is sufficient to affect national security or the health and security of U.S. citizens living abroad.

    If one of these four actions that can provide the basis for the Secretary of HHS to make a declaration under section 564(b)(1) of the FD&C Act occurs with respect to an influenza viral strain, then, after being notified that characterized viral samples are available from CDC, antigen based RIDT manufacturers must conduct analytical reactivity testing with those samples and make the results available in their device labeling within the timeframes set forth in § 866.3328(b)(4).

    In addition, the Secretary of HHS may determine under section 319(a) of the PHS Act (42 U.S.C. 247d(a)) that a disease or disorder presents a public health emergency or that a public health emergency otherwise exists. In the event of such a determination under section 319(a) of the PHS Act with respect to an influenza viral strain, then, after being notified that characterized viral samples are available from CDC, antigen based RIDT manufacturers would also need to conduct analytical reactivity testing with those samples and make the results available in their device labeling within the timeframes set forth in § 866.3328(b)(4).

    The final order also modifies the special controls to require that any emergency reactivity test results added to antigen based RIDT device labeling under § 866.3328(b)(4)(ii) remain in the labeling for a period of 3 years. Emerging influenza strains may still be circulating after the statutory actions described under section 564(b)(1)(A)-(D) of the FD&C Act and section 319(a) of the PHS Act have terminated. The change will align the period that emergency analytical reactivity test results must remain in device labeling with the requirement in § 866.3328(b)(3)(iii) that manufacturers provide the last 3 years of annual analytical reactivity testing in the device labeling. FDA believes that this makes the labeling requirements in the special controls more clear and consistent for industry.

    As discussed previously, after reviewing the comments received along with the proposed order and the Panel's recommendations, FDA is making a few clarifications and modifications to the special controls for antigen based RIDTs. These include: (1) Clarifying that clinical performance criteria must be met for each specimen type claimed in the intended use of the device; (2) clarifying that manufacturers of future antigen based RIDT devices may use a currently appropriate and FDA accepted comparator method other than comparison to an FDA-cleared nucleic acid based-test or viral culture methods to demonstrate that those devices meet the clinical performance criteria, if such a comparator method is established; (3) clarifying that a manufacturer choosing to provide analytical reactivity testing results via its public Web site must prominently provide hyperlink to that Web site in the device's label or in other labeling that physically accompanies the device; (4) clarifying the circumstances in which emergency analytical reactivity testing is required under § 866.3328(b)(4); and (5) requiring results of such emergency analytical reactivity testing to remain in the device labeling for a period of 3 years.

    III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order, with the modifications discussed in section II of this final order. FDA is issuing this final order to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents under § 866.3330 from class I into class II with special controls and into a new device classification regulation for “influenza virus antigen detection test systems.” Currently, antigen based RIDTs are mostly found under product codes GNX and GNT. However, any antigen based rapid influenza virus antigen detection test system intended to detect influenza virus antigen directly from clinical specimens that is currently regulated as influenza virus serological reagents under § 866.3330 is subject to this reclassification regardless of the product code to which it is currently assigned.

    Section 510(m) of the FD&C Act provides that a class II device may be exempt from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this device, FDA believes that premarket notification is necessary to provide reasonable assurance of safety and effectiveness. Therefore, this type of device is not exempt from premarket notification requirements.

    In addition, FDA believes that special controls that: (1) Identify the minimum acceptable performance criteria; (2) require use of a currently appropriate and FDA accepted comparator method for establishing performance of new antigen based RIDTs; (3) require annual analytical reactivity testing of contemporary influenza strains; and (4) require analytical reactivity testing of newly emerging strains under certain situations involving an emergency or potential for an emergency, are necessary to provide reasonable assurance of safety and effectiveness of these devices.

    IV. Implementation Strategy

    The special controls identified in this final order are effective February 13, 2017.

    • For antigen based RIDTs that have not been legally marketed prior to February 13, 2017, or that have been legally marketed but are required to submit a 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in this final order, before marketing their new or changed device. If a manufacturer markets such a device after February 13, 2017 without obtaining 510(k) clearance and demonstrating compliance with the special controls included in this final order, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.

    • For antigen based RIDTs that have been legally marketed prior to February 13, 2017, FDA does not intend to enforce compliance with the special controls until January 12, 2018. If a manufacturer markets such a device after January 12, 2018, and that device does not comply with the special controls, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.

    FDA believes that a period of 1 year from the publication date of this final order is appropriate for manufacturers to come into compliance with the special controls and for those manufacturers whose currently legally marketed devices do not meet the minimum performance criteria to prepare and submit a 510(k) for a new or significantly changed or modified device. FDA believes this approach will help ensure the efficient and effective implementation of the order.

    V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this reclassification 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.

    VI. Paperwork Reduction Act of 1995

    This administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 regarding investigational device exemptions have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 and § 809.10 have been approved under OMB control number 0910-0485; and the collections of information regarding pre-submissions have been approved under OMB control number 0910-0756.

    VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act, as amended, requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are codifying the reclassification of antigen based RIDTs into class II (special controls).

    VIII. Reference

    The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://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. Transcript and other meeting materials of FDA's Microbiology Devices Panel Meeting held on June 13, 2013, are available on FDA's Web site at: http://www.fda.gov/AdvisoryCommittees/ucm351035.htm. List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

    PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for part 866 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Add § 866.3328 to subpart D to read as follows:
    § 866.3328 Influenza virus antigen detection test system.

    (a) Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:

    (i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:

    (A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.

    (B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.

    (ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:

    (A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.

    (B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.

    (2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.

    (3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:

    (i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.

    (ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.

    (iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:

    (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or

    (B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

    (4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:

    (i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.

    (ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:

    (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or

    (B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

    Dated: January 4, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-00199 Filed 1-11-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 15 [Docket No. FR-5986-F-01] RIN 2501-AD81 Revision of Freedom of Information Act Regulation AGENCY:

    Office of the Secretary, HUD.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends HUD's Freedom of Information Act (FOIA) regulation to implement the FOIA Improvement Act of 2016. The FOIA Improvement Act enacted a range of procedural issues, including requirements that agencies establish a minimum of 90 days for requesters to file an administrative appeal, and codifies the foreseeable harm standard. In addition, this final rule revises a section of HUD's FOIA regulations to more accurately reflect statutory language.

    DATES:

    Effective Date: February 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Helen Foster, Deputy Chief Administrative Officer, Office of Administration, Department of Housing and Urban Development, 451 7th Street SW., Room 10139, Washington, DC 20410-0500, telephone number 202-402-2671 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number via TTY by calling the toll-free Federal Relay Service at telephone number 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: I. Background

    On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016 (2016 Act) (Pub. L. 114-185, 130 Stat. 538), which contains several substantive and procedural amendments to the Freedom of Information Act (FOIA). The 2016 Act addresses a range of procedural issues, including requirements that agencies establish a minimum of 90 days for requesters to file an administrative appeal, and that agencies provide dispute resolution services at various times throughout the FOIA process. The 2016 Act also codifies a “foreseeable harm” standard, amends Exemption 5 to the FOIA, creates a new Chief FOIA Officer Council within the Executive Branch, and adds two new elements to agency Annual FOIA Reports. The amendments apply to any request made after the date of enactment, which was June 30, 2016.

    Section 3 of the 2016 Act requires agencies to review and issue updated regulations on procedures for the disclosure of records under the FOIA, in accordance with the amendments made by the 2016 Act, within 180 days of enactment. Accordingly, HUD revises its FOIA regulation to incorporate changes enacted by the 2016 Act.

    II. Changes Made in This Final Rule

    The following is an overview of the changes made in this final rule.

    Section 15.101 Proactive Disclosures of Department Records

    The 2016 Act requires agencies to “make available for public inspection in an electronic format” records that, because of their subject matter, the agency determines “have become or are likely to become the subject of subsequent requests for substantially the same records,” or that have been requested 3 or more times. In response, HUD is amending §§ 15.101(a) and 15.101(b)(7) to comply with this requirement. The revisions mirror the language from the 2016 Act.

    The 2016 Act also adds agency reporting requirements for agencies' annual FOIA reports. The 2016 Act requires that a report covering the preceding fiscal year is to be submitted to the Attorney General of the United States and to the Director of the Office of Government Information Services (OGIS). The raw statistical data used in each report must be made available without charge, license, or registration requirement; in an aggregated, searchable format, and in a format that may be downloaded in bulk. Both the report and the raw statistical data used in the report must be made available for public inspection in an electronic format. In response to this requirement, HUD is adding § 15.101(b)(8) in conformance with these new reporting requirements.

    Section 15.103 Timing of Responses to Requests

    When a FOIA request involves “unusual circumstances,” agencies have long been required to provide written notice to the requester, and in those instances where an extension of time of more than ten working days is specified, agencies have been required to provide the requester with an opportunity to limit the scope of the request so that it can be processed more quickly or to arrange an alternative time to respond. The 2016 Act adds an additional requirement when unusual circumstances exist. Specifically, whenever agencies extend the time limits by more than ten additional working days, in the written notice to the requester they must notify the requester of their right to seek dispute resolution services from the OGIS. To address this requirement, HUD is revising § 15.103(c) to incorporate the change enacted by the 2016 Act.

    HUD is also using this final rule to update several specific provisions of § 15.103 to more accurately reflect the statutory language in 5 U.S.C. 552(a)(6)(A)(i). First, HUD is revising § 15.103(a) to state that HUD will generally “make a determination whether to comply with a FOIA request within 20 working days.” Second, HUD is revising § 15.103(c), which addresses when HUD may extend the time periods for processing a FOIA request, to remove the sentence that limited extensions to 10 working days. HUD is removing this language as inconsistent with the plain reading of the statute, the logic of the rest of the language in § 15.103(c), and Department of Justice guidance. Finally, in accordance with 5 U.S.C. 552(a)(6)(B)(ii), HUD has updated § 15.103(c) to include the provision that HUD shall make available its FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and HUD.

    Section 15.105 Responses to Requests

    When an agency makes a determination regarding whether to comply with a FOIA request, the 2016 Act provides that the agency is required to immediately notify the requester of such determination and the reasons therefore, and also notify the requester that they have a right to seek assistance from the agency's FOIA Public Liaison. For adverse determinations, the 2016 Act requires that agencies afford the requester no less than 90 days from the date of the adverse determination on the request to file an appeal. In addition, the 2016 Act requires that agencies notify the requester that they may seek dispute resolution services from the FOIA Public Liaison or from OGIS.

    Consistent with this requirement, HUD has revised § 15.105(d) to provide that, once HUD makes a determination regarding compliance within the time line provided in § 15.103(a), HUD will immediately notify the requester of such determination, the reasons therefore, and their right to seek assistance from the FOIA Public Liaison.

    For adverse determinations, HUD has added § 15.105(d)(2)(iv) to provide that HUD will notify the requester of their right to file an appeal no less than 90 days after the date of receiving the adverse determination. Finally, § 15.105(d)(2)(v) has been added to provide that HUD will notify the requester of their right to seek dispute resolution services from the FOIA Public Liaison or from OGIS.

    Section 15.106 Fees

    The 2016 Act contains several new provisions regarding agencies' ability to assess search and duplication fees. First, the 2016 Act provides that an agency shall not assess any search fees, or in some cases, duplication fees, if the agency has failed to comply with any time limit described in § 15.103, with limited exceptions. Second, if an agency determines that unusual circumstances apply to the processing of a FOIA request, and the agency has provided timely written notice to the requester, then a delayed response time is excused for an additional ten days; if the agency fails to comply with the extended time limit, it may not charge search fees, or, in some cases, duplication fees, with limited exceptions. Third, the 2016 Act provides an exception allowing agencies to charge search fees, or in some cases, duplication fees, if unusual circumstances apply, more than 5,000 pages are necessary to respond to the request, timely written notice has been made to the requester, and the agency has discussed with the requester via written mail, electronic mail, or telephone (or made not less than 3 good-faith attempts to do so) how the requester could effectively limit the scope of the request. Fourth, the 2016 Act maintains that if a court determines that “exceptional circumstances” exist, as defined in 5 U.S.C. 552(a)(6)(C), the agency's failure to comply with a time limit “shall be excused for the length of time provided by the court order.”

    In accordance with the first change, HUD is updating § 15.106(d) to provide that HUD will not assess search fees or, for requesters that are educational or noncommercial scientific institutions or representatives of the news media requesting records not sought for commercial use, duplication fees, if it fails to comply with the extended time limits as described in § 15.103. To comply with the second change, HUD is adding § 15.106(d)(5) to grant HUD an additional ten days when unusual circumstances apply and timely written notice has been provided to the requester and to terminate HUD's ability to assess search fees or duplication fees, as applicable, if HUD does not comply with the additional ten days. Regarding the third change, HUD is adding § 15.106(d)(6) to allow HUD to charge search fees when unusual circumstances apply and more than 5,000 pages are necessary to respond to the FOIA request. Regarding the fourth amendment, HUD is adding § 15.106(d)(7)(i) to excuse a failure to comply with any time limit if a court determines that exceptional circumstances exist; and § 15.106(d)(7)(ii), which provides the definition of “exceptional circumstances” as defined in 5 U.S.C. 552(a)(6)(C), has also been added for clarifying purposes.

    Section 15.107 Documents Generally Protected From Disclosure

    The 2016 Act requires that agencies withhold information under FOIA “only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or if disclosure is prohibited by law. The 2016 Act further directs agencies to consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible, and to take reasonable steps necessary to segregate and release nonexempt information. The 2016 Act does not require disclosure of information that is otherwise prohibited from disclosure by law, or otherwise exempted from disclosure under Exemption 3.

    Consistent with these changes, HUD is restructuring § 15.107 and adding paragraph (a) to provide that HUD shall withhold information only if it is reasonably foreseeable that disclosure would harm an interest protected by an exemption, or if disclosure is prohibited by law. Paragraph (a) also emphasizes that HUD will consider whether partial disclosure of information is possible if it determines that a full disclosure of a requested record is not possible, and that HUD will take reasonable steps necessary to segregate and release nonexempt information.

    In addition, the 2016 Act sunsets the deliberative process privilege, as protected from disclosure under Exemption 5 of the FOIA. Specifically, the 2016 Act amends Exemption 5 to provide that the deliberative process privilege does not apply to records created 25 years or more before the date on which the records were requested. In accordance with the 2016 Act, HUD is revising § 15.107(b)(5) to state that the deliberative process privilege “shall not apply to records created 25 years or more before the date on which the records were requested.”

    III. Justification for Final Rulemaking

    In general, HUD publishes a rule for public comment before issuing a rule for effect, in accordance with HUD's regulations on rulemaking at 24 CFR part 10. Part 10, however, provides in § 10.1 for exceptions from that general rule where HUD finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when the prior public procedure is “impracticable, unnecessary or contrary to the public interest.”

    HUD finds that good cause exists to publish this rule for effect without first soliciting public comment because prior public comment is unnecessary. This final rule follows the statutory directive in Section 3 of the 2016 Act, which requires agencies to review and issue updated regulations on procedures for the disclosure of records under the FOIA, in accordance with the amendments made by the 2016 Act, within 180 days of enactment. The 2016 Act codifies a number of transparency and openness principles and enacts a number of procedural requirements, including requiring that agencies establish a minimum of 90 days for requesters to file an administrative appeal and that they provide dispute resolution services at various times throughout the FOIA process. This final rule reflects the changes required by the 2016 Act. Finally, the rule revises provisions § 15.103 to more accurately reflect the statutory language in 5 U.S.C. 552(a)(6)(A)(i).

    IV. Findings and Certifications Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select the regulatory approach that maximizes net benefits. Because this final rule incorporates changes enacted by the 2016 Act, this rule was determined to not be a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and therefore was not reviewed by OMB.

    Environmental Impact

    This rule is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321). The revision of the FOIA-related provisions of 24 CFR part 15 falls within the exclusion provided by 24 CFR 50.19(c)(1), in that it does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This final rule establishes procedures by which HUD will respond to requests for information under FOIA. Costs assessed by HUD for search, review, and duplication required to process the information requested by a requester are limited by FOIA to direct costs and are not significant. Accordingly, the undersigned certifies that this rule will not have a significant economic impact on a substantial number of small entities.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This final rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.

    Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This final rule does not impose any federal mandates on any state, local, or tribal governments, or on the private sector, within the meaning of the Unfunded Mandates Reform Act of 1995.

    List of Subjects in 24 CFR Part 15

    Classified information, Courts, Freedom of information, Government employees, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, HUD amends 24 CFR part 15 as follows:

    PART 15—PUBLIC ACCESS TO HUD RECORDS UNDER THE FREEDOM OF INFORMATION ACT AND TESTIMONY AND PRODUCTION OF INFORMATION BY HUD EMPLOYEES 1. The authority for 24 CFR part 15 is revised to read as follows: Authority:

    42 U.S.C. 3535(d), 5 U.S.C. 552.

    2. Amend § 15.101 by removing in paragraph (a) “and copying” and adding in its place “in an electronic format”, and by adding paragraphs (b)(7) and (b)(8), to read as follows:
    § 15.101 Proactive disclosures of departmental records.

    (b) * * *

    (7) Copies of all records, regardless of form or format that have been released to any person under § 15.105; and

    (i) Because of the nature of their subject matter, the agency determines that the records have become or are likely to become the subject of subsequent requests for substantially the same records; or

    (ii) Have been requested three or more times.

    (8) Report for the preceding fiscal year submitted to the U.S. Attorney General and the Director of the Office of Government Information Services (OGIS) as required by 5 U.S.C. 552(e) and the raw statistical data used in each report. This report will be made available:

    (i) Without charge, license, or registration requirement;

    (ii) In an aggregated, searchable format; and

    (iii) In a format that may be downloaded in bulk.

    3. In § 15.103, amend paragraph (a) by removing “respond to” and adding in its place “make a determination whether to comply with”, and revise paragraph (c) introductory text, to read as follows:
    § 15.103 Timing of responses to requests.

    (c) Extension of time periods for processing a request. In unusual circumstances, as defined in this paragraph, HUD may extend the time period for processing a FOIA request. In such circumstances, HUD will provide the requester with written notice setting forth the unusual circumstances for the extension and the date on which a determination is expected to be dispatched. If processing a request would require more than 10 working days beyond the general time limit established in paragraph (a) of this section, HUD will offer the requester an opportunity to limit the scope of the request so that HUD may process it within the extra 10-day working period or arrange an alternative time period within which the FOIA request will be processed. To aid the requester, HUD shall make available its FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and HUD, and notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services. For purposes of this section, unusual circumstances include:

    § 15.104 [Amended]
    4. Amend paragraph (b) by adding “the” between “contacting” and “FOIA”. 5. Amend § 15.105 as follows: a. Add paragraph (d) introductory text; b. In paragraph (d)(1) remove “Once” and replace it with “If ”. c. Redesignate paragraph (d)(2)(iv) as (d)(2)(vi); and d. Add paragraphs (d)(2)(iv) and (v).

    Revisions and additions to read as follows:

    § 15.105 Responses to requests.

    (d) Forms of response. Once HUD makes a determination regarding whether to comply with a request pursuant to time limits established in § 15.103(a), HUD shall immediately notify the requester of such determination and the reasons therefor, and the requester's right to seek assistance from the FOIA Public Liaison.

    (2) * * *

    (iv) Notice of the right of the requester to appeal to the head of the agency, within a period determined by the head of the agency that is not less than 90 days after the date of such adverse determination; and

    (v) Notice of the right of the requester to seek dispute resolution services from the FOIA Public Liaison of the agency or the Office of Government Information Services; and

    6. In § 15.106 revise paragraph (d)(1) and add paragraphs (d)(5), (6) and (7) to read as follows:
    § 15.106 Fees.

    (d) Restrictions on charging fees. (1) No search fee will be charged for requests by educational institutions, noncommercial scientific institutions, or representatives of the news media. In addition, except as provided in paragraphs (d)(5), (d)(6), and (d)(7) of this section, HUD shall not assess any search fees (or, for requesters that are educational institutions, noncommercial scientific institutions or representatives of the news media requesting records not sought for commercial use, duplication fees) if HUD has failed to comply with any time limit described in § 15.103.

    (5) If HUD determines that unusual circumstances apply and HUD provides timely written notice to the requester pursuant to requirements provided in § 15.103(c), a failure to comply with any time limit as described in § 15.103 is excused for an additional 10 days. If HUD fails to comply with the extended time limit, HUD may not assess any search fees (or for requesters that are educational or noncommercial scientific institutions or representatives of the news media requesting records not sought for commercial use, duplication fees).

    (6) If unusual circumstances apply and more than 5000 pages are necessary to respond to the request, HUD may charge search fees or, for requesters that are educational or noncommercial scientific institutions or representatives of the news media requesting records not sought for commercial use, duplication fees, if timely written notice has been made to the requester pursuant to requirements provided in § 15.103(c) and HUD has discussed with the requester through written mail, electronic mail, or telephone (or made not less than 3 good-faith attempts to do so) how the requester could effectively limit the scope of the request as stipulated in § 15.103(c).

    (7)(i) If a court has determined that exceptional circumstances exist, a failure to comply with any time limit as described in § 15.103 shall be excused for the length of time provided by the court order.

    (ii) For purposes of this section, the term “exceptional circumstances” does not include a delay that results from a predictable workload of requests, unless HUD demonstrates reasonable progress in reducing its backlog of pending requests. However, refusal by the requester to reasonably modify the scope of a request or arrange an alternative time frame for processing a request (or a modified request) after HUD gives them an opportunity to do so shall be considered a factor in determining whether exceptional circumstances exist.

    7. Amend § 15.107 as follows: a. Remove paragraph (b); b. Redesignate the introductory text as new paragraph (b); c. Revise paragraph (a); d. Redesignate paragraphs (c) through (i) as (b)(1) through (b)(9), respectively, and e. Revise redesignated paragraph (b)(5);

    Revisions and addition to read as follows:

    § 15.107 Documents generally protected from disclosure.

    (a) HUD shall withhold information only if HUD reasonably foresees that disclosure would harm an interest protected by an exemption as provided in paragraph (b) of this section, or disclosure is prohibited by law. HUD will consider whether partial disclosure of information is possible whenever HUD determines that a full disclosure of a requested record is not possible, and will take reasonable steps necessary to segregate and release nonexempt information. Nothing in this section requires disclosure of information that is otherwise prohibited from disclosure by law, or otherwise exempted from disclosure as provided in paragraph (b)(3) of this section.

    (b) * * *

    (5) Certain interagency or intra-agency communications. Exemption 5 (5 U.S.C. 552(b)(5)) protects interagency or intra-agency communications that are protected by legal privileges, such as the attorney-client privilege, attorney work-product privilege, or communications reflecting the agency's deliberative process. The deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested.

    Dated: December 27, 2016. Nani A. Coloretti, Deputy Secretary.
    [FR Doc. 2017-00178 Filed 1-11-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 891 [Docket No. FR 5890-C-03] RIN 2501-AD75 Narrowing the Digital Divide Through Installation of Broadband Infrastructure in HUD-Funded New Construction and Substantial Rehabilitation of Multifamily Rental Housing; Correction AGENCY:

    Office of General Counsel, HUD.

    ACTION:

    Final rule; correction.

    SUMMARY:

    On December 20, 2016, HUD published a final rule requiring the installation of broadband infrastructure at the time of new construction or substantial rehabilitation of multifamily rental housing that is funded or supported by HUD, the point at which such installation is generally easier and less costly than when undertaken as a stand-alone effort. This document corrects incorrect paragraph designations in one section of the regulatory text. The effective date for HUD's final rule of January 19, 2017 is unchanged.

    DATES:

    Effective January 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    With respect to this supplementary document, contact Ariel Periera, Associate General Counsel for Legislation and Regulations, Department of Housing and Urban Development, 451 7th Street SW., Room 10238, Washington, DC 20410; telephone number 202-708-1793 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    In the final rule FR Doc. 2016-30708, published in the Federal Register on December 20, 2016 (81 FR 92626), the following correction is made:

    § 891.20 [Corrected]

    On page 92638, in the third column, in § 891.20, paragraphs (f)(a) through (c) are redesignated as paragraphs (f)(1) through (3).

    Dated: January 4, 2017. Aaron Santa Anna, Assistant General Counsel for Regulations.
    [FR Doc. 2017-00167 Filed 1-11-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS OMAHA (LCS 12) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.

    DATES:

    This rule is effective January 12, 2017 and is applicable beginning December 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Commander Theron R. Korsak, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone number: 202-685-5040.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

    This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS OMAHA (LCS 12) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2 (a)(i), pertaining to the height of the forward masthead light above the hull; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light; Annex I, paragraph 3(c), pertaining to the task light's horizontal distance from the fore and aft centerline of the vessel in the athwartship direction. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

    Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

    List of Subjects in 32 CFR Part 706

    Marine safety, Navigation (water), Vessels.

    For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

    PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read as follows: Authority:

    33 U.S.C. 1605.

    2. Section 706.2 is amended by: a. In Table One, adding, in alpha numerical order, by vessel number, an entry for USS OMAHA (LCS 12); b. In Table Four: i. Under paragraph 15, adding, in alpha numerical order, by vessel number, an entry for USS OMAHA (LCS 12); ii. Under paragraph 16, adding, in alpha numerical order, by vessel number, an entry for USS OMAHA (LCS 12); and c. In Table Five, adding, in alpha numerical order, by vessel number, an entry for USS OMAHA (LCS 12).
    § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table One Vessel Number Distance in meters of forward masthead light below minimum required height.
  • § 2(a)(i) Annex I
  • *         *         *         *         *         *         * USS OMAHA LCS 12 4.27 *         *         *         *         *         *         *

    15. * * *

    Table Four Vessel Number Horizontal distances from the fore and aft centerline of the vessel in the athwartship
  • direction
  • *         *         *         *         *         *         * USS OMAHA LCS 12 Upper—0.17 meters.
  • Middle—1.3 meters.
  • Lower—1.3 meters.
  • 16. * * *

    Vessel Number Obstruction angle
  • relative ship's
  • headings
  • *         *         *         *         *         *         * USS OMAHA LCS 12 72° thru 74°.
  • 286° thru 288°.
  • *         *         *         *         *         *         *
    Table Five Vessel Number Masthead lights not over all other lights and obstructions. Annex I, sec. 2(f) Forward masthead light not in forward quarter of ship. Annex I,
  • sec. 3(a)
  • After mast-head light less than 1/2 ship's length aft of forward masthead light. Annex I,
  • sec. 3(a)
  • Percentage
  • horizontal
  • separation
  • attained
  • *         *         *         *         *         *         * USS OMAHA LCS 12 X X 17.3 *         *         *         *         *         *         *
    Approved: December 12, 2016. A.S. Janin, Captain, USN, JAGC, Deputy Assistant Judge Advocate, General (Admiralty and Maritime Law). Dated: December 27, 2016. A.M. Nichols, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2016-31873 Filed 1-11-17; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2016-0675] RIN 1625-AA87 Security Zone; Potomac River and Anacostia River, and Adjacent Waters; Washington, DC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce a security zone along the Potomac River and Anacostia River, and adjacent waters at Washington, DC, for activities associated with the 58th Presidential Inauguration. The zone will be enforced on the days leading up to and through the cessation of activities associated with the 58th Presidential Inauguration taking place on January 20, 2017. This action is necessary to protect government officials, mitigate potential terrorist acts and incidents, and enhance public and maritime safety and security immediately before, during, and after these activities. During the enforcement period, entry into or remaining within the zone is prohibited unless authorized by the Captain of the Port or his designated representative.

    DATES:

    The regulations in 33 CFR 165.508 will be enforced from 6 a.m. on January 15, 2017, through 6 a.m. on January 24, 2017, for the zone identified in 33 CFR 165.508(a)(6).

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email Mr. Ron Houck, U.S. Coast Guard Sector Maryland-National Capital Region (Waterways Management Division); telephone 410-576-2674, email [email protected]

    SUPPLEMENTARY INFORMATION:

    On December 1, 2016, the Coast Guard was notified by the event organizer that the anticipated dates for the activities associated with the 58th Presidential Inauguration are scheduled from January 15, 2017, to January 24, 2017. The Coast Guard will enforce regulations in 33 CFR 165.508 for the zone identified in paragraph (a)(6). This action is being taken to protect government officials, mitigate potential terrorist acts and incidents, and enhance public and maritime safety and security immediately before, during, and after this event.

    Our regulations for Security Zone; Potomac River and Anacostia River, and adjacent waters; Washington, DC, § 165.508, specifies the location for this security zone as an area that includes all navigable waters described in paragraphs (a)(1) through (a)(3). This zone includes (1) Security Zone 1; all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by the Francis Scott Key (US-29) Bridge, at mile 113, and bounded to the south by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport, at 38°51′21.3″ N., 077°02′00.0″ W., eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., including the waters of the Boundary Channel, Pentagon Lagoon, Georgetown Channel Tidal Basin, and Roaches Run. (2) Security Zone 2; all navigable waters of the Anacostia River, from shoreline to shoreline, bounded to the north by the John Philip Sousa (Pennsylvania Avenue) Bridge, at mile 2.9, and bounded to the south by a line drawn from the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N., 077°01′10.9″ W., including the waters of the Washington Channel. (3) Security Zone 3 all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport, at 38°51′21.3″ N., 077°02′00.0″ W., eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., thence southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N., 077°01′10.9″ W., and bounded to the south by the Woodrow Wilson Memorial (I-95/I-495) Bridge, at mile 103.8.

    As specified in § 165.508 (b), during the enforcement period, entry into or remaining in the zone is prohibited unless authorized by the Coast Guard Captain of the Port Maryland-National Capital Region. Public vessels and vessels already at berth at the time the security zone is implemented do not have to depart the security zone. All vessels underway within the security zone at the time it is implemented are to depart the zone at the time the security zone is implemented. To seek permission to transit the zone, the Captain of the Port Maryland-National Capital Region can be contacted at telephone number (410) 576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). Coast Guard vessels enforcing this zone can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard may be assisted by other Federal, state or local law enforcement agencies in enforcing this regulation. If the Captain of the Port or his designated on-scene patrol personnel determines the security zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to suspend enforcement and grant general permission to enter the security zone.

    This notice of enforcement is issued under authority of 33 CFR 165.508 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

    Dated: January 4, 2017. Michael W. Batchelder, Commander, U.S. Coast Guard, Acting Captain of the Port Maryland-National Capital Region.
    [FR Doc. 2017-00251 Filed 1-11-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 13 [NPS-AKRO-22487; PPAKAKROZ5, PPMPRLE1Y.L00000] RIN 1024-AE28 Alaska; Subsistence Collections AGENCY:

    National Park Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    The National Park Service amends it regulations for National Park System units in Alaska to allow qualified subsistence users to collect nonedible fish and wildlife parts and plants for creating handicrafts for barter and customary trade. The rule also clarifies that capturing, collecting or possessing living wildlife is generally prohibited and adopts restrictions on using human-produced foods to bait bears for subsistence uses.

    DATES:

    This rule is effective February 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Andee Sears, Regional Law Enforcement Specialist, Alaska Regional Office, 240 West 5th Ave., Anchorage, AK 99501. Phone (907) 644-3410. Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Background Proposed Rule and Public Comment Period

    On January 13, 2016, the National Park Service (NPS) published the proposed rule in the Federal Register (81 FR 1592). The rule was open for public comment for 90 days, until April 12, 2016, to coincide with scheduled meetings of the NPS Subsistence Resource Commissions and Federal Subsistence Regional Advisory Councils. The NPS invited comments through the mail, hand delivery, and through the Federal eRulemaking Portal at http://www.regulations.gov. The NPS received 27 comments on the proposed rule during the public comment period. A summary of comments and NPS responses is provided below in the section entitled “Summary of and Responses to Public Comments”. After considering the public comments and additional review, the NPS made some changes in the final rule from what was proposed. These changes are summarized below in the section entitled “Changes from the Proposed Rule”.

    Subsistence Uses Authorized by ANILCA

    In 1980, Congress enacted the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 410hh-410hh-5; 3101-3233) to preserve various nationally significant areas in Alaska. One of the purposes of ANILCA is “to provide the opportunity for rural residents engaged in a subsistence way of life to continue to do so.” 16 U.S.C. 3101(c). The subsistence take of fish and wildlife on (federal) public lands is governed by Title VIII of ANILCA (16 U.S.C. 3111-3126).

    Title II of ANILCA established new National Park System units, added to existing units, and specified in which units that subsistence uses shall be allowed. 16 U.S.C. 410hh-2. Subsistence uses by local rural residents in Alaska are authorized in all national preserves and in the Alagnak Wild River (managed as a national preserve), Aniakchak National Monument, Cape Krusenstern National Monument, Gates of the Arctic National Park, Kobuk Valley National Park, Lake Clark National Park, Wrangell-Saint Elias National Park, 16 U.S.C. 410hh-(1)-(4), (6)-(10); and the additions to Denali National Park, 16 U.S.C. 410hh-1(3)(a).

    ANILCA defines “subsistence uses” as:

    [T]he customary and traditional uses by rural Alaska residents of wild, renewable resources for direct personal or family consumption as food, shelter, fuel, clothing, tools, or transportation; for the making and selling of handicraft articles out of nonedible byproducts of fish and wildlife resources taken for personal or family consumption; for barter, or sharing for personal or family consumption; and for customary trade. 16 U.S.C. 3113

    This definition reflects that the creation of hand-made crafts from nonedible natural materials has long been a part of the cultural, social, and economic practices of those living a subsistence way of life in Alaska. These individuals requested that the NPS allow this customary and traditional practice.

    Consistency With NPS Regulations

    NPS regulations for subsistence uses in park units in Alaska are found in 36 CFR part 13, subpart F—Subsistence. The regulations authorize local rural residents to take fish and to hunt and trap wildlife in specific park units for subsistence uses in compliance with state and federal law. 36 CFR 13.470 and 13.480. The Federal Subsistence Board (FSB) regulations governing the subsistence take of fish and wildlife on federal lands in Alaska are found at 50 CFR part 100. These part 100 regulations are limited to fish, wildlife and non-migratory birds. NPS regulations regarding the non-commercial subsistence use of timber and plant materials are located at 36 CFR 13.485. The non-commercial cutting of standing timber for firewood and house logs is authorized under 36 CFR 13.485(a) while the non-commercial gathering of plant materials such as fruits, berries, and mushrooms for subsistence uses without a permit is authorized by 36 CFR 13.485(b).

    The NPS regulation at 36 CFR 13.420 defining the term “barter” is derived from the statutory definition of “subsistence uses” in section 803 of ANILCA (16 U.S.C. 3113). Barter means the exchange of fish or wildlife or their parts for other fish or game or their parts; or for other food or for nonedible items other than money if the exchange is of a limited and noncommercial nature. The term ”customary trade” is limited by definition to the exchange of furs for cash, and other activities designated for a particular NPS unit by special regulation. These definitions recognize the traditional cultural, social, and economic practices of non-cash exchange of subsistence resources among those living a “genuine subsistence lifestyle”, and that trapping was an “integral and longstanding part of the subsistence lifestyle in many regions in Alaska.” See 1981 U.S. Fish and Wildlife Service interim regulations interpreting similar definitions of “barter” and “customary trade” (46 FR 31824, June 17, 1981).

    Since the June 1981 rulemaking, two NPS units in Alaska where such customary trade was known to have occurred, Gates of the Arctic National Preserve and Kobuk Valley National Park, have promulgated special regulations that expand the definition of “customary trade” in those units to include the sale of handicrafts made from plant material taken by local rural residents of the park area. These special regulations do not require any written authorization from the superintendent. 36 CFR 13.1006 and 13.1504, respectively.

    Except for these specific and limited authorizations for barter and customary trade of handicrafts in Gates of the Arctic National Preserve and Kobuk Valley National Park in Alaska, National Park System-wide regulations at 36 CFR 5.3 generally prohibit engaging in any business without authorization. This means that other forms of sale, barter, and trade that are customary and traditional uses of wild, renewable resources by rural Alaska residents are not allowed under current NPS regulations. In addition, National Park System-wide regulations at 36 CFR 2.1(a)(1) prohibit the collection of wildlife, plants, or parts thereof. There is a limited authorization for the hand-collection of fruits, berries, nuts, or unoccupied seashells for personal use or consumption, and a separate limited authorization for members of federally-recognized tribes to collect plants for traditional purposes under an agreement with the NPS, but the sale or commercial use of the products collected under these authorities is prohibited. 36 CFR 2.1(c) and (d).

    Environmental Impact Analysis

    The NPS prepared an Environmental Assessment (EA) to analyze the impacts of various alternatives that would address the collection of plant materials and nonedible animal parts to make handicrafts for barter and customary trade. On April 14, 2014, the Regional Director for the Alaska Region signed a Finding of No Significant Impact (FONSI) that selected a modified version of the preferred alternative (Alternative D) in the EA as the selected action. In the FONSI, the Regional Director determined that written authorization from the NPS would be required to collect both animal parts and plant materials for making handicrafts for barter and customary trade. On December 2, 2016, the NPS amended the FONSI to exempt plant materials from this requirement. The provisions in this rule about the capture, collection, or possession of live wildlife and restrictions on the types of bait that may be used to take bears for subsistence purposes were categorically excluded from further environmental analysis.

    Final Rule Summary of Final Rule

    This rule implements the selected action identified in the amended FONSI and applies to all NPS units in Alaska where subsistence uses by local rural residents are authorized by ANILCA. The rule allows NPS-qualified local rural residents to collect and use the following items to make and sell handicrafts:

    • Plant Materials; and

    • nonedible animal parts (e.g., antlers, horns, bones, teeth, claws, hooves, skins, hides, fur, hair, feathers, or quills) that are naturally shed or discarded, lawfully taken, or that remain on the landscape due to the natural mortality of an animal.

    While ANILCA does not expressly address making and selling of handicrafts out of plant materials, the NPS concludes it falls within this definition, and that it is not otherwise prohibited. Making and selling handicrafts out of plant materials is clearly use of a wild renewable resource for barter or customary trade. The omission of plant materials from the statute's specific provision on handicraft articles does not indicate any intent to prohibit their use. That definition provides that fish and wildlife-based handicraft articles for subsistence purposes are only made from “nonedible byproducts” to avoid the take of fish and wildlife solely for the purpose of making handicrafts out of them. Plant materials fall within the definition's more general provision of wild, renewable resources and the making and selling of plant-based handicrafts is a customary and traditional use of wild, renewable resources for barter or customary trade.

    Feathers may only be collected if such collection is not prohibited by the Bald and Golden Eagle Protection Act, the Migratory Bird Treaty Act, or other applicable law. Collection and use of bird feathers remains subject to any applicable federal and state laws.

    Eligibility to collect plants or nonedible animal parts follows the same criteria for other subsistence uses in national parks, monuments and preserves. Collection of nonedible wildlife parts is limited to NPS-qualified subsistence users who are residents of communities or areas with a federally recognized customary and traditional use determination (as listed in 50 CFR part 100) for each species in the game management unit within the affected area. Thus, if an NPS qualified subsistence user can lawfully harvest the wildlife species in a particular area for subsistence uses, then they are allowed to collect nonliving, nonedible parts of that same species they encounter in the area. Eligible persons must have written authorization from the superintendent to collect nonedible animal parts. The sale of raw unworked materials or parts remains prohibited because of concern about overuse and commercialization of the resource. The rule also allows NPS-qualified subsistence users to collect nonedible animal parts and plants on behalf of another NPS-qualified subsistence user or for cultural or educational programs that are qualified under FSB regulations at 50 CFR 100.25(g). The rule provides superintendents with authority to set conditions, limits, and other restrictions on collection activities to protect resources and values.

    The rule allows the collection of nonedible animal parts and plants and their inclusion in handicrafts to be sold or exchanged through barter or customary trade. The regulatory definition of “barter” is amended to include exchange of handicrafts for fish or game or their parts; or for other food or nonedible items other than money if the exchange is of a limited and noncommercial nature. The regulatory definition of “customary trade” is amended to include exchange of handicrafts for cash to support personal or family needs, so long as these exchanges do not constitute a significant commercial enterprise.

    The rule adds a definition of “handicraft” that is taken from the current federal subsistence regulations at 50 CFR 100.25(a). This definition clarifies that a handicraft must result from the alteration or manipulation of the shape and appearance of natural materials to create something of greater monetary or aesthetic value than the unaltered natural material alone.

    Capture or Collection of Live Wildlife

    In the proposed rule, the NPS stated that collecting or possessing living wildlife (including eggs and offspring) is prohibited in NPS units located in Alaska unless specifically authorized by federal statute or pursuant to (1) an NPS research specimen collection permit issued under 36 CFR 2.5; (2) federal subsistence regulations; or (3) special regulations for Glacier Bay National Park and Preserve. This proposal originated from public inquiries about the collection of live falcon chicks in national preserves that would be trained and then used for sport hunting.

    The take of wildlife is generally prohibited on National Park System units. Although in Alaska hunting and trapping are allowed in national preserves in accordance with applicable federal and non-conflicting state laws and regulations, the NPS does not consider the capture or collection of live falcons to be hunting or trapping. The NPS concludes that the harvest of migratory birds (including their eggs) pursuant to the Migratory Bird Treaty Act and implementing regulations in 50 CFR part 92 is an appropriate “subsistence use” as defined in section 803 of ANILCA, 16 U.S.C. 3113. Similarly, the NPS concludes that the harvest of marine mammals in accordance with the Marine Mammal Protection Act and implementing regulations in 50 CFR part 18 by NPS-qualified subsistence users is also an appropriate “subsistence use” as defined by section 803 of ANILCA. Thus, in this final rule, the NPS clarifies the prior definition of “subsistence uses” to explicitly include harvest of migratory birds under the MBTA and the harvest of marine mammals under the MMPA by qualified individuals. Except for these subsistence uses, the final rule continues the previous prohibitions on collecting, capturing, or possessing living wildlife unless expressly authorized by federal statute or pursuant to a NPS research specimen collection permit. This rule does not affect the use of trained raptors for hunting activities where authorized by applicable federal and state law. It also does not affect the collection of gull eggs in Glacier Bay by the Huna Tlingit pursuant to Public Law 113-142, sec. 2, 128 Stat. 1749 (2014).

    Use of Bait for Taking Bears Under Federal Subsistence Regulations

    The NPS is adopting restrictions on the types of bait that may be used to take bears for subsistence uses under federal subsistence regulations in units of the National Park System in Alaska. Under this rule, bait is limited to (1) parts of legally taken native fish or wildlife that are not required to be salvaged; or (2) remains of native fish or wildlife that died of natural causes. The rule prohibits human-produced items such as dog food, grease, bread, and marshmallows, which are currently allowed and used to bait bears.

    Baiting alters the natural behavior of bears by predictably attracting them to a specific location for harvest. The use of human-produced food as bait can result human food-conditioned bears that are more likely to be killed by agency personnel or the public in defense of life or property. Human food-conditioned bears are also more likely to cause human injury. Bait stations tend to be located in accessible areas due to the infrastructure (typically a 55 gallon drum) used for baiting, the quantity of bait used to engage in this activity, and the frequency it must be replenished. Because of the accessibility of these areas, they are typically used by multiple user groups, which contributes to the public safety concerns associated with baiting.1

    1 More information about the impacts of bear baiting can be found in the September 2014 Environmental Assessment entitled “Wildlife Harvest On National Park Preserves In Alaska” (Wildlife EA) that can be found at https://parkplanning.nps.gov/projectHome.cfm?projectID=49062 and then clicking “Document List.”

    The NPS recognizes that hunting black bears over bait has been authorized by the State since the 1980s. Taking brown or black bears over bait, however, is not a common activity in most NPS units in Alaska. The only NPS unit where taking bears over bait has traditionally occurred is Wrangell-St. Elias National Park and Preserve.2 The final rule has been modified to give the superintendent of Wrangell-St. Elias National Park and Preserve the discretion to allow the use of human-produced food as bait pursuant to an annual permit. Permits would only be issued upon a written finding that such use is compatible with park purposes and values and that the permit applicant does not have reasonable access to natural materials that can be used as bait under this rule. Permits will identify specific baiting locations and will not be issued for areas where user conflicts are likely (i.e., areas that receive higher visitation particularly by the nonhunting public). This provision is similar to practices at Kenai National Wildlife Refuge, where the FWS issues permits for bear baiting but only for certain areas. Permits will also help the NPS document the level of use and minimize user conflicts.

    2 See Wildlife EA, pp. 11, 15.

    Summary of and Responses to Public Comments

    A summary of public comments received on the proposed rule and NPS responses is provided below followed by a table that sets out changes we have made to the rule based on the analysis of the comments and other considerations.

    General/Process

    1. Comment: Some commenters asked the NPS to rescind or re-propose the rule without two of the proposed changes (the limit on types of bait that can be used to bait bears for subsistence uses and the prohibition on collecting live wildlife). The commenters stated that they were not properly notified of these changes because they are not related to subsistence collections, which was the title of the proposed rule, and were not included in the 2014 EA.

    NPS Response: The NPS concludes the public was given sufficient notice for providing comments on all of the provisions in the proposed rule. In addition to publishing the proposed rule in the Federal Register, the NPS issued a press release and met with various interest groups and stakeholders during an extended 90-day comment period. Although the title of the proposed rule did not mention these other proposals, the summary on the first page of the proposed rule referred to these elements.

    2. Comment: Some comments were received that said the proposed rule is inconsistent with ANILCA, which—according to the commenters—made Alaska NPS units “open unless closed.” Another commenter said the NPS does not have authority to permanently close areas to subsistence uses.

    NPS Response: The commenters did not specify which section of ANILCA makes NPS units in Alaska open unless closed. NPS units are generally open to public uses unless they have been restricted or prohibited by law or regulation. The primary function of this rule is to authorize subsistence collection. This rule limits the type of bait that can be used for baiting bears, but it does not close any areas to taking fish or wildlife.

    3. Comment: Some commenters stated that the proposed restrictions on bait and capturing live wildlife should have been considered by the FSB and the State of Alaska Board of Game prior to being proposed as an NPS regulation.

    NPS Response: While the provisions on bait and collecting live wildlife could have been addressed by the FSB or the State, the NPS is implementing its responsibilities under ANILCA and the NPS Organic Act (54 U.S.C. 100101) using the well-established process for notice and comment rulemaking.

    4. Comment: Some commenters stated there was insufficient consultation with Tribes, the State of Alaska, and the affected public. One commenter suggested the NPS should consult on the proposed rule in addition to the Environmental Assessment (EA) on subsistence collections. Another commenter suggested the NPS should consult with the State on the proposed baiting restriction since individuals are required to register bait stations with the State.

    NPS Response: This rule was published for an extended comment period (90 days as opposed to 30 days) in order to coincide with scheduled meetings of the NPS Subsistence Resource Commissions and Federal Subsistence Regional Advisory Councils. NPS staff attended these meetings and gave presentations on the proposed rule. Following these presentations, several SRCs and RACs submitted formal written comments on the proposed rule. The NPS met with the State both during the comment period and after the comment period closed when the NPS was analyzing public comments and considering changes to the final rule. Specific issues addressed in those meetings included the proposed restrictions on bait for hunting bears and capturing falcon chicks, among other topics. The content of those discussions, along with written comments submitted by the State and others, helped inform this final rule. Consultation with Tribes, Native corporations, and others is addressed in the compliance section of this rule.

    Customary Trade

    5. Comment: One commenter suggested retaining the reference to park-specific special regulations in the definition of customary trade. The existing definition states that the NPS can designate other activities as “customary trade” by promulgating a special regulation for a particular park unit.

    NPS Response: The proposed change does not result in a substantive change to the regulations. Removing the reference to park-specific regulations in the definition of customary trade does not affect the ability of parks to establish such regulations in the future if found to be necessary.

    6. Comment: Several commenters responded to the NPS's request for feedback on how the agency could better explain the phrase “significant commercial enterprise” in the definition of “customary trade”. Some commenters suggested the phrase was vague, while others stated that further defining this term was unnecessary. Some commenters suggested that “significant commercial enterprise” should not be based on the value of the handicrafts, which reflects the skill and time involved in their creation, but instead should be based upon the venue and quantity of sales (e.g., mass production and selling to a larger distributor for resale) or the use of paid employees in their production.

    NPS Response: The NPS agrees that the value of the handicraft does not necessarily determine whether the sale of that handicraft is a “significant commercial enterprise.” While quantity of sales is related to the level of commercial activity, the NPS concludes that the venue where the item is sold is not relevant. The NPS also concludes that prohibiting the use of paid employees helps to ensure that handicraft production under these regulations is not a “significant commercial enterprise.” This is also consistent with an existing NPS regulation in Alaska (36 CFR 13.42(c)) that prohibits the use of employees in trapping activities in national preserves. The final rule has been modified to prohibit the use of paid employees—except by qualified educational or cultural programs—to collect plant materials and animal parts.

    7. Comment: The NPS requested comment on how the term “substantially greater monetary and aesthetic value” could be further explained to provide more clarity to the public about what qualifies as a handicraft. Some commenters said this term was vague while others said no further clarification or definition was necessary. Other commenters suggested the NPS adopt the definition found in federal subsistence regulations.

    NPS Response: The NPS finds it is in the best interest of the public to be consistent with federal subsistence regulations to the extent possible. The NPS has modified the definition of “handicraft” in the rule to refer to the definition used in federal subsistence regulations (50 CFR 100.25(a)). As a result, any modifications made by the FSB to this definition in the future will be automatically adopted in NPS regulation. If the FSB clarifies the term “substantially greater monetary and aesthetic value” in the definition of “handicraft”, that change will be adopted in NPS regulation without additional rulemaking by the NPS. The NPS definition of handicraft differs in two ways from the FSB definition. First, the NPS definition includes plants. Plants are not included in the definition in 50 CFR part 100 because the FSB does not have authority to regulate subsistence use of plants. Second, the NPS definition of handicraft specifically excludes trophy or European mounts of horns or antlers. Both state and federal subsistence regulations specifically prohibit the sale of trophies or mounts of horns or antlers. See 5 AAC 92.200, 50 CFR 100.25(j)(10).

    Subsistence Collections

    8. Comment: One commenter stated that subsistence collections should be limited to Alaska Natives.

    NPS Response: ANILCA provides for subsistence uses by rural residents of Alaska regardless of ethnicity. Limiting subsistence collections to Alaska Natives is inconsistent with ANILCA.

    9. Comment: Several commenters objected to the requirement that subsistence users obtain written authorization for collecting animal parts and plants for the creation and sale of handicrafts.

    NPS Response: The preferred alternative in the EA would require individuals to obtain a permit in order to collect plants or animal parts for the making and sale of handicrafts. In the FONSI, however, the NPS decided to require written authorization for all items except for plant materials gathered in Kobuk Valley National Park and Gates of the Arctic National Park and Preserve where existing special regulations allow this activity without written authorization. Because colleting plants for subsistence uses is already authorized by NPS regulations, the NPS has decided to let the superintendent determine whether to require written authorization for collecting plants for making handicrafts for customary trade. Because the final rule does not require written authorization for this activity, the special regulations for Kobuk Valley and Gates of the Arctic are no longer necessary and are removed.

    10. Comment: Some commenters recommended the NPS issue written permission for the collection of plants and animal parts on a community-wide basis as opposed to issuing individual permits to each qualified subsistence user.

    NPS Response: The written authorizations could take many forms, and they need not always be permits issued to individual subsistence users. Alternatives include written authorizations to resident zone communities or to entire resident zones, or annual authorizations documented in park compendia. Park superintendents will work with SRCs and, as appropriate, RACs, tribes and ANCSA corporations to determine the most appropriate type of written authorization for individual NPS units.

    11. Comment: Some commenters said that requiring a permit or written authorization for subsistence uses was a closure. Other commenters stated that a permit requirement is burdensome and not justified in the absence of biological concerns.

    NPS Response: Requiring a permit or otherwise putting conditions on an activity is not a closure. The NPS concludes that the incremental burden placed upon subsistence users to be required to obtain written authorization to collect animal parts is an appropriate and prudent mechanism for regulating the commercial use of these resources.

    12. Comment: Some commenters stated that collected materials are sometimes exchanged before they reach an artist and are made into handicrafts, adding that it is too restrictive to say that materials must be modified before they can be exchanged. The commenters suggested that exchange of unworked material should be allowed to supply materials for elders to produce handicrafts and for qualified cultural and educational programs.

    NPS Response: In the EA on subsistence collections, the NPS recognized that the person collecting the materials would not always be the person who uses them to make handicrafts. The final rule has been modified to clarify that permits may be issued to allow an NPS-qualified subsistence user to gather plants or animal parts for making handicrafts on behalf of another NPS-qualified subsistence user or for qualified cultural and educational programs.

    Baiting Bears

    13. Comment: Some commenters stated that the proposed limits on the types of bait that may be used to take bears under federal subsistence regulations would essentially eliminate the opportunity for hunters to harvest bears over bait in the spring. This is because hunters may not have access to the types of baits that would be allowed in the spring, such as parts and remains of fish and wildlife.

    NPS Response: As discussed above, the NPS has made an allowance for other types of bait in certain circumstances in Wrangell-St. Elias National Park and Preserve. This is the only NPS unit where bear baiting traditionally occurred. The final rule allows for NPS qualified subsistence users who do not have reasonable access to natural bait to apply for a permit to use other types of bait. The NPS will issue this permit for specific locations in the park unit upon a finding that using other types of bait is compatible with park purposes and values (e.g. will not result in user conflicts, particularly in areas that receive higher visitation by the nonhunting public).

    14. Comment: Some commenters stated that using natural bait will attract more brown bears than black bears and that hunters could end up baiting brown bears even if that was not their intent.

    NPS Response: The NPS expects that natural bait will attract both brown and black bears, just as human-produced foods attract both species as well as other wildlife. The use of natural bait will help avoid conditioning brown and black bears to human-produced foods which can lead to more frequent interactions between humans and bears.

    15. Comment: Some commenters stated that natural bait, such as a gut pile or furbearer carcasses, would be more difficult to clean up at the end of the baiting season than human-produced foods that are commonly used to bait bears, such as dog food or popcorn.

    NPS Response: Federal subsistence regulations require that bait station sites be cleaned up when hunting is completed, including removing any litter, containers, chains, and other equipment used to set bait. The natural materials allowed by the rule—such as parts and remains of fish and wildlife—are not litter or equipment and thus would not be covered by this requirement.

    16. Comment: Some commenters stated that inconsistent regulations about the types of bait that can be used will increase the possibility for confusion.

    NPS Response: NPS acknowledges that this rule results in differences between the materials that can be used to harvest bears over bait under NPS-specific subsistence regulations and generally applicable federal subsistence regulations. In order to avoid the potential for confusion, the NPS will engage in outreach to local user groups, post information online, and make information available at park headquarters to inform local hunters of the rules that apply on NPS lands.

    17. Comment: Some commenters stated that there is no biological data or other evidence demonstrating that baiting bears has the same effects as feeding wildlife, such as habituating bears to human foods or causing nuisance bear behavior.

    NPS Response: Like feeding wildlife, baiting typically uses human or pet food to alter the natural behavior of bears to predictably attract them to a specific location for harvest. Food-conditioned bears are more likely to be killed by agency personnel or the public in defense of life or property. Food-conditioned bears are also believed more likely to cause human injury.3

    3 See Wildlife EA.

    Capture or Collection of Live Wildlife

    18. Comment: Two commenters addressed subsistence harvest of migratory birds and their eggs, noting that the collection of eggs is allowed under the Migratory Bird Treaty Act (MBTA) and that the harvest of migratory birds and their eggs is a customary and traditional practice.

    NPS Response: ANILCA authorized the harvest of fish and wildlife for subsistence uses in specific NPS units under Title VIII of ANILCA and pursuant to federal regulations applicable to NPS units. National preserves in Alaska are open to the harvest of fish and of wildlife for sport hunting and trapping under State of Alaska regulations. The FSB generally regulates subsistence harvest of fish and wildlife. It does not regulate the harvest of migratory birds for subsistence uses in Alaska which is provided for by law under the MBTA and implementing regulations at 50 CFR part 92. The NPS concludes that ANILCA's broad definition of subsistence uses authorizes NPS-qualified rural residents to harvest migratory birds, including eggs, in NPS units where subsistence is authorized in accordance with the MBTA and the migratory bird subsistence regulations at 50 CFR part 92. Collecting live wildlife, such as falcon chicks to raise and train for hunting, remains prohibited in NPS areas in accordance with national or Alaska-specific NPS regulations. 36 CFR 2.2(a)(2) or 13.35.

    In considering this comment, the NPS notes that a similar issue exists with respect to harvest of marine mammals by Alaska Natives under the Marine Mammal Protection Act (MMPA). The NPS concludes that ANILCA's definition of subsistence uses includes the harvest of marine mammals by Alaskan Natives who are NPS-qualified rural residents in park areas where the take of marine mammals is authorized in accordance with the Alaska Native exemption in the Marine Mammal Protection Act and the marine mammal regulations at 50 CFR 18.23 and 18.26. The NPS has modified the definition of subsistence uses to reflect that NPS-qualified subsistence users who are eligible to harvest under the MBTA and the MMPA can do so in NPS areas open to subsistence uses.

    Changes From the Proposed Rule

    After taking the public comments into consideration and after additional review, the NPS made the following substantive changes from the proposed rule:

    § 13.420 Modified the definition of “animal parts” to clarify that this also includes parts of fish. § 13.420 Modified the definition of “handicraft” to adopt the definition under federal subsistence regulations in 50 CFR part 100. § 13.420 Modified the definition of “subsistence uses” to include the harvest of migratory birds under the MBTA and marine mammals under the MMPA. § 13.482 Included a provision to allow an NPS-qualified subsistence user to designate another NPS-qualified subsistence user to collect, on their behalf, animal parts from nonliving wildlife for making handicrafts in accordance with a permit from the superintendent. Removed the reference to nonconflicting State regulations regarding use of bear claws because federal subsistence regulations address this activity. Added a prohibition on the use of paid employees. § 13.485(b) Removed the requirement for a written authorization to collect plants to make handicrafts for customary trade or barter. Added a prohibition on the use of paid employees. § 13.485(d) Included a provision to allow an NPS-qualified subsistence user to designate another NPS-qualified subsistence user to collect, on their behalf, plants for making handicrafts in accordance with a permit from the superintendent. § 13.1902(d) Included a provision to allow the superintendent of Wrangell-St. Elias National Park and Preserve to issue a permit to use human-produced food as bait upon a finding that such use is compatible with the park purposes and values and that the permit applicant has no reasonable access to natural bait. Compliance With Other Laws, Executive Orders, and Department Policy Regulatory Planning and Review (Executive Order 12866)

    Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

    Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

    Regulatory Flexibility Act

    This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This certification is based on the cost-benefit and regulatory flexibility analyses found in the reports entitled “Regulatory Flexibility Threshold Analysis: Special Regulations for National Park Areas in Alaska” and “Preliminary Cost/Benefit Analysis: Special Regulations for National Park Service Areas in Alaska” which can be viewed online at http://parkplanning.nps.gov/akro by clicking the link “Subsistence Uses of Horns, Antlers, Bones and Plants” and then clicking “Document List.”

    Small Business Regulatory Enforcement Fairness Act (SBREFA)

    This rule is not a major rule under 5 U.S.C. 804(2), the SBREFA. This rule:

    a. Does not have an annual effect on the economy of $100 million or more.

    b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions

    c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

    Unfunded Mandates Reform Act

    This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

    Takings (Executive Order 12630)

    This rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630. A takings implication assessment is not required.

    Federalism (Executive Order 13132)

    Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. The proposed rule is limited in effect to federal lands managed by the NPS in Alaska and would not have a substantial direct effect on state and local government in Alaska. A Federalism summary impact statement is not required.

    Civil Justice Reform (Executive Order 12988)

    This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

    (a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

    (b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

    Consultation With Tribes (E.O. 13175 and Department Policy) and ANCSA Corporations

    The Department of the Interior strives to strengthen its government-to-government relationship with federally recognized Tribes through a commitment to consultation with Tribes and recognition of self-governance and Tribal sovereignty. We have evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and Alaska Native Claims Settlement Act (ANCSA) Corporations consultation policy. Tribes were notified of the proposal regarding the subsistence collections provisions early in the process of developing the regulation. Because the provision on taking live wildlife is not a new prohibition, it will not have a substantial direct effect on federally recognized Tribes or ANCSA Corporation lands, water areas, or resources. The NPS concludes that the types of bait local rural residents can use for hunting bears will not have a substantial direct effect on federally recognized Tribes or ANCSA Corporation lands, water areas, or resources. This is based on previous consultation with Tribes on proposed restrictions related to taking wildlife, the limited nature of the restriction (hunting bears, including over bait, remains authorized), and the infrequent basis that local rural residents take bears over bait on NPS lands (records show three bears taken over bait by local rural residents between 1992-2010). Most of this limited activity has occurred in Wrangell-St. Elias National Park and Preserve. Tribes associated with Wrangell-St. Elias National Park and Preserve where invited to consult on the proposed bait restriction; no Tribes requested consultation.

    Paperwork Reduction Act (44 U.S.C. 3501 et seq.)

    This final rule does not contain any new collections of information that require approval by Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Information collection requirements associated with the requirement for the Superintendent's written authorization to collect nonedible animal parts and for the designated gatherer permit are covered under OMB Control Number 1024-0026 (expires 12/31/2016 and in accordance with 5 CFR 1320.10, the agency may continue to conduct or sponsor this collection of information while the submission is pending at OMB). We estimate the annual burden associated with this information collection to be 2.5 hours per year. Information collection requirements associated with FSB customary and traditional use determinations have been approved under OMB Control Number 1018-0075 (expires 06/30/2019). We may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    National Environmental Policy Act

    This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because we reached the FONSI. The EA and amended FONSI are available online at http://parkplanning.nps.gov/akro by clicking the link “Subsistence Uses of Horns, Antlers, Bones and Plants” and then clicking “Document List.” The other parts of this rule (collection/capture of live wildlife, bear baiting under federal subsistence regulations) are excluded from the requirement to prepare a detailed statement because they fall within the categorical exclusion covering modifications to existing regulations for NPS-administered areas that do not (a) increase public use to the extent of compromising the nature and character of the area or cause physical damage to it; (b) introduce non-compatible uses that might compromise the nature and characteristics of the area or cause physical damage to it; (c) conflict with adjacent ownerships or land uses; or (d) cause a nuisance to adjacent owners or occupants. (For further information see Section 3.3 of Director's Order #12 Handbook). We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

    Effects on the Energy Supply (Executive Order 13211)

    This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

    Drafting Information

    The primary authors of this regulation are Mary McBurney and Andee Sears of the Alaska Regional Office, National Park Service; Barbara Cellarius of Wrangell-St. Elias National Park and Preserve, National Park Service; and Jay Calhoun and Russel J. Wilson of the Division of Regulations, Washington Support Office, National Park Service.

    List of Subjects in 36 CFR Part 13

    Alaska, National parks, Reporting and recordkeeping requirements.

    In consideration of the foregoing, the National Park Service amends 36 CFR part 13 as set forth below:

    PART 13—NATIONAL PARK SYSTEM UNITS IN ALASKA 1. The authority citation for part 13 continues to read as follows: Authority:

    16 U.S.C. 3124; 54 U.S.C. 100101, 100751, 320102; Sec. 13.1204 also issued under Sec. 1035, Public Law 104-333, 110 Stat. 4240.

    2. Amend § 13.42 by adding paragraph (j) to read as follows:
    § 13.42 Taking of wildlife in national preserves.

    (j) Collecting, capturing, or possessing living wildlife is prohibited unless expressly authorized by federal statute or pursuant to § 2.5 of this chapter. A falconry permit or other permit issued by the State of Alaska does not provide the required authorization. These collecting activities are not hunting or trapping activities and therefore are not allowed in national preserves under paragraph (a) of this section. This regulation does not prohibit the use of trained raptors for hunting activities where authorized by applicable federal and state law.

    3. Amend § 13.420 by: a. Adding introductory text and the definitions of “Animal parts” and “Handicraft” in alphabetical order; and b. Revising the definition of “Subsistence uses.”

    The additions and revision read as follows:

    § 13.420 Definitions.

    The following definitions apply to this part:

    Animal parts. As used in this part, this term means nonedible antlers, horns, bones, teeth, claws, hooves, skins, hides, fur, hair, feathers, or quills that:

    (1) Are obtained from lawfully hunted or trapped fish or wildlife;

    (2) Have been shed or discarded as a result of natural life-cycle events; or

    (3) Remain on the landscape as a result of the natural mortality of fish or wildlife.

    Handicraft. As used in the part, this term has the same meaning as used in federal subsistence regulations (50 CFR part 100) except that:

    (1) The term also includes products made from plant materials; and

    (2) The term does not include a trophy or European mount of horns or antlers.

    Subsistence uses. As used in this part, this term means the customary and traditional uses by rural Alaska residents of wild, renewable resources for direct personal or family consumption as food, shelter, fuel, clothing, tools or transportation; for the making and selling of handicraftsout of nonedible byproducts of fish and wildlife resources taken for personal or family consumption; for barter or sharing for personal or family consumption; and for customary trade pursuant to Title VIII of ANILCA. Harvest of migratory birds pursuant to the Migratory Bird Treaty Act (and implementing regulations at 50 CFR part 92) and marine mammals pursuant to the Marine Mammal Protection Act Act (and implmenting regulations at 50 CFR 18.23 and 18.26) by qualified individuals is a subsistence use in accordance with this subpart. For the purposes of this subpart, the terms—

    (1) “Family” means all persons related by blood, marriage, or adoption, or any person living within the household on a permanent basis; and

    (2) “Barter” means the exchange of handicrafts or fish or wildlife or their parts taken for subsistence uses—

    (i) For other fish or game or their parts; or

    (ii) For other food or for nonedible items other than money if the exchange is of a limited and noncommercial nature; and

    (3) “Customary trade” means the exchange of handicrafts or furs for cash to support personal or family needs; and does not include trade which constitutes a significant commercial enterprise.

    4. Amend § 13.480 by: a. Designating the undesignated paragraph as paragraph (a). b. Adding paragraph (b).

    The addition reads as follows:

    § 13.480 Subsistence hunting and trapping.

    (b)(1) The following types of bait may be used to take bears for subsistence uses:

    (i) Parts of legally taken native fish or wildlife that are not required to be salvaged; or

    (ii) Remains of native fish or wildlife that died of natural causes.

    (2) The use of any other type of bait to take bears for subsistence uses is prohibited except under the terms and conditions of a permit issued under paragraph (d) of § 13.1902.

    5. Add § 13.482 to read as follows:
    § 13.482 Subsistence collection and use of animal parts.

    (a) Local rural residents may collect animal parts (excluding parts of threatened or endangered species) for subsistence uses in park areas where subsistence uses are authorized, provided that:

    (1) The resident's primary permanent residence is in an area or community with a federally recognized customary and traditional use determination for the species in the game management unit where the collecting occurs (50 CFR part 100); and

    (2) The resident has written authorization from the superintendent issued under § 1.6 of this chapter that identifies specific areas where this activity is allowed.

    (3)(i) If you are a NPS-qualified subsistence user (recipient), you may designate another NPS-qualified subsistence user to collect animal parts on your behalf in accordance with this section for the following purposes:

    (A) Making handicrafts for personal use, customary trade, or barter; or

    (B) Making handicrafts for qualified educational or cultural programs.

    (ii) The designated collector must obtain a permit from the superintendent. The designated collector may not charge the recipient for his/her services or for the collected items.

    (4) The use of paid employees to collect animal parts is prohibited. This prohibition does not apply to qualified educational or cultural programs that collect animal parts to create handicrafts, provided that the resulting handicrafts are not exchanged through barter or customary trade.

    (b) The superintendent may establish conditions, limits, and other restrictions on collection activities. Areas open to collections will be identified on a map posted on the park Web site and available at the park visitor center or park headquarters. Violating a condition, limit, or restriction is prohibited.

    6. Amend § 13.485 by: a. Revising paragraph (b); b. Redesignating paragraph (c) as paragraph (f); and c. Adding paragraphs (c), (d), and (e).

    The revision and additions read as follows:

    § 13.485 Subsistence use of timber and plant material.

    (b) The gathering by local rural residents of fruits, berries, mushrooms, and other plant materials for subsistence uses, and the gathering of dead or downed timber for firewood for noncommercial subsistence uses, shall be allowed without a permit in park areas where subsistence uses are allowed.

    (c) The gathering by local rural residents of plant materials to make handicrafts for customary trade or barter is authorized in park areas where subsistence uses are allowed in accordance with terms and conditions established by the superintendent and posted on the park Web site. The use of paid employees to collect plant materials is prohibited. This prohibition does not apply to qualified educational or cultural programs that collect plant materials to create handicrafts, provided that the resulting handicrafts are not exchanged through barter or customary trade.

    (d)(1) If you are a NPS-qualified subsistence (recipient), you may designate another NPS-qualified subsistence user to collect plants on your behalf in accordance with this section for the following purposes:

    (i) Making handicrafts for personal use, customary trade, or barter; or

    (ii) Making handicrafts for qualified educational or cultural programs.

    (2) The designated collector must obtain a permit from the superintendent. The designated collector may not charge the recipient for his/her services or for the collected items.

    (e) The superintendent may establish conditions, limits, and other restrictions on gathering activities. Violating a condition, limit, or restriction is prohibited.

    7. Amend § 13.1902 by adding paragraph (d) to read as follows:
    § 13.1902 Subsistence.

    (d) Use of bait for taking bears. (1) The superintendent may issue individual, annual permits allowing the use of human-produced food items as bait for taking bears upon a finding that:

    (i) Such use is compatible with the purposes and values for which the area was established (e.g. does not create a user conflict); and

    (ii) The permit applicant does not have reasonable access to natural bait that may be used under § 13.480(b)(1).

    (2) Permits will identify specific locations within the park area where the bait station may be established and will not include areas where the use of such materials could create a user conflict.

    Dated: December 29, 2016. Michael Bean, Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
    [FR Doc. 2016-32045 Filed 1-11-17; 8:45 am] BILLING CODE 4312-52-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 19 [FRL-9958-06-OECA] Civil Monetary Penalty Inflation Adjustment Rule AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is promulgating this final rule to adjust the level of statutory civil monetary penalty amounts under the statutes EPA administers. This action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (“the 2015 Act”). The 2015 Act prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance with the law. The rule does not necessarily revise the penalty amounts that EPA chooses to seek pursuant to its civil penalty policies in a particular case. EPA's civil penalty policies, which guide enforcement personnel in how to exercise EPA's statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator's good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and a violator's ability to pay.

    DATES:

    This final rule is effective on January 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    David Smith-Watts, Office of Civil Enforcement, Office of Enforcement and Compliance Assurance, Mail Code 2241A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460, telephone number: (202) 564-4083; [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Since 1990, Federal agencies have been required to issue regulations adjusting for inflation the statutory civil penalties 1 that can be imposed under the laws administered by that agency. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (DCIA), required agencies to review their statutory civil penalties every 4 years, and to adjust the statutory civil penalty amounts for inflation if the increase met the DCIA's adjustment methodology. In accordance with the DCIA, EPA reviewed and, as appropriate, adjusted the civil penalty levels under each of the statutes the agency implements in 1996 (61 FR 69360), 2004 (69 FR 7121), 2008 (73 FR 75340), and 2013 (78 FR 66643).

    1 The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 28 U.S.C. 2461 note, defines “civil monetary penalty” as “any penalty, fine, or other sanction that—(A)(i) is for a specific monetary amount as provided by Federal law; or (ii) has a maximum amount provided for by Federal law; and (B) is assessed or enforced by an agency pursuant to Federal law; and (C) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts.”

    The 2015 Act 2 requires agencies to: (1) Adjust the level of statutory civil penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) beginning January 15, 2017, make subsequent annual adjustments for inflation. The purpose of the 2015 Act is to maintain the deterrent effect of civil penalties by translating originally enacted statutory civil penalty amounts to today's dollars and rounding statutory civil penalties to the nearest dollar.

    2 The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701 of Pub. L. 114-74) was signed into law on Nov. 2, 2015, and further amended the Federal Civil Penalties Inflation Adjustment Act of 1990.

    As required by the 2015 Act, EPA issued a catch up rule on July 1, 2016, which was effective August 1, 2016 (81 FR 43091). This rule implements the annual penalty inflation adjustments mandated by the 2015 Act. Beginning in 2017, Section 4 of the 2015 Act requires each federal agency to publish annual adjustments to all civil penalties under the laws implemented by that agency. These annual adjustments are required to be published by January 15 of each year. The 2015 Act describes the method for calculating the adjustments. Each statutory maximum civil monetary penalty is multiplied by the cost-of-living adjustment, which is the percentage by which the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October 2016 exceeds the CPI-U for the month of October 2015.

    With this rule, the new statutory maximum (or minimum 3 ) penalty levels listed in Table 2 to 40 CFR 19.4 will apply to all statutory civil penalties assessed on or after January 15, 2017, for violations that occurred after November 2, 2015, when the 2015 Act was enacted. The statutory civil penalty levels, as codified at Table 1 to 40 CFR 19.4, will continue to apply to: (1) Violations that occurred on or before November 2, 2015, and (2) violations that occurred after November 2, 2015, where the penalty assessment was made prior to August 1, 2016.

    3 Under Section 3(2)(A) of the 2015 Act, “civil monetary penalty” means “a specific monetary amount as provided by Federal law”; or “has a maximum amount provided for by Federal law.” EPA-administered statutes generally refer to statutory maximum penalties, with the following exceptions: Section 311(b)(7)(D) of the Clean Water Act, 33 U.S.C. 1321(b)(7)(D), refers to a minimum penalty of “not less than $100,000 . . .”; Section 104B(d)(1) of the Marine Protection, Research, and Sanctuaries Act, 33 U.S.C. 1414b(d)(1), refers to an exact penalty of $600 “[f]or each dry ton (or equivalent) of sewage sludge or industrial waste dumped or transported by the person in violation of this subsection in calendar year 1992. . .”; and Section 325(d)(1) of the Emergency Planning and Community Right-to-Know Act, 42 U.S.C. 11045(d)(1), refers to an exact civil penalty of $25,000 for each frivolous trade secret claim.

    The formula for determining the cost-of-living or inflation adjustment to statutory civil penalties consists of the following steps:

    Step 1: The cost-of-living adjustment multiplier for 2017, based on the CPI-U of October 2016, is 1.01636.4 Multiply 1.01636 by the current penalty amount. This is the raw adjusted penalty value.

    4 Office of Management and Budget Memorandum, Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (OMB Memorandum M-17-11) at p. 1 (December 16, 2016).

    Step 2: Round the raw adjusted penalty value. Section 5 of the 2015 Act states that any adjustment shall be rounded to the nearest multiple of $1. The result is the final penalty value for the year.

    II. The 2015 Act Requires Federal Agencies To Publish Annual Penalty Inflation Adjustments Notwithstanding Section 553 of the Administrative Procedures Act

    Section 4 of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15, 2017. In accordance with section 553 of the Administrative Procedures Act (APA), most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, Section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB guidance issued to Federal agencies on the implementation of the 2017 annual adjustment,5 the phrase “notwithstanding section 553” means that “the public procedure the APA generally provides—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.” Consistent with the language of the 2015 Act and OMB's implementation guidance, this rule is not subject to notice and an opportunity for public comment and will be effective immediately upon publication.

    5See OMB Memorandum M-17-11 at p. 3.

    III. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866, OMB determined this final rule to be a “non-significant” regulatory action and, therefore, it did not undergo interagency review.6

    6See OMB Memorandum M-17-11 at p. 3.

    B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA. This rule merely increases the level of statutory civil penalties that could be imposed in the context of a Federal civil administrative enforcement action or civil judicial case for violations of EPA-administered statutes and their implementing regulations.

    C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. Because the 2015 Act directs Federal agencies to publish this rule notwithstanding section 553 of the APA, this rule is not subject to notice and comment requirements or the RFA.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action is required by the 2015 Act, without the exercise of any policy discretion by EPA. This action also imposes no enforceable duty on any state, local or tribal governments or the private sector. Because the calculation of any increase is formula-driven pursuant to the 2015 Act, EPA has no policy discretion to vary the amount of the adjustment.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have a substantial direct effect on the states, or on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. This rule merely reconciles the real value of current statutory civil penalty levels to reflect and keep pace with the levels originally set by Congress when the statutes were enacted. The calculation of the increases is formula-driven and prescribed by statute, and EPA has no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, this rule will not have a substantial direct effect on tribal governments, 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.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

    H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act

    The rule does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. Rather, this action is mandated by the 2015 Act, which prescribes a formula for adjusting statutory civil penalties on an annual basis to reflect inflation.

    K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency finds that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The 2015 Act directs Federal agencies to publish their annual penalty inflation adjustments “notwithstanding section 553 [of the APA].” Because OMB has instructed Federal agencies that this provision means that “notice, an opportunity for comment, and a delay in the effective date” are not required for agencies to issue regulations implementing the annual adjustment,7 EPA finds that the APA's notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest.

    7See OMB Memorandum M-17-11 at p. 3.

    List of Subjects in 40 CFR Part 19

    Environmental protection, Administrative practice and procedure, Penalties.

    Dated: January 3, 2017. Gina McCarthy, Administrator.

    For the reasons set out in the preamble, EPA amends title 40, chapter I, part 19 of the Code of Federal Regulations as follows:

    PART 19—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION 1. The authority citation for part 19 continues to read as follows: Authority:

    Pub. L. 101-410, Oct. 5, 1990, 104 Stat. 890, as amended by Pub. L. 104-134, title III, sec. 31001(s)(1), Apr. 26, 1996, 110 Stat. 1321-373; Pub. L. 105-362, title XIII, sec. 1301(a), Nov. 10, 1998, 112 Stat. 3293; Pub. L. 114-74, title VII, sec. 701(b), Nov. 2, 2015, 129 Stat. 599.

    2. Revise § 19.2 to read as follows:
    § 19.2 Effective date.

    The penalty levels in the last column of Table 1 to § 19.4 apply to all violations which occurred after December 6, 2013 through November 2, 2015, and to violations occurring after November 2, 2015, where penalties are assessed before August 1, 2016. The statutory civil penalty levels set forth in the fourth column of Table 2 to § 19.4 apply to all violations which occur after November 2, 2015, where the penalties are assessed on or after August 1, 2016 and before January 15, 2017. The statutory civil penalty levels set forth in the last column of Table 2 to § 19.4 apply to all violations which occur after November 2, 2015, where the penalties are assessed on or after January 15, 2017.

    3. Amend § 19.4 by revising the introductory text and Table 2 to read as follows:
    § 19.4 Statutory civil penalties, as adjusted for inflation, and tables.

    Table 1 to § 19.4 sets out the statutory civil penalty provisions of statutes administered by EPA, with the original statutory civil penalty levels, as enacted, and the operative statutory civil penalty levels, as adjusted for inflation, for violations occurring on or before November 2, 2015, and for violations occurring after November 2, 2015, where penalties are assessed before August 1, 2016. Table 2 sets out the statutory civil penalty provisions of statutes administered by EPA, with the third column displaying the original statutory civil penalty levels, as enacted. The fourth column of Table 2 displays the operative statutory civil penalty levels where penalties are assessed on or after August 1, 2016 but before January 15, 2017, for violations that occurred after November 2, 2015; the last column displays the operative statutory civil penalty levels where penalties are assessed on or after January 15, 2017, for violations that occurred after November 2, 2015.

    Table 2 of Section 19.4—Civil Monetary Penalty Inflation Adjustments U.S. Code citation Environmental statute Statutory civil penalties, as enacted Statutory civil penalties for violations that occurred after November 2, 2015 and assessed on or after August 1, 2016 but before January 15, 2017 Statutory civil penalties for violations that occurred after November 2, 2015 and assessed on or after January 15, 2017 7 U.S.C. 136l.(a)(1) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) $5,000 $18,750 $19,057 7 U.S.C. 136l.(a)(2) 1 FIFRA $1,000/$500/$1,000 $2,750/$1,772/$2,750 $2,795/$1,801/$2,795 15 U.S.C. 2615(a)(1) Toxic Substances Control Act (TSCA) $25,000 $37,500 $38,114 15 U.S.C. 2647(a) TSCA $5,000 $10,781 $10,957 15 U.S.C. 2647(g) TSCA $5,000 $8,908 $9,054 31 U.S.C. 3802(a)(1) Program Fraud Civil Remedies Act (PFCRA) $5,000 $10,781 $10,957 31 U.S.C. 3802(a)(2) PFCRA $5,000 $10,781 $10,957 33 U.S.C. 1319(d) Clean Water Act (CWA) $25,000 $51,570 $52,414 33 U.S.C. 1319(g)(2)(A) CWA $10,000/$25,000 $20,628/$51,570 $20,965/$52,414 33 U.S.C. 1319(g)(2)(B) CWA $10,000/$125,000 $20,628/$257,848 $20,965/$262,066 33 U.S.C. 1321(b)(6)(B)(i) CWA $10,000/$25,000 $17,816/$44,539 $18,107/$45,268 33 U.S.C. 1321(b)(6)(B)(ii) CWA $10,000/$125,000 $17,816/$222,695 $18,107/$226,338 33 U.S.C. 1321(b)(7)(A) CWA $25,000/$1,000 $44,539/$1,782 $45,268/$1,811 33 U.S.C. 1321(b)(7)(B) CWA $25,000 $44,539 $45,268 33 U.S.C. 1321(b)(7)(C) CWA $25,000 $44,539 $45,268 33 U.S.C. 1321(b)(7)(D) CWA $100,000/$3,000 $178,156/$5,345 $181,071/$5,432 33 U.S.C. 1414b(d)(1) Marine Protection, Research, and Sanctuaries Act (MPRSA) $600 $1,187 $1,206 33 U.S.C. 1415(a) MPRSA $50,000/$125,000 $187,500/$247,336 $190,568/$251,382 33 U.S.C. 1901 note (see 1409(a)(2)(A)) Certain Alaskan Cruise Ship Operations (CACSO) $10,000/$25,000 $13,669/$34,172 $13,893/$34,731 33 U.S.C. 1901 note (see 1409(a)(2)(B)) CACSO $10,000/$125,000 $13,669/$170,861 $13,893/$173,656 33 U.S.C. 1901 note (see 1409(b)(1)) CACSO $25,000 $34,172 $34,731 33 U.S.C. 1908(b)(1) Act To Prevent Pollution From Ships (APPS) $25,000 $70,117 $71,264 33 U.S.C. 1908(b)(2) APPS $5,000 $14,023 $14,252 42 U.S.C. 300g-3(b) Safe Drinking Water Act (SDWA) $25,000 $53,907 $54,789 42 U.S.C. 300g-3(g)(3)(A) SDWA $25,000 $53,907 $54,789 42 U.S.C. 300g-3(g)(3)(B) SDWA $5,000/$25,000 $10,781/$37,561 $10,957/$38,175 42 U.S.C. 300g-3(g)(3)(C) SDWA $25,000 $37,561 $38,175 42 U.S.C. 300h-2(b)(1) SDWA $25,000 $53,907 $54,789 42 U.S.C. 300h-2(c)(1) SDWA $10,000/$125,000 $21,563/$269,535 $21,916/$273,945 42 U.S.C. 300h-2(c)(2) SDWA $5,000/$125,000 $10,781/$269,535 $10,957/$273,945 42 U.S.C. 300h-3(c) SDWA $5,000/$10,000 $18,750/$40,000 $19,057/$40,654 42 U.S.C. 300i(b) SDWA $15,000 $22,537 $22,906 42 U.S.C. 300i-1(c) SDWA $100,000/$1,000,000 $131,185/$1,311,850 $133,331/$1,333,312 42 U.S.C. 300j(e)(2) SDWA $2,500 $9,375 $9,528 42 U.S.C. 300j-4(c) SDWA $25,000 $53,907 $54,789 42 U.S.C. 300j-6(b)(2) SDWA $25,000 $37,561 $38,175 42 U.S.C. 300j-23(d) SDWA $5,000/$50,000 $9,893/$98,935 $10,055/$100,554 42 U.S.C. 4852d(b)(5) Residential Lead-Based Paint Hazard Reduction Act of 1992 $10,000 $16,773 $17,047 42 U.S.C. 4910(a)(2) Noise Control Act of 1972 $10,000 $35,445 $36,025 42 U.S.C. 6928(a)(3) Resource Conservation and Recovery Act (RCRA) $25,000 $93,750 $95,284 42 U.S.C. 6928(c) RCRA $25,000 $56,467 $57,391 42 U.S.C. 6928(g) RCRA $25,000 $70,117 $71,264 42 U.S.C. 6928(h)(2) RCRA $25,000 $56,467 $57,391 42 U.S.C. 6934(e) RCRA $5,000 $14,023 $14,252 42 U.S.C. 6973(b) RCRA $5,000 $14,023 $14,252 42 U.S.C. 6991e(a)(3) RCRA $25,000 $56,467 $57,391 42 U.S.C. 6991e(d)(1) RCRA $10,000 $22,587 $22,957 42 U.S.C. 6991e(d)(2) RCRA $10,000 $22,587 $22,957 42 U.S.C. 7413(b) Clean Air Act (CAA) $25,000 $93,750 $95,284 42 U.S.C. 7413(d)(1) CAA $25,000/$200,000 $44,539/$356,312 $45,268/$362,141 42 U.S.C. 7413(d)(3) CAA $5,000 $8,908 $9,054 42 U.S.C. 7524(a) CAA $25,000/$2,500 $44,539/$4,454 $45,268/$4,527 42 U.S.C. 7524(c)(1) CAA $200,000 $356,312 $362,141 42 U.S.C. 7545(d)(1) CAA $25,000 $44,539 $45,268 42 U.S.C. 9604(e)(5)(B) Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) $25,000 $53,907 $54,789 42 U.S.C. 9606(b)(1) CERCLA $25,000 $53,907 $54,789 42 U.S.C. 9609(a)(1) CERCLA $25,000 $53,907 $54,789 42 U.S.C. 9609(b) CERCLA $25,000/$75,000 $53,907/$161,721 $54,789/$164,367 42 U.S.C. 9609(c) CERCLA $25,000/$75,000 $53,907/$161,721 $54,789/$164,367 42 U.S.C. 11045(a) Emergency Planning and Community Right-To-Know Act (EPCRA) $25,000 $53,907 $54,789 42 U.S.C. 11045(b)(1)(A) EPCRA $25,000 $53,907 $54,789 42 U.S.C. 11045(b)(2) EPCRA $25,000/$75,000 $53,907/$161,721 $54,789/$164,367 42 U.S.C. 11045(b)(3) EPCRA $25,000/$75,000 $53,907/$161,721 $54,789/$164,367 42 U.S.C. 11045(c)(1) EPCRA $25,000 $53,907 $54,789 42 U.S.C. 11045(c)(2) EPCRA $10,000 $21,563 $21,916 42 U.S.C. 11045(d)(1) EPCRA $25,000 $53,907 $54,789 42 U.S.C. 14304(a)(1) Mercury-Containing and Rechargeable Battery Management Act (Battery Act) $10,000 $15,025 $15,271 42 U.S.C. 14304(g) Battery Act $10,000 $15,025 $15,271 1 Note that 7 U.S.C. 136l.(a)(2) contains three separate statutory maximum civil penalty provisions. The first mention of $1,000 and the $500 statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L. 95-396), and the second mention of $1,000 was enacted in 1972 (Pub. L. 92-516).
    [FR Doc. 2017-00160 Filed 1-11-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2014-0431; FRL-9957-93-Region 4] Approval and Promulgation of Implementation Plans; Alabama; Infrastructure Requirements or the 2010 Sulfur Dioxide National Ambient Air Quality Standard AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve in part and disapprove in part portions of the April 23, 2013, State Implementation Plan (SIP) submission, submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), for inclusion into the Alabama SIP. This final action pertains to the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour sulfur dioxide (SO2) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure SIP submission.” ADEM certified that the Alabama SIP contains provisions that ensure the 2010 1-hour SO2 NAAQS is implemented, enforced, and maintained in Alabama. EPA has determined that portions of Alabama's infrastructure SIP submission, provided to EPA on April 23, 2013, satisfy certain required infrastructure elements for the 2010 1-hour SO2 NAAQS.

    DATES:

    This rule will be effective February 13, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2014-0431. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Michele Notarianni, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Ms. Notarianni can be reached via electronic mail at [email protected] or via telephone at (404) 562-9031.

    SUPPLEMENTARY INFORMATION:

    I. Background and Overview

    On June 2, 2010 (75 FR 35520, June 22, 2010), EPA revised the primary SO2 NAAQS to an hourly standard of 75 parts per billion (ppb) based on a 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2010 1-hour SO2 NAAQS to EPA no later than June 2, 2013.

    EPA is taking final action to approve Alabama's April 23, 2013, submission that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2010 1-hour SO2 NAAQS, with the exception of interstate transport provisions pertaining to visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4) and the state board requirements of section 110(a)(2)(E)(ii). With respect to the visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4), EPA is not finalizing any action at this time regarding this requirement. With respect to Alabama's infrastructure SIP submission related to section 110(a)(2)(E)(ii) requirements respecting the section 128 state board requirements, EPA is finalizing a disapproval of this element of Alabama's submission in this rulemaking.

    In a proposed rulemaking published on July 14, 2016, EPA proposed to approve in part and disapprove in part Alabama's 2010 1-hour SO2 NAAQS infrastructure SIP submission submitted on April 23, 2013. See 81 FR 45428. The details of Alabama's submission and the rationale for EPA's actions are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before August 15, 2016. EPA received adverse comments on the proposed action.

    II. Response to Comments

    EPA received two sets of comments, one of which was incomplete and therefore could not be addressed, on the July 14, 2016, proposed rulemaking on Alabama's 2010 1-hour SO2 NAAQS infrastructure SIP submission. A summary of the complete comment and EPA's response is provided below. A full set of these comments is provided in the docket for today's final rulemaking action.

    Comment: The Commenter stated that EPA must disapprove element 110(a)(2)(C) unless Alabama's SIP provides that no new minor source or minor modification of a major source can cause or contribute to a violation of any NAAQS.

    Response: EPA agrees that section 110(a)(2)(C) and the minor new source regulations at 40 CFR 51.160 through 51.164 require SIPs to includes procedures to prevent the construction of new minor sources and minor modifications of major sources if the new or modified source will interfere with attainment or maintenance of a NAAQS. EPA explained its approach to reviewing the minor source element of 110(a)(2)(C) in its proposed rulemaking for this action: “Thus, EPA evaluates whether the state has an EPA-approved minor NSR program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.” See 81 FR 45431-45432 (July 14, 2016). In its 2010 1-hour SO2 NAAQS infrastructure SIP submission, Alabama certified that its SIP contains provisions to address the 110(a)(2)(C) requirements regarding new minor sources and modifications, and, as noted in EPA's proposed rulemaking, the following SIP-approved rules address the minor source element of section 110(a)(2)(C): ADEM Admin. Code r. 335-3-14-.01 General Provisions, 335-3-14-.02 Permit Procedure, and 335-3-14-.03—Standards for Granting Permits. These SIP-approved rules address NAAQS pollutants including SO2. While the Commenter did not specifically object to any aspect of Alabama's SIP submission with respect section 110(a)(2)(C), EPA notes that Alabama's SIP addresses this non-interference component for the minor new source/minor modification permitting element. Specifically relevant to this comment, these SIP-approved rules include provisions to prohibit the issuance of construction permits if the source at issue would result in a violation of any air quality standard. See ADEM Admin. Code r. 335-3-14-.03(1)(g).

    III. Final Action

    With the exception of interstate transport provisions pertaining to visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4), and the state board requirements of section 110(a)(2)(E)(ii), EPA is taking final action to approve Alabama's infrastructure submission submitted on April 23, 2013, for the 2010 1-hour SO2 NAAQS for the above described infrastructure SIP requirements. EPA is taking final action to approve Alabama's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS because the submission is consistent with section 110 of the CAA. EPA is finalizing disapproval of section 110(a)(2)(E)(ii) of Alabama's infrastructure submission because the State's implementation plan does not contain provisions to comply with section 128 of the Act, and thus Alabama's April 23, 2013, infrastructure SIP submission does not meet the requirements of the Act.

    Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of a CAA Part D Plan, or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP call), starts a sanctions clock. The portion of section 110(a)(2)(E)(ii) provisions (the provisions disapproved in today's notice) were not submitted to meet requirements for Part D or a SIP call, and therefore, no sanctions will be triggered. However, that final action will trigger the requirement under section 110(c) that EPA promulgate a Federal Implementation Plan (FIP) no later than two years from the date of this disapproval unless the State corrects the deficiency, and EPA approves the plan or plan revision before EPA promulgates such FIP.

    IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

    • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

    • does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 13, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: December 20, 2016. Heather McTeer Toney, Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart B—Alabama 2. Section 52.50(e) is amended by adding a new entry “110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour SO2 National Ambient Air Quality Standard” at the end of the table to read as follows:
    § 52.50 Identification of plan.

    (e) * * *

    EPA-Approved Alabama Non-Regulatory Provisions Name of nonregulatory SIP provision Applicable geographic or nonattainment area State
  • submittal date/effective date
  • EPA approval date Explanation
    *         *         *         *         *         *         * 110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour SO2 NAAQS Alabama 4/23/2013 1/12/2017, [Insert Federal Register page citation] With the exception of interstate transport requirements of section 110(a)(2)(D)(i)(II) (prong 4), and the state board requirements of section 110(a)(2)(E)(ii).
    3. Section 52.53 is amended by adding paragraph (d) to read as follows:
    § 52.53 Approval status.

    (d) Disapproval. Submittal from the State of Alabama, through the Alabama Department of Environmental Management (ADEM) on April 23, 2013, to address the Clean Air Act section 110(a)(2)(E)(ii) for the 2010 1-hour sulfur dioxide (SO2) National Ambient Air Quality Standards (NAAQS) concerning state board requirements. EPA is disapproving section 110(a)(2)(E)(ii) of ADEM's submittal because the Alabama SIP lacks provisions respecting state boards per section 128 of the CAA for the 2010 1-hour SO2 NAAQS.

    [FR Doc. 2017-00159 Filed 1-11-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2015-0252; FRL-9957-90-Region 4] Air Plan Approval; TN Infrastructure Requirements for the 2010 NO2 NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action on portions of the State Implementation Plan (SIP) submission, submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), on March 13, 2014, to demonstrate that the State meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 nitrogen dioxide (NO2) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP submission. TDEC certified that the Tennessee SIP contains provisions that ensure the 2010 NO2 NAAQS is implemented, enforced, and maintained in Tennessee. EPA has determined that portions of Tennessee's infrastructure SIP submission, provided to EPA on March 13, 2014, satisfies the certain required infrastructure elements for the 2010 NO2 NAAQS.

    DATES:

    This rule will be effective February 13, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0252. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Wong can be reached via electronic mail at [email protected] or via telephone at (404) 562-8726.

    SUPPLEMENTARY INFORMATION:

    I. Background and Overview

    On February 9, 2010 (75 FR 6474), EPA published a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion (ppb), based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2010 1-hour NO2 NAAQS to EPA no later than January 22, 2013.

    In a proposed rulemaking published on July 14, 2016, EPA proposed to approve Tennessee's infrastructure SIP submission for the applicable requirements of the 2010 1-hour NO2 NAAQS, with the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J), and the interstate transport provisions of prongs 1, 2, and 4 of section 110(a)(2)(D)(i). On March 18, 2015, EPA approved Tennessee's March 13, 2014, infrastructure SIP submission regarding the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2010 1-hour NO2 NAAQS. See 80 FR 14019. Therefore, EPA is not taking any action today pertaining to these requirements. With respect to the interstate transport requirements of section 110(a)(2)(D)(i)(I) (prongs 1 and 2), EPA does not yet have a submission before the Agency for action. Additionally, EPA will address prong 4 element of Tennessee's March 13, 2014, SIP submission for the 2010 1-hour NO2 NAAQS through a separate rulemaking. The details of Tennessee's submission and the rationale for EPA's action are explained in the proposed rulemaking.

    II. Response to Comment

    Comments on the proposed rulemaking were due on or before July 28, 2016. EPA received one comment, which is summarized below, on the proposed action.

    Comment: The Commenter stated that EPA must disapprove element 110(a)(2)(C) unless Tennessee's SIP provides that no new minor source or minor modification of a major source can cause or contribute to a violation of any NAAQS.

    Response: EPA agrees that section 110(a)(2)(C) and the minor new source regulations at 40 CFR 51.160 through 51.164 require SIPs to includes procedures to prevent the construction of new minor sources and minor modifications of major sources if the new or modified source will interfere with attainment or maintenance of a NAAQS. EPA explained its approach to reviewing the minor source element of 110(a)(2)(C) in its proposed rulemaking for this action: “EPA evaluates whether the state has an EPA-approved minor new source review program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.” See 81 FR 45441 (July 14, 2016). In its 2010 1-hour NO2 NAAQS infrastructure SIP submission, Tennessee certified that its SIP contains provisions to address the 110(a)(2)(C) requirements regarding new minor sources and modifications, and, as noted in EPA's proposed rulemaking, the following SIP-approved rules address the minor source element of section 110(a)(2)(C): Tennessee Air Pollution Control Regulations 1200-03-09-.01, Construction Permits, and 1200-03-09-.03, General Provisions. These SIP-approved rules address NAAQS pollutants including NO2. While the Commenter did not specifically object to any aspect of Tennessee's SIP submission with respect section 110(a)(2)(C), EPA notes that Tennessee's SIP addresses this non-interference component for the minor new source/minor modification permitting element. Specifically relevant to this comment, these SIP-approved rules include provisions to prohibit the issuance of construction permits if the source at issue would result in a violation of any air quality standard. See Regulation 1200-03-09-.01(1)(e).

    III. Final Action

    With the exception of the preconstruction PSD permitting requirements for major sources of section 110(a)(2)(C), prong 3 of (D)(i), and (J), and the interstate transport provisions pertaining to visibility of prong 4 of section 110(a)(2)(D)(i), EPA is taking final action to approve that Tennessee's March 13, 2014, SIP submission for the 2010 1-hour NO2 NAAQS because the submission is consistent with section 110 of the CAA.

    IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

    • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

    • does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 13, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: December 20, 2016. Heather McTeer Toney, Regional Administrator, Region 4.

    For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart RR—Tennessee 2. Section 52.2220(e) is amended by adding a new entry “110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour NO2 NAAQS” at the end of the table to read as follows:
    § 52.2220 Identification of plan.

    (e) * * *

    EPA-Approved Tennessee Non-Regulatory Provisions Name of nonregulatory SIP provision Applicable
  • geographic or
  • nonattainment
  • area
  • State effective date EPA approval date Explanation
    *         *         *         *         *         *         * 110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour NO2 NAAQS Tennessee 03/13/2014 1/12/2017, [Insert citation of publication] With the exception of sections:
  • 110(a)(2)(C) and (J) concerning PSD permitting requirements and;
  • 110(a)(2)(D)(i) (prongs 1 through 4) concerning interstate transport requirements.
  • [FR Doc. 2017-00161 Filed 1-11-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 704 [EPA-HQ-OPPT-2010-0572; FRL-9957-81] RIN 2070-AJ54 Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    EPA is establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale as described in this rule. Specifically, EPA is requiring persons that manufacture (defined by statute to include import) or process, or intend to manufacture or process these chemical substances to electronically report to EPA certain information, which includes insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. This rule involves one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials before those new forms are manufactured or processed.

    DATES:

    This final rule is effective May 12, 2017.

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0572, is available electronically at http://www.regulations.gov or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. 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 OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Jim Alwood, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. Who does this action apply to?

    You may be potentially affected by this action if you manufacture or process or intend to manufacture or process nanoscale forms (forms with particle sizes of 1-100 nm) of certain chemical substances as defined in section 3 of TSCA. You are not manufacturing or processing a TSCA chemical substance when you are manufacturing or processing a chemical for use as, e.g., a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug, cosmetic or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act). However, persons that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research and development will not be subject to this action. In addition, the discussion in Unit III. describes in more detail which chemical substances will and will not be subject to reporting under the rule. You may also consult 40 CFR 704.3 and 704.5, as well as the regulatory text in this document, for further information on the applicability of these and other exemptions to this rule.

    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 may apply to them:

    • Chemical Manufacturing or Processing (NAICS codes 325).

    • Synthetic Dye and Pigment Manufacturing (NAICS code 325130).

    • Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).

    • Rolled Steel Shape Manufacturing (NAICS code 331221).

    • Semiconductor and Related Device Manufacturing (NAICS code 334413).

    • Carbon and Graphite Product Manufacturing (NAICS code 335991).

    • Home Furnishing Merchant Wholesalers (NAICS code 423220).

    • Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330).

    • Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510).

    B. What action is the Agency taking?

    On April 6, 2015 (80 FR 18330; FRL-9920-90) (Ref. 1), EPA proposed reporting and recordkeeping requirements for persons that manufacture (including import) or process certain chemical substances as described in the proposed rule. EPA received numerous public comments and conducted a public meeting on June 11, 2015 to obtain additional public input. This final rule is based on that proposal and the consideration of the public comments received.

    This TSCA section 8(a) rule requires one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information; as well as keeping records of this information for 3 years. EPA is finalizing the proposed requirements with changes to the definition of a reportable chemical substance, including a definition of unique and novel properties and a numerical value to replace the proposed term of trace amounts. There are also additional exemptions to reporting for certain biological materials, while zinc oxide and nanoclays are no longer exempt from reporting. The definition of a small manufacturer or processor exempt from reporting requirements has been changed. These changes, the reasons for the changes, and other clarifications are discussed in more detail in Unit III. EPA has also prepared a detailed response to public comments document (Ref. 2) that is available in the docket. EPA's responses to some of those comments are summarized in Unit III.

    C. Why is the Agency taking this action?

    These reporting and recordkeeping requirements will assist EPA in its continuing evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence. As with current new chemical reviews of chemical substances manufactured at the nanoscale, each nanoscale material derived from substances on the TSCA inventory would be evaluated on a case-by-case basis without a presumption of either harm or safety. Any evaluation will be based on the specific nanoscale material's own properties and those of any structural analogs.

    As indicated in the proposed rule, the requirements of the rule are not based on an assumption that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely to cause harm to people or the environment. Rather, any information gathered under this rule will facilitate EPA's determination of whether further action, including additional information collection, is needed for that specific nanoscale material. Consistent with the President's memorandums for Executive Agencies regarding Principles for Regulation and Oversight of Emerging Technologies and U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials (Ref. 3), this rule will facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.

    In addition, EPA will not publish an inventory of chemical substances manufactured at the nanoscale based on the information that will be collected pursuant to the rule. EPA will make non-confidential information reported under the rule available in ChemView (see http://www.epa.gov/chemview/).

    D. What is the Agency's authority for taking this action?

    As described in more detail in Unit II.A. of the proposed rule, the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA), 15 U.S.C. 2601 et seq., provides EPA with authority to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances and/or mixtures. The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public.

    EPA is issuing this rule under TSCA section 8(a), 15 U.S.C. 2607(a), in compliance with the requirements of section 8(a)(5). Under TSCA section 8(a)(5)(A) EPA is to the extent feasible: (A) Not require reporting which is unnecessary or duplicative; (B) minimize the cost of compliance with this section and the rules issued thereunder on small manufacturers and processors; and (C) apply any reporting obligations to those persons likely to have information relevant to the effective implementation of TSCA. As noted in the response to comments several elements of this rule address duplicative reporting such as the exemption for chemical substances that are nanoscale materials that have already been reported under section 5 of TSCA and for the exemption for information already submitted under the Nanoscale Materials Stewardship Program. The response also explains why this rule does not duplicate chemical data reporting (CDR) under 40 CFR part 711. EPA's economic analysis demonstrated that this rule would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is summarized in Unit V.C. of this rule and is presented in the small entity impact analysis that EPA prepared for this action as part of the Agency's economic analysis in the public docket for this rule. This rule focuses on manufacturers and processors of chemical substances as nanoscale materials with unique and novel properties which are the persons likely to have relevant information on nanoscale materials in commerce.

    E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of this reporting and recordkeeping requirement for manufacturers and processors. This analysis (Ref. 4), which is available in the docket, is briefly summarized here.

    Industry is conservatively estimated to incur a burden of approximately 360,000 hours in the first year and 40,100 hours in subsequent years, with costs of approximately $27.79 million and $3.09 million, respectively (see Chapter 3 in Ref. 4), while the Agency is expected to use approximately 16,300 hours in the first year and 1,800 hours in subsequent years, with costs of approximately $1.34 million and $0.15 million respectively (see Chapter 4 in Ref. 4). Discounted over a 10-year period at three and seven percent, total annualized social costs are estimated to be approximately $5.71 million and $6.26 million, respectively. (Ref. 4).

    II. Overview of the Final Rule

    EPA is describing in this unit the reporting and recordkeeping requirements for manufacturers and processors of certain chemical substances pursuant to TSCA section 8(a). A processor is someone who prepares a chemical substance or mixture after its manufacture for distribution in commerce. Processor activities include a variety of activities. Some examples of processing of a chemical substance are developing or modifying formulations for additional processing or use in commercial applications, incorporating a chemical substance into articles, and using the chemical substance to form other chemical substances.

    A. What chemical substances are reportable under this rule?

    1. Reportable chemical substances. This rule applies to chemical substances, as defined in section 3 of TSCA, that are solids at 25 °C and standard atmospheric pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers (nm) in at least one dimension; and that are manufactured or processed to exhibit one or more unique and novel properties. This rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm. These parameters are for purposes of identifying chemical substances that are subject to the rule and do not establish a definition of nanoscale material.

    EPA added a definition of unique and novel properties in the definitions section of the regulatory text (See 704.20(a)). Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size. A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also demonstrate a size-dependent property different from properties at sizes greater than 100 nm and is a reason the chemical is manufactured or processed in that form or size. Chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm are not reportable chemical substances. EPA used “trace amounts” in the proposed rule to define this concept. However, based on the public comments to better define trace amounts including several comments to establish a numerical value, EPA is now using a numerical value of less than 1% of particles from 1-100 nm by weight to define those chemical substances that are not reportable.

    i. Discrete forms. Manufacturers and processors of multiple nanoscale forms of the same chemical substance will, in some cases, need to report separately for each discrete form of the reportable chemical substance. Reporting of these discrete forms are not the same as new chemical reporting under TSCA section 5. The rule distinguishes between discrete forms in three different ways. The first is based on a combination of three factors: (1) A change in process to effect a change in size, a change in properties of the chemical substances manufactured at the nanoscale, or both; (2) a change in mean particle size greater than 7 times the standard deviation of the measured values (±7 times the standard deviation); and (3) the change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values (±7 times the standard deviation).

    For example, if the specific surface area of one discrete form was measured to be 50 m2/g with a standard deviation of ±5 m2/g, then a change resulting in a new average specific surface area of 85 m2/g would result in a discrete form of a reportable chemical substance, if factors 1 and 2 were also met. While testing is not required, if performing the test EPA recommends using the same test medium and method when measuring the change in these properties, as even minor changes in the medium and methods can result in large differences in the measured results. EPA's intent for these reporting requirements is to focus reporting on chemical substances on the TSCA inventory that are intentionally manufactured at the nanoscale.

    It is the combination of the above three factors, rather than simply size, which distinguishes between different forms of a chemical substance manufactured at the nanoscale, so that unintended variation in size range between production batches does not trigger separate reporting for each batch. The rule does not rely solely on process changes because there may be process changes that are not intended to change the material produced, but rather are intended to improve the efficiency of the process or to use a less expensive reactant. EPA is focusing on the properties of zeta potential, specific surface area, dispersion stability, and surface reactivity because these properties are of particular interest in health and safety evaluation. Other properties of chemical substances manufactured at the nanoscale (e.g., the wavelength at which light is emitted) may be important for how that form of the chemical substance functions but are less likely to be relevant to hazard, fate, exposure, or risk. The combination of the above three factors provides a clear and transparent way to distinguish among discrete forms of chemical substances manufactured at the nanoscale for purposes of TSCA section 8(a) reporting.

    For the purposes of this rule, specific surface area is the ratio of the surface area of the nanoscale material to its mass (m2/kg), or the area of the surface of the nanoscale material divided by volume (m2/m3). This is an important factor because chemical reactions take place at the surface of the material. Thus, the higher the surface area, the greater the chemical reactivity, which is an important consideration for human health toxicity and environmental toxicity assessments.

    Zeta potential is the electrostatic potential near the particle surface. It can be measured using various methods. See the International Organization for Standardization (ISO) ISO/TR 13014:2012 “Guidance on Physicochemical Characterization for Manufactured Nano-objects Submitted for Toxicological Testing” (Ref. 5) and the description of zeta potential by Colloidal Dynamics (Ref. 6) for examples. It is typically measured by electrophoresis. This is also an important factor as it measures chemical reactivity at the particle surface.

    Dispersion stability is the ability of a dispersion to resist changes in properties over time and can be defined in terms of the change in one or more physical properties over a given time period. See ISO/TR 13097:2013 “Guidelines for characterization of dispersion stability” (Ref. 7) as an example. Changes in dispersion stability affect physical properties that in turn can affect the environmental fate and hazard properties of a chemical substance.

    Surface reactivity is the degree to which the nanoscale material will react with biological systems. The surface reactivity of the form of a chemical substance is dependent upon factors such as redox potential, which is a measure of the tendency of a chemical species to lose or acquire electrons, and photocatalytic activity, including the potential to generate free radicals. Reactive oxygen species and free radicals are important in considering toxicity for these materials.

    The second way of distinguishing a discrete nanoscale form of a particular chemical substance is by morphology or shape. Examples include spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and sheets. The third way is that forms of a reportable chemical substance that are coated with different chemical substances would be considered discrete forms for each chemical coating.

    ii. Chemical mixtures. Chemical substances that are manufactured or processed in a nanoscale form for the purposes of being sold to others for use as a component of a mixture, encapsulated material, or composite are subject to reporting. Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials or composites by that manufacturer do not require separate reporting for their incorporation. However, the person reporting as to the chemical substance must report the information required as to each step of its manufacture, processing and use to the extent it is known or reasonably ascertainable.

    2. Substances excluded from reporting. EPA is excluding from the requirements of this rule certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms.

    EPA is excluding chemical substances which dissociate completely in water to form ions with a size of less than 1 nm. This exclusion does not apply to chemical substances manufactured at the nanoscale that release ions but do not dissociate in water to form those ions. Chemical substances that dissociate completely in water to form ions with a size of less than 1 nm do not exhibit new size-dependent properties because the same properties would manifest in the dissociated form regardless of whether the substance is at the nanoscale before dissociation. Manufacturing or processing such substances are therefore not subject to the reporting requirements of the rule.

    EPA is excluding chemical substances formed at the nanoscale as part of a film on a surface. See the explanation in Unit III. for the changes from the proposed rule and the detailed response to comments in the docket for EPA's explanation and reasoning.

    3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 are applicable to this rule. These include, among other exemptions, the exemption for research and development (R&D) under which a person who manufactures or processes a chemical substance only in small quantities for research and development is exempt from the reporting requirements of this rule. Examples of R&D activity are the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance. It can include production of a chemical substance for use by others in their R&D activities. R&D activity generally includes specific monitored tests undertaken as part of a planned program of activity.

    There is also an exemption from reporting for TSCA section 8(a) rules for small manufacturers and processors. For purposes of this rule EPA is defining and exempting any small manufacturer or processor as a company that has sales of less than $11 million per year.

    4. Other exceptions to reporting. The rule does not require manufacturers or processors to report certain information that has already been submitted to EPA. A person who submitted a notice under TSCA section 5 to EPA for a reportable chemical substance on or after January 1, 2005 is not required to report regarding the same substance under this rule, except where the person manufactured or processed a new discrete form of the reportable chemical substance. In addition, any person who has already reported part of or all of the information that is required under this rule for EPA's Nanoscale Materials Stewardship Program (NMSP) would not need to report that information again under this rule. If, however, information required by this rule was not reported under the NMSP (including information for each discrete form of a reportable chemical substance), then reporting of that information would be required under this rule. The purpose of these exemptions is to avoid duplicative reporting. For example, new chemical notices under TSCA section 5 that have been reviewed by EPA as nanoscale materials are not subject to reporting for the discrete form of a reportable chemical substance that was submitted and reviewed.

    B. When will reporting be required?

    Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of this rule must report to EPA one year after the final effective date of the rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form except where the person has not formed an intent to manufacture or process a discrete form of a reportable chemical substance 135 days before such manufacturing or processing, in which case the information must be filed within 30 days of the formation of such an intent. For example, if a person forms the intent on July 1 to manufacture a reportable chemical substance and intends to commence manufacture of the substance in less than 135 days, that person must report the required information as to the chemical substance no more than 30 days after forming the intent, which would be July 31.

    C. What information must be reported?

    This rule requires one-time reporting of certain information, including specific chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information.

    EPA developed a form (Ref. 8) for reporting information including specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing and processing, exposure and release information, and existing information concerning environmental and health effects. Any person required to report under this rule must supply the information identified in the form to the extent it is known to or reasonably ascertainable by them. EPA intends to issue guidance for the final rule within six months of issuing the rule including guidance on the reasonably ascertainable standard, consolidating submissions and generic chemical names.

    D. How will information be submitted to EPA?

    The rule requires electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 704.20(e)). Submitters will use EPA's CDX, the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). (Ref. 9) The final rule follows two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA Chemical Data Reporting and for Pre-Manufacture Notices. EPA expects that electronic reporting will save time, improve data quality and increase efficiencies for both the submitters and the Agency.

    EPA developed the Chemical Information Submission System (CISS) for use in submitting data for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The web reporting tool is available for use with Windows, iOS, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. CISS, a web-based reporting tool, provides user-friendly navigation, works with CDX to secure online communication, creates a completed document in Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML.

    EPA is requiring submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPA's CDX (if not already registered) and use CISS to prepare a data file for submission. Registration enables CDX to authenticate identity and verify authorization. To submit electronically to EPA via CDX, individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.

    Users who have previously registered with CDX for other TSCA submissions, Chemical Data Reporting, or the Toxics Release Inventory TRI-ME web reporting flow, can add the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, and use the CISS web-based reporting tool.

    All submitters must use CISS to prepare their submissions. CISS guides users through the process of creating an electronic submission. Once a user completes the relevant data fields, attaches appropriate PDF files, or other file types, such as XML files, and completes metadata information, CISS validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions on submitting and instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information are available through CISS reporting guidance.

    CISS allows the user to choose “Print,” “Save,” or “Transmit through CDX.” When “Transmit through CDX” is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then encrypts the file and submits it via CDX. The user will log in to the application and check the status of their submissions. Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user registration. Information on accessing the CDX user inbox is provided in the guidance document for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for reporting chemical substances under this rule are similar.

    Any person submitting a reporting form could claim any of the information on the form as CBI. Any information which is claimed as confidential will be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2.

    D. Confidentiality and the Recent Revisions to TSCA

    The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016, and became immediately effective. This final rule contains one minor change to reflect the new statutory requirements for asserting confidentiality claims. Section 14(c)(1)(B) of the law now requires a supporting statement for confidentiality claims. This statement is similar to the certification currently required in 40 CFR 704.7, which is cross-referenced in the proposed rule. In this final rule, EPA is substituting the wording of the section 14(c)(1)(B) statement for the wording of the certification in § 704.7(d) so as to eliminate any possibility of doubt that the certification meets the statutory requirements. While this change was not discussed in the proposed rule, EPA finds there is good cause to make this change without notice and comment. Notice and comment are unnecessary because the new statement is required by statute, and the new language is sufficiently similar to that in the § 704.7(d) certification that EPA anticipates no significant effect of the change on companies reporting under the rule or on the public in general.

    The law also requires that a generic chemical identity be provided when companies claim a specific chemical identity as confidential. No conforming change is necessary for this rule, because companies reporting under this rule will be claiming chemical identities as confidential only when there is already a generic identity on the confidential portion of the TSCA Chemical Substances Inventory. CISS will automatically populate the submission with the generic chemical name associated with the Inventory listing. This process provides the greatest degree of structural specificity that is practicable to afford at the current time. EPA will develop guidance regarding generic names as required by TSCA, and will determine appropriate procedures regarding their use and submission.

    III. Summary of Response to Comments Including Changes and Clarifications From the Proposed Rule

    This unit summarizes EPA's responses to comments for several general areas of comments from multiple stakeholders, and where responses are particularly relevant to the requirements of the final rule. EPA also discusses any changes to and clarifications from the proposed rule. A separate document that summarizes the comments relevant to the proposal and EPA's responses to those comments has been prepared and is available in the docket for this rulemaking (Ref. 2).

    Comment 1: Several commenters stated that TSCA applies to chemical substances, not different physical forms or different particle sizes of chemical substances, and that discrete forms or discrete physical forms are not “chemical substances” subject to reporting under section 8(a) of TSCA.

    Response: TSCA section 8(a) authorizes EPA to promulgate rules for submission of such reports as the Agency “may reasonably require.” EPA believes that the information from this reporting will help EPA to determine whether chemical substances manufactured and processed at the nanoscale may exhibit behavior relevant to health and safety that is different from that of non-nanoscale forms of chemical substances. EPA thus has the authority to require reporting pertaining to different forms of chemical substances.

    Comment 2: Several commenters stated that the proposed information requests are outside those allowed by section 8(a) of TSCA. Commenters specifically identified material characterization including particle size and morphology, methods of manufacture, weight percent of impurities, environmental release information, general population, consumer exposure, risk management practices, and engineering controls. One commenter wanted EPA to explain more clearly the basis of authority for requesting information that does not fall within the scope of the clear statutory authority of TSCA section 8(a).

    Response: Section 8(a) gives EPA broad authority to collect information that the Administrator may reasonably require. Section 8(a)(1) authorizes EPA to require reporting of such information with respect to chemical substances as the Administrator may reasonably require. Although it contains limitations with respect to requirements to report with mixtures and to chemical substances manufactured in small quantities for experimentation, those limitations are not relevant to the requirements imposed by this rulemaking. Section 8(a)(2) is best interpreted as listing examples of the kinds of information EPA can require reporting on under section 8(a)(1), not as limiting EPA's authority. If Congress had intended to impose limitations on the kinds of information EPA can collect under section 8(a)(1), it would have added them to the limitations it included in section 8(a)(1). EPA has always interpreted section 8(a) in this fashion, see 58 FR 63134 (November 30, 1993)—an interpretation that is supported by the legislative history of section 8(a), H.R. Conf. Rep. 94-1679, at 80 (1976); S. Rep. No. 94-698, at 22 (1976), H.R. Rep. No. 94-1341, at 42 (1976). Further, the information required under the rule is consistent with the examples of information discussed in section 8(a)(2). For example, requiring weight percent of impurities is analogous to byproducts, material characterization including particle size and morphology is analogous to molecular structure of chemical substances manufactured and processed at the nanoscale, environmental release falls under methods of disposal, while methods of manufacture, risk management practices, engineering controls, general population and consumer exposure fall under estimates of individuals who would be exposed.

    Comment 3: Several commenters noted that processors do not know about the particle size and other characteristics of formulations they process or use and should not be required to report.

    Response: Reporting of information under TSCA section 8(a) is required only to the extent the information is known or reasonably ascertainable, and includes information that the Administrator may reasonably require. This standard applies both to the extent of an entity's obligation to determine whether it is required to report, and to the extent of information any entity is required to report. If processors do not know about specific physical properties of chemical substances, they must still take reasonable measures to ascertain the information that would determine whether they are subject to the rule. If processors do not know about specific properties such as particle size and other properties that would allow them to know if they are processing a chemical substance subject to the rule, it would be within the reasonably ascertainable standard to ask their suppliers for information that would enable the processor to determine whether the supplier is selling them a nanoscale material subject to reporting and if so provide them with what reportable information they have. Their supplier is not required to provide any additional information to the processor but might provide other supporting information, for example, whether their supplier has reported or intends to report the chemical substance under this rule. If the supplier provides information indicating that the substance is not reportable or if the processor lacks any other means of reasonably ascertaining whether the substance is reportable, the processor does not need to perform tests to determine whether the substance is reportable. Information developed in the normal course of business or that the processor chooses to develop must also be used. The processor may want to document the steps they took to determine if reporting was required. Companies that purchase formulations but do not change or modify those formulations and only use them are not considered processors and are not required to report.

    If the information provided by the supplier indicates that reporting is required, the processor is required to report information that is known or reasonably ascertainable, which may include information obtained from the supplier. This would include situations where the processor may not know the exact chemical identity or some of its physical properties.

    The obligations imposed by the reasonably ascertainable standard are discussed more fully in the Chemical Data Reporting final rule, 76 FR 50816, 50829 (August 16, 2011).

    Comment 4: Several commenters also asked EPA if manufacturers and processors are only required to report available or reasonably ascertainable information, does this mean they need to develop information to comply with the rule. Other commenters asked EPA to clarify if manufacturers and processors need to develop information to comply with the rule.

    Response: Manufacturers and processors are not required to conduct testing or develop new information under this rule. However, they are required to report information that is known or reasonably ascertainable.

    Comment 5: Many commenters stated the proposal gives too much discretion to interpret compliance obligations. Commenters suggested clarifying the definition of unique and novel properties, adopting an alternative, or not using it at all. One commenter noted that if the requirement that reportable chemicals exhibit unique and novel attributes due to particle size is removed from the definition, the rule would not differentiate genuinely new nanoscale materials from traditional legacy products in commerce. Several commenters stated there should be some differentiation between genuinely new nanoscale materials in commerce and traditional products. Two commenters supported the proposed definition while one commenter supported a definition of 1-100 nm and unique or novel characteristics.

    Response: Based on these comments, EPA agrees that what is a reportable chemical substance should be better defined and clarified. EPA is finalizing the rule with further explanation of “unique and novel properties” as described in the National Nanotechnology Initiative's definition. Some nanostructured materials are stronger or have different magnetic properties compared to other forms or sizes of the same material. Others are better at conducting heat or electricity. See http://www.nano.gov. They may become more chemically reactive or reflect light better or change color as their size or structure is altered. A property is novel when it is different from the properties associated with other forms or sizes of the same chemical substance. As also noted on http://www.nano.gov, when particle sizes of solid matter in the visible scale are compared to what can be seen in a regular optical microscope, there is little difference in the properties of the particles. But when particles are created with dimensions of about 1-100 nm, the materials' properties can change significantly from those at larger scales. See also comment 11 and the response for further clarification on what is considered a reportable chemical substance.

    For purposes of this rule, EPA is defining unique and novel properties to include an element of intent, meaning that those properties are the reason why the chemical substance is manufactured in that form or size. The rule includes a definition of unique and novel properties in the definitions section of the regulatory text (See § 704.20(a)). Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size. In order to be reportable it's not sufficient that a chemical substance contains particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm and those properties are a reason that the chemical substance is manufactured or processed in that form or size. Intentionally manufacturing or processing nanoscale gold so that it exhibits a red or purple color instead of a yellow color would create a unique or novel optical property seen at the nanoscale. Such a change would likely result in changes of other properties, such as specific surface area which can result in different health and safety impacts. Unique and novel properties which impact performance generally cannot be isolated from concurrent changes in properties that impact biological systems. For example, see the discussion in Unit II.B. of the proposed rule of the range of biological impacts of nanoscale materials. EPA is exempting certain biological materials, in part, because they do not exhibit different size-dependent properties in the size range of 1-100 nm.

    Other chemical substances, including as an example some chemicals that commenters proposed that EPA exempt from reporting, such as pigments, polymers, and polymer dispersions, could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. In the concept paper for the NMSP (Ref. 10), EPA stated that many polymers or oligomers, particularly linear or planar polymers, should not be reported even though they have dimensions in the nanoscale. Those polymers did not demonstrate size-dependent properties. The paper did note that when conditions of polymerization or post-reaction processing create free particles that fit the general description of “engineered nanoscale material” those chemical substances should be reported under the NMSP. Please also refer to the comment and response to comment 12 in the response to comments document regarding the difference between enhanced and novel properties.

    Comment 6: Several commenters suggested alternative definitions of trace amounts stating that the term in the proposed rule is not definitive and gives too much discretion to interpret compliance obligations. The commenters suggested including a numerical value to define trace amount. Most commenters did not suggest a specific value, although one commenter noted the original definition of the Agency's draft proposed rule submitted to OMB would have required reporting for those substances containing ≥10% particles in the range of 1-100 nm while another commenter suggested using a numerical value of less than 10% of particles as trace amount that would not be considered to be a reportable chemical substance. Commenters asked EPA to clarify if particle size was to be determined by weight, volume, or count. One commenter stated that EPA should not use weight based criteria to determine particle size as that measurement is sometimes skewed by the inclusion of very large particles. Several other commenters suggested using weight based criteria to identify particle size but did not give any reasons why.

    Response: Chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm are not reportable chemical substances. EPA used trace amounts in the proposed rule to define this concept. However, based on the public comments to more clearly define trace amounts including several comments to establish a numerical cutoff, EPA is instead using a numerical value of less than 1% of particles from 1-100 nm by weight to more clearly define those chemical substances that would not be reportable. EPA has chosen this number because it is the percentage cut-off used in OSHA's hazard communication standard for all chemicals substances that are not OSHA carcinogens (for which there is a 0.1% cut-off) (Ref. 11). This 1% cut-off is a level that industry has used to identify chemicals in safety data sheets (and previously in material safety data sheets.) Industry is already using this cut-off to identify at least some nanoscale chemical substances, e.g., carbon nanotubes in mixtures. EPA is using the weight based method for measuring particles even though that measurement is sometimes altered by the presence of very large particles because it is the most widely used method, and more data will therefore be available. The final rule does not require reporting for any chemical substance where less than 1% percent of the particle size distribution by weight is less than 100 nm.

    Changes to the Definition of a Reportable Chemical Substance in the Final Rule. EPA has added a definition of unique and novel properties in the definitions section of the regulatory text (See 704.20(a)). Unique and novel properties means any size-dependent property that vary from other properties associated with other forms or sizes of the same chemical substance, and such properties are the reason that the chemical substance is manufactured or processed in that form or size. A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm. The final rule no longer states that a reportable chemical substance does not include a chemical substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. The final rule now states that a reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates and agglomerates, measured by weight are in the size range of 1-100 nm.

    Comment 7: A variety of commenters stated that EPA should add additional exemptions for biological materials such as enzymes, lipids, carbohydrates, peptides, polypeptides, nucleotides, liposomes, antibodies, viruses, virus-like particles, viral based products, organelles, and microorganisms. The commenters stated that the additional biological materials should be exempted for the same reason EPA proposed to exempt DNA, RNA, and proteins, that the additional biological materials did not exhibit properties as a function of their size range.

    Response: Because they meet the same criteria that EPA identified in the proposed rule, EPA is adding an exemption for enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms in the final rule. The properties of all the exempted biological materials, which can be in the nanoscale, are not a function of the size range per se but rather of the precise nucleotide sequence (in the case of DNA and RNA), shape, and complex biological structures (living cells).

    Comment 8: Several commenters identified additional possible exemptions for organic and inorganic pigments and dyes; polymers including polymer dispersions; and chemical substances used in adhesives, coatings and sealants and chemical substances when they are embedded in a polymer matrix or incorporated into a formulated product such as adhesives, cement, ink, coatings, glass, paint, plastic and rubber because they are well understood or characterized and present low risk and low potential for exposure. Commenters suggested that EPA include an exemption for polymers and polymer dispersions to be consistent with the polymer exemption under section 5 of TSCA. Commenters also noted TSCA section 5 regulations such as SNURs which exempted requirements for carbon nanotubes, silica, and pigments when incorporated into polymer matrices.

    Response: A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm. The chemical substances or activities identified by commenters could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. If a chemical substance does not exhibit unique and novel properties, then no reporting would be required. EPA lacks information demonstrating minimal risk and exposure for nanoscale forms of the chemical substances or activities that commenters proposed for exemption. The polymer exemption under TSCA section 5 is not based on any consideration of the potential for impacts from polymers with size dependent properties and does not include all polymers. Most of the activities described by commenters for exemption would only require reporting for a reportable chemical substance before it is incorporated into a formulated product or polymer matrix. Reporting would not be required by persons who use the formulated product or polymer matrix. EPA is not including an exemption for these chemical substances and activities because doing so would exempt some of the nanoscale materials in commerce for which EPA is collecting information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

    Comment 9: Several commenters proposed limited or no reporting for nanoscale materials such as carbon black, silica, titanium dioxide, nanosilver, and nanocellulose, based on the proposed exemption for nanoclays and zinc oxide. The commenters asked EPA to better define the criteria it used to exempt nanoclays and zinc oxide as well-characterized so that the criteria could be applied to these chemical substances. One commenter noted that available information for commercial forms of nanocellulose demonstrate low hazard and risk. Several commenters also described the hazards and exposures of these chemical substances as well-characterized. Several commenters stated that EPA should not exempt zinc oxide and nanoclays as EPA had not identified and made available the data that demonstrated why they are well-characterized.

    Response: EPA has decided to not exempt nanoclays and zinc oxide from reporting. When considering the comments to exempt other chemical substances based on its proposed exemption for zinc oxide and nanoclays, EPA realized that it had given too much weight to the available information on zinc oxide and nanoclays. While there is some available information on these chemical substances, EPA does not consider the available information sufficient to extrapolate to all other forms of these chemical substances to exclude information collection under TSCA. Further, this limited information is not a sufficient basis to create a broader exemption by analogy for other chemical substances. Thus, even for chemical substances manufactured as nanoscale materials that could be described as a group as well-characterized or demonstrating low hazard based on data not relating to nanoscale forms in particular, EPA lacks information on how much and what type of specific nanoscale materials are in commerce and what kind of information is available to assess the properties that can impact health and safety and thus potential risks of those nanoscale materials. The chemical substances that commenters and EPA stated were well characterized could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. EPA is not exempting from reporting any of the chemical substances proposed by commenters, including zinc oxide and nanoclays because doing so would exempt some of the nanoscale materials in commerce for which EPA is collecting information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials. The type of information described by the commenter regarding nanocellulose is the type of information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

    Changes to Chemical Substances That are Exempt from the Final Rule: EPA added exemptions for enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, microorganisms in the final rule. EPA did not add any other exemptions to the final rule. EPA did not include the proposed exemptions for nanoclays and zinc oxide in the final rule.

    Comment 10: Several commenters stated that EPA cannot require information that violates the language under TSCA section 8(a) prohibiting “any reporting which is unnecessary or duplicative.” Commenters stated that requiring reporting of some of the information already reported to the NMSP would be duplicative, especially the large amount of health and safety information submitted for broad classes of chemical substances such as silica and carbon black. Commenters also asked EPA to explain why the proposed reporting requirements do not duplicate reporting required under CDR.

    Response: The reporting required by this rule does not duplicate reporting EPA would receive under other TSCA regulations. Chemical data reporting (CDR) under 40 CFR part 711 does not require manufacturers to distinguish reporting for different forms of chemical substances including nanoscale materials. This rule also exempts reporting for chemical substances that are nanoscale materials that have already been reported under section 5 of TSCA since 2005 except for new discrete forms. As noted in the interim report on the NMSP (Ref. 12), EPA received limited reporting on nanoscale materials in commerce. The reporting for nanoscale materials such as silica and carbon black gave an overview of the entire industry but not information on individual nanoscale materials. A company reporting a silica or carbon black-based nanoscale material does not have to resubmit the information submitted under the NMSP. However, any reporting of silica or carbon black nanoscale materials would need to include any health and safety information that company possesses for the specific nanoscale material it is reporting. As already noted, CDR reporting does not distinguish between different nanoscale forms of chemical substances. Several commenters stated that EPA needs more information on nanoscale materials in commerce. In the full response to comments document, EPA addresses more specific comments about information required by the rule.

    Comment 11: There were numerous comments to not include the 135 day reporting requirement for new discrete forms. This requirement was characterized by several commenters as de facto new chemical reporting. Commenters also asked EPA to clarify if persons subject to the rule had to wait until the 135 day period was completed before commencing manufacture or processing. The 135 day reporting requirement was supported by several commenters because it provides the Agency with more time to identify potential concerns and initiate appropriate action to address them.

    Response: EPA did not intend to create de facto new chemical reporting for new discrete forms of nanoscale materials, because the 135-day period is not a formal review-period that prohibits manufacture before the end of the 135-day period. Rather, based on EPA's experience with the Premanufacture Notice (PMN) program, EPA believes that in most cases companies have the requisite intent to manufacture or process at least 135 days before manufacturing or processing will begin, and the rule requires reporting based upon this presumed intent. However, if a company does not form the requisite intent 135 days ahead of time, the company must report within 30 days of the formation of such an intent. Moreover, if a company desires to begin manufacture or processing less than 135 days after the submission for this rule is made, the company is free to do so. There is no obligation upon the company to wait 135 days after reporting to manufacture or process. EPA is revising the language in 704.20(f)(2) to clarify that the rule does not prevent manufacturing before the 135-day period has passed. If the company changes its schedule or does not form the intent until a later time, it may wish to document supporting facts.

    Further, the comments made EPA realize that the regulatory text as written in the proposal created a result unintended by the Agency (and not commented upon): Because (1) the default period of 135 days is greater than the advance of periods required for various section 5 submissions, and (2) the reporting exemption for section 5 submissions in 704.20(c)(2) of the proposal would apply only where the company had already filed a section 5 submission, a company proposing to manufacture a discrete form of a reportable substance for which a section 5 submission had not been filed might conceivably be required to first file a section 8(a) report, followed by a section 5 submission. In such cases EPA only needs the section 5 submission and exercise whatever section 5 authority might be necessary in a specific case, rather than imposing an additional burden of requiring a duplicative section 8(a) submission. Therefore EPA is adding a new subcategory of non-reportable chemical substances to 704.20(c)(1), for chemical substances that are not on the TSCA Inventory at the time reporting would otherwise be required, to clarify the Agency's original intent in the NPRM. If a reportable chemical substance is not on the TSCA Inventory a manufacturer only needs to submit a new chemical notification under section 5 of TSCA.

    Changes to the 135-day Reporting Requirement for Discrete Forms of a Reportable Chemical Substance: EPA has added language to 40 CFR part 704.20(f)(2): “except where the person has not formed an intent to manufacture or process that discrete form at least 135 days before commencing such manufacture or processing, in which case the information must be filed within 30 days of the formation of such an intent.” The language makes clear what companies must do if they do form an intent to manufacture or process a discrete form of a reportable chemical substance less than 135 days ahead of manufacture or processing.

    Changes to Chemical Substances That Are Not Reportable: EPA has added language to 704.20(c)(1), exempting chemical substances that are not on the TSCA Inventory from reporting.

    Comment 12: There is not standardized testing for the physical properties in the proposed rule identified for manufacturers and processors to determine if they qualify for the rule. EPA should identify test methods to be used to comply with the rule. Many processors will not know to test for these properties. EPA cannot require this testing until validated protocols are developed.

    Response: Testing or developing new information is not required by the rule. Only known or reasonably ascertainable information needs to be reported. Companies are only required to report on known or reasonably ascertainable information. See the response to comment 3 for guidance as to situations in which a company does not know about the physical properties identified in the regulation. In the proposed rule, EPA supplied examples of testing guidelines that could be used for these types of properties should the company desire to do such testing.

    Comment 13: Several commenters supported the $4 million dollar small business exemption. One commenter wanted an even smaller dollar amount so that more small businesses would be required to report. Other commenters supported just using the dollar amount but stated it should be increased to $9.5 million dollars to account for inflation since 1988 when the current small business amount of $4 million was established.

    Response: Based on these comments and updated economic information, EPA is changing the definition of small business in the final rule to include any company with sales of $11 million dollars or less. In suggesting EPA change the value to $9.5 million, the commenter assumed the original $4 million was promulgated in 1988. However, the $4 million was initially promulgated in 1984 (49 FR 45425) with a base year of 1983. Therefore, it is appropriate to inflate the $4 million from $1983 to $2015. When accounting for inflation since 1983, EPA calculated the figure to be $11 million dollars.

    In proposing this definition, EPA provided notice and comment on the criteria for small manufacturers and processors subject to this rule, and consulted with the Small Business Administration (SBA) in accordance with TSCA section 8(a)(3)(B). EPA's change to this definition is consistent with both public comments and the feedback we received from SBA.

    EPA recognizes that recent amendments to TSCA include a new and separate obligation under amended TSCA section 8(a)(3)(C), which requires EPA, after consultation with the SBA, to review the adequacy of the standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). TSCA furthermore requires that (after consulting with the SBA and providing public notice and an opportunity for comment) EPA make a determination as to whether revision of the standards is warranted. In the Federal Register of December 15, 2016 (81 FR 90840) (FRL-9956-03), EPA sought public comment on whether a revision of the current size standard definitions is warranted at this time; announced EPA's initiation of the required consultation with the SBA, and provided its preliminary determination that revision to the currently codified size standards for TSCA section 8(a) is indeed warranted. As part of this effort, EPA will review the adequacy of the standards for small manufacturers and processors in existing TSCA section 8(a) rules, including this one. Any changes resulting from the assessment will undergo consultation with SBA and will be proposed for notice and comment as required by TSCA section 8(a)(3)(C).

    Changes to the Definition of a Small Manufacturer or Processor Exempt from the Reporting Requirements of the Rule: The final rule retains a small business exemption based only on sales, but a small manufacturer or processor will be defined as any company with sales of less than $11 million per year.

    Comment 14: Several commenters asked EPA to clarify the objects and collections of objects to which the 1-100 nm measurement applies. In other words, does that mean any form with particles 1-100 nm or does that include aggregates and agglomerates greater than 100 nm but based on primary particles less than 100 nm?

    Response: Chemical substances required to be reported would include any form with particles 1-100 nm but would not include aggregates or agglomerates greater than 100 nm even if they contain primary particles less than 100 nm. EPA has modified the description of particles that would be subject to reporting in the definition of reportable chemical substance to better reflect this understanding. The language in the reportable chemical substance definition now reads, “where any particles, including aggregates and agglomerates, are in the size range of 1-100 nm”

    Comment 15: Several commenters suggested that EPA should better define particle. One commenter stated “The word `particle' is not a term with specific meaning. It is critical that EPA is clear about the definition of `particle' so that companies understand what materials require reporting. For example, does the term `particle' include solid objects that contain internal crystalline domains at the nanoscale? Does it include dispersions, suspensions, or aerosols? A definition of `particle' would provide an important starting point for determining whether a material is subject to reporting. It should take into account the ability of a `particle' to move freely in its environment.”

    Response: EPA will use the definition of particle from ISO, which is a “minute piece of matter with defined physical boundaries.” The notes to the ISO definition should be used as guidance in applying this definition. Note 1: A physical boundary can also be described as an interface. Note 2: A particle can move as a unit. EPA is using this definition because there is international agreement on the definition; the definition addresses the commenter's questions about the ability of a particle to move in the environment and whether “particle” includes dispersions, suspensions, or aerosols.

    Changes to the Final Rule to Clarify the Types of Particles to be Measured: EPA has added a definition of particle and modified the language in the definition of reportable chemical substance for the types of particles that will be measured.

    Comment 16: Several commenters stated that the shape criteria for identifying reportable chemical substances are too vague and unworkable. The commenters asked what the criteria are to discern one shape from another. For example one commenter stated “For morphology, how would manufacturers and processors distinguish between the different morphologies identified in the proposed regulatory text: What definitions would distinguish for example a rod from an ellipsoid, needle, wire, and/or fiber as these shapes could be considered on a continuum? Another commenter stated “It is unclear how different the shapes of two forms would have to be in order to trigger the discrete forms requirement.”

    Response: As noted in the proposed rule the different morphology could be any change in the shape of particles. Different morphology does not include random shape changes or natural variation in shapes of particles that are not definitive and that, as commenters have noted, occur in a continuum. Some nanoscale materials are engineered to give all the particles a certain morphology or shape. The change in shape needs to be a specifically engineered change in the shape of particles of a nanoscale material, to effect a change and form a unique and novel property for a chemical substance in the particle size range of 1-100 nm.

    Comment 17: Several commenters objected to imposing the same reporting requirements on both processors and manufacturers stating that some processors will not be aware of information known to manufacturers such as for example chemical identity, physical-chemical properties, byproducts, impurities, health effects data, and general population exposure. In addition, the commenters speculated that processors may report uses and processes already reported by the manufacturer. The commenters felt the reporting requirements place impractical or burdensome obligations on processors without collecting information that would serve the intended purposes of the rule when manufacturers were in the best position to report information required by the rule. Commenters suggested limiting reporting to only manufacturers or limiting the information to be reported by processors.

    Response: Processors are only required to submit information that is known or reasonably ascertainable. In addition, processors may have access to pertinent information that manufacturers do not have access to. Processors can often describe in greater detail how the nanoscale material is processed and used and any characteristics that change because of processing. Details on the processing and use of nanoscale forms of chemical substances with unique or novel properties will give EPA a better understanding regarding how to assess those chemical substances and whether any further actions are warranted under TSCA.

    Comment 18: Several commenters stated that EPA should exempt naturally occurring or mined nanoscale materials. One commenter noted that CDR regulations exempt naturally occurring chemical substances as described at 40 CFR 710.4(b). Several commenters also stated naturally occurring nanoscale materials should be exempt from reporting as they do not meet the criteria of the definition of “manufactured or processed.” Another commenter suggested limiting reporting to engineered nanomaterials as they are “generated for a specific function” or “deliberately manipulated.”

    Response: EPA did not exempt naturally occurring materials or limit reporting to chemical substances engineered at the nanoscale because some of these chemical substances meet the criteria of a reportable chemical substance and some of them do not. These chemical substances must be reported only if they meet the definition of containing particles in the size range of 1-100 nanometers and a size-dependent property different from properties at sizes greater than 100 nanometers. EPA expects that reportable chemical substances would usually be the result of processing of naturally occurring or mined materials by manufacturers and processors

    Comment 19: A commenter stated that EPA should add an explicit exemption for nanoscale substances that are unintentionally generated during manufacturing and processing. Another commenter asked EPA to clarify if it matters if a nanoscale substance is intentionally added versus accidentally formed.

    Response: If a nanoscale chemical substance is unintentionally generated or added and not intended to be part of the commercially manufactured or processed chemical substance, it may be considered a byproduct or impurity and would be exempt under 40 CFR 704.5(b) or (c). If a nanoscale chemical substance is unintentionally formed but is considered to be part of the function of the commercial product, it would be a reportable chemical substance. A chemical substance which is intentionally produced but is in total or in part unintentionally produced at the nanoscale is not an impurity or a byproduct. There are examples where a chemical substance is intentionally produced, but unintentionally produced at the nanoscale, and the manufacturer knows that it contributes to the function of their product. In those cases, where a company knows about its functionality, the chemical substance is still subject to TSCA reporting requirements. See, for example, EPA's PMN regulations at 40 CFR 720.30(h)(2), which exempts from reporting a byproduct not used for commercial purposes, but retains the reporting requirement if the byproduct is used for commercial purposes. The rule does not require a company to determine the functionality of every impurity or byproduct. A company is required to report that chemical substance when it knows the chemical substance has commercial functionality.

    Other Changes to the Final Rule: EPA made other changes to the rule. See the Response to Comments Document (Ref. 2) for further details. EPA has modified the definition of zeta potential to address public comments that zeta potential was not accurately defined in the proposed rule. Because “chemical substances manufactured at the nanoscale as part of a film on a surface” did not adequately describe the films on a surface exemption that was proposed, EPA changed the wording of the exemption to state “chemical substances formed at the nanoscale as part of a film on a surface.”

    Changes to the Reporting Form: EPA made the following changes to the reporting form. See the Response to Comments Document (Ref. 2) for further explanation. EPA removed the requirement for an overview of the life cycle in Section C of the reporting form, as that information duplicates information already identified in other parts of the form. Because not all enhanced properties are unique or novel properties, EPA replaced the word enhanced with novel in section C.5. of the reporting form. EPA added language to the form instructions that “You may want to consult with your customers or suppliers about the confidentiality of any information you report about them on this form” in response to comments that manufacturers or processors may not accurately identify confidential information obtained from suppliers or customers. In order to help facilitate continued work on sharing available information and to inform future alignment on activities pertaining to nanoscale materials, EPA included the option on the reporting form to share information with Environment and Climate Change Canada and Health Canada per one commenter's request to provide the option of sharing CBI.

    IV. References

    The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. EPA. Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements; Proposed Rule. Federal Register April 6, 2015 (80 FR 18330) (FRL-9920-90).

    2. 2016. EPA. Response to Comments to the Proposed Rule, Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements; RIN 2070-AJ54. Docket # EPA-HQ-OPPT-2010-0572.

    3. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials. https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf, and Principles for Regulation and Oversight of Emerging Technologies at https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf.

    4. 2016. EPA. Economic Analysis for the TSCA Section 8(a) Reporting Requirements for Certain Nanoscale Materials (RIN 2070-AJ54). December 2016.

    5. 2012. International Organization for Standardization (ISO). Nanotechnologies—Guidance on Physicochemical Characterization for Manufactured Nano-objects Submitted for Toxicological Testing. ISO/TR (Technical Report) ISO/TR 13014:2012.

    6. 1999. Colloidal Dynamics. The Zeta Potential. http://www.colloidal-dynamics.com/docs/CDElTut1.pdf.

    7. 2013. ISO/TR. Guidelines for Characterization of Dispersion Stability. ISO/TR 13097:2013.

    8. 2016. EPA. Information Submission Form. TSCA section 8(a) Information Reporting for Nanoscale Materials. EPA Form No. 7710-[tbd]; EPA ICR No. 2517.02; OMB Control No. 2070—NEW.

    9. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL 9394-6).

    10. 2007. EPA. Nanoscale Materials Stewardship Program—Concept Paper.

    11. OSHA. OSHA Hazard Communication Standard; 29 CFR part 1910.1200, https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099.

    12. 2009. EPA. Interim Report on the Nanoscale Materials Stewardship Program.

    13. 2015. EPA. Chemical-Specific Rules, Toxic Substances Control Act Section 8(a). OMB control No. 2070-0067 (EPA ICR No. 1198.10).

    14. 2015. EPA. Addendum to an Existing EPA ICR Entitled: Chemical-Specific Rules, Toxic Substances Control Act Section 8(a). EPA ICR No. 2157.02; OMB Control No. 2070—[new].

    V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

    A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations are documented in the docket. EPA prepared an economic analysis for this action (Ref. 4), which is available in the docket and discussed in Unit I.E.

    B. Paperwork Reduction Act (PRA)

    The information collection activities in 40 CFR part 704 related to TSCA section 8(a) reporting rules are approved by OMB under the PRA and assigned OMB control No. 2070-0067 (EPA ICR No. 1198) (Ref. 13). Because this rule revises those information collection activities and the related collection instrument, additional approval by OMB is required. As such, EPA has prepared an addendum to the currently approved ICR; the addendum is identified under EPA ICR No. 2517.02 (OMB Control No. 2070—[new]) (Ref. 14). The ICR document provides the estimated burden and costs for the information collection activities contained in this final rule. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

    Respondents/affected entities: Chemical manufacturers (including importers) and processors.

    Respondent's obligation to respond: Mandatory.

    Estimated number of respondents: 2,681.

    Frequency of response: Variable.

    Total estimated burden: 146,855 hours (average per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated burden cost: $11.33 million (per year), includes $0 annualized capital or operation and maintenance costs.

    Change in approved burden: The total burden in OMB's inventory for the existing, approved ICR (275 hours), will be increased by 146,855 hours, for a new total burden of 147,130 hours. If an entity were to submit a report to the Agency, the annual burden is estimated to average 164 hours per response. Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and the ICR addenda, EPA estimates that the TSCA section 8(a) rule will create a total incremental industry burden of 440,566 hours over three years.

    An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

    C. Regulatory Flexibility Act (RFA)

    I certify under section 605(b) of the RFA, 5 U.S.C. 601 et seq., that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small businesses, small governmental jurisdictions and small non-profits. A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). For this action, EPA is modifying the exemption. EPA analyzed potential small business impacts from this rule using both the SBA employee size standards and the TSCA sales-based definition of small business. The Agency has determined that up to 411 small businesses may be impacted and evaluated the number that may incur costs at below 1% and 3%, and above 3% of sales. EPA estimates that all 411 small businesses identified will incur costs below 1% of sales, which EPA has determined is not a significant adverse economic impact on a substantial number of small entities. Details of this analysis are presented in the small entity impact analysis that EPA prepared for this action as part of the Agency's economic analysis that is in the public docket for this rule (Ref. 4).

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing rules under TSCA section 8(a), State, local and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local or Tribal government will be impacted by this rulemaking. In addition, this action will not result in annual expenditures of $100 million or more for the private sector.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health or safety risk. Nevertheless, the information obtained by the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemical substances addressed in this rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

    H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

    This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use.

    I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards, and is therefore not subject to considerations under NTTAA section 12(d), 15 U.S.C. 272 note.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    This action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment. The information collected under this rule will, however, assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured processed, and used at the nanoscale. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better assess and protect human health and the environment, including in low-income and minority communities.

    K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 704

    Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting requirements.

    Dated: December 29, 2016. Louise P. Wise, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 704—REPORTING AND RECORDKEEPING REQUIREMENTS 1. The authority citation for part 704 continues to read as follows: Authority:

    15 U.S.C. 2607(a).

    2. Add § 704.20 to Subpart B, to read as follows:
    § 704.20 Chemical substances manufactured or processed at the nanoscale.

    (a) Definitions. For purposes of this section the terms below are defined as follows:

    An agglomerate is a collection of weakly bound particles or aggregates or mixtures of the two where the resulting external surface area is similar to the sum of the surface areas of the individual components.

    An aggregate is a particle comprising strongly bonded or fused particles where the resulting external surface area may be significantly smaller than the sum of calculated surface areas of the individual components.

    Central Data Exchange or CDX means EPA's centralized electronic submission receiving system.

    CISS tool means the Chemical Information Submission System, EPA's electronic, web-based reporting tool for the completion and submission of data, reports, and other information, or its successors.

    Discrete form of a reportable chemical substance differs from another form of the same reportable chemical substance in one or more of the following 3 characteristics: (i) The change in the reportable chemical substance is due to all of the following:

    (A) There is a change in process to effect a change in size, a change in one or more of the properties of the reportable chemical substances identified in paragraph (i)(C) of this definition, or both;

    (B) There is a size variation in the mean particle size that is greater than 7 times the standard deviation of the mean particle size (+/− 7 times the standard deviation); and

    (C) There is a change in at least one of the following properties: Zeta potential, specific surface area, dispersion stability, or surface reactivity, that is greater than 7 times the standard deviation of the measured value (+/− 7 times the standard deviation).

    (ii) The reportable chemical substance has a different morphology. Examples of morphologies include but are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, torus, cone, and sheet.

    (iii) A reportable chemical substance that is coated with another chemical substance or mixture at the end of manufacturing or processing has a coating that consists of a different chemical substance or mixture.

    Nanoscale Materials Stewardship Program was a program conducted by EPA from January 2008 to December 2009 under which some nanoscale material manufacturers and processors voluntarily provided EPA available information on engineered nanoscale materials that were manufactured, processed or used.

    Particle is a minute piece of matter with defined physical boundaries.

    Primary particles are particles or droplets that form during manufacture of a chemical substance before aggregation or agglomerization occurs.

    Reportable chemical substance is a chemical substance as defined in section 3 of TSCA that is solid at 25 °C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nm in at least one dimension, and that is manufactured or processed to exhibit unique and novel properties because of its size. A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1-100 nm.

    Small manufacturer or processor means any manufacturer or processor whose total annual sales, when combined with those of its parent company (if any), are less than $11 million. The definition of small manufacturer in section 704.3 of this title does not apply to reporting under this section (40 CFR 704.20).

    Specific surface area means the ratio of the area of the surface of the reportable chemical substance to its mass or volume. Specific surface area by mass is the ratio of the area of the surface of a nanoscale material divided by the mass (m2/kg) and the specific surface area by volume is the area of the surface of the reportable chemical substance divided by its volume m2/m3.

    Surface reactivity means the reactivity at the surface of a reportable chemical substance. It is dependent upon factors such as redox potential, which is a measure of the tendency of a substance to lose or acquire electrons, photocatalytic activity, including the potential to generate free radicals.

    Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.

    Zeta potential is the electrostatic potential near the particle surface.

    (b) Persons who must report. (1) Persons who can reasonably ascertain that they are manufacturers and processors of a discrete form of a reportable chemical substance during the three years prior to the final effective date of the rule must report except as provided in paragraph (c) of this section.

    (2) Persons who can reasonably ascertain that they propose to manufacture or process a discrete form of a reportable chemical substance after the final effective date of the rule which was not reported under paragraph (b)(1) of this section must report except as provided in paragraph (c) of this section.

    (c) When reporting is not required. (1) The following chemical substances are not subject to reporting under this section:

    (i) Chemical substances formed at the nanoscale as part of a film on a surface.

    (ii) DNA.

    (iii) RNA.

    (iv) Proteins.

    (v) Enzymes.

    (vi) Lipids.

    (vii) Carbohydrates.

    (viii) Peptides.

    (ix) Liposomes.

    (x) Antibodies.

    (xi) Viruses.

    (xii) Microorganisms.

    (xiii) Chemical substances which dissociate completely in water to form ions that are smaller than 1 nanometer.

    (xiv) Chemical substances that are not on the TSCA Chemical Substance Inventory at the time reporting would otherwise be required under this section.

    (2) Persons who submitted a notice under 40 CFR parts 720, 721, or 723 for a reportable chemical substance on or after January 1, 2005 are not required to submit a report for the reportable chemical substance submitted except where the person manufactures or processes a discrete form of the reportable chemical substance.

    (3) Section 704.5(a) through (e) apply to reporting under this section. Small manufacturers and processors as defined in paragraph (a) of this section are exempt from reporting under this section.

    (4) Persons who submitted some or all of the required information for a reportable chemical substance as part of the Nanoscale Materials Stewardship Program are not required to report the information previously submitted except where the person manufactures or processes a discrete form of the reportable chemical substance.

    (d) What information to report. The following information must be reported for each discrete form of a reportable chemical substance to the extent that it is known to or reasonably ascertainable by the person reporting:

    (1) The common or trade name, the specific chemical identity including the correct Chemical Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the molecular structure of each chemical substance or mixture. Information must be reported as specified in § 720.45.

    (2) Material characteristics including particle size, morphology, and surface modifications.

    (3) Physical/chemical properties.

    (4) The maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance.

    (5)(i) Persons described in paragraph (b)(1) of this section must report the annual production volume for the previous three years before the effective date of the final rule and an estimate of the maximum production volume for any consecutive 12-month period during the next two years of production after the final effective date of this rule.

    (ii) Persons described in paragraph (b)(2) of this section must report the estimated maximum 12 month production volume and the estimated maximum production volume for any consecutive 12 month period during the first three years of production.

    (iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section must be on 100% chemical basis of the discrete form of the solid nanoscale material.

    (6) Use information describing the category of each use by function and application, estimates of the amount manufactured or processed for each category of use, and estimates of the percentage in the formulation for each use.

    (7) Detailed information on methods of manufacturing or processing.

    (8) Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions and estimates of any general population or consumer exposures.

    (9) Release information with estimates of the amounts released, descriptions and duration of the activities that cause such releases, and whether releases are directly to the environment or to control technology.

    (10) Risk management practices describing protective equipment for individuals, engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, or other information which is provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, or disposal of the substance.

    (11) Existing information concerning the environmental and health effects.

    (e) How to report. You must use CDX and the CISS tool to complete and submit the information required under this part to EPA electronically.

    (1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA § 8(a) Reporting for Nanoscale Materials: Information Submission Form.

    (2) Electronic submission. You must submit the required information to EPA electronically via CDX and using the CISS tool.

    (i) To access the CDX portal, go to https://cdx.epa.gov.

    (ii) The CISS tool is accessible in CDX.

    (f) When to report. (1) Persons specified in paragraph (b)(1) of this section must report the information specified in paragraph (d) of this section within one year after the final effective date of the rule.

    (2) Persons specified in paragraph (b)(2) of this section must report the information specified in paragraph (d) of this section at least 135 days before commencing manufacture or processing of a discrete form of the reportable chemical substance, except where the person has not formed an intent to manufacture or process that discrete form at least 135 days before commencing such manufacture or processing, in which case the information must be filed within 30 days of the formation of such an intent.

    (g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to the recordkeeping requirements in § 704.11(a) and (b).

    (h) Confidential business information. (1) Persons submitting a notice under this rule are subject to the requirements for confidential business information claims in § 704.7(a) through (c).

    (2) In submitting a claim of confidentiality, a person attests to the truth of the following four statements concerning all information which is claimed confidential:

    (i) My company has taken measures to protect the confidentiality of the information,

    (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law.

    (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person.

    (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

    [FR Doc. 2017-00052 Filed 1-11-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 229 [Docket No. 160219129-6999-02] RIN 0648-BF78 List of Fisheries for 2017 AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    The National Marine Fisheries Service (NMFS) publishes its final List of Fisheries (LOF) for 2017, as required by the Marine Mammal Protection Act (MMPA). The LOF for 2017 reflects new information on interactions between commercial fisheries and marine mammals. NMFS must classify each commercial fishery on the LOF into one of three categories under the MMPA based upon the level of mortality and serious injury of marine mammals that occurs incidental to each fishery. The classification of a fishery on the LOF determines whether participants in that fishery are subject to certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan (TRP) requirements.

    DATES:

    The effective date of this final rule is February 13, 2017.

    ADDRESSES:

    Chief, Marine Mammal and Sea Turtle Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Lisa White, Office of Protected Resources, 301-427-8494; Allison Rosner, Greater Atlantic Region, 978-281-9328; Jessica Powell, Southeast Region, 727-824-5312; Penny Ruvelas, West Coast Region (CA), 562-980-4197; Lynne Barre, West Coast Region (WA/OR), 206-526-4745; Suzie Teerlink, Alaska Region, 907-586-7240; Dawn Golden, Pacific Islands Region, 808-725-5000. Individuals who use a telecommunications device for the hearing impaired may call the Federal Information Relay Service at 1-800-877-8339 between 8 a.m. and 4 p.m. Eastern time, Monday through Friday, excluding Federal holidays.

    SUPPLEMENTARY INFORMATION: What is the List of Fisheries?

    Section 118 of the MMPA requires NMFS to place all U.S. commercial fisheries into one of three categories based on the level of incidental mortality and serious injury of marine mammals occurring in each fishery (16 U.S.C. 1387(c)(1)). The classification of a fishery on the LOF determines whether participants in that fishery may be required to comply with certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements. NMFS must reexamine the LOF annually, considering new information in the Marine Mammal Stock Assessment Reports (SARs) and other relevant sources, and publish in the Federal Register any necessary changes to the LOF after notice and opportunity for public comment (16 U.S.C. 1387 (c)(1)(C)).

    How does NMFS determine in which category a fishery is placed?

    The definitions for the fishery classification criteria can be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2). The criteria are also summarized here.

    Fishery Classification Criteria

    The fishery classification criteria consist of a two-tiered, stock-specific approach that first addresses the total impact of all fisheries on each marine mammal stock and then addresses the impact of individual fisheries on each stock. This approach is based on consideration of the rate, in numbers of animals per year, of incidental mortalities and serious injuries of marine mammals due to commercial fishing operations relative to the potential biological removal (PBR) level for each marine mammal stock. The MMPA (16 U.S.C. 1362(20)) defines the PBR level as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population. This definition can also be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2).

    Tier 1: Tier 1 considers the cumulative fishery mortality and serious injury for a particular stock. If the total annual mortality and serious injury of a marine mammal stock, across all fisheries, is less than or equal to 10 percent of the PBR level of the stock, all fisheries interacting with the stock will be placed in Category III (unless those fisheries interact with other stock(s) in which total annual mortality and serious injury is greater than 10 percent of PBR). Otherwise, these fisheries are subject to the next tier (Tier 2) of analysis to determine their classification.

    Tier 2: Tier 2 considers fishery-specific mortality and serious injury for a particular stock.

    Category I: Annual mortality and serious injury of a stock in a given fishery is greater than or equal to 50 percent of the PBR level (i.e., frequent incidental mortality and serious injury of marine mammals).

    Category II: Annual mortality and serious injury of a stock in a given fishery is greater than 1 percent and less than 50 percent of the PBR level (i.e., occasional incidental mortality and serious injury of marine mammals).

    Category III: Annual mortality and serious injury of a stock in a given fishery is less than or equal to 1 percent of the PBR level (i.e., a remote likelihood of or no known incidental mortality and serious injury of marine mammals).

    Additional details regarding how the categories were determined are provided in the preamble to the final rule implementing section 118 of the MMPA (60 FR 45086; August 30, 1995).

    Because fisheries are classified on a per-stock basis, a fishery may qualify as one category for one marine mammal stock and another category for a different marine mammal stock. A fishery is typically classified on the LOF at its highest level of classification (e.g., a fishery qualifying for Category III for one marine mammal stock and for Category II for another marine mammal stock will be listed under Category II). Stocks driving a fishery's classification are denoted with a superscript “1” in Tables 1 and 2.

    Other Criteria That May Be Considered

    The tier analysis requires a minimum amount of data, and NMFS does not have sufficient data to perform a tier analysis on certain fisheries. Therefore, NMFS has classified certain fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, or according to factors discussed in the final LOF for 1996 (60 FR 67063; December 28, 1995) and listed in the regulatory definition of a Category II fishery: “In the absence of reliable information indicating the frequency of incidental mortality and serious injury of marine mammals by a commercial fishery, NMFS will determine whether the incidental mortality or serious injury is `frequent,' `occasional,' or `remote' by evaluating other factors such as fishing techniques, gear used, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area, or at the discretion of the Assistant Administrator for Fisheries” (50 CFR 229.2).

    Further, eligible commercial fisheries not specifically identified on the LOF are deemed to be Category II fisheries until the next LOF is published (50 CFR 229.2).

    How does NMFS determine which species or stocks are included as incidentally killed or injured in a fishery?

    The LOF includes a list of marine mammal species and/or stocks incidentally killed or injured in each commercial fishery. The list of species and/or stocks incidentally killed or injured includes “serious” and “non-serious” documented injuries as described later in the List of Species and/or Stocks Incidentally Killed or Injured in the Pacific Ocean and the Atlantic Ocean, Gulf of Mexico, and Caribbean sections. To determine which species or stocks are included as incidentally killed or injured in a fishery, NMFS annually reviews the information presented in the current SARs and injury determination reports. The SARs are based upon the best available scientific information and provide the most current and inclusive information on each stock's PBR level and level of interaction with commercial fishing operations. The best available scientific information used in the SARs reviewed for the 2017 LOF generally summarizes data from 2009-2013. NMFS also reviews other sources of new information, including injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports from that time period. In some cases, more recent information may be available and used in the LOF, but in an effort to be consistent with the most recent SARs and across the LOF, NMFS typically restricts the analysis to data within the five-year time period summarized in the current SAR.

    For fisheries with observer coverage, species or stocks are generally removed from the list of marine mammal species and/or stocks incidentally killed or injured if no interactions are documented in the five-year timeframe summarized in that year's LOF. For fisheries with no observer coverage and for observed fisheries with evidence indicating that undocumented interactions may be occurring (e.g., fishery has low observer coverage and stranding network data include evidence of fisheries interaction that cannot be attributed to a specific fishery) species and stocks may be retained for longer than five years. For these fisheries, NMFS will review the other sources of information listed above and use its discretion to decide when it is appropriate to remove a species or stock.

    Where does NMFS obtain information on the level of observer coverage in a fishery on the LOF?

    The best available information on the level of observer coverage and the spatial and temporal distribution of observed marine mammal interactions is presented in the SARs. Data obtained from the observer program and observer coverage levels are important tools in estimating the level of marine mammal mortality and serious injury in commercial fishing operations. Starting with the 2005 SARs, each SAR includes an appendix with detailed descriptions of each Category I and II fishery on the LOF, including the observer coverage in those fisheries. The SARs generally do not provide detailed information on observer coverage in Category III fisheries because, under the MMPA, Category III fisheries are generally not required to accommodate observers aboard vessels due to the remote likelihood of mortality and serious injury of marine mammals. Fishery information presented in the SARs' appendices and other resources referenced during the tier analysis may include: Level of observer coverage; target species; levels of fishing effort; spatial and temporal distribution of fishing effort; characteristics of fishing gear and operations; management and regulations; and interactions with marine mammals. Copies of the SARs are available on the NMFS Office of Protected Resources Web site at: http://www.nmfs.noaa.gov/pr/sars/. Information on observer coverage levels in Category I, II, and III fisheries can be found in the fishery fact sheets on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html. Additional information on observer programs in commercial fisheries can be found on the NMFS National Observer Program's Web site: http://www.st.nmfs.gov/observer-home/.

    How do I find out if a specific fishery is in Category I, II, or III?

    This rule includes three tables that list all U.S. commercial fisheries by LOF Category. Table 1 lists all of the commercial fisheries in the Pacific Ocean (including Alaska); Table 2 lists all of the commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean; and Table 3 lists all U.S.-authorized commercial fisheries on the high seas. A fourth table, Table 4, lists all commercial fisheries managed under applicable TRPs or take reduction teams (TRTs).

    Are high seas fisheries included on the LOF?

    Beginning with the 2009 LOF, NMFS includes high seas fisheries in Table 3 of the LOF, along with the number of valid High Seas Fishing Compliance Act (HSFCA) permits in each fishery. As of 2004, NMFS issues HSFCA permits only for high seas fisheries analyzed in accordance with the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The authorized high seas fisheries are broad in scope and encompass multiple specific fisheries identified by gear type. For the purposes of the LOF, the high seas fisheries are subdivided based on gear type (e.g., trawl, longline, purse seine, gillnet, troll, etc.) to provide more detail on composition of effort within these fisheries. Many fisheries operate in both U.S. waters and on the high seas, creating some overlap between the fisheries listed in Tables 1 and 2 and those in Table 3. In these cases, the high seas component of the fishery is not considered a separate fishery, but an extension of a fishery operating within U.S. waters (listed in Table 1 or 2). NMFS designates those fisheries in Tables 1, 2, and 3 by a “*” after the fishery's name. The number of HSFCA permits listed in Table 3 for the high seas components of these fisheries operating in U.S. waters does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels/participants holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries in Tables 1 and 2.

    HSFCA permits are valid for five years, during which time Fishery Management Plans (FMPs) can change. Therefore, some vessels/participants may possess valid HSFCA permits without the ability to fish under the permit because it was issued for a gear type that is no longer authorized under the most current FMP. For this reason, the number of HSFCA permits displayed in Table 3 is likely higher than the actual U.S. fishing effort on the high seas. For more information on how NMFS classifies high seas fisheries on the LOF, see the preamble text in the final 2009 LOF (73 FR 73032; December 1, 2008). Additional information about HSFCA permits can be found at: http://www.nmfs.noaa.gov/ia/permits/highseas.html.

    Where can I find specific information on fisheries listed on the LOF?

    Starting with the 2010 LOF, NMFS developed summary documents, or fishery fact sheets, for each Category I and II fishery on the LOF. These fishery fact sheets provide the full history of each Category I and II fishery, including: When the fishery was added to the LOF; the basis for the fishery's initial classification; classification changes to the fishery; changes to the list of species and/or stocks incidentally killed or injured in the fishery; fishery gear and methods used; observer coverage levels; fishery management and regulation; and applicable TRPs or TRTs, if any. These fishery fact sheets are updated after each final LOF and can be found under “How Do I Find Out if a Specific Fishery is in Category I, II, or III?” on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, linked to the “List of Fisheries by Year” table. NMFS is developing similar fishery fact sheets for each Category III fishery on the LOF. However, due to the large number of Category III fisheries on the LOF and the lack of accessible and detailed information on many of these fisheries, the development of these fishery fact sheets is taking significant time to complete. NMFS began posting Category III fishery fact sheets online with the LOF for 2016.

    Am I required to register under the MMPA?

    Owners of vessels or gear engaging in a Category I or II fishery are required under the MMPA (16 U.S.C. 1387(c)(2)), as described in 50 CFR 229.4, to register with NMFS and obtain a marine mammal authorization to lawfully take non-endangered and non-threatened marine mammals incidental to commercial fishing operations. Owners of vessels or gear engaged in a Category III fishery are not required to register with NMFS or obtain a marine mammal authorization.

    How do I register and receive my Marine Mammal Authorization Program (MMAP) authorization certificate?

    NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program (MMAP), with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Participants in these fisheries are automatically registered under the MMAP and are not required to submit registration or renewal materials. In the Pacific Islands, West Coast, and Alaska regions, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail or with their state or Federal license or permit at the time of issuance or renewal. In the West Coast Region, authorization certificates may be obtained from the Web site http://www.westcoast.fisheries.noaa.gov/protected_species/marine_mammals/fisheries_interactions.html. In the Alaska Region, authorization certificates may be obtained from the Web site https://alaskafisheries.noaa.gov/pr/mmapregistration. In the Greater Atlantic Region, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail automatically at the beginning of each calendar year. Certificates may also be obtained by visiting the Greater Atlantic Regional Office Web site http://www.greateratlantic.fisheries.noaa.gov/Protected/mmp/mmap/. In the Southeast Region, NMFS will issue vessel or gear owners notification of registry and vessel or gear owners may receive their authorization certificate by contacting the Southeast Regional Office at 727-209-5952 or by visiting the Southeast Regional Office Web site http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/ and following the instructions for printing the certificate.

    The authorization certificate, or a copy, must be on board the vessel while it is operating in a Category I or II fishery, or for non-vessel fisheries, in the possession of the person in charge of the fishing operation (50 CFR 229.4(e)). Although efforts are made to limit the issuance of authorization certificates to only those vessel or gear owners that participate in Category I or II fisheries, not all state and Federal license or permit systems distinguish between fisheries as classified by the LOF. Therefore, some vessel or gear owners in Category III fisheries may receive authorization certificates even though they are not required for Category III fisheries. Individuals fishing in Category I and II fisheries for which no state or Federal license or permit is required must register with NMFS by contacting their appropriate Regional Office (see ADDRESSES).

    How do I renew my registration under the MMAP?

    In Alaska regional and Greater Atlantic regional fisheries, registrations of vessel or gear owners are automatically renewed and participants should receive an authorization certificate by January 1 of each new year. In Pacific Islands regional fisheries, vessel or gear owners receive an authorization certificate by January 1 for state fisheries and with their permit renewal for Federal fisheries. In West Coast regional fisheries, vessel or gear owners receive authorization either with each renewed state fishing license in Washington and Oregon, with their permit renewal for Federal fisheries, the timing of which varies based on target species, or via U.S. mail. Vessel or gear owners who participate in fisheries in these regions and have not received authorization certificates by January 1 or with renewed fishing licenses must contact the appropriate NMFS Regional Office (see FOR FURTHER INFORMATION CONTACT).

    In Southeast regional fisheries, vessel or gear owners' registrations are automatically renewed and participants will receive a letter in the mail by January 1 instructing them to contact the Southeast Regional Office to have an authorization certificate mailed to them or to visit the Southeast Regional Office Web site http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/ to print their own certificate.

    Am I required to submit reports when I kill or injure a marine mammal during the course of commercial fishing operations?

    In accordance with the MMPA (16 U.S.C. 1387(e)) and 50 CFR 229.6, any vessel owner or operator, or gear owner or operator (in the case of non-vessel fisheries), participating in a fishery listed on the LOF must report to NMFS all incidental mortalities and injuries of marine mammals that occur during commercial fishing operations, regardless of the category in which the fishery is placed (I, II, or III) within 48 hours of the end of the fishing trip or, in the case of non-vessel fisheries, fishing activity. “Injury” is defined in 50 CFR 229.2 as a wound or other physical harm. In addition, any animal that ingests fishing gear or any animal that is released with fishing gear entangling, trailing, or perforating any part of the body is considered injured, regardless of the presence of any wound or other evidence of injury, and must be reported.

    Mortality/injury reporting forms and instructions for submitting forms to NMFS can be found at: http://www.nmfs.noaa.gov/pr/interactions/mmap/#form or by contacting the appropriate regional office (see FOR FURTHER INFORMATION CONTACT). Forms may be submitted via any of the following means: (1) Online using the electronic form; (2) emailed as an attachment to [email protected]; (3) faxed to the NMFS Office of Protected Resources at 301-713-0376; or (4) mailed to the NMFS Office of Protected Resources (mailing address is provided on the postage-paid form that can be printed from the web address listed above). Reporting requirements and procedures can be found in 50 CFR 229.6.

    Am I required to take an observer aboard my vessel?

    Individuals participating in a Category I or II fishery are required to accommodate an observer aboard their vessel(s) upon request from NMFS. MMPA section 118 states that the Secretary is not required to place an observer on a vessel if the facilities for quartering an observer or performing observer functions are so inadequate or unsafe that the health or safety of the observer or the safe operation of the vessel would be jeopardized; thereby authorizing the exemption of vessels too small to accommodate an observer from this requirement. However, U.S. Atlantic Ocean, Caribbean, or Gulf of Mexico large pelagics longline vessels operating in special areas designated by the Pelagic Longline Take Reduction Plan implementing regulations (50 CFR 229.36(d)) will not be exempted from observer requirements, regardless of their size. Observer requirements can be found in 50 CFR 229.7.

    Am I required to comply with Any marine mammal TRP regulations?

    Table 4 in this rule provides a list of fisheries affected by TRPs and TRTs. TRP regulations can be found at 50 CFR 229.30 through 229.37. A description of each TRT and copies of each TRP can be found at: http://www.nmfs.noaa.gov/pr/interactions/trt/teams.html. It is the responsibility of fishery participants to comply with applicable take reduction regulations.

    Where can I find more information about the LOF and the MMAP?

    Information regarding the LOF and the MMAP, including: Registration procedures and forms; current and past LOFs; descriptions of each Category I and II fishery; and some Category III fisheries; observer requirements; and marine mammal mortality/injury reporting forms and submittal procedures; may be obtained at: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, or from any NMFS Regional Office at the addresses listed below:

    NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2298, Attn: Allison Rosner;

    NMFS, Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701, Attn: Jessica Powell;

    NMFS, West Coast Region, Seattle Office, 7600 Sand Point Way NE., Seattle, WA 98115, Attn: Lynne Barre, Protected Resources Division;

    NMFS, West Coast Region, Long Beach Office, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213, Attn: Penny Ruvelas;

    NMFS, Alaska Region, Protected Resources, P.O. Box 22668, 709 West 9th Street, Juneau, AK 99802, Attn: Suzie Teerlink; or

    NMFS, Pacific Islands Regional Office, Protected Resources Division, 1845 Wasp Blvd., Building 176, Honolulu, HI 96818, Attn: Dawn Golden.

    Sources of Information Reviewed for the 2017 LOF

    NMFS reviewed the marine mammal incidental mortality and serious injury information presented in the SARs for all fisheries to determine whether changes in fishery classification are warranted. The SARs are based on the best scientific information available at the time of preparation, including the level of mortality and serious injury of marine mammals that occurs incidental to commercial fishery operations and the PBR levels of marine mammal stocks. The information contained in the SARs is reviewed by regional Scientific Review Groups (SRGs) representing Alaska, the Pacific (including Hawaii), and the U.S. Atlantic, Gulf of Mexico, and Caribbean. The SRGs were created by the MMPA to review the science that informs the SARs, and to advise NMFS on marine mammal population status, trends, and stock structure, uncertainties in the science, research needs, and other issues.

    NMFS also reviewed other sources of new information, including marine mammal stranding data, observer program data, fisher self-reports through the MMAP, reports to the SRGs, conference papers, FMPs, and ESA documents.

    The LOF for 2017 was based on, among other things, stranding data; fisher self-reports; and SARs, primarily the 2015 SARs, which are based on data from 2009-2013 and the draft 2016 SARs, which cover 2010-2014. The SARs referenced in this LOF include: 2014 (80 FR 50599; August 20, 2015), 2015 (81 FR 38676; June 14, 2016), and draft 2016 (81 FR 70097; October 11, 2016). The SARs are available at: http://www.nmfs.noaa.gov/pr/sars/.

    Comments and Responses

    NMFS received four comment letters on the proposed LOF for 2017 (81 FR 54019; August 15, 2016). Comments were received from the Alaska Commercial Fisheries Entry Commission (CFEC), Alaska Trollers Association (ATA), Center for Biological Diversity (CBD), and West Coast Fisheries Consultants, LLC (WCFC). Comments on Commercial Fisheries in the Pacific Ocean

    Comment 1: CBD recommends NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the Hawaii shallow-set longline fishery based on 2015 documented interactions.

    Response: The 2017 LOF is based on information on marine mammals and fisheries from the 2015 SARs and draft 2016 SARs. The recently observed Guadalupe fur seal interaction from 2015 has not yet been included in the SARs and has not yet been evaluated as part of the tier analysis for this fishery. This species will be included in a future LOF, as appropriate.

    Comment 2: CBD recommends that NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the CA drift gillnet and the gillnet fisheries that operate from Tillamook County, Oregon, to Jefferson County, Washington, such as the WA Willapa Bay drift gillnet, WA/OR lower Columbia River drift gillnet, and the WA Grays Harbor salmon drift gillnet based on seven documented interactions from 2010-2014.

    Response: As described in the 2016 Sources of human-related injury and mortality for U.S. Pacific West Coast marine mammal stocks, 2010-2014, there have been 16 records of deaths and/or serious injuries to Guadalupe fur seals from stranding data from 2010-2014 (Carretta et al., 2016a). These strandings included entanglement in marine debris and gillnet of unknown origin, and shootings. The available data, including observer information from the CA drift gillnet fishery and the draft 2016 SAR, have been reviewed and the source(s) of those entanglements could not be determined; thus we have not made any changes to the LOF based on this information.

    Comment 3: CBD concurs with NMFS that the CA spiny lobster fishery should be classified as Category II and recommends NMFS list humpback whale, CA/OR/WA stock, as a species/stock driving classification.

    Response: NMFS agrees that the Category II reclassification of the CA spiny lobster fishery is warranted. In the proposed 2010 LOF (74 FR 27739; June 11, 2009), NMFS proposed to add humpback whale, CA/OR/WA stock, to the species or stocks incidentally killed or injured in the CA spiny lobster fishery and to reclassify the fishery as Category II due to a 2007 report of a humpback whale entanglement that had been attributed to the fishery. However, during public comment on the proposed 2010 LOF, NMFS received information from the California Department of Fish and Game (the agency that reported the entanglement) that the report of the gear type and fishery was not considered reliable. Further, the entanglement was observed in July and the CA spiny lobster fishery occurs October through March. Based upon these public comments, NMFS did not add humpback to the species or stock incidentally killed or injured in the CA spiny lobster fishery and did not reclassify it in the final 2010 LOF (73 FR 73032; December 1, 2008). The original 2007 entanglement report, attributing the entanglement to the spiny lobster fishery, was used in the SAR for the 2013 humpback whale, CA/OR/WA stock and includes a mortality/serious injury of humpback whale in this fishery. The entanglement information in the SAR was not updated following public comment on the 2010 LOF. Based upon NMFS' review of this entanglement and input from the reporting agency during the 2010 LOF process, we are not using this humpback whale entanglement to recategorize the CA spiny lobster fishery. NMFS agrees that the new distinct population segment listings may change the way we identify the humpback whale stock along the U.S. West Coast. However, at this time we continue to use the CA/OR/WA stock of humpbacks, and associated PBR, as described in the MMPA for the LOF.

    Comment 4: CBD recommends NMFS add harbor seals to the list of species and/or stocks incidentally killed or injured in the CA spiny lobster fishery based on a 2010 documented injury.

    Response: NMFS disagrees with this recommendation. We reviewed all sources of human-related injury and mortality of harbor seals from 2010 through 2014 and there were no interactions with pot/trap gear. Although the record for this specific incident does indicate that a piece of lobster trap gear was attached to the line on the animal, lobster trap was not indicated as the cause of the interaction, the interaction type was a hook and line fishery. Entanglement in hook and line, not pot/trap, gear is consistent with other documented interactions with harbor seals.

    Comment 5: WCFC recommends NMFS classify CA spiny lobster as Category III. WCFC believes the 2008 bottlenose dolphin injury, which is driving the classification of this fishery, did not warrant serious injury designation. WCFC notes that there have been no documented interactions with bottlenose dolphins in the most recent five-year period.

    Response: The commenter's first point is outside the scope of the LOF. Serious injury determinations are made by NMFS consistent with the current Guidelines for Assessing Marine Mammal Stocks (GAMMS) and the 2012 policy on assessing serious injury. The commenter should make any comments on injury determinations during the annual comment period for the relevant stock's SAR change. On the commenter's second point, there are no observers in the CA spiny lobster fishery. The interaction with the common bottlenose dolphin was based upon a stranding report and disentanglement effort. In 2015, there was an entanglement of a humpback whale in spiny lobster gear. This incident was not used in making our recommendations for the 2017 LOF because it was outside the 5-year data period (2009-2013) we relied upon. When the 2015 entanglement is included in the SAR and accounted for on the LOF, the entanglement will keep the spiny lobster trap fishery in Category II.

    Comment 6: CBD recommends NMFS reclassify the Gulf of Alaska sablefish longline fishery as a Category II fishery and add the western U.S. stock of Steller sea lions to the list of species incidentally killed or injured in the fishery. CBD stated their proposed reclassification should be based on the total annual mortality and serious injury of this stock due to fisheries (31), which is more than 10 percent of the PBR (297). Therefore, the fishery should be listed as Category II. In addition, CBD reiterates its 2016 comment (81 FR 40874; June 23, 2016) about incidental take of sperm whales in the sablefish longline fishery. Four sperm whales were observed seriously injured incidental to the Gulf of Alaska sablefish longline fishery (two each observed in 2012 and 2013). However, NMFS did not provide extrapolated estimates of sperm whale mortality and serious injury. Nonetheless, using the extrapolation applied in 2012 for the mortality of western U.S. stock of Steller sea lions in this fishery would result in an estimated 11 sperm whales seriously injured in 2012. Observer coverage in 2013 (13 percent) was slightly less than in 2012 (14 percent), which according to CBD means that a conservative estimate of sperm whales seriously injured in 2013 would likely be approximately 11. CBD expressed concern that PBR is said to be unknown for this stock of sperm whales in the stock assessment report. CBD noted the response to their 2016 comment said that NMFS would “conduct a full evaluation of this stock and this fishery pursuant to the LOF” and predicted that it would be done “for the next annual LOF, likely the 2017 LOF.” CBD requests NMFS now consider the information.

    Response: The single observed Steller sea lion mortality in 2012 referenced in this comment is extrapolated and averaged over five years to account for inter-annual variability in the 5-year window being considered for the 2017 LOF (2009-2013). Therefore, the 5-year average annual mortality and serious injury estimate for the western U.S. stock of Steller sea lions specific to the Gulf of Alaska sablefish longline is 1.1 (CV = 0.91). Please refer to the preamble supplementary information of this Rule for clarification on the complete process under which commercial fisheries are annually categorized for the LOF. In short, the LOF analysis is conducted in a two-tier process. The Tier 1 analysis assesses potential impacts to a particular marine mammal stock from all fisheries. NMFS compares the average annual mortality and serious injury estimates across fisheries to that stock's PBR. If the average annual mortality and serious injury estimate is greater than 10 percent of the PBR, NMFS considers the contribution of individual fisheries in the Tier 2 analysis. The Tier 2 analysis then compares mortality and serious injury by individual fisheries to that marine mammal stock's PBR and places the fishery in the appropriate LOF Category in accordance with established thresholds for Category I to III.

    The Tier 1 analysis of the western U.S. stock of Steller sea lions indicates the annual mortality and serious injury estimate from all fisheries (31) is greater than 10 percent of the PBR (297). Therefore, fisheries that interact with this stock are subject to a Tier 2 analysis. The Tier 2 analysis for the Gulf of Alaska sablefish longline with an average annual mortality and serious injury of 1.1 western U.S. Steller sea lions (0.37 percent of PBR) results in the fishery being placed in Category III, as it is below the Category II threshold of 1 percent of PBR.

    In regards to sperm whales, since the close of the proposed 2017 LOF comment period, NMFS published the draft 2016 SARs (81 FR 70097; October 11, 2016). The sperm whale SAR now includes an average annual mortality and serious injury estimate (2.2). NMFS will consider this new estimate and evaluate the fishery for the 2018 LOF when the 2016 SAR should be final.

    Comment 7: CFEC and ATA recommend NMFS leave the AK miscellaneous finfish handline/hand troll and mechanical jig fishery classified as Category III. The commenters note that there is no documentation to link the vessel to a commercial fishing trip and that the vessel was at anchor in safe harbor and not involved in the act of commercial fishing.

    Response: NMFS reviewed the available reports and data surrounding this incident. The vessel's crew identified themselves as Pacific cod jig fishermen, but it appears that this vessel did not land any Pacific cod fished by jig during the year that the incident took place (2013). Further, this vessel had only 7 reported landings in 2013, all in the Pacific cod pot fishery. However, these landings occurred outside the time frame of the incident. Specifically, the vessel landed Pacific cod (using pot gear) two weeks prior to the incident and not again until five months after the incident. Therefore, the interaction will not be assigned to the AK miscellaneous finfish handline/hand troll and mechanical jig fishery. This fishery will not be reclassified as Category II and will remain in Category III in the 2017 LOF Final Rule.

    Comment 8: CFEC and ATA recommend NMFS consider re-characterizing the fisheries grouped together in the AK miscellaneous finfish handline/hand troll and mechanical jig fishery.

    Response: NMFS agrees that AK miscellaneous finfish handline/hand troll and mechanical jig is currently grouped to include gear and fishing techniques too diverse to effectively evaluate potential risk to marine mammals. NMFS will review the characteristics of these fisheries and will propose a more appropriate characterization in the 2018 LOF.

    Comments on Commercial Fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean

    Comment 9: CBD recommends NMFS add humpback whales to the list of species and/or stocks incidentally killed or injured in the Southeastern U.S. Atlantic shark gillnet fishery based on a 2012 injury.

    Response: The 2012 gillnet entanglement of the humpback whale occurred in the Mid-Atlantic Gillnet Fishery (Waring et al., 2015). The humpback whale, Gulf of Maine stock is currently listed as a “marine mammal species and/or stock incidentally killed or injured” in the Mid-Atlantic gillnet fishery in the LOF.

    Summary of Changes From the Proposed Rule

    NMFS retains AK miscellaneous finfish handline/hand troll and mechanical jig fishery as Category III and does not reclassify the fishery to Category II as proposed.

    Summary of Changes to the LOF for 2017

    The following summarizes changes to the LOF for 2017, including the classification of fisheries, fisheries listed, the estimated number of vessels/persons in a particular fishery, and the species and/or stocks that are incidentally killed or injured in a particular fishery. NMFS re-classifies one fishery in the LOF for 2017. Additionally, NMFS adds one fishery to the LOF. NMFS is aware a new fishery, AK Gulf of Alaska sablefish pot, will be starting in 2017 and will characterize this fishery on the 2018 LOF. NMFS makes changes to the estimated number of vessels/persons and list of species and/or stocks killed or injured in certain fisheries. The classifications and definitions of U.S. commercial fisheries for 2017 are identical to those provided in the LOF for 2016 with the changes discussed below. State and regional abbreviations used in the following paragraphs include: AK (Alaska), BSAI (Bering Sea and Aleutian Islands), CA (California), DE (Delaware), FL (Florida), GMX (Gulf of Mexico), HI (Hawaii), MA (Massachusetts), ME (Maine), NC (North Carolina), NY (New York), OR (Oregon), RI (Rhode Island), SC (South Carolina), VA (Virginia), WA (Washington), and WNA (Western North Atlantic).

    Commercial Fisheries in the Pacific Ocean Classification of Fisheries

    NMFS reclassifies the CA spiny lobster fishery from Category III to Category II. NMFS makes an administrative correction to list this fishery under Category II in Table 1. In the proposed rule, the fishery was mistakenly left as Category III.

    Number of Vessels/Persons

    NMFS updates the estimated number of vessels/persons in the Pacific Ocean (Table 1) as follows:

    Category Fishery Number of
  • vessels/persons
  • (2016 LOF)
  • Number of
  • vessels/persons
  • (2017 LOF)
  • I HI deep-set longline 135 139 II HI shallow-set longline 15 20 II American Samoa longline 22 20 III American Samoa bottomfish handline 17 24
    List of Species and/or Stocks Incidentally Killed or Injured in the Pacific Ocean

    NMFS adds the Hawaii stock of pygmy killer whale and removes the Hawaii pelagic stock of pantropical spotted dolphin on the list of stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery.

    NMFS adds the Hawaii stock of rough-toothed dolphin and removes the Hawaii stock of Kogia spp. on the list of stocks killed or injured in the Category II Hawaii shallow-set longline fishery.

    NMFS adds the Northeast Pacific stock of fin whale to the list of stocks killed or injured in the AK miscellaneous finfish handline/hand troll and mechanical jig fishery.

    NMFS adds the CA/OR/WA stock of short-finned pilot whale to the list of stocks incidentally killed or injured in the CA thresher shark/swordfish drift gillnet (≥14 in mesh) fishery.

    Commercial Fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean Addition of Fisheries

    NMFS adds the Northeast and Mid-Atlantic fyke net fishery to the list of Category III fisheries.

    Number of Vessels/Persons

    NMFS updates the estimated number of vessels/persons in the Atlantic Ocean, Gulf of Mexico, and Caribbean (Table 2) as follows:

    Category Fishery Number of
  • vessels/persons
  • (2016 LOF)
  • Number of
  • vessels/persons
  • (2017 LOF)
  • I Mid-Atlantic Gillnet 4063 3950 II Chesapeake Bay Inshore Gillnet 272 248 II Gulf of Mexico Gillnet 724 248 II NC Inshore Gillnet 1323 2850 II Northeast Anchored Gillnet 995 852 II Northeast Drift Gillnet 1567 1036 II Southeast Atlantic Gillnet 357 273 II Mid-Atlantic Mid-water Trawl 507 382 II Mid-Atlantic Bottom Trawl 994 785 II Northeast Bottom Trawl 3132 2238 II Southeastern U.S. Atlantic, Gulf of Mexico Stone Crab Trap/Pot 1282 1384 II Atlantic Mixed Species Trap/Pot 3284 3436 II Atlantic Blue Crab Trap/Pot 8557 7714 II Mid-Atlantic Haul Beach Seine 243 359 II NC Long Haul Seine 372 30 II NC Roe Mullet Stop Net 13 1 II VA Pound Net 47 26
    List of Species and/or Stocks Incidentally Killed or Injured in the Atlantic Ocean, Gulf of Mexico, and Caribbean

    NMFS removes the Western North Atlantic stock of harbor seal from the list of species incidentally killed or injured in the Category I Northeast/Mid-Atlantic American lobster trap/pot fishery.

    NMFS removes Risso's dolphin, Western North Atlantic stock, and adds the Western North Atlantic stocks of harbor seal and gray seal to the list of species incidentally killed or injured in the Category II Mid-Atlantic Mid-water trawl fishery.

    NMFS adds the Canadian East coast stock of minke whale to the list of species incidentally killed or injured in the Category II Northeast midwater trawl fishery.

    NMFS removes the Canadian East coast stock of minke whale from the list of species incidentally killed or injured in the Category II Northeast bottom trawl fishery.

    NMFS removes the Western North Atlantic stock of short-finned pilot whale from the list of species incidentally killed or injured in the Category II Northeast sink gillnet fishery.

    NMFS removes the following stocks from the list of species incidentally killed or injured in the Category I Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline fishery: Western North Atlantic stock of Atlantic spotted dolphin, Gulf of Mexico stock of Gervais beaked whale, Gulf of Mexico oceanic stock of killer whale, Western North Atlantic stock of Pantropical spotted dolphin, and Gulf of Mexico oceanic stock of sperm whale.

    NMFS adds unknown stock (likely Northern migratory coastal or Southern migratory coastal) of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category II Chesapeake Bay inshore gillnet fishery.

    NMFS adds the Mississippi Sound, Lake Borgne, Bay Boudreau stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category II Gulf of Mexico menhaden purse seine fishery.

    NMFS adds the Florida Keys stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category III Florida spiny lobster trap/pot fishery.

    NMFS adds the Barataria Bay stock and the Mississippi Sound, Lake Borgne, Bay Boudreau stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category III Gulf of Mexico blue crab trap/pot fishery.

    Commercial Fisheries on the High Seas Number of Vessels/Persons

    NMFS updates the estimated number of vessels/persons on the High Seas (Table 3) as follows:

    Category Fishery Number of
  • vessels/persons
  • (2016 LOF)
  • Number of
  • vessels/persons
  • (2017 LOF)
  • I Western Pacific pelagic longline (HI deep-set component) 135 139 II Atlantic highly migratory species drift gillnet 1 0 II South Pacific tuna purse seine 39 38 II South Pacific albacore troll longline 15 10 II South Pacific tuna longline 8 2 II Western Pacific pelagic longline (HI shallow-set component) 15 20 II Pacific highly migratory species handline/pole and line 50 46 II South Pacific albacore troll handline/pole and line 9 7 II Western Pacific pelagic handline/pole and line 5 2 II South Pacific albacore troll troll 38 30 II South Pacific tuna troll 5 4 II Western Pacific pelagic troll 21 17 III Pacific highly migratory species longline 126 114 III Pacific highly migratory species purse seine 8 6 III Pacific highly migratory species troll 243 187
    List of Species and/or Stocks Incidentally Killed or Injured on the High Seas

    NMFS adds the Hawaii stock of pygmy killer whale and removes the Hawaii pelagic stock of pantropical spotted dolphin on the list of stocks incidentally killed or injured in the Category I Western Pacific pelagic longline (HI deep-set component) fishery.

    NMFS adds the Hawaii stock of rough-toothed dolphin and removes the Hawaii stock of Kogia spp. on the list of stocks killed or injured in the Category II Western Pacific pelagic longline (HI shallow-set component) fishery.

    NMFS adds the CA breeding stock of northern elephant seal to the list of stocks killed or injured in the Category II Western Pacific pelagic longline (HI shallow-set component) fishery.

    List of Fisheries

    The following tables set forth the list of U.S. commercial fisheries according to their classification under section 118 of the MMPA. Table 1 lists commercial fisheries in the Pacific Ocean (including Alaska), Table 2 lists commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean, Table 3 lists commercial fisheries on the high seas, and Table 4 lists fisheries affected by TRPs or TRTs.

    In Tables 1 and 2, the estimated number of vessels or persons participating in fisheries operating within U.S. waters is expressed in terms of the number of active participants in the fishery, when possible. If this information is not available, the estimated number of vessels or persons licensed for a particular fishery is provided. If no recent information is available on the number of participants, vessels, or persons licensed in a fishery, then the number from the most recent LOF is used for the estimated number of vessels or persons in the fishery. NMFS acknowledges that, in some cases, these estimates may be inflations of actual effort. For example, the State of Hawaii does not issue fishery-specific licenses, and the number of participants reported in the LOF represents the number of commercial marine license holders who reported using a particular fishing gear type/method at least once in a given year, without considering how many times the gear was used. For these fisheries, effort by a single participant is counted the same whether the fisher used the gear only once or every day. In the Mid-Atlantic and New England fisheries, the numbers represent the potential effort for each fishery, given the multiple gear types for which several state permits may allow. Changes made to Mid-Atlantic and New England fishery participants will not affect observer coverage or bycatch estimates, as observer coverage and bycatch estimates are based on vessel trip reports and landings data. Tables 1 and 2 serve to provide a description of the fishery's potential effort (state and Federal). If NMFS is able to extract more accurate information on the gear types used by state permit holders in the future, the numbers will be updated to reflect this change. For additional information on fishing effort in fisheries found on Table 1 or 2, contact the relevant regional office (contact information included above in SUPPLEMENTARY INFORMATION).

    For high seas fisheries, Table 3 lists the number of valid HSFCA permits currently held. Although this likely overestimates the number of active participants in many of these fisheries, the number of valid HSFCA permits is the most reliable data on the potential effort in high seas fisheries at this time. As noted previously in this rule, the number of HSFCA permits listed in Table 3 for the high seas components of fisheries that also operate within U.S. waters, does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries in Tables 1 and 2.

    Tables 1, 2, and 3 also list the marine mammal species and/or stocks incidentally killed or injured (seriously or non-seriously) in each fishery based on SARs, injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports. The best available scientific information included in these reports is based on data through 2012. This list includes all species and/or stocks known to be killed or injured in a given fishery but also includes species and/or stocks for which there are anecdotal records of a mortality or injury. Additionally, species identified by logbook entries, stranding data, or fishermen self-reports (i.e., MMPA reports) may not be verified. In Tables 1 and 2, NMFS has designated those species/stocks driving a fishery's classification (i.e., the fishery is classified based on mortalities and serious injuries of a marine mammal stock that are greater than or equal to 50 percent (Category I), or greater than 1 percent and less than 50 percent (Category II), of a stock's PBR) by a “1” after the stock's name.

    In Tables 1 and 2, there are several fisheries classified as Category II that have no recent documented mortalities or serious injuries of marine mammals, or fisheries that did not result in a mortality or serious injury rate greater than 1 percent of a stock's PBR level based on known interactions. NMFS has classified these fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, as discussed in the final LOF for 1996 (60 FR 67063; December 28, 1995), and according to factors listed in the definition of a “Category II fishery” in 50 CFR 229.2 (i.e., fishing techniques, gear types, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area). NMFS has designated those fisheries listed by analogy in Tables 1 and 2 by a “2” after the fishery's name.

    There are several fisheries in Tables 1, 2, and 3 in which a portion of the fishing vessels cross the exclusive economic zone (EEZ) boundary and therefore operate both within U.S. waters and on the high seas. These fisheries, though listed separately between Table 1 or 2 and Table 3, are considered the same fisheries on either side of the EEZ boundary. NMFS has designated those fisheries in each table by a “*” after the fishery's name.

    Table 1—List of Fisheries—Commercial Fisheries in the Pacific Ocean Fishery description Estimated
  • number of vessels/
  • persons
  • Marine mammal species and/or stocks incidentally killed or injured
    CATEGORY I LONGLINE/SET LINE FISHERIES: HI deep-set longline * 139 Bottlenose dolphin, HI Pelagic.
  • False killer whale, MHI Insular.1
  • False killer whale, HI Pelagic.1
  • False killer whale, NWHI.
  • Pygmy killer whale, HI.
  • Risso's dolphin, HI.
  • Short-finned pilot whale, HI.
  • Sperm whale, HI.
  • Striped dolphin, HI.
  • GILLNET FISHERIES: CA thresher shark/swordfish drift gillnet (≥14 in mesh) * 18 Bottlenose dolphin, CA/OR/WA offshore.
  • California sea lion, U.S.
  • Humpback whale, CA/OR/WA.
  • Long-beaked common dolphin, CA.
  • Minke whale, CA/OR/WA.
  • Northern elephant seal, CA breeding.
  • Northern right-whale dolphin, CA/OR/WA.
  • Pacific white-sided dolphin, CA/OR/WA.
  • Risso's dolphin, CA/OR/WA.
  • Short-beaked common dolphin, CA/OR/WA.
  • Short-finned pilot whale, CA/OR/WA.
  • Sperm Whale, CA/OR/WA.1
  • CATEGORY II GILLNET FISHERIES: CA halibut/white seabass and other species set gillnet (>3.5 in mesh) 50 California sea lion, U.S.
  • Harbor seal, CA.
  • Humpback whale, CA/OR/WA.1
  • Long-beaked common dolphin, CA.
  • Northern elephant seal, CA breeding.
  • Sea otter, CA.
  • Short-beaked common dolphin, CA/OR/WA.
  • CA yellowtail, barracuda, and white seabass drift gillnet (mesh size ≥3.5 in and <14 in) 2 30 California sea lion, U.S.
  • Long-beaked common dolphin, CA.
  • Short-beaked common dolphin, CA/OR/WA.
  • AK Bristol Bay salmon drift gillnet 2 1,862 Beluga whale, Bristol Bay.
  • Gray whale, Eastern North Pacific.
  • Harbor seal, Bering Sea.
  • Northern fur seal, Eastern Pacific.
  • Pacific white-sided dolphin, North Pacific.
  • Spotted seal, AK.
  • Steller sea lion, Western U.S.
  • AK Bristol Bay salmon set gillnet 2 979 Beluga whale, Bristol Bay.
  • Gray whale, Eastern North Pacific.
  • Harbor seal, Bering Sea.
  • Northern fur seal, Eastern Pacific.
  • Spotted seal, AK.
  • AK Kodiak salmon set gillnet 188 Harbor porpoise, GOA.1
  • Harbor seal, GOA.
  • Sea otter, Southwest AK.
  • Steller sea lion, Western U.S.
  • AK Cook Inlet salmon set gillnet 736 Beluga whale, Cook Inlet.
  • Dall's porpoise, AK.
  • Harbor porpoise, GOA.
  • Harbor seal, GOA.
  • Humpback whale, Central North Pacific.1
  • Sea otter, South central AK.
  • Steller sea lion, Western U.S.
  • AK Cook Inlet salmon drift gillnet 569 Beluga whale, Cook Inlet.
  • Dall's porpoise, AK.
  • Harbor porpoise, GOA.1
  • Harbor seal, GOA.
  • Steller sea lion, Western U.S.
  • AK Peninsula/Aleutian Islands salmon drift gillnet 2 162 Dall's porpoise, AK
  • Harbor porpoise, GOA.
  • Harbor seal, GOA.
  • Northern fur seal, Eastern Pacific.
  • AK Peninsula/Aleutian Islands salmon set gillnet 2 113 Harbor porpoise, Bering Sea.
  • Northern sea otter, Southwest AK.
  • Steller sea lion, Western U.S.
  • AK Prince William Sound salmon drift gillnet 537 Dall's porpoise, AK.
  • Harbor porpoise, GOA.1
  • Harbor seal, GOA.
  • Northern fur seal, Eastern Pacific.
  • Pacific white-sided dolphin, North Pacific
  • Sea otter, South central AK.
  • Steller sea lion, Western U.S.1
  • AK Southeast salmon drift gillnet 474 Dall's porpoise, AK.
  • Harbor porpoise, Southeast AK.
  • Harbor seal, Southeast AK.
  • Humpback whale, Central North Pacific.1
  • Pacific white-sided dolphin, North Pacific.
  • Steller sea lion, Eastern U.S.
  • AK yakutat salmon set gillnet 2 168 Gray whale, Eastern North Pacific.
  • Harbor Porpoise, Southeastern AK.
  • Harbor seal, Southeast AK.
  • Humpback whale, Central North Pacific (Southeast AK).
  • WA Puget Sound Region salmon drift gillnet (includes all inland waters south of U.S.-Canada border and eastward of the Bonilla-Tatoosh line-Treaty Indian fishing is excluded) 210 Dall's porpoise, CA/OR/WA.
  • Harbor porpoise, inland WA.1
  • Harbor seal, WA inland.
  • TRAWL FISHERIES: AK Bering Sea, Aleutian Islands flatfish trawl 32 Bearded seal, AK.
  • Gray whale, Eastern North Pacific.
  • Harbor porpoise, Bering Sea.
  • Harbor seal, Bering Sea.
  • Humpback whale, Western North Pacific.1
  • Killer whale, AK resident.1
  • Killer whale, GOA, AI, BS transient.1
  • Northern fur seal, Eastern Pacific.
  • Ringed seal, AK.
  • Ribbon seal, AK.
  • Spotted seal, AK.
  • Steller sea lion, Western U.S.1
  • Walrus, AK.
  • AK Bering Sea, Aleutian Islands pollock trawl 102 Bearded Seal, AK.
  • Dall's porpoise, AK.
  • Harbor seal, AK.
  • Humpback whale, Central North Pacific.
  • Humpback whale, Western North Pacific.
  • Northern fur seal, Eastern Pacific.
  • Ribbon seal, AK.
  • Ringed seal, AK.
  • Spotted seal, AK.
  • Steller sea lion, Western U.S.1
  • AK Bering Sea, Aleutian Islands rockfish trawl 17 Killer whale, ENP AK resident.1
  • Killer whale, GOA, AI, BS transient.1
  • POT, RING NET, AND TRAP FISHERIES: CA spiny lobster 194 Bottlenose dolphin, CA/OR/WA offshore.
  • Humpback whale, CA/OR/WA.
  • Gray whale, Eastern North Pacific.
  • CA spot prawn pot 25 Gray whale, Eastern North Pacific.
  • Humpback whale, CA/OR/WA.1
  • CA Dungeness crab pot 570 Gray whale, Eastern North Pacific.
  • Humpback whale, CA/OR/WA.1
  • OR Dungeness crab pot 433 Gray whale, Eastern North Pacific.
  • Humpback whale, CA/OR/WA.1
  • WA/OR/CA sablefish pot 309 Humpback whale, CA/OR/WA.1 WA coastal Dungeness crab pot 228 Gray whale, Eastern North Pacific.
  • Humpback whale, CA/OR/WA.1
  • LONGLINE/SET LINE FISHERIES: AK Bering Sea, Aleutian Islands Pacific cod longline 45 Dall's Porpoise, AK.
  • Killer whale, GOA, BSAI transient.1
  • Northern fur seal, Eastern Pacific.
  • Ringed seal, AK.
  • HI shallow-set longline * 20 Blainville's beaked whale, HI.
  • Bottlenose dolphin, HI Pelagic.
  • False killer whale, HI Pelagic.1
  • Humpback whale, Central North Pacific.
  • Risso's dolphin, HI.
  • Rough-toothed dolphin, HI.
  • Short-finned pilot whale, HI.
  • Striped dolphin, HI.
  • American Samoa longline 2 22 Bottlenose dolphin, unknown.
  • Cuvier's beaked whale, unknown.
  • False killer whale, American Samoa.
  • Rough-toothed dolphin, American Samoa.
  • Short-finned pilot whale, unknown.
  • HI shortline 2 9 None documented. CATEGORY III GILLNET FISHERIES: AK Kuskokwim, Yukon, Norton Sound, Kotzebue salmon gillnet 1,778 Harbor porpoise, Bering Sea. AK miscellaneous finfish set gillnet 54 Steller sea lion, Western U.S. AK Prince William Sound salmon set gillnet 29 Harbor seal, GOA.
  • Sea otter, South central AK.
  • Steller sea lion, Western U.S.
  • AK roe herring and food/bait herring gillnet 920 None documented. CA set gillnet (mesh size <3.5 in) 296 None documented. HI inshore gillnet 36 Bottlenose dolphin, HI.
  • Spinner dolphin, HI.
  • WA Grays Harbor salmon drift gillnet (excluding treaty Tribal fishing) 24 Harbor seal, OR/WA coast. WA/OR Mainstem Columbia River eulchon gillnet 15 None documented. WA/OR lower Columbia River (includes tributaries) drift gillnet 110 California sea lion, U.S.
  • Harbor seal, OR/WA coast.
  • WA Willapa Bay drift gillnet 82 Harbor seal, OR/WA coast.
  • Northern elephant seal, CA breeding.
  • MISCELLANEOUS NET FISHERIES: AK Cook Inlet salmon purse seine 83 Humpback whale, Central North Pacific. AK Kodiak salmon purse seine 376 Humpback whale, Central North Pacific. AK Southeast salmon purse seine 315 None documented in the most recent five years of data. AK Metlakatla salmon purse seine 10 None documented. AK miscellaneous finfish beach seine 2 None documented. AK miscellaneous finfish purse seine 2 None documented. AK octopus/squid purse seine 0 None documented. AK roe herring and food/bait herring beach seine 10 None documented. AK roe herring and food/bait herring purse seine 356 None documented. AK salmon beach seine 31 None documented. AK salmon purse seine (excluding salmon purse seine fisheries listed elsewhere) 936 Harbor seal, GOA.
  • Harbor seal, Prince William Sound.
  • WA/OR sardine purse seine 42 None documented. CA anchovy, mackerel, sardine purse seine 65 California sea lion, U.S.
  • Harbor seal, CA.
  • CA squid purse seine 80 Long-beaked common dolphin, CA Short-beaked common dolphin, CA/OR/WA. CA tuna purse seine * 10 None documented. WA/OR Lower Columbia River salmon seine 10 None documented. WA/OR herring, smelt, squid purse seine or lampara 130 None documented. WA salmon purse seine 75 None documented. WA salmon reef net 11 None documented. HI lift net 17 None documented. HI inshore purse seine <3 None documented. HI throw net, cast net 23 None documented. HI seine net 24 None documented. DIP NET FISHERIES: CA squid dip net 115 None documented. MARINE AQUACULTURE FISHERIES: CA marine shellfish aquaculture unknown None documented. CA salmon enhancement rearing pen >1 None documented. CA white seabass enhancement net pens 13 California sea lion, U.S. HI offshore pen culture 2 None documented. WA salmon net pens 14 California sea lion, U.S.
  • Harbor seal, WA inland waters.
  • WA/OR shellfish aquaculture 23 None documented. TROLL FISHERIES: WA/OR/CA albacore surface hook and line/troll 705 None documented. CA halibut hook and line/handline unknown None documented. CA white seabass hook and line/handline unknown None documented. AK salmon troll 1,908 Steller sea lion, Eastern U.S.
  • Steller sea lion, Western U.S.
  • American Samoa tuna troll 13 None documented. CA/OR/WA salmon troll 4,300 None documented. HI troll 2,117 Pantropical spotted dolphin, HI. HI rod and reel 322 None documented. Commonwealth of the Northern Mariana Islands tuna troll 40 None documented. Guam tuna troll 432 None documented. LONGLINE/SET LINE FISHERIES: AK Bering Sea, Aleutian Islands rockfish longline 3 None documented. AK Bering Sea, Aleutian Islands Greenland turbot longline 4 Killer whale, AK resident. AK Bering Sea, Aleutian Islands sablefish longline 22 None documented. AK Gulf of Alaska halibut longline 855 None documented. AK Gulf of Alaska Pacific. cod longline 92 Steller sea lion, Western U.S. AK Gulf of Alaska rockfish longline 25 None documented. AK Gulf of Alaska sablefish longline 295 Sperm whale, North Pacific. AK halibut longline/set line (state and Federal waters) 2,197 None documented in the most recent five years of data. AK octopus/squid longline 3 None documented. AK state-managed waters longline/setline (including sablefish, rockfish, lingcod, and miscellaneous finfish) 464 None documented. WA/OR/CA groundfish, bottomfish longline/set line 367 Bottlenose dolphin, CA/OR/WA offshore. WA/OR Pacific. halibut longline 350 None documented. CA pelagic longline 1 None documented in the most recent five years of data. HI kaka line 15 None documented. HI vertical line 3 None documented. TRAWL FISHERIES: AK Bering Sea, Aleutian Islands Atka mackerel trawl 13 Ribbon seal, AK.
  • Steller sea lion, Western U.S.
  • AK Bering Sea, Aleutian Islands Pacific cod trawl 72 Ringed seal, AK.
  • Steller sea lion, Western U.S.
  • AK Gulf of Alaska flatfish trawl 36 Northern elephant seal, North Pacific. AK Gulf of Alaska Pacific. cod trawl 55 Steller sea lion, Western U.S. AK Gulf of Alaska pollock trawl 67 Dall's porpoise, AK.
  • Fin whale, Northeast Pacific.
  • Northern elephant seal, North Pacific.
  • Steller sea lion, Western U.S.
  • AK Gulf of Alaska rockfish trawl 43 None documented. AK food/bait herring trawl 4 None documented. AK miscellaneous finfish otter/beam trawl 282 None documented. AK shrimp otter trawl and beam trawl (statewide and Cook Inlet) 38 None documented. AK state-managed waters of Cook Inlet, Kachemak Bay, Prince William Sound, Southeast AK groundfish trawl 2 None documented. CA halibut bottom trawl 47 California sea lion, U.S.
  • Harbor porpoise, unknown.
  • Harbor seal, unknown.
  • Northern elephant seal, CA breeding.
  • Steller sea lion, unknown.
  • CA sea cucumber trawl 16 None documented. WA/OR/CA shrimp trawl 300 None documented. WA/OR/CA groundfish trawl 160-180 California sea lion, U.S.
  • Dall's porpoise, CA/OR/WA.
  • Harbor seal, OR/WA coast.
  • Northern fur seal, Eastern Pacific.
  • Pacific. white-sided dolphin, CA/OR/WA.
  • Steller sea lion, Eastern U.S.
  • POT, RING NET, AND TRAP FISHERIES: AK statewide miscellaneous finfish pot 4 None documented. AK Aleutian Islands sablefish pot 4 None documented. AK Bering Sea, Aleutian Islands Pacific cod pot 59 None documented. AK Bering Sea, Aleutian Islands crab pot 540 Gray whale, Eastern North Pacific. AK Bering Sea sablefish pot 2 None documented. AK Gulf of Alaska crab pot 381 None documented. AK Gulf of Alaska Pacific cod pot 128 Harbor seal, GOA. AK Southeast Alaska crab pot 41 Humpback whale, Central North Pacific (Southeast AK). AK Southeast Alaska shrimp pot 269 Humpback whale, Central North Pacific (Southeast AK). AK shrimp pot, except Southeast 236 None documented. AK octopus/squid pot 26 None documented. AK snail pot 1 None documented. CA/OR coonstripe shrimp pot 36 Gray whale, Eastern North Pacific.
  • Harbor seal, CA.
  • CA rock crab pot 124 Gray whale, Eastern North Pacific.
  • Harbor seal, CA.
  • WA/OR/CA hagfish pot 54 None documented. WA/OR shrimp pot/trap 254 None documented. WA Puget Sound Dungeness crab pot/trap 249 None documented. HI crab trap 5 Humpback whale, Central North Pacific. HI fish trap 9 None documented. HI lobster trap <3 None documented in recent years. HI shrimp trap 10 None documented. HI crab net 4 None documented. HI Kona crab loop net 33 None documented. HOOK-AND-LINE, HANDLINE, AND JIG FISHERIES: AK miscellaneous finfish handline/hand troll and mechanical jig 456 Fin whale, Northeast Pacific. AK North Pacific. halibut handline/hand troll and mechanical jig 180 None documented. AK octopus/squid handline 7 None documented. American Samoa bottomfish 24 None documented. Commonwealth of the Northern Mariana Islands bottomfish 28 None documented. Guam bottomfish >300 None documented. HI aku boat, pole, and line <3 None documented. HI bottomfish handline 578 None documented in recent years. HI inshore handline 357 None documented. HI pelagic handline 534 None documented. WA groundfish, bottomfish jig 679 None documented. Western Pacific. squid jig 0 None documented. HARPOON FISHERIES: CA swordfish harpoon 6 None documented. POUND NET/WEIR FISHERIES: AK herring spawn on kelp pound net 409 None documented. AK Southeast herring roe/food/bait pound net 2 None documented. HI bullpen trap 3 None documented. BAIT PENS: WA/OR/CA bait pens 13 California sea lion, U.S. DREDGE FISHERIES: Alaska scallop dredge 108 (5 AK) None documented. DIVE, HAND/MECHANICAL COLLECTION FISHERIES: AK abalone 0 None documented. AK clam 130 None documented. AK Dungeness crab 2 None documented. AK herring spawn on kelp 339 None documented. AK urchin and other fish/shellfish 398 None documented. HI black coral diving <3 None documented. HI fish pond 5 None documented. HI handpick 46 None documented. HI lobster diving 19 None documented. HI spearfishing 163 None documented. WA/CA kelp 4 None documented. WA/OR bait shrimp, clam hand, dive, or mechanical collection 201 None documented. OR/CA sea urchin, sea cucumber hand, dive, or mechanical collection 10 None documented. COMMERCIAL PASSENGER FISHING VESSEL (CHARTER BOAT) FISHERIES: AK/WA/OR/CA commercial passenger fishing vessel >7,000 (2,702 AK) Killer whale, unknown.
  • Steller sea lion, Eastern U.S.
  • Steller sea lion, Western U.S.
  • LIVE FINFISH/SHELLFISH FISHERIES: CA nearshore finfish live trap/hook-and-line 93 None documented. HI aquarium collecting 90 None documented. List of Abbreviations and Symbols Used in Table 1: AI—Aleutian Islands; AK—Alaska; BS—Bering Sea; CA—California; ENP—Eastern North Pacific.; GOA—Gulf of Alaska; HI—Hawaii; MHI—Main Hawaiian Islands; OR—Oregon; WA—Washington; 1 Fishery classified based on mortalities and serious injuries of this stock, which are greater than or equal to 50 percent (Category I) or greater than 1 percent and less than 50 percent (Category II) of the stock's PBR; 2 Fishery classified by analogy; * Fishery has an associated high seas component listed in Table 3; The list of marine mammal species and/or stocks killed or injured in this fishery is identical to the list of species and/or stocks killed or injured in high seas component of the fishery, minus species and/or stocks that have geographic ranges exclusively on the high seas. The species and/or stocks are found, and the fishery remains the same, on both sides of the EEZ boundary. Therefore, the EEZ components of these fisheries pose the same risk to marine mammals as the components operating on the high seas.
    Table 2—List of Fisheries—Commercial Fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean Fishery description Estimated number
  • of vessels/persons
  • Marine mammal species and/or stocks incidentally killed or injured
    CATEGORY I GILLNET FISHERIES: Mid-Atlantic gillnet 3,950 Bottlenose dolphin, Northern Migratory coastal.1
  • Bottlenose dolphin, Southern Migratory coastal.1
  • Bottlenose dolphin, Northern NC estuarine system.1
  • Bottlenose dolphin, Southern NC estuarine system.1
  • Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.
  • Gray seal, WNA.
  • Harbor porpoise, GME/BF.
  • Harbor seal, WNA.
  • Harp seal, WNA.
  • Humpback whale, Gulf of Maine.
  • Minke whale, Canadian east coast.
  • Northeast sink gillnet 4,332 Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.
  • Fin whale, WNA.
  • Gray seal, WNA.
  • Harbor porpoise, GME/BF.1
  • Harbor seal, WNA.
  • Harp seal, WNA.
  • Hooded seal, WNA.
  • Humpback whale, Gulf of Maine.
  • Long-finned pilot whale, WNA.
  • Minke whale, Canadian east coast.
  • North Atlantic right whale, WNA.
  • Risso's dolphin, WNA.
  • White-sided dolphin, WNA.
  • TRAP/POT FISHERIES: Northeast/Mid-Atlantic American lobster trap/pot 10,163 Humpback whale, Gulf of Maine.
  • Minke whale, Canadian east coast.
  • North Atlantic right whale, WNA.1
  • LONGLINE FISHERIES: Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline * 234 Atlantic spotted dolphin, GMX continental and oceanic.
  • Bottlenose dolphin, Northern GMX oceanic.
  • Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.
  • Cuvier's beaked whale, WNA.
  • False killer whale, WNA.
  • Harbor porpoise, GME, BF.
  • Kogia spp. (Pygmy or dwarf sperm whale), WNA.
  • Long-finned pilot whale, WNA.1
  • Mesoplodon beaked whale, WNA.
  • Minke whale, Canadian East coast.
  • Pantropical spotted dolphin, Northern GMX.
  • Pygmy sperm whale, GMX.
  • Risso's dolphin, Northern GMX.
  • Risso's dolphin, WNA.
  • Short-finned pilot whale, Northern GMX.
  • Short-finned pilot whale, WNA.1
  • CATEGORY II GILLNET FISHERIES: Chesapeake Bay inshore gillnet 2 248 Bottlenose dolphin, unknown (Northern migratory coastal or Southern migratory coastal). Gulf of Mexico gillnet 2 248 Bottlenose dolphin, GMX bay, sound, and estuarine.
  • Bottlenose dolphin, Northern GMX coastal.
  • Bottlenose dolphin, Western GMX coastal.
  • NC inshore gillnet 2,850 Bottlenose dolphin, Northern NC estuarine system.1
  • Bottlenose dolphin, Southern NC estuarine system.1
  • Northeast anchored float gillnet 2 852 Harbor seal, WNA.
  • Humpback whale, Gulf of Maine.
  • White-sided dolphin, WNA.
  • Northeast drift gillnet 2 1,036 None documented. Southeast Atlantic gillnet 2 273 Bottlenose dolphin, Central FL coastal.
  • Bottlenose dolphin, Northern FL coastal.
  • Bottlenose dolphin, SC/GA coastal.
  • Bottlenose dolphin, Southern migratory coastal.
  • Southeastern U.S. Atlantic shark gillnet 30 Bottlenose dolphin, unknown (Central FL, Northern FL, SC/GA coastal, or Southern migratory coastal).
  • North Atlantic right whale, WNA.
  • TRAWL FISHERIES: Mid-Atlantic mid-water trawl (including pair trawl) 382 Gray seal, WNA.
  • Harbor seal, WNA.
  • White-sided dolphin, WNA.1
  • Mid-Atlantic bottom trawl 785 Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.1
  • Gray seal, WNA.
  • Harbor seal, WNA.
  • Risso's dolphin, WNA.1
  • Northeast mid-water trawl (including pair trawl) 1,087 Common dolphin, WNA.
  • Gray seal, WNA.
  • Harbor seal, WNA.
  • Long-finned pilot whale, WNA.1
  • Minke whale, Canadian East Coast.
  • Northeast bottom trawl 2,238 Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.
  • Gray seal, WNA.
  • Harbor porpoise, GME/BF.
  • Harbor seal, WNA.
  • Harp seal, WNA.
  • Long-finned pilot whale, WNA.
  • Risso's dolphin, WNA.
  • White-sided dolphin, WNA.1
  • Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl 4,950 Atlantic spotted dolphin, GMX continental and oceanic.
  • Bottlenose dolphin, Charleston estuarine system.
  • Bottlenose dolphin, Eastern GMX coastal.1
  • Bottlenose dolphin, GMX bay, sound, estuarine.1
  • Bottlenose dolphin, GMX continental shelf.
  • Bottlenose dolphin, Northern GMX coastal.
  • Bottlenose dolphin, SC/GA coastal.1
  • Bottlenose dolphin, Southern migratory coastal.
  • Bottlenose dolphin, Western GMX coastal.1
  • West Indian manatee, Florida.
  • TRAP/POT FISHERIES: Southeastern U.S. Atlantic, Gulf of Mexico stone crab trap/pot 2 1,384 Bottlenose dolphin, Biscayne Bay estuarine.
  • Bottlenose dolphin, Central FL coastal.
  • Bottlenose dolphin, Eastern GMX coastal.
  • Bottlenose dolphin, FL Bay.
  • Bottlenose dolphin, GMX bay, sound, estuarine (FL west coast portion).
  • Bottlenose dolphin, Indian River Lagoon estuarine system.
  • Bottlenose dolphin, Jacksonville estuarine system.
  • Bottlenose dolphin, Northern GMX coastal.
  • Atlantic mixed species trap/pot 2 3,436 Fin whale, WNA.
  • Humpback whale, Gulf of Maine.
  • Atlantic blue crab trap/pot 7,714 Bottlenose dolphin, Central FL coastal.
  • Bottlenose dolphin, Central GA estuarine system.
  • Bottlenose dolphin, Charleston estuarine system.1
  • Bottlenose dolphin, Indian River Lagoon estuarine system.
  • Bottlenose dolphin, Jacksonville estuarine system.
  • Bottlenose dolphin, Northern FL coastal.1
  • Bottlenose dolphin, Northern GA/Southern SC estuarine system.
  • Bottlenose dolphin, Northern Migratory coastal.
  • Bottlenose dolphin, Northern NC estuarine system.1
  • Bottlenose dolphin, Northern SC estuarine system.
  • Bottlenose dolphin, SC/GA coastal.
  • Bottlenose dolphin, Southern GA estuarine system.
  • Bottlenose dolphin, Southern Migratory coastal.
  • Bottlenose dolphin, Southern NC estuarine system.
  • West Indian manatee, FL.
  • PURSE SEINE FISHERIES: Gulf of Mexico menhaden purse seine 40-42 Bottlenose dolphin, GMX bay, sound, estuarine.
  • Bottlenose dolphin, Mississippi Sound, Lake Borgne, Bay Boudreau.
  • Bottlenose dolphin, Northern GMX coastal.1
  • Bottlenose dolphin, Western GMX coastal.1
  • Mid-Atlantic menhaden purse seine 2 19 Bottlenose dolphin, Northern Migratory coastal.
  • Bottlenose dolphin, Southern Migratory coastal.
  • HAUL/BEACH SEINE FISHERIES: Mid-Atlantic haul/beach seine 359 Bottlenose dolphin, Northern Migratory coastal.1
  • Bottlenose dolphin, Northern NC estuarine system.1
  • Bottlenose dolphin, Southern Migratory coastal.1
  • NC long haul seine 30 Bottlenose dolphin, Northern NC estuarine system.1
  • Bottlenose dolphin, Southern NC estuarine system.
  • STOP NET FISHERIES: NC roe mullet stop net 1 Bottlenose dolphin, Northern NC estuarine system.
  • Bottlenose dolphin, unknown (Southern migratory coastal or Southern NC estuarine system).
  • POUND NET FISHERIES: VA pound net 26 Bottlenose dolphin, Northern migratory coastal.
  • Bottlenose dolphin, Northern NC estuarine system.
  • Bottlenose dolphin, Southern Migratory coastal.1
  • CATEGORY III GILLNET FISHERIES: Caribbean gillnet >991 None documented in the most recent five years of data. DE River inshore gillnet unknown None documented in the most recent five years of data. Long Island Sound inshore gillnet unknown None documented in the most recent five years of data. RI, southern MA (to Monomoy Island), and NY Bight (Raritan and Lower NY Bays) inshore gillnet unknown None documented in the most recent five years of data. Southeast Atlantic inshore gillnet unknown Bottlenose dolphin, Northern SC estuarine system. TRAWL FISHERIES: Atlantic shellfish bottom trawl >58 None documented. Gulf of Mexico butterfish trawl 2 Bottlenose dolphin, Northern GMX oceanic.
  • Bottlenose dolphin, Northern GMX continental shelf.
  • Gulf of Mexico mixed species trawl 20 None documented. GA cannonball jellyfish trawl 1 Bottlenose dolphin, SC/GA coastal. MARINE AQUACULTURE FISHERIES: Finfish aquaculture 48 Harbor seal, WNA. Shellfish aquaculture unknown None documented. PURSE SEINE FISHERIES: Gulf of Maine Atlantic herring purse seine >7 Harbor seal, WNA.
  • Gray seal, WNA.
  • Gulf of Maine menhaden purse seine >2 None documented. FL West Coast sardine purse seine 10 Bottlenose dolphin, Eastern GMX coastal. U.S. Atlantic tuna purse seine* 5 Long-finned pilot whale, WNA.
  • Short-finned pilot whale, WNA.
  • LONGLINE/HOOK-AND-LINE FISHERIES: Northeast/Mid-Atlantic bottom longline/hook-and-line >1,207 None documented. Gulf of Maine, U.S. Mid-Atlantic tuna, shark swordfish hook-and-line/harpoon 428 Bottlenose dolphin, WNA offshore.
  • Humpback whale, Gulf of Maine.
  • Southeastern U.S. Atlantic, Gulf of Mexico, and Caribbean snapper-grouper and other reef fish bottom longline/hook-and-line >5,000 Bottlenose dolphin, GMX continental shelf. Southeastern U.S. Atlantic, Gulf of Mexico shark bottom longline/hook-and-line <125 Bottlenose dolphin, Eastern GMX coastal.
  • Bottlenose dolphin, Northern GMX continental shelf.
  • Southeastern U.S. Atlantic, Gulf of Mexico, and Caribbean pelagic hook-and-line/harpoon 1,446 None documented. U.S. Atlantic, Gulf of Mexico trotline unknown None documented. TRAP/POT FISHERIES: Caribbean mixed species trap/pot >501 None documented. Caribbean spiny lobster trap/pot >197 None documented. FL spiny lobster trap/pot 1,268 Bottlenose dolphin, Biscayne Bay estuarine Bottlenose dolphin, Central FL coastal.
  • Bottlenose dolphin, Eastern GMX coastal.
  • Bottlenose dolphin, FL Bay estuarine.
  • Bottlenose dolphin, FL Keys.
  • Gulf of Mexico blue crab trap/pot 4,113 Bottlenose dolphin, Barataria Bay.
  • Bottlenose dolphin, Eastern GMX coastal.
  • Bottlenose dolphin, GMX bay, sound, estuarine.
  • Bottlenose dolphin, Mississippi Sound, Lake Borgne, Bay Boudreau.
  • Bottlenose dolphin, Northern GMX coastal.
  • Bottlenose dolphin, Western GMX coastal.
  • West Indian manatee, FL.
  • Gulf of Mexico mixed species trap/pot unknown None documented. Southeastern U.S. Atlantic, Gulf of Mexico golden crab trap/pot 10 None documented. U.S. Mid-Atlantic eel trap/pot unknown None documented. STOP SEINE/WEIR/POUND NET/FLOATING TRAP/FYKE NET FISHERIES: Gulf of Maine herring and Atlantic mackerel stop seine/weir >1 Harbor porpoise, GME/BF.
  • Harbor seal, WNA.
  • Minke whale, Canadian east coast.
  • Atlantic white-sided dolphin, WNA.
  • U.S. Mid-Atlantic crab stop seine/weir 2,600 None documented. U.S. Mid-Atlantic mixed species stop seine/weir/pound net (except the NC roe mullet stop net) unknown Bottlenose dolphin, Northern NC estuarine system. RI floating trap 9 None documented. Northeast and Mid-Atlantic fyke net unknown None documented. DREDGE FISHERIES: Gulf of Maine sea urchin dredge unknown None documented. Gulf of Maine mussel dredge unknown None documented. Gulf of Maine, U.S. Mid-Atlantic sea scallop dredge >403 None documented. Mid-Atlantic blue crab dredge unknown None documented. Mid-Atlantic soft-shell clam dredge unknown None documented. Mid-Atlantic whelk dredge unknown None documented. U.S. Mid-Atlantic/Gulf of Mexico oyster dredge 7,000 None documented. New England and Mid-Atlantic offshore surf clam/quahog dredge unknown None documented. HAUL/BEACH SEINE FISHERIES: Caribbean haul/beach seine 15 None documented in the most recent five years of data. Gulf of Mexico haul/beach seine unknown None documented. Southeastern U.S. Atlantic haul/beach seine 25 None documented. DIVE, HAND/MECHANICAL COLLECTION FISHERIES: Atlantic Ocean, Gulf of Mexico, Caribbean shellfish dive, hand/mechanical collection 20,000 None documented. Gulf of Maine urchin dive, hand/mechanical collection unknown None documented. Gulf of Mexico, Southeast Atlantic, Mid-Atlantic, and Caribbean cast net unknown None documented. COMMERCIAL PASSENGER FISHING VESSEL (CHARTER BOAT) FISHERIES: Atlantic Ocean, Gulf of Mexico, Caribbean commercial passenger fishing vessel 4,000 Bottlenose dolphin, Biscayne Bay estuarine.
  • Bottlenose dolphin, Central FL coastal.
  • Bottlenose dolphin, Choctawhatchee Bay.
  • Bottlenose dolphin, Eastern GMX coastal.
  • Bottlenose dolphin, FL Bay.
  • Bottlenose dolphin, GMX bay, sound, estuarine.
  • Bottlenose dolphin, Indian River Lagoon estuarine system.
  • Bottlenose dolphin, Jacksonville estuarine system.
  • Bottlenose dolphin, Northern FL coastal.
  • Bottlenose dolphin, Northern GA/Southern SC estuarine.
  • Bottlenose dolphin, Northern GMX coastal.
  • Bottlenose dolphin, Northern migratory coastal.
  • Bottlenose dolphin, Northern NC estuarine.
  • Bottlenose dolphin, Southern migratory coastal.
  • Bottlenose dolphin, Southern NC estuarine system.
  • Bottlenose dolphin, Southern SC/GA coastal.
  • Bottlenose dolphin, Western GMX coastal.
  • List of Abbreviations and Symbols Used in Table 2: DE—Delaware; FL—Florida; GA—Georgia; GME/BF—Gulf of Maine/Bay of Fundy; GMX—Gulf of Mexico; MA—Massachusetts; NC—North Carolina; NY—New York; RI—Rhode Island; SC—South Carolina; VA—Virginia; WNA—Western North Atlantic. 1 Fishery classified based on mortalities and serious injuries of this stock, which are greater than or equal to 50 percent (Category I) or greater than 1 percent and less than 50 percent (Category II) of the stock's PBR. 2 Fishery classified by analogy. * Fishery has an associated high seas component listed in Table 3.
    Table 3—List of Fisheries—Commercial Fisheries on the High Seas Fishery description Number of HSFCA permits Marine mammal species and/or stocks incidentally killed or injured Category I LONGLINE FISHERIES: Atlantic Highly Migratory Species * 86 Atlantic spotted dolphin, WNA.
  • Bottlenose dolphin, Northern GMX oceanic.
  • Bottlenose dolphin, WNA offshore.
  • Common dolphin, WNA.
  • Cuvier's beaked whale, WNA.
  • False killer whale, WNA.
  • Killer whale, GMX oceanic.
  • Kogia spp. whale (Pygmy or dwarf sperm whale), WNA.
  • Long-finned pilot whale, WNA.
  • Mesoplodon beaked whale, WNA.
  • Minke whale, Canadian East coast.
  • Pantropical spotted dolphin, WNA.
  • Risso's dolphin, GMX.
  • Risso's dolphin, WNA.
  • Short-finned pilot whale, WNA.
  • Western Pacific Pelagic (HI Deep-set component) *  139 Bottlenose dolphin, HI Pelagic.
  • False killer whale, HI Pelagic.
  • Pygmy killer whale, HI.
  • Risso's dolphin, HI.
  • Short-finned pilot whale, HI.
  • Sperm whale, HI.
  • Striped dolphin, HI.
  • DRIFT GILLNET FISHERIES: Pacific Highly Migratory Species  5 Long-beaked common dolphin, CA.
  • Humpback whale, CA/OR/WA.
  • Northern right-whale dolphin, CA/OR/WA.
  • Pacific white-sided dolphin, CA/OR/WA.
  • Risso's dolphin, CA/OR/WA.
  • Short-beaked common dolphin, CA/OR/WA.
  • Category II DRIFT GILLNET FISHERIES: Atlantic Highly Migratory Species 0 Undetermined. TRAWL FISHERIES: Atlantic Highly Migratory Species ** 1 Undetermined. CCAMLR 0 Antarctic fur seal. PURSE SEINE FISHERIES: South Pacific Tuna Fisheries 38 Undetermined. Western Pacific Pelagic 3 Undetermined. LONGLINE FISHERIES: CCAMLR 0 None documented. South Pacific Albacore Troll 10 Undetermined. South Pacific Tuna Fisheries ** 2 Undetermined. Western Pacific Pelagic (HI Shallow-set component) *  20 Blainville's beaked whale, HI.
  • Bottlenose dolphin, HI Pelagic.
  • False killer whale, HI Pelagic.
  • Humpback whale, Central North Pacific.
  • Northern elephant seal, CA breeding.
  • Risso's dolphin, HI.
  • Rough-toothed dolphin, HI.
  • Short-beaked common dolphin, CA/OR/WA.
  • Short-finned pilot whale, HI.
  • Striped dolphin, HI.
  • HANDLINE/POLE AND LINE FISHERIES: Atlantic Highly Migratory Species 3 Undetermined. Pacific Highly Migratory Species 46 Undetermined. South Pacific Albacore Troll 7 Undetermined. Western Pacific Pelagic 2 Undetermined. TROLL FISHERIES: Atlantic Highly Migratory Species 2 Undetermined. South Pacific Albacore Troll 30 Undetermined. South Pacific Tuna Fisheries ** 4 Undetermined. Western Pacific Pelagic 17 Undetermined. Category III LONGLINE FISHERIES: Northwest Atlantic Bottom Longline 1 None documented. Pacific Highly Migratory Species 114 None documented in the most recent 5 years of data. PURSE SEINE FISHERIES: Pacific Highly Migratory Species *  6 None documented. TRAWL FISHERIES: Northwest Atlantic 1 None documented. TROLL FISHERIES: Pacific Highly Migratory Species * 187 None documented. List of Terms, Abbreviations, and Symbols Used in Table 3: CA—California; GMX—Gulf of Mexico; HI—Hawaii; OR—Oregon; WA—Washington; WNA—Western North Atlantic. * Fishery is an extension/component of an existing fishery operating within U.S. waters listed in Table 1 or 2. The number of permits listed in Table 3 represents only the number of permits for the high seas component of the fishery. ** These gear types are not authorized under the Pacific HMS FMP (2004), the Atlantic HMS FMP (2006), or without a South Pacific Tuna Treaty license (in the case of the South Pacific Tuna fisheries). Because HSFCA permits are valid for five years, permits obtained in past years exist in the HSFCA permit database for gear types that are now unauthorized. Therefore, while HSFCA permits exist for these gear types, it does not represent effort. In order to land fish species, fishers must be using an authorized gear type. Once these permits for unauthorized gear types expire, the permit-holder will be required to obtain a permit for an authorized gear type.  The list of marine mammal species and/or stocks killed or injured in this fishery is identical to the list of marine mammal species and/or stocks killed or injured in U.S. waters component of the fishery, minus species and/or stocks that have geographic ranges exclusively in coastal waters, because the marine mammal species and/or stocks are also found on the high seas and the fishery remains the same on both sides of the EEZ boundary. Therefore, the high seas components of these fisheries pose the same risk to marine mammals as the components of these fisheries operating in U.S. waters.
    Table 4—Fisheries Affected by Take Reduction Teams and Plans Take reduction plans Affected fisheries Atlantic Large Whale Take Reduction Plan (ALWTRP)—50 CFR 229.32 Category I
  • Mid-Atlantic gillnet.
  • Northeast/Mid-Atlantic American lobster trap/pot.
  • Northeast sink gillnet.
  • Category II
  • Atlantic blue crab trap/pot.
  • Atlantic mixed species trap/pot.
  • Northeast anchored float gillnet.
  • Northeast drift gillnet.
  • Southeast Atlantic gillnet.
  • Southeastern U.S. Atlantic shark gillnet *.
  • Southeastern, U.S. Atlantic, Gulf of Mexico stone crab trap/pot .
  • Bottlenose Dolphin Take Reduction Plan (BDTRP)—50 CFR 229.35 Category I
  • Mid-Atlantic gillnet.
  • Category II
  • Atlantic blue crab trap/pot.
  • Chesapeake Bay inshore gillnet fishery.
  • Mid-Atlantic haul/beach seine.
  • Mid-Atlantic menhaden purse seine.
  • NC inshore gillnet.
  • NC long haul seine.
  • NC roe mullet stop net.
  • Southeast Atlantic gillnet.
  • Southeastern U.S. Atlantic shark gillnet.
  • Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl .
  • Southeastern, U.S. Atlantic, Gulf of Mexico stone crab trap/pot .
  • VA pound net.
  • False Killer Whale Take Reduction Plan (FKWTRP)—50 CFR 229.37 Category I
  • HI deep-set longline.
  • Category II
  • HI shallow-set longline.
  • Harbor Porpoise Take Reduction Plan (HPTRP)—50 CFR 229.33 (New England) and 229.34 (Mid-Atlantic) Category I
  • Mid-Atlantic gillnet.
  • Northeast sink gillnet.
  • Pelagic Longline Take Reduction Plan (PLTRP)—50 CFR 229.36 Category I
  • Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline.
  • Pacific Offshore Cetacean Take Reduction Plan (POCTRP)—50 CFR 229.31 Category I
  • CA thresher shark/swordfish drift gillnet (≥14 in mesh).
  • Atlantic Trawl Gear Take Reduction Team (ATGTRT) Category II
  • Mid-Atlantic bottom trawl.
  • Mid-Atlantic mid-water trawl (including pair trawl).
  • Northeast bottom trawl.
  • Northeast mid-water trawl (including pair trawl).
  • * Only applicable to the portion of the fishery operating in U.S. waters.  Only applicable to the portion of the fishery operating in the Atlantic Ocean.
    Classification

    The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) at the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. No comments were received on that certification, and no new information has been discovered to change that conclusion. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

    This rule contains collection-of-information (COI) requirements subject to the Paperwork Reduction Act. The COI for the registration of individuals under the MMPA has been approved by the Office of Management and Budget (OMB) under OMB control number 0648-0293 (0.15 hours per report for new registrants). The requirement for reporting marine mammal mortalities or injuries has been approved by OMB under OMB control number 0648-0292 (0.15 hours per report). These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the COI. Send comments regarding these reporting burden estimates or any other aspect of the COI, including suggestions for reducing burden, to NMFS and OMB (see ADDRESSES and SUPPLEMENTARY INFORMATION).

    Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with a COI, subject to the requirements of the Paperwork Reduction Act, unless that COI displays a currently valid OMB control number.

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

    An environmental assessment (EA) was prepared under the NEPA in 1995 and 2005. The 1995 EA examined the effects of regulations implementing section 118 of the 1994 Amendments of the MMPA on the affected environment. The 2005 EA analyzed the environmental impacts of continuing the existing scheme (as described in the 1995 EA) for classifying fisheries on the LOF. The 1995 EA and the 2005 EA concluded that implementation of MMPA section 118 regulations would not have a significant impact on the human environment. NMFS reviewed the 2005 EA in 2009 and 2014. NMFS concluded that because there were no changes to the process used to develop the LOF and implement section 118 of the MMPA, there was no need to update the 2005 EA. This rule would not change NMFS' current process for classifying fisheries on the LOF. Therefore, this rule is not expected to change the analysis or conclusion of the 2005 EA and Finding of No Significant Impact (FONSI), and no update is needed. If NMFS takes a management action, for example, through the development of a TRP, NMFS would first prepare an environmental document, as required under NEPA, specific to that action.

    This rule would not affect species listed as threatened or endangered under the ESA or their associated critical habitat. The impacts of numerous fisheries have been analyzed in various biological opinions, and this rule will not affect the conclusions of those opinions. The classification of fisheries on the LOF is not considered to be a management action that would adversely affect threatened or endangered species. If NMFS takes a management action, for example, through the development of a TRP, NMFS would consult under ESA section 7 on that action.

    This rule would have no adverse impacts on marine mammals and may have a positive impact on marine mammals by improving knowledge of marine mammals and the fisheries interacting with marine mammals through information collected from observer programs, stranding and sighting data, or take reduction teams.

    This rule would not affect the land or water uses or natural resources of the coastal zone, as specified under section 307 of the Coastal Zone Management Act.

    References Allen, B.M. and R.P. Angliss, editors. 2016. Alaska Marine Mammal Stock Assessments, 2015. NOAA Tech. Memo. NMFS-AFSC-323. 309 p. Carretta, J.V., K.A. Forney, E. Oleson, K. Martien, M.M. Muto, M.S. Lowry, J. Barlow, J. Baker, B. Hanson, D. Lynch, L. Carswell, R.L. Brownell Jr., J. Roobins, D.K. Mattila, K. Ralls and M.C. Hill. 2011. U.S. Pacific Marine Mammal Stock Assessments: 2010. NOAA Technical Memorandum NOAA-TM-NMFS-SWFSC-476. 357 p. Carretta, J.V., E. Oleson, D.W. Weller, A.R. Lang, K.A. Forney, J. Baker, B. Hanson, K. Martien, M.M. Muto, A.J. Orr, H. Huber, M.S. Lowry, J. Barlow, D. Lynch, L. Carswell, R.L. Brownell Jr., and D.K. Mattila. 2014. U.S. Pacific Marine Mammal Stock Assessments: 2013. NOAA Technical Memorandum NOAA-TM-NMFS-SWFSC-532. 414 p. Carretta, J.V., E. Oleson, D.W. Weller, A.R. Lang, K.A. Forney, J. Baker, B. Hanson, K. Martien, M.M. Muto, M.S. Lowry, J. Barlow, D. Lynch, L. Carswell, R.L. Brownell Jr., D.K. Mattila, and M.C. Hill. 2016. U.S. Pacific Marine Mammal Stock Assessments: 2015. NOAA Technical Memorandum NOAA-TM-NMFS-SWFSC-561. 426 p. Carretta, J.V., K.A. Forney, E. Oleson, D.W. Weller, A.R. Lang, J. Baker, M.M. Muto, B. Hanson, A.J. Orr, H. Huber, M.S. Lowry, J. Barlow, J.E. Moore, D. Lynch, L. Carswell, and R.L. Brownell Jr. 2016. U.S. Pacific Draft Marine Mammal Stock Assessments: 2016. NOAA Technical Memorandum NOAA-TM-NMFS-SWFSC-XXX. 146p. Carretta, J.V., M.M. Muto, S. Wilkin, J. Greenman, K. Wilkinson, M. DeAngelis, J. Viezbicke, and J. Jannot. 2016. Sources of human-related injury and mortality for U.S. Pacific west coast marine mammal stocks assessments, 2010-2014. NOAA-TM-NMFS-SWFSC-554. Fishing Gear Types. Fyke nets. Technology Fact Sheets. In: FAO Fisheries and Aquaculture Department [online]. Rome. Updated 13 September 2001. [Cited 16 March 2016]. http://www.fao.rog/fishery/geartype/226/en Fullencamp, L. 2006. Characterization of fisheries operating in State Waters of the Atlantic Ocean from Maine through Florida. Atlantic States Fisheries Marine Commission. Gilbert, J.R. and K.M. Wynne. 1985. Harbor seal populations and fisheries interactions with marine mammals in New England, 1984. Interim Rep., NOAA NA-84-EAC-00070, to NMFS, Northeast Fisheries Science Center, 166 Water St., Woods Hole, MA. 15 p. Jannot, J.E., V. Tuttle, K. Somers, Y-W. Lee, J. McVeigh. 2016. Marine Mammal, Seabird, and Sea Turtle Summary of Observed Interactions, 2002-2014. Fisheries Observation Science, Fishery Resource Analysis and Monitoring Division, Northwest Fisheries Science Center. McCracken, M.L. 2014. Assessment of Incidental Interactions with Marine Mammals in the Hawaii Deep and Shallow Set Fisheries from 2008 through 2012. NMFS Pacific Islands Fisheries Science Center, PIFSC Internal Report IR-14-006. 1 p. + Excel spreadsheet. NMFS (National Marine Fisheries Service). 2004. Evaluating bycatch: a national approach to standardized bycatch monitoring programs. U.S. Dep. Commer., NOAA Tech. Memo. NMFSF/SPO-66, 108 p. On-line version, http://spo.nmfs.noaa.gov/tm. National Marine Fisheries Service. 2012. National Marine Fisheries Service Policy Directive 02-238. Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals, 4 p. (Available at: http://www.nmfs.noaa.gov/op/pds/documents/02/02-238.pdf). Stevenson, D., L. Chiarella, D. Stephan, R. Reid, K. Wilhelm, J. McCarthy, and M. Pentony. 2004. Characterization of the Fishing Practices and Marine Benthic Ecosystems of the Northeast U.S. Shelf, and an Evaluation of the Potential Effects of Fishing on Essential Fish Habitat. NOAA Technical Memorandum NMFS-NE-181. Waring, G.T., E. Josephson, C.P. Fairfield and K. Maze-Foley, editors. 2006. U.S. Atlantic and Gulf of Mexico Marine Mammal Stocks Assessments, 2005. NOAA Technical Memorandum NOAA-NE-194. Waring, G.T., E. Josephson, K. Maze-Foley, and P.E. Rosel, editors. 2015. U.S. Atlantic and Gulf of Mexico Marine Mammal Stocks Assessments, 2014. NOAA Technical Memorandum NOAA-NE-231. 355 p. Waring, G.T., E. Josephson, K. Maze-Foley, and P.E. Rosel, editors. 2016. U.S. Atlantic and Gulf of Mexico Marine Mammal Stocks Assessments, 2015. NOAA Technical Memorandum NOAA-NE-238. 512 p. Dated: January 5, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2017-00250 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 151211999-6343-02] RIN 0648-XF133 Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure and Possession Prohibition for the Common Pool Fishery AGENCY:

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

    ACTION:

    Temporary rule; area closure and inseason adjustment.

    SUMMARY:

    This action closes the Georges Bank Cod Trimester Total Allowable Catch Area to Northeast multispecies common pool vessels and prohibits the possession of Georges Bank cod by common pool vessels for the remainder of the fishing year, through April 30, 2017. The common pool fishery has exceeded its annual quota for Georges Bank cod. The closure and possession prohibition are intended to prevent further overage of the common pool's quota for this stock.

    DATES:

    This action is effective January 9, 2017, through April 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Kyle Molton, Fishery Management Specialist, (978) 281-9236.

    SUPPLEMENTARY INFORMATION:

    Federal regulations at 50 CFR 648.82(n)(2)(ii) require the Regional Administrator to close a common pool Trimester Total Allowable Catch (TAC) Area for a stock when 90 percent of the Trimester TAC is projected to be caught. The closure applies to all common pool vessels on a groundfish trip using gear capable of catching that stock for the remainder of the trimester.

    As of December 26, 2016, the common pool fishery has exceeded its annual TAC for Georges Bank (GB) cod by 0.3 mt, or 2.7 percent. Additionally, any overages in Trimesters 1 and 2 must be deducted from the Trimester 3 TAC. The combined overages in Trimesters 1 and 2 (4.7 mt) exceed the Trimester 3 TAC of 4.3 mt. As a result, there is no TAC available to be harvested in Trimester 3.

    Effective January 9, 2017, the GB Cod Trimester TAC Area is closed for the remainder of the fishing year, through April 30, 2017, to all common pool vessels fishing on a groundfish trip with trawl gear, sink gillnet gear, and longline/hook gear. The GB Cod Trimester TAC Area consists of statistical areas 521, 522, 525, and 561. The area reopens at the beginning of fishing year 2017 on May 1, 2017.

    Data indicates that common pool vessels have caught a significant portion of the total catch from outside the statistical areas that will be affected by the closure described above. The Regional Administrator is authorized under 50 CFR 648.86(o)(1) to adjust possession and trip limits for common pool vessels to prevent exceeding the pertinent common pool quotas during the fishing year. To prevent the common pool from further exceeding its quota and discourage fishing behavior that results in bycatch of GB cod in areas not affected by the closure, the possession of GB cod by all common pool vessels is prohibited, effective January 9, 2017, through April 30, 2017.

    If a vessel declared its trip through the Vessel Monitoring System (VMS) or the interactive voice response system, and crossed the VMS demarcation line prior to January 9, 2017, it may complete its trip within the Trimester TAC Area. Additionally, such vessels are not subject to the new possession prohibition for that trip. A vessel that has set gillnet gear prior to January 9, 2017, may complete its trip by hauling such gear and will not be subject to the new possession limit on that trip for fish caught with that gear.

    Weekly quota monitoring reports for the common pool fishery are on our Web site at: www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. Because the common pool fishery has exceeded its annual quota for GB cod in the 2016 fishing year, the overage will be deducted from the common pool's annual quota for fishing year 2017. The final 2016 overage, and the adjustment to the 2017 common pool quota, will be announced as close to May 1, 2017, as possible, once final catch information for the 2016 fishing year are available. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information.

    Classification

    This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

    The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.

    Regulations require the Regional Administrator to close a trimester TAC area to the common pool fishery when 90 percent of the Trimester TAC for a stock has been caught. Updated catch information only recently became available indicating that the common pool fishery had exceeded its annual quota for GB cod. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, prevents the immediate closure of the GB Cod Trimester 3 TAC Area and prohibition of GB cod possession. Delaying the effective date of a closure and possession prohibition may increase the overage in fishing year 2016 that will need to be deducted from next year's quota. This would be to the detriment of the GB cod stock, and could undermine management objectives of the Northeast Multispecies Fishery Management Plan. Additionally, the overage of the common pool quota could cause negative economic impacts to the common pool fishery as a result of required catch limit deductions in the 2017 fishing year.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 6, 2017. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-00484 Filed 1-9-17; 8:45 am] BILLING CODE 3510-22-P
    82 8 Thursday, January 12, 2017 Proposed Rules OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 532 RIN 3206-AN48 Prevailing Rate Systems; Redefinition of Certain Nonappropriated Fund Federal Wage System Wage Areas AGENCY:

    U.S. Office of Personnel Management.

    ACTION:

    Proposed rule with request for comments.

    SUMMARY:

    This rule proposes to amend the geographic boundaries of several nonappropriated fund (NAF) Federal Wage System (FWS) wage areas. Based on recommendations of the Federal Prevailing Rate Advisory Committee (FPRAC), the U.S. Office of Personnel Management (OPM) would define Lee County, Florida, as an area of application county to the Hillsborough, FL, NAF FWS wage area; Leon County, FL, as an area of application county to the Lowndes, Georgia, NAF FWS wage area; Fulton County, GA, as an area of application county to the Cobb, GA, NAF FWS wage area; and Lane County, Oregon, as an area of application county to the Pierce, Washington, NAF FWS wage area. These changes are necessary because there are NAF FWS employees working in these four counties, and the counties are not currently defined to NAF wage areas. In addition, OPM is proposing to remove Mississippi County, AR, from the wage area definition of the Shelby, TN, NAF FWS wage area because there are no longer NAF FWS employees working in the county.

    DATES:

    We must receive comments on or before February 13, 2017.

    ADDRESSES:

    You may submit comments, identified by RIN 3206-AN48, using any of the following methods:

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

    Mail: Brenda L. Roberts, Deputy Associate Director for Pay and Leave, Employee Services, U.S. Office of Personnel Management, Room 7H31, 1900 E Street NW., Washington, DC 20415-8200.

    Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Madeline Gonzalez, by telephone at (202) 606-2838 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    OPM is issuing a proposed rule that would make changes to several NAF FWS wage area definitions. The Department of Veterans Affairs notified OPM that the Veterans Canteen Service (VCS) now employs NAF FWS employees in Lee and Leon Counties, FL; Fulton County, GA; and Lane County, OR. In addition, OPM is proposing to remove Mississippi County, AR, from the wage area definition of the Shelby, TN, NAF FWS wage area because there are no longer NAF FWS employees working in the county.

    Under § 532.219 of title 5, Code of Federal Regulations (CFR), each NAF wage area “shall consist of one or more survey areas, along with nonsurvey areas, if any, having nonappropriated fund employees.” Lee, Leon, Fulton, and Lane Counties do not meet the regulatory criteria under 5 CFR 532.219 to be established as separate NAF wage areas; however, nonsurvey counties may be combined with a survey area to form a wage area. Section 532.219 lists the regulatory criteria that OPM considers when defining FWS wage area boundaries:

    (i) Proximity of largest facilities activity in each county;

    (ii) Transportation facilities and commuting patterns; and

    (iii) Similarities of the counties in—

    (A) Overall population;

    (B) Private employment in major industry categories; and

    (C) Kinds and sizes of private industrial establishments.

    OPM recently completed reviews of the definitions of Lee, Leon, Fulton, Lane, and Mississippi Counties and is proposing the changes described below. FPRAC, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended these changes by consensus. These changes would apply on the first day of the first applicable pay period beginning on or after 30 days following publication of the final regulations.

    Lee County, FL

    Lee County would be defined as an area of application county to the Hillsborough, FL, NAF FWS wage area. The proximity criterion favors the Hillsborough wage area. The transportation facilities criterion favors the Hillsborough wage area. The commuting patterns criterion does not favor one wage area more than another. The overall population, employment sizes, and kinds and sizes of private industrial establishments criterion does not favor one wage area more than another. While a standard review of regulatory criteria shows mixed results, the proximity criterion solidly favors the Hillsborough wage area.

    With the definition of Lee County to the Hillsborough NAF wage area, the Hillsborough wage area would consist of one survey county, Hillsborough County, and three area of application counties: Lee, Pinellas, and Polk Counties, FL.

    Leon County, FL

    Leon County would be defined as an area of application county to the Lowndes, GA, NAF FWS wage area. The proximity criterion favors the Lowndes wage area. The transportation facilities and commuting patterns criterion does not favor one wage area more than another. Although the overall population, employment sizes, and kinds and sizes of private industrial establishments criterion does not favor one wage area more than another, the industrial distribution pattern for Leon County is similar to the Lowndes survey area. Based on this analysis, we recommend that Leon County be defined to the Lowndes NAF wage area.

    With the definition of Leon County to the Lowndes NAF wage area, the Lowndes wage area would consist of one survey county, Lowndes County, GA, and one area of application county, Leon County, FL.

    Fulton County, GA

    Fulton County would be defined as an area of application county to the Cobb, GA, NAF FWS wage area. The closest NAF wage area to Fulton County is the Cobb wage area. There are no other NAF wage areas in the immediate vicinity of Fulton County. The VCS No.357 is located approximately 22 miles from Dobbins Air Reserve Base, the Cobb wage area's host activity. Based on this analysis, we recommend that Fulton County be defined to the Cobb NAF wage area.

    With the definition of Fulton County to the Cobb NAF wage area, the Cobb wage area would consist of one survey county, Cobb County, GA, and three area of application counties: Bartow, De Kalb, and Fulton Counties, GA.

    Lane County, OR

    Lane County would be defined as an area of application county to the Pierce, WA, NAF FWS wage area. The closest NAF wage area to Lane County is the Pierce, WA, wage area. There are no other NAF wage areas in the immediate vicinity of Lane County. While VCS No. 356 is located approximately 240 miles from Joint Base Lewis-McChord, the Pierce wage area's host activity, Lane County is adjacent to two counties currently defined to the Pierce wage area: Coos and Douglas Counties, OR. Based on this analysis, we recommend that Lane County be defined to the Pierce NAF wage area.

    With the definition of Lane County to the Pierce NAF wage area, the Pierce wage area would consist of one survey county, Pierce County, WA, and eight area of application counties: Clatsop, Coos, Douglas, Lane, Multnomah, and Tillamook Counties, OR, and Clark and Grays Harbor, WA.

    Mississippi County, AR

    Mississippi County would be removed as an area of application county to the Shelby, TN, NAF FWS wage area. No NAF FWS employment has been reported in Mississippi County since the closure of Eaker Air Force Base in 1992, and NAF employers have no plans to establish an activity there in the future. Under 5 U.S.C. 5343(a)(1)(B)(i), NAF wage areas “shall not extend beyond the immediate locality in which the particular prevailing rate employees are employed.” Therefore, Mississippi County should not be defined as part of an NAF wage area.

    With the removal of Mississippi County from the Shelby NAF wage area, the Shelby wage area would consist of one survey county, Shelby County, TN, and one area of application county, Butler County, MO.

    Regulatory Flexibility Act

    I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would affect only Federal agencies and employees.

    List of Subjects in 5 CFR Part 532

    Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.

    U.S. Office of Personnel Management. Beth F. Cobert, Acting Director.

    Accordingly, OPM is proposing to amend 5 CFR part 532 as follows:

    PART 532—PREVAILING RATE SYSTEMS 1. The authority citation for part 532 continues to read as follows: Authority:

    5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.

    Appendix D to Subpart B of Part 532—Nonappropriated Fund Wage and Survey Areas 2. Appendix D to Subpart B is amended by revising the wage area listing for the Hillsborough, FL; Cobb, GA; Lowndes, GA; Shelby, TN; and Pierce, WA, wage areas to read as follows: *    *    *    *    * FLORIDA *    *    *    *    * Hillsborough Survey Area Florida: Hillsborough Area of Application. Survey area plus: Florida: Lee Pinellas Polk *    *    *    *    * GEORGIA *    *    *    *    * Cobb Survey Area Georgia: Cobb Area of Application. Survey area plus: Georgia: Bartow De Kalb Fulton *    *    *    *    * Lowndes Survey Area Georgia: Lowndes Area of Application. Survey area plus: Florida: Leon *    *    *    *    * TENNESSEE Shelby Survey Area Tennessee: Shelby Area of Application. Survey area plus: Missouri: Butler *    *    *    *    * WASHINGTON *    *    *    *    * Pierce Survey Area Washington: Pierce Area of Application. Survey area plus: Oregon: Clatsop Coos Douglas Multnomah Tillamook Washington: Clark Grays Harbor Lane *    *    *    *    *
    [FR Doc. 2017-00577 Filed 1-11-17; 8:45 a.m.] BILLING CODE 6325-39-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 424 [CMS-6012-P] RIN 0938-AR84 Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom-fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, this rule would remove the current exemption from accreditation and quality standards for certain practitioners and suppliers.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 13, 2017.

    ADDRESSES:

    In commenting, please refer to file code CMS-6012-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6012-P, P.O. Box 8013, Baltimore, MD 21244-8013.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6012-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:

    a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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    FOR FURTHER INFORMATION CONTACT:

    John Spiegel, (410) 786-1909.

    SUPPLEMENTARY INFORMATION:

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    Follow the search instructions on that Web site to view public comments.

    Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

    I. Background A. General Overview

    Medicare services are furnished by two types of entities, providers and suppliers. The term “provider of services” is defined in sections 1861(u) and 1866(e) of the Social Security Act (the Act). Based on the statute definition of “provider of services” in sections 1861(u) and 1866(e) of the Act we define and use the term “provider” in our regulations. At § 400.202, the term “provider” is defined as a hospital, a critical access hospital (CAH), a skilled nursing facility (SNF), a comprehensive outpatient rehabilitation facility (CORF), a home health agency (HHA), or a hospice that has in effect an agreement to participate in Medicare, or a clinic, a rehabilitation agency, or a public health agency that has in effect a similar agreement but only to furnish outpatient physical therapy or speech pathology services, or a community mental health center that has in effect a similar agreement but only to furnish partial hospitalization services.

    The term supplier is defined in section 1861(d) of the Act. Supplier is defined as a physician or other practitioner, facility or an entity other than a provider of services that furnishes items or services under Medicare. A supplier that furnishes durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) is one category of supplier. Section 424.57(a) of our regulations defines a DMEPOS supplier as an entity or individual, including a physician or Part A provider, that sells or rents covered DMEPOS items to Medicare beneficiaries that meets the DMEPOS supplier standards. Other supplier categories may include, for example, physicians, nurse practitioners, and physical therapists. If a supplier, such as a physician, nurse practitioners, or physical therapist, also furnishes DMEPOS to a patient and bills for those items, then the supplier is also considered to be a DMEPOS supplier and must be screened and enrolled in Medicare as a DMEPOS supplier, meeting all standards and requirements applicable to DMEPOS suppliers in order to be enrolled in and bill Medicare.

    Section 1861(n) of the Act defines “durable medical equipment.” See https://www.ssa.gov/OP_Home/ssact/title18/1861.htm. Also, the term DME is included in the definition of “medical and other health services” in section 1861(s)(6) of the Act, see https://www.ssa.gov/OP_Home/ssact/title18/1861.htm and also included in the definition of medical equipment and supplies in section 1834(j)(5) of the Act. See https://www.ssa.gov/OP_Home/ssact/title18/1834.htm. Furthermore, the term is defined in § 414.202 as equipment furnished by a supplier or a HHA that—

    • Can withstand repeated use;

    • Effective for items classified as DME after January 1, 2002 has an expected life of at least 3 years;

    • Is primarily and customarily used to serve a medical purpose;

    • Generally, is not useful to an individual in the absence of an illness or injury; and

    • Is for use in the home.

    Prosthetics and orthotics which are defined under section 1861(s)(9) of the Act as leg, arm, back, and neck braces and artificial legs, arms, and eyes, including replacements if required because of a change in the patient's physical condition, are included under the coverage definition under section 1861(s)(9) of the Act. We are using this definition of prosthetics and orthotics for the purposes of this proposed rule. They are also described in the Medicare Benefit Policy Manual (100-02), Chapter 15, Section 130 that specifies that these appliances are covered under Part B when furnished incident to physicians' services or on a physician's order.

    B. Legislative History 1. Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA)

    Section 427 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) added section 1834(h)(1)(F) of the Act, which states that no payment shall be made for custom-fabricated orthotics or for an item of prosthetics unless furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier at a facility that meets criteria the Secretary determines appropriate. Section 1834(h)(1)(F) of the Act describes custom-fabricated orthotics as individually fabricated for the patient over a positive model of the patient and also requires education, training, and experience to custom-fabricate.

    A qualified practitioner is defined by BIPA as a physician or other individual who is a qualified physical therapist or a qualified occupational therapist; or is licensed in orthotics or prosthetics, in the cases where the state provides such licensing; or, in states where the state does not provide such licensing, is specifically trained and educated to provide or manage the provision of prosthetics and custom-designed or fabricated orthotics and is certified by the American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC) or the Board for Orthotist/Prosthetist Certification International, Incorporated (BOC); or is credentialed and approved by a program that the Secretary determines has training and education standards that are necessary to provide such prosthetics and orthotics.

    A qualified supplier is defined by BIPA as any entity that is accredited by the ABC or the BOC or is accredited and approved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Boards.

    The Congress directed the Secretary to implement section 427 of BIPA no later than 1 year after the date of the enactment using a negotiated rulemaking process. The negotiated rulemaking committee (the Committee) on Special Payment Provisions for Prosthetics and Certain Custom-Fabricated Orthotics was established following the requirements set forth by the Federal Advisory Committee Act (FACA). The Committee held nine meetings from October 2002 to July 2003 and failed to reach a consensus on the rulemaking. Given the continued need to address payment provisions for prosthetics and certain custom-fabricated orthotics, we are proposing policies and inviting public comment on our proposals as described section II. of this proposed rule.

    2. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)

    Section 302(a)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added a new paragraph (20) to section 1834(a) of the Act requiring the Secretary to establish and implement DMEPOS quality standards that suppliers must meet in order to furnish and bill for covered items and services described in new section 1834(a)(20)(D) of the Act, which includes prosthetics and orthotics. The new paragraph (20) also required the Secretary to designate and approve one or more independent accreditation organizations to apply the quality standards. In addition, the new section 1834(a)(20) of the Act required that to obtain or retain a Medicare Part B billing number DMEPOS suppliers must be accredited by one of the approved accreditation organizations.

    The DMEPOS quality standards were posted on our Web site at www.cms.gov/medicareprovidersupenroll as required by section 1834(a)(20)(E) of the Act. On May 1, 2006, we published a proposed rule (71 FR 25654) and a subsequent final rule on August 18, 2006 (71 FR 48354) that specified the criteria that all approved accreditation organizations must meet, set forth in § 424.58. In December 2006, we approved 11 accreditation organizations. As a result of a merger of two of the accreditation organizations, there are now 10 accreditation organizations.

    All DMEPOS suppliers must meet the quality standards. The quality standards required by section 1834(a)(20) of the Act are used by the approved accrediting organizations as the basis for their accrediting decisions.

    3. Medicare Improvement for Patients and Providers Act of 2008 (MIPPA)

    Section 154(b) of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275 amended section 1834(a)(20) of the Act by adding a new subparagraph (F) to require DMEPOS suppliers furnishing covered items and services, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of being accredited as meeting the applicable quality standards on or after October 1, 2009. Section 1834 (a)(20)(F)(ii) of the Act provided the Secretary the authority to exempt “eligible professionals” and such “other persons” from the quality standards and accreditation requirement unless the Secretary determined that the standards are designed specifically to be applied to such eligible professionals and other persons or if the Secretary determined that licensing, accreditation or other mandatory quality requirements apply to such eligible professionals and other persons. Eligible professionals are defined at section 1848(k)(3)(B) of the Act as a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse-midwife, clinical social worker, clinical psychologist, physical or occupational therapist or a qualified speech-language pathologist. Section 1834(a)(20)(F)(ii) of the Act specifically refers to orthotists and prosthetists as examples of “other persons.” Since orthotists and prosthetists specifically were mentioned in the statute, we believe that the Congress intended for those persons to be exempt unless there were standards designed specifically to be applied to such eligible professionals and other persons.

    To date there have not been accreditation or quality requirements designed specifically to be applied to such eligible professionals and thus as a result, all eligible professionals and other persons, including orthotists and prosthetists, that furnish, fabricate, and bill for prosthetics and certain custom-fabricated orthotic items are currently exempt from the quality standards and the accreditation requirement.

    II. Provisions of the Proposed Regulations

    This proposed rule would implement certain provisions of section 1834(h)(1)(F) of the Act. It would establish the qualifications and requirements that must be met in order to be considered a qualified practitioner or a qualified supplier. This proposed rule would also amend the special payment rules for items furnished by DMEPOS suppliers set forth at § 424.57 and the accreditation organization requirements in § 424.58. Only qualified practitioners who furnish or fabricate prosthetics and custom-fabricated orthotics and qualified suppliers that fabricate or bill for prosthetics and custom-fabricated orthotics would be subject to these requirements.

    Specifically, we are proposing the following:

    • Removing the exemption from quality standards and accreditation that is currently in place in accordance with section 1834(a)(20) of the Act for certain practitioners and suppliers who furnish or fabricate prosthetics and custom-fabricated orthotics.

    • Revising § 424.57 to include a definition of custom-fabricated orthotics as an item as listed in section 1861(s)(9) of the Act that must be individually made for a specific patient, constructed using one of the positive model techniques listed in § 424.57(a).

    • Revising § 424.57(a) to include a definition of positive model of the patient as a particular type of custom fabrication in which one of the following modeling techniques is used:

    ++ Molded to the patient model as a negative impression of the patient's body part and a positive model rectification are constructed.

    ++ Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system.

    ++ Direct formed model.

    • Defining “qualified supplier” as a DMEPOS supplier that is accredited in accordance with the section 1834(a)(20) of the Act.

    • Defining “qualified practitioner” as an eligible professional or other person that meets the education, training, licensure, and certification requirements of the section 1834(h)(1)(F)of the Act.

    • Specifying training, licensure, and certification requirements that qualified practitioners must meet in order to furnish or fabricate prosthetics and custom-fabricated orthotics.

    • Requiring that claims for prosthetics and custom-fabricated orthotics that are submitted by qualified suppliers or by beneficiaries must have been furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier as defined in this proposed rule. Suppliers that do not meet these requirements are at risk of revocation of their Medicare enrollment.

    • Defining the requirements that must be met by organizations that are designated and approved by CMS to accredit suppliers that bill for prosthetics and custom-fabricated orthotics.

    • Define “fabrication facility” and specify the requirements that a facility must meet in order for qualified practitioners and qualified suppliers to be able to fabricate prosthetics and custom-fabricated orthotics that can be paid for by Medicare.

    Separately, in this proposed rule we also—

    • Describe our intent to modify the DMEPOS quality standards to reflect the provisions of this rule, including the effective date for meeting the revised quality standards; and

    • Provide the list of services and supplies subject to the requirements of this rule (www.cms.gov/medicareprovidersupenroll).

    We provide a link to the list of items and describe our intent to revise the quality standards as information only. We are not soliciting comments on the content of or the process for updating the quality standards, which will be addressed through the regulatory process we reference in section II.A.6.a. of this proposed rule. Nor are we soliciting comment on the content of or process for updating the list of items and supplies, which is described in section II.B. of this proposed rule. Comments on those matters will be considered outside the scope of this rule.

    A. Updating of Accreditation and Certification Requirements 1. Removing the MIPPA Exemptions for DMEPOS Suppliers and Certain Eligible Professionals and Other Persons Who Furnish or Fabricate Prosthetics and Custom-Fabricated Orthotics

    Consistent with the provisions of the Act, including those provisions added by BIPA, MMA, and MIPPA, we have put in place a framework for accreditation of suppliers that fabricate DMEPOS and bill for DMEPOS services. However, qualified practitioners and qualified suppliers are currently exempt from having to meet the quality standards or to be accredited as suppliers in order to be able to bill Medicare for prosthetics and custom-fabricated orthotics. We are removing the exemptions in order to implement the provisions of section 1834(a)(20) of the Act.

    As noted previously, section 1834(a)(20)(F)(ii) of the Act provided the Secretary the authority to exempt “eligible professionals” (as defined in section 1848(k)(3)(B) of the Act) and such “other persons” from the quality standards and accreditation requirement unless the Secretary determined that the standards are designed specifically to be applied to such eligible professionals and other persons or if the Secretary determined that licensing, accreditation or other mandatory quality requirements apply to such eligible professionals and other persons. The Secretary did not determine that there were standards designed specifically to be applied to such eligible professionals and other persons and the Secretary did not determine that licensing, accreditation or other mandatory quality requirements apply to such eligible professionals and other persons. Therefore, we issued a fact sheet on our Web site announcing the exemption at www.cms.gov/medicareprovidersupenroll.

    Through this proposed rule, we are now designing standards specifically to apply to such eligible professionals and other persons. We believe that it is imperative to have both licensure and certification requirements for all qualified practitioners (eligible professionals and other persons who furnish or fabricate prosthetics and custom-fabricated orthotics) and to have accreditation requirements for all qualified suppliers (DMEPOS suppliers that fabricate or bill for prosthetics and custom-fabricated orthotics that are subject to the requirements of this proposed rule). Moreover, we believe that the provisions in section 1834(a)(20) of the Act were enacted to achieve that objective.

    Therefore, in order to ensure that only those who are qualified to do so can furnish, fabricate, and bill for the prosthetics and custom-fabricated orthotics addressed by this proposed rule, we would remove the exemption from having to meet the quality standards and the exemption from having to be accredited that currently exist for eligible professionals and other persons that furnish, fabricate or bill for prosthetics and custom-fabricated orthotics.

    2. Definition and Accreditation Requirements for Qualified Suppliers

    Consistent with the provisions in section 1834(h)(1)(F) of the Act, which require that no payment will be made unless those furnishing prosthetics and custom-fabricated orthotics are qualified to do so, we are proposing to define qualified supplier, in§ 424.57(a), as an entity that is—

    • Enrolled in Medicare as a DMEPOS supplier; and

    • Accredited by one of the CMS-approved accreditation organizations that meets the proposed requirements that an organization must meet to accredit qualified suppliers of prosthetics and custom-fabricated orthotics in § 424.58(c) (described in section II.A.5. of this proposed rule).

    In our existing regulations at § 424.57(c)(22), we require DMEPOS suppliers to be accredited by a CMS-approved accrediting organization to receive and retain a supplier billing number. We also state that the accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the supplier to receive payment. To implement the statutory requirements regarding accreditation requirements for eligible professionals and other persons who want to furnish and bill for prosthetics and custom-fabricated orthotics, we would revise § 424.57(c)(22) by—

    • Redesignating the existing text as paragraph (c)(22)(i). We would also make clarifying, technical, and conforming changes. We note that changes would not modify the intent of this provision. We also note that this requirement would still be applicable to all DMEPOS suppliers.

    • Adding a new paragraph (c)(22)(ii) to state the additional accreditation requirements for DMEPOS suppliers that would be fabricating and billing for prosthetics and custom-fabricated orthotics. In order to be a qualified supplier, the DMEPOS supplier must be accredited by a CMS-approved accreditation organization for prosthetics and custom-fabricated orthotics as described in § 424.58(c). The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the qualified supplier (as defined in § 424.57(a)) to receive payment for the specific prosthetics and custom-fabricated orthotics. We are also proposing that as part of compliance with the ongoing accreditation process, qualified suppliers must notify the AO of any change in conditions, practices, or operations that were relied upon by the AO at the time of accreditation. This would include, but not be limited to, a requirement for notifying the AO of any changes in personnel, including changes in status or qualifications of employees of the qualified supplier or of any personnel utilized by the qualified supplier via contract or other business relationship. This requirement is included to ensure that qualified suppliers, once accredited, continue to meet all of the accreditation and other supplier standards. (See section II.A.5. of this proposed rule for more detailed information regarding our proposed requirements for accrediting organizations.)

    Section 1834(h)(1)(F) of the Act requires, in part, that no payment can be made for prosthetics or custom-fabricated orthotics unless the item is fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate. Therefore, we are proposing to define and establish the criteria that such a facility must meet. We are proposing to define “fabrication facility” to distinguish this facility type from others referenced in our regulations. In § 424.57(a), we would define a fabrication facility as a physical structure that—

    • Meets the requirements in § 424.57(d)(4); and

    • Is utilized by a qualified practitioner or a qualified supplier to fabricate prosthetics or custom-fabricated orthotics.

    In § 424.57(d)(4), based on input from other government agencies and contractors that are involved in ensuring that prosthetics and custom-fabricated orthotics are furnished, fabricated and paid for properly, we would specify that the fabrication facility at which qualified suppliers and qualified practitioners fabricate prosthetics and custom-fabricated orthotics, as defined in § 424.57(a), must meet all of the following requirements:

    • Be located within the United States or one of its territories.

    • Be a business that is organized, established and licensed under applicable state and federal laws.

    • Have a process for maintenance and production of fabrication records including the following:

    ++ Job/work orders.

    ++ Record tracking systems.

    ++ Real time recordkeeping, for example, ensuring that records are updated as the fabrication takes place.

    ++ Secure storage of records with electronic and hard copy back-up.

    • Have a quality assurance process to identify non-standard production outcomes, and improve fabrication outcomes.

    • Have a periodic review and employee demonstration of fabrication/safety/communication/operations competencies with corrective action plans for staff that do not meet the minimal standards.

    • Have full time appropriately credentialed staff member(s) who are (qualified practitioners or qualified suppliers) onsite to fabricate and to supervise fabrication.

    • Have a laboratory area with appropriate safety equipment (for example, flammable material storage, gloves, safety glasses, and proper ventilation).

    • Have a separate waiting area and chairs with armrests, as necessary.

    • Have patient care and fitting rooms with appropriate levels of privacy and sanitation. Patient fitting and care areas should be separate from the fabrication area.

    • Have disinfecting supplies, gloves, masks, and plastic for containing contaminated materials.

    • Have a fabrication facility information system, paper or digital, that can track the production, list component part number (and serial number if available) and quantity, and that is linked to patient information and be Health Insurance Portability and Accountability Act compliant. Such a system must allow facility staff and management, including those fabricating, to identify any parts that could be recalled at a later date.

    • Have parallel bars, a full-length mirror, and other appropriate assessment tools.

    • Have a process that mandates following precautions to handle used patient devices that are contaminated.

    • Have repair and disinfecting areas clearly labeled.

    • Have the ability to handle all potentially hazardous materials in facility properly.

    • Have an emergency management plan and a safety management plan.

    • Have policy for detecting/reporting counterfeit supplies.

    • Have the proper tools, equipment, and computers commonly used in the fabrication of particular items and typically associated with the particular technical approach (negative impression/positive model, CAD-CAM, or direct formed), as applicable. These tools and equipment would include, but are not limited to the following:

    ++ Computers with appropriate graphics/modeling capacity and technology.

    ++ Band saw.

    ++ Disc sander.

    ++ Sanding paper.

    ++ Flexible shaft sander.

    ++ Lathe.

    ++ Drill press.

    ++ Sewing machine.

    ++ Grinding equipment.

    ++ Paint-spraying equipment.

    ++ Welding equipment.

    ++ Alignment jig.

    ++ Ovens capable of heating plastics for molding.

    ++ Computer controlled milling machine.

    ++ Lockable storage areas for raw materials and finished devices.

    ++ Air compressor.

    We note that these requirements would apply even if the fabrication facility is the same location as that of the DMEPOS supplier.

    We intend to require that AO's cannot accredit a qualified supplier or renew the accreditation of a qualified supplier unless the qualified supplier uses a fabrication facility that meets these criteria. We are seeking comment on the definition of a fabrication facility and its requirements.

    3. Definition of Qualified Practitioner

    We are also proposing to define qualified practitioner in § 424.57(a). Our proposal would permit certain eligible professionals and other persons who are not enrolled as an accredited DMEPOS supplier to become a qualified practitioner to furnish or fabricate prosthetic and custom-fabricated services and supplies that are billed to Medicare if the eligible professional or other person meets the training, licensure, and certification requirements in proposed § 424.57(d)(3).

    a. Specific Eligible Professionals and Other Persons

    In § 424.57(a), we would identify and define the types of eligible professionals and other persons who can become qualified practitioners, and therefore, in accordance with the BIPA provisions, furnish or fabricate prosthetics and custom-fabricated orthotics. Specifically, we propose to identify and to add definitions for the following practitioners: (1) Occupational therapist; (2) ocularist; (3) orthotist; (4) pedorthist; (5) physical therapist; (6) physician; and (7) prosthetist.

    Occupational Therapist. Our current regulations at § 484.4 specify in detail the personnel qualifications for an occupational therapist. We are proposing to define an occupational therapist as an individual who meets the requirements in § 484.4. We are specifically requesting comments on these proposed qualifications for an occupational therapist to furnish/fabricate prosthetics and custom-fabricated orthotics.

    Ocularist. The American Society of Ocularists defines an ocularist as a trained technician skilled in the arts of fitting, shaping, and painting ocular prostheses. We note, as indicated by the National Examining Board of Ocularists, that in addition to creating ocular prostheses, the ocularist typically shows the patient how to handle and care for the prosthesis, and provides long-term care through periodic examinations. We are proposing to define an ocularist as a trained technician skilled in the arts of fitting, shaping, and painting ocular prostheses who is certified by the American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC), the Board for Orthotist/Prosthetist Certification International, Incorporated (BOC) or the National Examining Board of Ocularists. We are specifically requesting comments on these proposed qualifications for an ocularist to furnish/fabricate prosthetics and custom-fabricated orthotics.

    Orthotist. Our current regulations in § 485.70(d) specify the following personnel qualifications for an orthotist:

    ++ Be licensed by all states in which practicing, if applicable.

    ++ Have successfully completed a training program in orthotics that is jointly recognized by the American Council on Education and the American Board for Certification in Orthotics and Prosthetics.

    ++ Be eligible to take that Board's certification examination in orthotics.

    We are proposing to define an orthotist as an individual who meets the personnel qualifications in § 485.70(d). We are specifically requesting comments on these proposed qualifications for an orthotist to furnish or fabricate prosthetics and custom-fabricated orthotics.

    Pedorthist. The Pedorthic Footcare Association defines a pedorthist as a specialist in using footwear—which includes shoes, shoe modifications, foot orthoses and other pedorthic devices—to solve problems in, or related to, the foot and lower limb. We are proposing to define pedorthist in this manner. We are specifically requesting comments on these proposed qualifications for a pedorthist to furnish or fabricate prosthetics and custom-fabricated orthotics.

    Physical Therapist. Our current regulations at § 484.4 specify in detail the personnel qualifications for a physical therapist. We are proposing to define a physical therapist as an individual who meets the requirements in § 484.4. We are specifically requesting comments on these proposed qualifications for a physical therapist to furnish or fabricate prosthetics and custom-fabricated orthotics.

    Physician. Our current regulations at § 484.4 specify the personnel qualifications for a physician. In addition to those requirements, we propose to require that for purposes of furnishing or fabricating prosthetics and custom-fabricated orthotics, a physician must be specifically educated, certified or trained in the area of prosthetics and custom-fabricated orthotics. The physician must be knowledgeable and competent (as evidenced by education and experience) in the assessment, furnishing, fabrication, care, and follow-up needs of the patient as specifically delineated in the DMEPOS quality standards (discussed in section II.A.6. of this proposed rule). We are proposing such knowledge and competency requirements because we believe it is only specialty physicians who are trained and experienced, and who understand the specialized needs of the beneficiary requiring prosthetics and custom-fabricated orthotics. We are specifically requesting comments on these proposed additional qualifications for a physician to furnish prosthetics and custom-fabricated orthotics.

    Doctors of dental surgery or dental medicine, doctors of optometry, psychiatrists, and chiropractors do not customarily furnish or fabricate prosthetics and custom-fabricated orthotics. Therefore, we have not proposed requirements for these eligible professionals or any others who do not typically furnish or fabricate the prosthetics and custom-fabricated orthotics that are subject to the provisions of this proposed rule. However, any qualified practitioner who furnishes or fabricates prosthetics or custom-fabricated orthotics and any qualified supplier that fabricates or bills for such services must meet the applicable requirements as specified in this rule.

    Prosthetist. A prosthetist is able to provide all types prosthetics, with the exception of facial prosthetics. Our current regulations at § 485.70(f) specify the personnel qualifications for a prosthetist as follows:

    ++ Be licensed by all states in which they are practicing, if applicable.

    ++ Have successfully completed a training program in prosthetics that is jointly recognized by the American Council on Education and the American Board for Certification in Orthotics and Prosthetics.

    ++ Be eligible to take that Board's certification examination in prosthetics.

    We are proposing to define a prosthetist as an individual who meets the personnel qualifications in § 485.70(f). We are specifically requesting comments on these proposed qualifications for a prosthetist to furnish or fabricate prosthetics and custom-fabricated orthotics.

    b. Training, Licensure, and Certification Requirements for Qualified Practitioners

    In addition to defining the types of professionals that would be eligible to furnish and fabricate prosthetics and custom-fabricated orthotics, we are proposing certain licensure, training, and certification requirements that these practitioners must meet to be qualified practitioners who furnish or fabricate prosthetics or custom-fabricated orthotics that are billed to Medicare by qualified suppliers. Furnishing and fabricating prosthetics and custom-fabricated orthotics for Medicare beneficiaries, who need these items and services, is multifaceted and complex. We have proposed a framework of requirements designed to ensure that eligible professionals possess the skills and training to furnish and fabricate these items and services. It is important that the qualified practitioners who furnish and fabricate these items meet the requirements specified in this proposed rule.

    Therefore, in proposed § 424.57(d)(3), we would specify that an eligible professional or other person who wants to be a qualified practitioner who furnishes or fabricates prosthetics or custom-fabricated orthotics must meet either of the following licensure and certification requirements:

    ++ Licensed in orthotics, pedorthics or prosthetics by the state.

    ++ In states that do not provide licenses for orthotics, pedorthics or prosthetics, must be both of the following:

    —Specifically, trained and educated to provide and manage the provision of pedorthics, prosthetics, and orthotics.

    —Certified by the one of the following:

    +++ ABC.

    +++ BOC.

    +++ A Secretary-approved organization that has standards equivalent to the ABC or BOC.

    We believe these proposed requirements would ensure that the specialized needs of Medicare beneficiaries who require prosthetics and custom-fabricated orthotics are met. We are specifically seeking comment on these requirements and, in particular, we are very interested in comments regarding standards by which we should determine that qualified practitioners are specifically trained and educated to provide and manage the provision of pedorthics, prosthetics, and orthotics. For example, we solicit feedback on any relevant metrics, data sources or methods and processes to gauge competencies. We would appreciate comments on whether a qualified practitioner who is also a qualified supplier that is enrolled in Medicare as a DMEPOS supplier should be required to obtain certification from ABC or BOC in addition to meeting the qualified suppler requirements in this proposed rule.

    We also clarify that, to the extent that a qualified supplier does not fabricate a prosthetic or a custom-fabricated orthotic, such prosthetic or custom-fabricated orthotic must be fabricated by a qualified practitioner, and that it is the responsibility of the qualified supplier to verify the practitioner's qualified status.

    4. Claims for Prosthetics and Custom-Fabricated Orthotics

    As stated previously, we are proposing that all DMEPOS suppliers that bill for prosthetics and custom-fabricated orthotics must meet the supplier standards in § 424.57, the quality standards (discussed in section II.A.6. of this proposed rule) and be accredited by one of the CMS-approved accrediting organizations.

    We have proposed in § 424.535(a)(2)(iii) that we may revoke a qualified supplier's enrollment from Medicare for billing for prosthetics and custom-fabricated orthotics that are not furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate. This is particularly important because for those qualified practitioners who are not eligible to be enrolled in Medicare or who are not permitted to opt out of Medicare, there will be no CMS repository of information about their licensure or certification. The qualified supplier would be responsible for ensuring that the qualified practitioners who furnish or the qualified practitioners and qualified suppliers who fabricate the items for which the qualified supplier submits a bill meet the requirements of this rule. The decision about revocation based on the authority in § 424.535(a)(2)(iii) will be made based on the facts and circumstances of the particular situation, and will not be based on a single individual billing or miscoding mistake alone on the part of a supplier. We are specifically seeking comment on the implementation of this requirement, including how DMEPOS suppliers envision that they would comply with the requirements that they can bill only for prosthetics and custom-fabricated orthotics that have been furnished by qualified practitioners and fabricated by qualified practitioners or qualified suppliers at a facility that meets such criteria as the Secretary determines appropriate.

    5. Requirements for Accreditation Organizations

    Section 1834(a)(20)(B) of the Act requires the Secretary to designate and approve one or more independent accreditation organizations to apply the quality standards required in section 1834(a)(20)(A) of the Act. In the August 18, 2006 final rule (71 FR 48354), we implemented our regulations at § 424.58 that specified the criteria that all approved accreditation organizations must meet. In this proposed rule, we would specify requirements for any of the CMS-approved accreditation organizations that accredit suppliers fabricating prosthetics and custom-fabricated orthotics. In § 424.58, we are proposing to redesignate paragraphs (c) through (e), as paragraphs (d) through (f), and adding a new paragraph (c). In paragraph (c), we would specify that any approved accreditation organization must meet the following additional accreditation requirements to accredit suppliers that bill for prosthetics and custom-fabricated orthotics. In addition to meeting the current requirements set forth under § 424.58, the accreditation organization must be one of the following:

    • The ABC.

    • The BOC.

    • An approved DMEPOS accreditation organization that has standards equivalent to the ABC or BOC.

    We are proposing to define “a DMEPOS accreditation organization that has standards equivalent to the ABC or BOC” as one that employs or contracts with an orthotist, prosthetist, occupational therapist, or physical therapist who meets the qualified practitioner definition at § 424.57(a) and who is utilized for the purpose of surveying the supplier for compliance, and has the authority to approve or deny accreditation of qualified suppliers.

    We believe that these proposed requirements are in concert with the provisions of section 1834(h) of the Act requiring that the supplier be accredited by the ABC, the BOC or accredited by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board. We are specifically seeking comment on the proposed definition.

    6. Quality Standards Required in Section 1834(a)(20) of the Act a. Overview of and Process for Updating the Quality Standards

    The quality standards required by section 1834(a)(20) of the Act are used by the accreditation organizations in order to determine whether a supplier meets statutory and regulatory requirements and therefore can be accredited. Any supplier would have to maintain these standards in order to meet the accreditation requirements and be approved as a qualified supplier to bill, continue to bill or fabricate Medicare Part B prosthetics and custom-fabricated orthotics.

    After issuance of the final rule, we would update the DMEPOS quality standards to reflect the provisions contained in the final rule resulting from this proposed rule. The revised quality standards would include specifically the requirements that qualified practitioners must meet to furnish and fabricate prosthetics and custom-fabricated orthotics and that qualified suppliers must meet in order to fabricate and bill Medicare for prosthetics and custom-fabricated orthotics. We plan to solicit comments on the proposed updates to the quality standards as we have done in the past, and as set forth in section 1834(a)(20)(E) of the Act, by posting the proposed updates to the quality standards on our Web site at: www.cms.gov/medicareprovidersupenroll. The quality standards are updated via our subregulatory process. Therefore, while we are notifying the public of our intent to update the quality standards, we are not, in this proposed rule, soliciting comment on the quality standards or the process for updating these standards.

    b. Effective Date for Compliance With New Quality Standards

    We are proposing in § 424.57(c)(22)(ii) that qualified suppliers who bill Medicare for prosthetics and custom-fabricated orthotics would need to meet the requirements included in the final rule no later than 1 year after the posting date of the final quality standards or at the time of the supplier's re-accreditation cycle, whichever is later. For qualified practitioners, we would expect them to meet the licensure and certification requirements proposed and subsequently finalized via rulemaking within 1 year of publication of the final rule. This takes into consideration the average length of time (5.5 months) needed by a DMEPOS supplier to complete the DMEPOS accreditation process, in addition to the time that may be needed for an eligible professional to become a qualified practitioner and become licensed or certified, as well as an extended period due to the additional numbers of suppliers or individuals that may need to meet the new requirements. We are requesting comment on the proposed implementation schedule so that we may ensure that there is no disruption in patient access to services or care.

    If an ocularist, orthotist, prosthetist, physicians, pedorthist, occupational therapist, physical therapist or any other eligible professional is not furnishing or fabricating prosthetics or custom-fabricated orthotics, then they would not need to meet the specific prosthetics and custom-fabricated orthotics requirements in this proposed rule. Similarly, if an enrolled DMEPOS supplier is not billing for the prosthetics and custom-fabricated orthotics subject to the provisions of this proposed rule, then the supplier would not need to meet the specific prosthetics and custom-fabricated orthotics requirements in this proposed rule.

    B. List of Prosthetics and Certain Custom-Fabricated Orthotics

    The requirements of section 1834(h)(1)(F) of the Act apply to all prosthetics and certain custom-fabricated orthotics described in section 1834(h)(1)(F)(ii) of the Act. Section 1834(h)(1)(F)(ii)(I) of the Act, as added by section 427 of BIPA, states that an item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experience to custom-fabricate and that is included in a list established by the Secretary. Section 1834(h)(1)(F)(ii)(I) of the Act also specifies that an item of custom-fabricated orthotics does not include shoes and shoe inserts.

    Section 1834(h)(1)(F)(ii)(II) of the Act as added by section 427 of BIPA states that the Secretary, in consultation with appropriate experts in orthotics (including national organizations representing manufacturers of the same), shall establish and update as appropriate a list of items to which this subparagraph applies. No orthotic may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient as defined later. On August 19, 2005, we issued program instructions (Transmittal 656, CR 3959) implementing the list of HCPCS codes describing prosthetics and custom-fabricated orthotics subject to the requirements of section 1834(h)(1)(F) of the Act. The list of HCPCS codes describing items subject to the requirements of section 1834(h)(1)(F) of the Act has been updated to reflect changes in HCPCS codes that have occurred since 2005. This list of HCPCS codes describing items subject to the requirements of section 1834(h)(1)(F) of the Act would continue to be updated through program instructions, as needed. The list is available on the CMS Web site at www.cms.gov/medicareprovidersupenroll.

    In keeping with the statute's intent to consult with appropriate experts in developing the list, we not only reviewed the Committee's recommendations, but also consulted with the following:

    • American Physical Therapy Association.

    • Medicare Pricing, Data, Analysis and Coding (PDAC) contractor(s).

    • Orthotic & Prosthetic Alliance.

    • The American Occupational Therapy Association.

    • The American Orthotic & Prosthetic Association.

    • The U.S. Department of Veterans Affairs.

    To implement this statutory provision, we propose to add the following definitions in § 424.57(a):

    • Positive model of the patient means a particular type of custom fabrication in which one of the following occurs:

    ++ Is molded to the patient model as a negative impression taken of the patient's body part and a positive model rectification are constructed.

    ++ A Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the modified shape is electronically transmitted to a commercial milling machine that carves the rectified model.

    ++ A direct formed model is one in which the patient serves as the positive model. The device is constructed over the model of the patient and is then fabricated to the patient. The completed custom fabrication is checked and all the necessary adjustments are made.

    • Custom-fabricated means an item that is individually made for a specific patient. Specifically, a custom-fabricated item is a device that is fabricated based on clinically derived and rectified castings, tracings, measurements, and other images such as x-rays of the body part. The fabrication may involve using calculation, templates and components. This process requires the use of basic materials including, but not limited to plastic, metal, leather or cloth in the form of uncut or unshaped sheets, bars or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, laminating, and finishing prior to fitting on the patient. An item is considered custom-fabricated if it is constructed by using one of the positive model techniques described in the definition of positive model of the patient.

    Lastly, we would specify in § 424.57(d)(2) that items on the list must be—(1) furnished by a qualified practitioner; (2) fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate; and (3) billed by a qualified supplier or, submitted as a claim by a beneficiary.

    The list would be updated through periodic program instructions to reflect any changes. We intend to update the list as needed on the CMS Web site at www.cms.gov/medicareprovidersupenroll. We note that the list of services and supplies that are subject to the provisions of this proposed rule is being provided for information only. We are not, in this proposed rule, soliciting comments on the list.

    We would continue to consult with experts in orthotics as changes in positive model techniques occur that might impact the definition and list of items subject to section 1834(h)(1)(F) of the Act. Any such changes to the list of items would be issued through program instructions. We would continue to ensure that any change to the list of prosthetics and custom-fabricated orthotics is done in concert with our established processes.

    We would issue contractor instructions and a provider educational article detailing the list of HCPCS codes for the prosthetics and custom-fabricated orthotic items to which the requirements apply, as well as instructions to DMEPOS suppliers regarding billing, data collection, and systems operations following the publication of the final rule. Any changes to the list items would also be published in future CMS contractor instructions.

    III. Collection of Information Requirements A. Background

    Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

    • The need for the information collection and its usefulness in carrying out the proper functions of our agency.

    • The accuracy of our estimate of the information collection burden.

    • The quality, utility, and clarity of the information to be collected.

    • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

    B. ICRs Regarding DMEPOS Suppliers and Eligible Professionals Providing Custom-Fabricated Orthotics (§ 424.57) 1. Accreditation for Physicians and Practitioners Enrolled as DMEPOS Suppliers

    Under § 424.57(c)(22), DMEPOS suppliers that furnish, fabricate and bill for prosthetics or custom-fabricated orthotics must meet all accreditation requirements specified in these provisions, and be licensed in orthotics, pedorthics, or prosthetics in the state in which its practice is located (if the state requires such licensure). Table 1 identifies categories and approximate numbers of individuals who, as of February 2014: (1) Are enrolled in Medicare as DMEPOS suppliers; (2) have billed Medicare for prosthetic devices; and (3) are ABC or BOC certified. This data is based on internal CMS statistics, though the figures in Table 1 are merely rough estimates for purposes of this proposed rule. These individuals have met all applicable state licensure requirements (for example, for furnishing prosthetics).

    Table 1—Prosthetics Category Number
  • enrolled as
  • DMEPOS
  • suppliers
  • Number who
  • are ABC or
  • BOC certified
  • Prosthetists 8,000 5,000 Physicians 5,000 3,000 Physical and Occupational Therapists 1,000 500 Ocularists 400 200 Orthotists 1,500 800 Pedorthists 900 500 Total 16,800 10,000

    The 10,000 physicians and practitioners in Table 1 who are enrolled as DMEPOS suppliers and are accredited would meet the requirements of proposed § 424.57(c)(22); hence, the information collection requirements in this proposed rule would not affect them. However, the remaining 6,800 would need to obtain ABC or BOC accreditation in order to bill Medicare for prosthetics.

    Table 2 identifies categories and approximate numbers of individuals who, as of February 2014: (1) Are enrolled in Medicare as DMEPOS suppliers; (2) have billed Medicare for custom-fabricated orthotics; and (3) are ABC or BOC certified. This data, too, is based on internal CMS statistics. All of these persons have met the applicable state licensure requirements (for example, for furnishing custom-fabricated orthotics).

    Table 2—Custom-Fabricated Orthotics Category Number
  • enrolled as
  • DMEPOS
  • suppliers
  • Number who
  • are ABC or
  • BOC certified
  • Prosthetists 4,000 2,000 Physicians 3,000 1,500 Physical and Occupational Therapists 1,000 500 Ocularists 300 200 Orthotists 4,000 2,500 Pedorthists 700 400 Total 13,000 7,100

    The 7,100 physicians and practitioners in Table 2 who are currently enrolled as DMEPOS suppliers and are accredited would meet the requirements of proposed § 424.57(c)(22). Accordingly, the information collection requirements in this proposed rule would not affect them. However, the remaining 5,900 would need to obtain ABC or BOC accreditation in order to bill Medicare for custom-fabricated orthotics.

    Although it is highly likely that some of the individuals in Tables 1 and 2 provide both prosthetics and custom-fabricated orthotics, we have chosen to assume that the tables reflect unduplicated counts of physicians and practitioners.

    We cannot estimate the number of physicians and practitioners in the universe of 12,700 (6,800 + 5,900) who would either decline to obtain accreditation because of cost, other factors or inability to meet the accreditation requirements. We believe that the overwhelming majority of the 12,700 physicians and practitioners would elect to and become accredited to continue to provide, bill, or both provide and bill for these devices. We expect that a lower percentage of physicians, physical therapists, and occupational therapists would seek accreditation than would prosthetists, orthotists, pedorthists, and ocularists. This is because furnishing prosthetics and custom-fabricated orthotics traditionally constitutes a smaller portion of their practices than is the case with the latter four practitioner types. For purposes of this burden estimate only, and as outlined in Table 3, we project that—(1) all prosthetists, orthotists, ocularists, and pedorthists would pursue accreditation; and (2) 90 percent of physicians, physical therapists, and occupational therapists would seek accreditation. This results in a base figure of 12,250 physicians and practitioners that is only slightly less than the 12,700-person universe mentioned previously.

    Table 3—Number of Physicians and Practitioners Seeking Accreditation Category Approximate
  • percentage
  • of universe *
  • Number
    Prosthetists 40.8 5,000 Physicians 25.7 3,150 Physical and Occupational Therapists 7.3 900 Ocularists 2.5 300 Orthotists 18.0 2,200 Pedorthists 5.7 700 Total 12,250 * Rounded to nearest tenth.

    The hour and cost burdens on these physicians and practitioners of completing and submitting the paperwork associated with accreditation would vary because each physician's and practitioner's specific circumstances differ. However, we believe that an average per physician/practitioner time burden of 10 hours is reasonable, though we welcome comments on this estimate. This 10-hour period would include the time involved in completing and submitting the necessary accreditation paperwork, including obtaining any required supporting documentation.

    Many of the 12,250 physicians and practitioners are part of group practices that have administrative personnel who handle various paperwork functions on behalf of the group's physicians and practitioners. It is probable that some administrative personnel would complete and submit the physicians' and practitioners' accreditation paperwork. However, we have no data that can help us predict the number of instances in which this would occur. In an effort not to underestimate the potential cost burden, we will assume for purposes of our analysis that physicians and practitioners would complete and submit their accreditation applications.

    Table 4 identifies the mean hourly wages for the Bureau of Labor Statistics (BLS) categories that most appropriately apply to the physician and practitioner types mentioned previously. The data is from May 2015, the most recent month for which information is available; see http://www.bls.gov/oes/current/oes_nat.htm#43-0000. As there are no specific BLS categories for ocularists and pedorthists, we will include them within the larger category of orthotists and prosthetists.

    Table 4—BLS Mean Hourly Wages Using May 2015 Data BLS category BLS mean
  • hourly
  • wage
  • ($)
  • Hourly wage
  • with fringe
  • benefits and
  • overhead
  • ($)
  • Orthotists and Prosthetists * 33.63 67.26 Physicians and Surgeons 97.33 194.66 Physical Therapists 41.25 ** 82.50 Occupational Therapists 39.27 ** 78.54 * Includes ocularists and pedorthists. ** The average mean hourly wage for physical and occupational therapists combined, which we will use in our analysis, is $80.52 (or ($82.50 + $78.54)/2).

    Table 5 identifies the total hour and cost burdens for enrolled physicians and practitioners seeking accreditation. The cost burdens are based on the wage estimates in Table 4.

    Table 5—Total Hour and Costs Burdens for Enrolled Physicians and Practitioners Seeking Accreditation Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 5,000 10 50,000 67.26 3,363,000 Physicians 3,150 10 31,500 194.66 6,131,790 Physical and Occupational Therapists 900 10 9,000 80.52 724,680 Ocularists 300 10 3,000 67.26 201,780 Orthotists 2,200 10 22,000 67.26 1,479,720 Pedorthists 700 10 7,000 67.26 470,820 Total 12,250 122,500 12,371,790

    Although this burden would be incurred in the first year of our proposed requirement, 3 years is the maximum length of an OMB approval. Therefore, we must average the totals in Table 5 over a 3-year period. This result in the following average annual figures of: (1) 4,083 affected physicians and practitioners; (2) 40,830 ICR burden hours; and (3) $4,123,930 in ICR burden costs.

    2. Accreditation for Newly Enrolling Physicians and Practitioners

    Table 6 outlines the annual number of physicians and practitioners who, based on historical CMS data, would—(1) seek accreditation in accordance with § 424.57(c)(22); (2) enroll in Medicare as DMEPOS suppliers; and (3) bill Medicare for prosthetics or custom-fabricated orthotics.

    Table 6—Annual Number of Physicians and Other Practitioners Seeking Accreditation, Enrolling in Medicare as DMEPOS Suppliers, and Billing for Prosthetics or Custom-Fabricated Orthotics Category Number of
  • enrollees
  • Prosthetists 400 Physicians 250 Physical and Occupational Therapists 100 Ocularists 40 Orthotists 400 Pedorthists 100 Total 1,290

    Table 7 outlines the annual hour and cost burdens for newly enrolling physicians and practitioners. The table applies the 10-hour and BLS wage estimates mentioned previously.

    Table 7—Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Seeking Accreditation Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 400 10 4,000 67.26 269,040 Physicians 250 10 2,500 194.66 486,650 Physical and Occupational Therapists 100 10 1,000 80.52 80,520 Ocularists 40 10 400 67.26 26,904 Orthotists 400 10 4,000 67.26 269,040 Pedorthists 100 10 1,000 67.26 67,260 Total 1,290 12,900 1,199,414
    3. Reporting Accreditation via the CMS-855S (Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers)

    The CMS-855S is currently approved under OMB control number 0938-1056. In order to account for the application information collection requirements contained in this notice of proposed rulemaking, we will submit a revised information collection request for OMB review and approval.

    a. Enrolled Physicians and Practitioners

    Upon becoming accredited, physicians and practitioners would need to report the accreditation to us via a CMS-855S change of information request. We estimate that it would take physicians and practitioners 30 minutes to complete and submit this change request. Table 8 outlines the total hour and cost burdens of this requirement.

    Table 8—Total Hour and Cost Burdens for Enrolled Physicians and Practitioners Reporting Accreditation via CMS-855S Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 5,000 0.5 2,500 67.26 168,150 Physicians 3,150 0.5 1,575 194.66 306,590 Physical and Occupational Therapists 900 0.5 450 80.52 36,234 Ocularists 300 0.5 150 67.26 10,089 Orthotists 2,200 0.5 1,100 67.26 73,986 Pedorthists 700 0.5 350 67.26 23,541 Total 12,250 6,125 618,590

    Although this burden would be incurred in the first year of our proposed requirement, we must average the totals in Table 8 over a 3-year period. This results in: (1) 4,083 affected physicians and practitioners; (2) 2,042 ICR burden hours; and (3) $206,197 in ICR burden costs.

    b. Newly Enrolling Physicians and Practitioners

    When completing the CMS-855S initial enrollment application, physicians and practitioners would have to furnish accreditation information on the form. We estimate that this would take 30 minutes per application. Table 9 outlines the total annual hour and cost burdens.

    Table 9—Total Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Reporting Accreditation via CMS-855S Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 400 0.5 200 67.26 13,452 Physicians 250 0.5 125 194.66 24,333 Physical and Occupational Therapists 100 0.5 50 80.52 4,026 Ocularists 40 0.5 20 67.26 1,345 Orthotists 400 0.5 200 67.26 13,452 Pedorthists 100 0.5 50 67.26 4,026 Total 1,290 645 60,634
    4. Requirements for Becoming a Qualified Practitioner

    Under § 424.57(d)(3), all eligible professionals who wish to become qualified practitioners, to provide prosthetics or custom-fabricated orthotics, and who are not enrolled in Medicare as DMEPOS suppliers (and therefore do not bill Medicare for these items) must—

    • Be licensed in orthotics, pedorthics, or prosthetics in the state in which his or her practice is located if the state requires such licensure; or

    • If the state does not require such licensure—

    • Be specifically trained and educated to provide and manage the provision of pedorthics, prosthetics, or orthotics; and

    • Meet the certification requirements specified in § 424.57(d)(3)(i)(B)(2).

    Specifically, this section discusses the hour and cost burdens for physicians and practitioners who are—(1) not enrolled in Medicare as DMEPOS suppliers; (2) located in a state that does not require licensure in orthotics, pedorthics, and prosthetics; and (3) must obtain certification under § 424.57(d)(3).

    Approximately 15 states require licensure to furnish prosthetics and custom-fabricated orthotics. However, we do not have concrete data regarding the number of unenrolled and unlicensed individuals in the 35 other states or the territories who provide these items, for these persons do not bill Medicare for them. For purposes of this burden estimate, and solely to establish a rough figure on which commenters can submit feedback to us, we project that approximately 5,000 physicians and practitioners would seek certification within the first year following the implementation of § 424.57(d)(3). We estimate that 500 physicians and practitioners would seek certification under § 424.57(d)(3) each year thereafter.

    As we lack sufficient data regarding the number of qualified practitioners, who fall within the universe of 5,000 physicians and practitioners, we will use the figures in Table 3 as a baseline estimate. To illustrate, orthotists represented 18 percent of the 12,250 suppliers referenced in Table 3 (or 2,200 out of 12,250); we project that 18 percent of the 5,000-person universe (or 900) would consist of orthotists. We also utilized the wage estimates and the 10-hour projection. This results in the following Year 1 hour and cost burdens associated with § 424.57(d)(3).

    Table 10—Hour and Cost Burdens Associated With § 424.57(d)(3) in Year 1 Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 2,040 10 20,400 67.26 1,372,104 Physicians 1,285 10 12,850 194.66 2,501,381 Physical and Occupational Therapists 365 10 3,650 80.52 293,898 Ocularists 125 10 1,250 67.26 84,075 Orthotists 900 10 9,000 67.26 605,340 Pedorthists 285 10 2,850 67.26 191,691 Total 5,000 50,000 5,048,489

    Table 11 reflects the annual hour and cost burdens in Year 2 and each year thereafter. The figures are based on the 500-individual universe.

    Table 11—Annual Hour and Cost Burdens of § 424.57(d)(3) in Year 2 and Subsequent Years Category Number of
  • physicians
  • and
  • practitioners
  • Hour burden
  • per
  • submission
  • Total hour
  • burden
  • Hourly wage
  • ($)
  • Total cost
  • burden
  • ($)
  • Prosthetists 204 10 2,040 67.26 137,210 Physicians 128 10 1,280 194.66 249,165 Physical and Occupational Therapists 36 10 360 80.52 28,987 Ocularists 13 10 130 67.26 8,744 Orthotists 90 10 900 67.26 60,534 Pedorthists 29 10 290 67.26 19,505 Total 500 5,000 504,145

    We averaged the totals in Tables 10 and 11 over a 3-year period. This results in the following annual figures of: (1) 2,000 affected physicians and practitioners; (2) 20,000 burden hours; and (3) $2,018,926.

    C. Final ICR Hour and Cost Burdens

    We estimate the following total ICR burdens associated with our proposed provisions in each of the first 3 years of this rule.

    Table 12—Summary of Annual Information Collection Burdens Regulation
  • section(s)
  • OMB
  • Control No.
  • Number of
  • respondents
  • Number of
  • responses
  • Burden per
  • response
  • (hours)
  • Total annual
  • burden
  • (hours)
  • Hourly labor
  • cost
  • ($)
  • Total
  • labor cost
  • ($)
  • Total
  • cost
  • ($)
  • § 424.57(c)(22)—Enrolled seeking accreditation 0938-New 12,250 12,250 10 122,250 4,123,930 4,123,930 § 424.57(c)(22)—Newly enrolling seeking accreditation 0938-New 1,290 1,290 10 12,290 †† 1,199,414 1,199,414 § 424.57(c)(22)—Enrolled reporting accreditation via 855S 0938-1056 4,083 4,083 0.5 2,042 ††† 206,197 206,197 §§ 424.57(c)(22)—Newly enrolling reporting accreditation via 855S 0938-1056 1,290 1,290 0.5 645 †††† 60,634 60,634 § 424.57(d)(3) *** 0938-New 2,000 2,000 10 20,000 ††††† 2,018,926 2,018,926 Total 12,746 12,746 75,807 7,609,101 7,609,101 Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 1. † See the values listed in Table 5. †† See the values listed in Table 7. ††† See the values listed in Table 8. †††† See the values listed in Table 9. *** The values are based on the 3-year average of the values listed in tables 10 and 11. Three years is the maximum length of an OMB approval. ††††† See the values listed in Tables 10 and 11.

    We welcome comments on all burden estimates contained in the collection of information section of this notice of proposed rulemaking.

    If you comment on these information collection and recordkeeping requirements, please do either of the following:

    1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule; or

    2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, (CMS-6012-P), Fax: (202) 395-6974; or Email: [email protected].

    IV. Regulatory Impact Statement

    This proposed rule would implement a statutory mandate that only individuals and suppliers qualified to do so can furnish, fabricate or bill for prosthetics and custom fabricated orthotics. The statute was enacted to ensure quality of care and eliminate care or services furnished or fabricated by individuals who were not qualified to do so. The idea inherent in the statute is not to deny necessary services but to ensure that the individuals and suppliers furnishing or fabricating these items are qualified to do so. As with all program changes, whether undertaken by us or in response to statutory imperative—as is the case with this rule—we always consider the impact of the proposed changes on access to care. In the case of the statutory provisions being implemented via this rule, we do not believe beneficiary access to care will be significantly affected. This rule involves only a very small percentage of the overall universe of physician, non-physician practitioner, and organizational suppliers. Of those affected, we believe that many either already comply with our proposed requirements or would come into compliance. We acknowledge that there may be some discontinuity of care in instances where a beneficiary seeks or has been receiving items from an individual or supplier that does not meet the requirements of the statute. However, we believe it will be minimal, and the benefit in improved quality of care outweighs the possible discontinuity. In addition, the phased in effective dates for compliance will allow reasonable time for practitioners and suppliers to meet the statutory and regulatory requirements thus minimizing any disruption in access to needed services. We welcome comment on these assumptions.

    In summary, we believe that our proposed rule would, as the Congress ostensibly intended in its enactment of section 1834(h)(1)(F) of the Act, protect Medicare beneficiaries and the Medicare Trust Funds by ensuring that only qualified practitioners furnish prosthetics and custom fabricated orthotics.

    We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

    Executive Order 12866 and 13563 directs 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). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

    As previously stated in section III. of this proposed rule, we estimate that 12,250 physicians and practitioners who are enrolled as DMEPOS suppliers and who have billed Medicare for prosthetics or custom-fabricated orthotics, but who are not accredited, would seek to obtain accreditation under § 424.57(c)(22) in order to continue billing for such items. Though accreditation figures vary by accreditation organization and by supplier type, we project (based on internal statistics and our review of the range of accreditation fees charged by various accreditation organizations) that the average annual cost for a physician or practitioner to obtain and remain accredited under § 424.57(c)(22) would be roughly $1,500; this represents the fee charged by the applicable accreditation organization. (This is predicated on a triennial accreditation cycle, with the accreditation costs being incurred incrementally over the 3-year period.) This results in an annual cost to these individuals of $18,375,000 (12,250 × $1,500). In combining this cost with the ICR costs of this proposed rule (as shown in section III. of this proposed rule), we determine that in no year would the total costs of this proposed rule exceed $100 million. Therefore, this is not a major rule.

    The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organization and small governmental jurisdictions. Most entities and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities for two reasons. First, the number of affected parties represents only an extremely small percentage of the universe of over 1.5 million individual and organizational medical providers nationwide. Second, we do not believe an annual cost of $1,500 combined with the occasional submission of paperwork (as described in section III. of this proposed rule) would have a significant economic impact on these suppliers and practitioners. We believe these costs would be less than 3 percent of the supplier's or practitioner's revenue, as defined by HHS for significant impact.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipates costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation, as the anticipated annual spending is $30 million. In 2016, that threshold is approximately $146 million. This proposed rule would have no consequential effect on state, local or tribal governments or on the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement cost on state and local governments, preempts state law, or otherwise has Federalism implications. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    There were several uncertainties associated with our proposed projections. First, we could not determine precisely the number of DMEPOS suppliers who would choose not to pursue accreditation or be unable to become accredited. Second, we had no data on which to base our 5,000-person and 500-person estimates in Tables 10 and 11. As such, these estimates are merely designed to solicit comment on the number of individuals who would be affected by § 424.57(d)(3). Third, we welcome comment on our estimation of $1,500 as the annual cost for a qualified supplier to obtain and remain accredited in accordance our proposals. Fourth, as we lack sufficient data to estimate any potential burden on fabricating facilities, we request comments regarding the types of possible burden and, if there are any, the costs involved.

    We note that by limiting payment to the circumstances described in this rule, our regulations would likely reduce the provision of and billing for these items to instances consistent with the statute. We believe, however, that this would enhance the quality of services and items by ensuring that unqualified entities and individuals are not furnishing such goods, while simultaneously having no real effect on how prices are set for them.

    In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.

    V. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    List of Subjects for 42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, Medicare.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 424 as set forth below:

    PART 424—CONDITIONS FOR MEDICARE PAYMENT 1. The authority citation for part 424 continues to read as follows: Authority:

    Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).

    2. Section 424.57 is amended as follows: a. In paragraph (a) by adding the definition of “Custom-fabricated orthotics,” Fabrication facility”, “Occupational therapist”, “Ocularist”, “Orthotist”, “Pedorthist”, “Physical therapist”, “Physician”, “Positive model of the patient”, “Prosthetics”, “Prosthetist”, “Qualified practitioner”, and “Qualified supplier” in alphabetical order and in the definition of “DMEPOS supplier” by removing the reference “paragraphs (c) and (d) of this section” and adding in its place the reference “paragraphs (c) and (h) of this section”. b. Revising paragraph (c)(22); c. In paragraph (c)(26) removing the reference “paragraph (d) of this section” and adding in its place the reference “paragraph (h) of this section”; d. Redesignating paragraph (d) as paragraph (h) and adding a new paragraph (d); e. In newly designated paragraph (h)(1)(i) and (ii), removing the reference “paragraph (d)(15) of this section” and adding in its place the reference “paragraph (h)(15) of this section”. f. In newly designated paragraphs (h)(1)(i), (ii), (h)(4)(ii)(B), (h)(5)(iii) introductory text, (h)(12), and (h)(15)(ii), removing the reference “paragraph (d)” of this section and adding in its place the reference “paragraph (h)” of this section. g. In newly designated paragraphs (h)(2)(i), (ii), and (iii) removing the reference “paragraph (d)(3) of this section” and adding in its place the reference “paragraph (h)(3) of this section”. h. In newly designated paragraphs (h)(3)(i), removing the references “paragraph (d)(2) of this section” and adding in its place the reference “paragraph (h)(2)” and removing the reference “paragraph (d)(3)(ii) of this section” and adding in its place the reference “paragraph (h)(3)(ii) of this section”. i. In newly designated paragraph (h)(15)(ii), removing the reference “paragraph (d)(15)(i) of this section” and adding in its place “paragraph (h)(15)(i) of this section”.

    The revisions and additions read as follows:

    § 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges.

    (a) * * *

    Custom-fabricated orthotic means an item as listed in section 1861(s)(9) of the Act that meets all of the following:

    (i) Is individually made for a specific patient.

    (ii) Is constructed using one of the positive model techniques (as defined in this paragraph).

    (iii) Is made based on clinically derived and rectified castings, tracings, measurements, and other images (such as x-rays) of the body part and may involve the use of calculations, templates, and components.

    (iv) Is made using basic materials including, but not limited to the following:

    (A) Plastic.

    (B) Metal.

    (C) Leather or cloth in the form of uncut or unshaped sheets or bars.

    (D) Other basic forms and involves substantial work such as the following:

    (1) Vacuum forming.

    (2) Cutting.

    (3) Bending.

    (4) Molding.

    (5) Sewing.

    (6) Drilling.

    (7) Laminating.

    Fabrication facility means the physical structure that—

    (1) Meets the requirements in paragraph (d)(4) of this section; and

    (2) Must be used by a qualified practitioner or a qualified supplier to fabricate prosthetics or custom-fabricated orthotics that are billed to and paid for by Medicare.

    Occupational therapist means an individual who meets the personnel qualifications for an occupational therapist as specified in § 484.4 of this chapter.

    Ocularist means a trained technician skilled in the arts of fitting, shaping, and painting ocular prostheses who is certified by the National Examining Board of Ocularist.

    Orthotist means an individual who meets the personnel qualifications for an orthotist as specified in § 485.70(d) of this chapter.

    Pedorthist means an individual with specific training in footwear which includes other pedorthic devices to solve problems in, or related to, the foot.

    Physical therapist means an individual who meets the personnel qualifications for a physical therapist as specified in § 484.4 of this chapter.

    Physician means an individual who meets the personnel qualifications for a physician as specified in § 484.4 of this chapter.

    Positive model of the patient means a particular type of custom fabrication in which one of the following modeling techniques is used:

    (i) Molded to the patient model as a negative impression of the patient's body part and a positive model rectification are constructed.

    (ii) Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system.

    (iii) Direct formed model.

    Prosthetics means an item as described in section 1861(s)(9) of the Act.

    Prosthetist means an individual who meets the personnel qualifications for a prosthetist as specified in § 485.70(f) of this chapter.

    Qualified practitioner means one of the following eligible professionals or other persons defined in paragraph (a) of this section who meets the prosthetic and custom-fabricated orthotic requirements specified in paragraph (d)(3) of this section:

    (i) Occupational therapist.

    (ii) Ocularist.

    (iii) Orthotist.

    (iv) Pedorthist.

    (v) Physical therapist.

    (vi) Physician.

    (vii) Prosthetist.

    Qualified supplier means a DMEPOS supplier as defined in paragraph (a) of this section that is accredited by a CMS-approved accreditation organization to fabricate prosthetics and custom-fabricated orthotics as described in § 424.58(c).

    (c) * * *

    (22)(i) DMEPOS supplier requirements. A DMEPOS supplier must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number and to enroll in Medicare. The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the DMEPOS supplier to receive payment for those specific products and services.

    (ii) Requirements for DMEPOS suppliers fabricating or billing prosthetics and custom-fabricated orthotics. Effective 1 year after the posting of the final revised quality standards or the next revalidation, whichever is later, a DMEPOS supplier fabricating or billing for prosthetics or any of the custom-fabricated orthotics identified on the list described in paragraph (d)(2) of this section must do all of the following:

    (A) Meet the requirements specified in paragraph (c)(22)(i) of this section.

    (B) Be accredited by a CMS-approved accreditation organization for orthotics and prosthetics as described in § 424.58(c). The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the qualified supplier (as defined in § 424.57(a)) to receive payment for the prosthetics and specific custom-fabricated orthotics.

    (C) Notify the AO of any change in conditions, practices, or operations that were relied upon by the AO at the time of accreditation. This would include, but not be limited to, a requirement for notifying the AO of any changes in personnel, including changes in status or qualifications of employees of the qualified supplier or of any personnel utilized by the qualified supplier via contract or other business relationship. This requirement is included to ensure that qualified suppliers, once accredited, continue to meet all of the accreditation and other supplier standards.

    (d) Additional standards for qualified suppliers fabricating or billing for prosthetics or custom-fabricated orthotics, or qualified practitioners furnishing or fabricating prosthetics and custom-fabricated orthotics.

    (1) General rule. CMS makes payment for a bill or claim for a prosthetic or custom-fabricated orthotic identified on the list in paragraph (d)(2) of this section and meets all of the following:

    (i) Furnished by a qualified practitioner.

    (ii) Fabricated by a qualified practitioner or qualified supplier at a fabrication facility as defined in paragraph (a) of this section.

    (iii)(A) Billed by a qualified supplier; or

    (B) Submitted as a claim by a Medicare beneficiary.

    (2) List of prosthetics and custom-fabricated orthotics subject to the additional standards. CMS maintains a list of prosthetics and custom-fabricated orthotics subject to the requirements in this section. The list is—

    (i) Updated as necessary; and

    (ii) Posted on the CMS Web site.

    (3) Training, licensure, and certification requirements for qualified practitioners. (i) A qualified practitioner who is not enrolled in Medicare as a DMEPOS supplier must meet either of the following licensure and certification requirements:

    (A) Licensed in orthotics, pedorthics or prosthetics by all States in which they practice.

    (B) In States that do not provide licenses for orthotics, pedorthics or prosthetics a qualified practitioner must be—

    (1) Specifically trained and educated to provide and manage the provision of pedorthics, prosthetics, and orthotics; and

    (2) Certified by any of the following:

    (i) ABC.

    (ii) BOC.

    (iii) A Secretary-approved organization that has standards equivalent to the ABC or BOC.

    (ii) Qualified practitioners must meet the licensure, training, education and certification requirements specified in this section within 1 year of publication of the final rule.

    (4) Fabrication facility requirements. A fabrication facility at which qualified suppliers and qualified practitioners fabricate prosthetics and custom-fabricated orthotics, as defined in § 424.57(a), must meet all of the following requirements:

    (i) Be located within the United States or one of its territories.

    (ii) Be a business that is organized, established and licensed under applicable state and federal laws.

    (iii) Have a process for maintenance and production of fabrication records including the following:

    (A) Job/work orders.

    (B) Record tracking systems.

    (C) Real time recordkeeping, for example, ensuring that records are updated as the fabrication takes place.

    (iv) Have a quality assurance process to identify non-standard production outcomes, and improve fabrication outcomes.

    (v) Have a periodic review and employee demonstration of fabrication/safety/communication/operations competencies with corrective action plans for staff that do not meet the minimal standards.

    (vi) Have full time appropriately credentialed staff member(s) who are (qualified practitioners or qualified suppliers) onsite to fabricate and to supervise fabrication.

    (vii) Have a laboratory area with appropriate safety equipment (for example, flammable material storage, gloves, safety glasses, proper ventilation).

    (viii) Have a separate waiting area and chairs with armrests, as necessary.

    (ix) Have a patient care and fitting rooms with appropriate levels of privacy and sanitation. Patient fitting and care areas should be separate from the fabrication area.

    (x) Have disinfecting supplies, gloves, masks, and plastic for containing contaminated materials.

    (xi) Have a fabrication facility information system, paper or digital, that can track the production, list component part number (and serial number if available), quantity, that is linked to patient information and be Health Insurance Portability and Accountability Act compliant. Such a system must allow facility staff and management, including those fabricating, to identify any parts that could be recalled at a later date.

    (xii) Have parallel bars, a full-length mirror, and other appropriate assessment tools.

    (xiii) Have a process using precautions to handle used patient devices that are contaminated.

    (xiv) Have repair and disinfecting areas clearly labeled.

    (xv) Have the ability to handle all potentially hazardous materials in facility properly.

    (xvi) Have an emergency management plan and a safety management plan.

    (xvii) Have policy for detecting/reporting counterfeit supplies.

    (xviii) Have the proper tools, equipment, and computers commonly used in the fabrication of particular items and typically associated with the particular technical approach (negative impression/positive model, CAD-CAM, or direct formed), as applicable: These tools and equipment would include, but are not limited to the following

    (A) Computers with appropriate graphics/modeling capacity and technology.

    (B) Band saw.

    (C) Disc sander.

    (D) Sanding paper.

    (E) Flexible shaft sander.

    (F) Lathe.

    (G) Drill press.

    (H) Sewing machine.

    (I) Grinding equipment.

    (J) Paint-spraying equipment.

    (K) Welding equipment.

    (L) Alignment jig.

    (M) Ovens capable of heating plastics for molding.

    (N) Computer controlled milling machine.

    (O) Lockable storage areas for raw materials and finished devices.

    (P) Air compressor.

    3. Section 424.58 is amended as follows: a. Revising the section heading. b. Redesignating paragraphs (c) through (e) as paragraphs (d) through (f) respectively. c. Adding a new paragraph (c).

    The revision and addition read as follows:

    § 424.58 Requirements for DMEPOS accreditation organizations.

    (c) Additional requirements for accrediting qualified suppliers. To accredit qualified suppliers that fabricate or bill Medicare for prosthetics and custom-fabricated orthotics as specified in § 424.57(c)(22)(ii), an independent accreditation organization must be one of the following:

    (1) American Board for Certification in Orthotics and Prosthetics, Incorporated (ABC).

    (2) Board for Orthotist/Prosthetist Certification International, Incorporated (BOC).

    (3) An organization that—

    (i) Employs or contracts with an orthotist, prosthetist, occupational therapist or physical therapist who—

    (A) Meets the definition of qualified practitioner specified in § 424.57(a); and

    (B) Is utilized for the purpose of surveying the supplier or practitioner for compliance; and

    (ii) Has the authority granted by CMS to approve or deny the accreditation of qualified suppliers as defined in § 424.57(a) based on a determination that the organization has standards equivalent to the ABC or BOC.

    4. Section § 424.535 is amended as follows: a. Revising the section heading. b. In paragraph (a)(2) introductory text by removing the phrase “the provider or supplier is—” and adding in its place “the provider or supplier is any of the following:”. c. In paragraph (a)(2)(ii) by removing the phrase “Is debarred, suspended, or” and adding in its place the phrase “Debarred, suspended or”. d. Adding paragraph (a)(2)(iii).

    The revision and addition reads as follows:

    § 424.535 Revocation of enrollment and billing privileges in the Medicare program.

    (a) * * *

    (2) * * *

    (iii) A qualified supplier as defined in § 424.57(a) that submitted a claim for payment for a prosthetic or custom-fabricated orthotic that was not—

    (A) Furnished by a qualified practitioner; and

    (B) Fabricated by a qualified practitioner or qualified supplier as defined in § 424.57(a) at a fabrication facility as defined in § 424.57(a).

    Dated: December 9, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: December 22, 2016. Sylvia M. Burwell Secretary, Department of Health and Human Services.
    [FR Doc. 2017-00425 Filed 1-11-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 223 [Docket No. 160105011-6999-02] RIN 0648-XE390 12-Month Finding on a Petition To List Giant and Reef Manta Rays as Threatened or Endangered Under the Endangered Species Act AGENCY:

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

    ACTION:

    Proposed rule; 12-month petition finding; request for comments.

    SUMMARY:

    We, NMFS, announce a 12-month finding on a petition to list the giant manta ray (Manta birostris) and reef manta ray (Manta alfredi) as threatened or endangered under the Endangered Species Act (ESA). We have completed a comprehensive status review of both species in response to this petition. Based on the best scientific and commercial information available, including the status review report (Miller and Klimovich 2016), and after taking into account efforts being made to protect these species, we have determined that the giant manta ray (M. birostris) is likely to become an endangered species within the foreseeable future throughout a significant portion of its range. Therefore, we propose to list the giant manta ray as a threatened species under the ESA. Any protective regulations determined to be necessary and advisable for the conservation of the proposed threatened giant manta ray under ESA section 4(d) would be proposed in a subsequent Federal Register announcement. Should the proposed listing be finalized, we would also designate critical habitat for the species, to the maximum extent prudent and determinable. We solicit information to assist this proposed listing determination, the development of proposed protective regulations, and designation of critical habitat in the event the proposed threatened listing for the giant manta ray is finalized. Additionally, we have determined that the reef manta ray (M. alfredi) is not currently in danger of extinction throughout all or a significant portion of its range and is not likely to become so within the foreseeable future. Therefore, we find that the reef manta ray does not warrant listing under the ESA at this time.

    DATES:

    Comments on the proposed rule to list the giant manta ray must be received by March 13, 2017. Public hearing requests must be made by February 27, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0014, by either of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0014. Click the “Comment Now” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Maggie Miller, NMFS Office of Protected Resources (F/PR3), 1315 East West Highway, Silver Spring, MD 20910, USA.

    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 personally 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).

    You can find the petition, status review report, Federal Register notices, and the list of references electronically on our Web site at www.fisheries.noaa.gov/pr/species/fish/manta-ray.html.

    FOR FURTHER INFORMATION CONTACT:

    Maggie Miller, NMFS, Office of Protected Resources, (301) 427-8403.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 10, 2015, we received a petition from Defenders of Wildlife to list the giant manta ray (M. birostris), reef manta ray (M. alfredi) and Caribbean manta ray (M. c.f. birostris) as threatened or endangered under the ESA throughout their respective ranges, or, as an alternative, to list any identified distinct population segments (DPSs) as threatened or endangered. The petitioners also requested that critical habitat be designated concurrently with listing under the ESA. On February 23, 2016, we published a positive 90-day finding (81 FR 8874) announcing that the petition presented substantial scientific or commercial information indicating that the petitioned action may be warranted for the giant manta ray and reef manta ray, but that the Caribbean manta ray is not a taxonomically valid species or subspecies for listing, and explained the basis for that finding. We also announced the initiation of a status review of the giant manta ray and reef manta ray, as required by section 4(b)(3)(a) of the ESA, and requested information to inform the agency's decision on whether these species warrant listing as endangered or threatened under the ESA.

    Listing Species Under the Endangered Species Act

    We are responsible for determining whether giant and reef manta rays are threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we first consider whether a group of organisms constitutes a “species” under section 3 of the ESA, then whether the status of the species qualifies it for listing as either threatened or endangered. Section 3 of the ESA defines species to include “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” On February 7, 1996, NMFS and the U.S. Fish and Wildlife Service (USFWS; together, the Services) adopted a policy describing what constitutes a DPS of a taxonomic species (61 FR 4722). The joint DPS policy identified two elements that must be considered when identifying a DPS: (1) The discreteness of the population segment in relation to the remainder of the species (or subspecies) to which it belongs; and (2) the significance of the population segment to the remainder of the species (or subspecies) to which it belongs.

    Section 3 of the ESA defines an endangered species as “any species which is in danger of extinction throughout all or a significant portion of its range” and a threatened species as one “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” Thus, in the context of the ESA, the Services interpret an “endangered species” to be one that is presently at risk of extinction. A “threatened species” is not currently at risk of extinction, but is likely to become so in the foreseeable future. The key statutory difference between a threatened and endangered species is the timing of when a species may be in danger of extinction, either now (endangered) or in the foreseeable future (threatened).

    Additionally, as the definition of “endangered species” and “threatened species” makes clear, the determination of extinction risk can be based on either assessment of the range wide status of the species, or the status of the species in a “significant portion of its range.” The Services published a final policy to clarify the interpretation of the phrase “significant portion of the range” in the ESA definitions of “threatened species” and “endangered species” (79 FR 37577; July 1, 2014) (SPR Policy). The policy consists of the following four components:

    (1) If a species is found to be endangered or threatened in only an SPR, and the SPR is not a DPS, the entire species is listed as endangered or threatened, respectively, and the ESA's protections apply across the species' entire range.

    (2) A portion of the range of a species is “significant” if its contribution to the viability of the species is so important that without that portion, the species would be in danger of extinction or likely to become so in the foreseeable future.

    (3) The range of a species is considered to be the general geographical area within which that species can be found at the time USFWS or NMFS makes any particular status determination. This range includes those areas used throughout all or part of the species' life cycle, even if they are not used regularly (e.g., seasonal habitats). Lost historical range is relevant to the analysis of the status of the species, but it cannot constitute an SPR.

    (4) If a species is not endangered or threatened throughout all of its range but is endangered or threatened within an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

    The statute also requires us to determine whether any species is endangered or threatened throughout all or a significant portion of its range as a result of any one or a combination of the following five factors: the present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence (ESA section 4(a)(1)(A)-(E)). Section 4(b)(1)(A) of the ESA requires us to make listing determinations based solely on the best scientific and commercial data available after conducting a review of the status of the species and after taking into account efforts being made by any State or foreign nation or political subdivision thereof to protect the species. In evaluating the efficacy of existing domestic protective efforts, we rely on the Services' joint Policy on Evaluation of Conservation Efforts When Making Listing Decisions (“PECE”; 68 FR 15100; March 28, 2003) for any conservation efforts that have not been implemented, or have been implemented but not yet demonstrated effectiveness.

    Status Review

    A NMFS biologist in the Office of Protected Resources led the status review for the giant manta ray and reef manta ray (Miller and Klimovich 2016). The status review examined both species' statuses throughout their respective ranges and also evaluated if any portion of their range was significant as defined by the Services' SPR Policy (79 FR 37578; July 1, 2014).

    In order to complete the status review, information was compiled on each species' biology, ecology, life history, threats, and status from information contained in the petition, our files, a comprehensive literature search, and consultation with experts. We also considered information submitted by the public in response to our petition finding. In assessing the extinction risk of both species, we considered the demographic viability factors developed by McElhany et al. (2000). The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our status reviews, including for Pacific salmonids, Pacific hake, walleye pollock, Pacific cod, Puget Sound rockfishes, Pacific herring, scalloped, great, and smooth hammerhead sharks, and black abalone (see www.nmfs.noaa.gov/pr/species/ for links to these reviews). In this approach, the collective condition of individual populations is considered at the species level according to four viable population descriptors: abundance, growth rate/productivity, spatial structure/connectivity, and diversity. These viable population descriptors reflect concepts that are well-founded in conservation biology and that individually and collectively provide strong indicators of extinction risk (NMFS 2015).

    The draft status review report was subjected to independent peer review as required by the Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review (M-05-03; December 16, 2004). The draft status review report was peer reviewed by independent specialists selected from the academic and scientific community, with expertise in manta ray biology, conservation, and management. The peer reviewers were asked to evaluate the adequacy, appropriateness, and application of data used in the status review, including the extinction risk analysis. All peer reviewer comments were addressed prior to dissemination and finalization of the draft status review report and publication of this finding.

    We subsequently reviewed the status review report, its cited references, and peer review comments, and believe the status review report, upon which this 12-month finding and proposed rule is based, provides the best available scientific and commercial information on the two manta ray species. Much of the information discussed below on manta ray biology, distribution, abundance, threats, and extinction risk is attributable to the status review report. However, in making the 12-month finding determination and proposed rule, we have independently applied the statutory provisions of the ESA, including evaluation of the factors set forth in section 4(a)(1)(A)-(E) and our regulations regarding listing determinations. The status review report is available on our Web site (see ADDRESSES section) and the peer review report is available at http://www.cio.noaa.gov/services_programs/prplans/PRsummaries.html. Below is a summary of the information from the status review report and our analysis of the status of the giant manta ray and reef manta ray. Further details can be found in Miller and Klimovich (2016).

    Description, Life History, and Ecology of the Petitioned Species Species Description

    Manta rays are large bodied, planktivorous rays, considered part of the Mobulidae subfamily that appears to have diverged from Rhinoptera around 30 million years ago (Poortvliet et al. 2015). Manta species are distinguished from other Mobula rays in that they tend to be larger, with a terminal mouth, and have long cephalic fins (Evgeny 2010). The genus Manta has a long and convoluted taxonomic history due partially to the difficulty of preserving such large specimens and conflicting historical reports of taxonomic characteristics (Couturier et al. 2012; Kitchen-Wheeler 2013). All manta rays were historically categorized as Manta birostris, but Marshall et al. (2009) presented new data that supported the splitting of the monospecific Manta genus into two species: M. birostris and M. alfredi.

    Both Manta species have diamond-shaped bodies with wing-like pectoral fins; the distance over this wingspan is termed disc width (DW). There are two distinct color types in both species: chevron and black (melanistic). Most of the chevron variants have a black dorsal surface and a white ventral surface with distinct patterns on the underside that can be used to identify individuals (Marshall et al. 2008; Kitchen-Wheeler 2010; Deakos et al. 2011). While these markings are assumed to be permanent, there is some evidence that the pigmentation pattern of M. birostris may actually change over the course of development (based on observation of two individuals in captivity), and thus caution may be warranted when using color markings for identification purposes in the wild (Ari 2015). The black color variants of both species are entirely black on the dorsal side and almost completely black on the ventral side, except for areas between the gill-slits and the abdominal area below the gill-slits (Kitchen-Wheeler 2013).

    Range, Distribution and Habitat Use

    Manta rays are circumglobal in range, but within this broad distribution, individual populations are scattered and highly fragmented (CITES 2013). The ranges of the two manta species sometimes overlap; however, at a finer spatial scale, the two species generally appear to be allopatric within those habitat areas (Kashiwagi et al. 2011) and exhibit different habitat use and movement patterns (inshore versus offshore reef habitat use) (Marshall and Bennett 2010b; Kashiwagi et al. 2011). Clark (2010) suggests that the larger M. birostris may forage in less productive pelagic waters and conduct seasonal migrations following prey abundance, whereas M. alfredi is more of a resident species in areas with regular coastal productivity and predictable prey abundance. Kashiwagi et al. (2010) observed that even in areas where both species are found in large numbers at the same feeding and cleaning sites, the two species do not interact with each other (e.g., they are not part of the same feeding group, and males of one species do not attempt to mate with females of the other species). Additional studies on habitat use for both species are needed, particularly investigating how these individuals influence their environment as studies have shown that the removal of large plankton feeders, like manta rays, from the ecosystem can cause significant changes in species composition (Springer et al. 2003).

    The giant manta ray can be found in all ocean basins. In terms of range, within the Northern Hemisphere, the species has been documented as far north as southern California and New Jersey on the United States west and east coasts, respectively, and Mutsu Bay, Aomori, Japan, the Sinai Peninsula and Arabian Sea, Egypt, and the Azores Islands (Gudger 1922; Kashiwagi et al. 2010; Moore 2012; CITES 2013). In the Southern Hemisphere, the species occurs as far south as Peru, Uruguay, South Africa, New Zealand and French Polynesia (Mourier 2012; CITES 2013). Despite this large range, sightings are often sporadic. The timing of these sightings also varies by region (for example, the majority of sightings in Brazil occur during June and September, while in New Zealand sightings mostly occur between January and March) and seems to correspond with the movement of zooplankton, current circulation and tidal patterns, seawater temperature, and possibly mating behavior (Couturier et al. 2012; De Boer et al. 2015; Armstrong et al. 2016).

    Within its range, M. birostris inhabits tropical, subtropical, and temperate bodies of water and is commonly found offshore, in oceanic waters, and near productive coastlines (Marshall et al. 2009; Kashiwagi et al. 2011). As such, giant manta rays can be found in cooler water, as low as 19 °C, although temperature preference appears to vary by region (Duffy and Abbott 2003; Marshall et al. 2009; Freedman and Roy 2012; Graham et al. 2012). Additionally, giant manta rays exhibit a high degree of plasticity in terms of their use of depths within their habitat, with tagging studies that show the species conducting night descents of 200-450 m depths (Rubin et al. 2008; Stewart et al. 2016b) and capable of diving to depths exceeding 1,000 m (A. Marshall et al. unpubl. data 2011 cited in Marshall et al. (2011a)).

    The giant manta ray is considered to be a migratory species, with satellite tracking studies using pop-up satellite archival tags registering movements of the giant manta ray from Mozambique to South Africa (a distance of 1,100 km), from Ecuador to Peru (190 km), and from the Yucatan, Mexico, into the Gulf of Mexico (448 km) (Marshall et al. 2011a). In a tracking study of six M. birostris individuals from off Mexico's Yucatan peninsula, Graham et al. (2012) calculated a maximum distance travelled of 1,151 km (based on cumulative straight line distance between locations; tag period ranged from 2 to 64 days). Similarly, Hearn et al. (2014) report on a tagged M. birostris that was tracked from Isla de la Plata (Ecuador) to west of Darwin Island (tag was released after 104 days), a straight-line distance of 1,500 km, further confirming that the species is capable of fairly long distance migrations but also demonstrating connectivity between mainland and offshore islands. However, a recent study by Stewart et al. (2016a) suggests that the species may not be as highly migratory as previously thought. Using pop-up satellite archival tags in combination with analyses of stable isotope and genetic data, the authors found evidence that M. birostris may actually exist as well-structured subpopulations off Mexico's coast that exhibit a high degree of residency (Stewart et al. 2016a). Additional research is required to better understand the distribution and movement of the species throughout its range.

    In terms of range of the reef manta ray, M. alfredi, the species is currently only observed in the Indian Ocean and the western and south Pacific. The northern range limit for the species in the western Pacific is presently known to be off Kochi, Japan (32°48′ N., 132°58′ E.), and its eastern limit in the Pacific is known to be Fatu Hiva in French Polynesia (10°29′ S.; 138°37′ W.) (Kashiwagi et al. 2010; Mourier 2012). However, it is difficult to estimate the historical range of M. alfredi due to confusion until recently about its identification (Marshall et al. 2009). For example, prior to the splitting of the genus, it was assumed that all manta rays found in the Philippines were M. birostris; however, based on recent survey efforts, it has been confirmed that both M. birostris and M. alfredi occur in these waters (Verdote and Ponzo 2014; Aquino et al. 2015; Rambahiniarison et al. 2016). This may be the case elsewhere through its range and underscores the need for concentrated survey effort in order to better understand the distribution of these two manta ray species.

    Manta alfredi is commonly seen inshore near coral and rocky reefs and appears to avoid colder waters (<21 °C) (Rohner et al. 2013; Braun et al. 2014). Reef manta rays prefer habitats along productive nearshore environments (such as island groups or near upwelling events), and while recent tracking studies indicate that M. alfredi is capable of traveling long distances, similar to M. birostris (Yano et al. 1999; Germanov and Marshall 2014), reef manta rays are considered a more resident species than giant manta rays (Homma et al. 1999; Dewar et al. 2008; Clark 2010; Kitchen-Wheeler 2010; Anderson et al. 2011a; Deakos et al. 2011; Marshall et al. 2011b; McCauley et al. 2014), with residencies estimated at up to 1.5 years (Clark 2010). For example, along the east coast of Australia, mark-recapture methods and photographic identification of reef manta rays from 1982 to 2012 revealed a re-sighting rate of more than 60 percent (with females more likely to be re-sighted than males), suggesting high site fidelity to aggregation sites, including several locations within a range of up to 650 km (Couturier et al. 2014). In Hawaii, 76 percent of 105 M. alfredi individuals observed over 15 years of surveys were re-sighted along the Kona coast, also confirming the high site fidelity behavior of the species (Clark 2010). Additionally, predictable seasonal aggregations of M. alfredi, largely thought to be feeding-related and influenced by the seasonal distribution of prey (Anderson et al. 2011a), have been documented off the Maldives (Anderson et al. 2011a), Maui, Hawaii (Deakos et al. 2011), Lady Elliott Island, Australia (Couturier et al. 2014), Ningaloo Reef, Western Australia (McGregor et al. 2008), and southern Mozambique (Marshall et al. 2011c; Rohner et al. 2013).

    Diet and Feeding

    As previously mentioned, manta feeding habits appear to be influenced by the movement and accumulation of zooplankton (Armstrong et al. 2016). Both manta species primarily feed on planktonic organisms such as euphausiids, copepods, mysids, decapod larvae and shrimp, but some studies have noted their consumption of small and moderate sized fishes as well (Bertolini 1933; Bigelow and Schroeder 1953; Carpenter and Niem 2001; The Hawaii Association for Marine Education and Research Inc. 2005). Mantas appear to be primarily nocturnal feeders, consistent with the upward migration of zooplankton at night, increasing their accessibility (Cushing 1951; Forward 1988). Known manta feeding areas that have been reported in the literature are summarized in Table 1 of Miller and Klimovich (2016); however, it is likely that additional feeding areas exist throughout both species' respective ranges.

    Growth and Reproduction

    Manta rays are viviparous (i.e., give birth to live young), with a gestation period of around one year (Matsumoto and Uchida 2008; Uchida et al. 2008), and a reproductive periodicity of anywhere from 1 to 5 years (see Table 3 in Miller and Klimovich (2016)). Generally, not much is known about manta ray growth and development. Free swimming wild mantas have been observed as small as 1.02 m DW and 1.22 m DW (Kitchen-Wheeler 2013), with size at birth estimates ranging from 0.9 m DW to 1.92 m DW (see Tables 2 and 3 in Miller and Klimovich (2016)); however, the lack of observations of small manta rays throughout the species' respective ranges may indicate that manta rays segregate by size, with different habitats potentially used by neonates and juveniles (Deakos 2010b). While these habitats have yet to be identified, Erdmann (2014) presents a hypothesis, based on tagging data of a juvenile M. alfredi (~1.5m DW), that mantas likely give birth in protected areas, such as lagoons, that provide protection from larger predators.

    In M. alfredi, Deakos (2012) observed that sexual maturity was delayed until growth had reached 90 percent of maximum size, pointing to large body size providing a reproductive advantage. Deakos (2010) concluded that the minimum size at sexual maturity was 3.37 DW for female M. alfredi and 2.80 m DW for males in Maui. There is no evidence that male size affects mating success of M. alfredi in any way, but larger females were observed to have higher rates of pregnancy than smaller females (Deakos 2012). Homma et al. (1999) hypothesized that age at sexual maturity was 8-13 years in mantas and the data of Uchida et al. (2008), Marshall et al. (2011a) and Marshall and Bennett (2010b) confirmed this estimate. However, a population of female M. alfredi in the Maldives displayed late maturity (15 years or more) and lower reproductive rates than previously reported (one pup every five years, instead of biennially) (G. Stevens in prep. as cited in CITES (2013)). In contrast, Clark (2010) described a rapid transition to maturity for M. alfredi in Kona, Hawaii, with estimates of males reaching sexual maturity as early as 3-4 years.

    In terms of mating behavior, during courting, manta rays are commonly observed engaging in “mating chains,” where multiple males will pursue a single female. The mating displays can last hours or days, with the female swimming rapidly ahead of the males and occasionally somersaulting or turning abruptly (Deakos et al. 2011). Sexual dimorphism is present in manta rays, with female M. alfredi as much as 18 percent larger than males, so it is unlikely that a male could force a female to mate against her will (Deakos 2010; Marshall and Bennett 2010b). Additionally, males have never been observed to compete with each other directly for the attention of the female, so these mating chains may function as a kind of endurance rivalry (Andersson 1994; Deakos 2012). No copulations have been observed in the wild, so it is difficult to determine which males have a mating advantage, but this kind of endurance trial usually selects for the success of larger males (Andersson and Iwasa 1996; Deakos 2012).

    Although mantas have been reported to live to at least 40 years old (Marshall and Bennett 2010b; Marshall et al. 2011b; Kitchen-Wheeler 2013) with low rates of natural mortality (Couturier et al. 2012), the time needed to grow to maturity and the low reproductive rates mean that a female will be able to produce only 5-15 pups in her lifetime (CITES 2013). Generation time for both species (based on M. alfredi life history parameters) is estimated to be 25 years (Marshall et al. 2011a; Marshall et al. 2011b). Known life history characteristics of M. birostris and M. alfredi are summarized in Tables 2 and 3 in Miller and Klimovich (2016).

    Population Structure

    Since the splitting of the Manta genus, most of the recent research has examined the genetic discreteness, phylogeny, and the evolutionary speciation in manta rays (Cerutti-Pereyra et al. 2012; Kashiwagi et al. 2012; Poortvliet et al. 2015). Very few studies have focused on the population structure within each species. However, based on genetic sampling, photo-identification, and tracking studies, preliminary results tend to indicate that reef manta rays exist in isolated and potentially genetically divergent populations. For example, using genetic sequencing of mitochondrial DNA (which is maternally-inherited) Cerutti-Pereyra et al. (2012) found low genetic divergence (<1 percent) but “phylogeographic disjunction” between the M. alfredi samples from Australia (n = 2; Ningaloo Reef) and Indonesia (n = 2), suggesting biogeographic factors may be responsible for population differentiation within the species. Although based on very few samples (4 total), these findings are consistent with photo-identification and tracking studies, which suggest high site-fidelity and residency for M. alfredi in many portions of its range, including Indonesia, Ningaloo Reef, Hawaii, Fiji, New Caledonia, and eastern Australia (Dewar et al. 2008; Clark 2010; Couturier et al. 2011; Deakos et al. 2011; Cerutti-Pereyra et al. 2012; Couturier et al. 2014).

    The population structure for the wider-ranging M. birostris is less clear. While Clark (2010), using photo-identification survey data collected between 1992 and 2007 along the Kona, Hawaii, coast, found low site-fidelity for M. birostris and high rate of immigration, indicative of a population that is pelagic rather than coastal or island-associated, Stewart et al. (2016a) provided recent evidence to show that the giant manta rays off Pacific Mexico may exist as isolated subpopulations, with distinct home ranges. Additionally, researchers are presently investigating whether there is a potential third manta ray species resident to the Yucatán coastal waters of the Gulf of Mexico (previously identified as M. birostris) (Hinojosa-Alvarez et al. 2016). Using the mitochondrial ND5 region (maternally-inherited DNA), Hinojosa-Alvarez et al. (2016) found shared haplotypes between Yucatán manta ray samples and known M. birostris samples from Mozambique, Indonesia, Japan, and Mexico, but discovered four new manta ray haplotypes, exclusive to the Yucatán samples. While analysis using the nuclear RAG1 gene (bi-parentally-inherited DNA) showed the Yucatán samples to be consistent with identified M. birostris samples, the authors suggest that the ND5 genetic evidence indicates the potential for a third, distinctive manta genetic group or possibly M. birostris subspecies. At this time, additional studies, including in-depth taxonomic studies and additional genetic sampling, are needed to better understand the population structure of both species throughout their respective ranges.

    Population Demographics

    Given their large sizes, manta rays are assumed to have fairly high survival rates after maturity (e.g., low natural predation rates). Using estimates of known life history parameters for both giant and reef manta rays, and plausible range estimates for the unknown life history parameters, Dulvy et al. (2014) calculated a maximum population growth rate of Manta spp. and found it to be one of the lowest values when compared to 106 other shark and ray species. After taking into consideration different model assumptions, and the criteria for assessing productivity in Musick (1999), Dulvy et al. (2014) estimated realized productivity (r) for manta rays to be 0.029 (Dulvy et al. 2014). This value is similar to the productivity estimate from Kashiwagi (2014) who empirically determined an r value of 0.023 using capture-mark-recapture analyses. Ward-Paige et al. (2013) calculated slightly higher estimates for the intrinsic rate of population increase, with r = 0.05 for M. alfredi and r = 0.042 for M. birostris; however, these estimates still place both manta ray species into or at the very edge of the “very low” productivity category (r <0.05), based on the productivity parameters and criteria in Musick (1999).

    In order to determine how changes in survival may affect populations, Smallegange et al. (2016) modeled the demographics of reef manta rays. Results showed that increases in yearling or adult annual survival rates resulted in much greater responses in population growth rates, mean lifetime reproductive success, and cohort generation time compared to similar increases in juvenile annual survival rates (Smallegange et al. 2016). Based on the elasticity analysis, population growth rate was most sensitive to changes in the survival rate of adults (Smallegange et al. 2016). In other words, in order to prevent populations from declining further, Smallegange et al. (2016) found that adult survival rates should be increased, such as through protection of adult aggregation sites or a reduction in fishing of adult manta rays (Smallegange et al. 2016). For those populations that are currently stable, like the Yaeyama Islands (Japan) population (where adult annual survival rate is estimated at 0.95; noted above), Smallegange et al. (2016) note that any changes in adult survival may significantly affect the population.

    Overall, given their life history traits and productivity estimates, particularly their low reproductive output and sensitivity to changes in adult survival rates, giant and reef manta ray populations are inherently vulnerable to depletions, with low likelihood of recovery.

    Historical and Current Distribution and Population Abundance

    There are no current or historical estimates of the global abundance of M. birostris. Despite their larger range, they are encountered with less frequency than M. alfredi. Most estimates of subpopulations are based on anecdotal diver or fisherman observations, which are subject to bias. These populations seem to potentially range from around 100 to1,500 individuals (see Table 4 in Miller and Klimovich (2016)). In the proposal to include manta rays on the appendices of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), it states that because 10 populations of M. birostris have been actively studied, 25 other aggregations have been anecdotally identified, and all other sightings are rare, the total global population may be small (CITES 2013). The greatest number of M. birostris identified in the four largest known aggregation sites ranges from 180 to 1,500. Ecuador is thought to be home to the largest identified population of M. birostris in the world, with large aggregation sites within the waters of the Machalilla National Park and the Galapagos Marine Reserve (Hearn et al. 2014). Within the Indian Ocean, numbers of giant manta rays identified through citizen science in Thailand's waters (primarily on the west coast, off Khao Lak and Koh Lanta) have been increasing over the past few years, from 108 in 2015 to 288 in 2016. These numbers reportedly surpass the estimate of identified giant mantas in Mozambique (n = 254), possibly indicating that Thailand may be home to the largest aggregation of giant manta rays within the Indian Ocean (MantaMatcher 2016). In the Atlantic, very little information on M. birostris populations is available, but there is a known, protected population within the Flower Garden Banks National Marine Sanctuary in the Gulf of Mexico. However, researchers are still trying to determine whether the manta rays in this area are only M. birostris individuals or potentially also comprise individuals of a new, undescribed species (Marshall et al. 2009; Hinojosa-Alvarez et al. 2016).

    In areas where the species is not subject to fishing, populations may be stable. For example, Rohner et al. (2013) report that giant manta ray sightings remained constant off the coast of Mozambique over a period of 8 years. However, in regions where giant manta rays are (or were) actively targeted or caught as bycatch, such as the Philippines, Mexico, Sri Lanka, and Indonesia, populations appear to be decreasing (see Table 5 in Miller and Klimovich (2016)). In Indonesia, declines in manta ray landings are estimated to be on the order of 71 to 95 percent, with potential extirpations noted in certain areas (Lewis et al. 2015). Given the migratory nature of the species, population declines in waters where mantas are protected have also been observed but attributed to overfishing of the species in adjacent areas within its large home range. For example, White et al. (2015) provide evidence of a substantial decline in the M. birostris population in Cocos Island National Park, Costa Rica, where protections for the species have existed for over 20 years. Using a standardized time series of observations collected by dive masters on 27,527 dives conducted from 1993 to 2013, giant manta ray relative abundance declined by approximately 89 percent. Based on the frequency of the species' presence on dives (4 percent), with a maximum of 15 individuals observed on a single dive, the authors suggest that Cocos Island may not be a large aggregating spot for the species, and suggest that the decline observed in the population is likely due to overfishing of the species outside of the National Park (White et al. 2015).

    Given that all manta rays were identified as M. birostris prior to 2009, information on the historical abundance and distribution of M. alfredi is scarce. In the proposal to include the reef manta ray on the appendices of the Convention on the Conservation of Migratory Species of Wild Animals (CMS), it states that current global population numbers are unknown and no historical baseline data exist (CMS 2014). Local populations of M. alfredi have not been well assessed either, but appear generally to be small, sparsely distributed, and isolated. Photo-identification studies in Hawaii, Yap, Japan, Indonesia, and the eastern coast of Australia suggest these subpopulations range from 100 to 350 individuals (see Table 6 in Miller and Klimovich (2016)), despite observational periods that span multiple decades. However, in the Maldives, population estimates range from 3,300 to 9,677 individuals throughout the 26 atolls in the archipelago (Kitchen-Wheeler et al. 2012; CITES 2013; CMS 2014), making it the largest identified population of M. alfredi in the world. Other larger populations may exist off southern Mozambique (superpopulation estimate of 802-890 individuals; Rohner et al. (2013); CITES (2013)) and Western Australia (metapopulation estimate = 1,200-1,500; McGregor (2009) cited in CITES (2013)).

    In terms of trends, studies report that the rate of population reduction appears to be high in local areas, from 50-88 percent, with areas of potential local extirpations of M. alfredi populations (Homma et al. 1999; Rohner et al. 2013; Lewis et al. 2015). In the portions of range where reef manta rays are experiencing anthropogenic pressures, including Indonesia and Mozambique, encounter rates have dropped significantly over the last 5 to 10 years (CMS 2014). However, where M. alfredi receives some kind of protection, such as in Australia, Hawaii, Guam, Japan, the Maldives, Palau, and Yap, CITES (2013) reports that subpopulations are likely to be stable. For example, in Hawaii, based on photo-identification survey data collected between 1992 and 2007 along the Kona Coast, Clark (2010) used a discovery curve to estimate that an average of 4.27 new pups were entering the population per year. Off the Yaeyama Islands, Japan, Kashiwagi (2014) conducted quantitative analyses using encounter records, biological observations, and photo-ID of manta rays over the period of 1987 to 2009 and found that the apparent population size increased steadily but slowly over the 23-year period, with a population growth rate estimate of 1.02-1.03. Based on aerial surveys of Guam conducted from 1963 to 2012, manta ray observations were infrequent but showed an increase over the study period (Martin et al. 2015). Off Lady Elliott Island, Australia, Couturier et al. (2014) modeled annual population sizes of M. alfredi from 2009 to 2012 and found an annual increase in abundance for both sexes, but cautioned that the modeled increase could be an artifact of improvements in photo-identification by observers over the study period. Within Ningaloo Marine Park, the status of reef manta rays was assessed as “Good” in 2013, but with low confidence in the ratings (Marine Parks & Reserves Authority 2013). Overall, however, the reef manta ray population of Australia is deemed to be one of the world's healthiest (Australian Government 2012).

    Species Finding

    Based on the best available scientific and commercial information described above, we find that M. birostris and M. alfredi are currently considered taxonomically-distinct species and, therefore, meet the definition of “species” pursuant to section 3 of the ESA. Below, we evaluate whether these species warrant listing as endangered or threatened under the ESA throughout all or a significant portion of their respective range.

    Summary of Factors Affecting Giant and Reef Manta Rays

    As described above, section 4(a)(1) of the ESA and NMFS' implementing regulations (50 CFR 424.11(c)) state that we must determine whether a species is endangered or threatened because of any one or a combination of the following factors: The present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; inadequacy of existing regulatory mechanisms; or other natural or man-made factors affecting its continued existence. We evaluated whether and the extent to which each of the foregoing factors contribute to the overall extinction risk of both manta ray species, with a “significant” contribution defined, for purposes of this evaluation, as increasing the risk to such a degree that the factor affects the species' demographics (i.e., abundance, productivity, spatial structure, diversity) either to the point where the species is strongly influenced by stochastic or depensatory processes or is on a trajectory toward this point. This section briefly summarizes our findings and conclusions regarding threats to the giant and reef manta rays and their impact on the overall extinction risk of the species. More details can be found in the status review report (Miller and Klimovich 2016).

    The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    Due to their association with nearshore habitats, manta rays are at elevated risk for exposure to a variety of contaminants and pollutants, including brevotoxins, heavy metals, polychlorinated biphenyls, and plastics. Many pollutants in the environment have the ability to bioaccumulate in fish species; however, only a few studies have specifically examined the accumulation of heavy metals in the tissues of manta rays (Essumang 2010; Ooi et al. 2015), with findings that discuss human health risks from the consumption of manta rays. For example, Essumang (2010) found platinum levels within M. birostris samples taken off the coast of Ghana that exceeded the United Kingdom (UK) dietary intake recommendation levels, and Ooi et al. (2015) reported concentrations of lead in M. alfredi tissues from Lady Elliot Island, Australia, that exceeded maximum allowable level recommendations for fish consumption per the European Commission and the Codex Alimentarius Commission (WHO/FAO). While consuming manta rays may potentially pose a health risk to humans, there is no information on the lethal concentration limits of these metals or other toxins in manta rays. Additionally, at this time, there is no evidence to suggest that current concentrations of these environmental pollutants are causing detrimental physiological effects to the point where either species may be at an increased risk of extinction.

    Plastics within the marine environment may also be a threat to the manta ray species, as the animals may ingest microplastics (through filter-feeding) or become entangled in plastic debris, potentially contributing to increased mortality rates. Jambeck et al. (2015) found that the Western and Indo-Pacific regions are responsible for the majority of plastic waste. These areas also happen to overlap with some of the largest known aggregations for manta rays. For example, in Thailand, where recent sightings data have identified over 288 giant manta rays (MantaMatcher 2016), mismanaged plastic waste is estimated to be on the order of 1.03 million tonnes annually, with up to 40 percent of this entering the marine environment (Jambeck et al. 2015). Approximately 1.6 million tonnes of mismanaged plastic waste is being disposed of in Sri Lanka, again with up to 40 percent entering the marine environment (Jambeck et al. 2015), potentially polluting the habitat used by the nearby Maldives aggregation of manta rays. While the ingestion of plastics is likely to negatively impact the health of the species, the levels of microplastics in manta ray feeding grounds and frequency of ingestion are presently being studied to evaluate the impact on these species (Germanov 2015b; Germanov 2015a).

    Because manta rays are migratory and considered ecologically flexible (e.g., low habitat specificity), they may be less vulnerable to the impacts of climate change compared to other sharks and rays (Chin et al. 2010). However, as manta rays frequently rely on coral reef habitat for important life history functions (e.g., feeding, cleaning) and depend on planktonic food resources for nourishment, both of which are highly sensitive to environmental changes (Brainard et al. 2011; Guinder and Molinero 2013), climate change is likely to have an impact on the distribution and behavior of both M. birostris and M. alfredi. Currently, coral reef degradation from anthropogenic causes, particularly climate change, is projected to increase through the future. Specifically, annual, globally averaged surface ocean temperatures are projected to increase by approximately 0.7 °C by 2030 and 1.4 °C by 2060 compared to the 1986-2005 average (IPCC 2013), with the latest climate models predicting annual coral bleaching for almost all reefs by 2050 (Heron et al. 2016). As declines in coral cover have been shown to result in changes in coral reef fish communities (Jones et al. 2004; Graham et al. 2008), the projected increase in coral habitat degradation may potentially lead to a decrease in the abundance of manta ray cleaning fish (e.g., Labroides spp., Thalassoma spp., and Chaetodon spp.) and an overall reduction in the number of cleaning stations available to manta rays within these habitats. This potential decreased access to cleaning stations may negatively impact the fitness of the mantas by hindering their ability to reduce parasitic loads and dead tissue, which could lead to increases in diseases and declines in reproductive fitness and survival rates. However, these scenarios are currently speculative, as there is insufficient information to indicate how and to what extent changes in reef community structure will affect the status of both manta ray species.

    Changes in climate and oceanographic conditions, such as acidification, are also known to affect zooplankton structure (size, composition, diversity), phenology, and distribution (Guinder and Molinero 2013). As such, the migration paths and locations of both resident and seasonal aggregations of manta rays, which depend on these animals for food, may similarly be altered (Australian Government 2012; Couturier et al. 2012). It is likely that those M. alfredi populations that exhibit site-fidelity behavior will be most affected by these changes. For example, resident manta ray populations may be forced to travel farther to find available food or randomly search for new productive areas (Australian Government 2012; Couturier et al. 2012). As research to understand the exact impacts of climate change on marine phytoplankton and zooplankton communities is still ongoing, the severity of this threat to both species of manta rays has yet to be fully determined.

    Overutilization for Commercial, Recreational, Scientific or Educational Purposes

    Manta rays are both targeted and caught as bycatch in fisheries worldwide. In fact, according to Lawson et al. (2016), manta ray catches have been recorded in at least 30 large and small-scale fisheries covering 25 countries. The majority of fisheries that target mobulids are artisanal (Croll et al. 2015) and target the rays for their meat; however, since the 1990s, a market for mobulid gill rakers has significantly expanded, increasing the demand for manta ray products, particularly in China. The gill rakers of mobulids are used in Asian medicine and are thought to have healing properties, such as curing diseases from chicken pox to cancer, boosting the immune system, purifing the body, enhancing blood circulation, remedying throat and skin ailments, curing male kidney issues, and helping with fertility problems (Heinrichs et al. 2011). The use of gill rakers as a remedy, which was widespread in Southern China many years ago, has recently gained renewed popularity over the past decade as traders have increased efforts to market its healing and immune boosting properties directly to consumers (Heinrichs et al. 2011). As a result, demand has significantly increased, incentivizing fishermen who once avoided capture of manta rays to directly target these species (Heinrichs et al. 2011; CITES 2013). According to Heinrichs et al. (2011), it is primarily the older population in Southern China as well as Macau, Singapore, and Hong Kong, that ascribes to the belief of the healing properties of the gill rakers; however, unlike products like shark fins, the gill rakers are not considered “traditional” or “prestigious” items and many consumers and sellers are not even aware that gill rakers come from manta or mobula rays. Meat, cartilage, and skin of manta rays are also utilized, but valued significantly less than the gill rakers, and usually enter local trade or are kept for domestic consumption (Heinrichs et al. 2011; CITES 2013). Indonesia, Sri Lanka, and India presently represent the largest manta ray exporting range state countries; however, Chinese gill plate vendors have also reported receiving mobulid gill plates from other countries and regions as well, including Malaysia, Vietnam, South Africa, South America, the Middle East, and the South China Sea (CMS 2014). To examine the impact of this growing demand for gill rakers on manta ray populations, information on landings and trends (identified by species where available) are evaluated for both fisheries that target mantas and those that catch mantas as bycatch.

    Targeted Fisheries

    Indonesia is reported to be one of the countries that catch the most mobulid rays (Heinrichs et al. 2011). Manta and mobula ray fisheries span the majority of the Indonesian archipelago, with most landing sites along the Indian Ocean coast of East and West Nusa Tenggara and Java (Lewis et al. 2015). Manta rays (presumably M. birostris, but identified prior to the split of the genus) have traditionally been harvested in Indonesia using harpoons and boats powered by paddles or sails, with manta fishing season lasting from May through October. Historically, the harvested manta rays would be utilized by the village, but the advent of the international gill raker market in the 1970s prompted the commercial trade of manta ray products, with gill plates generally sent to Bali, Surabaya (East Java), Ujung Pandant (Sulawasi), or Jakarta (West Java) for export to Hong Kong, Taiwan, Singapore and other places in Asia (Dewar 2002; White et al. 2006; Marshall and Conradie 2014). This economic incentive, coupled with emerging technological advances (e.g., motorized vessels) and an increase in the number of boats in the fishery, greatly increased fishing pressure and harvest of manta rays in the 1990s and 2000s (Dewar 2002). In Lamakera, Indonesia, one of the main landing sites for mobulids, and particularly manta rays, Dewar (2002) estimates that the total average harvest of “mantas” during the 2002 fishing season was 1,500 individuals (range 1,050-2,400), which is a significant increase from the estimated historical harvest levels of around 200-300 mantas per season. However, Lewis et al. (2015) note that this estimate likely represents all mobulid rays, not just manta rays.

    However, given these amounts, it is perhaps unsurprising that anecdotal reports from fishermen indicate possible local population declines, with fishermen noting that they have to travel farther to fishing grounds as manta rays are no longer present closer to the village (Dewar 2002; Lewis et al. 2015). In fact, using the records from Dewar (2002) and community (local) catch records, Lewis et al. (2015) show that there has been a steady decline in manta landings at Lamakera since 2002 (despite relatively unchanged fishing effort), with estimated landings in 2013-2014 comprising only 25 percent of the estimated numbers from 2002-2006. These declines in manta landings are not just limited to Lamakera, but also appear to be the trend throughout Indonesia at the common mobulid landing sites. For example, Lewis et al. (2015) reports a 95 percent decline in manta landings in Tanjung Luar (between 2001-2005 and 2013-2014), a decrease in the average size of mantas being caught, and a 71 percent decline in manta landings in the Cilacap gillnet fishery between 2001-2005 and 2014. Areas in Indonesia where manta rays have potentially been fished to extirpation, based on anecdotal reports (e.g., diver sightings data and fishermen interviews), include Lembeh Strait in northeast Sulawesi, Selayer Islands in South Sulawesi, and off the west coast of Alor Island (which may have been a local M. alfredi population) (Lewis et al. 2015).

    Although fishing for manta rays was banned within the Indonesian exclusive economic zone (EEZ) in February 2014 (see The Inadequacy of Existing Regulatory Mechanisms), in May 2014, manta rays were still being caught and processed at Lamakera, with M. birostris the most commonly targeted species (Marshall and Conradie 2014). Around 200 fishing vessels targeting mantas rays are in operation (Marshall and Conradie 2014). Most of the fishing occurs in the Solor Sea and occasionally in the Lamakera Strait, with landings generally comprising around one to two dozen manta rays per day. Taking into account the manta ray fishing season in Lamakera (June to October), Marshall and Conradie (2014) estimate that between 625 and 3,125 manta rays (likely majority M. birostris) may be landed each season. Lewis et al. (2015), however, report a much smaller number, with 149 estimated as landed in 2014.

    It is unlikely that fishing effort and associated utilization of the species will significantly decrease in the foreseeable future because interviews with fishermen indicate that many are excited for the new prohibition on manta rays in Indonesian waters, as it is expected to drive up the price of manta ray products and significantly increase the current income of resident fishermen (Marshall and Conradie 2014). Based on unpublished data, O'Malley et al. (2013) estimate that the total annual income from the manta ray fisheries in Indonesia is around $442,000 (with 94 percent attributed to the gill plate trade). Dharmadi et al. (2015) noted that there are still many fishermen, particularly in Raja Ampat, Bali, and Komodo, whose livelihoods depend on shark and ray fishing. Without an alternative for income, it is unlikely that these fishing villages will stop their traditional fishing practices. Additionally, enforcement of existing laws appears to be lacking in this region (Marshall and Conradie 2014). The high market prices for manta products, where a whole manta (~5 m DW) will sell for anywhere from $225-$450 (Lewis et al. 2015), drives the incentive to continue fishing the species, and evidence of continued targeted fishing despite prohibitions suggests that overutilization of the Indonesian manta ray populations (primarily M. birostris, based on the data) is likely to continue to occur into the foreseeable future.

    In the Philippines, fishing for manta rays mainly occurs in the Bohol Sea. According to Acebes and Tull (2016), the manta ray fishery can be divided into two distinct periods based on technology and fishing effort: (1) 1800s to 1960s, when mantas were mainly hunted in small, non-motorized boats using harpoons from March to May; and (2) 1970s to 2013 (present), when boats became bigger and motorized and the fishing technique switched to drift gillnets, with the manta hunting season extending from November to June. In the earlier period, the manta fishing grounds were fairly close to the shore (<5 km), noted along the coasts of southern Bohol, northwestern and southern coasts of Camiguin and eastern coasts of Limasawa. Boats would usually catch around one manta per day, with catches of 5-10 mantas for a fishing village considered a “good day” (Acebes and Tull 2016). As the fishery became more mechanized in the 1970s, transitioning to larger and motorized boats, and as the primary gear changed from harpoons to non-selective driftnets, fishermen were able to access previously unexplored offshore fishing grounds, stay out for longer periods of time, and catch more manta rays (Acebes and Tull 2016). Additionally, it was during this time that the international gill raker market opened up, increasing the value of gill rakers, particularly for manta species. By 1997, there were 22 active mobulid ray fishing sites in the Bohol Sea (Acebes and Tull 2016). In Pamilacan, 18 boats were fishing for mobulids in 1993, increasing to 40 by 1997, and in Jagna, at least 20 boats were engaged in mobulid hunting in the 1990s (Acebes and Tull 2016). Catches from this time period, based on the recollection of fishermen from Pamilacan and Baclayon, Bohol, were around 8 manta rays (for a single boat) in 1995 and 50 manta rays (single boat) in 1996 (Alava et al. 2002). However, it should be noted that the mobulid fishery ended in Lila and Limasawa Island in the late 1980s and in Sagay in 1997, around the time that the whale fishery closed and a local ban in manta ray fishing was imposed (Acebes and Tull 2016).

    Despite increases in fishing effort, catches of manta rays began to decline in Philippine waters, likely due to a decrease in the abundance of the population, prompting fishermen to shift their fishing grounds farther east and north. Although a ban on hunting and selling giant manta rays was implemented in the Philippines in 1998 (see The Inadequacy of Existing Regulatory Mechanisms), this has not seemed to impact the mobulid fishery in any way. In Pamilacan, there were 14 mobulid hunting boats reported to be in operation in 2011 (Acebes and Tull 2016). In the village of Bunga Mar, Bohol, there were 15 boats targeting mobulids in 2012, and out of 324 registered fishermen, over a third were actively engaged in ray fishing (Acebes and Tull 2016). Acebes and Tull (2016) monitored the numbers of manta rays landed at Bunga Mar over a period of 143 days from April 2010 to December 2011 (during which there were around 16-17 active fishing boats targeting mobulids), and in total, 40 M. birostris were caught. In 2013, records from a single village (location not identified) showed over 2,000 mobuilds landed from January to May, of which 2 percent (n = 51 individuals) were M. birostris (Verdote and Ponzo 2014). As there is little evidence of enforcement of current prohibitions on manta ray hunting, and no efforts to regulate the mobulid fisheries, with mobulid fishing providing the greatest profit to fishermen, it is unlikely that fishing for mantas, of which the majority appears to be M. birostris, will decrease in the future.

    Manta rays are also reportedly targeted in fisheries in India, Ghana, Peru, Thailand, Mozambique, Tonga, Micronesia, possibly the Republic of Maldives, and previously in Mexico. In India, Ghana, Peru, and Thailand, little information is available on the actual level of take of manta rays. In India, manta rays are mainly landed as bycatch in tuna gillnetting and trawl fisheries; however, a harpoon fishery at Kalpeni, off Lakshadweep Islands, is noted for “abundantly” landing mantas (likely M. alfredi; A.M. Kitchen-Wheeler pers. comm. 2016) during peak season (from June-August) (Raje et al. 2007). In Ghana, there is no available data on the amount of manta rays landed in Ghanaian fisheries; however, Debrah et al. (2010) observed that giant manta rays were targeted using wide-mesh drift gillnets in artisanal fisheries between 1995 and 2010, and D. Berces (pers. comm. 2016) confirmed that manta rays are taken during artisanal fishing for pelagic sharks, and not “infrequently,” with manta rays consumed locally. In Peru, Heinrichs et al. (2011), citing to a rapid assessment of the mobulid fisheries in the Tumbes and Piura regions, reported estimated annual landings of M. birostris on the order of 100-220 manta rays for one family of fishermen. As such, total landings for Peru are likely to be much larger. According to Heinrichs et al. (2011), dive operators in the Similan Islands, Thailand, have also observed an increase in fishing for manta rays, including in protected Thai national marine parks, and while information on catches is unavailable, sightings of Manta spp. (likely M. birostris) decreased by 76 percent between 2006 and 2012 (CITES 2013b).

    In southern Mozambique, reef manta rays are targeted by fishermen, with estimates of around 20-50 individuals taken annually from only a 50 km section of studied coastline (Rohner et al. 2013). As annual estimates of this M. alfredi population range only from 149 to 454 individuals (between 2003 and 2007), this take is equivalent to removing anywhere from 4 percent to 34 percent of the population per year. This removal rate is potentially unsustainable for a species with such a low productivity, and has likely contributed to the estimated 88 percent decline that has already been observed in the local reef manta ray population (Rohner et al. 2013). Manta birostris, on the other hand, has not exhibited a decline off Mozambique, represents only 21 percent of the identified manta rays in this area, and is rarely observed in the local fishery (one observed caught over an 8-year period), indicating that fishing pressure is likely low for this species (Rohner et al. 2013; Marine Megafauna Foundation 2016).

    Opportunistic hunting of manta rays (likely M. alfredi) has been reported in Tonga and Micronesia (B. Newton and J. Hartup pers. comms. cited in CMS 2014), and in the Maldives, Anderson and Hafiz (2002) note that very small catches of manta rays occur in the traditional fisheries, with meat used for bait for shark fishing and skin used for musical drums. Given the available information, it is unlikely that fishing pressure on either manta ray species is significant in these areas.

    In Mexico, giant manta rays and mobula rays were historically targeted for their meat in the Gulf of California. In 1981, Notarbartolo di Sciara (1988) observed a seasonally-active mobulid fishery located near La Paz, Baja California Sur. Mobulids were fished in the Gulf of California using both gillnets and harpoons, with their meat either fileted for human consumption or used as shark bait. The giant manta ray was characterized as “occasionally captured” by the fishery, and while it is unclear how abundant M. birostris was in this area, by the early 1990s, Homma et al. (1999) reported that the entire mobulid fishery had collapsed.

    Bycatch

    Given the global distribution of manta rays, they are frequently caught as bycatch in a number of commercial and artisanal fisheries worldwide. In a study of elasmobranch bycatch patterns in commercial longline, trawl, purse seine and gillnet fisheries, Oliver et al. (2015) presented information on species-specific composition of ray bycatch in 55 fisheries worldwide. Based on the available data, Oliver et al. (2015) found that manta rays comprised the greatest proportion of ray bycatch in the purse seine fisheries operating in the Indian Ocean (specifically M. birostris; ~40 percent) and especially the Eastern Pacific Ocean (identified as Manta spp.; ~100 percent, but would be M. birostris as well), but were not large components of the ray bycatch in the longline, trawl, or gillnet fisheries in any of the ocean basins.

    In the Atlantic Ocean, bycatch of giant manta rays has been observed in purse seine, trawl, and longline fisheries; however, M. birostris does not appear to be a significant component of the bycatch. For example, in the European purse seine fishery, which primarily operates in the Eastern Atlantic off western Africa, observer data collected over the period of 2003-2007 (27 trips, 598 sets; observer coverage averaged 2.93 percent) showed only 11 M. birostris caught, with an equivalent weight of 2.2 mt (Amandè et al. 2010). In the U.S. bottom longline and gillnet fisheries operating in the western Atlantic, M. birostris is also a very rare occurrence in the elasmobranch catch, with the vast majority that are caught released alive (see NMFS Reports available at http://www.sefsc.noaa.gov/labs/panama/ob/bottomlineobserver.htm and http://www.sefsc.noaa.gov/labs/panama/ob/gillnet.htm). Overall, given the present low fishing pressure on giant manta rays, and evidence of minimal bycatch of the species (see Miller and Klimovich (2016) for additional discussion), it is unlikely that overutilization as a result of bycatch mortality is a significant threat to M. birostris in the Atlantic Ocean. However, information is severely lacking on both population sizes and distribution of the giant manta ray as well as current catch and fishing effort on the species throughout this portion of its range.

    In the Indian Ocean, manta rays (primarily M. birostris) are mainly caught as bycatch in purse seine and gillnet fisheries. In the western Indian Ocean, data from the pelagic tuna purse seine fishery suggests that manta and mobula rays, together, are an insignificant portion of the bycatch, comprising less than one percent of the total non-tuna bycatch per year (Romanov 2002; Amandè et al. 2008). However, in the eastern Indian Ocean, manta rays appear at higher risk of capture from the fisheries operating throughout this area, with two of the top three largest Manta spp. fishing and exporting range states (Sri Lanka and India) located in this region (Heinrichs et al. 2011). In Sri Lanka, manta rays are primarily caught as bycatch in the artisanal gillnet fisheries. While fishermen note that they generally tend to avoid deploying nets near large aggregations of manta rays or regularly release them when caught, as recently as 2011, giant manta rays were observed being sold at Sri Lanka fish markets (Fernando and Stevens 2011). Additionally, although Sri Lankan fishermen state that they try to release pregnant and young manta rays alive, based on 40 observed M. birostris being sold at markets (from May through August 2011), 95 percent were juveniles or immature adults (Fernando and Stevens 2011). Extrapolating the observed market numbers to a yearly value, Fernando and Stevens (2011) estimated total annual landings for M. birostris in Sri Lanka to be around 1,055 individuals, which they concluded would likely result in a population crash (Fernando and Stevens 2011). Additionally, more recent data from the Indian Ocean Tuna Commission (IOTC) database (http://www.iotc.org/iotc-online-data-querying-service) covering the time period of 2012-2014 indicate that over 2,400 mt of M. birostris were recorded caught by the Sri Lankan gillnet and longline fleets primarily engaged in artisanal fishing. This amount is almost double the 1,413 mt total catch that was reported in Clarke and IOTC Secretariat (2014) by both Sri Lanka and Sudan fleets from a time period that was more than twice as long (2008-2013). Using the maximum observed weight of M. birostris in the Indian Ocean (2,000 kg; which was described as “unusually large” (Kunjipalu and Boopendranath 1982)), this translates to a minimum of around 400 giant manta rays caught annually in recent years by Sri Lankan fishing fleets. Given that fishermen have already noted a decrease in catches of manta rays over the past 5 years, it is likely that the continued and heavy fishing pressure on M. birostris, and associated bycatch mortality, is significantly contributing to the overutilization of the species in this portion of its range.

    Manta ray landings have also become a more common occurrence in the bycatch of fishermen operating off India. Here, mobulids, including mantas, are landed as bycatch during tuna gillnetting and trawling operations and are auctioned off for their gill plates, while the meat enters the local markets. Historical reports (from 1961-1995) indicate that manta rays were only sporadically caught by fishermen along the east and west coasts of India, likely due to the fact that the species was rarely found near the shore (Pillai 1998). However, based on available information, it appears that landings have increased in recent years, particularly on the southwest coast. For the years 2003 and 2004, Raje et al. (2007) reported 647 mt of M. birostris from the southwest coast of India by the trawl fisheries. In a snapshot of the Indian tuna gillnet fishery, Nair et al. (2013) documented 5 individuals of M. birostris that were landed by fishermen off the coast of Vizhinjam, Kovalam and Colachel over the course of only 7 days. On the east coast of India, Raje et al. (2007) documented 43 mt of M. birostris landed in 2003 and 2004 at the Chennai fishing harbor. The apparent increase in landings since the sporadic reports of the species in the mid-1990s is likely due to the demand for the species' gill rakers, with M. birostris gill plates characterized as “First Grade” and fetching the highest price at auction at the major fishing port of Cochin Fisheries Harbour (Nair et al. 2013).

    While Manta spp. are rarely reported in the catch from the western Pacific, with Hall and Roman (2013) noting that M. japonica represents the most abundant mobulid in the fisheries data, the available information still suggests the potential for bycatch mortality and indicates declining trends within this region. For example, based on observer data from the Western and Central Pacific Fisheries Commission (WCPFC) fisheries, M. birostris is observed at a rate of 0.0017 individuals per associated set and 0.0076 individuals per unassociated set in the purse seine fisheries, and at a rate of 0.001-0.003 individuals per 1,000 hooks in the longline fisheries (Tremblay-Boyer and Brouwer 2016). The longline standardized catch-per-unit-effort data, while covering observations from only the past decade, indicates that M. birostris is observed less frequently in recent years compared to 2000-2005 (Tremblay-Boyer and Brouwer 2016). Additionally, a sharp decline in the catches of manta rays off Papua New Guinea, where WCPFC fishing effort is high, was observed in Papua New Guinea purse seiner bycatch in 2005-2006, after a previously steady rise in manta ray catches from 1994-2005 (C. Rose pers. comm. cited in Marshall et al. 2011b).

    In the eastern Pacific, giant manta rays are frequently reported as bycatch in the purse seine fisheries; however, identification to species level is difficult, and, as such, most manta and mobula ray captures are pooled together (Hall and Roman 2013). Based on reported M. birostris catch to the Inter-American Tropical Tuna Commission (IATTC), including available national observer program data, an average of 135 giant manta rays were estimated caught per year from 1993-2015 in the eastern Pacific purse seine fishery by IATTC vessels (Hall unpublished data). While the impact of these bycatch levels on giant manta ray populations is uncertain, effort in the fishery appears to coincide with high productivity areas, such as the Costa Rica Thermal Dome, west of the Galapagos, off the Guayas River estuary (Ecuador), and off central and northern Peru, where giant mantas are likely to aggregate and have been observed caught in sets (Hall and Roman 2013). If effort is concentrated in manta ray aggregation areas, this could lead to substantial declines and potential local extirpations of giant manta ray populations. Already, evidence of declines in this portion of the giant manta ray's range is apparent, with White et al. (2015) estimating an 89 percent decline in the relative abundance of M. birostris off Cocos Island, Costa Rica. Presently, the largest population of M. birostris is thought to reside within the waters of the Machalilla National Park and the Galapagos Marine Reserve (Hearn et al. 2014); however, given the distribution of purse seine fishing effort, and the migratory nature of the species, it is likely that individuals from this population are highly susceptible to the purse seine fisheries operating in the area.

    Overall, given that the majority of observed declines in landings and sightings of manta rays originate from the Indo-Pacific and eastern Pacific portions of their range (see Table 5 in Miller and Klimovich 2016), additional pressure on these species through bycatch mortality may have significant negative effects on local populations throughout this area. This is particularly a risk for M. birostris, which appears to be the species most frequently observed in the fisheries catch and bycatch, with this pressure already contributing to declines in the species (of up to 95 percent) throughout many areas (i.e., Indonesia, Philippines, Sri Lanka, Thailand, Madagascar, Costa Rica). As such, we find that current fisheries-related mortality rates are a threat significantly contributing to the overutilization of M. birostris throughout this portion of its range. Additionally, given the high market prices for manta ray gill plates, we find that the practice of landing these species as valuable bycatch will likely continue through the foreseeable future.

    Disease or Predation

    No information has been found to indicate that disease or predation is a factor that is significantly and negatively affecting the status of manta rays. Manta rays are frequently observed congregating in inshore cleaning stations, often associated with coral reefs, where small cleaner fish remove parasites and dead tissue from their bodies (Marshall and Bennett 2010a; O'Shea et al. 2010; CITES 2013). They may remain at these cleaning stations for large periods of time, sometimes up to 8 hours a day, and may visit daily (Duinkerken 2010; Kitchen-Wheeler 2013; Rohner et al. 2013). While there is no information on manta ray diseases, or data to indicate that disease is contributing to population declines in either species, impacts to these cleaning stations (such as potential loss through habitat degradation) may negatively impact the fitness of the mantas by decreasing their ability to reduce their parasite load. However, at this time, the impact and potential loss of cleaning stations is highly speculative.

    In terms of predation, manta rays are frequently sighted with non-fatal injuries consistent with shark attacks, although the prevalence of these sightings varies by location (Homma et al. 1999; Ebert 2003; Mourier 2012). For example, Deakos et al. (2011) reported that scars from shark predation, mostly on the posterior part of the body or the wing tip, were evident in 24 percent of M. alfredi individuals observed at a manta ray aggregation site off Maui, Hawaii. At Lady Elliott Island, off eastern Australia, Couturier et al. (2014) observed 23 percent of individuals had shark scars. In contrast, in southern Mozambique, between 2003 and 2006, 76.3 percent of the M. alfredi identified by Marshall and Bennett (2010a) exhibited shark-inflicted bite marks, the majority of which were already healed. Rohner et al. (2013) found a lower rate for M. birostris, with only 35 percent of individuals observed with bite marks. Marshall and Bennett (2010a) also recorded two mid-pregnancy abortions by pregnant female M. alfredi attributed to damage from shark attacks. The authors observed that the rate of shark-inflicted bites in southern Mozambique appears to be higher than predation rates in other manta ray populations, which is generally noted at less than five percent (Ito 2000; Kitchen-Wheeler et al. 2012), but it is unknown why this difference exists.

    Because the damage from a shark bite usually occurs in the posterior region of the manta ray, there may be disfigurement leading to difficult clasper insertion during mating or inhibited waste excretion (Clark and Papastamatiou 2008). Given the already low reproductive ability of these species, attacks by sharks (or occasionally killer whales, see Fertl et al. (1996) and Visser and Bonoccorso (2003)) may pose a threat to the species by further impairing the manta rays' ability to rebuild after depletion. However, at this time, the impact of shark bites on manta ray reproduction, or predation mortality rates on the status of either species, is highly speculative.

    The Inadequacy of Existing Regulatory Mechanisms

    Protections for manta rays are increasing, yet there are still a number of areas where manta rays are targeted or allowed to be landed as bycatch. In fact, only one of the Regional Fishery Management Organizations (RFMOs) has prohibited retention of bycaught manta rays. Additionally, because both manta species were identified as M. birostris prior to 2009, some national protections that were implemented before 2009 are specific only to giant manta rays, despite both species being present in that nation's waters. Below we provide an analysis of the adequacy of measures in terms of controlling threats to each species where available data permit. A list of current protections for manta rays can be found in the Appendix of Miller and Klimovich (2016).

    Overutilization of M. birostris

    Based on the available data, M. birostris appears to be most at risk of overutilization in the Indo-Pacific and eastern Pacific portions of its range. Targeted fishing and incidental capture of the species in Indonesia, Philippines, Sri Lanka, and India, and throughout the eastern Pacific, has led to observed declines in the M. birostris populations. Despite national protections for the species, poor enforcement and illegal fishing have essentially rendered the existing regulatory mechanisms inadequate to achieve their purpose of protecting the giant manta ray from fishing mortality.

    In Indonesia, M. birostris and M. alfredi were provided full protection in the nation's waters in 2014 (4/KEPMEN-KP/2014), with the creation of the world's largest manta ray sanctuary at around 6 million km2. Fishing for the species and trade in manta ray parts are banned. Despite this prohibition, fishing for manta rays continues, with evidence of the species being landed and traded in Indonesian markets (AFP 2014; Marshall and Conradie 2014; Dharmadi et al. 2015). As mentioned previously (see Overutilization for commercial, recreational, scientific, or educational purposes), many fishermen throughout Indonesia rely on shark and ray fishing for their livelihoods, and without an alternative source of income, are unlikely to stop their traditional fishing practices, including the targeting of manta rays. Additionally, in interviews with fishermen, many viewed the prohibition positively because it would likely drive up the market price of manta ray products (Marshall and Conradie 2014). Given the size of the Indonesian archipelago, and current resources, Dharmadi et al. (2015) note there are many issues with current enforcement of regulations. For example, the collection of data is difficult due to insufficient fisheries officers trained in species identification and the large number of landing sites that need to be monitored (over 1,000). Catch data are typically not accurately recorded at the smaller landing sites either, with coastal waters heavily fished by artisanal fishermen using non-selective gear (Dharmadi et al. 2015). Given the issues with enforcement and evidence of illegal fishing, existing regulatory mechanisms are inadequate to protect the species from further declines due to overutilization.

    In the Philippines, legal protection for manta rays was introduced in 1998; however, similar to the situation in Indonesia, enforcement of the prohibitions is lacking and illegal fishing of the species is evident. For example, in a random sampling of 11 dried products of sharks and rays confiscated for illegal trading, Asis et al. (2016) found that four of the products could be genetically identified as belonging to M. birostris. Dried manta meat and gill rakers were frequently observed in markets between 2010 and 2012, and fishing boats specifically targeting mobulids (including manta rays) were identified in a number of local fishing villages in the Philippines, with landings consisting of M. birostris individuals. Fishing for mobulids is a “way of life” and the primary source of income for many fishermen, and with the high prices for manta gill rakers in the Philippine markets (where an average manta ray of around 3 m DW could fetch up to $808; Acebes and Tull (2016)), it is unlikely that pressure on the species will decrease. With essentially no efforts to regulate the mobulid fisheries in the Philippines, and a severe lack of enforcement of the current manta ray hunting prohibition, current regulations to protect M. birostris from overutilization in the Philippines are inadequate.

    In the eastern and central Indian Ocean, very few national protections have been implemented for M. birostris. Essentially, fishing for the species and retention of bycatch is allowed except within the Republic of Maldives EEZ and within specific marine parks of Western Australia. Given the declines observed in the species throughout the Indian Ocean, and the migratory nature of the animal, with the potential for the species to move out of protected areas into active fishing zones (e.g., from the Maldives to Sri Lanka—a distance of ~820 km, well within the ability of M. birostris), it is likely that existing regulatory measures within this portion of the species' range are inadequate to protect it from overutilization.

    In the eastern Pacific portion of the species' range, the IATTC recently implemented a prohibition on the retention, transshipment, storage, landing, and sale of all devil and manta (mobula and manta) rays taken in its large-scale fisheries (Resolution C-15-04). This regulation went into force on August 1, 2016. Cooperating members must report mobulid catch data and ensure safe release; however, developing countries were granted an exception for small-scale and artisanal fisheries that catch these species for domestic consumption. Given that M. birostris is primarily caught as bycatch in the IATTC purse seine fisheries, the adequacy of this prohibition in protecting the species from overutilization depends on the post-release survival rate of the species. While injuries from entanglements in fishing gear (e.g., gillnets and longlines) have been noted (Heinrichs et al. 2011), at this time, at-vessel and post-release mortality rates for manta rays in purse seine nets are unknown. For other Mobula species, Francis and Jones (2016) provided preliminary evidence that may indicate a potential for significant post-release mortality of the spinetail devilray (Mobula japanica) in purse seine fisheries; however, the study was based on only seven observed individuals and, because of this, the authors caution that it is “premature to draw conclusions about survival rates.” In fact, based on observer data in the New Zealand purse seine fishery, mentioned in Francis and Jones (2016), rays that were caught during sets and released were “usually lively” and swam away from the vessel and judged by the observers as “likely to survive.” Although decreasing purse seine fishing effort in manta ray hotspots would significantly decrease the likelihood of bycatch mortality, without further information on post-release survival rates, it is highly uncertain if the prohibition will be adequate in decreasing the mortality of the species.

    Additionally, in 2016, prohibitions on the fishing and sale of M. birostris and requirement for immediate release of mantas caught as bycatch were implemented in Peru. Ecuador banned the fishing, landing and sale of manta rays in its waters back in 2010. Given that the largest population of M. birostris is found in the waters between Peru and Ecuador (with the Isla de la Plata population estimated at around 1,500 individuals), these prohibitions should provide some protection to the species from fishing mortality when in these waters. However, illegal fishing still occurs in these waters. For example, in Ecuador's Machalilla National Park (a major M. birostris aggregation site), researchers have observed large numbers of manta rays with life-threatening injuries as a result of incidental capture in illegal wahoo (Acanthocybium solandri) trawl and drift gillnet fisheries operating within the park (Heinrichs et al. 2011; Marshall et al. 2011a). Depending on the extent of the activities, illegal fishing could potentially contribute to local declines in the population if not adequately controlled. Also, given the migratory nature of the species, national protections may not be adequate to protect the species from overutilization throughout its range, particularly when the species crosses boundary lines where protections no longer exist, as evidenced by the significant decline in M. birostris observed in Cocos Island National Park, Costa Rica (White et al. 2015).

    Overutilization of M. alfredi

    Despite a significant overlap in range with M. birostris in the Indian and Pacific Oceans, and the more nearshore and reef-associated resident behavior, M. alfredi is rarely identified in commercial and artisanal fisheries catch. While the prior lumping of all manta rays as M. birostris may account for these findings, in certain portions of the species' range, the distribution of M. alfredi may not overlap with the areas of fishing operations. For example, in the Philippines, Rambahiniarison et al. (2016) explains that capture of reef manta rays is unusual, as the main mobulid fishing ground in the Bohol Sea lies offshore in deeper waters, where the presence of the more coastal M. alfredi is unlikely. Additionally, while M. alfrediare known to make night time deep-water dives offshore for foraging (>150 m; Braun et al. (2014)), the driftnets deployed by the mobulid fishermen are set at night at much shallower maximum depths of 40 m and thus are unlikely to catch the species (Rambahiniarison et al. 2016). However, Acebes and Tull (2016) did observe a new, active mobulid fishery off Dinagat Island in northern Mindanao that appears to target M. alfredi around seamounts in the Leyte Gulf. In 2010, there were 4 active fishing boats in this fishery, supplying manta ray products to Bohol during the “off season” (Acebes and Tull 2016). While it is uncertain whether fishing pressure on M. alfredi will increase in the future (given that the majority of effort is presently concentrated outside of their distribution), current regulations in the Philippines only prohibit fishing of M. birostris, and, as such, are inadequate to protect the species from potential declines in the future.

    In Indonesia, while the majority of landings data is reported as M. birostris, anecdotal reports from fishermen note that M. alfredi used to be caught as bycatch in drift gillnets. Evidence of declines and extirpations of local reef manta ray populations suggest that the species is at risk of overutilization by fisheries in these local, inshore areas, despite a lack of records. As such, the inadequacy of existing mechanisms (discussed previously) may pose a threat to the remaining local reef manta ray populations in Indonesia.

    In the Indian Ocean, M. alfredi is subject to targeted fishing in the western Indian Ocean (off Mozambique) where declines of up to 88 percent have been observed but no fishery protections or regulatory measures are in place. While the Commonwealth of Australia has now listed both species of Manta on its list of migratory species under its Environment Protection and Biodiversity Conservation Act 1999, which means that any action that may have a significant impact on the species must undergo an environmental assessment and approval process, there are no specific regulatory protections for the species throughout Western Australian waters. Manta spp. are only explicitly protected from targeted fishing within Ningaloo Marine Park and, collectively, with all species in small designated zones along the Western Australian coast; however, it is important to note that neither species is subject to directed fishing in these waters. In fact, in those portions of the species' range where populations are either not fished and/or are afforded protection and appear stable, we find existing regulatory measures to be adequate in protecting the species from overutilization. These areas include waters of Australia, Hawaii, Guam, Japan, the Republic of Maldives, Palau, and Yap. Given the more coastal and resident behavior of M. alfredi, national measures prohibiting fishing of manta rays are likely to provide adequate protection to the species from overutilization through the foreseeable future.

    Tourism Impacts

    Codes of conduct have been developed by a number of organizations and used by dive operators to promote the safe viewing of manta rays and reduce the potential negative impacts of these activities on manta rays (see Other Natural or Man-Made Factors Affecting Its Continued Existence for discussion of this threat). The Manta Trust, a UK-registered charity, has developed a number of guidelines for divers, snorkelers, tour group operators, and in-water tourists, based on studies of interaction effects conducted by the organization from 2005-2013 (available here: http://www.mantatrust.org/awareness/resources/). The Hawaii Association for Marine Education and Research Inc. (2014) notes that codes of conduct for manta ray dive operators have been implemented in a number of popular manta ray diving locales, including Kona, Hawaii, Western Australia, Mozambique, Bora Bora, and in the Maldives; however, information on the adherence to, effectiveness, or adequacy of these codes of conduct in minimizing potential negative impacts of tourism activities on the populations could not be found.

    Other Natural or Man-Made Factors Affecting Its Continued Existence

    Manta rays are known to aggregate in various locations around the world, in groups usually ranging from 100-1,000 for M. birostris and 100-700 for M. alfredi (Notarbartolo-di-Sciara and Hillyer 1989; Graham et al. 2012; Venables 2013). These sites function as feeding sites, cleaning stations, or sites where courtship interactions take place (Heinrichs et al. 2011; Graham et al. 2012; Venables 2013), with the appearance of manta rays at these locations generally predictable and related to food availability (Notarbartolo-di-Sciara and Hillyer 1989; Heinrichs et al. 2011; Jaine et al. 2012). Additionally, manta rays exhibit learned behaviors, with diving spots using artificial lights to concentrate plankton and attract manta rays (Clark 2010). These behavioral traits, including the predictable nature of manta ray appearances, combined with their slow swimming speeds, large size, and lack of fear towards humans, may increase their vulnerability to other threats, such as overfishing, which was previously discussed, and tourism (O'Malley et al. 2013; CMS 2014).

    Tourism was identified as a potential threat to the species, given that interacting (i.e., swimming) with manta rays is a significant tourist attraction throughout the range of both species. In fact, O'Malley et al. (2013) estimated that the manta ray tourism industry provides $140 million annually in direct revenue or economic impact. Regular manta ray concentrations off Mozambique, parts of Indonesia, Australia, Philippines, Yap, southern Japan, Hawaii, and Mexico have all become tourist attractions where manta dives are common (Anderson et al. 2011b). Estimates of the number of people interacting with manta rays per year at these popular dive sites are significant, ranging from over 10,000 at Ho'ona Bay (Hawaii; Clark (2010)) to at least 14,000 in the Maldives (Anderson et al. 2011b).

    While manta ray tourism is far less damaging to the species than the impact of fisheries, this increasing demand to see and dive with the animals has the potential to lead to other unintended consequences that could harm the species. For example, Osada (2010) found that a popular manta dive spot in Kona, Hawaii, had fewer emergent zooplankton and less diversity compared to a less used dive spot, and attributed the difference to potential inadvertent habitat destruction by divers. Tour groups may also be engaging in inappropriate behavior, such as touching the mantas. Given the increasing demand for manta ray tourism, with instances of more than 10 tourism boats present at popular dive sites with over 100 divers in the water at once (Anderson et al. 2011b; Venables 2013), without proper tourism protocols, these activities could have serious consequences for manta ray populations.

    Already, evidence of tourism activities potentially altering manta ray behavior has been observed. For example, from 2007-2008, low numbers of mantas were observed at normally popular manta dive sites in the Maldives while manta ray numbers remained stable at less visited sites (Anderson et al. 2011b). Similarly, De Rosemont (2008) noted the disappearance of a resident manta ray colony from a popular cleaning station in a Bora Bora lagoon in 2005, and attributed the absence to new hotel construction and increased tourism activities; however, by 2007, the author notes that the mantas had returned to the site. In a study of the tourism impacts on M. alfredi behavior in Coral Bay, Western Australia, Venables (2013) observed that mantas exhibited a variety of behavioral changes in response to swim group interactions (i.e., their response was different than their behavior prior to the approach of the swim group). Although the long-term effects of tourism interactions are at this time unknown, the results from the Venables (2013) study provide a preliminary estimate of the potentially minimum response of the species to interactions with tourists, and indicates that these interactions can cause the species to alter (and even stop) behaviors that serve critical biological functions (such as feeding and cleaning). Additional studies on both the short-term and long-term impact of tourist interactions with manta rays are needed in order to evaluate if this interaction is a potential threat to the survival of the species.

    In addition to tourism activities, another potential threat to both manta ray species is an increase in mortality from boat strikes and entanglements. Because manta ray aggregation sites are sometimes in areas of high maritime traffic (such as Port Santos in Brazil or in the Caribbean (Marshall et al. 2011a; Graham et al. 2012)), manta rays are at potential risk of being struck and killed by boats. Mooring and boat anchor line entanglement may also wound manta rays or cause them to drown (Deakos et al. 2011; Heinrichs et al. 2011). For example, in a Maui, Hawaii, M. alfredi population (n = 290 individuals), Deakos et al. (2011) observed that 1 out of 10 reef manta rays had an amputated or disfigured non-functioning cephalic fin, likely a result of line entanglement. Internet searches also reveal photographs of mantas with injuries consistent with boat strikes and line entanglements, and manta researchers report that such injuries may affect manta fitness in a significant way (The Hawaii Association for Marine Education and Research Inc. 2005; Deakos et al. 2011; Heinrichs et al. 2011; Couturier et al. 2012; CMS 2014; Germanov and Marshall 2014; Braun et al. 2015), potentially similar to the impacts of shark or orca attacks. However, there is very little quantitative information on the frequency of these occurrences and no information on the impact of these injuries on the overall health of the populations.

    Assessment of Extinction Risk

    The ESA (section 3) defines an endangered species as “any species which is in danger of extinction throughout all or a significant portion of its range.” A threatened species is defined as “any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” For the term “foreseeable future,” we define it as the time frame over which identified threats could be reliably predicted to impact the biological status of the species. For the assessment of extinction risk for both manta ray species, the “foreseeable future” was considered to extend out several decades (>50 years). Given both species' life history traits, with longevity estimated to be greater than 20-40 years, maturity ranges from 3 to >15 years, reproductive periodicity anywhere from an annual cycle to a 5-year cycle, with a litter of only 1 pup, and a generation time estimated to be around 25 years, it would likely take more than a few decades (i.e., multiple generations) for any recent management actions to be realized and reflected in population abundance indices. Similarly, the impact of present threats to both species could be realized in the form of noticeable population declines within this time frame, as demonstrated in the very limited available sightings time-series data. As the main potential operative threat to the species is overutilization by commercial and artisanal fisheries, this time frame would allow for reliable predictions regarding the impact of current levels of fishery-related mortality on the biological status of the two species. Additionally, this time frame allows for consideration of the previously discussed impacts on manta ray habitat from climate change and the potential effects on the status of these two species.

    In determining the extinction risk of a species, it is important to consider both the demographic risks facing the species as well as current and potential threats that may affect the species' status. To this end, a demographic analysis was conducted for the giant manta ray and the reef manta ray. A demographic risk analysis is an assessment of the manifestation of past threats that have contributed to the species' current status and informs the consideration of the biological response of the species to present and future threats. This analysis evaluated the population viability characteristics and trends available for the manta rays, such as abundance, growth rate/productivity, spatial structure and connectivity, and diversity, to determine the potential risks these demographic factors pose to each species. The information from this demographic risk analysis was considered alongside the information previously presented on threats to these species, including those related to the factors specified by the ESA section 4(a)(1)(A)-(E) (and summarized in a separate Threats Assessment section below) and used to determine an overall risk of extinction for M. birostris and M. alfredi. Because species-specific information is sporadic and sometimes uncertain (due to the prior lumping of the Manta genus), the qualitative reference levels of “low risk,” “moderate risk” and “high risk” were used to describe the overall assessment of extinction risk, with detailed definitions of these risk levels found in the status review report (Miller and Klimovich 2016).

    Demographic Risk Analysis Giant Manta Ray Abundance

    Current and accurate abundance estimates are unavailable for the giant manta ray, as the species tends to be only sporadically observed. While observations of individuals in local aggregations range from around 40 individuals to over 600, estimates of subpopulation size have only been calculated for Mozambique (n = 600 individuals) and Isla de la Plata, Ecuador (n = 1,500 individuals).

    If a population is critically small in size, chance variations in the annual number of births and deaths can put the population at added risk of extinction. Demographic stochasticity refers to the variability of annual population change arising from random birth and death events at the individual level. When populations are very small, chance demographic events can have a large impact on the population. The conservation biology “50/500” rule-of-thumb suggests that the effective population size (Ne; the number of reproducing individuals in a population) in the short term should not be <50 individuals in order to avoid inbreeding depression and demographic stochasticity (Franklin 1980; Harmon and Braude 2010). In the long-term, Ne should not be <500 in order to decrease the impact of genetic drift and potential loss of genetic variation that will prevent the population from adapting to environmental changes (Franklin 1980; Harmon and Braude 2010). Given the two available subpopulation estimates, M. birostris is not likely to experience extreme fluctuations that could lead to depensation; however, data are severely lacking. The threshold for depensation in giant manta rays is also unknown. Additionally, the genetic diversity in the giant manta ray has not been investigated. While a preliminary study suggests that the species may exist as isolated subpopulations, available tracking information indicates these manta rays are pelagic and migratory and can likely travel large distances to reproduce. It is this more transient and pelagic nature of the species that has made it difficult to estimate population sizes.

    Yet, given the reports of anecdotal declines in sightings and decreases in M. birostris landings (of up to 95 percent) in areas subject to fishing (particularly the Indo-Pacific and eastern Pacific portions of the species' range), with take estimates that currently exceed those subpopulation and aggregation estimates (e.g., 50-3,125 individuals), abundance of these particular populations may be at levels that place them at increased risk of genetic drift and potentially at more immediate risks of inbreeding depression and demographic stochasticity. Extirpations of these populations would inherently increase the overall risk of extinction for the entire species.

    Growth Rate/Productivity

    The current net productivity of M. birostris is unknown due to the imprecision or lack of available abundance estimates or indices. Fecundity, however, is extremely low, with one pup per litter and a reproductive periodicity of 1-2 years. Using estimates of life history parameters for both giant and reef manta rays, Dulvy et al. (2014) calculated a median maximum population growth rate to be 0.116 (one of the lowest values compared to other shark and ray species), and estimated productivity (r) to be 0.029. Ward-Paige et al. (2013) calculated a slightly higher intrinsic rate of population increase for M. birostris at r = 0.042; however, both these estimates indicate that the giant manta ray has very low productivity and, thus, is extremely susceptible to decreases in its abundance.

    Given their large sizes, manta rays are assumed to have a fairly high survival rate after maturity (e.g., low natural predation), with estimated annual survival rates for M. alfredi populations supporting this assumption. Based on modeling work on M. alfredi, adult survival rate was found to be the most significant factor affecting the viability of the population.

    Additionally, at this time, no changes in demographic or reproductive traits or barriers to the exploitation of requisite habitats/niches/etc. have been observed in M. birostris.

    Spatial Structure/Connectivity

    The giant manta ray inhabits tropical, subtropical, and temperate bodies of water and is commonly found offshore, in oceanic waters, and near productive coastlines. It occurs over a broad geographic range and is found in all ocean basins. Most tagging and tracking studies indicate that the home range of individuals is likely large, with the species exhibiting migratory behavior and distances tracked of up to 1,500 km. However, a recent study of the M. birostris population found off Pacific Mexico suggests there may be a degree of spatial structuring within the species. At this time, it is unknown whether natural rates of dispersal among populations are too low to prevent sufficient gene flow among populations. Additionally, there is no information to indicate that M. birostris is composed of conspicuous source‐sink populations or habitat patches.

    Diversity

    Rates of dispersal and gene flow are not known to have been altered in M. birostris. Presently, giant manta rays are wide‐ranging inhabitants of offshore, oceanic waters and productive coastline ecosystems and thus are continually exposed to ecological variation at a broad range of spatial and temporal scales. As such, large-scale impacts that affect ocean temperatures, currents, and potentially food chain dynamics, may pose a threat to this species. However, given the migratory behavior of the giant manta ray and tolerance to both tropical and temperate waters, these animals likely have the ability to shift their range or distribution to remain in an environment conducive to their physiological and ecological needs, providing the species with resilience to these effects. At this time, there is no information to suggest that natural processes that cause ecological variation have been significantly altered to the point where M. birostris is at risk.

    Reef Manta Ray Abundance

    Current and accurate abundance estimates are unavailable for the reef manta ray. Observations of individuals in local aggregations range from 35 individuals to over 2,400; however, many are on the order of 100-600 individuals. Subpopulation sizes range from 100 to 350 individuals, with the exception of the Maldives at 3,300-9,677 individuals. Meta-population estimates for southern Mozambique and Ningaloo Reef, Australia are 802-890 and 1,200-1,500 individuals, respectively.

    The rather low subpopulation estimates for M. alfredi throughout most of its range suggest that the species may be at increased risk of genetic drift and potential loss of genetic variation. Unlike the giant manta ray, M. alfredi is thought to be a more resident species, with populations that occur year-round at certain sites. This reproductive isolation further increases the risk of inbreeding depression and potential inability of the population to respond to environmental variation or anthropogenic perturbations. For example, Kashiwagi (2014) recently estimated the effective population size of the M. alfredi population off the Yaeyama Islands to be Ne = 89, indicating that the population is not part of a large gene pool and may be close to a level where viability could be jeopardized in the shorter term. Total population was estimated at 165-202 individuals, indicating long-term viability vulnerability. With most available subpopulation estimates ranging only from 100 to 600 individuals (with the exception of Western Australia, Maldives, and Southern Mozambique), it is likely that these populations similarly have low effective population sizes that may increase their vulnerability to inbreeding depression, the loss of genetic variants, or fixation of deleterious mutations.

    Overall, based on the information above, the estimates of small and isolated subpopulations throughout most of the species' range, with the three exceptions off Mozambique, Maldives, and Western Australia, inherently place M. alfredi at an increased risk of extinction from environmental variation or anthropogenic perturbations. However, the trend in overall abundance of M. alfredi is highly uncertain.

    Growth Rate/Productivity

    The current net productivity of M. alfredi is unknown due to the imprecision or lack of available abundance estimates or indices. Fecundity, however, is extremely low, with one to, rarely, two pups per litter and a reproductive periodicity of anywhere from 1-5 years. Estimated productivity (r) values range from 0.023 to 0.05, indicating that the reef manta ray has very low productivity and, thus, is extremely susceptible to decreases in its abundance.

    Annual survival rate for reef manta rays is fairly high. Estimated survival rates for subpopulations range from 0.95 to 1 off Australia, Hawaii, and Japan (Deakos et al. 2011; Couturier et al. 2014; Kashiwagi 2014). In Mozambique, rates were lower, between 0.6-0.7; however shark attacks are also more common in this area (Marshall et al. 2011c). Based on modeling work, Smallegange et al. (2016) showed that population growth rate was most sensitive to changes in the survival of adults.

    Additionally, no changes in demographic or reproductive traits or barriers to the exploitation of requisite habitats/niches/etc. have been observed.

    Spatial Structure/Connectivity

    The reef manta ray is commonly seen inshore near coral and rocky reefs. The species is associated with warmer waters (>21 °C) and productive nearshore habitats (such as island groups). It is considered a more resident species than M. birostris.While the species has been tracked undertaking long-distance movements (>700 km), usually to exploit offshore productive areas, reef manta rays tend to return to known aggregation sites, indicating a degree of site-fidelity. Based on photo-identification surveys of the M. alfredi population off Maui, Hawaii, Deakos et al. (2011) suggested that geographic barriers, such as deep channels, might be barriers to movement between neighboring M. alfredi populations. Collectively, this information suggests that gene flow is likely limited among populations of M. alfredi, particularly those separated by deep ocean expanses.

    With the exception of the Yaeyama, Japan population of M. alfredi, which Kashiwagi (2014) hypothesized may be a “sink” population but is presently increasing with a population growth rate of 1.02-1.03, there is no information to indicate that M. alfredi is composed of conspicuous source‐sink populations or habitat patches whose loss may pose a risk of extinction.

    Diversity

    Given their tendency towards site fidelity, M. alfredi likely exists as isolated populations with low rates of dispersal and little gene flow among populations. Currently, there is no information to suggest that natural processes that cause ecological variation have been significantly altered to the point where the species is at risk. Reef manta rays also likely have the ability to shift their distribution to remain in an environment conducive to their physiological and ecological needs, providing the species with resilience to these effects. For example, in response to changing ecological conditions, like the biannual reversal of monsoon currents, reef manta rays will migrate to the downstream side of atolls, potentially to remain in nutrient-rich waters year-round (Anderson et al. 2011a). Presently, there is no information to suggest that natural processes that cause ecological variation have been significantly altered to the point where M. alfredi is at risk.

    Threats Assessment Giant Manta Ray

    The most significant and certain threat to the giant manta ray is overutilization for commercial purposes. Giant manta rays are both targeted and caught as bycatch in a number of global fisheries throughout their range. Estimated take of giant manta rays, particularly in many portions of the Indo-Pacific, frequently exceeds numbers of observed individuals in those areas, and is accompanied by observed declines in sightings and landings of the species. Efforts to address overutilization of the species through regulatory measures appear inadequate, with evidence of targeted fishing of the species despite prohibitions (Indo-Pacific; Eastern Pacific) and only one regional measure to address bycatch issues, with uncertain effectiveness (Eastern Pacific). Additionally, given the migratory and pelagic behavior, national protections for the species are less likely to adequately protect the species from fisheries-related mortality. Giant manta rays are not confined by national boundaries and may, for example, lose certain protections as they conduct seasonal migrations or even as they move around to feed if they cross particular national jurisdictional boundaries (e.g., between the Maldives and Sri Lanka or India), move outside of established Marine Protected Areas, or enter into high seas. While the species recently has been added to CITES Appendix II (added in March 2013 with a delayed effectiveness of September 2014), which may curb targeted fishing as countries must ensure that manta ray products are legally obtained and trade is sustainable, the species is still likely to be caught as bycatch in the industrial fisheries and targeted by artisanal fisheries for domestic consumption.

    Other threats to M. birostris that potentially contribute to long-term risk of the species include (micro) plastic ingestion rates, increased parasitic loads as a result of climate change effects, and potential disruption of important life history functions as a result of increased tourism; however, due to the significant data gaps, the likelihood and impact of these threats on the status of the species is highly uncertain.

    Reef Manta Ray

    Given their more inshore distribution and association with shallow coral and rocky reefs, M. alfredi does not appear to be as vulnerable to commercial and larger-scale artisanal fishing operations as M. birostris. These fisheries tend to operate in deeper and more pelagic waters, targeting migratory and commercially valuable species (like tunas, billfishes, and sharks), and, hence, have a higher likelihood of catching giant manta rays. In the available information, only two countries are reported to have targeted artisanal fisheries for M. alfredi: The Philippines (documented 4 fishing boats) and Mozambique. The species has been identified in bycatch from Indonesia, Papua New Guinea, and Kiribati, with subsequent observed declines in sightings, and potential local extirpations; however, the extent of fishing mortality on the species throughout its range is highly uncertain. Additionally, the lumping of both species as M. birostris prior to 2009, as well as the fact that much of the catch is not reported down to species level, also significantly contributes to this uncertainty. However, based on the data available, many of the identified populations of M. alfredi throughout the western and central Pacific are currently protected by regulations and appear stable, indicating that these existing regulatory measures are adequate at protecting the species from declines due to fishing mortality. Within the Indian Ocean, national protections exist for the large population of M. alfredi off the Maldives, and while specific protections for M. alfredi have not been implemented in Western Australia, the species is not subject to directed fishing (or prevalent in bycatch) and is presently one of the largest identified populations.

    Climate change was identified as a potential threat contributing to the long-term extinction risk of the species. Because M. alfredi are more commonly associated with coral reefs compared to giant manta rays, frequently aggregating within these habitats and showing a high degree of site-fidelity and residency to these areas, we found the impact of climate change on coral reefs to be a potential risk to the species. Although the species itself is not dependent on corals, which are most susceptible to the effects of climate change, the manta rays rely on the reef community structure, like the abundance of cleaner fish, to carry out important functions, such as removing parasite loads and dead tissue. Coral reef community structure is likely to be altered as a result of increasing events of coral bleaching through the foreseeable future; however, what this change will look like and its subsequent impact on the species is highly uncertain. Similarly, changes in zooplankton communities and distribution, including in and around coral reefs, are also likely to occur as a result of climate change, affecting the potential previous predictability of M. alfredi food resources. Reef manta rays may need to venture out farther to find available food or search for new productive areas; however, given that the species has been shown capable of making long-distance foraging movements, the impact of this potential displacement or change in distribution of zooplankton may not be a significant contributor to the species' extinction risk.

    Other threats that potentially contribute to long-term risk of the species include (micro) plastic ingestion rates, and potential disruption of important life history functions or destruction of habitat as a result of increased tourism; however, due to the significant data gaps, the likelihood and impact of these threats on the status of the species is highly uncertain.

    Overall Risk Summary Giant Manta Ray

    Given the extremely low reproductive output and overall productivity of the giant manta ray, it is inherently vulnerable to threats that would deplete its abundance, with a low likelihood of recovery. While there is considerable uncertainty regarding the current abundance of M. birostris throughout its range, the best available information indicates that the species has experienced population declines of potentially significant magnitude within areas of the Indo-Pacific and eastern Pacific portions of its range, primarily due to fisheries-related mortality. Yet, larger subpopulations of the species still exist, including off Mozambique (where declines were not observed) and Ecuador. However, as giant manta rays are a migratory species and continue to face fishing pressure, particularly from the industrial purse seine fisheries and artisanal gillnet fisheries operating within the Indo-Pacific and eastern Pacific portions of its range, overutilization will continue to be a threat to these remaining M. birostris populations through the foreseeable future, placing them at a moderate risk of extinction.

    While we assume that declining populations within the Indo-Pacific and eastern Pacific portions of its range will likely translate to overall declines in the species throughout its entire range, there is very little information on the abundance, spatial structure, or extent of fishery-related mortality of the species within the Atlantic portion of its range. As such, we cannot conclude that the species is at a moderate risk of extinction throughout its entire range. However, under the final Significant Portion of Its Range (SPR) policy, we must consider whether the species may be in danger of extinction, or likely to become so within the foreseeable future, in a significant portion of its range (79 FR 37577; July 1, 2014).

    Significant Portion of Its Range (SPR) Analysis

    To identify only those portions that warrant further consideration under the SPR Policy, we must determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. With respect to the second of those determinations, as mentioned previously, the best available information indicates that the giant manta ray faces concentrated threats throughout the Indo-Pacific and eastern Pacific portion of its range. Estimated take of giant manta rays is frequently greater than the observed individuals in those areas, with observed declines in sightings and landings of the species of up to 95 percent. Efforts to address overutilization of the species through regulatory measures appear inadequate in this portion of its range, with evidence of targeted fishing of the species despite prohibitions and bycatch measures that may not significantly decrease fisheries-related mortality rates of the species. Based on the demographic risks and threats to the species in this portion, we determined that the species has a moderate risk of extinction in this portion of its range.

    Next, we must evaluate whether this portion is “significant.” As defined in the SPR Policy, a portion of a species' range is “significant” “if the species is not currently endangered or threatened throughout its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range” (79 FR 37578; July 1, 2014). Without the Indo-Pacific and eastern Pacific portion of the species' range, the species would have to depend on only its members in the Atlantic for survival. While areas exhibiting source-sink dynamics, which could affect the survival of the species, are not known, the largest subpopulations and records of individuals of the species come from the Indo-Pacific and eastern Pacific portion. The only data from the Atlantic on the abundance of the species are records of >70 individuals in the Flower Garden Banks Marine Sanctuary (Gulf of Mexico) and 60 manta rays from waters off Brazil (see Table 4 in Miller and Klimovich (2016)). Given that the species is rarely identified in the fisheries data in the Atlantic, it may be assumed that populations within the Atlantic are small and sparsely distributed. These demographic risks, in conjunction with the species' inherent vulnerability to depletion, indicate that even low levels of mortality may portend drastic declines in the population. As such, without the Indo-Pacific and eastern Pacific portion, the minimal targeted fishing of the species by artisanal fishermen and bycatch mortality from the purse seine, trawl, and longline fisheries operating in the Atlantic becomes a significant contributing factor to the extinction risk of the species. Based on the above findings, we conclude that the Indo-Pacific and eastern Pacific portion of the giant manta ray's range comprises a significant portion of the range of the species because this portion's contribution to the viability of M. birostris is so important that, without the members in this portion, the giant manta ray would likely become in danger of extinction within the foreseeable future, throughout all of its range.

    Under the SPR policy, we conclude that the Indo-Pacific and eastern Pacific portion of the giant manta ray's range qualifies as a significant portion of the species' range. Additionally, based on the information above and further discussed in our demographic risks analysis and threats assessment, as well as the information in the status review report, we conclude that M. birostris is at a moderate risk of extinction within this significant portion of its range.

    Distinct Population Segment (DPS) Analysis

    In accordance with the SPR policy, if a species is determined to be threatened or endangered in a significant portion of its range, and the population in that significant portion is a valid distinct population segment (DPS), NMFS will list the DPS rather than the entire taxonomic species or subspecies. Because the Indo-Pacific and eastern Pacific represents a significant portion of the range of the species, and this portion is at a risk of extinction that is higher than “low,” we performed a DPS analysis on the population within this portion to see if it qualifies as a valid DPS.

    The Services' policy on identifying DPSs (61 FR 4722; February 7, 1996) identifies two criteria for DPS designations: (1) The population must be discrete in relation to the remainder of the taxon (species or subspecies) to which it belongs; and (2) the population must be “significant” (as that term is used in the context of the DPS policy, which is different from its usage under the SPR policy) to the remainder of the taxon to which it belongs.

    In terms of discreteness, a population segment of a vertebrate species may be considered discrete if it satisfies either one of the following conditions: (1) “It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors. Quantitative measures of genetic or morphological discontinuity may provide evidence of this separation”; or (2) “it is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D)” of the ESA (61 FR 4722; February 7, 1996).

    Research on the genetics of the species, which may provide evidence of discreteness between populations, is ongoing. As discussed previously in this finding, while there may be evidence of a potential M. birostris subspecies, or new manta species, found off the Yucatán coast in the Gulf of Mexico, the study by Hinojosa-Alvarez et al. (2016) also showed that some of the Yucatán manta rays found in the area shared haplotypes with M. birostris samples from the Indo-Pacific and eastern Pacific. Additionally, based on nuclear DNA, the Yucatán samples were consistent with the M. birostris samples from the Indo-Pacific and eastern Pacific portions of its range. This is the only study that we are aware of that has compared potential genetic differences between ocean basins for giant manta rays. Given the available data, we do not find evidence to indicate genetic discreteness between M. birostris in the Atlantic and M. birostris in the Indo-Pacific and eastern Pacific.

    In terms of physical, physiological, morphological, ecological, behavioral, and regulatory factors, there is no evidence that the Indo-Pacific and eastern Pacific population of M. birostris is markedly separate from the population in the Atlantic. There is no evidence of differences in the morphology or physiology between the populations, nor any information to indicate changes in habitat use or behavior across ocean basins. Also, given that the species is highly migratory and pelagic, with no identified barriers to movement, these populations cannot be delimited by international governmental boundaries. As such, we find that the M. birostris population in the Indo-Pacific and eastern Pacific does not meet the discreteness criteria of the DPS policy, and, thus, is not a valid DPS.

    Reef Manta Ray

    Overall, the species' life history characteristics increase its inherent vulnerability to depletion. Its tendency towards site fidelity and high residency rates suggests that there may be little gene flow between subpopulations, meaning that reestablishment after depletion is unlikely. Additionally, because these aggregations tend to be small, even light fishing may lead to population depletion. However, despite these inherent risks, the species does not appear subjected to significant threats that are causing declines, or likely to cause declines, to the point where the species would be at risk of extinction. As mentioned in the threats analysis, targeted fishing of the species has only been observed in a select few locations, and its identification in bycatch is limited. The majority of the known M. alfredi subpopulations, particularly throughout the western and Central Pacific, while small, are protected from fishing mortality and appear stable. Some of the larger known M. alfredi subpopulations, such as off the Maldives (n = 3,300-9,677 individuals) and Western Australia (n = 1,200-1,500 individuals), are not subject to directed fishing, with Australia's overall population considered to be one of the world's healthiest. While climate change may alter aspects of the habitat and food resources of the species, the subsequent impact on the species is highly uncertain. Thus, based on the above evaluation of demographic risks and threats to the species, we find that the reef manta ray is likely to be at a low overall risk of extinction.

    SPR Analysis

    As was done for the giant manta ray, we must conduct an SPR analysis to determine if the species is in danger of extinction, or likely to become so within the foreseeable future, in a significant portion of its range. In applying the policy, we first examined where threats are concentrated to evaluate whether the species is at risk of extinction within those portions. Targeted fishing and subsequent declines in populations of M. alfredi are known from waters off Mozambique and the Philippines, and the species has also been identified in bycatch from Indonesia, Papua New Guinea, and Kiribati. However, with the exception of the southern Mozambique population, the extent of decline of the species throughout these other areas has not been quantified. But while the rate of decline is unknown, fishing pressure on the species continues in these portions of range and, combined with the species' demographic risks of isolated, small populations and extremely low productivity, these threats are likely placing these populations on a trajectory toward a higher risk of extinction.

    The second question that needs to be addressed in the SPR analysis is whether these portions can be considered “significant.” Without these portions, would the species be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range? We find that this is unlikely to be the case. Even if these populations were gone, the species would still exist as small, isolated populations throughout the Indo-Pacific. There is no evidence of source-sink dynamics between these portions and other areas, which could affect the survival of the species. In fact, the only indication of a potential source-sink dynamic was hypothesized for the M. alfredi population off Yaeyama, Japan, which Kashiwagi (2014) found is presently increasing, indicating no risk of loss to this population. In fact, many of the M. alfredi populations outside of the portions identified above, while small in size, are presently thought to be stable or increasing. Additionally, these populations, such as the largest identified M. alfredi population, off the Maldives, benefit from national protections that prohibit the fishing, landing, or selling of the species. Because these populations occur nearshore, and the species exhibits high residency rates and site-fidelity behavior, these protections will be adequate to prevent overutilization of the species through the foreseeable future. As such, even without the portions identified above, the species will unlikely be in danger of extinction throughout all of its range now or in the foreseeable future.

    Thus, under the SPR policy, we could not identify any portions of the species' range that meet both criteria (i.e., the portion is biologically significant and the species may be in danger of extinction in that portion, or likely to become so within the foreseeable future). Therefore, we find that our conclusion about the species' overall risk of extinction does not change and conclude that M. alfredi is likely to be at a low risk of extinction throughout its range.

    Protective Efforts

    There are many conservation efforts presently ongoing to collect research on manta ray life history, ecology, and biology, and to raise awareness of threats to manta rays (see Miller and Klimovich (2016) for detailed discussion). The available research and citizen science data that have resulted from these conservation efforts have already been considered in the above analysis, and future research activities will continue to provide valuable information on these manta ray species. Additionally, the efforts by these organizations to educate the public, such as through awareness campaigns, could eventually lead to decreases in the demand for manta ray products. For example, Lawson et al. (2016), citing unpublished data, noted an 18-month awareness-raising campaign conducted in 2015 in Guangzhou, China, that seemed to indicate a level of success in decreasing consumer demand for gill rakers, which, in turn, decreased the interest of traders to carry gill plates in the future. While more monitoring of trade and consumer behavior is required to evaluate the success of these efforts, it may indicate that awareness-raising campaigns could be successful tools for influencing customer behavior. With demand reduction viewed as a potential avenue to indirectly reduce fishing pressure on manta rays, these campaigns may ultimately help decrease the main threat to the species (Lawson et al. 2016).

    Awareness campaigns are also being used to educate the public on appropriate tourist behavior during manta ray dives, which can help decrease potential negative impacts of tourism activities on manta rays. As mentioned previously, best practice codes of conduct have been developed by a number of organizations and are increasingly being used by dive operators at a number of popular manta ray diving sites, including Kona, Hawaii, Western Australia, Mozambique, Bora Bora, and the Maldives, to promote the safe viewing of manta rays.

    While we find that these efforts will help increase the scientific knowledge and promote public awareness about manta rays, with the potential (but not certainty) to decrease the impacts of specific threats in the future, we do not find that these efforts have significantly altered the extinction risk for the giant manta ray to where it would not be at risk of extinction in the foreseeable future. However, we seek additional information on these and other conservation efforts in our public comment process (see below).

    Determination

    Section 4(b)(1) of the ESA requires that NMFS make listing determinations based solely on the best scientific and commercial data available after conducting a review of the status of the species and taking into account those efforts, if any, being made by any state or foreign nation, or political subdivisions thereof, to protect and conserve the species. We have independently reviewed the best available scientific and commercial information including the petition, public comments submitted on the 90-day finding (81 FR 8874; February 23, 2016), the status review report (Miller and Klimovich 2016), and other published and unpublished information, and have consulted with species experts and individuals familiar with manta rays. We considered each of the statutory factors to determine whether it presented an extinction risk to each species on its own, now or in the foreseeable future, and also considered the combination of those factors to determine whether they collectively contributed to the extinction risk of the species, now or in the foreseeable future.

    Based on our consideration of the best available scientific and commercial information, as summarized here and in Miller and Klimovich (2016), including our SPR and DPS analyses, we find that the giant manta ray (Manta birostris) is at a moderate risk of extinction within a significant portion of its range, with the species likely to become in danger of extinction within the foreseeable future throughout that portion. We did not find that the significant portion meets the criteria of a DPS. Therefore, we have determined that the giant manta ray meets the definition of a threatened species and, per the SPR policy, propose to list it is as such throughout its range under the ESA.

    Based on our consideration of the best available scientific and commercial information, as summarized here and in Miller and Klimovich (2016), we find that the reef manta ray (Manta alfredi) faces an overall low risk of extinction throughout its range. As previously explained, we could not identify any portion of the species' range that met both criteria of the SPR policy. Accordingly, the reef manta ray does not meet the definition of a threatened or endangered species, and thus, the reef manta ray does not warrant listing as threatened or endangered at this time. This is a final action on the aforementioned petition to list the reef manta ray under the ESA, and, therefore, we do not solicit comments on it.

    Effects of Listing

    Conservation measures provided for species listed as endangered or threatened under the ESA include recovery actions (16 U.S.C. 1533(f)); concurrent designation of critical habitat, if prudent and determinable (16 U.S.C. 1533(a)(3)(A)); Federal agency requirements to consult with NMFS under section 7 of the ESA to ensure their actions do not jeopardize the species or result in adverse modification or destruction of critical habitat should it be designated (16 U.S.C. 1536); and prohibitions on “taking” (16 U.S.C. 1538). Recognition of the species' plight through listing promotes conservation actions by Federal and state agencies, foreign entities, private groups, and individuals.

    Identifying Section 7 Conference and Consultation Requirements

    Section 7(a)(2) (16 U.S.C. 1536(a)(2)) of the ESA and NMFS/USFWS regulations require Federal agencies to confer with us on actions likely to jeopardize the continued existence of species proposed for listing, or that result in the destruction or adverse modification of proposed critical habitat. If a proposed species is ultimately listed, Federal agencies must consult on any action they authorize, fund, or carry out if those actions may affect the listed species or its critical habitat and ensure that such actions do not jeopardize the species or result in adverse modification or destruction of critical habitat should it be designated. Examples of Federal actions that may affect the giant manta ray include, but are not limited to: Alternative energy projects, discharge of pollution from point sources, non-point source pollution, contaminated waste and plastic disposal, dredging, pile-driving, development of water quality standards, vessel traffic, military activities, and fisheries management practices.

    Critical Habitat

    Critical habitat is defined in section 3 of the ESA (16 U.S.C. 1532(3)) as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the ESA, on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed upon a determination that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the ESA is no longer necessary. Section 4(a)(3)(a) of the ESA (16 U.S.C. 1533(a)(3)(A)) requires that, to the extent prudent and determinable, critical habitat be designated concurrently with the listing of a species. Designations of critical habitat must be based on the best scientific data available and must take into consideration the economic, national security, and other relevant impacts of specifying any particular area as critical habitat. If we determine that it is prudent and determinable, we will publish a proposed designation of critical habitat for the giant manta ray in a separate rule. Public input on features and areas in U.S. waters that may meet the definition of critical habitat for the giant manta ray is invited.

    Protective Regulations Under Section 4(d) of the ESA

    We are proposing to list the giant manta ray (Manta birostris) as a threatened species. In the case of threatened species, ESA section 4(d) leaves it to the Secretary's discretion whether, and to what extent, to extend the section 9(a) “take” prohibitions to the species, and authorizes us to issue regulations necessary and advisable for the conservation of the species. Thus, we have flexibility under section 4(d) to tailor protective regulations, taking into account the effectiveness of available conservation measures. The 4(d) protective regulations may prohibit, with respect to threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. We are not proposing such regulations at this time, but may consider potential protective regulations pursuant to section 4(d) for the giant manta ray in a future rulemaking. In order to inform our consideration of appropriate protective regulations for the species, we seek information from the public on the threats to giant manta rays and possible measures for their conservation.

    Role of Peer Review

    The intent of peer review is to ensure that listings are based on the best scientific and commercial data available. In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing minimum peer review standards, a transparent process for public disclosure of peer review planning, and opportunities for public participation. The OMB Bulletin, implemented under the Information Quality Act (Pub. L. 106-554), is intended to enhance the quality and credibility of the Federal government's scientific information, and applies to influential or highly influential scientific information disseminated on or after June 16, 2005. To satisfy our requirements under the OMB Bulletin, we obtained independent peer review of the status review report. Independent specialists were selected from the academic and scientific community for this review. All peer reviewer comments were addressed prior to dissemination of the status review report and publication of this proposed rule.

    Public Comments Solicited on Listing

    To ensure that the final action resulting from this proposal will be as accurate and effective as possible, we solicit comments and suggestions from the public, other governmental agencies, the scientific community, industry, environmental groups, and any other interested parties. Comments are encouraged on this proposal (See DATES and ADDRESSES). Specifically, we are interested in information regarding: (1) New or updated information regarding the range, distribution, and abundance of the giant manta ray; (2) new or updated information regarding the genetics and population structure of the giant manta ray; (3) habitat within the range of the giant manta ray that was present in the past but may have been lost over time; (4) new or updated biological or other relevant data concerning any threats to the giant manta ray (e.g., post-release mortality rates, landings of the species, illegal taking of the species); (5) current or planned activities within the range of the giant manta ray and their possible impact on the species; (6) recent observations or sampling of the giant manta ray; and (7) efforts being made to protect the giant manta ray.

    Public Comments Solicited on Critical Habitat

    We request information describing the quality and extent of habitats for the giant manta ray, as well as information on areas that may qualify as critical habitat for the species in U.S. waters. Specific areas that include the physical and biological features essential to the conservation of the species, where such features may require special management considerations or protection, should be identified. Areas outside the occupied geographical area should also be identified, if such areas themselves are essential to the conservation of the species. ESA implementing regulations at 50 CFR 424.12(g) specify that critical habitat shall not be designated within foreign countries or in other areas outside of U.S. jurisdiction. Therefore, we request information only on potential areas of critical habitat within waters under U.S. jurisdiction.

    Section 4(b)(2) of the ESA requires the Secretary to consider the “economic impact, impact on national security, and any other relevant impact” of designating a particular area as critical habitat. Section 4(b)(2) also authorizes the Secretary to exclude from a critical habitat designation those particular areas where the Secretary finds that the benefits of exclusion outweigh the benefits of designation, unless excluding that area will result in extinction of the species. For features and areas potentially qualifying as critical habitat, we also request information describing: (1) Activities or other threats to the essential features or activities that could be affected by designating them as critical habitat; and (2) the positive and negative economic, national security and other relevant impacts, including benefits to the recovery of the species, likely to result if these areas are designated as critical habitat. We seek information regarding the conservation benefits of designating areas within waters under U.S. jurisdiction as critical habitat. In keeping with the guidance provided by OMB (2000; 2003), we seek information that would allow the monetization of these effects to the extent possible, as well as information on qualitative impacts to economic values.

    Data reviewed may include, but are not limited to: (1) Scientific or commercial publications; (2) administrative reports, maps or other graphic materials; (3) information received from experts; and (4) comments from interested parties. Comments and data particularly are sought concerning: (1) Maps and specific information describing the amount, distribution, and use type (e.g., foraging or migration) by the giant manta ray, as well as any additional information on occupied and unoccupied habitat areas; (2) the reasons why any habitat should or should not be determined to be critical habitat as provided by sections 3(5)(A) and 4(b)(2) of the ESA; (3) information regarding the benefits of designating particular areas as critical habitat; (4) current or planned activities in the areas that might be proposed for designation and their possible impacts; (5) any foreseeable economic or other potential impacts resulting from designation, and in particular, any impacts on small entities; (6) whether specific unoccupied areas may be essential to provide additional habitat areas for the conservation of the species; and (7) potential peer reviewers for a proposed critical habitat designation, including persons with biological and economic expertise relevant to the species, region, and designation of critical habitat.

    References

    A complete list of the references used in this proposed rule is available upon request (see ADDRESSES).

    Classification National Environmental Policy Act

    The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), NMFS has concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

    Executive Order 12866, Regulatory Flexibility Act, and Paperwork Reduction Act

    As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this proposed rule is exempt from review under Executive Order 12866. This proposed rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

    Executive Order 13132, Federalism

    In accordance with E.O. 13132, we determined that this proposed rule does not have significant Federalism effects and that a Federalism assessment is not required. In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and Federal interest, this proposed rule will be given to the relevant governmental agencies in the countries in which the species occurs, and they will be invited to comment. As we proceed, we intend to continue engaging in informal and formal contacts with the states, and other affected local, regional, or foreign entities, giving careful consideration to all written and oral comments received.

    List of Subjects in 50 CFR Part 223

    Endangered and threatened species.

    Dated: January 5, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 223 is proposed to be amended as follows:

    PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority:

    16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

    2. In § 223.102, in the table in paragraph (e) add a new entry for “ray, giant manta” in alphabetical order by common name under the “Fishes” subheading to read as follows:
    § 223.102 Enumeration of threatened marine and anadromous species.

    (e) * * *

    Species 1 Common name Scientific name Description
  • of listed
  • entity
  • Citation(s) for listing determination(s) Critical
  • habitat
  • ESA
  • rules
  •      *         *          *          *          *          *      Fishes      *         *          *          *          *          *      Ray, giant manta Manta birostris Entire species [Insert Federal Register page where the document begins],
  • [Insert date of publication when published as a final rule]
  • NA NA.
         *         *          *          *          *          *      1 Species includes taxonomic species, subspecies, distinct population segments (DPSs) (for a policy statement, see 61 FR 4722, February 7, 1996), and evolutionarily significant units (ESUs) (for a policy statement, see 56 FR 58612, November 20, 1991).
    [FR Doc. 2017-00370 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    82 8 Thursday, January 12, 2017 Notices DEPARTMENT OF AGRICULTURE Forest Service National Urban and Community Forestry Advisory Council AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The National Urban and Community Forestry Advisory Council (Council) will meet via teleconference.

    DATES:

    The teleconference will be held on Thursday February 9, 2017, from 10:00 a.m. to 5:00 p.m., Eastern Standard Time (EST) or until Council business is completed.

    All meetings are subject to cancellation. For an updated status of the teleconference prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held via teleconference. For anyone who would like to attend the teleconference, please visit the Web site listed in the SUMMARY section or contact Nancy Stremple at [email protected] for further details. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the USDA Forest Service, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024. Please call ahead at 202-309-7829 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Stremple, Executive Staff, National Urban and Community Forestry Advisory Council, by telephone at 202-205-7829, or by email at [email protected], or by cell phone at 202-309-9873, or via facsimile at 202-690-5792.

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The Council is authorized under Section 9 of the Cooperative Forestry Assistance Act, as amended by Title XII, Section 1219 of Public Law 101-624 (the Act) (16 U.S.C. 2105g) and the Federal Advisory Committee Act (FACA) (5 U.S.C. App. II). Additional information concerning the Council, can be found by visiting the Council's Web site at: http://www.fs.fed.us/ucf/nucfac.shtml.

    The purpose of the meeting is to:

    1. Review the 2017 Work Plan;

    2. Update on the 2017 grant proposal review; and 2018 Call for Proposals

    3. Listen to presentation on innovation in timber building construction;

    4. Listen to local constituents with urban forestry concerns;

    5. Discuss the National ten year action plan (2016-2026) implementation;

    6. Receive Forest Service budget, administration, and program updates; and

    7. Discuss the annual accomplishments/recommendations report.

    The teleconference is open to the public. However, the public is strongly encouraged to RSVP prior to the teleconference to ensure all related documents are shared with public meeting participants. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by January 31, 2017, to be scheduled on the agenda. Council discussion is limited to Forest Service staff and Council members, however anyone who would like to bring urban and community forestry matters to the attention of the Council may file written statements with the Council's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Nancy Stemple, Executive Staff, National Urban and Community Forestry Advisory Council, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024, or by email at [email protected]

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: January 4, 2017. Steven W. Koehn, Director, Cooperative Forestry.
    [FR Doc. 2017-00485 Filed 1-11-17; 8:45 am] BILLING CODE 3411-15-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Virginia Advisory Committee To Discuss Potential Projects of Study Including a Proposal on Hate Crimes AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EDT) on Thursday, February 2, 2017. The purpose of the meeting is to discuss project planning and eventually select topic(s) for the Committee's civil rights review.

    DATES:

    The meeting will be held on Thursday, February 2, 2017, at 12:00 p.m. EST.

    ADDRESSES:

    Public call information: Dial: 888-601-3861, Conference ID: 417838.

    FOR FURTHER INFORMATION CONTACT:

    Ivy L. Davis, at [email protected] or by phone at 202-376-7533.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-601-3861 and conference ID: 417838. Please be advised that before being placed into the conference call, you will be prompted to provide your name, organizational affiliation (if any), and email address (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-601-3861 and conference call ID: 417838.

    Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

    Records and documents discussed during the meeting will be available for public viewing as they become available at http://facadatabase.gov/committee/meetings.aspx?cid=279; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

    Agenda I. Welcome and Introductions —Rollcall II. Planning Meeting —Discuss Project Planning III. Other Business IV. Adjournment Dated: January 9, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-00542 Filed 1-11-17; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Nevada State Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of public meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Nevada Advisory Committee (Committee) to the Commission will be held at 1:30 p.m. (Pacific Time) Thursday, January 19, 2017, for the purpose of discussing the logistics and agenda for the Committee's upcoming public meeting to hear testimony on the civil rights issues regarding municipal fees and policing practices in Nevada.

    DATES:

    The meeting will be held on Thursday, January 19, 2017, at 1:30 p.m. PST

    Public Call Information: Dial: 888-298-3457. Conference ID: 5007352.

    FOR FURTHER INFORMATION CONTACT:

    Ana Victoria Fortes (DFO) at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-298-3457, conference ID number: 5007352. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60603. They may be faxed to the Commission at (312) 353-8324, or emailed to David Mussatt, Regional Programs Unit at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=261. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Introductions—Wendell Blaylock, Chair of the Nevada Advisory Committee II. Discussion of Potential Panelists and Logistics: Civil Rights Issues Regarding Municipal Fees and Police Practices in Nevada—Member of the Nevada Advisory Committee III. Public Comment IV. Adjournment

    Exceptional Circumstance: Pursuant to the Federal Advisory Committee Management Regulations (41 CFR 102-3.150), the notice for this meeting cancelation is given less than 15 calendar days prior to the meeting due to exceptional circumstance of the Committee project supporting the Commission's 2017 statutory enforcement report.

    Dated: January 9, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-00530 Filed 1-11-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; Monthly Retail Surveys AGENCY:

    U.S. Census Bureau, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

    DATES:

    To ensure consideration, written comments must be submitted on or before March 13, 2017.

    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(s) and instructions should be directed to Rebecca DeNale, U.S. Census Bureau, EID HQ-8K181, 4600 Silver Hill Road, Washington, DC 20233-6500, (301) 763-3113 (or via the Internet at [email protected]).

    SUPPLEMENTARY INFORMATION I. Abstract

    The Census Bureau plans to request a revision of the current Office of Management and Budget clearance for the surveys known as the Monthly Retail Trade Survey (MRTS) and the Advance Monthly Retail Trade Survey (MARTS). The MRTS and MARTS are related collections sharing the same initial sample frame and collect data that are published in conjunction with each other. These two surveys, currently cleared separately under control numbers 0607-0717 and 0607-0104, respectively, will therefore be combined under one control number and will be collectively called the Monthly Retail Surveys (MRS).

    The Monthly Retail Trade Survey (MRTS) provides estimates of monthly retail sales, end-of-month merchandise inventories, and quarterly e-commerce sales for firms located in the United States and classified in the Retail Trade or Food Services sectors as defined by the North American Industry Classification System (NAICS).

    Estimates produced from the MRTS are based on a probability sample of approximately 11,500 firms. The sample design consists of one fixed panel where all cases are requested to report sales, e-commerce sales, and/or inventories for the prior month. If reporting data for a period other than the calendar month, the survey asks for the period's length (4 or 5 weeks) and the date on which the period ended. The survey also asks for the number of establishments covered by the data provided and whether or not the sales data provided are estimates or more accurate “book” figures. The sample is drawn approximately every 5 years from the Business Register, which contains all Employer Identification Numbers (EINs) and listed establishment locations. The sample is updated quarterly to reflect employer business “births” and “deaths”; adding new employer businesses identified in the Business and Professional Classification Survey (SQ-CLASS) and deleting firms and EINs when it is determined they are no longer active. Estimates from the MRTS are released in three different reports each month. High level aggregate estimates for end of month inventories are first released as part of the Advance Economic Indicators Report approximately 27 days after the close of the reference month. The sales and inventories estimates from MRTS are released approximately 44 days after the close of the reference month as part of the Monthly Retail Trade report and the Manufacturing and Trade Inventories and Sales (MTIS) report, which are released on the same day. Additionally, once per quarter, data for quarterly e-commerce sales are released approximately 48 days after the close of the reference quarter as part of the Quarterly Retail E-Commerce Sales report.

    Effective with the next MRTS sample, which begins collection in December of 2017, we will be removing the Leased Department question and all impacted forms, and will no longer provide monthly estimates for this data series moving forward. All historical series including these estimates will still be available to data users.

    The Advance Monthly Retail Trade Survey (MARTS) provides an early indication of monthly sales for retail trade and food services firms located in the United States. It was developed in response to requests by government, business, and other users to provide an early indication of current retail trade activity in the United States. Retail sales are one of the primary measures of consumer demand for both durable and non-durable goods. The MARTS survey results are published approximately 14 days after the end of the reference month. MARTS provides a designated principal economic indicator and the earliest available monthly estimates of broad based retail trade activity. It also provides an estimate of monthly sales at food service establishments and drinking places. If the advance survey were not conducted, there would be a delay in the availability of these results as the results from the MRTS are not published until approximately 6 weeks after the end of the reference month.

    The MARTS sample is a sub-sample of companies selected from the MRTS. The advance survey sample of about 4,900 companies are selected using a stratified design where the companies are selected by stratifying the companies in the larger MRTS sample by industry and size and selecting the desired number of cases within each size stratum using a systematic probability-proportional-to-size procedure where the size used is the MRTS sampling weight. Some 1,250 firms, because of their relatively large effect on the sales of certain industry groups, are selected with certainty. The MARTS sample is re-selected, generally at 21/2 to 3 year intervals, to ensure it is representative of the target population and redistribute burden for small and medium size businesses.

    Advance sales estimates for each kind of business are developed by applying a ratio of current-month to previous-month sales (derived from the advance retail and food service sample) to the preliminary estimate of sales for the previous month (from the larger monthly sample). Industry estimates are summed to derive total retail sales figures.

    The MARTS survey requests sales and e-commerce sales for the month just ending. As on the MRTS survey, if firms report data for a period other than the calendar month, the survey asks for the period's length (4 or 5 weeks) and the date on which the period ended. Also similar to MRTS, the survey also asks for the number of establishments covered by the data provided and whether or not the sales data provided are estimates or more accurate “book” figures. At this time, there are no planned changes for MARTS.

    The Bureau of Economic Analysis (BEA) uses the information collected on these surveys to prepare the National Income and Products Accounts, to benchmark the annual input-output tables and as critical inputs to the calculation of the Gross Domestic Product (GDP). Policymakers such as the Federal Reserve Board (FRB) need to have the timeliest estimates in order to anticipate economic trends and act accordingly. The Council of Economic Advisors (CEA) and other government agencies and businesses use the survey results to formulate and make decisions about economic policy.

    II. Method of Collection

    We will collect this information by mail, FAX, telephone follow-up, and internet.

    III. Data

    OMB Control Numbers: 0607-0104 and 0607-0717.

    Form Numbers: SM-4412A-A, SM-4412A-E, SM-4412AE-A, SM-4412AE-E, SM-4412AS-A, SM-4412AS-E, SM-7212A-A, SM7212A-E, SM-2012I-A, SM-2012I-E, SM-4412B-A, SM4412B-E, SM-4412BE-A, SM-4412BE-E, SM4412BS-A, SM-4412BS-E, SM-4412S-A, SM-4412S-E, SM-4412SE-A, SM-4412SE-E, SM-4412SS-A, SM-4412SS-E, SM-7212S-A, SM-7212S-E, SM-4512B-A, SM-4512B-E, SM-4512BE-A, SM-4512BE-E, SM-4512BS-A, SM-4512BS-E, SM-4512S-A, SM-4512S-E, SM-4512SE-A, SM-4512SE-E, SM-4512SS-A, SM-4512SS-E.

    Type of Review: Regular submission.

    Affected Public: Retail and Food Services firms in the United States.

    Estimated Number of Respondents: MRTS-10,305; MARTS-4,700.

    Estimated Time per Response: MRTS-7 minutes; MARTS-5 minutes.

    Estimated Total Annual Burden Hours: 19,327.

    Estimated Total Annual Cost: $0.

    Respondent's Obligation: Voluntary.

    Legal Authority: Title 13, United States Code, Sections 131 and 182.

    V. 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.

    Sheleen Dumas, PRA Departmental Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-00525 Filed 1-11-17; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE [Docket No. 161018975-6975-01] Privacy Act of 1974, Amended System of Records AGENCY:

    National Oceanic and Atmospheric Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an Amended Privacy Act System of Records: COMMERCE/NOAA-20, Search and Rescue Satellite Aided Tracking (SARSAT) 406 MHz Emergency Beacon Registration Database.

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, Title 5 of the United States Code (U.S.C.) sections 552a(e)(4) and (11); and Office of Management and Budget (OMB) Circular A-130, Appendix I, “Federal Agency Responsibilities for Maintaining Records About Individuals,” the Department of Commerce (Department) is issuing a notice of intent to establish an amended system of records entitled, “COMMERCE/NOAA-20, Search and Rescue Satellite Aided Tracking (SARSAT) 406 MHz Emergency Beacon Registration Database.” Amendments (updates) were made to the Addresses, Supplementary Information, Routine Uses and Storage sections.

    SARSAT is responsible for keeping and maintaining a registration database for 406 MHz emergency beacons as directed by the Federal Communications Commission (FCC). This database contains personally identifiable information that is required to be protected by the Privacy Act, as amended. The purpose of this system of records is to provide search and rescue (SAR) authorities with information about the user of the beacon, such as the name, phone number, and emergency contact information. This information provides the Rescue Coordination Center (RCC) and Mission Control Center (MCC) with the identity of the individual(s) they are searching for, contact information so that the RCC can determine whether or not the beacon has been activated as the result of an actual emergency, and information about the vessel or aircraft. The registration information allows the RCC and MCC to resolve a distress case by telephone instead of wasting valuable resources responding to false alerts. Information may be provided to or received from international registration authorities to ensure registration information resides in the correct database based on the country code of the beacon or the mailing address of the beacon owner. This information allows SAR authorities to shorten response times, and it provides a way to cancel false alerts quickly and safely, thereby increasing safety for SAR authorities and decreasing costs to the government and the SAR system. The completed forms also contain personal identifiable information that is required to be protected by the Privacy Act. We invite public comment on the amended system in this publication.

    DATES:

    To be considered, written comments must be submitted on or before February 13, 2017. Unless comments are received, the amended system of records will become effective as proposed on February 21, 2017. If comments are received, the Department will publish a subsequent notice in the Federal Register within 10 days after the comment period closes, stating that the current system of records will remain in effect until publication of a final action in the Federal Register.

    ADDRESSES:

    Comments may be mailed to: NOAA SARSAT, NSOF E/SPO53, 1315 East West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    NOAA SARSAT, NSOF E/SPO53, 1315 East West Highway, Silver Spring, MD 20910.

    SUPPLEMENTARY INFORMATION:

    The National Oceanic and Atmospheric Administration's (NOAA's) National Environmental Satellite, Data, and Information Service (NESDIS) is revising its system of records for SARSAT, which is required by the FCC under 47 CFR parts 80, 87, and 95 to maintain a registration for emergency beacons that operate on the 406 MHz frequency. SARSAT has not found any probable or potential adverse effects of the proposal on the privacy of individuals. To minimize the risk of unauthorized access to the system of records, electronic data will be stored securely with access password protected, two-factor authentication for internal System Administrators, and limited to those SARSAT program employees whose official duties require access.

    COMMERCE/NOAA-20 System name:

    Search and Rescue Satellite Aided Tracking (SARSAT) 406 MHz Emergency Beacon Registration Database.

    Security classification:

    None.

    System Location:

    U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), 4231 Suitland Road, Suitland, MD 20746-4304

    Categories of individuals covered by the system:

    Owners of 406 MHz Emergency Position Indicating Radio Beacons (EPIRBs), 406 MHz Emergency Location Transmitters (ELTs), 406 MHz Personnel Locator Beacons (PLBs), and 406 MHz Ship Security Alerting System (SSAS) Beacons.

    Categories of records in the system:

    Personal Identifiable Information: Beacon Unique Identifier Number (Beacon ID), beacon category, beacon manufacturer, beacon model; owner name, owner address, owner email address, owner telephone number by home, work, cellular, and fax; and name and telephone number of primary/alternate 24-hour emergency contact. Additional categories specifically for:

    a. EPIRBs and SSAS beacon registrations—vessel information including usage, type, name, color, survival and radio equipment, vessel telephone numbers with call sign, Inmarsat number, cellular and MMSI number, federal/state registration number, length, capacity, and homeport;

    b. ELT registrations—aircraft information including registration (tail) number, type, manufacturer, model, color, seating capacity, radio equipment, survival equipment, principal airport; and

    c. PLB registrations—general use data including usage, specific usage, and type.

    Authority for maintenance of the system:

    This system of records is consistent with 47 CFR parts 80, 87, and 95. The system is also authorized by the U.S. Office of Management & Budget (OMB) Control Number: OMB 0648-0295.

    Purposes:

    The records are maintained and used to assist search and rescue forces in carrying out their mission of rescue assistance and false alert abatement.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    These records may be disclosed as follows:

    1. A record in this system of records is used when a beacon alert is received at the United States Mission Control Center (USMCC) from a registered beacon. The information kept in the database is automatically forwarded to rescue coordination centers operated by the United States Air Force, United States Coast Guard, State Police/State SAR authority, or another foreign SARSAT Mission Control Center, should it be requested for use in a SAR case in a foreign search and rescue region. The information is used by SAR controllers as a tool to coordinate and resolve the SAR event.

    2. Every two years, NOAA uses the information in the database to alert beacon owners to update and renew their registration in the database.

    3. In the event that a system or records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute or contract, or rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, state, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, or rule, regulation or order issued pursuant thereto, or protecting the interest of the Department.

    4. A record from this system of records may be disclosed, as a routine use, to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.

    5. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.

    6. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.

    7. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.

    8. A record in this system of records which contains medical information may be disclosed, as a routine use, to the medical advisor of any individual submitting a request for access to the record under the Act and 15 CFR part 4b if, in the sole judgment of the Department, disclosure could have an adverse effect upon the individual, under the provision of 5 U.S.C. 552a(f)(3) and implementing regulations at 15 CFR 4b26.

    9. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.

    10. A record in this system of records may be disclosed, as a routine use, to the Department of Justice in connection with determining whether disclosure thereof is required by the Freedom of Information Act (5 U.S.C. 552).

    11. A record in this system of records may be disclosed, as a routine use, to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).

    12. A record in this system may be transferred, as a routine use, to the Office of Personnel Management: For personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained or for related manpower studies.

    13. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e. GSA or Department) directive. Such disclosure shall not be used to make determinations about individuals.

    14. A record in this system of records may be disclosed to appropriate agencies, entities and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.

    15. A record in this system of records may be disclosed to student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees, when they are performing work for the Department and/or its agencies, as authorized by law, as needed to perform their assigned Agency functions.

    Disclosure to consumer reporting agencies:

    None.

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    Computerized database stored behind several layers of firewalls configured with the firm policy of denying all and allow only by exception, electronic storage media, and paper records. All three mediums are retained in accordance with NOAA Records Disposition Handbook, Chapter 1404-02.

    Retrievability:

    Records may be retrieved by unique beacon identification number, the name of beacon owner, date of submittal, vessel name, aircraft name, or aircraft tail number; however, records can be accessed by any file element or any combination thereof.

    Safeguards:

    Due to the sensitive information stored in the registration database, access has been granted only to a limited number of personnel in accordance with this system of records routine uses provision. This access comes in four different categories; beacon owners, system administrators, SAR users, and vessel/aircraft inspectors.

    The beacon owner is granted access to his/her own registration information through the use of a user ID and an online password. Information can be accessed and updated by the beacon owner at any time.

    The system administrator consists of personnel at the USMCC who maintains and operates the registration database. Access to records is through the use of a user ID and an online password.

    The SAR user is limited to rescue coordination personnel responsible for SAR operations within internationally recognized SAR regions. Each SAR controller is issued a user ID and an online password. SAR controllers are given a view-only capability.

    The vessel or aircraft inspector is an approved representative of a federal agency charged with inspecting vessels or aircraft which includes verifying that the emergency beacons carried onboard the vessel or aircraft are properly registered. Each inspector is issued a user ID and an online password. Inspectors are given a view-only capability.

    Exceptions to the above categories can only be approved by the SARSAT Program Steering Group. Consideration for access to the database by a requesting individual/agency will be based in light of their overall contribution to the SAR mission versus balancing the individual beacon owner's right to privacy.

    Retention and disposal:

    NESDIS shall maintain its records in accordance with NOAA's Records Management Guide and Records Disposition Handbook, Departmental directives, and comprehensive records schedules.

    System manager(s) and address:

    NOAA/SARSAT, NSOF E/SPO53, 1315 East West Highway, Silver Spring, MD 20910.

    Notification procedure:

    Beacon owners are notified by letter once registration information has been put into the database. Every two years thereafter, beacon owners are contacted by email or letter to update their information or to confirm that their information is correct.

    In accordance with the Department of Commerce regulations implementing the Privacy Act, at Title 15 of the Code of Federal Regulations, part 4, subpart B—Privacy Act, individuals interested in determining if the system contains their name should direct their Privacy Act request to the National Oceanic and Atmospheric Administration, Public Reference Facility, OFA56, 1315 East West Highway (SSMC3), Room 10730, Silver Spring, Maryland 20910.

    Record access procedures:

    Individuals with information in the database have the ability to review and update their own individual information on the internet at http://www.beaconregistration.noaa.gov. User ID and user password are set-up with initial Web registration or with a first visit to the Web site.

    Contesting record procedures:

    Individual beacon owners have access to their database file and have the ability to update or correct information. Other issues are addressed by the system manager who can be contacted at NOAA/SARSAT, NSOF E/SPO53, 1315 East West Highway, Silver Spring, MD 20910.

    Record source categories:

    The individual on whom the record is maintained provides information to NOAA by either the Web site or mail. Existing registrations can be updated according to the above processes, by a phone call from the beacon owner, or by rescue coordination center controllers when updated information is collected while processing a case.

    Exemptions claimed for the system:

    None.

    Michael J. Toland, Department of Commerce, Deputy Chief Officer, Department Privacy Act Officer.
    [FR Doc. 2017-00495 Filed 1-11-17; 8:45 am] BILLING CODE 3510-12-P
    DEPARTMENT OF COMMERCE [ Docket No. 160809701-6701-01] Privacy Act of 1974, Amended System of Records AGENCY:

    National Oceanic and Atmospheric Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an Amended Privacy Act System of Records: COMMERCE/NOAA-11, Contact Information for Members of the Public Requesting or Providing Information Related to NOAA's Mission.

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, and Office of Management and Budget (OMB) Circular A-130, Appendix I, “Federal Agency Responsibilities for Maintaining Records About Individuals,” the Department of Commerce (Department) is issuing a notice of intent to establish an amended system of records entitled, “COMMERCE/NOAA-11, Contact Information for Members of the Public Requesting or Providing Information Related to NOAA's Mission.” Amendments (updates) were made to categories of individuals, categories of records, and purpose, as well as to the lists of system locations and system managers and addresses. Updates also include the addition of a new routine use for student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees.

    DATES:

    To be considered, written comments must be submitted on or before February 13, 2017. Unless comments are received, the amended system of records will become effective as proposed on February 21, 2017. If comments are received, the Department will publish a subsequent notice in the Federal Register within 10 days after the comment period closes, stating that the current system of records will remain in effect until publication of a final action in the Federal Register.

    ADDRESSES:

    Comments may be mailed to Sarah Brabson, NOAA Office of the Chief Information Officer, Room 9856, 1315 East-West Highway, SSMC3, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Brabson, NOAA Office of the Chief Information Officer, Room 9856, 1315 East-West Highway, Silver Spring, MD 20910.

    SUPPLEMENTARY INFORMATION:

    The National Oceanic and Atmospheric Administraton (NOAA), pursuant to Title 5 of the United States Code (U.S.C.) sections 552a(e)(4) and (11); is amending this system of records to include development of satellite data system user agreements with government or non-government entities, and to allow further communication and information sharing with these entities. This system of records notice encompasses all NOAA systems which collect, store and/or disseminate contact information for members of the public requesting or providing information related to NOAA's mission. Information collections would be requested from individuals under the authority of 5 U.S.C. 301, Departmental Regulations and 15 U.S.C. 1512, Powers and duties of Department. The collection of information is necessary to facilitate communication with, and share mission-related information with, the public. NOAA would collect information from individuals in order to provide and acquire NOAA mission-related data. The resulting system of records, as amended, appears below.

    COMMERCE/NOAA-11 SYSTEM NAME:

    Contact Information for Members of the Public Requesting or Providing Information Related to NOAA's Mission.

    SECURITY CLASSIFICATION:

    None.

    SYSTEM LOCATION:

    1. National Environmental Satellite, Data, and Information Service (NESDIS):

    a. NOAA5004, Data Collection System: (1) NSOF: 4231 Suitland Rd., Suitland, Md 20746. (2) Wallops: U.S. Department of Commerce, NOAA Wallops CDA Station, 35663 Chincoteague Road, Wallops, Virginia 23337.

    b. NOAA5009, National Climatic Data Center Local Area Network: Federal Building, Room 311, 151 Patton Avenue, Asheville, NC 28801.

    NOAA5010, National Oceanographic Data Center: 1315 East West Highway, Silver Spring, MD 20910.

    c. NOAA5036, National Coastal Data Development Center Local Area Network: 1021 Balch Blvd., Stennis Space Center, MS 39529.

    d. NOAA5036 Mirror Site: 25 Broadway, E/GC4, Boulder, CO 80305.

    e. NOAA5040, Comprehensive Large Array-data Stewardship System: 2110 Pleasant Valley Road, Fairmont, WV 26554.

    f. NOAA5045, NOAA Environmental Satellite Processing Center: 4231 Suitland Rd., Suitland, MD 20746.

    2. National Marine Fisheries Service (NMFS):

    a. NOAA4010, NMFS Headquarters Local Area Network: 1315 East West Highway, Silver Spring, MD 20910.

    b. NOAA4960, Honolulu, HI Pacific Islands Fisheries Science Center Local Area Network: 2570 Dole Street, Honolulu, HI 96822.

    3. National Ocean Service (NOS):

    a. NOAA6001, NOS Enterprise Information System: 1305 East West Highway, Floor 13, Silver Spring, MD 20910.

    b. NOAA6101, Coastal Services Center (CSC) Information Technology Support System: 2234 S. Hobson Ave., Charleston, SC 29405.

    c. NOAA6301, National Centers for Coastal Ocean Science (NCCOS) Research Support System: 1305 East West Highway, 13th Floor, Silver Spring, MD 20910.

    d. NOAA6501, Office of Coast Survey (OCS) Nautical Charting System: 1315 East West Highway, Floors 5, 6 & 7, Silver Spring, MD 20910.

    4. National Weather Service (NWS):

    a. NOAA8860, National Centers for Environmental Prediction: 5830 University Research Court, College Park, MD 20740.

    b. NOAA8874, National Operations Hydrologic Remote Sensing Center, 1735 Lake Dr. West, Chanhassen, MN 55317.

    c. NOAA8884, Southern Region Headquarters, 819 Taylor St., Rm. 10A05C, Fort Worth, TX 76102.

    d. NOAA8885, Western Region Headquarters, 125 South State St., Salt Lake City, UT 84103.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    Members of the public requesting information. Members of the public (non-NOAA researchers), who provide information to NOAA for dissemination to the public. Members of the public who are users of NOAA data or access NOAA information who provide information to NOAA in order to gain access to or use NOAA information.

    CATAGORIES OF RECORDS IN THE SYSTEM:

    This information is collected and/or maintained by all systems covered by this system of records: Name, address, email address, telephone number (business or private, by individuals' choice), organization name, address and position if applicable, as well as affected public classification (whether they are government (foreign, federal, state, local or tribal, or non-government (public or private agencies).

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    5 U.S.C. 301, Departmental Regulations and 15 U.S.C. 1512, Powers and duties of Department.

    PURPOSES:

    This information will allow NOAA to contact customers who have requested data, will participate or have participated in NOAA conferences, meetings and trainings, as well as those researchers providing data and making presentations. Maintenance of this contact information allows further communication and information sharing, as well as a mechanism for customer surveys with the goal of improving services. Maintenance and use of this contact information will also be used to improve user experience, electronic accessibility, and functionality of NOAA information.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:

    1. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature and whether arising by general statute or particular program statute or contract, rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, State, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, rule, regulation, or order issued pursuant thereto, or protecting the interest of the Department.

    2. A record from this system of records may be disclosed, as a routine use, to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.

    3. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.

    4. A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate, hearing officer or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations, administrative appeals and hearings.

    5. A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.

    6. A record in this system of records which contains medical information may be disclosed, as a routine use, to the medical advisor of any individual submitting a request for access to the record under the Act and 15 CFR part 4b if, in the sole judgment of the Department, disclosure could have an adverse effect upon the individual, under the provision of 5 U.S.C. 552a(f)(3) and implementing regulations at 15 CFR part 4b.26.

    7. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.

    8. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether the Freedom of Information Act (5 U.S.C. 552) requires disclosure thereof.

    9. A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract but not operating a system of records within the meaning of 5 U.S.C. 552a(m).

    10. A record in this system may be transferred, as a routine use, to the Office of Personnel Management: For personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.

    11. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e. GSA or Commerce) directive. Such disclosure shall not be used to make determinations about individuals.

    12. A record in this system of records may be disclosed to appropriate agencies, entities and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or whether systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.

    13. A record in this system of records may be disclosed to student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees, when they are performing work for the Department and/or its agencies, as authorized by law, as needed to perform their assigned Agency functions.

    DISCLOSURE TO CONSUMER REPORTING AGENCIES:

    Disclosure to consumer reporting agencies pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) and the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).

    POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE:

    Computerized database (in some instances, also CDs; back-up files stored on tape and/or paper records stored in file folders in locked metal cabinets and/or locked rooms).

    RETRIEVABILITY:

    Records are organized and retrieved by category of entity.

    SAFEGUARDS:

    The system of records is stored in a building with doors that are locked during and after business hours. Visitors to the facility must register with security guards and must be accompanied by Federal personnel at all times. Paper records are stored in a locked room and/or a locked file cabinet. Electronic records containing Privacy Act information are protected by a user identification/password. The user identification/password is issued to individuals as authorized by authorized personnel.

    All electronic information disseminated by NOAA adheres to the standards set out in Appendix III, Security of Automated Information Resources, OMB Circular A-130; the Computer Security Act (15 U.S.C. 278g-3 and 278g-4); and the Government Information Security Reform Act, Public Law 106-398; and follows NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems; NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems; and NIST SP 800-53, Recommended Security Controls for Federal Information Systems. NIST 800-122 recommended security controls for protecting Personally Identifiable Information are in place. The Federal Information Processing Standard (FIPS) 199, Standards for Security Categorization of Federal Information and Information Systems, security impact category for these systems is moderate or higher, except for two systems: NOAA4960 and NOAA6101. Contractors that have access to the system are subject to information security provisions in their contracts required by Department policy.

    RETENTION AND DISPOSAL:

    All records are retained and disposed of in accordance with National Archive and Records Administration regulations (36 CFR Chapter XII, Subchapter B—Records Management); Departmental directives and comprehensive records schedules; NOAA Administrative Order 205-01; and the NMFS Records Disposition Schedule, Chapters 1200, 1300, 1400, 1500 and 1600.

    SYSTEM MANGER(S) AND ADDRESS:

    For records at location 1., NESDIS:

    a. NOAA5004, Mark Hall, U.S. Department of Commerce, NOAA Wallops CDA Station, 35663 Chincoteague Road, Wallops, Virginia 23337.

    b. NOAA5009, John Jensen, Federal Building, Room 311, 151 Patton Avenue, Asheville, NC 28801.

    c. NOAA5010, Parmesh Dwivedi, 1315 East West Highway, Silver Spring, MD 20910.

    d. NOAA5036: Juanita Sandidge, 1021 Balch Blvd., Stennis Space Center, MS 39529.

    e. NOAA 5036 Mirror Site: 25 Broadway, E/GC4, Boulder, CO 80305.

    f. NOAA5040: Kern Witcher, 2110 Pleasant Valley Road, Fairmont, WV 26554.

    g. NOAA5045: Linda Stathoplos, 4231 Suitland Rd., Suitland, MD 20746.

    For records at location 2., NMFS:

    a. NOAA4010: Kevin Schulke, 1315 East West Highway, Silver Spring, MD 20910.

    b. NOAA4960: Donald Tieman, 2570 Dole Street, Honolulu, HI 96822.

    For records at location 3., NOS:

    a. NOAA6001: Tim Morris, 1305 East West Highway, Floor 13, Silver Spring, MD 20910.

    b. NOAA6101: Paul Scholz, 2234 S. Hobson Ave, Charleston, SC 29405.

    c. NOAA6301: Linda Matthews, 1305 East West Highway, 13th Floor, Silver Spring, MD 20910.

    d. NOAA6501: Kathryn Ries, 1315 East West Highway, Floors 5, 6 & 7, Silver Spring, MD 20910.

    For records at location 4., NWS:

    a. NOAA8860: David Glotfelty, 5830 University Research Court, College Park, MD 20740.

    b. NOAA8874: Andy Rost, National Operations Hydrologic Remote Sensing Center, 1735 Lake Dr. West, Chanhassen, MN 55317.

    c. NOAA8884: John Duxby, Southern Region Headquarters, 819 Taylor St., Rm. 10A05C, Fort Worth, TX 76102.

    d. NOAA8885: Sean Wink, Western Region Headquarters, 125 South State St., Salt Lake City, UT 84103.

    NOTIFICATION PROCEDURE:

    Individuals seeking to determine whether information about them is contained in this system should address written inquiries to the National or Line Office Privacy Act Officers:

    Privacy Act Officer, NOAA, 1305 East West Highway, Room 7437, Silver Spring, MD 20910.

    Privacy Act Officer, NESDIS, 1335 East West Highway, Room 8245, Silver Spring, MD 20910.

    Privacy Act Officer, NMFS, 1315 East West Highway, Room 10843, Silver Spring, MD 20910.

    Privacy Act Officer, NOS, 1305 East West Highway, Rm. 13236, Silver Spring, MD 20910.

    Privacy Act Officer, NWS, 1325 East West Highway, Room 18426, Silver Spring, MD 20910.

    Written requests must be signed by the requesting individual. Requestor must make the request in writing and provide his/her name, address, and date of the request and record sought. All such requests must comply with the inquiry provisions of the Department's Privacy Act rules which appear at 15 CFR part 4, Appendix A.

    RECORD ACCESS PROCEDURES:

    Requests for access to records maintained in this system of records should be addressed to the same address given in the Notification section above.

    CONTESTING RECORD PROCEDURES:

    The Department's rules for access, for contesting contents, and appealing initial determinations by the individual concerned are provided for in 15 CFR part 4, Appendix A.

    RECORD SOURCE CATEGORIES:

    Information in this system will be collected from individuals requesting or providing NOAA mission-related information.

    EXEMPTIONS CLAIMED FOR THE SYSTEM:

    None.

    Michael J. Toland, Department of Commerce, Deputy Chief FOIA Officer, Department Privacy Act Officer.
    [FR Doc. 2017-00494 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE Economic Development Administration Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance AGENCY:

    Economic Development Administration, Department of Commerce.

    ACTION:

    Notice and opportunity for public comment.

    Pursuant to Section 251 of the Trade Act 1974, as amended (19 U.S.C. 2341 et seq.), the Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of these firms contributed importantly to the total or partial separation of the firm's workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

    List of Petitions Received by EDA for Certification Eligibility To Apply for Trade Adjustment Assistance [12/24/2016 through 12/31/2016] Firm name Firm address Date
  • accepted for
  • investigation
  • Product(s)
    Throttle Up, Corporation d/b/a Throttle Up! Corporation 141 Burnett Drive Durango, CO 80301 12/29/2016 The firm manufactures toy model train components and accessories.

    Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.

    Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

    Miriam Kearse, Lead Program Analyst.
    [FR Doc. 2017-00535 Filed 1-11-17; 8:45 am] BILLING CODE 3510-WH-P
    DEPARTMENT OF COMMERCE International Trade Administration Proposed Information Collection; Comment Request; Request for Duty-Free Entry of Scientific Instrument or Apparatus AGENCY:

    Enforcement and Compliance (E&C), International Trade Administration, 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 March 13, 2017.

    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 Charlie Michael, Enforcement and Compliance (E&C), phone number 202-482-0596, or via the internet at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The Departments of Commerce and Homeland Security (DHS) are required to determine whether nonprofit institutions established for scientific or educational purposes are entitled to duty-free entry for scientific instruments the institutions import under the Florence Agreement. Form ITA-338P enables: (1) DHS to determine whether the statutory eligibility requirements for the institution and the instrument are fulfilled, and (2) Commerce to make a comparison and finding as to the scientific equivalency of comparable instruments being manufactured in the United States. Without the collection of the information, DHS and Commerce would not have the necessary information to carry out the responsibilities of determining eligibility for duty-free entry assigned by law.

    II. Method of Collection

    A copy of Form ITA-338P is provided on and downloadable from a Web site at http://enforcement.trade.gov/sips/sipsform/ita-338p.pdf or the potential applicant may request a copy from the Department. The applicant completes the form and then forwards it via mail to DHS.

    Upon acceptance by DHS as a valid application, the application is transmitted to Commerce for further processing.

    III. Data

    OMB Control Number: 0625-0037.

    Form Number(s): ITA-338P.

    Type of Review: Regular submission.

    Affected Public: State or Local government; Federal agencies; not for-profit institutions.

    Estimated Number of Respondents: 65.

    Estimated Time per Response: 2 hours.

    Estimated Total Annual Burden Hours: 130.

    Estimated Total Annual Cost to Public: $2,138.

    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.

    Sheleen Dumas, PRA Departmental Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-00470 Filed 1-11-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF152 Council Coordination Committee Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    NMFS will host a meeting of the Council Coordination Committee (CCC), consisting of the Regional Fishery Management Council chairs, vice chairs, and executive directors on February 28-March 1, 2017. The intent of this meeting is to discuss issues of relevance to the Councils and NMFS, including issues related to the implementation of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act. Agenda items include discussions on budget allocations for FY2017 and budget planning for FY2018; an update on current joint science initiatives, including Ecosystem Based Fisheries Management; the FY2017 legislative outlook; updates on planning for the CCC Scientific Coordination Committee meeting, NMFS bycatch reduction strategy, the NMFS National Standard 1 guidance and implementation, Marine Recreational Information Program updates, stock assessment improvement plan; and other topics related to implementation of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act.

    DATES:

    The meeting will begin at 8:30 a.m. on Tuesday, February 28, 2017, recess at 5:00 p.m. or when business is complete; and reconvene at 8:30 a.m. on Wednesday, March 1, 2017, and adjourn by 4:30 p.m. or when business is complete.

    ADDRESSES:

    The meeting will be held at the Ritz-Carlton, Pentagon City, 1250 South Hayes Street; Arlington, VA 22202; Telephone: (703) 415-5000.

    FOR FURTHER INFORMATION CONTACT:

    Brian Fredieu: telephone 301-427-8505 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Magnuson-Stevens Fishery Conservation and Management Reauthorization Act established the CCC by amending Section 302 (16 U.S.C. 1852) of the MSA. The committee consists of the chairs, vice chairs, and executive directors of each of the eight Regional Fishery Management Councils authorized by the MSA or other Council members or staff. NMFS will host this meeting and provide reports to the CCC for its information and discussion. All sessions are open to the public. Updates to this meeting will be provided in subsequent notices and additional information will be posted on http://www.nmfs.noaa.gov/sfa/management/councils/ccc/ccc.htm when available.

    The CCC will meet as late as necessary to complete scheduled business.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Brian Fredieu at 301-427-8505 at least five working days prior to the meeting.

    Dated: January 9, 2017. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-00558 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Alaska Region Crab Permits 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 March 13, 2017.

    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 Sally Bibb, (907) 586-7389 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for extension of a currently approved information collection.

    The king and Tanner crab fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands, Alaska, are managed under the Fishery Management Plan for Bering Sea and Aleutian Islands King and Tanner Crabs (FMP). The North Pacific Fishery Management Council prepared the FMP under the Magnuson-Stevens Fishery Conservation and Management Act as amended in 2006. The National Marine Fisheries Service (NMFS) manages the crab fisheries in the waters off the coast of Alaska under the FMP. Regulations implementing the FMP and all amendments to the Crab Rationalization Program (CR Program) appear at 50 CFR part 680. Program details are found at: http://www.alaskafisheries.noaa.gov/regs/680/default.htm.

    The CR Program balances the interests of several groups who depend on the crab fisheries. The CR Program addresses conservation and management issues associated with the previous derby fishery, reduces bycatch and associated discard mortality, and increases the safety of crab fishermen by ending the race for fish. Share allocations to harvesters and processors, together with incentives to participate in fishery cooperatives, increases efficiencies, provides economic stability, and facilitates compensated reduction of excess capacities in the harvesting and processing sectors. Community interests are protected by Western Alaska Community Development Quota allocations and regional landing and processing requirements, as well as by several community protection measures.

    NMFS established the CR Program as a catch share program for nine crab fisheries in the BSAI, and assigned quota share (QS) to persons and processor quota share (PQS) to processors based on their historic participation in one or more of these nine crab fisheries during a specific period. The CR Program components include QS allocation, PQS allocation, individual fishing quota (IFQ) issuance, and individual processing quota (IPQ) issuance, quota transfers, use caps, crab harvesting cooperatives, protections for Gulf of Alaska groundfish fisheries, arbitration system, monitoring, economic data collection, and cost recovery fee collection.

    II. Method of Collection

    Respondents have a choice of either electronic or paper forms. Methods of submittal include online, email of electronic forms, mail, and facsimile transmission of paper forms.

    III. Data

    OMB Control Number: 0648-0514.

    Form Number: None.

    Type of Review: Regular submission (extension of a currently approved collection).

    Affected Public: Individuals or households; business or other for-profit organizations.

    Estimated Number of Respondents: 1,993.

    Estimated Time per Response: Annual application for crab IFQ permit, application for Crab IPQ permit, application to become an eligible crab community organization (ECCO), 150 minutes each; application for an Annual Crab Harvesting Cooperative IFQ Permit, Right of first refusal (ROFR) contracts and waivers, 1 hour each; annual application for Crab Converted CPO QS and CPO IFQ and application for Registered Crab Receiver (RCR) Permit, BSAI Crab Rationalization Program Quota Share Beneficiary Designation Form, 30 minutes; application for Crab IFQ Hired Master Permit and application for Federal crab vessel permit (FCVP) 21 minutes each; application for eligibility to receive crab QS/IFQ or PQS/IPQ by transfer, application for transfer of crab IFQ, application for transfer of crab QS/IFQ to or from an ECCO, Application to transfer crab QS or PQS, application for Annual Exemption from Western Aleutian Islands Golden King Crab West Region Delivery Requirements, Community Impact Report or IPQ Holder Report (North or South Response Report), 2 hours each; ECCO Annual report and appeal of denial to NMFS decisions, 4 hours each; application for transfer of IFQ between crab harvesting cooperatives, electronic, 5 minutes, non-electronic, 2 hours; application to Transfer Crab IPQ, electronic, 1 hour; non-electronic, 2 hours; CDQ notification of community representative, 5 hours; application for exemption from CR Crab North or South Region Delivery Requirements and North or South Region Delivery Exemption Report, 20 hours each.

    Estimated Total Annual Burden Hours: 7,226.

    Estimated Total Annual Cost to Public: $13,841 in recordkeeping/reporting 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: January 9, 2017. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2017-00557 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF085 Marine Mammals; File Nos. 18059 and 19655 AGENCY:

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

    ACTION:

    Notice; receipt of applications.

    SUMMARY:

    Notice is hereby given that David Wiley, Ph.D., Stellwagen Bank National Marine Sanctuary, 175 Edward Foster Road, Scituate, MA 02066 and Adam Pack, Ph.D., University of Hawaii at Hilo, 200 West Kawili Street, Hilo, HI 96720, have applied in due form for permits to conduct scientific research on cetaceans.

    DATES:

    Written, telefaxed, or email comments must be received on or before February 13, 2017.

    ADDRESSES:

    The applications and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 18059 or 19655 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on these applications should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on these applications would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Sara Young or Amy Hapeman (File No. 18059), Carrie Hubard or Shasta McClenahan (File No. 19655), (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permits are requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR 222-226).

    File No. 18059: The applicant requests a five-year scientific research permit to investigate the foraging ecology, habitat use, physiology, and acoustic and social behavior of humpback (Megaptera noveaeangliae), fin (Balaenoptera physalus), minke (B. acutorostrata), and sei (B. borealis) whales in the Gulf of Maine. Up to 130 adult and juvenile humpbacks, 90 fin, 60 minke, and 70 sei whales would be approached for suction cup tagging, prey mapping, obtaining biological samples including biopsies, and photo ID. Up to 10 humpback calves, 5 fin calves, and 4 sei calves would also be approached for tagging and blow sampling. Up to 690 humpback, 480 fin, 250 minke, and 370 sei whales would be incidentally harassed during this research.

    File No. 19655: The applicant proposes to study humpback whales and other cetacean species in the waters off the Hawaiian Islands and Alaska. Research methods include passive acoustics, photo-identification, photogrammetry, opportunistic collection of fecal and skin samples, and remote biopsy sampling. A subset of humpback whales would also receive suction cup tags. Other endangered species targeted for study include: Blue (B. musculus), bowhead (Balaena mysticetus), fin, North Pacific right (Eubalaena japonica), sei, and sperm whales (Physeter macrocephalus) and the Main Hawaiian Insular stock of false killer whales (Pseudorca crassidens). An additional 21 marine mammal species would also be studied. The objectives of the research are to continue the long-term population study of the behavior, biology, and communication systems of humpback whales and other cetaceans. Specific topics to be investigated include individual life histories, social roles, migration, habitat use, distribution, and evolution of humpback song. The permit would be valid for five years.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the applications to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: January 6, 2017. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-00472 Filed 1-11-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF084 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Rocky Intertidal Monitoring Surveys Along the Oregon and California Coasts AGENCY:

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

    ACTION:

    Notice; proposed incidental harassment authorization; request for comments.

    SUMMARY:

    NMFS has received an application from the Partnership for Interdisciplinary Study of Coastal Oceans (PISCO) at the University of California (UC) Santa Cruz for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to rocky intertidal monitoring surveys. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to PISCO to incidentally take, by Level B harassment only, marine mammals during the specified activity.

    DATES:

    Comments and information must be received no later than February 13, 2017.

    ADDRESSES:

    Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is [email protected]. NMFS is not responsible for email comments sent to addresses other than the one provided here. Comments sent via email, including all attachments, must not exceed a 25-megabyte file size.

    Instructions: All comments received are a part of the public record and will generally be posted to http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    An electronic copy of the application containing a list of the references used in this document may be obtained by writing to the address specified above, telephoning the contact listed below (see FOR FURTHER INFORMATION), or online at: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm. PISCO's 2016-17 monitoring report can also be found at this Web site. Documents cited in this notice may also be viewed, by appointment, during regular business hours, at the aforementioned address.

    FOR FURTHER INFORMATION CONTACT:

    Robert Pauline, Office of Protected Resources, NMFS, (301) 427-8401.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking, other means of effecting the least practicable impact on the species or stock and its habitat, and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).”

    Summary of Request

    On September 23, 2016 NMFS received an application from PISCO for the taking of marine mammals incidental to rocky intertidal monitoring surveys along the Oregon and California coasts. NMFS determined that the application was adequate and complete on October 9, 2016. NMFS has previously issued four IHAs for this ongoing project (77 FR 72327, December 5, 2012; 78 FR 79403, December 30, 2013; 79 FR 73048, December 9, 2014; 81 FR 7319, February 2, 2016).

    The research group at UC Santa Cruz operates in collaboration with two large-scale marine research programs: PISCO and the Multi-agency Rocky Intertidal Network (MARINe). The research group at UC Santa Cruz (PISCO) is responsible for many of the ongoing rocky intertidal monitoring programs along the Pacific coast. Monitoring occurs at rocky intertidal sites, often large bedrock benches, from the high intertidal to the water's edge. Long-term monitoring projects include Community Structure Monitoring, Intertidal Biodiversity Surveys, Marine Protected Area Baseline Monitoring, Intertidal Recruitment Monitoring, and Ocean Acidification. Research is conducted throughout the year along the California and Oregon coasts and will continue indefinitely. Most sites are sampled one to two times per year over a 4-6 hour period during a negative low tide series. This IHA, if issued, would be effective for a 12-month period. The following specific aspects of the proposed activities are likely to result in the take of marine mammals: Presence of survey personnel near pinniped haulout sites and unintentional approach of survey personnel towards hauled out pinnipeds. Take, by Level B harassment only, of individuals of California sea lions (Zalophus californianus), harbor seals (Phoca vitulina richardii), and northern elephant seals (Mirounga angustirostris) is anticipated to result from the specified activity.

    Description of the Specified Activity Overview

    PISCO proposes to continue rocky intertidal monitoring work that has been ongoing for 20 years. PISCO focuses on understanding the nearshore ecosystems of the U.S. west coast through a number of interdisciplinary collaborations. The program integrates long-term monitoring of ecological and oceanographic processes at dozens of sites with experimental work in the lab and field. A short description of project components is found below. Additional information can be found in PISCO's application (see ADDRESSES).

    Dates and Duration

    PISCO's research is conducted throughout the year. Most sites are sampled one to two times per year over a 1-day period (4-6 hours per site) during a negative low tide series. Due to the large number of research sites, scheduling constraints, the necessity for negative low tides and favorable weather/ocean conditions, exact survey dates are variable and difficult to predict. Some sampling may occur in all months.

    Specified Geographic Region

    Sampling sites occur along the California and Oregon coasts. Community Structure Monitoring sites range from Ecola State Park near Cannon Beach, Oregon to Government Point located northwest of Santa Barbara, California. Biodiversity Survey sites extend from Ecola State Park south to Cabrillo National Monument in San Diego County, California. Exact locations of sampling sites can be found in Tables 1 and 2 of PISCO's application.

    Detailed Description of Activities

    Community Structure Monitoring involves the use of permanent photoplot quadrats which target specific algal and invertebrate assemblages (e.g. mussels, rockweeds, barnacles). Each photoplot is photographed and scored for percent cover. The Community Structure Monitoring approach is based largely on surveys that quantify the percent cover and distribution of algae and invertebrates that constitute these communities. This approach allows researchers to quantify both the patterns of abundance of targeted species, as well as characterize changes in the communities in which they reside. Such information provides managers with insight into the causes and consequences of changes in species abundance. There are 47 Community Structure sites, each of which is surveyed over a 1-day period during a low tide series one to two times a year.

    Biodiversity Surveys are part of a long-term monitoring project and are conducted every 3-5 years across 140 established sites. Note that many, but not all, of the 47 Community Structure sites are also Biodiversity Survey sites. Thirty-eight of the Community Structure sites are utilized for Biodiversity Surveys, leaving nine sites that are only Biodiversity Survey locations. These Biodiversity Surveys involve point contact identification along permanent transects, mobile invertebrate quadrat counts, sea star band counts, and tidal height topographic measurements.

    Sixteen Biodiversity Survey sites will be visited as part of this proposed IHA including Point Arena, Saunders Reef, Del Mar Landing, Gerstle Cove, Chimney Rock, Fitzgerald Marine Reserve, Ano Nuevo, Diablo, Jajolla Caves, Sea Ridge, Point Sierra Nevada, Cayucos, Hazards, Stairs, Treasure Island, and Cabrillo Zone III. Four of the Biodiversity Survey sites are also Community Structure sites, leaving 12 sites that are only Biodiversity Survey sites. As such, a total of 59 sites would be visited under the proposed IHA.

    The intertidal zones where PISCO conducts intertidal monitoring are also areas where pinnipeds can be found hauled out on the shore at or adjacent to some research sites. Pinnipeds are likely to be observed at 17 out of the 59 survey sites. Accessing portions of the intertidal habitat at these locations may cause incidental Level B (behavioral) harassment of pinnipeds through some unavoidable approaches if pinnipeds are hauled out directly in the study plots or while biologists walk from one location to another. No motorized equipment is involved in conducting these surveys.

    Description of Marine Mammals in the Area of the Specified Activity

    Several pinniped species can be found along the California and Oregon coasts. The three that are most likely to occur at some of the research sites are California sea lion, harbor seal, and northern elephant seal. PISCO researchers have seen very small numbers (i.e., five or fewer) of Steller sea lions at one of the sampling sites. However, these sightings are extremely rare.

    We refer the public to Carretta et al. (2016) for general information on these species, which are presented below this section. The publication is available at: http://www.nmfs.noaa.gov/pr/sars/species.htm. Additional information on the status, distribution, seasonal distribution, and life history can also be found in PISCO's application.

    Northern Elephant Seal

    Northern elephant seals range widely throughout the eastern Pacific for most of the year to forage. They return to haul-out locations along the west coast of the continental United States including the Channel Islands, the central California coast, and islands off of Baja California to breed and molt. Breeding occurs from December through early spring, with males returning to haul-out locations earlier than females to establish dominance hierarchies. Molting occurs from late April to August, with juveniles and adult females returning earlier than adult males (Reeves et al., 2002). Due to very little movement between colonies in Mexico and those in California, the California population is considered to be a separate stock (Carretta et al., 2010).

    This species was hunted by indigenous peoples for several thousand years and by commercial sealers in the 1800s. By the late 1800s the species was thought to be extinct, although several were seen on Guadalupe Island in the 1880s and a few dozen to several hundred survived off of Mexico (Stewart et al., 1994). The population began increasing in the early 1900s and progressively colonized southern and central California through the 1980s (Reeves et al., 2002).

    According to the 2015 Pacific Marine Mammal Stock Assessment, the minimum population size of the California stock is 81,368 individuals and the estimated population size is 179,000 (Carretta et al., 2016, Lowry et al., 2014). This species has grown at 3.8 percent annually since 1988 (Lowry et al., 2014). Northern elephant seals are not listed under the Endangered Species Act (ESA) and are not a strategic species nor considered depleted under the MMPA. The most recent monitoring report (2016) recorded four takes of elephant seals. Thirty takes were authorized under the IHA. All were recorded at Piedras Blancas.

    California Sea Lions

    California sea lions are distributed along the west coast of North America from British Columbia to Baja California and throughout the Gulf of California. Breeding occurs on offshore islands along the west coast of Baja California and the Gulf of California as well as on the California Channel Islands. There are three recognized California sea lion stocks (U.S. stock, Western Baja stock, and the Gulf of California stock) with the U.S. stock ranging from the U.S./Mexico border into Canada. Although there is some movement between stocks, U.S. rookeries are considered to be isolated from rookeries off of Baja California (Barlow et al., 1995).

    California sea lions were hunted for several thousand years by indigenous peoples and early hunters. In the early 1900s, sea lions were killed in an effort to reduce competition with commercial fisheries. They were also hunted commercially from the 1920-1940s. Following the passage of the Marine Mammal Protection Act (MMPA) in 1972, as well as limits on killing and harassment in Mexico, the population has rapidly increased (Reeves et al., 2002). Declines is pup production did occur during the 1983-84, 1992-93, 1997-98, and 2003 El Niño events, but production returned to pre- El Niño levels within 2-5 years (Carretta et al., 2016). In 2013, NOAA declared an Unusual Mortality Event (UME) due to the elevated number of sea lion pup strandings in southern California. The cause of this event is thought to be nutritional stress related to declines in prey availability. This UME has continued through 2016 (NMFS 2016). According to the 2015 Pacific Marine Mammal Stock Assessment, California sea lions have a minimum population size of 153,337 individuals and the population is estimated to number 296,750 (Carretta et al., 2016). This species is not listed under the ESA and is not a strategic species nor considered depleted under the MMPA.

    The number of California sea lions historically found at any one of PISCO's study sites is variable, and often no California sea lions are observed during sampling. The most recent monitoring report (2016) reported 19 takes of this species. All takes occurred at Government Point. A total of 60 takes were authorized under the IHA.

    Pacific Harbor Seal

    Pacific harbor seals are not listed as threatened or endangered under the ESA, nor are they categorized as depleted under the MMPA. The most recent census of the California stock of harbor seals occurred in 2012 during which 20,109 hauled-out harbor seals were counted. A 1999 census of the Oregon/Washington harbor seal stock found 16,165 individuals, of which 5,735 were in Oregon (Carretta et al., 2016). The population is estimated to number 30,968 individuals in California and 24,732 individuals in Oregon/Washington (Carretta et al., 2016). At several sites harbor seals are often observed and have the potential to be disturbed by researchers accessing or sampling the site. The largest number of harbor seals occurs at Hopkins in Monterey, CA where often 20-30 adults and occasionally 10-15 pups are hauled-out on a small beach adjacent to the site.

    The animals inhabit near-shore coastal and estuarine areas from Baja California, Mexico, to the Pribilof Islands in Alaska. Pacific harbor seals are divided into two subspecies: P. v. stejnegeri in the western North Pacific, near Japan, and P. v. richardii in the northeast Pacific Ocean. The latter subspecies, recognized as three separate stocks, inhabits the west coast of the continental U.S., including: The outer coastal waters of Oregon and Washington states; Washington state inland waters; and Alaska coastal and inland waters.

    In California, over 500 harbor seal haulout sites are widely distributed along the mainland and offshore islands, and include rocky shores, beaches and intertidal sandbars (Lowry et al., 2005). Harbor seals mate at sea, and females give birth during the spring and summer, although, the pupping season varies with latitude. Pups are nursed for an average of 24 days and are ready to swim minutes after being born. Harbor seal pupping takes place at many locations, and rookery size varies from a few pups to many hundreds of pups. Pupping generally occurs between March and June, and molting occurs between May and July.

    At several sites, harbor seals are often observed and have the potential to be disturbed by researchers accessing or sampling the site. The most recent monitoring report (2016) described a total of 44 takes of harbor seals. A total of 183 takes had been authorized under the IHA.

    Steller Sea Lion

    Steller sea lions range throughout the north Pacific from Japan to the Kamchatka Peninsula, along the Aleutian Islands, into the Gulf of Alaska, and down the west coast of North America to central California. Based on distribution, population dynamics, and genotypic data, the species occurring in United States waters has been divided into two stocks, the eastern U.S. stock (east of Cape Suckling, AK) and the western U.S. stock (west of Cape Sucking, AK) (Loughlin 1997). Breeding of the eastern stock occurs in rookeries in Alaska, British Columbia, Oregon, and California.

    This species was hunted by indigenous peoples for several thousand years throughout its range and as recently as the 1990s in the Aleutian Islands. Individuals from British Columbia to California were also killed in the early 1900s to reduce competition with commercial fisheries. The species dramatically declined from the 1970s to 1990s due to competition with commercial fishing and long-term environmental changes (Reeves et al., 2002). There has also been a continued decrease in population numbers along the southern and central California coast possibly due to a northward shift, and subsequent southern contraction in breeding locations (Pitcher et al., 2007).

    According to the 2015 Alaska Marine Mammal Stock Assessment, the minimum population size of the eastern U.S stock is 59,968 and the estimated population size is between 60,131 and 74,480 individuals (Muto et al., 2016). In 1990, due to accelerating declines across its range, the species was listed as threatened under the ESA. In 2013, the eastern U.S. stock was determined to be recovered and was delisted from the ESA (NMFS 2013) and is, therefore, no longer a strategic species under the MMPA.

    Past monitoring reports have not typically reported Steller sea lion observations. However, in 2009 five Steller sea lions were observed at the Cape Arago, OR site.

    Table 1—Marine Mammals Potentially Present in the Vicinity of Study Areas Species Scientific name Stock ESA/MMPA status; strategic
  • (Y/N) 1
  • Stock abundance (CV, Nmin, most recent abundance survey) 2
    California sea lion Zalophus californianus U.S. -; N 296,750 (n/a; 153,337; 2011). Steller sea lion Eumetopias jubatus Eastern U.S. D; Y 60,131-74,448 (n/a; 36,551; 2013). Harbor seal Phoca vitulina richardii California/Oregon/Washington -; N 30,968 (0.157; 27,348; 2012 [CA])/
  • 24,732 (n/a; n/a [OR/WA].3
  • Northern elephant seal Mirounga angustirostris California breeding stock -; N 179,000 (n/a; 81,368; 2010). 1 ESA status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. 2 CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable. For certain stocks of pinnipeds, abundance estimates are based upon observations of animals (often pups) ashore multiplied by some correction factor derived from knowledge of the specie's (or similar species') life history to arrive at a best abundance estimate; therefore, there is no associated CV. In these cases, the minimum abundance may represent actual counts of all animals ashore. 3 The most recent abundance estimate is >8 years old, there is no current estimate of abundance available for this stock.
    Other Marine Mammals in the Proposed Action Area

    Guadalupe fur seals (Arctocephalus townsendi) and Northern fur seals (Callorhinus ursinus) are occasionally observed within the rage of the study areas. However, Guadalupe fur seals only known breeding colony is on Guadalupe Island, off the Mexican coast. Increasing numbers have been seen on California's Channel Islands, and in recent years, several Guadalupe fur seals have stranded along the central California coast. Northern fur seals have recently re-established a rookery on the Farallon Islands. They rarely come ashore except during pupping and breeding times and are almost never seen on mainland beaches unless they are sick. Given that the likelihood of observing these two fur seal species is quite low, they are not considered further.

    Potential Effects of the Specified Activity on Marine Mammals

    This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity (e.g., personnel presence) have been observed to impact marine mammals. This discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of a take. This section is intended as a background of potential effects and does not consider either the specific manner in which this activity will be carried out or the mitigation that will be implemented, and how either of those will shape the anticipated impacts from this specific activity.

    The appearance of researchers may have the potential to cause Level B harassment of any pinnipeds hauled out at sampling sites. Although marine mammals are never deliberately approached by survey personnel, approach may be unavoidable if pinnipeds are hauled out in the immediate vicinity of the permanent study plots. Disturbance may result in reactions ranging from an animal simply becoming alert to the presence of researchers (e.g., turning the head, assuming a more upright posture) to flushing from the haul-out site into the water. NMFS does not consider the lesser reactions to constitute behavioral harassment, or Level B harassment takes, but rather assumes that pinnipeds that flee some distance or change the speed or direction of their movement in response to the presence of researchers are behaviorally harassed, and thus subject to Level B taking. Animals that respond to the presence of researchers by becoming alert, but do not move or change the nature of locomotion as described, are not considered to have been subject to behavioral harassment (Table 2).

    Numerous studies have shown that human activity can flush harbor seals off haulout sites (Allen et al., 1985; Calambokidis et al., 1991; Suryan and Harvey, 1999). The Hawaiian monk seal (Neomonachus schauinslandi) has been shown to avoid beaches that have been disturbed often by humans (Kenyon 1972). And in one case, human disturbance appeared to cause Steller sea lions to desert a breeding area at Northeast Point on St. Paul Island, Alaska (Kenyon 1962).

    There are three ways in which disturbance, as described previously, could result in more than Level B harassment of marine mammals. All three are most likely to be consequences of stampeding, a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus. The three situations are (1) falling when entering the water at high-relief locations; (2) extended separation of mothers and pups; and (3) crushing of elephant seal pups by large males during a stampede.

    Because hauled-out animals may move towards the water when disturbed, there is the risk of injury if animals stampede towards shorelines with precipitous relief (e.g., cliffs). If disturbed, hauled-out animals in these situations may move toward the water without risk of encountering barriers or hazards that would otherwise prevent them from leaving the area. In these circumstances, the risk of injury, serious injury, or death to hauled-out animals is very low. Thus, research activity poses no risk that disturbed animals may fall and be injured or killed as a result of disturbance at high-relief locations.

    Furthermore, few pups are anticipated to be encountered during the proposed monitoring surveys. A small number of harbor seal, northern elephant seal and California sea lion pups, however, have been observed during past years. Though elephant seal pups are occasionally present when researchers visit survey sites, risk of pup mortalities is very low because elephant seals are far less reactive to researcher presence than the other two species. Harbor seals are very precocious with only a short period of time in which separation of a mother from a pup could occur. Pups are also typically found on sand beaches, while study sites are located in the rocky intertidal zone, meaning that there is typically a buffer between researchers and pups. Finally, the caution used by researchers in approaching sites generally precludes the possibility of behavior, such as stampeding, that could result in extended separation of mothers and dependent pups or trampling of pups.

    Anticipated Effects on Marine Mammal Habitat

    The only habitat modification associated with the proposed activity is the placement of permanent bolts and other sampling equipment in the intertidal. Once a particular study has ended, the respective sampling equipment is removed. No trash or field gear is left at a site. Sampling activities are also not expected to result in any long-term modifications of haulout use or abandonment of haulouts since these sites are only visited 1-2 times per year, which minimizes repeated disturbances. During periods of low tide (e.g., when tides are 0.6 m (2 ft) or less and low enough for pinnipeds to haul-out), we would expect the pinnipeds to return to the haulout site within 60 minutes of the disturbance (Allen et al., 1985). The effects to pinnipeds appear at the most to displace the animals temporarily from their haul out sites, and we do not expect that the pinnipeds would permanently abandon a haul-out site during the conduct of rocky intertidal surveys. Thus, the proposed activity is not expected to have any habitat-related effects that could cause significant or long-term consequences for individual marine mammals or their populations.

    Proposed Mitigation

    In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must, where applicable, set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

    Proposed Mitigation Measures

    PISCO proposes to implement several mitigation measures to reduce potential take by Level B (behavioral disturbance) harassment. Measures include the following:

    • When possible, researchers will observe a site from a distance with binoculars to detect any marine mammals prior to approaching the site. Researchers will approach a site with caution (slowly and quietly) to avoid surprising any hauled-out individuals and to reduce stampeding of individuals towards the water.

    • If possible to avoid pinnipeds along access ways to sites, by locating and taking a different access way, researchers will do so. Researchers will keep a safe distance from and not approach any marine mammal while conducting research, unless it is absolutely necessary to flush a marine mammal in order to continue conducting research (i.e. if a site cannot be accessed or sampled due to the presence of pinnipeds).

    • Researches will monitor the offshore area for predators (such as killer whales and white sharks) and avoid flushing of pinnipeds when predators are observed in nearshore waters. Note that PISCO has never observed an offshore predator while researchers were present at any of the survey sites.

    • Intentional flushing will be avoided if pups are present and nursing pups will not be disturbed.

    • To avoid take of Steller sea lions, any site where they are present will not be approached and will be sampled at a later date. Note that observation of sea lions at survey sites is extremely rare.

    • Researchers will promptly vacate sites at the conclusion of sampling.

    The methodologies and actions noted in this section will be utilized and included as mitigation measures in any issued IHA to ensure that impacts to marine mammals are mitigated to the lowest level practicable. The primary method of mitigating the risk of disturbance to pinnipeds, which will be in use at all times, is the selection of judicious routes of approach to study sites, avoiding close contact with pinnipeds hauled out on shore, and the use of extreme caution upon approach. Each visit to a given study site will last for approximately 4-6 hours, after which the site is vacated and can be re-occupied by any marine mammals that may have been disturbed by the presence of researchers. By arriving before low tide, worker presence will tend to encourage pinnipeds to move to other areas for the day before they haul out and settle onto rocks at low tide.

    Mitigation Conclusions

    NMFS has carefully reviewed PISCO's proposed mitigation measures to ensure these measures would have the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    • The practicability of the measure for applicant implementation.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).

    5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Proposed Monitoring and Reporting

    In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. PISCO has described their long-standing monitoring actions in Section 13 of the Application. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.

    Monitoring measures proposed by the applicant or prescribed by NMFS should accomplish one or more of the following general goals:

    1. An increase in our understanding of the likely occurrence of marine mammal species in the vicinity of the action, i.e., presence, abundance, distribution, and/or density of species.

    2. An increase in our understanding of how many marine mammals are likely to be exposed to levels of disturbance that we associate with specific adverse effects, such as behavioral harassment;

    3. An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

    Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

    Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

    Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

    4. An increased knowledge of the affected species; and

    5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

    PISCO will contribute to the knowledge of pinnipeds in California and Oregon by noting observations of: (1) Unusual behaviors, numbers, or distributions of pinnipeds, such that any potential follow-up research can be conducted by the appropriate personnel; (2) tag-bearing carcasses of pinnipeds, allowing transmittal of the information to appropriate agencies and personnel; and (3) rare or unusual species of marine mammals for agency follow-up.

    Proposed monitoring requirements in relation to PISCO's rocky intertidal monitoring will include observations made by the applicant. Information recorded will include species counts (with numbers of pups/juveniles when possible) of animals present before approaching, numbers of observed disturbances, and descriptions of the disturbance behaviors during the monitoring surveys, including location, date, and time of the event. For consistency, any reactions by pinnipeds to researchers will be recorded according to a three point scale shown in Table 2. Note that only observations of disturbance Levels 2 and 3 should be recorded as takes.

    Table 2—Levels of Pinniped Behavioral Disturbance Level Type of response Definition 1 Alert Seal head orientation or brief movement in response to disturbance, which may include turning head towards the disturbance, craning head and neck while holding the body rigid in a u-shaped position, changing from a lying to a sitting position, or brief movement of less than twice the animal's body length. 2 Movement Movements away from the source of disturbance, ranging from short withdrawals at least twice the animal's body length to longer retreats over the beach, or if already moving a change of direction of greater than 90 degrees. 3 Flush All retreats (flushes) to the water.

    In addition, observations regarding the number and species of any marine mammals observed, either in the water or hauled-out, at or adjacent to a site, are recorded as part of field observations during research activities. Information regarding physical and biological conditions pertaining to a site, as well as the date and time that research was conducted are also noted. This information will be incorporated into a monitoring report for NMFS.

    If at any time the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, PISCO shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the Southwest Regional Stranding Coordinator, NMFS. The report must include the following information:

    (1) Time and date of the incident;

    (2) Description of the incident;

    (3) Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    (4) Description of all marine mammal observations in the 24 hours preceding the incident;

    (5) Species identification or description of the animal(s) involved;

    (6) Fate of the animal(s); and

    (7) Photographs or video footage of the animal(s).

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with PISCO to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. PISCO may not resume the activities until notified by NMFS.

    In the event that an injured or dead marine mammal is discovered and it is determined that the cause of the injury or death is unknown and the death is relatively recent (e.g., in less than a moderate state of decomposition), PISCO shall immediately report the incident to the Office of Protected Resources, NMFS, and the Southwest Regional Stranding Coordinator, NMFS. The report must include the same information identified in the paragraph above IHA. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with PISCO to determine whether additional mitigation measures or modifications to the activities are appropriate.

    In the event that an injured or dead marine mammal is discovered and it is determined that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), PISCO shall report the incident to the Office of Protected Resources, NMFS, and the Southwest Regional Stranding Coordinator, NMFS, within 24 hours of the discovery. PISCO shall provide photographs or video footage or other documentation of the stranded animal sighting to NMFS. Activities may continue while NMFS reviews the circumstances of the incident.

    A draft final report must be submitted to NMFS Office of Protected Resources within 60 days after the conclusion of the 2016-2017 field season or 60 days prior to the start of the next field season if a new IHA will be requested. The report will include a summary of the information gathered pursuant to the monitoring requirements set forth in the IHA. A final report must be submitted to the Director of the NMFS Office of Protected Resources and to the NMFS West Coast Regional Administrator within 30 days after receiving comments from NMFS on the draft final report. If no comments are received from NMFS, the draft final report will be considered to be the final report.

    Monitoring Results From Previously Authorized Activities

    PISCO complied with the mitigation and monitoring that were required under the IHA issued in December 2014. In compliance with the IHA, PISCO submitted a report detailing the activities and marine mammal monitoring they conducted. The IHA required PISCO to conduct counts of pinnipeds present at study sites prior to approaching the sites and to record species counts and any observed reactions to the presence of the researchers.

    From December 17, 2014, through December 16, 2015, PISCO researchers conducted rocky intertidal sampling at numerous sites in California and Oregon (see Table 1 and 2 in PISCO's 2014-2015 monitoring report). During this time period, no injured, stranded, or dead pinnipeds were observed. Tables 7, 8, and 9 in PISCO's monitoring report (see ADDRESSES) outline marine mammal observations and reactions. During this period there were 44 takes of harbor seals, 19 takes of California sea lions, and 4 takes of northern elephant seals. NMFS had authorized the take of 183 harbor seals, 60 California sea lions, and 30 Northern Elephant seals under the IHA.

    Based on the results from the monitoring report, we conclude that these results support our original findings that the mitigation measures set forth in the 2014-2015 IHA effected the least practicable impact on the species or stocks. There were no stampede events this year and most disturbances were Level 1 and 2 from the disturbance scale (Table 2)—meaning the animal did not fully flush but observed or moved slightly in response to researchers. Those that did fully flush to the water did so slowly. Most of these animals tended to observe researchers from the water and then re-haulout farther upcoast or downcoast of the site within approximately 30 minutes of the disturbance.

    Estimated Take by Incidental Harassment

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    All anticipated takes would be by Level B harassment, involving temporary changes in behavior. The proposed mitigation and monitoring measures are expected to minimize the possibility of injurious or lethal takes such that take by injury, serious injury, or mortality is considered remote. Animals hauled out close to the actual survey sites may be disturbed by the presence of researchers and may alter their behavior or attempt to move away from the researchers.

    As discussed earlier, NMFS considers an animal to have been harassed if it moved greater than two times its body length in response to the researcher's presence or if the animal was already moving and changed direction and/or speed, or if the animal flushed into the water. Animals that became alert without such movements were not considered harassed.

    For the purpose of this proposed IHA, only Oregon and California sites that are frequently sampled and have a marine mammal presence during sampling were included in calculating take estimates. Sites where only Biodiversity Surveys are conducted did not provide enough data to confidently estimate takes since they are sampled infrequently (once very 3-5 years). A small number of harbor seal, northern elephant seal and California sea lion pup takes are anticipated as pups may be present at several sites during spring and summer sampling.

    Take estimates are based on marine mammal observations from each site. Marine mammal observations are done as part of PISCO site observations, which include notes on physical and biological conditions at the site. The maximum number of marine mammals, by species, seen at any given time throughout the sampling day is recorded at the conclusion of sampling. A marine mammal is counted if it is seen on access ways to the site, at the site, or immediately up-coast or down-coast of the site. Marine mammals in the water immediately offshore are also recorded. Any other relevant information, including the location of a marine mammal relevant to the site, any unusual behavior, and the presence of pups is also noted.

    These observations formed the basis from which researchers with extensive knowledge and experience at each site estimated the actual number of marine mammals that may be subject to take. Take estimates for each species for which take would be authorized were based on the following equation:

    Take estimate per survey site = (number of expected animals per survey site * number of survey days per survey site)

    Individual species' totals for each survey site were summed to arrive at a total estimated take. In most cases the number of takes is based on the maximum number of marine mammals that have been observed at a site throughout the history of the site (1-3 observation per year for 5-10 years or more) with additional input provided by the researchers with site-specific knowledge and experience. Section 6 in PISCO's application outlines the number of visits per year for each sampling site and the potential number of pinnipeds anticipated to be encountered at each site. Tables 3, 4, 5 in PISCO's application outlines the number of potential takes per site (see ADDRESSES).

    Harbor seals are expected to occur at 16 locations in numbers ranging from 5 to 30 per visit (Table 3 in PISCO's application). It is anticipated that there will be 220 takes of adult harbor seals and 13 takes of weaned pups. Therefore, NMFS proposes to authorize the take of up to 233 harbor seals.

    California sea lions are expected to be present at five sites. Eighty-five adult and five pups are expected to be taken. Therefore, NMFS proposes to authorize the take of 90 California sea lions.

    Northern elephant seals are only expected to occur at one site this year, Piedras Blancs, which will experience two separate visits. Up to 20 adult and 40 pup takes are anticipated. Therefore, NMFS proposes to authorize the take of up to 60 northern elephant seals.

    PISCO researchers report that they have very rarely observed Stellers at any research sites and none have been observed over the last several years. Therefore, PISCO has not requested, and NMFS does not propose to authorize, take of any Steller sea lions.

    NMFS proposes to authorize the take, by Level B harassment only, of 203 harbor seals, 90 California sea lions, and 60 northern elephant seals. These numbers are considered to be maximum take estimates; therefore, actual take may be less if animals decide to haul out at a different location for the day or animals are out foraging at the time of the survey activities.

    Analysis and Preliminary Determinations Negligible Impact Analysis

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, feeding, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, effects on habitat, and the status of the species.

    To avoid repetition, the discussion of our analyses applies generally to the three species for which take is authorized, given that the anticipated effects of these surveys on marine mammals are expected to be relatively similar in nature. Where there are species-specific factors that have been considered, they are identified below.

    No injuries or mortalities are anticipated to occur as a result of PISCO's rocky intertidal monitoring, and none are proposed to be authorized. The risk of marine mammal injury, serious injury, or mortality associated with rocky intertidal monitoring increases somewhat if disturbances occur during breeding season. These situations present increased potential for mothers and dependent pups to become separated and, if separated pairs do not quickly reunite, the risk of mortality to pups (through starvation) may increase. Separately, adult male elephant seals may trample elephant seal pups if disturbed, which could potentially result in the injury, serious injury, or mortality of the pups. The risk of either of these situations is greater in the event of a stampede; however, as described previously, stampede is not considered likely to occur.

    Very few pups are anticipated to be encountered during the proposed monitoring surveys. However, a small number of harbor seal, northern elephant seal and California sea lion pups have been observed at several of the proposed monitoring sites during past years. Harbor seals are very precocious with only a short period of time in which separation of a mother from a pup could occur. Though elephant seal pups are occasionally present when researchers visit survey sites, risk of pup mortalities is very low because elephant seals are far less reactive to researcher presence than the other two species. Further, pups are typically found on sand beaches, while study sites are located in the rocky intertidal zone, meaning that there is typically a buffer between researchers and pups. Finally, the caution used by researchers in approaching sites generally precludes the possibility of behavior, such as stampeding, that could result in extended separation of mothers and dependent pups or trampling of pups. No research would occur where separation of mother and her nursing pup or crushing of pups can become a concern.

    Typically, even those reactions constituting Level B harassment would result at most in temporary, short-term disturbance. In any given study season, researchers will visit sites one to two times per year for a total of 4-6 hours per visit. Therefore, disturbance of pinnipeds resulting from the presence of researchers lasts only for short periods of time and is separated by significant amounts of time in which no disturbance occurs.

    Some of the pinniped species may use some of the sites during certain times of year to conduct pupping and/or breeding. However, some of these species prefer to use offshore islands for these activities. At the sites where pups may be present, PISCO has proposed to implement certain mitigation measures, such as no intentional flushing if dependent pups are present, which will avoid mother/pup separation and trampling of pups.

    Of the marine mammal species anticipated to occur in the proposed activity areas, none are listed under the ESA. Taking into account the mitigation measures that are planned, effects to marine mammals are generally expected to be restricted to short-term changes in behavior or temporary abandonment of haulout sites, Pinnipeds are not expected to permanently abandon any area that is surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual monitoring counts. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed mitigation and monitoring measures, NMFS preliminarily finds that the total marine mammal take from PISCO's rocky intertidal monitoring program will not adversely affect annual rates of recruitment or survival and therefore will have a negligible impact on the affected species or stocks.

    Small Numbers

    Table 3 presents the abundance of each species or stock, the proposed take estimates, and the percentage of the affected populations or stocks that may be taken by Level B harassment.The numbers of animals authorized to be taken would be considered small relative to the relevant stocks or populations (0.75-0.94 percent for harbor seals, and <0.01 percent for California sea lions and northern elephant seals). Because these are maximum estimates, actual take numbers are likely to be lower, as some animals may not be present on survey days.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, we preliminarily find that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Table 3—Population Abundance Estimates, Total Proposed Level B Take, and Percentage of Population That May Be Taken for the Potentially Affected Species During the Proposed Rocky Intertidal Monitoring Program Species Abundance * Total proposed level B take Percentage of stock or
  • population
  • Harbor seal 1 30,968
  • 2 24,732
  • 233 <0.75-0.94
    California sea lion 296,750 90 <0.01 Northern elephant seal 179,000 60 <0.01 * Abundance estimates are taken from the 2015 U.S. Pacific Marine Mammal Stock Assessments (Carretta et al., 2016). 1 California stock abundance estimate. 2 Oregon/Washington stock abundance estimate from 1999-Most recent surveys.
    Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses

    There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    No species listed under the ESA are expected to be affected by these activities. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.

    National Environmental Policy Act (NEPA)

    In 2012, we prepared an Environmental Assessment (EA) analyzing the potential effects to the human environment from conducting rocky intertidal surveys along the California and Oregon coasts and issued a Finding of No Significant Impact (FONSI) on the issuance of an IHA for PISCO's rocky intertidal surveys in accordance with section 6.01 of the NOAA Administrative Order 216-6 (Environmental Review Procedures for Implementing the National Environmental Policy Act, May 20, 1999). We will review activities and impacts from the 2012 EA to determine if the proposed activities fall within the scope of the EA. We will also review any public comments submitted concerning the 2012 EA.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposes to issue an IHA to PISCO for conducting rocky intertidal monitoring research activities in California and Oregon between February 3, 2017 and February 2, 2018, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.

    This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).

    1. This IHA is valid from February 3, 2017 through February 2, 2018.

    2. This IHA is valid only for specified activities associated with rocky intertidal monitoring surveys at specific sites along the U.S. California and Oregon coasts.

    3. General Conditions.

    a. A copy of this IHA must be in the possession of personnel operating under the authority of this authorization.

    b. The incidental taking of marine mammals, by Level B harassment only, is limited to the following species along the Oregon and California coasts:

    i. 203 harbor seal (Phoca vitulina richardii);

    ii. 90 California sea lion (Zalophus californianus);

    iii. 60 northern elephant seal (Mirounga angustirostris); and

    c. The taking by injury (Level A harassment), serious injury, or death of any of the species listed in condition 3(b) of the IHA or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.

    4. Mitigation Measures: The holder of this IHA is required to implement the following mitigation measures:

    a. Researchers will observe a site from a distance with binoculars (if necessary) to detect any marine mammals prior to approaching the site. Researchers will approach a site with caution (slowly and quietly) to avoid surprising any hauled-out individuals and to reduce stampeding of individuals towards the water.

    b. Researchers will avoid pinnipeds along access ways to sites, by locating and taking a different access way if possible.

    c. Researchers will keep a safe distance from and not approach any marine mammal while conducting research, unless it is absolutely necessary to flush a marine mammal in order to continue conducting research (i.e. if a site cannot be accessed or sampled due to the presence of pinnipeds).

    d. Researches will monitor the offshore area for predators (such as killer whales and white sharks) and avoid flushing of pinnipeds when predators are observed in nearshore waters.

    e. Intentional flushing will be avoided if pups are present. Staff shall reschedule work at sites where pups are present, unless other means of accomplishing the work can be done without causing disturbance to mothers and dependent pups.

    f. Any site where Steller sea lions are present will not be approached and will be sampled at a later date.

    g. Personnel shall vacate the study area as soon as sampling of the site is completed.

    5. Monitoring: The holder of this IHA is required to conduct monitoring of marine mammals present at study sites prior to approaching the sites.

    a. Information to be recorded shall include the following:

    i. Species counts (with numbers of pups/juveniles); and

    ii. Numbers of disturbances, by species and age, according to a three-point scale of intensity including:

    (1) seal head orientation or brief movement in response to disturbance, which may include turning head towards the disturbance, craning head and neck while holding the body rigid in a u-shaped position, changing from a lying to a sitting position, or brief movement of less than twice the animal's body length, “alert”;

    (2) movements away from the source of disturbance, ranging from short withdrawals at least twice the animal's body length to longer retreats over the beach, or if already moving a change of direction of greater than 90 degrees, “movement”; and

    (3) all retreats (flushes) to the water, “flush”.

    iii. Observations of disturbance Levels 2 and 3 are recorded as takes.

    6. Reporting: The holder of this IHA is required to:

    a. Report observations of unusual behaviors, numbers, or distributions of pinnipeds, or of tag-bearing carcasses, to NMFS Southwest Fisheries Science Center (SWFSC).

    b. Submit a draft monitoring report to NMFS Office of Protected Resources within 60 days after the conclusion of the 2015-2016 field season or 60 days prior to the start of the next field season if a new IHA will be requested. A final report shall be prepared and submitted within 30 days following resolution of any comments on the draft report from NMFS. This report must contain the informational elements described above, at minimum.

    c. Reporting injured or dead marine mammals:

    i. In the event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, PISCO shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the Southwest Regional Stranding Coordinator, NMFS. The report must include the following information:

    (1) Time and date of the incident;

    (2) Description of the incident;

    (3) Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    (4) Description of all marine mammal observations in the 24 hours preceding the incident;

    (5) Species identification or description of the animal(s) involved;

    (6) Fate of the animal(s); and

    (7) Photographs or video footage of the animal(s).

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with PISCO to determine what measures are necessary to minimize the