Federal Register Vol. 80, No.145,

Federal Register Volume 80, Issue 145 (July 29, 2015)

Page Range45051-45394
FR Document

80_FR_145
Current View
Page and SubjectPDF
80 FR 45250 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the NYSE Arca Equities Schedule of Fees and Charges for Exchange ServicesPDF
80 FR 45393 - National Korean War Veterans Armistice Day, 2015PDF
80 FR 45389 - Anniversary of the Americans with Disabilities Act, 2015PDF
80 FR 45227 - Promise Zones Initiative: Proposed Third Round Selection Process Solicitation of CommentPDF
80 FR 45184 - Implementation of Determinations Under Section 129 of the Uruguay Round Agreements Act: Aluminum Extrusions From the People's Republic of China; Certain Circular Welded Carbon Quality Steel Line Pipe From the People's Republic of China; Certain Kitchen Appliance Shelving and Racks From the People's Republic of China; Certain Magnesia Carbon Bricks From the People's Republic of China; Certain New Pneumatic Off-the-Road Tires From the People's Republic of China; Certain Oil Country Tubular Goods From the People's Republic of China; Certain Potassium Phosphate Salts from the People's Republic of China; Certain Steel Grating From the People's Republic of China; Certain Tow Behind Lawn Groomers and Certain Parts Thereof From the People's Republic of China; Circular Welded Austenitic Stainless Pressure Pipe From the People's Republic of China; Citric Acid and Certain Citrate Salts From the People's Republic of China; Lightweight Thermal Paper From the People's Republic of China; Narrow Woven Ribbons With Woven Selvedge From the People's Republic of China; Prestressed Concrete Steel Wire Strand From the People's Republic of China; Raw Flexible Magnets From the People's Republic of China; Sodium Nitrite From the People's Republic of ChinaPDF
80 FR 45183 - Certain Cut-to-Length Carbon Quality Steel Plate from the Republic of Korea: Partial Rescission of Countervailing Duty Administrative Review; 2014PDF
80 FR 45230 - Final Decision on Remand Against Federal Acknowledgment of the Duwamish Tribal OrganizationPDF
80 FR 45182 - Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2013-2014PDF
80 FR 45192 - Multilayered Wood Flooring From the People's Republic of China: Initiation of Antidumping Duty New Shipper Reviews; 2014-2015PDF
80 FR 45051 - Fees for Testing, Evaluation, and Approval of Mining ProductsPDF
80 FR 45267 - Notification of United States-Chile Environment Affairs Council and Joint Commission on Environmental Cooperation MeetingsPDF
80 FR 45219 - Pesticide Experimental Use Permit; Receipt of Application; Comment RequestPDF
80 FR 45218 - Pesticide Cumulative Risk Assessment: Framework for Screening Analysis; Notice of Availability and Request for CommentPDF
80 FR 45079 - Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from the Requirement of a TolerancePDF
80 FR 45220 - Announcement of the Board of Directors for the National Environmental Education FoundationPDF
80 FR 45085 - National Oil and Hazardous Substance Pollution Contingency Plan National Priorities List: Deletion of the Crown Vantage Landfill Superfund SitePDF
80 FR 45225 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment RequestPDF
80 FR 45221 - Notice of Agreements FiledPDF
80 FR 45222 - National Vaccine Injury Compensation Program; List of Petitions ReceivedPDF
80 FR 45086 - Endangered and Threatened Wildlife and Plants; Listing the Honduran Emerald Hummingbird (Amazilia luciae)PDF
80 FR 45197 - Endangered and Threatened Species; Take of Anadromous FishPDF
80 FR 45222 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
80 FR 45222 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
80 FR 45270 - Deepwater Port License Application: Delfin LNG LLC, Delfin LNG Deepwater PortPDF
80 FR 45231 - Draft Environmental Impact Statement and Visitor Use Management Plan for Delaware Water Gap National Recreation Area, Pennsylvania and New JerseyPDF
80 FR 45231 - Notice of Termination of the Environmental Impact Statement for the General Management Plan for Martin Van Buren National Historic Site, New YorkPDF
80 FR 45207 - Submission for OMB Review; Comment RequestPDF
80 FR 45206 - Submission for OMB Review; Comment RequestPDF
80 FR 45274 - Proposed Agency Information Collection Activities; Comment RequestPDF
80 FR 45226 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 45100 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Trimester Total Allowable Catch Area Closure for the Common Pool FisheryPDF
80 FR 45205 - Agency Information Collection Activities Under OMB ReviewPDF
80 FR 45098 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
80 FR 45248 - Arts Advisory Panel MeetingsPDF
80 FR 45226 - 1670-0023 Technical Assistance Request and Evaluation; CorrectionPDF
80 FR 45227 - Establishment of the U.S. Immigration and Customs Enforcement Advisory Committee on Family Residential Centers and Solicitation of Nominations for MembershipPDF
80 FR 45233 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Members of SGIP 2.0, Inc.PDF
80 FR 45234 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Open Mobile AlliancePDF
80 FR 45233 - Certain Formatted Magnetic Data Storage Tapes and Cartridges Containing Same; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on SettlementPDF
80 FR 45235 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Allseen Alliance, Inc.PDF
80 FR 45234 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on Mechanical Stratigraphy and Natural Deformation in Eagle Ford Formation and Equivalent Boquillas Formation, South-Central and West Texas (Eagle Ford II)PDF
80 FR 45206 - Notice of LG Electronics Tianjin Appliance Co., Ltd. and LG Electronics USA Inc., Provisional Acceptance of a Settlement Agreement and Order, CPSC Docket No. 15-C0005; CorrectionPDF
80 FR 45204 - Agency Information Collection Activities Under OMB ReviewPDF
80 FR 45213 - Equitrans, L.P.; Notice of ApplicationPDF
80 FR 45214 - Combined Notice of FilingsPDF
80 FR 45216 - Combined Notice of Filings #1PDF
80 FR 45215 - Combined Notice of Filings #2PDF
80 FR 45209 - Combined Notice of Filings #1PDF
80 FR 45249 - Agency Information Collection Activities: Comment RequestPDF
80 FR 45181 - Siskiyou County Resource Advisory CommitteePDF
80 FR 45265 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
80 FR 45065 - Records and InformationPDF
80 FR 45264 - New Jersey Disaster #NJ-00011PDF
80 FR 45264 - Louisiana Disaster Number LA-00009PDF
80 FR 45230 - Indian GamingPDF
80 FR 45057 - Imposition of Special Measure Against FBME Bank Ltd., Formerly Known as the Federal Bank of the Middle East Ltd., as a Financial Institution of Primary Money Laundering ConcernPDF
80 FR 45203 - Endangered Species; File No. 18238PDF
80 FR 45204 - Endangered Species; File No. 17183PDF
80 FR 45196 - Marine Mammals; File No. 19091PDF
80 FR 45221 - Notice to All Interested Parties of the Termination of the Receivership of 10089, Security Bank of North Fulton, Alpharetta, GeorgiaPDF
80 FR 45237 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Ventilation Plans, Tests, and Examinations in Underground Coal MinesPDF
80 FR 45073 - Fluxapyroxad; Pesticide TolerancesPDF
80 FR 45259 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Price Check ParametersPDF
80 FR 45250 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify NASDAQ Rule 7014(g) Concerning Rebates Available Under the NBBO ProgramPDF
80 FR 45256 - Self-Regulatory Organizations: Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 612 Regarding the Reset on Quote Functionality Included in the MIAX Aggregate Risk ManagerPDF
80 FR 45067 - Air Quality Designations for the 2006 24-hour Fine Particle National Ambient Air Quality Standards (2006 24-hour PM2.5PDF
80 FR 45236 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Mine Mapping and Records of Opening, Closing, and Reopening of MinesPDF
80 FR 45217 - Clean Water Act Section 303(d): Availability of List DecisionsPDF
80 FR 45267 - Projects Approved for Consumptive Uses of WaterPDF
80 FR 45276 - Publication of Ukraine General Licenses 5, 6, 7, 8, and 9PDF
80 FR 45131 - Proposed Finding That Greenhouse Gas Emissions From Aircraft Cause or Contribute to Air Pollution That May Reasonably Be Anticipated To Endanger Public Health and Welfare and Advance Notice of Proposed Rulemaking; Notice of Updates to Public HearingPDF
80 FR 45270 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BLUEWATER; Invitation for Public CommentsPDF
80 FR 45051 - Electronic Applications for Licenses, Permits, and Safety ApprovalsPDF
80 FR 45115 - Rulemaking Petition: Contributions From Corporations and Other Organizations to Political CommitteesPDF
80 FR 45116 - Rulemaking Petition: Independent Spending by Corporations, Labor Organizations, Foreign Nationals, and Certain Political Committees (Citizens United)PDF
80 FR 45154 - Endangered and Threatened Wildlife and Plants; Revision of the Section 4(d) Rule for the African Elephant (Loxodonta africana)PDF
80 FR 45232 - Certain Communications or Computing Devices and Components Thereof Commission Determination Not To Review an Initial Determination Terminating the Investigation in Its Entirety Based Upon Settlement; Termination of Investigation; and Vacatur of Order No. 34PDF
80 FR 45210 - Columbia Gas Transmission, LLC; Notice of Intent To Prepare an Environmental Assessment for the Planned WB Xpress Project, Request for Comments on Environmental Issues, and Notice of Public Scoping MeetingPDF
80 FR 45214 - Commission Information Collection Activities (FERC-732); Comment Request; ExtensionPDF
80 FR 45209 - Sweetwater Authority; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
80 FR 45208 - Dan Sullivan; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
80 FR 45249 - Information Collection: NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s)PDF
80 FR 45226 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
80 FR 45248 - Extension of Comment Period; Mass Digitization Pilot Program; Request for CommentsPDF
80 FR 45194 - Genome in a Bottle Consortium-Progress and Planning WorkshopPDF
80 FR 45193 - Judges Panel of the Malcolm Baldrige National Quality AwardPDF
80 FR 45238 - Newport News Shipbuilding; Notice of Application for a Permanent Variance and Request for CommentsPDF
80 FR 45195 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys in the Atlantic OceanPDF
80 FR 45224 - Meeting of the National Advisory Committee on Children and DisastersPDF
80 FR 45181 - Agenda and Notice of Public Meeting of the West Virginia Advisory CommitteePDF
80 FR 45278 - Submission for OMB Review; Comment RequestPDF
80 FR 45254 - Joint Industry Plan; Order Approving Amendment No. 35 to the Joint Self-Regulatory Organization Plan Governing the Collection, Consolidation and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on Exchanges on an Unlisted Trading Privileges Basis Submitted by the BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc.PDF
80 FR 45252 - Consolidated Tape Association; Order Approving the Twenty Second Substantive Amendment to the Second Restatement of the CTA Plan and Sixteenth Substantive Amendment to the Restated CQ PlanPDF
80 FR 45101 - Freedom of Information Act RegulationsPDF
80 FR 45235 - Agency Information Collection Activities: Proposed eCollection eComments Requested; Firearms and Explosives Services Division Customer Service SurveyPDF
80 FR 45086 - Federal Travel Regulation; Temporary Duty (TDY) Travel AllowancesPDF
80 FR 45339 - Revision to the Guideline on Air Quality Models: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches To Address Ozone and Fine Particulate MatterPDF
80 FR 45116 - Clarification of Employer's Continuing Obligation To Make and Maintain an Accurate Record of Each Recordable Injury and IllnessPDF
80 FR 45132 - National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TablePDF
80 FR 45279 - National Emissions Standards for Hazardous Air Pollutants for Mineral Wool Production and Wool Fiberglass ManufacturingPDF

Issue

80 145 Wednesday, July 29, 2015 Contents Agriculture Agriculture Department See

Forest Service

Antitrust Division Antitrust Division NOTICES Membership Changes under National Cooperative Research and Production Act: AllSeen Alliance, Inc., 45235 2015-18577 Cooperative Research Group on Mechanical Stratigraphy and Natural Deformation in Eagle Ford Formation and Equivalent Boquillas Formation, South-Central and West Texas (Eagle Ford II), 45234 2015-18576 Members of SGIP 2.0, Inc., 45233-45234 2015-18580 Open Mobile Alliance, 45234-45235 2015-18579 Civil Rights Civil Rights Commission NOTICES Meetings: West Virginia Advisory Committee, 45181-45182 2015-18435 Commerce Commerce Department See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45204-45206 2015-18574 2015-18585 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45274-45276 2015-18588 Consumer Product Consumer Product Safety Commission NOTICES Settlement Agreements and Orders: LG Electronics Tianjin Appliance Co., Ltd. and LG Electronics USA Inc.; Correction, 45206 2015-18575 Copyright Office Copyright Office, Library of Congress NOTICES Mass Digitization Pilot Program, 45248 2015-18473 Defense Acquisition Defense Acquisition Regulations System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45206-45208 2015-18589 2015-18590 2015-18591 Defense Department Defense Department See

Defense Acquisition Regulations System

Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality Designations: 2006 24-hour Fine Particle National Ambient Air Quality Standards (2006 24-hour PM2.5 NAAQS), 1997 Annual PM2.5 NAAQS, and 1987 Annual Coarse Particle (PM10) NAAQS, 45067-45073 2015-18532 National Emissions Standards for Hazardous Air Pollutants: Mineral Wool Production and Wool Fiberglass Manufacturing, 45280-45338 2015-16643 National Oil and Hazardous Substance Pollution Contingency Plan National Priorities List: Deletion of the Crown Vantage Landfill Superfund Site, 45085-45086 2015-18607 Pesticide Tolerances: Fluxapyroxad, 45073-45078 2015-18544 Tolerance Requirement Exemptions: Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, Sodium, Potassium, Calcium, Magnesium, and Zinc Salts, 45079-45085 2015-18610 PROPOSED RULES Air Quality Model Guidelines: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches to Address Ozone and Fine Particulate Matter; Revisions, 45340-45387 2015-18075 Finding that Greenhouse Gas Emissions from Aircraft Cause or Contribute to Air Pollution that May Reasonably Be Anticipated to Endanger Public Health and Welfare, 45131-45132 2015-18518 NOTICES Applications: Pesticide Experimental Use Permits, 45219-45220 2015-18615 Board of Directors for the National Environmental Education Foundation, 45220-45221 2015-18608 Clean Water Act; List Decisions, 45217-45218 2015-18523 Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, 45218-45219 2015-18612 Federal Aviation Federal Aviation Administration RULES Electronic Applications for Licenses, Permits, and Safety Approvals, 45051 2015-18502 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45274-45276 2015-18588 Receivership Terminations: Security Bank of North Fulton, Alpharetta, GA, 45221 2015-18548 Federal Election Federal Election Commission PROPOSED RULES Rulemaking Petitions: Contributions from Corporations and Other Organizations to Political Committees, 45115 2015-18495 Independent Spending by Corporations, Labor Organizations, Foreign Nationals, and Certain Political Committees (Citizens United), 45116 2015-18494 Federal Emergency Federal Emergency Management Agency PROPOSED RULES Freedom of Information Act, 45101-45115 2015-18388 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45214-45215 2015-18481 Applications: Equitrans, LP, 45213-45214 2015-18570 Combined Filings, 45209, 45214-45217 2015-18566 2015-18567 2015-18568 2015-18569 Environmental Assessments; Availability, etc.: Columbia Gas Transmission, LLC; WB XPress Project, 45210-45213 2015-18484 Qualifying Conduit Hydropower Facility Applications: Dan Sullivan, 45208-45209 2015-18479 Sweetwater Authority, 45209-45210 2015-18480 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 45221-45222 2015-18604 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45274-45276 2015-18588 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 45222 2015-18598 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 45222 2015-18597 Financial Crimes Financial Crimes Enforcement Network RULES Imposition of Special Measures Against Institutions of Primary Money Laundering Concern: FBME Bank Ltd., formerly known as the Federal Bank of the Middle East Ltd., 45057-45065 2015-18552 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Listing the Honduran Emerald Hummingbird (Amazilia luciae), 45086-45097 2015-18602 PROPOSED RULES Endangered and Threatened Wildlife and Plants: African Elephant (Loxodonta africana) Rule; Revision, 45154-45180 2015-18487 Foreign Assets Foreign Assets Control Office NOTICES Ukraine General Licenses 5, 6, 7, 8, and 9, 45276-45278 2015-18520 Forest Forest Service NOTICES Meetings: Siskiyou County Resource Advisory Committee, 45181 2015-18560 General Services General Services Administration RULES Federal Travel Regulations: Temporary Duty Travel Allowances, 45086 2015-18289 Health and Human Health and Human Services Department See

Health Resources and Services Administration

See

National Institutes of Health

PROPOSED RULES National Vaccine Injury Compensation Program: Vaccine Injury Table Revisions, 45132-45154 2015-17503 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45225-45226 2015-18606 Meetings: National Advisory Committee on Children and Disasters, 45224-45225 2015-18442
Health Resources Health Resources and Services Administration NOTICES Petitions: National Vaccine Injury Compensation Program, 45222-45224 2015-18603 Homeland Homeland Security Department See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

PROPOSED RULES Freedom of Information Act, 45101-45115 2015-18388 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Technical Assistance Request and Evaluation; Corrections, 45226-45227 2015-18582 Requests for Nominations: U.S. Immigration and Customs Enforcement Advisory Committee on Family Residential Centers; Establishment of Committee, 45227 2015-18581
Housing Housing and Urban Development Department NOTICES Promise Zones Initiative: Proposed Third Round Selection Process, 45227-45230 2015-18626 Indian Affairs Indian Affairs Bureau NOTICES Final Decision on Remand Against Federal Acknowledgment of the Duwamish Tribal Organization; Correction, 45230 2015-18621 Indian Gaming, 45230-45231 2015-18553 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

National Park Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Aluminum Extrusions from the People's Republic of China; Certain Circular Welded Carbon Quality Steel Line Pipe from the People's Republic of China, etc., 45184-45192 2015-18625 Certain Cut-to-Length Carbon Quality Steel Plate from the Republic of Korea, 45183-45184 2015-18622 Multilayered Wood Flooring from the People's Republic of China, 45192-45193 2015-18618 Polyethylene Terephthalate Film, Sheet, and Strip from Taiwan, 45182-45183 2015-18619 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Communications or Computing Devices and Components Thereof, 45232-45233 2015-18485 Formatted Magnetic Data Storage Tapes and Cartridges Containing Same, 45233 2015-18578 Justice Department Justice Department See

Antitrust Division

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Firearms and Explosives Services Division Customer Service Survey, 45235-45236 2015-18379
Labor Department Labor Department See

Mine Safety and Health Administration

See

Occupational Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45237-45238 2015-18546 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mine Mapping and Records of Opening, Closing, and Reopening of Mines, 45236-45237 2015-18529
Library Library of Congress See

Copyright Office, Library of Congress

Maritime Maritime Administration NOTICES Deepwater Port License Applications: Delfin LNG, LLC, 45270-45274 2015-18594 Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel BLUEWATER, 45270 2015-18504 Mine Mine Safety and Health Administration RULES Fees for Testing, Evaluation, and Approval of Mining Products, 45051-45057 2015-18617 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 45248 2015-18583 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Institute National Institute of Standards and Technology NOTICES Meetings: Genome in a Bottle Consortium -- Progress and Planning Workshop, 45194-45195 2015-18470 Judges Panel of the Malcolm Baldrige National Quality Award, 45193-45194 2015-18469 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 45226 2015-18587 National Institute on Alcohol Abuse and Alcoholism, 45226 2015-18475 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 45098-45100 2015-18584 Fisheries of the Northeastern United States: Northeast Multispecies Fishery; Trimester Total Allowable Catch Area Closure for the Common Pool Fishery, 45100 2015-18586 NOTICES Endangered and Threatened Species: Takes of Anadromous Fish, 45197-45203 2015-18600 Permit Applications: Endangered Species; File No. 17183, 45204 2015-18550 Endangered Species; File No. 18238, 45203 2015-18551 Marine Mammals; File No. 19091, 45196-45197 2015-18549 Takes of Marine Mammals Incidental to Geophysical Surveys in the Atlantic Ocean: Fisheries Research, 45195-45196 2015-18467 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Delaware Water Gap National Recreation Area, Pennsylvania and New Jersey; Visitor Use Management Plan, 45231 2015-18593 Martin Van Buren National Historic Site, New York; General Management Plan, 45231-45232 2015-18592 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45249 2015-18563 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s), 45249-45250 2015-18476 Occupational Safety Health Adm Occupational Safety and Health Administration PROPOSED RULES Clarification of Employer's Continuing Obligation to Make and Maintain an Accurate Record of Each Recordable Injury and Illness, 45116-45131 2015-18003 NOTICES Permanent Variance Applications: Newport News Shipbuilding, 45238-45248 2015-18468 Postal Service Postal Service RULES Records and Information, 45065-45067 2015-18557 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Americans with Disabilities Act; Anniversary (Proc. 9302), 45389-45392 2015-18785 National Korean War Veterans Armistice Day (Proc. 9303), 45393-45394 2015-18791 Securities Securities and Exchange Commission NOTICES Amendment to the Second Restatement of the Consolidated Tape Association Plan and Sixteenth Substantive Amendment to the Restated Consolidated Quotation Plan; Approval, 45252-45254 2015-18392 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Inc., et al., 45254-45256 2015-18393 C2 Options Exchange, Inc., 45259-45264 2015-18540 Miami International Securities Exchange LLC, 45256-45259 2015-18537 NASDAQ Stock Market LLC, 45250-45252 2015-18539 NYSE Arca, Inc.; Correction, 45250 C1--2015--17660 Small Business Small Business Administration NOTICES Disaster Declarations: Louisiana Number LA-00009, 45264-45265 2015-18554 New Jersey Disaster NJ-00011, 45264 2015-18556 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45265-45267 2015-18558 State Department State Department NOTICES Meetings: United States-Chile Environment Affairs Council and Joint Commission on Environmental Cooperation, 45267 2015-18616 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 45267-45270 2015-18521 Transportation Department Transportation Department See

Federal Aviation Administration

See

Maritime Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Financial Crimes Enforcement Network

See

Foreign Assets Control Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 45278 2015-18394
Customs U.S. Customs and Border Protection PROPOSED RULES Freedom of Information Act, 45101-45115 2015-18388 Separate Parts In This Issue Part II Environmental Protection Agency, 45280-45338 2015-16643 Part III Environmental Protection Agency, 45340-45387 2015-18075 Part IV Presidential Documents, 45389-45394 2015-18785 2015-18791 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

80 145 Wednesday, July 29, 2015 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 401, 413, and 414 [Docket No.: FAA-2015-1745; Amdt. Nos 413-11 and 414-3] RIN 2120-AK58 Electronic Applications for Licenses, Permits, and Safety Approvals AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Direct final rule; confirmation of effective date and response to public comments.

SUMMARY:

This action confirms the effective date of the direct final rule, request for comments, published on May 27, 2015, and dispositions the one public comment received. The rule amends commercial space transportation regulations to allow an applicant for a license, experimental permit, or safety approval the option of submitting an application electronically.

DATES:

The effective date of July 27, 2015, for the direct final rule published on May 27, 2015 (80 FR 30147), is confirmed.

ADDRESSES:

For information on where to obtain copies of rulemaking documents and other information related to this action, see “How To Obtain Additional Information” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

For technical questions concerning this action, contact Shirley McBride, Office of Commercial Space Transportation, Regulations and Analysis Division, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-7470; email [email protected]

For legal questions concerning this action, contact Alex Zektser, Office of Chief Counsel, International Law, Legislation, and Regulations Division, AGC-250, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-3073; email [email protected]

SUPPLEMENTARY INFORMATION:

Background

Before publication of the direct final rule on May 27, 2015 (Electronic Applications for Licenses, Permits, and Safety Approvals, 80 FR 30147), applications for a license, an experimental permit, or a safety approval made under 14 CFR part 413 or 414 had to be submitted to the FAA in paper form. The FAA determined that this paper-based submission process was unduly burdensome because an electronically-submitted application would provide the FAA with the same information as a paper application. In addition, the Government Paperwork Elimination Act (GPEA) requires that, when practicable, a federal agency must provide the public with an option to transact with the agency electronically.1 Accordingly, the FAA published a direct final rule, request for comments, amending the application process under 14 CFR part 413 for a license or experimental permit, and under part 414 for a safety approval to allow applicants to submit their applications electronically.

1 Office of Management and Budget, Implementation of the Government Paperwork Elimination Act, http://www.whitehouse.gov/omb/fedreg_gpea2 (explaining implementation of Pub. Law 105-277, sec. 1704).

The comment period on the direct final rule closed on June 26, 2015. Only one commenter submitted a comment document.

Discussion of Comments

The FAA only received one comment on June 3, 2015, from an individual commenter supporting the final rule. The commenter also recommended that in addition to this rulemaking, the FAA also institute a practice of providing an electronic response acknowledging receipt of the application.

Conclusion

Because there were no adverse comments submitted on this rulemaking and the only comment submitted on the rule supported the agency action, the FAA has determined that no further rulemaking action is necessary. The direct final rule is effective on July 27, 2015. The FAA will consider the additional suggestion submitted by the individual commenter separately from this rulemaking action, as the suggestion was that the FAA institute a practice in addition to the one that is the subject of this rulemaking.

Issued under authority provided by 49 U.S.C. 160(f), and 51 U.S.C. 50901-50923 in Washington, DC, on July 23, 2015. Lirio Liu, Director, Office of Rulemaking.
[FR Doc. 2015-18502 Filed 7-28-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Part 5 [Docket No. MSHA-2014-0016] RIN 1219-AB82 Fees for Testing, Evaluation, and Approval of Mining Products AGENCY:

Mine Safety and Health Administration, Labor.

ACTION:

Final rule.

SUMMARY:

The Mine Safety and Health Administration (MSHA) is revising the Agency's regulation for administering fees for testing, evaluation, and approval of products manufactured for use in mines. This final rule revises the fees charged for these services. The final rule also includes a fee for approval services that MSHA provides to applicants or approval holders under the existing rule, but for which the Agency currently does not charge a fee, and for other activities required to support the approval process. This change will allow MSHA to charge fees that reflect the full cost of the approval services provided.

DATES:

The final rule is effective on October 1, 2015.

FOR FURTHER INFORMATION CONTACT:

Sheila A. McConnell, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at [email protected] (email); 202-693-9440 (voice); or 202-693-9441 (facsimile). (These are not toll-free numbers).

SUPPLEMENTARY INFORMATION:

Table of Contents I. Executive Summary II. Background III. Section-by-Section Analysis IV. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review V. Feasibility VI. Regulatory Flexibility Act, Small Business Regulatory Enforcement Fairness Act, and Executive Order 13272: Proper Consideration of Small Entities in Agency Rulemaking VII. Paperwork Reduction Act of 1995 VIII. Other Regulatory Considerations Availability of Information

Docket: Access rulemaking documents electronically at http://www.msha.gov/regsinfo.htm or http://www.regulations.gov. [Docket Number MSHA-2014-0016]. Obtain a copy of a rulemaking document from the Office of Standards, Regulations, and Variances, MSHA, by request to 202-693-9440 (voice) or 202-693-9441 (facsimile). (These are not toll-free numbers.)

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I. Executive Summary A. Purpose of Regulatory Action

As part of the U.S. Department of Labor, under the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, MSHA's mission is to prevent death, disease, and injury from mining and promote safe and healthy workplaces for the Nation's miners. Since 1911, MSHA and its predecessor agencies have evaluated and tested products for use in mines to prevent fires, explosions, and accidents.

B. Summary of Major Provisions

Under the final rule, MSHA revises the hourly rate for the fees charged to applicants and approval holders to include all costs associated with the approval program. MSHA calculates the hourly rate by dividing the total approval program costs (direct and indirect) during a prior fiscal year, including internal quality control activities and post-approval product audits, by the number of total direct hours spent on approval program activities for the same period. These changes in how MSHA calculates fees increase the hourly rate to $121.

C. Costs and Benefits

This rule is not economically significant. The final rule will produce zero costs and zero benefits because the fees MSHA collects are transfer payments. MSHA discusses transfer payments in section IV of this preamble.

II. Background

Under various authorities,1 MSHA historically has collected fees for its services in evaluating, testing, and approving products. Originally, the U.S. Bureau of Mines, an MSHA predecessor agency, billed applicants for approval services using published individual fee schedules, e.g., each approval part in Title 30, Chapter I, included a list of flat fees for different tests, evaluations, and other services performed for approval activities (30 FR 3752-3757). On May 8, 1987 (52 FR 17506), MSHA eliminated the individual fee schedules and established part 5, which created an hourly rate for administration and calculation of fees for services in Title 30, Chapter I, Subchapter B, Testing, Evaluation, and Approval of Mining Products. On August 9, 2005 (70 FR 46336), MSHA revised part 5 and its fee procedures. That rule eliminated the application fee, allowed pre-authorization of expenditures for processing applications, and allowed outside organizations to set fees when conducting part 15 testing on MSHA's behalf.

1 These authorities are: Public Law 61-525, Ch. 285, 36 Stat. 1419 (1911); Public Law 62-386, Ch. 72, Sec. 5, 37 Stat. 682 (1913); Public Law 72-212, Ch. 314, Sec. 311, 47 Stat. 410 (1932); 30 U.S.C. 961(c)(2); and Title V of the Independent Offices Appropriations Act of 1952, Public Law 82-137, 65 Stat. 290 (1951), as amended, 31 U.S.C. 9701.

Section 205 of the Chief Financial Officers Act of 1990 (CFO Act) and Office of Management and Budget (OMB) Circular No. A-25 Revised, User Charges (7/8/1993), require agencies to review the user charges in their programs to ensure that the charges reflect the full costs of the services provided. Traditionally, MSHA reviews its user charges annually; however, MSHA last revised its hourly rate under part 5 to $97.00 on December 29, 2010 (75 FR 82074).

Under 30 U.S.C. 966, MSHA may retain up to $2,499,000 of fees collected for the approval and certification of equipment, materials, and explosives for use in mines.

MSHA proposed revisions to its existing regulations on fees for testing, evaluation and approval of mining products on October 9, 2014 (79 FR 61035). This final rule addresses the comments received in response to the proposed rule.

III. Section-by-Section Analysis

In this final rule, the term “approval” includes approvals, certifications, acceptances, and evaluations MSHA issues under Title 30, Chapter I, Subchapter B, Testing, Evaluation, and Approval of Mining Products.

A. § 5.10 Purpose and Scope

Final § 5.10, like the proposal, provides the purpose and scope of the rule. It also establishes a system under which MSHA charges a fee for approval program services for products manufactured for use in mines. Like the proposal, the final rule identifies the activities in the approval program.

The approval program represents all the activities necessary for MSHA to assure that products approved for use in mines are designed, manufactured, and maintained in accordance with approval requirements. The approval program includes: (1) Application processing; (2) testing and evaluation; (3) approval decisions; (4) post-approval activities; and (5) the termination of approvals.

1. Application processing begins when an applicant files a new application for approval. MSHA administratively reviews each new application and, on determining that the application is complete, prepares a maximum fee estimate and sends it to the applicant. The applicant must agree to pay the estimated fee before MSHA will begin testing, as needed, and evaluating the product.

2. Testing and evaluation includes technical evaluation, analysis, test set up, testing, test tear down, any consultation on the application, and internal quality control activities. MSHA uses internal quality control programs to monitor and improve its testing and evaluation processes (e.g., internal administrative and technical reviews; internal audits; and calibration, repair, and maintenance of test equipment).

3. Following testing and evaluating a product, MSHA makes an approval decision and notifies the applicant by letter of the Agency's findings and decision. If the product is approved, the letter identifies the approved specifications for the design, construction, maintenance, and conditions of use for the product. If the product is not approved or if the application is cancelled, the letter identifies the reasons for the decision. All approval documentation is kept on file at MSHA.

4. MSHA also conducts the following post-approval activities:

• Changing approvals (e.g., extensions 2 of approvals, field modifications, and modification through the Revised Acceptance Modification Program (RAMP)).

2 An extension of the approval is a document MSHA issues that states that a change to the product previously approved by MSHA is approved and authorizes the continued use of the approval marking with the appropriate extension number for the change added.

• Conducting post-approval product audits and field audits.

• Responding to complaints.

• Investigating product failures.

• Monitoring regional or nationwide product recall or retrofit programs.

• Conducting administrative actions, such as transfer of approval numbers.

5. Termination of an approval may occur when an approval holder voluntarily requests termination of an approval, when MSHA revokes an approval because of compliance or safety issues, or when MSHA issues regulations that make an approval obsolete.

MSHA did not receive any comments on § 5.10 and it is finalized as proposed.

B. § 5.30 Fee Calculation

Final § 5.30, like the proposal, addresses the hourly rate calculation, the activities for which MSHA charges a fee, activities that are not subject to a fee, the fee estimate, and any changes to the fee estimate. Section 5.30 is finalized as proposed.

Under final § 5.30(a), like the proposal, MSHA will continue to charge a fee based on an hourly rate for approval program activities and other associated costs, such as travel expenses and part 15 fees. Part 15 fees for services provided to MSHA by other organizations will be set by those organizations.

Final paragraph § 5.30(b), like the proposal, is derived from existing § 5.30(a) and identifies the costs MSHA incurs in administering the approval program. Under the final rule, like the proposal, the hourly rate is calculated to reflect the costs of the overall approval program. Under the existing rule, the hourly rate includes only the application processing; testing and evaluation; and approval decision costs.

Also under the existing rule, some post-approval activities, such as changes to approvals, are included in the approval program costs used in calculating the hourly rate. Under the existing rule, however, MSHA had excluded the costs of monitoring to assure approved products continue to be manufactured and maintained as approved because MSHA considered these activities to be enforcement activities rather than approval program activities (52 FR 17507-17508). As stated previously, OMB Circular No. A-25 requires that agencies recover the full costs of services rendered. To more accurately account for costs, MSHA proposed to include the direct and indirect cost of these post-approval product activities in the hourly rate calculation because these activities are an important part of the approval program. These activities assure MSHA, operators, and miners that products continue to be designed, manufactured, and maintained in accordance with the approval requirements.

Under the final rule, like the proposal, MSHA will continue to determine an hourly rate to cover direct and indirect costs. MSHA bases the hourly rate on all approval program costs the Agency incurred during a prior fiscal year. The hourly rate is the total approval program costs (direct and indirect) divided by the number of direct hours spent on all approval program activities. Final paragraph § 5.30(b) lists the approval program costs that MSHA will include in the hourly rate calculation.

Final paragraph § 5.30(b)(1), like the proposal, defines direct costs as consisting of compensation and benefit costs for all hours worked in support of the approval program and is derived, in part, from existing § 5.10(b)(1) and (b)(2). These costs include approval program activities, such as testing and evaluation, including internal quality control; and post-approval activities, including post-approval product audits.

Final paragraph § 5.30(b)(2), like the proposal, defines indirect costs and is derived, in part, from existing § 5.10(b)(3) and (b)(4). Indirect costs include the approval program's proportionate share of the hours worked to manage and operate the Approval and Certification Center (A&CC). These costs are associated with activities required for information technology (IT) and A&CC management and administration. Indirect costs also include the approval program's proportionate share of depreciation for buildings, their improvements, and equipment; a proportionate share of utilities, equipment rental, facility and equipment maintenance, security, supplies and materials, and other costs necessary for the operation and maintenance of the A&CC; and a proportionate share of Department of Labor-provided services that would include financial systems, and audit and IT support.

A commenter asked what MSHA considers to be indirect costs. Section 5.30(b)(2) in this final rule and in the preamble to the proposed rule (79 FR 61037) defines indirect costs. MSHA's definition of indirect costs is consistent with OMB Circular No. A-25. MSHA determined that the definition in the final rule adequately addresses the commenter's question.

Final § 5.30(c), like the proposal, is derived from existing § 5.10(b) and includes activities for which MSHA charges a fee. These activities continue to include application processing (e.g., administrative and technical review of applications, computer tracking, and status reporting); testing and evaluation (e.g., analysis of drawings, technical evaluation, testing, test set up and test tear down, and internal quality control activities); approval decisions (e.g., consultation on applications, records control and security, document preparation); and post-approval activities, such as changes to approvals. Like the proposal, final § 5.30(c) describes internal quality control activities and post-approval product audits as part of the approval program, as MSHA is required to recover costs associated with the approval program (OMB Circular No. A-25).

A commenter objected to MSHA charging for internal quality control. Under the final rule, like the proposal, MSHA will charge applicants and approval holders a fee for internal quality control activities. These activities are an integral part of the approval program. MSHA uses internal quality control activities to monitor and improve the Agency's testing and evaluation processes and for quality control. These internal quality control activities assure applicants and approval holders that consistent, accurate, and up-to-date scientific methods are used when MSHA is evaluating and testing products. For example, MSHA has standard procedures to repair, maintain, and calibrate laboratory equipment in accordance with the manufacturers' specifications. Each applicant and approval holder receives a benefit from these internal quality control activities.

MSHA will distribute the hours worked and costs of internal quality control activities, based on the hours worked on each application. Hours worked on specific internal quality control activities, however, are not charged to a particular application. Instead, MSHA will charge each applicant a prorated share. MSHA will calculate the prior year's internal quality control hours as a percentage of total hours, multiply that percentage by the number of direct hours worked on a particular application, and add the result to the number of direct hours worked on that application.

A commenter objected to MSHA charging a fee for post-approval product audits stating that MSHA could charge for exaggerated paperwork evaluations and could audit the same company as often as they want. Under existing 30 CFR 7.8(b), 14.10(b), and 15.10(b), MSHA audits a specific product no more than once a year, except for cause, and the approval-holder may attend any testing MSHA conducts on their product. Post-approval product audits are part of the approval program (post-approval activities) because they are necessary to assure that products have been manufactured as approved.

Under the final rule, like the proposal, MSHA will charge approval holders for the Agency's post-approval product audits, but will not charge for investigations or audits based on complaints about the products.

Internal quality control activities and post-approval product audits assure MSHA, operators, and miners that products are and continue to be designed, manufactured, and maintained in accordance with the approval requirements to ensure the health and safety of miners. For these reasons, MSHA will charge a fee for these activities.

Existing § 5.10(c)(1), (c)(2), (c)(3), and (c)(4) are revised and redesignated, in part, as final § 5.30(d). Final § 5.30(d), like the proposal, addresses the activities for which MSHA will not charge a fee. These include technical assistance not related to approval applications; technical programs, including development of new technology programs; participation in research conducted by other government agencies or private organizations; and regulatory review activities, including participation in the development of health and safety standards, regulations, and legislation.

MSHA did not receive any comments on proposed § 5.30(d) and it is finalized as proposed.

Existing paragraphs § 5.30(b), (c), and (d) are redesignated as final paragraphs § 5.30(e), (f), and (g) under § 5.30 Fee Calculation.

Final paragraph § 5.30(e), like the proposal, is revised by renumbering existing paragraphs § 5.30(b)(1) and (b)(2) as § 5.30(e)(1) and (e)(2), respectively. Final paragraphs § 5.30(f) and (g) remain unchanged.

MSHA did not receive any comments on § 5.30(e), (f), and (g) and these sections are finalized as proposed.

C. § 5.40 Fee Administration

Final § 5.40, like the proposal, is revised by adding “approval holders” to entities to be billed and replacing “processing of the application is completed” with “approval program activities are completed.” MSHA will continue to charge applicants a fee for approvals and some post-approval activities (e.g., modification to approvals), and will charge approval holders a fee for post-approval product audits when the approval program activities are completed.

MSHA received no comments on proposed § 5.40 and it is finalized as proposed.

D. § 5.50 Fee Revisions

Final § 5.50, like the proposal, replaces “fee schedule” with “hourly rate” because MSHA no longer has a fee schedule. A commenter questioned why MSHA has a scheduling fee. As discussed in this final rule and in the preamble to the proposed rule, MSHA eliminated the individual fee schedules in 1987 and created a single hourly rate for calculation of fees.

Like the proposal, MSHA is revising the hourly rate from $97 under the existing rule to $121 using fiscal year (FY) 2012 data. A commenter objected to MSHA raising the hourly rate, citing challenging times being faced by the coal industry. This commenter was particularly concerned about the impact of the increase in fees on a small manufacturing company in the coal service industry. In response to this comment, MSHA states below, in Section V. Feasibility, that the increase in the hourly rate is below one percent of the estimated annual revenues of the impacted industries. The final rule, like the proposal, removes the term “fee schedule” from § 5.50 and it is finalized as proposed.

E. Other Comments

MSHA received general comments that objected to the overall rulemaking and to MSHA collecting more money than the Agency has the authority to retain. Under OMB Circular No. A-25, MSHA is required to review the user fees in its programs to ensure that the charges reflect the full costs of the services provided. This action transfers the cost of MSHA approval program services from the taxpayer to the applicants or approval holders who benefit from these services. Fees collected in excess of those the Agency is authorized to retain are sent back to the U.S. Treasury.

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

Executive Orders (E.O.) 12866 and 13563 generally direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. To comply with these Executive Orders, MSHA has included the following impact analysis.

Section 3(f) of the E.O. 12866 defines a significant regulatory action as an action that is likely to result in a rule that: (1) Has an annual effect on the economy of $100 million or more, or adversely and materially affects a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; (2) creates a serious inconsistency or otherwise interferes with an action taken or planned by another agency; (3) materially alters the budgetary impacts of entitlement grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. OMB has determined that this is a significant regulatory action.

The final rule would not have an annual effect of $100 million or more on the economy and, under E.O. 12866, is not considered economically significant. MSHA has not prepared a separate regulatory economic analysis for this rulemaking. Rather, the analysis is presented below.

A. Overview

MSHA will continue to charge a fee for approval services based on an hourly rate. As under the existing rule, MSHA's hourly rate will include direct costs and indirect costs. However, under the final rule, MSHA will calculate the hourly rate by dividing all approval program costs incurred by the Agency during a prior fiscal year by the number of direct hours spent on approval program activities for the same period.

The final rule will increase the hourly rate from $97 to $121, an increase of $24.

MSHA will also begin to charge a fee for internal quality control activities and post-approval product audits. In FY 2012, MSHA collected approximately $1.2 million in fees. Under this final rule, MSHA estimates that the Agency would have collected a total of $2.7 million in fees in FY 2012, an increase of $1.5 million.

The charges under the final rule are fees and are considered transfer payments, not costs, under OMB Circular No. A-4, Regulatory Analysis (09/17/2003). Transfer payments are payments from one group to another that do not affect total resources available to society. Under the final rule, the applicant or the approval holder pays for services for which they receive a benefit. These services are currently paid for by the taxpayer.

Because the fees MSHA collects are a transfer, there are zero costs and zero benefits regardless of the discount rate (OMB Circular No. A-4, Regulatory Analysis (09/17/2003) Section (G) Accounting Statement).

B. Benefits

The rule will not produce any quantifiable benefits because the only impact is the transfer payment.

C. Projected Impacts

MSHA analyzed A&CC invoice data from FY 2012. Using the U.S. Economic Census North American Industry Classification System (NAICS) data, MSHA estimated the impact of the final rule on mining and non-mining industries. NAICS is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy (http://www.census.gov/eos/www/naics/).

From the A&CC post-approval product audit data and FY 2012 invoices, MSHA identified 30 industries that received A&CC approval program services. MSHA grouped this data into three general industry categories: Coal Mining, Other Mining, and Non-Mining.

MSHA estimated the fees that will be collected under this final rule by summing the impact of the hourly rate increase and the increase from charging for internal quality control activities and post-approval product audits. Under this final rule, fees will increase by approximately $1.5 million annually ($0.3 million from the hourly rate increase + $1.1 million for internal quality control activities + $0.1 million for post-approval product audit activities). Of the $1.5 million, the increase in fees for the coal and other mining industries will total approximately $0.9 million annually. The remaining $0.6 million will be distributed among the non-mining industries that seek product approval from MSHA.

MSHA estimated the fee increase from the final hourly rate by multiplying the number of chargeable hours for FY 2012 (12,189 hours) by the final hourly rate of $121. In 2012, MSHA estimated that the final hourly rate would have resulted in approximately $1.5 million in fees collected, an increase of $300,000 (($121 new rate−$97 old rate) × 12,189 hours).

MSHA also estimated the fees from charging for internal quality control activities. MSHA uses internal quality control activities to monitor and improve the Agency's testing and evaluation processes. These activities include internal process reviews; maintaining laboratory equipment; and repairing, maintaining, and calibrating laboratory equipment to assure the equipment produces reliable and accurate results. In FY 2012, MSHA spent 9,015 hours on these activities. MSHA multiplied the 9,015 hours by the proposed $121 hourly rate. This results in an estimated annual impact of $1.1 million.

In addition, MSHA analyzed post-approval product audit data from 2008 to 2012 to estimate the increase in fees from charging for these services. In any given year, post-approval product audits are completed only on a subset of the total products approved by the A&CC. In 2012, MSHA spent approximately 1,000 hours on 125 post-approval product audits. Multiplying the 1,000 hours by the proposed $121 hourly rate results in an estimated annual impact of $121,000. The average estimated impact would have been $970 for each approval holder audited in 2012.

V. Feasibility

MSHA concludes that the final rule would be economically feasible.

MSHA has traditionally used a revenue screening test—whether the annualized compliance costs of a regulation are less than one percent of revenues (dollar change/revenue), or are negative (i.e., provide net cost savings) to establish presumptively that compliance with the regulation is economically feasible. MSHA relies on Agency data to identify revenue for covered mining entities and the 2007 Economic Census data to identify revenue by NAICS industry categories for non-mining entities.

MSHA performed the revenue screening test comparing the annual impact to annual revenues for all three categories and found that the percentage impact rounds to zero percent of revenue in each case. Given the relatively small impact compared to industry total revenues, any further analysis would not be productive.

Because the estimated impacts are below one percent of estimated annual revenue of the impacted industries, MSHA concludes that compliance with the provisions of the final rule is economically feasible.

VI. Regulatory Flexibility Act, Small Business Regulatory Enforcement Fairness Act, and Executive Order 13272: Proper Consideration of Small Entities in Agency Rulemaking

The Regulatory Flexibility Act of 1980 (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 and other statutes, and E.O. 13272 requires agencies to consider the effects of their final and existing regulations on small entities and to examine alternatives that would minimize the small entity impacts while still meeting the regulations' purposes. MSHA has reviewed the final rule to assess the potential impact on small businesses, small governmental jurisdictions, and small organizations.

The applicants who will be affected by the final rule represent 30 industries. The Small Business Administration's (SBA's) size standard for a small entity (13 CFR 121.201) differs by industry code. For mining, SBA defines a small entity as one with 500 or fewer employees. For non-mining industries that would be impacted by this rule, SBA defines a small entity as one that has revenues of $7.5 million or less. MSHA used the SBA's definitions for a small entity, FY 2012 invoice data, and NAICS industry data to evaluate the small business impact.

For the non-mining industries, the affected industries represent small business revenues of approximately $474 billion. The final rule will increase fees for non-mining industries by approximately $0.5 million. The impact from an increase in fees is essentially zero percent of revenue ($0.5 million/$474 billion).

For the mining industries, MSHA data shows small coal mine revenues of $30 billion. The final rule will increase fees for small coal mines by approximately $0.9 million. MSHA data shows other small mine revenues (not coal mines) of $57 billion. The final rule will increase fees for small mines other than coal by approximately $6,000. The impact from an increase in fees is zero percent for both mining categories.

Approximately $100,000 in increased fees is primarily attributable to foreign entities. MSHA concludes that the impact on the U.S. economy and its businesses would be de minimis.

Several commenters stated that large companies could absorb the increase in fees and that the small companies would be adversely affected. MSHA's analysis determined that the impact of the final rule for both small mining and small non-mining entities is essentially zero percent of annual revenues. Additionally, considering MSHA's traditional definition of small mines (1-19 employees), the impact of the final rule is essentially zero percent. The Agency concludes that one rate is appropriate for all company sizes.

MSHA certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

VII. Paperwork Reduction Act of 1995

This final rule contains no information collections subject to review by OMB under the Paperwork Reduction Act of 1995. The paperwork associated with applications for approval are considered under the specific part in Title 30, Chapter 1, Subchapter B that contains the requirements for the specific product submitted for MSHA approval.

VIII. Other Regulatory Considerations A. The Unfunded Mandates Reform Act of 1995

MSHA has reviewed the final rule under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). MSHA has determined that this final rule does not include any federal mandate that may result in increased expenditures by State, local, or tribal governments; nor would it increase private sector expenditures by more than $100 million (adjusted for inflation) in any one year or significantly or uniquely affect small governments. Accordingly, under the Unfunded Mandates Reform Act, no further Agency action or analysis is required.

B. The Treasury and General Government Appropriations Act of 1999: Assessment of Federal Regulations and Policies on Families

Section 654 of the Treasury and General Government Appropriations Act of 1999 (5 U.S.C. 601 note), as amended, requires agencies to assess the impact of agency action on family well-being. MSHA has determined that this final rule would have no effect on family stability or safety, marital commitment, parental rights and authority, or income or poverty of families and children. Accordingly, MSHA certifies that this final rule will not impact family well-being.

C. Executive Order 12630: Government Actions and Interference With Constitutionally Protected Property Rights

Executive Order 12630 requires Federal agencies to “identify the takings implications of final regulatory actions . . . .” MSHA has determined that this final rule will not include a regulatory or policy action with takings implications. Accordingly, under E.O. 12630, no further Agency action or analysis is required.

D. Executive Order 12988: Civil Justice Reform

Executive Order 12988 contains requirements for Federal agencies promulgating new regulations or reviewing existing regulations to minimize litigation by eliminating drafting errors and ambiguity, providing a clear legal standard for affected conduct rather than a general standard, promoting simplification, and reducing burden. MSHA has reviewed this final rule and has determined that it would meet the applicable standards provided in E.O. 12988 to minimize litigation and undue burden on the Federal court system.

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

MSHA has determined that this final rule will have no adverse impact on children. Accordingly, under E.O. 13045, no further Agency action or analysis is required.

F. Executive Order 13132: Federalism

MSHA has determined that this final rule does not have federalism implications because it would not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, under E.O. 13132, no further Agency action or analysis is required.

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

MSHA has determined that this final rule does not have tribal implications because it would not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Accordingly, under E.O. 13175, no further Agency action or analysis is required.

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

MSHA has reviewed this final rule for its impact on the supply, distribution, and use of energy because it applies to the coal mining industry. Insofar as the final rule would result in an increase to the yearly transfer of $0.9 million for the coal mining industry relative to annual revenues of $41 billion in 2012, it is not a “significant energy action” because it is not “likely to have a significant adverse effect on the supply, distribution, or use of energy (including a shortfall in supply, price increases, and increased use of foreign supplies).” Accordingly, under E.O. 13211, no further Agency action or analysis is required.

List of Subjects in 30 CFR Part 5

Mine safety and health.

Dated: July 23, 2015. Joseph A. Main, Assistant Secretary of Labor for Mine Safety and Health.

For the reasons set out in the preamble, and under the authority of the Federal Mine Safety and Health Act of 1977, as amended, MSHA is revising 30 CFR part 5 to read as follows:

PART 5—FEES FOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS Sec. 5.10 Purpose and scope. 5.30 Fee calculation. 5.40 Fee administration. 5.50 Fee revisions. Authority:

30 U.S.C. 957.

§ 5.10 Purpose and scope.

This part establishes a system under which MSHA charges a fee for services provided. This part includes the management and calculation of fees for the approval program, which includes: Application processing, testing and evaluation, approval decisions, post-approval activities, and termination of approvals.

§ 5.30 Fee calculation.

(a) Fee calculation. MSHA charges a fee based on an hourly rate for Approval and Certification Center (A&CC) approval program activities and other associated costs, such as travel expenses and part 15 fees. Part 15 fees for services provided to MSHA by other organizations may be set by those organizations.

(b) Hourly rate calculation. The hourly rate consists of direct and indirect costs of the A&CC's approval program divided by the number of direct hours worked on all approval program activities.

(1) Direct costs are compensation and benefit costs for hours worked on approval program activities.

(2) Indirect costs are a proportionate share of the following A&CC costs:

(i) Compensation and benefit hours worked in support of all A&CC activities;

(ii) A&CC building and equipment depreciation costs;

(iii) A&CC utilities, facility and equipment maintenance, and supplies and materials; and

(iv) Information Technology and other services the Department of Labor provides to the A&CC.

(c) Fees are charged for—

(1) Application processing (e.g., administrative and technical review of applications, computer tracking, and status reporting);

(2) Testing and evaluation (e.g., analysis of drawings, technical evaluation, testing, test set up and test tear down, and internal quality control activities);

(3) Approval decisions (e.g., consultation on applications, records control and security, document preparation); and

(4) Two post-approval activities: changes to approvals and post-approval product audits.

(d) Fees are not charged for—

(1) Technical assistance not related to processing an approval application;

(2) Technical programs, including development of new technology programs;

(3) Participation in research conducted by other government agencies or private organizations; and

(4) Regulatory review activities, including participation in the development of health and safety standards, regulations, and legislation.

(e) Fee estimate. Except as provided in paragraphs (e)(1) and (2) of this section, on completion of an initial administrative review of the application, the A&CC will prepare a maximum fee estimate for each application. A&CC will begin the technical evaluation after the applicant authorizes the fee estimate.

(1) The applicant may pre-authorize an expenditure for services, and may further choose to pre-authorize either a maximum dollar amount or an expenditure without a specified maximum amount.

(i) All applications containing a pre-authorization statement will be put in the queue for the technical evaluation on completion of an initial administrative review.

(ii) MSHA will concurrently prepare a maximum fee estimate for applications containing a statement pre-authorizing a maximum dollar amount, and will provide the applicant with this estimate.

(2) Where MSHA's estimated maximum fee exceeds the pre-authorized maximum dollar amount, the applicant has the choice of cancelling the action and paying for all work done up to the time of the cancellation, or authorizing MSHA's estimate.

(3) Under the Revised Acceptance Modification Program (RAMP), MSHA expedites applications for acceptance of minor changes to previously approved, certified, accepted, or evaluated products. The applicant must pre-authorize a fixed dollar amount, set by MSHA, for processing the application.

(f) If unforeseen circumstances are discovered during the evaluation, and MSHA determines that these circumstances would result in the actual costs exceeding either the pre-authorized expenditure or the authorized maximum fee estimate, as appropriate, MSHA will prepare a revised maximum fee estimate for completing the evaluation. The applicant will have the option of either cancelling the action and paying for services rendered or authorizing MSHA's revised estimate, in which case MSHA will continue to test and evaluate the product.

(g) If the actual cost of processing the application is less than MSHA's maximum fee estimate, MSHA will charge the actual cost.

§ 5.40 Fee administration.

Applicants and approval holders will be billed for all fees, including actual travel expenses, if any, when approval program activities are completed. Invoices will contain specific payment instruction, including the address to mail payments and authorized methods of payment.

§ 5.50 Fee revisions.

The hourly rate will remain in effect for at least one year and be subject to revision at least once every three years.

[FR Doc. 2015-18617 Filed 7-28-15; 8:45 am] BILLING CODE 4510-43-P
DEPARTMENT OF THE TREASURY Financial Crimes Enforcement Network 31 CFR Part 1010 RIN 1506-AB27 Imposition of Special Measure Against FBME Bank Ltd., Formerly Known as the Federal Bank of the Middle East Ltd., as a Financial Institution of Primary Money Laundering Concern AGENCY:

Financial Crimes Enforcement Network (FinCEN), Treasury.

ACTION:

Final rule.

SUMMARY:

In a Notice of Finding (NOF) published in the Federal Register on July 22, 2014, the Director of FinCEN found that reasonable grounds exist for concluding that FBME Bank Ltd. (FBME), formerly known as the Federal Bank of the Middle East, Ltd., is a financial institution of primary money laundering concern pursuant to the United States Code (U.S.C.). On the same date, FinCEN also published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to propose the imposition of a special measure authorized by the U.S.C. against FBME. FinCEN is issuing this final rule imposing the fifth special measure against FBME.

DATES:

This final rule is effective August 28, 2015.

FOR FURTHER INFORMATION CONTACT:

The FinCEN Resource Center at (800) 767-2825.

SUPPLEMENTARY INFORMATION: I. Background A. Statutory Provisions

On October 26, 2001, the President signed into law the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, Public Law 107-56 (the USA PATRIOT Act). Title III of the USA PATRIOT Act amends the anti-money laundering provisions of the Bank Secrecy Act (BSA), codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5314, 5316-5332, to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. Regulations implementing the BSA appear at 31 CFR chapter X. The authority of the Secretary of the Treasury (the Secretary) to administer the BSA and its implementing regulations has been delegated to the Director of FinCEN.

Section 311 of the USA PATRIOT Act (Section 311), codified at 31 U.S.C. 5318A, grants the Director of FinCEN the authority, upon finding that reasonable grounds exist for concluding that a foreign jurisdiction, financial institution, class of transaction, or type of account is of “primary money laundering concern,” to require domestic financial institutions and financial agencies to take certain “special measures” to address the primary money laundering concern. This rulemaking imposes the fifth special measure, codified at 31 U.S.C. 5318A(b)(5), against FBME. The fifth special measure allows the Director to prohibit or impose conditions on the opening or maintaining of correspondent or payable-through accounts for the identified institution by U.S. financial institutions.

B. FBME

FBME was established in 1982 in Cyprus as the Federal Bank of the Middle East, Ltd., a subsidiary of the private Lebanese bank, the Federal Bank of Lebanon. Both FBME and the Federal Bank of Lebanon are owned by Ayoub-Farid M. Saab and Fadi M. Saab. In 1986, FBME changed its country of incorporation to the Cayman Islands, and its banking presence in Cyprus was re-registered as a branch of the Cayman Islands entity. In 2003, FBME left the Cayman Islands and incorporated and established its headquarters in Tanzania. At the same time, FBME's Cypriot operations became a branch of FBME Tanzania Ltd. In 2005, FBME changed its name from the Federal Bank of the Middle East, Ltd. to FBME Bank Ltd.

FBME's headquarters in Tanzania is widely regarded as the largest bank in Tanzania based on its $2 billion asset size, but it has only four Tanzania-based branches. While FBME is presently headquartered in Tanzania, FBME transacts over 90 percent of its global banking business and holds over 90 percent of its assets in its Cyprus branch. FBME has always maintained a significant presence in Cyprus. FBME has stated, however, that it is not in direct competition with local retail banks in Cyprus for several reasons, including that it does not issue checks, it has no retail counters there, and its Cypriot customers are limited mainly to staff, contractors, and professionals providing services to FBME.

II. The 2014 Finding and Subsequent Developments A. The 2014 Finding

In a NOF published in the Federal Register on July 22, 2014, the Director of FinCEN explained her finding that reasonable grounds exist for concluding that FBME is a financial institution of primary money laundering concern pursuant to 31 U.S.C. 5318A.1 FinCEN's NOF identified two main areas of concern: (1) FBME's facilitation of money laundering, terrorist financing, transnational organized crime, fraud schemes, sanctions evasion, weapons proliferation, corruption by politically-exposed persons, and other financial crime, and (2) FBME's weak anti-money laundering (AML) controls, which allow its customers to perform a significant volume of obscured transactions and activities through the U.S. financial system. In particular, the Director found that FBME is used to facilitate money laundering, terrorist financing, transnational organized crime, fraud, sanctions evasion, and other illicit activity internationally and through the U.S. financial system and has systemic failures in its AML controls that attract high-risk shell companies (i.e., companies formed for the sole purpose of holding property or funds and that do not engage in any legitimate business activity). FBME performs a significant volume of transactions and activities that have little or no transparency and often no apparent legitimate business purpose.

1See 79 FR 42639 (July 22, 2014).

As detailed in the NOF, these activities have included (1) an FBME customer receiving a deposit of hundreds of thousands of dollars from a financier for Lebanese Hezbollah; (2) providing financial services to a financial advisor for a major transnational organized crime figure; (3) FBME's facilitation of the transfers to an FBME account involved in fraud against a U.S. person, with the FBME customer operating the alleged fraud scheme later being indicted in the United States District Court for the Northern District of Ohio; and (4) FBME's facilitation of U.S. sanctions evasion through its extensive customer base of shell companies, including at least one FBME customer that was a front company for a U.S.-sanctioned Syrian entity, the Scientific Studies and Research Center (SSRC) and which used its FBME account to process transactions through the U.S. financial system.

On the same date it published the NOF, FinCEN also published in the Federal Register a related NPRM to propose the imposition of the fifth special measure against FBME and to seek comment.2

2See 79 FR 42486 (July 22, 2014) (RIN 1506-AB27).

B. FBME Subsequent Developments

On July 21, 2014, the Central Bank of Cyprus (CBC) issued a decree announcing that it would formally place FBME's Cyprus branch “under resolution,” allowing the CBC to take numerous unilateral measures to protect FBME's depositors. On July 24, 2014, the Bank of Tanzania took over management of FBME's headquarters in Tanzania because of the potential effects of the CBC's actions on the Tanzanian banking system.

After considering all relevant comments and other information available to the agency, including both public and non-public reporting, FinCEN is issuing this final rule imposing the fifth special measure against FBME, which prohibits the opening or maintaining of correspondent or payable-through accounts for FBME by U.S. financial institutions. This information continues to provide reason to believe that FBME's AML compliance efforts are not adequate to address the risks faced by FBME, and that FBME facilitates illicit financial activity. As described below, audits performed by third parties in 2013 and 2014 that were provided to FinCEN by FBME to demonstrate the effectiveness of its AML compliance program instead identified significant, recurring weaknesses in FBME's compliance program. Several deficiencies were identified by one of the third party auditors as being of “high or medium significance.” These deficiencies, which FinCEN has reason to believe continue to exist following the issuance of the NOF, facilitate the illicit financial activities of FBME's customers.

III. FBME's September 22, 2014 Comment and Other Comments

FBME, through outside counsel, submitted comments, dated September 22, 2014, during the comment period. FBME made six additional submissions of information related to comments made during the comment period after the close of the comment period. FBME's September 22, 2014, comments were received during the comment period and accordingly made a part of the public record. The six additional submissions were not made a part of the public record, based in part on FBME's claim that these additional submissions contained sensitive commercial and business information and FBME's corresponding request that the additional submissions be afforded confidential treatment. However, FinCEN reviewed and considered each of these submissions in drafting this final rule.

FBME's September 22, 2014 comment consists of an introduction followed by two major sections. In its introduction, FBME makes six key points. First, FBME states that its AML compliance program policies are in line with applicable requirements, including the requirements of the European Union's Third Money Laundering Directive and the CBC's Fourth Directive. FBME contends that this alignment has been the case since at least 2013, according to third party audits. Second, FBME states that, in response to recommendations made as a result of audits conducted by Ernst & Young (EY) in 2011 and KPMG in 2013, FBME has substantially strengthened its compliance program over the last two years. Third, FBME states that FBME and its officers and directors do not condone the use of FBME for illicit purposes and strive to prevent such misuse. Fourth, FBME contends that some of the statements made in the NOF are incorrect or are based on incomplete information, which FBME also describes in the second section of its comment. Fifth, FBME states that, in some cases, FBME filed Suspicious Transaction Reports (STRs) with the Cypriot Financial Intelligence Unit (MOKAS) on activity described in the NOF and NPRM. Sixth, FBME claims that the NOF and NPRM have had a significant adverse impact on FBME and its customers.

The first section of FBME's September 22, 2014 comment then describes aspects of its AML compliance program, and the second section responds to statements made in the NOF that FBME asserts are inaccurate or based on incomplete information.

In this final rule, FinCEN is focusing its response on the six points in the introduction, which summarize FBME's concerns with the NOF and the NPRM. In responding to the first three points of FBME's introduction, FinCEN also refutes the first section of FBME's comment because the first three points of FBME's introduction and the first section of FBME's comment all refer to FBME's AML compliance program, its policies, audits conducted by third parties, and FBME's management. In responding to the fourth point of FBME's introduction, FinCEN is also addressing the second section of FBME's comment because both the fourth point of the introduction and the second section of the comment refer to the same statements in the NOF that FBME asserts are inaccurate or based on incomplete information.

With regard to FBME's first and second points, the information provided by FBME on the audits conducted by KPMG and EY in 2013 and 2014, respectively, show a pattern of recurring AML deficiencies at the bank. These included failures to maintain adequate customer identification files, along with other customer due diligence weaknesses, failure to ensure that third parties the bank relied on to establish new customer relationships employed appropriate AML controls with regard to such persons, and issues with sanctions-related screening.

According to FBME's comment, EY conducted an audit in 2011 (the 2011 EY Audit). During that audit, according to FBME, EY found that FBME's due diligence procedures with respect to obtaining information from new clients met the requirements of the CBC Directive at the time, but also noted that some customer information requirements of the Directive had not been fully met by FBME in previous iterations of its AML procedures and policies. According to FBME's comment, EY subsequently conducted another audit in 2014 (the 2014 EY Audit), which found that, although FBME had an AML compliance program in place that incorporated the requirements of both the CBC Fourth Directive and the European Union Third Directive, FBME nevertheless had deficiencies in its customer due diligence, automated alerts system, and AML training areas.

According to FBME's September 22, 2014 comment, KPMG also conducted an audit in 2013 (the 2013 KPMG Audit) which found that FBME “basically fulfills” its AML regulatory requirements set forth by the CBC and the European Union, but also identified issues of “high or medium” significance with FBME's use of Approved Third Parties and FBME's sanction screening procedures. As FBME stated in its September 22, 2014 comment, FBME uses its relationships with Approved Third Parties, some of which are in foreign jurisdictions, to develop potential new customer relationships. According to the KPMG 2013 Audit, FBME had never attempted to ensure the adequacy of its Approved Third Parties' AML measures. In addition, the 2013 KPMG Audit found that FBME only screened the related parties of its Approved Third Parties when the customers were initially onboarded.

The 2013 KPMG Audit also found FBME's customer due diligence deficient. As FBME disclosed in its September 22, 2014 comment, in its 2013 audit, KPMG “recommended better presentation of ownership information to demonstrate links between group entities for older customers, in line with a new structure that had been introduced for new customers. KPMG also found that certain customer files reviewed did not have sufficient information to gain a complete understanding of the customers' activities or business rationale.” In its 2013 audit, KPMG further found that FBME's use of hold-mail accounts and post office boxes managed by Approved Third Parties should be reconsidered by FBME in order to “avoid potential anonymisation.”

The 2014 EY Audit identified numerous deficiencies in FBME's compliance program. Specifically, the 2014 EY Audit found that the following recommendations were necessary for FBME's compliance program: Consistently documenting the efforts taken to verify the sources of funds and business purpose of accounts from prospective customers; more thoroughly investigating relationships among FBME customers, especially when inordinate volumes of internal transfers are identified; modifying FBME's periodic customer due diligence process to align with industry practices (e.g., moving to a rolling 12 or 36-month review cycle, depending on the customer's risk); implementing an automated case management system to record the alerts generated, stage of investigation, and ultimate disposition of the alerts generated by FBME's screening software, as opposed to the current process of manually entering the alerts/outcome on several different spreadsheets; and more thoroughly documenting the AML/sanctions training given for new hires and providing general awareness training to all employees on an annual basis.

The numerous AML compliance program deficiencies described in the 2013 KPMG Audit and the 2014 EY Audit in particular are similar to AML deficiencies FinCEN identified in the NOF. All of these findings follow action against FBME by the CBC for similar issues. As FBME acknowledged in its September 22, 2014 comment, in 2010, the CBC fined FBME 80,000 euros for customer identification, due diligence, and automated monitoring deficiencies. According to the 2013 KPMG Audit, FBME also undertook an extensive Know Your Customer (KYC) remediation project from 2009 through 2011 that was ordered by the CBC and resulted in the closure of thousands of FBME accounts.

Finally, FBME's argument that its AML compliance program is now adequate is weakened by the list of illicit actors identified in the NOF that have continued to make use of FBME as recently as 2014, including narcotics traffickers, terrorist financiers, and organized crime figures.

With regard to FBME's third point, information available to FinCEN makes it reasonable to conclude that FBME's management facilitated, either actively or passively, the illicit activities of its customers, as FinCEN set forth in the NOF.

With regard to FBME's fourth point, in which FBME has argued that portions of the eight statements in the NOF were incorrect or based on incomplete information, FinCEN believes that it is appropriate in two cases to amend the NOF based on these comments. In the first case, FBME stated that it was not fined by the CBC in 2008, but that the CBC imposed an administrative fine on FBME in 2010. FinCEN agrees that the fine in question was imposed in 2010, not in 2008.

In the second case, FBME argued that the report that FBME may be subject to a fine of up to 240 million euros is from a November 2013 article in the Cypriot press that relied on anonymous sources at the CBC. FinCEN agrees that the source of this statement was an article that appeared in the Cypriot press that referenced statements by a CBC official speaking anonymously. Neither these two cases nor any of FBME's remaining claims of incompleteness and factual inaccuracy presents any new information or in any way cause FinCEN to doubt the accuracy of the information presented in the NOF.

With regard to FBME's fifth point, FinCEN notes that the filing of STRs on suspicious activities or transactions by a financial institution is not, taken in isolation, an adequate indicator of the robustness and comprehensiveness of a compliance program. Although the filing of STRs is a critical component of any financial institution's AML compliance program, if STRs are filed in an incomplete, inaccurate, or untimely manner, their usefulness to authorities responsible for investigating money laundering and other illicit activities is greatly diminished. Moreover, filing STRs does not excuse a financial institution's failure to adequately implement other areas of its AML program, such as, for example, customer due diligence procedures.

With regard to FBME's sixth point, as part of FinCEN's consideration of the statutory factors supporting its selection of the fifth special measure, FinCEN has considered “the extent to which the action or the timing of the action would have a significant adverse systemic impact on . . . legitimate business activities involving” FBME. This is discussed in Part IV, section A below.3

3 31 U.S.C. 5318A(a)(4)(B)(iii).

In addition to its public comment, FBME has submitted a substantial volume of supplemental information regarding FBME's policies and procedures, and reports of the audits conducted by KPMG in 2013 and EY in 2014. FinCEN has carefully considered these materials, which outline some of the steps that FBME has taken to strengthen its compliance program. However, after a thorough review of these materials, FinCEN believes that, except as acknowledged above, the statements made in the NOF remain true and accurate, and that FBME is of “primary money laundering concern.”

FinCEN continues to have serious concerns regarding FBME's potential to be used wittingly or unwittingly for illicit purposes. As FinCEN explained in its NOF, FBME customers continue to exhibit shell company attributes and many are located in high-risk jurisdictions. FinCEN continues to have concerns with FBME's AML compliance program, in particular with the aforementioned customer due diligence deficiencies, which were identified over a number of years and which enable FBME customers to conduct financial activity in relative obscurity.

FinCEN also considered a comment received from the American Bankers' Association (ABA), dated September 22, 2014; a joint comment received from the Securities Industry and Financial Markets Association (SIFMA) and The Clearing House (TCH), dated September 22, 2014; and a separate comment received from SIFMA, dated September 22, 2014. FinCEN notes that these comments were procedural in nature and did not address the underlying conclusion surrounding the risk of money laundering through FBME.

FinCEN appreciates the thoughtful comments that were submitted and has addressed these comments, as appropriate, in the section-by-section analysis below.

IV. Imposition of Special Measure Against FBME as a Financial Institution of Primary Money Laundering Concern

As described in the NOF and this final rule, the Director of FinCEN found that reasonable grounds exist for concluding that FBME is a financial institution of primary money laundering concern. Based upon that finding, the Director of FinCEN is authorized to impose one or more special measures. Following the required consultations and the consideration of all relevant factors discussed in the NOF, the Secretary, through the Director of FinCEN, proposed the imposition of the fifth special measure in an NPRM published on July 22, 2014. The fifth special measure authorizes a prohibition against the opening or maintaining of correspondent accounts by any domestic financial institution or agency for, or on behalf of, a financial institution found to be a primary money laundering concern.

Consistent with the finding that FBME is a financial institution of primary money laundering concern and in consideration of additional relevant factors, this final rule imposes the fifth special measure with regard to FBME. The prohibition on the maintenance of correspondent accounts imposed by the fifth special measure will help to guard against the money laundering risks that FBME presents to the U.S. financial system as identified in the NOF, NPRM, and this final rule.

A. Discussion of Section 311 Factors

In determining which special measure to implement to address the primary money laundering concern posed by FBME, FinCEN has considered the following factors.

1. Whether Similar Actions Have Been or Will Be Taken by Other Nations or Multilateral Groups Against FBME

Other countries or multilateral groups have not yet taken action similar to those proposed in this rulemaking that would prohibit domestic financial institutions and agencies from opening or maintaining a correspondent account for, or on behalf of, FBME and that would require those domestic financial institutions and agencies to screen their correspondents in a manner that is reasonably designed to guard against indirect use by FBME, including access through the use of nested correspondent accounts held by FBME.

2. Whether the Imposition of the Fifth Special Measure Would Create a Significant Competitive Disadvantage, Including Any Undue Cost or Burden Associated With Compliance, for Financial Institutions Organized or Licensed in the United States

The fifth special measure imposed by this rulemaking prohibits covered financial institutions from opening and maintaining correspondent accounts for, or on behalf of, FBME. As a corollary to this measure, covered financial institutions also are required to take reasonable steps to apply special due diligence, as set forth below, to all of their correspondent accounts to help ensure that no such account is being used indirectly to provide services to FBME. FinCEN does not expect the burden associated with these requirements to be significant. Additionally, there is only a minimal burden involved in transmitting a one-time notice to correspondent account holders concerning the prohibition on indirectly providing services to FBME. U.S. financial institutions generally apply some level of transaction and account screening, often through the use of commercially available software. As explained in more detail in the section-by-section analysis below, financial institutions should, if necessary, be able to easily adapt their current screening procedures to support compliance with this final rule. Thus, the prohibition on the maintenance of correspondent accounts that would be required by this rulemaking is not expected to impose a significant additional burden upon U.S. financial institutions.

3. The Extent to Which the Action or Timing of the Action Will Have a Significant Adverse Systemic Impact on the International Payment, Clearance, and Settlement System, or on Legitimate Business Activities Involving FBME

FBME is not a major participant in the international payment system and is not relied upon by the international banking community for clearance or settlement services. Thus, the imposition of the fifth special measure against FBME will not have a significant adverse systemic impact on the international payment, clearance, and settlement system. In light of the underlying money laundering risks posed by FBME, FinCEN does not believe that the rule will impose an undue burden on legitimate business activities involving FBME. There are other banks in both Cyprus and Tanzania that could alleviate potential impact on legitimate business activities within those jurisdictions.4 On July 21, 2014, the CBC, under the authority of the Cyprus Resolution Act, issued a decree announcing that it would formally place FBME's Cyprus branch “under resolution,” allowing the CBC to take numerous unilateral measures regarding FBME, including selling off Cyprus-based FBME branch locations, to protect FBME's depositors. On July 24, 2014, the Bank of Tanzania took over management of FBME's headquarters in Tanzania because of the potential effects of the CBC's actions on the Tanzanian banking system. The control of FBME branches by state authorities in both jurisdictions also offers a means to support legitimate business activity involving FBME. Finally, FinCEN anticipates that its identification of the money laundering risks associated with FBME will assist banks in appropriately policing legitimate business involving FBME to guard against the use of their institutions for financial crime.

4See Central Bank of Cyprus (Web site: http://www.centralbank.gov.cy/) and Bank of Tanzania (Web site: http://www.bot-tz.org/) for lists of banks in Cyprus and Tanzania, respectively.

4. The Effect of the Action on United States National Security and Foreign Policy

The exclusion from the U.S. financial system of banks that, like FBME, serve as conduits for money laundering activity and other financial crimes will enhance U.S. national security by making it more difficult for terrorists, sanctions evaders, and money launderers to access the substantial resources of the U.S. financial system. More generally, the imposition of the fifth special measure will complement the U.S. Government's worldwide foreign policy efforts to expose and disrupt international money laundering, and to encourage other nations to do the same. The United States has played a leadership role in combating money laundering and terrorist financing not only through action with regard to specific institutions but also through participation in international operational and standard-setting bodies such as the Egmont Group and the Financial Action Task Force.

V. Section-by-Section Analysis for Imposition of the Fifth Special Measure A. 1010.658(a)—Definitions 1. FBME

Section 1010.658(a)(1) of the rule defines FBME to include all branches, offices, and subsidiaries of FBME operating in any jurisdiction, including Tanzania and Cyprus. Financial institutions should take commercially reasonable measures to determine whether a customer is a branch, office, or subsidiary of FBME. Currently, FBME's bank branches are located in Tanzania and Cyprus, with a representative office in Moscow, Russian Federation.

SIFMA, TCH, and the ABA noted that it would be useful for FinCEN to provide a list of FBME's subsidiaries; however, because subsidiary relationships can change frequently, covered financial institutions should use commercially-reasonable tools to determine the current subsidiaries of FBME.

2. Correspondent Account

Section 1010.658(a)(2) of the rule defines the term “correspondent account” by reference to the definition contained in 31 CFR 1010.605(c)(1)(ii). Section 1010.605(c)(1)(ii) defines a correspondent account to mean an account established to receive deposits from, or make payments or other disbursements on behalf of, a foreign bank, or to handle other financial transactions related to the foreign bank. Under this definition, “payable through accounts” are a type of correspondent account.

In the case of a U.S. depository institution, this broad definition includes most types of banking relationships between a U.S. depository institution and a foreign bank that are established to provide regular services, dealings, and other financial transactions, including a demand deposit, savings deposit, or other transaction or asset account, and a credit account or other extension of credit. FinCEN is using the same definition of “account” for purposes of this rule as was established for depository institutions in the final rule implementing the provisions of section 312 of the USA PATRIOT Act requiring enhanced due diligence for correspondent accounts maintained for certain foreign banks.5

5See 31 CFR 1010.605(c)(2)(i).

In the case of securities broker-dealers, futures commission merchants, introducing brokers-commodities, and investment companies that are open-end companies (mutual funds), FinCEN is also using the same definition of “account” for purposes of this rule as was established for these entities in the final rule implementing the provisions of section 312 of the USA PATRIOT Act requiring enhanced due diligence for correspondent accounts maintained for certain foreign banks.6

6See 31 CFR 1010.605(c)(2)(ii)-(iv).

3. Covered Financial Institution

Section 1010.658(a)(3) of the rule defines “covered financial institution” with the same definition used in the final rule implementing section 312 of the USA PATRIOT Act,7 which, in general, includes the following:

7See 31 CFR 1010.605(e)(1).

• An insured bank (as defined in section 3(h) of the Federal Deposit Insurance Act (12 U.S.C. 1813(h));

• A commercial bank;

• An agency or branch of a foreign bank in the United States;

• A Federally insured credit union;

• A savings association;

• A corporation acting under section 25A of the Federal Reserve Act (12 U.S.C. 611);

• A trust bank or trust company;

• A broker or dealer in securities;

• A futures commission merchant or an introducing broker-commodities; and

• A mutual fund.

4. Subsidiary

Section 1010.658(a)(4) of the rule defines “subsidiary” as a company of which more than 50 percent of the voting stock or analogous equity interest is owned by another company.

B. 1010.658(b)—Requirements for Covered Financial Institutions With Regard to the Fifth Special Measure

For purposes of complying with the final rule's prohibition on the opening or maintaining in the United States of correspondent accounts for, or on behalf of, FBME, covered financial institutions should take such steps as a reasonable and prudent financial institution would take to protect itself from loan or other fraud or loss based on misidentification of a person's status.

1. Prohibition on Opening or Maintaining Correspondent Accounts

Section 1010.658(b)(1) of the rule imposing the fifth special measure prohibits all covered financial institutions from establishing, maintaining, administering, or managing a correspondent account in the United States for, or on behalf of, FBME. The prohibition requires all covered financial institutions to review their account records to ensure that they maintain no accounts directly for, or on behalf of, FBME.

2. Special Due Diligence of Correspondent Accounts To Prohibit Indirect Use

As a corollary to the prohibition on maintaining correspondent accounts directly for FBME, § 1010.658(b)(2) of the rule imposing the fifth special measure requires a covered financial institution to apply special due diligence to its correspondent accounts that is reasonably designed to guard against processing transactions involving FBME. As part of that special due diligence, covered financial institutions must notify those foreign correspondent account holders that covered financial institutions know or have reason to know provide services to FBME that such correspondents may not provide FBME with access to the correspondent account maintained at the covered financial institution. Covered financial institutions should implement appropriate risk-based procedures to identify transactions involving FBME.

A covered financial institution may satisfy the notification requirement by transmitting the following notice to its foreign correspondent account holders that it knows or has reason to know provide services to FBME:

Notice: Pursuant to U.S. regulations issued under Section 311 of the USA PATRIOT Act, see 31 CFR 1010.658, we are prohibited from establishing, maintaining, administering, or managing a correspondent account for, or on behalf of, FBME Bank, Ltd., or any of its branches, offices or subsidiaries. The regulations also require us to notify you that you may not provide FBME Bank, Ltd., or any of its branches, offices or subsidiaries with access to the correspondent account you hold at our financial institution. If we become aware that the correspondent account you hold at our financial institution has processed any transactions involving FBME Bank, Ltd., or any of its branches, offices or subsidiaries, we will be required to take appropriate steps to prevent such access, including terminating your account.

A covered financial institution may, for example, have knowledge through transaction screening software that a correspondent account processes transactions for FBME. The purpose of the notice requirement is to aid cooperation with correspondent account holders in preventing transactions involving FBME from accessing the U.S. financial system. However, FinCEN would not require or expect a covered financial institution to obtain a certification from any of its correspondent account holders that access will not be provided to comply with this notice requirement. Instead, methods of compliance with the notice requirement could include, for example, transmitting a one-time notice by mail, fax, or email to appropriate correspondent account holders of the covered financial institution, informing them that they may not provide FBME with access to the covered financial institution's correspondent account, or including such information in the next regularly occurring transmittal from the covered financial institution to those correspondent account holders.

In its comment to the NPRM, SIFMA requested reconsideration of the notice provision, specifically regarding the meaning of “one-time notice,” and further objected to the requirement to send such a notice as overly burdensome and possibly duplicative. SIFMA also requested further clarification with regard to the timing of the required notice. FinCEN emphasizes that the scope of notice requirement is targeted toward those correspondent account holders that the covered financial institution knows or has reason to know provide services to FBME, not to all correspondent account holders. The term “one-time notice” means that a financial institution should provide notice to all existing correspondent account holders who the covered financial institution knows or has reason to know provide services to FBME, within a reasonably short time after this final rule is published, and to new correspondent account holders during the account opening process who the covered financial institution knows or has reason to know provide services to FBME. It is not necessary for the notice to be provided in any particular form. It may be provided electronically, orally (with documentation), or as part of the standard paperwork involved in opening or maintaining a correspondent account. Given the limited nature of FBME's correspondent relationships, FinCEN does not expect this requirement to be burdensome.

A covered financial institution is also required to take reasonable steps to identify any indirect use of its correspondent accounts by FBME, to the extent that such indirect use can be determined from transactional records maintained by the covered financial institution in the normal course of business. Covered financial institutions are expected to apply an appropriate screening mechanism to be able to identify a funds transfer order that on its face lists FBME as the financial institution of the originator or beneficiary, or otherwise references FBME. An appropriate screening mechanism could be the mechanism used by a covered financial institution to comply with various legal requirements, such as the commercially available software programs used to comply with the economic sanctions programs administered by the Office of Foreign Assets Control (OFAC).

Notifying certain correspondent account holders and taking reasonable steps to identify any indirect use of its correspondent accounts by FBME in the manner discussed above are the minimum due diligence requirements under the rule imposing the fifth special measure. Beyond these minimum steps, a covered financial institution must adopt a risk-based approach for determining what, if any, additional due diligence measures are appropriate to guard against the risk of indirect use of its correspondent accounts by FBME, based on risk factors such as the type of services it offers and the geographic locations of its correspondent account holders.

Under this rule imposing the fifth special measure, a covered financial institution that obtains knowledge that a correspondent account is being used by a foreign bank to provide indirect access to FBME must take all appropriate steps to prevent such indirect access, including the notification of its correspondent account holder per § 1010.658(b)(2)(i)(A) and, where necessary, terminating the correspondent account. A covered financial institution may afford the foreign bank a reasonable opportunity to take corrective action prior to terminating the correspondent account. Should the foreign bank refuse to comply, or if the covered financial institution cannot obtain adequate assurances that the account will no longer be available to FBME, the covered financial institution must terminate the account within a commercially reasonable time. This means that the covered financial institution may not permit the foreign bank to establish any new positions or execute any transactions through the account, other than those necessary to close the account. A covered financial institution may reestablish an account closed under the rule if it determines that the account will not be used to provide banking services indirectly to FBME.

3. Reporting Not Required

Section 1010.658(b)(3) of the rule imposing the fifth special measure clarifies that the rule does not impose any reporting requirement upon any covered financial institution that is not otherwise required by applicable law or regulation. A covered financial institution must, however, document its compliance with the requirement that it notify those correspondent account holders that the covered financial institution knows or has reason to know provide services to FBME, that such correspondents may not process any transaction involving FBME through the correspondent account maintained at the covered financial institution.

VI. Regulatory Flexibility Act

When an agency issues a final rule, the Regulatory Flexibility Act (RFA) requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis” that will “describe the impact of the Final Rule on small entities.” (5 U.S.C. 603(a)). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the final rule is not expected to have a significant economic impact on a substantial number of small entities.

A. Proposal To Prohibit Covered Financial Institutions From Opening or Maintaining Correspondent Accounts With Certain Foreign Banks Under the Fifth Special Measure 1. Estimate of the Number of Small Entities to Whom the Proposed Fifth Special Measure Will Apply

For purposes of the RFA, both banks and credit unions are considered small entities if they have less than $500,000,000 in assets.8 Of the estimated 7,000 banks, 80 percent have less than $500,000,000 in assets and are considered small entities.9 Of the estimated 7,000 credit unions, 94 percent have less than $500,000,000 in assets.10

8Table of Small Business Size Standards Matched to North American Industry Classification System Codes, Small Business Administration Size Standards (SBA Jan. 22, 2014) [hereinafter “SBA Size Standards”].

9 Federal Deposit Insurance Corporation, Find an Institution, http://www2.fdic.gov/idasp/main.asp; select Size or Performance: Total Assets, type Equal or less than $: “500000” and select Find.

10 National Credit Union Administration, Credit Union Data, http://webapps.ncua.gov/customquery/; select Search Fields: Total Assets, select Operator: Less than or equal to, type Field Values: “500000000” and select Go.

Broker-dealers are defined in 31 CFR 1010.100(h) as those broker-dealers required to register with the Securities and Exchange Commission (SEC). Because FinCEN and the SEC regulate substantially the same population, for the purposes of the RFA, FinCEN relies on the SEC's definition of small business as previously submitted to the Small Business Administration (SBA). The SEC has defined the term small entity to mean a broker or dealer that: (1) Had total capital (net worth plus subordinated liabilities) of less than $500,000 on the date in the prior fiscal year as of which its audited financial statements, were prepared pursuant to Rule 17a-5(d) or, if not required to file such statements, a broker or dealer that had total capital (net worth plus subordinated debt) of less than $500,000 on the last business day of the preceding fiscal year (or in the time that it has been in business if shorter); and (2) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in this release.11 Based on SEC estimates, 17 percent of broker-dealers are classified as small entities for purposes of the RFA.12

11 17 CFR 240.0-10(c).

12 76 FR 37572, 37602 (June 27, 2011) (the SEC estimates 871 small broker-dealers of the 5,063 total registered broker-dealers).

Futures commission merchants (FCMs) are defined in 31 CFR 1010.100(x) as those FCMs that are registered or required to be registered as a FCM with the Commodity Futures Trading Commission (CFTC) under the Commodity Exchange Act (CEA), except persons who register pursuant to section 4f(a)(2) of the CEA, 7 U.S.C. 6f(a)(2). Because FinCEN and the CFTC regulate substantially the same population, for the purposes of the RFA, FinCEN relies on the CFTC's definition of small business as previously submitted to the SBA. In the CFTC's “Policy Statement and Establishment of Definitions of `Small Entities' for Purposes of the Regulatory Flexibility Act,” the CFTC concluded that registered FCMs should not be considered to be small entities for purposes of the RFA.13 The CFTC's determination in this regard was based, in part, upon the obligation of registered FCMs to meet the capital requirements established by the CFTC.

13 47 FR 18618, 18619 (Apr. 30, 1982).

For purposes of the RFA, an introducing broker-commodities dealer is considered small if it has less than $35,500,000 in gross receipts annually.14 Based on information provided by the National Futures Association (NFA), 95 percent of introducing brokers-commodities dealers have less than $35.5 million in adjusted net capital and are considered to be small entities.

14 SBA Size Standards at 28.

Mutual funds are defined in 31 CFR 1010.100(gg) as those investment companies that are open-end investment companies that are registered or are required to register with the SEC. Because FinCEN and the SEC regulate substantially the same population, for the purposes of the RFA, FinCEN relies on the SEC's definition of small business as previously submitted to the SBA. The SEC has defined the term “small entity” under the Investment Company Act to mean “an investment company that, together with other investment companies in the same group of related investment companies, has net assets of $50 million or less as of the end of its most recent fiscal year.” 15 Based on SEC estimates, seven percent of mutual funds are classified as “small entities” for purposes of the RFA under this definition.16

15 17 CFR 270.0-10.

16 78 FR 23637, 23658 (April 19, 2013).

As noted above, 80 percent of banks, 94 percent of credit unions, 17 percent of broker-dealers, 95 percent of introducing brokers-commodities, no FCMs, and seven percent of mutual funds are small entities. The limited number of foreign banking institutions with which FBME maintains or will maintain accounts will likely limit the number of affected covered financial institutions to the largest U.S. banks, which actively engage in international transactions. Thus, the prohibition on maintaining correspondent accounts for foreign banking institutions that engage in transactions involving FBME under the fifth special measure would not impact a substantial number of small entities.

2. Description of the Projected Reporting and Recordkeeping Requirements of the Fifth Special Measure

The fifth special measure would require covered financial institutions to provide a notification intended to aid cooperation from foreign correspondent account holders in preventing transactions involving FBME from accessing the U.S. financial system. FinCEN estimates that the time it takes institutions to provide this notice is one hour. Covered financial institutions would also be required to take reasonable measures to detect use of their correspondent accounts to process transactions involving FBME. All U.S. persons, including U.S. financial institutions, currently must exercise some degree of due diligence to comply with OFAC sanctions and suspicious activity reporting requirements. The tools used for such purposes, including commercially available software used to comply with the economic sanctions programs administered by OFAC, can easily be modified to identify correspondent accounts with foreign banks that involve FBME. Thus, the special due diligence that would be required by the imposition of the fifth special measure—i.e., the one-time transmittal of notice to certain correspondent account holders, the screening of transactions to identify any use of correspondent accounts, and the implementation of risk-based measures to detect use of correspondent accounts—would not impose a significant additional economic burden upon small U.S. financial institutions.

B. Certification

For these reasons, FinCEN certifies that this final rulemaking would not have a significant impact on a substantial number of small businesses.

VII. Paperwork Reduction Act

The collection of information contained in the final rule has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), and has been assigned OMB Control Number 1506- AB19. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.

Description of Affected Financial Institutions: Banks, broker-dealers in securities, futures commission merchants and introducing brokers-commodities, and mutual funds.

Estimated Number of Affected Financial Institutions: 5,000.

Estimated Average Annual Burden in Hours per Affected Financial Institution: The estimated average burden associated with the collection of information in this rule is one hour per affected financial institution.

Estimated Total Annual Burden: 5,000 hours.

VIII. Executive Order 12866

Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that the Final Rule is not a “significant regulatory action” for purposes of Executive Order 12866.

List of Subjects in 31 CFR Part 1010

Administrative practice and procedure, Banks and banking, Brokers, Counter-money laundering, Counter-terrorism, Foreign banking.

Authority and Issuance

For the reasons set forth in the preamble, chapter X of title 31 of the Code of Federal Regulations is amended as follows:

PART 1010—GENERAL PROVISIONS 1. The authority citation for part 1010 is revised to read as follows: Authority:

12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332; title III, secs. 311, 312, 313, 314, 319, 326, 352, Pub. L. 107-56, 115 Stat. 307.

2. Subpart F of chapter X is amended by adding § 1010.658 to read as follows:
§ 1010.658 Special measures against FBME Bank, Ltd.

(a) Definitions. For purposes of this section:

(1) FBME Bank, Ltd. means all branches, offices, and subsidiaries of FBME Bank, Ltd. operating in any jurisdiction.

(2) Correspondent account has the same meaning as provided in § 1010.605(c)(1)(ii).

(3) Covered financial institution has the same meaning as provided in § 1010.605(e)(1).

(4) Subsidiary means a company of which more than 50 percent of the voting stock or analogous equity interest is owned by another company.

(b) Prohibition on accounts and due diligence requirements for covered financial institutions—(1) Prohibition on use of correspondent accounts. A covered financial institution shall terminate any correspondent account that is established, maintained, administered, or managed in the United States for, or on behalf of, FBME Bank, Ltd.

(2) Special due diligence of correspondent accounts to prohibit use—(i) A covered financial institution shall apply special due diligence to its foreign correspondent accounts that is reasonably designed to guard against their use to process transactions involving FBME Bank, Ltd. At a minimum, that special due diligence must include:

(A) Notifying those correspondent account holders that the covered financial institution knows or has reason to know provide services to FBME Bank, Ltd., that such correspondents may not provide FBME Bank, Ltd. with access to the correspondent account maintained at the covered financial institution; and

(B) Taking reasonable steps to identify any use of its foreign correspondent accounts by FBME Bank, Ltd., to the extent that such use can be determined from transactional records maintained in the covered financial institution's normal course of business.

(ii) A covered financial institution shall take a risk-based approach when deciding what, if any, other due diligence measures it reasonably must adopt to guard against the use of its foreign correspondent accounts to process transactions involving FBME Bank, Ltd.

(iii) A covered financial institution that obtains knowledge that a foreign correspondent account may be being used to process transactions involving FBME Bank, Ltd. shall take all appropriate steps to further investigate and prevent such access, including the notification of its correspondent account holder under paragraph (b)(2)(i)(A) of this section and, where necessary, termination of the correspondent account.

(iv) A covered financial institution required to terminate a correspondent account pursuant to paragraph (b)(2)(iii) of this section:

(A) Should do so within a commercially reasonable time, and should not permit the foreign bank to establish any new positions or execute any transaction through such correspondent account, other than those necessary to close the correspondent account; and

(B) May reestablish a correspondent account closed pursuant to this paragraph if it determines that the correspondent account will not be used to provide banking services indirectly to FBME Bank Ltd.

(3) Recordkeeping and reporting. (i) A covered financial institution is required to document its compliance with the notice requirement set forth in paragraph (b)(2)(i)(A) of this section.

(ii) Nothing in this paragraph (b) shall require a covered financial institution to report any information not otherwise required to be reported by law or regulation.

Dated: July 23, 2015. Jennifer Shasky Calvery, Director, Financial Crimes Enforcement Network.
[FR Doc. 2015-18552 Filed 7-28-15; 8:45 am] BILLING CODE 4810-2P-P
POSTAL SERVICE 39 CFR Parts 261, 262, and 265 Records and Information AGENCY:

Postal ServiceTM.

ACTION:

Final rule.

SUMMARY:

The Postal Service is amending its regulations concerning records and information management for administrative purposes, to clarify existing text, and to update and add definitions.

DATES:

These regulations will be effective July 29, 2015.

FOR FURTHER INFORMATION CONTACT:

Matthew J. Connolly, Chief Privacy Officer, 202-268-2608.

SUPPLEMENTARY INFORMATION: Overview

The Postal Service is amending 39 CFR parts 261, 262, and 265 to delineate more clearly the responsibility for managing postal records and ensuring compliance with the Freedom of Information Act (FOIA). See 5 U.S.C. 552; 39 U.S.C. 410(c). In general, these modifications should promote the coordination of activities among the Officers, Public Liaisons, Coordinators, and Records Custodians tasked with FOIA compliance, and facilitate the response to information requests by FOIA Requester Service Centers (RSCs).

Records and Information Management (Part 261)

As required by 5 U.S.C. 552(a)(1), the amendments to part 261 provide descriptions of the Postal Service's central and field organization for FOIA processing. Specifically, the amendments clarify the position of the Postal Service's Privacy and Records Office within the General Counsel's Office. As further required by 5 U.S.C. 552(a)(6)(B)(ii), the amendments also describe the Postal Service's FOIA Public Liaisons and their responsibilities to requesters through the Postal Service's FOIA Requester Service Centers.

Records and Information Management Definitions (Part 262)

As required by 5 U.S.C. 552(a)(6)(B), the amendments to part 262 provide further descriptions of the Postal Service's central and field organization for FOIA processing. Specifically, the amendments describe various officials involved in FOIA processing and their responsibilities.

Release of Information (Part 265)

As required by 5 U.S.C. 552(a)(1), the amendments to part 265 provide descriptions of the established places at which, the employees from whom, and the methods whereby the public may obtain information, make submittals or requests, and obtain decisions regarding FOIA requests. Specifically, the amendments describe how and to whom a FOIA request must be submitted, and clarify that the regulations must be read in conjunction with the text of the FOIA, the Fee Schedule and Guidelines published by the Office of Management and Budget, and Postal Service Handbook AS-353, Guide to Privacy, the Freedom of Information Act, and Records Management. FOIA requests must now be sent to the appropriate FOIA Requester Service Center (RSC), as detailed in the regulations. A request that is not initially submitted to the appropriate FOIA RSC will be deemed to have been received by the Postal Service for purposes of computing the time for response at the time that it is actually received by the appropriate FOIA RSC or at the time the request is referred to the appropriate records custodians by a FOIA RSC, but in any case a request will be deemed to have been received no later than 10 days after the request is first received by a FOIA RSC.

List of Subjects 39 CFR Part 261

Archives and records.

39 CFR Part 262

Archives and records.

39 CFR Part 265

Administrative practice and procedure, Courts, Freedom of information, Government employees.

For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I, subchapter D as follows:

PART 261—[AMENDED] 1. The authority citation for 39 CFR part 261 continues to read as follows: Authority:

39 U.S.C. 401.

2. Revise § 261.1 to read as follows:
§ 261.1 Purpose and scope.

Under 39 U.S.C. 410, as enacted by the Postal Reorganization Act, the U.S. Postal Service is not subject to the provisions of the Federal Records Act of 1950, or any of its supporting regulations which provide for the conduct of records management in Federal agencies. The objective of parts 261 through 268 of this chapter are to provide the basis for an organization-wide records and information management program affecting all Postal Service organizational components having the custody of any form of information and records.

3. Revise § 261.2 to read as follows:
§ 261.2 Authority.

(a) As provided in 39 U.S.C. 401(5), the Postal Service has the power to acquire property it deems necessary or convenient in the transaction of its business and to hold, maintain, sell, lease or otherwise dispose of such property.

(b) Under § 262.2 of this chapter, the Postal Service Privacy and Records Office, located under the Associate General Counsel and Chief Ethics and Compliance Officer, is responsible for the retention, security, and privacy of Postal Service records and is empowered to authorize the disclosure of such records and to order their disposal by destruction or transfer. Included is the authority to issue records management policy and to delegate or take appropriate action if that policy is not adhered to or if questions of interpretation of procedure arise.

4. Revise § 261.4 to read as follows:
§ 261.4 Responsibility.

(a) The Chief Freedom of Information Act (FOIA) Officer, whose duties are performed by the Associate General Counsel and Chief Ethics and Compliance Officer, is responsible for:

(1) Overseeing Postal Service compliance with the FOIA.

(2) Making recommendations to the Postmaster General regarding the Postal Service's FOIA program.

(3) Monitoring and reporting on FOIA implementation and performance for the Postal Service.

(b) The Chief Privacy Officer, under the Associate General Counsel and Chief Ethics and Compliance Officer, is responsible for administering records and information management policies, and the privacy of information programs, and for the compliance of all handbooks, directives, and instructions in support of these policies and programs.

(c) The Deputy Chief FOIA Officer, under the Privacy and Records Office, administers the Postal Service release of information program with the assistance of FOIA Coordinators in Headquarters departments and area and district offices.

(d) Freedom of Information Act Public Liaisons are responsible for:

(1) Managing FOIA Requester Service Centers (RSCs).

(2) Receiving concerns of requesters about the service provided by the FOIA RSC following an initial response.

(3) Ensuring a service-oriented response to requests and FOIA-related inquiries.

(4) Reporting to the Chief FOIA Officer on their activities.

(e) Freedom of Information Act Requester Service Centers are responsible for:

(1) Facilitating communication between the Postal Service and FOIA requesters.

(2) Providing information to requesters concerning the status of FOIA requests and information about responses to such requests.

(f) Freedom of Information Act Coordinators fill an ad hoc position located within each Headquarters department, and Area and District office, and are responsible for:

(1) Coordinating and tracking FOIA requests referred to or received by their functional or geographical area.

(2) Providing procedural guidance, upon request, to records custodians.

(3) Assisting the Deputy Chief FOIA Officer with national reporting activities, such as annual reporting of local FOIA and Privacy Act activities.

(g) Records Custodians are responsible for ensuring that records within their facilities or organizations are managed according to Postal Service policies. Vice presidents or their designees are the custodians of records maintained at Headquarters. In the field, the Records Custodian is the head of a Postal Service facility such as an area, district, Post Office, or other Postal Service installation or designee that maintains Postal Service records. Senior medical personnel are the custodians of restricted medical records maintained within Postal Service facilities. The Custodian of Employee Assistance Program (EAP) records is the Postal Service counselor, a supplier, or the public health service, whichever provided the services.

(h) Postal Service managers are responsible for administering records and information management policies and for complying with all handbooks, directives, and instructions in support of this policy.

PART 262—[AMENDED] 5. The authority citation for 39 CFR part 262 continues to read as follows: Authority:

5 U.S.C. 552, 552a; 39 U.S.C. 401.

6. Revise § 262.2 to read as follows:
§ 262.2 Officials.

(a) Chief Privacy Officer. The Chief Privacy Officer (CPO) is responsible for the issuance of policy on the protection of privacy and the release of Postal Service records. The CPO has the power to authorize the disclosure of such records. Additionally, the CPO is responsible for establishing procedures and guidelines to ensure that record management practices are in compliance with the Privacy Act and FOIA. The CPO directs the activities of the Privacy and Records Office and may also delegate or take appropriate action if policies are not adhered to or if questions of interpretation or procedures arise.

(b) Deputy Chief FOIA Officer. The Deputy Chief FOIA Officer, under the Privacy and Records Office, administers the Postal Service release of information program and has the power to authorize the disclosure of records. The Deputy Chief FOIA Officer oversees FOIA Requester Service Centers (RSCs).

(c) Records Custodian. The Records Custodian is the postmaster or other head of a facility such as an area vice president, district manager, or head of a postal installation or department who maintains Postal Service records. Vice presidents are the custodians of records maintained at Headquarters. Senior medical personnel are the custodians of restricted medical records maintained within postal facilities.

(d) Information System Executive. This is the Postal Service official, usually a vice president, who prescribes the existence of and the policies for an information system.

(e) Records Office. The Records Office is responsible for the issuance of policy on the maintenance and disposition of Postal Service records and information, and to delegate or take appropriate action if such policy is not adhered to or if questions of interpretation or procedure arise.

PART 265—[AMENDED] 7. The authority citation for 39 CFR part 265 continues to read as follows: Authority:

5 U.S.C. 552; 5 U.S.C. App. 3; 39 U.S.C. 401, 403, 410, 1001, 2601.

8. Revise § 265.1 to read as follows:
§ 265.1 Purpose and scope.

(a) This part contains the regulations of the Postal Service relating to the availability to the public of Postal Service records. Included in this part are the regulations which implement the Freedom of Information Act (FOIA), 5 U.S.C. 552, insofar as it applies to the Postal Service. These rules should be read in conjunction with the text of the FOIA and the Fee Schedule and Guidelines published by the Office of Management and Budget. Additionally, Postal Service Handbook AS-353, Guide to Privacy, the Freedom of Information, and Records Management, contains information for the public about submitting FOIA requests and the specific procedures used by the Postal Service when responding to FOIA requests. This resource is available at http://www.usps.com.

(b) Official records of the Postal Service made available pursuant to the requirements of the Act shall be furnished to members of the public as prescribed by this part.

9. Revise § 265.3 to read as follows:
§ 265.3 Responsibility.

(a) Records custodian. Official records are in the custody of the Postmaster or other head of a facility or department at which they are maintained, as defined at § 261.4(c) of this chapter. These custodians are responsible for responding in the first instance to requests from members of the public for Postal Service records.

(b) Deputy Chief FOIA Officer. The Deputy Chief FOIA Officer, under the Privacy and Records Office is responsible for the overall administration of this part, including the issuance of detailed instructions to custodians.

(c) General Counsel. The General Counsel decides timely appeals authorized by this part.

10. Revise § 265.4 to read as follows:
§ 265.4 Inquiries.

Inquiries regarding the availability of Postal Service records must be directed to the appropriate Freedom of Information Act (FOIA) Requester Service Center (RSC). A description of FOIA RSCs is available at http://www.usps.com. If the appropriate FOIA RSC is not known, inquiries should be directed to the FOIA Requester Service Center, Privacy and Records Office, U.S. Postal Service, 475 L'Enfant Plaza SW., Washington, DC 20260, telephone (202) 268-2608.

11. In § 265.7, revise the section heading and paragraphs (a)(1) and (2) to read as follows:
§ 265.7 Procedure for submitting a FOIA request.

(a) Submission of requests—(1) Form and content of request. To permit expeditious handling and timely response in accordance with the provisions of this part, a request to inspect or to obtain a copy of an identifiable Postal Service record must be in writing and bear the caption “Freedom of Information Act Request” or otherwise be clearly and prominently identified as a request for records pursuant to the Freedom of Information Act. A request must be clearly and prominently identified as such on the envelope or other cover. Requests for records, submitted by the public that are not labeled as Freedom of Information Act requests will be handled as FOIA requests when received by the appropriate Requester Service Center in accordance with paragraph (b) of this section, but they may be delayed in reaching the appropriate Requester Service Center. A Freedom of Information Act request must identify the record sought as completely as possible, by name, description, or subject matter, and be sufficient to permit the custodian to locate it with a reasonable amount of effort. The request may state the maximum amount of fees for which the requester is willing to accept liability without prior notice. See paragraph (f)(2) of § 265.8. If no amount is stated, the requester will be deemed willing to accept liability for fees not to exceed $25.

(2) To whom submitted. A request must be submitted to the appropriate Freedom of Information Act (FOIA) Requester Service Center (RSC). If the FOIA RSC is not known, an inquiry should be directed to the FOIA Requester Service Center, Privacy and Records Office, U.S. Postal Service, 475 L'Enfant Plaza SW., Washington, DC 20260, telephone (202) 268-2608. The FOIA RSC will either process the request or refer the request to the appropriate component or records custodians. The FOIA RSC will advise the requester of any such referral. A request that is not initially submitted to the appropriate FOIA RSC will be deemed to have been received by the Postal Service for purposes of computing the time for response in accordance with paragraph (b) of this section at the time that it is actually received by the appropriate FOIA RSC or at the time the request is referred to the appropriate records custodians by a FOIA RSC, but in any case a request will be deemed to have been received no later than 10 days after the request is first received by a FOIA RSC. If a request seeks records maintained at two or more facilities, the custodian shall be deemed to be the next senior common supervisor of the heads of the facilities, e.g., district manager, area vice president. The Records Office is deemed to be the custodian, for purposes of this part, in all instances in which a request is for a listing of postal employees. See paragraph (a)(6) of § 265.6.

Stanley F. Mires, Attorney, Federal Compliance.
[FR Doc. 2015-18557 Filed 7-28-15; 8:45 am] BILLING CODE 7710-12-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2015-0359; FRL-9929-97-OAR] RIN 2060-AR95 Air Quality Designations for the 2006 24-hour Fine Particle National Ambient Air Quality Standards (2006 24-hour PM2.5 NAAQS), 1997 Annual PM2.5 NAAQS, and 1987 Annual Coarse Particle (PM10) NAAQS; Technical Amendments to Inadvertent Errors AGENCY:

Environmental Protection Agency.

ACTION:

Final rule.

SUMMARY:

Pursuant to its authority under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) is promulgating this final action to make technical amendments to address several minor, inadvertent and nonsubstantive errors in the regulatory text establishing the air quality designations for the 2006 24-hour fine particle (PM2.5) National Ambient Air Quality Standards (NAAQS), 1997 annual PM2.5 NAAQS, and 1987 annual coarse particle (PM10) NAAQS. Consistent with the EPA's interpretation of the good cause exemption provisions outlined in the Administrative Procedure Act, this action is being taken without notice and comment. The states to which these amendments apply are New York and West Virginia.

DATES:

The effective date of these technical amendments is August 28, 2015.

FOR FURTHER INFORMATION CONTACT:

For general questions concerning this action, please contact Andy Chang, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Planning Division, C539-04, Research Triangle Park, NC 27711, telephone (919) 541-2416, email at [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents

The following is an outline of the preamble.

I. What is the good cause exemption, and why is the EPA using it? II. What is the purpose of this action? III. What are the technical amendments to inadvertent errors in prior designations? A. Technical Amendments Concerning Designations for the 2006 24-hour PM2.5 NAAQS B. Technical Amendments Concerning Designations for the 1997 Annual PM2.5 NAAQS C. Technical Amendments Concerning Designations for the 1987 Annual PM10 NAAQS IV. Environmental Justice Considerations V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act (NTTAA) J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act L. Judicial Review I. What is the good cause exemption, and why is the EPA using it?

Section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because such notice and opportunity for comment is unnecessary. In this action, we are amending 40 CFR part 81, which contains the tables of area designations and boundaries for each NAAQS. Notice and comment is unnecessary because the corrections made in this document were already the subject of prior notice and comment rulemakings; this action merely makes corrections to the tables in order to correctly align the information in the tables with those prior rulemakings.

II. What is the purpose of this action?

Whenever the EPA establishes a new NAAQS, section 107(d) of the CAA requires the EPA to designate all areas of the country as meeting or not meeting the new NAAQS, or as unclassifiable where available information does not support a determination whether an area is meeting the NAAQS. The area designations and boundaries for each NAAQS are set forth in tables at 40 CFR part 81.

This action makes technical amendments to minor, inadvertent and nonsubstantive errors in the 40 CFR part 81 regulatory text concerning the air quality designations for certain areas in two states for the 2006 24-hour PM2.5 NAAQS, 1997 annual PM2.5 NAAQS, and 1987 annual PM10 NAAQS. The states to which these technical amendments apply are New York and West Virginia.

Documents related to the affected designations are available in the following dockets: Docket ID No. EPA-HQ-OAR-2007-0562 (2006 24-hour PM2.5 NAAQS), Docket ID No. EPA-HQ-OAR-2003-0061 (1997 annual PM2.5 NAAQS), and Public Docket No. A-92-22 (1987 annual PM10 NAAQS). All documents in the dockets except for those for related to designations for the 1987 PM10 NAAQS, i.e., Public Docket No. A-92-22, are listed in the http://www.regulations.gov index. All materials for Public Docket No. A-92-22 are located at the EPA Docket Center. In addition, the EPA has established a Web site for these rulemakings at: http://www.epa.gov/pmdesignations/ and http://www.epa.gov/airquality/greenbook/pindex.html. These Web sites include the EPA's final PM2.5 and PM10 designations, as well as state and tribal initial recommendation letters, the EPA's modification letters, technical support documents, responses to comments and other related technical information.

A discussion of these inadvertent errors and associated corrections follows in the next section. The revisions to the regulatory text, specifically as codified in 40 CFR part 81, are provided at the end of this preamble.

III. What are the technical amendments to inadvertent errors in prior designations? A. Technical Amendments Concerning Designations for the 2006 24-hour PM2.5 NAAQS

The EPA published its air quality designations for the 2006 24-hour PM2.5 NAAQS on November 13, 2009 (74 FR 58688). In that action, two areas in West Virginia were designated as nonattainment for this NAAQS: Charleston, West Virginia (consisting of Kanawha County and Putnam County) and the Steubenville-Weirton, Ohio-West Virginia area (consisting of Brooke County and Hancock County in West Virginia and Jefferson County in Ohio). The EPA finalized approval of West Virginia's request to redesignate the Charleston, West Virginia area to attainment on March 31, 2014 (79 FR 17884), and finalized approval of West Virginia's request to redesignate the state's portion of the Steubenville-Weirton area to attainment on March 18, 2014 (79 FR 15019). Both of these final actions correctly revised West Virginia's entries in 40 CFR 81.349 to reflect that the areas are in attainment for the 2006 24-hour PM2.5 NAAQS. However, a subsequent rulemaking finalized in the Federal Register on June 2, 2014, by the EPA titled, “Identification of Nonattainment Classifications and Deadlines for Submission of State Implementation Plan (SIP) Provisions for the 1997 Fine Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) and 2006 PM2.5 NAAQS” (79 FR 31566) inadvertently and erroneously recodified the Charleston, West Virginia area and the West Virginia portion of the Steubenville-Weirton, Ohio-West Virginia area as nonattainment for the 2006 24-hour PM2.5 NAAQS. In this rulemaking, the EPA is correcting the 40 CFR 81.349 table for West Virginia with respect to the 2006 24-hour PM2.5 NAAQS to reflect that both areas within West Virginia have been redesignated to attainment, consistent with our previous March 18, 2014, and March 31, 2014, final rulemakings.

B. Technical Amendments Concerning Designations for the 1997 Annual PM2.5 NAAQS

The EPA published its air quality designations for the 1997 annual PM2.5 NAAQS on January 5, 2005 (70 FR 944). In this action, two areas in West Virginia were designated as nonattainment for this NAAQS: Charleston, West Virginia (consisting of Kanawha County and Putnam County) and the Steubenville-Weirton, Ohio-West Virginia area (consisting of Brooke County and Hancock County in West Virginia and Jefferson County in Ohio). The EPA finalized approval of West Virginia's request to redesignate the Charleston, West Virginia area to attainment on March 31, 2014 (79 FR 17884), and finalized approval of West Virginia's request to redesignate the state's portion of the Steubenville-Weirton area to attainment on March 18, 2014 (79 FR 15019). Both of these final actions correctly revised West Virginia's entries in 40 CFR 81.349 to reflect that the areas are in attainment for the 1997 annual PM2.5 NAAQS. However, a subsequent rulemaking finalized in the Federal Register on June 2, 2014, by the EPA titled, “Identification of Nonattainment Classifications and Deadlines for Submission of State Implementation Plan (SIP) Provisions for the 1997 Fine Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) and 2006 PM2.5 NAAQS” (79 FR 31566) inadvertently and erroneously recodified the Charleston, West Virginia area and the West Virginia portion of the Steubenville-Weirton, Ohio-West Virginia area as nonattainment for the 1997 annual PM2.5 NAAQS. In this rulemaking, the EPA is correcting the 40 CFR 81.349 table for West Virginia with respect to the 1997 annual PM2.5 NAAQS to reflect that both areas within West Virginia have been redesignated to attainment consistent with our previous March 18, 2014, and March 31, 2014, final rulemakings.

C. Technical Amendments Concerning Designations for the 1987 Annual PM10 NAAQS

The EPA redesignated New York County, New York as nonattainment for the 1987 annual PM10 NAAQS on January 20, 1994 (58 FR 67334).1 However, the 40 CFR part 81 table for the state is unclear as to which 1987 PM10 NAAQS the nonattainment designation applies to, specifically because at the time of the January 20, 1994, designation, there were two forms of the NAAQS. The 1987 PM10 NAAQS included an annual standard of 50 micrograms per cubic meter (annual arithmetic mean averaged over 3 years) and a 24-hour standard of 150 micrograms per cubic meter (not to be exceeded more than once per year on average over a 3-year period). The 40 CFR part 81 table for PM10 does not distinguish between the two forms of the NAAQS, and therefore New York County is codified as nonattainment for a non-specified, i.e., ambiguous form of the standard.

1 This area was originally designated as unclassifiable for the annual PM10 NAAQS by operation of law.

The EPA has confirmed that the Madison Avenue monitor in New York County (Air Quality Systems (AQS) Site ID 36-061-0077) recorded violations of the 1987 annual PM10 NAAQS and was the basis for the county's nonattainment designation for this NAAQS. This monitor continued to serve as the county's design value monitor until 1998; at this time the monitor underwent modifications that made it no longer valid for comparison to the NAAQS, i.e., it no longer met the siting criteria for a Federal Reference Method (FRM) monitor. As a result, decisions regarding PM10 air quality since 1998 have been informed by ambient air quality data collected at other FRM monitoring sites in New York County, including the Post Office site (AQS ID 36-061-0062). None of the monitors in New York County have recorded violations of the annual PM10 NAAQS since 1998, and no violations of the 24-hour PM10 NAAQS have ever been recorded in the county. On December 2, 2013, the EPA finalized a clean data determination in the Federal Register for New York County (78 FR 72032), which determined that even though the annual form of the 1987 PM10 NAAQS had been revoked on October 17, 2006 (71 FR 61144), ambient air quality data collected in New York County indicated that this NAAQS had been attained. To clarify, New York County was designated as nonattainment for the 1987 annual PM10 NAAQS only; the area received a clean data determination from the EPA for the 1987 annual PM10 NAAQS; and the Agency has revoked the 1987 annual PM10 NAAQS. Therefore, the EPA is revising and clarifying the table for the PM10 NAAQS for the state to reflect the form of the standard, i.e., the annual PM10 NAAQS, for which New York County was designated as nonattainment, and to reflect that that standard has been revoked.

IV. Environmental Justice Considerations

When the EPA establishes a new NAAQS, section 107(d) of the CAA requires the EPA to designate all areas of the country as meeting or not meeting the new NAAQS, or as unclassifiable where available information does not support a determination whether an area is meeting the NAAQS. The area designations and boundaries for each NAAQS are set forth in tables at 40 CFR part 81.This action makes technical amendments to minor, inadvertent and nonsubstantive errors in the 40 CFR part 81 regulatory text concerning the air quality designations for certain areas in two states for the 2006 24-hour PM2.5 NAAQS, 1997 annual PM2.5 NAAQS, and 1987 annual PM10 NAAQS. The amendments apply to the states of New York and West Virginia. This action continues to protect all those residing, working, attending school or otherwise present in those areas regardless of minority and economic status.

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

This action makes technical amendments to correct minor, inadvertent and nonsubstantive errors in prior area designations. This type of action is exempt from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). This action corrects minor, inadvertent and nonsubstantive errors in prior area designations and does not require any party to perform an information collection.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

Because the EPA has made a good cause finding that this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute as indicated in the SUPPLEMENTARY INFORMATION section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act.

D. Unfunded Mandates Reform Act (UMRA)

This action contains no federal mandate under the provisions of Title II of the UMRA of 1995, 2 U.S.C. 1531-1538 for state, local or tribal governments or the private sector. The action does not impose an enforceable duty on any state, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 and 205 of the UMRA.

This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action corrects minor, inadvertent and nonsubstantive errors in prior area designations.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action makes technical amendments to correct minor, inadvertent and nonsubstantive errors in prior area designations. Thus, Executive Order 13132 does not apply to this action.

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). This action only makes technical amendments to correct minor, inadvertent and nonsubstantive errors in prior area designations or redesignations. None of these technical amendments has a substantial direct effect on any tribal land; thus, Executive Order 13175 does not apply to this action.

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

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

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

This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

Section 12(d) of the NTTAA of 1995, Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impracticable. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by VCS bodies. The NTTAA directs the EPA to provide Congress, through the Office of Management and Budget, explanations when the agency decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, the EPA did not consider the use of any VCS.

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

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the U.S.

The EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This action makes technical amendments to correct minor, inadvertent, nonsubstantive errors in the designations for certain areas. The results are also contained in section IV titled, “Environmental Justice Considerations” of this preamble.

K. Congressional Review Act

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. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. However, section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, the EPA had made such a good cause finding, including the reasons therefore, and established an effective date of August 28, 2015. These technical amendments to inadvertent errors do not constitute a “major rule” as defined by 5 U.S.C. 804(2).

L. Judicial Review

In the final actions designating areas for the PM10 NAAQS, the EPA determined that the actions were “nationally applicable” within the meaning of CAA section 307(b)(1). Likewise, the EPA also determined that the final action identifying nonattainment classifications and deadlines for SIP provisions for the 1997 annual PM2.5 NAAQS and 2006 24-hour PM2.5 NAAQS was nationally applicable. Because this action is making corrections to those nationally applicable rules, we are determining that this action is also nationally applicable within the meaning of section 307(b)(1). Thus, petitions for review of this final action must be filed in the Court of Appeals for the District of Columbia Circuit. Section 307(b)(1) requires such petitions to be filed within 60 days from the date the final action is published in the Federal Register.

List of Subjects in 40 CFR Part 81

Environmental protection, Air pollution control, National parks, Wilderness areas.

Dated: July 21, 2015. Gina McCarthy, Administrator.

For the reasons set forth in the preamble, 40 CFR part 81 is amended as follows:

PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 1. The authority citation for part 81 continues to read as follows: Authority:

42 U.S.C. 7401, et seq.

Subpart C—Section 107 Attainment Status Designations 2. Section 81.333 is amended by revising the table titled “New York—PM-10” to read as follows:
§ 81.333 New York. New York—PM-10 Designated area Designation Date Type Classification Date Type New York County 1/20/94 Nonattainment 1 1/20/94 Moderate. 1This designation applied only to the annual form of the PM10 NAAQS. The annual PM10 NAAQS was revoked for all areas of the state on October 17, 2006.
3. Section 81.349 is amended by revising the tables titled “West Virginia—1997 Annual PM2.5 NAAQS” and “West Virginia—2006 24-Hour PM2.5 NAAQS” to read as follows:
§ 81.349 West Virginia. West Virginia—1997 Annual PM2.5 NAAQS [Primary and secondary] Designated area a Designation Date 1 Type Classification Date 2 Type Charleston, WV: Kanawha County 3/31/14 Attainment. Putnam County 3/31/14 Attainment. Huntington-Ashland, WV-KY-OH: Cabell County 12/28/12 Attainment. Mason County (part) 12/28/12 Attainment. Graham Tax District Wayne County 12/28/12 Attainment. Martinsburg, WV-Hagerstown, MD: Berkeley County 11/25/14 Attainment. Parkersburg-Marietta, WV-OH: Pleasants County (part) 9/12/13 Attainment. Tax District of Grant Wood County 9/12/13 Attainment. Steubenville-Weirton, OH-WV: Brooke County 3/18/14 Attainment. Hancock County 3/18/14 Attainment. Wheeling, WV-OH: Marshall County 9/30/13 Attainment. Ohio County 9/30/13 Attainment. Rest of State: Barbour County Unclassifiable/Attainment. Boone County Unclassifiable/Attainment. Braxton County Unclassifiable/Attainment. Calhoun County Unclassifiable/Attainment. Clay County Unclassifiable/Attainment. Doddridge County Unclassifiable/Attainment. Fayette County Unclassifiable/Attainment. Gilmer County Unclassifiable/Attainment. Grant County Unclassifiable/Attainment. Greenbrier County Unclassifiable/Attainment. Hampshire County Unclassifiable/Attainment. Hardy County Unclassifiable/Attainment. Harrison County Unclassifiable/Attainment. Jackson County Unclassifiable/Attainment. Jefferson County Unclassifiable/Attainment. Lewis County Unclassifiable/Attainment. Lincoln County Unclassifiable/Attainment. Logan County Unclassifiable/Attainment. McDowell County Unclassifiable/Attainment. Marion County Unclassifiable/Attainment. Mason County (remainder) Unclassifiable/Attainment. Mercer County Unclassifiable/Attainment. Mineral County Unclassifiable/Attainment. Mingo County Unclassifiable/Attainment. Monongalia County Unclassifiable/Attainment. Monroe County Unclassifiable/Attainment. Morgan County Unclassifiable/Attainment. Nicholas County Unclassifiable/Attainment. Pendleton County Unclassifiable/Attainment. Pleasants County (remainder) Unclassifiable/Attainment. Pocahontas County Unclassifiable/Attainment. Preston County Unclassifiable/Attainment. Raleigh County Unclassifiable/Attainment. Randolph County Unclassifiable/Attainment. Ritchie County Unclassifiable/Attainment. Roane County Unclassifiable/Attainment. Summers County Unclassifiable/Attainment. Taylor County Unclassifiable/Attainment. Tucker County Unclassifiable/Attainment. Tyler County Unclassifiable/Attainment. Upshur County Unclassifiable/Attainment. Webster County Unclassifiable/Attainment. Wetzel County Unclassifiable/Attainment. Wirt County Unclassifiable/Attainment. Wyoming County Unclassifiable/Attainment. a  Includes Indian Country located in each county or area, except as otherwise specified. 1 This date is 90 days after January 5, 2005, unless otherwise noted. 2 This date is July 2, 2014, unless otherwise noted. West Virginia—2006 24-Hour PM2.5 NAAQS [Primary and secondary] Designated area a Designation Date 1 Type Classification Date 2 Type Charleston, WV: Kanawha County 3/31/14 Attainment. Putnam County 3/31/14 Attainment. Steubenville-Weirton, OH-WV: Brooke County 3/18/14 Attainment. Hancock County 3/18/14 Attainment. Rest of State: Barbour County Unclassifiable/Attainment. Berkeley County Unclassifiable/Attainment. Boone County Unclassifiable/Attainment. Braxton County Unclassifiable/Attainment. Cabell County Unclassifiable/Attainment. Calhoun County Unclassifiable/Attainment. Clay County Unclassifiable/Attainment. Doddridge County Unclassifiable/Attainment. Fayette County Unclassifiable/Attainment. Gilmer County Unclassifiable/Attainment. Grant County Unclassifiable/Attainment. Greenbrier County Unclassifiable/Attainment. Hampshire County Unclassifiable/Attainment. Hardy County Unclassifiable/Attainment. Harrison County Unclassifiable/Attainment. Jackson County Unclassifiable/Attainment. Jefferson County Unclassifiable/Attainment. Lewis County Unclassifiable/Attainment. Lincoln County Unclassifiable/Attainment. Logan County Unclassifiable/Attainment. McDowell County Unclassifiable/Attainment. Marion County Unclassifiable/Attainment. Marshall County Unclassifiable/Attainment. Mason County Unclassifiable/Attainment. Mercer County Unclassifiable/Attainment. Mineral County Unclassifiable/Attainment. Mingo County Unclassifiable/Attainment. Monongalia County Unclassifiable/Attainment. Monroe County Unclassifiable/Attainment. Morgan County Unclassifiable/Attainment. Nicholas County Unclassifiable/Attainment. Ohio County Unclassifiable/Attainment. Pendleton County Unclassifiable/Attainment. Pleasants County Unclassifiable/Attainment. Pocahontas County Unclassifiable/Attainment. Preston County Unclassifiable/Attainment. Raleigh County Unclassifiable/Attainment. Randolph County Unclassifiable/Attainment. Ritchie County Unclassifiable/Attainment. Roane County Unclassifiable/Attainment. Summers County Unclassifiable/Attainment. Taylor County Unclassifiable/Attainment. Tucker County Unclassifiable/Attainment. Tyler County Unclassifiable/Attainment. Upshur County Unclassifiable/Attainment. Wayne County Unclassifiable/Attainment. Webster County Unclassifiable/Attainment. Wetzel County Unclassifiable/Attainment. Wirt County Unclassifiable/Attainment. Wood County Unclassifiable/Attainment. Wyoming County Unclassifiable/Attainment. a Includes Indian Country located in each county or area, except as otherwise specified. 1 This date is 30 days after November 13, 2009, unless otherwise noted. 2 This date is July 2, 2014, unless otherwise noted.
[FR Doc. 2015-18532 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2012-0638; FRL-9930-73] Fluxapyroxad; Pesticide Tolerances AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of fluxapyroxad in or on cotton, gin byproducts and cotton, undelinted seed. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective July 29, 2015. Objections and requests for hearings must be received on or before September 28, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0638, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0638 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 28, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0638, by one of the following methods:

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

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

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

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

II. Summary of Petitioned-for Tolerance

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8270) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.666 be amended by establishing tolerances for residues of the fungicide fluxapyroxad (BAS 700 F), 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide, its metabolites, and degradates, in or on cotton, gin byproducts at 20 parts per million (ppm); cotton undelinted seed at 0.30 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing

III. Aggregate Risk Assessment and Determination of Safety

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

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

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Fluxapyroxad is of low acute toxicity by the oral, dermal and inhalation routes, is not irritating to the eyes and skin, and is not a dermal sensitizer. The primary target organ for fluxapyroxad exposure via the oral route is the liver with secondary toxicity in the thyroid for rats only. Liver toxicity was observed in rats, mice, and dogs, with rats as the most sensitive species for all durations of exposure. In rats, adaptive effects of hepatocellular hypertrophy and increased liver weights and changes in liver enzyme activities were first observed. As the dose or duration of exposure to fluxapyroxad increased, clinical chemistry changes related to liver function also occurred, followed by hepatocellular necrosis, neoplastic changes in the liver, and tumors. Thyroid effects were observed only in rats. These effects were secondary to changes in liver enzyme regulation, which increased metabolism of thyroid hormone, resulting in changes in thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and thyroid tumor formation. Tumors were not observed in species other than rats or in organs other than the liver and thyroid.

Fluxapyroxad is classified as “Not likely to be Carcinogenic to Humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range. There is no mutagenicity concern from in vivo or in vitro assays. The hypothesized mode of action (i.e., a non-genotoxic) for treatment related tumors (i.e., the liver and thyroid) was supported by a full panel of in vitro and in vivo studies that showed no evidence of genotoxicity, together with mechanistic studies in the liver and thyroid of rats that satisfied stringent criteria for establishing tumorgenic modes of action. The studies clearly identified the sequence of key events, dose-response concordance and temporal relationship to the tumor types. The Agency has determined that the chronic population adjusted dose (PAD) will adequately account for all chronic effects, including carcinogenicity that could result from exposure to fluxapyroxad because the points of departure (POD) for the chronic population adjusted dose (cPAD) is based on the most sensitive endpoint, liver effects. Effects in the liver preceded liver tumors and the effects observed in the thyroid (in rats only) were believed to be secondary to the liver effects.

No evidence of neurotoxicity was observed in response to repeated administration of fluxapyroxad. An acute neurotoxicity study showed decreased rearing and motor activity. This occurred on the day of dosing only and in the absence of histopathological effects or alterations in brain weights. This indicated that any neurotoxic effects of fluxapyroxad are likely to be transient and reversible due to alterations in neuropharmacology and not from neuronal damage. There were no neurotoxic effects observed in the subchronic dietary toxicity study. No evidence of reproductive toxicity was observed. Developmental effects observed in both rats and mice (thyroid follicular hypertrophy and hyperplasia in rats and decreased defecation, food consumption, body weight/body weight gain, and increased litter loss in rabbits) occurred at the same doses as those that caused adverse effects in maternal animals, indicating no quantitative susceptibility. Since the maternal toxicities of thyroid hormone perturbation in rats and systemic toxicity in rabbits likely contributed to the observed developmental effects there is low concern for qualitative susceptibility. An immunotoxicity study in mice showed no evidence of immunotoxic effects from fluxapyroxad.

Subchronic oral toxicity studies in rats, developmental toxicity studies in rabbits, and in vitro and in vivo genotoxicity studies were performed for fluxapyroxad metabolites F700F001, M700F002, and M700F048. Like fluxapyroxad, no genotoxic effects were observed for any of these metabolites. All three metabolites displayed lower subchronic toxicity via the oral route than fluxapyroxad, with evidence of non-specific toxicity (decreased body weight) observed only for M700F0048 at the limit dose. Only M700F0048 exhibited developmental toxicity at doses similar to those that caused developmental effects in rabbits with fluxapyroxad treatment. However, these effects (abortions and resorptions) were of a different nature than for fluxapyroxad (paw hyperflexion) and are considered secondary to maternal toxicity. The Agency considers these studies sufficient for hazard identification and characterization and concludes that these metabolites do not have hazards that exceed those of fluxapyroxad in nature, severity, or potency.

Specific information on the studies received and the nature of the adverse effects caused by fluxapyroxad as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Human Health Risk Assessment for Use of Fluxapyroxad on Numerous Crops” at pp. 52 in docket ID number EPA-HQ-OPP-2012-0638.

B. Toxicological Points of Departure/Levels of Concern

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

A summary of the toxicological endpoints for chemical name used for human risk assessment is shown in Table 1 of this unit.

Table 1—Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Human Health Risk Assessment Exposure/scenario Point of departure and
  • uncertainty/safety factors
  • RfD, PAD, LOC for risk
  • assessment
  • Study and toxicological effects
    Acute dietary (General population including infants and children, and females 13-49 years of age) NOAEL = 125 mg/kg/day
  • UFA = 10×
  • UFH = 10×
  • FQPA SF = 1×
  • Acute RfD = 1.25 mg/kg/day
  • aPAD = 1.25 mg/kg/day
  • Acute neurotoxicity study in rats
  • LOAEL = 500 mg/kg/day based on decreased motor activity and decreased rearing.
  • Chronic dietary (All populations) NOAEL = 2.1 mg/kg/day
  • UFA = 10×
  • UFH = 10×
  • FQPA SF = 1×
  • Chronic RfD = 0.021 mg/kg/day
  • cPAD = 0.021 mg/kg/day
  • Chronic toxicity/carcinogenicity study in rats
  • LOAEL = 11 mg/kg/day based on non-neoplastic changes in the liver (foci, masses).
  • Incidental oral short-term (1 to 30 days) NOAEL = 9 mg/kg/day
  • UFA = 10×
  • UFH = 10×
  • FQPA SF = 1×
  • LOC for MOE = 100 28-day oral toxicity study in rats
  • LOAEL = 176 mg/kg/day based on changes in thyroid hormones and thyroid follicular hypertrophy/hyperplasia.
  • Inhalation short-term (1 to 30 days) NOAEL= 9 mg/kg/day
  • UFA = 10×
  • UFH = 10×
  • FQPA SF = 1×
  • LOC for MOE = 100 28-day oral toxicity study in rats
  • LOAEL = 176 mg/kg/day based on changes in thyroid hormones and thyroid follicular hypertrophy/hyperplasia.
  • Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans at doses sufficient to induce liver and/or thyroid tumors. Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluxapyroxad, EPA considered exposure under the petitioned-for tolerances as well as all existing fluxapyroxad tolerances in 40 CFR 180.666. EPA assessed dietary exposures from fluxapyroxad in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for fluxapyroxad. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues adjusted upward to account for metabolites of concern not included in the tolerance expression, 100 percent crop treated (PCT) assumptions, and dietary exposure evaluation model (DEEM) default and empirical processing factors.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, a moderately refined chronic dietary exposure analysis was performed. An assumption of 100 PCT and DEEM default and empirical processing factors were used for the chronic dietary analysis. Combined average field-trial residues for parent and highest field-trial residues for metabolites of concern were used for all plant commodities. For livestock commodities tolerance-level residues adjusted upward to account for metabolites of concern not included in the tolerance expression were used.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to fluxapyroxad. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

    iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

    2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluxapyroxad in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluxapyroxad. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Tier 1 Rice Model and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of fluxapyroxad for acute exposures are estimated to be 127 parts per billion (ppb) for surface water and 203 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are estimated to be 127 ppb for surface water and 184 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 203 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 184 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluxapyroxad is currently registered for the following uses that could result in residential exposures: Residential turf. EPA assessed residential exposure using the following assumptions: Residential handler exposures are expected to be short-term (1 to 30 days) via either the dermal or inhalation routes of exposures. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Since no dermal hazard was identified for fluxapyroxad, MOEs were calculated for the inhalation route of exposure only.

    Both adults and children may be exposed to fluxapyroxad residues from contact with treated lawns. Adult post-application exposures were not quantitatively assessed since no dermal hazard was identified for fluxapyroxad and inhalation exposures are typically negligible in outdoor settings. The exposure assessment for children included incidental oral exposure resulting from transfer of residues from the hands or objects to the mouth, and from incidental ingestion of soil. Post-application hand-to-mouth and object-to-mouth exposures are expected to be short-term (1 to 30 days) in duration due to the intermittent nature of applications in residential environments. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. No evidence of quantitative susceptibility was observed in a reproductive and developmental toxicity study in rats or in developmental toxicity studies in rats and rabbits. Developmental toxicity data in rats showed decreased body weight and body weight gain in the offspring at the same dose levels that caused thyroid follicular hypertrophy/hyperplasia in parental animals. Effects in rabbits were limited to paw hyperflexion, a malformation that is not considered to result from a single exposure and that usually reverses as the animal matures. Developmental effects observed in both rats and rabbits occurred at the same doses as those that caused adverse effects in maternal animals, indicating no quantitative susceptibility. The Agency has low concern for developmental toxicity because the observed effects were of low severity, were likely secondary to maternal toxicity, and demonstrated clear NOAELs. Further, the NOAELs for these effects were at dose levels higher than the points of departure selected for risk assessment for repeat-exposure scenarios. Therefore, based on the available data and the selection of risk assessment endpoints that are protective of developmental effects, there are no residual uncertainties with regard to pre- and/or postnatal toxicity.

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

    i. The toxicity database for fluxapyroxad is complete. Although no subchronic inhalation data is available, EPA has waived that data requirement based on, among other things, its conclusion that even if an additional 10X safety factor was applied, inhalation exposure would not raise a risk of concern.

    ii. There is no indication that fluxapyroxad is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Neither the acute nor the subchronic neurotoxicity studies indicated specific neurotoxicity responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid hormone levels, the Agency considered the potential for fluxapyroxad to cause developmental neurotoxicity as a result of thyroid hormone disruption, which is more sensitive endpoint than the endpoints used in a developmental neurotoxicity study. Based on its evaluation of thyroid hormone data submitted for fluxapyroxad and the ontogeny of thyroid hormone metabolism, the Agency has determined that adverse thyroid hormone disruptions in the young are unlikely to occur at dose levels as low as the points of departure chosen for risk assessment. The Agency has low concern for neurotoxic effects of fluxapyroxad at any life stage.

    iii. Based on the developmental and reproductive toxicity studies discussed in Unit III.D.2., there are no residual uncertainties with regard to prenatal and/or postnatal toxicity.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues or field trial residue data. The dietary risk assessment is based on reliable data, is conservative and will not underestimate dietary exposure to fluxapyroxad. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluxapyroxad in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluxapyroxad.

    E. Aggregate Risks and Determination of Safety

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

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluxapyroxad will occupy 12% of the aPAD for children 3-5 years old, the population group receiving the greatest exposure.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluxapyroxad from food and water will utilize 64% of the cPAD for infants (< 1 year old). Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluxapyroxad is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluxapyroxad is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to fluxapyroxad. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 320 for adults and 560 for children. Because EPA's level of concern for fluxapyroxad is a MOE of 100 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, fluxapyroxad is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for fluxapyroxad.

    5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has classified fluxapyroxad as “Not likely to be Carcinogenic to Humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range. The Agency has determined that the quantification of risk using the cPAD for fluxapyroxad will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to fluxapyroxad. As noted above, chronic exposure to fluxapyroxad from food and water will utilize 64% of the cPAD for infants (< 1year old) the population group receiving the greatest exposure.

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

    IV. Other Considerations A. Analytical Enforcement Methodology

    A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/MS) method is available as an enforcement method. This method uses reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient elution, and includes 2 ion transitions to be monitored for the parent fluxapyroxad.

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

    B. International Residue Limits

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

    There is a Codex MRL for cotton, undelinted seed at 0.01 ppm. However, this MRL is based on seed treatment of cotton, and not foliar applications (which is the proposed use for the U.S. registration and which results in higher residues). Therefore, there is no ground for harmonization of U.S. tolerance and Codex MRL.

    V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad [3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide], including its metabolites and degradates, in or on cotton, gin byproducts at 20 ppm and cotton undelinted seed at 0.30 ppm.

    VI. Statutory and Executive Order Reviews

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

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

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

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

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: July 22, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.666, revise the entries for “Cotton, gin byproducts” and “Cotton, undelinted seed” in the table in paragraph (a) to read as follows:
    § 180.666 Fluxapyroxad; tolerances for residues.

    (a) * * *

    Commodity Parts per million *         *         *         *         *         *         * Cotton, gin byproducts 20 Cotton, undelinted seed 0.30 *         *         *         *         *         *         *
    [FR Doc. 2015-18544 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0325; FRL-9930-22] Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients (chelator, sequestrant and conditioning agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals. Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000 Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethanesulfonic acid, 2-hydroxy- and its corresponding ammonium, sodium, potassium, calcium, magnesium, and zinc salts.

    DATES:

    This regulation is effective July 29, 2015. Objections and requests for hearings must be received on or before September 28, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0325, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0325 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 28, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0325, by one of the following methods:

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

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

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

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

    II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10684) by Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000, Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381). The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients (chelator, sequestrant, and conditioning agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals in accordance with 40 CFR 180.910 and 180.930, respectively. That document referenced a summary of the petition prepared by Technology Sciences Group Inc., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

    IV. Aggregate Risk Assessment and Determination of Safety

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

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

    Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethanesulfonic acid, 2-hydroxy and the corresponding ammonium, sodium, potassium, calcium, magnesium, and zinc salts (also referred to as isethionic acid and its salts) including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with isethionic acid and its salts follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by isethionic acid and its salts as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

    Isethionate salts are expected to metabolize and dissociate into isethionic acid in the body. Therefore, toxicity for each of the isethionate salt forms are expected to have equal toxicity and share similar physical and chemical characteristics. Studies on isethionic acid or any one of its salt can be considered relevant for the entire group.

    The acute oral toxicity of isethionic acid ammonium salt is low. The acute oral lethal dose (LD)50 in rats were > 1,000 milligram/kilogram/body weight (mg/kg-bw). The acute dermal toxicity in rats was > 1,000 mg/kg-bw. Ammonium isethionate is a minimal eye irritant based on a primary eye irritation study in rabbits. Ammonium isethionate is not dermally irritating based on a primary skin irritation study in rabbits. Ammonium isethionate has an acute inhalation lethal concentration (LC)50 > 6.295 milligram/liter (mg/L) and is not a dermal sensitizer.

    In a 90-day oral toxicity study on rats via gavage with sodium isethionate, decreased mean corpuscular hemoglobin concentration, increased mean absolute and relative reticulocyte counts, increased spleen weights and microscopic changes in the liver, bile duct, and spleen were observed at 1,000 milligram/kilogram/day (mg/kg/day) (LOAEL). Effects showed complete reversal after exposure was discontinued. The NOAEL for sodium isethionate was identified in this study as 200 mg/kg/day.

    In an OSCPP Harmonized Test Guideline 870.3650 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, ammonium isethionate was administered to rats by gavage. The parental systemic LOAEL for ammonium isethionate is 500 mg/kg/day based on absolute and relative kidney weights and relative adrenal weights, and the parental systemic NOAEL is 250 mg/kg/day. The reproductive/developmental LOAEL for ammonium isethionate in rats was not identified, and the reproductive/developmental NOAEL is greater than or equal to 500 mg/kg/day.

    Ammonium isethionate was negative for mutagenicity or chromosomal aberrations in a battery of tests of genotoxicity including a reverse gene mutation assay in bacteria, an in vitro mammalian cell gene mutation test using mouse lymphoma cells and an in vitro mammalian cell micronucleus test.

    The OncoLogicTM structure-activity model was used to evaluate the likelihood that isethionic acid and its salts may cause cancer. Structure-activity modeling using Oncologic indicates that isethionic acid does not contain structural alerts of potential concern for carcinogenicity. Based on the negative results for genotoxicity as well as the structure-activity model for carcinogenicity there is a low concern for isethionic acid and its salts as potential carcinogens.

    No neurotoxicity studies were available in the database for isethionic acid and its salts. However, a functional observational battery (FOB) and locomotor activity patterns were evaluated in the combined reproduction/developmental toxicity screening test and 90-day oral toxicity study. No alterations in the FOB or locomotor activity patterns were observed.

    No Immunotoxicity studies on isethionic acid and its salts were available in the database. Increased spleen weights and microscopic changes in the spleen were observed in the 90-day toxicity study in rats; however, the chronic reference dose (cRfD) is based on this study and is protective of these effects.

    No metabolism studies were available in the database for isethionic acid and its salts.

    B. Toxicological Points of Departure/Levels of Concern

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

    A summary of the toxicological endpoints for isethionic acid and its salts used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Isethionic Acid and Its Salts for Use in Human Risk Assessment Exposure/scenario Point of departure and
  • uncertainty/safety factors
  • RfD, PAD, LOC for risk assessment Study and toxicological effects
    Acute dietary (Females 13-50 years of age) An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Acute dietary (General population including infants and children) An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Chronic dietary (All populations) NOAEL = 200 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 200 mg/kg/day
  • cPAD = 2.0 mg/kg/day
  • 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Incidental oral short-term (1 to 30 days) NOAEL = 200 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Incidental oral intermediate-term (1 to 6 months) NOAEL = 200 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Dermal short-term (1 to 30 days) Dermal (or oral) study NOAEL = 200 mg/kg/day (dermal absorption rate = 100%
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Dermal intermediate-term (1 to 6 months) Dermal (or oral) study NOAEL = 200 mg/kg/day (dermal absorption rate = 100%
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Inhalation short-term (1 to 30 days) Inhalation (or oral) study NOAEL = 200 mg/kg/day (inhalation absorption rate = 100%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Inhalation (1 to 6 months) Inhalation (or oral) study NOAEL = 200 mg/kg/day (inhalation absorption rate = 100%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen.
    Cancer (Oral, dermal, inhalation) Based on structural activity analysis, lack of effects suggestive of potential carcinogenicity in subchronic studies and negative results for genotoxicity in bacterial and mammalian cell assays, there is a low concern for the salts of isethionate and isethionic acid as potential carcinogens. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isethionic acid and its salts, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from isethionic acid and its salts in food as follows:

    An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16 which includes food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, “What We Eat In America”, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model that assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for isethionic acid and its salts, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

    Isethionic acid and its salts may be used as inert ingredients in pesticide products that are registered for specific uses that may result in indoor or outdoor residential inhalation and dermal exposures. A screening level residential exposure and risk assessment was completed utilizing conservative residential exposure assumptions. The Agency assessed short- and intermediate-term dermal and inhalation exposures for residential handlers that would result from low pressure hand wand, hose end sprayer and trigger sprayer for each pesticide type, herbicide, insecticide, and fungicide. The Agency assessed post-application short-term dermal exposure for children short-term hand-to-mouth and dermal exposure for children and adults from contact with treated lawns.

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

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

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not observed in the combined developmental/reproduction toxicity screening test in rats. Neither offspring nor reproduction toxicity was observed in this study at dose levels up to 500 mg/kg/day in rats, the highest dose tested.

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

    i. The toxicity database for isethionic acid and its salts contains the following acceptable studies: Subchronic, reproduction/developmental screening study, and a mutagenicity study. The database is considered to be adequate to assess prenatal and postnatal toxicity.

    ii. There is no indication that isethionic acid and its salts are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UF) to account for neurotoxicity.

    iii. There is no indication that isethionic acid and its salts are immunotoxic chemicals. Although increased spleen weights and microscopic changes in the spleen were observed in the 90-day toxicity study in rats those effects were due to red blood cell destruction and therefore not considered an immuno toxic effect. In any event, the cRfD is based on this study and is protective of these effects. Therefore, there is no need for an Immunotoxicity study or additional UFs to account for Immunotoxicity.

    iv. There is no evidence that isethionic acid and its salts result in increased susceptibility for infants and children.

    v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isethionic acid and its salts in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isethionic acid and its salts.

    E. Aggregate Risks and Determination of Safety

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

    2. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isethionic acid and its salts is not expected to pose an acute risk.

    3. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isethionic acid and its salts from food and water will utilize 9.5% of the cPAD for the U.S. population and 35.3% of the cPAD for children 1-2 yrs. old, the population group receiving the greatest exposure.

    4. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isethionic acid and its salts may be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to isethionic acid and its salts.

    Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 187 for adults and 123 for children. Because EPA's level of concern for isethionic acid and its salts are MOEs of 100 or below, these MOEs are not of concern.

    5. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isethionic acid and its salts are currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure. The endpoint of concern selected for short- and intermediate-term exposure assessment is the same NOAEL, therefore intermediate term exposure is not expected to exceed short term aggregate exposure and therefore there are no concerns for intermediate-term aggregate exposure.

    6. Aggregate cancer risk for U.S. population. The Agency has not identified any concerns for carcinogenicity relating to isethionic acid and its salts; therefore, a cancer dietary exposure assessment was not performed and an aggregate risk and aggregate cancer risk assessment is not a concern.

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

    V. Analytical Enforcement Methodology

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

    VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are established under 40 CFR 180.910 and 40 CFR 180.930 for ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients (chelators, sequestrants, and conditioning agents) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals.

    VII. Statutory and Executive Order Reviews

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

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

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

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

    VIII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: July 21, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.910, add alphabetically the inert ingredients to the table to read as follows:
    § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * Ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107-36-8) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, ammonium salts (CAS Reg. No. 57267-78-4) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, calcium salts (CAS Reg. No. 10550-47-7) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, magnesium salts (CAS Reg. No. 17345-56-1) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, potassium salts (CAS Reg. No. 1561-99-5) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, sodium salts (CAS Reg. No. 1562-00-1) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, zinc salts (CAS Reg. No. 129756-32-7) Chelator, sequestrant, or conditioning agent. *         *         *         *         *         *         *
    3. In § 180.930, add alphabetically the inert ingredients to the table to read as follows:
    § 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * Ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107-36-8) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, ammonium salts (CAS Reg. No. 57267-78-4) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, calcium salts (CAS Reg. No. 10550-47-7) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, magnesium salts (CAS Reg. No. 17345-56-1) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, potassium salts (CAS Reg. No. 1561-99-5) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, sodium salts (CAS Reg. No. 1562-00-1) Chelator, sequestrant, or conditioning agent. Ethanesulfonic acid, 2-hydroxy-, zinc salts (CAS Reg. No. 129756-32-7) Chelator, sequestrant, or conditioning agent. *         *         *         *         *         *         *
    [FR Doc. 2015-18610 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-2005-0002; FRL-9931-47-Region 2] National Oil and Hazardous Substance Pollution Contingency Plan National Priorities List: Deletion of the Crown Vantage Landfill Superfund Site AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) Region 2 announces the deletion of the Crown Vantage Landfill Superfund Site (Site), located in Alexandria Township, Hunterdon County, New Jersey, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of New Jersey, through the New Jersey Department of Environmental Protection, have determined that all appropriate response actions under CERCLA, other than long-term maintenance and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

    DATES:

    This action is effective August 28, 2015.

    ADDRESSES:

    Docket: EPA has established a docket for this action under Docket Identification No. EPA-HQ-SFUND-2005-0002. All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in the hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Site Information repositories. Locations, contacts, telephone numbers and viewing hours are:

    U.S. Environmental Protection Agency, Region 2, Superfund Records Center, 290 Broadway, Room 1828, New York, NY 10007-1866, Telephone: 212-637-4308, Hours: Monday through Friday from 9:00 a.m. to 5:00 p.m. and

    Milford Public Library, Crown Vantage Landfill Site Repository File, 40 Frenchtown Road, Milford, NJ 08848, Telephone: 908-995-4072, Hours: Monday 12:00 p.m. to 7:00 p.m., Tuesday 11 a.m. to 5:00 p.m., Wednesday 12 p.m. to 8:00 p.m., Thursday 11 a.m. to 8:00 p.m., Friday 10:00 a.m. to 1:00 p.m. and 5:00 p.m. to 8:00 p.m., and Saturday 10:00 a.m. to 1:00 p.m.

    FOR FURTHER INFORMATION CONTACT:

    Alison Hess, Remedial Project Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 19th Floor, New York, NY 10007-1866; Telephone 212-637-3959; or Email [email protected]

    SUPPLEMENTARY INFORMATION:

    The site to be deleted from the NPL is: Crown Vantage Landfill Superfund Site, Alexandria Township, New Jersey. A Notice of Intent to Delete for this Site was published in the Federal Register (80 FR 23757) on April 29, 2015. The closing date for comments on the Notice of Intent to Delete was May 29, 2015. No comments were received and therefore no response to comments was required. The deletion action is appropriate.

    EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazards ranking system. Deletion of a site from the NPL does not affect the responsible party liability in the unlikely event that future conditions warrant further actions.

    List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.

    Dated: July 6, 2015. Judith A. Enck, Regional Administrator, Region 2.

    For reasons set out in the preamble, 40 CFR part 300 is amended as follows:

    PART 300—NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN 1. The authority citation for part 300 continues to read as follows: Authority:

    33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193.

    Appendix B to Part 300—[Amended]

    2. Table 1 of Appendix B to part 300 is amended by removing “NJ”, “Crown Vantage Landfill”, “Alexandria Township”. [FR Doc. 2015-18607 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P GENERAL SERVICES ADMINISTRATION 41 CFR Part 301-11 [FTR Amendment 2015-05; FTR Case 2015-302; Docket No. 2015-0012; Sequence No. 1] RIN 3090-AJ62 Federal Travel Regulation; Temporary Duty (TDY) Travel Allowances AGENCY:

    Office of Government-wide Policy (OGP), General Services Administration (GSA).

    ACTION:

    Final rule.

    SUMMARY:

    GSA is amending the Federal Travel Regulation (FTR) by removing the meals and incidental expenses (M&IE) breakdown table from the regulation. The table will continue to be published on GSA's Web site at www.gsa.gov/mie and any changes to the breakdown of M&IE reimbursement rates will be publicized via FTR Bulletins.

    DATES:

    Effective: This rule is effective on July 29, 2015.

    Applicability date: This rule is applicable beginning October 1, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Marcerto Barr, Office of Government-wide Policy (MAE), General Services Administration, at 202-208-7654 or email at [email protected] for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FTR Amendment 2015-05, FTR case 2015-302.

    SUPPLEMENTARY INFORMATION: A. Background

    In order to be more efficient and consistent, and in an effort to eliminate duplication, GSA is removing the M&IE breakdown table from the FTR and solely maintaining it on GSA's Web site at www.gsa.gov/mie. The table has been on this Web site for several years and can be updated quickly and efficiently. Changes to per diem reimbursement rates for lodging and M&IE are currently publicized by FTR bulletins and rates are published solely on GSA Web site's. Similarly, any future changes to the M&IE breakdown table will also be publicized in FTR Bulletins notifying agencies of updates to the per diem rates for lodging and M&IE.

    B. Executive Orders 12866 and 13563

    Executive Orders (E.O.s.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a “significant regulatory action,” and therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. The final rule has been reviewed by the Office of Management and Budget. This final rule is not a major rule under 5 U.S.C. 804.

    C. Regulatory Flexibility Act

    This final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. This final rule is also exempt from Administrative Procedure Act per 5 U.S.C. 553(a)(2), because it applies to agency management or personnel.

    D. Paperwork Reduction Act

    The Paperwork Reduction Act does not apply because the changes to the Federal Travel Regulation do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

    E. Small Business Regulatory Enforcement Fairness Act

    This final rule is also exempt from Congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

    List of Subjects in 41 CFR Part 301-11

    Government employees, per diem reimbursement, M&IE allowance, Travel and transportation.

    Dated: July 9, 2015. Denise Turner Roth, Acting Administrator of General Services.

    For the reasons set forth in the preamble, under 5 U.S.C. 5701-5707, GSA is amending 41 CFR part 301-11, as set forth below:

    PART 301-11—PER DIEM EXPENSES 1. The authority for part 301-11 continues to read as follows: Authority:

    5 U.S.C. 5707.

    § 301-11.18 [Amended]
    2. Amend § 301-11.18 by: A. Removing from paragraph (a) the phrase “in the chart in this section” and adding the phrase “at www.gsa.gov/mie” in its place; and B. Removing the table “Total M&IE” at the end of paragraph (a).
    [FR Doc. 2015-18289 Filed 7-28-15; 8:45 am] BILLING CODE 6820-14-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R9-ES-2009-0094; 450 003 0115] RIN 1018-AY64 Endangered and Threatened Wildlife and Plants; Listing the Honduran Emerald Hummingbird (Amazilia luciae) AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), are listing the Honduran emerald hummingbird (Amazilia luciae) as endangered under the Endangered Species Act of 1973, as amended (Act). This species is endemic to Honduras, and the population is estimated to be between 5,000 and 10,000 breeding pairs. Its suitable habitat has decreased significantly in the past 100 years; habitat degradation, fragmentation, and loss have been identified as the primary threats to the continued survival of this species.

    DATES:

    This final rule is effective August 28, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Janine Van Norman, Chief, Branch of Foreign Species, Ecological Services Program, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 420, Arlington, VA 22203; telephone 703-358-2171. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Executive Summary I. Purpose of the Regulatory Action

    We are listing the Honduran emerald hummingbird as endangered under the Endangered Species Act (ESA or Act) (16 U.S.C. 1531 et seq.) as habitat degradation, fragmentation, and loss have been identified as primary threats to the continued survival of this species.

    II. Major Provisions of the Regulatory Action

    This action lists the Honduran emerald hummingbird as endangered on the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h).

    Background

    The ESA was passed to prevent extinction of species by providing measures to help alleviate the loss of species and their habitats. Before a plant or animal species can receive the protection provided by the ESA, it must first be added to one of the Federal Lists of Endangered and Threatened Wildlife and Plants. Section 4 of the ESA and its implementing regulations at part 424 of title 50 of the Code of Federal Regulations (CFR) set forth the procedures for adding species to these lists.

    Previous Federal Actions

    On June 23, 2010, we published a 90-day finding (75 FR 35746) on the petition announcing that we would initiate a status review to determine if listing this species is warranted. On January 2, 2013, we published a 12-month finding and proposed rule (78 FR 59) to list this species as endangered under the Act.

    Summary of Comments

    We base this final rule on a review of the best scientific and commercial information available, including all information we received during the public comment period. In the January 2, 2013, proposed rule (78 FR 59), we requested that all interested parties submit information that might contribute to development of a final rule. The public comment period was open for 60 days, ending March 4, 2013. We also contacted appropriate scientific experts and organizations, and invited them to comment on the proposed listing in accordance with our peer review policy, described in the section below. We received five (5) comments during the comment period including two from peer reviewers, one comment from the Petitioner, one comment containing three reports, and one non-substantial comment. These comments are available at http://www.regulations.gov in Docket No. FWS-R9-ES-2009-0094. The information in the comments provided updated life history information about the species, documented where this species has been recently observed, and provided an updated population estimate (5,000-10,000 breeding pairs). This information is described in the Summary of Changes from Proposed Rule section below as well as incorporated into the rule.

    Peer Review

    In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” that was published on July 1, 1994 (59 FR 34270), we sought the expert opinion of three appropriate independent specialists regarding this rule. The purpose of such review is to ensure listing decisions are based on scientifically sound data, assumptions, and analysis. We sent copies of the proposed rule to the peer reviewers immediately following publication in the Federal Register. We invited these peer reviewers to comment, during the public comment period, on the specific assumptions and the data that were the basis for our conclusions regarding the proposal to list this species as endangered under the Act. We received comments from two peer reviewers.

    We reviewed all comments we received for substantive issues and new information regarding the proposed listing of this species; we address those comments in the section that follows. Comments that provided support or opposition without substantive information were noted, but not addressed in this final rule.

    Summary of Changes From Proposed Rule

    This final rule incorporates the comments we received on our proposed listing and newly available scientific and commercial information. Peer reviewers generally commented that the proposed rule was thorough and comprehensive. New reports relevant to the Honduran emerald hummingbird and its habitat were submitted during the comment period. Two resources were provided which provided new population estimates. The estimated number of Honduran emerald hummingbirds in one study (INGTELSIG 2013) was estimated to be larger than other estimates; however, there were several aspects of the methodology, assumptions, and study design that were questioned by other scientists to the extent that we did not have confidence in the population estimate provided in the study (Anderson et al. 2013, pp. 9-14). The second resource provided the most significant change; based on recent surveys, the population of this species appears to be greater than was previously believed. At the time our proposed rule published, the most current population estimate was 200-1,000 individuals; new information provided during the public comment period indicates that the population of the Honduran emerald hummingbird is likely between 5,000 to 10,000 pairs (Anderson et al. 2013, p. 10). The new information is incorporated into this final listing determination. There are very few individuals studying and working closely with this species, and future studies are needed to obtain more precise estimates of the Honduran emerald hummingbird population. Our determinations were based on the best available scientific and commercial information. None of the information obtained during the comment period changed our final listing determination. A list of literature used in finalizing this determination and comments we received are available at http://www.regulations.gov under Docket No. FWS-R9-ES-2009-0094.

    Species Information Taxonomy

    This hummingbird species was first taxonomically described by Lawrence in 1867, and placed in the Trochilidae family as Amazilia luciae (BLI 2013, p. 1; Sibley and Monroe 1993, 1990). Common names for the species include Honduran emerald hummingbird, Ariane De Lucy (French), and in Honduras it is commonly known as the colibrí esmeralda Hondureño (Spanish). BLI and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) both recognize the species as Amazilia luciae (BLI 2008, p. 1). We recognize this species as Amazilia luciae, which also follows the Integrated Taxonomic Information System (ITIS 2013). ITIS is a database maintained by a partnership of U.S., Canadian, and Mexican federal government agencies, other organizations, and taxonomic specialists to provide taxonomic information.

    Description

    The Honduran emerald hummingbird is one of more than 325 hummingbird species. Hummingbirds exhibit a wide range of flight-related morphology and behavior based on ecological factors (Altshuler and Dudley 2002, p. 2,325). As do all hummingbirds, the Honduran emerald hummingbird exhibits slight sexual dimorphism (physical differences between the females and males), which is demonstrated in the coloring of its plumage. This species is a medium-sized hummingbird with an average length of 9.5 centimeters (3.7 inches) (BLI 2008, p. 2). The male has an iridescent blue-green throat and upper chest and occasionally has a grey mottled coloring. Its back is an emerald green color, the ventral (underneath) side of the bird is pale grey with mottled green sides, and the tail is bright green with a bronze hint on the upper tail coverts (BLI 2008, p. 1). The plumage of the female is less brilliant (BLI 2008, p. 2). The tail of the female contains a grey tip, and the band of distinctive color on the throat of the female hummingbird is narrower, with pale edges (BLI 2008, p. 2; Monroe 1968, p. 183). Juveniles have grayish throats spotted with turquoise (BLI 2008, p. 2).

    Hummingbird bills vary among species and are adapted for specialized feeding. The bill of the Honduran emerald hummingbird is black and slightly curved with a red mandible and dark tip and is slightly longer and more decurved (downward curving) bill than the closely related species A. candida (Monroe 1968, p. 182). The curvature of its bill is associated with foraging for nectar in plant species within its habitat (Gill 1987, p. 780).

    Biology

    The Honduran emerald hummingbird historically has preferred arid interior valleys of thorn forest and shrubs. The Aguán River Valley area rarely receives more than 76 centimeters (30 inches) of rain per year (Perez and Thorn 2012, pers. comm.; Gallardo 2010, http://www.birdsofhonduras.com). Due to the arid climate, many of the plant species are adapted to retain water and are succulents or contain spines as protection from herbivores. Many of the plants lose all their leaves in the dry season, and Honduran emerald hummingbird habitat may appear almost lifeless. Typical plants within its habitat include cacti, acacias, and other succulents. Three species of arborescent (tree-like) cacti have been associated with the Honduran emerald hummingbird's habitat: Pilosocereus maxonii, Stenocereus yunckeri (endemic), and Opuntia hondurensis (endemic) (House 2004, p. 15). The flowering of Opuntia hondurensis coincides with the nesting period of the Honduran emerald hummingbird (House 2004, p. 23). Large clusters of three species of orchids, Myrmecophila wendlandii, Laelia rubescens, and Encyclia nematocaulon, were found growing on cacti within the habitat (House 2004, p. 16). The trees and shrubs found in one study of its habitat were almost 100 percent deciduous (House 2004, p. 15). In larger, more mature trees, some bromeliads (when blooming are sources of nectar and energy) were found. Although epiphytes (plants that grow non-parasitically on another plant, such as a tree) are usually rare in this habitat type, some epiphytes are well adapted to the extremes of this environment.

    In Honduras, this habitat occurs primarily along the Gulf of Fonseca, in the Agalta Valley in the Olancho Department, and in the Aguán Valley in the Yoro Department (for a map of the Honduran emerald populations, see our proposed rule, 78 FR 63). This species tends to be found in similar altitudes, although it has recently been observed at higher elevations (Germer 2013, pp. 1-2). Most of the hummingbird's occurrences have been noted at elevations between 150 and 600 meters (492 and 1,968.5 feet (ft)) above sea level; however, other observations were recorded at 845 and 1,220 meters (2,772 and 4,003 ft) (Germer 2012; pp. 55-56; Sanchez et al. 2011, p. 69).

    The Honduran emerald hummingbird nests in March and April, and its nest has been observed in a Guayabillo tree (Eugenia lempana) (Espinal and Marineros 2008, p. 1). Its nests are made of cobwebs, lichens, and mosses, and it usually lays two eggs which hatch in 21/2 weeks (Germer 2011, p. 52).

    Emerald hummingbirds are somewhat aggressive and territorial (Collar et al. 1992, p. 493; Howell and Webb 1989, p. 643), due to competition with other hummingbird species for resources. This species has been observed feeding at heights between 0.5 to 10 meters (2 to 32 ft) (Howell and Webb 1989, p. 643). Some aspects of this species' behavior remain unclear, such as how far individuals disperse, what habitats are important for dispersal, and how the populations are linked genetically (Perez and Thorn 2012 pers. comm.; Anderson et al. 2010, p. 7).

    As with all hummingbird species, the Honduran emerald hummingbird relies on nectar-producing flowers for food and energy, and relies on insects and spiders as sources of protein (Germer 2012, p. 2; Collar et al. 1992, p. 494). Thorn et al. (2000, p. 23) observed that habitat with abundant flowers, red in particular, appeared to be a critical characteristic for suitable habitat. Additionally, suitable habitat requirements include similar ecological conditions such as access to nectar and insects, rainfall, humidity and temperature. During one field study in Santa Barbara, Honduran emerald hummingbirds were observed hunting arthropods about 50 percent of their time (Stiles 1985).

    Hummingbirds are known to “disperse” rather than “migrate” in the sense that they do not follow routine, standard, round-trip movements; they follow sources of food availability (Berthold et al. 2003, pp. 40-41). Hummingbirds are the most specialized nectar-feeding birds in the New World (Graham et al. 2009, p. 19,673). Hummingbirds quickly shift to the best available sources of nectar; their choice of habitat may change concurrent with loss of their preferred food sources (Gill 1987, p. 785; Montgomerie et al. 1984). When a hummingbird's habitat does not provide its required resources, research indicates that they tend to abandon a territory and move to more productive areas (Feinsinger and Colwell 1978; Kodric-Brown and Brown 1978 in Justino et al. 2012, p. 194). Emerald hummingbirds are habitat generalists in the sense that they do not rely exclusively on a single species of plant for nourishment; rather, they utilize a wide variety of nectar-producing plants to meet their nutritional requirements (Graham et al. 2009, p. 19,675). Helicteres guazumaefolia, which produces nectar all year (as opposed to seasonally), was observed to be a preferred food source for the Honduran emerald hummingbird in Santa Barbara (Komar et al. 2013, pp. 25-26). This species has been observed actively foraging mid-morning, concurrent with the time during the day when nectar is most plentiful. For example, energy present in Heliconia stilesii flowers averaged 200 to 300 joules per flower in the early morning and 300 to 500 joules per flower by midmorning (Gill 1987, pp. 781-782).

    Germer (2011) found that during the dry season, the Honduran emerald hummingbird can be found in gallery forests (forests that grow in corridors along wetlands or rivers, projecting into sparsely treed areas), or near bodies of water where humidity and abundance of small arthropods is greater. Its use of these areas is believed to reduce its metabolic cost and escape heat during the driest seasons (pp. 52-53). High variability between detections was observed, which could imply that the species is not evenly distributed across the available habitat (Germer 2011, pp. 52-53); it may move seasonally in search of food sources.

    In Yoro, the Honduran emerald hummingbird uses the species Pedilanthus camporum, which produces flowers year-round, and Nopalea hondurensis, which flowers generally between February and April, 90 percent of the time observed. In the Coyoles area in the Aguán Valley, the thorn forest is primarily comprised of Mimosaceae (herbaceous and woody species), Cactaceae (cactus species), and Euphorbiaceae (herbs, shrubs, trees, and some succulent species) (Collar et al. 1992, p. 494). In western Honduras, 90 percent of foraging observations were on Aphelandra scabra and Helicteres guazaumifolia. A list of plant species utilized by Honduran emerald hummingbirds is available in our proposed rule, 78 FR 63.

    Population

    In our proposed rule (78 FR 59), we noted that several attempts have been made to estimate the population status of the Honduran emerald. In 2007, the total population was estimated to be between 200 and 1,000 individuals (Anderson et al. 2007, p. 1). At the time of the publication of our proposed rule, the best estimate suggested a population of approximately 200-1000 individuals (BLI 2012, unpaginated; Perez and Thorn pers. comm. 2012).

    During the public comment period, we received additional information indicating that the total population estimate for Honduran emerald may be higher than previously believed. One study, published in 2013, suggested that the population of Honduran emerald hummingbirds was significantly larger, estimated to be between 50,000 and 106,000 individuals (INGTELSIG 2013). We find this to be an overestimate due to several erroneous assumptions in the study design and sampling methodology, which were described in Anderson et al. (2013, pp. 10-12). More recent studies and research suggests that there are between 5,000 and 10,000 breeding pairs spread across seven separate populations (Anderson et al. 2013, p. 2). Table 1 provides the current population estimate for each of the populations based upon the best available scientific and commercial information submitted by researchers working with the species.

    Table 1—Population Estimates by Valley [Anderson 2013, pp. 2, 14] Honduran department Location of population Population estimate Santa Barbara Department Tencoa Valley
  • Jicatuyo Valley
  • Quimistán Valley
  • 2,500-5,000 breeding pairs.
    Yoro Department Aguán Valley 1,000-2,000 breeding pairs. Olancho Department Agalta Valley
  • Telica Valley
  • Guayape Valley (Valle de Olancho)
  • 1,000-2,000 breeding pairs.
  • 500-1,000 breeding pairs.
  • Extirpated.
  • Historic Distribution

    The Honduran emerald hummingbird is the only known endemic bird species in Honduras (Anderson and Devenish 2009, p. 258; Portillo 2007, p. 17; Thorn et al. 2000, p. 3; Collar et al. 1992, p. 493; Monroe 1968, p. 182). Based on specimen data, the species was originally known to occur in four departments (which are similar to “states” in the United States): Cortés and Santa Barbara in the west and Yoro and Olancho in the northeast. The Honduran emerald hummingbird was likely a forest inhabitant and described as locally common (Howell 1989, p. 642). The locations and dates where this species has been documented are as follows:

    • Catacamas, Olancho (1937 and 1991) (Howell and Webb 1992, pp. 46-47; Monroe 1968, p. 182).

    • Cofradía, Cortes (1933) (Monroe 1968, p. 182).

    • Coyoles, Yoro (1948 and 1950) (Monroe 1968, p. 182).

    • El Boquerón, Olancho (recorded September 1937) (Monroe 1968, p. 182).

    • Olanchito, Yoro (1988) (Howell and Webb 1989, pp. 642-643).

    • Santa Bárbara, Santa Bárbara (1935) (Monroe 1968, p. 182).

    Between 1950 and 1988 there were no recorded observations of the Honduran emerald hummingbird. In 1988, the species was described as common in Olanchito and Coyoles, which are located 16 km (9 miles) apart (BLI 2008, p. 2). In 1991, between 22 and 28 individuals were found in a patch of habitat measuring 500 by 50 meters (1,640 x 164 ft) near Olanchito (Howell and Webb 1992, pp. 46-47). In 1996, the bird was found in the Agalta Valley on less than 1 km2 (247 acres or .39 square miles (mi2)) of suitable habitat (BLI 2008, p. 3).

    Current Distribution

    Prior to its 1988 rediscovery in Olanchito and Coyoles, it was thought that habitat loss had restricted the Honduran emerald hummingbird to isolated patches of arid thorn-forest and scrub of the interior valleys of northern Honduras. Between 2007 and 2013, this species was documented in seven valleys in Honduras (Anderson et al. 2013, p. 2; Germer 2012, pp. 52-60; Anderson 2010, p. 4) (see Fig. 1). In the Tencoa Valley (Santa Barbara), researchers found individuals in five habitat patches, each separated by at least 5 km (3 miles). These habitat fragments were between 5 and 60 hectares (ha) (12 and 148 acres) each. It is estimated that the population in the Santa Barbara Department is approximately 200 km (124 miles) west of the nearest known population in the Aguán Valley (Anderson 2010, p. 5). The Honduran emerald hummingbird density within the Santa Barbara Department has been estimated to be between 76 and 167 individuals per km2 (29-64 mi2) (Sanchez et al. 2011, p. 5), but its density varies based on food availability. BLI reports that its range is 400 km2 (154 mi2). However, local experts believe its actual extent of occurrence may be closer to 150 km2 (58 mi2) (Perez and Thorn pers. comm. 2012). Observations of the Honduran emerald hummingbird have been recently reported in western Honduras in the Quimistán Valley (in the Río Chamelecón watershed) and Tencoa Valley (Río Ulúa watershed), in the Santa Barbara Department where it had not been recorded since 1935. The westernmost occurrence of the species is in the Oro River Valley, near Sula in the municipality of Macuelizo. The northernmost site is in the Valley of Azacualpa, also in the municipality of Macuelizo.

    Agalta Valley (Olancho Department)

    In 2007, this species was observed in the Agalta Valley and in the Telica Valley, both in the Olancho Department (Anderson and Hyman 2007, p. 6). The Agalta Valley is described as a remote region in the mountains of eastern Honduras containing over 1,000,000 ha (2,471,054 acres) of land characterized as dry basin. Here, the Honduran emerald hummingbird's habitat primarily is on large, privately owned cattle ranches that have restricted access (Anderson et al. 2010, p. 3). The species has been known to occur in this valley since the mid-1990s (Anderson et al. 1998, p. 181). Although this species exists in the Agalta Valley, very little information regarding the factors affecting this species in this area are known. Reports indicate that areas that contain suitable habitat characteristics for the Honduran emerald hummingbird are being cleared for rice cultivation (Hyman 2012, pers. comm.; Bonta 2011, pers. comm.). Several of the remaining habitat patches are connected by narrow corridors of habitat along property lines and waterways, but most of the patches of remaining habitat are “islands” within cattle pasture, which comprises approximately 90 percent of the Valley's area (Bonta 2011, pers. comm.).

    Aguán Valley (Yoro Department)

    This hummingbird species is known in the Aguán Valley, Yoro Department, in the areas of Olanchito and Coyoles, and is reported as relatively common, but only within its remaining suitable habitat (Gallardo 2010, p. 186; Thorn et al. 2000, pp. 22-23). This species has also been observed in New Valle del Rio de Oro, Valle de Azacualpa, and Rio Jicatuyo in the vicinity of San Luis. The Honduran emerald hummingbird's habitat formerly encompassed a large extent of the Aguán Valley, a once pristine plain of nearly 4,662 km2 (1,800 mi2). Ninety percent of its original habitat no longer exists in its original form due to the conversion of its habitat to banana plantations and cattle pasture. Much of the Honduran emerald hummingbird's habitat is on privately owned land and is often planted with nonnative grasses for cattle grazing (Perez and Thorn 2012, pers. comm.; Anderson pers. comm. 2008 in Petition 2008, p. 11). In some cases, it is planted with invasive grass species (http://www.birdlist.org/cam/honduras/hn_ecosystems.htm, accessed May 22, 2012). Today, due to decades of unregulated and expanding cattle ranching, the hummingbird's dry forest range is limited to a few small, isolated islands of habitat. Its increasingly smaller ecosystems are surrounded by human-dominated landscapes. One estimate indicated that between 2,428 and 3,237 ha (6,000-8,000 acres) of suitable habitat remains in the Aguán Valley, most of which is privately owned (Gallardo 2010, p. 186); however, other estimates indicate that the species has even less suitable habitat available than the above estimate (Perez and Thorn 2012 pers. comm.).

    The lands along the Aguán River have periodically been devastated by banana diseases, floods, and hurricanes, particularly Hurricane Fifi in 1974 and Hurricane Mitch in 1998 (NOAA 2012, p. 2; Winograd 2006; USGS 2002, p. 5). This valley is on the south side of the Nombre de Dios Mountain Range, primarily in the Yoro Department (Gallardo 2010, p. 185). The Aguán River Watershed is 10,546 km2 (4,072 mi2 or 2,605,973 acres), is delimited by the tributaries of the Aguán River, and extends across the departments of Yoro, Colon, Atlántida, and Olancho (WWF 2008, p. 12; see Map 5, Map of Honduras, Aguán Valley at http://www.regulations.gov under Docket No. FWS-R9-ES-2009-0094). This valley experiences a unique microclimate in which most of the rain falls between June and November (Gallardo 2010, p. 185). The land in the Aguán Valley is rich and fertile, and therefore, highly likely to be converted into agricultural lands fields, particularly in a country with a high poverty index that relies strongly on its land for agriculture (WWF 2008, p. 2).

    Western Honduras

    In 2000, a survey was conducted for the Honduran emerald hummingbird and concluded that it occurs in dry tropical forest (Anderson and Hyman 2007, pp. 1-4; Thorn et al. 2000, pp. 1-5). Upon the recent rediscovery of the species in western Honduras, researchers determined that the species was also residing in areas with different ecological characteristics (Anderson et al. 2010). Sites occupied by the Honduran emerald hummingbird in western Honduras are best described as semi-deciduous woodland, a habitat that has not previously been associated with the species. Canopy height in this area averages 15 meters (49 ft), dominated by semi-deciduous broad-leaved tree species, principally Eugenia oerstediana, Bursera simaruba, and Tabebuia rosea, that form a relatively closed tree canopy. Common understory species are Agave parvidentata, Tillandsia fasciculata, Bromelia pinguin, Bromelia plumieri, and Acanthocereus pentagonus (Anderson 2010, p. 5). According to Komar et al. 2013, this species has been observed utilizing four habitats (dry forest, dry scrubland, wooded pasture, and lowland pine/oak forest).

    Conservation Status

    The Honduran emerald hummingbird is listed as endangered by the IUCN (2012). The category of this species was reclassified as endangered from critically endangered following its recent discovery in the western part of Honduras, which increased its known range (BLI 2012, pp. 1-2). Its IUCN classification is based on its very small and severely fragmented range and population. However, this status under IUCN conveys no actual protections to the species. The Honduran emerald hummingbird has been listed in Appendix II of CITES since October 22, 1987, at which time all hummingbird species not previously listed in the Appendices were listed in Appendix II. Honduras and the United States are both Parties to CITES, an international treaty among 180 nations through which member countries, called Parties, work together to ensure that international trade in CITES-listed animals and plants is not detrimental to the survival of wild populations. This goal is achieved by regulating import, export, and re-export of CITES-listed animal and plant species and their parts and products through a permitting system (http://www.cites.org). Appendix II includes species which although not necessarily now threatened with extinction may become so unless trade in specimens of such species is subject to strict regulation in order to avoid utilization incompatible with their survival; and other species which must be subject to regulation in order that trade in specimens of certain species threatened with extinction which are or may be affected by trade may be brought under effective control (CITES Article II(2)). International trade in specimens of Appendix II species may be authorized through a system of permits or certificates under certain circumstances, and must be in accordance with CITES Article IV. For example, export may only be authorized when: (1) The CITES Scientific Authority of the country of export has determined that the export will not be detrimental to the survival of the species; (2) the CITES Management Authority of the country of export has determined that the specimens to be exported were legally acquired; and (3) the CITES Management Authority of the country of export has determined that any living specimen will be so prepared and shipped as to minimize the risk of injury, damage to health or cruel treatment (CITES Article IV(2)). In the United States, CITES is implemented through the Act and implementing regulations at 50 CFR part 23.

    Factors Affecting the Species Introduction

    The most serious threat affecting this species is the continued degradation and fragmentation of existing habitat, and the complete loss of habitat (estimated to be 90 percent) over the past 100 years due to land conversion from prime thorn forest habitat to banana plantations, agriculture, and cattle pastures (Komar et al. 2013, p. 28; Perez and Thorn 2012, pers. comm.). Studies published in 2013 indicate that in Santa Barbara, the area that contains the most suitable habitat for the Honduran emerald hummingbird, agriculture, cattle grazing, coffee cultivation, mining, dam construction, and fires are the primary factors contributing to the degradation, fragmentation and loss of habitat (Komar et al. 2013, p. 37; Anderson et al. 2013, pp. 1-3). This loss of habitat interacts with the ecologically deleterious factors associated with palm oil production, land ownership, pesticides and fertilizers, roads, hydroelectric and development projects, international trade, disease and predation, small and declining populations, and other factors in affecting the Honduran emerald hummingbird's habitat. These factors are discussed in detail below.

    Habitat Degradation and Fragmentation

    Honduras has been steadily losing thorn forest cover, particularly since the early 1960s, mostly due to the conversion of thorn forest areas to agricultural areas, such as cattle pastures and coffee, bean, corn, and banana plantations (World Wildlife Fund 2008, p. 11; Anderson pers. comm. 2008 in Petition 2008, p. 11; Portillo 2007, p. 75). In Yoro, there are only four large patches of suitable habitat for this species remaining (Perez and Thorn 2012, pers. comm.; Anderson 2010). The four largest fragments are between 360 and 476 ha (890 and 1,176 acres), for a combined total of 1,704 ha (4,210 acres) (Anderson 2010, p. 6). In the Aguán Valley, as of 2000, suitable habitat for the Honduran emerald had reduced in size to an estimated 8,495 ha (20,991 acres) from 16,000 ha (39,537 acres) in 1977, and 30,000 ha (74,132 acres) in 1938 (Thorn et al. 2000, p. 25). Even with the rediscovery of the species in Santa Barbara and the extension of its range in Olancho, the species' habitat has been reduced due to habitat conversion to plantations and cattle ranches (see Fig. 1; Perez and Thorn pers. comm. 2012). Due to habitat destruction/degradation rates in Santa Barbara, no suitable habitat for the Honduran emerald hummingbird may remain by the year 2025 (Anderson et al. 2013, p. 5).

    In the last ~100 years, the Aguán region has experienced three periods of agricultural economic growth (WWF 2008, p. 11). Thorn forests were initially cleared in the Aguán Valley to create banana and plantain plantations and rice farms, as well as pasture for cattle (Stattersfield and Capper 2000, p. 311). However, after an outbreak of Panama disease occurred in bananas, the Aguán Valley was largely abandoned, and much of the land reverted to pasture or forest. As a result of the agricultural reforms of the 1960s and 1970s, Honduran campesinos (farmers) received farmland in the Aguán Valley and proceeded to clear and develop the Valley that was previously forested into an agricultural region. In the late 1970s, lands were again cultivated with disease-resistant varieties of bananas. In the Aguán Valley, 10,319 ha (25,500 ac) now consist of banana plantations in an area known as the Barisma farm (Dole 2011, p. 67). One of the best patches of optimal Honduran emerald hummingbird habitat in the Aguán Valley has practically disappeared due to its proximity to a nearby town (Thorn 2012, pers. comm.). Now, only a single forest remnant larger than 100 ha (247 ac) that is suitable for this species is known to exist in this valley (Anderson 2010, p. 6). Habitat suitable for Honduran emerald hummingbirds continues to be cleared by private landowners in order to plant pasture grass for grazing cattle (Hyman 2012 pers. comm.).

    Several hummingbird species have persisted in fragmented tropical landscapes (Stouffer & Bierregaard 1995 in Hadley & Betts 2009, p. 207). However, hummingbird persistence at the landscape scale does not indicate that the population is at the same level it was prior to deforestation (Hadley & Betts 2009, p. 207). Flight paths used by the green hermit hummingbird (Phaethornis guy) indicate that gaps in suitable habitat alter hummingbird movement pathways (Hadley 2012, p. 48; Hadley & Betts 2009, p. 209). Due to the fragmentation of their habitat, Honduran emeralds and other hummingbird species are forced to expend more energy moving between suitable habitat patches to breed, feed, and nest; the flight of hummingbirds is one of the most energetically demanding forms of animal locomotion (Buermann et al. 2011, p. 1,671). In agricultural landscapes, hummingbirds were observed traveling longer distances and took more circuitous routes than in forested landscapes. Overall, movement paths were strongly linked to areas that contained higher forest cover (Hadley & Betts 2009, p. 209).

    Nectar is the primary source of carbohydrates for hummingbirds, and insects or pollen is the primary sources of protein for hummingbirds (Araújo et al. 2011, p. 827; Hegland et al. 2009, p. 188). Although studies of nutritional requirements have been conducted with respect to other hummingbird species, the home range required to support the breeding, feeding, and nesting requirements for each pair of Honduran emerald hummingbirds is unknown. Hadley noted in 2012 that plant densities, flower abundance, and flower quality (e.g., number of inflorescences, display size) can all be affected by landscape configuration such as edge effects (changes in population or community structures occurring at the boundaries of two habitats) due to factors such as light and humidity levels; therefore, hummingbird foraging behavior is likely sensitive to fragmentation (Hadley 2012, pp. 23-35). Efforts by Pico Bonito National Park Foundation (Fundación Parque Nacional Pico Bonito (FUPNAPIB)) and others have attempted to preserve important parts of this species' habitat; however, even the areas designated as protected are experiencing habitat degradation (Hyman 2013, pp. 1-2).

    Land Ownership

    Because approximately 84 percent of the Honduran emerald's suitable habitat is privately owned, it is difficult to provide protections to this species (Steiner 2012 pers. comm.; FAO 2010, p. 238). In many cases, the only sites in Honduras that have maintained a viable ecosystem in somewhat of a natural state are places with irregular topography. Subsequently, these areas have become protected or private nature reserves (Portillo 2007, p. 75). Much of this species' original habitat, thorn forest, has been cleared for housing, towns, agriculture, and cattle grazing (Stattersfield and Capper 2000, p. 311; Thorn et al. 2000, p. 4). This species' remaining habitat in the Aguán Valley (Yoro Department) and Agalta Valley (Olancho Department) is primarily privately owned as large haciendas (plantations or farms), where cattle grazing, clearing for cattle, and plantation agriculture continues to occur (Stattersfield and Capper 2000, p. 311). In the lower river valley, agricultural cooperatives are raising citrus fruits, corn (maize), rice, and African palm for oil (WWF 2008, p. 12). Because most of this species' habitat is unprotected, the species is likely to continue to experience habitat degradation through conversion of its habitat to other uses such as cattle grazing and agricultural plantations.

    Palm Oil Production

    Although palm oil plantations in the Aguán River Basin have not been directly implicated as the cause of Honduran emerald habitat loss, palm oil plantations have replaced pasture lands that were left behind after the banana plantations diminished from their initial success during the first part of the 20th century (WWF 2008, p. 30). The palm oil production in the Aguán River Basin is concentrated between Sava and Tumbaderos (WWF 2008, p. 17) and covers 28,082 ha (69,392 ac.). The area includes plantations, processing plants, nurseries, palm oil collecting sites, and other infrastructure. Honduras' palm oil industry exported over $21 million U.S. dollars' worth of palm oil in 2004, and Honduras is expected to increase its production of palm oil for biofuel (Silvestri 2008, pp. ii-iii). Other countries are encouraging Honduras to increase production of palm oil, which would likely affect the Aguán River Basin (Silvestri 2008, pp. 47; WWF 2008, pp. 37-38). These changes in land use have had an environmental cost (WWF 2008, pp. 30, 53-54), such as land degradation through deforestation and exposure to fertilizers and pesticides, which are discussed below. Although the conversion to palm oil plantations may not be occurring directly in Honduran emerald hummingbird habitat, its effects may impact this species via the development of roads, habitat conversion, and settlements.

    To provide perspective on the magnitude of the production in this valley, the Aguán Valley Palm Producers Association (APROVA) is a cooperative of 154 oil palm farmers (USDA 2012, pp. 1-3). In 2009, APROVA opened its first palm oil processing plant, which processes up to five tons of palm oil per day (USDA 2012, pp. 1-3); there are now five processing plants. As of 1938, within the Aguán Valley 30,000 ha (74,131 ac) were the arid, thorn forest preferred by the Honduran emerald (Tierra America 2012, pp. 1-2). By 1977, suitable habitat for the Honduran emerald hummingbird had been reduced to 16,000 ha (39,537 ac), and in 2000, only 8,495 ha (20,991 ac) remained. Of that area, only 3,900 ha (9,637 ac) can be considered preserved well enough to sustain significant populations of the Honduran emerald hummingbird (Mejía pers. comm. in Tierra America 2012).

    Table 1—Land Reduction in the Aguán Valley Aguán Valley Year Hectares Acres Tropical Dry Forest 1938 30,000 74,131 Tropical Dry Forest 1977 16,000 39,537 Tropical Dry Forest 2000 8,495 20,991 Source: Thorn et al. 2000. Pesticides and Fertilizers

    The World Wide Fund for Nature (WWF) notes that agricultural production yield level can only be increased with the use of agrochemicals such as fertilizer and pesticides, which in turn all have an environmental impact. Before palm oil tree canopies fully develop, sunlight is able to penetrate the ground resulting in aggressive weed growth and frequent weed control is needed. Mechanical weed mowers hauled by agricultural tractors are used to keep weeds at a manageable height in between rows. Before the canopy is fully developed, areas around young plants are kept free of competing weeds mostly by chemical herbicides and by manually removing them (WWF 2008, pp. 24-25). However, these plantations are approximately 161 km (100 miles) north of the Honduran emerald hummingbird's habitat, and are not known to directly affect this species (Hyman 2012, pers. comm.). Therefore, we do not find pesticides and fertilizers to be a threat to the continued existence of this species.

    Roads

    Honduras is ranked among the countries with the lowest development of road networks in Central America (Acevedo et al. 2008, p. 1). The agricultural sector is the most important of the Honduran economy (Acevedo et al. 2008, p. 1); however, this sector is limited by difficulties of transportation and access to many of the productive areas of the country due to poor road infrastructure (Quintero et al. 2007, pp. 15-18; Winograd 2006, pp. 1-5).

    Existing roads have been negatively impacted by hurricanes, flooding, and neglect after the crash of the banana industry. The Aguán and Agalta valleys, which contain this species' preferred habitat, are some of the most productive agricultural areas of the country, and this change in land use has decreased the available suitable habitat for the Honduran emerald hummingbird (Acevedo et al. 2008, p. 1). These agricultural areas of the country are in the departments of Atlantida (Aguán Valley) and Olancho (Agalta and Guayape valleys) and include bananas, coffee, palm oil, corn, beans, edible vegetables, fruits, and other crops. The improvement and development of roads to transport agricultural products to economic hubs is being considered by the Government of Honduras, which may affect the Honduran emerald hummingbird's habitat.

    Growth in this economic sector is impeded by the lack of access to the most productive agricultural areas of the country due to poor road infrastructure. The road improvement project (Central Road, Route no. 23) is funded by the World Bank through the “Second Reconstruction and Improvement Project Road” (World Bank 2013, pp. 1-3; World Bank 2011, pp. 1-3; Proceso Digital 2010). The road improvement project will likely bring more traffic, which will increase land speculation and settlement of homes along the road, ultimately impacting surrounding Honduran emerald hummingbird habitat (Perez and Thorn 2012, pers. comm.; Steiner and Coto 2011, pp. 1-2). Roads through prime Honduran emerald hummingbird habitat, which is presently affected by cultivation of bananas and plantains, link the river valley to the ports at Tela, La Ceiba, Trujillo, and Puerto Cortés.

    There are plans to pave the road between Olanchito (Yoro Department) and San Lorenzo (Valle Department (southcentral Honduras)), an approximately 57-km (35-mile) stretch that currently passes through the Aguán Valley, which will further impact this species' habitat (Hyman 2012; pers. comm.; World Bank 2011, pp. 1-3; Anderson pers. comm. 2008 in Petition 2008; Hyman 2007, p. 10). This project has been contingent on several factors, such as a loan from the World Bank and implementation of measures to mitigate the impact on the environment. A 2007 World Bank report indicated that during the project planning stage, the scope of the project changed so that the road segment passing through vital habitat for the Honduran emerald hummingbird was not implemented (Quintero 2007, pp. 14-16). In this report, the World Bank indicated that payments for an environmental services plan, if successfully implemented, could lead to the long-term protection of an additional 1,000-2,000 ha (2,474-4,942 acres) of Honduran emerald hummingbird habitat on private lands. This, in turn, would address environmental concerns associated with the proposed paving of the Olanchito-San Lorenzo road (Quintero et al. 2007, p. 15). The original plans for this project included a target completion date of December 2014 (World Bank 2013, pp. 1-2); however, the best available information indicates that the closing date of the loan has been extended to May 31, 2015 and implementation progress on the proposed infrastructure was rated as moderately successful (World Bank 2015, unpaginated; World Bank 2014, p. 1-6).

    The Agalta Valley is traversed by a highway that has been proposed to be repaved (Inter-American Development Bank 2013, pp. 1-2; Hyman 2012, pers. comm). This region is an area with a high rate of poverty, and this highway is, in part, intended to improve the economic conditions in this region. This region contains approximately 50,000 human inhabitants. The highway will complete the second paved transit route between the Pacific and Atlantic oceans in Honduras. The road is being improved in order to provide a better link between Tegucigalpa and the Atlantic coast of Honduras and will better connect the Departments of Francisco Morazán, Olancho, and Colón. It is unclear how this highway will affect the remaining 5,000 ha (12,355 ac) of this species' habitat (Bonta 2011, pers. comm.) in this valley.

    Hydroelectric and Development Projects

    The construction of several development projects could possibly affect this species' habitat (Bonta 2012, pers. comm.) in the Agalta Valley and the Tencoa Valley. At least two hydroelectric projects have become operational in recent years (Bonta 2012, pers. comm.). These projects could likely result in more infrastructure development in the Valley, which could also affect the Honduran emerald hummingbird's habitat. Additionally, several agricultural development projects may be underway in the Agalta Valley (Bonta 2012, pers. comm.). Bonta indicates that the following projects, which can be located at http://www.hondurasopenforbusiness.com, are likely to affect the Honduran emerald hummingbird's habitat.

    • AGR112: Production of Transgenic Certified Maize,

    • AGR126: Cultivation of Piñón, Jatropha curcas, for biodiesel (5,000 ha in the Agalta Valley),

    • AGR401: Cultivation of Piñón (5,000 ha in the Agalta Valley),

    • AGR402: Cultivation of Piñón,

    • FOR204: Teak (Tectona grandis) plantation: 20,000 ha in three valleys; estimate of 4,000 to 8,000 ha in the Agalta Valley.

    Although highway construction, agricultural development, and resulting infrastructure is likely to occur in the Agalta Valley, it is unclear how these activities would negatively affect the Honduran emerald hummingbird in this valley. To mitigate the effects of development in this area, a Honduran emerald hummingbird conservation strategy paper for the Agalta Valley was funded by the Inter-American Development Bank (IADB) and partially developed by the American Bird Conservancy. In the area of influence of IADB project HO-L1003, the strategy paper identified 20 remaining fragments of suitable Honduran emerald hummingbird habitat; all but one of these fragments is located on private land. The paper recommended development of a payments-for-ecosystem-services scheme (PES scheme) as the most viable conservation option. This concept would compensate landowners for conserving or restoring Honduran emerald hummingbird habitat found on their land in the Agalta Valley; however, it is unclear whether this has been implemented (IADB 2013, pp. 1-2).

    International Trade

    Data obtained from the United Nations Environment Programme—World Conservation Monitoring Center (UNEP-WCMC) show that, since its listing in CITES Appendix II in 1987, only two Honduran emerald hummingbird specimens have been recorded in international trade, involving two carcasses of unknown origin from Germany to the United States in 1996 (UNEP-WCMC 2009b). Therefore, international trade is not a factor influencing the species' status in the wild. We are not aware of any other information that indicates that collection or overutilization of the Honduran emerald hummingbird is affecting this species.

    Disease and Predation

    The Intergovernmental Panel on Climate Change (2014, pp. 1530-1532) suggests that the distribution of some disease vectors may change as a result of climate change. However, after conducting a status review of the Honduran emerald hummingbird and consulting with experts, we have no information at this time to suggest that any specific diseases are or may become problematic to this species.

    Small and Declining Population

    In our proposed rule (78 FR 59), we found that the species' small population size (at the time of our proposal, estimated to be 200-1,000 individuals) combined with its highly restricted and severely fragmented range, increased the species' vulnerability to adverse natural events. The species' potential exposure to extreme weather events such as hurricanes, extended periods of drought, or flooding, in combination with habitat loss and degradation was believed to be affecting the continued existence of the species throughout its range.

    During the public comment period, we received new information indicating that the population estimates were much higher than previously believed (5,000-10,000 breeding pairs) (see Population Estimates). Based upon this updated estimate, we have re-evaluated whether the populations are susceptible to the risks associated with small and declining populations as described in detail below.

    Endemic to Honduras, Honduran emeralds hummingbirds have been found in seven populations. In the Santa Barbara Department (western Honduras), they have been found in three separate valleys, Tencoa Valley, Jicatuyo/Ulua river valley, and the Quimistan Valley. Anderson et al. (2013, p. 14) estimates a combined population for these three valleys to be roughly 2,500-5,000 breeding pairs; however, the researcher notes that no comprehensive, peer-reviewed population estimate has been completed for this area and as such, there is no current information indicating how the populations are distributed between the three separate valleys. Anderson et al. (2010, p. 258) stated that during research in Tencoa Valley alone, they found individuals in five habitat fragments, each fragment measuring between 5 to 60 hectares (ha), separated from each other by at least 5 km. A single individual was found in a 40 ha forest fragment in Quimistan Valley (Anderson et al. 2010, p. 258). In the Yoro Department, a single population exists in the Aguán Valley, a considerable distance from other known populations; Anderson et al. (2010, p. 259) estimates that the Santa Barbara populations are 200 km west of the population in the Aguán Valley. Anderson et al. (2013, p. 14) estimates a population of 1,000-2,000 breeding pairs within the Aguán Valley. In the Olancho Department, Honduran emeralds are found in three separate valleys, Agalta, Tilica, and Guayape. Anderson et al. (2013, p. 14) estimates a population of 1,000-2,000 breeding pairs within Agalta Valley. In Guayape, the species is believed to have been extirpated. In 2012 and 2013, researchers were unable to detect a single individual within this valley. Connected to Guayape Valley through a habitat corridor, it is believed the remaining population in the Tilica Valley may have historically been a part of the now-extirpated population (Anderson et al. 2013, p. 13). In Tilica, the population is estimated to be between 500-1,000 breeding pairs.

    Despite the increased total population estimate of 5,000-10,000 breeding pairs, research suggests the individual populations are small, including one population that is presumably extirpated. Research illustrates that the populations are both geographically and genetically isolated from one another. According to Anderson et al. (2013, p. 3), there has been no evidence to date of Honduran emeralds being found between any of the seven valleys, indicating that while there is the potential for gene flow between the populations, the probability is minimal.

    Species endemic to a few, widely dispersed locations are inherently more vulnerable to extinction than widespread species because of the higher risks from genetic bottlenecks, random demographic fluctuations, climate change, and localized catastrophes such as hurricanes, landslides, and drought (Lande 1988, p. 1,455; Mangel and Tier 1994, p. 607; Pimm et al. 1988, p. 757). Small populations can be more affected by factors such as demographic stochasticity (variability in population growth rates arising from random differences among individuals in survival and reproduction within a season), local catastrophes, and inbreeding (Pimm et al. 1988, pp. 757, 773-775). Due primarily to the current rate of habitat fragmentation, degradation, and loss, each Honduran emerald population is considered to be declining within their individual locales. Hummingbirds' flight and hovering abilities require a large amount of energy; this necessitates the utilization of foraging techniques that maximize the amount of nectar (energy) at a minimum cost. The degradation, fragmentation, and loss of habitat cause the species to expend more energy and resources in search of its basic nutritional requirements (Justino et al. 2012, pp. 194-195; Hadley and Betts 2009, p. 207). Habitat degradation, fragmentation, and loss can separate populations to the point where individuals can no longer disperse and breed among habitat patches, causing a shift in the demographic characteristics of a population and a reduction in genetic fitness (Gilpin and Soulé 1986, p. 31). A small, declining population makes the species vulnerable to genetic stochasticity (random changes in the genetic composition of a population) due to inbreeding depression and genetic drift (random changes in gene frequency). This, in turn, compromises a species' ability to adapt genetically to changing environments (Frankham 1996, p. 1,507), reduces fitness, and increases extinction risk (Reed and Frankham 2003, pp. 233-234).

    Although new population estimates have increased the worldwide population estimate from 200-1,000 individuals to 5,000 to 10,000 breeding pairs, the individual populations of Honduran emerald are small and declining. Additionally, the species range is restricted within Honduras and the individual populations are geographically and genetically isolated from one another. The Honduran emeralds small and declining populations combined with their highly restricted and severely fragmented range increase the species' vulnerability to adverse natural events and are affecting the continuing existence of the species throughout its range.

    Extreme Weather Events

    Small, declining populations can also be especially vulnerable to environmental disturbances such as flooding, drought, or hurricanes (O'Grady 2004, pp. 513-514). The Honduran emerald relies on arid, thorn forest habitat to provide nectar-producing plant species for energy and insects for protein in order to meet the biological requirements for breeding, feeding, and nesting. In 2012, Honduras was determined to be one of the countries most affected by climate change due to its geographic location, which is in the direct path of many tropical storms and hurricanes (Harmeling 2012, pp. 5-6). Research and modeling have explored how changes in climate might affect areas such as Honduras (Gasner et al. 2010, p. 1,250; Winograd 2002, p. 11). The term “climate change” refers to a change in the mean, variability, or seasonality of climate variables over time periods of decades or hundreds of years (Intergovernmental Panel on Climate Change (IPCC) 2014b, p. 5). Forecasts of the rate and consequences of future climate change are based on the results of extensive modeling efforts conducted by scientists around the world (Solman 2011, p. 20; Laurance and Useche 2009, p. 1,432; Nuñez et al. 2008, p. 1; Margeno 2008, p. 1; Meehl et al. 2007, p. 753).

    Climate change models, like all other scientific models, produce projections that have some uncertainty because of the assumptions used, the data available, and the specific model features. The science supporting climate model projections, as well as models assessing their impacts on species and habitats, will continue to be refined as more information becomes available. While projections from regional climate model simulations are informative, various methods to downscale projections to more localized areas in which the species lives are still imperfect and under development (Solman 2011, p. 20; Nuñez et al. 2008, p. 1; Marengo 2008, p. 1).

    Honduras appears to have entered a more active period of hurricane activity (Pielke et al. 2003, p. 102). Studies of natural events in the last 100 years indicate that Honduras is highly vulnerable to an increase in frequency and intensity in the future not only hurricanes, but also landslides, flooding, and drought (Şekercioğlu et al. 2011; Gasner et al. 2010, p. 1250; Winograd 2006, p. 1). Due to its location and the biophysical traits of the region, Honduras is likely to be affected every 3 to 4 years by climate-related events, such as drought-related fires, floods, and landslides (Winograd 2006, p. 1). Winograd notes that 50 percent of Honduras is at risk of landslides, 30 percent is at risk of severe droughts, and 25 percent is at risk of flooding, particularly agricultural areas.

    Arid-zone species are assumed to be more resilient to high temperatures and low humidity (Şekercioğlu et al. 2012, p. 5). However, species such as the Honduran emerald hummingbird are exposed to very dry conditions and are likely dependent on seasonal rains, as well as seasonal and permanent waterholes and rivers (Schneider and Griesser 2009 in Şekercioğlu et al. 2011, p. 5). Even small temperature increases can greatly increase the amount of birds' evaporative water loss (Şekercioğlu et al. 2011, p. 5). Warmer weather due to climate change is expected to impact the ability of birds in arid regions to sustain their water balance; this species has been observed at higher elevations (Germer 2012); which may indicate a response to warmer temperatures.

    Climate models are not always able to predict the possible effects of ecological interactions, adaptation, or how species, particularly pollinators, might disperse in response to climate change (Buermann et al. 2011, p. 1,671; Burkle and Alarcón 2011, p. 528; Pearson and Dawson 2003, p. 361). Honduras is clearly in the path of hurricanes (Winograd 2006, 2002; Pielke et al. 2003, pp. 101-103). While additional research is still needed to determine how changes in climate may affect species such as the Honduran emerald hummingbird, studies indicate that Honduras is highly vulnerable to an increase in frequency and intensity in hurricanes, landslides, flooding, and drought (Şekercioğlu et al. 2011; Gasner et al. 2010, p. 1250; Hegland et al. 2009, p. 184; Winograd 2006, p. 1). As the Honduran emerald has a restricted range within Honduras, and the seven remaining populations are small and declining, we find that that the Honduran emeralds potential exposure to extreme weather events, in combination with habitat loss and degradation, is affecting the continued existence of the species throughout its range.

    Conservation Measures in Place

    Several mechanisms are in place which are intended to provide protections to the Honduran emerald hummingbird. These protections include involvement by nongovernmental organizations (NGOs), wildlife protection laws, and a reserve designated to protect its habitat. These mechanisms are described below.

    Laws and Regulatory Mechanisms

    Honduras has made significant progress in conservation of its natural resources (Portillo 2007, p. 60; Vreugdenhil et al. 2002, pp. 6, 11, 20-25). In the past 30 years, protected areas have increased from fewer than 20 protected areas to approximately 600 areas with nationally protected status (Portillo 2007, p. 60). Between 1974 and 1987, meetings were held with regional authorities in order to promote the conservation of the natural and cultural heritage of Honduras (Portillo 2007, p. 60). In 2003, the First Mesoamerican Congress on Protected Areas was held in Managua, Nicaragua. In 2010, Honduras began an initiative to recover degraded areas and denuded forests (ECOLEX 2012). However, in some cases, these protected areas have not been managed effectively, as described below (Portillo 2007, p. 63; Vreugdenhil et al. 2002, pp. 6, 11, 20-25). Although the government of Honduras has shown initiative in protecting the species, implementation and enforcement seem to be lacking. Additionally, development projects are still occurring, such as the hydroelectric projects in Santa Barbara. Privately owned land continues to be sold to land speculators and converted from Honduran emerald hummingbird habitat to other uses, such as agriculture or cattle pastures.

    NGO Involvement and the Honduran Emerald Reserve

    In Honduras, several NGOs, such as The Nature Conservancy (TNC) and the Honduran Biodiversity Research Coalition, are participating in the conservation and management of this species. One protected area, the Honduran Emerald Reserve (Reserve), was established by the Honduran Government in 2005, with support from TNC. TNC has provided both technical and financial support to the government and local community groups to complete a 10-year management plan for the Reserve. This Reserve was established in connection with funding from the World Bank to finish building the main highway linking the capital with Olanchito, Yoro, via Cedros Francisco Morazán (Steiner and Coto 2011, pp. 1-2) (refer to Roads, above). Some aspects of TNC's involvement have included marking the official reserve boundaries and providing training to partners in the management of reserves and protected areas.

    In 2009, the National Conservation and Forestry Institute (ICF) began a management plan for the protected area specifically for the Honduran emerald. This was with the participation of nearby municipalities, Arenal Olanchito, the department of Yoro, SOPTRAVI Honduras Armed Forces (HAF), the Ministry of Education through the Regional Environmental Education Center, CREATE, the Ministry of Tourism, and the Ministry of Environment and Natural Resources (Steiner and Coto 2011, pp. 1-2; Portillo 2007, p. 99). The Interagency Technical Committee for Monitoring and Honduran Emerald Hummingbird Habitat Management Area was formed. In 2010, the ICF, with financial support from TNC, finalized the management plan for the protected area (Resolution No. DE-MP-147-2010).

    This reserve is located 34 km (21 miles) west of the city Olanchito in the Aguán Valley. The reserve encompasses 1,217 ha (3,007 ac) and spans elevations between 220 and 800 meters (722 and 2,625 ft). As of 2012, there were 651 ha (1,609 ac) of dry forest habitat remaining that is suitable for the Honduran emerald hummingbird (Perez and Thorn 2012, pers. comm.; Thorn et al. 2000 in Anderson 2010, p. 6). The Honduran Emerald Reserve is guarded by Honduran Air Force soldiers, who patrol the reserve and do not allow visitors into the protected area without prior permission (Hyman 2012 pers. comm.). However, cattle from neighboring land owners are frequently found grazing uncontrolled on the property within Honduran emerald habitat (Steiner 2011, p. 1; House 2004, p. 30). Despite conservation efforts, land owners around the protected area want to expand their properties and are cutting more suitable habitat in order to plant grass for cattle grazing (Hyman and Steiner 2012, pers. comm.). Because encroachment and livestock grazing continue to occur both around and in the protected area, and this species requires more suitable habitat than what exists in this protected area, this area is insufficient to provide adequate suitable habitat for this species.

    Another entity working towards conservation of the Honduran emerald is the Honduran Biodiversity Research Coalition, which is a group of scientists and conservationists established in 2011 that undertakes and promotes biodiversity research and conservation in Honduras. The American Bird Conservancy is another NGO working to protect this species. One of its current goals is to work towards the development of a payment for ecosystems services project in the Agalta Valley to restore and protect Honduran emerald hummingbird habitat.

    In conclusion, Honduras is improving its management of its resources (Food and Agriculture Organization of the United Nations 2010). However, most of the habitat required by the Honduran emerald hummingbird is privately owned, and the thorn forests are being converted to other uses that are not suitable for this species. Despite the progress made in Honduras with respect to laws and regulatory mechanisms in place to protect the Honduran emerald hummingbird, the species continues to face habitat degradation and fragmentation.

    Finding (Listing Determination)

    A species is “endangered” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range. A species is “threatened” for purposes of the Act if it 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 Act, the Service interprets an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future. In other words, the primary statutory difference between a threatened and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened). The statute requires us to determine whether any species is endangered or threatened as a result of any one or combination of the following five factors in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. In considering what factors might constitute threats to a species, we must look beyond the mere exposure of the species to the factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat and we attempt to determine how significant a threat it is. The threat is significant if it drives, or contributes to, the risk of extinction of the species such that the species may warrant listing as endangered or threatened as those terms are defined in the Act. Section 4(b)(1)(A) of the Act requires us to make this determination based solely on the best available scientific and commercial data available after conducting a review of the status of the species and taking into account any efforts being made by States or foreign governments to protect the species.

    In assessing whether the Honduran emerald hummingbird meets the definition of an endangered species or a threatened species, we considered the five factors in section 4(a)(1) of the Act. We conducted a review of the status of this species and assessed whether the Honduran emerald hummingbird is endangered or threatened throughout all or a significant portion of its range. We also reviewed all information we received during the public comment period. We have assessed the best scientific and commercial information available regarding the past, present, and future threats affecting this species.

    This species requires a constant source of energy, primarily in the form of nectar and insects. In order to meet its energy and nutritional requirements, this species needs access to intact, suitable habitat with a diversity of plant species that contain abundant energy sources throughout the year.

    We find that habitat loss due to conversion to agricultural development and cattle pastures is the main factor affecting the Honduran emerald hummingbird throughout its range (Factor A) (Komar et al. 2013, p. 40; Anderson et al. 2013, pp. 1-15; Bonta 2012 pers. comm.; Perez and Thorn 2012 pers. comm.). Habitat degradation and loss continue to occur and affect the species throughout its range. Uncontrolled clearing of the Honduran emerald's dry forest habitat for pastures or plantation agriculture has restricted the species to a few small, isolated “islands” of suitable dry forest habitat surrounded by banana plantations or cattle ranches (Perez and Thorn 2012, pers. comm.). Its current occupied and suitable range has been greatly reduced and is severely fragmented. This hummingbird species is expending more energy in order to find food sources to meet its nutritional needs, and as its suitable habitat becomes more scarce and fragmented, these habitat islands are growing farther apart.

    Historically, the Honduran emerald hummingbird existed in more continuous, connected habitat. Its suitable habitat has become increasingly limited, and it is not likely to expand in the future. This species' population is estimated to be between 5,000 and 10,000 breeding pairs distributed over seven valleys in Honduras. A lack of a sufficient number of individuals in a local area or a decline in their individual or collective fitness may cause a decline in the population size, despite the presence of suitable habitat patches. In cases where populations are small, effects on the species are exacerbated. Any loss of potentially reproducing individuals could have a devastating effect on the ability of the population to increase.

    A species may be affected by more than one factor, and these factors can act in combination. The most significant factor affecting the Honduran emerald hummingbird is the degradation, fragmentation, and loss of suitable habitat (Factor A). Fragmentation and isolation of populations can decrease the fitness and reproductive potential of the species, which exacerbate other threats. Changes in Honduras' climate are acting in combination with other factors to affect this species' habitat. Extreme weather events (an increase in the severity and frequency in hurricanes and increased periods of drought (Factor E)) are impacting this species' habitat.

    The species' small population size (Factor E), combined with its restricted and severely fragmented range (factor A), increase the species' vulnerability to adverse natural events (Factor E) that destroy individuals and their habitat. The species' potential exposure to extreme weather events, such as hurricanes, extended periods of drought, or flooding, in combination with habitat degradation and fragmentation, is currently affecting the continued existence of the species throughout its range now and in the future.

    In conclusion, we have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats affecting this species. We have identified multiple factors that have interrelated impacts on this species. These factors occur at a scale sufficient to affect the status of the species now and in the future. The most significant threat is habitat degradation and fragmentation due to conversion from thorn forest to agriculture and cattle pastures. Both biotic and abiotic ecological interactions influence species' distributions (Jankowski et al. 2010, pp. 1877-1883; Dunn et al. 2009, pp. 3037-3041). This species requires an environment that contains particular temperature and humidity levels, nectar, and insects. As a species' status continues to decline, the species becomes increasingly vulnerable to other impacts. The species' small population size, its reproductive and life-history traits, combined with its highly restricted and severely fragmented range, increases this species' vulnerability to one or more stochastic (random or unpredictable) events, such as hurricanes, drought, or flooding. These factors, in combination, are believed to be affecting the continued existence of the species throughout its range now and in the future.

    Based on our evaluation of the best available scientific and commercial information and given the significant loss, degradation, and fragmentation of suitable habitat, we have determined the species is in danger of extinction throughout all of its range and thus meets the definition of an endangered species. Because the species is in danger of extinction now, as opposed to likely to become an endangered species within the foreseeable future, the Honduran emerald hummingbird meets the definition of an endangered species rather than a threatened species. Therefore, we are listing the Honduran emerald hummingbird as endangered under the Act.

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or threatened under the Act include recognition, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and encourages and results in conservation actions by Federal and State governments, private agencies and interest groups, and individuals.

    Section 7(a) of the Act, as amended, and as implemented by regulations at 50 CFR part 402, requires Federal agencies to evaluate their actions within the United States or on the high seas with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is being designated. However, given that the Honduran emerald hummingbird is not native to the United States, we are not designating critical habitat for this species under section 4 of the Act.

    Section 8(a) of the Act authorizes the provision of limited financial assistance for the development and management of programs that the Secretary of the Interior determines to be necessary or useful for the conservation of endangered and threatened species in foreign countries. Sections 8(b) and 8(c) of the Act authorize the Secretary to encourage conservation programs for foreign endangered species and to provide assistance for such programs in the form of personnel and the training of personnel.

    The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife. These prohibitions, at 50 CFR 17.21 and 17.31, in part, make it illegal for any person subject to the jurisdiction of the United States to “take” (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt any of these) within the United States or upon the high seas; import or export; deliver, receive, carry, transport, or ship in interstate commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any endangered wildlife species. It also is illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken in violation of the Act. Certain exceptions apply to agents of the Service and State conservation agencies.

    Permits may be issued to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits for endangered species are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities.

    National Environmental Policy Act (NEPA)

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), need not be prepared in connection with regulations adopted under section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    References Cited

    A complete list of all references cited in this rule is available on the Internet at http://www.regulations.gov or upon request from the Branch of Foreign Species, Ecological Services Program, U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT).

    Author

    The primary author of this rule is the staff of the Branch of Foreign Species, Ecological Services Program, U.S. Fish and Wildlife Service.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Regulation Promulgation

    Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

    PART 17—[AMENDED] 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; 4201-4245, unless otherwise noted.

    2. Amend § 17.11(h) by adding a new entry for “Hummingbird, Honduran emerald” in alphabetical order under BIRDS to the List of Endangered and Threatened Wildlife to read as follows:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Species Common name Scientific name Historic
  • range
  • Vertebrate population where endangered or threatened Status When
  • listed
  • Critical
  • habitat
  • Special
  • rules
  • *         *         *         *         *         *         * Birds *         *         *         *         *         *         * Hummingbird, Honduran emerald Amazilia luciae Honduras Entire E 805 NA NA *         *         *         *         *         *         *
    Dated: July 15, 2015. James Kurth, Acting Deputy Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-18602 Filed 7-28-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 120328229-4949-02] RIN 0648-XE007 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

    ACTION:

    Temporary rule; inseason quota transfer.

    SUMMARY:

    NMFS is transferring 34 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the Longline category for the remainder of the 2015 fishing year. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments, and applies to eligible Atlantic Tunas Longline category (commercial) permitted vessels. As a result of this transfer, current vessel accounts with IBQ will be distributed 0.25 mt of Individual Bluefin Quota (IBQ) allocation each.

    DATES:

    Effective July 28, 2015 through December 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

    The currently codified baseline U.S. quota is 923.7 mt (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). Among other things, Amendment 7 revised the allocations to all quota categories, implemented an IBQ system, and added additional regulatory determination criteria for inseason (or annual) adjustments to BFT quota (see § 635.27(a)(8), effective January 1, 2015).

    The 2015 BFT fishing year, which is managed on a calendar-year basis and subject to an annual quota, began January 1, 2015. The Longline category was provided 137.3 mt of BFT quota, which was distributed among vessel accounts, (i.e. those which met the initial eligibility criteria implemented by Amendment 7). The Longline category season continues through December 31, 2015. On February 10, 2015, NMFS reallocated quota from the Purse Seine category to the Reserve category based on the amount of 2014 catch of BFT by Purse Seine vessels (80 FR 7547; February 11, 2015). Currently, the Reserve category quota is 108.8 mt.

    Under § 635.15(b)(5)(ii), as implemented through Amendment 7, additional IBQ may be allocated to vessels with BFT quota share after the initial annual allocations if the U.S. baseline quota increases as a result of an ICCAT recommendation or as a result of a transfer of quota from the Reserve category to the Longline category, pursuant to criteria for quota adjustments. NMFS has considered those criteria in relation to the 2015 and 2016 Longline category fishery and have determined that a quota transfer is warranted, as explained below. Consistent with the criteria for quota adjustments, this action is intended to increase the amount of quota available to pelagic longline permitted vessels with IBQ, and therefore help vessel owners account for BFT landings and dead discards while fostering conditions in which permit holders become more willing to lease IBQ. The revised Longline category quota would support the broader objectives of Amendment 7, which include reducing BFT interactions and dead discards while maintaining an economically viable swordfish and yellowfin directed fishery.

    Under Amendment 7, a vessel must have IBQ to account for its BFT landings and dead discards. If a vessel has insufficient IBQ to account for such landings and dead discards, it goes into “quota debt.” Starting in 2016, a permitted vessel will not be allowed to fish in the Longline category if it has outstanding quota debt. In 2015 only, however, the vessel may continue to fish but will accrue quota debt that must be accounted for at the end of the year. If by the end of 2015, a permitted vessel does not have adequate IBQ allocation to settle its debt, the allocation will be reduced in the subsequent year or years until the quota debt is fully resolved.

    Approximately one-fifth of active pelagic longline vessels currently have outstanding quota debt, and quota leasing among fishery participants has been limited. NMFS suspects the reason for the limited quota leasing is because the leasing program is so new, and shareholders may be unwilling to lease quota to other shareholders because they do not know if they will have sufficient quota to account for any BFT they may catch. Thus, leasing may be perceived as relatively risky from a business perspective.

    As of July 8, 2015, ten vessels are in quota debt, ranging from 108 lb (0.05 mt) to 2,912 lb (1.3 mt), with an average of 1,405 lb (0.64 mt) debt (and a total of 14,045 lb (6.4 mt)). Based on preliminary information, the ten vessels represent 22 percent of the active vessels (monthly average of 45 active vessels in 2015 to date). As of July 8, 2015, there were a total of 18 allocation leases (16 involving Longline category participants and two between Purse Seine category participants), however only four of those leases involved participants with quota debt. Some vessel owners have stated that they have been unable to lease quota from other IBQ shareholders, because of lack of willingness of those owners, and these small businesses face uncertainty in their operations because they do not know if they will have sufficient quota to account for BFT they may catch. Because the leasing program is so new, IBQ shareholders may be reluctant to lease quota to other vessels because they do not know if they will have sufficient quota to account for any bluefin tuna they may catch.

    Any adjustments to quotas must be based on consideration of the relevant criteria provided under § 635.27(a)(8), which include: The usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock; the catches of the particular category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made; the projected ability of the vessels fishing under the particular category quota to harvest the additional amount of BFT before the end of the fishing year; the estimated amounts by which quotas for other gear categories of the fishery might be exceeded; effects of the adjustment on BFT rebuilding and overfishing; effects of the adjustment on accomplishing the objectives of the fishery management plan; variations in seasonal distribution, abundance, or migration patterns of BFT; effects of catch rates in one area precluding vessels in another area from having a reasonable opportunity to harvest a portion of the category's quota; review of dealer reports, daily landing trends, and the availability of the BFT on the fishing grounds; optimizing fishing opportunity; accounting for dead discards, facilitating quota monitoring, supporting other fishing monitoring programs through quota allocations and/or generation of revenue; and support of research through quota allocations and/or generation of revenue.

    Regarding the determination criteria about accounting for dead discards and variations in seasonal distribution or abundance, a quota transfer from the Reserve category to the Longline category would contribute toward full accounting of BFT catch by vessels that have quota debt (i.e., reduce quota debt), enhance the likelihood that shareholders will make the decision to lease IBQ to others, and reduce the uncertainty in the fishery as a whole.

    With respect to the effects of the adjustment on rebuilding and overfishing and accomplishing the objectives of the fishery management plan, the fishery is a quota-managed fishery, a measure which supports objectives related to rebuilding and overfishing. The transfer of 34 mt of BFT quota from the Reserve category to the Longline category will result in an adjusted Longline quota of 171.3 mt, which remains within the ICCAT quota and is less than the historical average of landings and dead discards in the fishery (239 mt). The revised Longline category quota would support the broader objectives of Amendment 7, which include reducing BFT interactions and dead discards while maintaining an economically viable swordfish and yellowfin tuna directed fishery. As a result of this quota transfer, 0.25 mt (551 lb) of IBQ will be distributed to each of the 136 permit holders with IBQ shares, provided the permit is associated with a vessel. For those permits that qualified for IBQ shares and are not associated with a vessel at the time of the quota transfer, the IBQ will not be usable by the permit holder (i.e., may not be leased or used to account for BFT) unless and until the eligible permit is associated with a vessel. Eligible permits will be allocated either Gulf of Mexico (GOM) IBQ, Atlantic (ATL) IBQ, or both GOM and ATL IBQ, according to the eligible permit initial share's regional designations (and totaling 0.25 mt).

    Regarding the determination criteria “optimizing fishing opportunity,” the ability of pelagic longline vessel owners to account for BFT with allocated quota or lease IBQ at an affordable price is key to the success of the IBQ program. An inseason transfer of quota to the Longline category would facilitate accomplishing the objectives of the 2006 Consolidated HMS FMP by optimizing fishing opportunity, contributing to full accounting for landings and dead discards, and reducing uncertainty in the fishery as a whole. Where fishing opportunity for target species is constrained by BFT quota debt or a low IBQ balance, the additional quota will help reduce this effect. It will also reduce vessel owner uncertainty about whether a vessel owner will have sufficient quota to account for BFT they may catch in the future. Without this inseason quota transfer, it is more likely that permit holders will have difficulty leasing quota to account for BFT catch or reduce quota debt, permit holders may have a reduced ability to make business plans for the future, and a higher number of permitted vessels may be prohibited from fishing during 2016 as a result of quota debt accrued during 2015.

    This action is consistent with the rebuilding goals of the 2006 Consolidated HMS FMP because NMFS does not anticipate that the overall U.S. BFT quota will be exceeded. Based on the considerations above, NMFS is transferring 34 mt of Reserve category quota to the Longline category. As a result of this quota transfer, the Reserve category quota will be reduced from 108.8 mt to 74.8 mt, and the Longline category quota will be increased from 137.3 to 171.3 mt. This inseason quota transfer does not preclude future inseason quota transfers to any of the quota categories. This action is supported by the Amendment 7 Final Environmental Impact Statement and final rule, which analyzed and anticipated such an action.

    NMFS will continue to monitor the BFT fisheries, including the pelagic longline fishery, closely through the mandatory landings and catch reports. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Pelagic longline vessels are required to report BFT catch through Vessel Monitoring System, as well as through the online IBQ system.

    Longline category permit holders are reminded that all BFT discarded dead must be reported through the Vessel Monitoring System, and accounted for in the on-line IBQ system, consistent with requirements at § 635.15(a).

    Subsequent inseason actions, if any, will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (888) 872-8862 or (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

    Classification

    The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

    The regulations implementing the 2006 Consolidated HMS FMP, as amended, provide for inseason adjustments to quota and other aspects of BFT fishery management, to respond to the diverse range of factors which may affect BFT fisheries, including ecological (e.g, rebuilding, or the migratory nature of HMS) and commercial (e.g., optimizing fishing opportunity, or reducing bycatch). Specifically, Amendment 7 stated that NMFS may need to consider providing additional quota to the Longline category as a whole in order to increase the amount of quota available to eligible permitted vessels via the IBQ program, and balance the need to have an operational directed pelagic longline fishery with the need to reduce BFT bycatch.

    Based on available BFT quota in the Reserve category, the amount of quota debt in the pelagic longline fishery, and the catch of BFT by pelagic longline vessels during 2015 to date, among other considerations, adjustment to the Reserve and Longline category BFT quotas is warranted. Analysis of available data shows that adjustment to the Longline category quota from the initial level would result in minimal risks of exceeding the ICCAT-allocated quota. The regulations implementing the 2006 Consolidated HMS FMP, as amended, provide the flexibility to provide additional quota to the Longline category in order to optimize fishing opportunity, account for dead discards, and accomplish the objectives of the fishery management plan. NMFS provides notification of quota adjustments by publishing the notice in the Federal Register, emailing individuals who have subscribed to the Atlantic HMS News electronic newsletter, and updating the information posted on the Atlantic Tunas Information Line and on hmspermits.noaa.gov.

    Delays in adjusting the Reserve and Longline category quotas would adversely affect those Longline category vessels that would otherwise have an opportunity to reduce or resolve quota debt, lease quota to other vessels, as well as delay potential beneficial effects on the ability for vessel operators to make business plans for their future. Due to the migratory nature of the target species, delaying inseason action may preclude fishing opportunities for some vessel operators. NMFS is trying to balance providing opportunity to the pelagic longline fishery, with the reduction of BFT bycatch, and delaying this action would be contrary to the public interest. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

    This action is being taken under §§ 635.15(b)(5)(ii), 635.15(f), 635.27(a)(8) and (9), and is exempt from review under Executive Order 12866.

    Authority:

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

    Dated: July 24, 2015. Emily H. Menashes Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-18584 Filed 7-28-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 150105004-5355-01] RIN 0648-XE073 Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Trimester Total Allowable Catch Area Closure for the Common Pool Fishery AGENCY:

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

    ACTION:

    Temporary rule; area closure.

    SUMMARY:

    This action closes the Southern New England/Mid-Atlantic yellowtail flounder Trimester Total Allowable Catch Area to Northeast multispecies common pool trawl and gillnet vessels for the remainder of Trimester 1, through August 31, 2015. The closure is required by regulation because the common pool fishery has caught over 90 percent of its Trimester 1 quota for Southern New England/Mid-Atlantic yellowtail flounder. This closure is intended to prevent the overharvest of the common pool's allocation for this stock.

    DATES:

    This action is effective July 29, 2015, through August 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Liz Sullivan, Fishery Management Specialist, (978) 282-8493.

    SUPPLEMENTARY INFORMATION:

    Federal regulations at § 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 fishing with gear capable of catching that stock for the remainder of the trimester.

    We have determined that 95 percent of the Trimester 1 TAC was caught as of July 21, 2015. The fishing year 2015 common pool sub-annual catch limit (sub-ACL) for Southern New England/Mid-Atlantic (SNE/MA) yellowtail flounder is 114.5 mt and the Trimester 1 TAC is 24 mt.

    Effective July 29, 2015, the SNE/MA yellowtail flounder Trimester TAC Area is closed for the remainder of Trimester 1, through August 31, 2015, to all common pool vessels fishing with trawl and gillnet gear. The SNE/MA yellowtail flounder Trimester TAC Area consists of statistical areas 537, 538, 539, and 613. The area reopens at the beginning of Trimester 2 on September 1, 2015.

    If a vessel declared its trip through the VMS or the interactive voice response system, and crossed the VMS demarcation line prior to July 29, 2015, it may complete its trip within the Trimester TAC Area.

    Any overage of a Trimester TAC is deducted from the Trimester 3 TAC, and any overage of the common pool's sub-ACL at the end of the fishing year is deducted from the common pool's sub-ACL for fishing year 2016. Any uncaught portion of the Trimester 1 and Trimester 2 TACs is carried over into the next trimester. However, any uncaught portion of the common pool's sub-ACL may not be carried over into the following fishing year.

    Weekly quota monitoring reports for the common pool fishery are on our Web site at: http://www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information and, if necessary, we will make additional adjustments to common pool management measures.

    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.

    The 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 has caught over 90 percent of its Trimester 1 TAC for SNE/MA yellowtail flounder as of July 21, 2015. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, prevents the immediate closure of the SNE/MA yellowtail flounder Trimester 1 TAC Area. This increases the likelihood that the common pool fishery exceeds its quota of SNE/MA yellowtail flounder to the detriment of this stock, which could undermine management objectives of the Northeast Multispecies Fishery Management Plan (FMP). Additionally, an overage of the common pool quota could cause negative economic impacts to the common pool fishery as a result of overage paybacks in a future trimester or fishing year.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 24, 2015. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-18586 Filed 7-28-15; 8:45 am] BILLING CODE 3510-22-P
    80 145 Wednesday, July 29, 2015 Proposed Rules DEPARTMENT OF HOMELAND SECURITY Office of the Secretary 6 CFR Part 5 U.S. Customs and Border Protection 19 CFR Part 103 Federal Emergency Management Agency 44 CFR Part 5 [Docket No. DHS-2009-0036] RIN 1601-AA00 Freedom of Information Act Regulations AGENCY:

    Office of the Secretary, Department of Homeland Security.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    This rule proposes to amend the Department of Homeland Security's (DHS) regulations under the Freedom of Information Act (FOIA). The Department (DHS) is proposing to update and streamline the language of several procedural provisions, and to incorporate changes brought about by the amendments to the FOIA under the OPEN Government Act of 2007, among other changes. DHS invites comment on all aspects of this proposal.

    DATES:

    Comments and related material must be submitted to the docket for this rulemaking, DHS-2009-0036, on or before September 28, 2015.

    ADDRESSES:

    You may submit comments, identified by docket number DHS-2009-0036, by one of the following methods:

    (1) Federal eRulemaking Portal:http://www.regulations.gov.

    (2) Fax: 202-343-4011.

    (3) Mail: By mail to the Department of Homeland Security, Office of the Chief Privacy Officer, ATTN: James Holzer, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655.

    Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change and may be read at http://www.regulations.gov, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    James Holzer, Senior Director, FOIA Operations, Office of the Chief Privacy Officer, Department of Homeland Security, at 1-866-431-0486.

    SUPPLEMENTARY INFORMATION: I. Background

    The Secretary of Homeland Security has authority under 5 U.S.C. 301, 552, and 552a, and 6 U.S.C. 112(e), to issue FOIA and Privacy Act regulations. On January 27, 2003, the Department of Homeland Security (Department or DHS) published an interim rule in the Federal Register (68 FR 4056) that established DHS procedures for obtaining agency records under the FOIA, 5 U.S.C. 552, or Privacy Act, 5 U.S.C. 552a. DHS solicited comments on this interim rule, but received none.1

    1 This rule proposes revisions to DHS's FOIA regulations, but not its Privacy Act regulations. DHS intends to finalize its Privacy Act regulations by separate rulemaking.

    In 2005, Executive Order 13392 called for the designation of a Chief FOIA Officer and FOIA Public Liaisons, along with the establishment of FOIA Requester Service Centers as appropriate. Subsequently, the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act), Public Law 110-175, required agencies to designate a Chief FOIA Officer who is then to designate one or more FOIA Public Liaisons (5 U.S.C. 552(j) and 552(k)(6)). Sections 6, 7, 9, and 10 of the OPEN Government Act amended provisions of the FOIA by setting time limits for agencies to act on misdirected requests and limiting the tolling of response times (5 U.S.C. 552(a)(6)(A)); requiring tracking numbers for requests that will take more than 10 days to process (5 U.S.C. 552 (a)(7)(A)); providing requesters a telephone line or Internet service to obtain information about the status of their requests, including an estimated date of completion (5 U.S.C. 552(a)(7)(B)); expanding the definition of “record” to include records “maintained for an agency by an entity under Government contract, for the purposes of records management” (5 U.S.C. 552(f)(2)); and introducing alternative dispute resolution to the FOIA process through FOIA Public Liaisons (5 U.S.C. 552(a)(6)(B)(ii) & (l)) and the Office of Government Information Services (5 U.S.C. 552(h)(3)).

    DHS now proposes to revise its FOIA regulations at 6 CFR part 5, which apply to all components of DHS. This proposed rule would implement changes required by the OPEN Government Act and make other revisions to DHS FOIA regulations to improve access to Departmental records.

    DHS describes the primary proposed changes in the section-by-section analysis below. DHS invites public comment on each of the proposed changes described, as well as any other matters within the scope of the rulemaking.

    II. Section-by-Section Analysis

    The proposed rules continue to inform the public of the responsibilities of DHS in conjunction with requests received under the Freedom of Information Act as well as the requirements for filing a proper FOIA request.

    DHS is proposing to amend Subpart A to eliminate the provision for “brick and mortar” public reading rooms, amend DHS rules for third-party requests for records, and add information about proactive DHS disclosures.

    Section 5.1 General Provisions

    DHS is proposing to amend this part to incorporate reference to additional DHS policies and procedures relevant to the FOIA process. These resources, which are available at http://www.dhs.gov/freedom-information-act-foia, also include descriptions of the types of records maintained by different DHS components. DHS is also proposing to amend this section to clarify the definition of a component for purposes of this proposed rule. Component means each separate organizational entity within DHS that reports directly to the Office of the Secretary. A full list of all DHS components would be provided in appendix I of this proposed rule (as well as in the web resources described above) for informational purposes.

    DHS is proposing to add paragraph (d) to section 5.1, “Unofficial release of DHS information.” This proposed paragraph seeks to inform the public about how information that is not released through official DHS channels will be treated in the FOIA process. DHS does not consider information that is either inadvertently or inappropriately released by means other than the official release process used by DHS, whether in FOIA or otherwise, to be a FOIA release and accordingly, DHS does not waive its ability to assert exemptions to withhold some or all of the same records in response to a FOIA request.

    Finally, DHS is proposing to remove at least two additional portions of current section 5.1. First, current paragraph (a)(1) clarifies that “[i]nformation routinely provided to the public as part of a regular DHS activity . . . may be provided to the public without following this subpart.” Second, current paragraph (a)(2) provides that “Departmental components may issue their own guidance under this subpart pursuant to approval by DHS.” DHS considers each of these provisions to be self-evident, and therefore proposes to remove them from the regulation.

    Section 5.2 Proactive Disclosures of DHS Records

    DHS proposes to replace prior section 5.2, “Public Reading Rooms,” which was outdated, with a new section describing the proactive disclosure of DHS records. The FOIA requires DHS to make certain records available for public inspection and copying. Such records are available via the internet through the electronic reading rooms of each component. For those individuals with no access to the internet, the DHS Privacy Office or the component Public Liaison can provide assistance with access to records available in the electronic reading rooms. Contact information is provided in Appendix I to this subpart.

    Section 5.3 Requirements for Making Requests

    DHS proposes to amend paragraph 5.3(a) to eliminate the requirement that third-party requesters of records pertaining to an individual provide a written authorization from the individual that is the subject of the records (or proof of death of the individual) as a prerequisite to making such a request for records. As proposed, paragraph (a)(4) would inform third-party requesters that they may receive greater access if they provide written authorization from, or proof of death of, the subject of the records. In certain circumstances, they may in fact receive no access absent such authorization or proof. This paragraph would further advise that DHS may exercise its administrative discretion in seeking additional information from the requester to ensure that the proper consent has been received from the subject of the records.

    DHS also proposes to amend paragraph (b) to direct requesters to contact the FOIA Public Liaison for each component if the requester has questions about how to describe the records that the requester seeks. DHS also proposes to amend this part to eliminate paragraph (c), which would be addressed under section 5.11, “Fees.” DHS proposes to insert a new paragraph (c), which describes the process under which DHS may administratively close a request if a requester fails to comply with a request for additional information.

    Section 5.4 Responsibility for Responding to Requests

    DHS proposes to insert a new paragraph (c), “Re-routing of misdirected requests,” to advise requesters that a component that is in receipt of a misdirected request within DHS will redirect such a request to the proper component without the need for further action from the requester. In the event that a component receives a request that should be directed outside DHS entirely, the component would inform the requester that DHS does not collect or retain the type of records requested. Proposed paragraph (c) would cover a different situation than current paragraph (c), which only applies “[w]hen a component receives a request for a record in its possession.”

    DHS proposes to combine paragraph 5.4(c), “Consultations and referrals,” with current paragraph (d), “Law Enforcement Information,” which covers consultation and referral of law enforcement records. Proposed paragraph (d) would describe the process of consultation, coordination, and referral of all records, to include law enforcement records, consistent with equities of components, agencies, or departments other than the responding component. Proposed paragraph (e) restates much of the current content of section 5.7, “Classified information.”

    DHS proposes to revise current paragraph (f), “Notice of referral.” Paragraph (f) currently provides that when a component refers a request to another component or agency, it ordinarily shall notify the requester of such referral. Consistent with current law, DHS proposes to insert an exception to this requirement, such that the component should not refer the records if disclosure of the identity of the component or agency would harm an interest protected by an applicable exemption. Instead, the component should coordinate the response with the other component or agency, as appropriate.

    DHS proposes a new paragraph, paragraph 5.4(i), “Electronic records and searches,” to advise requesters of DHS's responsibilities under the FOIA with regard to conducting searches of electronic records and databases. DHS adheres to the requirement in 5 U.S.C. 552(a)(3)(C), which states that agencies will make reasonable efforts to search for records in electronic form or format, except when such efforts would significantly interfere with the operation of the agency's automated information systems. Proposed paragraph 5.4(i) seeks to clarify to requesters the types of situations that would amount to “significant interference” with the operation of agency information systems such that DHS would not conduct a search for the requested records.

    Section 5.5 Timing of Responses to Requests

    DHS proposes to amend paragraph 5.5(a) to advise requesters that the response time for misdirected requests that are re-routed under paragraph 5.4(c) will commence on the date the request is received by the proper component, but in any event, no later than ten working days after the request is first received by any component. DHS proposes to amend paragraph (b), “Multitrack Processing,” to include a specific provision for a track for requests granted expedited processing.

    DHS proposes to split current paragraph (c), “Unusual Circumstances,” into two separately designated paragraphs. As revised, the rule would include in paragraph 5.5(d) information on how DHS will aggregate multiple related requests submitted by a single requester or a group of requesters acting in concert.

    DHS also proposes to redesignate current paragraph 5.5(d), “Expedited Processing,” as paragraph 5.5(e). DHS proposes in proposed paragraph 5.5(e) to amend text that describes the procedures for making a request for expedited processing of an initial request or an appeal (current paragraph (d)), to include two new available justifications for requesting expedited processing.

    5.6 Responses to requests. DHS proposes to revise paragraph 5.6(a) to encourage components to communicate with FOIA requesters having access to the internet through electronic means, to the extent practicable. This new paragraph is intended to address the increasing number of FOIA requesters who are corresponding with DHS via electronic mail and web portals. DHS proposes to move paragraph (a) to paragraph (b), “Acknowledgment of Requests.” DHS proposes to amend this paragraph to specify that DHS and its components will acknowledge a request and assign the request an individualized tracking number if the request will take more than ten working days to process. DHS also proposes to require acknowledgment letters to contain a brief description of the request to allow requesters to more easily keep track of their requests. The provision in paragraph (a) referencing that the acknowledgment letter will confirm the requester's agreement to pay fees would be addressed in proposed section 5.11(e).

    DHS proposes to move paragraph (b), “Grants of requests,” to paragraph (c). DHS proposes to amend paragraph (b) by removing the description of the treatment of information, both released and redacted in documents provided to the requester. Substantially the same information is now included in a new proposed paragraph, paragraph 5.6(f), “Markings on Released Documents.” DHS proposes to move the remainder of current paragraph 5.6(c), “Adverse determinations of requests,” to two paragraphs, (d) and (e), “Adverse determinations of requests” and “Content of denial.” The language regarding adverse determination of requests remains substantially the same. DHS proposes to describe the content and process for denial letters in the newly proposed paragraph (e), but does not intend this paragraph to significantly change the current regulatory requirements concerning denial letters.

    DHS also proposes new paragraph (g), “Use of record exclusions,” which describes the DHS's use of exclusions under 5 U.S.C. 552(c). This paragraph proposes to incorporate the requirement set forth by the Department of Justice's Office of Information Policy (OIP) that all federal agencies obtain the approval of OIP prior to invoking an exclusion. This proposed paragraph also includes a requirement that DHS maintain an administrative record of the process of the invocation of the exclusion and approval by OIP.

    5.7 Confidential commercial information. Proposed section 5.7, “Confidential commercial information,” would replace current section 5.8 of the current regulations, “Business information.” DHS proposes to reorder several paragraphs within this section. The changes are for clarity and to better advise requesters and providers of commercial information how DHS will treat requests for confidential commercial information, but the information contained in the proposed section remains substantively the same.

    DHS proposes to amend the “Notice of intent to disclose” paragraph by splitting it into two paragraphs, proposed new paragraph (f), “Analysis of objections” and proposed new paragraph (g), “Notice of intent to disclose.” The proposed division of the information previously contained in a single paragraph is intended to improve clarity by highlighting in a separate paragraph that DHS will consider a submitter's objections and specific grounds for nondisclosure in deciding whether to disclose the requested information. Otherwise, the information contained in the new proposed paragraphs remains substantively the same.

    Finally, DHS proposes to include an exception to this section for commercial information provided to U.S. Customs and Border Protection (CBP) by a business submitter. Although CBP's FOIA regulations (located at 19 CFR part 103, subpart A) are displaced by the DHS FOIA regulations, this rule proposes to allow CBP to continue treating commercial information in the same manner as it has since the promulgation of current 19 CFR 103.35.

    5.8 Administrative appeals. This section corresponds to section 5.9 of the current regulations. In the time following the publication of the interim regulations in January 2003, DHS has designated Appeals Officers for each component. As such, DHS proposes to amend paragraph (a) to direct requesters seeking to appeal adverse determinations to the DHS Web site or FOIA phone line for FOIA information to obtain the name and address of the appropriate appeals officer.

    DHS proposes new paragraph (b) “Adjudication of appeal,” which replaces former paragraph (c) “When appeal is required.” The proposed new paragraph informs requesters that the DHS Office of the General Counsel or its designee component appeals officers are the authorized appeals authority for DHS. New proposed paragraph (b) also informs requesters about the treatment of appeals involving classified information. Finally, former paragraph (a)(3), which informs requesters that appeals will not normally be adjudicated if a FOIA lawsuit is filed, is incorporated into proposed paragraph (b).

    DHS proposes to add a new paragraph (c), “Appeal decisions,” which is substantially similar to current paragraph 5.9(b). Proposed paragraph (c) would advise requesters that appeal decisions will be made in writing, and that decisions will inform requesters of their right to file a lawsuit and about mediation services offered by the Office of Government Information Services. Proposed paragraph (c) would also advise requesters of what to expect if the appeals officer reverses or modifies the original administrative decision on appeal. DHS also proposes to add a new paragraph (d), “Time limit for issuing appeal decision,” which advises requesters of the statutory 20-day time limit for responding to appeals, and also of the statutory 10-day extension of the 20-day limit available to the appeals officers in certain circumstances.

    Finally, DHS proposes to add paragraph (e), “Appeal necessary before seeking court review,” which advises requesters that an administrative appeal is generally required before seeking judicial review of a component's adverse determination. This language is substantially similar to current paragraph 5.9(c). This proposed paragraph also advises requesters that there is no administrative appeal requirement prior to seeking judicial review of a denial of request for expedited processing.

    5.9 Preservation of records. DHS proposes to redesignate current section 5.10 “Preservation of records” as section 5.9. There is no change to the substantive information in the section.

    5.10 FOIA requests for information contained in a Privacy Act system of records. DHS proposes to add the new above-referenced section, to explain to requesters how DHS treats FOIA requests for information protected by the Privacy Act. When applicable, DHS analyzes all requests under both the FOIA and the Privacy Act to ensure that the requester receives the greatest amount of information possible under federal law. This proposed section also explains the circumstances under which a third-party requester can obtain access to information protected by the Privacy Act.

    5.11 Fees. DHS proposes to address all fee issues in section 5.11. Most of this section remains essentially unchanged. Proposed changes to paragraph (b) would clarify some of the definitions used by DHS in determining a requester's fee category. For instance, paragraph (b)(1) “Commercial use request,” would clarify that components will make determinations on commercial use on a case-by-case basis. Paragraph (b)(4) “Educational institution,” would add several examples to help requesters understand the analysis that DHS will apply to determine whether a requester meets the criteria to be considered an educational institution. Paragraph (b)(6), “News media,” clarifies the criteria used by DHS to determine whether a requester qualifies to be considered a member of the news media for fee purposes. Paragraph (b)(8) “Search,” would eliminate superfluous language that does not improve the comprehensibility of the paragraph. Because these and similar proposed changes are consistent with current regulations and describe current process, DHS does not expect that they will result in additional costs for the government or the public.

    DHS also proposes to change paragraph (c)(1)(iii), which discusses direct costs associated with conducting any search that requires the creation of a new computer program, as discussed in new proposed paragraph 5.4(i), to locate the requested records. This change is intended to improve comprehension and to more accurately describe the circumstances under which a requester may be charged for a computerized search or a search of electronic records. It does not represent a change in practice, as DHS currently charges direct costs for specialized data searches. Again, because these proposed changes are consistent with current regulations and describe current process, DHS does not expect that they will result in additional costs for the government or the public.

    DHS proposes to restructure paragraph (c)(3)(d), “Restrictions on charging fees.” Under this proposal, search fees, and in some cases, duplication fees may not be charged if a component fails to comply with the time limits in which to respond to a request provided no unusual or exceptional circumstances are present. This provision directly tracks a mandatory provision from section 6 of the OPEN Government Act of 2007, Public Law 110-175, 121 Stat. 2524, 5 U.S.C. 552(a)(4)(A)(viii).

    In addition, DHS proposes to renumber former paragraph (d)(2) as paragraph (d)(3), and paragraph (d)(3) as (d)(4). DHS proposes minor changes in paragraph (d)(4) to improve clarity. Current paragraphs (d)(4) and (d)(5) would be combined into proposed paragraph (d)(5). DHS proposes changes to paragraphs (e) and (f) to improve clarity; no significant changes are intended with respect to those paragraphs. DHS proposes no major changes to paragraphs (g), (h), (i), or (j), but proposes to modify a number of procedural provisions consistent with the practices of other agencies in this area. DHS also proposes minor changes to paragraph (k) to improve clarity. DHS proposes to eliminate current paragraph (l), “Payment of outstanding fees,” as the information in that paragraph is largely duplicative of the information contained within proposed paragraph (i)(3)—although proposed paragraph (i)(3) is discretionary, DHS anticipates that the result will be substantially the same as under current paragraph (l). Except in extraordinary circumstances, DHS will not process a FOIA request from persons with an unpaid fee from any previous FOIA request to any Federal agency until that outstanding fee has been paid in full to the agency. Finally, DHS proposes to insert a chart showing fee applicability, for ease of reference.

    5.12 Confidential commercial information; CBP procedures.

    As noted above, DHS proposes to include an exception to proposed § 5.7 for commercial information provided to U.S. Customs and Border Protection (CBP) by a business submitter. Although CBP's FOIA regulations (located at 19 CFR part 103, subpart A) are displaced by the DHS FOIA regulations, because of the unique nature of CBP's mission, this rule proposes to allow CBP to continue treating commercial information in the same manner as it has since the promulgation of current 19 CFR 103.35. CBP's FOIA regulations, located at 19 CFR part 103, subpart A, will be removed no later than the effective date of the final rule for this rulemaking. CBP may, however, retain cCurrent 19 CFR 103.35 as an interim measure.

    5.13 Other rights and services. DHS proposes no substantive changes to this section.

    FEMA Regulations

    DHS also proposes to remove FEMA's outdated FOIA regulations at 44 CFR part 5, subparts A through E. FEMA is currently operating under DHS's title 6 FOIA regulations for all purposes.

    III. Regulatory Analyses Executive Orders 12866 and 13563—Regulatory Review

    Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

    DHS has considered the costs and benefits of this proposed rule. Previously in this preamble, DHS has provided a section-by-section analysis of the provisions in this proposed rule and concludes this rule does not impose additional costs on the public or the government. This rule does not collect any additional fee revenues compared to current practices or otherwise introduce new regulatory mandates. The rule's benefits include additional clarity for the public and DHS personnel with respect to DHS's implementation of the FOIA and subsequent statutory amendments.

    Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, and section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 note, agencies must consider the impact of their rulemakings on “small entities” (small businesses, small organizations and local governments). The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. DHS has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Based on the previous discussion in this preamble, DHS does not believe this rule imposes any additional direct costs on small entities.

    Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

    List of Subjects 6 CFR Part 5

    Classified information, Courts, Freedom of information, Government employees, Privacy.

    19 CFR Part 103

    Administrative practice and procedure, Confidential business information, Courts, Freedom of information, Law enforcement, Privacy, Reporting and recordkeeping requirements.

    44 CFR Part 5

    Courts, Freedom of information, Government employees.

    For the reasons stated in the preamble, the Department of Homeland Security proposes to amend 6 CFR chapter I, part 5, 19 CFR chapter I, part 103, and 44 CFR chapter I, part 5, as follows:

    Title 6—Domestic Security PART 5—DISCLOSURE OR PRODUCTION OF MATERIAL OR INFORMATION 1. The authority citation for part 5 is revised to read as follows: Authority:

    5 U.S.C. 552; 5 U.S.C. 552a; 5 U.S.C. 301; 6 U.S.C. 101 et seq.; E.O. 13392.

    2. In Chapter I, revise subpart A of part 5 to read as follows: Subpart A—Procedures for Disclosure of Records Under the Freedom of Information Act Sec. 5.1 General provisions. 5.2 Proactive disclosures of DHS records. 5.3 Requirements for making requests. 5.4 Responsibility for responding to requests. 5.5 Timing of responses to requests. 5.6 Responses to requests. 5.7 Confidential commercial information. 5.8 Administrative appeals. 5.9 Preservation of records. 5.10 FOIA requests for information contained in a Privacy Act system of records. 5.11 Fees. 5.12 Confidential commercial information; CBP procedures. 5.13 Other rights and services. Appendix I to Subpart A—FOIA Contact Information Subpart A—Procedures for Disclosure of Records Under the Freedom of Information Act
    § 5.1 General provisions.

    (a)(1) This subpart contains the rules that the Department of Homeland Security follows in processing requests for records under the Freedom of Information Act (FOIA), 5 U.S.C. 552 as amended. The Freedom of Information Act applies to third-party requests for documents concerning the general activities of the government and of DHS in particular. When an individual requests access to his or her own records, it is considered a Privacy Act request. Such records are maintained by DHS under the individual's name or personal identifier. Although requests are considered either FOIA requests or Privacy Act requests, agencies process requests in accordance with both laws, which provides the greatest degree of lawful access while safeguarding an individual's personal privacy.

    (2) These rules should be read in conjunction with the text of the FOIA and the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget at 52 FR 10012 (March 27, 1987) (hereinafter “OMB Guidelines”). Additionally, DHS has additional policies and procedures relevant to the FOIA process. These resources are available at http://www.dhs.gov/freedom-information-act-foia. Requests made by individuals for records about themselves under the Privacy Act of 1974, 5 U.S.C. 552a, are processed under subpart B of part 5 as well as under this subpart. As a matter of policy, DHS makes discretionary disclosures of records or information exempt from disclosure under the FOIA whenever disclosure would not foreseeably harm an interest protected by a FOIA exemption, but this policy does not create any right enforceable in court.

    (b) As referenced in this subpart, component means the FOIA office of each separate organizational entity within DHS that reports directly to the Office of the Secretary.

    (c) DHS has a decentralized system for processing requests, with each component handling requests for its records.

    (d) Unofficial release of DHS information. The disclosure of exempt records, without authorization by the appropriate DHS official, is not an official release of information; accordingly, it is not a FOIA release. Such a release does not waive the authority of the Department of Homeland Security to assert FOIA exemptions to withhold the same records in response to a FOIA request. In addition, while the authority may exist to disclose records to individuals in their official capacity, the provisions of this part apply if the same individual seeks the records in a private or personal capacity.

    § 5.2 Proactive disclosure of DHS records.

    Records that are required by the FOIA to be made available for public inspection and copying are accessible on DHS's Web site, http://www.dhs.gov/freedom-information-act-foia-and-privacy-act. Each component is responsible for determining which of its records are required to be made publicly available, as well as identifying additional records of interest to the public that are appropriate for public disclosure, and for posting and indexing such records. Each component shall ensure that posted records and indices are updated on an ongoing basis. Each component has a FOIA Public Liaison who can assist individuals in locating records particular to a component. A list of DHS's FOIA Public Liaisons is available at http://www.dhs.gov/foia-contact-information and in appendix I to this subpart. If you have no access to the internet, please contact the Public Liaison for the component from which you are seeking records for assistance with publicly available records.

    § 5.3 Requirements for making requests.

    (a) General information. (1) DHS has a decentralized system for responding to FOIA requests, with each component designating a FOIA office to process records from that component. All components have the capability to receive requests electronically, either through email or a web portal. To make a request for DHS records, a requester should write directly to the FOIA office of the component that maintains the records being sought. A request will receive the quickest possible response if it is addressed to the FOIA office of the component that maintains the records sought. DHS's FOIA Reference Guide contains or refers the reader to descriptions of the functions of each component and provides other information that is helpful in determining where to make a request. Each component's FOIA office and any additional requirements for submitting a request to a given component are listed in Appendix I of this subpart. These references can all be used by requesters to determine where to send their requests within DHS.

    (2) A requester may also send his or her request to the Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW STOP-0655, or via the internet at http://www.dhs.gov/dhs-foia-request-submission-form, or via fax to (202) 343-4011. The Privacy Office will forward the request to the component(s) that it determines to be most likely to maintain the records that are sought.

    (3) A requester who is making a request for records about him or herself must comply with the verification of identity provision set forth in subpart B of this part.

    (4) Where a request for records pertains to a third party, a requester may receive greater access by submitting either a notarized authorization signed by that individual, in compliance with the verification of identity provision set forth in subpart B of this part, or a declaration made in compliance with the requirements set forth in 28 U.S.C. 1746 by that individual, authorizing disclosure of the records to the requester, or by submitting proof that the individual is deceased (e.g., a copy of a death certificate or an obituary). As an exercise of its administrative discretion, each component can require a requester to supply additional information if necessary in order to verify that a particular individual has consented to disclosure.

    (b) Description of records sought. Requesters must describe the records sought in sufficient detail to enable DHS personnel to locate them with a reasonable amount of effort. A reasonable description contains sufficient information to permit an organized, non-random search for the record based on the component's filing arrangements and existing retrieval systems. To the extent possible, requesters should include specific information that may assist a component in identifying the requested records, such as the date, title or name, author, recipient, subject matter of the record, case number, file designation, or reference number. Requesters should refer to Appendix I of this subpart for additional component-specific requirements. In general, requesters should include as much detail as possible about the specific records or the types of records that they are seeking. Before submitting their requests, requesters may contact the component's FOIA Officer or FOIA public liaison to discuss the records they are seeking and to receive assistance in describing the records. If after receiving a request, a component determines that it does not reasonably describe the records sought, the component should inform the requester what additional information is needed or why the request is otherwise insufficient. Requesters who are attempting to reformulate or modify such a request may discuss their request with the component's designated FOIA Officer, its FOIA Public Liaison, or a representative of the DHS Privacy Office, each of whom is available to assist the requester in reasonably describing the records sought. If a request does not reasonably describe the records sought, the agency's response to the request may be delayed.

    (c) If a request does not adequately describe the records sought, DHS may seek additional information from the requester. If the requester does not respond to the request for additional information within thirty (30) days, the request may be administratively closed at DHS's discretion. This administrative closure does not prejudice the requester's ability to submit a new request for further consideration with additional information.

    § 5.4 Responsibility for responding to requests.

    (a) In general. Except in the instances described in paragraphs (c) and (d) of this section, the component that first receives a request for a record and maintains that record is the component responsible for responding to the request. In determining which records are responsive to a request, a component ordinarily will include only records in its possession as of the date that it begins its search. If any other date is used, the component shall inform the requester of that date. A record that is excluded from the requirements of the FOIA pursuant to 5 U.S.C. 552(c), shall not be considered responsive to a request.

    (b) Authority to grant or deny requests. The head of a component, or designee, is authorized to grant or to deny any requests for records that are maintained by that component.

    (c) Re-routing of misdirected requests. Where a component's FOIA office determines that a request was misdirected within DHS, the receiving component's FOIA office shall route the request to the FOIA office of the proper component(s).

    (d) Consultations, coordination and referrals. When a component determines that it maintains responsive records that either originated with another component or agency, or which contains information provided by, or of substantial interest to, another component or agency, then it shall proceed in accordance with either paragraph (d)(1), (2), or (3) of this section, as appropriate:

    (1) The component may respond to the request, after consulting with the component or the agency that originated or has a substantial interest in the records involved.

    (2) The component may provide a combined or joint response to the request after coordinating with the other components or agencies that originated the record. This may include situations where the standard referral procedure is not appropriate where disclosure of the identity of the component or agency to which the referral would be made could harm an interest protected by an applicable exemption, such as the exemptions that protect personal privacy or national security interests. For example, if a non-law enforcement component responding to a request for records on a living third party locates records within its files originating with a law enforcement agency, and if the existence of that law enforcement interest in the third party was not publicly known, then to disclose that law enforcement interest could cause an unwarranted invasion of the personal privacy of the third party. Similarly, if a component locates material within its files originating with an Intelligence Community agency, and the involvement of that agency in the matter is classified and not publicly acknowledged, then to disclose or give attribution to the involvement of that Intelligence Community agency could cause national security harms. In such instances, in order to avoid harm to an interest protected by an applicable exemption, the component that received the request should coordinate with the originating component or agency to seek its views on the disclosability of the record. The release determination for the record that is the subject of the coordination should then be conveyed to the requester by the component that originally received the request.

    (3) The component may refer the responsibility for responding to the request or portion of the request to the component or agency best able to determine whether to disclose the relevant records, or to the agency that created or initially acquired the record as long as that agency is subject to the FOIA. Ordinarily, the component or agency that created or initially acquired the record will be presumed to be best able to make the disclosure determination. The referring component shall document the referral and maintain a copy of the records that it refers.

    (e) Classified information. On receipt of any request involving classified information, the component shall determine whether information is currently and properly classified and take appropriate action to ensure compliance with 6 CFR part 7. Whenever a request involves a record containing information that has been classified or may be appropriate for classification by another component or agency under any applicable executive order concerning the classification of records, the receiving component shall refer the responsibility for responding to the request regarding that information to the component or agency that classified the information, or should consider the information for classification. Whenever a component's record contains information classified by another component or agency, the component shall coordinate with or refer the responsibility for responding to that portion of the request to the component or agency that classified the underlying information.

    (f) Notice of referral. Whenever a component refers any part of the responsibility for responding to a request to another component or agency, it will notify the requester of the referral and inform the requester of the name of each component or agency to which the records were referred, unless disclosure of the identity of the component or agency would harm an interest protected by an applicable exemption, in which case the component should coordinate with the other component or agency, rather than refer the records.

    (g) Timing of responses to consultations and referrals. All consultations and referrals received by DHS will be handled according to the date that the FOIA request initially was received by the first component or agency, not any later date.

    (h) Agreements regarding consultations and referrals. Components may establish agreements with other components or agencies to eliminate the need for consultations or referrals with respect to particular types of records.

    (i) Electronic records and searches—(1) Significant interference. The FOIA allows components to not conduct a search for responsive documents if the search would cause significant interference with the operation of the component's automated information system.

    (2) Business as usual approach. A “business as usual” approach exists when the component has the capability to process a FOIA request for electronic records without a significant expenditure of monetary or personnel resources. Components are not required to conduct a search that does not meet this business as usual criterion.

    (i) Creating computer programs or purchasing additional hardware to extract email that has been archived for emergency retrieval usually are not considered business as usual if extensive monetary or personnel resources are needed to complete the project.

    (ii) Creating a computer program that produces specific requested fields or records contained within a well-defined database structure usually is considered business as usual. The time to create this program is considered as programmer or operator search time for fee assessment purposes and the FOIA requester may be assessed fees in accordance with 6 CFR 5.11(c)(1)(iii). However, creating a computer program to merge files with disparate data formats and extract specific elements from the resultant file is not considered business as usual, but a special service, for which additional fees may be imposed as specified in 6 CFR 5.11. Components are not required to perform special services and creation of a computer program for a fee is up to the discretion of the component and is dependent on component resources and expertise.

    (3) Data links. Components are not required to expend DHS funds to establish data links that provide real time or near-real-time data to a FOIA requester.

    § 5.5 Timing of responses to requests.

    (a) In general. Components ordinarily will respond to requests according to their order of receipt. Appendix I to this subpart contains the list of components that are designated to accept requests. In instances involving misdirected requests that are re-routed pursuant to 6 CFR 5.4(c), the response time will commence on the date that the request is received by the proper component, but in any event not later than ten working days after the request is first received by any DHS component designated in appendix I of this subpart.

    (b) Multitrack processing. All components must designate a specific track for requests that are granted expedited processing, in accordance with the standards set forth in paragraph (e) of this section. A component may also designate additional processing tracks that distinguish between simple and more complex requests based on the estimated amount of work or time needed to process the request. Among the factors a component may consider are the number of pages involved in processing the request or the need for consultations or referrals. Components shall advise requesters of the track into which their request falls, and when appropriate, shall offer requesters an opportunity to narrow their request so that the request can be placed in a different processing track.

    (c) Unusual circumstances. Whenever the statutory time limits for processing a request cannot be met because of “unusual circumstances,” as defined in the FOIA, and the component extends the time limits on that basis, the component shall, before expiration of the twenty-day period to respond, notify the requester in writing of the unusual circumstances involved and of the date by which processing of the request can be expected to be completed. Where the extension exceeds ten working days, the component shall, as described by the FOIA, provide the requester with an opportunity to modify the request or agree to an alternative time period for processing. The component shall make available its designated FOIA Officer and its FOIA Public Liaison for this purpose.

    (d) Aggregating requests. For the purposes of satisfying unusual circumstances under the FOIA, components may aggregate requests in cases where it reasonably appears that multiple requests, submitted either by a requester or by a group of requesters acting in concert, constitute a single request that would otherwise involve unusual circumstances. Components will not aggregate multiple requests that involve unrelated matters.

    (e) Expedited processing. (1) Requests and appeals will be processed on an expedited basis whenever the component determines that they involve:

    (i) Circumstances in which the lack of expedited processing could reasonably be expected to pose an imminent threat to the life or physical safety of an individual;

    (ii) An urgency to inform the public about an actual or alleged federal government activity, if made by a person who is primarily engaged in disseminating information;

    (iii) The loss of substantial due process rights; or

    (iv) A matter of widespread and exceptional media interest in which there exist possible questions about the government's integrity which affect public confidence.

    (2) A request for expedited processing may be made at any time. Requests based on paragraphs (e)(1)(i), (ii), and (iii) of this section must be submitted to the component that maintains the records requested. When making a request for expedited processing of an administrative appeal, the request should be submitted to the DHS Office of General Counsel or the component Appeals Officer. Address information is available at the DHS Web site, http://www.dhs.gov/freedom-information-act-foia, or by contacting the component FOIA officers via the information listed in Appendix I. Requests for expedited processing that are based on paragraph (e)(1)(iv) of this section must be submitted to the Senior Director of FOIA Operations, the Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20598-0655. A component that receives a misdirected request for expedited processing under the standard set forth in paragraph (e)(1)(iv) of this section shall forward it immediately to the DHS Senior Director of FOIA Operations, the Privacy Office, for determination. The time period for making the determination on the request for expedited processing under paragraph (e)(1)(iv) of this section shall commence on the date that the Privacy Office receives the request, provided that it is routed within ten working days, but in no event shall the time period for making a determination on the request commence any later than the eleventh working day after the request is received by any component designated in appendix I of this subpart.

    (3) A requester who seeks expedited processing must submit a statement, certified to be true and correct, explaining in detail the basis for making the request for expedited processing. For example, under paragraph (e)(1)(ii) of this section, a requester who is not a full-time member of the news media must establish that he or she is a person whose primary professional activity or occupation is information dissemination, though it need not be his or her sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request—one that extends beyond the public's right to know about government activity generally. The existence of numerous articles published on a given subject can be helpful to establishing the requirement that there be an “urgency to inform” the public on the topic. As a matter of administrative discretion, a component may waive the formal certification requirement.

    (4) A component shall notify the requester within ten calendar days of the receipt of a request for expedited processing of its decision whether to grant or deny expedited processing. If expedited processing is granted, the request shall be given priority, placed in the processing track for expedited requests, and shall be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision shall be acted on expeditiously.

    § 5.6 Responses to requests.

    (a) In general. Components should, to the extent practicable, communicate with requesters having access to the internet using electronic means, such as email or web portal.

    (b) Acknowledgments of requests. A component shall acknowledge the request and assign it an individualized tracking number if it will take longer than ten working days to process. Components shall include in the acknowledgment a brief description of the records sought to allow requesters to more easily keep track of their requests.

    (c) Grants of requests. Ordinarily, a component shall have twenty (20) working days from when a request is received to determine whether to grant or deny the request unless there are unusual or exceptional circumstances. Once a component makes a determination to grant a request in full or in part, it shall notify the requester in writing. The component also shall inform the requester of any fees charged under 6 CFR 5.11 and shall disclose the requested records to the requester promptly upon payment of any applicable fees.

    (d) Adverse determinations of requests. A component making an adverse determination denying a request in any respect shall notify the requester of that determination in writing. Adverse determinations, or denials of requests, include decisions that the requested record is exempt, in whole or in part; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; or the requested record is not readily reproducible in the form or format sought by the requester. Adverse determinations also include denials involving fees, including requester categories or fee waiver matters, or denials of requests for expedited processing.

    (e) Content of denial. The denial shall be signed by the head of the component, or designee, and shall include:

    (1) The name and title or position of the person responsible for the denial;

    (2) A brief statement of the reasons for the denial, including any FOIA exemption applied by the component in denying the request;

    (3) An estimate of the volume of any records or information withheld, for example, by providing the number of pages or some other reasonable form of estimation. This estimation is not required if the volume is otherwise indicated by deletions marked on records that are disclosed in part, or if providing an estimate would harm an interest protected by an applicable exemption; and

    (4) A statement that the denial may be appealed under 6 CFR 5.8(a), and a description of the requirements set forth therein.

    (f) Markings on released documents. Markings on released documents must be clearly visible to the requester. Records disclosed in part shall be marked to show the amount of information deleted and the exemption under which the deletion was made unless doing so would harm an interest protected by an applicable exemption. The location of the information deleted also shall be indicated on the record, if technically feasible.

    (g) Use of record exclusions. (1) In the event that a component identifies records that may be subject to exclusion from the requirements of the FOIA pursuant to 5 U.S.C. 552(c), the head of the FOIA office of that component must confer with Department of Justice's Office of Information Policy (OIP) to obtain approval to apply the exclusion.

    (2) Any component invoking an exclusion shall maintain an administrative record of the process of invocation and approval of the exclusion by OIP.

    § 5.7 Confidential commercial information.

    (a) Definitions.

    (1) Confidential commercial information means commercial or financial information obtained by DHS from a submitter that may be protected from disclosure under Exemption 4 of the FOIA.

    (2) Submitter means any person or entity from whom DHS obtains confidential commercial information, directly or indirectly.

    (b) Designation of confidential commercial information. A submitter of confidential commercial information must use good faith efforts to designate by appropriate markings, either at the time of submission or within a reasonable time thereafter, any portion of its submission that it considers to be protected from disclosure under Exemption 4. These designations will expire ten years after the date of the submission unless the submitter requests and provides justification for a longer designation period.

    (c) When notice to submitters is required. (1) A component shall promptly provide written notice to a submitter whenever records containing such information are requested under the FOIA if, after reviewing the request, the responsive records, and any appeal by the requester, the component determines that it may be required to disclose the records, provided:

    (i) The requested information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or

    (ii) The component has a reason to believe that the requested information may be protected from disclosure under Exemption 4.

    (2) The notice shall either describe the commercial information requested or include a copy of the requested records or portions of records containing the information. In cases involving a voluminous number of submitters, notice may be made by posting or publishing the notice in a place or manner reasonably likely to accomplish it.

    (d) Exceptions to submitter notice requirements. The notice requirements of paragraphs (c) and (g) of this section shall not apply if:

    (1) The component determines that the information is exempt under the FOIA;

    (2) The information lawfully has been published or has been officially made available to the public;

    (3) Disclosure of the information is required by a statute other than the FOIA or by a regulation issued in accordance with the requirements of Executive Order 12600 of June 23, 1987; or

    (4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous, except that, in such a case, the component shall give the submitter written notice of any final decision to disclose the information and must provide that notice within a reasonable number of days prior to a specified disclosure date.

    (e) Opportunity to object to disclosure. (1) A component will specify a reasonable time period within which the submitter must respond to the notice referenced above. If a submitter has any objections to disclosure, it should provide the component a detailed written statement that specifies all grounds for withholding the particular information under any exemption of the FOIA. In order to rely on Exemption 4 as basis for nondisclosure, the submitter must explain why the information constitutes a trade secret, or commercial or financial information that is privileged or confidential.

    (2) A submitter who fails to respond within the time period specified in the notice shall be considered to have no objection to disclosure of the information. Information received by the component after the date of any disclosure decision will not be considered by the component. Any information provided by a submitter under this subpart may itself be subject to disclosure under the FOIA.

    (f) Analysis of objections. A component shall consider a submitter's objections and specific grounds for nondisclosure in deciding whether to disclose the requested information.

    (g) Notice of intent to disclose. Whenever a component decides to disclose information over the objection of a submitter, the component shall provide the submitter written notice, which shall include:

    (1) A statement of the reasons why each of the submitter's disclosure objections was not sustained;

    (2) A description of the information to be disclosed; and

    (3) A specified disclosure date, which shall be a reasonable time subsequent to the notice.

    (h) Notice of FOIA lawsuit. Whenever a requester files a lawsuit seeking to compel the disclosure of confidential commercial information, the component shall promptly notify the submitter.

    (i) Requester notification. The component shall notify a requester whenever it provides the submitter with notice and an opportunity to object to disclosure; whenever it notifies the submitter of its intent to disclose the requested information; and whenever a submitter files a lawsuit to prevent the disclosure of the information.

    (j) Scope. This section shall not apply to any confidential commercial information provided to CBP by a business submitter. 6 CFR 5.12 applies to such information. 6 CFR 5.12 also defines “confidential commercial information” as used in this paragraph.

    § 5.8 Administrative appeals

    (a) Requirements for filing an appeal.

    (1) A requester may appeal adverse determinations denying his or her request or any part of the request to the appropriate Appeals Officer. A requester may also appeal if he or she questions the adequacy of the component's search for responsive records, or believes the component either misinterpreted the request or did not address all aspects of the request (i.e., it issued an incomplete response), or if the requester believes there is a procedural deficiency (e.g., fees were improperly calculated). For the address of the appropriate component Appeals Officer, contact the applicable component FOIA liaison using the information in appendix I to this subpart, visit www.dhs.gov/foia, or call 1-866-431-0486. An appeal must be in writing, and to be considered timely it must be postmarked or, in the case of electronic submissions, transmitted to the Appeals Officer within 60 business days after the date of the component's response. The appeal should clearly identify the component determination (including the assigned request number if the requester knows it) that is being appealed and should contain the reasons the requester believes the determination was erroneous. To facilitate handling, the requester should mark both the letter and the envelope, or the transmittal line in the case of electronic transmissions “Freedom of Information Act Appeal.”

    (2) An adverse determination by the component appeals officer will be the final action of DHS.

    (b) Adjudication of appeals. (1) The DHS Office of the General Counsel or its designee (e.g., component Appeals Officers) is the authorized appeals authority for DHS;

    (2) On receipt of any appeal involving classified information, the Appeals Officer shall consult with the Chief Security Officer, and take appropriate action to ensure compliance with 6 CFR part 7;

    (3) If the appeal becomes the subject of a lawsuit, the Appeals Officer is not required to act further on the appeal.

    (c) Appeal decisions. The decision on the appeal will be made in writing. A decision that upholds a component's determination will contain a statement that identifies the reasons for the affirmance, including any FOIA exemptions applied. The decision will provide the requester with notification of the statutory right to file a lawsuit and will inform the requester of the mediation services offered by the Office of Government Information Services, of the National Archives and Records Administration, as a non-exclusive alternative to litigation. If the adverse decision is reversed or modified on appeal, in whole or in part, the requester will be notified in a written decision and the request will be thereafter be further processed in accordance with that appeal decision.

    (d) Time limit for issuing appeal decision. The statutory time limit for responding to appeals is generally 20 workdays after receipt. However, the Appeals Officer may extend the time limit for responding to an appeal provided the circumstances set forth in 5 U.S.C. 552(a)(6)(B)(i) are met.

    (e) Appeal necessary before seeking court review. If a requester wishes to seek court review of a component's adverse determination on a matter appealable under subsection (a)(1) of this section, the requester must generally first appeal it under this subpart. However, a requester is not required to first file an appeal of an adverse determination of a request for expedited processing prior to seeking court review.

    § 5.9 Preservation of records.

    Each component shall preserve all correspondence pertaining to the requests that it receives under this subpart, as well as copies of all requested records, until disposition or destruction is authorized pursuant to title 44 of the United States Code or the General Records Schedule 4.2 and/or 14 of the National Archives and Records Administration. Records will not be disposed of or destroyed while they are the subject of a pending request, appeal, or lawsuit under the FOIA.

    § 5.10 FOIA requests for information contained in a Privacy Act system of records.

    (a) Information subject to Privacy Act. (1) If a requester submits a FOIA request for information about him or herself that is contained in a Privacy Act system of records applicable to the requester (i.e., the information contained in the system of records is retrieved by the component using the requester's name or other personal identifier, and the information pertains to an individual covered by the Privacy Act) the request will be processed under both the FOIA and the Privacy Act.

    (2) If the information the requester is seeking is not subject to the Privacy Act (e.g., the information is filed under another subject, such as an organization, activity, event, or an investigation not retrievable by the requester's name or personal identifier), the request, if otherwise properly made, will be treated only as a FOIA request. In addition, if the information is covered by the Privacy Act and the requester does not provide proper verification of the requester's identity, the request, if otherwise properly made, will be processed only under the FOIA.

    (b) When both Privacy Act and FOIA exemptions apply. Only if both a Privacy Act exemption and a FOIA exemption apply can DHS withhold information from a requester if the information sought by the requester is about him or herself and is contained in a Privacy Act system of records applicable to the requester.

    (c) Conditions for release of Privacy Act information to third parties in response to a FOIA request. If a requester submits a FOIA request for Privacy Act information about another individual, the information will not be disclosed without that person's prior written consent that provides the same verification information that the person would have been required to submit for information about him or herself, unless—

    (1) The information is required to be released under the FOIA, as provided by 5 U.S.C. 552a (b)(2); or

    (2) In most circumstances, if the individual is deceased.

    (d) Privacy Act requirements. See DHS's Privacy Act regulations in 5 CFR part 5, subpart B for additional information regarding the requirements of the Privacy Act.

    § 5.11 Fees.

    (a) In general. Components shall charge for processing requests under the FOIA in accordance with the provisions of this section and with the OMB Guidelines. Components will ordinarily use the most efficient and least expensive method for processing requested records. In order to resolve any fee issues that arise under this section, a component may contact a requester for additional information. A component ordinarily will collect all applicable fees before sending copies of records to a requester. If you make a FOIA request, it shall be considered a firm commitment by you to pay all applicable fees charged under § 5.11, up to $25.00, unless you seek a waiver of fees. Requesters must pay fees by check or money order made payable to the Treasury of the United States.

    (b) Definitions. Generally, “requester category” means one of the three categories in which agencies place requesters for the purpose of determining whether a requester will be charged fees for search, review and duplication; categories include commercial requesters, noncommercial scientific or educational institutions or news media requesters, and all other requesters. The term “fee waiver” means that processing fees will be waived, or reduced, if a requester can demonstrate that certain statutory standards are satisfied including that the information is in the public interest and is not requested for a commercial interest. For purposes of this section:

    (1) Commercial use request is a request that asks for information for a use or a purpose that furthers a commercial, trade, or profit interest, which can include furthering those interests through litigation. A component's decision to place a requester in the commercial use category will be made on a case-by-case basis based on the requester's intended use of the information.

    (2) Direct costs are those expenses that an agency expends in searching for and duplicating (and, in the case of commercial use requests, reviewing) records in order to respond to a FOIA request. For example, direct costs include the salary of the employee performing the work (i.e., the basic rate of pay for the employee, plus 16 percent of that rate to cover benefits) and the cost of operating computers and other electronic equipment, such as photocopiers and scanners. Direct costs do not include overhead expenses such as the costs of space, and of heating or lighting a facility.

    (3) Duplication is reproducing a copy of a record or of the information contained in it, necessary to respond to a FOIA request. Copies can take the form of paper, audiovisual materials, or electronic records, among others.

    (4) Educational institution is any school that operates a program of scholarly research. A requester in this fee category must show that the request is authorized by, and is made under the auspices of, an educational institution and that the records are not sought for a commercial use, but rather are sought to further scholarly research. To fall within this fee category the request must serve the scholarly research goal of the institution rather than an individual research goal.

    Example 1. A request from a professor of geology at a university for records relating to soil erosion, written on letterhead of the Department of Geology, would be presumed to be from an educational institution if the request adequately describes how the requested information would further a specific research goal of the educational institution.

    Example 2. A request from the same professor of geology seeking immigration information from the U.S. Immigration and Customs Enforcement in furtherance of a murder mystery he is writing would not be presumed to be an institutional request, regardless of whether it was written on institutional stationery.

    Example 3. A student who makes a request in furtherance of the completion of a course of instruction would be presumed to be carrying out an individual research goal, rather than a scholarly research goal of the institution, and would not qualify as part of this fee category.

    Note:

    These examples are provided for guidance purposes only. Each individual request will be evaluated under the particular facts, circumstances, and information provided by the requester.

    (5) Noncommercial scientific institution is an institution that is not operated on a “commercial” basis, as defined in paragraph (b)(1) of this section, and that is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any particular product or industry. A requester in this category must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are sought to further scientific research and not for a commercial use.

    (6) Representative of the news media is any person or entity organized and operated to publish or broadcast news to the public that actively gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. The term “news” means information that is about current events or that would be of current interest to the public. Examples of news media entities include television or radio stations that broadcast “news” to the public at large and publishers of periodicals that disseminate “news” and make their products available through a variety of means to the general public, including but not limited to, news organizations that disseminate solely on the Internet. A request for records that supports the news-dissemination function of the requester shall not be considered to be for a commercial use. In contrast, data brokers or others who merely compile and market government information for direct economic return shall not be presumed to be news media entities. “Freelance” journalists must demonstrate a solid basis for expecting publication through a news media entity in order to be considered as working for a news media entity. A publication contract would provide the clearest evidence that publication is expected; however, components shall also consider a requester's past publication record in making this determination.

    (7) Review is the page-by-page, line-by-line examination of a record located in response to a request in order to determine whether any portion of it is exempt from disclosure. Review time includes processing any record for disclosure, such as doing all that is necessary to prepare the record for disclosure, including the process of redacting the record and marking the appropriate exemptions. Review costs are properly charged even if a record ultimately is not disclosed. Review time also includes time spent both obtaining and considering any formal objection to disclosure made by a confidential commercial information submitter under 6 CFR 5.7 or 6 CFR 5.12, but it does not include time spent resolving general legal or policy issues regarding the application of exemptions.

    (8) Search is the process of looking for and retrieving records or information responsive to a request. Search time includes page-by-page or line-by-line identification of information within records; and the reasonable efforts expended to locate and retrieve information from electronic records. Components shall ensure that searches are done in the most efficient and least expensive manner reasonably possible by readily available means.

    (c) Charging fees. In responding to FOIA requests, components shall charge the following fees unless a waiver or reduction of fees has been granted under paragraph (k) of this section. Because the fee amounts provided below already account for the direct costs associated with a given fee type, unless otherwise stated in § 5.11, components should not add any additional costs to those charges.

    (1) Search. (i) Search fees shall be charged for all requests subject to the restrictions of paragraph (d) of this section. Components may properly charge for time spent searching even if they do not locate any responsive records or if they determine that the records are entirely exempt from disclosure.

    (ii) For each quarter hour spent by personnel searching for requested records, including electronic searches that do not require new programming, the fees will be as follows: Managerial—$10.25; professional—$7.00; and clerical/administrative—$4.00.

    (iii) Requesters will be charged the direct costs associated with conducting any search that requires the creation of a new computer program, as referenced in section 5.4, to locate the requested records. Requesters shall be notified of the costs associated with creating such a program and must agree to pay the associated costs before the costs may be incurred.

    (iv) For requests that require the retrieval of records stored by an agency at a federal records center operated by the National Archives and Records Administration (NARA), additional costs shall be charged in accordance with the Transactional Billing Rate Schedule established by NARA.

    (2) Duplication. Duplication fees will be charged to all requesters, subject to the restrictions of paragraph (d) of this section. A component shall honor a requester's preference for receiving a record in a particular form or format where it is readily reproducible by the component in the form or format requested. Where photocopies are supplied, the component will provide one copy per request at a cost of ten cents per page. For copies of records produced on tapes, disks, or other media, components will charge the direct costs of producing the copy, including operator time. Where paper documents must be scanned in order to comply with a requester's preference to receive the records in an electronic format, the requester shall pay the direct costs associated with scanning those materials. For other forms of duplication, components will charge the direct costs.

    (3) Review. Review fees will be charged to requesters who make commercial use requests. Review fees will be assessed in connection with the initial review of the record, i.e., the review conducted by a component to determine whether an exemption applies to a particular record or portion of a record. No charge will be made for review at the administrative appeal stage of exemptions applied at the initial review stage. However, when the appellate authority determines that a particular exemption no longer applies, any costs associated with a component's re-review of the records in order to consider the use of other exemptions may be assessed as review fees. Review fees will be charged at the same rates as those charged for a search under paragraph (c)(1)(ii) of this section.

    (d) Restrictions on charging fees. (1) No search fees will be charged for requests by educational institutions (unless the records are sought for a commercial use), noncommercial scientific institutions, or representatives of the news media.

    (2) If a component fails to comply with the time limits in which to respond to a request, and if no unusual or exceptional circumstances, as those terms are defined by the FOIA, apply to the processing of the request, it may not charge search fees, or, in the instances of requests from requesters described in paragraph (d)(1) of this section, may not charge duplication fees.

    (3) No search or review fees will be charged for a quarter-hour period unless more than half of that period is required for search or review.

    (4) Except for requesters seeking records for a commercial use, components will provide without charge:

    (i) The first 100 pages of duplication (or the cost equivalent for other media); and

    (ii) The first two hours of search.

    (5) When, after first deducting the 100 free pages (or its cost equivalent) and the first two hours of search, a total fee calculated under paragraph (c) of this section is $14.00 or less for any request, no fee will be charged.

    (e) Notice of anticipated fees in excess of $25.00. (1) When a component determines or estimates that the fees to be assessed in accordance with this section will exceed $25.00, the component shall notify the requester of the actual or estimated amount of the fees, including a breakdown of the fees for search, review and/or duplication, unless the requester has indicated a willingness to pay fees as high as those anticipated. If only a portion of the fee can be estimated readily, the component shall advise the requester accordingly. If the requester is a noncommercial use requester, the notice will specify that the requester is entitled to his or her statutory entitlements of 100 pages of duplication at no charge and, if the requester is charged search fees, two hours of search time at no charge, and will advise the requester whether those entitlements have been provided.

    (2) In cases in which a requester has been notified that the actual or estimated fees are in excess of $25.00, the request shall not be considered perfected and further work will not be completed until the requester commits in writing to pay the actual or estimated total fee, or designates some amount of fees he or she is willing to pay, or in the case of a noncommercial use requester who has not yet been provided with his or her statutory entitlements, designates that he or she seeks only that which can be provided by the statutory entitlements. The requester must provide the commitment or designation in writing, and must, when applicable, designate an exact dollar amount the requester is willing to pay. Components are not required to accept payments in installments.

    (3) If the requester has indicated a willingness to pay some designated amount of fees, but the component estimates that the total fee will exceed that amount, the component will toll the processing of the request while it notifies the requester of the estimated fees in excess of the amount the requester has indicated a willingness to pay. The component shall inquire whether the requester wishes to revise the amount of fees he or she is willing to pay and/or modify the request. Once the requester responds, the time to respond will resume from where it was at the date of the notification.

    (4) Components will make available their FOIA Public Liaison or other FOIA professional to assist any requester in reformulating a request to meet the requester's needs at a lower cost.

    (f) Charges for other services. Although not required to provide special services, if a component chooses to do so as a matter of administrative discretion, the direct costs of providing the service will be charged. Examples of such services include certifying that records are true copies, providing multiple copies of the same document, or sending records by means other than first class mail.

    (g) Charging interest. Components may charge interest on any unpaid bill starting on the 31st day following the date of billing the requester. Interest charges will be assessed at the rate provided in 31 U.S.C. 3717 and will accrue from the billing date until payment is received by the component. Components will follow the provisions of the Debt Collection Act of 1982 (Pub. L. 97-365, 96 Stat. 1749), as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.

    (h) Aggregating requests. When a component reasonably believes that a requester or a group of requesters acting in concert is attempting to divide a single request into a series of requests for the purpose of avoiding fees, the component may aggregate those requests and charge accordingly. Components may presume that multiple requests of this type made within a 30-day period have been made in order to avoid fees. For requests separated by a longer period, components will aggregate them only where there is a reasonable basis for determining that aggregation is warranted in view of all the circumstances involved. Multiple requests involving unrelated matters will not be aggregated.

    (i) Advance payments. (1) For requests other than those described in paragraphs (i)(2) and (3) of this section, a component shall not require the requester to make an advance payment before work is commenced or continued on a request. Payment owed for work already completed (i.e., payment before copies are sent to a requester) is not an advance payment.

    (2) When a component determines or estimates that a total fee to be charged under this section will exceed $250.00, it may require that the requester make an advance payment up to the amount of the entire anticipated fee before beginning to process the request. A component may elect to process the request prior to collecting fees when it receives a satisfactory assurance of full payment from a requester with a history of prompt payment.

    (3) Where a requester has previously failed to pay a properly charged FOIA fee to any component or agency within 30 calendar days of the billing date, a component may require that the requester pay the full amount due, plus any applicable interest on that prior request and the component may require that the requester make an advance payment of the full amount of any anticipated fee, before the component begins to process a new request or continues to process a pending request or any pending appeal. Where a component has a reasonable basis to believe that a requester has misrepresented his or her identity in order to avoid paying outstanding fees, it may require that the requester provide proof of identity.

    (4) In cases in which a component requires advance payment, the request shall not be considered received and further work will not be completed until the required payment is received. If the requester does not pay the advance payment within 30 calendar days after the date of the component's fee determination, the request will be closed.

    (j) Other statutes specifically providing for fees. The fee schedule of this section does not apply to fees charged under any statute that specifically requires an agency to set and collect fees for particular types of records. In instances where records responsive to a request are subject to a statutorily-based fee schedule program, the component will inform the requester of the contact information for that source.

    (k) Requirements for waiver or reduction of fees. (1) Records responsive to a request shall be furnished without charge or at a reduced rate below that established under paragraph (c) of this section, where a component determines, on a case-by-case basis, based on all available information, that the requester has demonstrated that:

    (i) Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government; and

    (ii) Disclosure of the information is not primarily in the commercial interest of the requester.

    (2) In deciding whether disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of operations or activities of the government, components will consider the following factors:

    (i) The subject of the request must concern identifiable operations or activities of the federal government, with a connection that is direct and clear, not remote or attenuated.

    (ii) Disclosure of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either the same or a substantially identical form, would not contribute to such understanding where nothing new would be added to the public's understanding.

    (iii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area as well as his or her ability and intention to effectively convey information to the public shall be considered. It shall be presumed that a representative of the news media will satisfy this consideration.

    (iv) The public's understanding of the subject in question must be enhanced by the disclosure to a significant extent. However, components shall not make value judgments about whether the information at issue is “important” enough to be made public.

    (3) To determine whether disclosure of the requested information is primarily in the commercial interest of the requester, components will consider the following factors:

    (i) Components shall identify any commercial interest of the requester, as defined in paragraph (b)(1) of this section, that would be furthered by the requested disclosure. Requesters shall be given an opportunity to provide explanatory information regarding this consideration.

    (ii) A waiver or reduction of fees is justified where the public interest is greater than any identified commercial interest in disclosure. Components ordinarily shall presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return shall not be presumed to primarily serve the public interest.

    (4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver shall be granted for those records.

    (5) Requests for a waiver or reduction of fees should be made when the request is first submitted to the component and should address the criteria referenced above. A requester may submit a fee waiver request at a later time so long as the underlying record request is pending or on administrative appeal. When a requester who has committed to pay fees subsequently asks for a waiver of those fees and that waiver is denied, the requester will be required to pay any costs incurred up to the date the fee waiver request was received.

    (6) Summary of fees. The following table summarizes the chargeable fees (excluding direct fees identified in § 5.11) for each requester category.

    Category Search fees Review fees Duplication fees Commercial-use Yes Yes Yes. Educational or Non-Commercial Scientific Institution No No Yes (100 pages free). News Media No No Yes (100 pages free). Other requesters Yes (2 hours free) No Yes (100 pages free).
    § 5.12 Confidential commercial information; CBP procedures.

    (a) In general. For purposes of this section, “commercial information” is defined as trade secret, commercial, or financial information obtained from a person. Commercial information provided to CBP by a business submitter and that CBP determines is privileged or confidential commercial or financial information will be treated as privileged or confidential and will not be disclosed pursuant to a Freedom of Information Act request or otherwise made known in any manner except as provided in this section.

    (b) Notice to business submitters of FOIA requests for disclosure. Except as provided in paragraph (b)(2) of this section, CBP will provide business submitters with prompt written notice of receipt of FOIA requests or appeals that encompass their commercial information. The written notice will describe either the exact nature of the commercial information requested, or enclose copies of the records or those portions of the records that contain the commercial information. The written notice also will advise the business submitter of its right to file a disclosure objection statement as provided under paragraph (c)(1) of this section. CBP will provide notice to business submitters of FOIA requests for the business submitter's commercial information for a period of not more than 10 years after the date the business submitter provides CBP with the information, unless the business submitter requests, and provides acceptable justification for, a specific notice period of greater duration.

    (1) When notice is required. CBP will provide business submitters with notice of receipt of a FOIA request or appeal whenever:

    (i) The business submitter has in good faith designated the information as commercially- or financially-sensitive information. The business submitter's claim of confidentiality should be supported by a statement by an authorized representative of the business entity providing specific justification that the information in question is considered confidential commercial or financial information and that the information has not been disclosed to the public; or

    (ii) CBP has reason to believe that disclosure of the commercial information could reasonably be expected to cause substantial competitive harm.

    (2) When notice is not required. The notice requirements of this section will not apply if:

    (i) CBP determines that the commercial information will not be disclosed;

    (ii) The commercial information has been lawfully published or otherwise made available to the public; or

    (iii) Disclosure of the information is required by law (other than 5 U.S.C. 552).

    (c) Procedure when notice given. (1) Opportunity for business submitter to object to disclosure. A business submitter receiving written notice from CBP of receipt of a FOIA request or appeal encompassing its commercial information may object to any disclosure of the commercial information by providing CBP with a detailed statement of reasons within 10 days of the date of the notice (exclusive of Saturdays, Sundays, and legal public holidays). The statement should specify all the grounds for withholding any of the commercial information under any exemption of the FOIA and, in the case of Exemption 4, should demonstrate why the information is considered to be a trade secret or commercial or financial information that is privileged or confidential. The disclosure objection information provided by a person pursuant to this paragraph may be subject to disclosure under the FOIA.

    (2) Notice to FOIA requester. When notice is given to a business submitter under paragraph (b)(1) of this section, notice will also be given to the FOIA requester that the business submitter has been given an opportunity to object to any disclosure of the requested commercial information.

    (d) Notice of intent to disclose. CBP will consider carefully a business submitter's objections and specific grounds for nondisclosure prior to determining whether to disclose commercial information. Whenever CBP decides to disclose the requested commercial information over the objection of the business submitter, CBP will provide written notice to the business submitter of CBP's intent to disclose, which will include:

    (1) A statement of the reasons for which the business submitter's disclosure objections were not sustained;

    (2) A description of the commercial information to be disclosed; and

    (3) A specified disclosure date which will not be less than 10 days (exclusive of Saturdays, Sundays, and legal public holidays) after the notice of intent to disclose the requested information has been issued to the business submitter. Except as otherwise prohibited by law, CBP will also provide a copy of the notice of intent to disclose to the FOIA requester at the same time.

    (e) Notice of FOIA lawsuit. Whenever a FOIA requester brings suit seeking to compel the disclosure of commercial information covered by paragraph (b)(1) of this section, CBP will promptly notify the business submitter in writing.

    § 5.13 Other rights and services.

    Nothing in this subpart shall be construed to entitle any person, as of right, to any service or to the disclosure of any record to which such person is not entitled under the FOIA.

    Appendix I to Subpart A—FOIA Contact Information Department of Homeland Security Chief FOIA Officer

    Chief Privacy Officer/Chief FOIA Officer, The Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655.

    Department of Homeland Security Deputy Chief FOIA Officer

    Deputy Chief FOIA Officer, The Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655.

    Senior Director, FOIA Operations

    Sr. Director, FOIA Operations, The Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655, Phone: 202-343-1743 or 866-431-0486, Fax: 202-343-4011, Email: [email protected]

    Director, FOIA Production and Quality Assurance

    Public Liaison, FOIA Production and Quality Assurance, The Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655, Phone: 202-343-1743 or 866-431-0486, Fax: 202-343-4011, Email: [email protected]

    U.S. Customs & Border Protection (CBP)

    FOIA Officer/Public Liaison, 90 K Street NE., 9th Floor, Washington, DC 20229-1181, Phone: 202-325-0150, Fax: 202-325-0230.

    Office of Civil Rights and Civil Liberties (CRCL)

    FOIA Officer/Public Liaison, U.S. Department of Homeland Security, Washington, DC 20528, Phone: 202-357-1218, Email: [email protected]

    Federal Emergency Management Agency (FEMA)

    FOIA Officer/Public Liaison, 500 C Street SW., Room 7NE, Washington, DC 20472, Phone: 202-646-3323, Email: [email protected]

    Federal Law Enforcement Training Center (FLETC)

    FOIA Officer/Public Liaison, Building #681, Suite 187B, Glynco, GA 31524, Phone: 912-267-3103, Fax: 912-267-3113, Email: [email protected]

    National Protection and Programs Directorate (NPPD)

    FOIA Officer/Public Liaison, U.S. Department of Homeland Security, Washington, DC 20528, Phone: 703-235-2211, Fax: 703-235-2052, Email: [email protected]

    Office of Biometric Identity Management (OBIM) FOIA Officer

    Department of Homeland Security, Washington, DC 20598-0628, Phone: 202-298-5454, Fax: 202-298-5445, E-Mail: [email protected]

    Office of Intelligence & Analysis (I&A)

    FOIA Officer/Public Liaison, U.S. Department of Homeland Security, Washington, DC 20528, Phone: 202-447-4883, Fax: 202-612-1936, Email: I&[email protected]

    Office of Inspector General (OIG)

    FOIA Public Liaison, DHS-OIG Counsel, STOP 0305, 245 Murray Lane SW., Washington, DC 20528-0305, Phone: 202-254-4001, Fax: 202-254-4398, Email: [email protected]

    Office of Operations Coordination and Planning (OPS)

    FOIA Officer/Public Liaison, U.S. Department of Homeland Security, Washington, DC 20528, Phone: 202-447-4156, Fax: 202-282-9811, Email: [email protected]

    Science & Technology Directorate (S&T)

    FOIA Officer/Public Liaison, U.S. Department of Homeland Security, Washington, DC 20528, Phone: 202-254-6342, Fax: 202-254-6739, Email: [email protected]

    Transportation Security Administration (TSA)

    FOIA Officer/Public Liaison, Freedom of Information Act Branch, 601 S. 12th Street, 11th Floor, East Tower, TSA-20, Arlington, VA 20598-6020, Phone: 1-866-FOIA-TSA or 571-227-2300, Fax: 571-227-1406, Email: [email protected]

    U.S. Citizenship & Immigration Services (USCIS)

    FOIA Officer/Public Liaison, National Records Center, FOIA/PA Office, P.O. Box 648010, Lee's Summit, MO 64064-8010, Phone: 1-800-375-5283 (USCIS National Customer Service Unit), Fax: 816-350-5785, Email: [email protected]

    United States Coast Guard (USCG)

    Commandant (CG-611), 2100 2nd St. SW., Attn: FOIA Officer/Public Liaison, Washington, DC 20593-0001, FOIA Requester Service Center Contact: Amanda Ackerson, Phone: 202-475-3522, Fax: 202-475-3927, Email: [email protected]

    United States Immigration & Customs Enforcement (ICE)

    Freedom of Information Act Office, FOIA Officer/Public Liaison, 500 12th Street SW., Stop 5009, Washington, DC 20536-5009.

    FOIA Requester Service Center Contact, Phone: 866-633-1182, Fax: 202-732-4265, Email: [email protected]

    United States Secret Service (USSS)

    Freedom of Information and Privacy Acts Branch, FOIA Officer/Public Liaison, 245 Murray Drive, Building 410, Washington, DC 20223, Phone: 202-406-6370, Fax: 202-406-5586, Email: [email protected]

    Please direct all requests for information from the Office of the Secretary, Citizenship and Immigration Services Ombudsman, Domestic Nuclear Detection Office, Office of the Executive Secretary, Office of Intergovernmental Affairs, Management Directorate, Office of Policy, Office of the General Counsel, Office of Health Affairs, Office of Legislative Affairs, Office of Public Affairs and the Privacy Office, to the DHS Privacy Office at: The Privacy Office, U.S. Department of Homeland Security, 245 Murray Lane SW., STOP-0655, Washington, DC 20528-0655, Phone: 202-343-1743 or 866-431-0486, Fax: 202-343-4011, Email: [email protected].

    Appendix B to Part 5—[Removed]
    3. Remove appendix B to part 5. Title 19—Customs Duties PART 103—AVAILABILITY OF INFORMATION 4. The authority citation for part 103 is revised to read as follows: Authority:

    5 U.S.C. 301, 552, 552a; 19 U.S.C. 66, 1624; 31 U.S.C. 9701.

    Section 103.31 also issued under 19 U.S.C. 1431; Section 103.31a also issued under 19 U.S.C. 2071 note and 6 U.S.C. 943; Section 103.33 also issued under 19 U.S.C. 1628; Section 103.34 also issued under 18 U.S.C. 1905.

    § 103.35 [Removed]
    5. Remove § 103.35. Title 44—Emergency Management and Assistance PART 5—PRODUCTION OR DISCLOSURE OF INFORMATION 6. The authority citation for part 5 is revised to read as follows: Authority:

    Pub. L. 107-296, 116 Stat. 2135; 5 U.S.C. 301.

    Subparts A Through E—[Removed and Reserved] 7. Remove and reserve subparts A through E of part 5. 8. In § 5.86, revise the section to read as follows:
    § 5.86 Records involved in litigation or other judicial process.

    Subpoenas duces tecum issued pursuant to litigation or any other adjudicatory proceeding in which the United States is a party shall be referred to the Chief Counsel.

    Jeh Charles Johnson, Secretary.
    [FR Doc. 2015-18388 Filed 7-28-15; 8:45 am] BILLING CODE 9110-9L-P
    FEDERAL ELECTION COMMISSION 11 CFR Parts 102, 104, 110 [Notice 2015-10] Rulemaking Petition: Contributions From Corporations and Other Organizations to Political Committees AGENCY:

    Federal Election Commission.

    ACTION:

    Rulemaking petition; notice of availability.

    SUMMARY:

    On May 14, 2015, the Federal Election Commission received a Petition for Rulemaking that asks the Commission to revise existing rules concerning the reporting of contributions to political committees from corporations and other organizations. The Commission seeks comments on this petition.

    DATES:

    Comments must be submitted on or before October 27, 2015.

    ADDRESSES:

    All comments must be in writing. Commenters are encouraged to submit comments electronically via the Commission's Web site at http://www.fec.gov/fosers, reference REG 2015-03, or by email to [email protected] Alternatively, commenters may submit comments in paper form, addressed to the Federal Election Commission, Attn.: Robert M. Knop, Assistant General Counsel, 999 E Street NW., Washington, DC 20463.

    Each commenter must provide, at a minimum, his or her first name, last name, city, state, and zip code. All properly submitted comments, including attachments, will become part of the public record, and the Commission will make comments available for public viewing on the Commission's Web site and in the Commission's Public Records room. Accordingly, commenters should not provide in their comments any information that they do not wish to make public, such as a home street address, personal email address, date of birth, phone number, social security number, or driver's license number, or any information that is restricted from disclosure, such as trade secrets or commercial or financial information that is privileged or confidential.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Robert M. Knop, Assistant General Counsel, or Mr. Sean J. Wright, Attorney, Office of General Counsel, 999 E Street NW., Washington, DC 20463, (202) 694-1650 or (800) 424-9530.

    SUPPLEMENTARY INFORMATION:

    On May 14, 2015, the Federal Election Commission received a Petition for Rulemaking from Make Your Laws PAC, Inc. and Make Your Laws Advocacy, Inc. The petition asks the Commission to modify its regulations requiring disclosure of contributions from corporations and other organizations to political committees.

    The Federal Election Campaign Act, 52 U.S.C. 30101-46 (the “Act”), and Commission regulations require all political committees to abide by certain organizational, record-keeping, and reporting requirements. See 52 U.S.C. 30102, 30103, 30104; 11 CFR 102.1, 102.2, 102.7, 104.3. This includes maintaining records of contribution receipts and disbursements, reporting independent expenditures, and filing periodic disclosure reports that identify the source of each contribution exceeding $200. See 11 CFR 104.3(a)(4)(i), 104.4, 104.5(c). Commission regulations also require every person who makes electioneering communications aggregating in excess of $10,000 in a calendar year and every person (other than a political committee) that makes independent expenditures in excess of $250 with respect to a given election in a calendar year to report certain information to the Commission. 11 CFR 104.20(b) and (c), 109.10(b) and (e); 52 U.S.C. 30104(c)(1) and (2), (f).

    The petition asks the Commission to establish a new rule requiring that “any person, other than a natural person, contributing an aggregate of more than $1,000 in any calendar year to any political committee, whether directly or indirectly” (emphasis omitted), must do so from an account subject to certain reporting requirements. Specifically, the petition asks the Commission to require that these accounts disclose “the original source of all election-related contributions and expenditures, traceable through all intermediary entities to a natural person, regardless of the amounts or entities involved” (emphasis omitted). The petition also asks the Commission to apply to these accounts the identification requirements of 11 CFR 100.12; the Act's prohibition on foreign national contributions, 52 U.S.C. 30121; allocation rules for administrative expenses; and, in some circumstances, the Act's limitations on contributions to political committees.

    The Commission seeks comments on the petition. The public may inspect the petition on the Commission's Web site at http://www.fec.gov/fosers, or in the Commission's Public Records Office, 999 E Street NW., Washington, DC 20463, Monday through Friday, from 9 a.m. to 5 p.m. Interested persons may also obtain a copy of the petition by dialing the Commission's Faxline service at (202) 501-3413 and following its instructions. Request document #279.

    The Commission will not consider the petition's merits until after the comment period closes. If the Commission decides that the petition has merit, it may begin a rulemaking proceeding. The Commission will announce any action that it takes in the Federal Register.

    On behalf of the Commission,

    Dated: July 16, 2015. Ann M. Ravel, Chair, Federal Election Commission.
    [FR Doc. 2015-18495 Filed 7-28-15; 8:45 am] BILLING CODE 6715-01-P
    FEDERAL ELECTION COMMISSION 11 CFR Parts 104, 109, 110, 114 [Notice 2015-09] Rulemaking Petition: Independent Spending by Corporations, Labor Organizations, Foreign Nationals, and Certain Political Committees (Citizens United) AGENCY:

    Federal Election Commission, Energy.

    ACTION:

    Rulemaking petition; notice of availability.

    SUMMARY:

    On June 19 and June 22, 2015, the Federal Election Commission received two Petitions for Rulemaking that ask the Commission to issue new rules and revise existing rules concerning: (1) The disclosure of certain financing information regarding independent expenditures and electioneering communications; (2) election-related spending by foreign nationals; (3) solicitations of corporate and labor organization employees and members; and (4) the independence of expenditures made by independent-expenditure-only political committees and accounts. The Commission seeks comments on these petitions.

    DATES:

    Comments must be submitted on or before October 27, 2015.

    ADDRESSES:

    All comments must be in writing. Commenters are encouraged to submit comments electronically via the Commission's Web site at http://www.fec.gov/fosers, reference REG 2015-04, or by email to [email protected] Alternatively, commenters may submit comments in paper form, addressed to the Federal Election Commission, Attn.: Amy L. Rothstein, Assistant General Counsel, 999 E Street NW., Washington, DC 20463.

    Each commenter must provide, at a minimum, his or her first name, last name, city, state, and zip code. All properly submitted comments, including attachments, will become part of the public record, and the Commission will make comments available for public viewing on the Commission's Web site and in the Commission's Public Records Office. Accordingly, commenters should not provide in their comments any information that they do not wish to make public, such as a home street address, personal email address, date of birth, phone number, social security number, or driver's license number, or any information that is restricted from disclosure, such as trade secrets or commercial or financial information that is privileged or confidential.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy L. Rothstein, Assistant General Counsel, or Ms. Esther D. Gyory, Attorney, Office of General Counsel, 999 E Street NW., Washington, DC 20463, (202) 694-1650 or (800) 424-9530.

    SUPPLEMENTARY INFORMATION:

    On June 19, 2015, the Federal Election Commission received a Petition for Rulemaking from Make Your Laws PAC, Inc. and Make Your Laws Advocacy, Inc. On June 22, 2015, the Commission received a Petition for Rulemaking from Craig Holman and Public Citizen. Both petitions, citing Citizens United v. FEC, 558 U.S. 310 (2010), ask the Commission to modify its regulations in four respects.

    First, the Federal Election Campaign Act, 52 U.S.C. 30101-46 (the “Act”), and Commission regulations require every person who makes an electioneering communication aggregating in excess of $10,000 in a calendar year and every person (other than a political committee) that makes independent expenditures in excess of $250 with respect to a given election in a calendar year to report certain information to the Commission. 11 CFR 104.20(b) and (c), 109.10(b), (e); 52 U.S.C. 30104(c)(1) and (2), (f). The petitions ask the Commission to “[e]nsure full public disclosure of corporate and labor organization independent spending” by “requir[ing] that outside spending groups disclose their donors.”

    Second, the Act and Commission regulations prohibit foreign nationals from “directly or indirectly” making contributions, expenditures, and electioneering communications. 11 CFR 110.20; 52 U.S.C. 30121(a). The petitions ask the Commission to “[c]larify that th[is] prohibition on foreign national campaign-related spending restricts such spending by U.S. corporations owned or controlled by a foreign national.”

    Third, Commission regulations prohibit corporations and labor organizations from “using coercion . . . to urge any individual to make a contribution or engage in fundraising activities on behalf of a candidate or political committee,” 11 CFR 114.2(f)(2)(iv), and restrict how corporations and labor organizations may solicit contributions to their separate segregated funds from employees and members. 11 CFR 114.5(a)(2) through (5); see also 52 U.S.C. 30118(b)(3). The petitions ask the Commission to “[c]larify that corporations and labor organizations are prohibited from coercing their employees and members into providing financial or other support for the corporation's or labor organization's independent political activities.”

    Finally, the petitions ask the Commission to “[e]nsure that the expenditures made by” independent-expenditure-only political committees and accounts, see, e.g., SpeechNow.org v. FEC, 599 F.3d. 686 (D.C. Cir. 2010), “are truly independent of federal candidates.”

    The Commission seeks comments on the petitions. The public may inspect the petitions on the Commission's Web site at http://www.fec.gov/fosers, or in the Commission's Public Records Office, 999 E Street NW., Washington, DC 20463, Monday through Friday, from 9 a.m. to 5 p.m. Interested persons may also obtain copies of the petitions by dialing the Commission's Faxline service at (202) 501-3413 and following its instructions. Request document #280.

    The Commission will not consider the petitions' merits until after the comment period closes. If the Commission decides that the petitions have merit, it may begin a rulemaking proceeding. The Commission will announce any action that it takes in the Federal Register.

    Dated: July 16, 2015.

    On behalf of the Commission,

    Ann M. Ravel, Chair, Federal Election Commission.
    [FR Doc. 2015-18494 Filed 7-28-15; 8:45 am] BILLING CODE 6715-01-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR part 1904 [Docket No. OSHA-2015-0006] RIN 1218-AC84 Clarification of Employer's Continuing Obligation To Make and Maintain an Accurate Record of Each Recordable Injury and Illness AGENCY:

    Occupational Safety and Health Administration (OSHA), Labor.

    ACTION:

    Notice of proposed rule.

    SUMMARY:

    OSHA is proposing to amend its recordkeeping regulations to clarify that the duty to make and maintain accurate records of work-related injuries and illnesses is an ongoing obligation. The duty to record an injury or illness continues for as long as the employer must keep records of the recordable injury or illness; the duty does not expire just because the employer fails to create the necessary records when first required to do so. The proposed amendments consist of revisions to the titles of some existing sections and subparts, and changes to the text of some existing provisions. The proposed amendments add no new compliance obligations; the proposal would not require employers to make records of any injuries or illnesses for which records are not currently required to be made.

    DATES:

    Written comments to this proposed rule must be submitted (postmarked, sent or received) by September 28, 2015. All submissions must bear a postmark or provide other evidence of the submission date.

    ADDRESSES:

    You may submit comments, identified by Docket No. OSHA-2015-0006, by any of the following methods:

    Electronically: You may submit comments and attachments electronically at http://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow the instructions on the Web site for making electronic submissions.

    Fax: If your submission, including attachments, does not exceed ten pages, you may fax it to the OSHA Docket Office at (202) 693-1648. OSHA does not require hard copies of documents transmitted by facsimile. However, if you have supplemental attachments that are not delivered by facsimile, you must submit those attachments, by the applicable deadline, to the OSHA Docket Office, Technical Data Center, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC 20210. Any such attachment must clearly identify the sender's name, the date of submission, the title of the rulemaking (Clarification of Employer's Continuing Obligation to Make and Maintain an Accurate Record of Each Recordable Injury and Illness), and the docket number (OSHA-2015-0006) so that the Docket Office can add the attachment(s) to the appropriate facsimile submission.

    Mail, express mail, hand delivery, messenger, or courier service: You may submit comments to the OSHA Docket Office, Docket Number OSHA-2015-0006, Technical Data Center, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC 20210; telephone: (202) 693-2350. (OSHA's TTY number is (877) 889-5627). Please contact the OSHA Docket Office for information about Department of Labor security procedures that could affect the delivery of materials by express mail, hand delivery, and messenger or courier service. Also note that security-related procedures may delay the Agency's receipt of comments submitted by regular mail. The Docket Office will accept deliveries by hand, express mail, or messenger and courier service during the Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m.

    Instructions for submitting comments: All submissions must include the Agency's name (OSHA), the title of the rulemaking (Clarification of Employer's Continuing Obligation to Make and Maintain an Accurate Record of Each Recordable Injury and Illness), and the docket number (OSHA-2015-0006). OSHA will place comments and other material, including any personal information you provide, in the public docket without revision, and the comments and other materials will be available online at http://www.regulations.gov. Therefore, OSHA cautions you about submitting statements and information that you do not want made available to the public or that contain personal information (about yourself or others) such as Social Security numbers, birthdates, and medical data. For further information on submitting comments, plus additional information on the rulemaking process, see the Public Participation heading in the SUPPLEMENTARY INFORMATION part of this document.

    Docket: To read or download comments or other material in the docket, go to Docket Number OSHA-2015-0006 at http://www.regulations.gov or to the OSHA Docket Office at the address provided previously. The electronic docket for this proposed rule, established athttp://www.regulations.gov, lists all of the documents in the docket. However, some information (e.g., copyrighted material) is not publicly available to read or download through that Web site. All submissions, including copyrighted material, are available for inspection at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions.

    FOR FURTHER INFORMATION CONTACT:

    General information and press inquiries: Press inquiries: Mr. Frank Meilinger, Director, Office of Communications, OSHA, U.S. Department of Labor, Room N-3647, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1999; email [email protected]

    Technical inquiries: Mr. William Perry, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3718, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1950; email [email protected]

    Copies of this Federal Register notice and news releases: Electronic copies of these documents are available at OSHA's Web page at http://www.osha.gov.

    SUPPLEMENTARY INFORMATION: I. Table of Contents I. Table of Contents II. Background A. The OSH Act and OSH Act Violations B. The History and Importance of OSHA's Recordkeeping Regulations C. A Failure To Record a Recordable Illness or Injury is a Continuing Violation D. The D.C. Circuit's Decision in Volks II E. Advisory Committee on Construction Safety and Health III. Legal Authority A. Overview B. The OSH Act authorizes the Secretary To Impose a Continuing Obligation on Employers To Make and Maintain Accurate Records of Work-Related Injuries and Illnesses, and Incomplete or Otherwise Inaccurate Records Create Ongoing, Citable Conditions 1. Section 8(c) of the Act Governs Employers' Recordkeeping Obligations, and That Provision Imposes Continuing Obligations on Employers To Make and Maintain Accurate Records of Work-Related Illnesses and Injuries 2. The OSH Act's Statute of Limitations Does Not Define OSHA Violations, or Address When Violations Occur, Nor Does the Language in Section 9(c) Preclude Continuing Recordkeeping Violations 3. Incomplete or otherwise inaccurate records of work-related illnesses and injuries create an ongoing condition detrimental to full enforcement of the Act. 4. Interpreting the Duty to Record as a Continuing One Under the Act's Civil, Remedial Scheme is Entirely Consistent With the General Case Law IV. Summary and Explanation of the Proposed Rule A. Description of proposed revisions 1. Section 1904.0—Purpose 2. Subpart C—Making and Maintaining Accurate Records, Recordkeeping Forms, and Recording Criteria 3. Paragraph (a) of § 1904.4—Basic requirement 4. Note to paragraph (a) of § 1904.4 5. Paragraph (b)(3) of § 1904.29—How quickly must each injury or illness be recorded? 6. Section 1904.32—Year-end review and annual summary 7. Paragraph (a) of § 1904.32—Basic requirement 8. Paragraph (b)(1) of § 1904.32—How extensively do I have to review the OSHA 300 Log at the end of the year? 9. Section 1904.33—Retention and maintenance of accurate records 10. Paragraph (b)(1) of § 1904.33—Other than the obligation identified in § 1904.32, do I have further recording duties with respect to OSHA 300 Logs and 301 Incident Reports during the five-year retention period? 11. Paragraph (b)(2) of § 1904.33—Do I have to make additions or corrections to the annual summary during the five-year retention period? 12. Paragraph (b)(3) of § 1904.33 13. Paragraph (b)(2) of § 1904.35—Do I have to give my employees and their representatives access to the OSHA injury and illness records? 14. Paragraph (b)(2)(iii) of § 1904.35—If an employee or representative asks for access to the OSHA 300 Log, when do I have to provide it? 15. Subpart E—Reporting Accurate Fatality, Injury, and Illness Information to the Government 16. Section 1904.40—Providing accurate records to government representatives 17. Paragraph (a) of § 1904.40—Basic requirement V. State Plans VI. Preliminary Economic Analysis VII. Regulatory Flexibility Certification VIII. Environmental Impact Assessment IX. Federalism X. Unfunded Mandates XI. Consultation and Coordination With Indian Tribal Governments XII. Public Participation XIII. The Paperwork Reduction Act of 1995 II. Background A. The OSH Act and OSH Act Violations

    The Occupational Safety and Health Act of 1970 (OSH Act or Act) arose out of a Congressional finding that personal injuries and illnesses arising out of work situations impose a substantial burden upon, and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments. See 29 U.S.C. 651(a). Accordingly, the purpose of the statute is to assure so far as possible every working man and woman in the Nation safe and healthful working conditions. See 29 U.S.C. 651(b).

    To effectuate the Act's purpose, Congress authorized the Secretary of Labor to promulgate occupational safety and health standards (29 U.S.C. 655); a standard, as defined in the Act, requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment. See 29 U.S.C. 652(8). The Act also grants broad authority to the Secretary to promulgate regulations related to recordkeeping, employer self-inspections, and keeping employees informed of matters related to occupational safety and health. 29 U.S.C. 657(c). OSHA issues citations and assesses monetary penalties when it finds that employers are not complying with applicable standards and regulations. 29 U.S.C. 658, 659, 666.

    Section 9(c) of the OSH Act contains a statute of limitations providing that no citation may be issued after the expiration of six months following “the occurrence of any violation.” 29 U.S.C. 658(c). Generally, OSH Act violations continue to occur for as long as employees are exposed to the hazard posed by the non-compliant workplace. See Sec'y of Labor v. Cent. of Georgia R.R. Co., 5 BNA OSHC 1209, 1211 (Rev. Comm'n 1977) (explaining that a violation occurs “whenever . . . [a] standard is not complied with and an employee has access to the resulting zone of danger”). Thus, employers have an ongoing obligation to correct conditions that violate OSHA standards and regulations, and under section 9(c), violations are subject to citations and penalties for up to six months after the last instance of employee exposure to the relevant hazard.

    B. The History and Importance of OSHA's Recordkeeping Regulations

    The OSH Act requires the Secretary of Labor to promulgate regulations requiring employers to make and maintain accurate records of work-related injuries and illnesses. 29 U.S.C. 657(c)(1) and (2), 673(a); see also 651(b)(12), 657(g)(2), 673(e). In 1971, the Secretary (via OSHA) issued the first recordkeeping regulations at 29 CFR part 1904. The Agency promulgated revisions to these regulations in 2001 in an effort to improve the quality of workplace injury and illness records by making OSHA's recordkeeping system easier to use and understand. See 66 FR 5916 (January 19, 2001).

    OSHA's recordkeeping regulations require employers to record information about certain injuries and illnesses occurring in their workplaces, and to make that information available to employees, OSHA, and the Bureau of Labor Statistics (BLS). Employers must record work-related injuries and illnesses that meet one or more recording criteria, including injuries and illnesses resulting in death, loss of consciousness, days away from work, restricted work activity or job transfer, medical treatment beyond first aid, or a diagnosis of a significant injury or illness by a physician or other licensed health care professional. 29 CFR 1904.7. Employers must document each recordable injury or illness on an “OSHA 300” form, which is a log of all work-related injuries and illnesses. 29 CFR 1904.29(a) through (b)(1). Employers also must prepare a supplementary “OSHA 301 Incident Report” or equivalent form for each recordable injury and illness; the Incident Reports provide additional details about the injuries and illnesses recorded in the 300 Log. 29 CFR 1904.29(b)(2).

    At the end of each calendar year, employers must review their 300 Logs to verify that the entries are complete and accurate. 29 CFR 1904.32(a)(1). Employers also must correct any deficiencies identified during the annual review. Id. By February 1 of each year, employers must create, certify, and post annual summaries of the cases listed on their 300 Logs for the prior calendar year. 29 CFR 1904.32(a)(2) through (4) and (b)(6). Annual summaries must remain posted until April 30 each year. 29 CFR 1904.32(b)(6). Employers must retain their OSHA Logs, Incident Reports, and annual summaries for five years following the end of the calendar year that they cover. 29 CFR 1904.33(a). During the retention period, employers must update their 300 Logs to include newly discovered recordable cases and to show any changes in the classification, description, or outcome of previously-recorded cases. 29 CFR 1904.33(b)(1). The regulations do not require employers to update Incident Reports or annual summaries during the retention period. 29 CFR 1904.33(b)(2) and (3).

    Accurate injury and illness records serve several important purposes. See 66 FR at 5916-17, January 19, 2001. One purpose is to provide information to employers. The information in the OSHA-required records makes employers more aware of the kinds of injuries and illnesses occurring and the hazards that cause or contribute to them. When employers analyze and review the information in their records, they can identify and correct hazardous workplace conditions. Injury and illness records are essential for employers to effectively manage their safety and health programs; these records permit employers to track injuries and illnesses over time so they can evaluate the effectiveness of protective measures implemented in response to identified hazards.

    Similarly, employees—who have access to OSHA injury and illness records throughout the five-year retention period (see 29 CFR 1904.35)—can use information about the occupational injuries and illnesses occurring in their workplaces to become better informed about, and more alert to, the hazards they face. Employees who are aware of the hazards around them may be more likely to follow safe work practices and to report workplace hazards to their employers. When employees are aware of workplace hazards, and participate in the identification and control of those hazards, the overall level of safety and health in the workplace can improve.

    OSHA also has access to employer injury and illness records during the retention period (see 29 CFR 1904.40 and 1904.41), and these records are an important source of information for the Agency and enhance the Agency's enforcement efforts. During the initial stages of an inspection, an OSHA representative reviews the employer's injury and illness data so that the Agency can focus its inspection on the hazards revealed by the records. In some years, OSHA has also surveyed a subset of employers covered by the OSH Act for their injury and illness data, and used that information to help identify the most dangerous types of worksites and the most prevalent types of safety and health hazards.

    Additionally, BLS uses data derived from employers' injury and illness records to develop national statistics on workplace injuries and illnesses. These statistics include information about the source, nature, and type of the injuries and illnesses that are occurring in the nation's workplaces. To obtain the data to develop national statistics, BLS and participating State agencies conduct an annual survey of employers in almost all sectors of private industry. BLS makes the aggregate survey results available for research purposes and for public information. This data provides information about the incidence of workplace injuries and illnesses and the nature and magnitude of workplace safety and health problems. Congress, OSHA, and safety and health policymakers in Federal, State, and local governments use BLS statistics to make decisions concerning safety and health legislation, programs, and standards. And employers and employees can use BLS statistics to compare the injury and illness data from their workplaces with data from the nation as a whole.

    C. A Failure To Record a Recordable Illness or Injury is a Continuing Violation

    A continuing violation exists when there is noncompliance with “the text of . . . [a] pertinent law [that] imposes a continuing obligation to act or refrain from acting.” Earle v. Dist. of Columbia, 707 F.3d 299, 307 (D.C. Cir. 2012). Where there is an ongoing obligation to act, each day the action is not taken results in a continuing, ongoing violation. In other words, “a new claim accrues each day the violation is extant.” Interamericas Inv., Ltd. v. Fed. Reserve Sys., 111 F.3d 376, 382 (5th Cir. 1997). For example, in United States v. Edelkind, 525 F.3d 388 (5th Cir. 2008), the Fifth Circuit found that the crime of willfully failing to pay child support as required by federal law was a continuing offense because “each day's acts . . . [brought] a renewed threat of the substantive evil Congress sought to prevent.” Id. at 394-95 (internal quotation marks and citations omitted). And in Postow v. OBA Federal Savings & Loan Association, 627 F.2d 1370 (D.C. Cir. 1980), the D.C. Circuit held that a lender's failure to provide required disclosures to borrowers was a continuing violation of the Truth-in-Lending Act because the violation subverted the goals of the statute every day the borrowers did not have the information. Id. at 1379-80. See, also, e.g., United States v. Bailey, 444 U.S. 394, 413 (1980) (escape from federal custody is a continuing offense in light of “the continuing threat to society posed by an escaped prisoner”); United States v. George, 625 F.3d 1124 (9th Cir. 2010) (failure to comply with statute requiring registration as a sex offender is a continuing offense), vacated on other grounds, 672 F.3d 1126 (9th Cir. 2012); United States v. Franklin, 188 F.2d 182 (7th Cir. 1951) (Alien Registration Act imposes ongoing registration obligation; failure to register is a continuing violation).

    Recordkeeping violations under the OSH Act are likewise continuing violations. OSHA's longstanding position is that an employer's duty to record an injury or illness continues for the full duration of the record-retention-and-access period, i.e., for five years after the end of the calendar year in which the injury or illness became recordable. This means that if an employer initially fails to record a recordable injury or illness, the employer still has an ongoing duty to record that case; the recording obligation does not expire simply because the employer failed to record the case when it was first required to do so. As long as an employer fails to comply with its ongoing duty to record an injury or illness, there is an ongoing violation of OSHA's recordkeeping requirements that continues to occur every day employees work at the site. Therefore, OSHA can cite employers for such recordkeeping violations for up to six months after the five-year retention period expires without running afoul of the OSH Act's statute of limitations.1

    1 Of course, OSHA may not issue a citation more than six months after the employer corrects the violation. See, e.g. , Sec'y of Labor v. Manganas Painting Co., 21 BNA OSHC 2043, 2048 (Rev. Comm'n 2007) (citation was time-barred where the employer abated the violation more than six months prior to the issuance date).

    The Occupational Safety and Health Review Commission has upheld OSHA's position on the continuing nature of recordkeeping violations. See, e.g., Sec'y of Labor v. Gen. Dynamics, 15 BNA OSHC 2122 (Rev. Comm'n 1993) (recordkeeping violations “occur” at any point during the retention period when records are inaccurate, so citations for those violations are not barred simply because they are issued more than six months after the obligation to record first arose); Sec'y of Labor v. Johnson Controls, Inc., 15 BNA OSHC 2132 (Rev. Comm'n 1993) (recordkeeping violations continue until correction or expiration of the retention period). The Commission addressed this issue most recently in Secretary of Labor v. AKM LLC (Volks I), 23 BNA OSHC 1414 (Rev. Comm'n 2011), confirming that an employer's failure to make a required OSHA record is a continuing violation, and that an uncorrected violation continues until the employer is no longer required to keep OSHA records for the year at issue.

    D. The D.C. Circuit's Decision inVolks II

    A panel of the D.C. Circuit reviewed the Commission's Volks I decision, and on April 6, 2012, issued a decision—Volks II—reversing the Commission. AKM LLC v. Sec'y of Labor (Volks II), 675 F.3d 752 (D.C. Cir. 2012). The majority opinion in Volks II disagreed with the Commission and held that “the . . . language in [the OSH Act] . . . which deals with record-keeping is not authorization for OSHA to cite the employer for a record-making violation more than six months after the recording failure.” Id. at 758. According to the majority opinion, OSHA must cite an employer for failing to record an injury or illness within six months of the first day on which the regulations require the recording; a citation issued later than that is barred by the OSH Act's statute of limitations. Id. at 753-59.

    In a separate concurring opinion in Volks II, Judge Garland recognized that the OSH Act allows for continuing violations of recordkeeping requirements. He concluded, however, that the specific language in OSHA's existing recordkeeping regulations does not implement this statutory authority and does not create continuing recordkeeping obligations. Id. at 759-64. No other appellate court has ruled on these issues.

    The Volks II decision has led to a need for OSHA to clarify employers' obligations under its recordkeeping regulations and to elaborate on its understanding of the statutory basis for those obligations. The Agency is proposing changes to its recordkeeping regulations to clarify that the duty to make and maintain an accurate record of a work-related illness or injury is an ongoing obligation that continues until the required record is made or until the end of the record-retention-and-access period prescribed by the regulations. To that end, OSHA is proposing revisions to the titles of some existing sections and subparts in part 1904, and changes to the text of some existing recordkeeping requirements. The Agency describes the proposed changes in SUPPLEMENTARY INFORMATION, Section IV, later in this notice.

    E. Advisory Committee on Construction Safety and Health

    OSHA consulted with the Advisory Committee on Construction Safety and Health (ACCSH) on this rulemaking. The Agency provided ACCSH with a summary and explanation of this proposal and a statement regarding the need for the proposed revisions to 29 CFR part 1904. On December 4, 2014, ACCSH voted to recommend that OSHA proceed with this proposal.

    III. Legal Authority A. Overview

    As explained previously, in SUPPLEMENTARY INFORMATION, Section II.A, the OSH Act authorizes the Secretary of Labor to issue “standards” and other “regulations.” See, e.g., 29 U.S.C. 655, 657. An occupational safety and health standard, issued pursuant to section 6 of the Act, prescribes measures to be taken to remedy an identified occupational hazard. Other regulations, issued pursuant to general rulemaking authority found, inter alia, in section 8 of the Act, establish enforcement or detection procedures designed to further the goals of the Act generally. 29 U.S.C. 657(c); Workplace Health and Safety Council v. Reich, 56 F. 3d 1465, 1468 (D.C. Cir. 1995). The proposed amendments are to a regulation issued pursuant to authority expressly granted by sections 8 and 24 of the Act. 29 U.S.C. 657, 673. They simply clarify existing duties under part 1904, and do not impose any new substantive recordkeeping requirements. Numerous provisions of the OSH Act both underscore Congress' acknowledgement that accurate injury and illness records are a critical component of the national occupational safety and health program and give the Secretary broad authority to enact recordkeeping regulations that create a continuing obligation for employers to make and maintain accurate records of work-related illnesses and injuries. Section 2(b)(12) of the Act states that one of the purposes of the OSH Act is to assure, so far as possible, safe and healthful working conditions by providing for appropriate reporting procedures that will help achieve the objectives of the Act and “accurately describe” the nature of the occupational safety and health problem. See 29 U.S.C. 651(b)(12). Section 8(c)(1) requires each employer to “make, keep and preserve” and “make available” to the Secretary such records prescribed by regulation as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational accidents and illnesses. See 29 U.S.C. 657(c)(1). Section 8(c)(2) requires the Secretary to prescribe regulations requiring employers to “maintain accurate records” of, and to make periodic reports on, work-related deaths, injuries and illnesses. See 29 U.S.C. 657(c)(2). Section 8(g)(2) of the Act generally empowers the Secretary to prescribe such rules and regulations as he may deem necessary to carry out his responsibilities under the Act. See 29 U.S.C. 657(g)(2). Section 24(a) requires the Secretary to develop and maintain an effective program of collection, compilation and analysis of occupational safety and health statistics and to compile accurate statistics on work injuries and illnesses. See 29 U.S.C. 673(a). Section 24(e) provides that on the basis of the records made and kept pursuant to section 8(c) of the Act, employers must file such reports with the Secretary that the Secretary prescribes by regulation as necessary to carry out his functions under the Act. See 29 U.S.C. 673(e). Some of these provisions will be addressed more thoroughly in SUPPLEMENTARY INFORMATION, Section III.B, later in this notice.

    B. The OSH Act Authorizes the Secretary To Impose a Continuing Obligation on Employers To Make and Maintain Accurate Records of Work-Related Injuries and Illnesses, and Incomplete or Otherwise Inaccurate Records Create Ongoing, Citable Conditions 1. Section 8(c) of the Act Governs Employers' Recordkeeping Obligations, and That Provision Imposes Continuing Obligations on Employers To Make and Maintain Accurate Records of Work-Related Illnesses and Injuries

    “Whether [an] . . . obligation is continuing is a question of statutory construction,” Earle, 707 F.3d at 307. The express language of the OSH Act readily supports a continuing violation theory in recordkeeping cases. And, section 8(c) grants the Secretary broad authority to issue requirements he considers “necessary or appropriate,” including recordkeeping regulations that provide that an employer's duty to make records of injuries and illnesses is an ongoing obligation. 29 U.S.C. 657(c).

    Section 8(c)(2) requires the Secretary to prescribe regulations requiring employers to “maintain accurate records” of work-related deaths, injuries and illnesses. See 29 U.S.C. 657(c)(2) (emphasis added). And section 8(c)(1) requires employers to “make, keep and preserve” and to “make available” records that the Secretary identifies as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational accidents and illnesses. See 29 U.S.C. 657(c)(1) (emphasis added). The language Congress used in these provisions therefore authorizes the Secretary to require employers to have on hand and make available records that accurately reflect all of the recordable injuries and illnesses that occurred during the years for which the Agency requires the keeping of records. And this statutory language also is inconsistent with any suggestion that Congress intended the duty to record an injury or illness to be a discrete obligation that expires if the employer fails to comply on the first day the Agency's regulations require recording.

    Moreover, the words “accurate” and “maintain” in section 8(c)(2) of the Act connote a continued course of conduct that includes an ongoing obligation to create records. The word “maintain” means to “[c]ause or enable (a condition or state of affairs) to continue,” an example being when one works to ensure that something stays “in good condition or in working order by checking or repairing it regularly.” http://www.oxforddictionaries.com/us/definition/american_english/maintain?searchDictCode=all. “Maintain” is also synonymous with “keep.” http://thesaurus.com/browse/maintain. In ordinary speech, an instruction to “keep records” of something requires both creating and preserving the records, and may include organizing and managing them as well. Therefore, “maintain” plainly implies an ongoing action. See, e.g., Carey v. Shiley, Inc., 32 F.Supp.2d 1093, 1103 (S.D. Iowa 1998) (“continuing duty to maintain records for” the Food and Drug Administration). And “accurate” means “conforming exactly to truth,” and is synonymous with “exact.”http://www.meriam-webster.com/dictionary/accurate. See also, e.g., Huntington Sec. Corp. v. Busey, 112 F.2d 368, 370 (6th Cir. 1940) (noting that the term “ `accurately' . . . in its ordinary use[ ] means precisely, exactly correctly, without error or defect”). Therefore, the OSH Act's call for regulations requiring employers to “maintain accurate [injury and illness] records” is a mandate for the Secretary to impose an ongoing or continuing duty on employers to have (or keep) true or exact documentation of recordable incidents. An employer cannot be said to have (or to be keeping or maintaining) accurate (or true or exact) records of injuries and illnesses for a particular calendar year if there are recordable injuries or illnesses that occurred during that year that are missing from those records. Put simply, the Secretary cannot fulfill the statutory obligation of ensuring that employers “maintain” (or keep) “accurate records” without imposing on employers an ongoing duty to create records for injuries and illnesses in the first place; a duty to make and maintain accurate records inherently implies an ongoing obligation to create the records that must be maintained.

    The Fourth Circuit recognized as much in Sierra Club v. Simkins Industries, 847 F.2d 1109, 1115 (4th Cir. 1988), a Clean Water Act case, when it refused to allow a company to defend against its failure to file and retain water sampling records on the grounds that it never collected the data it needed to create the records in the first place. The court ruled that an ongoing duty to maintain records implies a corresponding, and continuing, duty to have those records, explaining that it would not allow the company “to escape liability . . . by failing at the outset to sample and to create and retain the necessary . . . records.” Id. See also, e.g., Big Bear Super Mkt. No. 3 v. INS, 913 F.2d 754, 757 (9th Cir. 1990) (per curiam) (statutory and regulatory scheme described by the court as requiring companies to “maintain” documents is interpreted to impose a “continuing duty” on those companies “to prepare and make” the documents in the first instance); Park v. Comm'r of Internal Revenue, 136 T.C. 569, 574 (U.S. Tax Ct. 2011) (noting that a party that did not create required records thereby failed to “keep” those records), rev'd and remanded on other grounds, 722 F.3d 384 (D.C. Cir. 2013).

    The “make, keep, and preserve” and “make available” language in section 8(c)(1) similarly envisions a continuing duty to record and provides additional support for the Agency's interpretation of the “maintain accurate records” language in section 8(c)(2). The corresponding authorization to the Secretary to prescribe such recordkeeping regulations as he considers “necessary or appropriate” emphasizes the breadth of the Secretary's discretion in implementing the statute. As mentioned previously, “keep” is a synonym for “maintain,” and both words imply a continued course of conduct, as of course does “preserve.” 2 See e.g., Powerstein v. Comm'r of Internal Revenue, T.C. Memo 2011-271, 2011 WL 5572600, at *13 (U.S. Tax Ct. Nov. 16, 2011) (interpreting statutory and regulatory requirements to “keep” tax records to mean that taxpayers must “maintain” such records); Freedman v. Comm'r of Internal Revenue, T.C. Memo 2010-155, 2010 WL 2942167, at *1 (U.S. Tax Ct. July 21, 2010) (same).

    2 The legislative history of the OSH Act shows that Congress used “keep” and “maintain” synonymously. In a Senate Report, Congress described section 8(c)(2)—which talks about “maintaining” records—as “requiring employers to keep records of all work-related injuries and diseases.” S. Rep. No. 91-1282, at 31 (1970), reprinted in Subcomm. on Labor of the Comm. on Labor and Public Welfare, Legislative History of the Occupational Safety and Health Act of 1970, at 171 (1971) (emphasis added).

    The fact that Congress included the word “make” in a phrase with two other terms that both call for a continuing action suggests that “make” was also intended to signify a continuing course of conduct in the recordkeeping context. The most reasonable reading of section 8(c)(1), particularly in light of the “maintain accurate records” language in section 8(c)(2), is that the phrase “make, keep, and preserve” authorizes one continuous recordkeeping requirement that includes both the creation and the keeping of records. See, e.g., Davis v. Michigan Dep't of Treasury, 489 U.S. 803, 809 (1989) (noting a “fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme”).

    Thus, the Secretary does not believe that section 8(c) authorizes two and only two discrete duties: A duty to create a record that can arise at only one moment in time, and a duty to preserve that record, if it should be created. Such a view would be inconsistent with the most relevant provision of the Act, section 8(c)(2), which is the provision that specifically addresses the Secretary's authority to prescribe regulations for injury and illness recordkeeping, i.e., to prescribe regulations that require employers to “maintain accurate records” of workplace illnesses and injuries. Nothing about the Congressional direction to “maintain accurate records” is naturally read as creating two entirely discrete obligations, or as conveying Congressional intent to limit the duty to make a required record to a single point in time. Records that omit work-related injuries and illnesses are not accurate, and no purpose is served by maintaining inaccurate records. Instead, Congress intended employees, and the Secretary, to have access to accurate information about injuries and illnesses occurring in workplaces.

    The requirement in section 8(c)(1) that employers “make available” such records as the Secretary prescribes regarding accidents and illnesses further illustrates that section 9(c)'s statute of limitations does not limit the Secretary to acquiring only six months of injury and illness data. A regulation requiring employers, if requested, to make available accurate records showing injuries and illness that have occurred within the past few years is on its face well within the OSH Act's grant of authority. Nothing in the statutory language suggests that the Secretary can only require employers to provide information regarding work-related injuries and illnesses that have occurred within the past six months. Such a limitation would cripple the Agency's ability to gather complete information and to improve understanding of safety and health issues, contrary to Congressional intent. Furthermore, the duty to make accurate multi-year records available upon request arises when the request is made, and the statute of limitations therefore does not begin to run until the request is made and the employer fails to comply.3

    3 This does not mean that the Secretary's authority is unconstrained. Under section 8(c)(1), the records the Secretary requires must be “necessary or appropriate” to enforcement of the Act or to gathering information regarding the causes or prevention of occupational accidents or illnesses. 29 U.S.C. 657(c)(1). Under section 8(d), the Secretary must obtain information with a minimum burden on employers, especially small businesses, and reduce unnecessary duplication to the maximum extent feasible. 29 U.S.C. 657(d). Moreover, under the Paperwork Reduction Act, the Secretary and the Office of Management and Budget must determine that a recordkeeping requirement will have practical utility and will not be unduly burdensome. 44 U.S.C. 3506(c)(3).

    It therefore follows that section 8(c) of the Act authorizes the Secretary to enact regulations that impose a continuing obligation on employers to make and maintain accurate records of work-related illnesses and injuries. Not only are such recordkeeping regulations expressly called for by the language of section 8(c), but they are also consistent with Congressional intent and the purpose of the OSH Act. The Supreme Court recognizes a “familiar canon of statutory construction that remedial legislation should be construed broadly to effectuate its purposes.” Tcherepnin v. Knight, 389 U.S. 332, 336 (1967). And reading the statute in light of its protective purposes further supports the Secretary's interpretation that the Act calls for treating the duty to record injuries and illnesses as a continuing obligation. See, e.g., United States v. Advance Mach. Co., 547 F.Supp. 1085, 1090-91 (D.Minn. 1982) (requirement in Consumer Product Safety Act to “immediately inform” the government of product defects is read as creating a continuing obligation to report because any other reading would frustrate the statute's goal of protecting the public from hazards).

    Finally, the legislative history of the OSH Act also demonstrates that Congress wanted employers to have accurate injury and illness records both for the purpose of making workplaces safer and healthier, and for the purpose of allowing the Agency to study the nation's occupational safety and health problems. As the House Committee on Education and Labor noted, before passage of the OSH Act it was impossible to know the extent of national occupational safety and health issues due to variability in state reporting measures; thus, Congress viewed it as an “evident Federal responsibility” to provide for “[a]ccurate, uniform reporting standards.” H.R. Rep. No. 91-1291, at 15 (1970), reprinted in Subcomm. on Labor of the Comm. on Labor and Public Welfare, Legislative History of the Occupational Safety and Health Act of 1970, at 845 (1971). See also 29 U.S.C. 673(a) (“The Secretary shall compile accurate statistics on work injuries and illnesses . . . .”); Sec'y of Labor v. Gen. Motors Corp., 8 BNA OSHC 2036, 2039 (Rev. Comm'n 1980) (“Examination of the legislative history of [sections 8(c)(1) and 8(c)(2)] . . . shows a clear congressional intent that th[e] reporting requirement be interpreted broadly in order to develop information for future scientific use.”).

    2. The OSH Act's Statute of limitations Does Not Define OSHA Violations, or Address When Violations Occur, Nor Does the Language in Section 9(c) Preclude Continuing Recordkeeping Violations

    As explained previously, it is section 8(c) of the OSH Act that determines the nature and scope of employers' recordkeeping obligations. The statute of limitations in section 9(c) deals only with the question of when OSHA can cite a violation; it says nothing about what constitutes a violation, or when a violation occurs. A violation is a breach of a duty, and the question of what duties the Secretary may prescribe must logically be dealt with prior to addressing the statute of limitations. Section 9(c) cannot be read as prohibiting the Secretary from imposing continuing recordkeeping obligations on employers covered by the OSH Act, when the text and legislative history of the Act show that section 8(c) authorizes the Secretary to create such obligations. Thus, the OSH Act's statute of limitations simply sets the period within which legal action must be taken after the obligation ceases to continue or the employer comes into compliance. See, e.g., Inst. For Wildlife Prot. v. United States Fish & Wildlife Serv., No. 07-CV-358-PK, 2007 WL 4117978, at *6 (D.Or. Nov. 16, 2007) (declining to apply applicable statute of limitations to “nullify . . . [the government's] ongoing duty to designate critical habitat” for an endangered species “and . . . insulate the agency from challenges to any continued inaction”).

    In any event, “statutes of limitation in the civil context are to be strictly construed in favor of the Government against repose,” Interamericas, 111 F.3d at 382 (citing Badaracco v. Comm'r of Internal Revenue, 464 U.S. 386 (1984) and E.I. Dupont De Nemours & Co. v. Davis, 264 U.S. 456 (1924)), and nothing in section 9(c) precludes continuing violations in recordkeeping cases. To the contrary, the language in section 9(c) is very broad, providing only that “[n]o citation may be issued . . . after the expiration of six months following the occurrence of any violation.” 29 U.S.C. 658(c). The “occurrence” of something is not necessarily a discrete event; it can encompass actions or events that continue over time. For example, one dictionary defines “occurrence” as “the existence or presence of something.” http://dictionary.cambridge.org/dictionary/american-english/occurrence_2. See also, e.g., PECO Energy Co. v. Boden, 64 F.3d 852, 856-57 (3d Cir. 1995) (scheme of repeated thefts over the span of six years constituted a single “occurrence” such that only one insurance deductible applied to the resulting loss). Similarly, the term “occurrence of any violation” in section 9(c) does not mean that an OSHA violation is necessarily a discrete event that takes place at one, and only one, point in time.

    Had Congress wanted the statute of limitations to run from the time a violation first occurred, it could have used language so stating. Indeed, Congress has used language more readily susceptible to that interpretation in other statutes. See, e.g., the Multiemployer Pension Plans Amendments Act, 29 U.S.C. 1451(f)(1) (statute of limitations runs from “the date on which the cause of action arose”); the Federal Employers' Liability Act, 45 U.S.C. 56 (statute of limitations runs from “the day the cause of action accrued”); the general statute of limitations governing civil actions against the United States, 28 U.S.C. 2401(a) (claims barred unless “filed within six years after the right of action first accrues”).

    Neither OSHA nor the Commission has ever treated section 9(c) as precluding continuing violations. Indeed, continuing violations are common in the OSHA context, with the Commission taking the position that violations of OSHA requirements, including recordkeeping violations, generally continue as long as employees are exposed to the non-complying conditions. See, e.g., Sec'y of Labor v. Arcadian Corp., 20 BNA OSHC 2001 (Rev. Comm'n 2004) (violation of the OSH Act's general duty clause stemming from the unsafe operation of a urea reactor); Johnson Controls, 15 BNA OSHC 2132 (recordkeeping); Sec'y of Labor v. Safeway Store No. 914, 16 BNA OSHC 1504 (Rev. Comm'n 1993) (hazard communication program and material safety data sheets); Sec'y of Labor v. Yelvington Welding Serv., 6 BNA OSHC 2013 (Rev. Comm'n 1978) (fatality reporting); Cent. of Georgia R.R., 5 BNA OSHC 1209 (housekeeping). Indeed, the Volks II panel also acknowledged that the duties to preserve records, to train employees, and to correct unsafe machines may continue. 675 F.3d 756, at 758. The OSH Act simply would not achieve Congress' fundamental objectives if basic employer obligations were not continuing.

    These cases reflect fundamental OSH Act principles. Safety and health standards are rules that require, inter alia, “conditions.” 29 U.S.C. 652(8). The absence of a required condition violates the standard. It does not matter when the absence first arose or how long it has persisted. If a condition is required and is not present (e.g., a machine is not guarded or a hazardous materials container is not labeled), a violation occurs and a citation requiring abatement may be issued within six months of the observed noncompliance. This construction follows from the language of the Act and is essential to the Secretary's ability to enforce compliance. Accordingly, continuing obligations and violations are a regular occurrence under the OSH Act. Nothing in section 9(c), which applies equally to standards and recordkeeping violations, bars them.

    In addition, continuing violations have been found to exist under other laws with statutes of limitations that contain language similar to that in section 9(c) of the OSH Act. For example, in National Railroad Passenger Corporation v. Morgan, 536 U.S. 101 (2002), the Supreme Court addressed the statute of limitations in Title VII of the Civil Rights Act of 1964, which precludes the filing of claims a certain number of days after the alleged unlawful employment practice “occurred.” See 42 U.S.C. 2000e-5(e)(1). The Court concluded that the statute authorized application of a continuing violations doctrine in hostile work environment cases, holding that in such cases, an unlawful employment action can “occur” over a series of days or even years. Morgan, 536 U.S. at 116-20. Similarly, in Havens Realty Corporation v. Coleman, 455 U.S. 363 (1982), the Supreme Court found continuing violations of the Fair Housing Act, which at the time required the commencement of civil actions within 180 days “after the alleged discriminatory housing practice occurred.” And in Postow, 627 F.2d 1370, the D.C. Circuit found a continuing violation of the Truth-in-Lending Act, which, at 15 U.S.C. 1640(e), provides that actions must be brought within one year from the date of the “occurrence” of the violation. The language of section 9(c) of the OSH Act is at least equally receptive to continuing violations, since it allows citation within six months of “the occurrence of any violation.” “Occurrence” of “any” violation is open-ended language that does not suggest that a violation can exist at only one moment of time.

    Notably, even the Volks II panel appeared to recognize that the word “occurrence” does not necessarily have a single fixed meaning, stating that “[o]f course, where . . . a company continues to subject its employees to unsafe machines . . . or continues to send its employees into dangerous situations without appropriate training . . . OSHA may be able to toll the statute of limitations on a continuing violations theory since the dangers created by the violations persist.” 675 F.3d at 758. The court also stated that a violation of the record-retention requirement—through the loss or destruction of a previously-created record—is a violation that continues from the time of the loss or destruction until the conclusion of the five-year retention period. Id. at 756.

    Moreover, continuing violations have been found even under statutes of limitations that contain language that is arguably less receptive to continuing violations than section 9(c); courts implicitly recognize that the underlying legal requirement, not the statute of limitations, determines whether there is a continuing legal obligation. For example, courts have found continuing violations of various laws that are governed by the general five-year statute of limitations for criminal cases in 18 U.S.C. 3282(a), which requires initiation of an action “within five years . . . after . . . [the] offense shall have been committed.” See, e.g., United States v. Bell, 598 F.3d 366, 368-69 (7th Cir. 2010) (continuing violation of child support payment requirements), overruled on other grounds, United States v. Vizcarra, 668 F.3d 516 (7th Cir. 2012); Edelkind, 525 F.3d 388 (same); United States v. Are, 498 F.3d 460 (7th Cir. 2007) (crime of being found in the United States after deportation is a continuing violation).

    The D.C. Circuit has suggested that suits alleging a continuing failure to act are permissible even under the general statute of limitations governing civil actions against the United States (28 U.S.C. 2401(a)), which provides that claims are barred unless “filed within six years after the right of action first accrues.” Wilderness Soc'y v. Norton, 434 F.3d 584 (D.C. Cir. 2006). In Wilderness Society, the court intimated, but did not decide, that an agency's failure to act in accordance with a statutory deadline for action was a continuing violation, such that a lawsuit to compel agency action would not be time barred just because it was filed more than six years after the agency first missed the statutory deadline. The court explained that because the suit “ `does not complain about what the agency has done but rather about what the agency has yet to do,' ” it likely would not be time-barred. Id. at 589 (quoting In re United Mine Workers of America Int'l Union, 190 F.3d 545, 549 (D.C. Cir. 1999)). See also, e.g., Padres Hacia Una Vida Mejor v. Jackson, No. 1:11-CV-1094 AWI DLB, 2012 WL 1158753 (E.D. Cal. April 6, 2012) (28 U.S.C. 2401(a) did not bar a claim based on EPA's ongoing failure to act on complaints of discrimination within regulatory deadlines). And the Fifth Circuit found continuing violations of the Bank Holding Company Act in a case governed by the general statute of limitations in 28 U.S.C. 2462, which requires actions to enforce civil fines, penalties, or forfeitures to be “commenced within five years from the date when the claim first accrued.” Interamericas, 111 F.3d 376. See also, e.g., Newell Recycling Co. v. EPA, 231 F.3d 204 (5th Cir. 2000) (finding a continuing violation of disposal requirements for polychlorinated biphenyls under the Toxic Substances Control Act in a case involving the general statute of limitations at 28 U.S.C. 2462); Advance Mach Co., 547 F.Supp. 1085 (finding a continuing violation of the Consumer Product Safety Act in a case governed by 28 U.S.C. 2462); 4 cf. Capital Tel. Co v. FCC, 777 F.2d 868, 871 (2d Cir. 1985) (per curiam) (deferring to FCC determination that company's “actions constituted a `continuing violation' ” despite an applicable statute of limitations (47 U.S.C. 415(b)) requiring the filing of complaints “within two years from the time the cause of action accrues”).

    4 In Gabelli v. SEC, 133 S.Ct. 1216 (2013)—a case involving a civil enforcement action under the Investment Advisers Act—the Supreme Court held that the five-year statute of limitations in 28 U.S.C. 2462 ran from the date a fraud was complete, not from the date the government discovered the fraud. Gabelli does not, however, stand for the proposition that the language in 28 U.S.C. 2462 precludes application of a continuing violation theory. In Gabelli, the government agreed that the alleged illegal activity ended more than five years prior to the filing of the complaint, so there was no issue about the duration of the violative conduct.

    Finally, concerns about stale claims have little bearing on OSHA recordkeeping cases. The Agency recognizes that statutes of limitations are designed to “keep stale claims out of the courts.” Havens Realty, 455 U.S. at 380. They protect parties from having to defend against stale claims and ensure that courts are not faced with “adjudicat[ing] claims that because of their staleness may be impossible to resolve with even minimum accuracy.” Stephan v. Goldinger, 325 F.3d 874, 876 (7th Cir. 2003). Claims generally are considered stale when so much time has passed that relevant evidence has been lost and witnesses are no longer available or do not have reliable memories of the relevant occurrence. Id. But “[w]here the challenged violation is a continuing one, the staleness concern disappears.” Havens Realty, 455 U.S. at 380. And nothing about continuing violations in the context of OSHA recordkeeping violations undermines this general principle.

    In the vast majority of OSHA cases stemming from an employer's failure to record an injury or illness, the issues will be very straightforward. The first question will be whether a work-related injury or illness occurred that required more than a minimum level of treatment. And the second question will be whether the employer recorded the injury or illness as required by the OSHA regulations. The availability of evidence and witnesses should not be a problem on either question—especially given that even under a continuing violation theory, OSHA must cite the recordkeeping violation within six months after the end of the five-year retention period for injury and illness records.

    One can ordinarily ascertain whether an injury or illness occurred, and what treatment was necessary, by looking at medical reports, workers' compensation documents, and other relevant records, even if the affected employee or other witnesses are no longer available. In fact, OSHA's Recordkeeping Policies and Procedure Manual, CPL 02-00-135 (Dec. 30, 2004), directs compliance officers to review medical records to determine whether an employer has failed to enter recordable injuries and illnesses on the OSHA forms. And with respect to whether the employer recorded the injury or illness, the only evidence the parties and the court will need are the employer's OSHA Log and Incident Report Forms, which existing regulations require employers to maintain for five years. Furthermore, given that OSHA ultimately bears the burden of proving that an injury or illness occurred and the employer did not record it, the absence of documents and witnesses generally will be more prejudicial to OSHA's case than to the employer's defense. And, any limited staleness concerns that exist are outweighed by the fact that ongoing recordkeeping requirements are essential to fulfilling the purposes of the OSH Act. See generally Connecticut Light & Power Co. v. Sec'y of Labor, 85 F.3d 89, 96 (2d Cir. 1996) (“Consideration of limitations periods requires a fair and reasonable weighing of the conflicting concerns of the remedial intent of the [statute] . . . and the desire to keep stale claims out of the courts.”).

    3. Incomplete or Otherwise Inaccurate Records of Work-Related Illnesses and Injuries Create an Ongoing Condition Detrimental to Full Enforcement of the Act

    OSHA records “are a cornerstone of the Act and play a crucial role in providing the information necessary to make workplaces safer and healthier.” Gen. Motors Corp., 8 BNA OSHC at 2041. As explained previously, in SUPPLEMENTARY INFORMATION, Section II.B, employers must give employees (as well as OSHA and BLS) access to injury and illness records. OSHA injury and illness records are designed to be used by employers, employees, and the government to learn about the injuries and illnesses that are occurring in American workplaces. Accurate OSHA injury and illness records enable employers to identify, and correct, hazardous conditions, allow employees to learn about the hazards they face, and permit the government to determine where and why injuries are occurring so that appropriate regulatory or enforcement measures can be taken. (See SUPPLEMENTARY INFORMATION, Section II.B, earlier in this preamble, for a full discussion of the purposes served by OSHA injury and illness records.) Thus, Congress viewed accurate records as necessary for the enforcement of the Act. 29 U.S.C. 657(c). Inaccurate or incomplete injury and illness records, however, will leave all of the relevant parties underinformed, and thereby create an ongoing condition detrimental to full enforcement of the Act. The Commission has recognized as much. See, e.g., Gen. Dynamics, 15 BNA OSHC at 2131 n. 17 (recordkeeping regulations “clearly are safety- and health-related”); Johnson Controls, 15 BNA OSHC at 2135-36 (“[A] failure to record an occupational injury or illness . . . does not differ in substance from any other condition that must be abated pursuant to . . . occupational safety and health standards . . . .”).

    Nor is there any meaningful distinction to be drawn between cases involving inadequate training or unsafe machines (which may be seen as involving repeated affirmative acts, for example, sending untrained employees to work in hazardous conditions) and recordkeeping cases (which may be seen as failures to right past wrongs). The lack of access—by employers, employees and OSHA—to accurate records is as much an ongoing non-complying condition under the Act as is an untrained employee or an unguarded machine. Whether the condition was created by an act of omission or of commission, the condition is one that continues to violate the Act until it is abated.

    Moreover, under the scheme Congress established in the OSH Act, any distinction that can be drawn between overt action and inaction lacks legal significance. As the Commission recognizes, “unlike other federal statutes in which an overt act is needed to show any violation, the OSH Act penalizes both overt acts and failures to act in the face of an ongoing, affirmative duty to perform prescribed obligations.” Volks I, 23 BNA OSHC at 1417 n.3 (emphasis in original). See also, e.g., Gen. Dynamics, 15 BNA OSHC at 2130 (“[T]he Act penalizes the occurrence of noncomplying conditions which are accessible to employees and of which the employer knew or reasonably could have known. That is the only `act' that the Secretary must show to prove a violation.”). That is why it is still a citable violation if an employer has left a hazardous machine unguarded for years—even though the employer has not done anything to the machine since first removing the guard. That is why it is a violation if an employer fails to label containers of hazardous chemicals or have safety data sheets on hand, regardless how long the inaction persists. And courts regularly find that a failure to act in accordance with an ongoing legal obligation constitutes a continuing violation. Such cases have included a lender's failure to make required disclosures to a borrower (Postow, 627 F.2d 1370), a sex offender's failure to register with authorities (George, 625 F.3d 1124), a parent's failure to pay child support (Edelkind, 525 F.3d 388), an agency's failure to comply with statutory mandates and deadlines (Wilderness Soc'y, 434 F.3d 584), a company's failure to create and maintain water sampling records (Sierra Club, 847 F.2d 1109), and a failure on the part of the government to act on complaints of discrimination (Padres Hacia Una Vida Mejor, 2012 WL 1158753).

    Additionally, the legislative history of the Act reflects Congress' concern about harm resulting to employees in workplaces with incomplete records of occupational injuries and illnesses. Most notably, a report of the Senate Committee on Labor and Public welfare stated that “[f]ull and accurate information is a fundamental precondition for meaningful administration of an occupational safety and health program.” S. Rep. No. 91-1282, at 16 (1970), reprinted in Subcomm. on Labor of the Comm. on Labor and Public Welfare, Legislative History of the Occupational Safety and Health Act of 1970, at 156 (1971) (emphasis added). Additionally, a report from the House of Representatives shows that Congress recognized “comprehensive [injury and illness] reporting” as playing a key role in “effective safety programs.” H.R. Rep. No. 91-1291, at 15 (1970), reprinted in Subcomm. on Labor of the Comm. on Labor and Public Welfare, Legislative History of the Occupational Safety and Health Act of 1970, at 845 (1971).

    Incomplete and inaccurate OSHA records therefore result in an ongoing non-complying condition—namely employers, employees, and the government, being denied access to information necessary to full enforcement of the Act. And this non-complying condition continues every day that the records are inaccurate.

    4. Interpreting the Duty To Record as a Continuing One Under the Act's Civil, Remedial Scheme Is Entirely Consistent With the General Case Law

    As touched upon previously in this notice, general case law on continuing violations also supports a continuing violation theory for OSHA recordkeeping violations. The Volks II majority stated that recordkeeping violations are not “the sort of conduct we generally view as giving rise to a continuing violation[,]” i.e., the kind of violation “whose `character as a violation . . . [does] not become clear until . . . repeated during the limitations period . . . because it is . . . [the] cumulative impact . . . that reveals . . . illegality.' ” Volks II, 675 F.3d at 757 (quoting Taylor v. FDIC, 132 F.3d 753, 765 (D.C. Cir. 1997)). On the other hand, all OSHA violations—including recordkeeping violations—“continue” only insofar as non-compliant conditions exist and employees are exposed to the relevant hazards. While the “cumulative impact” theory is one way to establish a continuing violation (see, e.g., Morgan, 536 U.S. 101 (hostile environment claims under Title VII)), established precedent recognizes an additional type of continuing violation—a violation that continues to occur on a day-by-day (or act-by-act) basis and whose illegality was clear from the beginning. See, e.g. , Edelkind, 525 F.3d 388 (failure to pay child support is a continuing offense); Sierra Club, 847 F.2d 1109 (finding continuing violations of the Clean Water Act where the company failed to comply with permit requirements for reporting and record retention); Postow, 627 F.2d 1370 (violation of Truth-in-Lending Act's disclosure requirements is a continuing violation).

    The DC Circuit explicitly recognized the existence of these two types of continuing violation cases in Earle, 707 F.3d 299. The court explained that where a statute “ `imposes a continuing obligation to act, a party can continue to violate it until that obligation is satisfied and the statute of limitations will not begin to run until it does.' ” Id. at 307 (quoting Judge Garland's concurring opinion in Volks II, 675 F.3d at 763). And “[w]hether the obligation is continuing is a question of statutory construction.” Earle, 707 F.3d at 307. The court explained that Postow had found a continuing violation of the Truth-in-Lending Act because the “goals of the Act” required construing the obligation to be continuing. Id. So too, the goals of the OSH Act require construing the recordkeeping obligation to be continuing. The purpose of recording injuries is so that the recorded information can be used thereafter, throughout the retention and access period. Accurate and complete OSHA records enable employers, employees, and the Government to understand the hazards present in the workplace, so that corrective measures can be taken. Inaccurate and incomplete records, by contrast, are likely to be misleading.

    The Secretary recognizes that one court has said that: “The Supreme Court has made clear . . . that the application of the continuing violations doctrine should be the exception, rather than the rule.” Cherosky v. Henderson, 330 F.3d 1243, 1248 (9th Cir. 2003) (not referring to any specific decision) (quoted in Volks II, 675 F.3d at 757). Even so, the Secretary believes that the language and purposes of the OSH Act make it clear that the duty to maintain and make available records is a continuing obligation for all the reasons set forth previously.5

    5 In Toussie v. United States, 397 U.S. 112 (1970), the Supreme Court stated that “the doctrine of continuing offenses should be applied in only limited circumstances since . . . `the tension between the purpose of a statute of limitations and the continuing offense doctrine is apparent.' ” Id. at 115 (citations omitted). But Toussie was a criminal case subject to the general principle that “criminal limitations statutes are `to be liberally interpreted in favor of repose.' ” Id. (emphasis added and citations omitted). See also Diamond v. United States, 427 F.2d 1246, 1247 (Ct. Cl. 1970) (per curiam) (“[T]he considerations moving the Court to decide [in Toussie] that the offense was not a continuing one were entwined with the criminal aspects of the matter, and the holding was limited to criminal statutes of limitations.”). In contrast, as noted previously, in SUPPLEMENTARY INFORMATION, Section III.B.2, OSHA civil enforcement cases are subject to the opposing principle that “statutes of limitation in the civil context are to be strictly construed in favor of the Government against repose.” Interamericas, 111 F.3d at 382.

    IV. Summary and Explanation of the Proposed Rule

    OSHA is proposing to amend its recordkeeping regulations, 29 CFR part 1904, to clarify that employers covered by the recordkeeping requirements have a continuing obligation to make and maintain accurate records of all recordable injuries and illnesses. This obligation continues for as long as the employer must maintain records for the year in which an injury or illness became recordable, and it does not expire if the employer fails to create a record when first required to do so.

    The continuing obligation to make and maintain accurate records of work-related illnesses and injuries is in accord with longstanding OSHA policy. Thus, this proposal is not meant to impose new or additional obligations on employers covered by part 1904. Employers will not be required to make records of any injuries or illnesses for which records are not currently required; nor are the recording requirements themselves changing. As discussed at length previously, the amendments are meant simply to clarify employers' obligations in the wake of the Volks II decision. The amendments being proposed consist of revisions to various sections of the regulatory text as well as changes to the titles of some sections and subparts.

    As discussed in more detail later in this notice, the amendments clarify the following: (1) OSHA 300 Log. Employers must record every recordable injury or illness on the Log. This obligation continues through the five-year record retention-and-access period. In addition, during that period, employers must update the Log by adding cases not previously recorded and by showing changes to previously recorded cases. (2) OSHA 301 Incident Report. Employers must prepare a Form 301 Incident Report for each recordable illness or injury. This obligation continues throughout the five-year retention-and-access period. Employers are not required to update the form to show changes to the case that occur after the form is initially prepared. (3) Year-end records review; preparation certification, and posting of the Form 300A annual summary. These ancillary tasks are intended to be performed at particular times during each year. They are not continuing obligations.

    A. Description of Proposed Revisions 1. Section 1904.0—Purpose

    OSHA is proposing to revise this section to clarify and emphasize employers' ongoing duties to make and maintain accurate records of each and every recordable injury and illness under part 1904. The proposed new language reflects the existing requirement for employers to provide their injury and illness records to certain government representatives, and to employees and former employees and their representatives. The proposed additions to the regulatory text include language reiterating that these recordkeeping requirements are important in helping the Agency achieve its mission of providing safe and healthful working conditions for the nation's workers.

    OSHA is proposing to add a new sentence at the end of this section to explain what the Agency deems to be an “accurate” record. Records will be considered “accurate” if correct and complete records are made and maintained for each and every recordable injury and illness in accordance with the provisions of part 1904. This concept is not new, as the requirement for employers to maintain accurate records is derived directly from the OSH Act, 29 U.S.C. 657(c)(2).

    2. Subpart C—Making and Maintaining Accurate Records, Recordkeeping Forms, and Recording Criteria

    OSHA is proposing to amend the title of this Subpart to better reflect the content of revised §§ 1904.4 and 1904.29, which address employers' duties to make and maintain accurate records, as well as recordkeeping forms and criteria.

    3. Paragraph (a) of § 1904.4—Basic Requirement

    OSHA is proposing to revise this paragraph to reiterate the requirement that employers make and maintain accurate records of every injury and illness that meets the recording criteria in paragraphs (a)(1) through (3) of § 1904.4. The current version of paragraph (a), which requires employers to “record” injuries and illnesses, is less explicit in expressing OSHA's intent that employers both create and keep accurate records. The proposed language is intended to express that an employer's duty includes both creating and preserving accurate records of recordable injuries and illnesses. To be accurate, these records must be correct and complete. The proposed language is also meant to reflect more closely the language of the OSH Act at 29 U.S.C. 657(c)(1) and (2). OSHA is not proposing to change the recording criteria in paragraphs (a)(1) through (3) of existing § 1904.4.

    4. Note to Paragraph (a) of § 1904.4

    OSHA is proposing to add this note to § 1904.4(a) to clarify the Agency's longstanding position that the duty to make and maintain accurate injury and illness records continues throughout the entire record-retention period set out in § 1904.33(a). This retention period runs for five years from the end of the calendar year that the records cover. An employer who fails to create a required record during the seven-day period provided for in § 1904.29(b)(3) must still create the record so long as the retention period has not elapsed. Given this ongoing duty, OSHA may issue recordkeeping citations to employers that have incomplete or otherwise inaccurate records at any point during the retention period, and, under the six-month statute of limitations set out in 29 U.S.C. 658(c), for up to six months thereafter.

    5. Paragraph (b)(3) of § 1904.29—How quickly must each injury or illness be recorded?

    Proposed paragraph (b)(3) of § 1904.29 states the Agency's long-standing requirement that each and every recordable injury and illness must be recorded on both the OSHA 300 Log for that year and a 301 Incident Report within seven calendar days of when the employer gets information that the injury or illness occurred. OSHA is proposing minor wording changes to the first sentence of existing paragraph (b)(3). The remainder of proposed paragraph (b)(3) is designed to make clear that employers that miss this seven-day recording deadline are not excused from the recording obligations after the seven-day period expires. Thus the obligation to record continues until the five-year retention period in § 1904.33(a) has run.

    OSHA has always interpreted the seven-day recording period in the existing recordkeeping rules as a grace period when an employer can gather information on an injury or illness without fear of being cited by OSHA for a failure to record. Similarly, OSHA has always interpreted the obligation to record as continuing throughout the record retention period. The amendments to this paragraph simply clarify OSHA's long-held positions.

    6. Section 1904.32—Year-End Review and Annual Summary

    OSHA is proposing to amend the title of this section to more accurately describe the topics covered by § 1904.32, which include an employer's year-end review of records.

    7. Paragraph (a) of § 1904.32—Basic Requirement

    OSHA is proposing revisions to paragraph (a)(1) of § 1904.32 to make clear that employers must examine each year's OSHA 300 Log at the end of the year to ensure that each and every recordable injury and illness is recorded on the Log, and that each entry is accurate. If an employer discovers, during this review, that an injury or illness is missing or that any aspect of an entry is inaccurate, the employer must correct the deficiency.

    The Agency is also proposing a new paragraph (a)(2) for § 1904.32. This proposed paragraph provides that after reviewing and verifying the Log entries under § 1904.32(a)(1), employers must verify that all entries on the Log are accurately recorded on OSHA 301 Incident Reports. Proposed paragraph (a)(2) clarifies that if an employer discovers, during the § 1904.32(a)(1) review, that an injury or illness was initially left off of the OSHA 300 Log, the employer must both add it to the log and create an accurate Incident Report for that injury or illness.

    OSHA is proposing to move the language from existing paragraph (a)(2) in § 1904.32 to proposed paragraph (a)(3) in the same section. The Agency is proposing to add a clause to that paragraph to explain that the annual summary should be created only after an employer verifies the accuracy of the Log. This language is for clarification purposes only and does not add any new compliance requirements. OSHA is also proposing to renumber existing paragraphs (a)(3) and (4) of § 1904.32 as paragraphs (a)(4) and (5), respectively. The Agency is not proposing any substantive changes to these provisions.

    The specific tasks required of employers under § 1904.32(a)—to conduct a year-end review of the Log, and to prepare, certify and post the annual summary—are in addition to the duties described elsewhere in part 1904, and do not supersede or modify them. These other duties include the fundamental continuing obligation for employers to ensure that Logs are accurate and complete and that all recordable cases are included on them. The specific steps required under § 1904.32(a) are supplementary tasks designed to help ensure that employers are maintaining accurate records. These supplementary tasks are to be performed at specified times (at the end of each calendar year, and from February 1 to April 30 for posting). Failure to perform one of these supplementary tasks by the required deadline or during the required time period is a violation of § 1904.32 that may be cited during the following six months. See Volks II, 675 F.3d at 761-62 (concurring opinion).

    8. Paragraph (b)(1) of § 1904.32—How extensively do I have to review the OSHA 300 Log at the end of the year?

    OSHA is proposing to amend paragraph (b)(1) of § 1904.32 to reflect the proposed revisions to § 1904.32(a)(1). The proposed changes to paragraph (b)(1) reiterate that employers must review the Log and its entries sufficiently to verify that all recordable injuries and illnesses for the relevant year are entered, and that those entries are accurate. In addition, OSHA is proposing one minor, non-substantive change to the heading of existing paragraph (b)(1).

    9. Section 1904.33—Retention and Maintenance of Accurate Records

    OSHA is proposing to update the title of this section to more accurately reflect the obligations described in proposed § 1904.33.

    10. Paragraph (b)(1) of § 1904.33—Other than the obligation identified in § 1904.32, do I have further recording duties with respect to OSHA 300 Logs and 301 Incident Reports during the five-year retention period?

    OSHA is proposing to amend the heading for this paragraph to reflect that employers have recording duties with respect to Incident Reports, as well as OSHA 300 Logs, during the five-year retention period. The Agency is also proposing to amend the text of paragraph (b)(1) of § 1904.33 to provide an introduction to the paragraphs that follow.

    OSHA is proposing to add paragraphs (b)(1)(i) through (iii) to § 1904.33 to provide further guidance to employers on the existing duties to update Log entries and Incident Reports. Proposed paragraph (b)(1)(i) clarifies employers' duties to make and keep OSHA 300 Log entries for each and every recordable injury and illness that occurs during the year to which the Log relates. There must also be an associated Incident Report for each illness and injury recorded on the Log. As the proposed language makes explicit, these duties continue until the five-year retention period ends; thus, an employer may be required to make an entry on the OSHA Log or fill out an Incident Report for an illness or injury that occurred several years ago.

    Proposed paragraph (b)(1)(ii) addresses changes that must be made to OSHA Logs throughout the retention period. As emphasized throughout this proposed rule, employers' OSHA 300 Logs must be accurate. This means that if an employer discovers that any aspect of a previously-recorded case (such as the classification, description, or outcome of the case) has changed, or that a case was recorded incorrectly at the outset, the employer must amend the entry to reflect the new or corrected information.

    Proposed paragraph (b)(1)(iii) reiterates the requirement in proposed paragraph (b)(1)(i) that there must be an Incident Report for each and every recordable injury and illness. The primary purpose of proposed paragraph (b)(1)(iii) is to explain that employers are not required to update or correct existing Incident Reports during the retention period. This principle is currently stated in existing § 1904.33(b)(3).

    These proposed requirements are not intended to change, but rather to state more clearly, what is required under the existing rule. The existing rule provides that during the five-year retention period, the employer must update the Logs to include newly discovered recordable injuries and illnesses and to show changes that have occurred in previously recorded cases. It does not explicitly state the employer's continuing duty to record cases it had previously learned about. Judge Garland's concurring opinion in Volks II drew the inference that the regulation does not create a continuing obligation to record such cases, as compared with newly discovered cases. Volks II, 675 F.3d at 760-61. This was not the Secretary's intention. At the time the current regulation was issued in 2001, it was well-established law in the Commission that employers had a continuing duty to record these older cases on their Logs. See Gen. Dynamics, 15 BNA OSHC 2122; Johnson Controls, 15 BNA OSHC 2132. Nothing in the 2001 rulemaking suggested that the Agency had any intention of changing this fundamental requirement.

    The existing recordkeeping regulations explain that the employer must promptly record cases on the 300 Log, and that, throughout the five-year retention period, if the employer discovers a case that occurred previously, it must record that case on the applicable Log. As with nearly all rules, this rule is written to describe compliance. As with other rules, it does not assume noncompliance, in other words, it does not explicitly state what an employer must do if it fails to record a case it knows about. By stating that newly discovered cases should be recorded, the Secretary did not intend to signify that other cases the employer had learned about need not be recorded. The command to update was not intended to signify permission to ignore knowledge that had been acquired earlier.

    The current regulations also state that the employer is not required to “update” Form 301 Incident Reports. In Volks II, Judge Garland read this to mean that employers do not have to create a form at all, once the initial seven-day recording period is over. See Volks II, 675 F.3d at 760-61 (concurring opinion). That was not the Secretary's intention. The intent was to distinguish between the Log, which employers must update to reflect new and changed information, and the 301 Form, which employers do not need to update. (The Secretary explained that although updating the Log would provide useful, accurate information, updating Incident Reports would not enhance the information in the employer's records sufficiently to warrant the additional burden that would be associated with such a requirement. See 66 FR at 6050, January 19, 2001.) The fact that the Agency does not require employers to update Incident Reports does not mean that the Agency does not require employers to create the forms in the first place. The language in the proposed rule clarifies this.

    11. Paragraph (b)(2) of § 1904.33—Do I have to make additions or corrections to the annual summary during the five-year retention period?

    OSHA is proposing minor changes to paragraph (b)(2) of § 1904.33. These changes are not substantive. Neither the proposed nor the existing rules require employers to update or make changes to annual summaries during the five-year retention period.

    12. Paragraph (b)(3) of § 1904.33

    OSHA is proposing to delete existing paragraph (b)(3). In the proposal, this paragraph has been moved, in slightly modified form, to paragraph (b)(1)(iii) in § 1904.33.

    13. Paragraph (b)(2) of § 1904.35—Do I have to give my employees and their representatives access to the OSHA injury and illness records?

    Paragraph (b)(2) of existing § 1904.35 addresses employee access to records created under part 1904. OSHA is proposing only one minor change to this paragraph—the addition of the word “accurate” to describe the records to which employees, former employees, and their representatives must be given access. Accurate records are described in proposed § 1904.0.

    14. Paragraph (b)(2)(iii) of § 1904.35—If an employee or representative asks for access to the OSHA 300 Log, when do I have to provide it?

    In proposed paragraph (b)(2)(iii) of § 1904.35, OSHA is simply adding the term “accurate” to describe the OSHA 300 Logs to which employees, former employees, and their representatives must be given access. Accurate records are described in proposed § 1904.0. Records are required so they can be used, and records must be accurate if they are to serve this purpose. The duty to provide an accurate record upon request arises when the request is made, not before, so the six-month statute of limitations cannot begin to run until the request is made.

    15. Subpart E—Reporting Accurate Fatality, Injury, and Illness Information to the Government

    OSHA is proposing to revise the title of Subpart E to more precisely reflect the requirement in the Subpart that government representatives be given access to accurate fatality, injury, and illness information.

    16. Section 1904.40—Providing Accurate Records to Government Representatives

    OSHA is proposing to revise the title of § 1904.40 to reflect the proposed changes to paragraph (a) of that section.

    17. Paragraph (a) of § 1904.40—Basic Requirement

    OSHA is proposing to add the term “accurate” to paragraph (a) of § 1904.40(a) to reflect OSHA's long-standing expectation that employers provide government representatives with accurate records upon request. OSHA is also proposing some non-substantive wording changes to this paragraph.

    V. State Plans

    The 27 States and U.S. Territories with their own OSHA-approved occupational safety and health plans must adopt a rule comparable to any amendments that Federal OSHA ultimately promulgates to 29 CFR part 1904. The States and U.S. Territories with OSHA-approved occupational safety and health plans covering private employers and State and local government employees are: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. In addition, five States and U.S. Territories have OSHA-approved State plans that apply to State and local government employees only: Connecticut, Illinois, New Jersey, New York, and the Virgin Islands.

    Under 29 CFR 1952.4(a), States with approved occupational safety and health plans under section 18 of the OSH Act (29 U.S.C. 667) must adopt recordkeeping and reporting regulations that are “substantially identical” to those set forth in 29 CFR part 1904. State plans' recording and reporting requirements for determining which injuries and illnesses must be recorded, and how they will be recorded, must be the same as the Federal requirements. 29 CFR 1952.4(a). Otherwise, State plans may promulgate injury or illness recording and reporting requirements that are more stringent than, or supplemental to, 29 CFR part 1904, after consulting with, and obtaining approval from, Federal OSHA. Id.

    State plans may not grant variances from injury and illness recording and reporting requirements for private sector employers; any such variances must be granted by Federal OSHA. 29 CFR 1952.4(b). And a State may grant such a variance for a State or local government entity only after obtaining Federal OSHA approval. Id.

    VI. Preliminary Economic Analysis

    The proposed revisions to OSHA's recordkeeping rules do not constitute an economically significant regulatory action under Executive Order 12866. (See 58 FR 51735, September 30, 1993). Executive Order 12866 requires regulatory agencies to conduct an economic analysis for significant rules. A rule is economically significant under Executive Order 12866 if it will have an annual effect on the economy of $100 million or more. This proposal does not satisfy that criterion; as explained later in this notice, neither the benefits nor the costs of the proposal equal or exceed $100 million. OSHA has also determined that this proposal does not meet the definition of a major rule under the Congressional Review provisions of the Small Business Regulatory Enforcement Fairness Act (SBREFA). See 5 U.S.C. 804(2).

    The Regulatory Flexibility Act of 1980, as amended by SBREFA in 1996, requires OSHA to determine whether the Agency's regulatory actions will have a significant impact on a substantial number of small entities. See 5 U.S.C. 601 et seq. OSHA's analysis indicates that the proposed rule will not have such an impact.

    This proposal simply reiterates and clarifies employers' existing obligations to record work-related injuries and illnesses. This proposal would not require employers to make records of any injuries or illnesses for which records are not currently required. OSHA estimated the costs to employers of these requirements when the existing regulations were promulgated in 2001, see 66 FR 6081-6120, January 19, 2001. The proposed revisions impose no new cost burden.

    Moreover, even if the proposed revisions to OSHA's recordkeeping rules would result in some costs beyond those the Agency estimated in 2001, any such costs would be nominal. According to OSHA's 2014 request to the Office of Management and Budget for an extension of the approval of the information collection requirements in the recordkeeping rules, an estimated 2.44 million injuries and illnesses must be recorded on OSHA logs each year. See http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201405-1218-003. Although OSHA accounted for the costs associated with full recordkeeping compliance as part of the 2001 rulemaking, the Agency assumes, for the sake of this analysis, a non-compliance rate under the current rule of 1 percent of recordable injuries and illnesses, or an additional 24,400 injuries and illnesses that would be recorded as a result of the proposal. (In OSHA's view, this is a high, or conservative, estimate.)

    In 2014, OSHA prepared a Final Economic Analysis for a final rule addressing the industries entitled to a partial exemption from recordkeeping requirements and the reporting of injuries and fatalities to the Agency. In that analysis, OSHA estimated that it takes .38 of an hour to record an injury or illness on all required OSHA forms, taking into account requirements for providing access to records. See 79 FR 56130, 56165 (September 18, 2014). And according to the 2014 ICR, the average hourly rate for an Occupational Health and Safety Specialist (Standard Occupational Classification code 29-9011) is estimated to be $46.72 (which includes a 43% addition for benefits). See http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201405-1218-003. This means that the total estimated cost of preparing OSHA records is $17.75 per injury or illness.

    Thus, if 24,400 cases would be newly recorded as a result of the proposal, the total cost associated with this regulatory action would be 24,400 times $17.75, or approximately $433,100 per year. (The Agency notes that if it makes the even more conservative assumption that 5 percent of 2.44 million injuries and illnesses (122,000) would be newly recorded as a result of the proposal, the total estimated cost of the proposed rule, across all affected employers, would be under $2.2 million per year.)

    Just as there are no (or minimal) new costs associated with this proposal, the proposal will result in no new economic benefits. OSHA believes the proposed revisions to the recordkeeping rules are technologically feasible because they do not require employers to perform any actions that they are not performing under existing requirements. And because the proposal does not impose any significant new compliance costs, the Agency deems it economically feasible.

    VII. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (as amended), OSHA examined the regulatory requirements of the proposed rule to determine if they would have a significant economic impact on a substantial number of small entities. As indicated in Section VI, Preliminary Economic Analysis, earlier in this notice, the proposed rule is expected to have no effect, or at most a nominal effect, on compliance costs and regulatory burden for employers, whether large or small. Accordingly, the Agency certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities.

    VIII. Environmental Impact Assessment

    OSHA has reviewed the proposed rule in accordance with the requirements of the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.), the regulations of the Council on Environmental Quality (40 CFR parts 1500 through 1508), and the Department of Labor's NEPA procedures (29 CFR part 11). The Agency finds that the revisions included in the proposal would have no major negative impact on air, water, or soil quality, plant or animal life, the use of land or other aspects of the environment. And recordkeeping and reporting requirements normally qualify for categorical exclusion from NEPA requirements in any event. See 29 CFR 11.10(a).

    IX. Federalism

    OSHA reviewed this proposed rule in accordance with the most recent Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This Executive Order requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States prior to taking any actions that would restrict State policy options, and take such actions only when clear constitutional authority exists and the problem is national in scope. Executive Order 13132 provides for preemption of State law only with the expressed consent of Congress. Any such preemption must be limited to the extent possible. Because this proposed rulemaking action involves a regulation that is not an occupational safety and health standard under section 6 of the OSH Act, it does not preempt State law. See 29 U.S.C. 667(a). The effect of a final rule on states and territories with OSHA-approved occupational safety and health plans is discussed previously in Section V, State Plans.

    X. Unfunded Mandates

    OSHA cannot enforce compliance with its regulations or standards on “any State or political subdivision of a State.” 29 U.S.C. 652(5). Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. But the proposed rule does not involve any unfunded mandates being imposed on any State or local government entity. Moreover, as discussed previously, OSHA estimates that that there are no, or minimal, compliance costs associated with the proposed rule. Therefore, this proposed rule would not impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. Thus, OSHA certifies that this proposed rule is not a significant regulatory action within the meaning of Section 202 of the Unfunded Mandates Reform Act (2 U.S.C. 1532).

    XI. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this proposed rule in accordance with Executive Order 13175 (65 FR 67249, November 6, 2000) and determined that it does not have “tribal implications” as defined in that order. The proposed rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

    XII. Public Participation

    Recordkeeping requirements promulgated under the Occupational Safety and Health Act of 1970 (OSH Act) are regulations, not standards. Therefore, this rulemaking is governed by the notice and comment requirements in the Administrative Procedure Act (APA), 5 U.S.C. 553, rather than by section 6(b) of the OSH Act (29 U.S.C. 655(b)) and 29 CFR part 1911 (both of which apply only to promulgating, modifying or revoking occupational safety or health standards). The OSH Act requirement for the Agency to hold an informal public hearing on a proposed rule, when requested, does not apply to this rulemaking. See 29 U.S.C. 655(b)(3).

    The APA, which governs this rulemaking, does not require a public hearing; instead, it states that the agency must “give interested persons an opportunity to participate in the rulemaking through submission of written data, views, or arguments with or without opportunity for oral presentation.” 5 U.S.C. 553(c). To promulgate a proposed regulation, the APA requires the Agency to provide the terms of the proposed rule (or a description of those terms) and specify the time, place, and manner of rulemaking proceedings. See 5 U.S.C. 553(b). The APA does not specify a minimum period for submitting comments. In accordance with the goals of Executive Order 12866, OSHA is providing 60 days for public comment (see section 6(a)(1) of Executive Order 12866).

    Public Submissions: OSHA invites comments on all aspects of the proposed rule. OSHA will carefully review and evaluate any comments, information, or data received, as well as all other information in the rulemaking record, to determine how to proceed.

    When submitting comments, please follow the procedures specified in the sections titled DATES and ADDRESSES of this document. The comments should clearly identify the provision of the proposal being addressed, the position taken with respect to each issue, and the basis for that position. Comments, along with supporting data and references, submitted by the end of the specified comment period will become part of the rulemaking record, and will be available for public inspection at the Federal eRulemaking Portal (http://www.regulations.gov) and at the OSHA Docket Office, 200 Constitution Avenue NW.—Room N-2625, Washington, DC 20210. (See the section titled ADDRESSES of this document for additional information on how to access these documents.)

    XIII. The Paperwork Reduction Act of 1995

    The information collection requirements contained in 29 CFR part 1904 Recording and Reporting Occupational Injuries and Illnesses have been approved by OMB and have been assigned OMB control number 1218-0176. This proposal simply reiterates and clarifies employers' existing obligations to record and maintain work-related injuries and illnesses and does not add any new collection of information requirements. Therefore, there are no increases or decreases to the Recording and Reporting Occupational Injuries and Illnesses burden hour and cost estimates. The Agency solicits comments on this determination, and on the following items:

    • Whether the revised collection of information requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;

    • The accuracy of OSHA's estimate of the burden (time and cost) of the information collection requirements, including the validity of the methodology and assumptions used;

    • The quality, utility and clarity of the information collected; and

    • Ways to minimize the compliance burden on employers, for example, by using automated or other technological techniques for collecting and transmitting information.

    As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the following paragraphs provide information about this ICR:

    Title: 29 CFR part 1904 Recordkeeping and Reporting Occupational Injuries and Illnesses (29 CFR part 1904).

    Description of the ICR: The Occupational Safety and Health Act and 29 CFR part 1904 require that certain employers generate, maintain, and post records of job-related injuries and illnesses; and report to OSHA any work-related incident resulting in the death of the worker and work-related incidents resulting in in-patient hospitalization, amputation or loss of an eye.

    Summary of the Collections of Information: Completion of the OSHA Forms 300 and 301; Entry on privacy concern case confidential list; Complete, certify and post OSHA Form 300A, Employee access to OSHA Forms 300 and 301; Reporting fatalities/catastrophes to OSHA; Requests for variances.

    Number of respondents: 1,594,040.

    Frequency of responses: Frequency of response varies depending on the specific collection of information.

    Number of responses: 6,312,003.

    Average time per response: Ranges from 58 minutes to complete, certify and post Form 300A to five minutes for employers to allow employees, former employees, or employee representatives access to records being maintained by 29 CFR part 1904.

    Estimated total burden hours: 2,881,842.

    Estimated costs (capital-operation and maintenance): 0.

    Members of the public who wish to comment on the Agency's revised collection of information must send their written comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, OSHA (please reference control number 1218-0176 in order to help ensure proper consideration), Office of Management and Budget, Room 10235, Washington, DC 20503, Fax: 202-395-5806 (this is not a toll-free number), email: [email protected] The Agency encourages commenters also to submit their comments related to the Agency's clarification of the collection of information requirements to the rulemaking docket (Docket Number OSHA-2015-0006) along with their comments on other parts of the proposed rule. For instructions on submitting these comments to the rulemaking docket, see the sections of this Federal Register document titled DATES and ADDRESSES. You also may obtain an electronic copy of the complete ICR by visiting the Web page at http://www.reginfo.gov/public/do/PRAMain and scrolling under “Currently Under Review” to “Department of Labor (DOL)” to view all of the DOL's ICRs, including those ICRs submitted for proposed rulemakings. To make inquiries, or to request other information, contact Mr. Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.

    OSHA notes that a federal agency cannot conduct or sponsor a collection of information unless it is approved by OMB under the PRA and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless the collection of information displays a currently valid OMB control number. Also, notwithstanding any other provision of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number.

    List of Subjects in 29 CFR Part 1904

    Health statistics, Occupational safety and health, Safety, Reporting and recordkeeping requirements, State plans.

    Authority and Signature

    This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor. It is issued pursuant to 29 U.S.C. 657, 673; 5 U.S.C. 553; and Secretary of Labor's Order No. 1-2012 (77 FR 3912, January 25, 2012).

    Signed at Washington, DC, on July 16, 2015. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health.

    Accordingly, the Occupational Safety and Health Administration proposes that part 1904 of title 29 of the Code of Federal Regulations be amended as follows:

    PART 1904—RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES 1. Revise the authority citation for part 1904 to read as follows: Authority:

    29 U.S.C. 657, 658, 660, 666, 669, 673, Secretary of Labor's Order No. 3-2000 (65 FR 50017), or 1-2012 (77 FR 3912), and 5 U.S.C. 553.

    2. Revise § 1904.0 to read as follows:
    § 1904.0 Purpose.

    The purpose of this rule (part 1904) is to require employers to make and maintain accurate records of and report work-related fatalities, injuries, and illnesses, and to make such records available to the Government and to employees and their representatives so that they can be used to secure safe and healthful working conditions. For purposes of this part, accurate records are records of each and every recordable injury and illness that are made and maintained in accordance with the requirements of this part.

    Note to § 1904.0:

    Recording or reporting a work-related injury, illness, or fatality does not mean that the employer or employee was at fault, that an OSHA rule has been violated, or that the employee is eligible for workers' compensation or other benefits.

    Subpart C—Making and Maintaining Accurate Records, Recordkeeping Forms, and Recording Criteria 3. Revise the heading of subpart C as set forth above. 4. In § 1904.4, revise paragraph (a) introductory text and add a note to § 1904.4(a) to read as follows:
    § 1904.4 Recording criteria.

    (a) Basic requirement. Each employer required by this part to keep records of fatalities, injuries, and illnesses must, in accordance with the requirements of this part, make and maintain an accurate record of each and every fatality, injury, and illness that:

    Note to § 1904.4(a):

    This obligation to make and maintain an accurate record of each and every recordable fatality, injury, and illness continues throughout the entire record retention period described in § 1904.33.

    5. Revise § 1904.29(b)(3) to read as follows:
    § 1904.29 Forms.

    (b) * * *

    (3) How quickly must each injury or illness be recorded? You must enter each and every recordable injury or illness on the OSHA 300 Log and on a 301 Incident Report within seven (7) calendar days of receiving information that the recordable injury or illness occurred. A failure to meet this deadline does not extinguish your continuing obligation to make a record of the injury or illness and to maintain accurate records of all recordable injuries and illnesses in accordance with the requirements of this part. This obligation continues throughout the entire record retention period described in § 1904.33. See §§ 1904.4(a); 1904.32(a)(1); 1904.33(b)(1); and 1904.40(a).

    6. Revise the heading and paragraphs (a) and (b)(1) of § 1904.32 to read as follows:
    § 1904.32 Year-end review and annual summary.

    (a) Basic requirement. At the end of each calendar year, you must:

    (1) Review that year's OSHA 300 Log to verify that it contains accurate entries for all recordable injuries and illnesses that occurred during the year, and make any additions or corrections necessary to ensure its accuracy;

    (2) Verify that each injury and illness recorded on the 300 Log, including any injuries and illnesses added to the Log following your year-end review pursuant to § 1904.32(a)(1), is accurately recorded on a corresponding 301 Incident Report form;

    (3) After you have verified the accuracy of the Log, create an annual summary of injuries and illnesses recorded on the Log;

    (4) Certify the summary; and

    (5) Post the summary.

    (b) * * *

    (1) How extensively do I have to review the OSHA 300 Log at the end of the year? You must review the Log and its entries as extensively as necessary to verify that all recordable injuries and illnesses that occurred during the year are entered and that the Log and its entries are accurate.

    7. Revise the heading and paragraph (b) of § 1904.33 to read as follows:
    § 1904.33 Retention and maintenance of accurate records.

    (b) Implementation—(1) Other than the obligation identified in § 1904.32, do I have further recording duties with respect to the OSHA 300 Logs and 301 Incident Reports during the five-year retention period? You must make the following additions and corrections to the OSHA Log and Incident Reports during the five-year retention period:

    (i) The OSHA Logs must contain entries for all recordable injuries and illnesses that occurred during the calendar year to which each Log relates. In addition, each and every recordable injury and illness must be recorded on an Incident Report. This means that if a recordable case occurred and you failed to record it on the Log for the year in which the injury or illness occurred, and/or on an Incident Report, you are under a continuing obligation to record the case on the Log and/or Incident Report during the five-year retention period for that Log and/or Incident Report;

    (ii) You must also make any additions and corrections to the OSHA Log that are necessary to accurately reflect any changes that have occurred with respect to previously recorded injuries and illnesses. Thus, if the classification, description, or outcome of a previously recorded case changes, you must remove or line out the original entry and enter the new information; and

    (iii) You must have an Incident Report for each and every recordable injury and illness; however, you are not required to make additions or corrections to Incident Reports during the five-year retention period.

    (2) Do I have to make additions or corrections to the annual summary during the five-year retention period? You are not required to make additions or corrections to the annual summaries during the five-year retention period.

    8. Revise paragraphs (b)(2) introductory text and (b)(2)(iii) of § 1904.35 to read as follows:
    § 1904.35 Employee involvement.

    (b) * * *

    (2) Do I have to give my employees and their representatives access to the OSHA injury and illness records? Yes, your employees, former employees, their personal representatives, and their authorized employee representatives have the right to access accurate OSHA injury and illness records, with some limitations, as discussed below.

    (iii) If an employee or representative asks for access to the OSHA 300 Log, when do I have to provide it? When an employee, former employee, personal representative, or authorized employee representative asks for copies of your current or stored OSHA 300 Log(s) for an establishment the employee or former employee has worked in, you must give the requester a copy of the relevant and accurate OSHA 300 Log(s) by the end of the next business day.

    Subpart E—Reporting Accurate Fatality, Injury, and Illness Information to the Government 9. Revise the heading of subpart E as set forth above. 10. Revise the heading and paragraph (a) of § 1904.40 to read as follows:
    § 1904.40 Providing accurate records to government representatives.

    (a) Basic requirement. When an authorized government representative requests the records you keep under part 1904, you must provide accurate records, or copies thereof, within four (4) business hours of the request.

    [FR Doc. 2015-18003 Filed 7-28-15; 8:45 am] BILLING CODE 4510-26-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 87 and 1068 [EPA-HQ-OAR-2014-0828; FRL-9931-43-OAR] RIN 2060-AS31 Proposed Finding That Greenhouse Gas Emissions From Aircraft Cause or Contribute to Air Pollution That May Reasonably Be Anticipated To Endanger Public Health and Welfare and Advance Notice of Proposed Rulemaking; Notice of Updates to Public Hearing AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Updates to public hearing.

    SUMMARY:

    The Environmental Protection Agency (EPA) published the Proposed Finding that Greenhouse Gas Emissions from Aircraft Cause or Contribute to Air Pollution that May Reasonably Be Anticipated to Endanger Public Health and Welfare and Advance Notice of Proposed Rulemaking in the Federal Register on July 1, 2015. This action provides notice of three updates regarding the public hearing.

    DATES:

    The EPA will hold a public hearing on August 11, 2015 in Washington, DC starting at 10 a.m. local time.

    ADDRESSES:

    The hearing will be held at the Headquarters office of the US EPA, the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue NW., Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    Ms. JoNell Iffland, Office of Transportation and Air Quality, Assessment and Standards Division (ASD), Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, Michigan 48105, telephone number: (734) 214-4454, fax number: (734) 214-4816, email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    EPA published a proposed finding that greenhouse gas emissions from aircraft cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare and an advance notice of proposed rulemaking regarding aircraft engine greenhouse gas emissions on July 1, 2015 (80 FR 37758). This action corrects a typographical error in the street address for the public hearing and provides notice of availability of a conference call-in number for the public to listen to the hearing. Additionally, this action provides notice that video recording will be allowed in the hearing room provided that it does not interfere with or interrupt the public hearing.

    Updates

    The DATES section of the proposed finding and advance notice of proposed rulemaking published in the Federal Register on July 1, 2015 (78 FR 37758), provided information on the public hearing. This action updates that information.

    The EPA will hold a public hearing on August 11, 2015 in Washington, DC, at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue NW., Washington, DC 20004. The EPA will provide the opportunity for the public to listen to the hearing through the following conference call-in line: 1-866-299-3188, conference code 1433527160. Please note that this conference line will allow the public to listen only; persons listening will not be able to give an oral presentation via the conference line.

    Additionally, the proposed finding and advance notice of proposed rulemaking stated that no large signs will be allowed in the building, cameras may only be used outside of the building and demonstrations will not be allowed on federal property for security reasons. This update confirms that video recording will be allowed in the hearing room provided that it does not interfere with or interrupt the public hearing.

    Dated: July 21, 2015. Christopher Grundler, Director, Office of Transportation and Air Quality, Office of Air and Radiation.
    [FR Doc. 2015-18518 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 100 RIN 0906-AB01 National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table AGENCY:

    Health Resources and Services Administration (HRSA), HHS.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    The Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.

    DATES:

    Written comments must be submitted on or before January 25, 2016.

    ADDRESSES:

    You may submit comments, identified by the Regulatory Information Number (RIN) 0906-AB01 in one of three ways, as listed below. The first is the preferred method. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions.

    1. Federal eRulemaking Portal. You may submit comments electronically to http://www.regulations.gov. Click on the link “Submit electronic comments on HRSA regulations with an open comment period.” Submit your comments as an attachment to your message or cover letter. (Attachments should be in Microsoft Word or WordPerfect; however, Microsoft Word is preferred).

    2. By regular, express or overnight mail. You may mail written comments to the following address only: Health Resources and Services Administration, Department of Health and Human Services, Attention: HRSA Regulations Officer, Parklawn Building, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. Delivery by hand (in person or by courier). If you prefer, you may deliver your written comments before the close of the comment period to the same address: Parklawn Building Room 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please call in advance to schedule your arrival with one of our HRSA Regulations Office staff members at telephone number (301) 443-1785. This is not a toll-free number.

    Because of staffing and resource limitations, and to ensure that no comments are misplaced, Program cannot accept comments by facsimile (FAX) transmission. In commenting, by any of the above methods, please refer to file code (#HRSA-0906-AB01). All comments received on a timely basis will be available for public inspection without change, including any personal information provided, in Room 14-101 of the Health Resources and Services Administration's offices at 5600 Fishers Lane, Rockville, MD, on Monday through Friday of each week from 8:30 a.m. to 5:00 p.m. (excluding Federal holidays). Phone: (301) 443-1785. This is not a toll-free number.

    FOR FURTHER INFORMATION CONTACT:

    Please visit the National Vaccine Injury Compensation Program's Web site, http://www.hrsa.gov/vaccinecompensation/, or contact Dr. Avril Melissa Houston, Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857. Phone calls can be directed to (301) 443-6593.

    SUPPLEMENTARY INFORMATION:

    The President encourages Federal agencies through Executive Order 13563 to develop balanced regulations by encouraging broad public participation in the regulatory process and an open exchange of ideas. The Department of Health and Human Services (HHS) accordingly urges all interested parties to examine this regulatory proposal carefully and to share your views with us, including any data to support your positions. If you have questions before submitting comments, please see the “For Further Information” box below for the name and contact information of the subject-matter expert involved in this proposal's development. We must consider all written comments received during the comment period before issuing a final rule.

    If you are a person with a disability and/or a user of assistive technology who has difficulty accessing this document, please contact HRSA's Regulations Officer at Parklawn Building, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857; or by telephone at 301-443-1785, to obtain this information in an accessible format. This is not a toll free telephone number. Please visit http://www.HHS.gov/regulations for more information on HHS rulemaking and opportunities to comment on proposed and existing rules.

    A public hearing on this proposed rule will be held before the end of the public comment period. A separate notice will be published in the Federal Register providing details of this hearing. Subject to consideration of the comments received, the Secretary intends to publish a final regulation.

    Background

    The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established a Federal compensation program for persons thought to be injured by vaccines. The statute governing the program has been amended several times since 1986 and is hereinafter referred to as “the Act.” Petitions for compensation under this Program are filed in the United States Court of Federal Claims, with a copy served on the Secretary, who is denominated the “Respondent.” The Court, acting through judicial officers called Special Masters, makes findings as to eligibility for, and amount of, compensation.

    In order to receive an award under this Program, a petitioner must establish a vaccine-related injury or death, either by proving that a vaccine actually caused or significantly aggravated an injury (causation-in-fact) or by demonstrating the occurrence of what has been referred to as a “Table Injury.” That is, a petitioner may show that the vaccine recipient suffered an injury of the type enumerated in the regulations at 42 CFR 100.3—the “Vaccine Injury Table”—corresponding to the vaccination in question, and that the onset of such injury took place within a time period also specified in the Table. If so, the injury is presumed to have been caused by the vaccination, and the petitioner is entitled to compensation (assuming that other requirements are satisfied), unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination (see sections 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B)), and 300aa-14(a) of the Act). Currently, cases are often resolved by settlements reached by both parties and approved by the Court.

    When Congress first enacted the Act, it mandated reviews by the Institute of Medicine (IOM) of the National Academy of Sciences with the express purpose of providing a better scientific rationale for any presumptions of vaccine causation. Under sections 312 and 313 of Public Law 99-660, Congress mandated that the IOM review the scientific literature and other information on specific adverse consequences of vaccines covered by the Program. Congress enacted a mechanism for modification of the statutory Table, through the promulgation of regulatory changes by the Secretary, after consultation with the Advisory Commission on Childhood Vaccines (ACCV). By statutory directive, the membership of the ACCV reflects a variety of stakeholders with different perspectives (42 U.S.C. 300aa-19).

    Efforts by the Secretary to modify the initial statutory Table, and its definitional counterpart, the Qualifications and Aids to Interpretation (QAI) began with publication of the two congressionally mandated IOM reviews in 1991 and 1994, respectively. With a few exceptions, the approach by the Secretary was straightforward: If the IOM concluded that there was evidence that a condition was “causally related,” it was added to or left on the Table. However, if there was no proven scientific evidence of an association, it was not added to the Table or it was removed. The entire process, from publication of the IOM reports, to promulgation of final rules in 1995 and 1997 took approximately 3 to 4 years.

    The IOM has analyzed numerous possible vaccine injury connections over the years and after conducting a third comprehensive review of the scientific literature on vaccines and adverse events, released a report entitled, Adverse Effects of Vaccines: Evidence and Causality (2012). This third IOM report was conducted under the Department's initiative and was not statutorily mandated. The committee charged with undertaking this review consisted of 16 members with expertise in the following fields: Pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology, epidemiology, biostatistics, and law (http://www.iom.edu/reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx). The members of the review committee are subject to the stringent conflict of interest criteria imposed by the IOM. The committee met eight times over the course of 35 months, surveying more than 11,000 abstracts and reviewing in-depth 1,487 scientific and medical studies. The committee did not perform any original research.

    The IOM Committee undertook the task of judging whether, based on available scientific evidence, a causal relationship exists between each adverse event examined and exposure to the following eight vaccines: Measles-mumps-rubella vaccine, varicella virus vaccine, seasonal influenza vaccines (which did not include the H1N1 influenza vaccine distributed in 2009), hepatitis A vaccine, hepatitis B vaccine, human papillomavirus vaccine, diphtheria tetanus toxoid and acellular pertussis-containing vaccines, and meningococcal vaccine. The charge to the Committee involved these eight vaccines because they are the vaccines with the vast majority of alleged adverse events in the claims for compensation filed under the Program. In addition, some of these vaccines had not been reviewed previously by the IOM.

    Two types of evidence were utilized by the IOM in determining the strength of a causal association: Epidemiologic evidence from studies of populations and mechanistic evidence derived primarily from biological and clinical studies in animals and humans such as case reports. To determine the weight of the evidence, the IOM used a summary classification scheme that incorporated both the quality and quantity of the individual articles and the consistency of the group of articles in terms of direction of effect. Four weight-of-evidence categories were utilized, with epidemiologic evidence assessed to be high, moderate, limited or insufficient, and mechanistic evidence assessments of strong, intermediate, weak or lacking.

    The IOM started each adverse event assessment from a position of neutrality, moving in either direction (i.e., evidence favoring or rejecting causation) only when the epidemiologic and/or mechanistic evidence suggested a more definitive assessment. As with the previous IOM studies, a classification system was used to categorize the IOM's conclusions about the strength of a causal association. These categories are as follows:

    1. Evidence convincingly supports a causal relationship;

    2. Evidence favors acceptance of a causal relationship;

    3. Evidence favors rejection of a causal relationship; or

    4. Evidence is inadequate to accept or reject a causal relationship.

    The IOM Committee concluded in certain circumstances that the evidence convincingly supports, or favors acceptance of, a causal relationship based only on a mechanistic assessment, even when the epidemiological evidence was inconclusive or absent. The 2012 IOM Report, on pages 17-18 explains that strong mechanistic evidence “always carries sufficient weight for the committee to conclude the evidence convincingly supports a causal relationship. . .This conclusion [attributing the disease to the vaccine and not to other etiologies] can be reached even if the epidemiologic evidence is rated high in the direction of no increased risk or even decreased risk.”

    The IOM concluded the evidence convincingly supports 14 specific vaccine-adverse event relationships, with all but one based on strong mechanistic evidence, and the epidemiologic evidence rated as either having limited confidence or being insufficient. Four vaccine adverse events judged to have either epidemiologic evidence of moderate certainty or mechanistic evidence of intermediate weight were placed in the “evidence favors acceptance of a causal relationship” category, while five other vaccine adverse events were placed in the “evidence favors rejection” category. A finding against a causal relationship required high or moderate epidemiologic evidence in the direction of no effect or decreased risk along with the absence of strong or intermediate mechanistic evidence supporting a causal relationship. The vast majority (135 vaccine-adverse event combinations) were placed in the “evidence is inadequate to accept or reject a causal relationship” category.

    After release of the report, nine HHS workgroups including HRSA and the Centers for Disease Control and Prevention (CDC) medical staff reviewed the IOM conclusions on 158 vaccine-adverse events, as well as any newly published scientific literature not contained in the IOM report, and developed a set of proposed changes to the Table and QAI. The work of the HHS workgroups ended and HRSA continued to monitor the literature.

    In 2006, the ACCV established “Guiding Principles for Recommending Changes to the Vaccine Injury Table” (Guiding Principles) to assist the ACCV in evaluating proposed Table revisions and determining whether to recommend changes to the Table to the Secretary. The Guiding Principles consist of two overarching principles: (1) The Table should be scientifically and medically credible; and (2) where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners. The Guiding Principles also state, among other factors, that “[t]o the extent that the [IOM] has studied the possible association between a vaccine and an adverse effect, the conclusions of the IOM should be considered by the ACCV and deemed credible but those conclusions should not limit the deliberations of the ACCV.” Although not binding on the Secretary, the ACCV Guiding Principles were utilized by the nine HHS workgroups in the development of the proposed changes to the Table. In particular, recommendations regarding appropriate time intervals for the onset of a Table injury, or diagnostic criteria in the QAI were influenced by the Guiding Principles. As part of its mandate under the Act, the ACCV considered the proposed changes set forth in this NPRM in its quarterly meetings on March 8, 2012, September 5, 2013, December 5, 2013, June 5, 2014, and September 4, 2014. The ACCV deliberations included scientific and public policy considerations, and were also influenced by the 2006 Guiding Principles. For each proposed change by the Secretary, the ACCV voted for one of three options:

    1. ACCV concurs with the proposed change(s) to the Table (and QAI) and would like the Secretary to move forward (with or without comments);

    2. ACCV does not concur with the proposed change(s) to the Table (and QAI) and would not like the Secretary to move forward; or

    3. ACCV would like to defer a recommendation on the proposed change(s) to the Table (and QAI) pending further review at a future ACCV meeting.

    Findings

    In prior Table revisions, the Secretary determined that the appropriate framework for making changes to the Table is to make specific findings as to the illnesses or conditions that can reasonably be determined in some circumstances to be caused or significantly aggravated by the vaccines under review and the circumstances under which such causation or aggravation can reasonably be determined to occur. The Secretary continues this approach based on the 2012 IOM report, the work of the nine workgroups that reviewed the IOM findings, and after giving due consideration to the ACCV's recommendations.

    For the vast majority of the vaccine adverse event pairs that were reviewed by the IOM (135), the IOM determined that the evidence is inadequate to accept or reject a causal relationship. With the exception of seasonal influenza vaccine and Guillain-Barré Syndrome (GBS), unless the IOM findings addressed a condition that was already on the Table, the Secretary makes no additional findings and proposes no change to the Table with regard to the vaccine adverse event pairs in this category. For seasonal influenza vaccines, the Secretary proposes to add the injury of GBS to the Table for the policy reasons discussed in this NPRM. For any vaccine adverse event pairs for which future scientific evidence develops to support a finding of a causal relationship, the Secretary will consider future rulemaking to revise the Table accordingly.

    Applying the remaining IOM conclusions, with the Guiding Principles, the Secretary intends to make certain changes to the Table, and also intends to leave certain items already on the Table unchanged. In so doing, the Secretary makes the following findings:

    Findings That Result in Additions or Changes to the Table

    1. The scientific evidence convincingly supports a causal relationship between measles-mumps-rubella (MMR) vaccine and measles inclusion body encephalitis.

    2. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine disseminated varicella infection (widespread chickenpox rash shortly after vaccination).

    3. The scientific evidence convincingly supports a causal relationship between varicella vaccine and disseminated varicella infection with subsequent infection resulting in pneumonia, meningitis, or hepatitis in individuals with demonstrated immunodeficiencies.

    4. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine strain viral reactivation.

    5. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis.

    6. The scientific evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis.

    7. The scientific evidence convincingly supports a causal relationship between influenza vaccines and anaphylaxis.

    8. The scientific evidence convincingly supports a causal relationship between meningococcal vaccines and anaphylaxis.

    9. The scientific evidence favors acceptance of a causal relationship between human papillomavirus vaccines and anaphylaxis.

    10. The scientific evidence convincingly supports a causal relationship between an injection-related event and deltoid bursitis. For reasons detailed below, the Secretary proposed adding a more expansive injury of Shoulder Injury Related to Vaccine Administration (SIRVA) to the Table.

    11. The scientific evidence convincingly supports a causal relationship between an injection-related event and syncope.

    12. The scientific evidence is inadequate to accept or reject a causal relationship between seasonal influenza vaccines and GBS. However, the Secretary proposes a Table change for the reasons discussed in this NPRM.

    Findings That Do Not Result in Changes to the Table Because the Injury Is Already on the Table

    1. The scientific evidence convincingly supports a causal relationship between MMR vaccine and anaphylaxis.

    2. The scientific evidence convincingly supports a causal relationship between Hepatitis B vaccine and anaphylaxis.

    3. The scientific evidence convincingly supports a causal relationship between tetanus toxoid vaccine and anaphylaxis.

    4. The scientific evidence is inadequate to accept or reject a causal relationship between tetanus toxoid-containing vaccines (including those containing the acellular pertussis component but not the whole cell pertussis component) and encephalopathy and encephalitis.

    5. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthritis in women.

    6. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthritis in children.

    7. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and encephalopathy or encephalitis.

    Findings That Do Not Result in Changes to the Table Because the Injury Is Transient in Nature

    1. The scientific evidence convincingly supports a causal relationship between MMR vaccine and febrile seizures.

    2. The scientific evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia in women.

    3. The scientific evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia in children.

    Findings That Do Not Result in Changes to the Table Because the Evidence Favors Rejection of a Causal Relationship

    1. The scientific evidence favors a rejection of a causal relationship between MMR vaccine and autism.

    2. The scientific evidence favors a rejection of a causal relationship between MMR vaccine and type 1diabetes.

    3. The scientific evidence favors a rejection of a causal relationship between DTaP (tetanus) vaccine and type 1diabetes.

    4. The scientific evidence favors a rejection of a causal relationship between inactivated (as opposed to the live intranasal) influenza vaccine and Bell's palsy.

    5. The scientific evidence favors a rejection of a causal relationship between inactivated influenza vaccine and exacerbation of asthma or reactive airway disease episodes in children and adults.

    Discussion of Proposed Table Changes

    The Secretary has examined the recommendations of the ACCV and proposes that the Table set forth at 42 CFR 100.3 be revised as described below. Following each vaccine and adverse event there is a discussion of the IOM conclusion and, where applicable, other relevant conclusions, as well as the Department's proposal. It should be noted that the ACCV concurred with all of the proposals regarding the Table and QAI. Each of the changes proposed by the Department and the rationale for the proposal is described in detail. An important consideration in proposing changes to the Table is the need to make the Table as easy to understand and as clear as possible. With this goal in mind, the Secretary has proposed new language and clarified certain sections of the QAI which must be used by the Special Masters and the parties in understanding when a particular set of symptoms is consistent with a particular Table injury.

    As provided in 42 U.S.C. 300aa-14(c)(4), the modified Table will apply only to petitions filed under the Program after the effective date of the final regulation. Petitions must also be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed with the VICP, set forth in 42 U.S.C. 300aa-16(a), continues to apply. In addition, the statute identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this section, an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than 2 years after the effective date of the revision if the injury or death occurred not more than 8 years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)). This is true even if such individual previously filed a petition for compensation, and is thus an exception to the “one petition per injury” limitation of 42 U.S.C. 300aa-11(b)(2).

    Based on the requirements of the Administrative Procedure Act, the Department publishes a Notice of Proposed Rulemaking in the Federal Register before a regulation is promulgated. The public is invited to submit comments on the proposed rule. In addition, a public hearing will be held for this proposed rule. After the public comment period has expired, the comments received and the Department's responses to the comments will be addressed in the preamble to the final regulation. The Department will publish the final rule in the Federal Register.

    In the following sections, background information on different categories of vaccines as well as the Secretary's rationale for any proposed Table change is provided. It should also be noted that the proposed QAIs are designed to define the conditions covered on the Table and to rule out other conditions that are not covered on the Table (and for which there has been no finding of a causal relation to the vaccines). In addition, the QAIs make clear that if certain other circumstances exist that do not, in the Secretary's view, warrant a presumption of causation, the Table presumption will not be apply.

    I. Vaccines Containing Tetanus Toxoid

    Currently there are four tetanus-diptheria (Td) vaccines licensed in the United States, two of which also contain acellular pertussis vaccines (Tdap and DTap); a diphtheria-tetanus (DT) vaccine for children younger than age 7 years; and one tetanus toxoid vaccine (TT). In addition, there are three combination vaccines approved for use in children, including (DTaP-IPV-HepB), (DTaP-IPV-Hib), and (DTaP-IPV). Immunity to tetanus wanes over time, so booster doses are needed. According to the CDC recommended schedule of immunizations for children, an infant and child should receive four doses of DTaP in the first 18 months of life and a booster dose between 4 to 6 years. Tdap is recommended at age 11 to 12 years.

    Since 2005, the Advisory Committee on Immunization Practices (ACIP) and the CDC have recommended a Tdap vaccine booster dose for all adolescents aged 11 through 18 years of age and for adults aged 19 through 64 years who have not received a dose. A Td booster is recommended every 10 years thereafter. As part of wound management care to prevent tetanus, a tetanus toxoid-containing vaccine is recommended for wound management in anyone who has not received a tetanus-containing vaccine for 5 years or more. The CDC recommends that one dose of Tdap be administered to pregnant women during each pregnancy regardless of the interval since the prior Td or Tdap vaccination.

    A. Shoulder Injury Related to Vaccination

    Shoulder Injury Related to Vaccine Administration (SIRVA) is an adverse event following vaccination thought to be related to the technique of intramuscular percutaneous injection (the procedure where access to a muscle is obtained by using a needle to puncture the skin) into an arm resulting in trauma from the needle and/or the unintentional injection of a vaccine into tissues and structures lying underneath the deltoid muscle of the shoulder. As the proposed definition indicates, SIRVA is an injury related to the intramuscular injection of a vaccine. Consequently, by definition, a Table injury of SIRVA will not result for those vaccines that are not administered by intramuscular injection, including oral polio and rotavirus; subcutaneous MMR, MMRV, varicella, and meningococcal-polysaccharide; intranasal influenza; and intradermal influenza. In addition, a Table injury of SIRVA will not result for those vaccines that are administered via a needleless jet device. Jet injectors are needleless systems for vaccine or medication administration that utilize a high-pressure jet of liquid to penetrate the skin. During administration, the needleless syringe is placed against the injection site and as the medication or vaccine passes through the injector under high pressure it forms a jet of fluid that penetrates the skin. These devices do not penetrate the skin to a degree that would result in SIRVA. Current information regarding routes of administration for various vaccine formulations is available on the Centers for Disease Control and Prevention's Web site: http://www.cdc.gov/vaccines/recs/vac-admin/default.htm?s_cid=.

    Clinical signs of shoulder pain and restricted motion in the affected shoulder appear shortly after vaccination. Medical review of VICP claims shows more than 30 cases of severe, persistent shoulder pain beginning shortly after vaccination and resulting in prolonged restriction of function. Often these cases were diagnosed as deltoid bursitis. [Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-8052.]

    The IOM reviewed the scientific and medical literature finding evidence that convincingly supports a causal relationship between vaccine injection (with a needle) into an arm and deltoid bursitis. The report noted that the published VICP case series (Atanasoff et al.), as described, were clinically consistent with deltoid bursitis. The VICP case series found that 93 percent of patients had the onset of shoulder pain within 24 hours of vaccine administration and 54 percent had immediate pain following vaccine injection. The VICP case series found several diagnoses, beyond deltoid bursitis, that resulted in shoulder pain following vaccination, including tendonitis, impingement syndrome, frozen shoulder syndrome, and adhesive capsulitis. Another case series reported two cases of shoulder pain, weakness and reduced range of motion following vaccination with onset of symptoms within 48 hours of vaccination. [Bodor M, Montalvo E, Vaccination related shoulder dysfunction, Vaccine 25(2007) 585-587.]

    In order to capture the broader array of potential injuries, the Secretary proposes to add SIRVA for all tetanus toxoid-containing vaccines that are administered intramuscularly through percutaneous injection into the upper arm. The interval of onset will be less than or equal to 48 hours.

    While the Secretary proposes adding SIRVA to the Table for the MMR and Varicella vaccines, to meet the proposed QAI for SIRVA, the vaccine must be one intended for intramuscular administration in the upper arm. The Secretary acknowledges that currently there are no MMR or Varicella vaccines that are administered by intramuscular injection. However, the Secretary proposes that the Table include SIRVA as an injury for those vaccines, recognizing that, presently, the absence of an intramuscular formulation of the vaccines will prevent petitioners from meeting the Table QAI for SIRVA with respect to those vaccines. The advantage of such proposal is that the Table would not require modification should an intramuscular formulation of those vaccines develop. The disadvantage of this proposal could be confusion about whether a Table injury for SIRVA may be satisfied for those vaccines, despite the QAI's requirement that the associated vaccine be intended for intramuscular administration. Accordingly, the Secretary specifically seeks the public's views on her proposal to include SIRVA as a Table injury for the MMR and varicella vaccines notwithstanding the fact that there currently is not an intramuscular formulation. Consequently, by definition, a Table injury of SIRVA will not result for those vaccines that are not administered by intramuscular injection, including oral polio and rotavirus; subcutaneous MMR, MMRV, varicella, and meningococcal-polysaccharide; intranasal influenza; and intradermal influenza.

    B. Vasovagal Syncope

    Vasovagal syncope is the loss of consciousness (fainting) caused by a transient decrease in blood flow to the brain. Vasovagal syncope is usually a benign condition but may result in falling and injury. Vaccination is known to be one cause of vasovagal syncope. Both serious and non-serious injuries can occur as a result of syncope. The types of serious injuries that may occur following a syncopal episode include, but are not limited to, skin lacerations, bone fractures, dental injuries, traumatic brain injuries, and death. Other injuries include traumatic injuries sustained from automobile accidents that occurred due to a vaccinee experiencing syncope while driving within a short time period after vaccine receipt.

    The IOM reviewed the literature concerning a possible link between the injection of a vaccine and syncope. Although the Committee found the epidemiologic evidence was insufficient or absent to assess an association between the injection of a vaccine (with a needle) and syncope, the Committee concluded the mechanistic evidence was strong based on 35 cases presenting definitive clinical evidence. In addition, the HHS's Division of Injury Compensation Programs (DICP) has identified eight cases from its database alleging syncope as a vaccine injury (unpublished data). All had six months of residual symptoms as a result of syncope. In all eight cases, DICP found that syncope was directly related to vaccine administration.

    The IOM concluded that the evidence convincingly supports a causal relationship between the injection of a vaccine (with a needle) and syncope. It did not limit this conclusion to a particular vaccine and explained that the evidence from one case report it examined as part of the mechanistic evidence it reviewed suggested “that the injection, and not the contents of the vaccine, contributed to the development of syncope.”

    In order to be eligible for compensation, the Act requires that the residual effects of the alleged vaccine injury must have continued for a period of at least 6 months (unless the injury results in in-patient hospitalization and surgery, or death). The Secretary recognizes that in many instances cases involving syncope will not meet the statutory severity criteria, as the reaction can be short-lived and treated effectively. However, there is a known risk of serious residual injury or of death from syncope.

    Although syncope typically has no long term consequences, the Program has found that not infrequently, syncope is associated with residual effects lasting more than 6 months. Therefore, the Secretary proposes to add vasovagal syncope to the Table for all tetanus toxoid containing vaccines that are administered through percutaneous injection to permit an award of compensation in serious cases meeting the severity criteria. The proposed time interval of onset is less than or equal to 1 hour following vaccination. Syncope is an injury related to the injection of a vaccine. Consequently, the Secretary does not propose adding syncope as a Table injury for those vaccines that are not administered by injection, including oral polio and rotavirus vaccine. With respect to other vaccines, such as the intranasal influenza vaccine, while syncope is proposed as an injury for the general category of vaccines (i.e., seasonal influenza vaccines), the specific formulation will not result in a Table injury of syncope by definition because it is not administered by injection. The Secretary is not aware of any reliable and persuasive evidence demonstrating that syncope occurs following administration of a vaccine via a needleless jet device; however, it may be plausible for syncope to occur with this route of administration. Therefore, the Secretary seeks the public's views as to whether the Secretary should include syncope as a Table injury for those vaccines that are administered via a needleless jet device. The Secretary also seeks the public's views as to whether syncope should be a Table injury for other categories of vaccines (e.g., rotavirus) notwithstanding the fact that there currently is not a formulation that is administered by injection in order to encompass future formulations that may be administered by injection.

    II. Vaccines Containing Extracted or Partial Cell Pertussis Bacteria, or Specific Pertussis Antigen(s)

    Diphtheria, tetanus, and whole cell pertussis (DTwP) vaccines were used for much of the 20th century to control pertussis (whooping cough) disease. Concerns about the safety of DTwP (also referred to as DTP) vaccine prompted development of vaccines with an acellular pertussis component. With data showing fewer local, systemic, and more serious adverse events after acellular (DTaP) vaccine when compared to whole cell DTwP vaccine, the FDA licensed diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines in 1991 for use in children aged 15 months to 6 years, and in 1996 for use in infants and children aged 6 weeks to 6 years. By 2000, DTaP had replaced DTwP and, like the whole cell pertussis vaccine, was subsequently licensed in combination with other vaccines for routine use in children. Further, in 2005, FDA licensed tetanus and diphtheria toxoid (Td) and, acellular pertussis (Tdap) vaccine, for use in persons 10 years of age and older, as this vaccine is thought to decrease the number of pertussis carriers in the population, which would lead to a decrease in the number of pertussis outbreaks.

    The Secretary notes that there are significant differences between whole cell and acellular pertussis vaccines. Although both vaccine types were developed for the same purpose (i.e., immunization against pertussis), they have significantly different compositions, and different effects on biological systems (e.g., the immune and nervous systems). DTwP is distinct from DTaP because the former contains many bacterial proteins, including endotoxins (some of which are known neurotoxins) and the latter does not. These neurotoxins are thought to possibly act synergistically to cause adverse neurologic events in susceptible DTwP vaccine recipients. To date, no adequate study has been published that demonstrates a causal relationship between acellular pertussis vaccines and encephalopathy/encephalitis. Furthermore, studies have demonstrated a significant reduction in the number of common adverse events with acellular pertussis, such as crying and fevers, and less common ones, such as febrile seizures. [Pertussis vaccination: use of acellular pertussis vaccines among infants and young children recommendations of the advisory committee on immunization practices (ACIP), MMWR, 1997; 46(RR-7):1-25.] [Le Saux N, et al. Health Canada Immunization Monitoring Program-Active (IMPACT)] [Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: A report from IMPACT. Pediatrics. 2003; 112(5):e348.] Pertussis antigen-containing vaccines were included in the original statutory Table.

    A. Encephalopathy/Encephalitis

    The initial Table and QAI set forth in the 1986 statute reflected Congress' initial legislative determinations on vaccine-related injuries for DTwP vaccine. Further, modifications to the Table and QAI promulgated by the Secretary in 1995 were based on the scientific findings related to DTwP vaccine, the key study being the British National Childhood Encephalopathy Study (NCES), which found some evidence of acute neurologic illness (encephalopathy) 1 to 7 days after vaccination with the whole cell pertussis vaccine. Similarly, a 10 year NCES follow-up found evidence of chronic nervous system effects. However, the evidence from this follow-up study remained insufficient to indicate the presence or absence of a causal relation between DTP and chronic nervous system dysfunction. On the other hand, a more recent epidemiologic study of whole cell pertussis-containing vaccines did not show a relationship with encephalopathy or encephalitis (Ray et al). The IOM conclusions in 1991 and 1994 were mixed regarding the statistically significant findings of encephalopathy in both the original NCES and its 10 year follow-up. [IOM, Adverse Effects of Pertussis and Rubella Vaccines, 1991. IOM, Adverse Events Associated with Childhood Vaccines, 1994.] In the end, the Secretary, with unanimous support of the ACCV, retained encephalopathy on the Table, but clarified the definition of encephalopathy in the QAI to make it more clinically precise. [Miller D, Wadsworth J, Ross E, Severe neurological illness: Further analysis of the British National Childhood Encephalopathy Study. Tokai J Exp Clin Med. 1988; 13(suppl):145-155; Miller D, Madge N, Diamond J, Wadsworth J, and Ross E, Pertussis Immunization and Serious Acute Neurological Illnesses in Children, BMJ, 1993;307:1171-6; Ray P, Hayward J, Michelson D, Lewis E, Schwalbe J, Black S, Shinefield H, Marcy M, Huff K, Ward J, Mullooly J, Chen R, Davis R, and the Vaccine Safety Datalink Group, Encephalopathy After Whole-Cell Pertussis or Measles Vaccination: Lack of Evidence for a Causal Association in a Retrospective Case-Control Study. Ped Infec Dis J. 2006; 25(9):768-773.]

    Acellular pertussis-containing vaccines were developed because of concerns about events due to whole cell pertussis. Toxicologists argue that components in these two types of pertussis vaccines differ greatly and should be treated as separate entities. Animal models have demonstrated that whole cell pertussis constituents have different effects than those with acellular pertussis. In one study, only whole cell pertussis vaccines caused seizure activity in mice. Levels of inflammatory markers were elevated in the whole cell pertussis group but not the acellular pertussis group. In another study, mice that received whole cell pertussis intravenously succumbed while those that received acellular pertussis did not. [Sato Y, Sato H, Comparison of Toxicities of Acellular Pertussis Vaccine with Whole Cell Pertussis Vaccine in Experimental Animals, Dev Biol Stand, 1991; 73:251-62; Donnelly S, Loscher CE, Lynch MA, Mills KH, Whole-cell but not Acellular Pertussis Vaccines Induce Convulsive Activity in Mice: evidence of a role for toxin-induced interleukin-1beta in a new murine model for analysis of neuronal side effects of vaccination. Infect Immun. 2001 July; 69(7):4217-4223.]

    The 2012 IOM report on adverse events found that the evidence was inadequate to accept or reject a causal association between acellular pertussis-containing vaccines and encephalopathy and encephalitis. As previously stated, there is no credible evidence of a causal relationship between acellular pertussis vaccines and encephalopathy/encephalitis. Clinical studies have demonstrated a significant reduction in the number of common adverse events with acellular pertussis vaccine, as compared to whole cell pertussis vaccine, such as crying and fevers, and less common ones, such as febrile seizures. Although there have been large-scale surveillance studies conducted on the effects of acellular pertussis vaccines in infants and young children, such as those done in Canada and Australia, the study design used passive surveillance and therefore, the evidence is not as definitive as a controlled, well-designed epidemiologic study using a case control or cohort design [Le Saux N, et al. e348] [Lawrence G., Menzies R., Burgess M., McIntyre P., Wood N., Boyd I., Purcell P., Isaacs D. Surveillance of adverse events following immunization: Australia, 2000-2002. Commun Dis Intell. 2003; 27(3):307-23]. With regard to adolescents and adults, the Committee included a study by Yih (2009) which found that the number of encephalitis, encephalopathy or meningitis cases within 42 days of Tdap vaccination were less than a historical Td cohort with a relative risk of 0.84. [Yih W. K., Nordin J.D., Kulldorff M., Lewis E., Lieu T.A., Shi P., and Weintraub E. S., 2009, An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the vaccine safety datalink, Vaccine 27(32):4257-4262]

    In view of the limited epidemiological data, and as influenced by the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of encephalopathy/encephalitis for vaccines containing pertussis antigens, with an onset less than 72 hours from vaccination. However, the Secretary proposes to re-organize, clarify, and update the QAI for acute and chronic encephalopathy, and to include a new definition for acute encephalitis based on the Brighton Collaboration criteria and several other references. The Brighton Collaboration is an international voluntary collaboration that develops globally accepted and standardized case definitions of adverse events following immunizations. More information can be found at: https://brightoncollaboration.org/public.

    B. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA for pertussis antigen-containing vaccines. [See I.A.] The interval of onset will be less than or equal to 48 hours.

    C. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for pertussis antigen-containing vaccines. [See I.B.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    III. Vaccines Containing Measles, Mumps, and Rubella Vaccine or Any of Its Components

    Since the 1960s, measles, mumps, and rubella (MMR), a live, attenuated virus vaccine, has been routinely administered to children in the U.S. In 2005, the tetravalent measles, mumps, rubella, and varicella (MMRV) vaccine was added to the immunization schedule. MMR vaccine was included in the original statutory Table.

    A. Vaccine Strain Measles Viral Disease Including Measles Inclusion Body Encephalitis (MIBE)

    Severe complications associated with the measles virus or a mutated form of the virus, such as measles inclusion body encephalitis (MIBE), can be broadly categorized as measles viral diseases. The Table currently lists “vaccine-strain measles viral infection in an immunodeficient recipient” as a Table injury for vaccines containing measles virus, with an onset of 6 months. This condition is defined in the QAI as “a disease caused by the vaccine-strain that should be determined by vaccine-specific monoclonal antibody or polymerase chain reaction tests.”

    MIBE is a rare, slow encephalitis caused by chronic with the measles virus, and is thus a subset of the condition already listed on the Table. MIBE is confined to immunodeficient individuals and is frequently fatal. MIBE occurs primarily in children and young adults, and typically occurs within 1 year of the initial infection or vaccination. A gradual decline in intellectual abilities and behavioral alterations are followed by progressive myoclonus; muscle spasticity; seizures; dementia; autonomic dysfunction; and ataxia. Death usually occurs 1 to 3 years after disease onset. Pathologic features include perivascular cuffing, eosinophilic cytoplasmic inclusions, neurophagia, and fibrous gliosis.

    The IOM concluded that the evidence convincingly supports a causal relationship between MMR vaccine and MIBE in individuals with demonstrated immunodeficiencies. Out of the five case reports the IOM found, two had wild-type measles infection and these did not contribute to the weight of evidence. Only one out of the three contributing case reports had vaccine-strain measles virus isolated. Because of limitations due to testing and viral properties, in most cases it is difficult to characterize wild-type versus vaccine-strain measles. [Bitnun A., Shannon P., Durward A., Rota P.A., Bellini W.J., Graham C., Wang E., Ford-Jones E.L., Cox P., Becker L., Fearon M., Petric M., and Tellier R.,. 1999. Measles inclusion-body encephalitis caused by the vaccine strain of measles virus. Clinical Infectious Diseases 29(4):855-861.] The current Table lists “Vaccine-strain measles viral infection in an immunodeficient recipient” for measles virus-containing vaccines with a time interval of onset of 6 months. Case reports of MIBE cited by the IOM showed a time interval of onset that varied from 8 days to 11 months.

    For the reasons discussed above and in keeping with the spirit of the Guiding Principles, the Secretary proposes to change the injury of “vaccine-strain measles viral infection in an immunodeficient recipient” to “vaccine-strain measles viral disease in an immunodeficient recipient.” Because MIBE is a type of measles virus-associated disease occurring in immunodeficient individuals, the Secretary proposes a new time interval of onset of up to 12 months from the date of vaccination for those cases in which the typing of vaccine strain was not performed, because most cases of vaccine-strain disease occur within 1 year of vaccination. There is no time interval for onset proposed if the vaccine strain of the virus is identified, as it can be concluded that the vaccine was a contributing cause of the injury. Cases in which wild-type measles strain is isolated will be excluded. Revisions to the Table will distinguish between cases in which the measles vaccine strain is identified versus those cases in which laboratory testing was not done or the results were inconclusive. In addition, the Secretary proposes adding diagnostic criteria to the QAI.

    B. Encephalopathy and Encephalitis

    The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between MMR vaccine and encephalopathy or encephalitis. Not only is there limited epidemiologic evidence on a possible causal association, the mechanistic evidence is weak, based on current knowledge about natural infection and few case reports. Natural (wild-type) infection (measles, mumps, and/or rubella virus) is thought to cause neurologic illness through damage to the neurons by direct viral invasion. This is thought to be either from direct viral infection and/or viral reactivation (particularly in immunocompromised patients). These same mechanisms may be responsible for vaccine-associated encephalopathy/encephalitis, but evidence linking these mechanisms directly to MMR vaccine strains (detection of viral antigens or antibodies) has not been shown. [Makela A., J. P. Nuorti, and H. Peltola. 2002. Neurologic disorders after measles-mumps-rubella vaccination. Pediatrics 110(5):957-963.] [Ray, P., J. Hayward, D. Michelson, E. Lewis, J. Schwalbe, S. Black, H. Shinefield, M. Marcy, K. Huff, J. Ward, J. Mullooly, R. Chen, and R. Davis. 2006. Encephalopathy after whole-cell pertussis or measles vaccination: Lack of evidence for a causal association in a retrospective case-control study. Pediatric Infectious Disease Journal 25(9):768-773.]

    In view of the limited mechanistic data, and as influenced by the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of encephalopathy/encephalitis for MMR vaccines, with an onset not less than 5 days and no more than 15 days from vaccination. However, the Secretary proposes to re-organize, clarify, and update the QAI for acute and chronic encephalopathy and include a new definition for acute encephalitis based on the Brighton Collaboration criteria and several other references. [Ford-Jones L., MacGregor D., Richardson S., et al. Acute childhood encephalitis and meningoencephalitis: Diagnosis and management. Paediatr Child Health (1988). Jan-Feb;3(1):33-40] [Ball R., Halsey N., Braun M., et al. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System. Journal of Clinical Epidemiology (2002). 55:819-824.]

    C. Febrile Seizures

    Febrile seizures are a common cause of convulsions in young children. Generally viewed as benign and not indicative of brain disease, they occur in two to four percent of children up to age 5 years. Febrile seizures are often seen as the body temperature increases rapidly; but, may develop as the fever is declining. Most events last a minute or two, although some can be as brief as a few seconds. A family history of febrile seizures increases the child's risk of occurrence. Anything that causes fever, such as viral or bacterial infections, can bring on a febrile seizure.

    The IOM Committee concluded that the evidence convincingly supports a causal relationship between MMR vaccine and febrile seizures. Based on seven epidemiologic studies, the Committee had a high degree of confidence that there is an increased risk of febrile seizures after receipt of MMR vaccine. The Committee assessed the mechanistic evidence regarding an association between MMR vaccine and febrile seizures as intermediate based on 12 cases presenting clinical evidence. [Farrington, P., S. Pugh, A. Colville, A. Flower, J. Nash, P. Morgan-Capner, M. Rush, and E. Miller. 1995. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 345(8949):567-569.] [Miller, E., N. Andrews, J. Stowe, A. Grant, P. Waight, and B. Taylor. 2007. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. American Journal of Epidemiology 165(6):704-709.] [Barlow, W. E., R. L. Davis, J. W. Glasser, P. H. Rhodes, R. S. Thompson, J. P. Mullooly, S. B. Black, H. R. Shinefield, J. I. Ward, S. M. Marcy, F. DeStefano, and R. T. Chen. 2001. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. New England Journal of Medicine 345(9):656-661.]

    Patients who had post-MMR vaccination febrile seizures had no higher risk of subsequent seizure or neurodevelopmental disability than other children with febrile seizures in the absence of vaccine administration. The long-term rate of epilepsy was not increased in children who had febrile seizures following MMR vaccination compared with children who had febrile seizures of a different etiology [Vestergaard, M., A. Hviid, K. M. Madsen, J. Wohlfahrt, P. Thorsen, D. Schendel, M. Melbye, and J. Olsen. 2004. MMR vaccination and febrile seizures: Evaluation of susceptible subgroups and long-term prognosis. Journal of the American Medical Association 292(3):351-357.] [Barlow, W. E., R. L. Davis, J. W. Glasser, P. H. Rhodes, R. S. Thompson, J. P. Mullooly, S. B. Black, H. R. Shinefield, J. I. Ward, S. M. Marcy, F. DeStefano, and R. T. Chen. 2001. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. New England Journal of Medicine 345(9):656-661.]

    Although febrile seizures can be alarming to parents and other family members, the overwhelming majority of children who have febrile seizures recover quickly and have no lasting effects. Only very rarely can febrile seizures lead to serious injury or disability.

    The National Childhood Vaccine Injury Act of 1986 requires the effects of the alleged vaccine injury must have continued for at least 6 months (unless the injury results in in-patient hospitalization and surgery, or death). Because the current medical literature supports febrile seizures only very rarely have long term consequences this condition is not being proposed for inclusion on the Table. However, the Program will consider causation-in-fact claims for febrile seizures leading to serious injury or death on a case-by-case basis.

    D. Transient Arthralgia in Women and Children

    Arthralgia means joint pain without signs of inflammation (e.g. erythema, warmth, pallor, edema, or decreased range of movement). Arthritis is arthralgia with signs of inflammation. Arthropathy encompasses arthralgia or arthritis and refers to any joint disease. Unlike arthritis, arthralgia is a symptom and there may be no objective measures for confirmation. The IOM concluded that the evidence favors acceptance of a causal relationship between MMR vaccine (attributable to the rubella component) and transient arthralgia in women and children. The IOM had a moderate degree of confidence in the epidemiologic evidence for women (based on four studies) that consistently reported an increased risk of transient arthralgia after MMR vaccination. Similarly, the mechanistic evidence regarding an association between rubella vaccine and transient arthralgia in women was intermediate based on 13 case reports. Two-thirds of the studies involved post-partum women. [Slater, P. E., T. Ben-Zvi, A. Fogel, M. Ehrenfeld, and S. Ever-Hadani. 1995. Absence of an association between rubella vaccination and arthritis in underimmune postpartum women. Vaccine 13(16):1529-1532.] [Ray, P., S. Black, H. Shinefield, A. Dillon, J. Schwalbe, S. Holmes, S. Hadler, R. Chen, S. Cochi, and S. Wassilak. 1997. Risk of chronic arthropathy among women after rubella vaccination. Journal of the American Medical Association 278(7):551-556] [Tingle, A. J., L. A. Mitchell, M. Grace, P. Middleton, R. Mathias, L. MacWilliam, and A. Chalmers. 1997. Randomised double-blind placebo-controlled study on adverse effects of rubella immunisation in seronegative women. Lancet 349(9061):1277-1281.] [Mitchell, L. A., A. J. Tingle, L. MacWilliam, C. Home, P. Keown, L. K. Gaur, and G. T. Nepom. 1998. HLA-DR class II associations with rubella vaccine-induced joint manifestations. Journal of Infectious Diseases 177(1):5-12.]

    There were seven epidemiologic studies of children that consistently reported an increased risk of arthralgia after MMR vaccination. The IOM had a moderate degree of confidence in the epidemiologic evidence based on the seven studies with sufficient validity and precision to assess an association between MMR vaccine and transient arthralgia in children. The mechanistic evidence was weak based on knowledge about natural rubella infection. [Peltola, H., and O. P. Heinonen. 1986. Frequency of true adverse reactions to measles-mumps-rubella vaccine. Lancet 327(8487):939-942.] [Virtanen, M., H. Peltola, M. Paunio, and O. P. Heinonen. 2000. Day-to-day reactogenicity and the healthy vaccinee effect of measles-mumps-rubella vaccination. Pediatrics 106(5):E62.] [Benjamin, C. M., G. C. Chew, and A. J. Silman. 1992. Joint and limb symptoms in children after immunization with measles, mumps, and rubella vaccine. BMJ 304(6834):1075-1078.] [Davis, R. L., E. Marcuse, S. Black, H. Shinefield, et al. 1997. MMR2 immunization at 4 to 5 years and 10 to 12 years of age: A comparison of adverse clinical events after immunization in the vaccine safety datalink project. Pediatrics 100(5):767-771] [dos Santos, B. A., T. S. Ranieri, M. Bercini, M. T. Schermann, S. Famer, R. Mohrdieck, T. Maraskin, and M. B. Wagner. 2002. An evaluation of the adverse reaction potential of three measles-mumps-rubella combination vaccines. Revista Panamericana de Salud Publica/Pan American Journal of Public Health 12(4):240-246.] [LeBaron, C. W., D. Bi, B. J. Sullivan, C. Beck, and P. Gargiullo. 2006. Evaluation of potentially common adverse events associated with the first and second doses of measles-mumps-rubella vaccine. Pediatrics 118(4):1422-143] [Heijstek, M. W., G. C. S. Pileggi, E. Zonneveld-Huijssoon, et al. 2007. Safety of measles, mumps and rubella vaccination in juvenile idiopathic arthritis. Annals of the Rheumatic Diseases 66(10):1384-1387.]

    Because transient arthralgia is a subjective symptom that frequently lacks objective evidence for confirmation and has no long-term effects or consequences, this condition is not being proposed for inclusion on the Table.

    E. Chronic Arthropathy in Women and Children and Arthropathy in Men

    The IOM concluded that the evidence was inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthropathy in women and children, as well as arthropathy in men. The committee had limited confidence in the epidemiologic evidence for rubella vaccine and chronic arthralgia or arthritis. The epidemiologic evidence was insufficient or absent to assess an association between measles or mumps vaccine and chronic arthralgia or chronic arthritis in women. The IOM assessed the mechanistic evidence regarding rubella vaccine and chronic arthralgia or chronic arthritis in women as low-intermediate; and as lacking between measles or mumps vaccine and chronic arthralgia or chronic arthritis in women. In children, the IOM found the epidemiologic evidence to be insufficient or absent for the association between MMR and chronic arthropathy. The IOM found the mechanistic evidence between rubella vaccine and chronic arthropathy to be weak and they found the evidence to be lacking for measles and mumps vaccines. The IOM had limited confidence in the epidemiologic evidence for an association between MMR vaccine and arthropathy in men. The IOM found the mechanistic evidence regarding the association between rubella vaccine and arthropathy in men to be weak. The IOM found the mechanistic evidence between measles or mumps vaccine and arthropathy in men as lacking. [Ray, P., S. Black, H. Shinefield, A. Dillon, J. Schwalbe, S. Holmes, S. Hadler, R. Chen, S. Cochi, and S. Wassilak. 1997. Risk of chronic arthropathy among women after rubella vaccination. Journal of the American Medical Association 278(7):551-556.] [Tingle, A. J., L. A. Mitchell, M. Grace, P. Middleton, R. Mathias, L. MacWilliam, and A. Chalmers. 1997. Randomised double-blind placebo-controlled study on adverse effects of rubella immunization in seronegative women. Lancet 349(9061):1277-1281.] Peters, M. E., and S. Horowitz. 1984. Bone changes after rubella vaccination. American Journal of Roentgenology 143(1):27-28. Geiger, R., F. M. Fink, B. Solder, M. Sailer, and G. Enders. 1995. Persistent rubella infection after erroneous vaccination in an immunocompromised patient with acute lymphoblastic-leukemia in remission. Journal of Medical Virology 47(4):442-444.]

    In spite of the limited epidemiological and mechanistic data, based on the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of chronic arthritis for MMR vaccines, with an onset not less than 7 days and no more than 42 days from vaccination. However, the Secretary proposes to provide a definition for chronic arthritis in the QAI, based on the Brighton Collaboration criteria and several other references.

    F. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA to the Table for vaccines containing measles, mumps and/or rubella virus. [See section I.A above.] The interval of onset will be less than or equal to 48 hours. However, the Secretary recognizes that there currently is no intramuscular formulation of this vaccine available and therefore, petitioners alleging an injury of SIRVA associated with this vaccine presently cannot meet the QAI for SIRVA. Please see section I.A., above, for additional discussion on this point.

    G. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for vaccines containing measles, mumps and/or rubella virus. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    IV. Vaccines Containing Polio Inactivated Virus

    Since 2000, inactivated polio vaccine (IPV) has been the only polio vaccine used in the United States, although live virus oral polio vaccine (OPV) is still used in many parts of the world. The Secretary proposes changes to the Table related only to IPV, as an injected vaccine. OPV was included in the original statutory Table and remains on the regulatory Table.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for vaccines containing polio inactivated virus. [See Section I.A above.] The interval of onset will be less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for vaccines containing polio inactivated virus. [See Section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    V. Hepatitis B Vaccines

    The recombinant hepatitis B vaccine was first licensed by the FDA in 1986. Produced from cultured and purified yeast cells, it is the current form of vaccine used in the United States. Prior to 1991, the vaccine was recommended only for high risk individuals. However, the recommendation was extended to include all infants, since infected infants and children are at higher risk for developing chronic liver disease with subsequent liver cancer, and approximately one-third of those who acquire hepatitis B infection do not have any identified risk factors, and, therefore, were frequently not immunized. The effective date of coverage for hepatitis B vaccine is August 6, 1997.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for hepatitis B vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for hepatitis B vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    VI. Haemophilus Influenzae Type B Vaccines

    Haemophilus influenzae type b (Hib) conjugate vaccines were first licensed by the FDA in 1987 and have been recommended by the CDC for routine use since 1991. The vaccine is given to infants and children up to the age of school entry. The effective date of coverage for Hib vaccines is August 6, 1997, with no injuries or conditions specified.

    In order for a category of vaccines to be covered under the VICP, the category of vaccine must be recommended for routine administration to children by the Centers for Disease Control and Prevention (for example, vaccines that protect against seasonal influenza), subject to an excise tax by Federal law, and added to the Program by the Secretary of Health and Human Services. The Internal Revenue Code defines a “taxable vaccine” as including “[a]ny HIB vaccine”. See 26 U.S.C. 4132(a)(1)(H). Thus, the Secretary proposes to modify category IX on the Table from “Haemophilus influenzae type b polysaccharide conjugate vaccines” to “Haemophilus influenza type b vaccines,” as a technical change in order to be most inclusive.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for Hib vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for Hib vaccines. [See I.B.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    VII. Varicella Vaccines

    The varicella (chickenpox) virus vaccine, which was first licensed by the Food and Drug Administration in 1995, contains a live, attenuated strain of the varicella virus. Chickenpox is a highly contagious disease and although usually mild, infants, adolescents, adults, pregnant women, and immunocompromised individuals are at higher risk for serious complications. Since the introduction of the vaccine there has been a significant decrease in the number of cases of the disease with the greatest effect in states with the highest vaccination coverage. Varicella vaccine is listed on the Table, effective August 6, 1997, with no injuries or conditions specified.

    A. Disseminated Vaccine-Strain Viral Disease

    Disseminated varicella vaccine-strain viral disease is a condition in which the affected individual develops the varicella rash caused by the vaccine strain that spreads beyond the dermatome (an area of skin supplied by the nerve fibers of a single spinal root) involved in the vaccination and/or there is involvement of other organs such as the brain, lungs, and liver. For organs other than the skin, disease, not just mildly abnormal laboratory values, must be demonstrated in the involved organ. In this section, the word “disseminated” is defined by the IOM as the spreading of the rash (or the virus) beyond the dermatome involved in the vaccination.

    The IOM reviewed the evidence for vaccine causation of disseminated varicella disease with and without involvement of organs beyond the skin. They found three case reports in which vaccinated individuals developed lesions confined to the skin after immunization, and in whose lesions the vaccine strain of the varicella virus was identified. In addition, the IOM identified 550 cases reported to passive surveillance systems in which an attempt was made to identify the virus from skin lesions in individuals who developed disseminated varicella disease after vaccination without involvement of another organ. The wild-type virus was identified in 210 cases; the vaccine-strain virus was identified in 125 cases; and in the remaining cases either the sample was inadequate, the virus could not be identified, or there was no virus present. The committee also identified nine cases in which the vaccine strain of the virus was identified in individuals who had meningitis, pneumonia or hepatitis in addition to skin lesions. Cases of disseminated disease, which were reviewed by the IOM in individuals who were thought to be immunocompetent, all occurred within 42 days of immunization. The time of onset was not further specified. In many cases the timeframe from vaccination to onset of disseminated illness, without other organ involvement, was not provided for immunocompromised individuals, but in the cases for which there was data, there was a broad range of onset, spanning from 1 week in one case to “up to 87 days” in another. For four cases, in which onset was reported, the interval following vaccination was 18 days to 6 weeks. For disseminated disease with other organ involvement, onset was 13 days after vaccination in the only immunocompetent patient for whom data was available, and onset was between 10 and 35 days in eight immunocompromised individuals. [Wise, R. P., M. E. Salive, M. M. Braun, G. T. Mootrey, J. F. Seward, L. G. Rider, and P. R. Krause. 2000. Postlicensure safety surveillance for varicella vaccine. Journal of the American Medical Association 284(10):1271-1279.] [Goulleret, N., E. Mauvisseau, M. Essevaz-Roulet, M. Quinlivan, and J. Breuer. 2010. Safety profile of live varicella virus vaccine (Oka/Merck): Five-year results of the European varicella zoster virus identification program (EU VZVIP). Vaccine 28 (36):5878-5882.]

    The IOM found the evidence convincingly supports a causal relationship between varicella vaccine and disseminated varicella disease, both for cases confined to the skin and for cases where the spread involves other organs. However, the IOM limited their finding of causation in cases in which organs beyond the skin were involved to those with demonstrated immunodeficiencies. The Secretary notes that there is a significant overlap in the time-frames involved in the onset of disseminated disease in both immunocompetent and immunocompromised individuals. The Secretary further notes that although the IOM found convincing support for disseminated disease with other organ involvement only in immunocompromised individuals, the Secretary proposes, in accordance with the ACCV Guiding Principles, that the Table injury apply to all individuals, regardless of the status of their immune system, because it is possible that an individual so affected may not have been completely evaluated for an existing immunodeficiency, or suffered from an immunodeficiency that is subtle and beyond our current ability to test.

    The Secretary proposes to add disseminated vaccine-strain infection, both with and without other organ involvement, as a Table injury for varicella-containing vaccines. There is no time interval for onset if the vaccine strain of the virus is identified. However, if testing is not done or does not identify the virus, it is proposed that the injury qualify as a Table injury if the onset is 7 to 42 days following vaccination. If the wild-type virus or another non-vaccine-strain virus is identified, there will be no presumption of causation and it will not meet the Table criteria. If there is involvement of an organ beyond the skin, and no virus was identified in that organ, the involvement of all organs must occur as part of the same discrete illness.

    B. Varicella Vaccine-Strain Viral Reactivation

    Varicella vaccine-strain viral reactivation disease is defined as the presence of the rash of herpes zoster (shingles) with or without concurrent disease in another organ. Shingles is a painful, blistering skin rash due to the reactivation of varicella (chickenpox) virus that involves one or more sensory dermatomes. After natural varicella infection, the virus lies dormant in the spinal dorsal root ganglia. Shingles occurs after the virus becomes active again.

    There is a significant body of literature showing that the vaccine-strain of the virus can cause shingles without other organ involvement. However, the wild-type chickenpox virus has been identified in many of the cases occurring after vaccination. The Committee reviewed 111 cases in which individuals who received a varicella-containing vaccine developed reactivated varicella disease without other organ involvement and in whom the vaccine-strain of the virus was identified. The IOM found six cases in which individuals who had received varicella vaccine developed reactivated disease in another organ, and in all the cases, the vaccine-strain of the virus was identified in the other organ. In four of those cases, the vaccine-strain of the virus was also identified in the skin. The findings for other organ involvement in these case reports were limited to the meninges and brain. The IOM concluded that the evidence convincingly supports a causal relationship between varicella vaccine and vaccine-strain viral reactivation, with or without involvement of an organ other than the skin. [Chaves, S. S., P. Haber, K. Walton, R. P. Wise, H. S. Izurieta, D. S. Schmid, and J. F. Seward. 2008. Safety of varicella vaccine after licensure in the United States: Experience from reports to the vaccine adverse event reporting system, 1995-2005. Journal of Infectious Diseases 197(SUPPL. 2):S170-S177.] [Iyer, S., M. K. Mittal, and R. L. Hodinka. 2009. Herpes zoster and meningitis resulting from reactivation of varicella vaccine virus in an immunocompetent child. Annals of Emergency Medicine 53(6):792-795.] [Levin, M. J., R. L. DeBiasi, V. Bostik, and D. S. Schmid. 2008. Herpes zoster with skin lesions and meningitis caused by two different genotypes of the Oka varicella-zoster virus vaccine. Journal of Infectious Diseases 198(10):1444-1447.]

    The Secretary proposes to add vaccine-strain viral reactivation, both with and without other organ involvement, as a Table injury for varicella-containing vaccines. Although the IOM specified whether they considered immunocompetent or immunocompromised individuals, their causality conclusions for vaccine-strain reactivation, with and without other organ involvement, did not differentiate between these two groups. Because disease caused by varicella virus reactivation can occur many years, or even decades, after the initial disease or vaccination, the Secretary proposes that the QAI require laboratory confirmation of the presence of the vaccine-strain of the virus. With such confirmation, the status of the affected individual's immune system is not relevant. In addition, there is no proposed time interval for this injury, as laboratory confirmation of vaccine-strain virus obviates the need for such a proposal. Since petitioners must demonstrate the presence of vaccine-strain varicella infection, the presumption includes the involvement of skin and other organs.

    C. Anaphylaxis

    Anaphylaxis is a single discrete event that presents as a severe and potentially life threatening multi-organ reaction, particularly affecting the skin, respiratory tract, cardiovascular system, and the gastrointestinal tract. The diagnosis of anaphylaxis requires the simultaneous involvement of two or more organ systems. In an anaphylactic reaction, an immediate reaction generally occurs within minutes after exposure, and in most cases, the individual develops signs and symptoms within 4 hours after exposure to the antigen. The immediate reaction leads to a combination of skin rash, mucus membrane swelling, leakage of fluid from the blood into surrounding tissues, tightening of the air passages in the lungs with tissue swelling, and gastrointestinal symptoms that can lead to shock, organ damage, and death if not promptly treated.

    Symptoms may include swelling, itching, rash, trouble breathing, chest tightness, and/or dizziness. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema (throat swelling) or bronchospasm and may be associated with cardiovascular collapse.

    Other significant clinical signs and symptoms may include the following: cyanosis (bluish coloration in the skin due to low blood oxygen levels), hypotension (low blood pressure), bradycardia (slow heart rate), tachycardia (fast heart rate), arrhythmia (irregular heart rhythm), edema (swelling) of the pharynx and/or larynx (throat or upper airway) with stridor (noisy breathing on inspiration), dyspnea (shortness of breath), diarrhea, vomiting, and abdominal pain. Autopsy findings may include acute emphysema (a type of lung abnormality), which results from lower respiratory tract obstruction, edema (swelling) of the upper airway, and minimal findings of eosinophilia (an excess of a type of white blood cell associated with allergy) in the liver. When death occurs within minutes of exposure without signs of respiratory distress, lack of significant pathologic findings would not exclude a diagnosis of anaphylaxis.

    Anaphylaxis may occur following exposure to allergens from a variety of sources including food, aeroallergens, insect venom, drugs, and immunizations. Most treated cases resolve without sequela. Anaphylaxis can be due to an exaggerated acute systemic hypersensitivity reaction, especially involving immunoglobulin E antibodies, as in allergic anaphylaxis, or it could be a non-immunologically mediated reaction leading to similar clinical symptomatology as in non-immune anaphylaxis. Non-immune anaphylaxis cannot be detected by skin tests or in vitro allergy diagnostic procedures. As stated, anaphylaxis is a single discrete event. It is not an initial episode of a chronic condition such as chronic urticaria (hives).

    Anaphylaxis following immunization is a rare occurrence with estimates in the range of 1-10 per 1 million doses distributed, depending on the vaccine studied. [The Brighton Collaboration Anaphylaxis Working Group, “Anaphylaxis: Case Definition and Guidelines for Data Collection, Analysis, and Presentation of Immunization Safety Data, Vaccine, Aug. 2007; 5676.] The IOM has reported that the evidence favors acceptance of a causal relationship between certain vaccines and anaphylaxis based on case reports and case series. The IOM has reported that causality could be inferred with reasonable certainty based on one or more case reports because of the unique nature and timing of anaphylaxis following vaccine administration and provided there is an absence of likely alternative causes. [Institute of Medicine (IOM), Immunization Safety Review Vaccination and Sudden Unexpected Death in Infancy, Washington, DC: The National Academies Press, 2003) 55.] The IOM concluded that the scientific evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis. There are multiple, well-documented reports in the literature that anaphylaxis occurs after receipt of the varicella vaccine. One case series reported 16 cases of anaphylaxis after vaccination against varicella, with nearly all demonstrating anti-gelatin immunoglobulin E (IgE) antibodies. [Sakaguchi, M., T. Nakayama, H. Fujita, M. Toda, and S. Inouye. 2000b. Minimum estimated incidence in Japan of anaphylaxis to live virus vaccines including gelatin. Vaccine 19(4-5):431-436.]

    There is a long history of including anaphylaxis as a known adverse effect of vaccines, including in the initial Table contained in the Act. The time-frame for the first symptom or manifestation of onset contained in the original statutory Table was shortened from 24 hours to 4 hours in the Table changes promulgated in 1995. Since that time, anaphylaxis has been added as an injury for the Hepatitis B vaccine.

    The statute requires that injuries eligible for compensation under the Program be of sufficient seriousness to cause continued effects for more than 6 months, result in death, or result in inpatient hospitalization and surgical intervention. The Secretary continues to recognize that in many instances, cases involving anaphylaxis will not meet the statutory severity criteria, as the reaction can be short-lived and treated effectively. However, because there is a known risk of serious residual injury or death from anaphylaxis, the Secretary continues to recommend that anaphylaxis be included on the Table for other vaccines, and be added for varicella virus vaccines.

    The Secretary proposes to add anaphylaxis as a Table injury for varicella virus-containing vaccines, with an onset less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI. (see proposed regulation text at proposed paragraph (c)(1)).

    D. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for varicella virus-containing vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours. However, the Secretary recognizes that there currently is no intramuscular formulation of this vaccine available, and therefore petitioners alleging an injury of SIRVA associated with this vaccine presently cannot meet the QAI for SIRVA. Please see section I.A., above, for additional discussion on this point.

    E. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for varicella virus-containing vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    VIII. Pneumococcal Conjugate Vaccines

    Pneumococcal conjugate vaccines were first licensed by FDA in 2000. Over the next decade, the heptavalent (seven serotypes) vaccine dramatically reduced the rate of invasive pneumococcal disease in young infants and nasal carriage of the vaccine serotypes among all age groups, including the immunocompromised and older individuals. A 13-valent pneumococcal conjugate vaccine licensed in 2010 has replaced the 7-valent product in the infant schedule. Pneumococcal conjugate vaccines are included on the Table, with an effective date of coverage of December 19, 1999, with no injuries or conditions specified.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for pneumococcal conjugate vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for pneumococcal conjugate vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    IX. Hepatitis A Vaccines

    Hepatitis A vaccine was first licensed by FDA in 1996 and introduced incrementally, first for children living in communities with the highest rates of disease and then in 1999 for children living in States/communities with consistently elevated rates of infection. The impact of immunization with hepatitis A vaccine has been a dramatic decline in the rates of disease and a sharp reduction in the groups with the highest risk of infection: Native Americans and Alaskan natives. Rates of hepatitis A infection are now similar in most areas of the United States. As a consequence, hepatitis A vaccine has now been recommended for all children in the United States who are 12-23 months of age. Hepatitis A vaccine is included on the Table, with an effective date of December 1, 2004.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for hepatitis A vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for hepatitis A vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    X. Seasonal Influenza Vaccines

    All seasonal trivalent influenza vaccines have been covered under the VICP since July 1, 2005. At that time, all seasonal influenza vaccines were trivalent. Quadrivalent vaccines for seasonal influenza became available for general use for the 2013-14 influenza season. On June 25, 2013, Public Law 113-15 was enacted, extending the applicable excise tax on trivalent influenza vaccines to also include any other vaccines against seasonal influenza. See Public Law 113-15 (amending 26 U.S.C. 4132(a)(1)(N)). The amendment included in Public Law 113-15 ensured that seasonal influenza vaccines are covered under the Program. Seasonal influenza vaccines (other than trivalent influenza vaccines) were added to the Table under the final catch-all category (42 CFR 100.3(c)(8)) with an effective date of November 12, 2013. The Secretary proposes to modify category XIV on the Table from “Trivalent influenza vaccines” to “Seasonal influenza vaccines.”

    There are currently six types of seasonal influenza vaccines distributed during flu season. The standard dose trivalent inactivated influenza vaccine (IIV3) contains three killed virus strains and is injected. IIV3 is indicated in individuals 6 months of age or older, including healthy people and those with chronic medical conditions (such as asthma, diabetes, or heart disease). High dose trivalent inactivated influenza vaccine (IIV3 High dose) is indicated in individuals who are 65 years of age or older. Trivalent recombinant influenza vaccine (RIV3) is indicated for individuals between the ages of 18 and 49 years. The standard dose quadrivalent inactivated influenza vaccine (IIV4) has the same indications as IIV3. The quadrivalent live attenuated influenza vaccine (LAIV4) is indicated for healthy, non-pregnant persons aged 2-49 years. The cell-culture based inactivated influenza vaccine (ccIIV3) is indicated for individuals who are 18 years of age and older.

    The covered injuries proposed for seasonal influenza vaccines are the same as those proposed for trivalent influenza vaccines. The trivalent influenza vaccine and the quadrivalent influenza vaccine, distributed each year during flu season, are types of seasonal influenza vaccines.

    A. Anaphylaxis

    The Secretary proposes to add anaphylaxis as a Table injury for seasonal influenza vaccines. [See section VII.C above.] The IOM concluded that the scientific evidence convincingly supports a causal relationship between trivalent influenza vaccines and anaphylaxis. Sensitivity to eggs has long been known to cause allergic reactions to influenza vaccination in some individuals. The IOM assessed the mechanistic evidence as strong, including the following: 21 case reports of potential anaphylaxis following influenza vaccine; a strong temporal relationship between vaccine administration and anaphylactic reaction; isolation of anti-gelatin IgE in two cases; positive skin testing as a positive re-challenge in two cases; and repeated symptoms to vaccination against influenza on two occasions. Their conclusion made no distinction between the intranasal live attenuated vaccine and the injected vaccine. [Coop, C.A., S.K. Balanon, K.M. White, B. A. Whisman, and M.M. Rathkopf. 2008. Anaphylaxis from the influenza virus vaccine. International Archives of Allergy and Immunology 146(1):85-88.] [Chung, E.Y., L. Huang, and L. Schneider. 2010. Safety of influenza vaccine administration in egg-allergic patients. Pediatrics 125(5):e1024-e1030.] [Lasley, M.V. 2007. Anaphylaxis after booster influenza vaccine due to gelatin allergy. Pediatric Asthma, Allergy and Immunology 20(3):201-205.]

    The Secretary proposes to add anaphylaxis as a Table injury for seasonal influenza vaccines, with an onset of less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

    B. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA only for seasonal influenza vaccines that are injected intramuscularly (as detailed in the proposed QAI). As proposed, this injury would not apply to formulations of the live attenuated influenza vaccine (LAIV), as LAIV is not administered intramuscularly with a needle. [See section I.A above.] In addition, this injury would not apply to the formulations of influenza vaccine where the route of administration is intradermal, such as the formulation that delivers 0.1 milliliters of vaccine through a prefilled microinjection system that contains a needle that is only 1.5 millimeters long. This needle is not long enough to enter the deltoid bursa or any other structure in the shoulder related to the development of SIRVA. SIRVA would apply only to formulations of the seasonal influenza vaccine that are administered through intramuscular injection. The interval of onset will be less than or equal to 48 hours.

    C. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for injected vaccines only (as detailed in the proposed QAI). As proposed, this injury would apply to the seasonal inactivated influenza vaccine that is injected intramuscularly but not to the LAIV, as LAIV is not administered with a needle, and the syncopal reaction appears to be related to the act of injection. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    D. Guillain-Barré Syndrome (GBS)

    GBS is an acute paralysis caused by dysfunction in the peripheral nervous system (i.e., the nervous system outside the brain and spinal cord). GBS may manifest with weakness, abnormal sensations, and/or abnormality in the autonomic (involuntary) nervous system. In the United States, each year approximately 3,000 to 4,000 cases of GBS are reported, and the incidence of GBS increases in older individuals. Senior citizens tend to have a poorer prognosis. Most people fully recover from GBS, but some people can either develop permanent disability or die due to respiratory difficulties. It is not fully understood why some people develop GBS, but it is believed that stimulation of the body's immune system, as occurs with infections, can lead to the formation of autoimmune antibodies and cell-mediated immunity that play a role in its development.

    GBS may present as one of several clinicopathological subtypes. The most common type in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and roots. Demyelination refers to a loss or disruption of the myelin sheath, which wraps around the axons of some nerve cells and which is necessary for the normal conduction of nerve impulses in those nerves that contain myelin. Polyneuropathy refers to the involvement of multiple peripheral nerves. Motor nerves affect muscles or glands. Sensory nerves transmit sensations. The axon is a portion of the nerve cell that transmits nerve impulses away from the nerve cell body. Another subtype of GBS, called acute motor axonal neuropathy (AMAN), is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the axons of sensory nerves and roots.

    The diagnosis of the AIDP, AMAN, and AMSAN subtypes of GBS requires bilateral flaccid (relaxed with decreased muscle tone) limb weakness and decreased or absent deep tendon reflexes in weak limbs, and a monophasic illness pattern with the interval between onset and nadir of weakness between 12 hours and 28 days with a subsequent clinical plateau. The clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse. Death may occur without clinical plateau. Treatment-related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time-frame would not be consistent with GBS. In addition, there must not be a more likely alternative diagnosis for the weakness.

    Other factors in all subtypes of GBS that add to diagnostic certainty, but are not required for diagnosis, include electrophysiologic findings consistent with GBS or cytoalbuminologic dissociation (i.e., elevation of cerebral spinal fluid (CSF) protein and a total white cell count in the CSF less than 50 cells per microliter).

    The weakness in the AIDP, AMAN, and AMSAN subtypes of GBS is usually, but not always, symmetric and usually has an ascending pattern of progression from legs to arms. However, other patterns of progression may occur. The cranial nerves can be involved. Respiratory failure can occur due to respiratory involvement. Fluctuations in the degree of weakness prior to reaching the point of greatest weakness or during the plateau or improvement phase may occur, especially in response to treatment. These fluctuations occur in the first 9 weeks after onset and are generally followed by eventual improvement.

    According to the Brighton Collaboration, Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and GBS may be seen with limb weakness. [James J. Sejvar et. al. Guillain-Barre Syndrome and Fisher Syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data Vaccine 29(3):599-612]. The diagnosis of FS requires bilateral ophthalmoparesis; bilateral reduced or absent tendon reflexes; ataxia; the absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP, AMAN, or AMSAN); a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms or subsequent improvement without significant relapse); no alteration in consciousness; no corticospinal track signs; and the absence of an identified, more likely, alternative diagnosis. Death may occur without a clinical plateau.

    Exclusionary criteria for the diagnosis of GBS include the ultimate diagnosis of any of the following conditions: Chronic inflammatory demyelinating polyneuropathy (CIDP), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive. [Sejvar 599-612].

    For all subtypes of GBS (AIDP, AMAN, AMSAN, and FS), the onset of symptoms less than 3 days (72 hours) after exposure excludes that exposure as a cause because the immunologic steps necessary to create symptomatic disease require a minimum of 3 days.

    CIDP is clinically and pathologically distinct from GBS. The onset phase of CIDP is generally greater than 8 weeks and the weakness may remit and relapse. CIDP is also not monophasic. [Sejvar 599-612.]

    In the past, GBS has been causally associated with certain vaccines. For example, the 1976 influenza A (swine flu) vaccine was found by the IOM to be causally associated with GBS. The risk of developing GBS in the 6 week period after receiving the 1976 swine flu vaccine was 9.2 times higher than the risk for those who were not vaccinated. [Lawrence B. Schonberger, et al., “Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976-1977,” American Journal of Epidemiology, 25 Apr. 1979; 118 and IOM, “Immunization Safety Review: Influenza Vaccines and Neurological Complications,” (Washington, DC: The National Academies Press, 2004) 25]. Since the 1976 influenza season, numerous studies have been conducted to evaluate whether other influenza vaccines were associated with GBS. In most published studies, no association was found, but one large study published in the New England Journal of Medicine evaluated the 1992-93 and 1993-94 influenza seasons and suggested approximately one additional case of GBS out of 1 million persons vaccinated, in the 6 weeks following vaccination, may be attributable to the vaccine formulation used in those years. The background incidence of GBS not associated with a vaccine among adults was documented in the study to be 0.87 cases per million persons for any 6 week period. [Tamar Lasky, et al., “The Guillain-Barré Syndrome and the 1992-1993 and 1993-1994 Influenza Vaccines,” The New England Journal of Medicine, Dec. 17, 1998; 1797.]

    The IOM published a thorough scientific review of the peer-reviewed literature in 2004 and concluded that people who received the 1976 swine influenza vaccine had an increased risk for developing GBS [IOM, Immunization Safety Review: Influenza Vaccines and Neurological Complications, 25]. Based on its review of the published literature, the IOM also decided that the evidence linking GBS and influenza vaccines in influenza seasons other than 1976 was not clear. This led to the IOM's conclusion that the evidence was inadequate to accept or reject a causal relationship between influenza immunization and GBS for years other than 1976.

    In 2012, the IOM published another report that evaluated the association of seasonal influenza vaccine and GBS. Pandemic vaccines, such as the influenza vaccine used in 1976 and the monovalent 2009 H1N1 influenza vaccine, were specifically excluded and not evaluated. The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between seasonal influenza vaccine and GBS. (IOM, Adverse Effects of Vaccines 334). It is important to note that monovalent vaccines are usually only given in response to an actual or potential pandemic, while seasonal influenza vaccines are offered annually. The monovalent 2009 H1N1 vaccine, a type of pandemic vaccine, is covered under the Countermeasures Injury Compensation Program. The VICP does not cover pandemic influenza vaccines, such as the 2009 H1N1 Influenza vaccine.

    A meta-analysis of the VSD, EIP (Emerging Infections Program—an active population-based surveillance program), and PRISM (Post-Licensure- Rapid Immunization Safety Monitoring—a cohort-based active surveillance network) data was performed and published, together with additional data from safety surveillance studies performed by Medicare, the Department of Defense, and the Department of Veterans Affairs, which, in total, analyzed data from 23 million people who were vaccinated with the influenza A (H1N1) 2009 monovalent vaccine. [Daniel A. Salmon et al., “Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis,” Lancet, electronically published March 13, 2013, http://dx.doi.org/10.1016/S0140-6736(12)62189-8.] The meta-analysis provides the benefit of additional statistical power. Additional power allows for the analyses of certain hypotheses which were not possible to analyze individually in the six studies that made up the meta-analysis. The meta-analysis found that the 2009 H1N1 inactivated vaccine was associated with a small increased risk of GBS within 6 weeks of vaccination. This excess risk is equivalent to 1.6 excess cases in the 6 weeks after vaccination per million people vaccinated. This increased risk found in the meta-analysis was consistent: (1) Across studies looking at different groups of people; (2) using different definitions of illness; (3) in people who received or did not receive a concurrent seasonal influenza vaccine or had influenza-like symptoms; (4) across various time windows; and (5) in different age categories. This suggests that these five factors did not affect the risk of developing GBS.

    Considering the totality of the evidence with the enhanced surveillance studies and meta-analysis performed to monitor the safety of the monovalent 2009 H1N1 vaccine, scientific evidence demonstrates a small increased risk of GBS in the 6 weeks following administration of the monovalent 2009 H1N1 vaccines.

    Presently, there is no scientific evidence demonstrating that current formulations of the seasonal influenza vaccine, which contain the H1N1 virus, can cause GBS. However, the degree of surveillance needed to detect an increased risk of one case per million vaccinations, as was seen with the monovalent 2009 H1N1 vaccine, is unlikely to be routinely performed as the strains in the flu vaccines change from year to year. Nonetheless, numerous studies have been conducted in order to determine whether a possible association between seasonal influenza vaccines and GBS exists, and almost all have not shown any causal relationship. The IOM reviewed literature concerning such studies and concluded that the evidence was inadequate to accept or reject a causal association for all versions of seasonal influenza vaccines since 1976.

    Using studies demonstrating a causal association between the 2009 H1N1 and 1976 swine flu vaccines and GBS as background, the Secretary proposes to add the injury of GBS to the Table for seasonal influenza vaccines. Although the scientific evidence does not show a causal association for current formulations of seasonal flu vaccines and GBS, the Secretary proposes including the injury of GBS for seasonal influenza vaccines on the Table in accordance with the ACCV Guiding Principles, acknowledging the fact that seasonal influenza vaccine formulations, unlike other vaccines, change from year-to-year and that enhanced surveillance activities may not occur with each virus strain change. This is done even though it appears that any instances of GBS caused by seasonal influenza vaccines, if they exist at all, are very rare. The Secretary proposes adding GBS to the Table for seasonal influenza vaccines and recognizes that this will create a presumption of causation that will result in compensation for numerous instances of GBS that are not vaccine-related.

    While there is no evidence demonstrating that current formulations of the seasonal influenza vaccine can cause GBS, the totality of the evidence, particularly the enhanced surveillance studies and meta-analysis performed to monitor the safety of the 2009 H1N1 vaccine, provides compelling evidence of a small increased risk of GBS in the 6 weeks following the administration of the 2009 H1N1 vaccine. Utilizing this scientific data as background, the Secretary proposes an onset interval of 3-42 days for GBS presumed to be caused by the seasonal influenza vaccine to be covered under the proposed Table. Day 3 begins 72 hours after administration of the vaccination and takes into account the time interval needed to show first signs or symptoms after exposure. [Peripheral Neuropathy (Philadelphia, PA: Elsevier Saunders, 2005, 626].

    XI. Meningococcal Vaccines

    There are two types of meningococcal vaccines administered in the United States. The polysaccharide vaccine was licensed by the FDA in 1978, and is indicated for persons 2 years of age and older; the meningococcal conjugate vaccines were licensed starting in 2005. The conjugate vaccines were developed with the expectation that they would provide more long-lasting immunity, a more rapid immune response upon exposure to Neisseria meningitidis, and the development of “herd immunity” through reduction of the asymptomatic carrier state. The meningococcal polysaccharide and conjugate vaccines were added to the Table with an effective date of February 1, 2007.

    A. Anaphylaxis

    The Secretary proposes to add anaphylaxis as a Table injury for meningococcal vaccines. [See section VII.C above.] The IOM Committee, following an extensive review of the scientific and medical literature, concluded that the evidence convincingly supported a causal relationship between meningococcal vaccines and anaphylaxis. The Institute of Medicine based their conclusion on a case report of anaphylaxis with onset 30 minutes following vaccination. [Yergeau, A., L. Alain, R. Pless, and Y. Robert. 1996. Adverse events temporally associated with meningococcal vaccines. Canadian Medical Association Journal 154(4):503-507.]

    The Secretary proposes to add anaphylaxis as a Table injury for meningococcal vaccines, with an onset less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

    B. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for meningococcal vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

    C. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for meningococcal vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    XII. Human Papillomavirus Vaccines

    The first human papillomavirus (HPV) vaccine was licensed by the FDA in June 2006 for females between the ages of 9-26 years. In 2011, one of the two licensed HPV vaccines was given a permissive use recommendation in males by the CDC and other recommending bodies (i.e., the American Academy of Pediatrics and the American Academy of Family Physicians). HPV vaccine was added to the Table with an effective date of February 1, 2007.

    A. Anaphylaxis

    The Secretary proposes to add anaphylaxis as a Table injury for HPV vaccines. [See VII.C] The IOM Committee concluded that the evidence favors acceptance of a causal relationship between human papillomavirus vaccines and anaphylaxis. They based their conclusion on temporality and clinical symptoms consistent with anaphylaxis in 9 reports from VAERS over 31 months of surveillance. [Slade, B.A., L. Leidel, C. Vellozzi E.J. et al. Post licensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. Journal of the American Medical Association 2009. 302(7):750-757.]

    The Secretary notes that there are limitations to the VAERS passive reporting system. First, there is underreporting; not all adverse events following vaccines are reported to the system. The rates of underreporting have been examined for different disorders and are greatest for adverse events of mild severity. Second, many reports are filed before a complete clinical evaluation has been conducted. Therefore, the presumptive diagnosis that has been provided at the time of the report may not be the correct diagnosis. Third, investigations conducted after the initial report sometimes reveal alternative causes for the adverse event. In many instances, incomplete information is provided in the initial report. Follow-up of the reports by the CDC and FDA may be conducted to collect additional information from the healthcare providers. The primary purpose of VAERS is to look for signals for evidence of unexpected adverse events that would require other investigations to try to determine causal relationships. Although conclusions about causation are not possible for most adverse events reported to VAERS, the IOM found likely causality based on the distinctive nature of anaphylactic reactions and the temporal relationship between the HPV vaccine administration and the event. The Secretary proposes to add anaphylaxis as a Table injury for HPV vaccines, with an onset of less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

    B. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA as a Table injury for HPV vaccines. [See section I.A above.] The proposed time interval of onset is less than or equal to 48 hours.

    C. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for HPV vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    XIII. Category for Any New Vaccine Recommended by the Centers for Disease Control and Prevention for Routine Administration to Children After Publication by the Secretary of a Notice of Coverage

    Category XVII of the current Table pertains to any new vaccine recommended by the CDC for routine administration to children, after publication by the Secretary of a notice of coverage. This category pertains to vaccines that are covered under the Program, but with respect to which the Secretary has not yet finalized actions adding the vaccines as separate categories to the Table. Through this rule, the Secretary proposes retaining this category and adding two associated injuries for vaccines covered by this category.

    A. Shoulder Injury Related to Vaccination

    The Secretary proposes to add SIRVA for the category of vaccines captured under Category XVII of the Table. [See section I.A above.] As detailed in the proposed QAI, this injury would only apply to intramuscular vaccines injected into the upper arm. The interval of onset will less than or equal to 48 hours.

    B. Vasovagal Syncope

    The Secretary proposes to add vasovagal syncope to the Table for this category of vaccines. As detailed in the proposed QAI, this injury would apply only to injected vaccines as the syncopal reaction appears to be related to the act of injection. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

    XIV. Additional Table Changes

    The Secretary is proposing a number of organizational and structural changes to the Table and QAI designed to increase clarity and scientific accuracy, including the addition of a glossary of terms used within the Table and the QAI.

    Organizational Changes

    • To streamline the Table, the Secretary proposes a new paragraph (b), Provision that applies to all vaccines listed. This section includes any acute complication or sequela, including death, of the illness, disability, injury, or condition listed, rather than adding this provision to every line of the Table.

    • To further streamline the Table, the Secretary proposes the deletion of redundant wording in the various definitions, particularly with regard to any references to the presumption of causation, and the importance of the entire medical record. These elements have been included in paragraph (b). In addition, complicated language previously included in the definition of encephalopathy, which indicated that idiopathic injuries do not rebut the Table presumption, has been simplified and made generally applicable to all injuries. This has also been included in paragraph (b).

    • The QAI (proposed paragraph (c)) contain definitions for those terms that are used in the Table (paragraphs (a) and (b)).

    • The newly added glossary (proposed paragraphs (d)) defines terms used in multiple places in the QAI (proposed paragraph (c)). Most of these terms were formerly contained in the QAI, and have been moved to the glossary so that each reference is consistent. These definitions include: chronic encephalopathy, significantly decreased level of consciousness, injected, and seizure.

    • The proposed Table and QAI include some changes made by the Final Rule adding Intussusception as an Injury for Rotavirus Vaccines to the Vaccine Injury Table (80 FR 35848, June 23, 2015).

    Expansion

    • The Secretary proposes to add definitions for new Table injuries, including SIRVA, disseminated varicella-strain virus disease, varicella vaccine-strain viral reactivation disease, GBS, and vasovagal syncope.

    • The Secretary proposes to add definitions of terms that had been on the Table or in the QAI, but that previously were undefined, including encephalitis, injected, and immunodeficient recipient.

    Harmonization

    • The Secretary proposes additional changes to the QAI to address certain changes in scientific nomenclature. Definitions, such as acute encephalopathy and acute encephalitis, both of which lead to chronic encephalopathy, have been harmonized. Definitions for brachial neuritis and SIRVA have also been harmonized.

    • The Secretary proposes modification of category XIV on the Table from “Trivalent influenza vaccines” to “Seasonal influenza vaccines”.

    • The Secretary proposes modification of category IX on the Table from “Haemophilus influenzae type b polysaccharide conjugate vaccines” to “Haemophilus influenzae type b vaccines”.

    • Minor technical changes resulting from updated medical information have been included in the definitions of anaphylaxis, encephalopathy, chronic arthritis, brachial neuritis, thrombocytopenic purpura, and seizure.

    All of the proposed changes were discussed and approved by the ACCV, although the ACCV expressed some reservations regarding the definition of “immunodeficient recipient”. The discussion was reviewed, and the Secretary has modified the definition to address the concerns raised by the ACCV.

    Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

    Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues require special analysis.

    The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner. This proposed rule only lessens the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

    The Secretary has also determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the proposed rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

    Nor on the basis of family well-being will the provisions of this rule affect the following family elements: family safety; family stability; marital commitment; parental rights in the education, nurture and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

    This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

    As stated above, this proposed rule would modify the Vaccine Injury Table based on legal authority.

    Impact of the New Rule

    This proposed rule will have the effect of making it easier for future petitioners alleging injuries that meet the criteria in the Vaccine Injury Table to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury).

    Paperwork Reduction Act of 1995

    This proposed rule has no information collection requirements.

    List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, Immunization.

    Dated: June 24, 2015. James Macrae, Acting Administrator, Health Resources and Services Administration. Approved: July 10, 2015. Sylvia M. Burwell, Secretary.

    Accordingly, 42 CFR part 100 is proposed to be amended as set forth below:

    PART 100—VACCINE INJURY COMPENSATION 1. The authority citation for 42 CFR part 100 continues to read as follows: Authority:

    Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 13632(a)(3) of Public Law 103-66.

    2. Revise § 100.3 to read as follows:
    § 100.3 Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program. Paragraph (b) of this section sets forth additional provisions that are not separately listed in this Table but that constitute part of it. Paragraph (c) of this section sets forth the Qualifications and Aids to Interpretation for the terms used in the Table. Conditions and injuries that do not meet the terms of the Qualifications and Aids to Interpretation are not within the Table. Paragraph (d) of this section sets forth a glossary of terms used in paragraph (c).

    Vaccine Injury Table Vaccine Illness, disability, injury or
  • condition covered
  • Time period for first symptom or manifestation of onset or of
  • significant aggravation after
  • vaccine administration
  • I. Vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT) A. Anaphylaxis
  • B. Brachial Neuritis
  • C. Shoulder Injury Related to Vaccine Administration
  • ≤4 hours.
  • 2-28 days (not less than 2 days and not more than 28 days)
  • ≤48 hours.
  • D. Vasovagal syncope ≤1 hour. II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib) A. Anaphylaxis
  • B. Encephalopathy or encephalitis
  • C. Shoulder Injury Related to Vaccine Administration
  • ≤4 hours.
  • ≤72 hours
  • ≤48 hours.
  • D. Vasovagal syncope ≤1 hour. III. Vaccines containing measles, mumps, and rubella virus or any of its components (e.g., MMR, MM, MMRV) A. Anaphylaxis
  • B. Encephalopathy or encephalitis
  • C. Shoulder Injury Related to Vaccine Administration
  • ≤4 hours.
  • 5-15 days (not less than 5 days and not more than 15 days)
  • ≤48 hours.
  • D. Vasovagal syncope ≤1 hour. IV. Vaccines containing rubella virus (e.g., MMR, MMRV) A. Chronic arthritis 7-42 days (not less than 7 days and not more than 42 days). V. Vaccines containing measles virus (e.g., MMR, MM, MMRV) A. Thrombocytopenic purpura
  • B. Vaccine-Strain Measles Viral Disease in an immunodeficient recipient
  • 7-30 days (not less than 7 days and not more than 30 days).
    —Vaccine-strain virus identified Not applicable. —If strain determination is not done or if laboratory testing is inconclusive ≤12 months. VI. Vaccines containing polio live virus (OPV) A. Paralytic Polio —in a non-immunodeficient recipient ≤30 days. —in an immunodeficient recipient ≤6 months. —in a vaccine associated community case Not applicable. B. Vaccine-Strain Polio Viral Infection —in a non-immunodeficient recipient ≤30 days. —in an immunodeficient recipient ≤6 months. —in a vaccine associated community case Not applicable. VII. Vaccines containing polio inactivated virus (e.g., IPV) A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. VIII. Hepatitis B vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. IX. Haemophilus influenzae type b (Hib) vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. X. Varicella vaccines A. Anaphylaxis ≤4 hours. B. Disseminated varicella vaccine-strain viral disease —Vaccine-strain virus identified Not applicable. —If strain determination is not done or if laboratory testing is inconclusive 7-42 days (not less than 7 days and not more than 42 days). C. Varicella vaccine-strain viral reactivation Not applicable. D. Shoulder Injury Related to Vaccine Administration ≤48 hours. E. Vasovagal syncope ≤1 hour. XI. Rotavirus vaccines A. Intussusception 1-21 days (not less than 1 day and not more than 21 days). XII. Pneumococcal conjugate vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. XIII. Hepatitis A vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. XIV. Seasonal influenza vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. D. Guillain-Barré Syndrome 3-42 days (not less than 3 days and not more than 42 days). XV. Meningococcal vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. XVI. Human papillomavirus (HPV) vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. XVII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage A. Shoulder Injury Related to Vaccine Administration
  • B. Vasovagal syncope
  • ≤48 hours.
  • ≤1hour.
  • (b) Provisions that apply to all conditions listed. (1) Any acute complication or sequela, including death, of the illness, disability, injury, or condition listed in paragraph (a) of this section (and defined in paragraphs (c) and (d) of this section) qualifies as a Table injury under paragraph (a) except when the definition in paragraph (c) requires exclusion.

    (2) In determining whether or not an injury is a condition set forth in paragraph (a) of this section, the Court shall consider the entire medical record.

    (3) An idiopathic condition that meets the definition of an illness, disability, injury, or condition set forth in paragraph (c) of this section shall be considered to be a condition set forth in paragraph (a) of this section.

    (c) Qualifications and aids to interpretation. The following qualifications and aids to interpretation shall apply to, define and describe the scope of, and be read in conjunction with paragraphs (a), (b), and (d) of this section:

    (1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially lethal systemic reaction that occurs as a single discrete event with simultaneous involvement of two or more organ systems. Most cases resolve without sequela. Signs and symptoms begin minutes to a few hours after exposure. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema or bronchospasm and may be associated with cardiovascular collapse. Other significant clinical signs and symptoms may include the following: cyanosis, hypotension, bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or trachea and/or larynx with stridor and dyspnea. There are no specific pathological findings to confirm a diagnosis of anaphylaxis.

    (2) Encephalopathy. A vaccine recipient shall be considered to have suffered an encephalopathy if an injury meeting the description below of an acute encephalopathy occurs within the applicable time period and results in a chronic encephalopathy, as described in paragraph (d) of this section.

    (i) Acute encephalopathy. (A) For children less than 18 months of age who present:

    (1) Without a seizure, an acute encephalopathy is indicated by a significantly decreased level of consciousness that lasts at least 24 hours,

    (2) Following a seizure, an acute encephalopathy is demonstrated by a significantly decreased level of consciousness that lasts at least 24 hours and cannot be attributed to a postictal state—from a seizure or a medication.

    (B) For adults and children 18 months of age or older, an acute encephalopathy is one that persists at least 24 hours and is characterized by at least two of the following:

    (1) A significant change in mental status that is not medication related (such as a confusional state, delirium, or psychosis);

    (2) A significantly decreased level of consciousness which is independent of a seizure and cannot be attributed to the effects of medication; and

    (3) A seizure associated with loss of consciousness.

    (C) The following clinical features in themselves do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness: sleepiness, irritability (fussiness), high-pitched and unusual screaming, poor feeding, persistent inconsolable crying, bulging fontanelle, or symptoms of dementia.

    (D) Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy and in the absence of other evidence of an acute encephalopathy seizures shall not be viewed as the first symptom or manifestation of an acute encephalopathy.

    (ii) Regardless of whether or not the specific cause of the underlying condition, systemic disease, or acute event (including an infectious organism) is known, an encephalopathy shall not be considered to be a condition set forth in the Table if it is shown that the encephalopathy was caused by:

    (A) An underlying condition or systemic disease shown to be unrelated to the vaccine (such as malignancy, structural lesion, psychiatric illness, dementia, genetic disorder, prenatal or perinatal central nervous system (CNS) injury); or

    (B) An acute event shown to be unrelated to the vaccine such as a head trauma, stroke, transient ischemic attack, complicated migraine, drug use (illicit or prescribed) or an infectious disease.

    (3) Encephalitis. A vaccine recipient shall be considered to have suffered encephalitis if an injury meeting the description below of an acute encephalitis occurs within the applicable time period and results in a chronic encephalopathy, as described in paragraph (d) of this section.

    (i) Acute encephalitis. Encephalitis is indicated by evidence of neurologic dysfunction, as described in paragraph (c)(3)(i)(A) of this section, plus evidence of an inflammatory process in the brain, as described in paragraph (c)(3)(i)(B) of this section.

    (A) Evidence of neurologic dysfunction consists of either:

    (1) One of the following neurologic findings referable to the CNS: Focal cortical signs (such as aphasia, alexia, agraphia, cortical blindness); cranial nerve abnormalities; visual field defects; abnormal presence of primitive reflexes (such as Babinski's sign or sucking reflex); or cerebellar dysfunction (such as ataxia, dysmetria, or nystagmus); or

    (2) An acute encephalopathy as set forth in paragraph (c)(2)(i) of this section.

    (B) Evidence of an inflammatory process in the brain (central nervous system or CNS inflammation) must include cerebrospinal fluid (CSF) pleocytosis (>5 white blood cells (WBC)/mm3 in children >2 months of age and adults; >15 WBC/mm3 in children <2 months of age); or at least two of the following:

    (1) Fever (temperature ≥ 100.4 degrees Fahrenheit);

    (2) Electroencephalogram findings consistent with encephalitis, such as diffuse or multifocal nonspecific background slowing and periodic discharges; or

    (3) Neuroimaging findings consistent with encephalitis, which include, but are not limited to brain/spine magnetic resonance imaging (MRI) displaying diffuse or multifocal areas of hyperintense signal on T2-weighted, diffusion-weighted image, or fluid-attenuation inversion recovery sequences.

    (ii) Regardless of whether or not the specific cause of the underlying condition, systemic disease, or acute event (including an infectious organism) is known, encephalitis shall not be considered to be a condition set forth in the Table if it is shown that the encephalitis was caused by:

    (A) An underlying malignancy that led to a paraneoplastic encephalitis;

    (B) An infectious disease associated with encephalitis, including a bacterial, parasitic, fungal or viral illness (such as herpes viruses, adenovirus, enterovirus, West Nile Virus, or human immunodeficiency virus), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing; or

    (C) Acute disseminated encephalomyelitis (ADEM). Although early ADEM may have laboratory and clinical characteristics similar to acute encephalitis, findings on MRI are distinct with ADEM displaying evidence of acute demyelination (scattered, focal, or multifocal areas of inflammation and demyelination within cerebral subcortical and deep cortical white matter; gray matter involvement may also be seen but is a minor component); or other conditions or abnormalities that would explain the vaccine recipient's symptoms.

    (4) Intussusception. (i) For purposes of paragraph (a) of this section, intussusception means the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus.

    (ii) For purposes of paragraph (a) of this section, the following shall not be considered to be a Table intussusception:

    (A) Onset that occurs with or after the third dose of a vaccine containing rotavirus;

    (B) Onset within 14 days after an infectious disease associated with intussusception, including viral disease (such as those secondary to non-enteric or enteric adenovirus, or other enteric viruses such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing;

    (C) Onset in a person with a preexisting condition identified as the lead point for intussusception such as intestinal masses and cystic structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or duplication cysts);

    (D) Onset in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or

    (E) Onset in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease).

    (5) Chronic arthritis. Chronic arthritis is defined as persistent joint swelling with at least two additional manifestations of warmth, tenderness, pain with movement, or limited range of motion, lasting for at least 6 months.

    (i) Chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of:

    (A) Medical documentation recorded within 30 days after the onset of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination; and

    (B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination; and

    (C) Medical documentation of an antibody response to the rubella virus.

    (ii) The following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/determatomyositis, fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction), metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders, and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's Syndrome, blood disorders, or arthralgia (joint pain), or joint stiffness without swelling.

    (6) Brachial neuritis. This term is defined as dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords). A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is typically followed in days or weeks by weakness in the affected upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. Atrophy of the affected muscles may occur. The neuritis, or plexopathy, may be present on the same side or on the side opposite the injection. It is sometimes bilateral, affecting both upper extremities. A vaccine recipient shall be considered to have suffered brachial neuritis as a Table injury if such recipient manifests all of the following:

    (i) Pain in the affected arm and shoulder is a presenting symptom and occurs within the specified time-frame;

    (ii) Weakness:

    (A) Clinical diagnosis in the absence of nerve conduction and electromyographic studies requires weakness in muscles supplied by more than one peripheral nerve.

    (B) Nerve conduction studies (NCS) and electromyographic (EMG) studies localizing the injury to the brachial plexus are required before the diagnosis can be made if weakness is limited to muscles supplied by a single peripheral nerve.

    (iii) Motor, sensory, and reflex findings on physical examination and the results of NCS and EMG studies, if performed, must be consistent in confirming that dysfunction is attributable to the brachial plexus; and

    (iv) No other condition or abnormality is present that would explain the vaccine recipient's symptoms.

    (7) Thrombocytopenic purpura. This term is defined by the presence of clinical manifestations, such as petechiae, significant bruising, or spontaneous bleeding, and by a serum platelet count less than 50,000/mm3 with normal red and white blood cell indices. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with other causes such as hypersplenism, autoimmune disorders (including alloantibodies from previous transfusions) myelodysplasias, lymphoproliferative disorders, congenital thrombocytopenia or hemolytic uremic syndrome. Thrombocytopenic purpura does not include cases of immune (formerly called idiopathic) thrombocytopenic purpura that are mediated, for example, by viral or fungal infections, toxins or drugs. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with disseminated intravascular coagulation, as observed with bacterial and viral infections. Viral infections include, for example, those infections secondary to Epstein Barr virus, cytomegalovirus, hepatitis A and B, human immunodeficiency virus, adenovirus, and dengue virus. An antecedent viral infection may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing. However, if culture or serologic testing is performed, and the viral illness is attributed to the vaccine-strain measles virus, the presumption of causation will remain in effect. Bone marrow examination, if performed, must reveal a normal or an increased number of megakaryocytes in an otherwise normal marrow.

    (8) Vaccine-strain measles viral disease. This term is defined as a measles illness that involves the skin and/or another organ (such as the brain or lungs). Measles virus must be isolated from the affected organ or histopathologic findings characteristic for the disease must be present. Measles viral strain determination may be performed by methods such as polymerase chain reaction test and vaccine-specific monoclonal antibody. If strain determination reveals wild-type measles virus or another, non-vaccine-strain virus, the disease shall not be considered to be a condition set forth in the Table. If strain determination is not done or if the strain cannot be identified, onset of illness in any organ must occur within 12 months after vaccination.

    (9) Vaccine-strain polio viral infection. This term is defined as a disease caused by poliovirus that is isolated from the affected tissue and should be determined to be the vaccine-strain by oligonucleotide or polymerase chain reaction. Isolation of poliovirus from the stool is not sufficient to establish a tissue specific infection or disease caused by vaccine-strain poliovirus.

    (10) Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following:

    (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection;

    (ii) Pain occurs within the specified time-frame;

    (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and

    (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy).

    (11) Disseminated varicella vaccine-strain viral disease. Disseminated varicella vaccine-strain viral disease is defined as a varicella illness that involves the skin beyond the dermatome in which the vaccination was given and/or disease caused by vaccine-strain varicella in another organ. For organs other than the skin, disease, not just mildly abnormal laboratory values, must be demonstrated in the involved organ. If there is involvement of an organ beyond the skin, and no virus was identified in that organ, the involvement of all organs must occur as part of the same, discrete illness. If strain determination reveals wild-type varicella virus or another, non-vaccine-strain virus, the viral disease shall not be considered to be a condition set forth in the Table. If strain determination is not done or if the strain cannot be identified, onset of illness in any organ must occur 7- 42 days after vaccination.

    (12) Varicella vaccine-strain viral reactivation disease. Varicella vaccine-strain viral reactivation disease is defined as the presence of the rash of herpes zoster with or without concurrent disease in an organ other than the skin. Zoster, or shingles, is a painful, unilateral, pruritic rash appearing in one or more sensory dermatomes. For organs other than the skin, disease, not just mildly abnormal laboratory values, must be demonstrated in the involved organ. There must be laboratory confirmation that the vaccine-strain of the varicella virus is present in the skin or in any other involved organ, for example by oligonucleotide or polymerase chain reaction. If strain determination reveals wild-type varicella virus or another, non-vaccine-strain virus, the viral disease shall not be considered to be a condition set forth in the Table.

    (13) Vasovagal syncope. Vasovagal syncope (also sometimes called neurocardiogenic syncope) means loss of consciousness (fainting) and postural tone caused by a transient decrease in blood flow to the brain occurring after the administration of an injected vaccine. Vasovagal syncope is usually a benign condition but may result in falling and injury with significant sequela. Vasovagal syncope may be preceded by symptoms such as nausea, lightheadedness, diaphoresis, and/or pallor. Vasovagal syncope may be associated with transient seizure-like activity, but recovery of orientation and consciousness generally occurs simultaneously with vasovagal syncope. Loss of consciousness resulting from the following conditions will not be considered vasovagal syncope: organic heart disease, cardiac arrhythmias, transient ischemic attacks, hyperventilation, metabolic conditions, neurological conditions, and seizures. Episodes of recurrent syncope occurring after the applicable time period are not considered to be sequela of an episode of syncope meeting the Table requirements.

    (14) Immunodeficient recipient. Immunodeficient recipient is defined as an individual with an identified defect in the immunological system which impairs the body's ability to fight infections. The identified defect may be due to an inherited disorder (such as severe combined immunodeficiency resulting in absent T lymphocytes), or an acquired disorder (such as acquired immunodeficiency syndrome resulting from decreased CD4 cell counts). The identified defect must be demonstrated in the medical records, either preceding or postdating vaccination.

    (15) Guillain-Barré Syndrome (GBS). (i) GBS is an acute monophasic peripheral neuropathy that encompasses a spectrum of four clinicopathological subtypes described below. For each subtype of GBS, the interval between the first appearance of symptoms and the nadir of weakness is between 12 hours and 28 days. This is followed in all subtypes by a clinical plateau with stabilization at the nadir of symptoms, or subsequent improvement without significant relapse. Death may occur without a clinical plateau. Treatment related fluctuations in all subtypes of GBS can occur within nine weeks of GBS symptom onset and recurrence of symptoms after this time-frame would not be consistent with GBS.

    (ii) The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and AMSAN requires:

    (A) Bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs;

    (B) A monophasic illness pattern;

    (C) An interval between onset and nadir of weakness between 12 hours and 28 days;

    (D) Subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau); and,

    (E) The absence of an identified more likely alternative diagnosis.

    (iii) Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and AIDP may be seen with limb weakness. The diagnosis of FS requires:

    (A) Bilateral ophthalmoparesis;

    (B) Bilateral reduced or absent tendon reflexes;

    (C) Ataxia;

    (D) The absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP, AMAN, or AMSAN);

    (E) A monophasic illness pattern;

    (F) An interval between onset and nadir of weakness between 12 hours and 28 days;

    (G) Subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau);

    (H) No alteration in consciousness;

    (I) No corticospinal track signs; and

    (J) The absence of an identified more likely alternative diagnosis.

    (iv) Evidence that is supportive, but not required, of a diagnosis of all subtypes of GBS includes electrophysiologic findings consistent with GBS or an elevation of cerebral spinal fluid (CSF) protein with a total CSF white blood cell count below 50 cells per microliter. Both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS.

    (v) To qualify as any subtype of GBS, there must not be a more likely alternative diagnosis for the weakness.

    (vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: chronic immune demyelinating polyradiculopathy (“CIDP”), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive.

    (d) Glossary for purposes of paragraph (c) of this section—(1) Chronic encephalopathy—(i) A chronic encephalopathy occurs when a change in mental or neurologic status, first manifested during the applicable Table time period as an acute encephalopathy or encephalitis, persists for at least 6 months from the first symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or encephalitis.

    (ii) Individuals who return to their baseline neurologic state, as confirmed by clinical findings, within less than 6 months from the first symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or encephalitis shall not be presumed to have suffered residual neurologic damage from that event; any subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute encephalopathy or encephalitis.

    (2) Injected refers to the intramuscular, intradermal, or subcutaneous needle administration of a vaccine.

    (3) Sequela means a condition or event which was actually caused by a condition listed in the Vaccine Injury Table.

    (4) Significantly decreased level of consciousness is indicated by the presence of one or more of the following clinical signs:

    (i) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli);

    (ii) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or

    (iii) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things).

    (5) Seizure includes myoclonic, generalized tonic-clonic (grand mal), and simple and complex partial seizures, but not absence (petit mal), or pseudo seizures. Jerking movements or staring episodes alone are not necessarily an indication of seizure activity.

    (e) Coverage provisions. (1) Except as provided in paragraph (e)(2), (3), (4), (5), (6), (7), or (8) of this section, this section applies to petitions for compensation under the Program filed with the United States Court of Federal Claims on or after [EFFECTIVE DATE OF THE FINAL REGULATION.]

    (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X of the Table) are included in the Table as of August 6, 1997.

    (3) Rotavirus vaccines (Item XI of the Table) are included in the Table as of October 22, 1998.

    (4) Pneumococcal conjugate vaccines (Item XII of the Table) are included in the Table as of December 18, 1999.

    (5) Hepatitis A vaccines (Item XIII of the Table) are included on the Table as of December 1, 2004.

    (6) Trivalent influenza vaccines (Included in item XIV of the Table) are included on the Table as of July 1, 2005. All other seasonal influenza vaccines (Item XIV of the Table) are included on the Table as of November 12, 2013.

    (7) Meningococcal vaccines and human papillomavirus vaccines (Items XV and XVI of the Table) are included on the Table as of February 1, 2007.

    (8) Other new vaccines (Item XVII of the Table) will be included in the Table as of the effective date of a tax enacted to provide funds for compensation paid with respect to such vaccines. An amendment to this section will be published in the Federal Register to announce the effective date of such a tax.

    [FR Doc. 2015-17503 Filed 7-28-15; 8:45 am] BILLING CODE 4160-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-HQ-IA-2013-0091; 96300-1671-0000-R4] RIN 1018-AX84 Endangered and Threatened Wildlife and Plants; Revision of the Section 4(d) Rule for the African Elephant (Loxodonta africana) AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), are proposing to revise the rule for the African elephant promulgated under section 4(d) of the Endangered Species Act of 1973, as amended (ESA), to increase protection for African elephants in response to the alarming rise in poaching of the species to fuel the growing illegal trade in ivory. The African elephant was listed as threatened under the ESA effective June 11, 1978, and at the same time a rule issued under section 4(d) of the ESA (a “4(d) rule”) was promulgated to regulate import and use of specimens of the species in the United States. This proposed rule would update the current 4(d) rule with measures that are appropriate for the current conservation needs of the species. We are proposing measures that are necessary and advisable to provide for the conservation of the African elephant as well as appropriate prohibitions from section 9(a)(1) of the ESA. Among other things, we propose to incorporate into the 4(d) rule certain restrictions on the import and export of African elephant ivory contained in the African Elephant Conservation Act (AfECA) as measures necessary and advisable for the conservation of the African elephant. We are not, however, revising or reconsidering actions taken under the AfECA, including our determinations in 1988 and 1989 to impose moratoria on the import of ivory other than sport-hunted trophies from both range and intermediary countries. We are proposing to take these actions under section 4(d) of the ESA to increase protection and benefit the conservation of African elephants, without unnecessarily restricting activities that have no conservation effect or are strictly regulated under other law.

    DATES:

    In preparing the final decision on this proposed rule, we will consider comments received or postmarked on or before September 28, 2015.

    ADDRESSES:

    You may submit comments by one of the following methods:

    Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-HQ-IA-2013-0091, which is the docket number for this rulemaking. You may submit a comment by clicking on “Comment Now!”

    By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-HQ-IA-2013-0091; Division of Policy, Performance, and Management Programs; U.S. Fish and Wildlife Service; 5275 Leesburg Pike, MS: BPHC; Falls Church, VA 22041.

    We will not accept email or faxes. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Public Comments section at the end of SUPPLEMENTARY INFORMATION for further information about submitting comments).

    FOR FURTHER INFORMATION CONTACT:

    Craig Hoover, Chief, Wildlife Trade and Conservation Branch, Division of Management Authority; U.S. Fish and Wildlife Service; 5275 Leesburg Pike, MS: IA; Falls Church, VA 22041 (telephone, (703) 358-2093).

    SUPPLEMENTARY INFORMATION: Applicable Laws

    In the United States, the African elephant is primarily protected and managed under the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.); the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES or Convention) (27 U.S.T. 1087), as implemented in the United States through the ESA; and the African Elephant Conservation Act (AfECA) (16 U.S.C. 4201 et seq.).

    Endangered Species Act

    Under the ESA, species may be listed either as “threatened” or as “endangered.” When a species is listed as endangered under the ESA, certain actions are prohibited under section 9 (16 U.S.C. 1538), as specified at 50 CFR 17.21. These include prohibitions on take within the United States, within the territorial seas of the United States, or upon the high seas; import; export; sale and offer for sale in interstate or foreign commerce; and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity.

    The ESA does not specify particular prohibitions and exceptions to those prohibitions for threatened species. Instead, under section 4(d) of the ESA, the Secretary of the Interior is given the discretion to issue such regulations as deemed necessary and advisable to provide for the conservation of the species. The Secretary also has the discretion to prohibit by regulation with respect to any threatened species any act prohibited under section 9(a)(1) of the ESA for endangered species. Exercising this discretion under section 4(d), the Service has developed general prohibitions (50 CFR 17.31) and established a permit process for specified exceptions to those prohibitions (50 CFR 17.32) that apply to most threatened species. Permits issued under 50 CFR 17.32 must be for “Scientific purposes, or the enhancement of propagation or survival, or economic hardship, or zoological exhibition, or educational purposes, or incidental taking, or special purposes consistent with the purposes of the [ESA].”

    Under section 4(d) of the ESA, the Service may also develop specific prohibitions and exceptions tailored to the particular conservation needs of a threatened species. In such cases, the Service issues a 4(d) rule that may include some of the prohibitions and authorizations set out at 50 CFR 17.31 and 17.32, but that also may be more or less restrictive than the general provisions at 50 CFR 17.31 and 17.32.

    Convention on International Trade in Endangered Species of Wild Fauna and Flora

    CITES entered into force in 1975, and is currently implemented by 180 countries (called Parties), including the United States. The aim of CITES is to regulate international trade in listed animal and plant species, including their parts and products, to ensure the trade is legal and does not threaten the survival of species. CITES regulates both commercial and noncommercial international trade through a system of permits and certificates that must be presented when leaving and entering a country with CITES specimens. Species are listed in one of three appendices, which provide different levels of protection. In some circumstances, different populations of a species are listed at different levels. Appendix I includes species that are threatened with extinction and are or may be affected by trade. The Convention states that Appendix-I species must be subject to “particularly strict regulation” and trade in specimens of these species should only be authorized “in exceptional circumstances.” Appendix II includes species that are not necessarily threatened with extinction now, but may become so if international trade is not regulated. Appendix III includes species that a range country has identified as being subject to regulation within its jurisdiction and as needing cooperation of other Parties in the control of international trade.

    Import and export of CITES species is prohibited unless accompanied by any required CITES documents. Documentation requirements vary depending on the appendix in which the species or population is listed and other factors. CITES documents cannot be issued until specific biological and legal findings have been made. CITES does not regulate take or domestic trade of listed species. It contributes to the conservation of listed species by regulating international trade and, in order to make the necessary findings, encouraging assessment and analysis of the population status of species in trade and the effects of international trade on wild populations to ensure that trade is legal and does not threaten the survival of the species.

    African Elephant Conservation Act

    The AfECA was enacted in 1988, to “perpetuate healthy populations of African elephants” by regulating the import and export of certain African elephant ivory to and from the United States. Building from and supporting existing programs under CITES, the AfECA called on the Service to establish moratoria on the import of raw and worked ivory from both African elephant range countries and intermediary countries (those that export ivory that does not originate in that country) that failed to meet certain statutory criteria. The statute also states that it does not provide authority for the Service to establish a moratorium that prohibits the import of sport-hunted trophies that meet certain standards.

    In addition to authorizing establishment of the moratoria and prohibiting any import in violation of the terms of any moratorium, the AfECA prohibits: The import of raw African elephant ivory from any country that is not a range country; the import of raw or worked ivory exported from a range country in violation of that country's laws or applicable CITES programs; the import of worked ivory, other than certain personal effects, unless the exporting country has determined that the ivory was legally acquired; and the export of all raw (but not worked) African elephant ivory. While the AfECA comprehensively addresses the import of ivory into the United States, it does not address other uses of ivory or African elephant specimens other than ivory and sport-hunted trophies. The AfECA does not regulate the use of ivory within the United States and, other than the prohibition on the export of raw ivory, does not regulate export of ivory from the United States. The AfECA also does not regulate the import or export of live African elephants.

    Regulatory Background

    Ghana first listed the African elephant in CITES Appendix III on February 26, 1976. Later that year, the CITES Parties agreed to add African elephants to Appendix II, effective February 4, 1977. In October 1989, all populations of African elephants were transferred from CITES Appendix II to Appendix I (effective in January 1990), which ended much of the previous legal commercial trade in African elephant ivory.

    In 1997, based on proposals submitted by Botswana, Namibia, and Zimbabwe and the report of a Panel of Experts (which concluded, among other things, that populations in these countries were stable or increasing and that poaching pressure was low) the CITES Parties agreed to transfer the African elephant populations in these three countries to CITES Appendix II. The Appendix-II listing included an annotation that allowed noncommercial export of hunting trophies, export of live animals to appropriate and acceptable destinations, export of hides from Zimbabwe, and noncommercial export of leather goods and some ivory carvings from Zimbabwe. It also allowed for a one-time export of raw ivory to Japan (which took place in 1999), once certain conditions had been met. All other African elephant specimens from these three countries were deemed to be specimens of a species listed in Appendix I and regulated accordingly.

    The population of South Africa was transferred from CITES Appendix I to Appendix II in 2000, with an annotation that allowed trade in hunting trophies for noncommercial purposes, trade in live animals for reintroduction purposes, and trade in hides and leather goods. (At that time, the Panel of Experts reviewing South Africa's proposal concluded, among other things, that South Africa's elephant population was increasing, that there were no apparent threats to the status of the population, and that the country's anti-poaching measures were “extremely effective.”) Since then, the CITES Parties have revised the Appendix-II listing annotation three times. The current annotation, in place since 2007, covers the Appendix-II populations of Botswana, Namibia, South Africa, and Zimbabwe and allows export of: Sport-hunted trophies for noncommercial purposes; live animals to appropriate and acceptable destinations; hides; hair; certain ivory carvings from Namibia and Zimbabwe for noncommercial purposes; and a one-time export of specific quantities of raw ivory, once certain conditions had been met (this export, to China and Japan, took place in 2009). As in previous versions of the annotation, all other African elephant specimens from these four populations are deemed to be specimens of species included in Appendix I and the trade in them is regulated accordingly.

    The African elephant was listed as threatened under the ESA, effective June 11, 1978 (43 FR 20499, May 12, 1978). A review of the status of the species at that time showed that the African elephant was declining in many parts of its range and that habitat loss, illegal killing of elephants for their ivory, and inadequacy of existing regulatory mechanisms were factors contributing to the decline. At the same time the African elephant was designated as a threatened species, the Service promulgated a 4(d) rule to regulate import and certain interstate commerce of the species in the United States (43 FR 20499, May 12, 1978).

    The 1978 4(d) rule for the African elephant stated that the prohibitions at 50 CFR 17.31 applied to any African elephant, alive or dead, and to any part, product, or offspring thereof, with certain exceptions. Specifically, under the 1978 rule, the prohibition at 50 CFR 17.31 against importation did not apply to African elephant specimens that had originated in the wild in a country that was a Party to CITES if they had been exported or re-exported in accordance with Article IV of the Convention, and had remained in customs control in any country not party to the Convention that they transited en route to the United States. (At that time, the only African elephant range States that were Parties to CITES were Botswana, Ghana, Niger, Nigeria, Senegal, South Africa, and Zaire [now the Democratic Republic of the Congo].) The 1978 rule allowed for a special purpose permit to be issued in accordance with the provisions of 50 CFR 17.32 to authorize any activity otherwise prohibited with regard to the African elephant, upon submission of proof that the specimens were already in the United States on June 11, 1978, or that the specimens were imported under the exception described above.

    The 4(d) rule has been amended twice in response to changes in the status of African elephants and the illegal trade in elephant ivory, and to more closely align U.S. requirements with actions taken by the CITES Parties. On July 20, 1982, the Service amended the 4(d) rule for the African elephant (47 FR 31384) to ease restrictions on domestic activities and to more closely align its requirements with provisions in CITES Resolution Conf. 3.12, Trade in African elephant ivory, adopted by the CITES Parties at the third meeting of the Conference of the Parties (CoP3, 1981). The 1982 rule applied only to import and export of ivory (and not other elephant specimens) and eliminated the prohibitions under the ESA against taking, possession of unlawfully taken specimens, and certain activities for the purpose of engaging in interstate and foreign commerce, including the sale and offer for sale in interstate commerce of African elephant specimens. At that time, the Service concluded that the restrictions on interstate commerce contained in the 1978 rule were unnecessary and that the most effective means of utilizing limited resources to control ivory trade was through enforcement efforts focused on imports.

    Following enactment of the AfECA (in October 1988), the Service established, on December 27, 1988, a moratorium on the import into the United States of African elephant ivory from countries that were not parties to CITES (53 FR 52242). On February 24, 1989, the Service established a second moratorium on all ivory imports into the United States from Somalia (54 FR 8008). On June 9, 1989, the Service put in place the current moratorium, which bans the import of ivory other than sport-hunted trophies from both range and intermediary countries (54 FR 24758).

    The 4(d) rule was revised on August 10, 1992 (57 FR 35473), following establishment of the 1989 moratorium under the AfECA on the import of African elephant ivory into the United States, and again on June 26, 2014 (79 FR 30400, May 27, 2014), associated with the update of U.S. CITES implementing regulations. In the 2014 revision of the 4(d) rule, we removed the CITES marking requirements for African elephant sport-hunted trophies. At the same time, these marking requirements were updated and incorporated into our CITES regulations at 50 CFR 23.74. The purpose of this change was to make clear what is required under CITES (at 50 CFR part 23) for trade in sport-hunted trophies and what is required under the ESA (at 50 CFR part 17).

    Need for Regulatory Actions

    We have reevaluated the provisions of the 4(d) rule and considered other administrative actions in response to unprecedented increases in the illegal killing of elephants, an alarming growth in illegal trade of elephant ivory, recommendations adopted by the CITES Parties in March 2013 to help curb the illegal killing and illegal trade, issuance of Executive Order 13648 on Combating Wildlife Trafficking in July 2013, and the stated priorities in the National Strategy for Combating Wildlife Trafficking, issued by President Obama in February 2014.

    Illegal Killing of Elephants and Illegal Ivory Trade

    The increase in poaching of elephants and the escalation of the illegal trade in ivory are described in documents made available at CoP16. See, in particular, CoP16 Doc. 53.1, Monitoring the illegal killing of elephants (including the Addendum); CoP16 Doc. 53.2.2, Monitoring of illegal trade in ivory and other elephant specimens; and Elephants in the Dust—the African Elephant Crisis, all available at http://www.cites.org. Status of African elephant populations and levels of illegal killing and the illegal trade in ivory: A report to the African Elephant Summit, December 2013 (also available at http://www.cites.org) provides an update to information presented at CoP16. A further update on the status of African elephants was prepared for the 65th meeting of the CITES Standing Committee (SC65), in July 2014, and presented in Annex 1 to document SC65 Doc. 42.1, Elephant conservation, illegal killing and ivory trade.

    CoP16 Doc. 53.1 and its Addendum (prepared by the CITES Secretariat), the December 2013 report for the African Elephant Summit (prepared by the CITES Secretariat, the International Union for Conservation of Nature (IUCN), and TRAFFIC, the Wildlife Trade Monitoring Network), and Annex 1 to SC65 Doc. 42.1 (prepared by the IUCN/Species Survival Commission Asian and African Elephant Specialists Groups, the CITES Secretariat, the United Nations Environment Programme's World Conservation Monitoring Centre (UNEP-WCMC), and TRAFFIC) provide analyses of trends in levels of illegal killing of elephants based on data from the CITES Monitoring the Illegal Killing of Elephants (MIKE) program. MIKE is a site-based monitoring system intended to measure levels and trends in the illegal killing of elephants and to determine changes in these trends over time. Data are collected by ranger patrols and others at established MIKE sites and reported to the CITES Secretariat. The reports in CoP16 Doc. 53.1 and its Addendum contain analyses of data collected between 2002 and 2011, from more than 40 MIKE sites across Africa. The report prepared for the African Elephant Summit in December 2013 contains an updated MIKE analysis using 2012 data, and the report in the Annex to SC65 Doc. 42.1 contains a further updated MIKE analysis using data collected through 2013. The data set used for the most recent analysis (in SC65 Doc. 42.1) consists of 12,073 records of elephant carcasses found between 2002 and the end of 2013, at 53 MIKE sites in 29 countries across Africa.

    MIKE data are used to evaluate relative poaching levels based on the Proportion of Illegally Killed Elephants (PIKE), which is calculated as the number of illegally killed elephants found divided by the total number of elephant carcasses encountered by patrols or other means, aggregated by year for each site. The data in these reports show a steady increase in levels of illegal killing starting in 2006, with 2011 having the highest levels of poaching since MIKE records began in 2002. In 2012 and 2013, there appears to be a gradual decline, with 2013 levels close to those recorded in 2010. Despite the decline since 2011, poaching levels overall remain alarmingly high, with nearly two-thirds of dead elephants found in 2013 deemed to have been illegally killed. These reports state that the PIKE levels translate to 17,000 elephants killed at African MIKE sites in 2011, and 15,000 elephants killed at African MIKE sites in 2012. These numbers were estimated using models. The authors of the 2014 report prepared for SC65 note that it was not possible to derive an estimate for 2013 using the same method as in previous years because some of the required covariates for 2013 were not yet available. However, the authors provide a “preliminary and rough calculation” using a different method that estimates more than 14,000 elephants were killed at MIKE sites in 2013. The authors stress that this estimate must be treated with caution, but they state that “there are good reasons to believe that the number of elephants illegally killed in Africa in 2013 ran, as in previous years, into the tens of thousands, perhaps in the order of 20 to 22 thousand.”

    A joint press release, issued by the CITES Secretariat, IUCN, and TRAFFIC International on December 2, 2013, at the opening of the African Elephant Summit in Gabarone, Botswana, asserted that the figures for MIKE sites amount to an estimated 25,000 elephants killed illegally across Africa in 2011, and 22,000 killed illegally in 2012. Others have suggested that the numbers killed continent-wide are likely even higher. The statistical model used to evaluate MIKE data estimates that the “threshold of sustainability” at MIKE sites was crossed in 2010, with poaching rates remaining above the population growth rate of 4 to 5 percent for healthy elephant populations every year since.

    A recent study, published in the Proceedings of the National Academy of Sciences (in July 2014), reaffirmed these assertions. Wittemyer et al. (2014) used MIKE data to analyze the impacts of illegal killing on elephant populations across the African continent, using two different approaches. The results demonstrate “an over-harvest driven decline in African elephants likely began in 2010.” The authors assumed an average annual population increase in the absence of illegal killing of 4.2 percent. They estimated that illegal killing rates averaged about 6.8 percent between 2010 and 2012, which the authors estimate corresponds to more than 33,000 elephants killed per year (based on current population estimates). They also noted that preliminary data for 2013 suggest regional and continental levels were slightly lower than for 2012, but still unsustainable.

    CoP16 Doc. 53.2.2 and Annex 1 to SC65 Doc. 42.1 contain reports, prepared by TRAFFIC, on data in the CITES Elephant Trade Information System (ETIS). ETIS is a system for collecting and compiling law enforcement data on seizures and confiscations in order to monitor the pattern and scale of illegal trade in elephant specimens. TRAFFIC receives seizure and confiscation data from CITES Parties, manages and coordinates the ETIS system, and produces a comprehensive report for meetings of the CoP and updates for meetings of the Standing Committee.

    The report in CoP16 Doc. 53.2.2 covers the period 1996 through 2011, and the report in SC65 Doc. 42.1 covers the period 1996 through 2012 (data for 2013 were not yet complete when the report was prepared). The data set used for the analysis presented in SC65 Doc. 42.1 includes 14,070 separate raw or worked ivory seizure records from 72 countries or territories during 1996-2012. Using 1998 as a baseline (because it is the first full year after some populations of African elephant were transferred from Appendix I to Appendix II and, at the same time, the development of monitoring systems, including ETIS, was mandated by the Parties), the reports examine trends in both the frequency of illegal ivory trade transactions and the scale of the illegal trade in ivory.

    Illegal trade activity (frequency of transactions) remained at or slightly above 1998 levels up to 2006. In 2006, a gradual increase in activity began and grew with each successive year, with a “major surge” in 2011. The authors report that the frequency of illegal ivory trade transactions in 2011 represented “a three-fold increase in illegal trade activity since 1998.”

    The scale of illegal trade was assessed by evaluating the weight of ivory traded illegally. The authors caution that there is more uncertainty in evaluating the weight of ivory in illegal trade than in evaluating the frequency of illegal transactions, but the trend is clear. Like the trend in frequency of transactions, there was relative stability in the weight of ivory in illegal trade through 2007, followed by a sharp increase in the following years. The authors estimate that the quantity of illegal ivory in trade in 2011, measured by weight, was nearly three times 1998 levels, and, although 2012 data show a slight decrease compared to 2011, levels in 2012 represent a value that is about two and a half times the 1998 levels. This upward trend reflects a major increase in large consignments of ivory (over 100 kg) in illegal trade, which, the authors note, points to the increasing involvement of international criminal syndicates. In its 2014 report to SC65, TRAFFIC states that the frequency of large-scale ivory seizures has increased greatly since 2000, and that the “upward surge in the weight of ivory seized from 2009 through 2012 has been primarily driven by increased seizures in the large ivory weight class.” Although 2013 data were not complete when the report was written and, therefore, were not included in the analysis, the authors note that the 18 seizures made in 2013 for which they had data “collectively constitute the greatest quantity of ivory derived from large-scale seizure events going back to 1989.”

    Elephants in the Dust—the African Elephant Crisis is a report commissioned by the CITES Secretariat through its MIKE program and prepared by UNEP, the CITES Secretariat, IUCN, and TRAFFIC for presentation at CoP16. This report highlights the long-term threats to African elephants posed by habitat loss due to human population growth and large-scale conversion of land for agriculture. It also raises alarm at the added impact of the increasing poaching levels on elephant populations, not only in central Africa but also in previously secure areas of east, west, and southern Africa. Both the TRAFFIC report to CoP16 and Elephants in the Dust conclude that elephants are facing the most serious conservation crisis since 1989, when the African elephant was transferred from CITES Appendix II to Appendix I. The poaching of African elephants to supply international demand for ivory has reached unprecedented levels, and opportunistic poaching has been replaced by coordinated slaughter commissioned by organized networks or syndicates.

    The CITES Parties have taken steps to address the growing illegal trade in ivory, including, at CoP16, calling on countries to ensure that they have comprehensive measures in place to regulate the domestic trade in raw and worked ivory. At SC65, the Standing Committee took steps to hold countries that have been identified as being significantly involved in illegal ivory trade (either as source, transit, or destination countries for illegal ivory) accountable. Identified countries that fail to take actions to resolve problems by the agreed deadlines may be subject to CITES trade sanctions.

    U.S. Involvement in the Illegal Ivory Trade

    Demand for ivory is driving the current poaching crisis. Although the primary markets are in Asia, particularly in China and Thailand, the United States continues to play a role as a destination and transit country for illegally traded elephant ivory. Service wildlife inspectors stationed at major U.S. ports intercept smuggled wildlife and ensure that wildlife importers and exporters comply with declaration, permit, and other requirements for international trade in elephants and other wildlife species. Over the years, seizures of unlawfully imported and exported elephant specimens at U.S. ports have ranged from whole elephant tusks and large ivory carvings to knife handles, jewelry made from ivory or hair, and tourist souvenirs including items made from elephant feet and bones. The Service provides seizure data to TRAFFIC annually for inclusion in the CITES ETIS database. Since 1990, the annual number of seizure cases involving elephant specimens at U.S. ports has ranged from over 450 (in 1990) to 60 (in 2008); in most other years the number falls between 75 and 250 cases. In 2012, the most recent year for which we have complete data, there were about 225 seizure cases involving elephant specimens, which resulted in seizure of over 1,500 items that contained or consisted of elephant parts or products. Nearly 1,000 of those items contained or consisted of elephant ivory. (About 300 of the items were elephant hairs.)

    Service special agents have investigated multiple smuggling operations involving the trafficking of elephant ivory for U.S. markets. Some examples of major investigations are provided here. In September 2012, the owner of a Philadelphia African art store was arrested and pleaded guilty to smuggling African elephant ivory into the United States. Approximately one ton of elephant ivory was seized from his store; it was the largest ivory seizure in U.S. history. According to the indictment, the art store owner paid a co-conspirator to travel to Africa to purchase raw elephant ivory and have it carved to his specifications and stained or dyed so that the carvings would appear old. He sold the carvings at his store in Philadelphia and elsewhere in the United States as “antiques.”

    The arrest in Philadelphia was an outgrowth of a multi-year investigation that documented over 20 shipments of newly carved elephant ivory smuggled into the United States in air and ocean cargo from Cameroon, Ivory Coast, Nigeria, and Uganda. The smuggled ivory came into the country through New Jersey and New York, and was distributed to collectors and retailers across the United States, including to Chicago, Houston, Memphis, New York City, Philadelphia, and Trenton. A total of 10 individuals were charged and later convicted as part of this investigation. Much of the ivory in this case was sent via parcel accompanied by fraudulent shipping and customs documents, and disguised with clay and other substances to look like musical instruments and wooden statues.

    Service investigators teamed with officers from the New York Department of Environmental Conservation to probe illegal ivory sales by a New York City jeweler distributor and two Manhattan retailers. This investigation documented a booming and unauthorized trade in ivory. Prosecutions were pursued by the Attorney General for the State of New York based on violations of State laws regulating the sale of elephant ivory. The stores prosecuted paid $50,000 in fines and forfeited over one ton of elephant ivory (which was destroyed at the Service's “ivory crush” described below). The distributor forfeited 70 pounds of elephant ivory valued at $30,000 and paid $10,000 in restitution.

    Service special agents worked with the Thai Royal Police to secure the 2010 U.S. indictment of two businessmen (the owner of a Los Angeles area donut shop and a Thai trafficker) and four arrests in Thailand in a case that exposed transcontinental trafficking in elephant ivory. Over the course of this 5-year undercover investigation, officers showed that ivory was being smuggled from Africa into Thailand by Thai operatives who then sold it to clients in the United States and other countries. The investigation began in 2006, when Service wildlife inspectors conducting an inspection “blitz” at the international mail facility in Los Angeles intercepted a package of elephant ivory that had been mailed from Thailand to a U.S. business and labeled as toys. The U.S. defendant pleaded guilty to Federal charges.

    Operation Scratchoff was a multi-year investigation, launched by the Service in New York in 2006. It documented and disrupted the illegal activities of both international smugglers who were bringing ivory into the country from Africa and U.S. retailers involved in this black market trade. Special agents documented smuggled ivory entering the United States from Cameroon, Gabon, Ghana, Ivory Coast, Kenya, Nigeria, and Uganda. Most of the ivory smuggled by defendants in this case was shipped from Africa via mail parcel through John F. Kennedy International Airport. The shipments were accompanied by fraudulent shipping and customs documents identifying their contents as African wooden handicrafts or wooden statues. The ivory itself was painted to look like wood; covered with clay; or hidden inside wooden handicrafts, such as traditional African musical instruments. Work on this investigation resulted in the arrest and conviction of eight individuals in the United States on felony smuggling and/or Lacey Act (16 U.S.C. 3371 et seq.) charges with final sentencing in 2010 and 2011. Prison terms for five of these defendants, which included a 33-month sentence for one, totaled more than 7 years. Operation Scratchoff also led to the arrest in January 2010 of an ivory supplier in Uganda by Ugandan authorities, and the identification of additional ivory trafficking suspects.

    In 2008, a Canadian citizen was sentenced to 5 years in prison and ordered to pay a $100,000 fine for illegally smuggling ivory from Cameroon into the United States for sale here. The perpetrator operated art import and export businesses in Montreal, Canada and in Cameroon that were fronts for smuggling products made from protected wildlife species, including raw elephant ivory. She ran a sophisticated smuggling operation that utilized local artists and craftsmen in Cameroon, operatives within international shipping companies, contacts in the illegal ivory trade, her business in Canada, and partners in three countries. Two of her shipments, sent to Ohio, included fresh ivory from more than 20 recently killed elephants.

    In 2006, Service special agents secured a 20-count criminal indictment against Primitive Art Works, a Chicago art gallery specializing in high-end exotic artifacts from around the world, and its two owners for smuggling elephant ivory and products made from other protected species into the United States. The Service seized over 1,000 ivory carvings and tusks from the defendants, who were asking as much as $50,000 a piece for these items. Both owners pleaded guilty to wildlife violations later that year.

    In 2001, during Operation Loxa, Service officers in Los Angeles intercepted more than 250 pounds of smuggled African elephant ivory, the largest ivory seizure ever on the west coast of the United States. The two shipments, which were smuggled from Nigeria, were declared to customs as handcrafted furniture. The ivory included whole tusks and pieces hidden inside furniture and concealed in beaded cloth. Four individuals were arrested and indicted for conspiracy to smuggle elephant ivory into the United States. Three of them were convicted.

    Service special agents have also investigated cases involving smuggling of elephant ivory out of the United States to other markets, particularly in Asia. In an investigation, known as Operation Crash, an Asian antique dealer was convicted for his role in the conspiracy to smuggle items made from elephant ivory and rhinoceros horn valued at over $1,000,000. The investigation revealed that this individual worked in the United States as a buyer for four different Asian dealers, who were purchasing numerous ivory carvings from auction houses in the United States. After purchasing the ivory at auctions, the antique dealer smuggled the ivory (through the mail) to various locations in Hong Kong, using false declarations to avoid export controls.

    In 2011, a Chinese national was intercepted at John F. Kennedy International Airport prior to boarding a plane to Shanghai, China. Service investigators found 18 elephant ivory carvings concealed in his luggage. This individual was an Asian art dealer who purchased the carvings at various U.S. auction houses during a week-long buying trip. Upon arrest, he told agents that he wrapped the ivory carvings in tin foil to avoid x-ray detection.

    At auctions in the United States, Service law enforcement officers have documented foreign buyers placing absentee bids on wildlife items, including those made from African elephant ivory. In some cases, the ivory items are smuggled directly to the foreign buyers. In many instances, however, the foreign buyers employ couriers with residences in the United States to collect the elephant ivory and smuggle it overseas on their behalf. We are concerned that foreign ivory buyers and couriers view the United States as a significant source and market for elephant ivory.

    In November 2013, the Service destroyed nearly six tons of contraband African and Asian elephant ivory that had been either seized at U.S. ports or as part of law enforcement investigations over the past 25 years for violation of wildlife laws. We crushed this contraband ivory, which had been stored at the Service's National Wildlife Property Repository, to raise public awareness about the current African elephant poaching crisis and to send a clear message that the United States will not tolerate ivory trafficking and the toll it is taking on wild elephant populations. The six tons of ivory crushed in 2013 underscores the continuing U.S. role in the illegal market and the need for us to take further actions to curtail that role.

    There is also a legal market for ivory within the United States. We do not have comprehensive information on the U.S. domestic ivory market. Tackling the Ivories, a 2004 report by Douglas Williamson for TRAFFIC North America, described the status of U.S. trade in elephant and hippopotamus ivory. At that time, the author noted that “as one of the world's largest markets for wildlife products, the [United States] has long played a significant role in the international ivory trade.” He concluded that the ivory trade within the United States was not closely monitored and that its full extent was unknown. In addition to ivory available from retail outlets, he noted that there was “significant trade conducted via the internet, with little oversight.” The domestic trade involved both raw and worked ivory. Worked ivory was readily available in the form of carvings, jewelry, piano keys, and other items. Raw ivory was bought by companies and individuals to be fashioned into specialty items including knife handles, gun grips, and pool cues. Along with legal trade, Williamson found evidence of illegal trade, including internet sellers in China that routinely shipped ivory to the United States, via express delivery service, and offered to falsely label the shipments as “bone carvings.”

    In a 2006-2007 survey of selected metropolitan areas across the United States, Martin and Stiles (2008) identified retail establishments trading in worked ivory, including ivory from African elephants. In each area surveyed, the surveyors visited major flea markets, antique markets, main shopping areas for antiques and crafts, department stores, and luxury hotel gift shops. The study does not identify all establishments trading in ivory, but gives a general idea of the number of establishments and geographic scope. In the 16 areas surveyed, the authors identified a total of 652 retail outlets offering a total of more than 23,000 ivory products for sale. Of the areas surveyed, those with the most retail outlets and the greatest number of ivory products for sale were: New York City (124 retail outlets containing a total of 11,376 ivory products); San Francisco Bay area (40 retail outlets containing a total of 2,777 ivory products); and greater Los Angeles (170 retail outlets containing a total of 2,605 ivory products). Martin and Stiles estimated that as much as one-third of the items they found were imported illegally after the 1989 AfECA import moratorium.

    In March and April of 2014, one of the authors of the 2008 study conducted a follow-up survey (Stiles 2015) in Los Angeles and San Francisco, California. He found a total of more than 1,250 ivory items offered for sale by 107 vendors in these two California cities, “with 777 items and 77 vendors in Los Angeles and well over 473 ivory items and 30 vendors in San Francisco.” While there were “significantly fewer venders” offering ivory for sale, compared to the 2006-2007 survey, Stiles noted “a much higher incidence of what appears to be ivory of recent manufacture in California, roughly doubling from approximately 25% in 2006 to about half in 2014. In addition, many of the ivory items seen for sale in California advertised as antiques (i.e., more than 100 years old) appear to be more likely from recently killed elephants.”

    Basis for Regulatory Changes and Necessary and Advisable Determination

    It is often impossible to distinguish ivory legally imported into the United States from that which has been smuggled into the country, which significantly undermines enforcement efforts and provides an opportunity for illegal ivory to be laundered through U.S. markets. In addition, U.S. citizens may be involved in the global ivory market with ivory that has never been imported into the United States. The Service has reevaluated our domestic controls, given the current poaching crisis in Africa and the associated increase in illegal trade in ivory, the recent CITES recommendations, and evidence that substantial quantities of illegal ivory are making their way into U.S. markets. We have determined that it is appropriate to take certain regulatory actions, including revision of the 4(d) rule as necessary and advisable for the conservation of the species and to include certain prohibitions from section 9(a)(1) of the ESA, to more strictly regulate U.S. trade in ivory. The proposed revisions would regulate import, export, and commercial use of African elephant ivory and sport-hunted trophies and appropriately protect live elephants within the United States, while including certain limited exceptions for items and activities that we do not believe, based on all available evidence, are contributing to the poaching of elephants in Africa, including trade in live animals, parts and products other than ivory, and certain manufactured items containing ivory that meet specific criteria.

    These new restrictions would facilitate enforcement efforts within the United States and improve regulation of both domestic and foreign trade in elephant ivory by U.S. citizens. Improved domestic controls will make it more difficult to launder illegal elephant ivory through U.S. markets, which will contribute to a reduction in poaching of African elephants.

    This proposed action is consistent with Executive Order 13648 on Combating Wildlife Trafficking signed by President Obama on July 1, 2013, to “address the significant effects of wildlife trafficking on the national interests of the United States.” The Executive Order calls on executive departments and agencies to take all appropriate actions within their authority to “enhance domestic efforts to combat wildlife trafficking, to assist foreign nations in building capacity to combat wildlife trafficking, and to assist in combating transnational organized crime.” Increased control of the U.S. market for elephant ivory is also among the administrative actions called for in the National Strategy for Combating Wildlife Trafficking, issued by President Obama on February 11, 2014. Director's Order No. 210, issued by the Director of the U.S. Fish and Wildlife Service, established policy and procedures for the Service to follow in implementing the National Strategy with regard to trade in African elephant ivory and parts and products of other ESA-listed species.

    This proposal is also in line with international efforts. At CoP16, in March 2013, the CITES Parties adopted a revised resolution on trade in elephant specimens (Resolution Conf. 10.10 (Rev. CoP16)), which, among other things, urges Parties with a legal domestic ivory market to ensure that they have in place “comprehensive internal legislative, regulatory, enforcement and other measures to regulate the domestic trade in raw and worked ivory.” Wittemyer et al. (2014) concluded that it is obvious that stemming the rate of illegal killing of elephants is paramount. They call for a global response, including heavy in situ conservation efforts, enforcement of end-use markets, and curbing demand to reduce black market prices for ivory and “alleviate the unsustainable pressure from illegal killing on wild populations.”

    In developing this proposed rule, we have also considered the provisions already in place for protection of African elephants under CITES, the AfECA, and the guidance provided in Director's Order No. 210. Provisions for African elephants under CITES and the AfECA can help to address current threats to the species, but the ESA can reach activities that are not regulated under these other laws. For each type of activity and specimen, the available protections provided through the combination of all applicable laws are analyzed to explain why the overall proposed regulatory framework is appropriate for the conservation of this species.

    General Provisions

    We are proposing to revise the 4(d) rule for the African elephant, in 50 CFR 17.40(e), so that all of the provisions at 50 CFR 17.31 and 17.32 would apply unless specifically indicated otherwise in the rule. Any activity that would be prohibited or exempted under 50 CFR 17.31 and any activity that would require authorization under 50 CFR 17.32 would be regulated as indicated in those sections except as provided in this proposed rule. This legal framework provides far greater protections for African elephants compared to the current rule, which regulates only certain import to and export from the United States; possession, sale, offer for sale, transport, and similar activities with any African elephant specimen illegally imported into the United States; and sale or offer for sale of any sport-hunted trophy imported into the United States in violation of a permit condition. The protections that would be offered to African elephants through this proposed rule and reasons each of the measures is appropriate for the conservation of the species are explained below.

    Nothing in this rule would affect other legal requirements applicable to African elephants and their parts and products under other laws such as the AfECA and CITES. For example, while an import into the United States that met all standards as a noncommercial transshipment under section 10(i) of the ESA would not be a violation of the ESA, it would remain a violation of the import moratorium under the AfECA. In addition, any person importing or exporting African elephants or their parts and products to or from the United States would need to comply with all applicable CITES requirements beyond what are described in this proposed rule, as well as the general wildlife import/export requirements found at 50 CFR part 14 and general permitting requirements in 50 CFR part 13. These additional requirements, when applicable, are noted in the text of the rule.

    Take of Live Elephants

    The current 4(d) rule does not regulate the taking of live African elephants. Take means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct, an ESA-protected species and therefore includes both lethal and certain non-lethal effects on protected wildlife. Under the proposed rule, the taking of any live African elephant would be prohibited within the United States, within the U.S. territorial sea, or upon the high seas (with the latter two acts possibly occurring during transport of a live elephant, such as during transport to or from the United States). Take of endangered or threatened species is not regulated under the ESA beyond these geographic areas, so this change to the 4(d) rule would not have any effect on the ability of U.S. citizens to travel to countries that allow hunting of African elephants and engage in sport hunting. However, the import of any associated sport-hunted trophy into the United States would be regulated as described below. For any African elephant held in captivity within the United States, take would not include animal husbandry practices that meet minimum standards under the Animal Welfare Act (AWA; 7 U.S.C. 2131 et seq.), breeding procedures, and veterinary care that is not likely to result in injury to the elephant. (See the definition of “harass” at 50 CFR 17.3.) Therefore this new restriction would not affect routine procedures for care of African elephants that are held in zoos and similar facilities in the United States. This prohibition is the same as the prohibition on take of Asian elephants, which has been in place since the Asian elephant was listed under the ESA in 1976.

    The proposed rule would help to ensure that elephants held in captivity receive an appropriate standard of care. Any activities that qualify as take, including those beyond the standard veterinary care, breeding procedures, and AWA care standards described in the definition of “harass,” would have to qualify for one of the purposes that allow for issuance of a threatened species permit under 50 CFR 17.32. While the taking of live African elephants held in captivity within the United States or being transported is not a threat to the species, including a prohibition against take, even for species that are not native to the United States, is a standard protection for threatened species and ensures an adequate level of care for wildlife held in captivity.

    Interstate and Foreign Commerce

    The current 4(d) rule for the African elephant does not regulate sale or offer for sale in interstate or foreign commerce or delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of African elephants (including live animals, parts and products, and sport-hunted trophies). The only commercial activities regulated under the current 4(d) rule are possession, sale or offer for sale, and receipt, delivery, transport, or shipment of African elephants (including parts and products) that were illegally imported into the United States and sale or offer for sale of any sport-hunted trophy imported into the United States in violation of a permit condition. These restrictions will remain in place through the ESA section 9(c)(1) prohibition on possession of any CITES specimen that was imported or exported contrary to the Convention, prohibitions under the Lacey Act (16 U.S.C. 3371 et seq.), and ESA section 11 penalties for violations of ESA or CITES permit conditions. We propose to allow continued sale or offer for sale in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of live animals and African elephant parts and products other than ivory and sport-hunted trophies without a threatened species permit.

    The poaching crisis is driven by demand for elephant ivory. There is no information to indicate that commercial activities involving live elephants or commercial use of elephant parts and products other than ivory has had any effect on the rates or patterns of illegal killing of elephants and the illegal trade in ivory. Live animals are occasionally removed from the wild and placed in captivity, often from populations in small management areas where there have been local over-population issues and consequent negative impacts to habitat. African elephant parts other than ivory (such as hides) that are commercialized generally become available when animals are culled for management purposes, during salvage of animals poached for their ivory, or when problem animals have to be killed. African elephants are not killed primarily for their hides or for parts other than ivory. In addition, the import and export of live African elephants and parts and products are regulated under CITES and other U.S. law. This includes import into and export from the United States for both commercial and noncommercial purposes. It is only commercial activity associated with interstate or foreign commerce not involving import or export that would not be regulated. We have no information indicating that such commercial activity is having any effect on the conservation status of African elephants. Requiring individuals to obtain a threatened species permit under 50 CFR 17.32 when the removal of a small number of live elephants or the incidental harvest of their hides or hair has no negative impact on the species would provide no meaningful protective measures for African elephants, especially when activities that also involve import or export to or from the United States are already regulated under CITES. For these reasons, we have determined that it is not necessary to propose restrictions on commercial activities in interstate or foreign commerce with live African elephants, leather goods, and other African elephant non-ivory parts and products.

    We do, however, propose to prohibit sale or offer for sale of ivory in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity, with some exceptions, and to prohibit the same commercial activities with sport-hunted African elephant trophies. “Foreign commerce” is defined in section 3 the ESA (16 U.S.C. 1532(9)). “Commercial activity” as used in the term “in the course of a commercial activity” is also defined in section 3 the ESA and means “all activities of industry and trade, including, but not limited to, the buying or selling of commodities and activities conducted for the purpose of facilitating such buying and selling” (16 U.S.C. 1532(2)). The Service has defined “industry or trade” at 50 CFR 17.3 to mean “the actual or intended transfer of wildlife . . . from one person to another person in the pursuit of gain or profit.” The ESA definition of “commercial activity” includes an exception for “exhibitions of commodities by museums or similar cultural or historical organizations.” “Person” is defined in the ESA to include corporations, partnerships, trusts, associations, or any other private entity along with Federal, State, local, and foreign governments, as well as individuals. Activities that would be prohibited could be authorized through a threatened species permit under 50 CFR 17.32 for scientific purposes, enhancement of propagation or survival of the species, zoological exhibition, educational purposes, or other special purposes consistent with the purposes of the ESA. The ESA does not reach sale or offer for sale or activities in the course of a commercial activity that occur solely within the boundaries of a State (i.e., intrastate commerce).

    There are a number of potential activities involving ivory or sport-hunted trophies that would not be prohibited under these ESA standards, provided the activity did not qualify as “sale” or “offer for sale.” Under our definition of “industry or trade,” commercial use of threatened specimens does not fall under the prohibition for “commercial activity” unless the transaction involves the transfer of the specimen from one person to another person in the pursuit of gain or profit. Activities that would involve the movement of ivory or sport-hunted trophies in interstate or foreign commerce for gain or profit where there would be no transfer of the item to another person would not be a violation of this rule. For example, a person who transported an item containing ivory across State lines for the purpose of having the item repaired would not fall under the prohibition for “commercial activity.” Not every transaction that involves the exchange of money qualifies as commercial activity under the ESA. In this case, the repair person would gain financially and the item may increase in value once repaired, but the payment of money would be to compensate the repair person for his or her labor and expenses and not involve gain or profit from the ivory item itself (unless the activity involved using additional ivory to repair the item, which would not be allowed). The donation of an item consisting of or containing ivory also would not be considered commercial activity, even if the donor qualified for a tax benefit where the tax benefit is not income. Exhibitions of ivory items or sport-hunted trophies involving gain or profit would remain exempt under the ESA definition of “commercial activity,” provided that all entities involved in the transaction qualified as “museums or similar cultural or historical organizations.” Finally, the exemption available through section 10(h) of the ESA (16 U.S.C. 1539(h)) would continue to allow commercialization of qualifying antiques in interstate and foreign commerce. There are, however, other Federal and State restrictions that may apply to commercial activities involving ivory, including “use after import” restrictions on certain specimens that have been imported under CITES (see below).

    As explained in the section Need for Regulatory Actions, while there has long been poaching of African elephants for their ivory and illegal trade in that ivory, since 2006, there has been an unprecedented increase in the illegal killing of African elephants, with estimates exceeding 20,000 per year in recent years. Concurrent with this increase in illegal killing there has been an alarming increase in illegal trade in ivory. Recent law enforcement efforts have demonstrated that the United States plays a role in the illegal trade and the associated illegal killing. The study by Martin and Stiles (2008) estimated that as much as one-third of the ivory found in selected metropolitan areas had been imported into the United States illegally since the 1989 AfECA moratorium. Stiles estimated, in his 2014 follow-up study, that as much as one half of the ivory for sale in two California cities during his survey had been imported illegally. All of this demonstrates the need to impose restrictions on commercializing elephant ivory within the United States. The proposed rule would restrict commercial activities with African elephant ivory consistent with the restrictions in place for endangered species and those in place for other threatened species, with a narrow exception for manufactured items containing a small (de minimis) quantity of ivory. Sale or offer for sale of ivory in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity would also remain available by threatened species permit under 50 CFR 17.32, provided the person met all of the requirements of that section as well as the general permitting requirements under 50 CFR part 13.

    For the same reasons that it is appropriate for the conservation of African elephants to restrict commercial activities involving ivory in interstate and foreign commerce, it is appropriate to restrict commercial activities involving sport-hunted trophies in interstate and foreign commerce. African elephant trophies contain raw or worked ivory, and in fact sometimes only the raw or worked ivory from the animal is imported into the United States as the trophy. Sport hunting is considered a noncommercial activity and CITES regulation of import and export of sport-hunted trophies reflects this approach. For example, the listing of the African elephant in CITES Appendix II for Botswana, Namibia, South Africa, and Zimbabwe is specifically annotated to note that trade in hunting trophies is for noncommercial purposes only. In Resolution Conf. 12.3 (Rev. CoP16), the CITES Parties have specified that a hunting trophy is an animal that was taken for the hunter's personal use. In addition, a CITES import permit for an African elephant trophy hunted in an Appendix I country can only be issued if the importing government finds that the specimen is not to be used for primarily commercial purposes. Reflecting these restrictions, CITES permits for African elephant sport-hunted trophies include a permit condition that the specimen can be used for noncommercial purposes only.

    Consistent with these and similar restrictions for other CITES species, in the 2007 revisions to our CITES-implementing regulations, we clarified that in situations where commercial import would be prohibited under CITES, an item imported for noncommercial purposes could not be used for commercial purposes after import into the United States. Under our CITES regulations, Appendix-I specimens (except those imported under a CITES exemption document or before the species was listed in Appendix I), CITES Appendix-II specimens with an annotation that trade is for noncommercial purposes only, and CITES Appendix-II specimens without a noncommercial annotation but listed as threatened under the ESA can only be used within the United States for noncommercial purposes (see 50 CFR 23.55). This restriction under the authority of CITES reaches intrastate as well as interstate and foreign commerce. We propose to prohibit the commercialization of sport-hunted African elephant trophies in a manner consistent with other legal standards under CITES, including the commercialization of any manufactured items that might otherwise qualify under the de minimis exception discussed below.

    Since announcing our intentions to remove or revise the 4(d) rule, we have received input from the public, including musicians and musical instrument manufacturers, museums, antique dealers, and others who may be impacted by these proposed changes. Having considered relevant information provided by these groups, in this proposed rule we would allow for continued commercialization of African elephant ivory in interstate and foreign commerce that is not contributing to the poaching of elephants and where we believe the risk of illegal trade is low.

    We propose to allow sale and offer for sale of ivory in interstate or foreign commerce along with delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity without a threatened species permit for manufactured items containing de minimis amounts of ivory, provided they meet the following criteria:

    • For items located in the United States, the ivory was imported into the United States prior to January 18, 1990 (the date the African elephant was listed in CITES Appendix I) or was imported into the United States under a CITES pre-Convention certificate with no limitation on its commercial use;

    • For items located outside the United States, the ivory is pre-Convention (removed from the wild prior to February 26, 1976 (the date the African elephant was first listed under CITES));

    • The ivory is a fixed component or components of a larger manufactured item and is not, in its current form, the primary source of value of the item;

    • The manufactured item is not made wholly or primarily of ivory;

    • The total weight of the ivory component or components is less than 200 grams;

    • The ivory is not raw; and

    • The item was manufactured before the effective date of the final rule for this action.

    We have included the phrase “in its current form” in the criterion stating that the ivory is not the primary source of value of the item, to make clear that we would consider the value added by the craftsmanship (carving, etc.) that went into the ivory component, not just the value of the ivory itself. We use the phrase “wholly or primarily” (in the next criterion) as those terms are commonly defined in the dictionary. We consider “wholly” to mean “entirely, totally, altogether” and “primarily” to mean “essentially, mostly, chiefly, principally.” We have chosen 200 grams as the weight limit because we understand that this is the approximate maximum weight of the ivory veneer on a piano with a full set of ivory keys and that this quantity would also cover most other musical instruments with ivory trim or appointments. We also understand the 200-gram limit would cover a broad range of decorative and utilitarian objects containing small amounts of ivory (insulators on old tea pots, decorative trim on baskets, and knife handles, for example).

    We have intentionally crafted this exception to allow commercial activity in a very narrow class of items. While we have given careful consideration to the types of items containing African elephant ivory for which we could allow continued commercialization in interstate and foreign commerce (because we do not believe the trade is contributing to the poaching of elephants and we believe the risk of illegal trade is low) we seek comment from the public on the specific criteria we have proposed to qualify for this de minimis exception. In particular, we are interested in input on criterion (iii), the ivory is a fixed component or components of a larger manufactured item and is not in its current form the primary source of value of the item and criterion (v), the manufactured item is not made wholly or primarily of ivory. We seek comment on the impact of not including these criteria in the rule and whether these criteria are clearly understandable.

    Examples of items that we do not expect would qualify for the de minimis exception include chess sets with ivory chess pieces (both because we would not consider the pieces to be fixed components of a larger manufactured item and because the ivory would likely be the primary source of value of the chess set), an ivory carving on a wooden base (both because it would likely be primarily made of ivory and the ivory would likely be the primary source of its value), and ivory earrings or a pendant with metal fittings (again both because they would likely be primarily made of ivory and the ivory would likely be the primary source of its value). For the reasons discussed in the section Import and export of ivory, other than sport-hunted trophies, this de minimis exception would not apply to manufactured items containing ivory that were imported to or exported from the United States for law enforcement or scientific purposes or to otherwise qualifying inherited items or items in a household move that were imported or exported under one of the exceptions in this rule.

    Our law enforcement experience over the last 25 years (see the U.S. involvement in the illegal ivory trade section) has shown that the vast majority of items in the illegal ivory trade are either raw ivory (tusks and pieces of tusks) or manufactured pieces (mostly carvings) that are composed entirely or primarily of ivory. As described earlier, in November 2013, the Service destroyed six tons of seized ivory that represented over 25 years of law enforcement efforts to control illegal ivory trade in the United States. The six tons of contraband ivory did not include any items that would be covered by this exception. As demonstrated by the thousands of seized ivory items destroyed in the “crush,” ivory traffickers are not manufacturing items with small amounts of pre-Convention ivory or dealing in such items. Rather, because the incentive to deal in illegal ivory is economic, the trade focuses on raw ivory and large pieces of carved ivory from which the highest profits can be made. Likewise, in the case described earlier involving the Philadelphia African art dealer, which included the seizure of approximately one ton of ivory, all of the seized ivory was in the form of whole ivory carvings and did not include any items that would qualify under the proposed de minimis exception.

    The information we have about the domestic market, including the surveys conducted by Martin and Stiles and our own investigations, indicates that trade in the types of manufactured items that would qualify for this proposed de minimis exception is not contributing to or driving the illegal ivory trade. Martin and Stiles identify recently made and presumably illegally imported items as figurines, netsukes, and jewelry, none of which would qualify under the criteria proposed for a de minimis exception.

    The requirement that the ivory is either pre-Convention (removed from the wild prior to February 26, 1976) or was imported into the United States prior to 1990, and the requirement that the item must have been manufactured before the effective date of a final rule would make it unlikely that commercialization of ivory under this exception would directly contribute to the future illegal killing of elephants. Noting the types of items that make up the illegal trade, and requiring that the ivory be a fixed component of a larger manufactured item, that the ivory is not raw, that it is not the primary source of value of the item, that the total weight of the ivory is less than 200 grams, and that the manufactured item is not made wholly or primarily of ivory would minimize the possibility of the ivory contributing to either global or U.S. illegal ivory markets or that the de minimis exception could be exploited as a cover for the illegal trade.

    These changes will allow us to appropriately regulate the U.S. domestic market in ivory as well as U.S. participation in global markets for ivory and achieve our goal of conserving the African elephant, while allowing limited continued trade that is not contributing to the poaching of elephants. Improved domestic controls will make it more difficult to launder illegal elephant ivory through U.S. markets, which we believe will ultimately contribute to a reduction in the illegal killing of African elephants.

    Since announcing our intention to revise the 4(d) rule for the African elephant and prohibit sale and offer for sale of African elephant ivory in interstate commerce, we have heard from a number of representatives of the U.S. museum community. They have expressed their concern about how prohibitions on interstate commerce will impact their ability to acquire items for museum collections. We recognize that museums can play a unique role in society by curating objects that are of historical and cultural significance. We are considering including an exception to the prohibitions on interstate commerce for museums, either through this rulemaking process or through a separate rulemaking under the ESA. We seek comment from the public on this issue. Additionally, we seek comment on how to best define museums in this regard, given the diverse interests that they serve.

    Import and Export, Other Than Ivory and Sport-Hunted Trophies

    Under the current 4(d) rule, African elephants and African elephant parts and products other than sport-hunted trophies and ivory (e.g., live elephants, including those with tusks, and leather products) may be imported into or exported from the United States without a threatened species permit, provided all permit requirements of 50 CFR parts 13 (general permitting regulations) and 23 (CITES regulations) have been met. This would not change with the proposed revisions to the 4(d) rule. We would, however, add a clarification that the requirements at 50 CFR part 14 (general import, export, and transport regulations) must also be met.

    As noted earlier, the import into the United States of live elephants, including those with tusks, is not regulated under the AfECA. In section 4202(2) (16 U.S.C. 4202(2)) of the statute, Congress found that it is the large illegal trade in ivory that is the major cause of decline of the species and threatens its existence. Although live elephants may have tusks, there is no information indicating that the limited import of live elephants for conservation or zoological exhibition purposes has ever negatively affected the species. Live African elephants are only occasionally imported into the United States (most live elephants held in captivity in the United States are Asian elephants). During the 5 years from 2009 to 2013, there were eight live African elephants imported into the United States (four in 2011 and four in 2013), all for zoological or educational purposes. Three of these animals were pre-Convention (removed from the wild prior to 1976); the other five were either captive born or captive bred. In addition, the AfECA's focus on regulating ivory primarily through moratoria on the import of raw and worked ivory (not elephants themselves) indicates Congress' intent to regulate ivory as a commodity, not ivory that is attached to a live elephant and therefore cannot be commercialized separate from the elephant itself. Likewise, the AfECA prohibitions all address the import or export of raw or worked “ivory,” not elephants. Finally, the definition of “raw ivory” also indicates that Congress intended the term not to apply to live elephants. The term raw ivory in section 4244(10) (16 U.S.C. 4244(10)) means any “tusk, and any piece thereof, the surface of which, polished or unpolished, is unaltered or minimally carved.” The references to pieces of tusks and the polishing or carving of tusks when read in the context of the definition and application of the term “raw ivory” in the statute indicate that the definition is speaking of tusks that are no longer attached to a live animal.

    When establishing regulations for threatened species under the ESA, the Service has generally adopted restrictions on the import and export of live as well as dead animals and their parts and products, either through a 4(d) rule or through the provisions of 50 CFR 17.31. In this case, import and export of both live and dead African elephants and all parts and products are already carefully regulated under CITES. Under CITES and the U.S. regulations that implement CITES at 50 CFR part 23, the United States regulates and monitors all commercial and noncommercial trade in African elephants and any parts and products that are imported into or exported from the country. All African elephant populations are protected under CITES, with most populations listed in Appendix I and only four populations (those in Botswana, Namibia, South Africa, and Zimbabwe) listed in Appendix II. Import into and export from the United States of African elephant specimens will continue to require CITES documentation.

    Under CITES, for nearly all live or dead elephants and elephant parts or products, including those from Appendix II populations, the exporting country must issue an export permit that is supported by findings that the specimen was legally acquired under national laws, that the export will not be detrimental to the survival of the species, and, for live animals, that the elephant will be shipped in a manner that minimizes the risk of injury, damage to health, or cruel treatment. The CITES export permit must be presented upon export and must also be presented to U.S. officials upon import into the United States. For nearly all Appendix-I African elephant specimens, a CITES import permit would also have to be issued by the Service after finding that the import will be for purposes that are not detrimental to the survival of the species, that the specimen will not be used for primarily commercial purposes, and, for a live animal, that the proposed recipient is suitably equipped to house and care for the elephant. Any later re-export of African elephant specimens would require additional CITES documents.

    Some limited exceptions to these permitting requirements exist. Consistent with an exception in the Convention, the Service provides an exemption from permitting requirements for personal and household effects, but only for dead specimens and not for most Appendix-I specimens. Personal and household effects must be personally owned for noncommercial purposes, and the quantity imported or exported must be necessary or appropriate for the nature of the trip or household use. The exemption is extremely limited for items containing African elephant ivory (see 50 CFR 23.15(f)). Not all CITES countries have adopted the personal and household effects exemption, so individuals who might cross an international border with an African elephant item and want to take advantage of this exemption would need to check with the Service and any country of transit in advance for documentation requirements. There is also an exemption for pre-Convention animals and parts or products, but a person who wants to transport an item under this exemption must obtain and present to government officials upon export and import a CITES pre-Convention certificate that verifies that the specimen was acquired before the Convention applied to it.

    In addition to the requirements under CITES, individuals who import or export wildlife and wildlife products into or from the United States must file wildlife declaration forms with the Service's Office of Law Enforcement and must use designated ports. Individuals who are in the business of importing and exporting wildlife and wildlife products must be licensed by the Service. These requirements allow us to monitor the species and quantity of wildlife that are imported into and exported from the United States and ensure that such trade is legal.

    The need to address the increase in illegal killing and illegal trade of African elephants is linked to the economic value of and international market in ivory. There is no information indicating that the conservation status and management needs of the species are linked to the occasional import of live elephants into the United States for captive propagation programs or public education and display, or to the market in hides and other non-ivory parts or products. The Service monitors U.S. imports and exports of elephant specimens through wildlife declaration forms, and all CITES Parties are required to submit annual reports on trade in CITES species and the number and types of CITES permits and certificates issued each year. This information verifies that import and export of live African elephants and parts or products other than ivory and sport-hunted trophies is small and does not affect the conservation of the species. There is no evidence of an illegal market in live elephants or parts and products other than ivory.

    In addition, as noted above, import and export of African elephant specimens would continue to be strictly regulated through the documentation procedures and required findings under CITES. Particularly relevant to the major threats facing African elephants, these CITES documents are not issued unless the importing or exporting countries find that the import or export would not be detrimental to the survival of the species, that the live animal or part or product was legally acquired, and that the specimen will not be used for primarily commercial purposes. Requiring individuals to obtain an ESA threatened species permit in addition to the required CITES documents prior to import or export of live animals and parts or products other than ivory and trophies would add no meaningful protection for the species and would be an unnecessary overlay of authorization on top of existing documentation that already ensures that the import or export is legal and not detrimental to the survival of the species. Therefore, because the import and export of live African elephants and parts or products other than ivory and sport-hunted trophies must comply with the strict provisions of CITES and other U.S. import/export requirements and because the import or export of such animals and parts or products poses no risk to the species, we find that authorization under the ESA to import or export African elephant specimens other than sport-hunted trophies or ivory remains neither necessary nor appropriate provided that all import and export requirements under CITES and other U.S. laws have been met.

    Import and Export of Sport-Hunted Trophies

    As noted earlier, the ESA does not prohibit U.S. hunters from traveling to other countries and taking threatened species, but authorization may be required under the ESA to import the sport-hunted trophy into the United States. We are proposing to limit the number of sport-hunted African elephant trophies that may be imported into the United States to two per hunter per year. This action is intended to address a small number of circumstances in which U.S. hunters have participated in legal elephant culling operations and imported, as sport-hunted trophies, a large number of elephant tusks from animals taken as part of the cull. We propose to disallow this activity, which has resulted, in some cases, in the import of commercial quantities of ivory as sport-hunted trophies. Based on our import records, we expect this proposed change to impact fewer than 10 hunters per year.

    This proposed change is consistent with the purposes of the ESA and CITES. Sport hunting is meant to be a personal, noncommercial activity. Engaging in hunting that results in acquiring quantities of ivory that exceed what would reasonably be expected for personal use and enjoyment is inconsistent with sport hunting as a noncommercial activity. Given the current conservation concerns with escalating illegal trade in ivory and the associated levels of illegal killing to supply that trade, it is consistent with the purposes of the ESA and other provisions in this proposed rule regulating commercialization of ivory to more closely regulate activities that have resulted in the import of large quantities of raw ivory into the United States.

    This provision is also consistent with Congress' intent under the AfECA. Congress included in the AfECA an exemption from the import moratorium for sport-hunted trophies legally taken in an elephant range country, but that was on the basis of finding that sport hunting does not directly or indirectly contribute to the illegal trade in African elephant ivory. The escalating illegal trade of ivory is currently driving unprecedented increases in the illegal killing of elephants. We therefore find it is necessary to use our authority under section 4(d) of the ESA to ensure that ivory imported into the United States as sport-hunted trophies is in fact the result of sport hunting and is not commercialized. Section 4241 of the AfECA (16 U.S.C. 4241) expressly states that the Service's authority under the AfECA is in addition to and does not affect the Service's legal authority under the ESA, which includes our legal authority under section 4(d). The AfECA therefore does not preclude us from using our authority under the ESA to limit the number of African elephant trophies imported by an individual hunter each year to appropriate levels. For certain species, the parties to CITES have set limits on the number of trophies that any one hunter may import in a calendar year, which currently for leopards is no more than two, for markhor is no more than one, and for black rhinoceros is no more than one. See 50 CFR 23.74(d). Taking into consideration these decisions by the parties to CITES, we similarly propose to set the limit at two African elephants per hunter per year.

    We are also proposing to require issuance of a threatened species permit under 50 CFR 17.32 for import of all African elephant sport-hunted trophies. The current 4(d) rule provides conditions under which sport-hunted African elephant trophies may be imported into the United States, one of which is that the Service has made a determination that the killing of the trophy animal would enhance the survival of the species.

    For elephant trophies taken from CITES Appendix-I populations, we issue a combined CITES/ESA import permit and the ESA finding is communicated through that permit. Under the current 4(d) rule, we do not issue an import permit for trophies from Appendix-II populations and the ESA finding is communicated through public notification, including in the Federal Register.

    For the import of sport-hunted trophies from Appendix-II populations, revision of the 4(d) rule would mean that the enhancement finding required under the current 4(d) rule would be communicated through the threatened species permitting process under 50 CFR 17.32. This change in procedure would not result in any significant burden to U.S. hunters and would not affect whether future hunters would be able to obtain trophy import permits. The standards for making enhancement findings for each African elephant range country under the current 4(d) rule are the same as the standards for making findings for import permits for sport-hunted trophies of other species classified as threatened, where such findings are required. The standards for making enhancement findings under the current 4(d) rule are also the same as the standards that would be used in the future for making enhancement findings for African elephant trophy imports through the threatened species permit process. Permits have always been required for the import of African elephant trophies from any Appendix-I country, so it is only trophies from the four Appendix-II countries that would now also require import authorization through a threatened species permit. Hunters would benefit from the consistency of having all African elephant import authorizations provided through the permitting process (we expect it would reduce confusion regarding the process for obtaining import authorization, depending on the country) and benefit from a process that would allow them to submit relevant information through the permit application. Hunters seeking authorization to import a trophy from an Appendix-II population would also now be able to take advantage of the process for requesting reconsideration and appeal of a permit denial under 50 CFR 13.29. The Service would benefit from having a consistent process for authorizing ESA importation of African elephant sport-hunted trophies, as well as having the ability to obtain current information from hunters that is relevant to making the enhancement findings.

    As provided in section 9(c)(2) (16 U.S.C. 1538(c)(2)) and our regulations at 50 CFR 17.8, the ESA provides a limited exemption for the import of some threatened species, which is frequently used by hunters to import sport-hunted trophies. Importation of threatened species that are also listed under CITES Appendix II are presumed not to be in violation of the ESA if the importation is not made in the course of a commercial activity, all CITES requirements have been met, and all general wildlife import requirements under 50 CFR part 14 have been met. This presumption can be rebutted, however, when information shows that the species' conservation and survival would benefit from the granting of ESA authorization prior to import. The Service determined that this was the case in 1997 and 2000, when the four populations of African elephants were transferred from CITES Appendix I to CITES Appendix II and we retained the requirement for ESA enhancement findings prior to the import of sport-hunted trophies. We amended the African elephant 4(d) rule in June of 2014, again maintaining the requirement for an ESA enhancement finding prior to allowing the import of African elephant sport-hunted trophies.

    Our proposal to require issuance of threatened species enhancement permits under 50 CFR 17.32 for the import of any African elephant hunting trophy would change the procedure for issuing ESA authorization but not change the requirement that an enhancement finding be made prior to import into the United States. As described in the Need for Regulatory Actions section, the overall conservation status of African elephants has deteriorated in the years following the transfer of the four populations of African elephants to CITES Appendix II. Extensive and well-documented information indicates that the escalating rate of illegal killing of African elephants is driven by the illegal markets for elephant ivory. This information affirms the need to continue making enhancement findings prior to allowing the import of sport-hunted trophies that consist entirely or in part of the ivory tusks from the elephant. Authorizing importation of all sport-hunted trophies through threatened species enhancement permits would allow us to more carefully evaluate trophy imports in accordance with legal standards and the conservation needs of the species. For example, the issuance of threatened species enhancement permits under 50 CFR 17.32 would mean that the standards under 50 CFR part 13 would also be in effect, such as the requirement that an applicant submit complete and accurate information during the application process and the ability of the Service to deny permits in situations where the applicant has been assessed a civil or criminal penalty under certain circumstances, failed to disclose material information, or made false statements. Therefore, we have determined that the additional safeguard of requiring the issuance of threatened species enhancement permits under 50 CFR 17.32 prior to the import of sport-hunted trophies is warranted.

    In addition, the 4(d) rule would incorporate certain restrictions under the AfECA on the import and export of sport-hunted trophies. We do not have separate AfECA regulations and consider that including restrictions in the 4(d) rule that have their source in the AfECA would provide hunters and other members of the public easy access to information on all requirements that apply to activities with African elephant sport-hunted trophies. All of these provisions are also appropriate conservation measures for the species under the ESA that ensure that hunting of African elephants by U.S. citizens is sustainable and legal under the laws of the range country and that any ivory associated with the trophy does not contribute to the illegal killing of elephants. Adopting these AfECA provisions as appropriate conservation measures for the species under section 4(d) of the ESA would also make a violation of relevant provisions of the AfECA a violation of the ESA, thus increasing protections for African elephants when a person violates the AfECA.

    The AfECA provides for the import of sport-hunted African elephant trophies but only if the trophy was legally taken in an African elephant range country that has declared an ivory export quota to the CITES Secretariat. These requirements have been incorporated into the proposed 4(d) rule. Also, the AfECA provides an exemption from any moratorium for the import of African elephant sport-hunted trophies, but the exemption applies to import only, not export. The export of all raw ivory is prohibited under section 4223(2) of the AfECA (16 U.S.C. 4223(2)). We propose to incorporate into the 4(d) rule the AfECA prohibition on the export of raw ivory. Export of raw ivory would not be allowed even under an ESA threatened species permit because the AfECA prohibition would still stand; similarly, export of raw ivory that qualified as an antique under the ESA, while not regulated under the proposed 4(d) rule, would still be prohibited under the AfECA. We have also proposed minor revisions to the 4(d) rule to clarify that general wildlife import requirements under 50 CFR part 14 also apply to the import of sport-hunted trophies and to more closely align import requirements with the recommendations in CITES Resolution Conf. 10.10 (Rev. CoP16), Trade in elephant specimens.

    The revised 4(d) rule would also allow the noncommercial export of worked ivory that was imported as part of a sport-hunted trophy provided it meets one of the exceptions we have proposed for scientific or law enforcement purposes or as part of a musical instrument, traveling exhibition, or household move or inheritance. Worked ivory that had been imported as a sport-hunted trophy could also be exported if it qualifies as an ESA antique.

    Import and Export of Ivory, Other Than Sport-Hunted Trophies

    Under the current 4(d) rule, import of raw or worked ivory other than sport-hunted trophies is allowed only if it is a bona fide antique greater than 100 years old or it is being imported following export from the United States after being registered with the Service. Under the terms of the 1989 AfECA moratorium, the import of raw and worked African elephant ivory, other than ivory from legally taken sport-hunted trophies, is prohibited from both African elephant range countries and intermediary countries (i.e., countries that export ivory that did not originate in the country).

    Under the proposed revisions to the 4(d) rule, import of ivory other than sport-hunted trophies would be prohibited, with limited, narrow exceptions including: the import of raw ivory by a government agency for law enforcement purposes or for a genuine scientific purpose that will contribute to the conservation of the African elephant; and the import of worked ivory under these same exceptions for law enforcement or scientific purposes that will contribute to the conservation of the species, or as part of a musical instrument, an item in a traveling exhibition, or as part of a household move or inheritance. The export of raw ivory would be prohibited under the proposed revisions to the 4(d) rule and the export of worked ivory would be limited to those items that qualify for the exceptions described above. Section 4(d) of the ESA does not apply to items that qualify as antiques and therefore these proposed prohibitions on import and export of ivory do not apply to ESA antiques. However, as noted previously, the prohibitions on import and export of ivory under the AfECA would still apply, regardless of the age of the item. The proposed revisions are consistent with the 1989 AfECA moratorium, and are generally consistent with the Service's Director's Order No. 210, as amended on May 15, 2014. We have determined that these provisions are appropriate under the ESA for the conservation of the African elephant.

    Restrictions on import and export are appropriate under both the AfECA and the ESA because strict regulation of the import and export of ivory are necessary to prevent U.S. citizens and others subject to the jurisdiction of the United States from engaging in activities that could contribute to the illegal killing of elephants. Nonetheless, situations where not allowing the activity could actually be detrimental to the conservation of the species, or limited circumstances where careful controls would be in place to make it likely that the activity will not contribute to illegal trade in ivory or the killing of elephants for their ivory, can be allowed. Adopting the AfECA provisions as appropriate conservation measures for the species under section 4(d) of the ESA would make a violation of the AfECA a violation of the ESA, thus increasing protections for African elephants when a person violates the AfECA. Finally, because there are no AfECA regulations in the Code of Federal Regulations, the public would benefit from having all legal requirements relating to the import and export of African elephant ivory located in one place through the 4(d) rule.

    On June 9, 1989, the Service established the current moratorium on the importation of both raw and worked ivory (other than that from sport-hunted trophies) after finding that most ivory was traded outside of the CITES Ivory Trade Control System that existed at that time and that illegal and excessive taking of elephants was taking place at unsustainable levels (54 FR 24758). African elephant range countries were unable to effectively control taking of elephants and intermediary countries could not ensure that all ivory in trade originated from legal sources. Specifically, the Service found that most ivory range countries had such low elephant populations that the countries had determined that no sustainable harvest was possible and had requested no ivory export quota for that year; that there was likely no sustainable harvest of elephants throughout most of Africa, even for those countries that had export quotas, due to declining populations; and that most African elephant range countries had significant poaching problems. For intermediary countries, the Service determined that all major intermediary countries that were parties to CITES at that time had engaged in import of raw ivory from other intermediary countries (alone a criterion for establishment of a moratorium under the AfECA) and that due to the virtual impossibility of distinguishing legal from illegal ivory, it was no longer possible for any intermediary country to ensure that it was not importing ivory from a range country in violation of the laws of that country.

    In recent years, many of the conditions that supported imposing the moratorium have continued or even worsened. In particular, recent information shows that for elephant range countries, the taking of elephants is not effectively controlled and the amounts of raw ivory that are being illegally exported from these countries are undermining the conservation of elephants. For intermediary countries, recent information on the scope and extent of illegal ivory trade shows that these countries are importing (through illegal trade) raw or worked ivory that originates in range countries in violation of the laws of the range countries. However, some actions in the United States, in other countries, and through CITES, have been taken to strengthen controls on poaching and illegal trade. In January 1990, all populations of African elephants were transferred from CITES Appendix II to Appendix I, which generally ended legal commercial trade in African elephant ivory. In 1997, based on proposals submitted by Botswana, Namibia, and Zimbabwe and the report of a Panel of Experts, the CITES Parties agreed to transfer the African elephant populations in these three countries to CITES Appendix II. The Appendix-II listing included an annotation that allowed noncommercial export of hunting trophies, export of live animals to appropriate and acceptable destinations, export of hides from Zimbabwe, and noncommercial export of leather goods and some ivory carvings from Zimbabwe. It also allowed for a one-time export of raw ivory to Japan (which took place in 1999), once certain conditions had been met. All other African elephant specimens from these three countries were deemed to be specimens of a species listed in Appendix I and regulated accordingly.

    The population of South Africa was transferred from CITES Appendix I to Appendix II in 2000, with an annotation that allowed trade in hunting trophies for noncommercial purposes, trade in live animals for reintroduction purposes, and trade in hides and leather goods. Since then, the CITES Parties have revised the Appendix-II listing annotation three times. The current annotation, in place since 2007, covers the Appendix-II populations of Botswana, Namibia, South Africa, and Zimbabwe and allows export of: Sport-hunted trophies for noncommercial purposes; live animals to appropriate and acceptable destinations; hides; hair; certain ivory carvings from Namibia and Zimbabwe for noncommercial purposes; and a one-time export of specific quantities of raw ivory, once certain conditions had been met (this export, to China and Japan, took place in 2009). As in previous versions of the annotation, all other African elephant specimens from these four populations are deemed to be specimens of species included in Appendix I and the trade in them is regulated accordingly.

    Most recently, the Service determined in April 2014 that import of sport-hunted trophies from Tanzania and Zimbabwe could not be allowed until new information is received, because the killing of African elephants for trophies does not meet the enhancement standard under the current 4(d) rule. The Service understands that Botswana has closed its sport-hunting program on government land for 2014 (although hunting on private concessions continues) and is not currently allowing exports. South Africa and Namibia continue to have well-managed elephant conservation programs; the Service's findings remain in place that the killing of trophy animals from these countries for import into the United States enhances the survival of the species.

    All of this information, along with the recent levels of illegal killing and illegal trade as described in the section Need for Regulatory Actions, indicates that the circumstances facing African elephants and involving ivory in both range countries and intermediary countries support adoption of these restrictions for the species under the ESA. The threats facing the species call for all appropriate actions to restrict the import of African elephant ivory where that import is likely to contribute to commercializing elephant ivory. We believe that it is appropriate to allow certain limited exceptions to these import restrictions under the 4(d) rule, however, where import either would be beneficial to law enforcement or the conservation of the species, or where import of certain worked ivory meets strict criteria and is regulated in such a manner that it does not contribute to the illegal trade in ivory and poses no risk to elephant populations.

    We propose to allow the import of raw or worked ivory into the United States or the export of worked ivory from the United States when it would be directly beneficial for law enforcement efforts. Under this exception, raw or worked ivory could be imported into the United States and worked ivory could be exported from the United States only by an employee or agent of a Federal, State, or tribal government agency for law enforcement purposes. Specimens from protected species are frequently used as evidence to prosecute violations of law in the United States, and this may require the import of ivory from other countries. Likewise, there may be situations where worked ivory would need to be exported from the United States by a Federal, State, or tribal agency to assist with a law enforcement action in another country. Not having this exception would hinder the Service's ability to enforce Federal laws such as the AfECA, the ESA, and the Lacey Act that protect African elephants and other wildlife. It could also hinder other Federal agencies, States, and tribes from effective enforcement of their laws. Not including this exception would be contrary to the AfECA's policy to assist in the conservation and protection of the African elephant by supporting the conservation programs of African countries and the CITES Secretariat, which represents the interests of all parties to CITES including the United States. The limitation that ivory could only be imported or exported by an employee or agent of a Federal, State, or tribal government would ensure that the exception is invoked only in appropriate circumstances. Any ivory imported or exported under this exception would be strictly for noncommercial law enforcement purposes, and therefore could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception. The limited applicability of this exception to noncommercial import or export by government officials for law enforcement purposes indicates that no ESA threatened species permit should be required. Such a permit would provide no protection for the species and would inhibit law enforcement officials' ability to respond quickly to enforcement needs involving the import or export of African elephant ivory.

    We also propose to allow the import or export of ivory when it would contribute to the conservation of African elephants. Under this exception, either raw or worked African elephant ivory could be imported into the United States and worked ivory could be exported from the United States for genuine scientific purposes that would benefit elephant conservation. For example, researchers in the United States have developed techniques to determine the origin of ivory, and the import of ivory samples is essential to this work. In such instances, prohibition of import would hinder science that could assist in protecting the species from poaching or illegal trade in ivory, or could result in valuable information that addresses other threats to the species. Similarly, the export of worked African elephant ivory could assist both U.S. scientists that are located outside the United States and scientists from other countries in their work to conserve the species. We believe that allowing under the 4(d) rule import and export of ivory in these circumstances is necessary and appropriate for the conservation of the African elephant; it is also consistent with the AfECA's purpose to “perpetuate healthy populations of African elephants.” Any ivory imported or exported under this exception would be strictly for genuine scientific purposes, and could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception. The requirement to obtain a threatened species permit under 50 CFR 17.32 prior to import or export would ensure that the activity meets the standard of being for a genuine scientific purpose and that the science will actually contribute to the conservation of African elephants.

    We are also proposing to allow the noncommercial import or export of carefully regulated items containing worked elephant ivory that are appropriate exceptions to the import moratorium and appropriate provisions under the 4(d) rule. None of these exceptions allows the import or export of raw ivory. The exceptions are for qualifying musical instruments, items in certain travelling exhibitions, and qualifying items that are part of an inheritance or household move.

    Under all three of these exceptions, the importer or exporter would need to show that the African elephant ivory in the item was legally acquired and removed from the wild prior to February 26, 1976 (the date the African elephant was first listed under CITES). This does not necessarily mean that the current owner of an item containing ivory, a musical instrument, for example, acquired the instrument or the ivory in the instrument prior to February 1976. It means that there is sufficient information to show that the ivory was harvested (taken from the wild) prior to February 26, 1976, even though the instrument may not have been manufactured until after that date. It also means that there is sufficient information to show that the ivory was harvested in compliance with all applicable laws of the range country and that any subsequent import and export of the ivory and the instrument containing the ivory was legal under CITES and other applicable laws (understanding that the instrument may have changed hands many times before being acquired by the current owner).

    These requirements would ensure that any item imported or exported under one of these three exceptions originated from elephants that were legally taken prior to the date that African elephants were first protected under CITES, the ESA, and the AfECA and therefore before contemporary laws and programs were developed to address current threats to the species. The ivory would have originated from elephants taken prior to development of the conservation programs of African countries and the CITES Secretariat referenced in section 4203 of the AfECA that the AfECA was enacted to support. This would also mean that any ivory imported or exported under the exceptions originated before U.S. citizens and other individuals subject to the jurisdiction of the United States were first regulated under these laws. The showing that the ivory was legally acquired would ensure that the ivory contained in the item was not previously part of the global market in illegal ivory. Thus these requirements would minimize the chances that the worked ivory in items imported or exported under these three exceptions contributed to the killing of elephants that the AfECA and listing under the ESA and CITES were designed to address or that the owner or others who may have owned the ivory played a role in the taking of the elephant in contravention of U.S. laws to protect the species.

    Under all three of these exceptions, the importer or exporter would have to obtain the appropriate CITES document showing that the import or export is in full compliance with CITES requirements. The requirement to obtain appropriate CITES documents would ensure that each item imported or exported under one of these three exceptions qualifies under CITES' strict standards and that all such import and export will be monitored and reported to the CITES Secretariat in each Party's annual report. Any musical instrument or item in a traveling exhibition would also have to be securely marked or uniquely identified so that authorities at U.S. and foreign ports can verify that the item presented for import or export is actually the specimen for which the CITES document was issued. While items imported or exported under a CITES pre-Convention certificate (as part of a household move or inheritance) do not specifically need to be marked or identified, port authorities would verify that the description and quantity of any items presented for import or export match what is described in the CITES document. All of this would ensure that each import or export of items under these exceptions is verified and monitored, which ensures that all such import and export remains legal.

    A CITES musical instrument certificate or equivalent CITES document would be issued for the import and export of personally owned instruments containing African elephant ivory to facilitate the frequent, noncommercial, cross-border movement of instruments that are being used for noncommercial purposes. Noncommercial purposes could include personal use, performance, display, or competition where the musician is financially compensated for his or her participation, but does not include financial gain through activities such as sale or lease of the instrument itself. Under the terms for obtaining a CITES musical instrument certificate (contained in CITES Resolution Conf. 16.8, Frequent cross-border non-commercial movements of musical instruments), the individual seeking a certificate would need to demonstrate that the CITES specimens contained in the instrument, in this case African elephant ivory, were acquired (removed from the wild) prior to February 26, 1976 (the date that African elephants were first listed under CITES). In addition, the country issuing the certificate would need to find that the elephant ivory used to manufacture the instrument was legally acquired under CITES. The issuing country would also include as a condition on the certificate a statement that the ivory covered by the certificate is for noncommercial use only and may not be sold, traded, or otherwise disposed of outside the certificate holder's country of usual residence. This restriction would also be included as a prohibition in the 4(d) rule, although musical instruments containing ivory that are owned by individuals whose residence is the United States could be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity once the instrument was returned to the United States if the instrument qualified under the de minimis exception. Musical instrument certificates are used like passports. Upon each export and import, the original certificate is presented to the appropriate border control officer, who inspects the certificate, verifies that the certificate corresponds to the instrument presented for import, and validates the certificate to document the history of each cross-border movement. All of these requirements would limit use of the exception to personally owned musical instruments containing legally acquired, pre-Convention ivory, and ensure that any instrument entering the United States would be used for noncommercial purposes only, and that an instrument would not be commercialized while traveling under the authorization of the CITES certificate. These requirements provide adequate assurances that any import or export of such instruments would not contribute to either the illegal trade in elephant ivory or the illegal killing of elephants.

    A CITES traveling exhibition certificate would be issued for the import and export of items consisting of or containing African elephant ivory to facilitate the frequent cross-border movement of items that are part of an orchestra, museum, or similar exhibition registered in the country in which the traveling exhibition is based. Under the terms for obtaining the CITES certificate (contained in CITES Resolution 12.3 (Rev. CoP16), Permits and certificates and in our regulations at 50 CFR 23.49), the ivory in the traveling exhibition must be pre-Convention ivory (i.e., it was acquired prior to February 26, 1976, the date that African elephants were first listed under CITES). Similar to the musical instrument certificate, the country issuing the certificate would need to find that any item containing elephant ivory was legally acquired under CITES and would be returned to the country in which the exhibition is based. The country issuing the certificate would also include the condition that the ivory covered by the certificate may not be sold or otherwise transferred in any country other than the country in which the exhibition is based and registered. This restriction would also be included as a prohibition in the 4(d) rule, although exhibition items containing ivory that are owned by persons who are based in the United States could be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity if the item qualified under the de minimis exception and the exhibition was back in the United States. Like musical instrument certificates, traveling exhibition certificates are used like passports. Upon each import or export, the original certificate is presented to the appropriate border control officer, who inspects the certificate, verifies that the certificate corresponds to the item presented for import, and validates the certificate to document the history of each cross-border movement. Similar to the strict regulation of musical instruments, these requirements would limit use of the exception to items consisting of or containing African elephant ivory legally acquired prior to February 26, 1976, and ensure that the item would not be commercialized while outside the country in which the exhibition is based while traveling under the authorization of the CITES certificate. These requirements provide adequate assurances that any import or export of these items would not contribute to either the illegal trade in elephant ivory or the illegal killing of elephants.

    Items imported or exported as part of an inheritance or a household move under the final exception would need to be for personal use only and accompanied by a valid CITES pre-Convention certificate. To qualify for a pre-Convention certificate, the importer or exporter of an item containing African elephant ivory would need to present sufficient information to show that the ivory was removed from the wild prior to February 26, 1976. There must also be sufficient information to show that the ivory was harvested in compliance with all applicable laws of the range country and that any subsequent import and export of the ivory and the instrument containing the ivory was legal under CITES and other applicable laws. For any item imported or exported as an inheritance, the importer or exporter would also need to show that the item was received through an inheritance. For any item imported or exported as part of a household move, the importer or exporter would need to show that they own the item, that it was legally acquired, and that they are moving it for personal use. Any such items would need to be imported or exported within 1 year of changing residence from one country to another and the shipment would need to contain only ivory items purchased, inherited, or otherwise acquired prior to the change in residence. Finally, the type and quantity of ivory items imported or exported under this exception would need to be appropriate for a household move. Because any ivory imported or exported under this exception would be solely for personal use, any such ivory could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception.

    All of these requirements would help to ensure that any imports or exports under these proposed exceptions did not contribute to past poaching and smuggling, did not contribute to the recent increase in illegal killing of elephants and illegal trade of ivory, and would be in compliance with AfECA requirements. In addition, the requirements that items under most of the exceptions must be imported or exported for personal or noncommercial use only, the limits on sale or other disposal of musical instruments and exhibition items while the item is traveling under the CITES certificate, the requirement that inherited items must be documented as acquired through an inheritance and not purchase, the requirement that household move items are limited to the number and type that would reasonably be expected for a person's move of their household, the requirement that household move items must be imported or exported within 1 year of a documented change of residence, and the prohibition on commercialization of inherited or household move items even if they qualify under the de minimis exception would minimize the chances of these exceptions being used as a means to commercialize ivory.

    Because of the strict requirements that must be met to be eligible for import or export of any item under these three exceptions, we are proposing that no additional threatened species permit would be required under 50 CFR 17.32. The requirements to obtain the relevant CITES document, the findings that must be made before the CITES document can be issued, and the requirement to present the item along with all required CITES and general wildlife import/export documents to Federal officials upon import or export would ensure that each import or export is legal and adequately monitored. Presentation of the items and documents upon import or export would also provide Federal officials the opportunity to make sure that all other requirements have been met. Requiring individuals to obtain an ESA threatened species permit in addition to the required CITES documents prior to import or export of items under these limited exceptions would be an unnecessary overlay of documents on top of existing CITES documentation that ensures that such import or export is not contributing to the illegal killing of elephants.

    All of these exceptions are identical or similar to the exceptions to the AfECA import moratorium that were provided as a matter of law enforcement discretion through Director's Order No. 210, as amended on May 15, 2014. The only substantive change is that the Director's Order contained an additional standard that any musical instrument, item in a traveling exhibition, item in a household move, or inherited item containing ivory could not be imported if it had been transferred from one person to another person for financial gain or profit since February 25, 2014 (the date of the original Director's Order). We have determined that this restriction is not needed because with this proposed rule it would be a violation of the ESA for any person to sell or offer for sale ivory or sport-hunted trophies in interstate or foreign commerce or to deliver, receive, carry, transport, or ship ivory or sport-hunted trophies in interstate or foreign commerce in the course of a commercial activity except for certain manufactured items that would qualify under the de minimis exception. Therefore any U.S. citizen or other person subject to the jurisdiction of the United States who commercialized an item containing ivory or a sport-hunted trophy in violation of these prohibitions would be in violation of this rule regardless of whether this additional restriction were in place.

    Under the current 4(d) rule, worked ivory may be exported in accordance with the requirements in 50 CFR parts 13 and 23, and raw ivory may not be exported from the United States for commercial purposes under any circumstances. Under the AfECA, the export of all raw ivory is prohibited. We propose to revise the 4(d) rule to prohibit export of raw ivory, consistent with the AfECA prohibition, with the exception of antiques. For the same reasons discussed above, we also propose to prohibit export of worked ivory, other than antiques, except in the same limited circumstances and for the same limited purposes allowed for import: By a government agency for law enforcement purposes, for a genuine scientific purpose that will contribute to the conservation of the African elephant, as part of a qualifying musical instrument, as a qualifying item in a traveling exhibition, or as a qualifying item that is part of a household move or inheritance.

    In developing this proposed rule, we have given very careful consideration to the types of circumstances and purposes for which we could allow exceptions to the prohibitions on import and export of African elephant ivory. However, we seek information and comment regarding the need for and advisability of finalizing a rule that includes a broader exception to those prohibitions for the noncommercial import or export of worked ivory in circumstances that are not covered by the exceptions for musical instrument, traveling exhibitions, household moves or inheritances, or genuine scientific purposes. In particular, we seek information from individuals who may wish to engage in noncommercial import or export of worked African elephant ivory that would be prohibited by this proposed rule. We are also interested in the potential impacts of these prohibitions on segments of the trade not covered by these exceptions.

    Information regarding the illegal killing of elephants and the alarming growth in illegal trade in elephant ivory shows that all appropriate actions are needed to restrict the export of raw and worked African elephant ivory where that export is likely to contribute to commercializing elephant ivory. It is appropriate, however, to allow certain limited exceptions to the export prohibition where export either would be beneficial to law enforcement or the conservation of the species, or where export of certain articles of worked ivory meet strict criteria and are regulated in such a manner that their export would not contribute to the illegal trade in ivory and pose no risk to elephant populations. Export of worked African elephant ivory would also be available by threatened species permit under 50 CFR 17.32, provided the person met all of the requirements of that section as well as the general permitting requirements under 50 CFR part 13.

    As noted previously, Section 4(d) of the ESA does not apply to items that qualify as antiques. While the prohibitions on import and export of ivory proposed here thus do not apply to ESA antiques, the prohibitions on import and export of ivory under AfECA would still apply, regardless of the age of the item. In addition, certain worked ivory items that qualify under the ESA section 9(b)(1) “pre-Act” exemption (see below) could also be exported (see below). No ESA permit would be required for any worked ivory that qualified under any of these provisions, but it would still need to be accompanied by any required CITES document and meet all requirements under the Service's general wildlife import/export regulations.

    Qualifying Pre-Act Specimens

    The ESA provides an exemption in section 9(b)(1) from any prohibitions contained in a 4(d) rule for specimens of threatened species “held in captivity or in a controlled environment” on the date the ESA entered into effect (December 28, 1973) or the date the final rule listing the species under the ESA was published in the Federal Register (which for the African elephant was May 12, 1978), whichever is later. The exemption applies only if “such holding and any subsequent holding or use of the fish or wildlife was not in the course of a commercial activity.” As noted above in Interstate and foreign commerce, activities with threatened species do not qualify as “commercial activity” unless the activity involves the transfer of the specimen from one person to another person in the pursuit of gain or profit. Therefore, the exemption would apply unless commercial activity with an African elephant specimen (including ivory) on or after May 12, 1978, involved the transfer of the specimen from one person to another person in pursuit of gain or profit. (See the discussion on activities that occur “in the course of a commercial activity” under Interstate and foreign commerce, above.)

    Persons wishing to engage in activities that otherwise would be prohibited under this 4(d) rule would have the burden of showing that their activities qualify for this “pre-Act” exemption. The statutory exemption would not change with revision of the 4(d) rule, but it is also important to remember that nothing in the ESA provides that an exemption under that law modifies or supersedes provisions in other applicable statutes such as the AfECA. (See Antique specimens, below, for a full discussion on the relationship between ESA exemptions and AfECA restrictions.) Therefore, activities prohibited under the AfECA remain prohibited, even if the ESA “pre-Act” exemption applies.

    The pre-Act exemption would apply to the following examples if the activity met all requirements of the ESA: The prohibition against take for qualifying live elephants that were held in captivity on May 12, 1978; the prohibition on the export of worked ivory that was held in a controlled environment on May 12, 1978; and the requirement to get a threatened species permit for the export of worked ivory to be used for genuine scientific purposes for ivory that was held in a controlled environment on May 12, 1978, provided that in each case the holding and any subsequent holding or use of the live animal or specimen since 1978 did not include transfer from one person to another person in the pursuit of gain or profit.

    In addition, if the holding as of May 12, 1978, or any subsequent holding or use included a transfer from one person to another person in the pursuit of gain or profit, the exemption would still be available if the activities qualified as exhibition of commodities by a museum or similar cultural or historical organization. All import and export requirements under CITES and the general wildlife import/export regulations at 50 CFR part 14 would still need to be met. Section 9(b)(1) of the ESA provides an exemption from ESA threatened-species prohibitions only, not from requirements that arise under CITES and the general import/export requirements under the ESA.

    Antique Specimens

    Section 10(h) of the ESA provides an exemption for antique articles that are: (a) Not less than 100 years of age; (b) composed in whole or in part of any endangered species or threatened species; (c) have not been repaired or modified with any part of any such species on or after the date of the enactment of the ESA; and (d) are entered at a port designated for ESA antiques. Any person who is conducting activities with a qualifying ESA antique is exempt from, among other things, any restrictions provided in a 4(d) rule for that species, including restrictions on import; export; sale or offer for sale in interstate or foreign commerce; and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce and in the course of a commercial activity. The taking prohibition would not apply to dead specimens such as antiques. Anyone wishing to engage in activities under this antiques exception must be able to demonstrate that the item meets the requirements of the ESA.

    Items that qualify as antiques under the ESA are not subject to the prohibitions in the proposed 4(d) rule. The ESA antiques exemption does not apply, however, to prohibitions imposed under the AfECA on the import of raw and worked African elephant ivory into the United States and the export of raw ivory from the United States. As with the ESA section 9(b)(1) “pre-Act” exemption, nothing in the ESA provides that an exemption under that law modifies or supersedes provisions in other applicable statutes such as the AfECA. The provisions in the AfECA regarding the import and certain export of African elephant ivory were specifically enacted to address conservation concerns with African elephants and were enacted later in time than the earlier, more general ESA exemption applicable to all endangered and threatened species, so the later, more specific restrictions on import and export in the AfECA take precedence over the earlier, more general exemption in the ESA. As noted previously, section 4241 of the AfECA (16 U.S.C. 4241) specifies that the authority of the Service under the AfECA is in addition to and does not affect the authority of the Service under the ESA.

    A qualifying ESA antique containing African elephant ivory could thus only be imported if it also qualified for one of the exceptions from enforcement of the AfECA moratorium created by Director's Order No. 210: antique raw or worked ivory for law enforcement purposes, antique raw or worked ivory for scientific purposes, antique worked ivory that is part of a musical instrument, antique worked ivory in a traveling exhibition, antique worked ivory that is part of a household move, or antique worked ivory that was inherited. As noted previously, we believe these exceptions are consistent with Congressional intent in enacting the AfECA, which focused on the harm caused by poaching to supply the illegal trade in ivory. An antique sport-hunted trophy could not qualify for import because it would not be able to meet the requirements under the AfECA that it was taken from an elephant range country with an elephant quota declared to the CITES Secretariat (which did not exist 100 years ago). Because the prohibition on the export of all raw ivory is under the AfECA, the ESA antique exemption also could not be used to export antique raw ivory.

    For qualifying ESA antiques containing African elephant ivory that could be imported as described above and antiques containing African elephant ivory that meet all of the requirements under section 10(h) of the ESA and were imported before the AfECA import moratorium was put in place in 1989, whether those antiques could be commercialized in interstate or foreign commerce would depend on whether restrictions are based on the ESA or CITES. Any restrictions that are based on CITES or laws other than the ESA would remain in place.

    As discussed earlier, one of the requirements to qualify for the ESA antiques exemption is that the antique must have been imported into the United States through a port designated for the import of ESA antiques. These ports were first designated on September 22, 1982. Therefore, under the terms of the ESA, no item that contains parts of any endangered or threatened species (including African elephant ivory) can qualify under the ESA antiques exemption unless it was imported into the United States through one of the designated ESA antiques ports on some date after September 22, 1982.

    On February 25, 2014 (as amended on May 15, 2014), the Service issued Director's Order No. 210, which, among other things, provides direction to Service employees on implementation and enforcement of the ESA antiques exemption. Appendix A to Director's Order No. 210 reiterates the four statutory requirements for an item to qualify as an ESA antique and states that, as a matter of law enforcement discretion, the prohibitions under the ESA would not be enforced for antiques that meet the requirements of being at least 100 years old; being composed of an endangered or threatened species; and not having been repaired or modified with any part of an endangered or threatened species since December 28, 1973, but were imported prior to September 22, 1982, or were created in the United States and never imported and therefore do not meet the requirement of having been imported at a designated ESA antiques port. This Director's Order remains in place. The Service will apply its law enforcement discretion regarding otherwise qualifying antiques that were imported prior to September 22, 1982, or were produced in the United States and never imported, allowing them to be exported, sold or offered for sale in interstate or foreign commerce, and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, provided all other legal requirements are met. Appendix A of the Director's Order also contains guidance on documentation needed and other information for conducting activities with ESA antiques. Director's Order No. 210, as amended on May 15, 2014, including Appendix A can be found at http://www.fws.gov/policy/do210.html.

    As described in Director's Order No. 210, the person claiming the benefit of the ESA antiques exemption must provide evidence to demonstrate that the item qualifies as an ESA antique. This evidence may include a qualified appraisal, documents that provide detailed provenance, and/or scientific testing. Since issuance of the Director's Order, we have heard from some people who are concerned about what the Service might require in terms of documentation or authentication of their antique items. We want to be clear that establishing provenance does not necessarily require destructive testing; there may be other ways to establish provenance, such as a qualified appraisal or another method that documents the age by establishing the origin of the item. We have listed scientific testing (in the Appendix to Director's Order No. 210) as an option for people who may want to make use of it in certain circumstance for certain items. However, this is only one option, in a suite of possible options. The provenance may be determined through a detailed history of the item, including but not limited to family photos, ethnographic fieldwork, or other information that authenticates the item and assigns the work to a known period of time or, where possible, to a known artist. Scientific testing could be necessary if there is no other way to establish the provenance of an item.

    In addition, we want to be clear that we do not require scientific testing of the ivory components in a manufactured antique item. Where a person can demonstrate that an item, for example a table with ivory inlays, is older than 100 years, and that the table has not been repaired or modified with ivory (or any other threatened or endangered species) since December 28, 1973, the Service considers the age criteria in Section 10(h) to be met. We would not require testing of the ivory itself to determine its age. Of course, to qualify for the ESA antiques exemption a person must demonstrate that all four of the criteria in Section 10(h) of the ESA have been met.

    We also want to clarify that these documentation requirements are not new. The ESA itself places the burden of proof on the person claiming the benefit of the exemption (Sec. 10(g)) and the Service has required documentation for antique items since the 1970s. This documentation requirement is also not unique to African elephant ivory; it applies to specimens of any species listed under the ESA when a person is claiming the benefit of this exemption from prohibitions. Over the years, the Service has provided information regarding acceptable documentation for establishing age and provenance; most recently, in the Appendix to Director's Order No. 210. Our CITES regulations at 50 CFR 23.34 also provide information on the kinds of records a person can use to show the origin of a specimen. We seek comment from the public on whether additional guidance is needed in the regulatory code regarding implementation of the ESA antiques exemption.

    Determination

    Section 4(d) of the ESA states that the “Secretary shall issue such regulations as [s]he deems necessary and advisable to provide for the conservation” of species listed as threatened. Additionally, section 4(d) of the ESA provides that the Secretary “may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1).” Thus regulations promulgated under section 4(d) of the ESA provide the Secretary, as delegated to the Service, discretion to select appropriate provisions for threatened species, including prohibitions, exceptions, and required authorizations. Some of the ESA prohibitions and exceptions from section 9(a)(1) of the ESA and from 50 CFR 17.31 and 17.32 may be appropriate for the species and be incorporated into a 4(d) rule. However, the 4(d) rule may also include other provisions that take into account other applicable laws and are tailored to the specific conservation needs of the listed species, and therefore may be more or less restrictive than the general provisions for threatened species. As noted by Congress when the ESA was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to [her] with regard to the permitted activities for those species. [She] may, for example, permit taking, but not importation of such species, or [she] may choose to forbid both taking and importation but allow the transportation of such species,” as long as the measures will “serve to conserve, protect, or restore the species concerned in accordance with the purposes of the [ESA]” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

    This proposed rule includes appropriate provisions that are necessary and advisable to provide for the conservation of the African elephant, while also including appropriate prohibitions from Section 9(a)(1) of the ESA. The primary threat to the African elephant is poaching of elephants for their tusks and the associated illegal trade in both raw and worked ivory. To restrict this illegal trade, the proposed provisions under this rule prohibit the import of African elephant ivory, with certain narrow exceptions, restrict the import of sport-hunted trophies, and prohibit the export of raw ivory. The rule provides two exceptions from the prohibition on import of ivory that would directly benefit law enforcement efforts that involve African elephants and science that would contribute to the conservation of the species. The rule provides three additional exceptions, which apply to the noncommercial import or export of worked ivory only, for qualifying musical instruments, items in a traveling exhibition, inherited items, and items that are part of a household move. Any worked ivory imported or exported under these exceptions would need to meet strict criteria under both CITES and this rule, resulting in restrictions that safeguard against import or export of ivory that could contribute to the illegal trade in ivory or pose a risk to elephant populations. The import and export of ivory is also subject to applicable restrictions under the AfECA, except to the extent allowed under Director's Order No. 210, as amended on May 15, 2014. Our information indicates that these strict controls on the import and export of African elephant ivory will help to ensure that U.S. participation in the ivory trade will not contribute to the illegal killing of elephants.

    For the same reasons that the import and export of raw and worked ivory need to be carefully regulated, the import and export of African elephant sport-hunted trophies must be regulated in a manner that would ensure that the import and export does not contribute to the illegal trade of ivory. The proposed rule would require that the import of all sport-hunted trophies, regardless of the CITES status of the source population, be authorized through the issuance of a threatened species permit under 50 CFR 17.32. Authorizing importation through threatened species enhancement permits would allow us to more carefully evaluate trophy imports in accordance with legal requirements and the conservation needs of the species. The limitation of two trophies per hunter per year would ensure that the importation of African elephant trophies is actually the result of personal, noncommercial sport hunting and would prevent the importation of commercial quantities of ivory.

    Perhaps the biggest change from the current 4(d) rule would be new restrictions on the commercialization of ivory in interstate and foreign commerce. The proposed rule would prohibit the sale or offer for sale of ivory and sport-hunted trophies in interstate or foreign commerce and the delivery, receipt, carrying, transport, or shipment of ivory and sport-hunted trophies in interstate or foreign commerce in the course of a commercial activity. Exceptions would be available for qualifying antiques and for certain items manufactured before the date of the final rule for this rulemaking that contain less than 200 grams of ivory and meet other conditions, while certain commercial activities could also be authorized through a threatened species permit under 50 CFR 17.32. However, the de minimis exception and threatened species permits would not be available for sport-hunted trophies and ivory items that were imported as part of a household move or inheritance. We have determined that items meeting the de minimis exception, including the requirements that the ivory be a fixed component of a larger manufactured item, that the ivory is not raw, that the ivory is not the primary source of value of the item, that the total weight of the ivory is less than 200 grams, and that the manufactured item is not made wholly or primarily of ivory, would minimize the possibility of the ivory contributing to either the global or U.S. markets in illegal ivory.

    The proposed rule, however, would continue to allow certain activities that pose no risk to African elephants. Live elephants and elephant parts or products other than ivory and sport-hunted trophies could continue to be imported into or exported from the United States, sold or offered for sale in interstate or foreign commerce, and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, provided all other requirements under CITES and the Service's general import/export regulations were met. CITES requirements, including findings that must be made before documents can be issued, would continue to ensure that all import and export of live animals and parts or products other than ivory and sport-hunted trophies remain legal and non-detrimental to the survival of the species. There is no information that indicates that import, export, or commercialization of live elephants or non-ivory parts and products as currently regulated under CITES has any negative effect on African elephants or is contributing in any way to the current crisis involving the killing of elephants for their ivory. The new restriction on the taking of live elephants held in captivity within the United States or during transport would help to ensure that animals in captivity receive an appropriate standard of care.

    In addition to this proposed rule being necessary and advisable to provide for the conservation of the species and including appropriate prohibitions from section 9(a)(1) of the ESA, it also is consistent with other efforts to improve elephant conservation. With this rule, the United States would ensure that we have in place comprehensive internal regulatory and enforcement measures to regulate domestic trade in raw and worked ivory, as called for at the 16th meeting of the Conference of the Parties to CITES in March 2013 (see Resolution Conf. 10.10 (Rev. CoP16)). More broadly, the proposed rule would respond to the President's Executive Order of July 1, 2013, calling for all Federal agencies to take action to combat wildlife trafficking in all wildlife and to reduce demand for illegally traded wildlife, both at home and abroad. All of the proposed revisions to the African elephant 4(d) rule would allow us to better regulate the U.S. domestic market and U.S. participation in the global market for African elephant ivory, which we believe will lead to a reduction of the illegal killing of elephants for their ivory.

    Table 1—How Would Proposed Changes to the African Elephant 4(d) Rule Affect Trade in African Elephant Ivory? [This table is only for guidance on proposed revisions to the existing Endangered Species Act 4(d) rule for the African elephant. Please see the proposed rule text for details. All imports and exports must be accompanied by appropriate CITES documents and meet other FWS import/export requirements] What activities are currently
  • allowed/prohibited?
  • What are the proposed changes?
    In 2014, the Service revised Director's Order No. 210 (effective May 15, 2014) and U.S. CITES implementing regulations [50 CFR part 23] (effective June 26, 2014)
  • Both of these actions created new rules for trade in elephant ivory
  • This column describes the contents of the proposed rule in general terms. Please refer to the proposed rule text for details. These provisions will not go into effect until we have considered input received during the public comment period and published a final rule in the Federal Register.
    Import Commercial
  • What's allowed:
  • • No commercial imports allowed
  • Commercial
  • The proposed rule does not include any changes for commercial imports.
  • Noncommercial
  • What's allowed:
  • • Sport-hunted trophies (no limit)
  • • Law enforcement and bona fide scientific specimens
  • • Worked elephant ivory that was legally acquired and removed from the wild prior to February 26, 1976 and has not been sold since February 25, 2014 and is either:
  • ○ Part of a household move or inheritance (see Director's Order No. 210 for details);
  • ○ Part of a musical instrument (see Director's Order No. 210 for details); or
  • ○ Part of a traveling exhibition (see Director's Order No. 210 for details).
  • What's prohibited:
  • • Worked ivory that does not meet the conditions described above.
  • • Raw ivory (except for sport-hunted trophies).
  • Noncommercial
  • The proposed rule includes the following changes for noncommercial imports:
  • • Limits sport-hunted trophies to two per hunter per year.
  • • Removes the requirement that worked elephant ivory has not been sold since February 25, 2014. All other requirements for worked elephant ivory (listed in the previous column) must be met.
  • Export Commercial
  • What's allowed:
  • • CITES pre-Convention worked ivory, including antiques.
  • What's prohibited:
  • • Raw ivory
  • Commercial
  • The proposed rule would further restrict commercial exports to only those items that meet the criteria of the ESA antiques exemption.*
  • Raw ivory remains prohibited regardless of age.
  • Noncommercial
  • What's allowed:
  • • Worked ivory
  • What's prohibited:
  • • Raw ivory
  • Noncommercial
  • The proposed rule would further restrict noncommercial exports to the following categories:
  • • Only those items that meet the criteria of the ESA antiques exemption.*
  • • Worked elephant ivory that was legally acquired and removed from the wild prior to February 26, 1976, and is either:
  • ○ Part of a household move or inheritance;
  • ○ Part of a musical instrument; or
  • ○ Part of a traveling exhibition.
  • • Worked ivory that qualifies as pre-Act
  • • Law enforcement and bona fide scientific specimens.
  • Raw ivory remains prohibited regardless of age.
  • Foreign commerce There are no restrictions on foreign commerce The proposed rule includes the following changes for foreign commerce:
  • • Restricts foreign commerce to:
  • ○ items that meet the criteria of the ESA antiques exemption,* and
  • ○ certain manufactured items that contain a small (de minimis) amount of ivory.
  • • Prohibits foreign commerce in:
  • ○ sport-hunted trophies, and
  • ○ ivory imported/exported as part of a household move or inheritance.
  • Sales across state lines † (interstate commerce) What's allowed:
  • • Ivory lawfully imported prior to the date the African elephant was listed in CITES Appendix I (January 18, 1990)—[seller must demonstrate].
  • • Ivory imported under a CITES pre-Convention certificate—[seller must demonstrate].
  • The proposed rule includes the following changes for interstate commerce:
  • • Further restricts interstate commerce to only:
  • ○ items that meet the criteria of the ESA antiques exemption,* and
  • ○ certain manufactured items that contain a small (de minimis) amount of ivory.**
  • • Prohibits interstate commerce in:
  • ○ ivory imported under the exceptions for household move or inheritance, or for law enforcement or genuine scientific purposes, and
  • ○ sport-hunted trophies.
  • Sales within a state (intrastate commerce) What's allowed:
  • • Ivory lawfully imported prior to the date the African elephant was listed in CITES Appendix I (January 18, 1990)—[seller must demonstrate].
  • • Ivory imported under a CITES pre-Convention certificate—[seller must demonstrate].
  • The proposed rule does not include any changes for intrastate commerce.
    Noncommercial movement † within the United States Noncommercial use, including interstate and intrastate movement within the United States, of legally acquired ivory is allowed The proposed rule does not include any changes for noncommercial movement within the United States. Personal possession Possession and noncommercial use of legally acquired ivory is allowed The proposed rule does not include any changes for personal possession. † See preamble discussion in the section titled Interstate and foreign commerce. * To qualify for the ESA antique exemption an item must meet all of the following criteria [seller/importer/exporter must demonstrate]:  A. It is 100 years or older.  B. It is composed in whole or in part of an ESA-listed species;  C. It has not been repaired or modified with any such species after December 27, 1973; and  D. It is being or was imported through an endangered species “antique port.” Under Director's Order No. 210, as a matter of enforcement discretion, items imported prior to September 22, 1982, and items created in the United States and never imported must comply with elements A, B, and C above, but not element D. ** To qualify for the de minimis exception, manufactured items must meet all of the following criteria: (i) If the item is located within the United States, the ivory was imported into the United States prior to January 18, 1990, or was imported into the United States under a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) pre-Convention certificate with no limitation on its commercial use; (ii) If the item is located outside the United States, the ivory was removed from the wild prior to February 26, 1976; (iii) The ivory is a fixed component or components of a larger manufactured item and is not in its current form the primary source of the value of the item; (iv) The ivory is not raw; (v) The manufactured item is not made wholly or primarily of ivory; (vi) The total weight of the ivory component or components is less than 200 grams; and (vii) The item was manufactured before the effective date of the final rule]. For a discussion of the de minimis exception see the section of the preamble titled Interstate and foreign commerce; for details of the de minimis exception see paragraph (e)(3) in the rule text at the end of this document.
    Required Determinations

    Regulatory Planning and Review: Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is significant because it may raise novel legal or policy issues. 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. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

    A brief assessment to identify the economic costs and benefits associated with this proposed rule follows. The Service has prepared an economic analysis, as part of our review under the National Environmental Policy Act (NEPA), which we will make available for review and comment (see the paragraph in this Required Determinations section on the National Environmental Policy Act). The proposed rule would revise the 4(d) rule, which regulates trade of African elephants (Loxodonta africana), including African elephant parts and products. We are proposing to revise the 4(d) rule to more strictly control U.S. trade in African elephant ivory. Revision of the 4(d) rule as proposed would mean that African elephants are subject to some of the standard provisions for species classified as threatened under the ESA. This means that the taking of live elephants and (with certain exceptions) import, export, and commercial activities in interstate or foreign commerce of African elephant parts and products containing ivory would generally be prohibited without a permit issued under 50 CFR 17.32 for “Scientific purposes, or the enhancement of propagation or survival, or economic hardship, or zoological exhibition, or educational purposes, or incidental taking, or special purposes consistent with the purposes of the [ESA].” There are specific exceptions for certain activities with specimens containing de minimis quantities of ivory; ivory items that meet certain requirements for musical instruments, traveling exhibitions, inherited items, and items that are part of a household move; ivory imported or exported for scientific purposes or law enforcement; certain live elephants; and ivory items that qualify as “pre-Act” or as antiques under the ESA.

    This rule would regulate only African elephants and African elephant ivory. Asian elephants and parts or products from Asian elephants, including ivory, are regulated separately under the ESA. Ivory from other species such as walrus is also regulated separately under the Marine Mammal Protection Act (16 U.S.C. 1361 et seq.). Ivory from extinct species such as mammoths is not regulated under statutes implemented by the Service.

    Impacted markets include those involving U.S. citizens or other persons subject to the jurisdiction of the United States that buy, sell, or otherwise commercialize African elephant ivory products across State lines and those that buy, sell, or otherwise commercialize such specimens in international trade. Examples of products in trade containing African elephant ivory include cue sticks, pool balls, knife handles, gun grips, furniture inlay, jewelry, artwork, and musical instrument parts.

    The market for African elephant products, including ivory, is not large enough to have major data collections or reporting requirements, which results in a limited amount of available data for economic analysis. Some import and export data are available from the Service's Office of Law Enforcement and Division of Management Authority, and from reports produced by other organizations. On the whole, the available data provide a general overview of the African elephant ivory market. Using this information, we can make reasonable assumptions to approximate the potential economic impact of revision of the 4(d) rule for the African elephant. With this proposed rule, we solicit public input on impacts to sales, percentage of revenue impacted, and the number of businesses affected, particularly with regard to interstate and foreign commerce, for which we have the least amount of information, to help quantify these costs and benefits. Please see the Public Comments section at the end of SUPPLEMENTARY INFORMATION for further information about submitting comments.

    Imports. There has been a moratorium on the import of African elephant ivory other than sport-hunted trophies, established under the AfECA and in place since 1989. In recent years, the Service has allowed, as a matter of law enforcement discretion, the import of certain antique African elephant ivory. Director's Order No. 210, issued in February 2014, clarified that we will no longer allow any commercial import of African elephant ivory, regardless of its age. We are proposing to reflect this provision of Director's Order No. 210 in the 4(d) rule (except for antiques, which are exempt from this 4(d) rule, but remain subject to the AfECA moratorium). Import of live African elephants and non-ivory African elephant parts and products would continue to be allowed under the proposed revisions, provided the requirements at 50 CFR parts 13, 14, and 23 are met. Import of African elephant sport-hunted trophies would be limited to two trophies per hunter per year. This may impact about seven hunters, representing about 3 percent to 4 percent of hunters, annually.

    Exports. Under the current 4(d) rule, raw ivory may not be exported from the United States for commercial purposes under any circumstances. In addition, export of raw ivory from the United States is prohibited under the AfECA. Therefore, the revisions to the 4(d) rule would have no impact on exports of raw ivory. Revision of the 4(d) rule as proposed would mean that export of worked African elephant ivory would be prohibited without an ESA permit issued under 50 CFR 17.32, except for specimens that qualify as “pre-Act” or as ESA antiques and certain musical instruments; items in a traveling exhibition; items that are part of a household move or inheritance; items exported for scientific purposes; and items exported for law enforcement purposes that meet specific conditions and, therefore, may be exported without an ESA permit. Export of live African elephants and non-ivory products made from African elephants would continue to be allowed provided the requirements at 50 CFR parts 13, 14, and 23 are met.

    From 2007 to 2011, the total declared value of worked African elephant ivory exported from the United States varied widely from $32.1 million to $175.7 million. The declared value of items containing African elephant ivory that were less than 100 years old (and, therefore, could not qualify as ESA antiques) ranged from $607,000 to $3.7 million annually during the same time period. As this rule would no longer permit the commercial export of non-antique ivory, we expect based on the information currently available that, on average, commercial export of worked ivory would decrease by about 2 percent annually.

    Domestic and Foreign Commerce. The proposed rule would prohibit certain commercial activities such as sale in interstate or foreign commerce of African elephant ivory and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity (except for qualifying ESA antiques and certain manufactured items containing de minimis amounts of ivory) without an ESA permit issued under 50 CFR 17.32. Otherwise, commercial activities in interstate and foreign commerce with live African elephants and African elephant parts and products other than ivory would continue to be allowed under the proposed revisions to the 4(d) rule. While revisions to the 4(d) rule would generally result in prohibitions on sale or offer for sale in interstate or foreign commerce as well as prohibitions on delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of both raw and worked African elephant ivory, it would not have an impact on intrastate commerce. Businesses would not be prohibited by the 4(d) rule from selling raw or worked ivory within the State in which they are located. (There are, however, restrictions under our CITES regulations at 50 CFR 23.55 for intrastate sale of elephant ivory.) As noted earlier, available data provide only a general overview of the African elephant ivory market. Assuming that the domestic market is similar to the export market, then non-antique worked ivory domestic sales would also decrease about 2 percent annually under the proposed rule. We request information from the public about the potential impact to the domestic market. Because we are proposing to allow domestic and foreign commerce commercial activities with certain items containing de minimis amounts of ivory, and many of these items would be precluded from export, it is possible that an even smaller percentage of the domestic market would be impacted compared to the export market. Certain commercial activities such as sale in interstate or foreign commerce with raw ivory and non-antique worked ivory, with the exception of those items containing de minimis amounts of worked ivory mentioned above, would no longer be permitted.

    Revising the 4(d) rule for African elephant, as proposed here, would improve domestic regulation of the U.S. market as well as foreign markets where commercial activities involving elephant ivory are conducted by U.S. citizens and facilitate enforcement efforts within the United States. We are proposing to take this action to increase protection for African elephants in response to the alarming rise in poaching of African elephants, which is fueling the rapidly expanding illegal trade in ivory. As noted in the preamble to this proposed rule, the United States continues to play a role as a destination and transit country for illegally traded elephant ivory. Increased control of the U.S. domestic market and foreign markets where commercial activities involving elephant ivory are conducted by U.S. citizens would benefit the conservation of the African elephant.

    Regulatory Flexibility Act: Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions) (5 U.S.C. 601 et seq.). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule would not have a significant economic impact on a substantial number of small entities. Thus, for a regulatory flexibility analysis to be required, impacts must exceed a threshold for “significant impact” and a threshold for a “substantial number of small entities.” See 5 U.S.C. 605(b). SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities.

    The U.S. Small Business Administration (SBA) defines a small business as one with annual revenue or employment that meets or is below an established size standard. To assess the effects of the rule on small entities, we focus on businesses that buy or sell elephant ivory. Businesses produce a variety of products from elephant ivory including cue sticks, pool balls, knife handles, gun grips, furniture inlay, jewelry, and instrument parts. Depending on the type of product produced, these businesses could be included in a number of different industries, including (1) Musical Instrument Manufacturing (North American Industry Classification System (NAICS) 339992), where small businesses have less than $10.0 million revenue; (2) Sporting and Recreational Goods and Supplies Merchant Wholesalers (NAICS 423910), where small businesses have fewer than 100 employees; (3) All Other Miscellaneous Wood Product Manufacturing (NAICS 321999), where small businesses have fewer than 500 employees; (4) Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing (NAICS 332215), where small businesses have fewer than 500 employees; (5) Jewelry and Silverware Manufacturing, (NAICS 339910), where small businesses have fewer than 500 employees; (6) Used Merchandise Stores (NAICS 453310), where small businesses have less than $7.5 million in revenue; and (7) Art Dealers (NAICS 453920), where small businesses have less than $7.5 million in revenue. Table 2 describes the number of businesses within each industry and the estimated percentage of small businesses. The U.S. Economic Census does not capture the detail necessary to determine the number of small businesses that are engaged in commerce with African elephant ivory products within these industries. Based on the distribution of small businesses with these industries as shown in Table 2, we expect that the majority of the entities involved with trade in African elephant ivory would be considered small as defined by the SBA.

    Table 2—Distribution of Businesses Within Affected Industries NAICS Code Description Number of
  • businesses
  • Percentage
  • of small
  • businesses
  • 339992 Musical instrument manufacturing 597 73 423910 Sporting and recreational goods and supplies merchant wholesalers 5,953 97 321999 All other miscellaneous wood product manufacturing 1,763 100 332215 Metal kitchen cookware, utensil, cutlery, and flatware (except precious) manufacturing 188 99 339910 Jewelry and silverware manufacturing 2,119 100 453310 Used merchandise stores 19,793 74 453920 Art dealers 4,937 95 Source: U.S. Census Bureau, 2012 County Business Patterns.

    The impact on individual businesses is dependent on the percentage of interstate and export sales that involve non-antique African elephant ivory that would not fall under the de minimis exception. That is, the impact depends on where businesses are located, where their customers are located, and the kinds of items containing ivory that they sell. Information on business profiles to determine the percent of revenues affected by the rule is currently unavailable. Overall, we estimate that worked ivory exports would decrease about $2.1 million annually, which represents about 2 percent of the total declared value of worked ivory exported from 2007 to 2011. We also expect that domestic sales would decrease by about 2 percent annually. Because we are proposing to allow domestic commercial activities with certain items containing de minimis amounts of ivory, and many of these items would be precluded from export, it is possible that an even smaller percentage of the domestic market would be impacted compared to the export market.

    Based on the available information, we do not expect these changes to have a substantial impact on small entities within the five affected industries listed above. We, therefore, certify that this proposed rule would not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). A Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required.

    This proposed rule would create no substantial fee or paperwork changes in the permitting process. The regulatory changes would require issuance of ESA permits for import of sport-hunted African elephant trophies. We estimate that we would issue 300 ESA permits per year for these sport-hunted trophies, with a fee of $100 per permit. These changes are not major in scope and would create only a modest financial or paperwork burden on the affected members of the general public. The authority to regulate activities involving ESA-listed species already exists under the ESA and is carried out through regulations contained in 50 CFR part 17.

    Small Business Regulatory Enforcement Fairness Act: This proposed rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

    a. Would not have an annual effect on the economy of $100 million or more. This proposed rule revises the 4(d) rule for African elephant, which makes the African elephant subject to the same of the provisions applied to other threatened species not covered by a 4(d) rule, with certain exceptions. This proposed rule would not have a negative effect on this part of the economy. It would affect all importers, exporters, re-exporters, and domestic and certain traders in foreign commerce of African elephant ivory equally, and the impacts would be evenly spread among all businesses, whether large or small. There is not a disproportionate impact for small or large businesses.

    b. Would not cause a major increase in costs or prices for consumers; individual industries; Federal, State, tribal, or local government agencies; or geographic regions.

    c. Would 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: Under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

    a. This proposed rule would not significantly or uniquely affect small governments. A Small Government Agency Plan is not required. The proposed rule imposes no unfunded mandates. Therefore, this proposed rule would have no effect on small governments' responsibilities.

    b. This proposed rule would not produce a Federal requirement of $100 million or greater in any year and is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

    Takings: Under Executive Order 12630, this proposed rule does not have significant takings implications. While certain activities that were previously unregulated would now be regulated, possession and other activities with African elephant ivory such as sale in intrastate commerce would remain unregulated. A takings implication assessment is not required.

    Federalism: These proposed revisions to part 17 do not contain significant Federalism implications. A federalism summary impact statement under Executive Order 13132 is not required.

    Civil Justice Reform: Under Executive Order 12988, the Office of the Solicitor has determined that this proposed rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

    Paperwork Reduction Act: This proposed rule does not contain new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). OMB has reviewed and approved the information collection requirements associated with applications and reporting for CITES and ESA permits and assigned OMB Control No. 1018-0093, which expires May 31, 2017. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

    National Environmental Policy Act (NEPA): This proposed rule is being analyzed under the criteria of the National Environmental Policy Act, the Department of the Interior procedures for compliance with NEPA (Departmental Manual (DM) and 43 CFR part 46), and Council on Environmental Quality regulations for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508). We have prepared a draft environmental assessment to determine whether this rule will have a significant impact on the quality of the human environment under the National Environmental Policy Act of 1969. The draft environmental assessment is available online at http://www.regulations.gov at Docket Number FWS-HQ-IA-2013-0091.

    Government-to-Government Relationship with Tribes: The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required. Individual tribal members must meet the same regulatory requirements as other individuals who trade in African elephants, including African elephant parts and products.

    Energy Supply, Distribution, or Use: Executive Order 13211 pertains to regulations that significantly affect energy supply, distribution, or use. This proposed rule would revise the current regulations in 50 CFR part 17 regarding trade in African elephants and African elephant parts and products. This proposed rule would not significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

    Clarity of the Rule: We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, please send us comments by one of the methods listed under ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    Public Comments

    We are seeking comments on the impact of the provisions in this proposed rule on the affected public. You may submit your comments and materials concerning this proposed rule by one of the methods listed under ADDRESSES. We will not accept comments sent by email or fax or to an address not listed under ADDRESSES.

    We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your written comments, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

    Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays, at the U.S. Fish and Wildlife Service; Division of Management Authority; 5275 Leesburg Pike; Falls Church, VA 22041; telephone, (703) 358-2093.

    References Cited

    A list of references cited is available online at http://www.regulations.gov at Docket Number FWS-HQ-IA-2013-0091.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Proposed Regulation Promulgation

    For the reasons given in the preamble, we propose to amend title 50, chapter I, subchapter B of the Code of Federal Regulations as follows:

    PART 17—[AMENDED] 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.

    2. Section 17.40 is amended by revising paragraph (e) to read as follows:
    § 17.40 Special rules—mammals.

    (e) African elephant (Loxodonta africana). This paragraph (e) applies to any specimen of the species Loxodonta africana whether live or dead, including any part or product thereof. Except as provided in paragraphs (e)(2) through (9) of this section, all of the prohibitions and exceptions in §§ 17.31 and 17.32 apply to the African elephant. Persons seeking to benefit from the exceptions provided in this paragraph (e) must demonstrate that they meet the criteria to qualify for the exceptions.

    (1) Definitions. In this paragraph (e), antique means any item that meets all four criteria under section 10(h) of the Endangered Species Act (16 U.S.C. 1539(h)). Ivory means any African elephant tusk and any piece of an African elephant tusk. Raw ivory means any African elephant tusk, and any piece thereof, the surface of which, polished or unpolished, is unaltered or minimally carved. Worked ivory means any African elephant tusk, and any piece thereof, that is not raw ivory.

    (2) Live animals and parts and products other than ivory and sport-hunted trophies. Live African elephants and African elephant parts and products other than ivory and sport-hunted trophies may be imported into or exported from the United States; sold or offered for sale in interstate or foreign commerce; and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity without a threatened species permit issued under § 17.32, provided the requirements in 50 CFR parts 13, 14, and 23 have been met.

    (3) Interstate and foreign commerce of ivory. Except for antiques and certain manufactured items containing de minimis quantities of ivory, sale or offer for sale of ivory in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity is prohibited. Except as provided in paragraphs (e)(5)(iii) and (e)(6) through (8) of this section, manufactured items containing de minimis quantities of ivory may be sold or offered for sale in interstate or foreign commerce and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity without a threatened species permit issued under § 17.32, provided they meet all of the following criteria:

    (i) If the item is located within the United States, the ivory was imported into the United States prior to January 18, 1990, or was imported into the United States under a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) pre-Convention certificate with no limitation on its commercial use;

    (ii) If the item is located outside the United States, the ivory was removed from the wild prior to February 26, 1976;

    (iii) The ivory is a fixed component or components of a larger manufactured item and is not in its current form the primary source of the value of the item;

    (iv) The ivory is not raw;

    (v) The manufactured item is not made wholly or primarily of ivory;

    (vi) The total weight of the ivory component or components is less than 200 grams; and

    (vii) The item was manufactured before [EFFECTIVE DATE OF THE FINAL RULE].

    (4) Import/export of raw ivory. Except as provided in paragraphs (e)(6) through (9) of this section, raw ivory may not be imported into or exported from the United States.

    (5) Import/export of worked ivory. Except as provided in paragraphs (e)(6) through (9) of this section, worked ivory may not be imported into or exported from the United States unless it is contained in a musical instrument, or is part of a traveling exhibition, household move, or inheritance, and meets the following criteria:

    (i) Musical instrument. Musical instruments that contain worked ivory may be imported into and exported from the United States without a threatened species permit issued under § 17.32 provided:

    (A) The ivory was legally acquired prior to February 26, 1976;

    (B) The instrument containing worked ivory is accompanied by a valid CITES musical instrument certificate or equivalent CITES document;

    (C) The instrument is securely marked or uniquely identified so that authorities can verify that the certificate corresponds to the musical instrument in question; and

    (D) The instrument is not sold, traded, or otherwise disposed of while outside the certificate holder's country of usual residence.

    (ii) Traveling exhibition. Worked ivory that is part of a traveling exhibition may be imported into and exported from the United States without a threatened species permit issued under § 17.32 provided:

    (A) The ivory was legally acquired prior to February 26, 1976;

    (B) The item containing worked ivory is accompanied by a valid CITES traveling exhibition certificate (See the requirements for traveling exhibition certificates at 50 CFR 23.49);

    (C) The item containing ivory is securely marked or uniquely identified so that authorities can verify that the certificate corresponds to the item in question; and

    (D) The item containing worked ivory is not sold, traded, or otherwise disposed of while outside the certificate holder's country of usual residence.

    (iii) Household move or inheritance. Worked ivory may be imported into or exported from the United States without a threatened species permit issued under § 17.32 for personal use as part of a household move or as part of an inheritance if the ivory was legally acquired prior to February 26, 1976, and the item is accompanied by a valid CITES pre-Convention certificate. It is unlawful to sell or offer for sale in interstate or foreign commerce or to deliver, receive, carry, transport, or ship in interstate or foreign commerce and in the course of a commercial activity any African elephant ivory imported into the United States as part of a household move or inheritance. The exception in paragraph (e)(3) of this section regarding manufactured items containing de minimis quantities of ivory does not apply to items imported or exported under this paragraph (e)(5)(iii) as part of a household move or inheritance.

    (6) Sport-hunted trophies. (i) African elephant sport-hunted trophies may be imported into the United States provided:

    (A) The trophy was legally taken in an African elephant range country that declared an ivory export quota to the CITES Secretariat for the year in which the trophy animal was killed;

    (B) A determination is made that the killing of the trophy animal will enhance the survival of the species and the trophy is accompanied by a threatened species permit issued under § 17.32;

    (C) The trophy is legibly marked in accordance with 50 CFR part 23;

    (D) The requirements in 50 CFR parts 13, 14, and 23 have been met; and

    (E) No more than two African elephant sport-hunted trophies are imported by any hunter in a calendar year.

    (ii) It is unlawful to sell or offer for sale in interstate or foreign commerce or to deliver, receive, carry, transport, or ship in interstate or foreign commerce and in the course of a commercial activity any sport-hunted African elephant trophy. The exception in paragraph (e)(3) of this section regarding manufactured items containing de minimis quantities of ivory does not apply to ivory imported or exported under this paragraph (e)(6) as part of a sport-hunted trophy.

    (iii) Except as provided in paragraph (e)(9) of this section, raw ivory that was imported as part of a sport-hunted trophy may not be exported from the United States. Except as provided in paragraphs (e)(5), (7), (8), and (9) of this section, worked ivory imported as a sport-hunted trophy may not be exported from the United States. Parts of a sport-hunted trophy other than ivory may be exported from the United States without a threatened species permit issued under § 17.32 of this part, provided the requirements of 50 CFR parts 13, 14, and 23 have been met.

    (7) Import/export of ivory for law enforcement purposes. Raw or worked ivory may be imported into and worked ivory may be exported from the United States by an employee or agent of a Federal, State, or tribal government agency for law enforcement purposes, without a threatened species permit issued under § 17.32, provided the requirements of 50 CFR parts 13, 14, and 23 have been met. It is unlawful to sell or offer for sale in interstate or foreign commerce and to deliver, receive, carry, transport, or ship in interstate or foreign commerce and in the course of a commercial activity any African elephant ivory that was imported into or exported from the United States for law enforcement purposes. The exception in paragraph (e)(3) of this section regarding manufactured items containing de minimis quantities of ivory does not apply to ivory imported or exported under this paragraph (e)(7) for law enforcement purposes.

    (8) Import/export of ivory for genuine scientific purposes. (i) Raw or worked ivory may be imported into and worked ivory may be exported from the United States for genuine scientific purposes that will contribute to the conservation of the African elephant, provided:

    (A) It is accompanied by a threatened species permit issued under § 17.32; and

    (B) The requirements of 50 CFR parts 13, 14, and 23 have been met.

    (ii) It is unlawful to sell or offer for sale in interstate or foreign commerce and to deliver, receive, carry, transport, or ship in interstate or foreign commerce and in the course of a commercial activity any African elephant ivory that was imported into or exported from the United States for genuine scientific purposes. The exception in paragraph (e)(3) of this section regarding manufactured items containing de minimis quantities of ivory does not apply to ivory imported or exported under this paragraph (e)(8) for genuine scientific purposes.

    (9) Antique ivory. Antiques (as defined in paragraph (e)(1) of this section) are not subject to the provisions of this rule. Antiques containing or consisting of ivory may therefore be imported into or exported from the United States without a threatened species permit issued under § 17.32, provided the requirements of 50 CFR parts 13, 14, and 23 have been met. Also, the provisions and prohibitions under the African Elephant Conservation Act (16 U.S.C. 4201 et. seq.) apply, regardless of the age of the item. Antiques that consist of or contain raw or worked ivory may similarly be sold or offered for sale in interstate or foreign commerce and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity without a threatened species permit issued under § 17.32.

    Michael Bean, Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
    [FR Doc. 2015-18487 Filed 7-27-15; 8:45 am] BILLING CODE 4310-55-P
    80 145 Wednesday, July 29, 2015 Notices DEPARTMENT OF AGRICULTURE Forest Service Siskiyou County Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Siskiyou County Resource Advisory Committee (RAC) will meet in Yreka, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act.

    DATES:

    The meeting will be held August 24, 2015, at 6:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Klamath National Forest (NF) Supervisor's Office, Conference Room, 1312 Fairlane Road, Yreka, California.

    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 Klamath NF Supervior's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Natalie Stovall, RAC Coordinator, by phone at 530-841-4411 or via email at [email protected]

    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 purpose of the meeting is:

    1. Project update and financial status;

    2. Identifying a Chair for the RAC;

    3. Review current RAC committee charter;

    4. Recruitment for new committee members; and

    5. Time frames for new proposals submissions.

    6. Approval of funding for RAC administration and travel for RAC Committee members.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by August 17, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Natalie Stovall RAC Corrdinator, 1711 S. Main Street, Yreka, California 96097; by email to [email protected] or via facsimile to 530-841-4571.

    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: July 13, 2015. Patricia A. Gratham, Forest Supervisor.
    [FR Doc. 2015-18560 Filed 7-28-15; 8:45 am] BILLING CODE 3411-15-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the West Virginia Advisory Committee 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 public meeting of the West Virginia Advisory Committee to the Commission will convene at 9:00 a.m. (EDT) on Friday, August 14, 2015 in the House Government Organization Committee Room E-215 in Building 1 of the West Virginia State Capitol Complex, located at 1900 Kanawha Blvd., East, Charleston, WV 25305. The purpose of the meeting is to hear from government officials, advocates, and other experts as well as the public on the topic of the treatment by the West Virginia criminal justice system and mental health court of persons with mental health disabilities, including persons who are intellectually and developmentally disabled. In addition, the Committee will discuss the next steps that should be planned for completing the Committee's mental health project.

    For persons who plan to attend the meeting and are hearing-impaired or require other accommodations, please contact Evelyn Bohor at [email protected] at the Eastern Regional Office at least 10 working days before the scheduled meeting date with your request.

    Time will be set aside after the experts have completed their presentations so that members of the public may address the Committee. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, September 14, 2015. 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 about the public meeting may contact the Eastern Regional Office by phone at (202) 376-7533 or email to [email protected].

    Records and documents discussed during the meeting will be available for public viewing as they become available by clicking on the “Meeting Details” and “Documents” links at the following link: https://database.faca.gov/committee/meetings.aspx?cid=281. 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 meeting. 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 number, email or street address.

    Agenda
    Welcome and Introductions Tara Martinez, Chair Discuss Administrative Matters, Including Next Steps for Completing the Committee's Project